Klotho Neurosciences: securities offering

Cover page 94 changes

with the Securities and Exchange Commission on January 30, 2025

Registration No. 333-

WASHINGTON, D.C. 20549

KLOTHO NEUROSCIENCES, INC.

Delaware 2836 86-2727441

Classification Code) (I.R.S. Employer

13576 Walnut Street, Suite A

Telephone: (833) 931-6330

principal executive offices)

13576 Walnut Street, Suite A

Telephone: (833) 931-6330

420 Lexington Avenue

Telephone: (212) 212-6800

Approximate date of commencement of proposed sale

If any of the securities being registered on this

If this form is filed to register additional securities

If this form is a post-effective amendment filed

If this form is a post-effective amendment filed

If delivery of the prospectus is expected to be

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting registrant ☒

Emerging growth company ☒

The registrant hereby amends this registration

Act of 1933 or until this registration statement shall become effective on such date as the Commission, acting pursuant to said Section

8(a), may determine.

THE INFORMATION IN THIS

Preliminary Prospectus Dated January 30, 2025

KLOTHO NEUROSCIENCES, INC.

This prospectus relates to the offering and resale by the selling stockholders identified herein of up to 43,680,219 shares of common stock, par value $0.0001 per share, of Klotho Neurosciences, Inc. These shares include (a) up to 37,876,100 shares of common stock that we may issue to investors upon the conversion of promissory notes and exercise of warrants including up to 33,076,100 shares of common stock we may issue to 3i, LP ("3i") upon conversion of promissory notes and exercise of warrants, and (b) 5,804,119 of common stock currently held by certain other selling shareholders. The number of shares of common stock registered for resale by 3i pursuant to the registration statement of which this prospectus forms a part assumes and gives effect to the closing of a second note and a second warrant, each to be issued to 3i upon effectiveness of the registration statement. For additional information relating to 3i's promissory notes and warrants, see "The 3i Transaction" beginning on page 24.

The Selling Stockholders may offer all or part

Any broker-dealers or agents that are involved

ea0268254-s1_klotho.htm

REGISTRATION STATEMENT UNDER

As filed with the Securities

and Exchange Commission on December 5, 2025

SECURITIES AND EXCHANGE COMMISSION

THE SECURITIES ACT OF 1933

(Exact name of registrant as specified in its charter)

(State or other jurisdiction of

incorporation or organization) (Primary Standard Industrial

Classification Code)

South Boulevard, Suite D

(Address and telephone number of registrant's

South Boulevard, Suite D

(Name, address, including zip code, and telephone number,

including area code, of agent for service)

Copies of all Correspondence to:

Cyruli Shanks & Zizmor, LLP

date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, please check the following box: ☒

made pursuant to Rule 434, Securities Act of 1933, please check the following box: ☒

this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

pursuant to Rule 462 (d) under the Securities Act check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐ this form is a post-effective amendment filed pursuant to Rule 462 (d) under the Securities Act, check the following box and list the

Indicate Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐ delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box: ☐ by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

"smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

reporting registrant

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ (1) We are registering (a) up to 37,876,100 34,000,0000 shares of common stock that we may issue to investors upon the conversion of promissory notes and the exercise of warrants, and (b) 5,804,119 shares of common our Series C Preferred Stock currently and 1,000,000 shares held by certain other an existing selling shareholders. stockholder.

(2) The offering price has been estimated solely

(2) The offering price has been estimated solely for the purpose of computing the amount of the registration fee in accordance with Rule 457(c) of the Securities Act, based upon the average of the high and low sales prices for the registrant's common stock as reported by Nasdaq on January 27, December 2, 2025.

registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND IS SUBJECT TO COMPLETION AND MAY BE CHANGED. WE MAY NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT

THE REGISTRATION STATEMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IT IS NOT

SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.

Preliminary Prospectus Dated December 5, 2025

Up to a Maximum of 43,680,219 35,000,000 Shares of Common

prospectus relates to the offering and resale from time to time by the selling stockholders identified herein of up to 34,883,722 shares of common stock, par value $0.0001 per share, of Klotho Neurosciences, Inc. issuable upon conversion of the Series C Convertible Preferred

Stock sold in that private placement and 1,000,000 shares of common stock, par value $0.0001 per share already held by a selling stockholder.

Selling Stockholders may offer all or part of the shares for resale from time to time through public or private transactions at either fixed prices or prevailing market prices at the time of sale, at varying prices or negotiated prices.

broker-dealers or agents that are involved in such resales may be deemed to be "underwriters" within the meaning of the Securities

in such resales may be deemed to be "underwriters" within the meaning of the Securities Act in connection therewith. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. For more information, please see the section of this prospectus titled "Plan of Distribution" beginning on page 26. 5.

2 unchanged paragraphs

Our common stock is traded on the NASDAQ Global Capital

Market under the symbol "KLTO." On January 27, December 2, 2025, the average of the high and low sales prices of our common shares was

1 unchanged paragraph

Investing in our common shares involves a high

degree of risk. You should purchase shares only if you can afford a complete loss. See "Risk Factors" beginning on page 2.

Neither the Securities and Exchange Commission

Forward Looking Statements

Plan of Distribution

Description of Business

Management's Discussion and Analysis of Financial Condition and Results of Operations

and 14 more changes in the filing

Prospectus summary 16 changes

To understand this offering fully, you should

This summary highlights selected information

Shares of Common Stock

Shares of Common Stock

We will not receive any proceeds from the sale of the common stock by the Selling Stockholders. All net proceeds from the sale of the common shares covered by this prospectus will go to the Selling Stockholders. However, we may receive the proceeds from the exercise of any warrants if the Selling Stockholders do not exercise the Warrants on a cashless basis, if and when exercised. See the section of this prospectus titled "Use of Proceeds."

Our shares of common stock are listed on The Nasdaq Global Market under the symbol "KLTO" Transfer Agent Continental Stock Transfer and Trust Company Dividend Policy We have never declared or paid any cash dividends on our shares of common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future.

