What changed in Serina Therapeutics, Inc.'s 2025 10-K compared to 2024?

Across the narrative sections we track, Serina Therapeutics, Inc. (SER) added 320 paragraphs, removed 313, and edited 258 between the 2024 and 2025 10-K filings. The biggest movers are Item 1A. Risk Factors (+148/−150), Item 1. Business (+84/−91), Item 7. Management's Discussion & Analysis (+81/−63).

Did Serina Therapeutics, Inc. add new Risk Factors in the 2025 10-K?

Yes — Item 1A Risk Factors shows 148 new/edited paragraphs and 150 removed paragraphs versus the 2024 10-K.

What changed in Serina Therapeutics, Inc.'s MD&A (Item 7) in 2025?

Item 7 Management's Discussion & Analysis shows 81 new/edited paragraphs and 63 removed paragraphs year-over-year. Read the side-by-side diff to see exactly which revenue, margin, and outlook commentary was rewritten.

Did Serina Therapeutics, Inc. update its Cybersecurity disclosure (Item 1C) in 2025?

Item 1C Cybersecurity has 1 paragraph-level changes between the 2024 and 2025 filings.

Did Serina Therapeutics, Inc.'s Legal Proceedings (Item 3) change in 2025?

Item 3 shows 1 added/edited paragraphs and 1 removed paragraphs — usually indicating new litigation disclosed or settled cases removed.

Where does this SER 10-K diff come from?

The source filings are Serina Therapeutics, Inc.'s official 2024 and 2025 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

What changed in Serina Therapeutics, Inc.'s 10-K — 2024 vs 2025

Paragraph-level year-over-year comparison of Serina Therapeutics, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+320 added−313 removedSource: 10-K (2025-12-31) vs 10-K (2024-12-31)

Top changes in Serina Therapeutics, Inc.'s 2025 10-K

320 paragraphs added · 313 removed · 258 edited across 7 sections

Item 1A. Risk Factors+148 / −150 · 126 edited
Item 1. Business+84 / −91 · 77 edited
Item 7. Management's Discussion & Analysis+81 / −63 · 51 edited
Item 5. Market for Registrant's Common Equity+4 / −6 · 1 edited
Item 1C. Cybersecurity+1 / −1 · 1 edited

Item 1. Business

Business — how the company describes what it does

77 edited+7 added−14 removed214 unchanged

2024 filing

2025 filing

Biggest changeRegulations Concerning Reimbursement Sales of products depend, to a large degree, on the extent to which products will be reimbursed by third-party payors, such as government health programs, commercial insurance, and managed health care organizations. Increasingly, these third-party payors are becoming stricter in the ways they evaluate and reimburse medical products and services.

Biggest changeThe U.K. government has communicated an intent to remove or replace some of 26 Table of Contents these European Union provisions, which may increase some regulatory divergence between the U.K. and the European Union Regulations Concerning Reimbursement Sales of products depend, to a large degree, on the extent to which products will be reimbursed by third-party payors, such as government health programs, commercial insurance, and managed health care organizations.

Securities and Exchange Commission (SEC). In addition, we have previously filed registration statements and other documents with the SEC. Any document we file may be inspected without charge at the SEC’s website at www.sec.gov.

Securities and Exchange Commission (the "SEC"). In addition, we have previously filed registration statements and other documents with the SEC. Any document we file may be inspected without charge at the SEC’s website at www.sec.gov.

The family also covers such poly(oxazoline) polymers linked to various target molecules, such as therapeutic agents and targeting agents and of using such conjugates in the treatment or diagnosis of cancer: Country Type Status Application Date Application Number Grant Date Grant Number Expiration Date US Utility Granted Jan-12-2009 12/744,472 Feb-07-2012 8,110,651 3-21-2029 US Utility Granted (CIP of ‘651) May-25-2010 12/787,241 Jan-24-2012 8,101,706 3-20-2029 US Utility Granted (DIV of ‘706) Jan-23-2012 13/356,552 Aug-06-2013 8,501,899 1-29-2029 US Utility Granted (CON of ‘899) Feb-06-2012 13/367,128 Oct-27-2015 9,169,354 1-12-2029 US Utility Granted (CON of ‘354) Jul-08-2016 15/205,671 Jan-01-2019 10,166,294 1-12-2029 US Utility Granted (CON of ‘294) Dec-28-2018 16/235,936 Jan-04-2022 11,213,588 1-12-2029 17 Table of Content US Utility Granted (CON of ‘588) Jan-04-2022 17/568,042 Mar-12-2024 11,925,689 1-29-2029 US Utility Abandoned March 11-2024 18/601,960 China Utility Granted Jan-12-2009 200980106276.5 Dec-12-2012 1098857 1-12-2029 Japan Utility Granted Jan-12-2009 2010-542410 Apr-04-2014 5,514,736 1-12-2029 Korea (South) Utility Granted Jan-12-2009 10-2010-7017208 Jan-20-2015 10-1486449 1-12-2029 Belgium Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Belgium Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Belgium Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Switzerland Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Switzerland Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Switzerland Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Germany Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Germany Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Germany Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Denmark Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 France Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 France Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 France Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 United Kingdom Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 United Kingdom Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 United Kingdom Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Netherlands Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Netherlands Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Netherlands Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Sweden Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Sweden Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Sweden Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 SER-08 family: “Poly(oxazoline) with Inert Terminating Groups, Polyoxazolines Prepared from Protected Initiating Groups and Related Compounds” (M.

The family also covers such poly(oxazoline) polymers linked to various target molecules, such as therapeutic agents and targeting agents and of using such conjugates in the treatment or diagnosis of cancer: Country Type Status Application Date Application Number Grant Date Grant Number Expiration Date US Utility Granted Jan-12-2009 12/744,472 Feb-07-2012 8,110,651 3-21-2029 US Utility Granted (CIP of ‘651) May-25-2010 12/787,241 Jan-24-2012 8,101,706 3-20-2029 US Utility Granted (DIV of ‘706) Jan-23-2012 13/356,552 Aug-06-2013 8,501,899 1-29-2029 US Utility Granted (CON of ‘899) Feb-06-2012 13/367,128 Oct-27-2015 9,169,354 1-12-2029 US Utility Granted (CON of ‘354) Jul-08-2016 15/205,671 Jan-01-2019 10,166,294 1-12-2029 US Utility Granted (CON of ‘294) Dec-28-2018 16/235,936 Jan-04-2022 11,213,588 1-12-2029 US Utility Granted (CON of ‘588) Jan-04-2022 17/568,042 Mar-12-2024 11,925,689 1-29-2029 17 Table of Contents US Utility Abandoned Mar-11-2024 18/601,960 China Utility Granted Jan-12-2009 200980106276.5 Dec-12-2012 1098857 1-12-2029 Japan Utility Granted Jan-12-2009 2010-542410 Apr-04-2014 5,514,736 1-12-2029 Korea (South) Utility Granted Jan-12-2009 10-2010-7017208 Jan-20-2015 10-1486449 1-12-2029 Belgium Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Belgium Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Belgium Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Switzerland Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Switzerland Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Switzerland Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Germany Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Germany Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Germany Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Denmark Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 France Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 France Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 France Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 United Kingdom Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 United Kingdom Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 United Kingdom Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Netherlands Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Netherlands Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Netherlands Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 Sweden Utility Granted Jan-12-2009 09701187.8 Sep-04-2013 2,235,090 1-12-2029 Sweden Utility Granted Jan-12-2009 13181892.4 Mar-23-2016 2,669,313 1-12-2029 Sweden Utility Granted Jan-12-2009 16154587.6 Jul-19-2017 3,042,922 1-12-2029 SER-08 family: “Poly(oxazoline) with Inert Terminating Groups, Polyoxazolines Prepared from Protected Initiating Groups and Related Compounds” (M.

United States Government Regulation New Drug Application and Biologics License Application Approval Processes The process required by the FDA before a drug or biologic may be marketed in the U.S. generally involves the following: • completion of preclinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practices (“GLP”), and other applicable regulations; • submission to the FDA of an Investigational New Drug Application (“IND”), which must become effective before clinical trials in the U.S. may begin; • performance of adequate and well-controlled clinical trials according to Good Clinical Practices (“GCP”), and other clinical trial-related regulations to establish the safety and efficacy of the proposed drug for its intended use; • submission to the FDA of a New Drug Application (“NDA”) or a Biologics License Application (“BLA”); • satisfactory completion of a pre-approval FDA inspection of the manufacturing facility or facilities at which the product will be produced to assess compliance with cGMP; and • FDA review and approval of the NDA or BLA.

United States Government Regulation New Drug Application and Biologics License Application Approval Processes The process required by the FDA before a drug or biologic may be marketed in the United States generally involves the following: • completion of preclinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practices (“GLP”), and other applicable regulations; • submission to the FDA of an Investigational New Drug Application (“IND”), which must become effective before clinical trials in the United States may begin; • performance of adequate and well-controlled clinical trials according to Good Clinical Practices (“GCP”), and other clinical trial-related regulations to establish the safety and efficacy of the proposed drug for its intended use; • submission to the FDA of a New Drug Application (“NDA”) or a Biologics License Application (“BLA”); • satisfactory completion of a pre-approval FDA inspection of the manufacturing facility or facilities at which the product will be produced to assess compliance with cGMP; and • FDA review and approval of the NDA or BLA.

The AUC (area under the curve) for each set of doses was plotted versus dose administered. PK Simulations for SER 252 in Patients with Advanced Disease Although studies in humans are required for confirmation, Legacy Serina conducted a simulation of human PK based on the results from our preclinical studies in monkeys.

The AUC (area under the curve) for each set of doses was plotted versus dose administered. PK Simulations for SER 252 in Patients with Advanced Disease Although studies in humans are required for confirmation, Serina conducted a simulation of human PK based on the results from our preclinical studies in monkeys.

Licensing, Collaboration and Partnership Agreements In early 2021, Legacy Serina entered into FSAs with several large pharmaceutical and biotechnology companies to advance POZ-lipids as a replacement strategy for PEG-lipids in the current mRNA vaccines. After two years of work with these partners, Legacy Serina entered into licensing discussions to advance POZ-lipids as a replacement for PEG-lipids.

Licensing, Collaboration and Partnership Agreements In early 2021, Serina entered into FSAs with several large pharmaceutical and biotechnology companies to advance POZ-lipids as a replacement strategy for PEG-lipids in the current mRNA vaccines. After two years of work with these partners, Serina entered into licensing discussions to advance POZ-lipids as a replacement for PEG-lipids.

Country Type Status Application Date Application Number Grant Date Grant Number Expiration Date US Utility Granted Feb-04-2022 17/665,190 Feb-25-2025 12233132 5-23-2042 US Utility Pending Nov-7-2023 18/387,528 Canada Utility Pending Jul-24-2023 3206128 China Utility Pending Sept-28-2023 10000513331914 Japan Utility Pending Aug-08-2023 2023-547812 20 Table of Content Israel Utility Pending Jul-26-2023 304773 Europe Utility Pending Aug-24-2023 22753169.6 Australia Utility Pending Jul-24-2023 2022219902 New Zealand Utility Pending Jul-25-2023 802213 South Korea Utility Pending Sept-6-2023 10-2023-7030341 Hong Kong Published May 6, 2024 62024090980.9 SER-25: “Targeting of Antigen-Presenting Cells by Nanoparticles Containing POZ-Lipid Conjugates” (R.

Country Type Status Application Date Application Number Grant Date Grant Number Expiration Date US Utility Granted Feb-04-2022 17/665,190 Feb-25-2025 12233132 5-23-2042 US Utility Pending Nov-7-2023 18/387,528 Canada Utility Pending Jul-24-2023 3206128 China Utility Pending Sept-28-2023 10000513331914 Japan Utility Pending Aug-08-2023 2023-547812 Israel Utility Pending Jul-26-2023 304773 Europe Utility Pending Aug-24-2023 22753169.6 Australia Utility Pending Jul-24-2023 2022219902 20 Table of Contents New Zealand Utility Pending Jul-25-2023 802213 South Korea Utility Pending Sept-6-2023 10-2023-7030341 Hong Kong Published May 6, 2024 62024090980.9 SER-25: “Targeting of Antigen-Presenting Cells by Nanoparticles Containing POZ-Lipid Conjugates” (R.

Country Type Status Application Date Application Number Grant Date Grant Number Expiration Date Australia Utility Granted Jul-27-2019 2019309523 Jan-2-2025 2019309523 7-27-2039 Australia Utility Pending Dec-18-2024 2024278567 19 Table of Content Canada Utility Pending Jul-27-2019 3,107,317 China Utility Pending Jul-27-2019 CN201980063964 Hong Kong Utility Published Jan-26-2022 62022045767.0 Europe Utility Pending Jul-27-2019 19841823.8 Israel Utility Pending Jul-27-2019 280364 Japan Utility Pending Jul-27-2019 2021-504354 Jan-6-2025 7614086 7-27-2039 Korea (South) Utility Pending Jul-27-2019 10-2021-7006020 US Utility Granted Jan-27-2021 17/263,723 Sept-26-2023 11,766,432 7-27-2039 US Utility Pending Sept-19-2023 18/370,069 SER 23 Family: “Polyoxazoline-Drug Conjugates with Novel Pharmacokinetic Properties” (J.

Country Type Status Application Date Application Number Grant Date Grant Number Expiration Date Australia Utility Granted Jul-27-2019 2019309523 Jan-2-2025 2019309523 7-27-2039 Australia Utility Pending Dec-18-2024 2024278567 Canada Utility Pending Jul-27-2019 3,107,317 China Utility Pending Jul-27-2019 CN201980063964 19 Table of Contents Hong Kong Utility Published Jan-26-2022 62022045767.0 Europe Utility Pending Jul-27-2019 19841823.8 Israel Utility Pending Jul-27-2019 280364 Japan Utility Pending Jul-27-2019 2021-504354 Jan-6-2025 7614086 7-27-2039 Korea (South) Utility Pending Jul-27-2019 10-2021-7006020 US Utility Granted Jan-27-2021 17/263,723 Sept-26-2023 11,766,432 7-27-2039 US Utility Pending Sept-19-2023 18/370,069 SER 23 Family: “Polyoxazoline-Drug Conjugates with Novel Pharmacokinetic Properties” (J.

Legacy Serina was formed with the goal of inventing a polymer that was distinct from PEG that could be used for modification of drugs. Our research over the past fifteen years has led to the development of a new polymer technology based on poly(2-ethyl-2-oxazoline).

Serina was formed with the goal of inventing a polymer that was distinct from PEG that could be used for modification of drugs. Our research over the past fifteen years has led to the development of a new polymer technology based on poly(2-ethyl-2-oxazoline).

Our POZ technology is designed to be a “platform technology” in that we anticipate that multiple products can be developed using the same basic polymer. Legacy Serina was first to develop and patent methods to produce polymers of POZ suitable for pharmaceutical applications.

Our POZ technology is designed to be a “platform technology” in that we anticipate that multiple products can be developed using the same basic polymer. Serina was first to develop and patent methods to produce polymers of POZ suitable for pharmaceutical applications.

