Iovance Biotherapeutics reported a net loss of $22.27 million
- Form
- 10-Q
- Filed
- Importance
- Major
- Accession
- 0001193125-26-448809
- Revenue of $121.47 million for the three months ended Sep 30, 2026
- Net loss of $22.27 million for the three months ended Sep 30, 2026
- Diluted EPS of -$0.05 for the three months ended Sep 30, 2026
Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.
What changed
18 changes since the June 2026 10-Q
Compared with the 10-Q 0001104659-26-091716, filed Aug 6, 2026.
New legal mention
On September 14, 2026, the plaintiff filed an opposition to the Company's motion to dismiss.
From the filings
Now
On September 14, 2026, the plaintiff filed an opposition to the Company's motion to dismiss.New legal mention
On July 29, 2026, purported call option holder Shravan Reddy Kambam Family Protection Trust ("the Kambam Trust"), by and through its trustee, Jayakumar Reddy Kambam, filed a complaint in the United States District…
From the filings
Now
On July 29, 2026, purported call option holder Shravan Reddy Kambam Family Protection Trust ("the Kambam Trust"), by and through its trustee, Jayakumar Reddy Kambam, filed a complaint in the United States District Court for the Southern District of New York against the Company and certain individuals alleging violations of Sections 10(b) and 20(a) of the 1934 Act and SEC Rule 10b-5 as well as common law fraud in connection with the same course of action at issue in the securities class action and derivative litigations.New legal mention
At the joint request of the parties, the court stayed the action on September 23, 2026 pending resolution of the motion to dismiss in the securities litigation.
From the filings
Now
At the joint request of the parties, the court stayed the action on September 23, 2026 pending resolution of the motion to dismiss in the securities litigation.EPS up 55% from Jun 30
−$0.05, was −$0.11.
From the filings
Before
−$0.11Now
−$0.05Net income up 53% from Jun 30
−$22.3M, was −$47.3M.
From the filings
Before
−$47.3MNow
−$22.3MCash down 48% from Jun 30
$57.9M, was $111M.
From the filings
Before
$111MNow
$57.9M• costs associated with any potential business or product acquisitions (such as the acquisition of Proleukin…
Adds "provided"; drops "provides".
From the filings
Before
● costs associated with any potential business or product acquisitions (such as the acquisition of Proleukin ® ), strategic collaborations, licensing agreements, or other arrangements that we may establish. Unless and until we can generate a sufficient amount of revenue, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements. For example, in August 2025, we entered into an Amended and Restated Open Market Sale Agreement, or the 2025 Sale Agreement, with Jefferies, which provides for the sale of up to $350.0 million of our common stock from time to time. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to undergo further reductions in our workforce or other corporate restructuring activities, or delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. Our current license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under those agreements. As a result, we may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our…Now
• costs associated with any potential business or product acquisitions (such as the acquisition of Proleukin ® ), strategic collaborations, licensing agreements, or other arrangements that we may establish. Unless and until we can generate a sufficient amount of revenue, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements. For example, in August 2025, we entered into an Amended and Restated Open Market Sale Agreement, or the 2025 Sale Agreement, with Jefferies, which provided for the sale of up to $350.0 million of our common stock from time to time. As of September 30, 2026, all shares subject to the 2025 Sale Agreement had been sold and the 2025 Sale Agreement terminated in accordance with its terms. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to undergo further reductions in our workforce or other corporate restructuring activities, or delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. Our current license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under those agreements. As a result, we may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. The incurrence of indebtedness would result in increased…Subject to various spending levels approved by our Board of Directors, our management will have broad…
Adds "provided"; drops "provides".
From the filings
Before
Subject to various spending levels approved by our Board of Directors, our management will have broad discretion in the use of the net proceeds from our capital raises, including proceeds from sales pursuant to our "at-the-market" sale agreement with Jefferies LLC, and may not use them effectively. Our management will have discretion in the application of the net proceeds from our capital raises, including proceeds from sales pursuant to the 2025 Sale Agreement with Jefferies, which provides for the sale of up to $350.0 million of our common stock from time to time, and our stockholders will not have the opportunity as part of their investment decision to assess whether the net proceeds from our capital raises are being used appropriately. You may not agree with our decisions, and our use of the proceeds from our capital raises may not yield any return to stockholders. Because of the number and variability of factors that will determine our use of the net proceeds from our capital raises, their ultimate use may vary substantially from their currently intended use. Our failure to apply the net proceeds of our capital raises effectively could compromise our ability to pursue our growth strategy and we might not be able to yield a significant return, if any, on our investment of those net proceeds. Stockholders will not have the opportunity to influence our decisions on how to use our net proceeds from our capital raises. Pending their use, we may invest the net proceeds from our capital raises in interest and non-interest-bearing cash accounts, short-term, investment-grade, interest-bearing instruments, and U.S. government securities. These temporary investments are not likely to yield a significant return.Now
Subject to various spending levels approved by our Board of Directors, our management will have broad discretion in the use of the net proceeds from our capital raises, including proceeds from sales pursuant to our "at-the-market" sale agreement with Jefferies LLC, and may not use them effectively. Our management will have discretion in the application of the net proceeds from our capital raises, including proceeds from sales pursuant to the 2025 Sale Agreement with Jefferies, which provided for the sale of up to $350.0 million of our common stock from time to time, and terminated as of September 30, 2026, following the sale of all shares subject to it, and our stockholders will not have the opportunity as part of their investment decision to assess whether the net proceeds from our capital raises are being used appropriately. You may not agree with our decisions, and our use of the proceeds from our capital raises may not yield any return to stockholders. Because of the number and variability of factors that will determine our use of the net proceeds from our capital raises, their ultimate use may vary substantially from their currently intended use. Our failure to apply the net proceeds of our capital raises effectively could compromise our ability to pursue our growth strategy and we might not be able to yield a significant return, if any, on our investment of those net proceeds. Stockholders will not have the opportunity to influence our decisions on how to use our net proceeds from our capital raises. Pending their use, we may invest the net proceeds from our capital raises in interest and non-interest-bearing cash accounts, short-term, investment-grade, interest-bearing instruments, and U.S. government securities. These temporary investments are not likely to yield a significant return.Recently enacted tax reform legislation in the U.S., changes to existing tax laws, or challenges to our tax…
Adds "enhanced"; drops "result in an additional loss of coverage for approximately an estimated 24 million…".
From the filings
Before
Recently enacted tax reform legislation in the U.S., changes to existing tax laws, or challenges to our tax positions could adversely affect our business and financial condition. The tax regimes to which we are subject or under which we operate are unsettled and may be subject to significant change. The tax rate applied is based on the estimated statutory rates in the UK as this is where our intangible assets, including our intellectual property, are domiciled, and as a result, we receive certain tax benefits. Any such changes to existing federal and state tax laws or international and U.S. corporate tax rates could adversely impact our business, results of operations, and financial position as the impact of recent tax legislation is uncertain. In recent years, various tax legislations were signed into law. On December 22, 2017, the Tax Cuts and Jobs Act of 2017, or the Tax Act, was signed into law, making significant changes to the Internal Revenue Code. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, was enacted in response to the COVID-19 pandemic. Certain provisions of the CARES Act amend or suspend certain provisions of the Tax Act. For example, the tax relief measures under the CARES Act for businesses include a five-year net operating loss carryback, suspension of annual deduction limitation of 80% of taxable income from net operating losses generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property. On June 15, 2020, Assembly Bill 85 was passed in California, which suspended the use of net operating losses and limited the use of credits for certain corporations. On July 4, 2025, the One Big Beautiful Bill Act, or the OBBBA, was enacted in the U.S. The OBBBA includes significant provisions, such as the…Now
Recently enacted tax reform legislation in the U.S., changes to existing tax laws, or challenges to our tax positions could adversely affect our business and financial condition. The tax regimes to which we are subject or under which we operate are unsettled and may be subject to significant change. The tax rate applied is based on the estimated statutory rates in the UK as this is where our intangible assets, including our intellectual property, are domiciled, and as a result, we receive certain tax benefits. Any such changes to existing federal and state tax laws or international and U.S. corporate tax rates could adversely impact our business, results of operations, and financial position as the impact of recent tax legislation is uncertain. In recent years, various tax legislations were signed into law. On December 22, 2017, the Tax Cuts and Jobs Act of 2017, or the Tax Act, was signed into law, making significant changes to the Internal Revenue Code. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, was enacted in response to the COVID-19 pandemic. Certain provisions of the CARES Act amend or suspend certain provisions of the Tax Act. For example, the tax relief measures under the CARES Act for businesses include a five-year net operating loss carryback, suspension of annual deduction limitation of 80% of taxable income from net operating losses generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property. On June 15, 2020, Assembly Bill 85 was passed in California, which suspended the use of net operating losses and limited the use of credits for certain corporations. On July 4, 2025, the One Big Beautiful Bill Act, or the OBBBA, was enacted in the U.S. The OBBBA includes significant provisions, such as the…Future sales of our common stock in the public market could cause our stock price to fall.
Adds "September"; drops "June".
From the filings
Before
Future sales of our common stock in the public market could cause our stock price to fall. Our stock price could decline as a result of sales of a large number of shares of our common stock or the perception that these sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. As of June 30, 2026, we had 452,971,016 shares of common stock outstanding. In addition, we had 32,730,876 shares of common stock equivalents that would increase the number of common stock outstanding if these instruments were exercised or converted to purchase common stock based on vesting requirements of stock options and common stock issuable through purchases of employee stock purchase plan, or upon the conversion of preferred stock. The issuance and subsequent sale of the shares underlying these common stock equivalents could depress the trading price of our common stock. On June 10, 2019, our certificate of incorporation was amended to increase the number of authorized shares of our common stock, from 150,000,000 shares to 300,000,000 shares, which was approved by our stockholders on that date. On June 16, 2023, our certificate of incorporation was amended to increase the number of authorized shares of our common stock from 300,000,000 to 500,000,000 shares, which was approved by our stockholders on June 6, 2023. On June 12, 2026, our certificate of incorporation was amended to increase the number of authorized shares of our common stock from 500,000,000 to 650,000,000 shares, which was approved by our stockholders on June 10, 2026. In addition, in the future, we may issue additional shares of common stock or other equity or debt securities convertible into common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise. For example, in August 2025, we entered into a Sale Agreement…Now
Future sales of our common stock in the public market could cause our stock price to fall. Our stock price could decline as a result of sales of a large number of shares of our common stock or the perception that these sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. As of September 30, 2026, we had 462,543,386 shares of common stock outstanding. In addition, we had 29,660,828 shares of common stock equivalents that would increase the number of common stock outstanding if these instruments were exercised or converted to purchase common stock based on vesting requirements of stock options and common stock issuable through purchases of employee stock purchase plan, or upon the conversion of preferred stock. The issuance and subsequent sale of the shares underlying these common stock equivalents could depress the trading price of our common stock. On June 10, 2019, our certificate of incorporation was amended to increase the number of authorized shares of our common stock, from 150,000,000 shares to 300,000,000 shares, which was approved by our stockholders on that date. On June 16, 2023, our certificate of incorporation was amended to increase the number of authorized shares of our common stock from 300,000,000 to 500,000,000 shares, which was approved by our stockholders on June 6, 2023. On June 12, 2026, our certificate of incorporation was amended to increase the number of authorized shares of our common stock from 500,000,000 to 650,000,000 shares, which was approved by our stockholders on June 10, 2026. In addition, in the future, we may issue additional shares of common stock or other equity or debt securities convertible into common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise. Future issuances may result in substantial dilution to our…We recently reported a 24.6% ORR in 69 patients with non-squamous mNSCLC, including two unconfirmed…
New paragraph in MD&A.
From the filings
Now
We recently reported a 24.6% ORR in 69 patients with non-squamous mNSCLC, including two unconfirmed responses, consistent with previously reported results. IOV-LUN-202 Cohorts 1 and 2 are completing enrollment. A supplemental Biologics License Application for lifileucel based on Cohorts 1 and 2, with a target of approximately 80 patients, is planned in 2027. Independent review committee assessments, FDA discussions, and other pre-submission activities, including confirmatory trial preparation, are ongoing.• Efficacy results are potentially best-in-class, with durability continuing to mature and already greater…
New paragraph in MD&A.
From the filings
Now
• Efficacy results are potentially best-in-class, with durability continuing to mature and already greater than standard of care, including docetaxel, which offers an ORR of only 12.8%, a durability of only 5.6 months, and median overall survival of 12.3 months. The safety profile remains consistent with lifileucel regimen experience and was improved after switching to reduced-dose lymphodepletion.• The FDA awarded Fast Track Designation (FTD) on the strength of the clinical data and the high unmet…
New paragraph in MD&A.
From the filings
Now
• The FDA awarded Fast Track Designation (FTD) on the strength of the clinical data and the high unmet medical need of mNSCLC patients.• A novel biomarker-enriched subgroup within IOV-LUN-202 achieved a 59.1% ORR, leading to the start of…
New paragraph in MD&A.
From the filings
Now
• A novel biomarker-enriched subgroup within IOV-LUN-202 achieved a 59.1% ORR, leading to the start of POSITILITY, a first-in-class biomarker-enriched cohort with registrational intent, with enrollment beginning this month and a target of 80 patients.• We plan to initiate OPTILISM, an innovative frontline trial in biomarker-enriched non-squamous mNSCLC, in…
New paragraph in MD&A.
From the filings
Now
• We plan to initiate OPTILISM, an innovative frontline trial in biomarker-enriched non-squamous mNSCLC, in 2027. The U.S. market opportunity in frontline and second-line non-squamous mNSCLC in the biomarker-selected cohort is about ten times that of advanced melanoma.Results of Operations for the Three and Nine Months Ended September 30, 2026 and 2025
New paragraph in MD&A.
From the filings
Now
Results of Operations for the Three and Nine Months Ended September 30, 2026 and 2025Other clinical, preclinical, and research programs under development (2,604 (42 (8,100 (40
New paragraph in MD&A.
From the filings
Now
Other clinical, preclinical, and research programs under development (2,604 (42 (8,100 (40Restructuring expense was zero for the three and nine months ended September 30, 2026 as compared to $5.1…
New paragraph in MD&A.
From the filings
Now
Restructuring expense was zero for the three and nine months ended September 30, 2026 as compared to $5.1 million for the three and nine months ended September 30, 2025. Expense in 2025 was primarily related to severance payments, costs for outplacement services, and post-employment benefits associated with our August 2025 strategic restructuring plan, resulting from a review of current strategic priorities, the strategic restructuring plan included an associated reduction in workforce, resource allocations, and costs, intended to reduce operating costs, streamline operations and extend cash runway.
Show the redline
Section by section. Added words and removed words against the earlier filing.
Cover page 5 changes
3 unchanged paragraphs
For the quarterly period ended June September 30, 2026
8 unchanged paragraphs
825 Industrial Road, Suite 100 , San Carlos , CA 94070
300 Rouse Blvd ., Philadelphia , PA 19112
15 unchanged paragraphs
As of July 29, October 27, 2026, the issuer had 452,971,432 462,655,151 shares of common stock, par value $0.000041666 per share, outstanding.
1 unchanged paragraph
For the Quarter Ended June September 30, 2026
1 unchanged paragraph
Financial statements 33 changes
22 unchanged paragraphs
Series A Convertible Preferred stock, $ 0.001 par value; 17,000 shares designated, 194 shares issued and outstanding as of June September 30, 2026 and December 31, 2025
Series B Convertible Preferred stock, $ 0.001 par value; 11,500,000 shares designated, 1,932,667 shares issued and outstanding as of June September 30, 2026 and December 31, 2025
Common stock, $ 0.000041666 par value; 650,000,000 shares authorized, 452,971,016 462,543,386 and 411,938,061 shares issued and outstanding as of June September 30, 2026 and December 31, 2025, respectively
13 unchanged paragraphs
Restructuring charges
4 unchanged paragraphs
Income tax benefit (expense)
Income tax (expense) benefit
8 unchanged paragraphs
Condensed Consolidated Statements of Comprehensive Income (Loss)
1 unchanged paragraph
Other comprehensive loss:
Other comprehensive income (loss):
Unrealized income (loss) on investments
Foreign currency cumulative translation adjustment
3 unchanged paragraphs
For the Three Months Ended June September 30, 2026 and 2025
1 unchanged paragraph
Balance - March 31, 2026
Balance - June 30, 2026
3 unchanged paragraphs
Tax payments related to shares retired for vested restricted stock units ( 284,889 291,011 ( 2,419 ( 2,419
4 unchanged paragraphs
Balance - March 31, 2025
Balance - September 30, 2026
Balance - June 30, 2026 2025
3 unchanged paragraphs
Tax payments related to shares retired for vested restricted stock units ( 257,496 211,322 ( 464 ( 464
1 unchanged paragraph
Unrealized loss on investments
Unrealized gain on investments
1 unchanged paragraph
Balance - June 30, 2025
Balance - September 30, 2025
3 unchanged paragraphs
For the Six Nine Months Ended June September 30, 2026 and 2025
5 unchanged paragraphs
Tax payments related to shares retired for vested restricted stock units ( 1,247,841 1,538,852 ( 7,764 ( 7,764
4 unchanged paragraphs
Balance - June 30, 2026
Balance - September 30, 2026
4 unchanged paragraphs
Tax payments related to shares retired for vested restricted stock units ( 1,645,397 1,856,719 ( 6,614 ( 6,614
5 unchanged paragraphs
Balance - June 30, 2025
Balance - September 30, 2025
26 unchanged paragraphs
Purchase of intangible assets
2 unchanged paragraphs
Tax payments related to shares withheld for vested restricted stock units ( 5,345 7,764 ( 6,614
5 unchanged paragraphs
Net increase (decrease) in cash, cash equivalents and restricted cash ( 52,285 ) 105,106
9 unchanged paragraphs
Note 1: GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY 4 changes
2 unchanged paragraphs
The Company was founded to build upon the promise of TIL cell therapy initially developed at academic research centers, including the National Cancer Institute ("NCI"). The Company's multi-center trials, scalable manufacturing, regulatory approvals, and commercial infrastructure have transformed TIL cell therapy from a research product available to only a small number of patients into a commercially viable treatment that is accessible for thousands of cancer patients globally.
2 unchanged paragraphs
Globally, Amtagvi ® has the potential to address tens of thousands of previously treated advanced melanoma patients annually. The Company plans to launch Amtagvi ® into additional markets with a high prevalence of advanced melanoma. On June 4, 2026, the Company received marketing authorization with conditions from the Therapeutic Goods Administration of Australia for Amtagvi ® for previously treated advanced (metastatic or unresectable) melanoma. In the United Kingdom ("UK"), the Company resubmitted the marketing authorization application ("MAA") with additional information in July 2026. The Medicines and Healthcare products Regulatory Agency ("MHRA") is conducting an expedited review, with potential approval expected later in 2026. the first quarter of 2027. Potential approval is pending in Switzerland in the first quarter of 2027. In the European Union ("EU"), the Company is working with the European Medicines Agency ("EMA") to resubmit a centralized MAA in 2026 or 2027.
2 unchanged paragraphs
The accompanying unaudited condensed consolidated financial statements of the Company for the three and six nine months ended June September 30, 2026 and 2025 have been prepared in accordance with accounting principles generally accepted in the U.S. ("GAAP") for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for audited financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the Company's financial position and results of operations. Results shown for interim periods are not necessarily indicative of the results that may be expected for the year ended December 31, 2026 or for any other period. The condensed consolidated balance sheet as of December 31, 2025 was derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10‑K filed with the U.S. Securities and Exchange Commission (the "SEC") on February 24, 2026. Beginning in the third quarter of 2025, the Company began separately presenting depreciation and amortization expense on the condensed consolidated statement of operations. Certain prior period amounts reported in the Company's condensed consolidated financial statements and accompanying notes have been reclassified to conform to the current period's presentation. These reclassifications did not have an impact on the Company's previously presented net results of operations, financial position, or cash flows.
As of June September 30, 2026, the Company had $ 303.7 382.3 million in cash, cash equivalents, short-term investments, and restricted cash ($ 110.8 57.9 million of cash and cash equivalents, $ 186.9 318.4 million in short-term investments, and $ 6.0 million in restricted cash). The Company has launched its first internally developed commercial product and continues to be engaged in the development of therapeutics to fight cancer, specifically solid tumors. With the approval of the Biologics License Application ("BLA"), the Company began to generate revenue from the sale of its product Amtagvi ® in the second quarter of 2024. Furthermore, following the acquisition of the worldwide rights to Proleukin ® (as discussed below in Note 4 – Intangible Assets, Net) in 2023, the Company began to generate revenue from the sales of Proleukin ® . However, such revenues may not be material enough to generate positive operational cash flows during the 12 months from the date the condensed consolidated financial statements are issued and this Form 10-Q is filed. The Company has incurred a net loss of $ 126.4 148.6 million for the six nine months ended June September 30, 2026, and used $ 132.9 137.4 million of cash in its operating activities during the six nine months ended June September 30, 2026.
3 unchanged paragraphs
Note 2: SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 13 changes
1 unchanged paragraph
The Company's cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's investments are classified as "available-for-sale." The Company includes these investments in current assets or non-current assets in the condensed consolidated balance sheets based on the length of maturity from the reporting date and carries them at fair value. Unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive income (loss). Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest and other income, net. No impairment losses related to credit losses were recognized for the three and six nine months ended June September 30, 2026, and 2025 . The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in Interest and other income, net in the condensed consolidated statements of operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in Interest and other income, net in the condensed consolidated statements of operations. The Company has not incurred any realized gains or losses from sales of securities to date. The Company's investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities and commercial paper, and places restrictions on maturities and concentration by type and issuer, except for securities issued by the U.S. government.
As of June September 30, 2026 and December 31, 2025, restricted cash totaled $ 6.0 million, and $ 6.0 million, respectively. These amounts have been classified as either current or non-current assets in the Company's condensed consolidated balance sheet based on the maturity date of the underlying letter of credit agreement.
The Company maintains a required minimum balance in segregated bank accounts in connection with its letters of credit for which amounts are restricted as to their use by the Company. As of June September 30, 2026, the Company's letters of credit were primarily comprised of a letter of credit for the benefit of the i CTC used as a security deposit for the lease in the amount of $ 5.45 million. The letter of credit for $ 5.45 million originally expired on May 28, 2020, however, it automatically extends for additional one-year periods, without written agreement, to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration date. Further, on the expiration of the seventh year of the lease, and each anniversary date thereafter, the letter of credit may be decreased by $ 1.0 million, with a minimum security deposit of $ 1.5 million maintained through the end of the lease term. The letter of credit with the landlord for the Company's headquarters California office lease expires on February 1, 2032, however, it will be automatically extended, without written agreement, for one-year periods to February in each succeeding calendar year.
5 unchanged paragraphs
Deferred tax liabilities arising from basis differences in assets acquired are calculated using the simultaneous equations method under ASC Topic 740, Income Taxes ("ASC 740"), and based on the effective tax rate. The resulting deferred tax liability is recorded in the condensed consolidated balance sheet as of June September 30, 2026 and December 31, 2025.
2 unchanged paragraphs
Inventory is stated at the lower of cost or net realizable value on a first-in, first-out basis. Cost includes amounts related to materials, internal labor, costs of external manufacturing, and overhead. Net realizable value is the estimated selling price in the ordinary course of business less reasonably predictable costs of completion, disposal and transportation. Inventoriable c osts Certain costs incurred, such as manufacturing costs incurred prior to regulatory approval that did not qualify for capitalization and clinical manufacturing costs, are expensed as incurred as research and development expenses.
8 unchanged paragraphs
The Company reviews intangible assets for impairment at least annually and whenever events or changes in circumstances have occurred which could indicate that the carrying value of the assets are not recoverable. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of the assets is less than the sum of the undiscounted future cash flows of the assets. If the assets are found to not be recoverable, the Company measures the amount of impairment by comparing the carrying value of the assets to their fair values. The Company determined that no indicators of impairment existed as of June September 30, 2026 or December 31, 2025 .
The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its condensed consolidated balance sheets as operating lease right-of-use assets and operating lease liabilities as of June September 30, 2026 and December 31, 2025. Operating lease right-of-use assets represent the Company's right to use an underlying asset for the lease term and operating lease liabilities represent the Company's obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date or modification date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement or modification date.
3 unchanged paragraphs
In the U.S., products are sold principally to hospitals and clinics, as well as distributors and wholesalers, and outside of the U.S. to hospitals and clinics. Contractual performance obligations are usually limited to transfer of control of the product to the customer. In the case of Amtagvi ® , revenue is recognized primarily upon infusion while for Proleukin ® , transfer of control occurs either upon shipment or upon receipt of the product after considering when the customer obtains legal title to the product. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring its products and is generally based on a list of fixed prices less allowances for chargebacks, product returns, rebates and discounts. The Company's payment terms to customers range from 45 to 105 days; ; payment terms differ by customer and by product.
16 unchanged paragraphs
Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of shares of common stock outstanding and the dilutive common stock equivalent outstanding during the period. The Company's potentially dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options, (ii) vesting of restricted stock units, (iii) purchases through the 2020 Employee Stock Purchase Plan (the "2020 ESPP"), (iii) vesting of restricted stock units, and (iv) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive.
As of June September 30, 2026 and 2025, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive:
9 unchanged paragraphs
Beginning in the third quarter of 2025, the Company began separately presenting depreciation and amortization expense on the consolidated statement of operations. Certain prior period amounts reported in the Company's consolidated financial statements and accompanying notes have been reclassified to conform to the current period's presentation. These reclassifications did not have an impact on the Company's previously presented net results of operations, financial position, or cash flows.
1 unchanged paragraph
The condensed consolidated financial statements are presented in U.S. dollars, which is the Company's reporting currency. The assets and liabilities of the Company's subsidiaries whose functional currencies are not in U.S. dollars are translated into U.S. dollars at the related period-end exchange rate. The U.S. dollar effects that arise from translation of net assets of these subsidiaries at changing rates are recognized in accumulated other comprehensive income (loss) in the condensed consolidated balance sheets. The subsidiaries' net loss is translated into U.S. dollars by using the average exchange rate for the applicable period.
4 unchanged paragraphs
In July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326) Measurement of Credit Losses for Accounts Receivable and Contract Assets, which amends ASC 326 and provides a practical expedient to assume that current conditions as of the balance sheet date will persist through a reasonable and supportable forecast period when estimating credit losses for current accounts receivable and current contract assets. Entities will still be required to adjust historical data used in the estimation to reflect current conditions. ASU 2025-05 is effective for all entities for annual reporting periods beginning after December 15, 2025, and interim periods within those annual reporting periods. The Company adopted ASU 2025-05 during the quarter ended March 31, 2026, and the adoption did not have a material impact on the Company's condensed consolidated financial statements as of and for the three and six nine months ended June September 30, 2026 .
Note 3: CASH EQUIVALENTS AND INVESTMENTS 7 changes
The amortized cost and fair value of cash equivalents and investments as of June September 30, 2026 and December 31, 2025 were as follows (in thousands):
As of September 30, 2026
3 unchanged paragraphs
The fair value of cash equivalents and investments as of June September 30, 2026 and December 31, 2025, are classified as follows in the Company's condensed consolidated balance sheets (in thousands):
1 unchanged paragraph
Cash equivalents in the tables above exclude cash demand deposits of $ 49.6 million and $ 102.6 million as of June 30, 2026 and December 31, 2025, respectively. Unrealized gains and losses are included in accumulated other comprehensive loss, and as of June
Cash equivalents in the tables above exclude cash demand deposits of $ 36.7 million and $ 102.6 million as of September 30, 2026 and December 31, 2025, respectively. Unrealized gains and losses are included in accumulated other comprehensive income (loss), and as of September 30, 2026 and December 31, 2025 , no unrealized losses on available-for-sale securities have resulted from credit risk. All available-for-sale securities held as of June September 30, 2026 and December 31, 2025 had contractual maturities of less than one year. No available-for-sale securities held as of the periods presented have been in a continuous unrealized loss position for more than 12 months. To date, the Company has not recorded any impairment charges on its investments.