The shares of common stock offered hereby involve a high degree of risk and should not be purchased by investors who cannot afford the loss of their entire investment.

summary highlights selected information appearing elsewhere in this prospectus and in the documents we incorporate by reference herein.

appearing elsewhere in This prospectus. While this summary highlights what we consider to be important is not complete and does not contain all of the information about us, that you should carefully read this entire prospectus consider before investing deciding whether to invest in our common stock. especially the risks and other You should read this entire prospectus carefully, including information we discuss set forth under the headings heading "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our consolidated financial statements and the related notes beginning on page 46. Our fiscal year end is December 31 and our fiscal years ended December 31, 2023 and 2022 are sometimes referred to herein as fiscal years 2023 and 2022, respectively. included or incorporated by reference in this prospectus. Some of the statements made in this prospectus discuss future events and developments, including our future strategy and our ability to generate revenue, income and cash flow. These forward-looking statements involve risks and uncertainties which could cause actual results to differ materially from those contemplated in these forward-looking statements. See "Forward-Looking Statements". Unless otherwise indicated or the context requires otherwise, the words "we," "us," "our", the "Company" or "our Company" or "Klotho" refer to Klotho Neurosciences, Inc, a Delaware corporation, and our each of our subsidiaries.

understand this offering fully, you should read the entire prospectus carefully, including the risk factors beginning on page 2 and the consolidated financial statements.

On December 2, 2025 we entered into a Securities

Purchase Agreement with the investors named herein, pursuant to which we agreed to issue and sell shares of our Series C Convertible Preferred Stock in a private placement exempt from registration under Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D. The closing of the private placement is expected to occur on or before December 31, 2025. This prospectus relates to the resale from time to time by the selling stockholders identified herein of up to 35,000,000 shares of our common stock issuable upon conversion of the Series C Convertible Preferred Stock sold in that private placement.

Klotho Neurosciences, Inc., a Delaware corporation.

offered by the Selling Stockholders:

Outstanding Prior to the Offering:

The Selling Stockholders will determine when and how they will sell shares of common stock offered in this prospectus.

Risk factors 830 changes

This investment has a high degree of risk.

Before you invest you should carefully consider the risks and uncertainties described below and the other information in this prospectus.

If any of the following risks actually occur, our business, operating results and financial condition could be harmed and the value of our stock could go down. This means you could lose all or a part of your investment. You should carefully consider the risks described below together with all of the other information included in our public filings before making an investment decision with regard to our securities. The statements contained in or incorporated into this document that are not historic facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking statements. If any of the following events described in these risk factors actually occur, our business, financial condition or results of operations could be harmed. In that case, the trading price of our common stock could decline, and you may lose all or part of your investment. Moreover, additional risks not presently known to us or that we currently deem less significant also may impact our business, financial condition or results of operations, perhaps materially. For additional information regarding risk factors, see "Forward-Looking Statements".

Risks Related to Our Business and Operations

Our business is subject to a number of risks of

which you should be aware before making decision to invest in our common stock These risks are more fully described in this "Risk Factors" section, including the following:

We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.

We will need substantial additional funding to meet our financial obligations and to pursue our business objectives.

We currently primarily rely on our collaborations with Reliance Life Sciences Ltd. ("RLS") and Universitat Autònoma de Barcelona ("UAB"), for our preclinical research and development programs.

Negative public opinion of gene therapy and increased regulatory scrutiny of gene therapy and genetic research may adversely impact the development or commercial success of our current and future product candidates.

We face significant competition in the area of biosimilar biologics from other biotechnology and pharmaceutical companies.

We use AAV and lentiviral vectors, and lipid nanoparticles to delivery some gene therapies, but others may have property rights to these vectors that we may need to license.

We are dependent on the success of our biosimilar

and gene therapy product candidates, which are still in early stages of development.

We currently have no products that are approved

for commercial sale and may never be able to develop marketable products. We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to the development of our biosimilar product candidates, which are in the early stages of clinical development, and the gene therapy product candidates, all of which are in pre-clinical development. Accordingly, our business currently depends heavily on the successful development, regulatory approval and commercialization of these product candidates. We cannot be certain that any of our product candidates will receive regulatory approval or be successfully commercialized even if we receive regulatory approval.

We will require additional capital to fund

our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.

We expect to continue to incur significant operating

and net losses, as well as negative cash flows from operations, for the foreseeable future as we continue to develop our gene therapy product candidates and prepare for potential future regulatory approvals and commercialization of our products. We have not generated any revenue to date and does not expect to generate product revenue unless and until we successfully complete development and obtain regulatory approval for at least one of our gene therapy product candidates. Our current cash and cash equivalents balance will also not be sufficient to complete all necessary development activities and commercially launch our products.

We are unable to estimate the actual funds

that we will require for development and any approved marketing and commercialization activities.

We expect to spend substantial amounts to complete

the development of, seek regulatory approvals for and commercialize our product candidates. Because the length of time and activities associated with successful development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. Our future funding requirements, both near and long- term, will depend on many factors, including, but not limited to:

the progress, timing, costs and results of our clinical trials of our product candidates;

the outcome, timing and cost of meeting regulatory requirements;

the achievement of certain development, regulatory and commercialization milestones the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

the cost of obtaining necessary intellectual property and defending potential intellectual property disputes s brought by third parties against us;

the effect of competing technological and market developments;

the cost and timing of completion of clinical-stage and commercial-scale manufacturing activities;

the cost of establishing sales, marketing and distribution capabilities for our product candidates; and the initiation, progress, timing and results of our commercialization of our product candidates.

We may be required to make significant payments

to third parties under the agreements pursuant to which e acquired our gene therapy and biosimilar product candidates.

Under our agreements with RLS and UAB, we are

subject to significant obligations, including payment obligations upon achievement of specified milestones and payments based on product sales, as well as other material obligations. Some of these milestones require us to make payments prior to generating any product sales.

We may not have sufficient funds available to meet our obligations at such time as any of these payments become due, in which case our development efforts would be harmed. Further, failure to make these payments or to meet our other material obligations may result in our counterparties pursuing various remedies under those agreements that could harm our operations.

We are highly dependent on the services

of our key executives and personnel, including our Chief Executive Officer, Dr. Joseph Sinkule (Pharm. D.) and if we are not able to retain these members of our management or recruit additional management, clinical and scientific personnel, our business will suffer.

We are highly dependent on the principal members

of our management and scientific and technical staff, particularly, our Chief Executive Officer, Dr. Joseph Sinkule. The loss of service of any of our management or key scientific and business management staff could harm our business. In addition, we are dependent on our continued ability to attract, retain and motivate highly qualified additional management, clinical and scientific personnel. If we are not able to retain our management and to attract, on acceptable terms, additional qualified personnel necessary for the continued development of our business, we may not be able to sustain our operations or grow.

We need to attract and retain key personnel.

We may not be able to attract or retain qualified

management and commercial, scientific and clinical personnel due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses, and the cost of living. If we are not able to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.

Our senior management and key employees may terminate

their position with us at any time. If we lose one or more members of our senior management team or key employees, our ability to successfully implement our business strategy could be seriously harmed. Replacing these individuals may be difficult, cause disruption, and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products successfully. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate additional key personnel. We does not maintain "key person" insurance for any of our executives or other employees.

Many of the other biopharmaceutical companies

that we compete against for qualified personnel and consultants have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement.

Some of these characteristics may be more appealing to high- quality candidates and consultants than what we have to offer. If we are unable to continue to attract and retain high-quality personnel and consultants, the rate and success at which we can discover and develop product candidates, our ability to effectively manage any future growth and our business will be limited.

Our employees, independent contractors,

principal investigators, consultants, commercial collaborators, manufacturers, service providers and other vendors, or those of our affiliates, may engage in misconduct or other improper activities.

Misconduct by any of these parties could include

intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations, including those of the FDA and other similar regulatory bodies that require the reporting of true, complete and accurate information; manufacturing standards;

federal, state and foreign healthcare fraud and abuse laws and data privacy; or laws that require the true, complete and accurate reporting of financial information or data. In particular, sales, marketing and other business arrangements in the healthcare industry are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing, bribery, corruption, antitrust violations, and other abusive practices.

These laws may restrict or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. It is not always possible to identify and deter employee or third-party misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting our from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

Additionally, we are subject to the risk that

a person or government agency could allege such fraud or other misconduct, even if none occurred. If any of our employees, independent contractors, principal investigators, consultants, commercial collaborators, manufacturers, service providers or other vendors, or those of our affiliates, are alleged or found to be in violation of any such regulatory standards or requirements, or become subject to a corporate integrity agreement or similar agreement and curtailment of our operations, it could have a significant impact on our business and financial results, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, suspension or delay in clinical trials, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, FDA debarment, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight, any of which could adversely affect our ability to operate our business and our results of operations.

Operation of our business internationally

exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business in various jurisdictions globally.

Our business strategy includes establishing and

maintaining operations and certain key third party arrangements in various jurisdictions around the world. Doing business internationally involves a number of risks, including:

multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, anti-bribery and anti- corruption laws, regulatory requirements and other governmental approvals, permits and licenses;

failure by us or our distributors to obtain appropriate licenses or regulatory approvals for the sale or use of our product candidates, if approved, in various countries;

difficulties in managing foreign operations;

unexpected changes in tariffs or trade barriers;

complexities associated with managing multiple payor-reimbursement regimes or self-pay systems;

financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;

reduced protection for intellectual property rights;

reduced protection of contractual rights in the event of bankruptcy or insolvency of the other contracting party;

natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, including the recent COVID-19 pandemic and related shelter-in-place orders, travel, social distancing and quarantine policies, boycotts, curtailment of trade and other business restrictions;

failure to comply with foreign laws, regulations, standards and regulatory guidance governing the collection, use, disclosure, retention, security and transfer of personal data, including the European Union General Data Privacy Regulation ("GDPR"); and failure to comply with anti-bribery and anti-corruption laws including the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, including by failing to maintain accurate information and control over sales and distributors' activities.

Any of these risks, if encountered, could significantly

harm our current or future international operations and, consequently, negatively impact our financial condition, results of operations and cash flows.

Risks Related to Development of Biosimilar

Biologics and Cell and Gene Therapies

If we are unable to obtain regulatory approval

for, or successfully commercialize, bevacizumab-anew, or rituximab-anew, our business will be harmed.

Biosimilar product development is a highly speculative

undertaking and involves a substantial degree of risk. We have initiated preparatory activities for our confirmatory Phase 3 clinical trial of bevacizumab-anew (Avastin) biosimilar candidate, and rituximab-anew (Rituxan/Mabthera) candidate. It may be several years, if ever, before we complete Phase 3 clinical trials and has a product candidate ready to file for market approval with the relevant regulatory agencies. If we obtain regulatory approval to market a biosimilar product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval and our ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors and adequate market share for our product candidates in those markets. Even if one or more of our product candidates gain regulatory approval and are commercialized, we may never become profitable. Our biosimilar product candidates are for versions of products for which other approved biosimilar competitors are already being marketed. Thus, even if approved, our products will face significant established competition from both the original branded version of our products, as well as from other already-approved biosimilar products. We cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our product candidates, we may not be able to continue our operations.

The evolving regulatory approval processes

of the FDA, EMA and comparable foreign authorities are lengthy, time-consuming, rigorous and inherently unpredictable. If we and our collaboration partners are ultimately unable to obtain regulatory approval for our product candidates, our business will be harmed.

and 750 more changes in the filing

Forward-looking statements 459 changes

All statements other than statements of historical

facts contained in this report, including statements regarding future operations, are forward-looking statements. In some cases, forward-looking statements may be identified by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "would," "expect," "objective," "plan," "potential," "seek," "grow," "target," "if," and similar expressions intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations, objectives, and financial needs.

Klotho Neurosciences seeks to develop essential

medicines for the treatment of chronic diseases — cancer, cardiovascular, muscle, skin, and neurodegenerative disorders. We currently have two platform technologies. One platform consists of proprietary, patented technology programs that include (a) a gene therapy program that uses a gene therapy approach to produce a therapeutic protein called "Klotho" inside the body to treat neurodegenerative diseases and other diseases of aging, and (b) a library of melanocortin receptor-binding molecules that activate or inactive melanocortin receptors in the body. our second platform is an "off-patent" portfolio of generic drugs and biosimilar biologics selling hard-to source, difficult to find generic drugs and off-patent biologic therapies.

The Business Combination

On May 30, 2023, the Company, then known

as Redwoods Acquisition Corp. and a newly formed wholly-owned Wyoming subsidiary of Redwoods Acquisition Corp. ("Merger Sub") entered into a Business Combination Agreement with ANEW Medical, Inc., a Wyoming corporation ("ANEW Wyoming"). On June 21, 2024, at the closing of the Business Combination Agreement, Merger Sub merged with and into ANEW Wyoming and ANEW Wyoming become a wholly-owned subsidiary of Redwoods. At the same time, the name of the Company was changed to ANEW Medical, Inc. On September 17, 2024, the Company's name was change to Klotho Neurosciences, Inc. The business combination was accounted for as a reverse recapitalization. ANEW Wyoming was deemed the accounting predecessor, and the combined entity is the successor SEC registrant, meaning that the ANEW Wyoming's financial statements for previous periods will be disclosed in the registrant's future periodic reports filed with the SEC.

Components of Our Results of Operations

We have been a research and development stage

company, and our historical results may not be indicative of our future results for reasons that may be difficult to anticipate. Accordingly, the drivers of our future financial results, as well as the components of such results, may not be comparable to our historical or projected results of operations.

Management's Discussion and Analysis of Financial Condition

and Results of Operations

References in this Registration Statement to "we,"

"us" or the "Company" refer to Klotho Neurosciences, Inc. (formerly known as ANEW Medical, Inc.). References to our "management" or our "management team" refer to our officers and directors. The following discussion and analysis of the Company's financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the notes thereto contained elsewhere in this Quarterly Report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.

Special Note Regarding Forward-Looking Statements

This Registration Statement includes "forward-looking

statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), that are not historical facts and involve risks and uncertainties that could cause actual results to differ materially from those expected and projected. All statements, other than statements of historical fact included in this Quarterly Report, including, without limitation, statements in this "Management's Discussion and Analysis of Financial Condition and Results of Operations" regarding the search for an initial business combination, the Company's financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. Words such as "expect," "believe," "anticipate," "intend," "estimate," "seek" and variations and similar words and expressions are intended to identify such forward-looking statements. Such forward-looking statements relate to future events or future performance, but reflect management's current beliefs, based on information currently available. A number of factors could cause actual events, performance or results to differ materially from the events, performance and results discussed in the forward-looking statements. For information identifying important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the Risk Factors section of the Company's final prospectus for its initial public offering filed with the U.S. Securities and Exchange Commission (the "SEC"). The Company's filings with the SEC can be accessed on the EDGAR section of the SEC's website at www.sec.gov. Except as expressly required by applicable securities law, the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Klotho Neurosciences, Inc. (the "Company"

or "Klotho") develops essential medicines for the treatment of chronic diseases – cancer, cardiovascular, and neurodegenerative disorders. The Company currently has acquired two licensed platforms a generic drug portfolio and a biosimilar biologics platform that uses biologic therapies to treat cancer, and two proprietary, patented technologies involving the melanocortin receptor-binding molecules and a gene therapy platform which uses a gene therapy approach to introduce a therapeutic protein called "Klotho" inside the body to treat neurodegenerative diseases.

On May 30, 2023, the Company, then known as Redwoods

Acquisition Corp. entered into a business combination agreement (the "Business Combination Agreement") with ANEW Medical, Inc., a Wyoming corporation. Then, on June 21, 2024, the closing of the Business Combination Agreement occurred resulting in ANEW Medical, Inc., a Wyoming corporation becoming a wholly- owned subsidiary of the Company, and the Company simultaneously changed its name to ANEW Medical, Inc. On September 17, 2024, the Company's name was change to Klotho Neurosciences, Inc. Results of Operations For accounting purposes, the Business Combination are treated as a reverse acquisition and, as such, the historical financial statements of the accounting acquirer, ANEW Medical, Inc., a Wyoming corporation, became the historical financial statements of publicly traded ANEW Medical, Inc., a Delaware corporation. The Results of Operations herein are those of the accounting acquirer, ANEW Medical, Inc., a Wyoming corporation. On Septmber 17, 2024, the Company's name was change to Klotho Neurosciences, Inc. We have not generated any operating revenues to date. To date, the Company's operations have consisted of acquiring our licensed platforms and patents, and planning for the Business Combination. We incur expenses as a result of being a public company (for legal, financial reporting, accounting and auditing compliance), as well as our expenses associated with planning our research and clinical testing operations.

Results of Operations for the year ended December

31, 2023 Compared to the year ended December 31, 2022.

We have not earned any revenue since our inception.

Operating expenses are composed of consultant

fees and professional fees.

Our operating expenses for the year ended December

31, 2023 were $631,322 compared to $574,374 for the year ended December 31, 2022, an increase of $56,948 or 9.9%. The increase was primarily due to increased expenses associated with preparing for our business combination including increases in third party consulting fees and professional fees.

For the year ended December 31, 2023, we incurred

a net loss of $707,458 compared to a net loss of $598,593 for the year ended December 31, 2022, an increase of $108,865 or 18.2%. The increase in net loss was primarily due to increased expenses associated with preparing for our business combination, including increases in third party consulting fees and professional fees, and increased interest expense.

Liquidity and Capital Resources

Net cash (used in) operating activities

Net cash used in investing activities

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

Cash, beginning of year

Operating activities

Net cash used in operating activities for the

year ended December 31, 2023 was $470,916 compared to $599,573 for the year ended December 31, 2022. The decline in cash used in operating activities is primarily attributable to increases in expenses as we prepared to close our business combination offset by an increase in payables. We expect net cash from operating activities to be negative in the coming periods, until the Company's products are able to produce meaningful revenue.

Investing activities

Net cash used in investing activities for the

year ended December 31, 2023 declined by $149,260 when compared to the prior year, attributable to reduced licensing activity.

Financing activities

Net cash provided by financing activities for

the year ended December 31, 2023 was $374,000, all from the sale of convertible promissory notes and the Company's common stock and promissory notes to investors.

Results of Operations for the Three and Nine

Months Ended September 30, 2024 Compared to the Three and Nine Months Ended September 30, 2023 Revenues The Company had no revenue for the nine months ended September 30, 2024 and September 30, 2023.

Operating expenses are composed of consultant

fees and professional fees.

Our operating expenses for the three months ended

September 30, 2024 were $2,870,932 compared to $123,737 for the three months ended September 30, 2023, an increase of $2,747,195. The increase was primarily due to increased share-based compensation expense.

Our operating expenses for the nine months ended

September 30, 2024 were $3,688,584 compared to $520,589 for the nine months ended September 30, 2023, an increase of $3,167,995. The increase was primarily due to increased share-based compensation expense as well as expenses associated with our business combination including increases in third party consulting fees and professional fees.

For the three months ended September 30, 2024,

we incurred a net loss of $2,959,426 compared to a net loss of $144,111 for the three month period ended September 30, 2023. The increase in net loss was primarily due to increased share-based compensation expense.

For the nine months ended September 30, 2024,

we incurred a net loss of $4,083,109 compared to a net loss of $580,983 for the nine month period ended September 30, 2023, an increase of $3,502,126. The increase in net loss was primarily due to increased stock-based compensation expense as well as expenses associated with preparing for our business combination including increases in third party consulting fees and professional fees.

Liquidity and Capital Resources

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

Cash, beginning of year

Operating Activities

Net cash used in operating activities for the

nine months ended September 30, 2024 was $2,002,358, compared to $247,406, for the nine months ended September 30, 2023, an increase of approximately $1,755,000. The significant increase in cash used in operating activities is primarily attributable to increases in expenses related to the business combination and continued operating costs. We expect net cash used in operating activities to increase in the coming periods, until our products are able to produce meaningful revenue.

Investing Activities

Net cash used in investing activities for the

nine months ended September 30, 2024 was $123,497, compared to $76,325 for the nine months ended September 30, 2023, an increase of approximately $47,000. The increase in cash used in investing activities is primarily attributable to licensing payments made in the period.

