Serina Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Highlights

Rhea-AI Summary

Serina Therapeutics (NYSE American: SER) reported third quarter 2025 results and program updates on November 13, 2025. Key regulatory news: the FDA supported a 505(b)(2) pathway and recognized the Phase 1b as registrational for SER-252, but on Nov 3, 2025 placed the IND on clinical hold pending additional information about a formulation excipient; Serina expects formal FDA communication within 30 days.

Financing and liquidity: secured a convertible note/warrant financing providing up to $20.0M with $5.0M drawn; an ATM program has generated $2.8M net proceeds; cash and cash equivalents were $8.6M at Sept 30, 2025.

Positive

• FDA alignment on 505(b)(2) pathway for SER-252
• Phase 1b designated as registrational by FDA
• Convertible financing agreement provides up to $20.0M
• ATM program net proceeds of $2.8M through 474,712 shares

Negative

• IND placed on clinical hold on Nov 3, 2025 pending excipient data
• Net loss of $4.6M for Q3 2025 (loss of $0.45 per share)
• Cash and cash equivalents of $8.6M as of Sept 30, 2025
• Warrants tied to financing could produce dilution if fully issued and exercised

Insights

Regulatory and Clinical Development Expert

FDA supported a 505(b)(2) registrational plan but placed the IND on clinical hold over an excipient; outcome is mixed and timing is key.

Serina secured written FDA alignment to pursue SER-252 under a 505(b)(2) pathway with the company’s Phase 1b described as registrational, which can shorten the regulatory path if accepted. The subsequent IND clinical hold relates specifically to a commonly used formulation excipient and not the active drug substance or mechanism, so the principal scientific program remains intact.

Key dependencies include the content of the forthcoming formal FDA communication expected within 30 days and Serina’s ability to supply the requested excipient data promptly. Watch for the FDA letter and any required formulation changes; these items will determine whether the registrational trial can start on the accelerated timeline.

Corporate Finance and Liquidity Expert

Company shows partial near-term funding but cash of $8.6M and drawn financings leave runway uncertain; financing cadence matters.

Serina reported cash and cash equivalents of $8.6M at September 30, 2025, drew the first $5M tranche of a convertible note/warrant facility that could provide up to $20M, and has an ATM program with gross capacity of $13.3M that generated net proceeds of $2.8M from 474,712 shares. These items provide incremental liquidity but are contingent on future tranche draws, warrant issuance/exercise, and continued ATM sales.

Monitor the timing and conditions for additional tranche draws, any material dilution from warrant exercise, and quarterly cash burn given operating expenses of $6.4M for the quarter. Changes in those items within the next 3–6 months will materially affect near-term financial flexibility.

HUNTSVILLE, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ Platform^™ drug optimization technology, today announced its financial results for the third quarter ended September 30, 2025, along with key recent updates.

Steve Ledger, Chief Executive Officer of Serina, stated, "The FDA's alignment with our plan to advance SER-252 under a 505(b)(2) NDA pathway, and its recognition of the Phase 1b trial as registrational, represents a key milestone for Serina. This outcome underscores our regulatory and development strategy, positioning SER-252 for an accelerated path to potential approval. It also highlights the broader opportunity for our POZ platform to streamline development timelines and unlock significant value across our pipeline."

• Regulatory Update: SER-252 for Advanced Parkinson’s Disease: Following a Type B meeting with the U.S. Food and Drug Administration (the "FDA") in August 2025, the FDA's written feedback supported Serina’s proposal to advance SER-252 under a 505(b)(2) NDA pathway for advanced Parkinson’s disease. On November 3, 2025, the FDA placed the IND on clinical hold pending additional information regarding a commonly used formulation excipient. The hold does not relate to the active drug substance or its mechanism of action. Serina expects the formal FDA communication within 30 days and is actively working to address the FDA’s questions to enable the initiation of the registrational study as soon as possible.
  
  
• Advancement of SER-270 for Tardive Dyskinesia: Serina continues to advance SER-270, its next program from the POZ Platform, designed to deliver long-acting VMAT2 inhibition for the treatment of tardive dyskinesia (TD). The Company is on track to complete formulation optimization and pre-IND activities in 2026.
  
  
• Secured Up to $20 Million in Funding: In September 2025, Serina entered into a convertible note and warrant financing agreement providing up to $20 million in funding, led by a member of Serina’s Board of Directors. The first $5 million tranche was drawn in September. If all warrants are issued and exercised in full, the financing could yield additional gross proceeds of up to $20 million.
  