1 unchanged paragraph
As of June September 30, 2026 and December 31, 2025, the fair value of the Company's financial assets that are measured at fair value on a recurring basis, which consist of cash equivalents and short-term and long-term investments classified as available-for-sale securities, are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands):
Assets at Fair Value as of June September 30, 2026
3 unchanged paragraphs
Note 4: INTANGIBLE ASSETS, NET 4 changes
The gross carrying amounts and net book value of intangible assets as of June September 30, 2026, and December 31, 2025, , are as follows (in thousands):
6 unchanged paragraphs
* Amounts are translated using the foreign exchange rates as of June September 30, 2026 and December 31, 2025, respectively.
The Company recognized amortization expense of $ 5.7 million and $ 11.3 17.0 million during the three and six nine months ended June September 30, 2026 , and $ 5.7 5.8 million and $ 11.1 16.9 million during the three and six nine months ended June September 30, 2025, respectively, excluding non-cash amortization expense of the fair value step-up acquired inventory.
The total estimated amortization of the Company's intangible assets for the remainder of the year ending December 31, 2026, and the years ending December 31, 2027, 2028, 2029, and 2030 are $ 11.2 5.6 million, $ 22.5 million, $ 22.5 million, $ 22.5 million, and $ 22.5 million, respectively.
3 unchanged paragraphs
Note 5: INVENTORY 3 changes
As of June September 30, 2026, and December 31, 2025, inventory consists of the following (in thousands):
Inventory includes $ 15.7 15.2 million for excess and obsolescence reserves recorded as of June September 30, 2026, such reserve being primarily related to excess Proleukin ® inventory resulting from a manufacturer contract inherited in the Acquisition for which we the Company cannot yet fully utilize the required purchase quantities while we scale the Company scales the Amtagvi ® commercial launch.
Inventory expected to be used or sold more than twelve months from the balance sheet date is classified as long-term other assets on the condensed consolidated balance sheet. The Company recorded $ 6.2 4.3 million and $ 7.9 million of inventory as long-term other assets as of June September 30, 2026, and December 31, 2025 , respectively.
Note 6: REVENUE 1 change
9 unchanged paragraphs
The following table summarizes the amount and percentage of gross revenue attributable to customers that represented more than 10 % of the Company's gross revenue and all other customers as a group for the three and six nine months ended June September 30, 2026 and 2025, respectively (in thousands, except percentages):
2 unchanged paragraphs
Note 9: STOCKHOLDERS' EQUITY 20 changes
The Company's certificate of incorporation, as amended, authorizes the issuance of up to 650,000,000 shares of the Company's common stock, par value $ 0.000041666 . As of June September 30, 2026, 452,971,016 462,543,386 shares of the Company's common stock were issued and outstanding.
4 unchanged paragraphs
For the quarter ended June September 30, 2026, the Company raised approximately $ 49.6 87.9 million in net proceeds, through the sale of 14,000,743 8,666,654 shares of common stock pursuant to the 2025 Sale Agreement at a weighted average price per share of $ 3.61 10.34 . As of September 30, 2026, the 2025 Sale Agreement terminated upon the issuance and sale of all Common Shares subject to the 2025 Sale Agreement. For the quarter ended June September 30, 2025, the Company raised approximately $ 13.1 88.5 million in net proceeds, after offering costs, through the sale of 7,303,645 43,242,489 shares of common stock pursuant to the 2023 Sale Agreement at a weighted average price per share of $ 1.83 2.09 .
The Company's certificate of incorporation authorizes the issuance of up to 50,000,000 shares of "blank check" preferred stock. As of June September 30, 2026, 17,000 shares were designated as Series A Convertible Preferred Stock and 11,500,000 shares were designated as Series B Convertible Preferred Stock.
3 unchanged paragraphs
During the six nine months ended June September 30, 2026, and 2025 , no shares of Series A Convertible Preferred Stock were converted into shares of common stock. As of June September 30, 2026 and December 31, 2025, 194 shares of Series A Convertible Preferred Stock (that are convertible into 97,000 shares of common stock) remained outstanding.
3 unchanged paragraphs
During the six nine months ended June September 30, 2026 , no shares of Series B Convertible Preferred Stock were converted into shares of common stock. During the six nine months ended June September 30, 2025 , 909,491 shares of Series B Convertible Preferred Stock were converted into 909,491 shares of common stock. As of June September 30, 2026 and December 31, 2025, 1,932,667 shares of Series B Preferred Stock (that are convertible into 1,932,667 shares of common stock) remained outstanding.
3 unchanged paragraphs
On April 22, 2018, the Company's Board of Directors (the "Board") adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan, (the "2018 Plan"), which was approved by the Company's stockholders in June 2018. The 2018 Plan as approved initially authorized the issuance up to an aggregate of 6,000,000 shares of common stock in the form of incentive (qualified) stock options, non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards or any combination of the foregoing. On June 8, 2020, the Company's stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2018 Plan from 6,000,000 to 14,000,000 shares, which became effective immediately. Additionally on June 10, 2022, the Company's stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2018 Plan from 14,000,000 to 20,700,000 shares, which became effective immediately. On June 6, 2023, the Company's stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 20,700,000 to 29,700,000 shares, which became effective immediately. On June 11, 2024, the Company's stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 29,700,000 to 36,700,000 shares and permit share recapture from the 2014 Plan, which became effective immediately. On June 10, 2025, the Company's stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 36,700,000 to 49,200,000 shares and permit share recapture from the 2014 Plan, which became effective immediately. As of June September 30, 2026, 12,928,758 13,646,862 shares of common stock were available for grant under the 2018 Plan, including shares recaptured from the 2014 Plan.
2 unchanged paragraphs
Company). As of June 30, 2026, 1,149,935 shares of the Company's common stock were available for grant under the Inducement Plan.
The Compensation Committee approved additional amendments to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,750,000 to 2,250,000 shares of the Company's common stock on March 13, 2023, from 2,250,000 to 2,750,000 shares of the Company's common stock on February 26, 2024, from 2,750,000 shares to 4,750,000 shares on November 22, 2024, and from 4,750,000 shares to 6,000,000 shares on April 10, 2026, and from 6,000,000 to 6,450,000 shares on September 29, 2026, without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, equity awards under the 2021 Inducement Plan may only be made to an employee if such employee is granted such equity awards in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. In addition, awards under the 2021 Inducement Plan may only be made to employees who have not previously been an employee or member of the Board (or any parent or subsidiary of the Company) or following a bona fide period of non-employment of the employee by the Company (or a parent or subsidiary of the Company). As of September 30, 2026, 810,268 shares of the Company's common stock were available for grant under the Inducement Plan.
A summary of the status of stock options as of June September 30, 2026 and the changes during the six nine months ended June September 30, 2026 are presented in the following table:
1 unchanged paragraph
Outstanding at June September 30, 2026
Ending vested and expected to vest at June September 30, 2026
Options exercisable at June September 30, 2026
As of June September 30, 2026, there was $ 7.6 11.0 million of total unrecognized compensation expense related to unvested employee stock options. The unrecognized compensation expense is estimated to be recognized over a period of 1.96 2.0 years as of June September 30, 2026. The weighted average grant date fair value for employee options granted under the Company's stock option plans during the six nine months ended June September 30, 2026, was $ 2.61 5.29 per option.
The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (the difference between the Company's closing stock price on the last trading day of the quarter ended June September 30, 2026 and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on June September 30, 2026. The intrinsic value of the Company's stock options changes based on the closing price of the Company's common stock.
3 unchanged paragraphs
The compensation expense related to the 2020 ESPP for the three and six nine months ended June September 30, 2026 was $ 0.2 0.3 million and $ 0.5 0.8 million, respectively. The compensation expense related to the 2020 ESPP for the three and six nine months ended June September 30, 2025 was $ 0.3 million and $ 0.7 1.0 million, respectively. As of June September 30, 2026, there was $ 0.8 0.2 million of unrecognized compensation cost associated with the 2020 ESPP, which is expected to be recognized over the remaining 5.4 2.3 months.
2 unchanged paragraphs
Activity for PRSUs and RSUs as of June September 30, 2026 and the changes during the six nine months ended June September 30, 2026 are presented in the following table:
1 unchanged paragraph
Outstanding at June September 30, 2026
Ending vested and expected to vest at June September 30, 2026
As of June September 30, 2026, there was $ 58.7 50.3 million of unrecognized stock-based compensation expense associated with unvested PRSUs and RSUs, which the Company expects to recognize over a remaining weighted-average period of 2.20 2.03 years. The aggregate intrinsic value of the unvested RSUs and PRSUs outstanding as of June September 30, 2026 was $ 52.9 174.3 million.
5 unchanged paragraphs
The amount included in capitalized inventory for stock-based compensation expense for personnel engaged with manufacturing activities was $ 1.1 million as of June September 30, 2026 , and $ 0.6 million as of December 31, 2025 .
Note 10: SEGMENT INFORMATION 5 changes
2 unchanged paragraphs
Beginning in the third quarter of 2025, the Company began separately presenting depreciation and amortization expense on the condensed consolidated statement of operations as well as in its internal reporting to the CODM. As a result, the Company has recast prior period amounts to align with the information that is used by the CODM.
The table below highlights the Company's revenue, expenses and net loss for the segment and is reconciled to net loss on a consolidated basis for the three and six nine months ended June September 30, 2026 and 2025.
5 unchanged paragraphs
Restructuring charges
1 unchanged paragraph
a) Cost of goods sold represents inventory and period costs related to overhead, manufacturing costs of Amtagvi ® , and reserves associated with excess and obsolete inventory, as well as costs associated with the purchases and sales of Proleukin ® . Also included are manufacturing and period costs incurred for Amtagvi ® that do not meet specifications or a patient is unable to receive the infusion. For patients that can be administered Amtagvi ® as part of a clinical trial in an expanded or early access program, or single-patient investigational new drug submission, costs are recorded as research and development expenses based on the fact the Company receives clinical data related to these infusions. This category is provided to the CODM on a quarterly basis in comparison to that of previous quarters for review as these costs are controllable costs that indicate operating performance of the Company.
b) Other segment items include costs that are not considered significant expense segments nor reviewed by the CODM on a regular basis. Such amount includes stock-based compensation expenses (excluding stock-based compensation included in cost of sales), interest income, other income and expenses, and income tax benefits. .
Note 11: LICENSES AND AGREEMENTS 8 changes
4 unchanged paragraphs
Pursuant to the terms of the CRADA, as amended, the Company is required to make quarterly payments to the NCI for support of research activities through the end of the CRADA's term. To the extent the Company licenses patent rights relating to a TIL-based product candidate, the Company will be responsible for all patent-related expenses and fees, past and future, relating to the TIL-based product candidate. In addition, the Company may be required to supply certain test articles, including TIL, grown and processed under Current Good Manufacturing Practice ("cGMP") conditions, suitable for use in clinical trials. The Company or the NCI may unilaterally terminate the CRADA for any reason or for no reason at any time by providing written notice at least 60 days before the desired termination date. The Company recorded costs associated with the CRADA of $ 0.8 0.9 million and $ 1.7 2.6 million for the three and six nine months ended June September 30, 2026, and $ 0.8 0.9 million and $ 1.7 2.6 million for the three and six nine months ended June September 30, 2025, respectively, as research and development expenses.
2 unchanged paragraphs
The Patent License Agreement, as amended, requires the Company to pay royalties based on a percentage of net sales in jurisdictions where patent rights exist, which percentage can fall into a tier that may be less than one percent to mid-single digits depending upon certain events, including the exclusivity of the rights. The Company is also required to pay potential milestone payments on the achievement of certain clinical, regulatory, and commercial sales milestones for each of the indications and other direct costs incurred by the NIH pursuant to the Patent License Agreement, as amended. The Company has made and anticipates making additional payments that could range from several hundred thousand dollars to the mid-single-digit millions of dollars in conjunction with certain development milestones, the approval of a BLA or its foreign equivalent, or the first U.S. and foreign commercial sales of any of its product candidates covered by the Patent License Agreement, as amended. The term of the Patent License Agreement, as amended, continues until the expiry of the last-to-expire patent rights licensed thereunder, and the agreement contains standard termination provisions. The Company paid and recorded a $ 0.6 million milestone payment for an intellectual property license that was payable within 60 days of successful completion of the first Company-sponsored Phase 2 clinical study in melanoma, as research and development expenses, for the year ended December 31, 2023 . The Company also paid a $ 1.5 million milestone payment for an intellectual property license that was payable within 60 days of the approval of Amtagvi ® for use in the treatment of melanoma, and a $ 6.0 million milestone payment for an intellectual property license that was payable within 60 days of the approval of the first commercial sale of Amtagvi ® for use in the treatment of melanoma in the U.S. in accordance with the requirements of the Patent License Agreement, as amended. Both aforementioned milestone payments have been capitalized and recorded as intangible assets on the consolidated balance sheet. The Company recorded $ 0.2 million and $ 0.4 0.6 million, for each of the three and six nine months ended June September 30, 2026, and 2025, respectively, as a component of cost of sales related to amortization of the milestone payments.
1 unchanged paragraph
2026, and $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2025, respectively, as research and development expense.
The Company had a certain manufacturing services agreement (the "MSA") with Minaris Advanced Therapies, or "Minaris" for two cGMP manufacturing suites to be operated by Minaris for Iovance Manufacturing LLC to support clinical and commercial manufacturing and related testing services. Minaris concluded production of Amtagvi ® and clinical supply of lifileucel in the first quarter of 2026, and Minaris will conclude certain concluded closeout work for the Company in the third quarter of 2026. For the three and six nine months ended June September 30, 2026, the Company recorded de minimis costs and $ 6.2 million, respectively, and for the three and six nine months ended June September 30, 2025, the Company recorded $ 6.1 5.6 million and $ 14.5 20.1 million, respectively, as costs and expenses included in the condensed consolidated statement of operations. or as inventory in the condensed consolidated balance sheets.