Financing Activities

Net cash provided by financing activities for

the nine months ended September 30, 2024 was $2,173,942, which consisted of investments, proceeds from the business combination, as well as proceeds from related parties. For the nine months ended September 30, 2023, net cash provided by financing activities was $250,000, from repayment of an advance to a shareholder.

Liquidity, Capital Resources and Going Concern

As of September 30, 2024, the Company had cash of $50,895 and net working capital of ($827,783).

The Company has incurred and expects to continue

to incur significant professional costs to remain as a publicly traded company and incurred significant transaction costs related to the consummation of the Business Combination.

The accompanying consolidated financial statements

have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. As of September 30, 2024, the Company had cash of approximately $51,000 and an accumulated deficit of approximately $8.5 million. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations.

Without additional funding, there is substantial doubt about the Company's ability to continue as a going concern for twelve months from the date of these financial statements.

Off-Balance Sheet Arrangements

and 379 more changes in the filing

Dividend policy 7 changes

We have not paid any dividends to shareholders.

Issuer Purchases of Equity Securities

We have not repurchased any shares of our common stock since inception.

have not declared or paid dividends on our common shares since our formation, and we do not anticipate paying dividends in the foreseeable future.

we will retain any earnings for use in our business. This policy will be reviewed by our board of directors from time to time in light of, among other things, our earnings and financial position.

There are no restrictions which would limit our ability to pay dividends on common equity or that are likely to do so in the future. The Delaware General Corporation Law, however, does prohibit us from declaring dividends where, distribution may be made if, after giving it effect, to the distribution of the dividend; we would not be able to pay our its debts as they become due in the usual course of business; or our the corporation's total assets would be less than the sum of the its total liabilities plus (unless the articles of incorporation permit otherwise) the amount that would be needed, if we were to be dissolved at the time of the distribution, to satisfy the preferential rights upon dissolution of shareholders who have whose preferential rights are superior to those receiving the distribution.

board of directors may base a determination that a distribution is not prohibitive either on consolidated financial statements prepared on the basis of accounting practices and principles that are reasonable in the circumstances or on a fair valuation of other method that is reasonable in the circumstances.

Legal proceedings 19 changes

From time to time, we may become involved in various

time to time, we may become involved in various lawsuits and legal proceedings that may arise in the ordinary course of business. However, litigation is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may have an adverse effect on our business, financial conditions, or operating results. We are not aware of any legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results.

The validity of the common shares being offered

hereby will be passed upon by Cyruli, Shanks & Zizmor, LLP, Attorneys at Law, New York, New York.

INCORPORATED BY REFERENCE

SEC allows us to incorporate information into this prospectus "by reference," which means that we can disclose important information to you by referring you to another document that we file separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus. These documents contain important information about our financial condition, business and results.

are incorporating by reference the filings listed below:

following documents filed with the SEC are hereby incorporated by reference in this prospectus:

Annual Report on Form 10-K

for the year ended December 31, 2024, filed with the SEC on March 31, 2025;

Quarterly Report on Form 10-Q

for the period ended March 31, 2025 filed with the SEC on May 15, 2025 and our Quarterly Reports on Form 10-Q for the period ended June 30, 2025; filed with the SEC on August 18, 2025 and Quarterly Report on Form 10-Q for the period ended September 30, 2025; filed with the SEC on November 13, 2025.

Current Reports on Form 8-K, filed with the SEC on April

1, 2025 , April 4, 2025 ,

April 21, 2025 , June

2, 2025 , June 10, 2025 ,

June 11, 2025 , June

13, 2025 , June 30, 2025 ,

July 10, 2025 , July 18, 2025 , July 22, 2025 , August 12, 2025 and September 25, 2025 and our Form 8-K/A on July 23, 2025 .

Exhibits 6 changes

Business Combination Agreement, dated May 30, 2023, by and among Redwoods Acquisition Corp., ANEW MEDICAL SUB, INC. and ANEW MEDICAL, INC. ** 2.2 Amendment No.1 to Business Combination Agreement, dated November 4, 2023, by and among Redwoods Acquisition Corp., ANEW MEDICAL SUB, INC. and ANEW MEDICAL, INC. ** 3.1 Amended and Restated Certificate of Incorporation of Redwoods Acquisition Corp. (incorporated by reference to Exhibit 3.1 to Redwoods' Current Report on Form 8-K filed with the SEC on April 4, 2022).** 3.2 Bylaws of Redwoods Acquisition Corp. (incorporated by reference to Exhibit 3.4 filed with Redwoods' registration statement on Form S-1 filed by the Registrant on March 10, 2022).** 3.3 Form of Second Amended and Restated Certificate of Incorporation of Redwoods Acquisition Corp. ** 3.4 Form of Amended and Restated Bylaws of Redwoods Acquisition Corp. ** 4.1 Specimen Unit Certificate (incorporated by reference to Exhibit 4.1 to Redwoods' Registration Statement on Form S-1 filed with the SEC on March 10, 2022).** 4.2 Specimen Class A Common Stock Certificate. ** 4.3 Specimen Warrant Certificate ** 4.4 Warrant Agreement between Continental Stock Transfer & Trust Company and the Registrant ** 5.1 Legal opinion of Cyruli Shanks & Zizmor, LLP 10.1 Lock-Up Agreement, dated as of May 30, 2023, by and among Redwoods Acquisition Corp. and the other parties named therein ** 10.2 Sponsor Support Agreement, dated as of December 29, 2023, by and among Redwoods Acquisition Corp., Redwoods Capital LLC, and other parties thereto ** 10.3 Voting and Support Agreement, dated as of May 30, 2023, by and among Redwoods Acquisition Corp., ANEW MEDICAL, INC. and the other parties named therein ** 10.4 2023 Stock Incentive Plan ** 10.5 Registration Rights Agreement, dated May 30, 2023, by and among Redwoods Acquisition Corp., certain stockholders of ANEW MEDICAL, INC. and the Founder Holders (incorporated by reference to Exhibit 10.3 to Redwoods' Current Report on Form 8-K filed with the SEC on June 5, 2023).** 10.6 Letter Agreement, dated March 30, 2022, by and among Redwoods Acquisition Corp. and its officers, directors and the Sponsor (incorporated by reference to Exhibit 10.1 to Redwoods' Current Report on Form 8-K filed with the SEC on April 4, 2022).** 10.7 Investment Management Trust Agreement, dated March 30, 2022, by and between Redwoods Acquisition Corp. and Continental Stock Transfer & Trust Company, LLC (incorporated by reference to Exhibit 10.2 to Redwoods' Current Report on Form 8-K filed with the SEC on April 4, 2022).** 10.8 Registration Rights Agreement, dated March 30, 2022, by and among Redwoods Acquisition Corp. and certain security holders named therein (incorporated by reference to Exhibit 10.4 to Redwoods' Current Report on Form 8-K filed with the SEC on April 4, 2022).** 10.9 Administrative Support Agreement, dated March 30, 2022, by and between Redwoods Acquisition Corp. and the Sponsor (incorporated by reference to Exhibit 10.8 to Redwoods' Current Report on Form 8-K filed with the SEC on April 4, 2022).** 10.10 Indemnity Agreements, Each dated as of March 30, 2022, by and between the Registrant and Each of the officers and directors of the Registrant (incorporated by reference to Exhibit 10.7 to Redwoods' Current Report on Form 8-K filed with the SEC on April 4, 2022).** II- 2 10.11 Subscription Agreement, dated March 30, 2022, by and between the Registrant and the Sponsor (incorporated by reference to Exhibit 10.5 to Redwoods' Current Report on Form 8-K filed with the SEC on April 4, 2022).** 10.12 Subscription Agreement, dated March 30, 2022, by and between the Registrant and the Sponsor (incorporated by reference to Exhibit 10.6 to Redwoods' Current Report on Form 8-K filed with the SEC on April 4, 2022).** 10.13 Sponsored Research Agreement with Universitat Autònoma de Barcelona.** 10.14 Exclusive license with Universitat Autònoma de Barcelona and Institució Catalana De Recerca I Estudis Avançats for the cognition and Alzheimer's related inventions covered by USPTO Application No.: 15/777,456.** 10.15 Exclusive license with Universitat Autònoma de Barcelona and Institució Catalana De Recerca I Estudis Avançats for the neuromuscular related inventions covered by USPTO Application No.: 18/299,989.** 10.16 Non-exclusive license with University of Heidelberg, Germany for the myotropic AAV capsids related inventions covered by USPTO Application No. 17/051,123.** 10.17 Exclusive license agreement and exclusive license and manufacturing agreement in licensed territories with Reliance Life Science Private Limited.** Code of Ethics of Redwoods Acquisition Corp. (incorporated by reference to Exhibit 14 to Redwoods' Registration Statement on Form S-1 filed with the SEC on March 10, 2022).** 23.1 Consent of Cyruli Shanks & Zizmor, LLP (included in Exhibit 5.1) 23.2 Consent of BCRG Group 101.INS XBRL Instance Document 101.SCH XBRL Taxonomy Extension Schema Document 101.CAL XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF XBRL Taxonomy Extension Definition Linkbase Document 101.LAB XBRL Taxonomy Extension Label Linkbase Document 101.PRE XBRL Taxonomy Extension Presentation Linkbase Document Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

