Aspen Neuroscience files for IPO

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As confidentially submitted to the Securities and Exchange Commission on June 9, 2026. This draft registration statement has not been publicly filed with the Securities and Exchange Commission and all information herein remains strictly confidential.

As filed with the Securities and Exchange Commission on October 9, 2026

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Subject to Completion, Dated , October 9, 2026

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Prior to this offering, there has been no public market for our common stock. We intend to apply have applied to list our common stock on the Nasdaq Global Select Market under the symbol ASPE, and this offering is contingent upon obtaining approval for such listing.

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Investing in our common stock involves a high degree of risk. See the section titled Risk Factors beginning on page 15 14 to read about factors you should consider before deciding to invest in shares of our common stock.

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Prospectus summary 28 changes

This summary highlights selected information contained elsewhere in this prospectus and is qualified in its entirety by the more detailed information and financial statements included elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our common stock. You should carefully read this entire prospectus, including the information in the sections titled Risk Factors, Management s Discussion and Analysis of Financial Condition and Results of Operations and Special Note Regarding Forward-Looking Statements, and our financial statements and related notes included elsewhere in this prospectus, before making an investment decision. Unless the context requires otherwise, references in this prospectus to Aspen, the Company, we, us, and our refer to Aspen Neuroscience, Inc. Overview Aspen Neuroscience, Inc. is a leading, clinical-stage regenerative medicine biotechnology company focused on developing autologous induced-pluripotent stem cell (iPSC)-derived therapies to address neurodegenerative diseases with high unmet medical need. Our lead product candidate, sasineprocel, is an investigational single-dose, autologous iPSC-based cell therapy being evaluated for the treatment of Parkinson s disease (PD). We believe sasineprocel has the potential to be disease-modifying by primarily replacing a patient s lost dopaminergic (DA) neurons with dopaminergic neuron precursor cells (DANPCs). In an ongoing Phase 1/2a ASPIRO clinical trial of sasineprocel in mid-stage to moderately advanced sporadic PD, patients have experienced, what we believe to be, sustained and clinically meaningful improvements in motor, quality of life, and non-motor symptoms as measured by comparison to clinically meaningful change benchmarks. Based on these findings, we believe sasineprocel has the potential to improve upon the current standard of care in PD and address the significant unmet need in PD for a disease-modifying therapy that may slow or halt the progression of this devastating disease.

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The current standard of care is palliative dopamine replacement therapy (DRT), including levodopa and dopamine agonists, which addresses motor symptoms but does not replace lost DA neurons, nor does it slow continued neuronal degeneration. DRT inadequately addresses non-motor symptoms, decreases in effectiveness over time, and is associated with side effects that can significantly impact patient quality of life. As DRT loses its effectiveness or as its side effects become intolerable, advanced therapies, such as deep brain stimulation (DBS), are considered. While DBS can be effective in addressing certain motor symptoms of PD, it has not been shown to slow disease progression in mid-stage to moderately advanced PD patients and can potentially worsen cognition, gait, speech and other axial symptoms. DBS has other drawbacks as well, including frequent long delays in access and optimization, and multiple invasive surgeries with permanent implanted hardware, which includes risks such as hemorrhage, infection, and device failure. In contrast to DRT and DBS, cell replacement therapy holds significant promise as an approach to restore and replace lost dopamine neurons and the neural circuitry necessary for normal motor and non-motor function. We believe our cell replacement approach represents a promising therapy that could provide long-term benefits from a single administration without the need for permanently implanted hardware.

Allogeneic approaches in development for PD can require one year or more of immunosuppressive therapy post-treatment, which is associated with increased risks of infection, organ toxicity, and metabolic complications. In contrast, autologous cell therapies are derived from a patient s own cells, which reduces the risk of immune rejection after transplantation. For example, Our clinical trial of sasineprocel has not required any immunosuppression post-administration and is designed to support the formation of functional synaptic connections and neural circuitry in without the absence of need for immune suppression. In a third-party preclinical study in non-human primate (NHP) models of PD, autologous DA progenitor cell transplantation survived without immunosuppression and integrated more robustly and produced more sustained motor improvements than allogeneic transplants. without immunosuppression. Moreover, our autologous iPSC approach is designed to require minimal cell expansion, of cells, which mitigates may reduce the risk of opportunity for genomic instability abnormalities to arise and accumulating genetic mutations, which confer a selective or growth advantage in for cells harboring growth-promoting abnormalities to become selectively enriched during extended culture. While this is designed to be a one-time therapy, the autologous nature of the product could allow for redosing, if valuable over a patient s multi-year course. We believe our autologous cell replacement strategy presents a significant advantage over both current standard-of-care therapies and allogeneic cell therapies in development for PD, and has the potential to deliver a tolerable, disease-modifying treatment with durable, long-term effectiveness.

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As of April 7, August 18, 2026, the data cutoff date, 15 patients had been dosed, with seven participants receiving a low dose and eight participants receiving a high dose. Sasineprocel was observed to be generally well-tolerated with the majority of reported adverse events being mild to moderate. Among the patients dosed, 58 72 treatment-emergent adverse events (TEAEs) were reported. There was no evidence of graft-induced dyskinesias or graft rejection, and no clinically significant hemorrhages were observed post-operatively. As sasineprocel is autologous, with no requirement for immunosuppression, there were no immunosuppression-related events. Only one TEAE, myoclonus (sudden, uncontrollable muscle movement), was considered possibly related to sasineprocel, with sertraline, a selective serotonin reuptake inhibitor, identified as a co-suspect medication. One participant had two serious adverse events related to the surgical procedure. The most commonly reported TEAEs, defined as occurring in 10% or more of patients, were related to the surgery. See Business Our Pipeline Lead Program: Sasineprocel for PD for additional information regarding the safety profile observed in the ASPIRO trial. As of the data cutoff date, all 12 patients from the first three cohorts had at least one six-month or later follow up evaluation.

We assessed clinical efficacy outcomes every six months after administration of sasineprocel. We observed improvements across several secondary and exploratory endpoints, including changes in Good On Time and Movement Disorder Society Sponsored Revision of the Unified Parkinson s Disease Rating Scale (MDS-UPDRS) Part III OFF. Consistent with these motor improvements, we also observed improvements in activities of daily living and quality of life measures assessed by MDS-UPDRS Part II ON, and Parkinson s Disease Questionnaire (PDQ-39) scores, as summarized below. Certain of the secondary endpoints used in this trial, including Good On Time and MDS-UPDRS Part III OFF, are validated registrational endpoints used in previous PD registrational clinical trials. The mean improvements at 18 months in both cohorts and 24 months for the low dose cohort for Good On Time and MDS-UPDRS Part III OFF scores in both cohorts were above clinically meaningful change benchmarks. The mean PDQ-39 and MDS-UPDRS Part II ON scores improved above clinically meaningful change benchmarks in the low dose cohort at 18 and 24 months and were stable in the high dose cohort at 18 months. Fluorodopa ( 18 FDOPA) positron emission tomography (PET) imaging is also being used to evaluate the engraftment of cells. 18 FDOPA PET imaging showed elevated 18 FDOPA uptake values at 6, six, 12, and 18 months following sasineprocel administration compared to baseline, which is evidence of the survival, viability, and integration of transplanted iPSCs. Clinically meaningful change benchmarks are reviewed on an ongoing basis during the trial and reflect management s belief based on a review of published literature, regulatory agency guidelines and precedent in PD clinical research, and discussions with key opinion leaders in the field. The benchmarks have not been discussed with the U.S. Food and Drug Administration ( FDA) or any other government regulatory authority, and have not been independently validated by any third parties.

Additionally, the ASPIRO trial is exploring changes in DA medication as measured by levodopa equivalent daily dose (LEDD). As of the LEDD data cutoff date, of April 10, 2026, in the low dose cohort, two, three, three, and three patients showed a reduction in LEDD at six, 12, and 18 and 24 months, respectively, and one patient experienced an LEDD increase at 18 and 24 months. In the high dose cohort, at six months, three out of eight patients showed an LEDD reduction and one patient showed an LEDD increase; at 12 months, two out of four patients showed an LEDD reduction and one patient showed an LEDD increase; at 18 months, two three out of four patients showed an LEDD reduction and two one showed an LEDD increase.

Figure 1. Sustained improvements observed across multiple validated PD endpoints. Data summarized above is as of April 7, 2026, except LEDD data is summarized as of April 10, August 18, 2026. A decrease (negative number) compared to baseline is an improvement for MDS-UPDRS scores and PDQ-39. The numbers in parentheses represent standard deviations. Mean changes in data summarized above are driven by totality of data across patients and not driven by a limited number of patients exhibiting significantly better-than-average improvements. *For the four high dose patients for whom data was available at the 12-month and 18-month assessments, the baseline values for Good On Time (hours) Hauser Diary, Off Time (hours) Hauser Diary, MDS-UPDRS Part III OFF score, MDS-UPDRS Part II ON score, and PDQ-39 were: 11.7 (0.9), 4.3 (0.9), 44.0 (4.2), 9.5 (9.3), 16.1 (15.6), respectively. For the three low dose patients in Cohort 4, no data is yet available because six months have not elapsed since dosing for all three patients.

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Sasineprocel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for the treatment of levodopa-responsive PD, and Fast Track designation from the U.S. Food and Drug Administration FDA for the treatment of PD to improve motor function. RMAT or Fast Track designation does not ensure a faster development or regulatory review or approval process and does not increase the likelihood that sasineprocel will receive regulatory approval. We anticipate that sasineprocel would be regulated as a combination product by the FDA because it is designed to be administered through drug delivery devices. See the section titled Risk Factors RMAT and Fast Track designation by the FDA for sasineprocel, and other expedited designations if granted in the future, may not lead to a faster development or regulatory review or approval process, and do not increase the likelihood that sasineprocel or any other product candidate which may receive such designations will receive regulatory approval for more information. We expect to report further long-term data from the ASPIRO trial in . the first half of 2028. We have begun enrolling patients and are preparing to initiate dosing a new cohort in the Phase 1/2a ASPIRO trial to evaluate sasineprocel in patients with genetic PD. We anticipate initiating biopsy collection for the Phase 3 trial in . by the end of 2026. Following feedback from the FDA, we anticipate dosing patients in the Phase 3 trial in . the second half of 2027. In addition, we plan to dose a single cohort of approximately three to six patients with genetic PD in the ASPIRO trial. Pending results from this cohort, we intend to include all patients with PD (including both sporadic and genetic PD) in our Phase 3 program.

We are also developing a microglia program initially targeting pediatric leukodystrophies, a group of rare, genetically defined neurological disorders that primarily affect the white matter of the CNS. Our approach is designed to generate autologous, gene-corrected microglia precursor cells derived from patient-derived iPSCs. We utilize targeted genome editing approaches to address disease-associated genetic variants. These gene-corrected cells are then differentiated into microglia precursor cells intended for administration to the CNS, where they are designed to engraft and replace dysfunctional microglia and support the restoration of key microglial functions within the CNS. We plan expect to initiate Investigational New Drug application (IND)-enabling studies in . the second half of 2027.

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To manufacture sasineprocel, dermal fibroblast cells are generated from a PD patient via a minimally invasive skin biopsy (3mm), expanded, and reprogrammed into iPSCs using defined transcription factors (Yamanaka factors). These iPSCs undergo rigorous characterization to confirm sterility, identity, purity and pluripotency, and are subsequently differentiated into DANPCs using our proprietary processes. The final product consists primarily of DANPCs with defined levels of supporting neural progenitor cell types, and is cryopreserved and released based on established specifications for cell concentration, purity, identity, and potency before shipment for patient administration. We are reliant on a number of licenses from third parties for our manufacturing platform, as it relates to sasineprocel, including from iPS Academia Japan, Inc. and Sumitomo Pharma Co. Ltd. for transcription factors and reprogramming methods, the Scripps Research Institute for a specific cell characterization assay, and Cell X Technologies, Inc. (Cell X) and Cleveland Clinic Foundation (CCF) for automation. See Business Licensing and Collaboration Agreements for additional information.

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Damien McDevitt, Ph.D., our Chief Executive Officer, previously served as Chief Executive Officer of Akcea Therapeutics, a rare diseases company, prior to its acquisition by Ionis Pharmaceuticals in 2020, and held several leadership roles at Ionis Pharmaceuticals, Acadia Pharmaceuticals, and GlaxoSmithKline Pharmaceuticals. Dr. McDevitt was involved in the commercialization, late-stage development or in-licensing of the following approved products: TEGSEDI (inotersen) for hereditary transthyretin-mediated amyloidosis, WAYLIVRA (volanesorsen) for familial chylomicronemia syndrome (approved in the European Union) and DAYBUE (trofinetide) for Rett syndrome. Revati Shreeniwas, M.D., our Chief Medical Officer, previously served in senior clinical roles at several companies and has previously worked on Phase 3 trials and the New Drug Application submission of RYTARY (carbidopa/levodopa) for PD and has deep experience in CNS and other therapeutic areas. Dr. Shreeniwas has a proven track record of working on programs from pre-IND through Phase 3 and registration. Lisa Johnson-Pratt, M.D., our Sasineprocel Development Lead and Chief Commercial Officer, has successfully led programs across the entire product life cycle with leadership roles in medical affairs, clinical development, product development, portfolio planning and new product strategy. Dr. Johnson-Pratt was involved in the launch of GARDASIL (human papillomavirus 9-valent vaccine, recombinant), IMITREX (sumatriptan) and MAXALT (rizatriptan benzoate), and new indication launches of SINGULAIR (montelukast sodium) and COZAAR (losartan potassium), and led new product strategy for BLENREP (belantamab mafodotin-blmf), WAINUA (eplontersen), and TRYNGOLZA (olezarsen). Our scientific co-founder and Senior Vice President of R&D, Andr s Bratt-Leal, Ph.D., previously trained in Dr. Loring s laboratory, where he played a central role in developing the core technology underlying our DA neuron production and led our preclinical development efforts for autologous cell-based therapy for PD.

The Executive Chairman of our Board of Directors, Faheem Hasnain, is the Co-Founder, Chairman and Chief Executive Officer of Gossamer Bio. Mr. Hasnain previously served as President, Chief Executive Officer and Director of Receptos, which was acquired by Celgene in 2015. He is joined by a distinguished group of Board members who bring additional operational, scientific, financial and strategic expertise. Since our inception, we have raised approximately $347 million from a syndicate of leading life sciences investors and organizations, including OrbiMed, ARCH Venture Partners, Frazier Life Sciences, Medical Excellence Capital, and Kite, a Gilead Company, as well as support from the California Institute for Regenerative Medicine (CIRM). We believe our investor base reflects confidence in our scientific approach, platform capabilities and development strategy. Prospective investors, however, should not rely on the investment decisions of our existing investors, as those investors may have different risk tolerances and may have acquired their shares at prices lower than the price to public investors in this offering.

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Build scalable, autologous automated autologous cell manufacturing to support potential commercialization in North America (United States and Canada) with plans in the future to expand globally.

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Our financial condition raises substantial doubt as to our ability to continue as a going concern.

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We currently depend on the success of sasineprocel, which is our lead product candidate. If we are unable to advance sasineprocel in clinical development, obtain regulatory approval for and ultimately commercialize sasineprocel or experience significant delays in doing so, our business, financial condition, results of operations and prospects will be materially and adversely affected.

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We rely on third parties for certain manufacturing systems, materials and components for our product candidates and expect to continue to do so for the foreseeable future. This reliance on third parties increases the risk that we will not have be able to manufacture sufficient quantities of our products or such quantities at an acceptable cost, which could delay, prevent, or impair, our development or commercialization efforts.

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We may take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act of 1933, as amended (the Securities Act). However, if certain events occur prior to the end of such five-year period, including if we become a large accelerated filer as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the Exchange Act) , our annual gross revenues exceed $1.235 billion, or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

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In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. We have elected to avail ourselves of this exemption and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, our consolidated financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act.

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The number of shares of our common stock to be outstanding after this offering is based on 188,521,124 188,558,695 shares of our common stock outstanding as of March 31, June 30, 2026 after giving effect to the automatic conversion of all outstanding shares of our convertible preferred stock into 177,593,856 shares of our common stock immediately prior to the closing of this offering, and excludes:

28,157,570 30,078,745 shares of common stock issuable upon the exercise of stock options under our 2018 Equity Incentive Stock Plan (2018 Plan) outstanding as of March 31, June 30, 2026, with a weighted-average exercise price of $0.66 $0.68 per share;

6,153,610 shares of common stock that were not considered outstanding as of June 30, 2026 because they were subject to full recourse promissory notes, but which became outstanding as a result of the forgiveness of the related promissory notes effective August 2026 (5,550,221 shares) and September 2026 (603,389 shares);

2,210,000 270,000 shares of common stock issuable upon exercise of stock options granted under our 2018 Plan subsequent to March 31, June 30, 2026, with a weighted-average exercise price of $0.99 per share;

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shares of our common stock reserved for future issuance under our 2026 Employee Stock Purchase Plan (ESPP), which will become effective as of immediately prior to the completion of this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the ESPP; and 175,691 shares of common stock issuable upon the exercise of a warrant outstanding as of March 31, June 30, 2026, at an exercise price of $0.78 per share.

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a -for- reverse stock split of our common stock, effected on , 2026 (the Stock Split);

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The following tables set forth a summary of our historical financial data as of, and for the periods ended on, the dates indicated. We have derived the summary statements of operations data for the three six months ended March 31, June 30, 2026 and 2025 and the summary balance sheet data as of March 31, June 30, 2026 from our unaudited financial statements included elsewhere in this prospectus. We have derived the summary statements of operations data for the years ended December 31, 2025 and 2024 from our audited financial statements included elsewhere in this prospectus. You should read these data together with our financial statements and related notes included elsewhere in this prospectus and the section titled Management s Discussion and Analysis of Financial Condition and Results of Operations. Our historical results for any prior period are not necessarily indicative of our future results.

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As of March 31, 2026

Weighted-average shares used in net loss per common share calculation, basic and diluted (1) 10,692,532 10,093,319 10,816,448 10,214,636 10,318,638 9,261,740 Pro forma net loss per common share, basic and diluted (unaudited) (2) $ (0.09 (0.19 ) $ (0.48 ) Pro forma weighted-average shares used in pro forma net loss per common share calculation, basic and diluted (unaudited) (2) 188,286,388 188,410,304 129,963,415 (1) See Note 12 to our audited financial statements included elsewhere in this prospectus for an explanation of the methods used to calculate historical net loss per share, basic and diluted, and the weighted-average number of shares of common stock used in the computation of the per share amounts.

(2) Unaudited pro forma net loss per share, basic and diluted, attributable to common stockholders, is calculated giving effect to the conversion of all outstanding shares of our convertible preferred stock into shares of our common stock. Unaudited pro forma net loss per share attributable to common stockholders does not include the shares expected to be sold and related proceeds to be received in this offering. Unaudited pro forma net loss per share attributable to common stockholders for the three six months ended March 31, June 30, 2026 and for the year ended December 31, 2025 was calculated using the weighted-average number of shares of common stock outstanding, including the pro forma effect of the conversion of all outstanding shares of our convertible preferred stock into shares of our common stock, as if such conversion had occurred at the beginning of the period, or their issuance dates.

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Risk factors 58 changes

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Our net losses were $62.1 million and $48.6 million for the years ended December 31, 2025 and 2024, respectively. Our net losses were $17.5 million and $16.4 million for the three six months ended March 31, June 30, 2026 and 2025 were $36.5 million and $31.8 million, respectively. As of March 31, June 30, 2026, we had an accumulated deficit of $245.8 $264.9 million. Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations. All of our programs will require substantial additional development time and resources before we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase substantially if, and as, we:

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maintain relationships with our key third-party suppliers and manufacturing partners, such as Cell X Technologies, Inc. (Cell X); and Mytos Bio Limited (Mytos);

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Our financial condition raises substantial doubt as to our ability to continue as a going concern.

We have incurred net losses and negative cash flows from operating activities since inception and have an accumulated deficit of $264.9 million as of June 30, 2026. As of June 30, 2026, the Company had cash, cash equivalents and marketable securities of $72.4 million. Based on our current operating plan and without giving effect to any proceeds from any financing transaction, we believe that our existing cash, cash equivalents and marketable securities will not be sufficient to fund our operations for the 12 months following the date of issuance of our unaudited financial statements contained elsewhere in this prospectus. Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern.

If we are unable to raise additional capital as and when needed, our business, financial condition and results of operations will be materially and adversely affected, and we may be forced to delay our development efforts, limit our activities and reduce research and development costs. If we are unable to continue as a going concern, we may have to liquidate our assets, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. The reaction of investors to the inclusion of a going concern statement in our unaudited financial statements and the potential inability to continue as a going concern may materially adversely affect our ability to raise capital.

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Based on our current operating plans, we believe that the net proceeds from this offering, together with our existing cash, cash equivalents and marketable securities, will be sufficient to fund our operations into . In particular, we expect that the net proceeds from this offering and our existing cash, cash equivalents and marketable securities will allow us to continue to fund the Phase 1/2a ASPIRO trial evaluating sasineprocel in patients with sporadic and genetic PD, to continue to fund the development of sasineprocel in PD patients, including initiating a Phase 3 trial, and to continue to fund the development of our microglia program programs through the initiation of IND-enabling studies, and the remainder for working capital and other general purposes. We have based these estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands on our cash resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned. The net proceeds of this offering, together with our existing cash, cash equivalents and marketable securities, will not be sufficient to complete the Phase 1/2a ASPIRO trial, the Phase 3 trial for sasineprocel, which we intend to initiate prior to the completion of the Phase 1/2a ASPIRO trial, or the development of sasineprocel or any other current or future product candidates. After this offering, we will require additional capital in order to advance our current and future product candidates through clinical trials, regulatory approval, and commercialization. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. Our ability to raise additional funds may be adversely impacted by global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly, and more dilutive. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce, or eliminate our research and development programs or any future commercialization efforts, or even cease operations. We expect to finance our cash needs through public or private equity or debt financings or other capital sources, including potential collaborations, licenses, royalty financing and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop our product candidates.

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Risks Related to the Discovery, Development, and Regulatory Approval of Our Product Candidates We currently depend on the success of sasineprocel, which is our lead product candidate. If we are unable to advance sasineprocel in clinical development, obtain regulatory approval for and ultimately commercialize sasineprocel or experience significant delays in doing so, our business, financial condition, results of operations and prospects will be materially and adversely affected.

Our lead product candidate, sasineprocel, is in early clinical development. Our business presently depends on our ability to successfully develop, obtain regulatory approval for, and commercialize sasineprocel in a timely manner. This may make an investment in our company riskier than similar companies that have multiple product candidates in active clinical development and may be able to better sustain the delay or failure of a lead product candidate. The success of sasineprocel will depend on several factors, including the following:

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maintaining and expanding our in-house manufacturing capabilities and our ability to comply with cGMPs, as well as scaling and automating such capabilities at a cost and timeline sufficient to support commercialization;

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We expect the novel nature of sasineprocel to create further challenges in obtaining regulatory approval. Few stem-cell derived cell replacement therapies have been approved globally or by the FDA to date, and regulatory agencies have reviewed relatively few cell replacement therapy product candidates such as sasineprocel. In addition, we rely on stereotactic brain surgery for the administration of sasineprocel which carries risks, including infection, bleeding, stroke and brain swelling. This may lengthen the regulatory review process, increase our development costs and delay or prevent commercialization of our product candidates. Further, any autologous cell therapies that are approved may be subject to extensive post-approval regulatory requirements, including requirements pertaining to manufacturing, distribution and promotion. We may need to devote significant time and resources to compliance with these requirements.

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Additionally, our ongoing Phase 1/2a ASPIRO trial is an open-label trial and does not include a placebo or control cohort. The results of the ASPIRO trial or any other open-label trial that we may conduct may not be predictive of future clinical trial results when studied in a controlled environment with a placebo or active control. An open-label clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Open-label clinical trials are subject to various limitations that may exaggerate any observed therapeutic effect as patients in open-label clinical trials are aware that they are receiving an experimental treatment. Open-label clinical trials may be subject to a patient bias where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an investigator bias where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. If the limitations of our open-label clinical trial design cause us to overestimate the therapeutic effects of sasineprocel, we may experience setbacks in later-stage clinical development, which could delay or prevent regulatory approval. We expect to include a control group in our planned Phase 3 trial, However, which may include a sham surgery. In trials utilizing a sham control or surgical intervention, maintaining appropriate blinding presents substantial operational, clinical and logistical challenges compared to conventional placebo-controlled drug trials, and an inability to maintain a robust blinding protocol may undermine the results of any such trial. Further, even if we observe positive results in a controlled Phase 3 trial, there can be no assurance that such results will be sufficient to obtain regulatory approval.

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obtaining sufficient quantities of manufacturing sasineprocel or any other current or future product candidates and related obtaining sufficient quantities of required raw materials or obtaining sufficient quantities of combination therapies or other materials needed for use in clinical trials and preclinical studies;

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patients experiencing severe or serious unexpected drug-related or procedure-related adverse effects;

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the proximity of patients to clinical and surgical sites;

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Additionally, we may face challenges in recruiting and fully enrolling our clinical trials. The timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials, our ability to retain patients during the period after the biopsy and before surgical administration during the sasineprocel manufacturing process, as well as completion of required follow-up periods. The eligibility criteria of our clinical trials, once established, may further limit the pool of available trial participants. If patients are unwilling or unable to participate in our trials for any reason, including the existence of concurrent clinical trials for similar target populations, the availability of approved therapies, or the fact that enrolling in our trials may prevent patients from taking a different product, or we otherwise have difficulty enrolling a sufficient number of patients, the timeline for recruiting patients, conducting trials and obtaining regulatory approval of our product candidates may be delayed. Our inability to enroll and retain a sufficient number of patients for any of our future clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.

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Surgical administration of sasineprocel could cause patient harm and adversely affect our clinical development, and prospects for regulatory approval and ability to commercialize.

We use cannula based delivery to targeted brain regions to administer sasineprocel. Despite reliance on well-understood standard of care stereotactic neurosurgical techniques for the administration of sasineprocel, stereotactic brain surgery under anesthesia carries risks, including infection, bleeding, stroke and brain swelling. Safe cannula-based administration depends on accurate cannula placement and controlled infusion. Cannula obstruction, kinking, misplacement, malfunction, or reflux/off target distribution could cause suboptimal dosing, non target exposure, acute complications, or irreversible injury, even with imaging guidance and standardized procedures. Further, because sasineprocel is thawed immediately prior to surgery, handling deviations in thawing, preparation, timing, or sterility may affect cell viability, potency, or distribution, increasing the risk of adverse events, reducing potential benefit, or creating variability across patients or sites. Inconsistent execution of the thaw and infuse inject workflow could adversely affect development and approval prospects.

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In addition, standard of care surgical administration requires highly trained clinicians and specialized facilities, which could limit use of sasineprocel to select healthcare centers and reduce physician willingness to adopt sasineprocel or other product candidates. Third party payors may also be reluctant to adequately reimburse therapies that require a costly stereotactic neurosurgery, which could adversely affect commercial uptake and revenue potential for sasineprocel or other product candidates.

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The commercial success of our product candidates will depend in part on general public acceptance of the use of stem cell cell-based therapy for the prevention or treatment of human diseases. The use of embryonic cells and fetal tissue for research and stem cell therapy has been the subject of substantial national and international debate regarding related ethical, legal, and social issues. In the U.S., for example, until March 2009, federal government funding of embryonic stem cell research was limited to specifically identified cell lines and was not otherwise available. We do not use embryonic stem cells or fetal tissue, but the public may not be able to, or may fail to, differentiate our use of induced pluripotent stem cells from the use of embryonic stem cells or fetal tissue by others. This could result in a negative perception of us or our products or product candidates, thereby reducing demand, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

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The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of our product candidates are subject to extensive regulation by the FDA in the United States and by comparable foreign regulatory authorities in foreign markets. In the United States, we are not permitted to market our product candidates in the United States until we receive regulatory approval of a BLA from the FDA. The process of obtaining such regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved, as well as the target indications and patient population. Approval policies or regulations may change, and the FDA and comparable regulatory authorities have substantial discretion in the approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and expense invested in clinical development of product candidates, regulatory approval of a product candidate is never guaranteed. Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized.