In December 2019, the Company entered into a research collaboration and exclusive worldwide license agreement whereby the Company will license gene-editing technology from Cellectis S.A. ("Cellectis"), a clinical-stage biopharmaceutical company, to develop TIL cell therapies that have been genetically edited, including a PD-1 inactivated product that the Company refers to as IOV-4001. Financial terms of the license include annual license payments and development, regulatory and sales milestone payments from the Company to Cellectis, as well as royalty payments based on net sales of TALEN ® -modified TIL products. The Company recorded costs associated with the license agreement with Cellectis of de minimis, $ 0.1 million, and $ 0.2 million for the three and nine months ended September 30, 2026, and $ 0.1 million and $ 0.3 million for the three and six nine months ended June September 30, 2025, respectively, as research and development expense.
1 unchanged paragraph
In January 2020, the Company obtained a license from Novartis Pharma AG ("Novartis") to develop and commercialize an antibody cytokine engrafted protein, which the Company refers to as IOV-3001. Under the agreement, the Company paid an upfront payment to Novartis and may pay future milestones related to initiation of patient dosing in various phases of clinical development for IOV-3001 and approval of the product in the U.S., EU, and Japan. Novartis is also entitled to low-to-mid single digit percentage royalties from commercial sales of the product. The Company recorded costs associated with the license agreement from Novartis of $ 10.0 million as research and development expenses for the year ended December 31, 2020. No expenses were recorded for the three and six nine months ended June September 30, 2026, and for the three and six nine months ended June September 30, 2025 , the Company recorded zero and $ 2.5 million related to the initiation of patient dosing.
On May 18, 2023, as part of the completion of the Acquisition, the Company inherited two historical asset purchase agreements, one historical master cell bank license and working cell bank transfer agreement and one historical license agreement from Clinigen with Novartis AG, Novartis Pharma AG and Novartis Vaccines and Diagnostics, Inc. pursuant to which, among other things, the Company may be required to make future milestone payments based on net sales (as defined in the relevant underlying agreements) in the U.S. and the rest of world, which includes any and all sales outside of the U.S. The maximum amount of these milestone payments payable under these agreements is $ 30.0 million upon reaching several certain net sales amounts in the U.S. and $ 15.0 million upon reaching several certain net sales amounts in the rest of the world, of which 25 % of each milestone payment will be reimbursed by Clinigen by deduction from the deferred consideration due under the Option Agreement in the period such milestone payment is made. To date, the net sales milestones have not been achieved, and, therefore, no payments were made under these agreements for the three and six nine months ended June September 30, 2026 and 2025.
1 unchanged paragraph
On May 18, 2023 as part of the completion of the Acquisition, the Company inherited a manufacturing and supply agreement from Clinigen with Boehringer Ingelheim Biopharmaceuticals GmbH ("BI") pursuant to which BI will carry out the processing, manufacturing and supply of Proleukin ® in unlabeled vials. The original term of this agreement was through October 2025, with automatic renewals for a period of two years unless terminated as permitted by the contract. In September 2025, the agreement was amended and extended through December 31, 2028. Under this amended agreement, the Company must purchase a minimum number of vials, or drug substance, each year at fixed prices. The total estimated purchase obligations under this agreement for the remainder of the year ending December 31, 2026, and the years ending December 31, 2027, and 2028 are $ 15.1 15.0 million, $ 16.4 million, and $ 16.9 16.8 million, respectively.
Note 12: LEASES 5 changes
The Company leases corporate office space in San Carlos, California, manufacturing, ("California office"), m anufacturing, research and development lab facilities and office space in Philadelphia, Pennsylvania, including 136,000 square feet of commercial manufacturing and lab space at the i CTC, and research and development lab facilities in Tampa, Florida. The determination whether an arrangement is a lease occurs at inception, and for leases with terms greater than 12 months , the Company records a related right-of-use asset and lease liability at the present value of lease payments over the term. Many leases include fixed rental escalation clauses, renewal options and/or termination options that are factored into the determination of lease payments when appropriate. The Company's leases do not provide an implicit rate, and thus the Company estimated the incremental borrowing rate in calculating the present value of the lease payments.
3 unchanged paragraphs
Headquarters Office Lease
On November 15, 2024, the Company entered into a sublease agreement (the "Headquarters Lease") to relocate its office within the same building of its former San Carlos headquarters to lease approximately 16,731 square feet office space with the lease term of 24 months . The Headquarters Lease commenced on December 15, 2024 and includes two options to extend the terms of the lease for 12 months each, exercisable under certain conditions and at a rate increase by 3 % from the applicable monthly base rent of approximately $ 0.1 million. Upon the commencement date, the Company recognized operating lease liabilities and right-of-use assets of $ 2.3 million.
Simultaneously, the Company entered into an Agreement for Termination of Lease and Voluntary Surrender of Premises with its landlord related to its lease for its then existing and now former headquarters location to surrender 49,918 square feet office and laboratory space and paid an early lease termination payment to its landlord of $ 0.6 million and $ 2.5 million of related brokerage fees. In accordance with ASC 842, the termination of this lease resulted in derecognition of right-of-use assets and corresponding lease liabilities of $ 13.7 million and $ 22.3 million, respectively, which resulted in a $ 8.6 million gain, partially offset by the aforementioned lease termination related fees, recorded as interest and other income, net in the consolidated statement of operations for the year ended December 31, 2024.
In addition, as a result of the early termination of the former headquarters lease, the Company impaired approximately $ 7.4 million of long-lived assets, which included leasehold improvements, and furniture and fixtures, previously funded by the landlord through a tenant improvement allowance for the former corporate headquarters office lease (as discussed further below), and is included in the research and development expenses and selling, general, and administrative expenses in the consolidated statement of operations for the year ended December 31, 2024.
13 unchanged paragraphs
Other information 15 changes
4 unchanged paragraphs
As of June September 30, 2026, the maturities of the Company's operating lease liabilities were as follows (in thousands):
5 unchanged paragraphs
17, 2025, a non-party stockholder (The Paul Berger Revocable Trust), which objected to the revised proposed settlement, filed a derivative complaint and letter with the Court suggesting consolidation. On May 29, 2025, the Court issued an order consolidating the cases and appointing the Paul Berger Revocable Trust as lead plaintiff and its counsel as lead counsel. On September 2, 2025, the plaintiff filed a consolidated complaint in the matter, now captioned In re: Iovance Biotherapeutics, Inc. Stockholder Litigation . The defendants filed a motion to dismiss certain claims in the consolidated complaint on November 24, 2025, the plaintiff's response to which will be filed after resolution of certain discovery issues. The Company intends to vigorously defend against this matter.
Shumacher Derivative Lawsuit. On December 11, 2020, a purported stockholder derivative complaint was filed by plaintiff Leo Shumacher against the Company, as nominal defendant, and then current directors, as defendants, in the Court of Chancery in the State of Delaware (the "Court of Chancery"). The complaint alleges breach of fiduciary duty and a claim for unjust enrichment in connection with alleged excessive compensation of certain non-executive directors of the Company and seeks unspecified damages on behalf of the Company. The parties agreed to a proposed settlement, which was submitted to the Court of Chancery on June 15, 2022. After a hearing on November 17, 2022, the Court of Chancery required the parties to take additional steps before it would approve the settlement. The Company, as nominal defendant, and its current directors, as defendants, answered the complaint on February 3, 2023. The parties agreed to a revised proposed settlement, which was submitted to the Court of Chancery on March 12, 2024. On January 17, 2025, a non-party stockholder (The Paul Berger Revocable Trust), which objected to the revised proposed settlement, filed a derivative complaint and letter with the Court suggesting consolidation. On May 29, 2025, the Court issued an order consolidating the cases and appointing the Paul Berger Revocable Trust as lead plaintiff and its counsel as lead counsel. On September 2, 2025, the plaintiff filed a consolidated complaint in the matter, now captioned In re: Iovance Biotherapeutics, Inc. Stockholder Litigation . The defendants filed a motion to dismiss certain claims in the consolidated complaint on November 24, 2025, the plaintiff's response to which will be filed after resolution of certain discovery issues. The Company intends to vigorously defend against this matter.
4 unchanged paragraphs
On September 27, 2019, the Solomon Plaintiffs filed a new lawsuit (through new legal counsel) (the "Second Solomon Suit") titled Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Iovance Biotherapeutics, Inc., f/k/a/ Lion Biotechnologies Inc. f/k/a/ Genesis Biopharma Inc., and Manish Singh in the Supreme Court of the State of New York, County of New York (index no. 655668/2019). In the Second Solomon Suit, the Solomon Plaintiffs allege that they are third party beneficiaries of a "finder's fee agreement" that prior management entered into with a third party unlicensed entity in 2012 in connection with seeking financing, that an agreement or understanding existed between the Company and the plaintiffs that the plaintiffs would be paid fees and commissions (in cash and stock) if they obtained financing for the Company, and that they directly and indirectly introduced investors to the Company who invested in the Company, or were willing to invest in the Company. Finally, the Solomon Plaintiffs allege that they were promised a license to use the Company's technology in Israel. The plaintiffs claim that the Company breached the foregoing understandings, promises and agreements and, as a result, they are entitled to certain damages. The Solomon Plaintiffs also allege that Manish Singh, the Company's former Chief Executive Officer, committed fraud and took shares belonging to them.
Plaintiffs allege that they are third party beneficiaries of a "finder's fee agreement" that prior management entered into with a third party unlicensed entity in 2012 in connection with seeking financing, that an agreement or understanding existed between the Company and the plaintiffs that the plaintiffs would be paid fees and commissions (in cash and stock) if they obtained financing for the Company, and that they directly and indirectly introduced investors to the Company who invested in the Company, or were willing to invest in the Company. Finally, the Solomon Plaintiffs allege that they were promised a license to use the Company's technology in Israel. The plaintiffs claim that the Company breached the foregoing understandings, promises and agreements and, as a result, they are entitled to certain damages. The Solomon Plaintiffs also allege that Manish Singh, the Company's former Chief Executive Officer, committed fraud and took shares belonging to them.
1 unchanged paragraph
The Company intends to vigorously defend these complaints and pursue its counterclaims, as applicable. At the current stage of the litigation, in both the First Solomon Suit and the Second Solomon Suit, it is not possible to estimate the amount or range of possible loss that might result from an adverse judgment or a settlement of these matters.
Based on the preliminary nature of the proceedings in these actions, the outcomes remain uncertain and we cannot estimate the potential impact, if any, on the Company's business or financial statements at this time.
The Company intends to vigorously defend against these complaints and pursue its counterclaims, as applicable.
Securities Class Actions Litigation and Shareholder Derivative Cases. On May 15, 2025, two putative securities class actions were filed in the United States District Court for the Northern District of California ("Northern District of California"), captioned Sundaram v. Iovance Biotherapeutics, Inc., et al ., No. 25-cv-04177 (" Sundaram ") and Farberov v. Iovance Biotherapeutics, Inc., et al ., No. 25-cv-04199 (" Farberov "), naming the Company and certain of the Company's officers as defendants. The complaints purport to assert claims against the defendants under Section 10(b) of the Securities Exchange Act of 1934 (the "1934 Act"), SEC Rule 10b-5, and Section 20(a) of the 1934 Act. The Sundaram action is on behalf of persons or entities who acquired the Company's common stock between August 8, 2024 and May 8, 2025, and the Farberov action is on behalf of persons or entities who acquired the Company's common stock between May 9, 2024 and May 8, 2025. Each putative class action arises out of the Company's quarterly disclosure of financial results on May 8, 2025, and the decline in the price of the Company's common stock the following day, and involve allegations that during the respective class periods, defendants made materially false and misleading statements regarding the Company's expected revenue for fiscal year 2025, which the plaintiffs claim artificially inflated the price of the Company's common stock. The actions seek compensatory damages and costs and expenses incurred in the actions, including attorneys' fees. On December 15, 2025, the court consolidated the class actions, now captioned In re Iovance Biotherapeutics, Inc. Securities Litigation , No. 25-cv-04177, and appointed lead plaintiff and plaintiffs' counsel.
On June 5, 2025, two putative shareholder derivative lawsuits were filed in the Northern District of California, captioned Hollin v. Vogt, et al ., 3:25-cv-04740 and Gera, et al. v. Vogt, et al ., 3:25-cv-04794, purportedly brought on behalf of Iovance against certain current and former officers and directors of the Company. A third putative shareholder derivative lawsuit, captioned Bitton v. Bellemin, et. al ., 3:25-cv-09701, was filed in the Northern District of California on November 12, 2025. Iovance is named as a nominal defendant in the complaints. The lawsuits contain allegations based on or similar to those in the putative securities class actions and claim, among other things, that the named individual defendants breached their fiduciary duties and violated Section 14(a) of the 1934 Act by issuing or causing the Company to issue false and misleading disclosures concerning the Company's financial forecasts for fiscal year 2025. Before filing the complaints, the plaintiffs did not make a demand that the Company's Board of Directors consider the claims therein. The lawsuits seek money damages, corporate governance reforms, restitution, punitive damages, and costs and expenses of the lawsuits, including attorneys' fees. On December 15, 2025, the court consolidated the derivative lawsuits, now captioned In re Iovance Biotherapeutics, Inc. Derivative Litigation , No. 5:25-cv-04740, and appointed co-lead plaintiff and plaintiffs' counsel. On March 24, 2026, the court granted the parties' stipulation to stay the derivative litigation pending resolution of the securities litigation. The plaintiff in the securities litigation filed a consolidated amended complaint on April 15, 2026, which the Company moved to dismiss on June 15, 2026. On September 14, 2026, the plaintiff filed an opposition to the Company's motion to dismiss. The Company filed a reply on October 14, 2026.
On July 29, 2026, purported call option holder Shravan Reddy Kambam Family Protection Trust ("the Kambam Trust"), by and through its trustee, Jayakumar Reddy Kambam, filed a complaint in the United States District Court for the Southern District of New York against the Company and certain individuals alleging violations of Sections 10(b) and 20(a) of the 1934 Act and SEC Rule 10b-5 as well as common law fraud in connection with the same course of action at issue in the securities class action and derivative litigations. At the joint request of the parties, the court stayed the action on September 23, 2026 pending resolution of the motion to dismiss in the securities litigation.
The Company intends to vigorously defend against the securities class action and derivative action claims.
2 unchanged paragraphs
The Company generally calculates its provision for income taxes during each interim reporting period on the basis of an estimated annual effective tax rate adjusted for tax items that are discrete to each period. However, when a reliable estimate cannot be made, the Company computes its provision for income taxes using the actual effective tax rate (discrete method) for the year-to-date period. For the three and six nine months ended June September 30, 2026, small changes in estimated annual pretax income (loss) by legal entity can produce a significant variance in the annual effective tax rate. This variability produces an unreliable estimate of the income tax expense. As a result, in accordance with ASC 740, the Company has computed its benefit from income taxes tax expense and benefit for the three and six nine months ended June September 30, 2026 by applying the actual effective tax rate to the pretax loss for the six nine month period. For the three and six nine months ended June September 30, 2025, the Company used the estimated annual effective tax rate method to compute tax benefit.
The Company recorded a tax benefit expense of $ 1.4 0.6 million and tax benefit of $ 2.0 1.4 million for the three and six nine months ended June September 30, 2026, which resulted in effective tax rates of 2.82 - 2.84 % and 1.58 0.95 % , respectively. The Company recorded a tax expense benefit of $ 2.0 2.4 million and $ 0.2 2.3 million for the three and six months ended June 30, same periods in 2025, respectively, which resulted in effective tax rates of - 1.81 2.53 % and - 0.1 0.69 % , respectively. The effective tax rate is different from the U.S. statutory rate of 21 % due to the full valuation allowance against tax losses in the U.S. The income tax benefit and expense for the periods presented for 2026 and 2025, respectively, primarily relate relates to operations in the UK and realization of related deferred taxes.
As of June September 30, 2026 , the Company continued to maintain its full valuation allowance against U.S. federal and state net deferred tax assets as it expected to be in a cumulative loss position and does not have sufficient positive evidence to support the realizability of its U.S. net deferred tax assets.
MD&A 55 changes
2 unchanged paragraphs
Iovance was founded to build upon the promise of TIL cell therapy initially developed at academic research centers, including the National Cancer Institute, or the NCI. Our multi-center trials, scalable manufacturing, regulatory approvals and commercial infrastructure have transformed TIL cell therapy from a research product available to only a small number of patients into a commercially viable treatment that is accessible for thousands of cancer patients globally.
2 unchanged paragraphs
Globally, Amtagvi ® has the potential to address more than 30,000 previously treated advanced melanoma patients annually. We plan to launch into additional markets with a high prevalence of advanced melanoma. On June 4, 2026, we received marketing authorization with conditions from the Therapeutic Goods Administration of Australia for Amtagvi ® for previously treated advanced (metastatic or unresectable) melanoma. In the United Kingdom, or UK, we resubmitted the marketing authorization application, or MAA, with additional information in July 2026. The Medicines and Healthcare products Regulatory Agency, or MHRA, is conducting an expedited review, with potential approval expected later in 2026. the first quarter of 2027. Potential approval is pending in Switzerland in the first quarter of 2027. In the European Union, or EU, we are working with the European Medicines Agency, or EMA, to resubmit a centralized MAA in 2026 or 2027.
1 unchanged paragraph
We recently reported a 24.6% ORR in 69 patients with non-squamous mNSCLC, including two unconfirmed responses, consistent with previously reported results. IOV-LUN-202 Cohorts 1 and 2 are completing enrollment. A supplemental Biologics License Application for lifileucel based on Cohorts 1 and 2, with a target of approximately 80 patients, is planned in 2027. Independent review committee assessments, FDA discussions, and other pre-submission activities, including confirmatory trial preparation, are ongoing.
• Efficacy results are potentially best-in-class, with durability continuing to mature and already greater than standard of care, including docetaxel, which offers an ORR of only 12.8%, a durability of only 5.6 months, and median overall survival of 12.3 months. The safety profile remains consistent with lifileucel regimen experience and was improved after switching to reduced-dose lymphodepletion.
• The FDA awarded Fast Track Designation (FTD) on the strength of the clinical data and the high unmet medical need of mNSCLC patients.
• A novel biomarker-enriched subgroup within IOV-LUN-202 achieved a 59.1% ORR, leading to the start of POSITILITY, a first-in-class biomarker-enriched cohort with registrational intent, with enrollment beginning this month and a target of 80 patients.
• We plan to initiate OPTILISM, an innovative frontline trial in biomarker-enriched non-squamous mNSCLC, in 2027. The U.S. market opportunity in frontline and second-line non-squamous mNSCLC in the biomarker-selected cohort is about ten times that of advanced melanoma.
18 unchanged paragraphs
To date, more than 1,500 2,000 patients have been treated with commercial and investigational TIL cell therapies manufactured using Iovance processes. The Iovance Cell Therapy Center, or i CTC, in Philadelphia, Pennsylvania is the first FDA-approved facility to manufacture commercial TIL cell therapy. We believe that the i CTC is the only current Good Manufacturing Practice, or cGMP, facility with a centralized, scalable TIL manufacturing process. Facilitated by its proximity to multiple airports, the i CTC covers logistics and delivery of TIL cell therapies to treatment centers in North America, Europe, and Asia Pacific.
The current i CTC facility has the potential capacity to supply TIL cell therapies for more than 5,000 cancer patients annually. To utilize our internal manufacturing suites at greater scale, improve gross margin and reduce operating expenses, we transitioned all manufacturing for clinical and commercial Iovance TIL cell therapies to the i CTC and terminated an agreement with a contract manufacturer in the first quarter of 2026 to manage and reduce long-term product manufacturing costs. We have full control of manufacturing capacity and product quality, supply and delivery logistics, cost efficiencies and process improvements, such as automation and next generation approaches that may further streamline timelines and costs. Certain clinical trials for our next-generation investigational TIL cell therapies will continue to be supported by contract manufacturing organizations, or CMOs. Details of related agreements are provided in Note 11 Licenses and Agreements section of this Quarterly Report on Form 10-Q of our condensed consolidated financial statements for the quarter ended June September 30, 2026.
5 unchanged paragraphs
We have established a leading intellectual property portfolio developed internally and licensed from third parties. We currently own more than 100 U.S. patents related to TIL cell therapy, including patents directed to compositions and methods of treatment in a broad range of cancers, such as U.S. Patent Nos. 10,130,659; 10,166,257; 10,272,113; 10,363,273; 10,398,734; 10,420,799; 10,463,697; 10,517,894; 10,537,595; 10,639,330; 10,646,517; 10,653,723; 10,695,372; 10,894,063; 10,905,718; 10,918,666; 10,925,900; 10,933,094; 10,946,044; 10,946,045; 10,953,046; 10,953,047; 11,007,225; 11,007,226; 11,013,770; 11,026,974; 11,040,070; 11,052,115; 11,052,116; 11,058,728; 11,083,752; 11,123,371; 11,141,434; 11,141,438; 11,168,303; 11,168,304; 11,179,419; 11,202,803; 11,202,804; 11,220,670; 11,241,456; 11,254,913; 11,266,694; 11,273,180; 11,273,181; 11,291,687; 11,293,009; 11,304,979; 11,304,980; 11,311,578; 11,337,998; 11,344,579; 11,344,580; 11,344,581; 11,351,197; 11,351,198; 11,351,199; 11,364,266; 11,369,637; 11,384,337; 11,401,507; 11,433,097; 11,517,592; 11,529,372; 11,541,077; 11,631,483; 11,713,446; 11,819,517; 11,857,573; 11,865,140; 11,866,688; 11,939,596; 11,969,444; 11,975,028; 11,981,921; 11,998,568; 12,023,355; 12,024,718; 12,031,157; 12,104,172; 12,121,541; 12,159,700; 12,170,134; 12,188,048; 12,194,061; 12,226,434; 12,226,522; 12,230,378; 12,230,379; 12,233,075; 12,280,140; 12,343,380; 12,453,697; 12,473,532; 12,485,145; 12,495,791; 12,553,029; 12,553,031; 12,558,375; 12,570,959; 12,570,961; 12,611,427; 12,611,428; 12,611,429; 12,617,833; 12,622,927; 12,636,318; 12,642,268; 12,642,816; 12,642,832; 12,648,962; 12,655,389; and 12,678,499; and 12,767,928. More than 50 of these patents are related to our Gen 2 TIL manufacturing processes and have terms that we anticipate will extend to October 2037 or January 2038, not including any patent term extensions or adjustments that may be available. Our owned and licensed intellectual property portfolio also includes patents and patent applications relating to TIL, marrow-infiltrating lymphocytes, or MIL, and peripheral blood lymphocyte, or PBL, therapies; TIL cell expansion from core biopsy, small biopsy or fine needle aspirate; assays for evaluating potency and/or functionality of TIL products; frozen tumor-based TIL technologies; remnant TIL and digest TIL compositions, methods, and processes; methods of manufacturing TIL, MIL, and PBL therapies; the use of costimulatory and T cell modulating molecules in TIL cell therapy and manufacturing; stable and transient genetically-modified TIL cell therapies, including genetic knockouts of immune checkpoints; cytokine-tethered TIL cell therapies; methods of using immune checkpoint inhibitor, or ICIs, in combination with TIL cell therapies; TIL selection technologies; and methods of treating patient subpopulations.
1 unchanged paragraph
Revenues for the three and six nine months ended June September 30, 2026 represents product sales of Amtagvi ® , as well as Proleukin ® , primarily driven from sales in the U.S. to support the ongoing commercial launch of Amtagvi ® , which received FDA approval in February 2024. Proleukin ® , which we acquired the worldwide rights to in May 2023, is also sold in markets outside the U.S., primarily in the EU and UK.
18 unchanged paragraphs
Income tax (expense) benefit pertains to the operations in the UK and realization of related deferred taxes.
Results of Operations for the Three and Six Nine Months Ended June September 30, 2026 and 2025
1 unchanged paragraph
Revenue for the three and six nine months ended June September 30, 2026 increased by $39.4 $54.0 million, or 66%, 80%, and by $61.5million, $115.5 million, or 56%, 65%, compared to the same periods in 2025. The increase in revenue as compared to the prior period was driven by an increase in Amtagvi ® infusions, correspondent increase in Proleukin ® , and price increases for both products.
5 unchanged paragraphs
Restructuring charges
2 unchanged paragraphs
Cost of sales, excluding depreciation and amortization, for the three months ended June September 30, 2026 decreased increased by $5.3 $9.6 million, or 11%, 25%, compared to the same period in 2025. The decrease increase was driven by a (i) a $5.3 $6.7 million decrease in excess increase from sales of Amtagvi ® and obsolescence reserve supported by Proleukin ® products as well as costs related to the increased demand and manufacturing of Amtagvi ® , (ii) $3.9 a $2.4 million decrease increase in royalties payable related to the increase in sales of Proleukin, and (iii) a $1.4 million increase in period costs primarily related to patient drop-off driven by patient health and ability to receive the Amtagvi ® treatment, as well as manufacturing results that did not meet required specifications, and were not otherwise utilized under an expanded access program or single-patient IND to generate clinical data. This decrease increase was partially offset by (i) a $2.9 $0.9 million increase from sales of Amtagvi ® and Proleukin ® products as well as costs related to the manufacturing of Amtagvi ® decrease in excess and (ii) a $1.0 million increase obsolescence charges recorded in royalties payable related to the increase in sales of Proleukin. three months ended September 30, 2025, with no comparable charges recorded during the three month period ended September 30, 2026.
Cost of sales, excluding depreciation and amortization, for the six nine months ended June September 30, 2026 decreased increased by $5.5 $4.0 million, or 6%, 3%, compared to the same period in 2025. The decrease increase was driven by (i) a $9.2 $13.3 million increase from sales of Amtagvi ® and Proleukin ® products as well as costs related to the manufacturing of Amtagvi ® , and (ii) a $4.7 million increase in royalties payable related to the increase in sales of Proleukin. These increases were partially offset by (i) a $7.8 million decrease in period costs primarily related to patient drop-off driven by patient health and ability to receive the Amtagvi ® treatment, as well as manufacturing results that did not meet required specifications, and were not otherwise utilized under an expanded access program or single-patient IND to generate clinical data and (ii) a $5.3 $6.2 million decrease in excess and obsolescence reserve supported by the increased demand. These decreases were partially offset by (i) a $6.6 million increase from sales of Amtagvi ® and Proleukin ® products as well charges as costs related to the manufacturing of Amtagvi ® and (ii) a $2.4 million increase in royalties payable related compared to the increase same period in sales of Proleukin. 2025.
1 unchanged paragraph
Research and development expenses for the six months ended June 30, 2026 decreased by $32.6 million, or 21%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $12.1 million decrease in outside services cost driven by a decrease in the number of consultants, (ii) a $9.4 million decrease in clinical trial costs, driven primarily by completion of 144-01 and
144-05 clinical trials as well as other ongoing studies advancing into a late-stage of clinical trials, (iii) a $7.1 million decrease in stock-based compensation expense primarily driven by a lower number of stock awards granted at lower average stock price, (iv) a $2.4 million decrease in other costs, including travel and license cost, and (v) a $1.6 million decrease in manufacturing fees, primarily due to the contract termination with our external contract manufacturer.
Research and development expenses for the three months ended June September 30, 2026 decreased by $19.1 $25.8 million, or 24%, 34%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $7.3 $13.5 million decrease in consultant manufacturing costs, primarily driven by a decrease in outside services cost driven by the number of consultants, (ii) a $5.0 million decrease in lower clinical manufacturing fees, primarily due to the contract termination with our volume and reduced external contract manufacturer, (iii) manufacturing costs, (ii) a $3.9 $10.3 million decrease in clinical trial costs, driven primarily by due to the completion of melanoma and cervical clinical trials as well as and the progression of other ongoing studies advancing into a late-stage later stages of clinical trials, (iv) a $1.6 million decrease in other costs, including lab consumables, travel and license cost, development, and (v) (iii) a $1.3 $3.9 million decrease in stock-based compensation expense primarily outside service costs, driven by a lower reduction in the number of stock awards granted at lower average stock price. consultants. These decreases were partially offset by (i) a $1.9 million increase in other costs.
Research and development expenses for the nine months ended September 30, 2026 decreased by $58.4 million, or 25%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $19.6 million decrease in clinical trial costs, driven primarily due to the completion of melanoma and cervical clinical trials and the progression of other ongoing studies advancing into later stages of development, (ii) a $16.1 million decrease in manufacturing fees, primarily driven by lower clinical manufacturing volume resulting from reduced clinical activity, and lower external contract manufacturing costs, (iii) a $16.0 million decrease in outside services cost, driven by a reduction in the number of consultants, and (iv) a $6.3 million net decrease in stock-based compensation expense primarily due to the non-recurrence of expense related to special awards granted in March 2024, and (v) a $0.4 million decrease in other costs.
6 unchanged paragraphs
Other clinical, preclinical, and research programs under development (357) (2,604 (42 (8,100 (40
7 unchanged paragraphs
Selling, general, and administrative expenses for the three months ended June September 30, 2026 increased by $1.7 $4.0 million, or 5%, 12%, compared to the same period in 2025. The increase was primarily attributable to (i) a $3.9 $3.7 million increase in payroll and related expenses driven by an increase in the number of employees to support growth in the overall business, and (ii) a $0.4 million increase in other costs. This increases was were partially offset by and (i) a $1.3 $0.1 million decrease in stock-based compensation expense primarily driven by a lower number of stock due to fewer equity awards granted at a lower average stock price. and (ii) a $0.9 million decrease in other costs, including costs associated with intellectual property legal costs, outside service costs, and software license costs related to our information technology infrastructure.
Selling, general, and administrative expenses for the six nine months ended June September 30, 2026 decreased increased by $3.1 $0.9 million, or 4%, 1%, compared to the same period in 2025. The decrease increase was primarily attributable to (i) a $6.8 million decrease in stock-based compensation expense primarily driven by a lower number of stock awards granted at lower average stock price, and (ii) a $2.2 million decrease in intellectual property legal costs. These decreases were partially offset by (i) a $4.6 $8.3 million increase in payroll and related expenses driven by an increase in the number of employees to support growth in the overall business and (ii) a $1.0 $1.8 million increase in costs incurred in support of the marketing, advertising, and market research in rest of world of to support Amtagvi ® , in markets outside of the United States. These increases were partially offset by (i) a $6.9 million decrease in stock-based compensation expense primarily due to fewer equity awards granted at a lower average stock price, (ii) a $1.9 million decrease in intellectual property legal costs and (iii) a $0.3 $0.4 million increase decrease in other costs, including travel, facility fees and licensing costs.
1 unchanged paragraph
Depreciation and amortization expense for the three and six nine months ended June September 30, 2026 increased by $0.2 $0.5 million, or 2% 5% and increased by $0.6 $1.1 million, or 4%, compared to the same period in 2025. The increase was primarily driven by the expansion of our i CTC manufacturing facility.
Restructuring expense was zero for the three and nine months ended September 30, 2026 as compared to $5.1 million for the three and nine months ended September 30, 2025. Expense in 2025 was primarily related to severance payments, costs for outplacement services, and post-employment benefits associated with our August 2025 strategic restructuring plan, resulting from a review of current strategic priorities, the strategic restructuring plan included an associated reduction in workforce, resource allocations, and costs, intended to reduce operating costs, streamline operations and extend cash runway.
2 unchanged paragraphs
Income tax benefit (expense)
Income tax benefit (expense)
Income tax benefit for the three and six months ended June 30, 2026 increased by $3.4 million, or 169%, and $2.2 million, or 1459%, respectively, compared to the same periods in 2025. The increase was primarily driven by the mix of income across jurisdictions that with varying effective tax rates and an adjustment in the prior year in transfer pricing, true-up to tax attributes and deductions associated with the Proleukin ® business in the U.K.
Interest and other income, net for the three months ended June September 30, 2026 decreased increased by $0.9 $1.1 million, or 22%, 86%, compared to the same period in 2025. The decrease increase was primarily driven by a decrease an increase in average investment balances and a slightly lower higher rate of return on our investments.
Interest and other income, net for the six nine months ended June September 30, 2026 decreased by $2.8 $1.7 million, or 38%, 20%, compared to the same period in 2025. The decrease was primarily driven by a decrease in average investment balances and slightly lower rate of return on our investments.
Income tax (expense) benefit
Income tax (expense) benefit
Income tax expense for the three months ended September 30, 2026 was $0.6 million, as compared to an income tax benefit of $2.4 million for the same period in 2025, an unfavorable change of $3.0 million, or 126%. The change was primarily driven by discrete items in 2025 which did not occur in 2026.
For the nine months ended September 30, 2026 income tax benefit decreased by $0.8 million, or 37%, respectively, as compared to the same period in 2025. The decrease was primarily driven by discrete items in 2025 which did not occur in 2026.
Net loss for the three and six nine months ended June September 30, 2026 decreased by $64.3 $69.0 million, or 58%, 76%, and $101.5 $170.4 million, or 45%, 53%, compared to the same periods in 2025. The decrease in our net loss is primarily due to the increase in sales of Amtagvi ® and Proleukin ® products and a decrease in our overall spend, as we continue to streamline our operations. We anticipate that we will continue to incur net losses in the future as we further invest in our clinical and internal research and development programs, as well as ongoing execution of the launch of Amtagvi ® .
1 unchanged paragraph
As of June September 30, 2026, we had $303.7 $382.3 million in cash, cash equivalents, short-term investments, and restricted cash ($110.8 ($57.9 million of cash and cash equivalents, $186.9 $318.4 million in short-term investments, and $6.0 million in restricted cash). We have incurred losses and generated negative cash flows from operations since inception. Historically, we have funded our operations from various public and private offerings of our equity securities, both common stock and preferred stock, from option and warrant exercises, and from interest income. Since 2017, our primary source of funds has been from the public sale of our common stock. With the approval of our BLA, we expect to continue to generate revenue from the sale of our first internally developed product, Amtagvi ® . Furthermore, as Proleukin ® inventory that was previously with distributors in the U.S. market at the time of the acquisition of the worldwide rights to Proleukin ® in May 2023 has been substantially depleted, we also began to sell Proleukin ® into the U.S. market, where product margins are substantially higher than in other markets, to support ongoing and anticipated infusions related to the continued strong commercial launch of Amtagvi ® . However, such revenues for Amtagvi ® and Proleukin ® may not be material enough to generate positive operational cash flows during the 12 months from the date the condensed consolidated financial statements are issued and this Quarterly Report on Form 10-Q is filed.
We expect to continue to incur significant expenses to support our ongoing execution of the commercial launch of Amtagvi ® , fund ongoing clinical programs, including our NSCLC registrational study, IOV-LUN-202, and our frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of our pipeline candidates, and for other general corporate purposes. Based on the funds we have available as of the date our condensed consolidated financial statements for the three and six nine months ended June September 30, 2026 are issued, we believe that we have sufficient capital to fund our anticipated operating expenses and capital expenditures as planned for at least the twelve months following the issuance of our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
1 unchanged paragraph
As of June September 30, 2026, we had outstanding 452,971,016 462,543,386 shares of our $0.000041666 par value common stock, 194 shares of our $0.001 par value Series A Convertible Preferred Stock, and 1,932,667 shares of our $0.001 par value Series B Convertible Preferred Stock. The outstanding shares of Series A Convertible Preferred Stock are currently convertible into 97,000 shares of our common stock, and the outstanding shares of Series B Convertible Preferred Stock are currently convertible into 1,932,667 shares of our common stock. The shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock do not have voting rights or accrue dividends.
On August 22, 2025, we entered into an Amended and Restated Open Market Sale Agreement, or the 2025 Sale Agreement, with Jefferies with respect to an "at the market" offering program. Under the terms of the 2025 Sale Agreement, we may, were able to issue and sell, from time to time in our sole discretion, issue and sell up to $350.0 million of shares of our common stock pursuant to the "at the market" offering program. The 2025 Sale Agreement superseded and replaced in its entirety the 2023 Sale Agreement. The issuance and sale, if any, of shares of our common stock under the Sale Agreement was or will be made pursuant to a prospectus supplement dated August 22, 2025 to our Registration Statement on Form S-3ASR, which became effective immediately upon filing with the SEC on June 16, 2023, or the Registration Statement.
For the quarter ended June September 30, 2026, we received $49.6 $87.9 million in proceeds, net of offering costs, through the sale of 14,000,743 8,666,654 shares of our common stock under the 2025 Sale Agreement. As of September 30, 2026, the 2025 Sale Agreement terminated upon the issuance and sale of all Common Shares subject to the 2025 Sale Agreement.
2 unchanged paragraphs
Six Months Ended June 30,
Nine Months Ended September 30,
4 unchanged paragraphs
Net increase (decrease) in cash, cash equivalents and restricted cash* (51,948) (104,780
2 unchanged paragraphs
Net cash used in operating activities for the periods presented represents cash disbursements related to all activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Net cash used in operating activities for the six nine months ended June September 30, 2026 was $132.9 $137.4 million as compared to $171.1 $249.8 million for the same period in 2025. The $38.2 $112.4 million decrease in cash used in operating activities was driven by a $101.5 $170.4 million decrease in net loss resulting from an increase in revenues generated by sales of Amtagvi ® and Proleukin ® . The overall decrease in cash used in operating activities also includes a net decrease in non-cash charges of $23.2 $22.9 million. The net decrease in non-cash charges was primarily driven by lower stock-based compensation expenses, and lower amortization of right-of-use assets related to operating leases, an increase a decrease in deferred tax benefits related to the operations in the UK and excess and obsolescence costs, offset by amortization of intangible assets, and accretion of discounts and amortization of premiums on investments, net. In addition, net cash used in operating activities increased by $40.1 $35.1 million, primarily related to changes in operating assets and liabilities.
The $40.1 $35.1 million increase in net cash used in operating activities related to changes in operating assets and liabilities was driven by a $29.1 $27.1 million increase in trade accounts receivable, resulting from the sale of our products, a net $30.5 $29.6 million decrease in accounts payable and accrued expenses, resulting from timing of vendor invoicing and related payments, offset by a $19.5 $21.6 million decrease in net cash used driven primarily by purchases of inventory and an a decrease in prepaid expenses and other assets that resulted from the timing of related payments.
1 unchanged paragraph
Net cash used or provided by investing activities for the periods presented primarily relates to the cash utilized to fund the purchase and maturity of investments, and capital expenditures. Net cash used by investing activities for the six nine months ended June September 30, 2026 was $62.7 $197.3 million, compared to net cash provided by investing activities of $29.7 $46.7 million for the same period in 2025. The increase in cash used of $92.4 $244.0 million was primarily driven by a $94.0 $251.6 million increase associated with changes in the timing of maturities and purchases of investments, and a $0.1 million associated to an increase in the purchase of intangible assets, offset by a decrease in capital expenditures of $1.6 $7.7 million.
1 unchanged paragraph
Net cash provided by financing activities for the six nine months ended June September 30, 2026, was $143.6 $229.9 million compared to net cash provided of $156.5 $244.6 million for the same period in 2025. The decrease in net cash provided by financing activities of $12.9 $14.7 million was primarily driven by a decrease in net proceeds of $13.9 $14.6 million received through the sales of common stock through our "at the market" offering program during the six nine months ended June September 30, 2026, as compared to the net proceeds received from our "at the market" offering program for the same period in 2025, This was offset by and a $0.8 $1.1 million decrease increase in tax payments related to shares withheld for vested restricted stock units, and offset by a $0.2 $1.0 million increase in proceeds from the issuance of common stock upon the exercise of stock options and from our employee stock purchase plan program.
1 unchanged paragraph
The following table summarizes our non-cancellable contractual obligations as of June September 30, 2026, and the effects that such obligations are expected to have on our liquidity and cash flows in future periods (in thousands):
3 unchanged paragraphs
(1) Our operating lease obligations consist of obligations under non-cancellable operating leases for our facilities in San Carlos, California, Philadelphia, Pennsylvania, and Tampa, Florida.
(2) We have purchase obligations of $48.4 $48.2 million related to manufacturing and supply agreements for Proleukin ® under a contract we inherited as part of the Acquisition, which was subsequently extended through 2028.
(3) We acquire assets still in development and enter into research and development arrangements with third parties that often require milestone and royalty payments to the third-party contingent upon the occurrence of certain future events linked to the success of the asset in development. Milestone payments may be required, contingent upon the successful achievement of an important point in the development life cycle of the pharmaceutical product ( e.g ., approval of the product for marketing by a regulatory agency). If required by the arrangement, we may have to make royalty payments based upon a percentage of the sales of the pharmaceutical product in the event that regulatory approval for marketing is obtained. Because of the contingent nature of these milestone payments, they are not included in the table of contractual obligations. These arrangements may be material individually, and in the event that milestones for multiple products covered by these arrangements are reached in the same period, the aggregate charge to expense could be material to the results of operations in any one period. In addition, these arrangements often give us the discretion to unilaterally terminate development of the product, which would allow us to avoid making contingent payments.
1 unchanged paragraph
As of June September 30, 2026, we had no obligations that would require disclosure as off-balance sheet arrangements.
3 unchanged paragraphs
We make certain judgments to determine whether transactions should be accounted for acquisitions of assets or business combinations using the guidance in Accounting Standard Standards Codification, or ASC, Topic 805, Business Combinations, by first applying a screen test to assess if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further assessment is required to determine whether we have acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business.
5 unchanged paragraphs
We review intangible assets for impairment at least annually and whenever events or changes in circumstances have occurred which could indicate that the carrying value of the assets are not recoverable. If such indicators are present, we assess the recoverability of affected assets by determining if the carrying value of the assets is less than the sum of the undiscounted future cash flows of the assets. If the assets are found to not be recoverable, we measure the amount of impairment by comparing the carrying value of the assets to their fair values. We determined that no indicators of impairment or impaired intangible assets existed as of June September 30, 2026.
11 unchanged paragraphs
Market risk 2 changes
Our exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because a significant portion of our investments are in interest bearing investments consisting of short-term debt securities issued by the U.S. government. The primary objective of our investment activities is to preserve principal. We adhere to an investment policy that requires us to limit amounts invested in securities based on credit rating, maturity, industry group and investment type and issuer, except for securities issued by the U.S. government. We do not have any derivative financial instruments or foreign currency instruments. As of June September 30, 2026, we had $248.0 $339.6 million invested in marketable securities with a maturity date of less than one year. As such we believe that we are not exposed to any material market risk. If interest rates had varied by 1% in the quarter ended June September 30, 2026, the fair value of our investment portfolio would increase or decrease by approximately $0.5 $1.3 million.
3 unchanged paragraphs
The majority of our product sales during the three and six nine months ended June September 30, 2026 were denominated in the U.S. dollar, however, we do have some sales denominated in foreign currencies. Nevertheless, foreign currency transaction gains and losses were immaterial for the three and six nine months ended June September 30, 2026. No foreign currency exchange risk existed for the three months ended June September 30, 2026.
Controls and procedures 1 change
3 unchanged paragraphs
There have not been any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Legal proceedings 1 change
The information in Note 13 to the condensed consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q is incorporated herein by reference. There are no matters which constitute material pending legal proceedings to which we are a party other than those incorporated into this item by reference from Note 13 to our condensed consolidated financial statements for the quarter ended June September 30, 2026, contained in this Quarterly Report on Form 10-Q.
Risk factors 16 changes
45 unchanged paragraphs
As of June September 30, 2026, we had an accumulated deficit of $2.9 billion. In addition, during the six nine months ended June September 30, 2026, we incurred a net loss of $126.4 $148.6 million. While we are executing the U.S. launch of our first internally developed product, Amtagvi ® , we may not generate any meaningful product sales until later, and we expect to incur significant additional operating losses in the future as we expand our development and clinical trial activities in support of demonstrating the effectiveness of our product candidates.
2 unchanged paragraphs
Our operations have consumed substantial amounts of cash since inception. From our inception to June September 30, 2026, we have an accumulated deficit of $2.9 billion. In addition, our research and development and our operating costs have also been substantial and are expected to increase. As of June September 30, 2026, we had $303.7 $382.3 million in cash, cash equivalents, short-term investments, and restricted cash ($110.8 ($57.9 million of cash and cash equivalents, $186.9 $318.4 million in short-term investments, and $6.0 million in restricted cash).
15 unchanged paragraphs
Unless and until we can generate a sufficient amount of revenue, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements. For example, in August 2025, we entered into an Amended and Restated Open Market Sale Agreement, or the 2025 Sale Agreement, with Jefferies, which provides provided for the sale of up to $350.0 million of our common stock from time to time. As of September 30, 2026, all shares subject to the 2025 Sale Agreement had been sold and the 2025 Sale Agreement terminated in accordance with its terms. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to undergo further reductions in our workforce or other corporate restructuring activities, or delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. Our current license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under those agreements. As a result, we may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.
2 unchanged paragraphs
In August 2025, we announced a strategic restructuring plan with an associated reduction in workforce as a result of a review of current strategic priorities, resource allocation, and cost reduction intended to reduce operating costs, streamline operations, and extend our cash runway. The workforce reduction of approximately 19 percent was substantially complete by end of September 30, 2025. These types of restructuring and cost reduction activities are complex and may result in unintended consequences and costs, such as unforeseen delays in the implementation of our strategic initiatives, business and operational disruptions, decreased employee morale and retention, loss of institutional knowledge and expertise, and potential impacts on financial reporting. The reduction in our workforce could also make it difficult for us to pursue, or prevent us from pursuing, new opportunities, and initiatives due to insufficient personnel, or require us to incur additional and unanticipated costs to hire new personnel to pursue such opportunities or initiatives. If we do not successfully manage the impact of the restructuring plan or any other similar activities that we may undertake in the future, we may not achieve the expected cost savings and other expected benefits in the expected timeframe or at all, and our business, financial condition, and results of operations may be materially adversely affected.
1 unchanged paragraph
Our management will have discretion in the application of the net proceeds from our capital raises, including proceeds from sales pursuant to the 2025 Sale Agreement with Jefferies, which provides provided for the sale of up to $350.0 million of our common stock from time to time, and terminated as of September 30, 2026, following the sale of all shares subject to it, and our stockholders will not have the opportunity as part of their investment decision to assess whether the net proceeds from our capital raises are being used appropriately. You may not agree with our decisions, and our use of the proceeds from our capital raises may not yield any return to stockholders. Because of the number and variability of factors that will determine our use of the net proceeds from our capital raises, their ultimate use may vary substantially from their currently intended use. Our failure to apply the net proceeds of our capital raises effectively could compromise our ability to pursue our growth strategy and we might not be able to yield a significant return, if any, on our investment of those net proceeds. Stockholders will not have the opportunity to influence our decisions on how to use our net proceeds from our capital raises. Pending their use, we may invest the net proceeds from our capital raises in interest and non-interest-bearing cash accounts, short-term, investment-grade, interest-bearing instruments, and U.S. government securities. These temporary investments are not likely to yield a significant return.
5 unchanged paragraphs
In recent years, various tax legislations were signed into law. On December 22, 2017, the Tax Cuts and Jobs Act of 2017, or the Tax Act, was signed into law, making significant changes to the Internal Revenue Code. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, was enacted in response to the COVID-19 pandemic. Certain provisions of the CARES Act amend or suspend certain provisions of the Tax Act. For example, the tax relief measures under the CARES Act for businesses include a five-year net operating loss carryback, suspension of annual deduction limitation of 80% of taxable income from net operating losses generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property. On June 15, 2020, Assembly Bill 85 was passed in California, which suspended the use of net operating losses and limited the use of credits for certain corporations. On July 4, 2025, the One Big Beautiful Bill Act, or the OBBBA, was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The OBBBA has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The OBBBA has enacted, among others, changes to eligibility requirements for premium tax credits, which is expected to result in less coverage in the ACA's health insurance marketplace, or Marketplace, over the next few years. The enhanced ACA premium tax credits expired at the end of 2025, which has contributed to reduced Marketplace enrollment and is expected to result in an additional loss of coverage for approximately an estimated 24 million people currently that were previously enrolled in insurance plans obtained through increase the Marketplace. number of uninsured individuals. In addition, the OBBBA has made other changes to the enrollment and eligibility requirements for Medicaid, which is expected to result in the loss of coverage for certain individuals currently enrolled in Medicaid programs. There is uncertainty regarding future legislative and regulatory changes and policies related to matters such as taxation and importation, including tariffs, and any such proposed or enacted regulations, taxes, or tariffs by the current or a future U.S. administration, Congress, or taxing and importation authorities in other jurisdictions could adversely impact the global economy and materially affect our tax obligations, tariff obligations, and operating results.
171 unchanged paragraphs
Clinical testing is expensive, time consuming, and subject to uncertainty. We cannot guarantee that any current or future clinical trials will be conducted as planned or completed on schedule, if at all, or that any of our product candidates will receive regulatory approval. We initiated clinical trials in patients with metastatic melanoma, cervical, head and neck, and non-small cell lung cancers, and in other indications in collaboration with third parties. We completed enrollment in the pivotal clinical trial for melanoma, C-144-01, and in June 2022, we announced that initial Cohort 4 data read by the independent review committee, or IRC, met the primary endpoint in this clinical trial. In March 2023, we completed submission of our BLA to the FDA for the treatment of adult patients with metastatic melanoma for approval, and the FDA accepted the BLA in May 2023. We obtained BLA approval on February 16, 2024. We plan to initiate clinical trials in new indications and new cohorts in existing clinical trials. For example, in the second quarter of 2026, we plan to commence commenced a registrational trial in previously treated advanced undifferentiated pleomorphic sarcoma, or UPS, and dedifferentiated liposarcoma, or DDLPS. in the second quarter of 2026. Even as these clinical trials progress, issues may arise that could require us to suspend or terminate such clinical trials or could cause the results of one cohort to differ from a prior cohort. For example, we may experience slower than anticipated enrollment in our additional pivotal clinical trials, which may consequently delay BLA submissions to the FDA or permit competitors to obtain approvals that may alter our BLA filing strategy. Additionally, temporary or permanent clinical holds could be placed on our clinical trials for a variety of reasons. For instance, on December 22, 2023, the FDA placed a clinical hold on the IOV-LUN-202 trial in response to a reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen, and we paused enrollment and the lifileucel treatment regimen for new patients in IOV-LUN-202 during the clinical hold. On March 4, 2024, the FDA lifted the partial clinical hold on the IOV-LUN-202 trial, permitting us to resume patient enrollment. A failure of one or more clinical trials can occur at any stage of testing, and our future clinical studies may not be successful. Events that may prevent successful or timely initiation or completion of clinical development, or product approval include:
92 unchanged paragraphs
Disagreements between parties to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process or commercialization of the applicable product and/or product candidate and, in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority under the collaboration agreement.
In addition, in order to supplement our own efforts to improve TIL manufacturing and develop TIL cell therapies in new indications in clinical trials, we currently work and collaborate with government and academic research institutions, medical institutions, and corporate partners such as the NCI, Moffitt, Memorial Sloan Kettering Cancer Center, or MSKCC, Cellectis, and Novartis. For example, in February 2026, we announced positive initial data from a pilot clinical trial led by MSKCC and supported by us of lifileucel in patients with advanced UPS or DDLPS who were refractory to at least one prior line of systemic therapy. We also intend to continue to enter into additional third-party collaborative agreements in the future. However, we may not be able to successfully negotiate any additional collaborative arrangements. If established, these relationships may not be scientifically or commercially successful, or may be unable to enroll patients, which has occurred in one of our prior collaborations. The success of these and future collaborations and joint development arrangements may be subject to numerous risks and uncertainties, including the inability or unwillingness of our partners to perform in the manner, or to the extent anticipated, and may also be subject to disagreements regarding the rights, interests, and performance of the counterparties under our licenses and development agreements. Disagreements between parties to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process or commercialization of the applicable product and/or product candidate and, in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority under the collaboration agreement.
32 unchanged paragraphs
While there is currently no comprehensive federal legislation in the U.S. that regulates the development or use of AI, several governmental agencies in the U.S. and non-U.S. jurisdictions have proposed or enacted laws regulating AI technologies by setting out principles intended to guide AI design and deployment for the public and private sectors and signaling the increase in government involvement and regulation over AI technologies. The significant increase in companies that have incorporated the use of AI in their businesses has also increased the SEC's focus on AI-washing as a key enforcement priority. In May 2024, the European Union legislators approved the EU Artificial Intelligence Act, or the EU AI Act, which establishes a comprehensive, risk-based governance framework for AI in the EU market. The majority of the substantive requirements Additional provisions of the EU AI Act, are expected to apply from including certain transparency obligations, became applicable in August 2, 2026, while obligations applicable to high-risk AI systems were deferred to December 2027 and August 2028. In July 2025, the EU published a voluntary AI Code of Practice, which is intended to guide developers of AI systems in complying with the EU AI Act and avoid potential penalties. The EU AI Act, and developing interpretation and application of the GDPR in respect of automated decision making, together with developing guidance and/or decisions in the impact of AI technology on data privacy, may affect our use of AI technologies and our ability to provide, improve or commercialize our business, require additional compliance measures and changes to our operations and processes, and result in increased compliance costs and potential increases in civil claims against us, and could adversely affect our business, operations and financial condition.
10 unchanged paragraphs
There are numerous other laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security concerns, and some state privacy laws apply more broadly than the HIPPA Health Insurance Portability and Accountability Act of 1996 (as amended by the HITECH Act), or HIPAA, and associated regulations. For example, the California Consumer Privacy Act, or CCPA, which went into effect January 1, 2020, and as amended and expanded by the California Privacy Rights Act, or CPRA, which went into effect on January 1, 2023, among other things, create new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information. They also created a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.
43 unchanged paragraphs
We are conducting registrational trials for advanced NSCLC, and frontline advanced melanoma cancer, with our lifileucel product candidate, and we plan to commence a registrational trial in previously treated advanced UPS and DDLPS in the second quarter of 2026. with our lifileucel product candidate. The ongoing trials, which we refer to as IOV-LUN-202 Cohorts 1 and 2 in the case of advanced NSCLC, and TILVANCE-301 in the case of advanced melanoma, and SARATOGA in the case of advanced UPS and DDLPS are currently underway and have been the subject of formal FDA meetings and communications. For instance, on December 22, 2023, the FDA placed a clinical hold on the IOV-LUN-202 trial in response to a reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion, or NMA-LD, pre-conditioning regimen, and we paused enrollment and the lifileucel treatment regimen for new patients in IOV-LUN-202 during the clinical hold. On March 4, 2024, the FDA lifted the partial clinical hold on the IOV-LUN-202 trial, permitting us to resume patient enrollment using a reduced NMA-LD regimen. Our current beliefs regarding the registration pathway for lifileucel in these indications are based on our interpretation of communications with the FDA to date and our efforts to address such communications, which may be incorrect. Our statements that the clinical trial may support a BLA submission also assume that our as-adjusted clinical trial has addressed the additional requests and feedback by the FDA. Further, enrollment in these clinical trials may need to be further adjusted based on future feedback from the FDA, changes in the competitive environment, or other regulatory agency input. Protocol revisions may have an adverse effect on the results reported to date. Changes to implement an independent review committee and assay validation and implementation, and the data within these clinical trials may not ultimately be supportive of product approval, all of which could result in significant delays to our currently anticipated timeline for development and approval of the lifileucel product candidate or prevent their approval.