• Expanded Stakeholder Communications and Transparency Initiatives: In October 2025, Serina launched a comprehensive corporate communications platform to enhance stakeholder engagement and transparency. The initiative includes regular digital updates, educational content, multimedia resources, and expert commentary aimed at patients, clinicians, investors, and the scientific community.
• At-the-Market (ATM) Equity Program: In April 2025, Serina entered into a Capital on Demand^™ Sales Agreement with JonesTrading Institutional Services LLC, under which the Company may offer and sell up to $13.3 million of common stock. As of November 7, 2025, Serina has issued 474,712 shares of common stock at a gross average price of $6.00, resulting in net proceeds of $2.8 million.
  
  

Third Quarter Operating Results

Operating Expenses: Operating expenses for the three months ended September 30, 2025 and 2024 were $6.4 million and $5.3 million, respectively.

Research and Development (R&D) Expenses: R&D expenses were $3.6 million for the three months ended September 30, 2025, compared to $2.4 million for the same period in 2024. The increase of $1.2 million is primarily driven by increases in outsourced research services, consultant spend mainly for chemistry, manufacturing, and controls activities, amortization for a prepaid technology access fee and increased spend in clinical related activities. These increases were partially offset by decreases in legal patent fees for certain patent and other intellectual property and biological material assets included in Legacy Assets and salaries.

General and Administrative Expenses: General and administrative expenses were $2.7 million for the three months ended September 30, 2025, compared to $2.9 million for the same period in 2024. The net decrease of $0.2 million is due to the reduction of compensation related costs partially offset by an increase in investor outreach expenses.

Other Income, Net: Other income was $1.8 million for the three months ended September 30, 2025 compared to $6.7 million net income for the same period in 2024. The $4.9 million net decrease in income was primarily attributable to the change in fair value of liability classified warrants partially offset by a gain in warrant expirations.

Net (Loss) Income: The net loss attributable to Serina for the three months ended September 30, 2025 was $4.6 million, or $0.45 per basic and diluted share, compared to net income of $1.4 million, or $0.16 per basic share and $0.13 per diluted share for 2024.

Liquidity Information

Cash and cash equivalents totaled $8.6 million as of September 30, 2025.

About Serina Therapeutics

Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina’s POZ Platform^TM 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). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.

About the POZ Platform^™

Serina’s proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina’s 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. The therapeutic agents in Serina’s 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. Serina believes that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood.

Serina’s POZ platform delivery technology has potential for use across a broad range of payloads and indications. Serina intends to advance additional applications of the POZ platform via out-licensing, co-development, or other partnership arrangements, including the non-exclusive license agreement with Pfizer, Inc. to use Serina’s POZ polymer technology for use in lipid nanoparticle drug (LNP) delivery formulations.

About SER-252 (POZ-apomorphine)

SER 252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation (CDS). CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) in Parkinson’s disease. Preclinical studies support the potential of SER 252 to provide CDS without skin reactions. Serina plans to advance SER 252 to clinical testing in 2025.

SER-252 Registrational Study Design Overview

The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial with single-ascending-dose (five cohorts of eight; n=40) and multiple-ascending-dose components (up to three cohorts of sixteen; n=48) in adults with Parkinson’s disease and motor fluctuations. The registrational study is designed to evaluate safety, tolerability, and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures that include MDS-UPDRS motor scores and structured motor-state assessments. Dose escalation will be overseen by a Safety Review Committee and the study will be conducted across sites in the U.S. and Australia.

About SER-270 (POZ-VMAT2i)

SER-270 is an investigational once-weekly VMAT2 inhibitor developed with Serina’s POZ platform to address adherence and access challenges in tardive dyskinesia. TD is a disabling movement disorder often caused by long-term exposure to antipsychotic medications. The subcutaneous formulation of SER-270 is designed for patients on long-acting injectable antipsychotics, those with dysphagia, and institutionalized populations and other patients with challenged adherence. Serina is also exploring development in Huntington’s disease chorea.

For more information, please visit https://serinatx.com.

Cautionary Statement Regarding Forward-Looking Statement

References in this Report to “Serina,” “the Company,” “we” or “us” refer to Serina Therapeutics, Inc.