Filing Fee Calculation Table

Financial Statement Schedules.

All financial statement schedules have been omitted,

since the required information is not applicable or is not present in amounts sufficient to require submission of the schedule, or because the information required is included in the financial statements and notes thereto.

The following exhibits are filed as part of this registration statement:

Business 112 changes

As of May 30, 2023, Redwoods Acquisition Corp., a Delaware corporation and a special purpose acquisition company ("Redwoods"), Anew Medical Sub, Inc., a Wyoming corporation ("Merger Sub") and ANEW Medical, Inc., a Wyoming corporation ("ANEW") entered into a Business Combination Agreement, which was amended as of November 4, 2023 (the "Business Combination Agreement"). On June 21, 2024 (the "Closing Date"), Merger Sub merged with and into ANEW, with ANEW continuing as the surviving corporation and as a wholly owned subsidiary of Redwoods (the "Business Combination"). In connection with the Business Combination, on June 21, 2024, Redwoods filed its Second Amended Certificate of Incorporation with the Delaware Secretary of State, and adopted the amended and restated bylaws (the "Amended and Restated Bylaws"), which replaced Redwoods' Charter and Bylaws in effect as of such time. In connection with the closing of the Business Combination (the "Closing"), Redwoods changed its name to "ANEW Medical, Inc."

For accounting purposes, the transactions contemplated by the Business Combination are treated as a reverse acquisition and, as such, the historical financial statements of the accounting acquirer ANEW (Wyoming) will become the historical financial statements of the Company. Under this method of accounting, Redwoods was treated as the acquired company for financial reporting purposes. Accordingly, for accounting purposes, the Merger was treated as the equivalent of the Company issuing shares for the net assets of Redwoods, accompanied by a recapitalization. The net assets of Redwoods were stated at historical cost with no goodwill or other intangible assets recorded.

In connection with the merger, the Company issued six million shares in exchange for all of the outstanding shares of ANEW. At $ 10 per Redwood's share, the valuation of ANEW was $ 60 million.

Immediately after giving effect to the Business Combination, 15,130,393 shares of Company Common Stock were outstanding, from which 2,875,000 remain in escrow for the Redwoods founders. In addition, there were 12,030,000 warrants immediately exercisable and composed of 11,500,000 public warrants and 530,000 private warrants. Following the Closing, on June 21, 2024, the Company's Common Stock and Warrants began trading on the Nasdaq under the symbols "WENA" and "WENAW," respectively. The Public Units of Redwoods automatically separated into the component securities upon consummation of the Business Combination and, as a result, no longer trade as a separate security. Further, upon closing of the Business Combination on June 21, 2024, the Company received approximately $ 181,339 in net cash proceeds. During the three months ended September 30, 2024, the Company determined there was an additional approximate $ 8,500 cash.

pursuant to the terms of the Business Combination Agreement and after giving effect to the redemptions of shares of Redwoods Common Stock:

● The total consideration paid at Closing (the "Merger

Consideration") by Redwoods to ANEW Medical, Inc. security holders was 6,000,000 shares of the Company common stock valued at $ 60 million (the "Consideration Shares"), based on an implied ANEW equity value of $ 60,000,000 valued at $ 10 per share;

● Each share of ANEW Medical Common Stock, if any, that was

owned by Redwoods, Merger Sub, ANEW Medical, Inc. or any other affiliate of Redwoods immediately prior to the effective time of the Merger (the "Effective Time") was automatically cancelled and retired without any conversion or consideration;

● Each share of Merger Sub common stock, par value $ 0.0001

per share ("Merger Sub Common Stock"), issued and outstanding immediately prior to the Effective Time was converted into one newly issued share of Common Stock of the Surviving Corporation.

