- FDA Grants IND Clearance for SER-252
- SER-252 Phase 1b Trial Initiated
- Closed Private Placement Financing of up to
"This past year was defined by execution, advancing SER-252 from IND filing through FDA clearance, into the clinic while strengthening our balance sheet to support the clinical milestones ahead," said
Recent Highlights
- FDA Grants IND Clearance for SER-252; Phase 1b Trial Initiated: In
January 2026 , Serina announced theU.S. Food and Drug Administration (FDA) had cleared the Investigational New Drug (IND) application for its lead product, SER-252, for the treatment of advanced Parkinson's disease. InFebruary 2026 , the Company enrolled and dosed its first patient in its Phase 1 registrational trial evaluation SER-252. - Private Placement Financing of up to
$30 Million : OnMarch 17, 2026 , Serina entered into definitive agreements for the private placement of common stock and pre-funded warrants to raise at least an initial aggregate of$15 million in gross proceeds, with one or more additional closings for aggregate gross proceeds of at least$5.0 million and up to$15.0 million to be funded within 20 days after the initial closing. The financing structure includes 50% warrant coverage to provide additional potential proceeds of up to$33.3 million from the future exercise of warrants. The transaction was led byGreg Bailey , M.D., who will assume the role of Co-Chairman of the Board alongsideSimba Gill , Ph.D. In connection with the closing of the private placement, the Senior Unsecured Convertible Promissory Note previously entered onSeptember 9, 2025 , was amended to remove further obligations to borrow or loan funds under the note. As ofMarch 23, 2026 , gross proceeds of$16.0 million have been received. - At-the-Market (ATM) Equity Program: In
April 2025 , Serina entered into a Capital on Demand™ Sales Agreement withJonesTrading Institutional Services LLC , under which the Company may offer and sell up to$13.3 million of common stock. Thus far in 2026, we sold 3.0 million shares of common stock at an gross average price of$3.36 , resulting in gross proceeds of$10.0 million . To date, Serina has 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 .
Annual 2025 Operating Results
Operating expenses: Operating expenses for the years ended
Research and Development (R&D) Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Other Income, Net: Other income, net was
Net Loss: The net loss attributable to Serina common stockholders for the year ended
Liquidity Information
Cash and cash equivalents totaled
About
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 PlatformTM 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
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 has advanced SER 252 into the clinics in
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
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). 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
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
For inquiries, please contact:
sriley@serinatherapeutics.com
(256) 327-9630
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,056 | $ | 3,672 | ||||
| Prepaid expenses and other current assets | 3,024 | 2,004 | ||||||
| Total current assets | 6,080 | 5,676 | ||||||
| Property and equipment, net | 465 | 501 | ||||||
| Right of use assets - operating leases | 377 | 461 | ||||||
| Right of use assets - finance leases | — | 86 | ||||||
| Other long-term prepaid assets | 29 | — | ||||||
| TOTAL ASSETS | $ | 6,951 | $ | 6,724 | ||||
| LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,931 | $ | 744 | ||||
| Accrued expenses | 1,207 | 1,429 | ||||||
| Warrant liability | 88 | — | ||||||
| Other current liabilities | 337 | 193 | ||||||
| Total current liabilities | 3,563 | 2,366 | ||||||
| Warrant liability, non-current | 283 | 3,582 | ||||||
| Convertible Note, net | 2,946 | — | ||||||
| Operating lease liabilities, net of current portion | 196 | 268 | ||||||
| TOTAL LIABILITIES | 6,988 | 6,216 | ||||||
| TOTAL STOCKHOLDERS' (DEFICIT) EQUITY | (37 | ) | 508 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | $ | 6,951 | $ | 6,724 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| REVENUES | ||||||||
| Grant revenues | $ | 130 | $ | 56 | ||||
| Total revenues | 130 | 56 | ||||||
| OPERATING EXPENSES | ||||||||
| Research and development | 13,155 | 7,480 | ||||||
| General and administrative | 10,997 | 9,624 | ||||||
| Total operating expenses | 24,152 | 17,104 | ||||||
| Loss from operations | (24,022 | ) | (17,048 | ) | ||||
| OTHER INCOME, NET | ||||||||
| Total other income, net | 4,825 | 5,841 | ||||||
| Loss before income taxes | (19,197 | ) | (11,207 | ) | ||||
| Provision for income taxes | (18 | ) | - | |||||
| NET LOSS | (19,215 | ) | (11,207 | ) | ||||
| Net loss attributable to noncontrolling interest | 33 | 66 | ||||||
| NET LOSS ATTRIBUTABLE TO SERINA | $ | (19,182 | ) | $ | (11,141 | ) | ||
| NET LOSS ATTRIBUTABLE TO SERINA COMMON STOCKHOLDERS | $ | (19,436 | ) | $ | (11,141 | ) | ||
| NET LOSS ATTRIBUTABLE TO SERINA COMMON SHAREHOLDER, BASIC AND DILUTED | $ | (1.91 | ) | $ | (1.51 | ) | ||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING, WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING, | 10,190 | 7,359 | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| Net cash used in operating activities | $ | (17,955 | ) | $ | (17,137 | ) | ||
| Net cash used in investing activities | (59 | ) | (22 | ) | ||||
| Net cash provided by financing activities | 17,412 | 13,212 | ||||||
| Effect of foreign currency on cash and cash equivalents | (14 | ) | — | |||||
| (616 | ) | (3,947 | ) | |||||
| CASH AND CASH EQUIVALENTS: | ||||||||
| At beginning of the year | 3,672 | 7,619 | ||||||
| At end of the year | $ | 3,056 | $ | 3,672 | ||||
Source: