[10-Q] Serina Therapeutics, Inc. Quarterly Earnings Report
Filing Impact
Filing Sentiment
Form Type
10-Q
Serina Therapeutics reported Q3 2025 results marked by losses and liquidity pressure. The company posted a net loss of $4.6 million for the quarter and $15.9 million for the nine months ended September 30, 2025, with no Q3 revenue and $0.1 million in grant revenue year to date. Cash and cash equivalents were $8.6 million as of September 30, 2025. Management states there is substantial doubt about the company’s ability to continue as a going concern.
Operating cash outflow was $11.9 million for the nine‑month period. To bolster liquidity, Serina raised capital through a $4.9 million private placement of Series A preferred stock, $2.2 million of net proceeds via an at‑the‑market program, and drew $5.0 million from a new unsecured convertible note that provides up to $20 million across clinical milestones. The FDA placed a clinical hold on the IND for SER‑252 on November 3, 2025, requesting additional information on an excipient. Shares outstanding were 10,664,064 as of November 10, 2025.
Positive
- None.
Negative
- Going concern: Management states substantial doubt about continued operations over the next 12 months.
- FDA clinical hold: IND for SER-252 placed on hold on November 3, 2025, pending additional excipient information.
Insights
Going concern and FDA hold heighten risk despite new funding.
Serina Therapeutics reported a Q3 net loss of
Liquidity steps included a private placement of Series A preferred for
The FDA clinical hold on the SER‑252 IND was announced on
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||||||||
For the quarterly period ended September 30, 2025
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||||||||
For the transition period from ___________ to ___________
Commission file number 1-38519
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||||
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (256) 327-9630
| Title of each class | Trading Symbol | Name of exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. x Yes o No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). x Yes o No
Indicate 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.
| Large accelerated filer | o | Accelerated filer | o | ||||||||
| x | x | ||||||||||
| o | |||||||||||
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 to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes x No
The number of shares common stock outstanding as of November 10, 2025 was 10,664,064 , par value $0.0001 per share.
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SERINA THERAPEUTICS, INC.
TABLE OF CONTENTS
| Page Number | |||||||||||
Part I – FINANCIAL INFORMATION | |||||||||||
Item 1. | Financial Statements | 4 | |||||||||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 29 | |||||||||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 37 | |||||||||
Item 4. | Controls and Procedures | 38 | |||||||||
Part II – OTHER INFORMATION | |||||||||||
Item 1. | Legal Proceedings | 40 | |||||||||
Item 1A. | Risk Factors | 40 | |||||||||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 44 | |||||||||
Item 3. | Default Upon Senior Securities | 44 | |||||||||
Item 4. | Mine Safety Disclosures | 44 | |||||||||
Item 5. | Other Information | 45 | |||||||||
Item 6. | Exhibits | 45 | |||||||||
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Forward-Looking Statements
This Quarterly Report on Form 10-Q (“Report”) contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. 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 words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology.
Any forward-looking statements in this Report reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those discussed in this Report under Item 1 of the Notes to Condensed Consolidated Financial Statements, under Risk Factors in this Report, those incorporated by reference in the section titled “Risk Factors" in our Annual Report on Form 10-K and our other periodic reports and documents filed from time to time with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
The description or discussion, in this Report, of any contract or agreement is a summary only and is qualified in all respects by reference to the full text of the applicable contract or agreement.
As used herein, otherwise stated or the context otherwise requires, as used herein, references to "Serina," the "Company," "we," "our," "us" or similar terms refer to Serina Therapeutics, Inc. and its subsidiaries.
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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
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SERINA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value amounts)
| September 30, 2025 | December 31, 2024 | ||||||||||
| (unaudited) | |||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Prepaid expenses and other current assets | |||||||||||
| Total current assets | |||||||||||
| Property and equipment, net | |||||||||||
| Right of use assets - operating leases | |||||||||||
| Right of use assets - finance leases | |||||||||||
| Other long-term prepaid assets | |||||||||||
| TOTAL ASSETS | $ | $ | |||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued expenses | |||||||||||
| Warrant liability | |||||||||||
| Convertible Note, net | |||||||||||
| Other current liabilities | |||||||||||
| Total current liabilities | |||||||||||
| Warrant liability, non-current | |||||||||||
| Operating lease liabilities, net of current portion | |||||||||||
| TOTAL LIABILITIES | |||||||||||
| Stockholders’ equity: | |||||||||||
Series A convertible preferred stock, $ | |||||||||||
Common stock, $ | |||||||||||
| Additional paid-in capital | |||||||||||
| Accumulated other comprehensive loss | ( | ||||||||||
| Accumulated deficit | ( | ( | |||||||||
| Total Serina Therapeutics, Inc. stockholders’ equity | |||||||||||
| Noncontrolling interest | ( | ( | |||||||||
| Total stockholders’ equity | |||||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | |||||||||
See accompanying notes to these condensed consolidated interim financial statements.
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SERINA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| REVENUES | |||||||||||||||||||||||
| Grant revenues | $ | $ | $ | $ | |||||||||||||||||||
| Total revenues | |||||||||||||||||||||||
| OPERATING EXPENSES | |||||||||||||||||||||||
| Research and development | |||||||||||||||||||||||
| General and administrative | |||||||||||||||||||||||
| Total operating expenses | |||||||||||||||||||||||
| Loss from operations | ( | ( | ( | ( | |||||||||||||||||||
| OTHER INCOME, NET | |||||||||||||||||||||||
| Interest expense | ( | ( | ( | ( | |||||||||||||||||||
| Change in fair value of convertible promissory notes | ( | ||||||||||||||||||||||
| Change in fair value of warrants | |||||||||||||||||||||||
| Gain on warrants expiration | |||||||||||||||||||||||
| Other income, net | |||||||||||||||||||||||
| Total other income, net | |||||||||||||||||||||||
| NET (LOSS) INCOME | ( | ( | ( | ||||||||||||||||||||
| Net loss attributable to noncontrolling interest | |||||||||||||||||||||||
| NET (LOSS) INCOME ATTRIBUTABLE TO SERINA THERAPEUTICS, INC. | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
| NET (LOSS) INCOME | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
| OTHER COMPREHENSIVE LOSS | |||||||||||||||||||||||
| Foreign currency translation adjustment | ( | ( | |||||||||||||||||||||
| COMPREHENSIVE LOSS | ( | ( | ( | ||||||||||||||||||||
| Comprehensive loss attributable to noncontrolling interest | |||||||||||||||||||||||
| COMPREHENSIVE (LOSS) INCOME ATTRIBUTABLE TO SERINA THERAPEUTICS, INC. | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
| NET (LOSS) INCOME PER COMMON SHARE: | |||||||||||||||||||||||
| BASIC | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
| DILUTED | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: | |||||||||||||||||||||||
| BASIC | |||||||||||||||||||||||
| DILUTED | |||||||||||||||||||||||
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See accompanying notes to these condensed consolidated interim financial statements.
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SERINA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
(in thousands)
(unaudited)
| Series A Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) | Accumulated Deficit | Noncontrolling Interest | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||
| Number of Shares | Amount | Number of Shares | Par Value | ||||||||||||||||||||||||||||||||||||||||||||||||||
| BALANCE AT DECEMBER 31, 2024 | $ | $ | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of stock options | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock to Juvenescence, net of issuance costs of $ | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | — | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| BALANCE AT MARCH 31, 2025 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of stock options | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of Series A Convertible Preferred Stock, net of issuance costs of $ | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock under at-the-market sales agreement, net of issuance costs of $ | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock to consultant for services rendered | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Release of restricted stock units to consultant for services rendered | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | — | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| BALANCE AT JUNE 30, 2025 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of stock options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||
| Reclassification of warrant liability to equity | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock under at-the-market sales agreement, net of issuance costs of $ | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for services rendered by consultants | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | — | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| BALANCE AT SEPTEMBER 30, 2025 | $ | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||||||||||||||||||||||||||||
See accompanying notes to these condensed consolidated interim financial statements.
SERINA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(in thousands)
(unaudited)
| Redeemable Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Total Stockholders’ Deficit | ||||||||||||||||||||||||||||||||||||||||||||
| Number of Shares | Amount | Number of Shares | Par Value | Accumulated Deficit | Noncontrolling Interest | ||||||||||||||||||||||||||||||||||||||||||
| BALANCE AT DECEMBER 31, 2023 | $ | $ | $ | $ | ( | $ | $ | ( | |||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of stock options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon conversion of redeemable convertible preferred stock | ( | ( | — | — | |||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock to AgeX stockholders and conversion of AgeX-Serina Note upon consummation of Merger | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Deemed dividend from issuance of warrants | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
| BALANCE AT MARCH 31, 2024 | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of Post-Merger Warrants | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Transactions with noncontrolling interests | — | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||||
| Net income (loss) | — | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||||
| BALANCE AT JUNE 30, 2024 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of stock options | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Transactions with noncontrolling interests | — | — | — | — | ( | — | |||||||||||||||||||||||||||||||||||||||||
| Net income (loss) | — | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||||
| BALANCE AT SEPTEMBER 30, 2024 | $ | $ | $ | $ | ( | $ | ( | $ | ( | ||||||||||||||||||||||||||||||||||||||
See accompanying notes to these condensed consolidated interim financial statements.
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SERINA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
| Nine months ended September 30, | |||||||||||
| 2025 | 2024 | ||||||||||
| OPERATING ACTIVITIES: | |||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Depreciation and amortization | |||||||||||
| Non-cash lease expense | |||||||||||
| Non-cash interest expense on convertible promissory note | |||||||||||
| Amortization of debt issuance costs | |||||||||||
| Stock-based compensation | |||||||||||
| Common stock issued to consultant for services rendered | |||||||||||
| Restricted stock units released to consultant for services rendered | |||||||||||
| Change in fair value of convertible promissory notes | |||||||||||
| Change in fair value of warrants | ( | ( | |||||||||
Gain on expiration of warrants | ( | ||||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Grant receivable | |||||||||||
| Prepaid expenses and other current assets | ( | ||||||||||
| Accounts payable | ( | ||||||||||
| Accrued expenses | ( | ||||||||||
| Operating lease liabilities | ( | ( | |||||||||
| Other current liabilities | |||||||||||
| Net cash used in operating activities | ( | ( | |||||||||
| INVESTING ACTIVITIES: | |||||||||||
| Purchase of equipment | ( | ( | |||||||||
| Net cash used in investing activities | ( | ( | |||||||||
| FINANCING ACTIVITIES: | |||||||||||
| Drawdown on loan facilities from Juvenescence | |||||||||||
| Cash and restricted cash acquired in connection with the Merger | |||||||||||
| Proceeds from the exercise of Post-Merger Warrants by Juvenescence | |||||||||||
| Proceeds from the exercise of stock options | |||||||||||
| Proceeds from issuance of stock to Juvenescence, net | |||||||||||
| Principal repayment on loan facilities to Juvenescence | ( | ||||||||||
| Principal repayments on finance lease liabilities | ( | ||||||||||
| Proceeds from issuance of Series A Convertible Preferred Stock, net | |||||||||||
| Proceeds from issuance of common stock under at-the-market sales agreement, net | |||||||||||
| Proceeds from 2025 Convertible Note, net | |||||||||||
| Net cash provided by financing activities | |||||||||||
| Effect of foreign currency on cash | ( | ||||||||||
| NET CHANGE IN CASH AND CASH EQUIVALENTS | ( | ||||||||||
| CASH AND CASH EQUIVALENTS: | |||||||||||
| At beginning of the period | |||||||||||
| At end of the period | $ | $ | |||||||||
| SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES: | |||||||||||
| Issuance of common stock upon conversion of redeemable convertible preferred stock | $ | $ | |||||||||
| Merger and issuance of common stock upon consummation of Merger on March 26, 2024 | $ | $ | |||||||||
| Deemed dividend from issuance of warrants | $ | $ | |||||||||
| Issuance of warrants upon exercise of Post-Merger Warrants | $ | $ | |||||||||
| Transfer of right‑of‑use assets to property and equipment upon title transfer | $ | $ | |||||||||
| Issuance of warrants in connection with 2025 Convertible Note | $ | $ | |||||||||
| Recognition of debt discount on Convertible Note | $ | $ | |||||||||
| Reclassification of warrant liability to equity | $ | $ | |||||||||
See accompanying notes to these condensed consolidated interim financial statements.
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SERINA THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(unaudited)
1. Organization, Business Overview and Liquidity
Serina Therapeutics, Inc. was incorporated as AgeX Therapeutics, Inc. in January 2017 in the state of Delaware. On March 26, 2024, AgeX Therapeutics, Inc. (“AgeX”) completed a merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger and Reorganization, dated as of August 29, 2023 (the “Merger Agreement”), by and among AgeX, Canaria Transaction Corporation, an Alabama corporation and a wholly owned subsidiary of AgeX (“Merger Sub”), and Serina Therapeutics, Inc., an Alabama corporation (“Legacy Serina”), pursuant to which Merger Sub merged with and into Legacy Serina, with Legacy Serina surviving the merger as a wholly owned subsidiary of AgeX (the “Merger”). Additionally, on March 26, 2024, AgeX changed its name from “AgeX Therapeutics, Inc.” to “Serina Therapeutics, Inc.”. Unless otherwise stated or the context otherwise requires, together with its subsidiaries, "Serina" or the "Company"). See Note 3, Recapitalization, for the accounting for the Merger.
Following the consummation of the Merger, the business previously conducted by Legacy Serina became the business conducted by the Company, which is now a clinical-stage biotechnology company developing Legacy Serina’s drug product candidates. The Company’s headquarters are located in Huntsville, Alabama.