In connection with the Merger,

the Company entered into a convertible promissory note and Securities Purchase Agreement ("SPA") with certain accredited investors (the "Redwoods PIPE Investors") for an aggregate of 750,000 shares (bonus free trading shares and restricted shares issued at closing), with each unit consisting of one share of Company common stock (the "PIPE Shares") for an aggregate purchase price of $ 2,000,000 (the "Redwoods PIPE Financing"). Upon the closing of the Redwoods PIPE Financing (which closed in connection with the closing of the Merger), the $ 2,000,000 were used by the Company to settle transaction costs. The Company received approximately $ 181,339 in net cash proceeds and recorded a receivable of $ 50,000 from the Redwoods PIPE Financing funds.

In connection with the Merger,

the Company entered convertible promissory note and Securities Purchase Agreement ("SPA") with certain accredited investors (the "ANEW PIPE Investors") for an aggregate of 854,257 units (bonus free trading shares and restricted shares issued at closing), with each unit consisting of one share of Company common stock (the "PIPE Shares") for an aggregate purchase price of $ 2,000,000 (the "ANEW PIPE Financing"). Upon the closing of the ANEW PIPE Financing (which closed in connection with the closing of the Merger), $ 1,000,000 was used by the Company to settle transaction costs. The Company received approximately $ 950,000 in cash proceeds and recorded a receivable of $ 50,000 from the ANEW certain ANEW stockholders may be entitled to up to an additional 5,000,000 shares of Company Common Stock (the " Contingent Consideration Shares "), upon the following conditions being met:

(i) 2,000,000 Contingent Consideration Shares upon the Company's common stock achieving a closing price equal to or exceeding $12.50 for 10 trading days within a 20-day trading period in the first three years following the Closing;

2,000,000 Contingent Consideration Shares upon the Company's common stock achieving a closing price equal to or exceeding $15.00 for 10 trading days within a 20-day trading period in the first three years following the Closing; and (iii) 1,000,000 Contingent Consideration Shares upon the Company's common stock achieving a closing price equal to or exceeding $20.00 for 10 trading days within a 20-day trading period in the first five years following the Closing.

accordance with guidance applicable to these circumstances, the equity structure has been restated in all comparable periods up to June 21, 2024 and reflected as such as of September 30, 2024, to reflect the number of shares of the Company's common stock, $ 0.0001 par value per share, issued to ANEW's stockholders in connection with the merger. As such, the shares and corresponding capital amounts and earnings per share related to ANEW's common stock prior to the merger have been retroactively restated as shares reflecting the exchange ratio established in the merger.

For accounting purposes, the Merger was treated as the equivalent of the Company issuing shares for the net assets of Redwoods, accompanied by a recapitalization. The net assets of Redwoods were stated at historical cost with no goodwill or other intangible assets recorded. In connection with the Merger, in addition to the warrants, ANEW Medical assumed $ 589,081 in cash and $ 568,111 in income tax payable. The income tax payable of $ 568,111 was settled in full as of September 30, 2024 from the assumed $ 589,081 cash.

OF SIGNIFICANT ACCOUNTING POLICIES

The accompanying unaudited consolidated financial

statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. As of September 30, 2024, the Company had cash of approximately $ 51,000 and an accumulated deficit of approximately $ 8.5 million. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations. Without additional funding, there is substantial doubt about the Company's ability to continue as a going concern for twelve months from the date of these financial statements.

of Presentation and Principles of Consolidation

Company prepares its consolidated financial statements in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") and pursuant to the rules and regulations of the SEC. The Company prepared the Financial Statements, without audit, pursuant to the rules and regulations of the SEC applicable to quarterly reporting on Form 10-Q and reflect, in management's opinion, all adjustments necessary to present fairly the financial information. All such adjustments are of a normal recurring nature.

Certain information and footnote disclosures normally included in financial statements, prepared in accordance with generally accepted accounting principles, have been consolidated or omitted as permitted by such rules and regulations. These Financial Statements should be read in conjunction with the consolidated financial statements and related notes included in the 2023 Annual Report. Results of operations for interim periods are not necessarily indicative of annual results.

prior year amounts have been reclassified for comparative purposes to conform to the current-year financial statement presentation. These reclassifications had no effect on previously reported results of operations and were not material.

Company is an "emerging growth company," as defined in Section 2(a) of the Securities Act of 1933, as amended (the "Securities Act"), as modified by the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"), and it may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the "Exchange Act")) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of the Company's financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

preparation of unaudited consolidated financial statements in conformity with U.S. GAAP requires the Company's management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.

estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the date of the financial statements, which management considered in formulating its estimate, could change in the near term due to one or more future confirming events. Accordingly, the actual results could differ significantly from those estimates.

and Cash Equivalents

and cash equivalents represent cash on hand, demand deposits, and other short-term highly liquid investments placed with banks, which have original maturities of three months or less and are readily convertible to known amounts of cash.

instruments that potentially subject the Company to concentrations of credit risk consist of a cash account in a financial institution, which, at times, may exceed the Federal Depository Insurance Coverage of $ 250,000 . As of September 30, 2024, the Company has not experienced losses on this account and management believes the Company is not exposed to significant risks on such account.

Value of Financial Instruments

assets and liabilities are valued using a fair market basis as defined in the Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") ASC 820, Fair Value Measurement. Fair value is the price the Company would receive to sell an asset or pay to transfer a liability in an orderly transaction with a market participant at the measurement date. The Company uses a three-level hierarchy established by the FASB that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques (market approach, income approach and cost approach). The levels of the fair value hierarchy are described below:

prices in active markets for identical assets or liabilities.

other than quoted prices that are observable for the asset or liability, either directly or indirectly; these include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

inputs with little or no market data available, which require the reporting entity to develop its own assumptions.

Company's assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Financial assets and liabilities are classified in their entirety based on the most conservative level of input that is significant to the fair value measurement.

Fair value measurements at reporting date using:

Quoted prices in active markets for identical liabilities (Level 1)

Significant unobservable inputs

Representative warrant liabilities, September 30, 2024

Representative warrant liabilities, December 31, 2023

following tables present a reconciliation of the Level 3 Private Warrants liabilities:

Representative warrant liabilities, January 1

Issuances/Assumptions

Change in fair value

Representative warrant liabilities, September 30

Representative warrant liabilities, July 1

Change in fair value

Representative warrant liabilities, September 30

Company's intangible assets consist of acquired medical licenses and patents.

The Company acquires medical licenses for the treatment of medical conditions to market and sell in the future. The initial asset cost is the cost to acquire the license. Once in use, the Company amortizes the license cost over the useful life using the straight-line method. As part of the licensing agreements, the Company acquires patents and records the cost to acquire patents as the initial asset cost. Once the patents are approved and in use, assuming no litigations expenses, the Company amortizes the patent cost over the useful life using the straight-line method. The amortization period will not exceed the lifespan of the protection afforded by the patent. If the expected useful life of the patent is even shorter, the Company will use the useful life for amortization purposes. Thus, the shorter of a patent's useful life or legal life will be used for the amortization period.

of Long-Lived and Intangible Assets

The Company assesses the impairment of long-lived and intangible assets periodically, or at least annually, and whenever events or changes in circumstances indicate that the carrying value may not be recoverable.