Prior to obtaining approval to commercialize a product candidate in the United States or abroad, we must demonstrate with substantial evidence from adequate and well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidates are safe and effective for their intended uses, and in the case of biological products in the United States, that such product candidates are safe, pure and potent for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe available nonclinical or clinical data support the safety, purity, and potency (or efficacy) of our product candidates, such data may not be sufficient to obtain approval from the FDA and comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authorities, as the case may be, may also require us to conduct additional preclinical studies or clinical trials for our product candidates. either.

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The FDA has granted a Fast Track designation for sasineprocel for the treatment of PD to improve motor function, and we may seek Fast Track designations for other indications or other product candidates. The Fast Track program is programs are intended to expedite or facilitate the process for reviewing product candidates that meet certain criteria. Specifically, Biologics are eligible for Fast Track designation if they are intended, alone or in combination with one or more drugs or biologics, to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast Track designation applies to the combination of the product candidate and the specific indication for which it is being studied. The sponsor of a Fast Track product candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA is submitted, the application may be eligible for priority review. A BLA submitted for a Fast Track product candidate may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the Sponsor pays any required user fees upon submission of the first section of the BLA.

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A Regenerative Medicine Advanced Therapy, or RMAT, designation from the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive FDA approval.

The FDA has granted RMAT designation for sasineprocel for the treatment of levodopa-responsive PD, and may seek additional RMAT designations for sasineprocel or for our other product candidates. A biological product candidate is eligible for RMAT designation if: it meets the definition of a regenerative medicine therapy, which the FDA defines as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions; the candidate is intended to treat, modify, reverse, or cure a serious disease or condition, and; preliminary clinical evidence indicates that the candidate has the potential to address unmet medical needs for such disease or condition. RMAT designation provides potential benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate, and eligibility for rolling review and priority review of BLAs. Product candidates granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict long-term clinical benefit, or through reliance upon data obtained from a meaningful number of sites, including through expansion to a sufficient number sites, as appropriate. RMAT-designated product candidates that receive accelerated approval may, as appropriate, be able to fulfill their post-approval requirements through the submission of clinical evidence, clinical studies, patient registries, or other sources of real-world evidence, through the collection of larger confirmatory data sets, or via post-approval monitoring of all patients treated with such therapy prior to approval of the therapy. RMAT designation is within the sole discretion of the FDA. Accordingly, even if we believe one of our product candidates meets the criteria for RMAT designation, the FDA may disagree and instead determine not to make such designation. RMAT designation does not change the standards for product approval, and there is no assurance that such designation or eligibility for such designation will result in expedited review or approval or that the approved indication will not be narrower than the indication covered by the RMAT designation. Additionally, RMAT designation can be revoked if the product candidate fails to meet the qualifications as clinical data continue to emerge.

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The manufacture and supply of cell therapy product candidates, including sasineprocel, are generally more complex and costly than those required, for example, for small molecule or antibody-based drugs and accordingly present significant challenges. Our autologous cell therapy product candidates, including sasineprocel, are engineered human cells, and the process of manufacturing such product candidates is complex, highly regulated and subject to numerous risks. Manufacturing our product candidates involves isolating dermal fibroblast cells from a patient s skin punch biopsy, expanding the fibroblast cells, testing for correct cell type identity, harvesting and formulating the fibroblast cells, converting the fibroblasts into iPSCs through cellular reprogramming, differentiating the iPSCs into DANPCs, harvesting and finishing the DANPCs, cryopreservation, storage and eventually shipment. Our ability to consistently and reliably manufacture autologous cell therapy product candidates is essential to our success, and there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including cost overruns, potential problems with sourcing of materials, quality control, inter-patient variability, stability issues, consistency and timely availability of raw materials.

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We are still developing an optimized, automated manufacturing process for Phase 3 clinical and commercial-scale manufacturing of sasineprocel, and we may make changes to our manufacturing process at various points during development, and even after commercialization, for various reasons, such as to control costs, achieve scale, enhance automation, decrease processing time, increase manufacturing success rate, address intellectual property considerations, or for other reasons. Changes to our manufacturing process carry the risk that they will not achieve their intended objectives, and any of these changes could cause our product candidates to perform differently and affect the results of our ongoing clinical trials, or the performance of the product once commercialized. Changes to our process made during the course of clinical development could require us to show the comparability of the product candidate used in earlier clinical phases or at earlier portions of a trial to the product candidate used in later clinical phases or later portions of the trial. For example, we are currently transitioning to an automated manufacturing process for our Phase 3 study from the manual process used in our Phase 1/2a ASPIRO trial, and this transition has required manufacturing process changes. Prior to the start of manufacturing for our Phase 3 study, we must establish comparability of our automated manufacturing process with the manual process used in the Phase 1/2 ASPIRO trial. It is difficult to establish comparability of autologous cell therapy products, and this may complicate efforts to verify process changes during scale up. Other changes to our manufacturing process made before or after commercialization could require us to show the comparability of the resulting product to the product candidate used in the clinical trials using earlier processes. Such showings could require us to collect additional nonclinical or clinical data from any modified process prior to obtaining marketing approval for the product candidate produced with such modified process. If such data are not ultimately comparable to that seen in the earlier trials or earlier in the same trial in terms of safety or efficacy, or if regulatory authorities do not agree that comparability has been established, we may be required to make further changes to our process and/or undertake additional clinical testing, either of which could significantly delay the clinical development or commercialization of the associated product candidate, which would materially adversely affect our business, financial condition, results of operations and growth prospects.

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In addition, we rely on the treating physician performing the skin punch biopsy to collect the initial patient sample. Although we train treating physicians to ensure correct biopsy collection, we cannot guarantee that all physicians will have the necessary skills or experience to consistently perform such procedures that yield material suitable for manufacturing. For example, during our Phase 1/2a ASPIRO trial, several patients experienced biopsy failures, requiring re-collection of patient material, which delayed or necessitated a restart of the manufacturing process for those patients. Similar failures in the future, including any unexpected failures due to the characteristics of genetic PD patients, could result in manufacturing delays, supply disruptions, or the inability to manufacture a suitable product for a particular patient, any of which could adversely affect our clinical trials and, if our product candidates are approved, our ability to supply product to patients, and could materially adversely affect our business, financial condition, results of operations and growth prospects.

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We currently manufacture our product candidates at our manufacturing facility in San Diego, California, where we lease approximately 22,000 square feet of GMP cleanrooms, warehouse, QC laboratory, and office space. We are currently conducting technology transfer and implementation of our automated manufacturing process in the second phase clean rooms of our San Diego facility, and we have not completed implementation of our automated manufacturing process that we intend to utilize in our planned Phase 3 trial. We are entirely reliant on our manufacturing facility to manufacture our product candidates, including sasineprocel, and any failure to maintain the use of this facility would have a material and adverse effect on our business.

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Our manufacturing processes for sasineprocel incorporate highly specialized automated systems supplied by third parties, including the Cell X platform, also known as the Celligent system, potentially used across earlier all stages of production and scale-up, and the Mytos Bio (Mytos) device used during differentiation in stage 3 of our production process. These systems integrate robotics, liquid handling, optical machine vision and proprietary algorithms to evaluate and process patient-derived cells. We also depend on Cell X and other third parties for instruments and consumables under supply and license arrangements, and our Cell X license requires and The Cleveland Clinic Foundation (CCF) licenses require milestone payments upon achievement of specified development and regulatory milestones. Any delay, disruption, quality or performance issue affecting these third-party platforms or supplies including equipment malfunction, software or algorithm errors, supplier capacity constraints, delivery delays, component shortages, discontinuations, business interruptions or financial distress could delay or halt manufacturing runs, increase our costs, reduce yields, or result in product quality issues, which could delay our preclinical and clinical development, regulatory submissions and, if approved, commercialization.

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In addition, failures in our automated data capture, analytics and in-process controls, or errors in the machine-vision or algorithmic selection of cells, could lead to batch failures, inconsistent product quality, loss of patient-specific material, patient segregation issues or regulatory non-compliance. If we are unable to secure, maintain or scale access to the Cell X platform, Mytos devices, or other critical systems on commercially reasonable terms, or if these systems do not operate as intended within our modular manufacturing template, we may be unable to achieve the throughput, costs or consistency necessary to support later-stage development or potential commercialization. Any of the foregoing could materially and adversely affect our business, financial condition, results of operations and prospects.

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We rely on third parties for certain manufacturing systems, materials and components for our product candidates and expect to continue to do so for the foreseeable future. This reliance on third parties increases the risk that we will not have be able to manufacture sufficient quantities of our products or such quantities at an acceptable cost, which could delay, prevent, or impair, our development or commercialization efforts.

We rely on certain third-party suppliers and manufacturing partners for systems, components and consumables for manufacturing sasineprocel and other product candidates. For example, with respect to sasineprocel, we have a collaboration agreement with Cell X for the development of a GMP capable cell processing system, a services agreement with Mytos for the supply of the iDEM platform, services agreements with Veranex for the development and manufacture of metered delivery syringes used as part of the drug delivery system, and a supply agreement and master development agreement with ClearPoint Neuro for its SmartFlow cannula used as part of the drug delivery system. A third party s failure to execute on our supply requirements on commercially reasonable terms, in a timely manner and in compliance with regulatory requirements could adversely affect our business in a number of ways, including:

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requirements to cease development or to recall batches of our product candidates; and in the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our products on a reasonable timeframe.

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Our manufacturing processes depend on specialized raw materials, reagents, consumables, and equipment, some of which we currently obtain from sole or single sources. While we procure a number of cell culture reagents from multiple vendors, including Bio-Techne, Thermo Fisher, StemCell Technologies, Akron Biotech and ClearPoint Neuro, some of these materials may require supplier specific specifications, release testing, and process compatibility, and not all items, such as the Sendai virus supplied by Thermo Fisher, are readily substitutable on short notice. In addition, in some circumstances we rely on sole source suppliers, including for iPSC reprogramming kits and for certain automated manufacturing systems, such as the Cell X and Mytos systems. Our use of such technology is licensed directly from a sole source and our supplier s ability to supply these kits is subject to its own upstream license arrangements. We also rely on sole sourced manufacturing platforms.

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We believe that any of our product candidates, if approved as a biological product under a BLA, should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to Congressional action or otherwise, or that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, could be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products will depend on a number of marketplace and regulatory factors. continue to develop.

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our ability to obtain and maintain sufficient third-party coverage and adequate reimbursement from government healthcare programs, (e.g., Medicare and Medicaid), private health insurers, and other third-party payors for our product candidates in addition to the surgical administration;

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The availability of coverage and the adequacy of reimbursement by governmental healthcare programs ( e.g. , Medicare and Medicaid), private health insurers, and other third-party payors are essential for most patients to be able to afford prescription medications such as our product candidates, including sasineprocel, if approved. Our ability to achieve coverage and acceptable levels of reimbursement for our product candidates by third-party payors will have an effect on our ability to successfully commercialize those product candidates. Accordingly, we will need to successfully implement a coverage and reimbursement strategy for any approved product candidate, including for the surgical procedure required to administer sasineprocel or other product candidates. Even if we obtain coverage for a given product candidate by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.

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We expect to compete with commercially available advanced therapies used in patients with motor fluctuations despite optimization of L dopa, including DBS devices such as Infinity and Liberta RC (both marketed by Abbott), Vercise (marketed by Boston Scientific), and Percept (marketed by Medtronic), as well as Focused Ultrasound (FUS) technologies such as Exablate Neuro (marketed by Insightec). We anticipate that there will continue to be improvements in DBS and FUS technologies. We are aware of cell and gene therapy candidates in clinical development that target sporadic, genetic, or all forms of PD. This includes autologous cell therapies in development by Hope Bio, Oryon, and others; allogeneic therapies from BlueRock Therapeutics (BlueRock)/Bayer, Sumitomo (AMCHEPRY, approved in Japan), Cellular Intelligence, Kenai Therapeutics, iRegene, S.Biomedics, Xellsmart and others; and gene therapies from AskBio/Bayer, MeiraGTx, Prevail Therapeutics, and other earlier-stage competitors. We are also developing autologous microglia cell replacement therapies for a number of leukodystrophies. In this area, we expect to compete with commercially available therapies such as bone marrow transplant and Skysona (Genetix Biotherapeutics). We are also aware of small molecules, antibodies, and advanced therapies that are in development for leukodystrophies including a PPARg agonist in development by Minoryx Therapeutics, a thyroid receptor-b agonist in development by Viking Therapeutics, and an AMPK activator and a deuterium-modified thiazolidinedione both in development by Poxel SA and other earlier-stage competitors.

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Our success depends in part on our continued ability to attract, recruit, retain, manage, and motivate highly qualified management, clinical, and scientific personnel, and we face significant competition for experienced personnel. We are highly dependent upon the management, clinical, research and development, manufacturing, regulatory, financial and business development expertise of our senior management, particularly Damien McDevitt, Ph.D., our President and Chief Executive Officer, Revati Shreeniwas, M.D., our Chief Medical Officer, Lisa Johnson-Pratt, M.D., our Sasineprocel Development Lead and Chief Commercial Officer, and Kim Raineri, our Chief Technology Officer, and Andr s Bratt-Leal, Ph.D., our scientific co-founder and Senior Vice President of R&D, as well as our senior scientists and other members of our management team. The loss of services of any of these individuals could delay or prevent the successful development of our product pipeline, initiation or completion of our clinical trials and preclinical studies, regulatory approvals, or the commercialization of our product candidates. Although we have executed employment agreements or offer letters with each member of our senior management team, these agreements are terminable at will with or without notice and, therefore, we may not be able to retain their services as expected. We do not currently maintain key person life insurance on the lives of our executives or any of our employees. This lack of insurance means that we may not have adequate compensation for the loss of the services of these individuals.

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As of March 31, June 30, 2026, we had 117 120 full-time employees and three part-time employees. As we continue development and pursue the potential commercialization of our product candidates, as well as transition to functioning as a public company, we will need to expand our financial, development, regulatory, manufacturing, information technology, marketing, and sales capabilities or contract with third parties to provide these capabilities for us. As our operations expand, we expect that we will need to manage additional relationships with various strategic partners, suppliers, and other third parties, and we may not be successful in doing so. Our future financial performance and our ability to develop and commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future growth effectively. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

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In 2026, the U.S. government launched TrumpRx, a federal initiative to enable patients to gain access to certain prescription drugs at reduced costs based on pricing available in other countries (i.e., most-favored-nation pricing). In addition, the Trump administration is pursuing a two-fold strategy to reduce drug costs in the United States. While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for any product candidate that we commercialize. On the one hand, President Trump threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the United States to the lowest price in a group of other countries. In response, multiple manufacturers entered into confidential pricing agreements with the federal government. Subsequently, in April 2026, the Trump administration issued a proclamation imposing tariffs under Section 232 of the Trade Expansion Act on imports of brand pharmaceuticals, biologics and associated pharmaceutical ingredients, beginning July 31, 2026. Exempted from these tariffs, among others, are companies that have executed or are negotiating agreements with the federal government regarding most favored nation pricing and onshoring of production and research and development. On the other hand, the Trump administration is also pursuing traditional regulatory pathways to impose drug pricing policies and published two proposed regulations in December 2025, referred to as Globe and Guard. If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation international reference pricing for the drugs from economically comparable countries. While the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S. pharmaceutical sector and our business.

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Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States (in some circumstances), and the efficacy and longevity of current transfer mechanisms between the European Economic Area EEA and the United States remains uncertain. Case law from the Court of Justice of the European Union (CJEU) states that reliance on the standard contractual clauses a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case-by-case basis.

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Our business may be affected by the evolving regulatory framework for AI Technologies.

The regulatory framework for artificial intelligence (AI), machine learning, and automated decision-making technologies (collectively, AI Technologies) is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations. Additionally, existing laws and regulations may be interpreted in ways that would affect the operation of our AI Technologies.

It is possible that new laws and regulations will be adopted in the United States and in other non-U.S. jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI Technologies for our business, or require us to change the way we use AI Technologies in a manner that negatively affects the performance of our products, services, and business and the way in which we use AI Technologies. We may need to expend resources to adjust our products or services in certain jurisdictions if the laws, regulations, or decisions are not consistent across jurisdictions. Further, the cost to comply with such laws, regulations, or decisions and/or guidance interpreting existing laws, could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI Technologies). Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition and results of operations.

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We rely upon a combination of patent, trade secret, and trademark protection for our product candidates and proprietary technologies to prevent third parties from exploiting our achievements, thus eroding our competitive position in our market. These legal measures afford only limited protection, and competitors or others may gain access to or use our intellectual property and proprietary information. Our success depends in large part on our ability to obtain, maintain, expand, enforce, and defend the scope of our intellectual property protection in the United States and other countries with respect to our product candidates and other proprietary technologies we may develop. We generally seek to protect our proprietary position, in part, by filing patent applications in the United States and abroad relating to our product candidates, manufacturing processes, delivery devices and methods of use. We may also seek to protect our proprietary position by acquiring or in-licensing relevant issued patents or pending patent applications from third parties. For intellectual property we in-license, we may have limited control over prosecution, maintenance, and enforcement/defense and may depend on our licensors, which could adversely affect the scope or availability of protection. If we are unable to obtain, maintain, expand, enforce, and defend the scope of our intellectual property protection, our business, financial condition, results of operations, and prospects could be materially harmed.

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In 2012, the European Union Patent Package (EU Patent Package) regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court (UPC) for litigation involving European patents. The EU Patent Package was implemented on June 1, 2023. The UPC is an international court established by a subset of EU Member States, and not all EU Member States participate or have ratified the UPC Agreement; accordingly, the geographic scope of UPC jurisdiction and Unitary Patent coverage is limited to participating EU Member States that have ratified the UPC Agreement. As a result, European patents (including those issued prior to ratification of the EU Patent Package) validated in participating, ratifying EU Member States now by default automatically fall under the jurisdiction of the UPC, unless otherwise opted out. It is uncertain how the UPC will impact granted European patents in the biotechnology and pharmaceutical industries. Our European patent applications, if issued, could be challenged in the UPC. During the first seven years of the UPC s existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. We may decide to opt out our future European patents from the UPC, but doing so may preclude us from realizing the benefits of the UPC. Moreover, if we do not meet all of the formalities and requirements for opt-out under the UPC, our future European patents could remain under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patent, and allow for the possibility of a competitor to obtain pan-European injunction. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize our technology and product candidates dues due to increased competition and, resultantly, on our business, financial condition, results of operations, and prospects. The UPC and Unitary Patent are significant changes in European patent practice. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation in the UPC. We may choose to opt out of UPC jurisdiction for current and future European Patents and decline to request unitary effect for future European Patent grants.

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Numerous U.S. and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which we plan to commercialize our product candidates and in which we are developing other proprietary technologies. As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain greater visibility and market exposure as a public company, the risk increases that our product candidates and commercializing activities may give rise to claims of infringement of the patent rights of others. We cannot assure that our product candidates and other proprietary technologies we develop will not infringe existing or future patents owned by third parties. We may not be aware of patents that have already been issued for which a third party, such as a competitor in the fields in which we are developing our product candidates, might assert as infringed by us. It is also possible that patents owned by third parties of which we are aware, but which we do not believe we infringe or that we believe we have valid defenses to any claims of patent infringement, could be found to be infringed by us. It is not unusual that corresponding patents issued in different countries have different scopes of coverage, such that in one country a third-party patent does not pose a material risk, but in another country, the corresponding third-party patent may pose a material risk to our product candidates. As such, we monitor third-party patents in the relevant pharmaceutical markets. In addition, because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that we may infringe. For example, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover product candidates or the use of our products. We are aware of certain patents and patent applications in the United States and elsewhere that contain claims that if issued in their present form, may cover one of our product candidates. While we believe we would have valid defenses to claims of patent infringement, we cannot be certain that we would prevail in any dispute, and we cannot be certain how an adverse determination would affect our business.

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Our registered or unregistered trademarks or trade names may be challenged, infringed, diluted, circumvented, or declared generic or determined to be infringing, misappropriating, or violating other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in the markets of interest. During trademark registration proceedings, we may receive rejections of our applications by the USPTO or in other foreign jurisdictions. Although we are given an opportunity to respond to such rejections, we may be unable to overcome them. In the event that our trademarks are successfully challenged or determined to be infringing, misappropriating, or violating other marks, we could be forced to rebrand our products, which could result in loss of brand recognition, and could require us to devote resources to advertising and marketing new brands. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, which may not survive such proceedings. Moreover, any name we may propose to use with our product candidates in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. Similar requirements exist in Europe. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. If the FDA or a comparable foreign regulatory authority objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe, misappropriate, or otherwise violate the existing rights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark.

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We are dependent, in part, on patents, know-how and proprietary technology licensed from others, including Cell X, CCF, iPS Academia Japan and Sumitomo. In addition to the foregoing, we are a party to a number of other license agreements under which we are granted rights to intellectual property that are critical to our business, and we may enter into additional license agreements in the future with third parties. Our existing license agreements impose, and we expect that any future license agreements where we in-license intellectual property, will impose on us, various development, regulatory and/or commercial diligence obligations, payment of milestones and/or royalties and other obligations. If we fail to comply with our obligations under these agreements, or we are subject to bankruptcy-related proceedings, the licensor may have the right to terminate the license, in which event we would not be able to develop or market products covered by the license, or we may be subject to litigation for breach of these agreements.

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Prior to this offering, there has been no public market for our common stock. Although we intend to apply have applied to list our common stock on the Nasdaq Global Select Market (Nasdaq) under the symbol ASPE , an active trading market for our common stock may never develop or may not be sustained following this offering. We and the representatives of the underwriters will determine the initial public offering price of our common stock through negotiation. This price will not necessarily reflect the price at which investors in the market will be willing to buy and sell our shares following this offering. In addition, an active trading market may not develop following the consummation of this offering or, if it is developed, may not be sustained. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other businesses or technologies using our shares as consideration, which, in turn, could materially adversely affect our business.

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Based on shares of common stock outstanding as of March 31, June 30, 2026, upon the closing of this offering, we will have a total of shares of common stock outstanding, assuming no exercise of the underwriters option to purchase additional shares and no exercise of outstanding options. Of these shares, only the shares of common stock sold in this offering by us, plus any shares sold upon exercise of the underwriters option to purchase additional shares, will be freely tradable, without restriction, in the public market immediately following this offering, unless they are purchased by one of our affiliates.

Our directors and executive officers and substantially all of our securityholders have entered into lock-up agreements with the representatives pursuant to which they may not, with limited exceptions and among other things, for a period of 180 days from the date of this prospectus, offer, sell or otherwise transfer or dispose of any of our securities, without the prior written consent of Leerink Partners LLC, Piper Sandler & Co., Stifel, Nicolaus & Company, Incorporated and UBS Securities LLC. The underwriters may permit our officers, directors, and other securityholders who are subject to the lock-up agreements to sell shares prior to the expiration of the lock-up agreements at any time in their sole discretion. See the section titled Underwriting. Sales of these shares, or perceptions that they will be sold, could cause the trading price of our common stock to decline. After the lock-up agreements expire, up to an additional shares of common stock will be eligible for sale in the public market, of which shares will be held by directors, executive officers and other affiliates and will be subject to volume limitations under Rule 144 under the Securities Act, in each case based on shares of our common stock outstanding as of March 31, June 30, 2026 and without giving effect to any potential purchases by such persons in this offering.

In addition, as of March 31, June 30, 2026, 30,078,745 shares of common stock that are subject to outstanding options under our employee benefit plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements, and Rule 144 and Rule 701 under the Securities Act. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.

After this offering, the holders of shares of our outstanding common stock, or approximately % of our total outstanding common stock based on shares outstanding as of March 31, June 30, 2026, will be entitled to rights with respect to the registration of their shares under the Securities Act, subject to vesting and the 180-day lock-up agreements described above. See the section titled Description of Capital Stock Registration Rights. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates, as defined in Rule 144 under the Securities Act. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.

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the required approval of at least 80% two-thirds of the shares entitled to vote to remove a director for cause;

2 unchanged paragraphs

the required approval of at least 80% of the shares entitled to vote to approve certain business combinations with interested stockholders if the business combination has not been recommended by our Board;

the required approval of at least 80% two-thirds of the shares entitled to vote to adopt, amend, or repeal our amended and restated bylaws or repeal the provisions of our amended and restated certificate of incorporation regarding the election and removal of directors;

34 unchanged paragraphs

Use of proceeds 3 changes

1 unchanged paragraph

Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share would increase (decrease) the net proceeds to us from this offering by approximately $ million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each increase (decrease) of 1.0 million in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by $ million, assuming the assumed initial public offering price stays the same. We do not expect that a change in the offering price or the number of shares by these amounts would have a material effect on our intended uses of the net proceeds from this offering, although it may impact the amount of time prior to which affect how soon we may need to seek additional capital.

3 unchanged paragraphs

approximately $ million to continue funding the development of our microglia program, programs, including initiating IND-enabling studies; and the remainder for working capital and other general corporate purposes.

2 unchanged paragraphs

The net proceeds from this offering, together with our existing cash, cash equivalents, and marketable securities will not be sufficient to complete the Phase 1/2a ASPIRO trial, the Phase 3 trial for sasineprocel, which we intend to initiate prior to the completion of the Phase 1/2a ASPIRO trial, or the development of sasineprocel or any other current or future product candidates. After this offering, we will require additional capital in order to advance our current and any future products product candidates through clinical trials, regulatory approval, and commercialization. Until such time, if ever, as we can generate substantial revenue, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses, and other similar arrangements. Nevertheless, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all.

1 unchanged paragraph

Capitalization 10 changes

The following table sets forth our cash, cash equivalents and marketable securities and capitalization as of March 31, June 30, 2026:

2 unchanged paragraphs

As of March 31, 2026

3 unchanged paragraphs

Preferred stock, $0.0001 par value; no shares authorized, issued or outstanding, actual (other than the convertible preferred stock set forth above), 10,000,000 shares authorized, no shares issued or outstanding, pro forma and pro forma as adjusted (2) Common stock, $0.0001 par value; 228,898,561 shares authorized; 17,080,878 17,118,449 shares issued; and 10,927,268 10,964,839 shares outstanding, actual; 500,000,000 shares authorized, 194,712,305 shares issued and 188,558,695 shares outstanding, pro forma; 500,000,000 shares authorized, shares issued and shares outstanding, pro forma as adjusted (2) Additional paid-in capital 12,565 351,355 13,854 352,644 Accumulated other comprehensive loss (42 ) (42 ) Accumulated deficit (245,811 (264,886 ) (245,811 (264,886 ) Total stockholders (deficit) equity (233,287 (251,073 ) 105,521 87,735 Total capitalization $ 105,521 87,735 $ 105,521 87,735 $ (1) Each $1.00 increase or decrease in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the pro forma as adjusted amount of each of our cash, cash equivalents and marketable securities, additional paid-in capital, total stockholders (deficit) equity, and total capitalization by approximately $ million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each increase or decrease of 1.0 million shares in the number of shares offered by us at the assumed initial public offering price of $ per share would increase or decrease, as applicable, the pro forma as adjusted amount of each of our cash, cash equivalents and marketable securities, additional paid-in capital, total stockholders (deficit) equity, and total capitalization by approximately $ million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(2) Reflects the number of shares that will be authorized under our amended and restated certificate of incorporation, which will become effective immediately prior to the closing of this offering, and assumes the completion of the Stock Split prior to the effectiveness of the registration statement of which this prospectus forms a part. Except as otherwise indicated, the other information in the table above, including the number of shares issued and outstanding, does not give effect to the Stock Split.

If the underwriters option to purchase additional shares is exercised in full, our pro forma as adjusted cash, cash equivalents and marketable securities, additional paid-in capital, total stockholders equity, and total capitalization as of March 31, June 30, 2026, would be $ million, $ million, $ million, and $ million, respectively.

The number of shares of our common stock issued and outstanding, pro forma and pro forma as adjusted in the table above, is based on 188,521,124 188,558,695 shares of our common stock outstanding as March 31, of June 30, 2026 after giving effect to the automatic conversion of all outstanding shares of our convertible preferred stock into 177,593,856 shares of our common stock immediately prior to the closing of this offering, and excludes:

28,157,570 30,078,745 shares of common stock issuable upon the exercise of stock options outstanding as of March 31, June 30, 2026 under our 2018 Plan, with a weighted-average exercise price of $0.66 $0.68 per share;

6,153,610 shares of common stock that were not considered outstanding as of June 30, 2026 because they were subject to full recourse promissory notes, but which became outstanding as a result of the forgiveness of the related promissory notes effective August 2026 (5,550,221 shares) and September 2026 (603,389 shares);

2,210,000 270,000 shares of common stock issuable upon exercise of stock options granted subsequent to March 31, June 30, 2026, with a weighted-average exercise price of $0.99 per share;

1 unchanged paragraph

shares of common stock reserved for future issuance under our ESPP, which will become effective as of immediately prior to the completion of this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the ESPP; and 175,691 shares of common stock issuable upon the exercise of a warrant outstanding as of March 31, June 30, 2026, at an exercise price of $0.78 per share.

Dilution 10 changes

1 unchanged paragraph

As of March 31, June 30, 2026, our historical net tangible book value (deficit) was $(233.3) $(251.1) million, or $(13.66) $(14.67) per share of our common stock, based on 17,080,878 17,118,449 shares of common stock issued and 10,927,268 10,964,839 shares of common stock outstanding as of such date. Our historical net tangible book value (deficit) per share represents total tangible assets less total liabilities and convertible preferred stock, which is not included within permanent equity, divided by the number of shares of common stock issued and outstanding at March 31, June 30, 2026.

On a pro forma basis, after giving effect to the automatic conversion of all outstanding shares of our convertible preferred stock into 177,593,856 shares of our common stock and the related reclassification of the carrying value of the convertible preferred stock to permanent equity immediately prior to the closing of this offering, our pro forma net tangible book value as of March 31, June 30, 2026 would have been $105.5 $87.7 million, or $0.54 $0.45 per share of our common stock.

After giving further effect to the sale and issuance of shares of our common stock in this offering at an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of March 31, June 30, 2026 would have been approximately $ million, or approximately $ per share. This amount represents an immediate increase in pro forma net tangible book value of approximately $ per share to our existing stockholders and an immediate dilution in pro forma net tangible book value of approximately $ per share to new investors purchasing shares of common stock in this offering.

2 unchanged paragraphs

Historical net tangible book value (deficit) per share as of March 31, June 30, 2026 (13.66 (14.67 ) Pro forma increase in historical net tangible book value per share as of March 31, June 30, 2026 attributable to the pro forma adjustments described above 14.20 15.12 Pro forma net tangible book value per share as of March 31, June 30, 2026 0.54 0.45 Increase in pro forma net tangible book value per share attributable to new investors participating in this offering Pro forma as adjusted net tangible book value per share after this offering Dilution per share to new investors participating in this offering $ Each $1.00 increase or decrease in the assumed initial public offering price of $ per share would increase or decrease, as applicable, the pro forma as adjusted net tangible book value per share after this offering by approximately $ per share, and dilution in pro forma as adjusted net tangible book value per share to new investors by approximately $ per share, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us. Each increase or decrease of 1.0 million shares in the number of shares of common stock offered by us would increase or decrease, as applicable, our pro forma as adjusted net tangible book value per share after this offering by approximately $ per share and decrease or increase, as applicable, the dilution to investors participating in this offering by approximately $ per share, assuming that the assumed initial public offering price of $ per share remains the same, and after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us.

2 unchanged paragraphs

The following table summarizes on the pro forma as adjusted basis described above, as of March 31, June 30, 2026, the differences between the number of shares purchased from us, the total consideration paid to us in cash, and the weighted-average price per share paid by existing stockholders for shares issued prior to this offering and the price to be paid by new investors in this offering. The calculations below are based on an assumed initial public offering price of $ per share, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

4 unchanged paragraphs

The foregoing tables and calculations above (other than the historical net tangible book value calculations) are based on 188,521,124 188,558,695 shares of our common stock outstanding as of March 31, June 30, 2026 after giving effect to the automatic conversion of all outstanding shares of our convertible preferred stock into 177,593,856 shares of our common stock immediately prior to the closing of this offering, and exclude:

28,157,570 30,078,745 shares of common stock issuable upon the exercise of stock options outstanding as of March 31, June 30, 2026 under our 2018 Plan, with a weighted-average exercise price of $0.66 $0.68 per share;

6,153,610 shares of common stock that were not considered outstanding as of June 30, 2026 because they were subject to full recourse promissory notes, but which became outstanding as a result of the forgiveness of the related promissory notes effective August 2026 (5,550,221 shares) and September 2026 (603,389 shares);

2,210,000 270,000 shares of common stock issuable upon exercise of stock options granted subsequent to March 31, June 30, 2026, with a weighted-average exercise price of $0.99 per share;

1 unchanged paragraph

shares of common stock reserved for future issuance under our ESPP, which will become effective as of immediately prior to the completion of this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the ESPP; and 175,691 shares of common stock issuable upon the exercise of a warrant outstanding as of March 31, June 30, 2026, at an exercise price of $0.78 per share.

1 unchanged paragraph

MD&A 45 changes

1 unchanged paragraph

Aspen Neuroscience, Inc. is a leading, clinical-stage regenerative medicine biotechnology company focused on developing autologous iPSC-derived therapies to address neurodegenerative diseases with high unmet medical need. Our lead product candidate, sasineprocel, is an investigational single-dose, autologous iPSC-based cell therapy being evaluated for the treatment of PD. We believe sasineprocel has the potential to be disease-modifying by primarily replacing a patient s lost DA neurons with DANPCs. We are headquartered in San Diego, California, and were originally incorporated in Delaware on May 18, 2018.

1 unchanged paragraph

We have incurred significant net losses since inception and we expect to continue to incur substantial losses for the foreseeable future. Our net losses for the years ended December 31, 2025 and 2024 were $62.1 million and $48.6 million, respectively. Our net losses for the three six months ended March 31, June 30, 2026 and 2025 were $17.5 $36.5 million and $16.4 $31.8 million, respectively. As of March 31, June 30, 2026, we had an accumulated deficit of $245.8 $264.9 million.

4 unchanged paragraphs

In various closings from October 2025 to November 2025, we issued and sold to investors in private placements an aggregate of 76,173,492 shares of Series C convertible preferred stock at a per share purchase price of $1.5179, and we received gross proceeds of approximately $115.6 million. As of March 31, June 30, 2026, we had cash, cash equivalents and marketable securities of $90.9 $72.4 million. Based on our current plans, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our projected operating and capital expenditures for at least 12 months following the date of this prospectus. Together with the estimated net proceeds from this offering, we believe our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditures through . We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, our expected use of existing cash, cash equivalents, marketable securities, and our net proceeds from this offering represent our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. See Liquidity and Capital Resources Funding Requirements below.

39 unchanged paragraphs

Other (loss) income, net, primarily reflects changes in the fair value of the Cell X Convertible Note (described below in Contractual Obligations and Commitments Cell X A&R Collaboration and License Agreement ), which is accounted for under the fair value option, with changes in fair value recognized in other (loss) income. Other loss was $4.5 million for the year ended December 31, 2025, compared to other income of $0.5 million for the year ended December 31, 2024. The decrease of $5.0 million was primarily due to a reduction in the fair value of the Cell X Convertible Note (as described below) resulting from changes in our estimated expected future investment returns of the Cell X Convertible Note.

Comparison of the Three Six Months Ended March 31, June 30, 2026 and 2025

16 unchanged paragraphs

Research and development expenses were $13.6 $28.5 million for the three six months ended March 31, June 30, 2026, compared to $10.4 $20.8 million for the three six months ended March 31, June 30, 2025. The increase of $3.2 $7.6 million was due to an increase in non-personnel costs primarily associated with the development and production of sasineprocel of $1.6 $4.1 million, increased personnel costs for salaries, bonuses and benefits of $0.9 $2.2 million, increased facilities and equipment costs of $0.3 $0.6 million, increased stock-based compensation expense of $0.4 $0.7 million, and increased depreciation expense of $0.1 million. Substantially all of our non-personnel research and development expenses for the three six months ended March 31, June 30, 2026 and 2025 related to our lead product candidate, sasineprocel. Non-personnel research and development expenses related to other programs were immaterial for the three six months ended March 31, June 30, 2026 and 2025.

7 unchanged paragraphs

General and administrative expenses were $4.8 $9.8 million for the three six months ended March 31, June 30, 2026, compared to $5.8 $10.1 million for the three six months ended March 31, June 30, 2025. The decrease of $0.9 $0.3 million was primarily due to decreases in professional, consultant and other external spend of $0.6 $0.5 million, decreases in salaries, bonuses and benefits of $0.4 $0.2 million, partially offset by increases in stock-based compensation of $0.2 $0.5 million.

Interest income consists of interest earned on our cash equivalents and marketable securities. Interest income was $1.0 $1.7 million for the three six months ended March 31, June 30, 2026, compared to $0.5 $0.9 million for the three six months ended March 31, June 30, 2025. The increase of $0.5 $0.8 million was primarily due to the higher average balance of cash equivalents and marketable securities during the three six months ended March 31, June 30, 2026.

1 unchanged paragraph

Other income (loss), net, primarily reflects changes in the fair value of the Cell X Convertible Note (described below in Contractual Obligations and Commitments Cell X A&R Collaboration and License Agreement ), which is accounted for under the fair value option, with changes in fair value recognized in other income (loss). Other income was $12,000 $2,000 for the three six months ended March 31, June 30, 2026, compared to other loss of $0.7 $1.7 million for the three six months ended March 31, June 30, 2025. The increase of $0.8 $1.7 million was primarily due to a reduction in the fair value of the Cell X Convertible Note (as described below) of $0.8 $1.7 million during the three six months ended March 31, June 30, 2025, compared to an increase of $12,000 $2,000 of the fair value of the Cell X Convertible Note during the three six months ended March 31, June 30, 2026, each resulting from changes in our estimated expected future investment returns of the Cell X Convertible Note.

3 unchanged paragraphs

To date, we have funded our operations primarily through the sale of preferred stock. We have raised an aggregate of approximately $340 million in gross proceeds from the issuance of preferred stock, including $115.6 million in gross proceeds from the issuance and sale of our Series C preferred stock in the fourth quarter of 2025. As of March 31, June 30, 2026 and December 31, 2025, we had cash, cash equivalents and marketable securities of $90.9 $72.4 million and $110.7 million, respectively.

14 unchanged paragraphs

For the year ended December 31, 2024, net cash provided by financing activities was $0.5 million, primarily consisting of cash proceeds from stock option exercises by employees under the 2018 Stock Plan.

Comparison of the Three Six Months Ended March 31, June 30, 2026 and 2025

5 unchanged paragraphs

Net cash (used in) provided by financing activities

2 unchanged paragraphs

For the three six months ended March 31, June 30, 2026, net cash used in operating activities was $18.4 $34.5 million, reflecting a net loss of $17.5 $36.5 million and a net change in our operating assets and liabilities of $2.7 $1.8 million, offset by non-cash charges of $1.8 $3.8 million. Non-cash charges primarily consisted of stock-based compensation of $1.2 $2.5 million, amortization of our right-of-use lease assets of $0.6 $1.2 million, and depreciation of $0.4 $0.9 million, primarily offset by the accretion of discounts on short-term investments of $0.5 $0.7 million.

For the three six months ended March 31, June 30, 2025, net cash used in operating activities was $16.3 $30.6 million, reflecting a net loss of $16.4 $31.8 million and a net change in our operating assets and liabilities of $2.3 $3.8 million, offset by non-cash charges of $2.4 $4.9 million. Non-cash charges primarily consisted of a decrease in the fair value of the Cell X Convertible Note of $0.8 $1.7 million, stock-based compensation of $0.7 $1.2 million, amortization of our right-of-use lease assets of $0.6 $1.1 million, and depreciation of $0.4 $0.8 million.

1 unchanged paragraph

For the three six months ended March 31, June 30, 2026, net cash used in investing activities was $47.0 $25.6 million, consisting of purchases of marketable securities of $51.4 $55.6 million, and purchases of property and equipment of $2.0 $3.8 million, offset by maturities of marketable securities of $6.4 $33.8 million.

For the three six months ended March 31, June 30, 2025, net cash provided by investing activities was $13.4 $24.8 million, consisting of maturities of marketable securities of $24.0 $38.3 million, offset by purchase purchases of marketable securities of $9.4 $9.8 million, and purchases of property and equipment of $1.2 $3.7 million.

1 unchanged paragraph

For the three months ended March 31, 2026, net cash provided by financing activities was $91,000, consisting of proceeds from the exercises of employee stock options.

For the six months ended June 30, 2026, net cash used in financing activities was $0.7 million resulting from the payment of $0.8 million in deferred offering costs related to our planned initial public offering, offset by proceeds from the exercises of employee stock options of $0.1 million.

For the three six months ended March 31, June 30, 2025, net cash provided by financing activities was $44,000, $50,000, consisting of proceeds from the exercises of employee stock options.

1 unchanged paragraph

As of March 31, June 30, 2026, we had cash, cash equivalents and marketable securities of $90.9 $72.4 million. Based on our current plans, operating plan, we believe estimate that our existing cash, cash equivalents and marketable securities as of June 30, 2026 will not be sufficient to fund our projected operating and capital expenditure requirements and operating expenditures for at least 12 the twelve months following the date of this prospectus. the unaudited financial statements were issued, and there is substantial doubt about our ability to continue as a going concern. Nevertheless, together with the estimated net proceeds from this offering, we believe our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditures through . However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risk and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we currently expect. Additionally, our expected use of existing cash, cash equivalents, marketable securities, and our net proceeds from this offering represent our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve.

We will need substantial additional capital to develop our lead program and fund operations for the foreseeable future. The net proceeds from this offering, together with our existing cash, cash equivalents, and marketable securities will not be sufficient to complete the Phase 1/2a ASPIRO trial, the Phase 3 trial for sasineprocel, which we intend to initiate prior to the completion of the Phase 1/2a ASPIRO trial, or the development of sasineprocel or any other current or future product candidates. Our future capital requirements are difficult to predict and will depend on many factors, including but not limited to:

16 unchanged paragraphs

As of March 31, June 30, 2026, total future minimum lease payments under our operating lease agreements were $12.5 $11.6 million.

In August 2026, we entered into a noncancelable operating lease agreement with HCP Life Science REIT, Inc. for approximately 48,696 rentable square feet of office, research and development, laboratory, storage and warehouse space located in La Jolla, California (the New Lease), which we intend to establish as our corporate headquarters after the lease for our existing corporate headquarters expires in September 2027. The New Lease has an initial term of 93 months commencing on July 1, 2027 and expiring on March 31, 2035. The New Lease includes a beneficial occupancy period beginning on execution of the agreement and continuing through June 30, 2027, allowing us to complete facility improvements, install equipment and furniture, and begin certain operations prior to the July 1, 2027 lease commencement date without payment of base rent. At execution, we were obligated to pay $0.3 million, representing the first month s base rent and estimated direct expenses. The New Lease provides for a 23-month rent abatement period, during which no base rent is due; as a result, our next base rent payment is not due until July 2029. Aggregate base rent is approximately $20.2 million, net of abatements, with refurbishment and other construction allowances of up to approximately $2.5 million and a special allowance of up to $2.0 million, and a required letter of credit of approximately $0.4 million.

7 unchanged paragraphs

Pursuant to the AJ License Agreement, we have paid AJ aggregate upfront fees in the mid tens of thousands of dollars $60,000 and are obligated to pay annual maintenance fees in the low tens of thousands of dollars $25,000 until and including the calendar year in which we obtain approval of a first new drug application of a licensed product in the territory. We have paid development milestones in the low hundreds of thousands of dollars $290,000 and are obligated to pay future milestones in the low hundreds of thousands of dollars up to $135,000 upon the successful achievement of development milestones, and an amount up to $1.1 million in the low single-digit millions of dollars range, aggregate when certain net sales thresholds of a licensed product are met. We are obligated to pay AJ a running royalty rate in the low single digits, of net sales of licensed products. Our running royalty obligations are determined on a country-by-country and product-by-product basis, and shall only be due with respect to licensed products in the applicable country in the territory so long as the development, manufacture, sale, import or export of the licensed products is covered by licensed patents in such country. Once all licensed patents are extinguished in a given country, whether by expiration, lapse, revocation, or otherwise, our obligation to pay running royalties in that country ceases, except with respect to the applicable running royalties for the licensed patents used prior to the extinguishment in any such country. In addition, beginning in the calendar year following the first NDA approval of a licensed product in the territory and continuing through the expiration or termination of the AJ License Agreement, we must pay AJ a certain creditable annual minimum royalty in the mid-tens of thousands of dollars range, reduced by any running royalties paid during a certain number of preceding royalty reporting periods.

3 unchanged paragraphs

Payments related to the AJ License Agreement are expensed in the period when the contingency is resolved, and the amounts become payable. We incurred expenses of $235,000 and $25,000 under this agreement during the years ended December 31, 2025 and 2024, respectively. We did not incur any expenses under this agreement during the three six months ended March 31, June 30, 2026 and March 31, 2025.

4 unchanged paragraphs

We paid Sumitomo a non-refundable upfront payment 40.0 million in the mid tens of millions of Japanese yen December 2023 and are required to pay non-refundable annual license fees in the mid single-digit millions of Japanese yen, 6.0 million, creditable against royalties in the fiscal year of the first commercial sale of a licensed product and each year thereafter. Thus far, we have paid Sumitomo an amount in the low tens of millions of Japanese yen, 25.0 million towards certain development milestones and are obligated to pay Sumitomo future development milestone payments in an amount in the low hundreds of millions of Japanese yen, up to 125 .0 million per licensed product per region for each of the three regions in the licensed territory upon the successful achievement of each development milestone, and up to an amount in the low single-digit billions of Japanese yen 1.85 billion per licensed product when certain net sales thresholds of a licensed product are met. We are also required to pay Sumitomo a running royalty in the low single digits of annual net sales of each licensed product on a country-by-country basis during the royalty term, which lasts until the later of 1) the lapse, expiry or abandonment of the last valid claim covering the licensed intellectual property or 2) the tenth anniversary of the first commercial sale of a licensed product in the licensed territory. The royalty rate may be reduced pursuant to a customary reduction for certain intellectual property license payments in favor of third parties, subject to a low single-digit royalty rate floor. We incurred expenses in the low single-digit millions of Japanese yen 6.0 million and 6.0 million under the Sumitomo License Agreement during each of the years ended December 31, 2025 and 2024, respectively. We incurred expenses in the mid single-digit millions of Japanese yen 3.0 million and 3.0 million under the Sumitomo License Agreement during the three six months ended March 31, June 30, 2026 and 2025, respectively.

1 unchanged paragraph

From January 2025 to January 2026, we entered into four amendments to the Cell X Agreement, each of which expanded the scope of the collaboration plan to include additional development activities and design upgrades to the Cell X platform, and increased the collaboration budget by approximately $5.1 million in the aggregate.

We paid Cell X an upfront fee of $250,000 in 2024, which was included as a component of research and development expenses in the statement of operations. We are obligated to pay future milestone payments of up to $30.5 million in the aggregate, upon the achievement of specified development and regulatory milestones. If we choose to exercise our exclusive option to convert our non-exclusive license for additional CNS disease indications to an exclusive license, we may be obligated to pay additional license conversion fees up to $15.5 million. We paid Cell X a total of $2.8 million and $6.0 million during the years ended December 31, 2024 and 2025, respectively, which included those expenses incurred under the Cell X Agreement.

Certain patent rights underlying the Cell X Platform Technology are in-licensed (the CCF License) by Cell X from The Cleveland Clinic Foundation (CCF) under an exclusive license agreement (the CCF License Agreement). In January 2024, pursuant to a Side Letter Agreement among CCF, Cell X and us (the CCF Side Letter), CCF consented to our sublicense from Cell X pursuant to the Cell X Agreement. Pursuant to the CCF Side Letter, if the CCF License is terminated, our sublicense will automatically survive as a direct license between CCF and us, subject to certain conditions. Pursuant to the CCF License Agreement, CCF may terminate the CCF License upon, among various other triggers, Cell X s insolvency, failure to pay amounts due, false or misleading representations, failure to perform material covenants, or failure to achieve specified commercialization milestones, in each case subject to applicable notice and cure periods.

Cell X A&R Collaboration and License Agreement

In January 2024, we entered into a Collaboration and License Agreement (the Prior Cell X Agreement) with Cell X Technologies, Inc. (Cell X), which was amended and restated in August 2026 (as amended and restated, the A&R Cell X Agreement), pursuant to which we license systems and methods for automated detection, analysis, isolation, and harvesting of biological objects, including iPSCs, as well as related image analysis technologies (the Cell X Platform Technology). We hold (a) an exclusive, worldwide, sublicensable license under the Cell X Platform Technology to develop, practice, make, have made, use, sell, offer to sell, import and commercialize cellular therapeutic products made using the Cell X Platform Technology (Licensed Products) for the diagnosis, treatment, and or prevention of PD and leukodystrophies using autologous or allogenic allogeneic iPSCs and cells derived from iPSCs (the Exclusive License), (b) a perpetual, irrevocable, fully paid-up, non-exclusive, worldwide, sublicensable license under the Cell X Platform Technology to develop, practice, make, have made, use, sell, offer to sell, import and commercialize Licensed Products (as defined below) for the treatment or prevention all other indications including CNS and eye diseases using autologous iPSCs and cells derived from iPSCs, and (c) during the collaboration term, a non-exclusive an exclusive, worldwide, sublicensable license to perform collaboration activities. In connection with such licenses, we agreed with under the Cell X to collaborate Platform Technology for the purpose of improving PD and leukodystrophies, or non-exclusive, worldwide, sublicensable license under the Cell X Platform Technology for use by us other autologous indications, to develop, practice, have practiced, make, have made use, sell, offer to sell, import and commercialize cellular therapeutic products made using use automated cell processing systems (Licensed Instruments) incorporating the Cell X Platform Technology solely to the extent the Licensed Products). Instruments are used as research, manufacturing, processing or analytical tools to enable autologous or allogeneic iPSCs or cells derived from iPSCs for the diagnosis, treatment, and prevention of PD or leukodystrophies and the treatment or prevention all other indications (the Instrument License). The A&R Cell X Agreement does not require us to pay royalties on Licensed Products. We utilize the Cell X Platform Technology in connection with our manufacturing process for sasineprocel.

Under the A&R Cell X Agreement, the parties prior collaboration program was replaced with a technology transfer and support framework. Pursuant to this framework, Cell X is required to transfer specified licensed know-how and documentation to us and provide certain consultation and technical assistance. Pursuant to the A&R Cell X Agreement, we entered into a master services agreement with Cell X under which Cell X may perform services pursuant to statements of work entered into from time to time. We paid Cell X an upfront fee of $250,000 in 2024 under the Prior Cell X Agreement, which was included as a component of research and development expenses in the statement of operations. Under the A&R Cell X Agreement, we are obligated to pay future development and regulatory milestone payments of up to approximately $8.8 million in the aggregate, consisting of up to $6.0 million for up to two licensed products for PD and up to $2.8 million for one licensed product for leukodystrophies. We may also be required to reimburse Cell X for approved technical and regulatory support in excess of specified no-cost support hours. We paid Cell X a total of $2.8 million and $6.0 million during the years ended December 31, 2024 and 2025, respectively, which included those expenses incurred under the Prior Cell X Agreement. Unless terminated earlier, the A&R Cell X Agreement continues on a Licensed Product-by-Licensed Product, exclusive indication-by-exclusive indication and country-by-country basis until the expiration of the last-to-expire valid claim of the licensed patent rights in such country. Upon expiration, our Exclusive License converts to an irrevocable, perpetual, exclusive, and sublicensable license under the Cell X Platform Technology. and our Instrument License converts to an irrevocable, perpetual, fully paid-up, and sublicensable license. We may terminate the A&R Cell X Agreement in its entirety, or on a Licensed Product-by-Licensed Product, exclusive indication-by-exclusive indication, or country-by-country basis, at any time after the first anniversary of the effective date of the A&R Cell X Agreement, upon 90 days prior written notice to Cell X. Either party may terminate the A&R Cell X Agreement for the other party s material breach, subject to customary cure periods, or upon a bankruptcy event of the other party. Cell X may also terminate if we challenge the validity, enforceability or scope of the licensed rights. Upon an early termination, all licenses granted to us other than the non-exclusive licenses terminate; provided, however, that upon termination by us for Cell X s material breach, and upon our written election, our Exclusive License becomes irrevocable and perpetual, provided we continue to make milestone payments as set forth in the A&R Cell X Agreement. Qualifying sublicenses granted by us survive termination as direct licenses from Cell X, subject to specified conditions.

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In January 2024, we entered into a Secured Convertible Promissory Note Purchase Agreement with Cell X pursuant to which we purchased a secured convertible promissory note (the Cell X Convertible Note) with an original principal amount of $5.0 million bearing 8% simple interest per annum. The Cell X Convertible Note is secured by a first priority security interest in substantially all of Cell X s assets, including its intellectual property. The outstanding principal and interest shall automatically convert into shares of Cell X s preferred stock upon a qualified financing in Cell X. We have optional conversion rights upon a non-qualified equity financing and upon maturity of the Cell X Convertible Note. The principal and accrued interest are due and payable upon the earliest to occur of (i) the maturity date, (ii) a sale of Cell X (whether to us or to a third party), or (iii) the occurrence of an Event of Default, as defined in the Cell X Convertible Note. Following the Cell X Side Letter (as defined below), in the event we acquire Cell X we are entitled to receive the entire outstanding amount of the Cell X Convertible Note; or in the event of a third-party sale of Cell X, we are entitled to receive 200% of the entire outstanding amount of the Cell X Convertible Note. The fair value of the Cell X Convertible Note was $0.9 million and $5.5 million as of December 31, 2025 and December 31, 2024, respectively, which is included in other noncurrent assets on the balance sheet. The fair value of the Cell X Convertible Note was $1.0 $0.9 million as of March 31, June 30, 2026.

In January 2026, we entered into a First Amendment to the Cell X Convertible Note, which extended the original maturity date of January 22, 2026 to February 22, 2026. Subsequently, we entered into a series of additional amendments to further extend the maturity date. through June 10, In August 2026, we entered into a Side Letter agreement with Cell X (the Cell X Side Letter), pursuant to which, upon the satisfaction of certain conditions, the maturity date will be extended to March 31, 2028 and all security related to the Cell X Convertible Note will be released.

CCF Exclusive License Agreement

In August 2026, we entered into an Exclusive License Agreement (the CCF Agreement) with The Cleveland Clinic Foundation (CCF), pursuant to which CCF granted us direct licenses under certain patents, software and know-how underlying the Cell X Platform Technology (the CCF Licensed Technology). We hold (a) an exclusive, worldwide, sublicensable license under the CCF Licensed Technology to develop, practice, have practiced, make, have made, use, sell, offer to sell, import and commercialize cellular therapeutic products for the diagnosis, treatment and prevention of PD and leukodystrophies using autologous or allogeneic iPSCs and cells derived from iPSCs, (b) a non-exclusive, worldwide, sublicensable license under the CCF Licensed Technology to develop, practice, have practiced, make, have made, use, sell, offer to sell, import and commercialize cellular therapeutic products for the treatment or prevention of all other indications using autologous iPSCs and cells derived from iPSCs, and (c) an exclusive, worldwide sublicensable license under the CCF Licensed Technology for PD and leukodystrophies and non-exclusive, worldwide, sublicensable license under the CCF Licensed Technology for all other indications to develop, practice, have practiced, make, have made and automated cell processing systems (Licensed Instruments) incorporating the CCF Licensed Technology solely to the extent the Licensed Instruments are used as research, manufacturing, processing or analytical tools in connection with such cellular therapeutic products (and not as standalone commercial products) for the diagnosis, treatment, and prevention of PD or leukodystrophies and the treatment or prevention all other indications. We may elect, at any time before December 31, 2031, to convert leukodystrophies from an exclusive indication to a non-exclusive indication. We are required to use commercially reasonable efforts to develop and commercialize the licensed products worldwide. The CCF Agreement does not require us to pay running royalties based on a percentage of net sales of licensed products; however, we are obligated to pay fixed minimum annual payments and milestone payments as described below.

Under the CCF Agreement, we are obligated to pay CCF an upfront fee in the low five figures and a fixed, minimum annual royalty payment of $140,000 for 2026 and each calendar year thereafter during the term. We may also be obligated to pay milestone payments of up to approximately $6.1 million in the aggregate, consisting of up to approximately $3.1 million in development and commercialization milestone payments and up to $3.0 million in sales milestone payments. We are also obligated to reimburse CCF for our pro rata share of patent prosecution costs and expenses incurred by CCF after the effective date, calculated based on the total number of direct licensees of such patents at the time such costs are incurred.