The Company is a clinical-stage biotechnology company developing a pipeline of wholly-owned drug product candidates to treat neurological diseases and other indications. The Company’s POZ drug delivery technology is designed to enable certain existing drugs and novel drug candidates to be modified in a way that provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics, and antibody-based drug conjugates (ADCs). The Company’s proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline) and is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via easy-to-administer, long-acting subcutaneous injection.
The therapeutic agents in the Company’s product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic (PK) profiles that can include toxicity, side effects and short half-life. The Company believes that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood. The Company believes that POZ technology can be applied to small molecules, proteins, antibody drug conjugates, and other classes of molecules.
Prior to the closing of the Merger, any assets of AgeX other than certain “Legacy Assets” were transferred into a newly formed subsidiary of AgeX, UniverXome Bioengineering, Inc. (“UniverXome”). UniverXome assumed (i) any outstanding indebtedness of AgeX to Juvenescence Limited (“Juvenescence”), which was secured by the assets contributed to UniverXome, (ii) most of the Company’s contracts with third parties, other than certain designated contracts and any contracts that were terminated before the Merger, and (iii) all other liabilities of the Company in existence as of the effective time of the Merger (other than certain transaction expenses related to the Merger). In December 2024, the Company sold UniverXome to Juvenescence. See Note 5, Related Party Transactions.
Liquidity and Going Concern
In addition to general economic and capital market trends and conditions, the Company’s ability to raise sufficient additional capital to finance its operations from time to time will depend on a number of factors specific to the Company’s operations such as operating expenses and progress in out-licensing its technologies and development of its product candidates.
The unavailability or inadequacy of financing to meet future capital needs could force the Company to modify, curtail, delay, or suspend some or all aspects of planned operations. Sales of additional equity securities could result in the dilution of the interests of its stockholders. The Company cannot assure that adequate financing will be available on favorable terms, if at all.
The Company recognized a net loss of $15.8 million for the nine months ended September 30, 2025. The Company used $11.9 million in net cash from operating activities for the period ended September 30, 2025, and has historically incurred losses from operations and expects to continue to generate negative cash flows as the Company implements its business plan.
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Management believes that its cash and cash equivalents of $8.6 million as of September 30, 2025, are not expected to be sufficient to satisfy the Company’s anticipated operating and other funding requirements for the twelve months from the issuance of these condensed consolidated interim financial statements. As such, there is substantial doubt about the Company’s ability to continue as a going concern.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, technical risks associated with the successful research, development and manufacturing of therapeutic candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and the ability to secure additional capital to fund operations. Therapeutic drug candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts will require significant amounts of additional capital, adequate personnel, and infrastructure. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. The Company expects to largely rely on raising capital from equity investors, and additional funding through the Company's at-the-market offering ("ATM"), for funding its operations. Some funding may be obtained through licensing agreements or other arrangements with commercial entities.
2. Basis of Presentation and Summary of Significant Accounting Policies
The unaudited condensed consolidated interim financial statements presented herein, and as discussed below, have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. In accordance with those rules and regulations, certain information and footnote disclosures normally included in comprehensive consolidated financial statements have been condensed or omitted. The condensed consolidated balance sheet as of September 30, 2025 and the condensed consolidated statements of operations, condensed consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three and nine months ended September 30, 2025, and 2024 and condensed consolidated statements of cash flows for the nine months ended September 30, 2025, and 2024 are unaudited. The condensed consolidated balance sheet as of December 31, 2024 was derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by U.S. GAAP. These condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the years ended December 31, 2024 and 2023 in the Annual Report on Form 10-K filed with the SEC on March 24, 2025.
The accompanying condensed consolidated interim financial statements, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the Company’s financial condition and results of operations. The condensed consolidated results of operations are not necessarily indicative of the results to be expected for any other interim period or for the entire year.
Principles of consolidation
The consolidated financial statements include the accounts of the Company, its wholly owned subsidiary, Serina Therapeutics Australia Pty Ltd, and its subsidiaries in which the Company has a controlling financial interest. The Company established Serina Therapeutics Australia Pty Ltd on July 2, 2025, for the purpose of conducting clinical research activities in Australia. For consolidated entities where the Company has less than 100% of ownership, the Company records net loss attributable to noncontrolling interest on the consolidated statement of operations equal to the percentage of the ownership interest retained in such entities by the respective noncontrolling parties. The noncontrolling interest is reflected as a separate element of stockholders’ equity on the Company’s consolidated balance sheets. Any material intercompany transactions and balances have been eliminated upon consolidation.
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The Company assesses whether it is the primary beneficiary of a variable interest entity (“VIE”) at the inception of the arrangement and at each reporting date. This assessment is based on its power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and the Company’s obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE. If the entity is within the scope of the variable interest model and meets the definition of a VIE, the Company considers whether it must consolidate the VIE or provide additional disclosures regarding its involvement with the VIE. If the Company determines that it is the primary beneficiary of the VIE, the Company will consolidate the VIE. This analysis is performed at the initial investment in the entity or upon any reconsideration event. For entities the Company holds as an equity investment that are not consolidated under the VIE model, the Company will consider whether its investment constitutes a controlling financial interest in the entity and therefore should be considered for consolidation under the voting interest model.
Prior to the Merger, the Company had three subsidiaries: Legacy Serina and UniverXome, which were wholly owned subsidiaries, and NeuroAirmid Inc., a Delaware corporation ("NeuroAirmid"). Following the Merger, the Company is primarily focused on developing Legacy Serina's product candidates.
NeuroAirmid is jointly owned by the Company and certain researchers from the University of California and was organized to pursue certain cell therapies, focusing initially on Huntington’s Disease. The Company owns 47.5 % of the outstanding capital stock of NeuroAirmid. The Company consolidates NeuroAirmid despite not having majority ownership interest as it has the ability to influence decision making and financial results through contractual rights and obligations as per Accounting Standards Codification (“ASC”) 810, Consolidation. On March 27, 2024, the Board of Directors of the Company formed a special committee for the purpose of exploring strategic alternatives for the business, assets and/or stock of NeuroAirmid and UniverXome including its subsidiaries Reverse Bio, Inc., a Delaware corporation ("Reverse Bio") and ReCyte, Inc., a California corporation ("ReCyte").
Financial statement reclassification
Certain account balances from prior periods have been reclassified in these condensed consolidated financial statements to conform to current period classifications. Interest income and expenses, previously presented net on the condensed consolidated statement of operations, is now presented separately. The non-cash interest expense on convertible promissory note, previously combined with accrued expenses in the operating activities section of the condensed consolidated statement of cash flows, is now presented separately within operating activities. These reclassifications had no effect on the reported results of operations or financial position.
Use of estimates
Foreign currency translation and transactions
The Company’s reporting currency is the U.S. dollar. The functional currency of the Company’s subsidiary located in Australia is the Australian Dollar. Balance sheets prepared in the functional currencies are translated to the reporting currency at exchange rates in effect at the end of the accounting period, except for stockholders’ equity accounts, which are translated at rates in effect when these balances were originally recorded. Revenue and expense accounts are translated using a weighted-average rate during the year. The resulting foreign currency translation adjustments are recorded as a separate component of accumulated other comprehensive loss in the accompanying condensed consolidated balance sheets. Gains and losses resulting from exchange rate changes on transactions denominated in a currency other than the functional currency are included in earnings as incurred.
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Contingent warrants
Warrants issued in connection with future tranches of debt are initially recorded as Financial Commitment Assets ("FCAs") on the consolidated balance sheet at their fair value upon issuance. The FCAs remain as assets until the related debt tranches are drawn. Upon drawdown, the FCAs are reclassified as a debt discount, reducing the carrying value of the related debt tranche, and are subsequently amortized to interest expense over the term of the respective debt tranche.
Concentration of credit risk and other risks and uncertainties
Financial instruments that potentially subject the Company to concentrations of risk consist principally of cash equivalents. The Company maintains its cash deposits in Federal Deposit Insurance Corporation (“FDIC”) insured financial institutions and may at times hold investments at Securities Investor Protection Corporation (“SIPC”) insured broker-dealers.
At times, the balances in these accounts may be in excess of FDIC and SIPC insured limits. At September 30, 2025 and December 31, 2024, cash and cash equivalents deposits in excess of FDIC limits were both nominal 8.1 million and $2.9 million, respectively.
Segment reporting
Recently adopted accounting pronouncements
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The Company adopted interim requirements on January 1, 2025. There was no impact on the Company’s reportable segments identified and additional required disclosures have been included in Note 13.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, under which entities must consistently categorize and provide greater disaggregation of information in the rate reconciliation. They must also further disaggregate income taxes paid. ASU 2023-09 enhances annual income tax disclosures to address investor requests for more information about the tax risks and opportunities present in an entity’s worldwide operations. The Company adopted this standard as of January 1, 2025, and it did not have a material impact on the condensed consolidated financial statements.
In March 2024, the FASB issued ASU 2024-02, Codification Improvements—Amendments to Remove References to the Concepts Statements. ASU 2024-02 removes various references to the FASB’s Concepts Statements from the FASB’s Accounting Standards Codification (Codification or GAAP). The Concepts Statements are non-authoritative guidance issued by the FASB that provide the objectives, qualitative characteristics and other concepts that govern the development of accounting principles by the FASB. The ASU indicates that the goal of the amendments is to simplify the Codification and distinguish between nonauthoritative and authoritative guidance (since, unlike the Codification, the concepts
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Recently issued accounting pronouncements not yet adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses to improve disclosures by providing more detailed information about the types of expenses in commonly presented expense captions. The guidance is effective for annual reporting periods beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effect this standard will have on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract. The ASU adds a scope exception for certain non-exchange traded contracts whose underlyings are based on operations or activities specific to one party and not based on market rates or prices, indexes, or the price or performance of a financial asset or liability of either party. It also clarifies that share-based noncash consideration from a customer in a revenue contract is within the scope of Topic 606 until the entity’s right to receive or retain such consideration becomes unconditional under that Topic. The guidance is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those fiscal years, with early adoption permitted on either a prospective or modified retrospective basis. The Company is currently evaluating the effect this standard will have on its consolidated financial statements and related disclosures.
3. Recapitalization
As described in Note 1, Legacy Serina merged with Merger Sub on March 26, 2024, with Legacy Serina surviving the merger as a wholly owned subsidiary of AgeX. The Merger was accounted for as a reverse recapitalization, and Legacy Serina was considered the accounting acquirer for financial reporting purposes. This determination was based on the facts that, immediately following the Merger: (i) Legacy Serina stockholders owned a substantial majority of the voting rights; (ii) Legacy Serina designated a majority of the initial members of the board of directors of the combined company; (iii) Legacy Serina’s executive management team became the management team of the combined company, and (iv) the combined company intended to primarily focus on developing Legacy Serina’s product candidates, and would not continue to develop AgeX’s product candidates.
At the effective time of the Merger, each outstanding share of Legacy Serina capital stock (after giving effect to the automatic conversion of all shares of Legacy Serina preferred stock into shares of Legacy Serina common stock and excluding any shares held as treasury stock by Legacy Serina or held or owned by AgeX or any subsidiary of AgeX or of Legacy Serina and any dissenting shares) was converted into the right to receive 0.97682654 shares of AgeX common stock, which resulted in AgeX issuing an aggregate of 5,913,277 shares of AgeX common stock to the stockholders of Legacy Serina.
| Total AgeX shares outstanding prior to Merger | |||||
| Shares issued to Legacy Serina stockholders | |||||
| Total shares outstanding | |||||
In addition, AgeX assumed the Legacy Serina 2017 Stock Option Plan, and each outstanding and unexercised option to purchase Legacy Serina common stock and each outstanding and unexercised warrant to purchase Legacy Serina capital stock was adjusted with such stock options and warrants henceforth representing the right to purchase a number of shares of Company common stock equal to 0.97682654 multiplied by the number of shares of Legacy Serina common stock previously represented by such options and warrants.
In March 2023, AgeX provided Legacy Serina with bridge financing in the form of a convertible promissory note for the principal amount of $10.0 million (the “AgeX-Serina Note”). See Note 6, Fair Value Measurements, for additional information on the AgeX-Serina Note.
As part of the recapitalization, the Company obtained the assets and liabilities listed below (in thousands):
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| Cash and cash equivalents | $ | ||||
| Other current assets | |||||
| Intangible assets | |||||
| Accounts payable and accrued expenses | ( | ||||
| Loan payable to Juvenescence | ( | ||||
| Net liabilities acquired | ( | ||||
Conversion of AgeX-Serina Note | |||||
| Total | $ | ||||
The Company recognized the assets and liabilities acquired and the conversion of the outstanding balance of the AgeX-Serina Note into shares of the Company’s common stock upon closing of the Merger, as a net increase in additional paid-in capital within equity for the three months ended March 31, 2024.