In the course of these studies, Legacy Serina discovered that the rate-limiting step in the release of apomorphine from the polymer was the release of the “capping linker.” After three and a half years of dedicated efforts to control the release kinetics of apomorphine, Legacy Serina identified SER 252 as the IND candidate.

In the course of these studies, Serina discovered that the rate-limiting step in the release of apomorphine from the polymer was the release of the “capping linker.” After three and a half years of dedicated efforts to control the release kinetics of apomorphine, Serina identified SER 252 as the IND candidate.

In October 2023, Legacy Serina entered into a non-exclusive license agreement with Pfizer to use our POZ polymer technology for use in lipid nanoparticle drug delivery formulations. The agreement grants Pfizer non-exclusive rights to certain intellectual property, know-how, and proprietary technologies.

In October 2023, Serina entered into a non-exclusive license agreement with Pfizer to use our POZ polymer technology for use in lipid nanoparticle drug delivery formulations. The agreement grants Pfizer non-exclusive rights to certain intellectual property, know-how, and proprietary technologies.

Polymers can be used to improve the solubility and stability of such drugs, allowing for better bioavailability. ● Protection of Labile Drugs: Polymers can protect labile or sensitive drugs from degradation in the harsh conditions of the gastrointestinal tract, allowing for oral delivery of drugs that would otherwise be ineffective when taken orally. 7 Table of Content ● Reduced Toxicity: Polymer encapsulation can help reduce the toxicity of certain drugs by controlling their release and preventing peak concentrations that can lead to adverse effects. ● Long-Acting Formulations: Polymer-based formulations can extend the duration of drug action, reducing the frequency of administration.

Polymers can be used to improve the solubility and stability of such drugs, allowing for better bioavailability. ● Protection of Labile Drugs: Polymers can protect labile or sensitive drugs from degradation in the harsh conditions of the gastrointestinal tract, allowing for oral delivery of drugs that would otherwise be ineffective when taken orally. ● Reduced Toxicity: Polymer encapsulation can help reduce the toxicity of certain drugs by controlling their release and preventing peak concentrations that can lead to adverse effects. 7 Table of Contents ● Long-Acting Formulations: Polymer-based formulations can extend the duration of drug action, reducing the frequency of administration.

SER 252 (POZ-apomorphine) In early 2018, Legacy Serina initiated work on developing a polymer conjugate of apomorphine that could be delivered as a subcutaneous injection that is devoid of any skin reactions. The first step was attachment of apomorphine to the polymer.

SER 252 (POZ-apomorphine) In early 2018, Serina initiated work on developing a polymer conjugate of apomorphine that could be delivered as a subcutaneous injection that is devoid of any skin reactions. The first step was attachment of apomorphine to the polymer.

Products manufactured or distributed pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things: • record-keeping requirements; • reporting of adverse experiences with the product; 24 Table of Content • providing the FDA with updated safety and efficacy information; • drug sampling and distribution requirements; • notifying the FDA and gaining its approval of specified manufacturing or labeling changes; • complying with certain electronic records and signature requirements; and • complying with FDA promotion and advertising requirements.

Products manufactured or distributed pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things: • record-keeping requirements; • reporting of adverse experiences with the product; • providing the FDA with updated safety and efficacy information; 24 Table of Contents • drug sampling and distribution requirements; • notifying the FDA and gaining its approval of specified manufacturing or labeling changes; • complying with certain electronic records and signature requirements; and • complying with FDA promotion and advertising requirements.

Expiration dates for non-domestic patent rights are based on a strict calculation of 20 years from the 16 Table of Content earliest filing date and, as such, Patent Term Adjustment in accordance with the jurisdiction could extend this term further than indicated. SER 01 Family: “Activated Polyoxazolines and Compositions Comprising the Same” (J. M. Harris et al .).

Expiration dates for non-domestic patent rights are based on a strict calculation of 20 years from the earliest filing date and, as such, Patent Term Adjustment in accordance with the jurisdiction could extend this term further than indicated. 16 Table of Contents SER 01 Family: “Activated Polyoxazolines and Compositions Comprising the Same” (J. M. Harris et al .).

Higher drug loading per mole of polymer means that less amount of POZ polymer is required when compared to PEG polymer for delivery of the same amount of active drug. 5 Table of Content ● No accumulation –Studies to date indicate that POZ does not accumulate in tissues when given at dose levels anticipated to be given to humans, is not metabolized, and is cleared almost entirely through renal filtration.

Higher drug loading per mole of polymer means that less amount of POZ polymer is required when compared to PEG polymer for delivery of the same amount of active drug. 5 Table of Contents ● No accumulation –Studies to date indicate that POZ does not accumulate in tissues when given at dose levels anticipated to be given to humans, is not metabolized, and is cleared almost entirely through renal filtration.

The daily set-up often requires a healthcare provider to come in each day to help the 13 Table of Content patient administer the drug. We believe that development of a more convenient method of delivering apomorphine, without having to use a complicated infusion device or confounded by serious skin reactions, would be a major contribution to patient care.

The daily set-up often requires a healthcare provider to come in each day to help the patient 13 Table of Contents administer the drug. We believe that development of a more convenient method of delivering apomorphine, without having to use a complicated infusion device or confounded by serious skin reactions, would be a major contribution to patient care.

If the FDA accepts the IND, the drug or biologic can then be studied in human clinical trials to determine if the product candidate is safe and effective. Clinical trials typicaaly involve three separate phases that often overlap, can take many years and are expensive. These three phases, which are subject to considerable regulation, are as follows: • Phase 1.

If the FDA accepts the IND, the drug or biologic can then be studied in human clinical trials to determine if the product candidate is safe and effective. Clinical trials typically involve three separate phases that often overlap, can take many years and are expensive. These three phases, which are subject to considerable regulation, are as follows: • Phase 1.

There appeared to be a dose-dependent change from baseline as the doses were increased. This is shown in Figure 3 below. 11 Table of Content Figure 2: Effect of dose of SER 214 on change from baseline in UPDRS (Part III) Subjects who completed the final two weeks of dosing were shown to be at steady-state release.

There appeared to be a dose-dependent change from baseline as the doses were increased. This is shown in Figure 3 below. 11 Table of Contents Figure 2: Effect of dose of SER 214 on change from baseline in UPDRS (Part III) Subjects who completed the final two weeks of dosing were shown to be at steady-state release.

We believe that the anti-PEG antibody issue potentially has the unintended consequence of compromising the efficacy of the next generation of vaccines due to accelerated blood clearance. We have entered into preclinical feasibility studies with two major pharmaceutical companies toward the goal of developing “PEG-alternative” LNP vaccines for infectious diseases.

We believe that the anti-PEG antibody issue potentially has the unintended consequence of compromising the efficacy of the next generation of vaccines due to accelerated blood clearance. We previously entered into preclinical feasibility studies with two major pharmaceutical companies toward the goal of developing “PEG-alternative” LNP vaccines for infectious diseases.

We believe that it may be possible that this product candidate can be delivered in the patient’s home without the need for a healthcare provider. If the results show SER 252 is well-tolerated with predictable PK, we expect to proceed to a Phase I MAD study in advanced patients in 2026.

CDS is a long-sought clinical strategy for Parkinson’s disease that currently approved therapies fall short of delivering. We intend to develop other potential applications of the POZ technology, such as therapeutics delivered through Antibody Drug Conjugates ('ADCs and Lipid Nanoparticle ("LNP") technology, through partnerships.

CDS is a long-sought clinical strategy for Parkinson’s disease that currently approved therapies fall short of delivering. We intend to develop other potential applications of the POZ technology, such as therapeutics delivered through Antibody Drug Conjugates ("ADCs") and Lipid Nanoparticle ("LNP") technology, through partnerships.

There was no apparent dose relationship, and no patient experienced new onset or worsening of dyskinesia. 12 Table of Content In summary, the Phase Ia study demonstrated SER 214 is a well-tolerated injection when administered subcutaneously in stable patients with early signs of Parkinson’s disease.

There was no apparent dose relationship, and no patient experienced new onset or worsening of dyskinesia. 12 Table of Contents In summary, the Phase Ia study demonstrated SER 214 is a well-tolerated injection when administered subcutaneously in stable patients with early signs of Parkinson’s disease.

Our lead product candidate, SER 252 (POZ-apomorphine), is a POZ conjugate of the potent dopamine agonist apomorphine being developed for the treatment of Parkinson’s disease and is in preclinical development. SER 252 is designed to provide CDS via a subcutaneous injection delivered one to two times per week.

Our lead product candidate, SER 252 (POZ-apomorphine), is a POZ conjugate of the potent dopamine agonist apomorphine being developed for the treatment of Parkinson’s disease and is in clinical development. SER 252 is designed to provide CDS via a subcutaneous injection delivered one to two times per week.

We believe that there is significant potential for SER 252 to become such an alternative, potentially leading 15 Table of Content to a paradigm shift in how patients with Parkinson’s disease might be treated.

We believe that there is significant potential for SER 252 to become such an alternative, potentially leading 15 Table of Contents to a paradigm shift in how patients with Parkinson’s disease might be treated.

Under the BPCIA, a reference biological product is granted 12 years of data exclusivity, the period of time during which an innovator’s clinical data cannot be used by other companies, from the time of first licensure of the product, and an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by 25 Table of Content the FDA.

In almost all instances of oral treatment with any of these compounds, patients may experience “wearing off” where the drug fails to deliver an adequate dopaminergic stimulus after being used for months to years or the drugs may promote a disabling side effect known as dyskinesia (involuntary 9 Table of Content movements of the extremities).

For example, the member states of the E.U. can restrict the range of drugs for which their national health insurance systems provide reimbursement and can control the prices of prescription drugs. In addition, many ex-U.S. government payors require companies to provide health economic assessments of products, which are evaluated by government agencies set up for this purpose.

For example, the member states of the European Union can restrict the range of drugs for which their national health insurance systems provide reimbursement and can control the prices of prescription drugs. In addition, many ex-U.S. government payors require companies to provide health economic assessments of products, which are evaluated by government agencies set up for this purpose.

Fast track is a process designed to facilitate the development and expedite the review of such products by providing, among other things, more frequent meetings with the FDA to discuss the product’s 23 Table of Content development plan and rolling review, which allows submission of individually completed sections of an NDA or BLA for FDA review before the entire submission is completed.

Fast track is a process designed to facilitate the development and expedite the review of such products by providing, among other things, more frequent meetings with the FDA to discuss the product’s development plan and rolling review, which allows submission of individually completed sections of an NDA or BLA for FDA review before the entire submission is completed.

Clinical trials are next initiated in a limited patient population with the specified disease or condition the drug or biologic is intended to treat to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the drug or biologic candidate for the disease or condition it is intended to treat and to determine dosage tolerance and optimal dosage. 22 Table of Content • Phase 3.

Our preclinical studies in monkeys suggest SER 252 may be administered as a single subcutaneous injection twice a week, provides continuous delivery of apomorphine and has no skin liabilities. our use is designed to be administered in the convenience of the patient’s home without the need for a healthcare provider.

Our preclinical studies in 8 Table of Contents monkeys suggest SER 252 may be administered as a single subcutaneous injection twice a week, provides continuous delivery of apomorphine and has no skin liabilities. Our use is designed to be administered in the convenience of the patient’s home without the need for a healthcare provider.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk-benefit ratio of the drug or biologic and provide an adequate basis for regulatory approval and product labeling.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the 22 Table of Contents overall risk-benefit ratio of the drug or biologic and provide an adequate basis for regulatory approval and product labeling.

PEGylation technology has been applied to various therapeutic modalities or payloads including small molecules, aptamers, peptides, and proteins, leading to over 30 FDA approved PEGylated drugs currently in use and many investigational PEGylated agents under clinical trials. Government Regulation Our operations and activities are subject to extensive regulation by numerous government authorities in the U.S., Europe and other countries.

PEGylation technology has been applied to various therapeutic modalities or payloads including small molecules, aptamers, peptides, and proteins, leading to over 30 FDA approved PEGylated drugs currently in use and many investigational PEGylated agents under clinical trials. 21 Table of Contents Government Regulation Our operations and activities are subject to extensive regulation by numerous government authorities in the U.S., Europe and other countries.

W. Moreadith et al.) This family of patents provides for poly(oxazoline) conjugates of dopamine agonists and subcutaneous delivery of these conjugates for treatment of conditions related to dopamine insufficiency, such as Parkinson’s disease. In particular, this 18 Table of Content family includes claims to conjugates containing rotigotine, i.e ., SER-214.

W. Moreadith et al. ) This family of patents provides for poly(oxazoline) conjugates of dopamine agonists and subcutaneous delivery of these conjugates for treatment of conditions related to dopamine insufficiency, such as Parkinson’s disease. In particular, this family includes claims to conjugates containing rotigotine, i.e ., SER-214.

Our collection and use of personal data as part of our business activities is subject to various privacy and data security laws and regulations, including oversight by various regulatory or other governmental bodies, in the U.S., E.U., U.K., Canada, Australia, Brazil, Saudi Arabia and other jurisdictions.

Our collection and use of personal data as part of our business activities is subject to various privacy and data security laws and regulations, including oversight by various regulatory or other governmental bodies, in the U.S., European Union, U.K., Canada, Australia, Brazil, Saudi Arabia and other jurisdictions.

Figure 1: Pharmacokinetic profile of SER 214 in Parkinson’s disease subjects in Phase Ia 10 Table of Content Figure 1 : PK profile of released drug in Parkinson’s disease subjects who received an initial dose of 50 mg SER 214, followed by a single dose of 100 mg SER 214, and then two weekly doses of 200 mg SER 214.

Figure 1: Pharmacokinetic profile of SER 214 in Parkinson’s disease subjects in Phase Ia Figure 1 : PK profile of released drug in Parkinson’s disease subjects who received an initial dose of 50 mg SER 214, followed by a single dose of 100 mg SER 214, and then two weekly doses of 200 mg SER 214.

The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval. Under the E.U. regulatory system, a company may submit marketing authorization applications either under a centralized or decentralized procedure.

The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval. Under the European Union regulatory system, a company may submit marketing authorization applications either under a centralized or decentralized procedure.

“ON” time refers to those periods where the patient is able to perform routine daily activities. Apo-go is confounded by significant skin reactions in approximately 40% of patients, often leading to permanent scarring (nodules) on the abdomen.

“ON” time refers to those periods where the patient is able to perform routine daily activities. Onapgo is confounded by significant skin reactions in approximately 40% of patients, often leading to permanent scarring (nodules) on the abdomen.

The following results, which represent industry standard methodology for simulation, were obtained: Figure 6: 14 Table of Content Figure 6 : Simulations for human PK.

The following results, which represent industry standard methodology for simulation, were obtained: Figure 6: 14 Table of Contents Figure 6 : Simulations for human PK.

The centralized procedure, which is compulsory for orphan medicines, medicines produced by biotechnology, and those medicines intended to treat AIDS, cancer, neurodegenerative disorders, or diabetes, and optional for those medicines that are highly innovative, provides for the grant of a single marketing authorization that is valid for all E.U. member states.

Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as by the possibility of exclusion from federal healthcare 28 Table of Content programs (including Medicare and Medicaid).

In the U.S., Europe and other countries, our products are subject to rigorous regulations governing their testing, manufacture, labeling, storage, record keeping, approval, and advertising and promotion. As a result of these regulations, product development and product approval processes are very expensive and time consuming.

In the United States, Europe and other countries, our products are subject to rigorous regulations governing their testing, manufacture, labeling, storage, record keeping, approval, and advertising and promotion. As a result of these regulations, product development and product approval processes are very expensive and time consuming.

At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law. Biologics are also eligible for orphan drug exclusivity, as discussed below.

Failure to comply with the applicable U.S. requirements at any time during the drug or biologic development process, approval process or after approval, may subject us or our collaborators to administrative or judicial sanctions, any of which could have a material adverse effect on us.

Failure to comply with the applicable United States requirements at any time during the drug or biologic development process, approval process or after approval, may subject us or our collaborators to administrative or judicial sanctions, any of which could have a material adverse effect on us.

Thus, whether or not we obtain FDA approval for a product candidate, we must obtain approval from the comparable regulatory authorities of foreign countries or economic areas, such as the E.U., before we can commence clinical trials or market products in those countries or areas.

Thus, whether or not we obtain FDA approval for a product candidate, we must obtain approval from the comparable regulatory authorities of foreign countries or economic areas, such as the European Union, before we can commence clinical trials or market products in those countries or areas.

Orphan Drug Designation and Exclusivity Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 people in the U.S.

The Patient Protection and Affordable Care Act (“ACA”) was enacted in March 2010 and was designed to expand coverage for the uninsured while at the same time containing overall health care costs.

The Patient Protection and Affordable Care Act 27 Table of Contents (“ACA”) was enacted in March 2010 and was designed to expand coverage for the uninsured while at the same time containing overall health care costs.

The laws include U.S. federal and state “sunshine” provisions. The federal sunshine provisions apply to pharmaceutical manufacturers with products reimbursed under certain government programs and require those manufacturers to disclose annually to the federal government (for re-disclosure to the public) certain payments and other transfers of value made to physicians, physicians assistants, advanced practice registered nurses, and teaching hospitals.

The federal sunshine provisions apply to pharmaceutical manufacturers with products reimbursed under certain government programs and require those manufacturers to disclose annually to the federal government (for re-disclosure to the public) certain payments and other transfers of value made to physicians, physicians assistants, advanced practice registered nurses, and teaching hospitals.

“Regenerative Medicine Advanced Therapy,” (“RMAT”) designation is a process created by the 21st Century Cures Act in December 2016.

“Regenerative Medicine Advanced Therapy” (“RMAT”) designation is a process created by the 21st Century Cures Act in December 2016.

Specifically, PEGylation can improve the parent drug’s solubility, extend our circulation time, and reduce our immunogenicity, with minimal 21 Table of Content undesirable properties.

Specifically, PEGylation can improve the parent drug’s solubility, extend our circulation time, and reduce our immunogenicity, with minimal undesirable properties.

Country Type Status Application Date Application Number Grant Date Grant Number Expiration Date US Utility Granted Jun-15-2012 13/524,994 Feb-26-2013 8,383,093 6-15-2032 US Utility Granted Feb-22-2013 13/774,304 Dec-03-2013 8,597,633 6-15-2032 US Utility Granted Jun-29-2016 15/197,336 Jun-11-2019 10,314,837 6-15-2032 US Utility Granted Jun-10-2019 16/436,590 Jan-18-2022 11,224,595 6-15-2032 US Utility Granted Apr-05-2017 15/480,122 Oct-01-2019 10,426,768 6-15-2032 US Utility Granted Sep-30-2019 16/588,761 Apr-12-2022 11,298,350 6-15-2032 US Utility Granted Apr-11-2022 17/717,666 Apr-2-2024 11,944,618 6-15-2032 Canada Utility Granted Nov-01-2012 2,854,361 Aug-11-2020 2,854,361 11-1-2032 Japan Utility Granted Nov-01-2012 2014-540093 Jul-21-2017 6,177,787 11-1-2032 Japan Utility Granted Jul-11-2017 2017-135578 Apr-26-2019 6,517,281 11-1-2032 Japan Utility Granted Apr-16-2019 2019-077583 May-12-2021 6,883,605 11-1-2032 Korea (South) Utility Granted Nov-01-2012 10-2014-7014846 May-21-2020 10-2115862 11-1-2032 Belgium Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Switzerland Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Germany Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Denmark Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 United Kingdom Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 France Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Netherlands Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Sweden Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 SER 18 Family: “Polyoxazoline Antibody Drug Conjugates” (R.

The ʼ633 patent (US) has broader claims and would cover other molecules administered as subcutaneous injections, including but not limited to SER-226/227, SER-228/229 SER-232 and SER-252. 18 Table of Contents Country Type Status Application Date Application Number Grant Date Grant Number Expiration Date US Utility Granted Jun-15-2012 13/524,994 Feb-26-2013 8,383,093 6-15-2032 US Utility Granted Feb-22-2013 13/774,304 Dec-03-2013 8,597,633 6-15-2032 US Utility Granted Jun-29-2016 15/197,336 Jun-11-2019 10,314,837 6-15-2032 US Utility Granted Jun-10-2019 16/436,590 Jan-18-2022 11,224,595 6-15-2032 US Utility Granted Apr-05-2017 15/480,122 Oct-01-2019 10,426,768 6-15-2032 US Utility Granted Sep-30-2019 16/588,761 Apr-12-2022 11,298,350 6-15-2032 US Utility Granted Apr-11-2022 17/717,666 Apr-2-2024 11,944,618 6-15-2032 Canada Utility Granted Nov-01-2012 2,854,361 Aug-11-2020 2,854,361 11-1-2032 Japan Utility Granted Nov-01-2012 2014-540093 Jul-21-2017 6,177,787 11-1-2032 Japan Utility Granted Jul-11-2017 2017-135578 Apr-26-2019 6,517,281 11-1-2032 Japan Utility Granted Apr-16-2019 2019-077583 May-12-2021 6,883,605 11-1-2032 Korea (South) Utility Granted Nov-01-2012 10-2014-7014846 May-21-2020 10-2115862 11-1-2032 Belgium Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Switzerland Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Germany Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Denmark Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 United Kingdom Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 France Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Netherlands Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 Sweden Utility Granted Nov-01-2012 12846647.1 Oct-09-2019 2,773,379 11-1-2032 SER 18 Family: “Polyoxazoline Antibody Drug Conjugates” (R.

The treatment of advanced Parkinson’s disease relies on multiple therapies, including levodopa (“L-DOPA”), compounds that inhibit the breakdown of L-DOPA in the brain (catechol-O-methyl transferase, or COMT; for example, opicopone), dopamine agonists (transdermal rotigotine; for example, Neupro TM ) and others.

We have advanced SER 252 into Phase I clinical trials in February 2026 for patients with advanced Parkinson’s disease. The treatment of advanced Parkinson’s disease relies on multiple therapies, including levodopa (“L-DOPA”), compounds that inhibit the breakdown of L-DOPA in the brain (catechol-O-methyl transferase, or COMT; for example, opicopone), dopamine agonists (transdermal rotigotine; for example, Neupro TM ) and others.

Various laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import, export and use and disposal of hazardous or potentially hazardous substances are or may be applicable to our activities.

Subsequently, another product providing CDS (Abbvie - Vyalev) was approved by the FDA (October 2024). The Vyalev product is a liquid formulation of the prodrugs foslevodopa-foscarbidopa that is continuously infused subcutaneously using an electronic pump. This represented a substantial new treatment option for advanced Parkinson’s disease patients.

“Breakthrough Therapy” designation is a process designed to expedite the development and review of drugs or biologics that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug or biologic may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints.

Fast track status does not ensure that a product will be developed more quickly or receive FDA approval. 23 Table of Contents “Breakthrough Therapy” designation is a process designed to expedite the development and review of drugs or biologics that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug or biologic may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints.

The results in Figure 1 show that a single weekly injection of SER 214 provided continuous drug delivery in the predicted therapeutic window where plasma levels of rotigotine would be expected to provide control of symptoms of early Parkinson’s (yellow shaded area).

From the data, it would appear a weekly injection of SER 214 of 200 mg (in 1 mL) approximates the levels of rotigotine from the daily 3 mg transdermal patch. 10 Table of Contents The results in Figure 1 show that a single weekly injection of SER 214 provided continuous drug delivery in the predicted therapeutic window where plasma levels of rotigotine would be expected to provide control of symptoms of early Parkinson’s (yellow shaded area).

Among our development candidates, we intend to internally advance SER 252 for advanced Parkinson’s disease. We do not believe we will require a license to the API associated with SER 252. We are advancing our research and development efforts for POZ technology in LNP delivered ribonucleic acid (“RNA”) vaccines for infectious diseases.

We do not believe we will require a license to the API associated with SER 252. We are advancing our research and development efforts for POZ technology in LNP delivered ribonucleic acid (“RNA”) vaccines for infectious diseases. We intend to advance additional applications of the POZ platform via out-licensing, co-development, or other partnership arrangements.

In addition to the centralized procedure, the E.U. also has a nationalized procedure, which requires a separate application to and approval determination by each country; a decentralized procedure, whereby applicants submit identical applications to several countries and receive simultaneous approval; and a mutual recognition procedure, where applicants submit an application to one country for review and other countries may accept or reject the initial decision. 26 Table of Content Despite the U.K. formally withdrawing from the E.U. on January 31, 2020, a number of E.U. regulations were retained in U.K. law.

In addition to the centralized procedure, the European Union also has a nationalized procedure, which requires a separate application to and approval determination by each country; a decentralized procedure, whereby applicants submit identical applications to several countries and receive simultaneous approval; and a mutual recognition procedure, where applicants submit an application to one country for review and other countries may accept or reject the initial decision.

Liability under the FCA may also arise when a violation of certain laws or regulations related to the underlying products (e.g., violations regarding improper promotional activity, manufacturing regulations, or unlawful payments) contributes to the submission of a false claim. If we were subject to allegations concerning, or convicted of violating, these laws, our business could be harmed.

Liability under the FCA may also arise when a violation of certain laws or regulations related to the underlying products (e.g., violations regarding improper promotional activity, manufacturing regulations, or 28 Table of Contents unlawful payments) contributes to the submission of a false claim.

We have not internally advanced SER 214 beyond Phase Ia and will seek to partner on any further development. We believe the SER 214 program, while not being advanced internally, provided data important to the development of a POZ dopamine agonist 8 Table of Content (such as rotigotine and apomorphine) conjugate to enable CDS in Parkinson’s patients.

We believe the SER 214 program, while not being advanced internally, provided data important to the development of a POZ dopamine agonist (such as rotigotine and apomorphine) conjugate to enable CDS in Parkinson’s patients. This research led to the development of SER 252. SER 252 (POZ-apomorphine).

Our POZ technology platform has attributes that we believe has the potential to allow POZ-conjugates to deliver on the approach of prolonging the PKs of attached drugs, thus enabling continuous drug delivery.

This represented a substantial new treatment option for advanced Parkinson’s disease patients. 9 Table of Contents Our POZ technology platform has attributes that we believe has the potential to allow POZ-conjugates to deliver on the approach of prolonging the PKs of attached drugs, thus enabling continuous drug delivery.

Further, after approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of unapproved uses, as well as false or misleading promotion. Further, after approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval.

We intend to potentially out-license this product candidate. We have not received FDA approval for any of our product candidates and our lead product candidate remains in preclinical development. Our Development Pipeline We believe that our POZ platform delivery technology has potential for use across a broad range of payloads and indications.

We intend to potentially out-license this product candidate. Our Development Pipeline We believe that our POZ platform delivery technology has potential for use across a broad range of payloads and indications. Among our development candidates, we intend to internally advance SER 252 for advanced Parkinson’s disease.

As a consequence, these payors may not cover or adequately reimburse for use of our products or may do so at levels that disadvantage them relative to competitive products. 27 Table of Content The U.S. government has shown significant interest in implementing cost-containment programs for medicines and has enacted reforms at the state and federal level designed to, among other things, modify prescription drug reimbursement amounts and methodologies, and otherwise control health care costs.

The U.S. government has shown significant interest in implementing cost-containment programs for medicines and has enacted reforms at the state and federal level designed to, among other things, modify prescription drug reimbursement amounts and methodologies, and otherwise control health care costs.

Laws and regulations also have been enacted by the federal government and various states to regulate the sales and marketing practices of pharmaceutical manufacturers. The laws and regulations generally limit financial interactions between manufacturers and health care providers, require manufacturers to adopt certain compliance standards or require disclosure to the government and public of such interactions.

The laws and regulations generally limit financial interactions between manufacturers and health care providers, require manufacturers to adopt certain compliance standards or require disclosure to the government and public of such interactions. The laws include U.S. federal and state “sunshine” provisions.

We have not received FDA approval for any of our product candidates and our lead product candidate remains in preclinical development. Parkinson’s Disease Parkinson’s disease is a chronic, disabling disorder that results from a deficiency of dopamine in the brain. Dopamine deficiency results from a degeneration of dopaminergic neurons in a portion of the brain known as the substantia nigra.

Parkinson’s Disease Parkinson’s disease is a chronic, disabling disorder that results from a deficiency of dopamine in the brain. Dopamine deficiency results from a degeneration of dopaminergic neurons in a portion of the brain known as the substantia nigra.

An infusion therapy known as Apo-go (apomorphine) is available in the European Union, or EU, but is not yet available in the United States. Apo-go must be administered as a 12–16-hour continuous infusion through an electronic pump and a standard insulin infusion set.

An infusion therapy known as Onapgo (apomorphine) is now available in the United States after its approval by the FDA on Feb. 4, 2025. Onapgo must be administered as a 12–16-hour continuous infusion through an electronic pump and a standard insulin infusion set.

Item 1. Business 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).

Item 1. Business Overview We are a clinical-stage biotechnology company developing a pipeline of wholly-owned drug product candidates to treat neurological diseases and other indications.

In addition, the sponsor of an approved drug in the U.S. may not promote that drug for unapproved, although a physician may prescribe a drug for an unapproved use in accordance with the practice of medicine. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of unapproved uses, as well as false or misleading promotion.

In addition, the sponsor of an approved drug in the United States may not promote that drug for unapproved, although a physician may prescribe a drug for an unapproved use in accordance with the practice of medicine.

Facilities Our current headquarters located in Huntsville, Alabama is comprised of approximately 7,600 square feet of office and laboratory space. The lease term is two years for the office space and five years for the laboratory space. The lease termination date is October 31, 2025 for the office space and January 31, 2028 for the laboratory space.

We do not have any employees represented by a labor union or covered under a collective bargaining agreement. Facilities Our current headquarters located in Huntsville, Alabama is comprised of approximately 7,600 square feet of office and laboratory space. The lease term is two years for the office space and five years for the laboratory space.

Additionally, the containment of health care costs has become a priority of many governments, and the prices of drugs have been a focus in this effort. The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products.

The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could limit our revenues.

Current candidates include: SER 214 (POZ-rotigotine) was the first product from our pipeline to be advanced into humans. Legacy Serina initiated a Phase Ia trial in July 2015 in 19 stably treated Parkinson’s subjects. The trial was completed in January 2017 with data published in a June 2020 article in Movement Disorders.

Our Product Candidates Serina intends to focus on advancing our SER 252 POZ-apomorphine drug candidate and selectively explore new molecules for potential internal development, co-development and partnering. Current candidates include: SER 214 (POZ-rotigotine) was the first product from our pipeline to be advanced into humans. Serina initiated a Phase Ia trial in July 2015 in 19 stably treated Parkinson’s subjects.

We intend to advance SER 252 into Phase I clinical trials in second half of 2025 for patients with advanced Parkinson’s disease. Our Strategy Our strategy is to develop and commercialize polymer therapeutics based on conjugation of suitable small molecules to our proprietary POZ.

In February 2026, we enrolled and dosed our first patient in our Phase 1b clinical trial for SER-252. 6 Table of Contents Our Strategy Our strategy is to develop and commercialize polymer therapeutics based on conjugation of suitable small molecules to our proprietary POZ.

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could limit our revenues. Decisions by third-party payors to not cover a product could reduce physician usage of the product. There are a number of governmental pricing programs in the U.S., including the Medicaid Drug Rebate program, Medicare.

Decisions by third-party payors to not cover a product could reduce physician usage of the product. There are a number of governmental pricing programs in the United States, including the Medicaid Drug Rebate program, Medicare. Medicaid is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries.

Investor Information Financial and other information about us is available on our website at www.serinatherapeutics.com.

The lease termination date is October 31, 2028 for the office space and January 31, 2028 for the laboratory space. Investor Information Financial and other information about us is available on our website at https://www.serinatx.com/.

This was a single and multi-dose, dose-escalation study in patients who were not experiencing significant motor fluctuations. Patients in the study were allowed to be on existing therapy for Parkinson’s disease, or be on no therapy, but have a definitive diagnosis of Parkinson’s disease.

Patients in the study were allowed to be on existing therapy for Parkinson’s disease, or be on no therapy, but have a definitive diagnosis of Parkinson’s disease. We have not internally advanced SER 214 beyond Phase Ia and will seek to partner on any further development.

Removed

We intend to advance additional applications of the POZ platform via out-licensing, co-development, or other partnership arrangements. These applications may include other CNS disorders and POZ LNP relevant disease fields.

Added

Our 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.

Removed

We have not received FDA approval for any of our product candidates and our lead product candidate remains in preclinical development. 6 Table of Content SER 252 IND-enabling preclinical studies were initiated in August 2023 and are anticipated to be completed in the second quarter of 2025.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

126 edited+22 added−24 removed459 unchanged

2024 filing

2025 filing

Biggest changeTo the extent that we continue to generate taxable losses, unused losses will carry forward to offset future taxable income, if any, until such unused losses expire, if at all. As of December 31, 2024, we had U.S. federal NOL carryforwards of $87.8 million, which will begin to expire in 2027 and $63.1 million that have an unlimited carryforward period.

Biggest changeAs of December 31, 2025, we had U.S. federal NOL carryforwards of $106.8 million, which will begin to expire in 2027 and $82.8 million that have an unlimited carryforward period. Additionally, for state income tax purposes, we had NOLs of $94.2 million that will expire at various dates between 2026 and 2045.

You should consider carefully the risks and uncertainties described below, together with all of the other information in this Report, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes, before deciding whether to purchase any of our securities.

Market acceptance of our products by the medical community, patients, and third-party payors will depend on a number of factors, some of which are beyond our control, including: ● the efficacy of our products and the prevalence and severity of any adverse events; ● any potential advantages or disadvantages when compared to alternative treatments; ● interactions of our products with other medicines patients are taking and any restrictions on the use of our products together with other medications; ● the clinical indications for which the products are approved and the approved claims that we may make for the products; 47 Table of Content ● limitations or warnings contained in the product’s FDA approved labeling, including potential limitations or warnings for such products that may be more restrictive than other competitive products; ● changes in the standard of care for the targeted indications for such product candidates, which could reduce the marketing impact of any claims that we could make following approval, if obtained; ● the safety, efficacy, and other potential advantages over alternative treatments, such as relative convenience and ease of administration of such products, and the availability of alternative treatments already used or that may later be approved; ● cost of treatment versus economic and clinical benefit in relation to alternative treatments or therapies; ● the availability of formulary coverage and adequate coverage or reimbursement by third parties, such as insurance companies and other health care payors, and by U.S. and international government health care programs, including Medicaid and Medicare; ● the price concessions required by third-party payors and government health care programs to obtain coverage and payment; ● the extent and strength of our marketing and distribution of such products; ● distribution and use restrictions imposed by the FDA and equivalent foreign regulatory authorities with respect to such products or to which we agree, for instance, as part of a REMS or voluntary risk management plan; ● the timing of market introduction of such products, as well as competitive products; ● our ability to offer such products for sale at competitive prices; ● our ability to offer programs to facilitate market acceptance and insurance coverage from public and private insurance companies, provide patient assistance, and transition patient coverage; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the extent and strength of our third-party manufacturer and supplier support; ● the approval of other new products, including biosimilar products that may be priced at a substantially lower price than we expect to offer our product candidates for, if approved; ● adverse publicity about the product or favorable publicity about competitive products; ● the success of any efforts to educate the medical community and third-party payors regarding our products, which efforts may require significant resources and may not be successful; and ● potential product liability claims.

Market acceptance of our products by the medical community, patients, and third-party payors will depend on a number of factors, some of which are beyond our control, including: ● the efficacy of our products and the prevalence and severity of any adverse events; ● any potential advantages or disadvantages when compared to alternative treatments; ● interactions of our products with other medicines patients are taking and any restrictions on the use of our products together with other medications; ● the clinical indications for which the products are approved and the approved claims that we may make for the products; ● limitations or warnings contained in the product’s FDA approved labeling, including potential limitations or warnings for such products that may be more restrictive than other competitive products; ● changes in the standard of care for the targeted indications for such product candidates, which could reduce the marketing impact of any claims that we could make following approval, if obtained; ● the safety, efficacy, and other potential advantages over alternative treatments, such as relative convenience and ease of administration of such products, and the availability of alternative treatments already used or that may later be approved; ● cost of treatment versus economic and clinical benefit in relation to alternative treatments or therapies; ● the availability of formulary coverage and adequate coverage or reimbursement by third parties, such as insurance companies and other health care payors, and by U.S. and international government health care programs, including Medicaid and Medicare; ● the price concessions required by third-party payors and government health care programs to obtain coverage and payment; ● the extent and strength of our marketing and distribution of such products; 47 Table of Contents ● distribution and use restrictions imposed by the FDA and equivalent foreign regulatory authorities with respect to such products or to which we agree, for instance, as part of a REMS or voluntary risk management plan; ● the timing of market introduction of such products, as well as competitive products; ● our ability to offer such products for sale at competitive prices; ● our ability to offer programs to facilitate market acceptance and insurance coverage from public and private insurance companies, provide patient assistance, and transition patient coverage; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the extent and strength of our third-party manufacturer and supplier support; ● the approval of other new products, including biosimilar products that may be priced at a substantially lower price than we expect to offer our product candidates for, if approved; ● adverse publicity about the product or favorable publicity about competitive products; ● the success of any efforts to educate the medical community and third-party payors regarding our products, which efforts may require significant resources and may not be successful; and ● potential product liability claims.

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; 34 Table of Content ● 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; ● 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; 35 Table of Content ● 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.

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; 34 Table of Contents ● 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 we 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; ● 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 35 Table of Contents ● 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.

These risks and uncertainties include the following: ● patent applications may not result in any patent being issued; 52 Table of Content ● patents that may be issued may not include claims that cover a broad enough scope to prevent design around solutions by competitors; ● patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable, or otherwise may not provide adequate barriers to entry or any competitive advantage; ● because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that before a potential product can be commercialized, any related patent may expire, or remain in existence for only a short period following commercialization, reducing, or eliminating any advantage of the patent; ● our competitors, many of which have substantially greater resources than us or our partners do, and many of which have made significant investments in competing technologies, may seek, or may already have sought or obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our potential products; ● there may be significant pressure on the U.S. government and other international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful as a matter of public policy regarding worldwide health concerns; ● countries other than the United States may have patent laws less favorable to patentees than those upheld by United States courts, allowing foreign competitors a better opportunity to create, develop, and market competing products; and ● we may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and/or unsuccessful.

These risks and uncertainties include the following: ● patent applications may not result in any patent being issued; ● patents that may be issued may not include claims that cover a broad enough scope to prevent design around solutions by competitors; ● patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable, or otherwise may not provide adequate barriers to entry or any competitive advantage; ● because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that before a potential product can be commercialized, any related patent may expire, or remain in existence for only a short period following commercialization, reducing, or eliminating any advantage of the patent; ● our competitors, many of which have substantially greater resources than us or our partners do, and many of which have made significant investments in competing technologies, may seek, or may already have sought or obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our potential products; ● there may be significant pressure on the U.S. government and other international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful as a matter of public policy regarding worldwide health concerns; ● countries other than the United States may have patent laws less favorable to patentees than those upheld by United States courts, allowing foreign competitors a better opportunity to create, develop, and market competing products; and 52 Table of Contents ● we may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and/or unsuccessful.

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; 32 Table of Content ● 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.

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; 32 Table of Contents ● 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.

The enrollment of patients depends on many factors, including: ● the number of clinical trials for other product candidates in the same therapeutic area that are currently in clinical development, and our ability to compete with such trials for subjects and clinical trial sites; ● the severity of the disease under investigation and the existence of current treatments; 40 Table of Content ● the perceived risks and benefits of the product candidate, including the potential advantages or disadvantages of the product candidate being studied in relation to other available therapies; ● the subject eligibility criteria defined in the protocol, as well as our ability to compensate subjects for their time and effort; ● the size and nature of the patient population; ● the proximity and availability of clinical trial sites for prospective subjects; ● the design of the trial, including factors such as frequency of required assessments, length of the study and ongoing monitoring requirements; ● subjects’ and investigators’ ability to comply with the specific instructions related to the trial protocol, proper documentation, and use of the product candidate; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● patient referral practices of physicians and the effectiveness of publicity created by clinical trials sites regarding the trial; ● the ability to adequately monitor subjects during and after treatment and compensate them for their time and effort; ● the ability of our clinical study sites, CROs, and other applicable third parties to facilitate timely enrollment; ● the ability of clinical trial sites to enroll subjects that meet all inclusion criteria and any patient exclusion due to erroneous enrollment; ● our ability to obtain and maintain subject informed consents; and ● the risk that subjects enrolled in clinical trials will drop out of the trials before completion of the study or not return for post study follow up, especially subjects in control groups.

The enrollment of patients depends on many factors, including: ● the number of clinical trials for other product candidates in the same therapeutic area that are currently in clinical development, and our ability to compete with such trials for subjects and clinical trial sites; ● the severity of the disease under investigation and the existence of current treatments; ● the perceived risks and benefits of the product candidate, including the potential advantages or disadvantages of the product candidate being studied in relation to other available therapies; ● the subject eligibility criteria defined in the protocol, as well as our ability to compensate subjects for their time and effort; ● the size and nature of the patient population; ● the proximity and availability of clinical trial sites for prospective subjects; ● the design of the trial, including factors such as frequency of required assessments, length of the study and ongoing monitoring requirements; ● subjects’ and investigators’ ability to comply with the specific instructions related to the trial protocol, proper documentation, and use of the product candidate; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; 40 Table of Contents ● patient referral practices of physicians and the effectiveness of publicity created by clinical trials sites regarding the trial; ● the ability to adequately monitor subjects during and after treatment and compensate them for their time and effort; ● the ability of our clinical study sites, CROs, and other applicable third parties to facilitate timely enrollment; ● the ability of clinical trial sites to enroll subjects that meet all inclusion criteria and any patient exclusion due to erroneous enrollment; ● our ability to obtain and maintain subject informed consents; and ● the risk that subjects enrolled in clinical trials will drop out of the trials before completion of the study or not return for post study follow up, especially subjects in control groups.

For example: ● any of our current and future product candidates, if approved, may eventually become commercially available in generic or biosimilar product forms; ● others may be able to make immunotherapies that are similar to any of our current and future product candidates or utilize lymph node targeting technology but that are not covered by the claims of the patents that we license or may own in the future; ● we, or our licensors or current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future, potentially resulting in the invalidation of such patents or refusal of such applications; ● we, or our licensors or current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions; ● we, or our licensors or current or future collaborators, may fail to meet our obligations to the U.S. government regarding any in licensed patents and patent applications funded by U.S. government grants, leading to the loss or unenforceability of patent rights; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing on our owned or licensed intellectual property rights; ● it is possible that our pending, owned or licensed patent applications or those that we may own or license in the future will not lead to issued patents; ● it is possible that there are prior public disclosures that could invalidate our owned or in-licensed patents, or parts of our owned or in-licensed patents; ● it is possible that there are unpublished patent applications that may later issue with claims covering our product candidates or technology similar to ours; 59 Table of Content ● it is possible that our owned or in-licensed patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable or result in a change in ownership; ● issued patents to which we hold rights may be held invalid, unenforceable, or narrowed in scope, including as a result of legal challenges by our competitors; ● the claims of our owned or in-licensed issued patents or patent applications, if and when issued, may not cover our product candidates or narrowly cover our product candidates in such a way that competitors may be able to design around to avoid infringement allegations; ● the laws of foreign countries may not protect our proprietary rights or the proprietary rights of our licensors or current or future collaborators to the same extent as the laws of the United States; ● the inventors of our owned or in licensed patents or patent applications may become involved with competitors, develop products or processes that design around our patents, or become hostile to it or the patents or patent applications on which they are named as inventors; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we have engaged in scientific collaborations in the past and we intend to continue to do so in the future, and our collaborators may develop adjacent or competing products that are outside the scope of our patents; ● we may not develop additional proprietary technologies that are patentable; ● any product candidates we develop may be covered by third-party patents or other exclusive rights; ● the patents of others may prohibit or otherwise harm our business; or ● we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently commercialize the technology and/or file a patent covering such intellectual property.

For example: ● any of our current and future product candidates, if approved, may eventually become commercially available in generic or biosimilar product forms; ● others may be able to make immunotherapies that are similar to any of our current and future product candidates or utilize lymph node targeting technology but that are not covered by the claims of the patents that we license or may own in the future; ● we, or our licensors or current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future, potentially resulting in the invalidation of such patents or refusal of such applications; 58 Table of Contents ● we, or our licensors or current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions; ● we, or our licensors or current or future collaborators, may fail to meet our obligations to the U.S. government regarding any in licensed patents and patent applications funded by U.S. government grants, leading to the loss or unenforceability of patent rights; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing on our owned or licensed intellectual property rights; ● it is possible that our pending, owned or licensed patent applications or those that we may own or license in the future will not lead to issued patents; ● it is possible that there are prior public disclosures that could invalidate our owned or in-licensed patents, or parts of our owned or in-licensed patents; ● it is possible that there are unpublished patent applications that may later issue with claims covering our product candidates or technology similar to ours; ● it is possible that our owned or in-licensed patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable or result in a change in ownership; ● issued patents to which we hold rights may be held invalid, unenforceable, or narrowed in scope, including as a result of legal challenges by our competitors; ● the claims of our owned or in-licensed issued patents or patent applications, if and when issued, may not cover our product candidates or narrowly cover our product candidates in such a way that competitors may be able to design around to avoid infringement allegations; ● the laws of foreign countries may not protect our proprietary rights or the proprietary rights of our licensors or current or future collaborators to the same extent as the laws of the United States; ● the inventors of our owned or in licensed patents or patent applications may become involved with competitors, develop products or processes that design around our patents, or become hostile to it or the patents or patent applications on which they are named as inventors; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we have engaged in scientific collaborations in the past and we intend to continue to do so in the future, and our collaborators may develop adjacent or competing products that are outside the scope of our patents; ● we may not develop additional proprietary technologies that are patentable; ● any product candidates we develop may be covered by third-party patents or other exclusive rights; ● the patents of others may prohibit or otherwise harm our business; or 59 Table of Contents ● we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently commercialize the technology and/or file a patent covering such intellectual property.

Factors that may inhibit our efforts to commercialize product candidates on our own include: ● our inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs, and other support personnel; ● the inability of sales personnel to obtain access to physicians to discuss our products; ● the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement, and other acceptance by payors, and to secure adequate coverage; ● reduced realization on government sales from mandatory discounts, rebates and fees, and from price concessions to private health plans and pharmacy benefit managers necessitated by competition for access to managed formularies; ● the clinical indications for which the products are approved and the claims that we may make for the products, as well as any limitations on use or warnings; ● the costs associated with training sales and marketing personnel on legal and regulatory compliance matters and monitoring their actions, and any liability for sales or marketing personnel who fail to comply with the applicable legal and regulatory requirements; ● restricted or closed distribution channels that make it difficult to distribute our products to different segments of the patient population; ● the lack of complementary medicines to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and ● unforeseen costs and expenses associated with creating an independent commercialization organization.

Factors that may inhibit our efforts to commercialize product candidates on our own include: ● our inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs, and other support personnel; ● the inability of sales personnel to obtain access to physicians to discuss our products; 48 Table of Contents ● the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement, and other acceptance by payors, and to secure adequate coverage; ● reduced realization on government sales from mandatory discounts, rebates and fees, and from price concessions to private health plans and pharmacy benefit managers necessitated by competition for access to managed formularies; ● the clinical indications for which the products are approved and the claims that we may make for the products, as well as any limitations on use or warnings; ● the costs associated with training sales and marketing personnel on legal and regulatory compliance matters and monitoring their actions, and any liability for sales or marketing personnel who fail to comply with the applicable legal and regulatory requirements; ● restricted or closed distribution channels that make it difficult to distribute our products to different segments of the patient population; ● the lack of complementary medicines to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and ● unforeseen costs and expenses associated with creating an independent commercialization organization.

Some of the factors that may cause the market price of our common stock to fluctuate include: ● our ability to obtain regulatory approvals for our product candidates, and delays or failures to obtain such approvals; ● failure of any of our product candidates, if approved, to achieve commercial success; ● failure by us to maintain our existing third-party license and supply agreements; ● failure by us or our licensors to prosecute, maintain, or enforce our intellectual property rights; ● changes in laws or regulations applicable to our product candidates; ● any inability to obtain adequate supply of our product candidates or the inability to do so at acceptable prices; ● adverse regulatory authority decisions; ● introduction of new products, services or technologies by our competitors; ● failure to meet or exceed financial and development projections we may provide to the public; ● failure to meet or exceed the financial and development projections of the investment community; ● the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community; ● announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors; ● disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; ● additions or departures of key personnel; ● significant lawsuits, including patent or stockholder litigation; ● if securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our business and stock; ● changes in the market valuations of similar companies; ● general market or macroeconomic conditions; 71 Table of Content ● sales of our common stock by us or our stockholders in the future; ● trading volume of our common stock; ● failure to maintain compliance with the listing requirements of the NYSE American; ● announcements by commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant contracts, commercial relationships or capital commitments; ● adverse publicity generally, including with respect to other products and potential products in such markets; ● the introduction of technological innovations or new therapies that compete with our potential products; ● changes in the structure of health care payment systems; and ● period-to-period fluctuations in our financial results.

Some of the factors that may cause the market price of our common stock to fluctuate include: ● our ability to obtain regulatory approvals for our product candidates, and delays or failures to obtain such approvals; ● failure of any of our product candidates, if approved, to achieve commercial success; ● failure by us to maintain our existing third-party license and supply agreements; ● failure by us or our licensors to prosecute, maintain, or enforce our intellectual property rights; ● changes in laws or regulations applicable to our product candidates; ● any inability to obtain adequate supply of our product candidates or the inability to do so at acceptable prices; ● adverse regulatory authority decisions; ● introduction of new products, services or technologies by our competitors; 69 Table of Contents ● failure to meet or exceed financial and development projections we may provide to the public; ● failure to meet or exceed the financial and development projections of the investment community; ● the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community; ● announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors; ● disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; ● additions or departures of key personnel; ● significant lawsuits, including patent or stockholder litigation; ● if securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our business and stock; ● changes in the market valuations of similar companies; ● general market or macroeconomic conditions; ● sales of our common stock by us or our stockholders in the future; ● trading volume of our common stock; ● failure to maintain compliance with the listing requirements of the NYSE American; ● announcements by commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant contracts, commercial relationships or capital commitments; ● adverse publicity generally, including with respect to other products and potential products in such markets; ● the introduction of technological innovations or new therapies that compete with our potential products; ● changes in the structure of health care payment systems; and ● period-to-period fluctuations in our financial results.

If one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, including during any long term follow up observation period recommended or required for patients who receive treatment using our products, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw or limit their approvals of such products; ● regulatory authorities may require the addition of labeling statements, specific warnings or contraindications; ● we may be required to create a risk evaluation and mitigation strategy plan (a “REMS”), which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for health care providers, and/or other elements to assure safe use; ● we may be required to change the way such products are distributed or administered, or change the labeling of the products; ● the FDA or a comparable foreign regulatory authority may require us to conduct additional clinical trials or costly post marketing testing and surveillance to monitor the safety and efficacy of the products; ● we may decide to recall such products from the marketplace after they are approved; ● we could be sued and held liable for harm caused to individuals exposed to or taking our products; and ● our reputation may suffer.

If one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, including during any long term follow up observation period recommended or required for 41 Table of Contents patients who receive treatment using our products, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw or limit their approvals of such products; ● regulatory authorities may require the addition of labeling statements, specific warnings or contraindications; ● we may be required to create a risk evaluation and mitigation strategy plan (a “REMS”), which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for health care providers, and/or other elements to assure safe use; ● we may be required to change the way such products are distributed or administered, or change the labeling of the products; ● the FDA or a comparable foreign regulatory authority may require us to conduct additional clinical trials or costly post marketing testing and surveillance to monitor the safety and efficacy of the products; ● we may decide to recall such products from the marketplace after they are approved; ● we could be sued and held liable for harm caused to individuals exposed to or taking our products; and ● our reputation may suffer.

Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere in this prospectus and also include, among other things: ● our ability to obtain additional funding to develop our product candidates; ● our ability to conduct and complete nonclinical studies and clinical trials, ● delays in the commencement, enrollment, and timing of clinical trials; ● the success of our nonclinical studies and clinical trials through all phases of development; ● any delays in regulatory review and approval of product candidates in clinical development; ● our ability to obtain and maintain regulatory approval for our product candidates in the United States and foreign jurisdictions; ● potential toxicity and/or side effects of our product candidates that could delay or prevent commercialization, limit the indications for any approved products, require the establishment of risk evaluation and mitigation strategies, or cause an approved drug to be taken off the market; ● our ability to establish or maintain partnerships, collaborations, licensing or other arrangements; ● market acceptance of our product candidates, if approved; ● competition from existing products, new products or new therapeutic approaches that may emerge; ● the ability of patients or health care providers to obtain coverage of or sufficient reimbursement for our products; ● our ability to leverage our proprietary POZ technology platform to discover and develop additional product candidates; ● our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to our business; and ● potential product liability claims.

Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere in this annual report and also include, among other things: ● our ability to obtain additional funding to develop our product candidates; ● our ability to conduct and complete nonclinical studies and clinical trials, ● delays in the commencement, enrollment, and timing of clinical trials; ● the success of our nonclinical studies and clinical trials through all phases of development; ● any delays in regulatory review and approval of product candidates in clinical development; ● our ability to obtain and maintain regulatory approval for our product candidates in the United States and foreign jurisdictions; ● potential toxicity and/or side effects of our product candidates that could delay or prevent commercialization, limit the indications for any approved products, require the establishment of risk evaluation and mitigation strategies, or cause an approved drug to be taken off the market; ● our ability to establish or maintain partnerships, collaborations, licensing or other arrangements; ● market acceptance of our product candidates, if approved; ● competition from existing products, new products or new therapeutic approaches that may emerge; ● the ability of patients or health care providers to obtain coverage of or sufficient reimbursement for our products; ● our ability to leverage our proprietary POZ technology platform to discover and develop additional product candidates; ● our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to our business; and ● potential product liability claims.

We will also incur costs associated with corporate governance requirements, including requirements under the laws, rules and regulations of the SEC as well as the NYSE American rules. These laws, rules and regulations are expected to increase Legacy Serina’s legal and financial compliance costs and to make some activities more time consuming and costly.

We will also incur costs associated with corporate governance requirements, including requirements under the laws, rules and regulations of the SEC as well as the NYSE American rules. These laws, rules and regulations are expected to increase Serina’s legal and financial compliance costs and to make some activities more time consuming and costly.

In addition, our product candidates could fail to receive regulatory approval for many reasons, including the following: ● the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; ● the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; ● we may be unable to demonstrate that our product candidates’ risk-benefit ratios for their proposed indications are acceptable; ● the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● we may be unable to demonstrate that the clinical and other benefits of our product candidates outweigh their safety risks; ● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials; ● the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a new drug application (“NDA”) or biologics license application (“BLA”) or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; 37 Table of Content ● the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, our own manufacturing facilities, or a third-party manufacturer’s facilities with which it contracts for clinical and commercial supplies; and ● the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

In addition, our product candidates could fail to receive regulatory approval for many reasons, including the following: ● the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; ● the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; ● we may be unable to demonstrate that our product candidates’ risk-benefit ratios for their proposed indications are acceptable; ● the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● we may be unable to demonstrate that the clinical and other benefits of our product candidates outweigh their safety risks; ● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials; ● the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a new drug application (“NDA”) or biologics license application (“BLA”) or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; ● the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, our own manufacturing facilities, or a third-party manufacturer’s facilities with which it contracts for clinical and commercial supplies; and ● the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development or commercialization for many reasons, including the following: ● our platform may not be successful in identifying additional product candidates; ● we may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates; ● our product candidates may not succeed in nonclinical or clinical testing; ● a product candidate may upon further study demonstrate harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria; ● competitors may develop alternatives that render our product candidates obsolete or less attractive; ● product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights; ● the market for a product candidate may change during our program so that the continued development of that product candidate is no longer reasonable; ● a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and 38 Table of Content ● a product candidate may not be accepted as safe and effective by patients, the medical community, or third-party payors, if applicable.

Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development or commercialization for many reasons, including the following: ● our platform may not be successful in identifying additional product candidates; ● we may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates; ● our product candidates may not succeed in nonclinical or clinical testing; ● a product candidate may upon further study demonstrate harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria; ● competitors may develop alternatives that render our product candidates obsolete or less attractive; ● product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights; ● the market for a product candidate may change during our program so that the continued development of that product candidate is no longer reasonable; ● a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and ● a product candidate may not be accepted as safe and effective by patients, the medical community, or third-party payors, if applicable.

We will incur costs and demands upon management as a result of complying with the laws, rules and regulations affecting public companies. We will incur significant legal, accounting and other expenses that Legacy Serina did not incur as a private company, including costs associated with public company reporting requirements.

We will incur costs and demands upon management as a result of complying with the laws, rules and regulations affecting public companies. We will incur significant legal, accounting and other expenses that Serina did not incur as a private company, including costs associated with public company reporting requirements.

For instance, product liability claims may result in: ● loss of revenue from decreased demand for our products and/or product candidates; ● impairment of our business reputation or financial stability; ● incurred costs and time of related litigation; ● substantial monetary awards to patients or other claimants, and loss of revenue; ● diversion of management attention; ● withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs; ● the inability to commercialize our product candidates; ● significant negative media attention; ● a decrease in the value of Serina; ● initiation of investigations, and enforcement actions by regulators; and/or ● product recalls, withdrawals, revocation of approvals, or labeling, marketing or promotional restrictions.

For instance, product liability claims may result in: ● loss of revenue from decreased demand for our products and/or product candidates; ● impairment of our business reputation or financial stability; ● incurred costs and time of related litigation; ● substantial monetary awards to patients or other claimants, and loss of revenue; ● diversion of management attention; ● withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs; ● the inability to commercialize our product candidates; ● significant negative media attention; ● a decrease in the value of Serina; ● initiation of investigations, and enforcement actions by regulators; and/or 46 Table of Contents ● product recalls, withdrawals, revocation of approvals, or labeling, marketing or promotional restrictions.

Product candidates studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (“IMM”), that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.

Product candidates studied 36 Table of Contents for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (“IMM”), that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.

We have a limited operating history and expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance. 30 Table of Content Our operations to date have been primarily limited to organizing and staffing our company, developing and securing our proprietary technology and preclinical and clinical development of our product candidates.

We have a limited operating history and expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance. 30 Table of Contents Our operations to date have been primarily limited to organizing and staffing our company, developing and securing our proprietary technology and preclinical and clinical development of our product candidates.

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.

Some 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.

If a product that has ODD subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including an NDA, to market the same drug for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated.

If a product that has ODD subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not 39 Table of Contents approve any other applications, including an NDA, to market the same drug for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated.

Based on our most recent projected cash flows, we believe that our cash and cash equivalents would not be sufficient to satisfy our anticipated operating and other funding requirements for the next twelve months from December 31, 2024. These factors raise substantial doubt regarding our ability to continue as a going concern.

Based on our most recent projected cash flows, we believe that our cash and cash equivalents would not be sufficient to satisfy our anticipated operating and other funding requirements for the next twelve months from December 31, 2025. These factors raise substantial doubt regarding our ability to continue as a going concern.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or therapeutic product, if any, and us in general.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approval or commercialization of the particular product candidate or therapeutic product, if any, and us in general.

In the event of a successful claim of infringement against us, we may be required to: ● pay substantial damages and/or ongoing royalty payments; ● stop using some or all of our technologies and methods; ● stop certain research and development efforts; ● develop non infringing products or methods (i.e., develop or design around); and/or ● obtain one or more licenses from third parties for an upfront lump sum, an ongoing royalty, or a combination thereof.

In the event of a successful claim of infringement against us, we may be required to: 53 Table of Contents ● pay substantial damages and/or ongoing royalty payments; ● stop using some or all of our technologies and methods; ● stop certain research and development efforts; ● develop non infringing products or methods (i.e., develop or design around); and/or ● obtain one or more licenses from third parties for an upfront lump sum, an ongoing royalty, or a combination thereof.

Our future capital requirements will depend upon a number of factors, including: the number and timing of future product 69 Table of Content candidates in the pipeline; progress with and results from preclinical testing and clinical trials; the ability to manufacture sufficient drug supplies to complete preclinical and clinical trials; the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims; and the time and costs involved in obtaining regulatory approvals and favorable reimbursement or formulary acceptance.

Our future capital requirements will depend upon a number of factors, including: the number and timing of future product candidates in the pipeline; progress with and results from preclinical testing and clinical trials; the ability to manufacture sufficient drug supplies to complete preclinical and clinical trials; the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims; and the time and costs involved in obtaining regulatory approvals and favorable reimbursement or formulary acceptance.

Moreover, any problems or delays we experience in preparing for commercial scale manufacturing of a product candidate or component, including manufacturing validation, may result in a delay in a future marketing approval, if any, or commercial launch of any of our product candidates, should they receive regulatory approval, or may impair our ability to manufacture commercial quantities or manufacture such quantities at an acceptable cost, which could result in the delay, prevention, or impairment of commercialization of our product candidates, if approved, and could adversely affect our business.

Although we employ measures to ensure that our employees, consultants, and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer.

Although we employ measures to ensure that our employees, consultants, and 57 Table of Contents advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer.

We may identify additional material weaknesses in the future that may cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. If we fail to remediate our material weaknesses, we may not be able to report our financial results accurately or prevent fraud.

We may identify material weaknesses in the future that may cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. If we fail to remediate such material weaknesses, we may not be able to report our financial results accurately or prevent fraud.

The biotechnology and pharmaceutical industries have experienced substantial litigation and other proceedings concerning intellectual property rights, and third parties may initiate legal proceedings alleging that we are infringing, 54 Table of Content misappropriating, or otherwise violating their intellectual property rights, the outcome of which could be uncertain and may prevent, delay, or otherwise interfere with our product discovery and development efforts.

The biotechnology and pharmaceutical industries have experienced substantial litigation and other proceedings concerning intellectual property rights, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights, the outcome of which could be uncertain and may prevent, delay, or otherwise interfere with our product discovery and development efforts.

Furthermore, geopolitical instability, including the ongoing military conflicts between Russia and Ukraine and Israel and Hamas, as well as the impact of inflationary pressures and resulting rise in interest rates, on global financial markets could make the terms of any available financing less attractive to us and more dilutive to our existing stockholders.

Furthermore, geopolitical instability, including the ongoing military conflicts between the United States and Iran, Russia and Ukraine, and Israel and Hamas, as well as the impact of inflationary pressures and resulting rise in interest rates, on global financial markets could make the terms of any available financing less attractive to us and more dilutive to our existing stockholders.

However, the actual protection afforded by a patent varies from country to country, and also depends upon many factors, including the type of patent, the scope of coverage, the availability of regulatory related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent, and whether a portion of the patent term has been terminally disclaimed based on other patents.

However, the actual protection afforded by a patent varies from country to country, and also depends upon many factors, including 56 Table of Contents the type of patent, the scope of coverage, the availability of regulatory related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent, and whether a portion of the patent term has been terminally disclaimed based on other patents.

Unless otherwise indicated, references in these risk factors to our business being harmed will include harm to our business, reputation, brand, financial condition, results of operations, and prospects. In such event, the market price of our securities could decline, and you could lose all or part of your investment. Investing in our securities involves risks.

Unless otherwise indicated, references in these risk factors to our business 29 Table of Contents being harmed will include harm to our business, reputation, brand, financial condition, results of operations, and prospects. In such event, the market price of our securities could decline, and you could lose all or part of your investment. Investing in our securities involves risks.

Failure can occur at any time during the clinical 33 Table of Content 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.

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.

These agreements generally provide that all confidential information concerning our business or financial affairs developed by or made known to an individual or entity during the course of that party’s relationship with us are to be kept confidential and not disclosed to third parties, except in certain specified 57 Table of Content circumstances.

We may seek designations under the FDA’s expedited programs for serious conditions, such as fast track or breakthrough therapy designation, which are intended to facilitate and expedite the development or regulatory review or approval process for product candidates. The granting of fast track or breakthrough therapy designation to an investigational product is entirely within the FDA’s discretion.

We may seek designations under the FDA’s expedited programs for serious conditions, such as fast track or breakthrough therapy designation, which are intended to facilitate and expedite the development or regulatory review or approval process for product candidates. 38 Table of Contents The granting of fast track or breakthrough therapy designation to an investigational product is entirely within the FDA’s discretion.

If we license products, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture. Any licensed products may also subject us to the risk of regulatory enforcement should the product or business not be compliant with applicable regulatory requirements.

Depending on the severity of any potential regulatory action, supplies of our product candidates or products, if approved, could be interrupted or limited, which could have a material adverse effect on our business. We rely on third parties to conduct some of our nonclinical studies and all of our clinical trials.

Depending on the severity of any potential regulatory 44 Table of Contents action, supplies of our product candidates or products, if approved, could be interrupted or limited, which could have a material adverse effect on our business. We rely on third parties to conduct some of our nonclinical studies and all of our clinical trials.

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, 60 Table of Content referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support approval.

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.

In that event, we could still be a smaller reporting company if our annual revenues were below $100.0 million and we have a public float of less than $700.0 million. 74 Table of Content Changes in tax laws may materially adversely affect our business, prospects, financial condition and operating results.

In that event, we could still be a smaller reporting company if our annual revenues were below $100.0 million and we have a public float of less than $700.0 million. Changes in tax laws may materially adversely affect our business, prospects, financial condition and operating results.

However, our trademarks or trade names may be challenged, infringed, circumvented, or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we benefit from to build name recognition among potential partners or 58 Table of Content customers in our markets of interest.

In addition, the information we choose to publicly disclose regarding a particular nonclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we 36 Table of Content determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular therapeutic product, if any, product candidate or our business.

In addition, the information we choose to publicly disclose regarding a particular nonclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular therapeutic product, if any, product candidate or our business.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller 49 Table of Contents number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity, and are therefore costly, time consuming and inherently uncertain. Changes in either the patent laws or interpretation of the patent laws could increase the uncertainties and costs surrounding the prosecution of 56 Table of Content patent applications and the enforcement or defense of our issued patents.

Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity, and are therefore costly, time consuming and inherently uncertain. Changes in either the patent laws or interpretation of the patent laws could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of our issued patents.

The anti-bribery provisions of the FCPA are enforced primarily by the U.S. Department of Justice. The SEC is involved with enforcement of the books and records provisions of the FCPA. Similarly, the U.K. Bribery Act 2010 has extra territorial effect for companies and individuals having a connection with the United Kingdom. The U.K.

The anti-bribery provisions of the FCPA are enforced primarily by the U.S. Department of Justice. The SEC is involved with enforcement of the books and records provisions of the FCPA. 64 Table of Contents Similarly, the U.K. Bribery Act 2010 has extra territorial effect for companies and individuals having a connection with the United Kingdom. The U.K.

If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired. We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of the NYSE American.

If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired. 72 Table of Contents We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of the NYSE American.

Our business, results of operations, financial condition, and prospects could also be harmed by risks and uncertainties that are not presently known to us or that we currently believe are not material. If any of these risks actually occur, our business, results of operations, financial condition, and prospects 29 Table of Content could be materially and adversely affected.

As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claims, there is no assurance that a court of competent jurisdiction would invalidate the asserted claims of any such U.S. patent.

As 54 Table of Contents this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claims, there is no assurance that a court of competent jurisdiction would invalidate the asserted claims of any such U.S. patent.

We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for 66 Table of Content similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.

We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.

A third party that filed a patent application in the USPTO after March 2013, but before we or Legacy Serina filed could therefore be awarded a patent covering an invention of ours even if we or Legacy Serina had made the invention before it was made by such third party.

A third party that filed a patent application in the USPTO after March 2013, but before Serina filed could therefore be awarded a patent covering an invention of ours even if Serina had made the invention before it was made by such third party.

Cybersecurity incidents, which may not be immediately or ever detected, are 67 Table of Content increasing in frequency and evolving in nature. Additionally, due to geopolitical tensions related to Russia’s invasion of Ukraine, the risk of cyber-attacks may be elevated.

Cybersecurity incidents, which may not be immediately or ever detected, are increasing in frequency and evolving in nature. Additionally, due to geopolitical tensions related to Russia’s invasion of Ukraine, the risk of cyber-attacks may be elevated.

If one or more equity research 73 Table of Content analysts ceases coverage of us or fails to publish reports on us regularly, demand for our common stock could decrease, which in turn could cause our stock price or trading volume to decline.

If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our common stock could decrease, which in turn could cause our stock price or trading volume to decline.

Even if it does establish such collaborations or arrangements, our CMOs may 43 Table of Content breach, terminate, or not renew these agreements. These facilities may also be affected by a global pandemic, natural disasters such as floods, fires, explosions or such facilities could face manufacturing issues, such as contamination or adverse regulatory findings following a regulatory inspection.

Even if it does establish such collaborations or arrangements, our CMOs may breach, terminate, or not renew these agreements. These facilities may also be affected by a global pandemic, natural disasters such as floods, fires, explosions or such facilities could face manufacturing issues, such as contamination or adverse regulatory findings following a regulatory inspection.

If any collaboration is not pursued, we may require substantially greater capital to undertake development and marketing of our proposed products and may not be able to develop and market such products effectively, 50 Table of Content if at all.

For example, the Tax Act, the CARES Act, and the IRA enacted many significant changes to the U.S. tax laws. Future guidance from the IRS and other tax authorities with respect to such legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation.

For example, the Tax Act, the CARES Act, One Big Beautiful Bill Act and the IRA enacted many significant changes to the U.S. tax laws. Future guidance from the IRS and other tax authorities with respect to such legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation.

Our ability to utilize our NOL carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including potential changes in connection with the Merger or other transactions. Similar rules may apply under state tax laws.

Our ability to utilize our NOL carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including changes in connection with the Merger, changes in connection with the sale of our common stock, and other transactions. Similar rules may apply under state tax laws.

Individual EEA countries will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement.

Individual EEA countries will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) 63 Table of Contents aspects of health technologies, and making decisions on pricing and reimbursement.

Although we 72 Table of Content believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with our Board, they would apply even if the offer may be considered beneficial by some stockholders.

Although we believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with our Board, they would apply even if the offer may be considered beneficial by some stockholders.

Our future financial performance and our ability to compete effectively and commercialize our product candidates, if approved, will depend in part on our ability to effectively manage the future development and expansion of our company.

Our future 66 Table of Contents financial performance and our ability to compete effectively and commercialize our product candidates, if approved, will depend in part on our ability to effectively manage the future development and expansion of our company.

Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for 53 Table of Content development activities or any future sales, marketing, or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately.

Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately.

As of December 31, 2024, we had 13 full time employees and, in connection with the growth and advancement of our pipeline, we expect to increase the number of our employees and the scope of our operations, particularly in the areas of product development, business development, regulatory affairs, and sales and marketing.

As of December 31, 2025, we had 16 full time employees and, in connection with the growth and advancement of our pipeline, we expect to increase the number of our employees and the scope of our operations, particularly in the areas of product development, business development, regulatory affairs, and sales and marketing.

We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that we, our third-party service providers, or clinical trial sites are in substantial compliance with the applicable regulatory requirements.

We cannot assure you that upon inspection by a 45 Table of Contents given regulatory authority, such regulatory authority will determine that we, our third-party service providers, or clinical trial sites are in substantial compliance with the applicable regulatory requirements.

A maximum of one patent may be extended per FDA-approved drug as compensation for the patent term lost during the FDA regulatory review process.

A maximum of one patent may be extended per FDA-approved drug as compensation for the patent term lost 55 Table of Contents during the FDA regulatory review process.

While the directors affiliated with Juvenescence will be obligated to act in accordance with their fiduciary duty, they may have equity or other interests in Juvenescence and, accordingly, their interests may be aligned with Juvenescence’s interests, which may not always coincide with our corporate interests or the interests of our other stockholders. 75 Table of Content Item 1B.

In addition, the report of our independent registered public accountant accompanying our audited consolidated financial statements included elsewhere in this prospectus contains a qualification to such effect. We have incurred operating losses and negative cash flows since inception and had an accumulated deficit of approximately $44.3 million as of December 31, 2024.

In addition, the report of our 31 Table of Contents independent registered public accountant accompanying our audited consolidated financial statements included elsewhere in this annual report contains a qualification to such effect. We have incurred operating losses and negative cash flows since inception and had an accumulated deficit of approximately $63.5 million as of December 31, 2025.

If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or, in particular, if the U.S. government takes retaliatory trade actions due to the recent U.S.-China trade tension, such changes could have an adverse effect on our business, financial condition and results of operations.

If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or, in particular, if U.S. trade policy results in retaliatory trade actions, such changes could have an adverse effect on our business, financial condition and results of operations.

We need additional financing to execute our operating plan and continue to operate as a going concern. 31 Table of Content As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), we have the responsibility to evaluate whether conditions and/or events raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date the financial statements are issued.

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), we have the responsibility to evaluate whether conditions and/or events raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date the financial statements are issued.

For example, in May 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to allow Medicare Advantage plans the option to use step therapy for Part B drugs beginning January 1, 2020.

Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; ● fines, warning letters or other enforcement related letters or clinical holds on post approval clinical trials; ● refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals; ● product seizure or detention, or refusal to permit the import or export of products; ● injunctions or the imposition of civil or criminal penalties; and ● consent decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs; or mandated modification of promotional materials and labeling and the issuance of corrective information. 61 Table of Content The policies of the FDA and of other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of our product candidates.

