AgeX Therapeutics(US:AGE)2025-03-24 20:14Part I Business Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases using its proprietary POZ platform, a polymer drug delivery technology designed to improve the efficacy and safety of small molecules Overview and POZ Platform Serina Therapeutics is a clinical-stage biotech company utilizing its proprietary POZ platform to develop treatments for neurological diseases - The company is a clinical-stage biotechnology firm developing a pipeline of wholly-owned drug candidates for neurological and other diseases using its POZ platform29 - The POZ platform is designed to improve upon existing polymer delivery technologies like PEG, offering advantages in synthesis, stability, reduced immunogenicity, higher drug loading, programmable release, and no tissue accumulation313236 Development Pipeline and Strategy The company's strategy centers on developing polymer therapeutics using its POZ platform, with a primary focus on advancing its lead program, SER-252, for late-stage Parkinson's disease Development Pipeline | Drug Candidate | Indication | Research | Preclinical | Phase 1 | Phase 2 | Phase 3 | | --- | --- | --- | --- | --- | --- | --- | | SER-252 (POZ-apomorphine) | Advanced Parkinson's | IND-enabling studies | | | | | | SER-2xx (POZ-undisclosed) | CNS | Proof of concept | | | | | | SER-2xx (POZ-undisclosed) | Cardiology | Proof of concept | | | | | | POZ-RNA | RNA therapeutics | R&D with partners | | | | | | POZ-ADCs | Oncology | Proof of concept | | | | | - The company's core strategy includes advancing the lead program SER-252, seeking partnerships for POZ LNP and ADC applications, expanding the POZ platform's use, and building a network of collaborations40 Product Candidates Serina's pipeline is led by SER-252 (POZ-apomorphine) for advanced Parkinson's disease, currently in IND-enabling preclinical studies with Phase I trials planned for the second half of 2025 - SER-252 (POZ-apomorphine) is the lead product candidate for advanced Parkinson's disease, with IND-enabling preclinical studies initiated in August 2023 and expected to complete in Q2 2025. Phase I clinical trials are planned for H2 20253748 - SER-214 (POZ-rotigotine) completed a Phase Ia trial, demonstrating proof-of-principle for the POZ platform by providing continuous drug delivery. However, it is not being advanced internally and the company will seek a partner for further development4664 - The company is advancing preclinical research on POZ-lipids as a non-immunogenic alternative to PEG-lipids in LNP formulations for RNA therapeutics and has entered into feasibility studies with two major pharmaceutical companies48 Licensing and Collaboration Agreements In October 2023, Serina entered into a significant non-exclusive license agreement with Pfizer for the use of its POZ polymer technology in LNP drug delivery formulations - The company entered into a non-exclusive license agreement with Pfizer in October 2023 for the use of its POZ polymer technology in LNP drug delivery formulations82 Pfizer License Agreement Financial Terms | Term | Amount/Rate | | :--- | :--- | | Upfront Payment | $3.0 million (received Dec 15, 2023) | | Milestone Payments | Undisclosed, upon achievement of specific development, regulatory, and commercial milestones | | Royalties on Net Sales | 2.75% – 3.5% (tiered) | Intellectual Property Serina maintains an extensive intellectual property portfolio crucial to its business, focusing on patent protection for its proprietary POZ technology and product candidates - The company owns an extensive patent estate covering its POZ technology and product candidates, with patent families protecting various forms and applications of the technology8486 - The SER 03/07 patent family, expiring in 2029, is particularly broad, covering multifunctional POZ copolymers and their attachment to various molecules including small molecules, proteins, oligonucleotides, and lipids92 - The SER-16 patent family, expiring in 2032, specifically covers poly(oxazoline) conjugates of dopamine agonists (including SER-214 and SER-252) for subcutaneous delivery in treating conditions like Parkinson's disease9596 - The SER 22 patent family, with patents pending or granted and expiring in 2039, covers cleavable conjugates of catechol compounds, which is relevant to the SER-252 (POZ-apomorphine) program100 Competition Serina faces substantial competition from a wide range of large and specialty pharmaceutical, biopharmaceutical, and biotechnology companies, as well as academic and research institutions - The company faces competition from large pharmaceutical and biotech companies, academic institutions, and other research organizations in the fields of CNS disorders and drug delivery112113 - A key competitive technology is PEGylation, a clinically proven drug delivery approach used in over 30 FDA-approved drugs, which is marketed by several companies114115 Government Regulation The company's operations are subject to extensive government regulation in the U.S. and other countries, covering drug testing, manufacturing, labeling, and marketing - The FDA drug approval process is extensive, requiring preclinical studies and three phases of clinical trials to establish safety and efficacy before an NDA or BLA can be submitted for review117118119 - The company may be eligible for expedited FDA programs such as Fast Track, Breakthrough Therapy, or Accelerated Approval, which are designed to facilitate and speed up the development and review of drugs for serious conditions126127128 - Sales and pricing are subject to significant regulation and pressure from third-party payors, including government programs (Medicare, Medicaid, 340B) and private insurers, which are increasingly implementing cost-containment measures149155 - The company is also subject to healthcare fraud and abuse laws, such as the Anti-Kickback Statute and the False Claims Act, as well as federal and state "sunshine" provisions requiring disclosure of financial interactions with healthcare providers158160 Human Capital and Facilities As of December 31, 2024, Serina Therapeutics had thirteen employees and its headquarters is a 7,600 square foot leased facility in Huntsville, Alabama - As of December 31, 2024, the company had thirteen employees (twelve full-time, one part-time)163 - The company's headquarters is a 7,600 sq. ft. leased facility in Huntsville, Alabama, with the laboratory space lease expiring in January 2028164 Risk Factors The company faces significant risks, including a history of operating losses, dependence on additional financing to continue as a going concern, and the early stage of its product candidates - The company has a history of operating losses ($44.3 million accumulated deficit as of Dec 31, 2024) and expects them to continue, raising substantial doubt about its ability to continue as a going concern without additional financing169177178 - All current product candidates are in preclinical development and face a high risk of failure at any stage of development. Success in early trials is not predictive of later-stage results184185186 - The company relies on contract manufacturing organizations (CMOs) for clinical supplies and will for commercial supplies, creating risks related to manufacturing compliance (cGMP), supply chain disruptions, and protection of trade secrets229230 - Juvenescence Limited owns approximately 40.5% of the company's common stock and can substantially influence corporate matters, which may create conflicts of interest387389 Unresolved Staff Comments The company reports that there are no unresolved staff comments - Not Applicable390 Cybersecurity The company has implemented cybersecurity measures through third-party providers, which are periodically assessed and reported to the Audit Committee - The company utilizes third-party providers for its cybersecurity systems and measures, which are periodically assessed and reported to the Audit Committee391 - Serina is not aware of any cybersecurity incidents that have materially affected or are reasonably likely to materially affect its business392 Properties The company's principal place of business is a leased 7,600 square foot facility in Huntsville, Alabama, containing both office and laboratory space - The company leases approximately 7,600 square feet of office and laboratory space in Huntsville, Alabama. The laboratory space lease expires on January 31, 2028393 Legal Proceedings As of the report date, the company is not a party to any material legal proceedings - The company is not currently a party to any material legal proceedings394 Mine Safety Disclosures This item is not applicable to the company - Not applicable395 Part II Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities The company's common stock trades on the NYSE American under the symbol "SER", with Juvenescence providing significant capital through warrant exercises and stock purchases in 2024 - The company's common stock is listed on the NYSE American under the symbol "SER"398 - In June 2024, Juvenescence exercised warrants to purchase 377,865 shares for $5.0 million399 - In November 2024, Juvenescence entered into a stock purchase agreement to buy 1,000,000 shares for $10.0 million, paid in two tranches (November 2024 and January 2025)400401 Management's Discussion and Analysis of Financial Condition and Results of Operations The company reported a net loss of $11.2 million for 2024, a significant increase from 2023, primarily due to increased R&D and G&A expenses and the absence of one-time license revenue - The company's financial statements raise substantial doubt about its ability to continue as a going concern due to operating losses, negative cash flows, and the need for additional capital to fund operations within the next year408444 Comparison of Years Ended December 31, 2024 and 2023 (in thousands) | | 2024 | 2023 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | Total revenues | $ 56 | $ 3,153 | $ (3,097) | | License revenues | $ — | $ 3,000 | $ (3,000) | | Total operating expenses | $ 17,104 | $ 6,282 | $ 10,822 | | Research and development | $ 7,480 | $ 2,388 | $ 5,092 | | General and administrative | $ 9,624 | $ 3,894 | $ 5,730 | | NET (LOSS) INCOME | $ (11,207) | $ 5,269 | $ (16,476) | - Research and development expenses increased by $5.1 million in 2024, primarily due to a $1.9 million increase in outside services for the SER-252 program and a $1.8 million increase in compensation expenses437 - General and administrative expenses increased by $5.7 million in 2024, driven by a $2.5 million increase in compensation (including $2.0 million in stock-based compensation), and higher consulting, insurance, and legal fees associated with being a public company438 Financial Statements and Supplementary Data The audited consolidated financial statements for 2024 and 2023 are presented, with the auditor highlighting substantial doubt about the company's ability to continue as a going concern - The report from the independent registered public accounting firm includes a paragraph expressing substantial doubt about the company's ability to continue as a going concern464 Key Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $ 3,672 | $ 7,619 | | Total Assets | $ 6,724 | $ 8,968 | | Total Liabilities | $ 6,216 | $ 4,858 | | Accumulated deficit | $ (44,318) | $ (33,177) | | Total stockholders' equity (deficit) | $ 508 | $ (32,294) | - The merger with AgeX was accounted for as a reverse recapitalization, with Legacy Serina as the accounting acquirer. The historical financial statements prior to the merger are those of Legacy Serina542543 - The company