4. Selected Balance Sheet Components
Prepaid expenses and other current assets
Prepaid expenses and other current assets were as follows (in thousands):
| September 30, 2025 | December 31, 2024 | ||||||||||
| Financial commitment asset | $ | $ | |||||||||
| Prepaid technology access fee | |||||||||||
| Prepaid insurance | |||||||||||
| Other prepaid expenses | |||||||||||
| Other current assets | |||||||||||
| Total prepaid expenses and other current assets | $ | $ | |||||||||
Property and equipment, net
Property and equipment, net was as follows (in thousands):
| September 30, 2025 | December 31, 2024 | ||||||||||
| Equipment | $ | $ | |||||||||
| Software | |||||||||||
Total property and equipment, gross | |||||||||||
Less: accumulated depreciation and amortization | ( | ( | |||||||||
| Total property and equipment, net | $ | $ | |||||||||
Depreciation and amortization of property and equipment for the three and nine months ended September 30, 2025 and 2024 were no
Accrued liabilities
Accrued liabilities were comprised of the following (in thousands):
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| September 30, 2025 | December 31, 2024 | ||||||||||
| Research program and services | $ | $ | |||||||||
| Accrued compensation | |||||||||||
| Accrued severance | |||||||||||
| Other accrued expenses | |||||||||||
| Total accrued expenses | $ | $ | |||||||||
Other current liabilities
Included in other current liabilities is $0.5 million of financed directors and officers insurance premiums at a rate of 7.31 % with a nine-month maturity ending December 2025. As of September 30, 2025 the remaining unpaid balance was $0.2 million.
5. Related Party Transactions
Convertible Notes Agreement and Asset Contribution Agreement
On March 26, 2024, AgeX entered into an Asset Contribution Agreement with UniverXome (the “Asset Contribution Agreement”) pursuant to which AgeX transferred to UniverXome all of AgeX’s capital stock in Reverse Bio and ReCyte, along with certain patents, patent applications, and other intellectual property, certain biological materials, certain trademarks and service marks, certain equipment, certain inventory, and certain files and records relating to the foregoing, and UniverXome assumed all of the Liabilities (as defined in the Asset Contribution Agreement) in existence as the Effective Time (as defined in the Merger Agreement) other than the Transaction Expenses (as defined in the Merger Agreement) and certain other liabilities. Concurrently with the execution of the Asset Contribution Agreement, AgeX, and its subsidiaries UniverXome, Reverse Bio, and ReCyte (the “Subsidiary Obligors”), entered into an Agreement with Respect to the Convertible Notes (the “Convertible Notes Agreement”) with Juvenescence.
Pursuant to the Convertible Notes Agreement, AgeX transferred to UniverXome, and UniverXome assumed, all of AgeX’s rights and obligations under the convertible notes issued to Juvenescence in 2022 and 2023 (the "2022 Secured Note" and "2023 Secured Note", respectively) and related Security Agreements. Juvenescence agreed to release AgeX from its obligations under (i) the 2022 Secured Note and the 2023 Secured Note (collectively, the “Convertible Notes”), together with (ii) all agreements evidencing or securing the Convertible Notes, including the related Security Agreements, and UniverXome assumed all of AgeX’s obligations under the Convertible Notes and related agreements, including the Security Agreements. As a result, (i) Juvenescence agreed to look solely to UniverXome, and ReCyte and Reverse Bio as guarantors, for any and all obligations, including repayment, under the Convertible Notes, the Security Agreements, and related documents, and (ii) Juvenescence released its security interests in the assets of AgeX and certain subsidiaries, including its security interests in the stock of UniverXome, the stock and assets of Merger Sub, the stock and assets of NeuroAirmid, and certain cGMP embryonic cell lines used to support the NeuroAirmid business, and any security interest that it might have in the stock and assets of Merger Sub and Legacy Serina, while retaining its security interest in the stock and assets of ReCyte and Reverse Bio and in AgeX assets transferred to UniverXome. Juvenescence also agreed to provide the Company with a claims reserve for the purpose of settling and paying the costs associated with certain claims and demands against the Company, which claims reserve will be an additional debt obligation of UniverXome.
The Convertible Notes Agreement amended certain provisions of the 2022 Secured Note and 2023 Secured Note to eliminate (i) the provisions permitting Juvenescence and AgeX to convert outstanding amounts owed into shares of AgeX common stock, and (ii) certain related provisions. Upon the Merger, a portion of the Convertible Notes were converted, leaving a balance of $10.4 million in loans due to Juvenescence, net of debt issuance, on the condensed consolidated balance sheet. The 2022 Secured Notes also had terms which dictated the issuance of AgeX warrants upon drawdowns of loan funds, however, these were cancelled pursuant to the Merger Agreement and the remaining 2022 Warrants to purchase a total of 129,593 shares of common stock at prices ranging from $20.75 to $25.01 remained in effect. As of September 30, 2025, 41,217 warrants expired leaving 88,376
Sale of subsidiary to Juvenescence
On December 23, 2024, the Company entered into the Stock Purchase Agreement with Juvenescence, pursuant to which Juvenescence purchased all of the outstanding shares of UniverXome, thereby assuming all Legacy Assets AgeX
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transferred to UniverXome prior to the Merger. The Legacy Assets included all of AgeX’s interests in ReCyte, Reverse Bio along with certain patents, patent applications, and other intellectual property, certain biological materials, certain trademarks and service marks, certain equipment, certain inventory, and certain files and records relating to the foregoing. As consideration for the purchase of UniverXome, Juvenescence assumed the net assets of UniverXome primarily consisting of intangible assets, net, of $0.5 million, and approximately $11.3 million of secured debt, consisting of the 2022 Secured Note and 2023 Secured Note owed by UniverXome to Juvenescence in addition to a nominal cash payment. The debt assumed by Juvenescence was secured by substantially all of the assets of UniverXome. As a result of the sale, the Company derecognized all assets and liabilities of UniverXome with a corresponding increase to additional paid-in capital from Juvenescence calculated as the difference between the carrying amount of the extinguished debt and the fair value of the reacquisition price of the debt. For the year ended December 31, 2024, the Company recognized a $10.9 million capital contribution on the consolidated statement of redeemable convertible preferred stock and stockholders' equity/(deficit).
Series A Convertible Preferred Stock
On April 8, 2025, the Company entered into a securities purchase agreement with related parties for a private placement of 965,250 shares of Series A Convertible Preferred Stock, par value $0.0001 (the "Series A Preferred Stock"), at $5.18 per share for net proceeds of $4.9 million. See Note 7, Stockholders' Equity.
September 2025 Convertible note and warrants
On September 9, 2025, the Company entered into an unsecured convertible note (the “2025 Convertible Note”) with a member of the Company’s Board of Directors, making available to the Company an aggregate principal amount of up to $20 million.
Under the 2025 Convertible Note, borrowings may be drawn at the discretion of the Company in five tranches tied to certain clinical and operational milestones, provided if at the time the Company achieves a milestone, the Company does not have sufficient cash available to cover projected costs and expenses to achieve the next milestone, then the Company will be required to draw such deficiency. The five tranches correspond to the five following milestones: (i) up to $5 million on or before September 30, 2025; (ii) up to $2.5 million on or after December 15, 2025 upon enrollment of the first patient in the Company’s SER-252-1b registrational clinical study; (iii) up to $2.5 million upon enrollment of the second patient in the study; (iv) up to $5 million on or after March 15, 2026, upon dosing of the last patient in Cohort 1 of the study; and (v) up to $5 million on or after April 30, 2026, upon dosing of the first patient in Cohort 2 of the study (“Milestone 5”).
The funding tranches of the 2025 Convertible Note are subject to the accomplishment of certain SER-252-1b registrational clinical study accomplishments, and on November 3, 2025, the Company announced that it received a notice from the FDA placing a clinical hold on the Company’s Investigational New Drug (“IND”) application for SER-252, the Company’s lead development program for advanced Parkinson’s disease. The FDA has requested additional information related to a commonly used excipient in the formulation of SER-252. The FDA’s feedback does not relate to the active drug substance or its proposed mechanism of action. The Company plans to engage with the FDA in order to lift the clinical hold and commence with the planned SER-252-1b registrational clinical study.
Borrowings under the 2025 Convertible Note bear interest at an annual rate of 10 %, initially payable in cash on the first anniversary of the initial funding and on a quarterly basis after. The 2025 Convertible Note contains customary events of default, including an additional 2 % of default interest following an event of default, and has a maturity date of five years after the initial funding date. The Company can prepay the 2025 Convertible Note at any time with no penalty. The Company is required to repay all obligations outstanding under the 2025 Convertible Note in cash in the event of certain liquidity events or a change of control of the Company, all as defined in the 2025 Convertible Note.
The 2025 Convertible Note is convertible, at the option of the holder, into shares of the Company's common stock, at any time until the maturity date at a conversion price of $5.18 per share. The conversion price is subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization, or other similar transaction.
Borrowings under the 2025 Convertible Note constitute senior unsecured obligations of the Company and rank senior in right of payment to all indebtedness of the Company expressly subordinated to the 2025 Convertible Note, and pari passu in right of payment with all other unsecured indebtedness of the Company. The Company may incur additional indebtedness that is junior to the Convertible Note without restriction, but may not incur additional indebtedness that is senior or pari passu in right of payment to the 2025 Convertible Note without the prior written consent of the holder.
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Under the 2025 Convertible Note, the Company also agreed to issue warrants ("Contingent Warrants") for the purchase of shares of the Company's Common Stock on each funding date in an amount equal to 100 % of the number of shares issuable upon conversion of the funds extended by the investors on such funding date. See Note 7, Stockholders Equity, for terms regarding these warrants.
While the Contingent Warrants are not legally issued until the Company draws down on the associated tranches of the 2025 Convertible Note, they are considered to be issued for accounting purposes. As no amounts were drawn as of the effective date of the 2025 Convertible Notes agreement, the Contingent Warrants were recorded as Financial Commitment Assets (“FCAs”), corresponding to each of the five 2025 Convertible Note tranches, at the initial fair value of the Contingent Warrants of $3.7 million, in prepaid expenses and other current assets in the condensed consolidated balance sheet. The Company determined that the Contingent Warrants were liability classified as the number of shares underlying the warrants was variable (see Note 7, Stockholders' Equity).
In September 2025, the Company drew down the first tranche of $5.0 million under the 2025 Convertible Note ("First Tranche"), incurring $0.1 million in transaction costs which were accounted for as a debt discount. The Company also reclassified a pro rata portion of the FCA associated with the First Tranche, recorded at the initial warrant fair value of $2.0 million, as a debt discount resulting in the net carrying value of the First Tranche of $2.9 million.
6. Fair Value Measurements
Warrant Liabilities
The Company classifies the Merger Warrants and Contingent Warrants (as defined in Note 5, Related Party) as liabilities. At the end of each reporting period, changes in fair value during the period are recognized as a component of other income (expense), net within the consolidated statements of operations. The change in fair value of these warrant liabilities recognized during the three months ended September 30, 2025 and 2024 was a $1.0 million gain and a $6.7 million gain, respectively. The change in fair value of these warrant liabilities recognized during the nine months ended September 30, 2025 and 2024 amounted to a $1.1 million gain and a $10.4 million gain, respectively. The Company will continue adjusting the warrant liability for changes in fair value until the earlier of a) the exercise or expiration of the warrants or b) when the conditions for equity classification are met, at which time the warrant liabilities will be derecognized. In July 2025, the remaining unexercised Post-Merger warrants and the corresponding Incentive warrants expired, resulting in a gain of $0.7 million. In September 2025, in connection with the First Tranche drawdown of the 2025 Convertible Note, the Contingent Warrant related to the First Tranche met equity classification criteria and was remeasured at its estimated fair value of $2.0 million and reclassified to additional paid-in capital. (See Note 7, Stockholders’ Equity).
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The following is a reconciliation of the beginning and ending balances of warrant liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the nine months ended September 30, 2025 and 2024 (in thousands):
| Merger Warrants | Contingent Warrants | ||||||||||
| Balance as of December 31, 2024 | $ | $ | |||||||||
Fair value at inception | |||||||||||
| Change in fair value | ( | ( | |||||||||
Expiration | ( | ||||||||||
Reclassification to equity | ( | ||||||||||
| Balance as of September 30, 2025 | $ | $ | |||||||||
| Balance as of December 31, 2023 | $ | $ | |||||||||
| Fair value at inception | |||||||||||
Exercise | ( | ||||||||||
| Change in fair value | ( | ||||||||||
| Balance as of September 30, 2024 | $ | $ | |||||||||
The Company estimates the fair value of warrants using the Black-Scholes-Merton option pricing model with the following assumptions at the reporting date:
As of September 30, | |||||||||||
| 2025 | 2024 | ||||||||||
| Expected volatility | |||||||||||
| Expected term (in years) | |||||||||||
| Risk-free interest rate | |||||||||||
| Expected dividend yield | |||||||||||
Expected volatility is estimated using the historical volatilities of comparable publicly traded companies over a period equal to the expected term of the warrants as the Company does not have sufficient trading history. The Company estimates the expected term using time to expiration of the warrant. The risk-free interest rate is the yield on a U.S. Treasury zero-coupon issue with a remaining term equal to or approximating the expected term of the warrant.
Convertible Promissory Notes
AgeX-Serina Note
On March 15, 2023, Legacy Serina issued the AgeX-Serina Note in the amount of $10.0 million to AgeX. The AgeX-Serina Note bore interest at 7 % per annum and was scheduled to mature on March 15, 2026. Serina borrowed the $10.0 million pursuant to the AgeX-Serina Note to provide for general working capital needs.
Serina elected to initially and subsequently measure the AgeX-Serina Note in its entirety at fair value, with the fair value inception date adjustment as well as all subsequent changes in fair value recognized in the condensed consolidated statements of operations.