Unless terminated earlier, the CCF Agreement continues on a country-by-country and licensed product-by-licensed product basis until the expiration of the last-to-expire valid claim covering the applicable licensed product in such country. Upon expiration, the licenses granted under the CCF Agreement become fully paid-up, irrevocable and perpetual on a country-by-country and licensed product-by-licensed product basis. We may terminate the CCF Agreement for CCF s uncured material breach upon 60 days notice, or for any other reason upon 60 days notice and payment of a termination fee and any other amounts then due or owing. CCF may terminate the CCF Agreement upon specified events relating to our insolvency or for an uncured failure to pay amounts due, a materially false or misleading representation or statement, or an uncured failure to perform a material covenant. CCF may also terminate the CCF Agreement if we challenge specified licensed patents, subject to certain exceptions and a cure period. If CCF does not terminate the CCF Agreement following such a challenge, the fixed minimum annual royalty payment and certain milestone payments associated with the challenged patents may be increased. Upon termination, our rights to the CCF Licensed Technology terminate and revert to CCF. Qualifying sublicenses granted by us survive termination as direct licenses from CCF, subject to specified conditions.

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The Company has We have elected for accounting purposes to treat the Award as a direct research and development arrangement in accordance with ASC 730-20, Research and Development Research and Development Arrangements , as the Company does we do not intend to repay the Award other than by way of royalty payments on potential future sales of sasineprocel. The Award is recognized as an offset to research and development expenses as costs related to the project are incurred as the Company has we have concluded that the research and development risk is substantive and it is not yet probable that development will be successful. A deferred liability is recorded when the cash disbursements under the Award exceed the related research and development expenses incurred through such date.

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During the three six months ended March 31, June 30, 2026 and 2025, the Company we did not receive any cash disbursements under the Award. The Company We recognized $0.4 $0.9 million and $0.6 $1.0 million as an offset to research and development expense for the three six months ended March 31, June 30, 2026 and 2025, respectively. The Company We recorded no deferred liability for the Award as of March 31, June 30, 2026.

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This discussion and analysis of our financial condition and results of operations is based on our financial statements included elsewhere in this prospectus, which have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) in the United States (GAAP). The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

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Stock-based compensation expense represents the cost of the grant date fair value of equity awards recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. We estimate the fair value of equity awards using the Black-Scholes option pricing model and recognize forfeitures as they occur. Estimating the fair value of equity awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of variables, including the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop. See Note 6 to our financial statements included elsewhere in this prospectus for information concerning specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted during the years ended December 31, 2025 and 2024 and during the three six months ended March 31, June 30, 2026 and 2025.

We recorded stock-based compensation expense of $2.5 million and $2.7 million for the years ended December 31, 2025 and 2024, respectively. We recorded stock-based compensation expense of $1.2 $2.5 million and $0.7 $1.2 million for the three six months ended March 31, June 30, 2026 and 2025, respectively. As of March 31, June 30, 2026, there was $11.6 $12.0 million of total unrecognized stock-based compensation expense related to unvested stock options and early-exercised stock options, which we expect to recognize over a remaining weighted-average period of 3.2 years. We expect to continue to grant stock options and other equity-based awards in the future, and to the extent that we do, our stock-based compensation expense recognized in future periods will likely increase.

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Our cash, cash equivalents and short-term investments marketable securities consist of cash held in readily available checking and money market accounts, as well as short-term debt securities. We are exposed to market risk related to fluctuations in interest rates and market prices. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of United States interest rates. Because of the short-term nature of the instruments in our portfolio, a sudden change in market interest rates would not be expected to have a material impact on our financial condition or results of operations.

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Business 86 changes

Aspen Neuroscience, Inc. is a leading, clinical-stage regenerative medicine biotechnology company focused on developing autologous iPSC-derived therapies to address neurodegenerative diseases with high unmet medical need. Our lead product candidate, sasineprocel, is an investigational single-dose, autologous iPSC-based cell therapy being evaluated for the treatment of PD. We believe sasineprocel has the potential to be disease-modifying by replacing a patient s lost DA neurons with DANPCs, capable of integrating and reestablishing functional connections. In an ongoing Phase 1/2a ASPIRO clinical trial of sasineprocel in mid-stage to moderately advanced sporadic PD, patients have experienced, what we believe to be, sustained and clinically meaningful improvements in motor, quality of life, and non-motor symptoms as measured by comparison to clinically meaningful change benchmarks. Based on these findings, we believe sasineprocel has the potential to improve upon the current standard of care in PD and address the significant unmet need for a disease-modifying therapy that may slow or halt the progression of this devastating disease. These benchmarks are reviewed on an ongoing basis during the trial and reflect management s belief based on a review of published literature, regulatory agency guidelines and precedent in PD clinical research, and discussions with key opinion leaders in the field. The benchmarks have not been discussed with the FDA or any other government regulatory authority, and have not been independently validated by any third parties.

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The current standard of care is palliative DRT, including levodopa and dopamine agonists, which addresses motor symptoms but does not replace lost DA neurons, nor does it slow continued neuronal degeneration. DRT inadequately addresses non-motor symptoms, decreases in effectiveness over time, and is associated with side effects that can significantly impact patient quality of life. As DRT loses its effectiveness or as its side effects become intolerable, advanced therapies, such as DBS, are considered. While DBS can be effective in addressing certain motor symptoms of PD, it has not been shown to slow disease progression in mid-stage to moderately advanced PD patients and can potentially worsen cognition, gait, speech and other axial symptoms. DBS has other drawbacks as well, including long delays in access and optimization, multiple invasive surgeries with permanent implanted hardware and risks such as hemorrhage, infection, and device failure. In contrast to DRT and DBS, cell replacement therapy holds significant promise as an approach to restore and replace lost dopamine neurons and the neural circuitry necessary for normal motor and non-motor function. Our cell replacement approach represents a promising therapy that could provide long-term benefits from a single administration without the need for permanently implanted hardware.

Allogeneic approaches in development for PD can require one year or more of immunosuppressive therapy post-treatment, which is associated with increased risks of infection, organ toxicity, and metabolic complications. In contrast, autologous cell therapies are derived from a patient s own cells which reduces the risk of immune rejection after transplantation. For example, Our clinical trial of sasineprocel has not required any immunosuppression post-administration and is designed to support the formation of functional synaptic connections and neural circuitry in without the absence of need for immune suppression. In third-party NHP models of PD, autologous DA progenitor cell transplantation survived without immunosuppression and integrated more robustly and produced more sustained motor improvements than allogeneic transplants. without immunosuppression. Moreover, our autologous iPSC approach is designed to require minimal cell expansion, of cells, which mitigates may reduce the risk of opportunity for genomic instability abnormalities to arise and accumulating genetic mutations, which confer a selective or growth advantage in for cells harboring growth-promoting abnormalities to become selectively enriched during extended culture. While this is designed to be a one-time therapy, the autologous nature of the product could allow for redosing, if valuable over a patient s multi-year course. We believe our autologous cell replacement strategy presents a significant advantage over both current standard-of-care therapies and allogeneic cell therapies in development for PD, and has the potential to deliver a tolerable, disease-modifying treatment with durable, long-term effectiveness.

Sasineprocel and our end-to-end autologous iPSC platform are based on advances in cellular reprogramming, including the Nobel Prize winning discovery by Shinya Yamanaka and John B. Gurdon, which demonstrated that mature, specialized cells can be reprogrammed into iPSCs through the introduction of defined transcription factors (commonly referred to as Yamanaka factors). We combine these foundational reprogramming methods with our stem cell biology expertise, the latest artificial intelligence, ML and genomic approaches to optimize cell identity, purity and functional potential and to enable a scalable, reproducible, standardized, and data-driven manufacturing process for autologous cell therapy. Sasineprocel, our proprietary autologous iPSC-derived composition of DANPCs, CNS progenitors, and glial progenitors, is designed to establish a biologically active cellular microenvironment that supports cell engraftment, survival, and functional integration of transplanted cells with the goal of restoring functional dopamine signaling in PD patients. We believe the sustained benefit observed in patients treated with sasineprocel provides evidence of neural circuitry reconstruction and is further supported by preclinical studies, in which we observed that DANPCs transplanted into PD animal models differentiated into DA neurons that integrated into the brain and restored dopamine signaling. We hypothesize that sasineprocel s combination of cells beyond DANPCs may play a key role in supporting neural synapse formation and general microenvironmental health to enable a broad and profound treatment effect in PD patients, including improvement in non-motor symptoms.

We are currently conducting the open-label Phase 1/2a ASPIRO trial evaluating sasineprocel in patients with sporadic PD and have begun enrolling genetic PD patients. The trial consists of sequential dose cohorts with sasineprocel administered as a single bilateral intracranial injection into the post-commissural putamen, an area of the brain that participates in motor control, using well-understood, standard stereotactic neurosurgical techniques. The study s primary objective is to assess safety and tolerability. The study s secondary and exploratory objectives are to evaluate the potential efficacy of sasineprocel, measured by changes from baseline in multiple patient- and clinician-reported PD-specific outcomes. These include changes in MDS UPDRS Parts I-IV, which measures the severity and progression of PD, including motor and non-motor symptoms; Hauser diary (to measure Good On time, defined as time without troublesome dyskinesia); and quality of life measures including PDQ-39. 18 FDOPA PET imaging is being used to evaluate the engraftment of cells. Certain of the secondary endpoints used in this trial are validated endpoints used in previous PD registrational clinical trials.

As of April 7, August 18, 2026, the data cutoff date, 15 patients had been dosed, with seven participants receiving a low dose and eight participants receiving a high dose. Sasineprocel was observed to be generally well-tolerated with the majority of reported adverse events being mild to moderate. Among the patients dosed, 58 72 TEAEs were reported. There was no evidence of graft-induced dyskinesias or graft rejection, and no clinically significant hemorrhages were observed post-operatively. As sasineprocel is autologous, with no requirement for immunosuppression, there were no immunosuppression-related events. Only one TEAE, myoclonus (sudden, uncontrollable muscle movement), was considered possibly related to sasineprocel, with sertraline, a selective serotonin reuptake inhibitor, identified as a co-suspect medication. One participant had two serious adverse events related to the surgical procedure (neck swelling and dysphagia due to intubation in the prone position and ischemic stroke (cerebral infarction) due to pre-operative interruption of anticoagulants that the patient was taking for a history of deep venous thrombosis). The most commonly reported TEAEs, defined as occurring in 10% or more of patients, were related to the surgery, including incision site pain, swollen tongue, headache, infusion site pain, glossodynia, hypoesthesia, and oropharyngeal pain. Two patients had intracranial hemorrhages not requiring any surgical treatment. Of these two patients, one patient had no associated symptoms and the other, who had a history of migraine, experienced a headache which resolved, with levetiracetam identified as a co-suspect medication. As of the data cutoff date, all 12 patients from the first three cohorts had at least one six-month or later follow up evaluation.

We assessed clinical efficacy outcomes every six months after administration of sasineprocel. We observed improvements across several secondary and exploratory endpoints, including changes in Good On Time (On time without troublesome dyskinesia normalized to 16 hours of the day), Off time, MDS-UPDRS Part III OFF, MDS-UPDRS Part II ON, and PDQ-39 scores, as summarized below. Certain of the secondary endpoints used in this trial, including Good On Time and MDS-UPDRS Part III OFF, are validated registrational endpoints used in previous PD registrational clinical trials. The mean improvements at 18 months in both cohorts and 24 months in the low dose cohort for Good On Time and MDS-UPDRS Part III OFF scores in both cohorts were above clinically meaningful change benchmarks. The mean PDQ-39 and MDS-UPDRS Part II ON scores improved above clinically meaningful change benchmarks in the low dose cohort at 18 and 24 months and were stable in the high dose cohort at 18 months. 18 FDOPA PET imaging is also being used to evaluate the engraftment of cells. 18 FDOPA PET imaging showed elevated 18 FDOPA uptake values at 6, six, 12, and 18 months following sasineprocel administration compared to baseline, which is evidence of the survival, viability, and integration of transplanted iPSCs. Clinically meaningful change benchmarks are reviewed on an ongoing basis during the trial and reflect management s belief based on a review of published literature, regulatory agency guidelines and precedent in PD clinical research, and discussions with key opinion leaders in the field. The benchmarks have not been discussed with the FDA or any other government regulatory authority, and have not been independently validated by any third parties.

Additionally, the ASPIRO trial is exploring changes in DA medication as measured by LEDD, a standardized calculation that converts all DA medications a patient is taking into a single equivalent dose of levodopa, providing a measure of total daily DA medication burden using established methodology. A reduction in LEDD suggests that a patient requires less DA medication to manage their motor symptoms. As of the LEDD data cutoff date, of April 10, 2026, in the low dose cohort, two, three, three and three patients showed a reduction in LEDD at six, 12, and 18 and 24 months, respectively, and one patient experienced an LEDD increase at 18 and 24 months. In the high dose cohort, at six months, three out of eight patients showed an LEDD reduction and one patient showed an LEDD increase; at 12 months, two out of four patients showed an LEDD reduction and one patient showed an LEDD increase; at 18 months, two three out of four patients showed an LEDD reduction and two one showed an LEDD increase.

Figure 1. Sustained improvements observed across multiple validated PD endpoints. Data summarized above is as of April 7, 2026, except LEDD data is summarized as of April 10, August 18, 2026. A decrease (negative number) compared to baseline is an improvement for MDS-UPDRS scores and PDQ-39. The numbers in parentheses represent standard deviations. Mean changes in data summarized above are driven by totality of data across patients and not driven by a limited number of patients exhibiting significantly better-than-average improvements. * For the four high dose patients for whom data was available at the 12-month and 18-month assessments, the baseline values for Good On Time (hours) Hauser Diary, Off Time (hours) Hauser Diary, MDS-UPDRS Part III OFF score, MDS-UPDRS Part II ON score, and PDQ-39 were: 11.7 (0.9), 4.3 (0.9), 44.0 (4.2), 9.5 (9.3), 16.1 (15.6), respectively. For the three low dose patients in Cohort 4, no data is yet available because six months have not elapsed since dosing for all three patients.

We expect to report further long-term data from the ASPIRO trial in . the first half of 2028. In addition, we plan to dose a single cohort of approximately three to six patients with genetic PD in the ASPIRO trial. We anticipate initiating biopsy collection for the Phase 3 trial in . by the end of 2026. Following feedback from the FDA, we anticipate dosing patients in a the Phase 3 trial in . the second half of 2027.

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Damien McDevitt, Ph.D., our Chief Executive Officer, previously served as Chief Executive Officer of Akcea Therapeutics, a rare diseases company, prior to its acquisition by Ionis Pharmaceuticals in 2020, and held several leadership roles at Ionis Pharmaceuticals, Acadia Pharmaceuticals, and GlaxoSmithKline Pharmaceuticals. Dr. McDevitt was involved in the commercialization, late-stage development or in-licensing of the following approved products: TEGSEDI (inotersen) for hereditary transthyretin-mediated amyloidosis, WAYLIVRA (volanesorsen) for familial chylomicronemia syndrome (approved in the European Union) and DAYBUE (trofinetide) for Rett syndrome. Revati Shreeniwas, M.D., our Chief Medical Officer, previously served in senior clinical roles at several companies and has previously worked on Phase 3 trials and the New Drug Application submission of RYTARY (carbidopa/levodopa) for PD and has deep experience in CNS and other therapeutic areas. Dr. Shreeniwas has a proven track record of working on programs from pre-IND through Phase 3 and registration. Lisa Johnson-Pratt, M.D., our Sasineprocel Development Lead and Chief Commercial Officer, has successfully led programs across the entire product life cycle with leadership roles in medical affairs, clinical development, product development, portfolio planning and new product strategy. Dr. Johnson-Pratt was involved in the launch of GARDASIL (human papillomavirus 9-valent vaccine, recombinant), IMITREX (sumatriptan) and MAXALT (rizatriptan benzoate), and new indication launches of SINGULAIR (montelukast sodium) and COZAAR (losartan potassium), and led new product strategy for BLENREP (belantamab mafodotin-blmf), WAINUA (eplontersen), and TRYNGOLZA (olezarsen). Our scientific co-founder and Senior Vice President of R&D, Andr s Bratt-Leal, Ph.D., previously trained in Dr. Loring s laboratory, where he played a central role in developing the core technology underlying our DA neuron production and led our preclinical development efforts for autologous cell-based therapy for PD.

The Executive Chairman of our Board of Directors, Faheem Hasnain, is the Co-Founder, Chairman and Chief Executive Officer of Gossamer Bio. Mr. Hasnain previously served as President, Chief Executive Officer and Director of Receptos, which was acquired by Celgene in 2015. He is joined by a distinguished group of Board members who bring additional operational, scientific, financial and strategic expertise.

Since our inception, we have raised approximately $347 million from a syndicate of leading life science sciences investors and organizations, including OrbiMed, ARCH Venture Partners, Frazier Life Sciences, Medical Excellence Capital, and Kite, a Gilead Company, as well as a grant from CIRM. These investors have extensive experience supporting the development and commercialization of innovative biotechnology platforms and therapeutics. Prospective investors should not rely on the investment decisions of our existing investors, as these investors may have different risk tolerances and have received their shares in prior offerings at prices lower than the price offered to the public in this offering.

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Stage 2 (Fibroblasts to iPSCs): The fibroblasts are converted into iPSCs through a process known as cellular reprogramming , in which a defined set of transcription factors, classically Oct3/4, Sox2, Klf4, and L-Myc, collectively referred to as the Yamanaka factors, are introduced to reset the cells gene expression and epigenetic profiles, thereby reverting them from a differentiated somatic state back to a pluripotent, embryonic-like state. We utilize Yamanaka factors and viral vectors encoding Yamanaka factors licensed from third parties including iPS Academia Japan, Inc. and Sumitomo Pharma Co. Ltd. See Licensing and Collaboration Agreements below for additional information. These iPSCs are advanced to Stage 3 following characterization and QC testing for sterility, identity, purity and pluripotency (using our proprietary PluriTest).

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Our platform is designed to address key challenges associated with autologous cell therapies, including inter-patient variability, genomic instability, and inconsistent cellular differentiation. To mitigate these risks, we use multiple assays and proprietary datasets to assess genetic identity, genomic integrity, lineage specification, purity, and to predict assess functional performance prior to clinical administration. We have combined our data with work started in 2012, before the company was founded, by our scientific founders at the Scripps Research Institute to create proprietary data that integrates whole-genome sequencing, RNA sequencing, and transcriptomic analytics. Certain assays are currently used for product characterization and release, while additional RNA sequencing-based machine learning models continue to be refined as part of our broader potency assurance framework. A series of rigorous release assays are performed on the final manufactured product to validate assess product characteristics. quality attributes. These include RNA-sequencing-based tests to predict assess identity and maturity (NeuriTest), engraftment potential (GraftTest), and dopamine release (DopaTest). These bioinformatics-based assessments are informed by preclinical in vitro and in vivo studies testing different lots from individual PD patient cells, with lots from multiple PD donors evaluated. In addition, an in vitro bioassay, the DOPA decarboxylase (DDC) activity assay, is performed to measure conversion of levodopa (L-dopa) to dopamine to test cellular functionality and stability of DANPCs after cryopreservation.

Figure 3. Overview of expected potency assays (ML models and bioassays) used to predict assess sasineprocel performance. Four independent tests are performed: NeuriTest, GraftTest, DopaTest, and DDC activity.

We are developing an automated, robust, modular manufacturing process for sasineprocel that we believe could reduce the manual labor required by more than 90% while still maintaining GMP requirements. Our manufacturing system incorporates two principal automated systems. The first is the Cell X platform, which can be used in Stage 1, Stage 2, and the iPSC scale-up portion of Stage 3. The Cell X platform integrates incubation within an isolation chamber, robotics, liquid handling, and optical machine vision, along with proprietary ML algorithms to evaluate fibroblast cell culture and iPSC clones for quality and to identify the most promising cells for advancement through the manufacturing process. The Cell X platform automates all standard cell culture steps for derivation of iPSCs including cell selection, reprogramming, cell removal, expansion, and harvest. We expect that each module within the Cell X platform will be capable of autonomous (self-driving) manufacturing to support manufacturing capacity for hundreds of patients on an annual basis. The second system, the Mytos device, is used in Stage 3, during which iPSC clones are differentiated into DANPCs in a closed system process. This system automates the feeding, expansion, passaging, and harvest of the iPSC into DANPCs. The Cell X platform and the Mytos devices are supplied by third party technology solution providers and are purchased and owned by Aspen. We expect the automated manufacturing process to be ready for use in early 2027, but will be required to submit an IND amendment to the FDA prior to utilizing the automated manufacturing process in our clinical trials.

We have designed a modular automation template that combines these automated platforms within a small cleanroom footprint (approximately 5,000 square feet) intended to achieve manufacturing capacity for hundreds of patients annually. We expect that this automation template can be replicated and scaled up in through module replication for manufacturing to meet potential future demand.

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Advance sasineprocel, our personalized potentially disease-modifying product candidate for PD patients, through Phase 3 trials for sporadic PD. We are continuing to advance our lead product candidate, sasineprocel, in PD, following encouraging interim results in our Phase 1/2a ASPIRO trial, including sustained improvement in PD patients motor and non-motor symptoms, and quality of life measures. We believe sasineprocel has the potential to slow or halt the progression of PD, which would transform the lives of PD patients. Following feedback from the FDA, we plan to commence a Phase 3 study in patients with PD in . by the end of 2026. The initial phase of the study will involve collecting details of disease and natural history of PD and obtaining skin biopsies in in order to manufacture sasineprocel, with the goal of dosing patients in . the second half of 2027. After assessment of efficacy and safety at 18 and 24 months post dose, we plan to collect long-term safety follow-up data for a total of 15 years post dose, based on current FDA guidelines for cell and gene therapy product. products.

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Build scalable, autologous automated autologous cell manufacturing to support potential commercialization in North America (United States and Canada) with plans in the future to expand globally. We plan to continue to invest in automating our cell manufacturing process to decrease costs and maintain product consistency, while preparing for commercial scale with a focus on continuing to improve automation and implementing our plan to scale capacity to meet anticipated demand. Our end-to-end platform and modular automation template is designed to allow for capital-efficient scaling of our manufacturing system to enable the potential treatment of thousands hundreds of patients annually per module.

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Expand our pipeline by leveraging our platform to identify and develop additional product candidates in CNS indications where cell replacement therapy offers meaningful therapeutic potential. We have significant expertise in the discovery and development of autologous iPSCs to treat patients with CNS diseases. We have demonstrated the potential for our technology across additional neuronal cell types in preclinical proof-of-concept studies. We believe our ability to reestablish the neural circuitry through the administration of neuronal cells designed with high fidelity, reproducibility, and functional potency may extend beyond DA neurons. Using our platform, we are advancing a second program targeting microglial cells for the treatment of pediatric rare indications, such as inherited leukodystrophies. Additionally, we have discovery programs focused on deriving non-neuronal cell types with potential for application outside the CNS.

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After assessment of efficacy and safety at 18 and 24 months post dose, we plan to collect long-term safety follow-up data for a total of 15 years post dose, based on current FDA guidelines for cell and gene therapy product. products.

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We are developing sasineprocel, a single-dose, autologous iPSC-based therapeutic candidate for PD that is designed to replace a patient s lost dopamine neurons. We are currently conducting the open-label Phase 1/2a ASPIRO trial of a single dose of sasineprocel in mid-stage to moderately advanced PD patients. The trial consists of four cohorts at two dose levels, both of which were anticipated to be biologically active, with sasineprocel administered as a single bilateral intracranial injection into the post-commissural putamen using well-understood, standard stereotactic neurosurgical techniques. As of the data cutoff date, 15 patients had been dosed, with seven participants receiving a low dose and eight participants receiving a high dose. As of the data cutoff date, all 12 patients from the first three cohorts had at least one six-month or later follow up evaluation. We assessed clinical outcomes every six months after administration of sasineprocel. Sasineprocel has been granted RMAT designation from the FDA for the treatment of levodopa-responsive PD and Fast Track designation from the FDA for the treatment of PD to improve motor function. A biological product candidate is eligible for RMAT designation if it meets the definition of a regenerative medicine therapy, which the FDA defines as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exception, if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence indicates that it has the potential to address unmet medical needs for such disease or condition. A new drug or biologic is eligible for Fast Track designation if it is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for such disease or condition. However, RMAT or Fast Track designation may not result in a faster development process, review, or approval compared to conventional FDA procedures, and does not increase the likelihood that sasineprocel will receive regulatory approval. In addition, because sasineprocel is designed to be administered through drug delivery devices, we anticipate that sasineprocel would be regulated as a combination product by the FDA, which requires coordination between the FDA s Center for Biologics Evaluation and Research and the FDA s Center for Devices and Radiological Health for review. For additional information, see the section titled Risk Factors Additional time may be required to obtain marketing authorizations for any of our product candidates that we develop as combination products.

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We have begun enrolling patients and are preparing to initiate dosing a new cohort in the Phase 1/2a ASPIRO trial to evaluate sasineprocel in patients with genetically defined PD, leveraging our existing autologous DANPC manufacturing process. For the new cohort, we also plan to utilize additional standard of care stereotactic neurosurgical techniques including CT and MRI imaging guidance and robot assisted neurosurgery and an infusion pump to deliver sasineprocel. Pending the results of this cohort, we intend to include patients with genetic PD in our Phase 3 program to support a broad label for sasineprocel, if approved. Approximately 15%, or 150,000 of U.S. and 1.5 million of global PD patients have a genetic component of the condition. The most common PD-associated mutations are in the GBA1 and LRRK2 genes and are associated with increased susceptibility to PD, driving earlier disease onset. However, these mutations do not confer a developmental defect in neuronal function and the majority of people with these mutations will not develop PD. Although these mutations contribute to disease pathogenesis, preclinical studies have shown that iPSC reprogramming resets markers of cellular aging, mitochondrial dysfunction, and epigenetic abnormalities, and potentially winds back the epigenetic clock to a pre disease state. Further, preclinical studies evaluating iPSC-derived DA neurons carrying GBA1 mutations have not demonstrated consistent or material differences in key cellular characteristics compared to wild type iPSC-derived DA neurons under the conditions tested. Therefore, we believe functional DA neurons can be efficiently derived from autologous iPSCs, even in the presence of late onset disease-associated mutations, supporting the use of sasineprocel as a potential treatment for genetically defined PD.

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Our lead microglia program initially targets pediatric leukodystrophies, a group of rare, genetically defined neurological disorders that primarily affect the white matter of the CNS. Our approach is designed to generate autologous, gene-corrected microglia precursor cells derived from patient-derived iPSCs. We utilize targeted genome editing approaches to address disease-associated genetic variants. These gene-corrected cells are then differentiated into microglia precursor cells intended for administration to the CNS, where they are designed to engraft and replace dysfunctional microglia and support the restoration of key microglial functions within the CNS. Subject to the successful completion of ongoing preclinical and development activities, we plan expect to initiate IND-enabling studies in the second half of 2027.

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PD affects an estimated more than one million people in the United States with 90,000 new patients diagnosed each year. Globally, an estimated more than 10 million people are living with PD. 25.2 million people are projected to be living with PD worldwide by 2050, representing a 112% increase from 2021. Approximately 1.3 million PD patients are projected to be living in the United States by 2036. The prevalence has doubled globally in the past 25 years, driven by an aging global population and improved diagnosis through expanded access to movement disorder specialists (MDS). The economic burden in the United States has surpassed the $79 billion previously projected for 2037, with total annual costs reaching $82.2 billion in 2024 and expected to exceed $112 billion by 2045. Disability income is approximately $4.8 billion and, as most already-diagnosed patients are over the age of 65, Medicare bears the largest share of U.S. medical costs. Additionally, incidence of young-onset PD has increased globally. Overall, the disease can exert a significant impact on patients, their families, their caregivers and community, the healthcare system, payers, payors, and society.

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DBS is effective at reducing Off Time and managing tremor. It also often helps patients reduce doses of DRT, thus reducing peak-dose dyskinesia. However, it has some significant limitations. Due to the shortage of DBS-trained MDS, referrals to physicians capable of managing DBS patients can take many months. Further, only 10-15% of PD patients eligible for DBS are referred for treatment and <2% of patients elect to undergo the DBS placement procedure. Many patients are resistant to permanent placement of foreign hardware devices into their brains and elsewhere in their bodies (DBS extension wires are placed in the neck which connect the brain leads to batteries that are generally placed in the chest). Further, the hardware may limit use of diagnostic magnetic resonance imaging (MRI) scans and cause interference with electrocardiograms (ECGs) and other potentially needed emergency diagnostic studies. Additionally, it can take up to six months after an MDS recommendation referral to schedule DBS lead placement surgery (which is associated with a small risk of symptomatic hemorrhage), and a second surgery for battery placement is commonly performed separately. Then it can take many months working with a DBS neurologist to optimize device settings to maximize benefit and minimize stimulation-induced side effects. Moreover, the batteries for the system need to be periodically replaced. The DBS hardware may fail or become infected, often necessitating additional surgeries or removal of the hardware and sometimes long courses of antibiotics. DBS has not been shown to slow disease progression in mid-stage to moderately advanced PD patients and can potentially worsen cognition, gait, speech and other axial symptoms.

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Current studies in allogeneic therapies provide some early evidence for success, feasibility, and safety of stem cell transplantation, cell survival, and engraftment. Allogeneic approaches use a cell line derived from an individual other than the patient, while autologous therapies use the patient s own cells. The allogeneic, embryonic stem cell-derived, dopamine-producing neuronal product, bemdaneprocel, from BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, demonstrated favorable safety results at 36 months in Phase I 1 trial participants, which we believe validates the potential of a cell replacement approach for PD. However, bemdaneprocel and certain other allogeneic products can require systemic immunosuppression, with drugs like tacrolimus and prednisone, for one year or more following surgery. These immunosuppressants carry significant clinical risks and side effects, especially tacrolimus, which has a narrow therapeutic index and requires therapeutic drug monitoring and adds to the cost of treatment. The drawbacks of immunosuppression with tacrolimus and prednisone include:

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The burden and deleterious effects of immunosuppression alongside the ethical and regulatory complexities associated with embryonic stem cells make autologous iPSC-derived therapies a highly attractive alternative. We believe an autologous iPSC-derived product has the potential to create autologous dopamine-producing cells for PD patients while eliminating the need for immunosuppression. In addition, we believe primate experimental data support the absence of an ongoing neuroinflammatory immune response as typically seen in autologous allogeneic therapies, which can better facilitate optimal graft integration and improved synaptic circuit formation. Moreover, autologous manufacturing uses the patient s own cells, so there is no large-scale master cell bank expansion, thereby potentially reducing the risk of accumulating genomic abnormalities, including those that could lead to malignant transformation. Further, an autologous product is not expected to trigger immune rejection responses that are commonly associated with donor-derived allogeneic cell therapies, such as organ toxicity. As a result, autologous approaches may allow greater flexibility in dosing at a higher level unlike allogeneic therapies, where higher dosing may increase the risk of immune-mediated rejection or require intensive immunosuppressive regimens.

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A third-party preclinical study was conducted by the University of Wisconsin-Madison (Tao et al., Nature Medicine, 2021) comparing autologous to allogeneic iPSC-derived DA neuronal cell transplantation in NHP models of PD over a two-year period, without immunosuppression, was conducted to evaluate motor function, graft survival and integration, among other things. This study demonstrated improvements in motor behavior following transplantation of DA progenitor cells, with autologous grafts associated with approximately 40% to 60% improvement in motor function, sustained over a 24-month post-transplant period, compared with allogeneic grafts in the absence of immunosuppression (Figure 4 below). In addition, histological analyses showed that autologous grafts differentiated into tyrosine hydroxylase (TH)-positive DA neurons and exhibited extensive neurite and axonal outgrowth extending from graft sites into surrounding host tissue, consistent with reconstruction of DA neural circuitry. In contrast, allogeneic grafts in the same model demonstrated more limited neurite outgrowth and reduced integration in the absence of immunosuppression. These findings suggest that autologous DA progenitor transplantation may support more robust neural integration and restoration of DA signaling compared with donor-derived cells when immunosuppression is not administered. However, allogeneic cell therapies in clinical settings are generally administered with immunosuppression, and the results of this study may not be predictive of patient outcomes under conditions in which immunosuppression is used. To our knowledge, there are no published preclinical studies directly comparing autologous to allogeneic dopaminergic precursor cell transplantation under immunosuppression in comparable non-human primate models of Parkinson s disease.

Figure 4. Monthly clinical rating score (CRS) of the monkeys receiving allogeneic or autologous transplantation from 12 months before transplantation to 24 months after transplantation. The transplantation occurred at month 0. Lines show mean values for every 3 three months from the allogeneic group or the autologous group. Significance was assessed by Friedman test (non-parametric statistical test); (d, e); * p < 0.05, ** p < 0.01.

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We are developing sasineprocel, an investigational single-dose one and done, autologous iPSC-based product candidate for PD that is designed to replace a patient s lost dopamine neurons with DANPCs. We believe sasineprocel, our personalized and proprietary composition of neural precursors for each patient, has the potential to recapitulate and restore the neural circuitry in PD patients and, if approved, become the first FDA-approved disease-modifying therapy for PD with potential to address motor and non-motor symptoms. There are several characteristics of sasineprocel that differentiate it from standard of care and/or allogeneic therapies in development and position it as a potentially transformative treatment for PD patients:

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We are currently conducting the open-label Phase 1/2a ASPIRO trial of a single dose of sasineprocel in patients with PD. Promising interim clinical data from both the high and low dose cohorts suggests that the administration of sasineprocel could potentially lead to significant long-term clinical benefit for PD patients across both motor and non-motor symptoms and potentially slow or halt the progression of the disease. We expect to report 24-month data from four patients in the low dose cohort and 18-month data from four patients in the high dose cohort in . In addition, we plan to dose approximately a single cohort of three to six patients with genetic PD in the ASPIRO trial. We anticipate initiating biopsy collection for the Phase 3 trial in . by the end of 2026. Following feedback from the FDA, we anticipate dosing patients in a the Phase 3 trial in . the second half of 2027.

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Sasineprocel is a proprietary composition consisting primarily of dopamine neural precursors, DANPCs, along with supportive CNS and glial progenitors, designed to replace lost DA neurons and restore motor and non-motor function in patients with PD. The loss of these DA neurons in the substantia nigra pars compacta leads to a concentrated loss of dopamine within the striatum, specifically the post-commissural putamen, which is where sasineprocel is precisely administered. Placing sasineprocel into the putamen, an area where there is significant DA neuronal loss associated with PD pathology, is optimal for restoring the lost dopamine signaling and neurocircuitry. Following transplantation, DANPCs are intended to engraft and mature into dopamine-producing neurons. As these grafted DA neurons mature, they are designed to form synaptic connections with existing neurons and achieve graft-to-host integration with a patient s existing neural circuitry promoting functional recovery. Our hypothesis is that this functional recovery can re-establish the brain s ability to release dopamine on demand in a physiological manner. Consistent with this biological framework, proposed mechanism, our preclinical studies have demonstrated that sasineprocel differentiated into post-mitotic DA neurons following transplantation, established synaptic connectivity, and restored dopamine signaling in established animal models of PD. In addition to DANPCs, sasineprocel contains low percentages of supportive neural and glial progenitor cell populations, including astrocyte progenitors and progenitors capable of giving rise to other neuronal cell types. Based on ongoing preclinical studies and the known biological functions of these cell types, DANPCs, along with CNS other neural and glial progenitors, may help establish a biologically active microenvironment that promotes cell engraftment, survival, and functional integration. The sasineprocel composition also includes other midbrain-derived neurons (GABAergic, glutamatergic, and cholinergic) intended to restore non-DA circuitry and improve non-motor symptoms. Astrocyte progenitor cells are also present in the composition of sasineprocel and may play a key role in supporting neural synapse formation and improving general microenvironment health. It is possible that transplanted astrocyte progenitors can proliferate and replace aged and diseased astrocytes to support reconstruction of neural circuitry.

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We plan to evaluate the outcomes of these patients every six months for the first two years and yearly thereafter and intend to perform long-term safety follow-up extending through 15 years. Secondary endpoints include the evaluation of putaminal Fluorodopa uptake using Fluorodopa PET, which is specialized brain imaging technique that uses a radioactive tracer called 18 FDOPA to visualize DA nerve terminals in the striatum, the brain region most affected in PD. Additionally, we evaluated movement, function, sleep, and medication using two forms of digital health technologies (DHT), one for use at home and a wearable device for use both at home and outside the home.

We enrolled 15 patients in the ASPIRO trial of which 12 patients from the first three cohorts have available data for secondary and other exploratory objectives. Key patient enrollment criteria included age 50 to 70, at least four years post-PD diagnosis and responsiveness to L-dopa. Patients who had prior brain intervention (including DBS and FUS), were cognitively impaired or had medical or surgical risk factors for trial participation were excluded.

We use a streamlined, precise and minimally invasive process for sasineprocel administration that may generally allows allow patients to be discharged the next day. Prior to administration, the drug product arrives as cryopreserved cells in a vial, which is warmed at bedside one hour before surgery. The product is delivered using well-understood, standard stereotactic neurosurgical techniques. The administration is performed through a single 4mm approximately 5mm burr hole per hemisphere with bilateral cell deposition into the putamen over a duration of approximately 90 minutes.

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IND clearance was delayed from January to August 2023 due to a clinical hold imposed by FDA related to insufficient information in the IND regarding the syringe used as part of our drug delivery system. During the course of the ASPIRO trial, we also experienced a delay in patient dosing due to issues with the design of the syringe. used as part of our drug delivery system. The FDA imposed a clinical hold on the syringe used as part of our drug delivery system between January 2023 and August 2023. We worked with the supplier to design and validate a new syringe configuration, which has been implemented for subsequent dosing. We do not currently have arrangements in place for redundant supply or a second source for all required materials and components, including the delivery device, used in our clinical trials. See Risk Factors Risks Related to Our Reliance on Third Parties for additional information.

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As of April 7, August 18, 2026, the data cutoff date, sasineprocel was generally well tolerated with a majority of reported adverse events being mild to moderate. As of the data cutoff date, 15 patients had been dosed, with seven participants receiving a low dose and eight participants receiving a high dose. Among the patients dosed, 58 72 TEAEs were reported. There was no evidence of graft-induced dyskinesias or graft rejection, and no clinically significant hemorrhages were observed post-operatively. As sasineprocel is autologous, with no requirement for immunosuppression, there were no immunosuppression-related events. Only one TEAE, myoclonus (sudden, uncontrollable muscle movement), was considered possibly related to sasineprocel, with sertraline, a selective serotonin reuptake inhibitor, identified as a co-suspect medication. One participant had two serious adverse events related to the surgical procedure (neck swelling and dysphagia due to intubation in the prone position and ischemic stroke (cerebral infarction) due to pre-operative interruption of anticoagulants that the patient was taking for a history of deep venous thrombosis). The most commonly reported TEAEs, defined as occurring in 10% or more of patients, were related to the surgery, including incision site pain, swollen tongue, headache, infusion site pain, glossodynia, hypoesthesia, and oropharyngeal pain. As of the data cutoff date, all 12 patients from the first three cohorts had at least one six-month or later follow up evaluation. Two patients had intracranial hemorrhages not requiring any surgical treatment. Of these two patients, one patient had no associated symptoms and the other, who had a history of migraine, had a headache that resolved, with levetiracetam identified as a co-suspect medication.

We are assessing clinical outcomes every six months after administration of sasineprocel. As of the data cutoff date, we observed improvements across several secondary and exploratory endpoints, including changes in Good On Time (On time without troublesome dyskinesia normalized to 16 hours of awake time), MDS-UPDRS Part III OFF. Consistent with these motor improvements, we also observed improvements in activities of daily living and quality of life measures assessed by MDS-UPDRS Part II ON and PDQ-39 scores, as summarized below. Certain of the secondary endpoints used in this trial, including Good On Time and MDS-UPDRS Part III OFF, are validated registrational endpoints used in previous PD registrational clinical trials. The mean improvements at 18 months in both cohorts and 24 months for the low dose cohort for Good On Time and MDS-UPDRS Part III OFF scores in both cohorts were above clinically meaningful change benchmarks. The mean PDQ-39 and MDS-UPDRS Part II ON scores improved above clinically meaningful change benchmarks in the low dose cohort at 18 and 24 months and were stable in the high dose cohort at 18 months. 18 FDOPA PET imaging is also being used to evaluate the engraftment of cells. 18 FDOPA PET imaging showed elevated 18 FDOPA uptake values at 6, six, 12, and 18 months following sasineprocel administration compared to baseline, which is evidence of the survival, viability, and integration of transplanted iPSCs. Clinically meaningful change benchmarks are reviewed on an ongoing basis during the trial and reflect management s belief based on a review of published literature, regulatory agency guidelines and precedent in PD clinical research, and discussions with key opinion leaders in the field. The benchmarks have not been discussed with the FDA or any other government regulatory authority, and have not been independently validated by any third parties.

Additionally, the ASPIRO trial is exploring changes in DA medication as measured by LEDD, a standardized metric that converts all DA medications a patient is taking into a single equivalent dose of levodopa, providing a measure of total daily DA medication burden. A reduction in LEDD suggests that a patient requires less DA medication to manage their motor symptoms. As of the LEDD data cutoff date, of April 10, 2026, in the low dose cohort, two, three, three and three patients showed a reduction in LEDD at six, 12, and 18 and 24 months, respectively, and one patient experienced an LEDD increase at 18 and 24 months. In the high dose cohort, at six months, three out of eight patients showed an LEDD reduction and one patient showed an LEDD increase; at 12 months, two out of four patients showed an LEDD reduction and one patient showed an LEDD increase; at 18 months, two three out of four patients showed an LEDD reduction and two one showed an LEDD increase.

Figure 6. Sustained improvements observed across multiple validated PD endpoints. Data summarized above is as of April 7, 2026, except LEDD data is summarized as of April 10, August 18, 2026. A decrease (negative number) compared to baseline is an improvement for MDS-UPDRS scores and PDQ-39. The numbers in parentheses represent standard deviations. Mean changes in data summarized above are driven by totality of data across patients and not driven by a limited number of patients exhibiting significantly better-than-average improvements. * For the four high dose patients for whom data was available at the 12-month and 18-month assessments, the baseline values for Good On Time (hours) Hauser Diary, Off Time (hours) Hauser Diary, MDS-UPDRS Part III OFF score, MDS-UPDRS Part II ON score, and PDQ-39 were: 11.7 (0.9), 4.3 (0.9), 44.0 (4.2), 9.5 (9.3), 16.1 (15.6), respectively. For the three low dose patients in Cohort 4, no data is yet available because six months have not elapsed since dosing for all three patients.

Beyond these changes being what we believe to be clinically meaningful from baseline, third-party natural history studies suggest patients with PD worsen across all these measures. Parkinson s Progression Markers Initiative, or PPMI, is a large, internationally used research data set designed to collect standardized clinical data over time to better understand how PD starts and progresses. These PPMI data suggest progressive worsening of approximately two points per year on the MDS-UPDRS Part III OFF scale. In contrast, sasineprocel, including eight patients (low dose; n=4, high dose; n=4), shows a mean decrease, or improvement, at six, 12, and 18 months of 14.6, 14.5, and 16.1 points, respectively, and, including four patients (low dose; n=4), shows a mean decrease, or improvement, at 24 months of 15.8 points. Figure 7 below p resents the mean change from baseline in MDS-UPDRS Part III OFF scores for each patient at the six-month, 12-month, and 18-month and 24-month assessments together with the mean change from baseline observed in natural history study patients, reflecting the progressive worsening expected in PD patients over time .

Figure 8 below presents the Good On Time for each patient at each available assessment, as measured using the Hauser diary, together with the mean Good On Time hours for the low dose and high dose cohorts at each assessment, in each case as of the April 7, August 18, 2026 efficacy data cutoff. The mean Good On Time hours for each cohort at each assessment, as shown in Figure 8 below, reflect the average of the individual patient Good On Time hours at such assessment. As measured by mean change from baseline per patient, the low dose cohort showed a mean increase of 2.2 hours at 18 months and 2.6 hours at 24 months, and the high dose cohort showed a mean increase of 2.7 hours at 18 months. For the low dose cohort, there were four patients in each of the assessments shown. For the high dose cohort, there were eight patients for the baseline and Day 180 assessments. Day 365, and 18-month assessments had four patients; the mean baseline and standard deviation for the four patients shown at Day 365, and 18 months was 11.7 (0.9).

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Quality of life improvements are being assessed using PDQ-39, a 39-item, patient reported questionnaire used to measure health related quality of life in people with PD. PDQ-39 is the most widely used disease specific quality of life measure for PD. The questionnaire asks patients how often, over the past month, they have experienced difficulties related to PD across eight domains, including mobility, activities in daily living, emotional well-being, stigma associated with disease, social support, cognition, communication, and bodily discomfort. Each domain is scored on a standard scale ranging from 0 100 and the total score is the mean of the eight subdomains, with higher values indicating greater disease burden. As of the data cutoff date, patients in the first cohort 1 (low dose; n=4) and the second cohort 2 (high dose; n=4), treatment with sasineprocel resulted in a reduction in total PDQ-39 score of 5.0 at each of 18 months of 5.0 and 3.8, respectively, 24 months for the low dose cohort and 3.9 at 18 months for the high dose cohort demonstrating meaningful improvements in quality of life. As of April 7, August 18, 2026, the data cutoff date, the total PDQ-39 score at 18 months improved (decreased) in three out of eight patients, with a mean 29% reduction from baseline, remained stable in four patients, and worsened in one patient. As of the data cutoff date, the total PDQ-39 score at 24 months improved (decreased) in three out of four patients, with a mean 36% reduction from baseline, and worsened in one patient.

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We have explored endpoints across the Scales for Outcomes in Parkinson s Disease Autonomic (SCOPA-AUT) measurements, a validated, patient reported questionnaire specifically designed to assess autonomic nervous system symptoms in people with Parkinson s disease, and the Montreal Cognitive Assessment (MoCA) measurements, the most widely used brief cognitive screening tool for detecting mild cognitive impairment (PD MCI) and Parkinson s disease dementia (PDD). At 18 months, out of eight patients (low dose; n=4, high dose; n=4), we saw directional improvements in SCOPA-AUT in three patients, stability in four patients, and worsening in one patient. At 24 months, out of four patients (low dose; n=4), we saw directional improvements in SCOPA-AUT in two patients, stability in one patient, and worsening in one patient. At 18 months, out of eight patients (low dose; n=4, high dose; n=4), we observed stability in MoCA in all eight patients, and at 24 months, out of four patients (low dose; n=4), we observed stability in MoCA in all four patients. For purposes of evaluating clinical trends in SCOPA-AUT scores, management defined improvement as a greater than 20% decrease from baseline, stable as a change between a 20% decrease and a 20% increase from baseline, and worsening as a greater than 20% increase from baseline.

The gait axial subscore, a clinical metric derived from MDS-UPDRS Part III, improved in 7 seven out of 8 eight patients at 18 months, with a mean 46% increase, reduction, and improved in all four patients at 24 months, with a mean 45% reduction, as shown in Figure 9 below. Notably, all eight patients demonstrated improved gait axial subscores compared to baseline as of their most recent follow-up. Low gait axial subscores are associated with reduced fall risk. DRT typically has little effect on the axial symptoms of PD, suggesting the consistent improvement is potentially the result of neural circuitry reconstruction following the administration of sasineprocel. Mobility (gait, step count, stair ascent and descent speed, and sleep) was improved in a majority of patients measured by both forms of DHT.

We evaluated 18 FDOPA PET imaging to assess DA activity in the putamen following administration of sasineprocel. 18 FDOPA PET is a specialized neuroimaging technique that uses a radiolabeled dopamine precursor to assess DA activity in the striatum, including the putamen, a brain region significantly affected in PD. 18 FDOPA PET showed increased 18 FDOPA uptake at six, 12 and 18 months following sasineprocel administration compared to baseline, including a mean approximately 17% increase of 18 FDOPA uptake was reported in the eight patients with 18-month data as of the data cutoff date. These data, including the 18 FDOPA PET data from the eight patients that have reached 18 months, are supportive of engraftment and survival of transplanted cells and support continued clinical evaluation of sasineprocel as a cell replacement therapy for PD.

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Aspen intends to leverage insights from the Phase 1/2a ASPIRO trial including dose selection, neurosurgical techniques, sasineprocel delivery procedures endpoint performance, utilizing an infusion pump and manufacturing experience measures of clinical activity to inform the design of the Phase 3 trial. Based on preliminary discussions with FDA, we anticipate conducting a single Phase 3 registrational study that includes a sham-controlled trial design and an 18-month primary endpoint. We plan to further engage with regulatory authorities to obtain feedback on key aspects details of the Phase 3 program, including patient population, endpoint selection, statistical considerations, and trial design features. We also plan to meet with regulatory authorities to align on our CMC plan to support the manufacturing process for the Phase 3 study and potential future commercialization.

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This program builds on the same core platform technologies used to generate sasineprocel, including autologous iPSC reprogramming, iPSC clonal selection, and directed differentiation. Our microglia programs also leverage the manufacturing infrastructure, analytical assays, and QC systems developed for sasineprocel. This shared platform may enable efficient development and potential scalability of microglia replacement therapies across multiple CNS indications where microglial dysfunction contributes to disease pathology. Subject to the successful completion of ongoing preclinical and development activities, we plan expect to initiate IND-enabling studies in . the second half of 2027.

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While the autologous cell therapy field has advanced tremendously in the past decade, historical challenges have included the high cost of manufacturing and batch-to-batch variabilities. We are developing an automated, robust, modular manufacturing process designed to meet potential future demand of our product candidates. We use the Cell X platform and the Mytos device, which each has the potential to automate a significant part of our manufacturing process. Combined with our in-house bioinformatics capabilities and other enabling technologies, we aim to develop a manufacturing process template that can be replicated to scale up out manufacturing to meet potential future demand.

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In September 2024, we entered into a Main Services Agreement and related order forms and schedules (the Mytos Agreement) with Mytos. Bio Limited (Mytos). Under the Mytos Agreement, Mytos supplies us with automated cell culture devices, along with related software licensing and associated services. We use the Mytos iDEM Triple device and the iDEM platform in Stage 3 of our manufacturing process for sasineprocel to automate key cell culture steps during the differentiation process. Mytos provides cloud-based software to operate the device, installation services, and additional development services to validate the device for compatibility with our manufacturing requirements.

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We are responsible for all risk and liability arising from reliance on the outputs of the device. We may not sell the device to any third party without Mytos prior written consent. We paid Mytos $1.5 million and $0.2 million during the years ended December 31, 2025 and 2024, respectively. We paid Mytos $0.5 $1.3 million and $0.7 million during the three six months ended March 31, June 30, 2026 and 2025, respectively.

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In November 2021, we entered into a services agreement (hereinafter, the Veranex Agreement) with Ximedica, LLC (Ximedica), which was acquired by Veranex, Inc. (Veranex) in June 2021. The Veranex Agreement was assigned from Ximedica to Veranex on or about October 18, 2023. Under the Veranex Agreement, Veranex provides development and manufacturing services for metered delivery syringes used as part of our drug delivery system in connection with our clinical programs. Veranex performs services for us on a project basis. Upon acceptance of the proposal made in connection with the Veranex Agreement, a non-material payment was made as a deposit for the estimated first month s service and expenses. Following the initial deposit, Veranex is to issue monthly invoices for work in progress. Each invoice will include amounts for billable time, plus out-of-pocket and other expenses incurred during the monthly period preceding the invoice. All such out-of-pocket and project-related expenses (other than billable time) are invoiced at cost, plus a percentage markup in the high teens to cover administration and handling.

The Veranex Agreement does not have a fixed term or expiration date. However, we may cancel any project under the Veranex Agreement, at any time, with or without cause, upon 90 days prior written notice, subject to our obligation to pay for all work delivered and billable work performed during the notice period, as well as expenses and service costs incurred through the date of cancellation.

The Veranex Agreement provides that all project-related work product developed by Veranex will be delivered to us and become our sole property upon payment of any invoices due in full, and Veranex has assigned to us all right, title, and interest therein. Notwithstanding the foregoing, Veranex retains ownership of certain minor pre-existing code, programming and/or components, works and elements (such as tooling code, scripts, tools, subroutines, algorithms and plug-ins) and related know-how incorporated in the project work product, as well as enhancements and modifications to the foregoing, that were not specifically developed for our projects. Veranex has granted us a royalty-free, fully-paid-up, irrevocable, transferable, sublicensable, worldwide, perpetual license to use, reproduce, modify, publicly distribute and perform, display and otherwise commercially exploit such Veranex intellectual property in connection with our use and exploitation of the project work product under the Veranex Agreement.

We and Veranex are subject to mutual confidentiality obligations with respect to proprietary information disclosed pursuant to the Veranex Agreement, which obligations survive any project termination.

We are responsible for testing the project work, for assessing whether the project work infringes the intellectual property rights of any third parties, and for securing any patent protection. We paid Veranex $1.0 million and $0.5 million during the years ended December 31, 2025 and 2024, respectively. We paid Veranex $7,400 and $257,000 during the three months ended March 31, 2026 and 2025, respectively.

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We are solely responsible for obtaining all regulatory approvals relating to our therapies incorporating ClearPoint products, including the ClearPoint SmartFlow cannula. ClearPoint retains all right, title, and interest in and to the products sold to us pursuant to the ClearPoint MSA and all intellectual property rights related thereto, including sole ownership of any improvements, additions, or variations to the products, whether or not made at our request, except to the extent otherwise set forth in a development agreement with respect to custom products that have been enhanced, improved, or customized by ClearPoint solely for our use. ClearPoint further has the right to sell, offer, license, or otherwise commercialize the products and services covered by the ClearPoint MSA to third-party customers. We paid ClearPoint $0.3 million during each of the years ended December 31, 2025 and 2024. We paid ClearPoint $40,000 $0.3 million and $34,000 $0.1 million during the three six months ended March 31, June 30, 2026 and 2025, respectively.

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A series of rigorous release assays are performed on the final drug product to validate assess product characteristics. quality attributes. These include RNA sequencing based tests to predict assess identity and maturity (NeuriTest ), engraftment potential (GraftTest), and dopamine release (DopaTest). These bioinformatics-based assessments are informed by preclinical in vitro and in vivo studies testing different lots from individual PD patient cells, with lots from multiple PD donors evaluated. In addition, an in vitro bioassay, DDC activity assay, is performed to measure conversion of L-dopa to dopamine to test cellular functionality and stability of DANPCs after cryopreservation.

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The overall manufacturing process for the dose prep formulation and the thaw-and-inject formulation are the same with the exception of the post harvest downstream volume reduction step, the formulation step, the excipients utilized, the fill step, and the final product container. For dose prep formulation, the final cell concentration is 6.7 x 106 10 6 cells/mL filled at 1.5 mL in a 2mL cryovial whereas for the thaw-and-inject formulation, the final cell concentration is 1.0 x 108 10 8 cells/mL filled at 0.5mL in a 2mL CellSeal vial.

The thaw and inject formulation of sasineprocel (ANPD001 Suspension) was evaluated in a series of nonclinical studies designed to assess location, engraftment, and safety following direct intracerebral administration. In rodents, a non GLP engraftment study and a pivotal single dose GLP toxicity study demonstrated that ANPD001 Suspension was well tolerated and resulted in persistent engraftment of human cells with comparable average graft size and number of mature dopaminergic neurons after 3-month three-month in life maturation in a side-by-side evaluation with dose prep formulation (ANPD001 Injectable Suspension) and human cells appeared to remain localized to the target striatal region, with no morphological evidence of migration outside the brain. No adverse effects on clinical observations, body weights, functional assessments, clinical pathology, or macroscopic or microscopic pathology were observed. These studies support the safety of the thaw and inject formulation and its suitability for clinical administration without additional dose preparation steps.

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We continue to invest in process development and automation to support later-stage clinical development and commercialization. These efforts are designed to improve operational efficiency and scalability while maintaining product quality and regulatory compliance. We have successfully moved from an R&D stage process to a GMP, manual process for the Phase 1/2a ASPIRO trial and are in the process of automating significant portions of the manufacturing process for the planned Phase 3 trial. Prior to the start of manufacturing for our Phase 3 study, we plan to meet with regulatory authorities to align on our CMC plan to support the manufacturing process for the Phase 3 study and potential future commercialization. We expect our automation initiatives, if successful, can be used to scale up manufacturing to meet potential future demand.

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We are a clinical-stage company and have not yet established a full commercial organization or distribution capabilities. As we advance our product candidates toward potential approval, we intend to build a commercial infrastructure to support the product launch, sale, reimbursement and distribution of any approved products. We will continue to evaluate opportunities to work with strategic partners to enhance our development and commercialization capabilities with respect to sasineprocel and our other product candidates. In addition, we intend to commercialize our product candidates, if approved, in key markets in the United States, the European Union, and APAC, Asia Pacific, either alone or with partners to maximize the worldwide commercial potential of our programs.

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We are aware of cell and gene therapy candidates in clinical development that target sporadic, genetic, or all forms of PD. This includes autologous cell therapies in development by Hope Bio, Oryon, and others; allogeneic therapies from BlueRock/Bayer, Sumitomo (AMCHEPRY, approved in Japan), Cellular Intelligence, Kenai Therapeutics, iRegene, S.Biomedics, Xellsmart and others; and gene therapies from AskBio/Bayer, MeiraGTx, Prevail Therapeutics, and other earlier-stage competitors.

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As of March October 2026, our patent portfolio included 3 five granted U.S. patents, approximately 15 granted international patents, and approximately 63 69 pending patent applications across 16 patent families, including the nine seven families identified in more detail below. Our granted international patents are held in the following jurisdictions: the United Arab Emirates, Australia, the European Patent Convention (validated in Switzerland, Spain, Great Britain, Ireland, Turkey, and the Unitary Patent territory), Hong Kong, Israel, Japan, Mexico, and Saudi Arabia. We also have pending international patent applications in numerous international jurisdictions, including the United Arab Emirates, Australia, the European Patent Convention, Hong Kong, Israel, Japan, Mexico, Saudi Arabia, Brazil, Canada, China, India, Singapore, South Korea, and before the World Intellectual Property Organization (WIPO) under the Patent Cooperation Treaty. Our patent applications, if granted, are designed to provide protection for sasineprocel and our platform technologies, including:

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Methods for differentiating DANPCs from iPSCs stem cells

Assays and analytical methods for identifying and characterizing iPSCs and neuronal progenitor cells Potency assays and other functional assays for assessing functional characteristics of cell therapy products Automated manufacturing systems and methods Delivery devices for stereotactic implantation of cell suspensions Methods for treating genetically-linked PD DANPC Manufacturing, Differentiation and Resulting Compositions, Including Sasineprocel We own four patent families relating to manufacturing processes for producing DANPCs from iPSCs, stem cells, including computer-implemented methods and systems for identifying and isolating iPSCs and automated methods of manufacturing DANPCs from iPSCs, stem cells, DANPC compositions produced by the methods, DANPC compositions characterized by specific attributes, and methods of using the DANPCs to treat disease.

These patent families include granted patents in the United States and other foreign jurisdictions. See Intellectual Property for more information. These patent families also include pending Patent Cooperation Treaty (PCT) applications, pending United States patent applications, and pending patent applications in other foreign jurisdictions. One of these patents will expire in 2030. The other patents, and if issued these patent applications, will expire from 2041-2046, without taking into account any possible patent term adjustment or extension and assuming payment of all applicable maintenance, renewal, annuity or other governmental fees.

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PluriTest: A gene expression-based assay for identifying iPSCs (issued patent) GraftTest: An assay for predicting engraftment capability of differentiated neuronal cell products (covered by issued patents and pending applications) NeuriTest: Gene expression-based assays for identifying neuronal progenitor cells, including methods for classifying differentiation state (patent applications pending in the United States and internationally) DopaTest: An assay for predicting dopamine production capability of differentiated neuronal cells (covered by issued patents and pending applications) DDC Potency Assay: An assay measuring L-dopa decarboxylase activity and related potency assessment frameworks (covered by pending applications) Regulatory authorities, including the FDA, generally expect developers of cell therapy products to establish potency assays and other analytical methods that are relevant to the product s biological activity. We believe these assays and related quality control measures are important to support development and, if approved, commercial manufacturing of our product candidates.

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We own four patent families related to assays and analytical methods designed to identify, classify and characterize iPSCs or DANPCs and other cells differentiated from stem cells. therefrom, including DANPCs. The patent families are directed to assays and analytical approaches for assessing neuronal differentiation at various stages of our manufacturing process, and for assessing functional characteristics of the final cell product, such as engraftment capability, dopamine-related functional properties, and other activities or functions related to biological activity and potency. The assays and analytical methods include assays that use gene expression-based and related approaches and may be used in quality control, comparability analyses and other analytical characterization.

These patent families include a two granted patent patents in the United States. These patent families also include pending PCT applications, pending United States patent applications, and pending patent applications in other foreign jurisdictions. One of these patents will expire in 2030. The remaining patents, and, if issued, these the currently pending patent applications, will expire in 2044-2045, without taking into account any possible patent term adjustment or extension and assuming payment of all applicable maintenance, renewal, annuity or other governmental fees.

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We own one patent family that includes one pending U.S. provisional nonprovisional patent application and a pending PCT application directed to methods of treating PD associated with mutations in the GBA1 gene using non-genetically modified DANPCs, including autologous cell therapy approaches. If patents that issue from applications claiming priority to this provisional application these applications are obtained, they are expected to expire in 2046, without taking into account any possible patent term adjustment or extension and assuming payment of all applicable maintenance, renewal, annuity or other governmental fees.

We own one patent family that includes one pending U.S. provisional nonprovisional patent application and a pending PCT application directed, among other things, to methods and technologies related to microglia-based cell therapy products, including approaches that may be applicable to the treatment of X-linked adrenoleukodystrophy (X-ALD). If patents that issue from applications claiming priority to this provisional application these patent applications are obtained, they are expected to expire in 2046, without taking into account any possible patent term adjustment or extension and assuming payment of all applicable maintenance, renewal, annuity or other governmental fees.

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Our patent portfolio includes both internally developed intellectual property and technology licensed from third parties. We have obtained licenses to key foundational technologies important to supporting support the manufacturing process for sasineprocel, including:

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Sumitomo Pharma Co. Ltd: Use of Sendai viral vectors encoding the Yamanaka factors for reprogramming differentiated cells into iPSCs. The licensed patents include five issued U.S. patents directed to methods of producing iPSCs using Sendai virus vectors, together with corresponding foreign patents and applications. This license is a non-exclusive sublicense of rights originally granted by ID Pharma Co., Ltd. to Sumitomo, and requires payment of annual license fees, milestone payments upon achievement of specified sales thresholds, and royalties in the low single digits on net sales of licensed products. In connection with the Organizational Split, Sumitomo s rights and obligations under the Sumitomo License Agreement were assigned to and/or succeeded by RATCHERA RACTHERA Co., Ltd., with our prior consent.

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Cell X Technologies, Inc. (sublicensed from and the Cleveland Clinic Foundation: Systems and methods for automated detection, analysis, isolation, and harvesting of biological objects, including iPSCs, as well as related image analysis technologies. The licensed patents include four issued U.S. patents and a pending European patent application directed to automated cell culture systems and machine vision-based cell selection. This sublicense is The licenses are exclusive within the licensed field and territory. This license requires The licenses require milestone payments upon achievement of specified development and regulatory milestones but does do not require sales-based royalty payments. We are currently in discussions regarding the terms of this license in connection with our long-term automation strategy. If we are unable to maintain access to the licensed technology on commercially reasonable terms, we may need to develop alternatives or rely on less automated processes, which could increase costs and/or limit scalability.

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Once a biological product candidate is identified for development, it enters the preclinical testing stage. and before testing any biological product candidate in humans, the product candidate it enters the preclinical testing stage. Preclinical tests may include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. Results of these preclinical tests, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND. An IND is a request for allowance from the FDA to administer an investigational drug product to humans. An IND will also include a protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if the trial includes an efficacy evaluation. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a full or partial clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin or begin as proposed. Clinical holds also may be imposed by the FDA at any time before or during clinical trials due to safety concerns about ongoing or proposed clinical trials or non-compliance with specific FDA requirements, and in such case, the trials may not begin or continue as planned until the FDA notifies the sponsor that the hold has been lifted.

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The FDA conducts a preliminary review of a submitted BLA within the first 60 days after submission, before accepting the application for filing, to determine whether it is sufficiently complete to permit substantive review. The FDA may request additional information rather than accept a BLA for filing. In this event, the BLA must be resubmitted with additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once filed, the FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent for its intended use and whether its manufacturing the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product s continued safety, purity and potency. Under the Prescription Drug User Fee Act (PDUFA), guidelines that are currently in effect, the FDA has a goal of ten months from the date of filing to complete a standard review of an original BLA and act on the submission. This review typically takes twelve months from the date the BLA is submitted to FDA because the FDA has approximately two months to make a filing decision after the application is submitted.

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The FDA may send a non-compliance letter to any sponsor that fails to submit the required assessment, keep a deferral current, or fails to submit a request for approval of a pediatric formulation.

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and 6 more changes in the filing

Management 27 changes

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The following table sets forth the name, age, and position of each of our executive officers and directors as of , September 30, 2026.

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Sasineprocel Development Lead and Chief Commercial Officer

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Revati Shreeniwas, M.D.

Chief Medical Officer

General Counsel and Secretary

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Faheem Hasnain . Mr. Hasnain has served as a member and chairman of our board of directors since April 2020 and as our Executive Chairman since August 2026. Mr. Hasnain has served as chairman of the board of directors of Gossamer Bio, Inc., a publicly-held biopharmaceutical company, since 2018 and as Chief Executive Officer since November 2020 and previously served as Chief Executive Officer in 2018. In addition, Mr. Hasnain has served as a member of the board of directors of Kura Oncology, Inc., a publicly-held biopharmaceutical company, since April 2015. Previously, Mr. Hasnain was the President, Chief Executive Officer and on the board of directors of Receptos, Inc., a publicly-held biopharmaceutical company, from 2010 until the company s acquisition by Celgene Corporation in 2015. Prior to that, Mr. Hasnain was the President and Chief Executive Officer and a director of Facet Biotech Corporation, a publicly-held biology driven antibody company with a focus in multiple sclerosis and oncology. He held that position from 2008 until the company s acquisition by Abbott Laboratories in 2010. Previously, Mr. Hasnain was President, Chief Executive Officer and a director of PDL BioPharma, Inc. (PDL BioPharma), a publicly-held biopharmaceutical company, from 2008 until Facet Biotech was spun off from PDL BioPharma in 2008. From 2004 to 2008, Mr. Hasnain served at Biogen Inc. (Biogen), a publicly-held biotechnology company specializing in neurological disorders, autoimmune disorders and cancer, most recently as Executive Vice President in charge of the oncology/rheumatology strategic business unit. Prior to Biogen, Mr. Hasnain held roles with Bristol Myers Squibb Co., where he was President of the Oncology Therapeutics Network, and at GlaxoSmithKline plc and its predecessor organizations. He was chairman of the board of directors of Panacea Acquisition Corp., a newly incorporated special purpose acquisition company, from May 2020 through February 2021, and Mirati Therapeutics, Inc., a publicly-held biotechnology company, from 2019 to January 2024. Mr. Hasnain received a B.H.K. and B.Ed. from the University of Windsor Ontario in Canada.

We believe that Mr. Hasnain is qualified to serve as our Executive Chairman and on our board of directors because of his extensive experience as a member of senior management and boards of directors of multiple biopharmaceutical companies as well as his experience building and operating biopharmaceutical companies, strategic partnering and capital raising and investor relations in the biopharmaceutical industry.

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Revati Shreeniwas, M.D . Dr. Shreeniwas has served as our Chief Medical Officer since December 2025. Prior to Aspen, Dr. Shreeniwas served as Consulting Chief Medical Officer at Cystetic Medicines, a biotechnology company, from July 2024 to November 2024. In addition, Dr. Shreeniwas served as a Senior Clinical Consultant at Excision BioTherapeutics, a biotechnology company, from September 2020 to May 2021. Prior to that, Dr. Shreeniwas also served as Chief Medical Officer at Bright Minds Biosciences, a biotechnology company, from September 2020 to November 2022 and as Vice President, Clinical Development at Soleno Therapeutics, a biopharmaceutical company, from November 2019 to June 2020. Dr. Shreeniwas received her medical education from Armed Forces Medical College in Pune, India with further post-doctoral training in Pulmonary Disease and Critical Care at Columbia University, Roy and Diana Vagelos College of Physicians and Surgeons.

Lisa Johnson-Pratt, M.D. Dr. Johnson-Pratt has served as our Sasineprocel Development Lead and Chief Commercial Officer since January 2026 and previously served as our Executive Vice President, Therapeutic Program Lead from October 2024 to January 2026, our Senior Vice President, Therapeutic Program Lead from January 2024 to October 2024, and our Senior Strategic Advisor from September 2021 to October 2024. Also, since September 2019, Dr. Johnson-Pratt has served as a founder, and since June 2020, as Biotechnology, Cell and Gene Therapy Strategic Commercial Advisor, of Ananias Ventures, where she provides strategic advisory services to the biotechnology healthcare sector. Prior to joining Aspen, Dr. Johnson-Pratt served in various roles including as Senior Vice President at Ionis Pharmaceuticals, Inc., a biotechnology company, from November 2020 to May 2022. Prior to Ionis Pharmaceuticals, Inc., Dr. Johnson-Pratt served as Senior Vice President of Akcea Therapeutics, Inc., a biotechnology company. In addition, Dr. Johnson-Pratt has also held various positions of increasing scope, including Vice President of Global Franchise Operations, at GSK, a biopharmaceutical Company and prior to GSK, Dr. Johnson-Pratt held various positions of increasing scope at Merck, a biopharmaceutical company, including serving as the Global Dermatology Portfolio Leader. Dr. Johnson-Pratt served on the board of TRACON Pharmaceuticals, then a publicly-held company, from March 2021 to September 2024. Dr. Johnson-Pratt currently serves on the board of Assembly Biosciences, Inc., a biopharmaceutical company where she was first elected to the board in May 2021. Dr. Johnson-Pratt received her B.S. and M.D. from Howard University, with further post-doctoral training in Internal Medicine, Clinical Pharmacology and Pharmaceutical Medicine.

Kim Raineri . Mr. Raineri has served as our Chief Technology Officer since July 2022. Prior to joining Aspen, Mr. Raineri served as Chief Manufacturing and Technology Officer and a member of the executive team at Tectonic Therapeutic, Inc. (formally, (formerly, AVROBIO, Inc.), a biotechnology company, from June 2020 to July 2022. Prior to that, Mr. Raineri was Vice President of Operations for Nikon CeLL innovation Co., Ltd, a Japanese contract development and manufacturing organization and he held management positions at Lonza, a healthcare manufacturing organization as well as CryoLife Inc, a medical device company. Mr. Raineri earned his B.S. from the University of Miami and his MBA from Kennesaw State University.

Jeffrey Boerneke. Mr. Boerneke has served as our General Counsel and Secretary since May 2026. Prior to joining Aspen, Mr. Boerneke served as Senior Vice President, General Counsel and Secretary from February 2022 to April 2026, at Gossamer Bio, Inc., a publicly-held biopharmaceutical company, where he played a key role in the company s initial public offering and strategic global partnership activities. Mr. Boerneke previously served as Corporate Counsel at Amgen Inc., a publicly-held biopharmaceutical company. He began his career as an associate in the corporate group at Latham & Watkins LLP. Mr. Boerneke holds a J.D. from UCLA School of Law and a B.S. in Chemistry from Point Loma Nazarene University.

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Faheem Hasnain . Mr. Hasnain has served as a member and chairman of our board of directors since April 2020. Mr. Hasnain has served as chairman of the board of directors of Gossamer Bio, Inc., a publicly-held biopharmaceutical company, since 2018 and as Chief Executive Officer since November 2020 and previously served as Chief Executive Officer in 2018. In addition, Mr. Hasnain has served as a member of the board of directors of Kura Oncology, Inc., a publicly-held biopharmaceutical company, since April 2015. Previously, Mr. Hasnain was the President, Chief Executive Officer and on the board of directors of Receptos, Inc., a publicly-held biopharmaceutical company, from 2010 until the company s acquisition by Celgene Corporation in 2015. Prior to that, Mr. Hasnain was the President and Chief Executive Officer and a director of Facet Biotech Corporation, a publicly-held biology driven antibody company with a focus in multiple sclerosis and oncology. He held that position from 2008 until the company s acquisition by Abbott Laboratories in 2010. Previously, Mr. Hasnain was President, Chief Executive Officer and a director of PDL BioPharma, Inc. (PDL BioPharma), a publicly-held biopharmaceutical company, from 2008 until Facet Biotech was spun off from PDL BioPharma in 2008. From 2004 to 2008, Mr. Hasnain served at Biogen Inc. (Biogen), a publicly-held biotechnology company specializing in neurological disorders, autoimmune disorders and cancer, most recently as Executive Vice President in charge of the oncology/rheumatology strategic business unit. Prior to Biogen, Mr. Hasnain held roles with Bristol Myers Squibb Co., where he was President of the Oncology Therapeutics Network, and at GlaxoSmithKline plc and its predecessor organizations. He was chairman of the board of directors of Panacea Acquisition Corp., a newly incorporated special purpose acquisition company, from May 2020 through February 2021, and Mirati Therapeutics, Inc., a publicly-held biotechnology company, from 2019 to January 2024. Mr. Hasnain received a B.H.K. and B.Ed. from the University of Windsor Ontario in Canada.

We believe that Mr. Hasnain is qualified to serve on our board of directors because of his extensive experience as a member of senior management and boards of directors of multiple biopharmaceutical companies as well as his experience building and operating biopharmaceutical companies, strategic partnering and capital raising and investor relations in the biopharmaceutical industry.

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Cindy Perettie . Ms. Perettie has served on our board of directors since October 2025. Ms. Perettie has also served as the Executive Vice President and Global Head of Kite Pharma, a biotechnology company and subsidiary of Gilead Sciences, where she is responsible for overseeing the cell therapy business since 2023. From 2021 to 2023, she served as Head of Roche Molecular Lab Diagnostic Solutions at Roche, a pharmaceuticals and diagnostics company, where she oversaw the PCR (polymerase chain reaction) and Sequencing Business. Prior to that, she served as the Chief Executive Officer at Foundation Medicine, a precision medicine company, from 2019 to 2021. Before joining Foundation Medicine, Cindy Ms. Perettie was Head of Global Oncology Strategy at Roche s Oncology Unit. In 2012, Cindy Ms. Perettie joined Sarah Cannon Research Institute as President of Global Development Innovations. Ms. Perettie started her career at Johns Hopkins University as a senior research associate. Ms. Perettie holds an M.B.A. from Saint Mary s College of California and a bachelor s degree in biology with a minor in chemistry from The State University of New York at Potsdam.

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Our board of directors currently consists of eight members and will consist of eight members following the completion of this offering. Our board of directors has determined that all of our directors other than Dr. McDevitt and Mr. Hasnain are independent directors in accordance with the listing requirements of the Nasdaq Stock Market and in Rule 10A-3 under the Exchange Act. The Nasdaq independence definition includes a series of objective tests, including that the director is not, and has not been for at least three years, one of our employees and that neither the director nor any of his or her family members has engaged in various types of business dealings with us. In addition, as required by Nasdaq rules, our board of directors has made a subjective determination as to each independent director that no relationships exist, which, in the opinion of our board of directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of the director. In making these determinations, our board of directors reviewed and discussed information provided by the directors and us with regard to each director s business and personal activities and relationships as they may relate to us and our management. There are no family relationships among any of our directors or executive officers. Dr. McDevitt is not considered an independent director because of his position as our Chief Executive Officer. Mr. Hasnain is not considered an independent director because of the services he provides to the Company as Executive Chairman.

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the Class I directors will be , Dr. McDevitt, Dr. Daniel, and Dr. Thompson, and their terms will expire at our first annual meeting of stockholders following this offering;

the Class II directors will be , Mr. Hasnain, Ms. Perettie, and Dr. Fisher, and their terms will expire at our second annual meeting of stockholders following this offering; and the Class III directors will be , Ms. Peterson and Mr. Spaventa, and their terms will expire at our third annual meeting of stockholders following this offering.

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Our board of directors is currently chaired by Faheem Hasnain. Our board of directors recognizes that it is important to determine an optimal board leadership structure to ensure the independent oversight of management as the Company continues to grow. We separate the roles of chief executive officer and executive chairman of the board of directors in recognition of the differences between the two roles. The chief executive officer is responsible for setting the strategic direction for our company and the day-to-day leadership and performance of our company, while the executive chairman of the board of directors provides guidance to the chief executive officer and presides over meetings of the full board of directors. We believe that this separation of responsibilities provides a balanced approach to managing the board of directors and overseeing our company. Our board of directors has concluded that our current leadership structure is appropriate at this time. However, our board of directors will continue to periodically review our leadership structure and may make such changes in the future as it deems appropriate.

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Our board of directors has established three standing committees audit, compensation, and nominating and corporate governance each of which operates under a charter that has been approved by our board of directors. Our board of directors has also established a research and development committee to advise on scientific matters.

Our audit committee consists of , Andrew Spaventa, Douglas Fisher, and . Caryn Peterson. Our board of directors has determined that it satisfies the independence requirements under listing standards and Rule 10A-3(b)(1) of the Exchange Act. The chair of our audit committee is , Andrew Spaventa, who our board of directors has determined is an audit committee financial expert within the meaning of SEC regulations. Each member of our audit committee can read and understand fundamental financial statements in accordance with applicable requirements. In arriving at these determinations, our board of directors has examined each audit committee member s scope of experience and the nature of their employment in the corporate finance sector.

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Our compensation committee consists of , , Thomas Daniel, M.D., Cindy Perettie, and . Peter Thompson, M.D. The chair of our compensation committee is . Thomas Daniel, M.D. Our board of directors has determined that each of Thomas Daniel, M.D., Peter Thompson, M.D. and Cindy Perettie is independent under listing standards and a non-employee director as defined in Rule 16b-3 promulgated under the Exchange Act.

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Our nominating and corporate governance committee consists of , Caryn Peterson and . Thomas Daniel, M.D. The chair of our nominating and corporate governance committee is . Caryn Peterson. Our board of directors has determined that each member of the nominating and corporate governance committee is independent under the listing standards.

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Research and Development Committee

Our research and development committee consists of Thomas Daniel, M.D., Caryn Peterson, and Peter Thompson, M.D. The chair of our research and development committee is Thomas Daniel, M.D.

The principal duties and responsibilities of our research and development committee include, among other things:

reviewing and advising our board of directors and management on our research and development priorities and scientific strategy and key development milestones;

providing scientific and strategic perspectives on the design of our clinical and preclinical programs, our regulatory strategy and our significant interactions with the FDA and comparable foreign regulatory authorities; and evaluating the scientific merit of licensing and acquisition opportunities and monitoring emerging scientific and technological developments relevant to our programs.

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Executive and Director Compensation 86 changes

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(3) The shares subject to the option will were previously eligible to vest in 48 equal monthly installments measured from the vesting commencement date, subject to continuous service as of each such vesting date. As described below, in August 2026, Dr. McDevitt agreed to extend the monthly vesting schedule of the remaining unvested shares subject to this option, such that this option will vest in full six years following its vesting commencement date of November 20, 2025, rather than pursuant to its original four year vesting schedule. 100% of the unvested shares will vest immediately upon the consummation of a Change in Control (as defined in the 2018 2026 Plan), subject to continued service through the date of the Change in Control.

(4) 1/4th of the shares subject to the option will vest on the one year anniversary of the vesting commencement date, and the balance of the shares will vest in 36 equal monthly installments measured from the one year anniversary of the vesting commencement date, subject to continuous service as of each such vesting date. 100% of the unvested shares will vest immediately upon the consummation of a Change in Control (as defined in the 2018 2026 Plan), subject to continued service through the date of the Change in Control.

(5) 1/4th of the shares subject to the option will vest on the one year anniversary of the vesting commencement date, and the balance of the shares will vest in 36 equal monthly installments measured from the one year anniversary of the vesting commencement date, subject to continuous service as of each such vesting date. 100% of the unvested shares will vest immediately upon a qualifying termination of service in connection with the consummation of a Change in Control (as defined in the 2018 2026 Plan), subject to execution of a release.

(6) The shares subject to the option will vest in 48 equal monthly installments measured from the vesting commencement date, subject to continuous service as of each such vesting date. 100% of the unvested shares will vest immediately upon a qualifying termination of service in connection with the consummation of a Change in Control (as defined in the 2018 2026 Plan), subject to execution of a release.

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In August 2026, we entered into a loan forgiveness and option amendment agreement with Dr. McDevitt. Pursuant to this agreement, we forgave the outstanding principal and accrued interest, in the aggregate amount of approximately $2,114,989.07, owed by Dr. McDevitt under promissory notes that Dr. McDevitt entered into in order to pay the purchase price for shares of our common stock received upon the exercise of stock options. In exchange for such loan forgiveness, Dr. McDevitt agreed to extend the monthly vesting schedule of the remaining unvested shares subject to the option to purchase 3,825,000 shares that had been granted to Dr. McDevitt in November 2025, such that this option will vest in full six years following its vesting commencement date of November 20, 2025, rather than pursuant to its original four year vesting schedule. In addition, Dr. McDevitt further agreed that any refresh or top-up option or other equity award that may be granted to him in connection with this offering will be subject to a six-year monthly or quarterly vesting schedule. In addition, pursuant to this agreement, Dr. McDevitt s option was further amended to provide for vesting acceleration in the event of Dr. McDevitt s qualifying termination of employment, the terms of which are described below under Potential Payments Upon Termination or Change in Control.

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Dr. McDevitt s executive employment agreement provides that in the event of a termination by the Company without cause or by the executive for good reason, Dr. McDevitt will receive the following severance benefits, subject to the execution and non-revocation of a release agreement: (a) twelve (12) months base salary, paid in equal installments in accordance with the Company s regular payroll, (b) twelve (12) months COBRA premiums paid by the Company, (c) to the extent not yet received, payment of any annual bonus from the prior calendar year, and (d) the target bonus amount for the year in which employment is terminated.

However, if such termination by the Company without cause or by Dr. McDevitt for good reason occurs within the period beginning thirty (30) days prior to and ending on the twelve (12)-month anniversary of the consummation of a change in control, the base salary payments and COBRA premium benefits described in (a) and (b) above will be for eighteen (18) months (instead of twelve (12) months), and he will still be entitled to the same bonus severance benefits as described above. In addition, in November 2025, the board of directors amended all of Dr. McDevitt s outstanding and future grants of stock options so that all options accelerate vesting in full upon the occurrence of a change in control, regardless of whether Dr. McDevitt is terminated. Dr. McDevitt s agreement includes a 280G cutback provision.

Mr. Meeter s offer letter agreement provides that in the event of a termination by the Company without cause or by the executive for good reason, Mr. Meeter will receive the following severance benefits, subject to the execution and non-revocation of a release agreement: (a) nine (9) months base salary, paid in equal installments in accordance with the Company s regular payroll, (b) nine (9) months COBRA premiums paid by the Company, (c) any earned and unpaid bonus from prior years, (d) the target bonus amount for the year in which employment is terminated, pro-rated for all completed or partially completed months in such year, and (e) accelerated vesting of the number of shares subject to the executive s initial new hire options described in his offer letter agreement that would have otherwise vested over the nine (9) months following termination.

However, if such termination by the Company without cause or by Mr. Meeter for good reason occurs within the period beginning thirty (30) days prior to and ending on the twelve (12)-month anniversary of the consummation of a change in control, the equity described in (e) above shall immediately accelerate vesting in full. Mr. Meeter s offer letter includes a 280G best-after tax provision.

Mr. Raineri s offer letter agreement provides that in the event of a termination by the Company without cause, prior to consummation of a change in control, Mr. Raineri will receive severance benefits equal to six (6) months base salary, paid in equal installments in accordance with the Company s regular payroll, subject to the execution and non-revocation of a release agreement.

However, if such termination by the Company without cause occurs on or after the consummation of a change in control, Mr. Raineri will instead receive nine (9) months base salary. In addition, if Mr. Raineri is terminated by the Company without cause or Mr. Raineri resigns for good reason, within the period beginning on the consummation of a change in control and ending on the twelve (12)-month anniversary of the consummation of a change in control, Mr. Raineri s initial new hire option described in his offer letter agreement shall also immediately accelerate vesting in full.