classifies warrants issued in connection with the merger as liabilities, which are remeasured to fair value each reporting period. For the year ended Dec 31, 2024, this resulted in a $13.2 million non-cash gain from the change in fair value595 Controls and Procedures Management concluded that the company's disclosure controls and procedures were not effective as of December 31, 2024, due to identified material weaknesses in internal control over financial reporting - Management determined that the company's disclosure controls and procedures were not effective as of December 31, 2024662 - Material weaknesses were identified, including: insufficient qualified accounting personnel, lack of data validation, inadequate controls and segregation of duties, and reliance on manual reporting processes666667 - A remediation plan has been initiated, which involves hiring experienced professionals, engaging consultants, developing standardized processes, and improving financial IT systems669673 Part III Directors, Executive Officers, and Corporate Governance This section details the composition of the company's Board of Directors and executive leadership team, including key committee assignments and governance policies - The Board of Directors is composed of seven members, including CEO Steve Ledger and representatives with ties to major shareholder Juvenescence (Dr. Gregory H. Bailey and Dr. Richard Marshall)678680682 - The executive team includes Steve Ledger as CEO, Gregory S. Curhan as CFO (via FLG Partners), Dr. Randall Moreadith as Chief Development Officer, and Dr. Srini Tenjarla as SVP of CMC & Formulation691 - The company has established an Audit Committee, adopted a Code of Business Conduct and Ethics, and implemented an Insider Trading Policy in line with public company governance standards685688689 Executive Compensation As a smaller reporting company, Serina provides reduced executive compensation disclosure, detailing salaries, bonuses, and stock option awards for its named executive officers in 2024 2024 Summary Compensation Table | Name and principal position | Year | Salary ($) | Bonus ($) | Option Awards ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Steve Ledger, CEO | 2024 | 326,250 | 144,949 | 3,232,422 | — | 3,703,621 | | Gregory S. Curhan, CFO | 2024 | — | — | 1,447,750 | 252,663 | 1,700,413 | | Dr. Srinivas Tenjarla, SVP | 2024 | 171,875 | 89,453 | 1,519,960 | — | 1,781,288 | - CEO Steve Ledger's employment agreement provides for an annual base salary of $450,000 and a target bonus of up to 50% of base salary704 - A new director compensation policy was adopted in 2024, providing non-employee directors with annual cash retainers (e.g., $40,000 for board members) and initial and annual stock option grants714718720 Security Ownership of Certain Beneficial Owners and Management, and Related Stockholder Matters This section details the beneficial ownership of the company's common stock as of March 1, 2025, highlighting Juvenescence Limited as the largest beneficial owner Security Ownership of 5% Stockholders | Name of Beneficial Owner | Number of Shares Beneficially Owned | Percentage of Shares Beneficially Owned | | :--- | :--- | :--- | | Juvenescence Limited and certain affiliates | 4,530,374 | 40.5 % | | Puffinus L.P. | 980,025 | 9.8 % | | Helen W. McMillan | 842,404 | 8.4 % | | Barbara M. Fisk | 536,279 | 5.4 % | | Randall Moreadith | 614,961 | 5.8 % | | Miguel Loya | 497,242 | 5.0 % | - As of March 1, 2025, all executive officers and directors as a group beneficially owned approximately 13.5% of the company's common stock728 Certain Relationships and Related Transactions, and Director Independence The company has extensive and complex related-party transactions, primarily with its largest shareholder, Juvenescence Limited, and confirms the independence of five board members - In connection with the merger, AgeX's legacy assets and certain liabilities, including secured debt owed to Juvenescence, were transferred to a subsidiary, UniverXome732733 - In December 2024, the company sold the UniverXome subsidiary to Juvenescence. As consideration, Juvenescence assumed approximately $11.3 million of secured debt that UniverXome owed to it763 - Prior to the merger, AgeX provided Legacy Serina with $10.0 million in financing via a convertible note, which was converted into equity and treated as a capital contribution at the time of the merger764765 - Five directors (Gregory H. Bailey, Remy Gross, Richard Marshall, Karen J. Wilson, and Jay Venkatesan) are determined to be independent under NYSE American Company Guide rules770 Principal Accountant Fees and Services Following the merger, the company appointed Frazier & Deeter, LLC as its independent registered public accounting firm, with aggregate fees for 2024 and 2023 totaling $355,500 and $235,000 respectively Accountant Fees Billed (Fiscal Years 2024 & 2023) | | 2024 | 2023 | | :--- | :--- | :--- | | Audit Fees | $ 282,500 | $ 235,000 | | Audit Related Fees | $ 73,000 | $ — | | Tax Fees | $ — | $ — | | All Other Fees | $ — | $ — | | Total Fees | $ 355,500 | $ 235,000 | - On April 29, 2024, the Audit Committee appointed Frazier & Deeter, LLC as the company's independent registered public accounting firm, replacing WithumSmith+Brown, PC771 Part IV Exhibits and Financial Statement Schedules This section provides a comprehensive list of all exhibits filed with or incorporated by reference into the Form 10-K, including merger agreements and corporate governance documents - The report includes a detailed list of exhibits, such as the Agreement and Plan of Merger, Amended Certificate of Incorporation, various debt and warrant agreements with Juvenescence, and the company's equity incentive plans776777778 Form 10-K Summary The company has not provided a summary for its Form 10-K - None784