On March 15, 2023, the fair value of the $10.0 million principal amount under the AgeX-Serina Note was evaluated and an adjustment to reduce the fair value of the principal balance to $7.8 million was recorded at that time. On the date of the Merger, the AgeX-Serina Note was remeasured to its fair value of $10.7 million as it converted into equity upon the Merger. See Note 3, Recapitalization for details. The change in fair value recognized during the three and nine months ended September 30, 2025 and 2024 amounted to zero 7.0
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7. Stockholders’ Equity
Series A Convertible Preferred Stock
On April 8, 2025, the Company entered into a securities purchase agreement for a private placement of 965,250 shares of Series A Convertible Preferred Stock, par value $0.0001 (the "Series A Preferred Stock"), at $5.18 per share for net proceeds of $4.9 million. The Series A Preferred Stock earns cumulative dividends at a rate of 8 % per annum that are declared annually beginning on March 31, 2026, and paid in shares of the Company's common stock ("PIK Shares"). As of September 30, 2025, 37,764 dividend shares have been accrued but not declared. The preferred stock ranks pari passu with parity stock and senior to junior stock and other indebtedness, with automatic and optional conversion rights. The Series A Preferred Stock is not redeemable.
Per each whole share of Series A Preferred Stock, the holders of Series A Preferred Stock will be entitled to cast the number of votes equal to the number of shares of the Company's common stock into which such holder's Series A Preferred Stock would be convertible into on the record date for the vote or consent of stockholders. The holders of Series A Preferred Stock will vote with the holders of the Company's common stock as a single class and on an as-converted basis, except as provided by law.
The Series A Preferred Stock is convertible, at the holder's option, into the number of shares of the Company's common stock equal to the sum of (i) the quotient of the issuance price divided by the conversion price (initially set at $5.18 ) and (ii) any PIK Shares accrued but not yet issued with respect to the shares of Series A Preferred Stock being converted, subject to certain beneficial ownership limitations that require stockholder approval for conversion. All shares of Series A Preferred Stock will automatically convert into shares of the Company's common stock if (i) the volume weighted average price per share of common stock is greater than two times the then effective conversion price for ten trading days within any twenty consecutive trading days and (ii) upon the Company completing an underwritten offering or private placement of the Company's common stock resulting in gross cash proceeds to the Company of at least $20 million.
In the event of a liquidation, dissolution, or winding up of the Company, holders of Series A Preferred Stock are entitled to receive payment based on the greater of issuance price or the per share consideration paid to common stockholders in the liquidation as if the Series A Preferred Stock had been converted into common stock prior to the liquidation event. After payment of the full liquidation preference of Series A Preferred Stock, distributions by the Company shall be distributed with equal priority among holders of the Series A Preferred Stock and common stock, with Series A Preferred Stock being treated on an as converted basis, including payment for accrued but unpaid dividends. As of September 30, 2025 and December 31, 2024, the liquidation preference amounted to $5 million and zero , respectively.
Merger Warrants
On March 19, 2024, the Company issued to each holder of AgeX common stock as of the dividend record date, March 18, 2024, three warrants (“Post-Merger Warrants”) for each five shares of AgeX common stock held by such stockholder. Prior to their expiration on July 31, 2025, each Post-Merger Warrant was exercisable for one “Unit” at a price equal to $13.20 per Unit. Each Unit consisted of (i) one share of the Company's common stock and (ii) one warrant (“Incentive Warrant”). Each Incentive Warrant is exercisable for one share of the Company's common stock at an exercise price of $18.00 per warrant and will expire four-years after the closing date of the Merger. During the nine months ended September 30, 2025, 65 Post-Merger Warrants were exercised. Upon the exercise, the holders received 65 shares of the Company's common stock, and were issued 65 Incentive Warrants to purchase an additional 65 shares of the Company's common stock with an exercise price of $18.00 per share expiring on March 26, 2028. In July 2025, 366,626 Post-Merger warrants and the corresponding Incentive warrants expired, resulting in a gain on warrants expiration of $0.7 million. As of September 30, 2025, there were no Post-Merger Warrants issued and outstanding. The Company classified the Post-Merger Warrants and the Incentive Warrants as liabilities. See Note 6, Fair Value Measurements, regarding accounting for warrant liabilities.
Concurrently with the execution of the Merger Agreement, AgeX, Legacy Serina, and Juvenescence entered into a Side Letter, which became effective immediately prior to the closing of the Merger. The Side Letter provided, among other things, that Juvenescence will exercise all Post-Merger Warrants it holds to provide the Company an additional $15.0 million in capital according to the following schedule: (x) at least one-third on or before May 31, 2024, (y) at least one-third on or before November 30, 2024, and (z) at least one-third on or before June 30, 2025. Juvenescence received 1,133,593 Post-Merger Warrants. On June 6, 2024, Juvenescence exercised Post-Merger Warrants to purchase 377,865 shares of the Company’s common stock at an exercise price of $13.20 per share, for a total purchase price of $5.0 million. In addition to the shares of the Company's common stock, upon exercise of the Post-Merger Warrants, Juvenescence also
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received Incentive Warrants to purchase 377,865 shares of the Company's common stock with an exercise price of $18.00 per share that expire on March 26, 2028.
Replacement Incentive Warrants
On November 26, 2024, the Company entered into the agreement with Juvenescence (the "Agreement") whereby the Company agreed to issue 1,000,000 shares of its common stock at $10.00 per share, for an aggregate amount of $10 million in two equal tranches and to surrender to the Company its outstanding Post-Merger Warrants for the purchase of 755,728 shares of its common stock, including all underlying Incentive Warrants issuable upon exercise thereof. In connection with Agreement, the Company issued to Juvenescence warrants to purchase 755,728 shares of common stock at an exercise price of $18.00 per share (the “Replacement Incentive Warrants” and, together with the Post-Merger Warrants and the Incentive Warrants, collectively, the “Merger Warrants”). The Replacement Incentive Warrants expire on March 26, 2028. As a result of the transaction, the Company derecognized warrant liabilities of $1.8 million associated with the surrendered and cancelled Post-Merger and Incentive Warrants and recorded the initial warrant liabilities of $1.4 million associated with the Replacement Incentive Warrants in the condensed consolidated balance sheet as of December 31, 2024.
The closing on the first tranche occurred on November 27, 2024 and the Company issued 500,000 shares of its common stock to Juvenescence for $5.0 million. Juvenescence purchased the second tranche of 500,000 shares of its common stock and receive corresponding Replacement Incentive Warrants for $5.0 million on January 31, 2025.
As of September 30, 2025, Juvenescence held 377,865 Incentive Warrants and 755,728 Replacement Incentive Warrants. The Company classifies the Replacement Incentive Warrants as liabilities. See Note 6, Fair Value Measurements, regarding accounting for warrant liabilities.
Contingent Warrants
On September 9, 2025, in connection with the 2025 Convertible Note, the Company agreed to issue to the lender the Contingent Warrants exercisable into an aggregate of up to 3,861,004 shares of the Company's common stock. The number of shares is determined based on 100 % of the number of shares issuable upon conversion of respective tranche drawn down under the 2025 Convertible Note. The Contingent Warrants have an exercise price equal to $5.44 per share and expire on the earlier of sixty days following the achievement of Milestone 5 or September 30, 2026, unless stockholder approval has not been obtained. See Note 5, Related Party Transactions, for a discussion of the impact of recent FDA communication on the clinical study and achievement of Milestones.
As the number of shares underlying each Contingent Warrant is not fixed and varies depending on the amount drawn under each tranche of the 2025 Convertible Note, the Contingent Warrants did not meet equity classification criteria and are recorded as liabilities. The warrant liability is remeasured to fair value each reporting period until settlement or until equity classification criteria are met. See Note 6, Fair Value Measurements.
In September 2025, upon the Company's draw down of the First Tranche of the 2025 Convertible Note, the number of shares underlying the First Tranche Contingent Warrants became fixed at 965,251 shares and equity classification criteria were met. Therefore, the Company remeasured the warrant liability related to the first tranche Contingent Warrants to the fair value of $2.0 million, and reclassified the first tranche Contingent Warrants from liabilities to additional paid in capital.
Former AgeX Warrants
As of September 30, 2025, there were 88,376 20.75 to $24.27 and expiration dates ranging from October 20, 2025 to April 3, 2026. In nine months ended September 30, 2025, 41,217 Former AgeX warrants expired. These warrants were issued in connection with drawdowns of loan funds by AgeX from Juvenescence under the 2022 Secured Note and were equity classified. On March 26, 2024, as per the terms of the Side Letter executed concurrently with the Merger Agreement on August 29, 2023, all “out of the money” AgeX warrants were canceled. The number of shares of common stock issuable upon exercise of the remaining “in the money warrants” and the exercise prices of those warrants were adjusted for the reverse stock split ratio of 1 for 35.17.
At-the-Market Offerings
On April 25, 2025, the Company entered into a sales agreement (the "Sales Agreement") with JonesTrading Institutional Services LLC (the "Sales Agent"), with respect to an ATM program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $13.3 million through the Sales Agent. The Company will pay the Sales Agent a commission up to 3.0 % of the gross sales proceeds of
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8. Stock-Based Awards
Equity Incentive Plan Awards
Serina 2024 Inducement Equity Plan
On August 15, 2024, the Company’s Board of Directors adopted the 2024 Inducement Equity Plan, (the “2024 Inducement Plan”). Under the 2024 Inducement Plan, the Company has reserved 1,000,000 shares of its common stock for the grant to new employees or non-employee directors of stock options, stock appreciation rights (“SARs”), sale of restricted stock units (“RSUs”), or other securities as approved by its Board of Directors or the Compensation Committee. As of September 30, 2025, options to purchase 72,500 shares of the Company's common stock were outstanding under the 2024 Inducement Plan, which options have exercise prices ranging from $4.54 to $5.75 per share and expire on dates ranging from November 2034 to June 2035. As of September 30, 2025, zero stock options had been exercised and 927,500 stock options remain available for issuance under the 2024 Inducement Equity Plan.
Serina 2024 Equity Incentive Plan
On March 27, 2024, the Company’s Board of Directors adopted the 2024 Equity Incentive Plan, (the “2024 Incentive Plan”). Under the 2024 Incentive Plan, the Company has reserved 2,675,000 shares of its common stock for the grant to employees, directors, and consultants of stock options, SARs, RSUs, or other securities as approved by its Board of Directors or the Compensation Committee. As of September 30, 2025, options to purchase 1,757,473 shares of the Company's common stock at exercise prices ranging from $4.60 to $14.87 per share were outstanding under the 2024 Equity Incentive Plan, and expire on dates ranging from March 2034 to June 2035. During the nine months ended September 30, 2025, 5,000 RSUs were granted with immediate vesting, which were all outstanding as of September 30, 2025. Additionally, 18,319 stock options were forfeited and zero options expired. As of September 30, 2025, zero stock options had been exercised and 912,527 shares remain available for issuance under the 2024 Equity Incentive Plan.
Serina 2017 Stock Option Plan
In 2017, the Legacy Serina’s Board of Directors adopted the Serina Therapeutics, Inc. 2017 Stock Option Plan (the “2017 Option Plan”) that provides for the granting of stock options to employees. Pursuant to the Merger Agreement, the Company assumed the outstanding stock options granted by Legacy Serina under the 2017 Option Plan. As of September 30, 2025, options to purchase 1,310,586 shares of Company's common stock at an exercise price of $0.06 were outstanding under the 2017 Option Plan and expire on dates ranging from July 2027 to December 2032. In the nine months ended September 30, 2025, 180,207 stock options were exercised, totaling to 375,139 stock options exercised under the 2017 Option Plan as of September 30, 2025. Additionally, as of September 30, 2025, 30,379 options had been forfeited. Pursuant to the Merger Agreement, no additional options shall be granted under the 2017 Option Plan.
Serina 2017 Equity Incentive Plan
Under the Serina 2017 Equity Incentive Plan, as amended (the “2017 Incentive Plan” and formerly the AgeX 2017 Equity Incentive Plan), the Company has reserved 241,683 shares of common stock for the grant of stock options or the sale of Restricted Stock or for the settlement of RSUs. As of September 30, 2025, there were 1,812 stock options granted and outstanding with an exercise price of $13.19 per share and expiration dates in January 2034. As of September 30, 2025, no stock options under the 2017 Equity Incentive Plan assumed pursuant to the Merger Agreement had been exercised and no additional options shall be granted.
Stock-based Compensation Expense
During the nine months ended September 30, 2025, the Company granted stock options to purchase 150,500 shares of common stock to certain employees, the Board and consultants under the 2024 Equity Incentive Plan and 2024 Inducement Equity Plan, with a weighted average grant date fair value of $4.19 per share. The Company also granted 5,000 RSUs under the 2024 Equity Incentive Plan with a weighed average grant date fair value of $5.75 per share during the nine months ended September 30, 2025. Total unrecognized compensation cost related to unvested stock option grants of $8.4 million as of September 30, 2025 is expected to be of 2.5 years.
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Stock-based compensation expense has been allocated to operating expenses as follows (in thousands):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Research and development | $ | $ | $ | $ | |||||||||||||||||||
| General and administrative | |||||||||||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | |||||||||||||||||||
9. Profit Sharing Plan
Through its wholly owned subsidiary Legacy Serina, the Company has established a 401(k) profit sharing plan (the “PSP”) for all eligible employees of the Company. The PSP provides for eligible employee contributions subject to certain annual Internal Revenue Code limits. For participants who are age 50 or older during any calendar year, additional employee contributions are allowed under the PSP, subject to Internal Revenue Code limits.
10. Income Taxes
The provision for income taxes for interim periods is determined using an estimated annual effective tax rate in accordance with ASC 740-270, Income Taxes, Interim Reporting. The effective tax rate may be subject to fluctuations during the year as new information is obtained, which may affect the assumptions used to estimate the annual effective tax rate, including factors such as valuation allowances against deferred tax assets, the recognition or de-recognition of tax benefits related to uncertain tax positions, if any, and changes in or the interpretation of tax laws in jurisdictions where the Company conducts business.