In addition, in November 2025, the board of directors amended all of Mr. Meeter s and Mr. Raineri s outstanding and future grants of stock options so that all options accelerate and vest in full upon a termination by the Company without cause or by Mr. Meeter or Mr. Raineri, as applicable, for good reason in either case, within twelve (12) months following the consummation of a change in control.

For purposes of all severance benefits described above, the following definitions apply:

change in control generally means the occurrence of any one or a combination of the following: (i) an Ownership Change Event (as defined in the Company s 2018 Stock Plan) or a series of related Ownership Change Events (collectively, a Transaction) in which the stockholders of the Company immediately before the Transaction do not retain immediately after the Transaction direct or indirect beneficial ownership of more than fifty percent (50%) of the total combined voting power of the outstanding securities entitled to vote generally in the election of directors or, in the case of an Ownership Change Event involving an asset sale, the entity to which the assets of the Company were transferred, or (ii) a liquidation or dissolution of the Company.

For purposes of Dr. McDevitt s severance benefits described above, the following definitions apply:

cause means, unless such term or an equivalent term is otherwise defined by the applicable award agreement or other written agreement between the executive and the Company applicable to an award, any of the following: (i) the executive s theft, dishonesty, willful misconduct, breach of fiduciary duty for personal profit, or falsification of any Company documents or records; (ii) the executive s material failure to abide by the Company code of conduct or other policies (including, without limitation, policies relating to confidentiality and reasonable workplace conduct); (iii) the executive s unauthorized use, misappropriation, destruction or diversion of any tangible or intangible asset or corporate opportunity of the Company (including, without limitation, the executive s improper use or disclosure of the Company s confidential or proprietary information); (iv) any intentional act by the executive which has a material detrimental effect on the Company s reputation or business; (v) the executive s repeated failure or inability to perform any reasonable assigned duties after written notice from the Company of, and a reasonable opportunity to cure, such failure or inability; (vi) any material breach by the executive of any employment or service agreement between the executive and the Company, which breach is not cured pursuant to the terms of such agreement; or (vii) the executive s conviction (including any plea of guilty or nolo contendere) of any criminal act involving fraud, dishonesty, misappropriation or moral turpitude, or which impairs the executive s ability to perform his duties with the Company.

good reason means the executive s voluntary resignation of employment within sixty (60) days after the occurrence of one or more of the following circumstances, provided that the executive has notified the Company (or its successor) in writing of the executive s assertion that one of the following circumstances has occurred, which notice has been delivered within thirty (30) days following the executive becoming aware of such circumstance: (i) a reduction of more than ten percent (10%) in the executive s base salary or target annual bonus, each as then in effect, unless the reduction is made as part of, and is generally consistent with, a general reduction of salaries or bonuses of similarly situated executives; (ii) relocation of the executive s principal place of work to a location resulting in an increase in the executive s daily commute to such principal place of work by more than thirty-five (35) miles, without the executive s prior written approval; or (iii) a material diminution in the executive s authority, responsibility, duties, or role such that the executive s authority, responsibilities, duties and/or role are no longer commensurate with the executive being the Company s most senior executive officer (other than temporarily while the executive is physically or mentally incapacitated or as required by applicable law), provided that such action is not taken in connection with a termination of the executive s employment by the Company; provided, however, that the Company (or its successor) has been provided with written notice of the circumstances and thirty (30) days from the receipt of written notice in which to cure such circumstances and the Company (or its successor) fails to cure such circumstance during such thirty-day period.

For purposes of Mr. Meeter s severance benefits described above, the following definitions apply:

good reason for executive s resignation means: (i) a reduction of more than ten percent (10%) in the executive s base salary as then in effect, unless the reduction is made as part of, and is generally consistent with, a general reduction of similarly situated executives; or (ii) relocation of the executive s principal place of work to a location resulting in an increase in the executive s daily commute to such principal place of work by more than thirty-five (35) miles, without the executive s prior written approval; provided, however, that the Company (or its successor) has been provided with written notice of the circumstance and thirty (30) days from the receipt of written notice in which to cure such circumstance and the Company (or its successor) fails to cure such circumstance during such thirty-day period, and the executive s employment terminates within sixty (60) days following expiration of the cure period.

For purposes of Mr. Raineri s severance benefits described above, the following definitions apply:

cause is defined as (a) acts or omissions constituting gross negligence, recklessness or willful misconduct on the executive s part with respect to the executive s obligations or otherwise relating to the business of the Company; (b) any acts or conducts by the executive that are materially adverse to the Company s interests; (c) the executive s material breach of his offer letter agreement, the PIIA or the Arbitration Agreement (both as defined in the executive s offer letter agreement); (d) the executive s breach of any other agreement with the Company or any of the Company policies; (e) the executive s conviction or entry of a plea of nolo contendere for fraud, misappropriation or embezzlement or any felony or crime of moral turpitude; (f) the executive s failure to perform the executive s duties as determined in the sole and exclusive discretion of the board; (g) the executive s inability to perform the essential functions of the executive s position, with or without reasonable accommodation, due to Permanent Disability (as defined in the executive s offer letter agreement); (h) the executive s death; or (i) the winding down or dissolution of the Company. In the event of a termination based on (b), (c), (d) or (f), the executive will have fifteen (15) days from receipt of notice from the Company to cure the issue, if curable.

good reason generally means, unless such term or an equivalent term is otherwise defined by the applicable award agreement or other written agreement between the executive and the Company applicable to an award, the executive s voluntary resignation of service within sixty (60) days after the occurrence of one or more of the following circumstances, provided that the executive has notified the Company (or its successor) in writing of the executive s assertion that one of the following circumstances has occurred, which notice has been delivered within thirty (30) days following the executive becoming aware of such circumstance: (i) a reduction of more than ten percent (10%) in the executive s base salary as then in effect, unless the reduction is made as part of, and is generally consistent with, a general reduction of similarly situated executives; or (ii) relocation of the executive s principal place of work to a location resulting in an increase in the executive s daily commute to such principal place of work by more than thirty-five (35) miles, without the executive s prior written approval; provided, however, that the Company (or its successor) has been provided with written notice of the circumstance and thirty (30) days from the receipt of written notice in which to cure such circumstance and the Company (or its successor) fails to cure such circumstance during such thirty-day period.

In connection with this offering, we intend to adopt an Officer Severance and Change in Control Plan (the Severance and CIC Plan) and related participation agreements with each of our named executive officers and other eligible officers with the following terms that will supersede and replace any severance and change in control benefit agreements that we previously entered into with eligible officers, including any such benefits that would otherwise be provided to them under their existing employment agreements and employment offer letters.

Individuals eligible to participate in the Severance and CIC Plan will generally include all Company officers reporting to the Chief Executive Officer and specifically excluding any individual serving as Executive Chair. To receive benefits, the eligible officer must experience an involuntary termination by the Company without Cause (other than as a result of the officer s death or disability) or a resignation by the officer for Good Reason, as such terms are defined in the Severance and CIC Plan, and timely execute a separation agreement and general release of claims in the form provided by the Company and return all Company property.

Regular Termination Benefits

A regular termination is an involuntary termination that occurs during the period that is either more than three months before or more than 12 months after a Change in Control. In connection with a regular termination, the officer will be eligible to receive the following benefits:

continued payment of base salary in accordance with the Company s regular payroll practices for o 12 months if the officer is the Chief Executive Officer, o nine months if the officer is a Tier II Officer (a C-Suite officer who reports directly to the Chief Executive Officer) and o six months if the officer is a Tier III Officer (a Senior Vice President or Vice President who reports directly to the Chief Executive Officer).

the Chief Executive Officer also will receive 100% of the target bonus for the calendar year in which the termination occurs, payable in a lump sum on the first payroll period following the effective date of the release.

subject to timely election of COBRA coverage, the Company also will pay directly to the carrier the full COBRA premiums for the officer and the officer s eligible dependents until the earlier of the following periods or expiration of COBRA or analogous state-law coverage or the date the officer becomes eligible for substantially equivalent coverage in connection with new employment:

o 12 months for the Chief Executive Officer,

o nine months for a Tier II Officer, and

o six months for a Tier III Officer.

Pursuant to Mr. Meeter s participation agreement, upon a regular termination, Mr. Meeter also will be entitled to receive (i) a pro rata portion of his target bonus for the calendar year of termination, payable in a lump sum following the effective date of his release, and (ii) accelerated vesting of the stock options granted to him on March 13, 2025 for 1,000,000 shares and November 26, 2025 for 340,000 shares, as if he had continued in employment for an additional nine months following the termination date.

Change in Control Termination Benefits

A change in control termination is an involuntary termination that occurs during the period that begins three months before and ends 12 months after the effective date of a Change in Control. In connection with a change in control termination, an officer will be eligible to receive the following benefits:

cash severance paid in a single lump sum on the first payroll period following the later of the effective date of the Change in Control and the effective date of the officer s release, consisting of the following applicable number of months of base salary and percentage of target bonus:

o 18 months of base salary plus 150% of target bonus for the Chief Executive Officer, o 12 months of base salary plus 100% of target bonus for a Tier II Officer, and o nine months of base salary plus 75% of target bonus for a Tier III Officer, any annual bonus for a calendar year preceding the Change in Control Termination that remains unpaid and was otherwise earned subject solely to continued service, payable at the same time as the corresponding annual cash bonuses are paid to officers who remain employed, subject to timely election of COBRA coverage, the Company also will pay directly to the carrier the full COBRA premiums for the officer and the officer s eligible dependents until the earlier of the following periods or expiration of COBRA or analogous state-law coverage or the date the officer becomes eligible for substantially equivalent coverage in connection with new employment:

o 18 months for the Chief Executive Officer,

o 12 months for a Tier II Officer, and

o nine months for a Tier III Officer,

to the extent not previously vested, all outstanding equity awards held by the officer will fully vest and, where applicable, become exercisable, any Company reacquisition or repurchase rights will lapse and any shares issuable upon vesting will be issued, and for such purposes performance-based awards will vest based on the greater of 100% of target performance or actual performance for the applicable performance period.

Change in Control Acceleration

Separately, subject to the officer s continued employment through the date of a Change in Control, if the officer s equity awards are not assumed, continued or substituted by the acquiring or surviving entity, all of the officer s outstanding equity awards will fully vest upon the Change in Control. Any performance-based vesting conditions with multiple potential levels will be deemed satisfied at the greater of the performance level actually attained through the date of the Change in Control or the applicable target performance level. For this purpose, equity awards generally will be treated as assumed, continued or substituted if, following the Change in Control, the officer has the right to purchase or receive, for each share subject to an award, the same consideration received by the Company s stockholders for each share of common stock, after giving effect to any applicable exercise or purchase price and subject to the applicable vesting conditions.

Pursuant to Dr. McDevitt s participation agreement and subject to his continued services through a Change in Control, all of his then-outstanding and unvested equity awards granted to him before this offering will accelerate vesting immediately before and contingent upon that Change in Control. Equity awards granted to Dr. McDevitt upon or after the date of this offering will not be eligible for this additional Change in Control acceleration.

Definitions. For purposes of the Severance and CIC Plan, the following terms have the following meanings:

Cause is defined as (a) means (i) acts or omissions constituting gross negligence, recklessness or willful misconduct on the executive s part with respect to the executive officer s obligations or otherwise relating to the business of the Company (b) any s business; (ii) willful, reckless or negligent acts or conduct by the executive that are adverse to the Company s interests; (c) the executive s (iii) a material breach of his the officer s offer letter, proprietary information and inventions agreement the (PIIA) or other agreements between executive and agreement with the Company; ; (d) the executive s (iv) a knowing breach of any other agreement with the Company or any of the Company policies; (e) the executive s policy; (v) conviction or entry of a plea of nolo contendere for fraud, misappropriation or embezzlement, or commission of any felony or crime of moral turpitude; (f) the executive s or (vi) failure to perform the executive officer s duties, as determined in the sole and exclusive discretion of the Board. In the event of If a termination is based on (a), (b), (c), (d) any of clauses (i), (ii), (iii), (iv) or (f), (vi), the executive officer will have fifteen 15 days from receipt of after receiving notice from the Company to cure the issue, if curable.

Good Reason means (i) a material diminution in the officer s authority, duties or responsibilities; (ii) a reduction of more than 10% in the officer s base salary, unless the reduction is part of, and generally consistent with, a general reduction applicable to similarly situated officers; (iii) the Company s material breach of the officer s employment agreement; or (iv) relocation of the officer s principal place of work that increases the officer s daily commute by more than 35 miles without the officer s prior written approval. The Company or its successor will have 30 days after receiving written notice to cure the circumstance, and the officer must terminate employment within 60 days after expiration of the cure period. A Change in Control and a subsequent conversion of the Company to a division or unit of the surviving or acquiring entity will not, by itself, constitute a material diminution absent a material diminution of the officer s authority, duties or responsibilities with respect to that division or unit.

Change in Control has the meaning set forth in the 2026 Plan, as in effect on the date of this offering.

The Severance and CIC Plan includes a best-after-tax cutback provision. If any payment or benefit that the officer would receive would constitute a parachute payment within the meaning of Section 280G of the Code and would, absent a reduction, be subject to the excise tax imposed by Section 4999 of the Code, the payment or benefit will be reduced to the largest amount that either would result in no portion being subject to the excise tax or, after taking into account applicable federal, state and local employment and income taxes and the excise tax, would provide the officer with the greater after-tax economic benefit than the full amount subject to the excise tax.

All payments and benefits under the Severance and CIC Plan will be subject to the Company s compensation recovery policy and any other clawback policy required by applicable law or listing standards.

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Payments Under an Award . A participant will be entitled to payment under an award only if all conditions to payment have been satisfied in accordance with our Cash Incentive Plan and the terms of the award. Following the end of a performance period, the Administrator will determine whether and to what extent the applicable performance goals have been satisfied and will determine the amount payable under each award. The Administrator has the discretionary authority to increase or decrease the amount actually paid under any award. The actual cash award amounts will be fully paid in cash (or its equivalent) in all cases during no later than March 15th of the calendar year following the year in which the performance goals were attained. Unless otherwise determined by the Administrator, participants generally must be employed by the company in good standing on the bonus payment date in order to be eligible to receive payment. However, if a participant was employed in good standing through the last day of a calendar year and is terminated without cause, as such term is defined in the Cash Incentive Plan, prior to the date that actual awards in respect of performance for such calendar year are determined and paid, such participant is also eligible to receive an actual award at the same time as actual awards are regularly paid to other eligible participants, subject to the participant s timely provision of a release of claims. However, to the extent such participant may otherwise be entitled to such actual award as a severance benefit under any separate severance benefit agreement or severance pay plan, such participant will not be entitled to such actual award payment under the Cash Incentive Plan, and such participant s severance benefit eligibility will be determined solely by the terms of such other severance arrangement or plan.

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Our board of directors adopted the 2026 Plan in , 2026, and our stockholders approved the 2026 Plan in , 2026. The 2026 Plan became will become effective upon the execution of the underwriting agreement for this offering. The 2026 Plan is the successor to our 2018 Stock Plan, or the 2018 Plan, which is described below. No further grants will be made under the 2018 Plan following the effectiveness of the 2026 Plan.

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Authorized Shares . The maximum number of shares of common stock that may be issued under our 2026 Plan will initially be shares, which number is the sum of: new shares, plus the applicable number of returning shares from our 2018 Plan not exceeding a maximum of such returning shares. For such purposes, returning shares from our 2018 Plan means the applicable number shares subject to equity awards granted under the 2018 that are outstanding on the date of this offering, and that are not issued because such share award or any portion thereof expires or otherwise terminates without all of the shares covered by such share award having been issued, are not issued because such award or any portion thereof is settled in cash, are forfeited back to or repurchased by us because of the failure to meet a contingency or condition required for the vesting of such shares, are used to pay the exercise price of an award, or are used to satisfy tax withholding obligations with respect to an award.

Authorized Shares . The maximum number of shares of common stock that may be issued under our 2026 Plan will initially be shares. The number of shares of common stock reserved for issuance under our 2026 Plan will automatically increase on January 1 of each year, beginning on January 1, 2027, and continuing through and including January 1, 2036, by 5% of the sum of the total number of shares of common stock outstanding plus the number of shares issuable upon the exercise of any unexercised pre-funded warrants, in each case which are outstanding on December 31 of the immediately preceding calendar year, or a lesser number of shares determined by our board of directors. prior to the applicable January 1. The maximum number of shares that may be issued upon the exercise of ISOs under our 2026 Plan is shares.

Shares issued under our 2026 Plan will be authorized but unissued or reacquired shares of common stock. Shares subject to awards granted under our 2026 Plan that expire or terminate without being exercised in full, or that are paid out in cash rather than in shares, will not reduce the number of shares available for issuance under our 2026 Plan. Additionally, with respect to awards previously granted under our 2018 Plan and which are granted under our 2026 Plan, any shares subject to such awards that we repurchase or that are forfeited, as well as shares used to pay the exercise price of an award or to satisfy the tax withholding obligations to an award, and any shares subject to such awards which are not issued because the award is settled in cash, or because the award expires or otherwise terminates without all the shares having been issued, will become available for future grant under our 2026 Plan.

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Executive Chair Reserve . In addition to the general share reserve, the 2026 Plan establishes a separate reserve of shares of common stock, referred to as the Executive Chair Reserve, which is available solely for the issuance of shares pursuant to awards granted to our Executive Chair, Faheem Hasnain, in satisfaction of the Company s obligations under the Executive Chair Agreement (as defined below). The Executive Chair Reserve is separate from, and in addition to, the general share reserve (including any annual increases thereto). Shares from the Executive Chair Reserve may not be granted to any other participant under the 2026 Plan. To the extent shares from the Executive Chair Reserve are not granted, or are subject to an award that expires, is forfeited, cancelled, settled in cash, or otherwise terminates without issuance, or become no longer issuable because the applicable conditions are not satisfied, such shares will be permanently cancelled and will not become available for issuance under the 2026 Plan to any other participant. For the avoidance of doubt, the Company s obligation to grant awards from the Executive Chair Reserve may, in the Company s discretion, be satisfied in cash in lieu of shares to the extent provided in the Executive Chair Agreement, and any shares not issued as a result will be permanently cancelled. No shares from the Executive Chair Reserve may be transferred to or combined with the general share reserve. The 2026 Plan requires stockholder approval for any amendment to the 2026 Plan that would modify the exclusive use restrictions applicable to the Executive Chair Reserve or make shares from the Executive Chair Reserve available for awards to any person other than the Executive Chair.

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Subject to the restrictions of Section 409A of the Code, the Committee may provide for the acceleration of vesting or settlement of any or all outstanding awards upon such terms and to such extent as it determines. The vesting of all awards held by non-employee directors will be accelerated in full upon a Change in Control.

If a Change in Control occurs, the surviving, continuing, successor or purchasing entity or its parent may, without the consent of any participant, either assume or continue outstanding awards or substitute substantially equivalent awards for its stock. If so determined by the compensation committee, stock-based awards will be deemed assumed if, for each share subject to the award prior to the Change in Control, its holder is given the right to receive the same amount of consideration that a stockholder would receive as a result of the Change in Control. Any awards which are not assumed or continued in connection with a Change in Control or exercised or settled prior to the Change in Control will terminate effective as of the time of the Change in Control. In connection with a Change in Control, the compensation committee may also provide for the assignment or lapse of any reacquisition or repurchase right applicable to any awards. Awards may also be cancelled to the extent not vested or not exercised prior to the Change in Control, in exchange for no consideration or in exchange for such consideration as the compensation committee may determine in its discretion. The 2026 Plan also permits the compensation committee, in its discretion, to cancel each or any outstanding award denominated in shares upon a Change in Control in exchange for a payment to the participant with respect to each share subject to the cancelled award of an amount with a fair market value equal to the excess of the consideration to be paid per share of common stock in the Change in Control transaction over the exercise price or purchase price per share, if any, under the award, and which payments may be made on the same vesting schedule as the cancelled award, or alternatively accelerated to the Change in Control, if so determined by the compensation committee. Subject to the restrictions of Section 409A of the Code, the compensation committee may provide for the acceleration of vesting or settlement of any or all outstanding awards upon such terms and to such extent as it determines.

The vesting of all awards held by non-employee directors will be accelerated in full upon a Change in Control, and, except to the extent assumed, continued or substituted as described above or otherwise restricted by Section 409A, shall be settled effective immediately prior to the time of consummation of the Change in Control if not exercised prior to the Change in Control.

The 2026 Plan also authorizes the compensation committee, in its discretion and without the consent of any participant, to cancel each or any award denominated in shares of stock upon a Change in Control in exchange for a payment to the participant with respect to each vested share (and each unvested share if so determined by the compensation committee) subject to the cancelled award of an amount equal to the excess of the consideration to be paid per share of common stock in the Change in Control transaction over the exercise or purchase price per share, if any, under the award. Subject to the restrictions of Section 409A or Section 424 of the Code, the compensation committee may determine that an award may be subject to the same post-closing purchase price adjustments, escrow terms, offset rights, holdback terms, earnouts and similar conditions as the other holders of the Company s common stock. The Committee may also terminate unvested or unexercised awards for no consideration in connection with the Change in Control.

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Plan Amendment or Termination . Our board The compensation committee has the authority to amend, suspend or terminate our the 2026 Plan, provided that such action does not materially impair the existing rights of any participant without such participant s written consent. Certain material amendments also require the approval of our stockholders. No ISOs may be granted after the tenth anniversary of the date our board adopted our 2026 Plan. No awards may be granted under our 2026 Plan while it is suspended or after it is terminated.

The Company maintains the 2018 Plan. The maximum aggregate number of shares of common stock that may be issued under the 2018 Stock Plan is 42,146,191. The purpose of the 2018 Plan is to provide awards in the form of stock options and restricted stock awards in order to provide an incentive to attract, retain and reward persons performing services for the Company and to motivate such persons to contribute to the growth and profitability of the Company. Employees, directors and consultants are eligible to receive awards under the 2018 Plan.

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Our board of directors adopted the ESPP in , 2026, and our stockholders adopted the ESPP in , 2026. The ESPP became will become effective upon the execution of the underwriting agreement for this offering. The purpose of the ESPP is to secure the services of new employees, to retain the services of existing employees and to provide incentives for such individuals to exert maximum efforts toward our success and that of our affiliates. The ESPP includes two components. One component is designed to allow our eligible U.S. employees to purchase common stock in a manner that may qualify for favorable tax treatment under Section 423 of the Code. In addition, purchase rights may be granted under a component that does not qualify for such favorable tax treatment when necessary or appropriate to permit participation by our eligible employees who are foreign nationals or employed outside of the United States while complying with applicable foreign laws.

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Payroll Deductions . Generally, all regular employees, including executive officers, employed by us or by any of our designated affiliates, may participate in the ESPP and may contribute, normally through payroll deductions, a percentage of their earnings Compensation (as defined in the ESPP) not to exceed a maximum amount specified by the administrator for the purchase of common stock under the ESPP. Unless otherwise determined by the administrator, common stock will be purchased for the accounts of employees participating in the ESPP at a price per share equal to the lower of (a) 85% of the fair market value of a share of common stock on the first date of an offering or (b) 85% of the fair market value of a share of common stock on the date of purchase. For the initial offering, which we expect will commence upon the execution and delivery of the underwriting agreement relating to this offering, the fair market value on the first day of the initial offering will be the price at which shares are first sold to the public.

Limitations . Our employees, including executive officers, or any of our designated affiliates may have to satisfy one or more of the following service requirements before participating in our ESPP, as determined by the administrator: (1) customary employment with us or one of our affiliates for more than 20 hours per week, and or (2) customary employment more than five months per calendar year. or (2) continuous employment with us or one of our affiliates for a minimum period of time, not to exceed two years, prior to the first date of an offering. An employee may not be granted rights to purchase stock under our ESPP if such employee (1) immediately after the grant would own stock possessing 5% or more of the total combined voting power or value of common stock, or (2) holds rights to purchase stock under our ESPP that would accrue at a rate that exceeds $25,000 worth of our stock for each calendar year that the rights remain outstanding.

Changes to Capital Structure . In the event that there occurs a change in our capital structure through such actions as a stock split, merger, consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in property other than cash, large nonrecurring cash dividend, liquidating dividend, combination of shares, exchange of shares, change in corporate structure or similar transaction, the board of directors compensation committee will make appropriate adjustments to (1) the number of shares reserved under the ESPP, (2) the maximum number of shares by which the share reserve may increase automatically each year, (3) the number of shares and purchase price of all outstanding purchase rights and (4) the number of shares that are subject to purchase limits under ongoing offerings.

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ESPP Amendment or Termination . The administrator has the authority to amend or terminate our ESPP, provided that except in certain circumstances such amendment or termination may not materially impair adversely affect any outstanding purchase rights without the holder s consent. We will obtain stockholder approval of any amendment to our ESPP as required by applicable law or listing requirements.

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In connection with this offering, our board of directors expects to approve a new policy for setting non-employee director compensation, which will take effect following the completion of this offering. Under this director compensation policy that we intend to approve, we will pay our non-employee directors, other than the chairperson of the board, an annual cash retainer of $40,000 and the any non-employee chairperson of our board of directors will be paid an annual cash retainer of $70,000. Members of the following committees of our board of directors will be paid the following additional cash retainers:

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Each new non-employee director who joins our board of directors following the closing of this offering will receive a stock option grant under the 2026 Equity Incentive Plan for shares and which will vest in 36 equal monthly installments following the date of grant subject to the non-employee director s continuous service through applicable vesting dates.

On the date of each annual meeting of our stockholders following the closing of this offering, each continuing non-employee director will receive a stock option grant under the 2026 Plan for shares which will vest in full upon the earlier of the one year anniversary of the grant date or immediately prior to the date of the next annual meeting, subject to the non-employee director s continuous service.

1 unchanged paragraph

Ms. Perettie will not be eligible to receive any cash retainer fee or equity award benefits under our non-employee director compensation policy due to the restrictions in her separate agreement with Kita Pharma, a subsidiary of Gilead Sciences. Mr. Hasnain will also not be eligible for benefits under our non-employee director compensation policy while he remains employed as our Executive Chair.

Executive Chair Employment Agreement with Mr. Hasnain

In July 2026, we entered into an employment agreement with Mr. Hasnain to serve as our Executive Chair, effective August 3, 2026 (the Executive Chair Agreement). The Executive Chair Agreement provides that Mr. Hasnain s initial annual salary is $300,000 per year and he is eligible to receive an annual discretionary cash bonus with a target bonus opportunity equal to 55% of his base salary, based on performance objectives.

Pursuant to the Executive Chair Agreement, Mr. Hasnain is also eligible to receive, subject to his continued employment through the applicable dates listed below the following equity incentive awards provided that this offering is completed by December 31, 2026:

in connection with the completion of this offering, an award of restricted stock units with the amount of shares subject to such award equal to 1% of our shares outstanding on a fully diluted basis as of immediately following completion of this offering, which will be fully vested upon grant and with a deferred settlement feature so that the shares will in all cases be issued during the 2027 calendar year;

upon the second anniversary of the completion of this offering and subject to Mr. Hasnain s continued employment as our Executive Chair through such date, an award of restricted stock units with the amount of shares subject to such award equal to 1% of our shares outstanding on a fully diluted basis immediately following completion of this offering, minus a number of shares with a then current fair market value not exceeding the value of such number of shares as measured of the date of this offering, which will be fully vested upon grant, referred to as the second anniversary grant;

if our 90-day average closing price per share is at least 200% of the price per share in this offering at any time prior to the second anniversary of the completion of this offering, an award of restricted stock units with the amount of shares subject to such award equal to 1% of our shares outstanding on a fully diluted basis immediately following completion of this offering, minus a number of shares with a then current fair market value not exceeding the value of such number of shares as measured of the date of this offering , which will be fully vested upon grant;

if our 90-day average closing price per share is at least 600% of the price per share in this offering at any time prior to the third anniversary of the completion of this offering, an award of restricted stock units with the amount of shares subject to such award equal to 1% of our shares outstanding on a fully diluted basis immediately following completion of this offering, minus a number of shares with a then current fair market value not exceeding the value of such number of shares as measured of the date of this offering, which will be fully vested upon grant; and if our 90-day average closing price per share is at least 800% of the price per share in this offering at any time prior to the fourth anniversary of the completion of this offering, an award of restricted stock units with the amount of shares subject to such award equal to 1% of our shares outstanding on a fully diluted basis immediately following completion of this offering, minus a number of shares with a then current fair market value not exceeding the value of such number of shares as measured of the date of this offering, which will be fully vested upon grant.

In addition, subject to Mr. Hasnain s employment through a change in control (as defined in the 2026 Plan) that occurs before the fourth anniversary of the completion of this offering, Mr. Hasnain is eligible to receive either such of the foregoing equity awards that were not previously granted, or alternatively the right to receive a portion of the proceeds from the change in control that he would have been entitled to receive if the equity award had been granted immediately prior to the change in control, provided that with respect to the 200%, 600% or 800% 90-day average closing price RSU awards the fair market value of the proceeds payable to the holder of a share of common stock in connection with the change in control must not be less than the applicable 200%, 600% or 800% price goal threshold, which are referred to collectively as the Change in Control Awards.

The Executive Chair Agreement provides that in the event of a termination by the Company without cause, Mr. Hasnain will receive the following severance benefits, subject to the execution and non-revocation of a release agreement and his compliance with other obligations set forth in the Executive Chair Agreement: (a) eighteen (18) months base salary, paid in equal installments in accordance with the Company s regular payroll and (b) (i) if the second anniversary grant described above has not been granted, either the grant of such award or a cash payment equal to the fair market value of such award as of the date of termination as if it had been granted on such date; and (ii) if any of the 200%, 600% or 800% 90-day average closing price per share RSU awards described above have not been granted and the applicable price goal (200%, 600% or 800%, respectively) is attained within ninety (90) days following such termination, either the grant of such award or a cash payment equal to the fair market value of such award as of the date of termination as if it had been granted on such date.

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1 unchanged paragraph

1 unchanged paragraph

and 6 more changes in the filing

Certain Relationships and Related Person Transactions 4 changes

31 unchanged paragraphs

In August 2026, we entered into an agreement to forgive the outstanding principal and accrued interest of approximately $2.1 million on three promissory notes issued to Dr. McDevitt for the early exercise of stock options, representing 5,550,221 shares of underlying common stock. In connection with the forgiveness, Dr. McDevitt agreed to amend the vesting schedule applicable to his November 2025 option grant for 3,825,000 shares of common stock, extending the vesting period from four to six years for the remaining unvested options.

In September 2026, we entered into agreements to forgive the outstanding principal and accrued interest of approximately $212,928 and $30,550 on promissory notes issued to Faheem Hasnain and Andrew Spaventa, respectively, for the early exercise of stock options, representing 526,839 and 76,550 shares of underlying common stock, respectively. In connection with the forgiveness, Mr. Hasnain and Mr. Spaventa each agreed to amend the vesting schedule applicable to their November 2025 option grants for 410,000 and 190,000 shares of common stock, respectively, extending the vesting period from four to six years for the remaining unvested options.

For additional information regarding the loan forgiveness agreements and related option amendments, see the section titled Executive and Director Compensation Non-Employee Director Compensation.

3 unchanged paragraphs

Miranda Pratt, the daughter of Dr. Johnson-Pratt, our Sasineprocel Development Lead and Chief Commercial Officer, has been employed by us since December 1, 2025 as a Scientific Communications Manager. For the year ended December 31, 2025, Ms. Pratt s total compensation , including base salary, bonus and other compensation, including consulting fees paid prior to Ms. Pratt s hire date and the grant date fair value of the stock options granted to Ms. Pratt, was approximately $52,000. Ms. Pratt s total compensation , including base salary, bonus and other compensation for the 2026 fiscal year is expected to be approximately $161,000.

6 unchanged paragraphs

Principal stockholders 24 changes

The following table sets forth information with respect to the beneficial ownership of our common stock as of , September 15, 2026 and as adjusted to reflect the sale of shares of common stock in this offering, by:

4 unchanged paragraphs

The number of shares beneficially owned by each stockholder is determined under rules issued by the SEC. Under these rules, beneficial ownership includes any shares as to which a person has sole or shared voting power or investment power. Applicable percentage ownership is based on 194,951,589 shares of common stock outstanding on , September 15, 2026 which gives effect to the automatic conversion of all outstanding shares of our convertible preferred stock into 177,593,856 shares of our common stock immediately prior to the closing of this offering. In computing the number We have based our calculation of shares beneficially owned by a person and the percentage ownership of that person, beneficial ownership after this offering on shares of our common stock subject to options or other rights held by such person that are currently exercisable or that will become exercisable or otherwise vest within 60 days of , 2026 are considered outstanding although these shares are not considered outstanding for purposes immediately after the closing of computing this offering, which reflects the percentage ownership conversion of any other person. our convertible preferred stock into common stock as described in the table below excludes any potential purchases prior sentence and further reflects the issuance of shares of common stock in this offering, by the beneficial owners identified in assuming that the table below. underwriters will not exercise their option to purchase up to an additional shares of our common stock.

In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of common stock subject to options or other rights held by such person that are currently exercisable or that will become exercisable or otherwise vest within 60 days of September 15, 2026 are considered outstanding, although these shares are not considered outstanding for purposes of computing the percentage ownership of any other person.

The table below excludes any potential purchases in this offering by the beneficial owners identified in the table below.

8 unchanged paragraphs

Entities affiliated with Platinum Falcon B 2018 RSC Limited (6)

Entities affiliated with Abu Dhabi Investment Authority (6)

6 unchanged paragraphs

(4) Consists of shares of our common stock held by Q Healthcare Holding LLC (Q Healthcare). Qatar Investment Authority (QIA) may be deemed to have sole voting and investment power over the shares held or beneficially owned by Q Healthcare. Voting and investment decisions are the result of a collaborative process involving multiple functions within QIA, in accordance with its internal controls and delegated authorities. As such, no single individual, nor a group of three or fewer individuals, unilaterally exercises voting or dispositive authority over the relevant securities. The principal business address of Q Healthcare is c/o Qatar Investment Authority, Ooredoo Tower (Building 14), Al Dafna Street (Street 801), Al Dafna (Zone 61), Doha, Qatar.

All executive officers and directors as a group (14 (12 persons) (16)

(1) Consists of 25,586,039 shares of our common stock held by OrbiMed Private Investments VII, LP (OPI VII). OrbiMed Capital GP VII LLC (OrbiMed GP), VII), is the general partner of OPI VII. OrbiMed Advisors LLC (OrbiMed Advisors) is the managing member of OrbiMed GP. VII. By virtue of such relationships, OrbiMed GP VII and OrbiMed Advisors may be deemed to have voting and investment power with respect to the shares held by OPI VII. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild. Each of OrbiMed GP, VII OrbiMed Advisors, Dr. Gordon, Mr. Borho, and Mr. Neild and Dr. Gordon disclaims disclaim beneficial ownership of the shares held by OPI VII, except to the extent of its or his pecuniary interest therein if any. The address for each of the entities and individuals identified in this footnote is c/o OrbiMed Advisors LLC, 601 Lexington Avenue 54th Floor, New York, NY 10022.

(2) Consists of 16,470,124 shares of our common stock held by Gilead Sciences, Inc. (Gilead). The address for Gilead is 333 Lakeside Drive, Foster City, California 94404.

(3) Consists of 13,251,770 shares of our common stock held by Frazier Life Sciences X, L.P. (FLS X). FHMLS X, L.P. is the general partner of FLS X, and FHMLS X, L.L.C. is the general partner of FHMLS X, L.P. James Topper, M.D., Ph.D., and Patrick Heron are the sole managing members of FHMLS X, L.L.C. and share voting and investment power of the securities held by FLS X. Dr. Topper and Mr. Heron disclaim beneficial ownership of such securities except to the extent of their pecuniary interest therein. The address for above referenced entities and persons is 1001 Page Mill Rd., Building 4, Ste. B, Palo Alto, CA 94304.

(4) Q Healthcare Holding LLC (Q Healthcare) is a limited liability company formed pursuant to the regulations of the Qatar Financial Centre and is a wholly-owned subsidiary of Qatar Investment Authority ( QIA ). QIA is the sole member of Q Healthcare. Q Healthcare directly holds 13,176,099 shares of our common stock. Each of QIA and Q Healthcare may be deemed to beneficially own the shares of our common stock held by Q Healthcare. The business address of Q Healthcare and QIA is Ooredoo Tower (Building 14), Al Dafna Street (Street 801), Al Dafna (Zone 61), Doha, Qatar.

(5) Consists of (i) 13,115,315 shares of our common stock held by ARCH Venture Fund X, L.P. (ARCH X) and (ii) 10,815,021 shares of our common stock held by ARCH Venture Fund X Overage, L.P. (ARCH X Overage). ARCH Venture Partners X, L.P. (AVP X LP), is the sole general partner of ARCH X. ARCH Venture Partners X Overage, L.P. (AVP X Overage LP), is the sole general partner of ARCH X Overage. ARCH Venture Partners X, LLC (AVP X LLC), is the sole general partner of each of AVP X LP and AVP X Overage LP. Keith Crandell, Kristina Burow, Steven Gillis, and Robert Nelsen, collectively the AVP X Committee Members, comprise the investment committee of AVP X LLC. AVP X LP and AVP X Overage LP may be deemed to beneficially own the shares held by ARCH X and ARCH X Overage, respectively, AVP X LLC may be deemed to beneficially own the shares held by ARCH X and ARCH X Overage, and each of the AVP X Committee Members may be deemed to share the power to direct the disposition and vote of the shares held by ARCH X and ARCH X Overage. Each of AVP X LP, AVP X Overage LP, AVP X LLC, and the AVP X Committee Members disclaims beneficial ownership except to any pecuniary interest therein. The address of the for these entities and individuals is in c/o Arch Venture Partners, entities is 8755 W. Higgins Road, Suite 1025, Chicago, IL 60631.

(6) Consists of 12,816,358 shares of our common stock held by Abu Dhabi Investment Authority (ADIA), directly or through one or more of its direct or indirect subsidiaries, including primarily Platinum Falcon B 2018 RSC Limited (Platinum Falcon), a limited liability restricted scope company incorporated in the Abu Dhabi Global Market. and a wholly owned subsidiary of the Abu Dhabi Investment Authority ADIA is a public institution established by the Government of the Emirate of Abu Dhabi. By reason of its ownership of Platinum Falcon and pursuant to the rules and regulations of the SEC, ADIA may also be deemed to share investment and voting power over and, therefore, beneficial ownership of, the shares held directly by Platinum Falcon. The address for ADIA is 211 Corniche Street, P.O. Box 3600, Abu Dhabi, United Arab Emirates and the address for Platinum Falcon B 2018 RSC Limited is Level 26, Al Khatem Tower, Abu Dhabi Global Market Square, Al Maryah Island, Abu Dhabi, United Arab Emirates.

(7) Consists of (i) 5,091,158 shares of our common stock held by Medical Excellence Capital Partners, LP and (ii) 5,566,902 shares of our common stock held by Medical Excellence Capital Partners II, LP. LP.The address for each of the entities identified in this footnote is 355 Old Mill Road, Nissequogue, NY 11780.

(8) Consists of (i) 4,800,221 shares of our common stock held by Damien McDevitt and Pamela Marnell-McDevitt, Co-trustees of the Marnell-McDevitt Family Trust dated May 2, 2019, (ii) 250,000 shares of our common stock held by Finn McDevitt, Trustee of the Finn McDevitt 2025 Irrevocable Trust, (iii) 250,000 shares of our common stock held by Aran McDevitt, Trustee of the Aran McDevitt 2025 Irrevocable Trust, (iv) 250,000 shares of our common stock held by Conor McDevitt, Trustee of the Conor McDevitt 2025 Irrevocable Trust and (v) 2,703,870 shares subject to options that are exercisable within 60 days of . September 15, 2026.

(9) Represents 709,270 shares subject to options that are exercisable within 60 days of . September 15, 2026.

(10) Represents 1,114,583 shares subject to options that are exercisable within 60 days of . September 15, 2026.

(11) Consists of (i) 263,421 shares of our common stock held by Faheem Hasnain, (ii) 359,185 shares of our common stock held by Hasnain Revocable Trust, (iii) 131,709 shares of our common stock held by Premier Trust, Inc., Trustee of the Myles J. Hasnain 2021 Irrevocable Trust, (iv) 131,709 shares of our common stock held by Premier Trust, Inc., Trustee of the Aaron D. Hasnain 2021 Irrevocable Trust and (v) 363,958 shares subject to options that are exercisable within 60 days of . September 15, 2026.

(12) Consists of (i) 173,636 shares of our common stock held by 2024 Corinne Marie Daniel Irrevocable Trust Dated 12/19/2024, (ii) 173,636 shares of our common stock held by 2024 Lyle Robert Daniel Irrevocable Trust Dated 12/19/2024, and (iii) 770,206 shares subject to options that are exercisable within 60 days of . September 15, 2026.

(13) Represents 410,473 shares subject to options that are exercisable within 60 days of . September 15, 2026.

(14) Consists of (i) 76,550 shares of our common stock held by Andrew Spaventa, (ii) 493,251 shares of our common stock held by The Andrew K. Spaventa Living Trust Dated April 9, 2014, (iii) 200,000 shares of our common stock held by Sharon Spaventa, (iv) 200,000 shares of our common stock held by Jon Spaventa, (v) 693,655 shares of common stock held directly by Axon Holdings, LLC Series XIII - Aspen Seed, of which Mr. Spaventa is a managing partner, (vi) 1,780,946 shares of our common stock held directly by Axon Holdings, LLC Series XXI - Aspen C, of which Mr. Spaventa is a managing partner, and (vii) 333,542 shares subject to options that are exercisable within 60 days of September 15, 2026.

(15) Consists of 25,586,039 shares of our common stock held by OrbiMed Private Investments VII, LP OPI VII. OrbiMed Capital GP VII LLC (GP VII) is the general partner of OPI VII, and OrbiMed Advisors LLC (Advisors) is the managing member of OrbiMed GP. VII. By virtue of such relationships, GP VII and OrbiMed Advisors may be deemed to have voting power and investment power over the securities held by OPI VII and as a result, may be deemed to have beneficial ownership over such securities. OrbiMed Advisors exercises voting and investment power through a management committee comprised of Carl L. Gordon, Sven H. Borho, and W. Carter Neild, each of whom disclaims beneficial ownership of the shares held by OPI VII. Peter A. Thompson, M.D., a member of our board of directors, is a member of OrbiMed Advisors. Dr. Thompson disclaims beneficial ownership of the shares held by OPI VII, except to the extent of his pecuniary interest therein, if any.

(16) Consists of (i) 35,813,958 shares of our common stock beneficially owned by our current executive officers and directors and (ii) 7,038,193 shares subject to options that are exercisable within 60 days of . September 15, 2026.

Description of the securities 11 changes

1 unchanged paragraph

Following the closing of this offering, our authorized capital stock will consist of 500,000,000 shares of common stock, $0.0001 par value per share, and 10,000,000 shares of preferred stock, $0.0001 par value per share.

As of March 31, June 30, 2026, there were 188,521,124 188,558,695 shares of our common stock outstanding and held of record by stockholders, after giving effect to the automatic conversion of all outstanding shares of our convertible preferred stock into 177,593,856 shares of common stock, which will automatically occur immediately prior to the closing of this offering. Based on the number of shares of common stock outstanding as of March 31, June 30, 2026, and further assuming the issuance by us of shares of common stock in this offering, there will be shares of common stock outstanding upon the closing of this offering.

10 unchanged paragraphs

As of March 31, June 30, 2026, options to purchase 28,157,570 30,078,745 shares of our common stock were outstanding, of which 11,790,997 13,287,819 were vested as of that date. For additional information regarding the terms of our 2018 Plan, see the section titled Executive and Director Compensation Employee Stock Plans 2018 Equity Incentive Stock Plan.

As of March 31, June 30, 2026, the warrants to purchase 175,691 shares of our common stock are outstanding. On December 20, 2022 in connection with a Loan and Security Agreement (the Loan Agreement) with a lender (the Lender) , we issued Lender a warrant to purchase 131,761 shares of our common stock at an exercise price of $0.78 per share. In conjunction with amending our line of credit with Lender on November 15, 2024, we issued Lender a warrant to purchase 43,930 shares of our common stock at an exercise price of $0.78. The warrants contain a net exercise provision under which the Lender may, in lieu of payment of the exercise price in cash, surrender the warrant, and receive, a net amount of shares of our common stock based on the fair market value of our common stock at the time of the net exercise of the warrant after deduction of the aggregate exercise price. The warrants expire ten years from their date of issuance.

1 unchanged paragraph

Upon the closing of this offering, holders of 187,328,011 shares of our common stock, which includes all of the shares of common stock issuable upon the automatic conversion of convertible preferred stock immediately prior to the closing of this offering and 9,734,155 shares of common stock held by certain key holders, will be entitled to the following rights with respect to the registration of such shares for public resale under the Securities Act, pursuant to an investors rights agreement by and among us and certain investors. The registration of shares of common stock as a result of the following rights being exercised would enable holders to trade these shares without restriction under the Securities Act when the applicable registration statement is declared effective.

1 unchanged paragraph

Form S-1. If at any time beginning during the six months following the effective date of the registration statement of which this prospectus forms a part, the holders of at least 35% of the registrable securities then outstanding request in writing that we effect a registration with respect to the registrable securities having an aggregate offering price, net of selling expenses, of at least $10.0 million, we may be required to provide notice of such request to all holders of registrable securities and offer them the opportunity to participate in such registration (other than certain key holders who do not have demand registration rights), and to use commercially reasonable efforts to effect such registration; provided, however, that we will not be required to effect such a registration if, among other things, the board determines in its good faith judgment that it would be materially detrimental to us and our stockholders for such registration statement to become effective.

Form S- 3. If at any time we become entitled under the Securities Act to register our shares on Form S-3, and the holders of at least 20% of the registrable securities then outstanding request in writing that we effect a registration with respect to all or a part of the registrable securities then outstanding where the anticipated aggregate offering price, net of expenses, is at least $1.0 million, we may be required to provide notice of such request to all holders of registrable securities and offer them the opportunity to participate in such registration (other than certain key holders who do not have demand registration rights), and to use commercially reasonable efforts to effect such registration; provided, however, that we will not be required to effect such a registration if, among other things, the board determines in its good faith judgment that it would be materially detrimental to us and our stockholders for such registration statement to become effective.

If the holders requesting registration intend to distribute their shares by means of an underwritten offering, the underwriter will be selected by the board of directors and shall be reasonably acceptable to a majority in interest of the initiating holders of registrable securities. The underwriter of such offering will have the right to limit the number of shares to be underwritten for reasons related to the marketing of the shares in accordance with the cut-back provisions of the investors rights agreements. agreement.

26 unchanged paragraphs

Our Charter provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for any stockholder (including a beneficial owner of stock) to bring: (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of, or claim based on, breach of a fiduciary duty owed by any of our directors, officers, employees, agents or stockholders to us or to our stockholders; (iii) any action asserting a claim against us arising pursuant to any provision of the DGCL, the Charter or the Bylaws; (iv) any action to interpret, apply, enforce or determine the validity of the Charter or Bylaws; or (v) any action asserting a claim against us governed by the internal affairs doctrine. Our Charter also provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action under the Securities Act, the Exchange Act, and any claims for which federal courts have exclusive jurisdiction.

10 unchanged paragraphs

The transfer agent and registrar for our common stock will be . Odyssey Transfer and Trust Company. The transfer agent and registrar s address is . 860 Blue Gentian Rd., Suite 320, Eagan, MN 55121.

1 unchanged paragraph

We intend to apply have applied to list our common stock on the Nasdaq Global Select Market under the symbol ASPE, and this offering is contingent upon obtaining such approval.

Shares Eligible For Future Sale 3 changes

Immediately prior to this offering, there was no public market for our common stock. Future sales of substantial amounts of common stock in the public market, or the perception that such sales may occur, could adversely affect the market price of our common stock. Although we intend to apply have applied to have our common stock listed on Nasdaq, we cannot assure you that there will be an active public market for our common stock.

Based on the number of shares of our common stock outstanding as of March 31, June 30, 2026, and assuming (i) the issuance of shares in this offering, (ii) the automatic conversion of all of our outstanding shares of convertible preferred stock into 177,593,856 shares of common stock and the related reclassification of the carrying value of the convertible preferred stock to permanent equity upon the closing of this offering, (iii) no exercise of the underwriters option to purchase additional shares of common stock and (iv) no exercise of outstanding options, we will have outstanding an aggregate of shares of common stock following the closing of this offering.

16 unchanged paragraphs

Upon the closing of this offering, holders of 187,328,011 shares of our common stock, which includes all of the shares of common stock issuable upon the automatic conversion of our convertible preferred stock into shares of our common stock immediately prior to the closing of this offering and 9,734,155 shares of common stock held by certain key holders, will be entitled to various rights with respect to the registration of these shares under the Securities Act upon the closing of this offering. Registration of these shares under the Securities Act would result in these shares becoming freely tradable without restriction under the Securities Act immediately upon the effectiveness of the registration, except for shares purchased by our affiliates. See the section titled Description of Capital Stock Registration Rights for additional information. Shares covered by a registration statement will be eligible for sale in the public market upon the expiration or release from the terms of the lock-up agreements described above.

41 unchanged paragraphs

Plan of distribution 2 changes

13 unchanged paragraphs

We estimate expenses payable by us in connection with this offering, other than the underwriting discounts and commissions referred to above, will be approximately $ . We also have agreed to reimburse the underwriters for up to $ for their FINRA counsel fee. In accordance with FINRA Rule 5110, this reimbursed fee is deemed underwriting compensation for this offering.

12 unchanged paragraphs

We intend to apply have applied to list our common stock on the Nasdaq Global Select Market, subject to notice of issuance, under the symbol ASPE.

60 unchanged paragraphs

Experts 1 change

Ernst & Young LLP, independent registered public accounting firm, has audited our financial statements at December 31, 2025 and 2024, and for each of the two years in the period ended December 31, 2025, as set forth in their report. We ve have included our financial statements in the prospectus and elsewhere in the registration statement in reliance on Ernst & Young LLP s report, given on their authority as experts in accounting and auditing.

Notes to the financial statements 2 changes

Unaudited Financial Statements as of March 31, June 30, 2026 and December 31, 2025 and for the Three Six Months Ended March 31, June 30, 2026 and 2025 Balance Sheets F- 26 Statements of Operations F- 27 Statements of Comprehensive Loss F- 28 Statements of Convertible Preferred Stock and Stockholders Deficit F- 29 Statements of Cash Flows F- 30 Notes to Unaudited Financial Statements F- 31 F- 1 R eport of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Aspen Neuroscience, Inc. Opinion on the Financial Statements We have audited the accompanying balance sheets of Aspen Neuroscience, Inc. (the Company) as of December 31, 2025 and 2024, the related statements of operations, comprehensive loss, convertible preferred stock and stockholders deficit and cash flows for the years then ended and the related notes (collectively referred to as the financial statements ). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for the years then ended in conformity with U.S. generally accepted accounting principles.

1 unchanged paragraph

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States) and in accordance with auditing standards generally accepted in the United States of America. PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company s internal control over financial reporting. Accordingly, we express no such opinion.

67 unchanged paragraphs

Legal proceedings 44 changes

33 unchanged paragraphs

As of December 31, 2025, the Company has federal and state net operating loss ( NOL ) carryforwards of approximately $161.5 million and $194.5 million, respectively. For tax purposes, federal NOLs generated after December 31, 2017 can be carried forward indefinitely but are limited to 80% utilization against future taxable income each year starting with the taxable year beginning January 1, 2021. Of the amount of federal NOL carryforwards, all $161.5 million all can be carried forward indefinitely. Unless previously utilized, the state NOL carryforwards will begin to expire in 2038.

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Series Seed convertible preferred stock, $0.0001 par value; 8,323,862 shares authorized, issued and outstanding at March 31, June 30, 2026 and December 31, 2025; $4,500 aggregate liquidation preference at March 31, June 30, 2026 and December 31, 2025 4,445 4,445 Series Seed-2 convertible preferred stock, $0.0001 par value; 1,966,511 shares authorized, issued and outstanding at March 31, June 30, 2026 and December 31, 2025; $2,025 aggregate liquidation preference at March 31, June 30, 2026 and December 31, 2025 2,008 2,008 Series A-1 convertible preferred stock, $0.0001 par value; 20,631,861 shares authorized, issued and outstanding at March 31, June 30, 2026 and December 31, 2025; $35,000 aggregate liquidation preference at March 31, June 30, 2026 and December 31, 2025 34,843 34,843 Series A-2 convertible preferred stock, $0.0001 par value; 19,804,932 shares authorized, issued and outstanding at March 31, June 30, 2026 and December 31, 2025; $35,000 aggregate liquidation preference at March 31, June 30, 2026 and December 31, 2025 34,986 34,986 Series B convertible preferred stock, $0.0001 par value; 50,701,812 shares authorized at March 31, June 30, 2026 and December 31, 2025; 50,693,198 shares issued and outstanding at March 31, June 30, 2026 and December 31, 2025; $147,563 aggregate liquidation preference at March 31, June 30, 2026 and December 31, 2025 147,173 147,173 Series C convertible preferred stock, $0.0001 par value; 76,173,492 shares authorized, issued and outstanding at March 31, June 30, 2026 and December 31, 2025; $115,624 aggregate liquidation preference at March 31, June 30, 2026 and December 31, 2025 115,353 115,353 Stockholders deficit:

Common stock, $0.0001 par value; 228,898,561 shares authorized at March 31, June 30, 2026 and December 31, 2025; 17,080,878 17,118,449 and 16,767,841 shares issued at March 31, June 30, 2026 and December 31, 2025, respectively; 10,927,268 10,964,839 and 10,614,231 shares outstanding at March 31, June 30, 2026 and December 31, 2025, respectively Additional paid-in capital 12,565 13,854 11,249 Accumulated other comprehensive (loss) income (42 ) Accumulated deficit (245,811 (264,886 ) (228,340 ) Total stockholders deficit (233,287 (251,073 ) (217,077 ) Total liabilities, convertible preferred stock and stockholders deficit $ 126,600 110,275 $ 143,663 The accompanying notes are an integral part of these unaudited financial statements.

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Weighted-average shares used to calculate net loss per common share, basic and diluted 10,692,532 10,093,319 10,816,448 10,214,636 The accompanying notes are an integral part of these unaudited financial statements.

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Statements of Convertible Preferre d Stock and Stockholders Deficit (in thousands, except share data) (Unaudited) Convertible Preferred Stock Common Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Total Stockholders Shares Amount Shares Amount Capital Income (Loss) Deficit Deficit Balance at December 31, 2025 177,593,856 $ 338,808 10,614,231 $ $ 11,249 $ $ (228,340 ) $ (217,077 ) Exercise of stock options 313,037 350,608 Stock-based compensation 1,225 1,225 2,483 2,483 Unrealized loss on marketable securities (55 ) (55 ) Net loss (17,471 (36,546 ) (17,471 (36,546 ) Balance at March 31, June 30, 2026 177,593,856 $ 338,808 10,927,268 10,964,839 $ $ 12,565 13,854 $ (42 ) $ (245,811 (264,886 ) $ (233,287 (251,073 ) Convertible Preferred Stock Common Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Total Stockholders Shares Amount Shares Amount Capital Income (Loss) Deficit Deficit Balance at December 31, 2024 101,428,978 $ 223,480 10,023,079 $ $ 8,517 $ $ (166,284 ) $ (157,727 ) Exercise of stock options 69,682 77,928 Vesting of restricted stock 230,452 245,036 Stock-based compensation 1,220 1,220 Unrealized loss on marketable securities (25 (32 ) (25 (32 ) Net loss (16,374 (31,759 ) (16,374 (31,759 ) Balance at March 31, June 30, 2025 101,428,978 $ 223,480 10,323,213 10,346,043 $ $ 9,243 9,801 $ $ (182,658 (198,043 ) $ (173,400 (188,234 ) The accompanying notes are an integral part of these unaudited financial statements.

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Accretion of discounts and amortization of premiums on short-term investments, net (468 (13 (748 (Gain) loss from change in fair value of convertible note receivable (12 (2 ) 1,737 Changes in operating assets and liabilities:

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Payment of deferred offering costs

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Recent Sales of Unregistered Securities 1 change

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Undertakings 9 changes

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