Future sales of shares by existing stockholders could cause our stock price to decline. If our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after legal restrictions on resale discussed in this prospectus lapse, the trading price of our common stock could decline.

If our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after legal restrictions on resale discussed in this annual report lapse, the trading price of our common stock could decline.

Under currently applicable U.S. law, certain therapeutic products that are not usually self-administered (such as most injectable drugs and biologics) may be eligible for coverage under the Medicare Part B program if: ● they are incident to a physician’s services; ● they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice; and ● they have been approved by the FDA and meet other requirements of the statute. 51 Table of Content There may be significant delays in obtaining reimbursement for newly approved product candidates, and coverage may be more limited than the purposes for which the product candidate is approved by the FDA or other regulatory authorities.

The termination of a government contract or relationship as a result of our failure to satisfy any of our obligations under laws governing international business practices could have a 65 Table of Content negative impact on our operations and harm our reputation and ability to procure government contracts.

A conviction under the FCPA can result in long term disqualification as a government contractor. The termination of a government contract or relationship as a result of our failure to satisfy any of our obligations under laws governing international business practices could have a negative impact on our operations and harm our reputation and ability to procure government contracts.

Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. U.S. federal income tax reform could adversely affect our business and financial condition.

If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.

If we experience material weaknesses in the future or otherwise fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.

Following the Merger, we had a public float of less than $250 million and therefore qualify as a smaller reporting company under the rules of the SEC as of the date of this prospectus.

As of June 30, 2025, we had a public float of less than $250 million and therefore qualify as a smaller reporting company under the rules of the SEC as of the date of this annual report.

An active trading market for the shares of our common stock may never develop or be sustained. If an active market for our common stock does not develop or is not sustained, it may be difficult for our stockholders to sell their shares at an attractive price or at all.

If an active market for our common stock does not develop or is not sustained, it may be difficult for our stockholders to sell their shares at an attractive price or at all. Future sales of shares by existing stockholders could cause our stock price to decline.

An active trading market for our common stock may not develop and our stockholders may not be able to resell their shares of common stock for a profit, if at all. Prior to the Merger, there had been no public market for our common stock.

An active trading market for our common stock may not develop and our stockholders may not be able to resell their shares of common stock for a profit, if at all. An active trading market for the shares of our common stock may never develop or be sustained.

A key element of our strategy is to use and expand our POZ Platform drug delivery technology to build a pipeline of product candidates and progress these product candidates through preclinical and clinical development for the treatment of various diseases.

We may not be successful in our efforts to use and expand our discovery engine to build a pipeline of product candidates. 37 Table of Contents A key element of our strategy is to use and expand our POZ Platform drug delivery technology to build a pipeline of product candidates and progress these product candidates through preclinical and clinical development for the treatment of various diseases.

It is uncertain if and to what extent various states will conform to federal law. In addition, under Sections 382 and 383 of the Code, federal NOL carryforwards and other tax attributes may become subject to an annual limitation in the event of certain cumulative changes in ownership.

In addition, under Sections 382 and 383 of the Code, federal NOL carryforwards and other tax attributes may become subject to an annual limitation in the event of certain cumulative changes in ownership.

Among other things, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

In August 2022, President Biden signed into the law the Inflation Reduction Act of 2022 (the “IRA”). Among other things, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

If we do not establish commercialization capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing any products we may develop. 49 Table of Content We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.

We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

1 edited+0 added−0 removed3 unchanged

2024 filing

2025 filing

Biggest changeOur information technology and cybersecurity service providers primarily interface with members of our accounting and finance group. These processes are an integral part of our internal controls and risk management and the results of the third party assessment are reported annually to the Audit Committee along with a report from management on the effectiveness of internal controls.

Biggest changeOur information technology and cybersecurity service providers primarily interface with 74 Table of Contents members of our accounting and finance group. These processes are an integral part of our internal controls and risk management and the results of the third-party assessment are reported annually to the Audit Committee along with a report from management on the effectiveness of internal controls.

Item 2. Properties

Properties — owned and leased real estate

1 edited+0 added−0 removed1 unchanged

2024 filing

2025 filing

Biggest changeItem 2. Properties Our principal place of business is located in Huntsville, Alabama where we lease approximately 7,600 square feet of office and laboratory space. Our office space lease expires on October 31, 2025, with options to renew, and our laboratory space lease expires on January 31, 2028.

Biggest changeItem 2. Properties Our principal place of business is located in Huntsville, Alabama where we lease approximately 7,600 square feet of office and laboratory space. Our office space lease expires on October 31, 2028, with options to renew, and our laboratory space lease expires on January 31, 2028.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

1 edited+0 added−0 removed0 unchanged

2024 filing

2025 filing

Biggest changeItem 3. 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 4. Mine Safety Disclosures Not applicable. 76 Table of Content PART II

Biggest changeItem 3. 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 4. Mine Safety Disclosures Not applicable. 75 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

1 edited+3 added−5 removed0 unchanged

2024 filing

2025 filing

Biggest changeMarket for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities Our common stock is currently listed on the NYSE American under the symbol “SER.” Prior to the consummation of the Merger, on March 26, 2024, our common stock was listed on the NYSE American under the symbol “AgeX.” As of March 1, 2025 there were 100 holders of record of our common stock.

Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities Market Information Our common stock is currently listed on the NYSE American under the symbol “SER." Holders of Record As of March 1, 2026 there were 96 holders of record of our common stock.

Removed

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.

Added

Equity Compensation Plan Plan Category (a) Number of securities to be issued upon exercise of outstanding options, warrants and rights (b) Weighted-average exercise price of outstanding options, warrants and rights (c) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) Equity compensation plans approved by security holders 3,034,443 $ 5.21 868,629 Equity compensation plans not approved by security holders 122,250 $ 4.45 877,750 Total 3,156,693 $ 5.18 1,746,379 Unregistered Sales of Equity Securities Previously reported.

Removed

In addition to the shares of common stock, upon exercise of the Post-Merger Warrants, Juvenescence also received Incentive Warrants to purchase 377,865 shares of common stock with an exercise price of $18.00 per share that expire on March 26, 2028.

Added

Repurchases of Equity Securities None. Dividend Policy We have never declared or paid cash dividends on our common stock. We intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business and we do not anticipate paying any cash dividends in the foreseeable future.

Removed

On November 26, 2024, Juvenescence entered into an agreement (the "Stock Purchase Agreement") with the Company to purchase 1,000,000 shares of Common Stock at the purchase price of $10.00 per share, for an aggregate amount of $10.0 million in two equal tranches (November 2024 and January 2025), along with warrants to purchase an additional 755,728 shares of Common Stock at an exercise price of $18.00 per share (the “Replacement Incentive Warrants”).

Added

Any future determination related to dividend policy will be made at the discretion of our Board of Directors after considering our financial condition, results of operations, capital requirements, business prospects and other factors the board of directors deems relevant, and subject to the restrictions contained in any future financing Item 6. Reserved Not applicable.

Removed

In consideration for the Agreement, Juvenescence surrendered to the Company 755,728 Post-Merger warrants, including all underlying Incentive Warrants. The Replacement Incentive Warrants expire on March 26, 2028, and have substantially the same terms and conditions as the surrendered Incentive Warrants. The Company intends to use the proceeds from the common stock purchase for general corporate purposes.

Removed

The closing of the first and second tranches of 500,000 shares of Common Stock for $5 million occurred on November 27, 2024, and January 31, 2025, respectively. Item 6. Reserved Not applicable.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

51 edited+30 added−12 removed49 unchanged

2024 filing

2025 filing

Biggest changeThe increase of $5.1 million was primarily driven by (1) $1.8 million increase in compensation and related expenses, including $0.7 million in payroll and related expenses plus $0.6 million in stock-based compensation, as a result of higher headcount, (2) $1.9 million increase to outside services to develop our lead product candidate, SER 252 for research programs, (3) $0.4 million increase in consultants for research and development services, (4) amortization of $0.7 million for a prepaid technology access fee, and (5) $0.3 million for severance and related costs. 83 Table of Content General and Administrative Expenses General and administrative expenses were $9.6 million for the year ended December 31, 2024, compared to $3.9 million for the same period in 2023.

Biggest changeThe increase of $5.7 million was primarily due to increases of $2.0 million in clinical related activities, $1.4 million in salaries, payroll related expenses and stock based compensation as a result of increased headcount, $1.0 million in consultant spend for research programs, amortization of $0.7 million for a prepaid technology access fee, $0.6 million increased spend in outsourced research services and $0.3 million in miscellaneous expenses amounts that were individually insignificant.

See Notes 6, Fair Value Measurements and 7, Stockholders’ Equity/(Deficit) to our consolidated financial statements included elsewhere in this Report for additional information on fair value adjustments of convertible promissory notes, Legacy Serina warrants, liability classified Warrants, and conversion of the AgeX-Serina Note upon consummation of the Merger on March 26, 2024.

See Notes 6, Fair Value Measurements and 7, Stockholders’ (Deficit) Equity to our consolidated financial statements included elsewhere in this Report for additional information on fair value adjustments of convertible promissory notes, Legacy Serina warrants, liability classified Warrants, and conversion of the AgeX-Serina Note upon consummation of the Merger on March 26, 2024.

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 • laboratory supplies and equipment used for internal research and development activities.

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.

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 ("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; 85 Table of Content • 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.

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 ("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.

Food and Drug Administration, or FDA, or other applicable regulatory agencies of the Investigational New Drug, or 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; • 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.

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. 80 Table of Contents • 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; • 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 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 on the development of our preclinical candidates and advancing research on our POZ lipid technology.

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.

The net $2.7 million in non-cash items consisted of (1) a $13.2 million gain from the change in the fair value of warrant liabilities which were partially offset by (2) a $7.0 million loss from the change in fair value of convertible notes, (3) $2.6 million in stock-based compensation, (4) $0.3 million in amortization of deferred debt issuance costs, (5) a $0.2 million decrease in accrued interest on the AgeX-Serina Note and (6) $0.4 million in depreciation and non-cash lease expenses.

The net $2.7 million in non-cash items consisted of a $13.2 million gain from the change in the fair value of warrant liabilities which were partially offset by a $7.0 million loss from the change in fair value of convertible notes, $2.6 million in stock-based compensation, $0.3 million in amortization of deferred debt issuance costs, a $0.2 million decrease in accrued interest on the AgeX-Serina Note and $0.4 million in depreciation and non-cash lease expenses.

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 Securities and Exchange Commission ("SEC") requirements, director and officer insurance costs, and investor relations costs associated with being 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.

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 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 increased costs associated with being a public company.

After all relevant assessments, we conclude whether the warrants are classified as liability or equity. Liability classified warrants are recorded at fair value upon issuance and subsequently remeasured to fair value each reporting period until settlement with all changes in fair value recorded in the consolidated statements of operations.

We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and include these costs in the accrued expenses or prepaid expenses on the consolidated balance sheets and within research and development expense on the consolidated statements of operations.

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; 81 Table of Content • 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.

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.

For example, if the Food and Drug Administration ("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.

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.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to provide information necessary to understand our audited consolidated financial statements for the years ended December 31, 2024 and 2023.

If warrants do not meet liability classification under ASC 480-10, we assess the requirements 79 Table of Content under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature.

If warrants do not meet liability classification under ASC 480-10, we assess the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature.

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 78 Table of Content judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

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.

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 do raise additional capital through public or 84 Table of Contents 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.

Determining the appropriate fair value model and calculating the fair value of stock-based payment awards require the use of highly subjective assumptions, including the expected life of the stock-based payment awards and stock price volatility. We estimate the grant date fair value of stock options and the related compensation expense, using the Black-Scholes option valuation model.

Determining the appropriate fair value model and calculating the fair value of stock-based payment awards require the use of highly subjective assumptions, including the expected life of the stock-based payment awards and stock price volatility. 78 Table of Contents We estimate the grant date fair value of stock options and the related compensation expense, using the Black-Scholes-Merton option valuation model.

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 delivered via subcutaneous injection.

Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this report, including those set forth under Item 1A. “Risk Factors” and under “Explanatory Note” in this Annual Report.

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.

If we obtain 77 Table of Contents regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution.

Net cash used in operating activities during this period totaled $17.1 million. The $5.9 million difference between the net loss and net cash used in operating activities during the year ended December 31, 2024 was driven by $2.7 million in non-cash items and $3.3 million in changes to operating assets and liabilities.

The $5.9 million difference between the net loss and net cash used in operating activities during the year ended December 31, 2024 was driven by $2.7 million in non-cash items and $3.3 million in changes to operating assets and liabilities.

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 82 Table of Content development expenses.

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, insurance and facility related costs not otherwise included in 81 Table of Contents research and development expenses.

Net cash used in investing activities during the year ended December 31, 2023 was $0.5 million for purchases of office and laboratory equipment. 86 Table of Content Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 of $13.2 million was primarily attributable to $5.0 million in proceeds received from the exercise of 377,865 Post-Merger Warrants by Juvenescence, $5.0 million received from issuance of common stock to Juvenscence in November 2024, $3.0 million drawn under the loan facilities from Juvenescence, and $0.3 million cash and restricted cash acquired in connection with the Merger.

Net cash provided by financing activities for the year ended December 31, 2024 of $13.2 million was primarily attributable to $5.0 million in proceeds received from the exercise of 377,865 Post-Merger Warrants by Juvenescence, $5.0 million received from issuance of common stock to Juvenscence in November 2024, $3.0 million drawn under the loan facilities 86 Table of Contents from Juvenescence, and $0.3 million cash and restricted cash acquired in connection with the Merger.

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).

“Risk Factors” in this Annual Report. 76 Table of Contents 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).

While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements appearing elsewhere in this Report, we believe that the following accounting policies are the most critical for fully understanding and evaluating our financial condition and results of operations.

Actual conditions may differ from our assumptions and actual results may differ from our estimates. While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements appearing elsewhere in this Report, we believe that the following accounting policies are the most critical for fully understanding and evaluating our financial condition and results of operations.

Our operating loss was $17.0 million and $3.1 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $44.3 million and $3.7 million in cash and cash equivalents.

Our operating loss was $24.0 million and $17.0 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $63.5 million and cash and cash equivalents of $3.1 million.

Our operations through December 31, 2024, have been financed primarily by aggregate net proceeds of $56.9 million from the issuance of common stock, convertible preferred stock, convertible notes and the exercise of Post-Merger Warrants to purchase our common shares by Juvenescence. Since our inception, we have had significant operating losses.

Since inception our operations have been financed primarily by aggregate net proceeds from the issuance of common stock, convertible preferred stock, convertible notes, exercise of Post-Merger Warrants to purchase our common shares by Juvenescence and our at-the-market ("ATM") offerings. Since our inception, we have had significant operating losses.