Due to losses incurred for all periods presented, the Company did not record a provision or benefit for income taxes. A valuation allowance is provided when it is more likely than not that some portion of the deferred tax assets will not be realized. The Company established a full valuation allowance for all of its deferred tax assets for all periods presented due to the uncertainty of realizing future tax benefits from its net operating loss carryforwards and other deferred tax assets.
The Company reports income tax related interest and penalties within its provision for income tax in its condensed consolidated statements of operations. Similarly, the Company reports the reversal of income tax-related interest and penalties within its provision for income tax line item to the extent the Company resolves its liabilities for uncertain tax positions in a manner favorable to its accruals. During the three and nine months ended September 30, 2025 and 2024, the Company did not record unrecognized tax benefits.
During the quarter, the Company established a wholly owned foreign subsidiary in Australia. The tax impact of this entity is not material to the consolidated financial statements as of September, 30 2025, but will be monitored for future reporting periods.
11. Commitments and Contingencies
Facilities and Equipment Lease Agreements
The Company leases its lab and office facilities in Huntsville, Alabama for various terms under long-term, non-cancelable operating lease agreements. The leases expire on various dates from January 2028 through Oct 2028 and provide for renewal periods of two years . For the office lease, the Company has elected not to apply the recognition requirements
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under ASC 842, as the lease cost, if recognized under ASC 842, would not be materially different from the straight-line basis over the lease term.
The Company also leases laboratory equipment under a long-term, non-cancelable operating lease which expired in September 2024 and was subsequently replaced by a month-to-month cancellable agreement.
The Company also leases two pieces of equipment for various terms under long-term, non-cancelable finance lease agreements. One of the two finance leases expired in September 2024, with ownership passing to the Company in accordance with the original term of the lease agreement. The remaining finance lease expired in February 2025.
| Nine months ended September 30, | |||||||||||
| 2025 | 2024 | ||||||||||
| Cash paid for amounts included in the measurement of lease liabilities: | |||||||||||
| Operating cash flows from operating leases | $ | $ | |||||||||
| Operating cash flows from finance leases | $ | $ | |||||||||
| Financing cash flows from finance leases | $ | $ | |||||||||
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Supplemental balance sheet information related to leases was as follows (in thousands other than weighted average remaining lease term and discount rates):
| September 30, 2025 | December 31, 2024 | ||||||||||
| Operating lease | |||||||||||
| Right-of-use assets | $ | $ | |||||||||
| Accumulated Amortization | ( | ( | |||||||||
| Right-of-use asset, net | $ | $ | |||||||||
| Right-of-use lease liability, current | $ | $ | |||||||||
| Right-of-use lease liability, noncurrent | |||||||||||
| Total operating lease liabilities | $ | $ | |||||||||
| Finance leases | |||||||||||
| Right-of-use assets | $ | $ | |||||||||
| Accumulated Amortization | ( | ( | |||||||||
| Right-of-use asset, net | $ | $ | |||||||||
| Right-of-use lease liability, current | $ | $ | |||||||||
| Right-of-use lease liability, noncurrent | |||||||||||
Total finance lease liabilities | $ | $ | |||||||||
| Weighted average remaining lease term | |||||||||||
| Operating lease | |||||||||||
| Finance leases | — | ||||||||||
| Weighted average discount rate | |||||||||||
| Operating lease | % | % | |||||||||
| Finance leases | % | % | |||||||||
The following is a maturity analysis of the annual undiscounted cash flows of the operating lease liabilities as of September 30, 2025 (in thousands):
| Operating Leases | |||||||||||
Three months ending December 31, 2025 | $ | ||||||||||
| Year ending December 31, 2026 | |||||||||||
| Year ending December 31, 2027 | |||||||||||
| Year ending December 31, 2028 | |||||||||||
| Total undiscounted lease payments | |||||||||||
| Less: imputed interest | ( | ||||||||||
| Total lease obligations | |||||||||||
| Less: current portion | ( | ||||||||||
| Long-term lease obligations | $ | ||||||||||
Litigation – General
The Company is subject to various claims and contingencies in the ordinary course of its business, including those related to litigation, business transactions, employee-related matters, and others. When the Company is aware of a claim or
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potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably estimated, the Company will record a liability for the loss. If the loss is not probable or the amount of the loss cannot be reasonably estimated, the Company discloses the claim if the likelihood of a potential loss is reasonably possible and the amount involved could be material. The Company is not aware of any claims likely to have a material adverse effect on its financial condition or results of operations.
Tax Filings
The Company's tax filings are subject to audit by taxing authorities in jurisdictions where it conducts business. These audits may result in assessments of additional taxes that are subsequently resolved with the authorities or potentially through the courts. Management believes the Company has adequately provided for any ultimate amounts that are likely to result from these audits; however, final assessments, if any, could be significantly different than the amounts recorded in the condensed consolidated interim financial statements.
Employment Contracts
The Company has entered into employment contracts with certain executive officers. Under the provisions of the contracts, the Company may be required to incur severance obligations for matters relating to changes in control, as defined, and involuntary terminations.
Partnership with Enable
During May 2024, the Company entered into a partnership with Enable Injections, Inc. (“Enable”), a healthcare innovation company developing and manufacturing the enFuse® wearable drug delivery to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse for the treatment of Parkinson’s disease. The Company will develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuseTM for the treatment of Parkinson’s disease. The enFuseTM wearable technology from Enable is designed to overcome both IV infusion and other subcutaneous administration method shortcomings through fast, simple, and convenient delivery, benefiting patients, providers, as well as payers, with the ability for at home self-administration. The Company submitted an IND application to the FDA for a Phase 1 clinical trial in advanced Parkinson’s disease patients in 2025. See Note 5, Related Party Transactions, for a discussion of the impact of recent FDA communication on the clinical study. The Company paid $2.0 million in May 2024 for a technology access fee, which is included in prepaid expenses and other current assets prepaid and is being amortized through December 2025.
Indemnification
In the normal course of business, the Company may provide indemnifications of varying scope under the Company’s agreements with other companies or consultants, typically for the Company’s research and development programs. Pursuant to these agreements, the Company will generally agree to indemnify, hold harmless, and reimburse the indemnified parties for losses and expenses suffered or incurred by the indemnified parties arising from claims of third parties in connection with the Company’s research and development. Indemnification provisions could also cover third-party infringement claims with respect to patent rights, copyrights, or other intellectual property licensed from the Company to third parties. Office and laboratory leases will also generally indemnify the lessor with respect to certain matters that may arise during the term of the lease. The Registration Rights Agreement between Juvenescence and the Company includes indemnification provisions pursuant to which the parties will indemnify each other from certain liabilities in connection with the registration, offer, and sale of securities under a registration statement, including liabilities arising under the Securities Act. The Company has also agreed to provide the AST Indemnity and the ETC Indemnity pursuant to the Letter of Indemnification described in Note 5, Related Party Transactions. The term of these indemnification obligations will generally continue in effect after the termination or expiration of the particular license, lease, or agreement to which they relate. The potential future payments the Company could be required to make under these indemnification agreements will generally not be subject to any specified maximum amount. Historically, the Company has not been subject to any claims or demands for indemnification. The Company also maintains various liability insurance policies that limit the Company’s financial exposure and in the case of the AST Indemnity and the ETC Indemnity the Company has received a cross-indemnity from Juvenescence against all claims, damages, liabilities or losses arising out of the AST Indemnity and the ETC Indemnity. As a result, the Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these agreements to date.
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12. Net (Loss) Income Per Common Share
Net loss per common share is calculated in accordance with ASC 260, Earnings Per Share. Basic and diluted net loss per common share attributable to common stockholders is calculated for the periods presented (in thousands) as follows:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
Basic net loss per common share allocable to common stockholders | |||||||||||||||||||||||
| NUMERATOR | |||||||||||||||||||||||
| Net (loss) income | $ | ( | $ | ( | ( | ||||||||||||||||||
| Less: Net loss attributable to noncontrolling interest | |||||||||||||||||||||||
| Add: Cumulative undeclared Series A preferred stock dividends | ( | ( | |||||||||||||||||||||
| Net (loss) earnings available to common stockholders | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
| DENOMINATOR | |||||||||||||||||||||||
| Weighted-average shares of common stock outstanding used to calculate basic net (loss) earnings per common share | |||||||||||||||||||||||
| Basic net (loss) earnings per common share allocable to common stockholders | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
| Diluted net (loss) earnings per common share allocable to common stockholders | |||||||||||||||||||||||
| NUMERATOR | |||||||||||||||||||||||
| Net (loss) earnings attributable to common stockholders | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
| DENOMINATOR | |||||||||||||||||||||||
| Weighted-average shares of common stock outstanding used to calculate basic net loss per common share | |||||||||||||||||||||||
| Add: dilutive effect of stock options | |||||||||||||||||||||||
| Weighted-average shares of common stock outstanding used to calculate diluted net loss per common share | |||||||||||||||||||||||
| Diluted net (loss) earnings per common share attributable to common stockholders | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
For three months ended September 30, 2025, and nine months ended September 30, 2025 and 2024, the Company had a net (loss) earnings and most outstanding stock options and warrants were excluded from the calculation of diluted net (loss) earnings per share as their inclusion would have been anti-dilutive. See the following table for all the potential dilutive instruments that were excluded from the calculation of diluted net (loss) earnings per share (in thousands);
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Series A preferred stock | |||||||||||||||||||||||
| Stock options | |||||||||||||||||||||||
| Warrants | |||||||||||||||||||||||
| Total anti-dilutive securities | |||||||||||||||||||||||
Note 13 – Segment Reporting
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The Company has one reportable segment relating to the research and development of its POZ platform. The segment derived its revenues from Grant revenue.
The Company’s CODM, its Chief Executive Officer and the senior executive leadership team manage the Company’s operations on an integrated basis for the purposes of allocating resources. When evaluating the Company’s financial performance, the CODM regularly reviews total revenues and expenses by specific categories to make informed decisions.
The table below is a summary of the segment revenues and significant segment expenses (in thousands):
| Three Months Ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Revenue | $ | $ | $ | $ | |||||||||||||||||||
| Less: | |||||||||||||||||||||||
| Research and development | |||||||||||||||||||||||
Project specific (1) | |||||||||||||||||||||||
Non-Project specific (2) | |||||||||||||||||||||||
Compensation (3) | |||||||||||||||||||||||
| Infrastructure management and facilities | |||||||||||||||||||||||
| Depreciation | |||||||||||||||||||||||
| General and administrative | |||||||||||||||||||||||
Professional and outside service fees (4) | |||||||||||||||||||||||
Compensation (3) | |||||||||||||||||||||||
| Infrastructure management and facilities | |||||||||||||||||||||||
| Merger and integration related | |||||||||||||||||||||||
| Total operating expenses | |||||||||||||||||||||||
| Loss from operations | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
(1) Research and development project specific expenses largely consists of costs incurred to develop the Company's lead product candidate, SER 252 (POZ-apomorphine) as well as expenses incurred to develop other small molecules, RNA-based therapeutics and antibody-based drug conjugates ("ADCs").
(2) Research and development non-project specific expenses mainly consists of laboratory expenses and fees paid to outside services.
(3) Compensation includes employee salary and fringe benefits, stock-based compensation and compensation to independent contractors.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and in our audited consolidated financial statements for the years ended December 31, 2024 and 2023 in our Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 24, 2025. Past operating results are not necessarily indicative of results that may occur in future periods.
The following discussion includes forward-looking statements. See “Forward-Looking Statements,” above. Forward-looking statements are not guarantees of future performance and our actual results may differ materially from those currently anticipated and from historical results depending upon a variety of factors, including, but not limited to, those discussed in Part I, Item 1A.
All information presented in this report is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ending December 31 and the associated quarters, months and periods of those fiscal years.
Overview
We are a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Our POZ platform provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs). Our proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Our POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs. The therapeutic agents in our product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include toxicity, side effects and short half-life. We believe that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood.
The following discussion should be read in conjunction with Note 1 in our unaudited condensed consolidated interim financial statements and the related notes included in Item 1 of this Report.
On March 26, 2024, we completed the Merger, pursuant to which Merger Sub merged with and into Legacy Serina, with Legacy Serina surviving as our wholly owned subsidiary. Additionally, on March 26, 2024, we changed our name to “Serina Therapeutics, Inc.”
Our operations through September 30, 2025, have been financed primarily by aggregate net proceeds of $63.8 million from the issuance of convertible preferred stock, common stock, convertible notes and exercise of Post-Merger Warrants to purchase our common shares by Juvenescence. Since our inception in 2006, we have had significant operating losses. Our operating loss was $6.4 million and $5.3 million for nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $60.2 million and $8.6 million in cash and cash equivalents.
Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations within one year of the unaudited condensed consolidated interim financial statements issuance date, raise substantial doubt about our ability to continue as a going concern. We expect to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development.
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire additional personnel, pay fees to outside consultants, attorneys, and accountants, and, incur other increased costs associated with being a public company. In addition, if and when we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials and our expenditures on other research and development activities. We anticipate that our expenses will increase significantly in connection with our ongoing activities as we:
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•advance our lead product candidate, SER 252 into Phase I clinical trials;
•advance our other product candidates;
•advance our preclinical programs to clinical trials;
•further invest in our pipeline;
•seek regulatory approval for our investigational medicines;
•maintain, expand, protect, and defend our intellectual property portfolio;
•secure facilities to support continued growth in our research, development, and commercialization efforts; and
•increase our headcount to support our development efforts and to expand our clinical development team.
We have not had any products approved for sale. We do not expect to generate any product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses, or similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs.
Critical Accounting Policies and Estimates
This Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses and analyzes data in our unaudited condensed consolidated interim financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual conditions may differ from our assumptions and actual results may differ from our estimates.
An accounting policy is deemed critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate are reasonably likely to occur, that could materially impact the financial statements. Management believes that there have been no significant changes during the three and nine months ended September 30, 2025 to the items that we disclosed as our critical accounting policies and estimates in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report filed March 24, 2025 for the year ended December 31, 2024.
Components of Operating Results
Grant Revenues
Our grants and contracts reimburse us for direct and indirect costs relating to the grant projects and also provide us with a pre-negotiated profit margin on total direct and indirect costs of the grant award, excluding subcontractor costs, after giving effect to directly attributable costs and allowable overhead costs. Funds received from grants and contracts are generally deemed to be earned and recognized as revenue as allowable costs are incurred during the grant or contract period and the right to payment is realized.
Operating Expenses
Our operating expenses since inception have consisted primarily of research and development expenses and general and administrative costs.
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Research and Development
Our research and development expenses consist primarily of costs incurred for the development of our product candidates and our drug discovery efforts, which include:
•personnel costs, which include salaries, benefits and equity-based compensation expense;
•expenses incurred under agreements with consultants and contract organizations that conduct research and development activities on our behalf;
•costs related to production of preclinical and clinical materials, including fees paid to contract manufacturers;
•laboratory and vendor expenses related to the execution of preclinical studies and planned clinical trials; and
•facility related costs, laboratory supplies and equipment used for internal research and development activities.
We expense all research and development costs in the periods in which they are incurred. Costs for certain research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and service providers.
Our research and development expenses are not currently tracked on a program-by-program basis. We use our personnel and infrastructure resources across multiple research and development programs directed toward identifying and developing product candidates and therefore have not implemented the systems and procedures to track research and development expenses on a program-by-program basis. We track research and development expenses based on the type of expense as further described below under “Results of Operations – Research and Development Expenses.” Substantially all our historical research and development costs were incurred in the development of our preclinical candidates and advancing research on our POZ lipid technology.
We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in conducting clinical trials, manufacturing and otherwise advancing our programs. The process of conducting the clinical research necessary to obtain regulatory approval is costly and time consuming, and the successful development of our product candidates is highly uncertain.
Because of the numerous risks and uncertainties associated with product development and the current stage of development of our product candidates and programs, we cannot reasonably estimate or know the nature, timing, and estimated costs necessary to complete the remainder of the development of our product candidates or programs. We are also unable to predict if, when, or to what extent we will obtain approval and generate revenues from the commercialization and sale of any of our product candidates. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:
•successful completion of preclinical studies and initiation of clinical trials for future product candidates;
•successful enrollment and completion of clinical trials for our current product candidates;
•data from our clinical programs that support an acceptable risk benefit profile of our product candidates in the intended patient populations; acceptance by the U.S. Food and Drug Administration ("FDA") or other applicable regulatory agencies of the Investigational New Drug ("IND") applications, clinical trial applications and/or other regulatory filings for SER 252 and other product candidates.
•expansion and maintenance of a workforce of experienced scientists and others to continue to develop our product candidates;
•successful application for and receipt of marketing approvals from applicable regulatory authorities;
•obtainment and maintenance of intellectual property protection and regulatory exclusivity for our product candidates;
•making of arrangements with contract manufacturing organizations for, or establishment of, commercial manufacturing capabilities;
•establishment of sales, marketing and distribution capabilities and successful launch of commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;
•acceptance of our product candidates, if and when approved, by patients, the medical community and third party payors;
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•effective competition with other therapies;
•obtainment and maintenance of coverage, adequate pricing, and adequate reimbursement from third party payors, including government payors;
•maintenance, enforcement, defense, and protection of our rights in our intellectual property portfolio;
•avoidance of infringement, misappropriation, or other violations with respect to others’ intellectual property or proprietary rights; and
•maintenance of a continued acceptable safety profile of our products following receipt of any marketing approvals.
We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our preclinical studies and clinical trials. We may elect to discontinue, delay, or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current and future preclinical and clinical product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies or clinical trials, we could be required to expend significant additional financial resources and time on the completion of preclinical and clinical development. Research and development activities account for a significant portion of our operating expenses. On November 3, 2025, the Company announced that it received a notice from the FDA, placing a clinical hold on the Company’s IND application for SER-252, the Company’s lead development program for advanced Parkinson’s disease. The FDA has requested additional information related to a commonly used excipient in the formulation of SER-252. The FDA’s feedback does not relate to the active drug substance or its proposed mechanism of action. The Company plans to engage with the FDA in order to lift the clinical hold and commence with the planned SER-252-1b registrational clinical study.
We expect our research and development expenses to increase for the foreseeable future as we continue to implement our business strategy, which includes advancing SER 252 and our other product candidates, through clinical development, expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals for our product candidates that successfully complete clinical trials. In addition, product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development. However, we do not believe that it is possible at this time to accurately project total program specific expenses through commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.
General and Administrative Expenses
Our general and administrative expenses consist primarily of personnel costs, and other expenses for outside professional services, including legal, recruiting, audit and accounting, and facility related costs not otherwise included in research and development expenses. Personnel costs consist of salaries, benefits and equity-based compensation expense for our personnel in executive and other administrative functions. We expect our general and administrative expenses to increase over the next several years to support our continued research and development activities, manufacturing activities, increased costs of expanding our operations and operating as a public company. These increases will likely include increases related to the hiring of additional personnel and legal, regulatory, and other fees and services associated with maintaining compliance with the New York Stock Exchange American Company Guide and SEC requirements, director and officer insurance costs, and investor relations costs associated with being a public company.
Other Income/(Expense)
Our other income (expenses) are comprised of interest income on our cash equivalents, changes in fair value of our convertible notes and liability-classified warrants, interest accrued from the convertible notes and foreign currency transaction gains, primarily related to payables and intercompany loans.
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Results of Operations
Comparison of the three and nine months ended September 30, 2025 and 2024
The table presented below shows our operating expenses for the periods presented (in thousands).
| Three months ended September 30, | $ Increase/ (Decrease) | ||||||||||||||||||||||
| 2025 | 2024 | ||||||||||||||||||||||
| REVENUES | |||||||||||||||||||||||
| Grant revenues | $ | — | $ | 14 | $ | (14) | |||||||||||||||||
| OPERATING EXPENSES | |||||||||||||||||||||||
| Research and development expenses | 3,651 | 2,415 | 1,236 | ||||||||||||||||||||
| General and administrative expenses | 2,741 | 2,911 | (170) | ||||||||||||||||||||
Total operating expenses | 6,392 | 5,326 | 1,066 | ||||||||||||||||||||
| Loss from operations | (6,392) | (5,312) | (1,080) | ||||||||||||||||||||
| Total other income, net | 1,797 | 6,695 | (4,898) | ||||||||||||||||||||
| NET (LOSS) INCOME | $ | (4,595) | $ | 1,383 | $ | (5,978) | |||||||||||||||||
| Nine months ended September 30, | $ Increase/ (Decrease) | ||||||||||||||||
| 2025 | 2024 | ||||||||||||||||
| REVENUES | |||||||||||||||||
| Grant revenues | $ | 130 | $ | 70 | $ | 60 | |||||||||||
| OPERATING EXPENSES | |||||||||||||||||
| Research and development expenses | 9,754 | 5,115 | 4,639 | ||||||||||||||
| General and administrative expenses | 8,191 | 6,454 | 1,737 | ||||||||||||||
Total operating expenses | 17,945 | 11,569 | 6,376 | ||||||||||||||
| Loss from operations | (17,815) | (11,499) | (6,316) | ||||||||||||||
| Total other income, net | 1,936 | 3,044 | (1,108) | ||||||||||||||
| NET LOSS | $ | (15,879) | $ | (8,455) | (7,424) | ||||||||||||
Revenues
Revenues for the three and nine months ended September 30, 2025 and 2024 were not material.
Research and Development Expenses
Research and development expenses were $3.6 million for the three months ended September 30, 2025, compared to $2.4 million for the same period in 2024. The increase of $1.2 million is primarily due to increases of $0.5 million in outsourced research services, $0.5 million in consultant spend mainly for chemistry, manufacturing, and controls activities, amortization of $0.4 million for a prepaid technology access fee and $0.2 million increased spend in clinical related activities. These increases were offset by decreases of $0.2 million in professional fees for the maintenance of certain patent and other intellectual property and biological material assets included in Legacy Assets and $0.2 million in miscellaneous expenses amounts that were individually insignificant. See Note 1, Organization, Business Overview and Liquidity to our condensed consolidated interim financial statements included elsewhere in this Report for additional information about the Legacy Assets.
Research and development expenses were $9.8 million for the nine months ended September 30, 2025, compared to $5.1 million for the same period in 2024. The increase of $4.6 million is primarily due to increases of $2.3 million in outsourced
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research services, $1.3 million in salaries, payroll related expenses and stock based compensation as a result of increased headcount, $1.1 million in consultant spend for research programs, amortization of $0.7 million for a prepaid technology access fee and $0.3 million increased spend in clinical related activities. These increases were offset by decreases of $0.7 million in professional fees for the maintenance of certain patent and other intellectual property and biological material assets included in Legacy Assets, $0.3 million in severance and related costs and $0.1 million in miscellaneous expenses amounts that were individually insignificant.
General and Administrative Expenses
General and administrative expenses were $2.7 million for the three months ended September 30, 2025, compared to $2.9 million for the same period in 2024. The net decrease of $0.2 million is due primarily to a $0.3 million decrease in severance, and $0.3 million in stock based compensation and recruiting fees. These decreases were offset by increases of $0.3 million in investor outreach activities and $0.1 million in equity compensation for consultants.
General and administrative expenses were $8.2 million for the nine months ended September 30, 2025, compared to $6.5 million for the same period in 2024. The increase of $1.7 million is due primarily to increases of $0.9 million in stock based compensation expense as a result of new hires and directors, $1.0 million of consulting expenses for public company infrastructure, as well as Director fees and D&O insurance, and $0.4 million in investor outreach activities. These increases were offset by decreases in severance of $0.3 million, $0.2 million in marketing costs and $0.1 million in miscellaneous expenses amounts that were individually insignificant.
Other Income, Net
Other income was $1.8 million for the three months ended September 30, 2025, compared to $6.7 million for the same period in 2024. The $4.9 million decrease in Other income is primarily attributable to the reduction of $5.6 million in the change in fair value of liability classified warrants, partially offset by a $0.7 million gain from the expiration of liability classified warrants.
Other income was $1.9 million for the nine months ended September 30, 2025, compared to $3.0 million for the same period in 2024. The $1.1 million decrease is primarily attributable to a decrease in gain of $9.3 million from the change in fair value of liability classified warrants. This decrease was partially offset by the increase to income in 2025 from the $7.0 million loss from the change in fair value relating to the Legacy Serina Convertible Notes and the AgeX-Serina Note in 2024, a $0.7 million gain from the expiration of liability classified warrants and the decrease of $0.5 million in interest expense.
See Notes 6, Fair Value Measurements and Note 7, Stockholders’ Equity to our condensed consolidated interim financial statements included elsewhere in this Report for additional information on fair value adjustments of convertible promissory notes, Legacy Serina warrants, liability classified Merger Warrants and Contingent Warrants, and conversion of the AgeX-Serina Note upon consummation of the Merger on March 26, 2024.
Liquidity and Capital Resources
Sources of Liquidity
We had $8.6 million in cash and cash equivalents as of September 30, 2025. Our operations have been financed primarily by the issuance of common stock, convertible preferred stock, convertible notes by AgeX and Serina prior to the Merger, and 2025 Convertible Note. Post Merger, our operations have been funded by the exercise of Post-Merger warrants, $5.0 million from Juvenescence in June 2024, and the issuance of the Company's common stock to Juvenescence whereby we issued 1,000,000 shares of the Company's common stock at a purchase price of $10.00 per share, for an aggregate amount of $10.0 million which were received in two $5.0 million tranches in November 2024 and January 2025.
In April 2025, we entered into a Securities Purchase Agreement with certain investors for a private placement of securities. At the closing of the Private Placement, we issued an aggregate of 965,250 shares of newly authorized Series A Convertible Preferred Stock, par value $0.0001, at a purchase price of $5.18 per share, resulting in net proceeds of $4.9 million. Each share of Series A Preferred Stock is convertible into shares of the Company's common stock, par value
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($0.0001), at a conversion price of $5.18 per share and has a cumulative annual dividend of 8% beginning on March 31, 2026.
Additionally, on April 25, 2025, we entered into a sales agreement (the "Sales Agreement") with JonesTrading Institutional Services LLC (the "Sales Agent"), with respect to an at-the-market offering ("ATM") program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $13.3 million through the Sales Agent. We will pay the Sales Agent a commission up to 3.0% of the gross sales proceeds of any shares sold under the Sales Agreement. As of September 30, 2025, we have sold 385,851 shares of our common stock at an average price of $5.96, resulting in net proceeds of $2.2 million under the ATM.
On September 9, 2025, we entered into an unsecured convertible note (the “2025 Convertible Note”) with a member of the our Board of Directors, making available to Serina an aggregate principal amount of up to $20 million.Under the 2025 Convertible Note, borrowings may be drawn at our discretion in five tranches tied to certain clinical and operational milestones, provided that if at the time we achieve a milestone and do not have sufficient cash available to cover projected costs and expenses to achieve the next milestone, then we will be required to draw such deficiency. The five tranches correspond to the five following milestones: (i) up to $5 million on or before September 30, 2025; (ii) up to $2.5 million on or after December 15, 2025 upon enrollment of the first patient in the our SER-252-1b registrational clinical study; (iii) up to $2.5 million upon enrollment of the second patient in the study; (iv) up to $5 million on or after March 15, 2026, upon dosing of the last patient in Cohort 1 of the study; and (v) up to $5 million on or after April 30, 2026, upon dosing of the first patient in Cohort 2 of the study (“Milestone 5”). See Components of Operating Results in Item 2 (Management’s Discussion and Analysis of Financial Condition and Results of Operations) for a discussion of the impact of recent FDA communication on the clinical study.
The 2025 Convertible Note is convertible, at the option of the holder, into shares of the the Company's common stock, at any time until the maturity date at a conversion price of $5.18 per share. The conversion price is subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization, or other similar transaction.
On September 28, 2025, we drew down the first tranche of $5.0 million under the 2025 Convertible Note ("First Tranche"), incurring $0.1 million in transaction costs which were accounted for as a debt discount.
Our primary use of cash is to fund operating expenses, which consist of research and development expenditures and general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
Since inception, we have had significant operating losses and negative cash flows and as of September 30, 2025, we had an accumulated deficit of $60.2 million. Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations within twelve months of the issuance date of our condensed consolidated financial statements included in this Report, raise substantial doubt about our ability to continue as a going concern. We expect to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development. Our consolidated interim financial statements have been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated interim financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
The unavailability or inadequacy of financing to meet future capital needs could force us to modify, curtail, delay, or suspend some or all aspects of planned operations.
Funding Requirements
Any product candidates we may develop may never achieve commercialization, and we anticipate that we will continue to incur losses for the foreseeable future. We expect that our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. Our primary uses of capital are, and we expect will continue to be, costs related to pre-clinical and clinical research, clinical studies, manufacturing, and development services; laboratory expenses and costs for related supplies; compensation and related expenses; license payments or milestone obligations that may arise; legal and other regulatory expenses and general overhead costs.
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We believe that our cash on hand will not be sufficient to enable us to fund our operations at least twelve months following the issuance of the condensed consolidated financial statements based on our current plan. To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. We will continue to require additional financing to advance our current product candidates through clinical development, to develop, acquire or in license other potential product candidates and to fund operations for the foreseeable future. We will continue to seek funds through equity offerings, debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs.
Because of the numerous risks and uncertainties associated with research, development, and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
•the progress, costs and results of IND enabling studies for our lead product candidate SER 252 and our potential future clinical trials for SER 252;
•the scope, progress, results and costs of discovery research, preclinical development, laboratory testing and clinical trials for our other product candidates;
•the costs, timing, and outcome of regulatory review of our product candidates;
•our ability to enter into contract manufacturing arrangements for supply of active pharmaceutical ingredient, or API, and manufacture of our product candidates and the terms of such arrangements;
•our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;
•the payment or receipt of milestones and receipt of other collaboration-based revenues, if any; the costs and timing of any future commercialization activities, including product manufacturing, sales, marketing, and distribution, for any of our product candidates for which we may receive marketing approval;
•the amount and timing of revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property related claims;
•the extent to which we acquire or in license other products, product candidates, technologies, or data referencing rights;
•the ability to receive additional nondilutive funding, including grants from organizations and foundations; and
•the costs of operating as a public company
Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.
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Cash Flows
The following table summarizes the major sources and uses of cash for the periods set forth below (in thousands):
| Nine months ended September 30, | |||||||||||||||||||||||
| 2025 | 2024 | $ Change | % Change | ||||||||||||||||||||
| Net cash used in operating activities | $ | (11,922) | $ | (12,548) | $ | 626 | (5.0 | %) | |||||||||||||||
| Net cash used in investing activities | (59) | (17) | (42) | 247.1 | % | ||||||||||||||||||
| Net cash provided by financing activities | 16,931 | 8,181 | 8,750 | 107.0 | % | ||||||||||||||||||
| Net increase (decrease) in cash | $ | 4,950 | $ | (4,384) | $ | 9,334 | (212.9 | %) | |||||||||||||||
Operating Activities
Net loss for the nine months ended September 30, 2025 was $15.9 million. Net cash used in operating activities during this period amounted to $11.9 million. The $4.0 million difference between the net loss and net cash used in operating activities during the nine months ended September 30, 2025 was comprised of offsetting non-cash items of $1.3 million and changes in operating assets and liabilities totaling $2.7 million. The non-cash items consisted of $2.8 million in stock-based compensation, $0.2 million in non-cash lease expenses and $0.1 million in equity compensation to consultants for services. These non-cash items were reduced by the non-cash gain of $1.1 million from the change in the fair value of warrants and $0.7 million gain from warrant expirations. The net $2.7 million cash from operating assets and liabilities primarily consisted of a $2.0 million increase in accounts payable, decrease of $0.8 million in prepaid and other current assets and $0.2 million increase in other current liabilities. These cash increases were partially offset by the $0.3 million decrease in accrued expenses.
Net loss for the nine months ended September 30, 2024 was $8.5 million. Net cash used in operating activities during this period amounted to $12.5 million. The $4.0 million difference between the net loss and net cash used in operating activities during the nine months ended September 30, 2024 was comprised of non-cash items, totaling $1.0 million and changes in operating assets and liabilities totaling $3.0 million. The net $1.0 million increase of non-cash items primarily consisted of a $10.4 million gain from the change in the fair value of warrants. This increase was partially offset by a $7.0 million loss from the change in fair value of convertible notes, $1.6 million in stock-based compensation, $0.3 million amortization of deferred debt issuance costs, $0.3 million in depreciation and non-cash lease expenses and $0.2 million decrease in accrued interest on the AgeX-Serina Note. The net $3.0 million cash used in operating assets and liabilities primarily consisted of a $2.4 million increase in prepaid expenses (comprised of $1.7 million in prepaid technology access fee and $0.7 million in other prepaid expenses and current assets), and a $0.6 million decrease in accounts payable.
Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2025 of $16.9 million is primarily due to net proceeds received of $4.9 million from issuance of common stock to Juvenescence in January 2025, $4.9 million received in April 2025 from a securities purchase agreement entered with certain investors for a private placement of securities, net proceeds received of $4.9 million from the First Tranche drawdown under the 2025 Convertible Note, and $2.2 million net proceeds from our ATM. See Note 7. Stockholders’ Equity, to our condensed consolidated interim financial statements included elsewhere in this Report for additional information.
Net cash provided by financing activities for the nine months ended September 30, 2024, of $8.2 million is primarily attributable to $5.0 million of proceeds received from the exercise of 377,865 Post-Merger Warrants by Juvenescence, $2.9 million drawn under the loan facilities from Juvenescence, $0.3 million cash and restricted cash acquired in connection with the Merger and $0.1 million from the exercise of stock options. These changes were offset to some extent by $0.1 million repayment of principal on loan facilities to Juvenescence. See Note 5, Related Party Transactions, to our condensed consolidated interim financial statements included elsewhere in this Report for additional information about our loan agreements with Juvenescence.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Under SEC rules and regulations, as a smaller reporting company, we are not required to provide the information required by this item.
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Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
It is management’s responsibility to establish and maintain adequate internal control over all financial reporting pursuant to Rule 13a-15 under the Exchange Act. Our management, including our principal executive officer and principal financial officer, have reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) as of the end of the period covered by this report. Following this review and evaluation, the principal executive officer and principal financial officer determined that our disclosure controls and procedures were not effective as of September 30, 2025, due to material weaknesses described below.
In light of the conclusion that our disclosure controls and procedures are considered ineffective as of September 30, 2025, we have applied procedures and processes as necessary to ensure the reliability of our financial reporting in regard to this quarterly report. Accordingly, the Company believes, based on its knowledge, that: (i) this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which they were made, not misleading with respect to the period covered by this report; and (ii) the financial statements, and other financial information included in this quarterly report, fairly present in all material respects our financial condition, results of operations and cash flows as of and for the periods presented in this quarterly report.
Material Weaknesses
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
In the evaluation of our disclosure controls and procedures discussed above, we identified material weaknesses due to a lack of internal controls at the Company. Specifically, management has determined the following:
•management does not have sufficient qualified accounting personnel to support the preparation of financial statements that comply with U.S. GAAP and SEC reporting requirements
•a lack of validation of completeness and accuracy of internally prepared data, including key reports generated from systems, utilized in the operations of controls;
•inadequate controls and segregation of duties due to limited resources and number of employees;
•substantial reliance on manual reporting processes and spreadsheets external to the accounting system for financial reporting leading to delays in the Company’s closing process; and
•a lack of experience in monitoring and administering the Company’s internal control over financial reporting.
To mitigate the items identified in the assessment, we rely heavily on direct management oversight of transactions, along with the use of legal and accounting professionals/consultants.
Remediation Plan
We began implementation of remedial measures to address the material weaknesses, which primarily stem from our small workforce and limited resources prior to the Merger. Following the Merger, the accounting and financial operations personnel and resources from AgeX started to monitor and administer Legacy Serina’s internal controls over financial reporting and development. We are currently implementing the following measures for our remediation plan:
•We engaged financial operations employees and consultants to assess and establish internal controls.
•To strengthen our accounting and finance team, we hired professionals with technical expertise in public company accounting and financial reporting experience.
•In addition to expanding our internal team, we leverage third-party consultants and specialists to provide technical accounting experience and assist with systems implementation.
•We developed standardized templates and implemented enhanced processes and procedures for accounting, financial close and reporting.
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•We implemented automation and integration improvements in our financial IT systems, and are actively working on further enhancements to our platforms.
The material weaknesses will not be remediated until our remediation plan has been fully developed and implemented, the applicable controls operate for a sufficient period of time, and we have concluded, through testing by management and by our independent accountants, that the newly implemented and enhanced controls are operating effectively. We will continue to monitor and evaluate the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and are committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.
Changes in Internal Controls
Other than as described above, there was no change in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitation on the Effectiveness Over Financial Reporting
The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable and not absolute assurances. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business, but there can be no assurance such improvements will be sufficient to provide us with effective internal control over financial reporting.
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PART II — OTHER INFORMATION
Item 1. Legal Proceedings
From time to time we may become involved in legal proceedings or be subject to claims that arise in the ordinary course of business. As of the date of this report, we are not currently a party to any material legal proceedings.
Item 1A. Risk Factors
Our business, financial condition, results of operations and future growth prospects are subject to various risks, including those described under “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 24, 2025, which we encourage you to review. There have been no material changes from the risk factors disclosed in the Form 10-K, except as set forth below:
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
We may sell up to $13.3 million of shares of our common stock in "at-the-market" offerings pursuant to a sales agreement (the "Sales Agreement") entered into on April 25, 2025 with JonesTrading Institutional Services LLC. The sale of a substantial number of shares of our common stock pursuant to the Sales Agreement, or anticipation of such sales, could cause the trading price of our common stock to decline or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price favorable to our capital needs. In addition, there can be no assurance regarding the price at which we will be able to sell shares under the Sales Agreement, and any sales of our common stock under the Sales Agreement may be at prices that result in additional dilution to our existing stockholders.
The FDA regulatory approval process is lengthy, time consuming, and inherently unpredictable, and we may experience significant delays in the clinical development and regulatory approval, if any, of our product candidates.
The research, testing, manufacturing, labeling, approval, selling, import, export, adverse event reporting, record keeping, advertising, promotion, and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States. We are not permitted to market any drug product in the United States until we receive approval from the FDA. We have not previously submitted an NDA to the FDA, or similar approval filings to comparable foreign authorities. An NDA must include extensive nonclinical and clinical data and supporting information to establish that the product candidate is safe, pure, potent, and effective for each desired indication. The NDA must also include significant information regarding the chemistry, manufacturing, and controls for the product, and the manufacturing facilities must complete a successful pre license inspection. The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support approval. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of the product candidates based on the completed clinical trials. Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive, and lengthy, and approval may not be obtained.
Further, we are reliant on regulators having the resources necessary to evaluate and approve our products. In the United States, a partial federal government shutdown halted the work of many federal agencies and their employees from late December 2018 through late January 2019. A subsequent extended shutdown or, pursuant to the new Administration’s actions in early 2025 to freeze or reduce the federal workforce, significant reductions of, or disruptions to, staffing and resources available to government agencies could result in reductions or delays of FDA’s activities, including with respect to our ongoing clinical programs, our manufacturing of our products and product candidates and our product approvals. Recent initiatives to reduce the size and budgets of government agencies, including the FDA, may adversely impact our operations. In particular, reductions in staffing and resources at the FDA could result in delays in regulatory review timelines.
Issuance of a substantial number of shares of our common stock to certain investors could cause our stock price to fall.
Pursuant to the 2025 Convertible Note, the Company may draw up to a principal amount of $20 million, with such 2025 Convertible Note bearing interest at an annual rate of 10%. The 2025 Convertible Note is convertible, at the option of the holder, into shares of the Company’s common stock at any time until the maturity date. The Company also agreed under the 2025 Convertible Note to issue the Contingent Warrants for the purchase of shares of the Company's common stock when it drew funds under the 2025 Convertible Note. The number of shares of the Company’s common stock that may be purchased pursuant to such Contingent Warrants is equal to 100% of the number of shares of the Company’s common
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stock issuable upon conversion of the funds extended by the investors under the 2025 Convertible Note on such funding date. The issuance of a substantial number of shares of our common stock pursuant to the 2025 Convertible Note, or anticipation of such issuances, could cause the trading price of our common stock to decline or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that is favorable to our capital needs.
We have never generated revenue from product sales and may never become profitable.
Our ability to generate product sales and achieve profitability depends on our ability, alone or with collaborative partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, our current and future product candidates. We do not anticipate generating product sales for the next several years, if ever.
Our product candidates will require additional clinical, manufacturing, and non-clinical development, regulatory approval, commercial manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before we generate any product sales. We cannot guarantee that we will meet our timelines for our development programs, which may be delayed or not completed for a number of reasons. Our ability to generate future revenues from product sales depends heavily on our, or our collaborators’, ability to successfully:
•complete research and obtain favorable results from nonclinical and clinical development of our current and future product candidates, including addressing any clinical holds that may be placed on our development activities by regulatory authorities;
•seek and obtain regulatory and marketing approvals for any of our product candidates for which we complete clinical trials, as well as their manufacturing facilities;
•launch and commercialize any of our product candidates for which we obtain regulatory and marketing approval by establishing a sales force, marketing, and distribution infrastructure or, alternatively, collaborating with a commercialization partner;
•qualify for coverage and establish adequate reimbursement by government and third-party payors for any of our product candidates for which we obtain regulatory and marketing approval;
•develop, maintain, and enhance a sustainable, scalable, reproducible, and transferable manufacturing process for the product candidates we may develop;
•establish and maintain supply and manufacturing capabilities internally or with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and the market demand for any of our product candidates for which we obtain regulatory and marketing approval;
•obtain market acceptance of current or any future product candidates as viable treatment options and effectively compete with other therapies to establish market share;
•maintain a continued acceptable safety and efficacy profile of our product candidates following launch;
•address competing technological and market developments;
•implement internal systems and infrastructure, as needed;
•negotiate favorable terms in any collaboration, licensing, or other arrangements into which we may enter and perform our obligations in such collaborations;
•maintain, protect, enforce, defend, and expand our portfolio of intellectual property rights, including patents, trade secrets, and know-how;
•avoid and defend against third-party interference, infringement, and other intellectual property claims; and
•attract, hire, and retain qualified personnel.
Even if one or more of our current and future product candidates are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond our expectations if we are required by the FDA or other regulatory authorities to perform clinical and other studies in addition to those that we currently anticipate. If we are required to conduct additional clinical trials or other testing of our product candidates that we develop beyond those that we currently expect, if we are unable to successfully complete
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clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive, or if there are safety concerns, we may be delayed in obtaining marketing approval for our product candidates, not obtain marketing approval at all, or obtain more limited approvals. Even if we are able to generate revenues from the sale of any approved product candidates, we may not become profitable and may need to obtain additional funding to continue operations.
On November 3, 2025, the Company announced that it received a notice from the FDA, placing a clinical hold on the Company’s IND application for SER-252, the Company’s lead development program for advanced Parkinson’s disease. The FDA has requested additional information related to a commonly used excipient in the formulation of SER-252. The FDA’s feedback does not relate to the active drug substance or its proposed mechanism of action. The Company plans to engage with the FDA in order to lift the clinical hold and commence with the planned SER-252-1b registrational clinical study.
Our product candidates are at an early stage of development and may not be successfully developed or commercialized.
All of our current product candidates are in preclinical development and will require substantial further capital expenditures, development, testing, and regulatory approval prior to commercialization. We have limited experience designing clinical trials and have not yet filed or supported a marketing application. We may be unable to design and execute a clinical trial that ultimately supports marketing approval.
The time required to obtain approval from the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of regulatory authorities. The outcome of studies is also inherently uncertain. Of the large number of drugs in development, only a small percentage successfully complete the regulatory approval process and are commercialized. The results of nonclinical studies, interim or top line studies, and early clinical trials of our product candidates may not be predictive of the results of later stage clinical trials. Failure can occur at any time during the clinical trial process. Product candidates in later stages of clinical trials may fail to show the desired safety, purity, and potency traits despite having progressed through nonclinical studies and initial clinical trials. Nonclinical and early clinical studies may also reveal unfavorable product candidate characteristics, including safety concerns. A number of companies have suffered significant setbacks in advanced clinical trials, notwithstanding promising results in earlier trials. In some instances, there can be significant variability in results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols, and the rate of dropout among clinical trial participants.
Accordingly, even if we are able to obtain the requisite financing to fund our development programs, we cannot assure you that our product candidates will be successfully developed or commercialized. Our failure to develop, manufacture or receive regulatory approval for, or successfully commercialize any of, our product candidates could result in the failure of our business and a loss of all of our stockholders’ investment.
Our product candidates may fail at any stage of preclinical or clinical development, and may also reveal unfavorable product candidate characteristics, including safety concerns or the failure to demonstrate efficacy in initial clinical trials. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. Although we anticipate completing the preclinical development, including toxicology testing and clinical supply manufacturing development, necessary to file an investigational new drug application (“IND”) for SER 252 and additional INDs for other product candidates in the future, we may experience numerous unforeseen events before, during, or as a result of clinical trials that could delay or prevent our ability to commence or complete development, commence or complete clinical trials, receive marketing approval or commercialize our product candidates, including:
•we may be unable to generate sufficient nonclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials;
•regulators or independent review boards (“IRBs”) or Independent Ethics Committees (“IECs”) may not authorize us or our investigators to commence or continue a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or may require that we modify or amend our clinical trial protocols;
•Regulators, independent data safety monitoring committees, IRBs or IECs, we, or our data monitoring committee(s) may recommend or require the suspension or termination of clinical research for various reasons, including non-compliance with regulatory requirements or a finding that participants are being exposed to unacceptable health risks, undesirable side effects, or a failure of the product candidate to demonstrate any benefit to subjects, or other unexpected characteristics (alone or in combination with other products) of the product candidate, or due to findings of undesirable effects caused by a chemically or mechanistically similar therapeutic or therapeutic candidate;
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•new information may emerge regarding our product candidates or technology platform that result in continued development of some or all of our product candidates being deemed undesirable;
•we may have delays identifying, recruiting, and training suitable clinical investigators or investigators may withdraw from our studies;
•we may experience delays in reaching, or failing to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or contract research organizations (“CROs”. Contractual terms can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different CROs and trial sites;
•we may have delays in adding new investigators or clinical trial sites, or we may experience a withdrawal of clinical trial sites;
•the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials or be lost to follow up at a higher rate than we anticipate for a number of reasons, such as adverse events, an inadequate treatment response, fatigue with the clinical trial process or personal issues;
•patients who enroll in our studies may misrepresent their eligibility or may otherwise not comply with clinical trial protocols, resulting in the need to drop those patients from those studies, increase the needed enrollment size for those studies, or extend the duration of those studies;
•there may be flaws in our study design, which may not become apparent until a study is well advanced;
•our contractors may fail to comply with regulatory requirements or clinical trial protocols, or meet their contractual obligations to us in a timely manner, or at all, or we may be required to engage in additional clinical trial site monitoring;
•regulatory authorities or IRBs/IECs may disagree with the design, including endpoints, scope, or implementation of our clinical trials, or regulatory authorities may disagree with our intended indications;
•regulatory authorities may disagree with the formulation for our product candidates, or our product candidate dose or dosing schedule;
•we may be unable to demonstrate to the satisfaction of regulatory authorities that a product candidate is safe, pure, and potent for any indication;
•regulatory authorities may not accept, or Serina or our clinical trials may not meet the criteria required to submit, clinical data from trials which are conducted outside of their jurisdictions;
•the results of clinical trials may be negative or inconclusive, may not meet the level of statistical significance required for, or may not otherwise be sufficient to support marketing approval, and we may decide, or regulatory authorities may require us, to conduct additional clinical trials, analyses, reports, data, or nonclinical studies, or abandon product development programs;
•our product candidates may have undesirable or unintended side effects, toxicities, or other characteristics that preclude marketing approval or prevent or limit commercial use;
•we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks or otherwise provide an advantage over current standard of care or current or future competitive therapies in development;
•the standard of care for the indications we are investigating may change, which changes could impact the meaningfulness of the resulting study data, or which may necessitate changes to the studies;
•regulatory authorities may disagree with the scope, design, including endpoints, implementation, or our interpretation of data from nonclinical studies or clinical trials;
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•regulatory authorities may require us to amend our studies, perform additional or unanticipated clinical trials or nonclinical studies or manufacturing development work to obtain approval or initiate clinical trials, or we may decide to do so or abandon product development programs;
•regulatory authorities may find that we or our third-party manufacturers do not satisfy regulatory requirements and standards for the facilities and operations used in the manufacture of our product candidates;
•the cost of clinical trials of our product candidates may be greater than we anticipate, or we may have insufficient funds for a clinical trial or to pay the substantial user fees required by the FDA or other regulatory authorities upon the filing of a marketing application;
•the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;
•regulatory authorities may take longer than we anticipate to make a decision on our product candidates; or
•changes in, or the enactment of, the approval policies, statutes, or regulations of the applicable regulatory authorities may significantly change in a manner rendering our nonclinical or clinical data insufficient for approval.
Furthermore, we expect to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we expect to enter into agreements governing their committed activities, we have limited influence over their actual performance.
A clinical trial may be suspended or terminated by us, our partners, the IRBs of the institutions in which such trials are being conducted, the Data and Safety Monitoring Board for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we experience delays in the completion of, or termination of, any clinical trial of any of our potential future product candidates, the commercial prospects of such product candidate will be harmed, and our ability to generate product revenue from such product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow our product development and approval process, and jeopardize our ability to commence product sales and generate revenue, and we may not have the financial resources to continue development of the product candidate that is affected or any of our other product candidates. We may also lose, or be unable to enter into, collaborative arrangements for the affected product candidate and for other product candidates that we are developing. Any of these occurrences may materially and adversely affect our business, financial condition, results of operations and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our potential future product candidates.
On November 3, 2025, the Company announced that it received a notice from the FDA, placing a clinical hold on the Company’s IND application for SER-252, the Company’s lead development program for advanced Parkinson’s disease. The FDA has requested additional information related to a commonly used excipient in the formulation of SER-252. The FDA’s feedback does not relate to the active drug substance or its proposed mechanism of action. The Company plans to engage with the FDA in order to lift the clinical hold and commence with the planned SER-252-1b registrational clinical study.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Previously reported.
Item 3. Default Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not Applicable.
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Item 5. Other Information
Certain Trading Arrangements
During the three months ended September 30, 2025, none of the directors or officers of the Company, adopted terminated
Item 6. Exhibits
| Incorporation By Reference | ||||||||||||||||||||||||||||||||
| Exhibit Number | Description of Document | Form | SEC File No. | Exhibit | Filing Date | |||||||||||||||||||||||||||
| 3.1 | Second Amendment to Amended and Restated Bylaws of Serina Therapeutics, Inc. | 8-K | 001-38519 | 3.1 | 8/22/2025 | |||||||||||||||||||||||||||
| 4.1 | Form of Warrant Agreement | 8-K | 001-38519 | 4.1 | 9/15/2025 | |||||||||||||||||||||||||||
| 10.1 | Convertible Note, dated as of September 9, 2025, between Serina Therapeutics, Inc. and Gregory Bailey | 8-K | 001-38519 | 10.1 | 9/15/2025 | |||||||||||||||||||||||||||
| 31.1* | Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer | |||||||||||||||||||||||||||||||
| 31.2* | Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer | |||||||||||||||||||||||||||||||
| 32** | Section 1350 Certification | |||||||||||||||||||||||||||||||
| 101.INS* | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) | |||||||||||||||||||||||||||||||
| 101.SCH* | Inline XBRL Taxonomy Extension Schema | |||||||||||||||||||||||||||||||
| 101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase | |||||||||||||||||||||||||||||||
| 101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase | |||||||||||||||||||||||||||||||
| 101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase | |||||||||||||||||||||||||||||||
| 101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase | |||||||||||||||||||||||||||||||
| 104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) | |||||||||||||||||||||||||||||||
*Filed herewith.
**Furnished herewith.
†Certain schedules and exhibits to this agreement have been omitted in accordance with Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the Securities and Exchange Commission on request.
#Schedules and exhibits to this Exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K. A copy of any omitted schedule or exhibit will be furnished to the Securities and Exchange Commission or its staff upon request
‡Management contract or compensatory plan.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| SERINA THERAPEUTICS, INC. | |||||
Date: November 13, 2025 | /s/ Steve Ledger | ||||
| Steve Ledger | |||||
| Chief Executive Officer | |||||
Date: November 13, 2025 | /s/ Gregory S. Curhan | ||||
| Gregory S. Curhan | |||||
Chief Financial Officer and Principal Accounting Officer | |||||
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FAQ
What was Serina Therapeutics (SER) Q3 2025 net loss?
Q3 2025 net loss was $4.6 million, and nine-month net loss was $15.9 million.
How much cash did SER have at quarter-end Q3 2025?
Cash and cash equivalents were $8.6 million as of September 30, 2025.
Did SER disclose going concern issues in Q3 2025?
Yes. Management disclosed substantial doubt about the company’s ability to continue as a going concern.
What financing did SER secure in 2025?
SER raised $4.9 million via Series A preferred, $2.2 million net through its ATM, and drew $5.0 million from a new $20 million unsecured convertible note.
What happened with SER-252’s IND?
On November 3, 2025, the FDA placed a clinical hold requesting more information on a formulation excipient.
What were SER’s operating cash flows for the first nine months of 2025?
Net cash used in operating activities was $11.9 million for the nine months ended September 30, 2025.
How many shares of SER were outstanding?
Common shares outstanding were 10,664,064 as of November 10, 2025.
Serina Therapeutics
NYSE:SER
SER Rankings
SER Latest News
SER Latest SEC Filings
SER Stock Data
42.04M
5.49M
62.09%
4.03%
2.1%
Biotechnology
Pharmaceutical Preparations
United States
HUNTSVILLE