This release contains forward-looking statements within the meaning of federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “may,” “will,” “believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in Serina’s periodic reports filed with the Securities and Exchange Commission (the “SEC”) under the heading “Risk Factors” and other filings that Serina may make with the SEC. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change. Except as required by law, Serina disclaims any intent or obligation to update these forward-looking statements. These statements are based on management’s current expectations, plans, beliefs or forecasts for the future, and are subject to uncertainty and changes in circumstances. Any express or implied statements in this press release that are not statements of historical fact, including statements about the potential of Serina’s POZ polymer technology, Serina’s estimates regarding future revenue, expenses, capital requirements and need for additional financing, and Serina’s planned clinical programs, including planned clinical trials, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the timing and extent of the FDA's clinical-hold letter and of Serina's response, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; Serina’s ability to continue as a going concern; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; and competitive developments. These risks as well as other risks are more fully discussed in the company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the company’s other periodic reports and documents filed from time to time with the SEC. The information contained in this release is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

For inquiries, please contact:

Stefan Riley
sriley@serinatherapeutics.com
(256) 327-9630

SERINA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)

		September 30, 2025				December 31, 2024
ASSETS
Current assets:
Cash and cash equivalents		$	8,620			$	3,672
Prepaid expenses and other current assets			2,877				2,004
Total current assets			11,497				5,676
Property and equipment, net			580				501
Right of use assets - operating leases			312				461
Right of use assets - finance leases			—				86
Other long-term prepaid assets			24				—
TOTAL ASSETS		$	12,413			$	6,724
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	2,731			$	744
Accrued expenses			1,144				1,429
Warrant liability			1,676				—
Convertible Note, net			2,888				—
Other current liabilities			350				193
Total current liabilities			8,789				2,366
Warrant liability, non-current			1,882				3,582
Operating lease liabilities, net of current portion			148				268
Total liabilities			10,819				6,216
Total stockholders’ equity			1,594				508
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	12,413			$	6,724

SERINA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)

		Three months ended September 30,								Nine months ended September 30,
		2025				2024				2025				2024
REVENUES
Grant revenues		$	—			$	14			$	130			$	70
Total revenues			—				14				130				70
OPERATING EXPENSES
Research and development			3,651				2,415				9,754				5,115
General and administrative			2,741				2,911				8,191				6,454
Total operating expenses			6,392				5,326				17,945				11,569
Loss from operations			(6,392	)			(5,312	)			(17,815	)			(11,499	)
OTHER (EXPENSE) INCOME, NET
Interest expense			(6	)			(16	)			(15	)			(509	)
Change in fair value of convertible promissory notes			—				—				—				(7,017	)
Change in fair value of warrants			1,044				6,669				1,076				10,385
Gain on warrants expiration			724				—				724				—
Other income, net			35				42				151				185
Total other income, net			1,797				6,695				1,936				3,044
NET (LOSS) INCOME			(4,595	)			1,383				(15,879	)			(8,455	)
Net loss attributable to noncontrolling interest			10				27				33				54
NET (LOSS) INCOME ATTRIBUTABLE TO SERINA THERAPEUTICS, INC.		$	(4,585	)		$	1,410			$	(15,846	)		$	(8,401	)
NET (LOSS) INCOME PER COMMON SHARE:
BASIC		$	(0.45	)		$	0.16			$	(1.60	)		$	(1.24	)
DILUTED		$	(0.45	)		$	0.13			$	(1.60	)		$	(1.24	)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
BASIC			10,339				8,851				10,032				6,774
DILUTED			10,339				10,751				10,032				6,774

SERINA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)

		Nine months ended September 30,
		2025				2024
Net cash used in operating activities		$	(11,922	)		$	(12,548	)
Net cash used in investing activities			(59	)			(17	)
Net cash provided by financing activities			16,931				8,181
Effect of foreign currency on cash			(2	)			—
NET CHANGE IN CASH AND CASH EQUIVALENTS			4,948				(4,384	)
CASH AND CASH EQUIVALENTS:
At beginning of the period			3,672				7,619
At end of the period		$	8,620			$	3,235

FAQ

What did Serina (SER) announce about the FDA pathway for SER-252 on Nov 13, 2025?

The company said the FDA supported advancing SER-252 under a 505(b)(2) NDA pathway and recognized the Phase 1b as registrational.

Why is the SER-252 IND on clinical hold and when will Serina respond?

The IND was placed on hold on Nov 3, 2025 pending additional information about a commonly used formulation excipient; Serina expects formal FDA communication within 30 days.

How much funding did Serina (SER) secure in September 2025 and how much was drawn?

Serina entered a convertible note and warrant financing providing up to $20.0M; the first tranche of $5.0M was drawn in September 2025.

What proceeds has Serina generated from its ATM program as of Nov 7, 2025?

Under the ATM program Serina issued 474,712 shares at a gross average price of $6.00, producing $2.8M in net proceeds.

What were Serina's cash and quarterly net loss figures reported for Q3 2025?

Cash and cash equivalents were $8.6M as of Sept 30, 2025; net loss for the three months ended Sept 30, 2025 was $4.6M (loss of $0.45 per share).

What is the status and timeline for Serina's SER-270 program for tardive dyskinesia?

Serina said SER-270 remains on track to complete formulation optimization and pre-IND activities in 2026.