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.

These outflows were partially offset by a $0.4 million increase in accrued expenses. Net income for the year ended December 31, 2023 was $5.3 million. Net cash used in operating activities during this period amounted to $2.5 million.

These outflows were partially offset by a $0.4 million increase in accrued expenses. Investing Activities Net cash used in investing activities during the year ended December 31, 2025 and 2024 was immaterial.

The consolidated 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. 84 Table of Content 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.

The $7.7 million difference between the net gain and net cash used in operating activities during the year ended December 31, 2024 was comprised of non-cash items, totaling $7.8 million, offset by the increase in operating assets and liabilities totaling $0.1 million.

Net cash used in operating activities during this period amounted to $18.0 million. The $1.2 million difference between the net loss and net cash used in operating activities during the year ended December 31, 2025 was comprised of offsetting non-cash items of $0.2 million and changes in operating assets and liabilities totaling $1.4 million.

Grant Revenues Our grants and contracts reimburse us for direct and indirect costs relating to the grant projects and also provide us with a prenegotiated 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.

See Notes 5, Related Party Transactions, 6, Fair Value Measurements , for additional information regarding the warrants and 7, Stockholders’ (Deficit) Equity . 79 Table of Contents 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.

These increases were offset by a $0.1 million decrease in depreciation. See Notes 1, Organization, Business Overview and Liquidity and 5, Related Party Transactions to our audited consolidated financial statements included elsewhere in this Report for additional information about the Legacy Assets.

See Notes 1, Organization, Business Overview and Liquidity and 5, Related Party Transactions to our audited consolidated financial statements included elsewhere in this Report for additional information about the Legacy Assets. Other Income, net Other income, net was $4.8 million for the year ended December 31, 2025, compared to $5.8 million for the same period in 2024.

The decrease of $2.6 million is primarily attributable to the aggregate change in the fair value of the Legacy Serina Convertible Notes and the AgeX-Serina Note which amounted to a $14.6 million loss combined with a $0.1 million net decrease in miscellaneous expenses that were individually insignificant partially offset by a $12.1 million gain from the change in fair value of liability classified warrants.

These decreases were partially offset by by the absence in 2025 of a $7.0 million loss recognized in 2024 from the change in the fair value of the Legacy Serina Convertible Notes and the AgeX-Serina Note, a $0.7 million gain from the expiration of liability classified warrants, a decrease of $0.3 million in interest expense and $0.1 million decrease in miscellaneous expenses amounts that were individually insignificant.

However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all.

We will continue to seek funds through equity offerings, debt financings, our ATM, 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.

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 and interest accrued from our convertible notes. Results of Operations Comparison of Years Ended December 31, 2024 and 2023 The table presented below shows Net (Loss) Income for the periods presented (in thousands).

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/(losses).

See Note 5, Related Party Transactions to our consolidated financial statements included elsewhere in this Report for additional information about the 2022 Secured Note and sale of subsidiary.

These changes were partially offset by $0.1 million repayment of principal on loan facilities to Juvenescence. See Note 5, Related Party Transactions, to our consolidated financial statements included elsewhere in this Report for additional information about the related party transactions with Juvenescence.

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.

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.

Our primary use of cash is to fund operating expenses, which consist primarily 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.

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 December 31, 2025, had an accumulated deficit of $63.5 million.

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.

We expect that our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase.

The increase of $0.1 million cash from changes in operating assets and liabilities primarily consisted of $0.4 million increase in accounts payable, offset by $0.3 million net aggregate decrease in accrued expenses and operating leases liabilities. Investing Activities Net cash used in investing activities during the year ended December 31, 2024 was immaterial.

The net increase of $1.4 million cash from operating assets and liabilities primarily consisted of a $1.2 million increase in accounts payable and decrease of $0.7 million in prepaid and other current assets. These cash increases were partially offset by a $0.2 million decrease in accrued expenses and $0.1 million decrease in grant receivable.

Year Ended December 31, Increase/ (Decrease) 2024 2023 REVENUES License revenues $ — $ 3,000 $ (3,000) Grant revenues 56 153 (97) Total revenues 56 3,153 (3,097) OPERATING EXPENSES Research and development 7,480 2,388 5,092 General and administrative 9,624 3,894 5,730 Total operating expenses 17,104 6,282 10,822 Total other income, net 5,841 8,398 (2,557) NET (LOSS) INCOME $ (11,207) $ 5,269 $ (16,476) License Revenue License revenue for the year ended December 31, 2024 was zero compared to $3.0 million for the year ended December 31, 2023.

Year Ended December 31, Increase/ (Decrease) 2025 2024 REVENUES Grant revenues $ 130 $ 56 $ 74 Total revenues 130 56 74 OPERATING EXPENSES Research and development 13,155 7,480 5,675 General and administrative 10,997 9,624 1,373 Total operating expenses 24,152 17,104 7,048 Total other income, net 4,825 5,841 (1,016) Provision for income taxes 18 — 18 NET LOSS $ (19,215) $ (11,207) $ (8,008) Research and Development Expenses Research and development expenses were $13.2 million for the year ended December 31, 2025, compared to $7.5 million for the same period in 2024.

See Note 5, Related Party Transactions, to our consolidated financial statements included elsewhere in this Report for additional information about the related party transactions with Juvenescence. Off-Balance Sheet Arrangements As of December 31, 2024, we did not have any off-balance sheet arrangements, as defined in Item 303(a) (4) (ii) of SEC Regulation S-K. Item 7A.

Off-Balance Sheet Arrangements As of December 31, 2025, we did not have any off-balance sheet arrangements, as defined in Item 303(a) (4) (ii) of SEC Regulation S-K. Item 7A. Quantitative and Qualitative Disclosures about Market Risk Not required for smaller reporting companies. 87 Table of Contents

Liquidity and Capital Resources Sources of Liquidity We had $3.7 million in cash and cash equivalents as of December 31, 2024.

Liquidity and Capital Resources Sources of Liquidity We had $3.1 million in cash and cash equivalents as of December 31, 2025. Our operations have been financed primarily by the issuance of common stock, convertible preferred stock, convertible notes, warrant exercises and our ATM program.

Summary of Cash Flows The following table summarizes the major sources and uses of cash for the periods set forth below (in thousands): Year Ended December 31, 2024 2023 $ Change % Change Net cash used in operating activities $ (17,137) $ (2,476) $ (14,661) 592.1 % Net cash used in investing activities (22) (504) 482 (95.6) % Net cash provided by financing activities 13,212 10,067 3,145 31.2 % Net (decrease) increase in cash $ (3,947) $ 7,087 $ (11,034) (155.7) % Operating Activities Net loss for the year ended December 31, 2024 was $11.2 million.

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. 85 Table of Contents Summary of Cash Flows The following table summarizes the major sources and uses of cash for the periods set forth below (in thousands): Year Ended December 31, 2025 2024 $ Change % Change Net cash used in operating activities $ (17,955) $ (17,137) $ (818) 4.8 % Net cash used in investing activities (59) (22) (37) 168.2 % Net cash provided by financing activities 17,412 13,212 4,200 31.8 % Effect of foreign currency on cash and cash equivalents (14) — (14) 100.0 % Net decrease in cash and cash equivalents $ (616) $ (3,947) $ 3,331 (84.4) % Operating Activities Net loss for the year ended December 31, 2025 was $19.2 million.

The net $7.8 million of non-cash items primarily consisted of a $5.4 million gain from the change in fair value of convertible notes, $2.2 million loss from the fair value at inception adjustment on the convertible notes, a $1.1 million gain from the change in the fair value of warrants, offset by the increase in $0.6 million in accrued interest on the AgeX-Serina Note and $0.3 million increase in other non-cash items that were individually insignificant.

These non-cash items were reduced by the non-cash gain of $4.3 million from the change in the fair value of warrants and $0.7 million gain from warrant expirations.

The increase of $5.7 million was primarily driven by (1) $2.5 million increase in compensation and related expenses, including $0.5 million in payroll and related expenses and $2.0 million in stock-based compensation from new stock options granted to directors and new hires, (2) $1.0 million increase in consulting expenses to assist with the implementation of new platforms and software, (3) $0.6 million increase in directors and officers insurance,(4) $0.9 million increase in legal fees for the maintenance of certain patent and other intellectual property and biological material assets, (5) $0.5 million increase in outside professional services, and (6) $0.3 million increase for severance and related costs.

These increases were primarily offset by decreases of $0.6 million 82 Table of Contents in legal fees and professional fees for the maintenance of certain patent and other intellectual property and biological material assets included in Legacy Assets and $0.3 million in severance and related costs.

Other Income, net Other income, net was $5.8 million for the year ended December 31, 2024, compared to $8.4 million for the same period in 2023.

Net loss for the year ended December 31, 2024 was $11.2 million. Net cash used in operating activities during this period totaled $17.1 million.

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. 77 Table of Content 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.

On March 26, 2024, we 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”).

The decrease of $3.0 million was due to the one-time upfront payment we received in December 2023 from the non-exclusive license agreement with Pfizer. Research and Development Expenses Research and development expenses were $7.5 million for the year ended December 31, 2024, compared to $2.4 million for the same period in 2023.

These increases were primarily offset by a decrease of $0.3 million for severance and related costs. General and Administrative Expenses General and administrative expenses were $11.0 million for the year ended December 31, 2025, compared to $9.6 million for the same period in 2024.

Removed

Additionally, on March 26, 2024, we changed our name to “Serina Therapeutics, Inc.” See the Explanatory Note included elsewhere in this Report for additional information regarding completion of the Merger.

Added

Additionally, on March 26, 2024, AgeX changed its name from “AgeX Therapeutics, Inc.” to “Serina Therapeutics, Inc.” Following the consummation of the Merger, the business previously conducted by Legacy Serina became our business, which is now a clinical-stage biotechnology company developing Legacy Serina’s drug product candidates. Our headquarters are located in Huntsville, Alabama.

Removed

Senior management has discussed the development, selection and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual conditions may differ from our assumptions and actual results may differ from our estimates.

Added

On November 3, 2025, we announced that we received a notice from the FDA, placing a clinical hold on our IND application for SER-252, our lead development program for advanced Parkinson’s disease. The FDA requested additional information related to a commonly used excipient in the formulation of SER-252.

Removed

See Notes 5, Related Party Transactions and 6, Fair Value Measurements , for additional information regarding the warrants. 80 Table of Content Components of Operating Results License Revenues For the year ended December 31, 2023, our license revenue consists of a one-time upfront payment of $3.0 million from our non-exclusive license agreement with Pfizer, Inc. to use our POZ polymer technology in lipid nanoparticle drug delivery formulations.

Added

The FDA’s feedback did not relate to the active drug substance or its proposed mechanism of action.

Removed

Our operations have been financed primarily by the issuance of common stock, convertible preferred stock, and convertible notes by AgeX and Serina prior to the Merger, and by $2.9 million drawn under the 2022 Secured Convertible Promissory Note (the “2022 Secured Note”) subsequent to consummation of the Merger.

Added

In January 2026, we announced that the FDA had cleared its IND application for SER-252, which allowed us to proceed with regulatory and site-level activities to support initiation of a planned Phase 1b registrational clinical study evaluating SER-252 in patients with advanced Parkinson’s disease and in February 2026 we enrolled and dosed our first patient into the clinic.

Removed

We have drawn down the entire amount of credit that was made available to us through the 2022 Secured Note. See Note 5, Related Party Transactions to our consolidated financial statements included elsewhere in this Report for additional information about the 2022 Secured Note. In June 2024, we received $5.0 million from Juvenescence through the exercise of Post-Merger Warrants.

Added

Results of Operations Comparison of Years Ended December 31, 2025 and 2024 The table presented below shows Net Loss for the periods presented (in thousands).

Removed

In November 2024, pursuant to the Agreement, Juvenescence agreed to purchase 1,000,000 shares of our common stock at a purchase price of $10.00 per share, for an aggregate amount of $10.0 million in two tranches: $5.0 million was received in November 2024, and the second tranche of $5.0 million in January 2025.

Added

The increase of $1.4 million is due primarily to increases of $1.2 million in stock based compensation expense as a result of new hires, directors and consultants, $0.6 million of consulting expenses for public company infrastructure, $0.4 million in investor outreach activities and an increase of $0.1 million in miscellaneous expenses amounts that were individually insignificant.

Removed

Since inception, we have had significant operating losses and negative cash flows and as of December 31, 2024, had an accumulated deficit of $44.3 million.

Added

The $1.0 million decrease is primarily attributable to a decrease in gain of $8.9 million from the change in fair value of liability classified warrants and a $0.2 million loss from the sale of a subsidiary.

Removed

We believe that our cash on hand, along with the $5.0 million of cash proceeds received from Juvenescence through the closing of the second tranche in January 2025, as provided in the Agreement, will not be sufficient to enable us to fund our operations through calendar year 2025 based on our current plan.

Added

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.

Removed

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.

Added

Each share of Series A Preferred Stock is convertible into shares of our common stock, par value ($0.0001), at a conversion price of $5.18 per share, subject to adjustment upon consummation of certain qualified offering events and other standard adjustments due to subdivision or combination of common stock, and earns cumulative annual dividend 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").

Removed

Added

As of December 31, 2025, 56,645 dividend shares have been accrued but not declared.

Removed

These changes were partially offset by $0.1 million repayment of principal on loan facilities to Juvenescence. Net cash provided by financing activities for the year ended December 31, 2023 of $10.1 million was primarily attributable to the net proceeds from the issuance of $10.0 million from the AgeX-Serina Note and $0.1 million from the Serina Convertible Notes.

Added

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 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.

Removed

Quantitative and Qualitative Disclosures about Market Risk Not required for smaller reporting companies. 87 Table of Content

Added

We pay the Sales Agent a commission up to 3.0% of the gross sales proceeds of any shares sold under the Sales Agreement. In 2025, we have sold 0.5 million shares of our common stock at an gross average price of $6.00, resulting in gross proceeds of $2.8 million under the ATM.

Added

To date, we have issued 3.5 million shares of common stock under the ATM program at a gross average per share price of $3.72, resulting in gross proceeds of $12.9 million.

Added

Annual 2025 Operating Results On September 9, 2025, we entered into an unsecured convertible note (the “2025 Convertible Note”) with a member of our Board of Directors, making available to Serina an aggregate principal amount of up to $20 million. The 2025 Convertible Note was subsequently modified in March 2026.

Added

See in paragraph below and in Note 14, Subsequent Events to our consolidated financial statement for details.

Added

Under the original 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.

Added

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 83 Table of Contents (“Milestone 5”).

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Top changes in Serina Therapeutics, Inc.'s 2025 10-K

Item 1. Business

Item 1A. Risk Factors

Item 1C. Cybersecurity

Item 2. Properties

Item 3. Legal Proceedings

Item 5. Market for Registrant's Common Equity

Item 7. Management's Discussion & Analysis

Other SER 10-K year-over-year comparisons