Factors considered important, which could trigger an impairment review, include the following: significant underperformance relative to historical or projected future cash flows; significant changes in the manner of use of the assets or the strategy of the overall business;

and significant negative industry trends. When management determines that the carrying value of long-lived and intangible assets may not be recoverable, impairment is measured as the excess of the assets' carrying value over the estimated fair value. Management is not aware of any other impairment charges that may currently be required; however, the Company cannot predict the occurrence of events that might adversely affect the reported values in the future. On an annual basis, the Company tests the long-lived and intangible assets for impairment based on the projected net present value of cash flows for each asset. Prior to the annual impairment test, if circumstances change and a long-lived or intangible asset is deemed impaired, an impairment loss will be immediately recognized in the statements of operations. At December 31, 2023, the date of the last impairment test, it was determined that the estimated fair value of the intangible assets exceeded the carrying value of the assets by 50 %, indicating no impairment.

Company is in a pre-revenue state and does not generate revenue. When the Company commences to derive revenue, those contracts will be accounted in accordance with ASU 2014-09, Revenue from Contracts with Customers (Topic ASC 606).

Company uses the asset and liability method of accounting for income taxes in accordance with ASU 740, "Income Taxes". Under this method, income tax expense is recognized as the amount of: (i) taxes payable or refundable for the current year and (ii) future tax consequences attributable to differences between the consolidated financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of available evidence it is more likely than not that some portion or all of the deferred tax assets will not be realized.

Company is subject to Income tax filings requirements in U.S. federal and various state jurisdictions. The Company's tax returns for years from 2021, 2022, and 2023 are subject to U.S. federal, state, and local income tax examinations by tax authorities.

Company reports income tax related interest and penalties within the income tax line item on the consolidated statements of operations.

The Company likewise reports the reversal of income tax-related interest and penalties within such line item to the extent the Company resolves the liabilities for uncertain tax positions in a manner favorable to the accruals.

Loss Per Share (Basic and Diluted)

net loss per share is computed by dividing net loss by the weighted average number of shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of shares outstanding, plus the number of additional shares that would have been outstanding if the common share equivalents had been issued, if dilutive.

following table details the net loss per share calculation, reconciles between basic and diluted weighted average shares outstanding, and presents the potentially dilutive shares that are excluded from the calculation of the weighted average diluted common shares outstanding, because their inclusion would have been anti-dilutive:

For the Nine Months Ended

Weighted average shares outstanding (denominator for basic earnings per share) 16,588,940 15,130,393 Weighted average shares and assumed potential common shares (denominator for diluted earnings per share, treasury method) 16,588,940 15,130,393 Basic loss per share $ ( 0.25 ) $ ( 0.04 ) Diluted loss per share $ ( 0.25 ) $ ( 0.04 ) The following common share equivalents are excluded from the calculation of weighted average common shares outstanding, because their inclusion would have been anti-dilutive:

For the Nine Months Ended

Total potentially dilutive shares

and Development Cost

and development (R&D) costs are expensed as incurred. R&D costs are related to the Company's internally funded development of the Company medical licenses and patents. The Company R&D costs were $ 0 for the three and nine months ended September 30, 2024 and 2023, respectively.

Company accounts for share-based compensation in accordance with the fair value recognition provisions of the Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") No. 718 and No. 505. The Company issues restricted stock to employees and consultants for their services. Cost for these transactions are measured at the fair value of the equity instruments issued at the date of grant. These shares are considered fully vested and the fair market value is recognized as an expense in the period granted. The Company recognized consulting expenses and a corresponding increase to additional paid-in-capital related to stock issued for services. For agreements requiring future services, the consulting expense is to be recognized ratably over the requisite service period.

Company recorded share-based compensation of $ 1,990,366 and $ 100,000 for the nine months ended September 30, 2024, and 2023, respectively.

of September 30, 2024, the fair value of the Representative Warrant liabilities was $ 21,200 based on the closing price of the warrants on The Nasdaq Capital Market. The fair value of the Representative Warrants was approximately $ 0.04 per Representative Warrant, which was based on the relative fair value to the Public Warrants. During the quarter, our Public and Private Warrants met the conditions necessary to adjust the exercise price and the redemption trigger price. As of September 30, 2024, the exercise price was $ 3.49 per warrant, and the redemption trigger price was $ 5.01 . During the three months ended September 30, 2024, the fair value of the Representative warrants decreased by $ 41,022 .

During the three months

ended September 30, 2024, a warrant holder exercised 130,000 warrants issued as part of the Series D Preferred Shares related to the Business Combination, with a total value of $ 96,200 , valued as of September 27, 2024.

Company follows subtopic 850-10 of the FASB Accounting Standards Codification for the identification of related parties and disclosure of related party transactions.

to Section 850-10-20 the related parties include (a) affiliates of the Company; (b) entities for which investments in their equity securities would be required, absent the election of the fair value option under the Fair Value Option Subsection of Section 825–10–15, to be accounted for by the equity method by the investing entity; (c) trusts for the benefit of employees, such as pension and profit-sharing trusts that are managed by or under the trusteeship of management; (d) principal owners of the Company; (e) management of the Company;

(f) other parties with which the Company may deal if one party controls or can significantly influence the management or operating policies of the other to an extent that one of the transacting parties might be prevented from fully pursuing its own separate interests; and (g) other parties that can significantly influence the management or operating policies of the transacting parties or that have an ownership interest in one of the transacting parties and can significantly influence the other to an extent that one or more of the transacting parties might be prevented from fully pursuing its own separate interests.

financial statements shall include disclosures of material related party transactions, other than compensation arrangements, expense allowances, and other similar items in the ordinary course of business. However, disclosure of transactions that are eliminated in the preparation of consolidated or combined financial statements is not required in those statements. The disclosures shall include: (a) the nature of the relationship(s) involved; (b) description of the transactions, including transactions to which no amounts or nominal amounts were ascribed, for each of the periods for which income statements are presented, and such other information deemed necessary to an understanding of the effects of the transactions on the financial statements; (c) the dollar amounts of transactions for each of the periods for which income statements are presented and the effects of any change in the method of establishing the terms from that used in the preceding period; and (d) amounts due from or to related parties as of the date of each balance sheet presented and, if not otherwise apparent, the terms and manner of settlement.

and 32 more changes in the filing