82 unchanged paragraphs
Adoption of government controls and measures and tightening of restrictive policies in jurisdictions with existing controls and measures, could exclude or limit our product candidates from coverage and limit payments for pharmaceuticals. We continue to monitor the potential impact of these and other proposals to lower prescription drug costs at the federal and state level.
In addition, there have been a number of other policy, legislative and regulatory proposals aimed at changing the pharmaceutical industry. The U.S. government, state legislatures and foreign governmental entities have shown significant interest in implementing cost containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and coverage and requirements for substitution of generic products for branded prescription drugs. Adoption of government controls and measures and tightening of restrictive policies in jurisdictions with existing controls and measures, could exclude or limit our product candidates from coverage and limit payments for pharmaceuticals. We continue to monitor the potential impact of these and other proposals to lower prescription drug costs at the federal and state level.
60 unchanged paragraphs
As of June September 30, 2026, we had 452,971,016 462,543,386 shares of common stock outstanding. In addition, we had 32,730,876 29,660,828 shares of common stock equivalents that would increase the number of common stock outstanding if these instruments were exercised or converted to purchase common stock based on vesting requirements of stock options and common stock issuable through purchases of employee stock purchase plan, or upon the conversion of preferred stock. The issuance and subsequent sale of the shares underlying these common stock equivalents could depress the trading price of our common stock. On June 10, 2019, our certificate of incorporation was amended to increase the number of authorized shares of our common stock, from 150,000,000 shares to 300,000,000 shares, which was approved by our stockholders on that date. On June 16, 2023, our certificate of incorporation was amended to increase the number of authorized shares of our common stock from 300,000,000 to 500,000,000 shares, which was approved by our stockholders on June 6, 2023. On June 12, 2026, our certificate of incorporation was amended to increase the number of authorized shares of our common stock from 500,000,000 to 650,000,000 shares, which was approved by our stockholders on June 10, 2026.
In addition, in the future, we may issue additional shares of common stock or other equity or debt securities convertible into common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise. For example, in August 2025, we entered into a Sale Agreement with Jefferies with respect to an at the market offering program, under which we may, from time to time, issue and sell up to $350.0 million of our common stock, and we may offer additional shares under our automatic shelf registration statement in the future. Future issuances may result in substantial dilution to our existing stockholders and could cause our stock price to decline.
21 unchanged paragraphs
Unchanged: Mine Safety Disclosure, Exhibits, Notes to the financial statements, Note 7: PROPERTY AND EQUIPMENT, NET, Note 8: ACCRUED EXPENSES, Unregistered Sales of Securities, Use of Proceeds, and Issuer Purchases of Equity Securities, Defaults on senior securities, Mine Safety Disclosures
Compared by code from the two filings' text and XBRL. Not advice.
The reading, claim by claim
- We caution you that the risks, uncertainties and other factors referenced above may not contain all the risks, uncertainties and other factors that are important to you.
- The accompanying notes are an integral part of these condensed consolidated financial statements.
- For the quarter ended September 30, 2026, IOVANCE BIOTHERAPEUTICS, INC. reported: Revenue $121.5 million.
- Net income -$22.3 million.
4 of 6 claims matched the filing text.
Not found in the filing text
- The accompanying notes are an integral part of these condensed consolidated financial statements.
- The accompanying notes are an integral part of these condensed consolidated financial statements.
From the filing's financial data, not stated in its text
From this 10-Q's financial data (XBRL) for the quarter ended September 30, 2026
- Gross margin 60.5%.
- Operating margin -19.7%.
- Net margin -18.3%.
- Revenue change from a year earlier +80.1%.
From the filing
Item 6.
Item 6.
Exhibits
110
SIGNATURES
111
1
Table of Contents
Forward-Looking Statements and Market Data
This Quarterly Report on Form 10-Q contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "may," "will," "might," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "aim," "potential," "continue," "ongoing," "goal," "forecast," "guidance," "outlook," or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
• the success, cost, enrollment, design, and timing of our clinical trials;
• the success, cost, and timing of our product development activities;
• the ability of us or our third-party contract manufacturers to continue to manufacture tumor infiltrating lymphocytes, or TIL, in accordance with our selected process;
• our ability to design, construct, and staff our own manufacturing facility on a timely basis and within the estimated expenses;
• the success of competing therapies that are or may become available;
• regulatory developments in the United States of America, or U.S., and foreign countries;
• the timing of and our ability to obtain and maintain U.S. Food and Drug Administration, or the FDA, European Commission, or other regulatory authority approval of, or other action with respect to, our products and/or product candidates;
• our ability to attract and retain key scientific or management personnel;
• the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing;
• our ability to obtain funding for our operations, including funding necessary to complete further development of our product candidates and commercialization of our products;
• our ability to successfully commercialize Amtagvi ® (lifileucel) and Proleukin ® (aldesleukin), and any other products and/or product candidates for which we obtain or have obtained FDA or other regulatory approvals, including by the European Commission in the European Union, or the EU;
• the ability and willingness of our third-party research institution collaborators to continue research and development activities relating to our product candidates;
• the potential of our other research and development and strategic collaborations;
• our expectations regarding our ability to obtain and maintain intellectual property protection for our manufacturing methods and products and/or product candidates;
• our plans to research, develop, and commercialize our products and/or product candidates;
• the size and growth potential of the markets for our products and/or product candidates, and our ability to serve those markets;
• our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
• fluctuations in the trading price of our common stock; and
• our use of cash and other resources.
2
Table of Contents
Actual results may differ from those set forth in this Quarterly Report on Form 10-Q due to the risks and uncertainties inherent in our business, including those provided in the foregoing list of forward-looking statements and also including, without limitation: the FDA may not agree with our interpretation of the results of our clinical trials; later developments with the FDA that may be inconsistent with already completed FDA meetings; the preliminary clinical results, including efficacy and safety results, from ongoing Phase 2 and Phase 3 clinical trials may not be reflected in the final analyses of these clinical trials including new cohorts within these clinical trials; the results obtained in our ongoing clinical trials, such as the studies and clinical trials referred to in this Quarterly Report on Form 10-Q, may not be indicative of results obtained in future clinical trials or supportive of product approval; regulatory authorities may potentially delay the timing of FDA or other regulatory authority approval of, or other action with respect to, our product candidates, specifically, our description of FDA interactions are subject to the FDA's interpretation, as well as the FDA's authority to request new or additional information; we may not be able to obtain or maintain FDA or other regulatory authority approval of our product candidates; our ability to address FDA or other regulatory authority requirements relating to our clinical programs and registrational plans, such requirements including, but not limited to, clinical and safety requirements, as well as manufacturing and control requirements; risks related to our accelerated FDA review designations; our ability to obtain and maintain intellectual property rights relating to our product pipeline; and the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved.
We caution you that the risks, uncertainties and other factors referenced above may not contain all the risks, uncertainties and other factors that are important to you.1 In addition, we cannot guarantee future results, lev
Item 1. Condensed Consolidated Financial Statements (Unaudited)
Item 1. Condensed Consolidated Financial Statements (Unaudited)
IOVANCE BIOTHERAPEUTICS, INC.
Condensed Consolidated Balance Sheets (unaudited; in thousands, except share and per share information)
September 30,
December 31,
2026
2025
ASSETS
Current Assets
Cash and cash equivalents
$
57,934
$
163,078
Trade accounts receivable
106,988
82,448
Short-term investments
318,386
133,902
Inventory
55,222
51,678
Prepaid expenses and other assets
11,105
11,583
Total Current Assets
549,635
442,689
Property and equipment, net
129,310
131,112
Intangible assets, net
259,206
279,324
Operating lease right-of-use assets
42,564
45,899
Restricted cash
6,018
5,980
Long-term assets
4,481
8,166
Total Assets
$
991,214
$
913,170
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable
$
21,645
$
22,159
Accrued expenses and other liabilities
81,685
111,156
Note payable - current
—
1,000
Operating lease liabilities
2,444
4,043
Total Current Liabilities
105,774
138,358
Non-Current Liabilities
Operating lease liabilities – non-current
42,766
44,401
Deferred tax liabilities
30,012
31,828
Total Non-Current Liabilities
72,778
76,229
Total Liabilities
178,552
214,587
Commitments and contingencies
Stockholders' Equity
Series A Convertible Preferred stock, $ 0.001 par value; 17,000 shares designated, 194 shares issued and outstanding as of September 30, 2026 and December 31, 2025
—
—
Series B Convertible Preferred stock, $ 0.001 par value; 11,500,000 shares designated, 1,932,667 shares issued and outstanding as of September 30, 2026 and December 31, 2025
2
2
Common stock, $ 0.000041666 par value; 650,000,000 shares authorized, 462,543,386 and 411,938,061 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively
19
17
Accumulated other comprehensive income
13,853
16,440
Additional paid-in capital
3,722,949
3,457,654
Accumulated deficit
( 2,924,161
)
( 2,775,530
)
Total Stockholders' Equity
812,662
698,583
Total Liabilities and Stockholders' Equity
$
991,214
$
913,170
The accompanying notes are an integral part of these condensed consolidated financial statements.2
4
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited; in thousands, except per share information)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2026
2025
2026
2025
$
67,455
$
292,212
$
176,731
Total revenue
121,469
67,455
292,212
176,731
Costs and expenses *
Cost of sales **
$
48,028
$
38,477
$
134,121
$
130,073
Research and development **
49,337
75,174
170,675
229,067
Selling, general, and administrative **
38,575
34,555
116,796
115,922
Depreciation and amortization
9,497
9,007
27,536
26,422
Restructuring charges
—
5,143
—
5,143
Total costs and expenses
$
145,437
$
162,356
$
449,128
$
506,627
Loss from operations
( 23,968
)
( 94,901
)
( 156,916
)
( 329,896
)
Other income
Interest and other income, net
2,311
1,243
6,861
8,567
Net Loss before income taxes
$
( 21,657
)
$
( 93,658
)
$
( 150,055
)
$
( 321,329
)
Income tax (expense) benefit
( 614
)
2,405
1,424
2,255
)
$
( 91,253
)
$
( 148,631
)
$
( 319,074
)
Net Loss Per Share of Common Stock, Basic and Diluted
$
( 0.05
)
$
( 0.25
)
$
( 0.34
)
$
( 0.94
)
Weighted Average Shares of Common Stock Outstanding, Basic and Diluted
455,919
364,037
442,683
340,623
* Non-cash stock-based compensation included in cost of sales and operating expenses
Cost of sales
$
1,721
$
1,408
$
4,276
$
5,977
Research and development
4,771
5,011
14,966
21,287
Selling, general, and administrative
5,341
5,481
15,593
22,494
$
11,833
$
11,900
$
34,835
$
49,758
** Excludes depreciation and amortization
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Comprehensive Income (Loss) (unaudited; in thousands)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2026
2025
2026
2025
Net Loss
$
( 22,271
)
$
( 91,253
)
$
( 148,631
)
$
( 319,074
)
Other comprehensive income (loss):
Unrealized income (loss) on investments
( 114
)
100
( 251
)
( 40
)
Foreign currency cumulative translation adjustment
889
( 4,856
)
( 2,336
)
17,189
Comprehensive Loss
$
( 21,496
)
$
( 96,009
)
$
( 151,218
)
$
( 301,925
)
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Stockholders' Equity
For the Three Months Ended September 30, 2026 and 2025
(unaudited; in thousands, except share information)
Series A
Series B
Accumulated
Convertible
Convertible
Additional
Other
Total
Preferred Stock
Preferred Stock
Common Stock
Paid-In
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Income
Deficit
Equity
Balance - June 30, 2026
194
$
—
1,932,667
$
2
452,971,016
$
19
$
3,624,836
$
13,078
$
( 2,901,890
)
$
736,045
Stock-based compensation expense
—
—
—
—
—
—
11,830
—
—
11,830
Common stock issued upon purchase of employee stock purchase plan
—
—
—
—
—
—
—
—
—
—
Vesting of restricted shares issued for services
—
—
—
—
1,095,918
—
—
—
—
—
Tax payments related to shares retired for vested restricted stock units
—
—
—
—
( 291,011
)
—
( 2,419
)
—
—
( 2,419
)
Common stock issued upon exercise of stock options
—
—
—
—
100,809
—
805
—
—
805
Common stock sold in public and/or at the market offering, net of offering costs
—
—
—
—
8,666,654
—
87,897
—
—
87,897
Unrealized loss on investments
—
—
—
—
—
—
—
( 114
)
—
( 114
)
Foreign currency cumulative translation adjustment
—
—
—
—
—
—
—
889
—
889
Net loss
—
—
—
—
—
—
—
—
( 22,271
)
( 22,271
)
Balance - September 30, 2026
194
$
—
1,932,667
$
2
462,543,386
$
19
$
3,722,949
$
13,853
$
( 2,924,161
)
$
812,662
Balance - June 30, 2025
194
$
—
1,932,667
$
2
341,919,364
$
14
$
3,289,986
$
20,859
$
( 2,612,373
)
$
698,488
Stock-based compensation expense
—
—
—
—
—
—
11
Similar companies
Companies of similar size in SIC 2836 and related industry codes: the same peer list as the financial tables.
- Elite Pharmaceuticals ELTP public float $534M, Sep 30, 2025
- Opko Health OPK public float $540M, Dec 31, 2025
- Savara SVRA public float $544M, Jun 30, 2025
- Xencor XNCR public float $556M, Jun 30, 2025
- Evolus EOLS public float $560M, Jun 30, 2025