Serina Therapeutics · NYSE American: SER · Huntsville, Alabama
Serina is a clinical-stage biotechnology company. Its POZ technology links existing drugs to a synthetic polymer, poly(2-oxazoline), engineered to give more control over how much drug is attached and how fast it is released after a long-acting subcutaneous injection. The lead candidate, SER-252, is apomorphine on that polymer, now in a Phase 1b registrational study in advanced Parkinson’s disease. 10-K, Mar 25, 2026
The platform
POZ is a water-soluble, low-viscosity polymer made from 2-ethyl- or 2-methyl-2-oxazoline. Serina attaches copies of an existing drug to it, and the company believes this can let a single subcutaneous injection deliver the drug continuously. 10-K, Mar 25, 2026
PEGDrug copies sit at the two chain ends only: n = 1 or 2.
POZDrug copies sit along the side chains: n = 10 or higher, and the company says the number of attachment points can be controlled.
Counts as stated in the 10-K. A schematic, not to molecular scale.
Ten or more copies of the drug are bonded to the side chains of one polymer backbone. Higher drug loading per polymer means, the company says, that less polymer is needed to deliver the same amount of drug.
The conjugate is a long-acting subcutaneous injection. The company believes SER-252 may be given at home, as a single or twice-weekly injection, without a healthcare provider.
Programmable linkers let the drug come off the polymer slowly. The company reports that in animal studies POZ programmed the release of small molecules. For SER-252 in people, the first look is the blinded Cohort 1 pharmacokinetic profile, which it calls consistent with prolonged apomorphine exposure. 8-K, Sep 9, 2026
What the company says sets POZ apart from PEG
PEG carries one or two copies of a drug, at its ends. POZ carries ten or more along the side chain.
Repeat dosing of POZ in rabbits did not generate anti-POZ antibodies, and the Phase Ia study of SER-214 showed no toxicity concerns.
In preclinical IND-enabling studies in rodents and monkeys, POZ was cleared by the kidneys as an intact polymer, with no evidence of accumulation in any tissue. The company says PEG is known to accumulate in several tissues.
POZ is made in essentially one pot from low-cost monomers, and drug-POZ conjugates can be stored at room temperature or in a refrigerator. PEG starts from ethylene oxide, a flammable, toxic gas.
A limit on all of this. The company has not compared PEG-conjugated and POZ-conjugated molecules in humans. Its comparisons are in vitro and in animals. 10-K, Mar 25, 2026
The need
Most people diagnosed with Parkinson’s disease are treated with oral levodopa and carbidopa. The 10-K says that in almost all cases of oral treatment patients may experience “wearing off” or a disabling side effect called dyskinesia, and that most oral drugs deliver dopamine stimulation in peaks and troughs. 10-K, Mar 25, 2026
Swipe sideways to read the whole table.
| Approach | How it is given | Continuous? | What the 10-K says |
|---|---|---|---|
| Oral levodopa-carbidopa | Pills | No | The company says most oral drugs deliver dopamine stimulation in a peak and trough fashion, and that animal studies suggest this may lead to dyskinesia. It describes wearing off separately, as the drug failing to deliver enough stimulus. |
| Duopa (levodopa-carbidopa gel, AbbVie) | Infusion into the small intestine through a surgically placed catheter | Yes | In a double-blind, double-dummy study in advanced patients it added about two hours a day of ON time without troublesome dyskinesia against oral sustained-release capsules. The company calls the approach invasive. |
| Vyalev (foslevodopa-foscarbidopa, AbbVie) | Continuous subcutaneous infusion with an electronic pump | Yes | Approved by the FDA in October 2024; the company calls it a substantial new treatment option. |
| SER-252 (apomorphine on POZ), investigational | Subcutaneous injection; the company believes single or twice weekly, at home | Designed to be | In a Phase 1b study and not approved. The company has so far reported only blinded Cohort 1 observations. |
Continuous dopaminergic stimulation (CDS) has been shown, the company says, to reduce the severity of levodopa-related motor complications. SER-252 is designed to deliver it by subcutaneous injection, with the goal of reducing the administration burden of existing continuous infusion approaches. 8-K, Sep 9, 2026
Lead program
SER-252 is apomorphine, a dopamine agonist, attached to POZ. The SER-252-1b study is randomized, double-blind and placebo-controlled, in adults with Parkinson’s disease and motor fluctuations. It tests safety, tolerability and pharmacokinetics first, with exploratory measures of motor function. 8-K, Sep 9, 2026
Single ascending dose five cohorts of eight, n = 40
Cohort 1
Complete, lowest dose. The company announced the committee’s recommendation to advance on Sep 9, 2026.
Cohort 2
Next. The company is advancing into it.
Cohort 3
Planned, a higher dose.
Cohort 4
Planned, a higher dose.
Cohort 5
Planned, a higher dose.
Multiple ascending dose up to three cohorts of sixteen, n = 48
Cohort 1
Planned, if the study proceeds.
Cohort 2
Planned, if the study proceeds.
Cohort 3
Planned, if the study proceeds.
Cohort 1, in the company’s words
“blinded Cohort 1 observations showed a pharmacokinetic profile consistent with the sustained apomorphine exposure SER-252 is designed to provide and included sustained periods of improvement in motor function in individual patients on exploratory clinical measures.”
Serina, Sep 9, 2026 press release. 8-K, Sep 9, 2026
Context the release also gives: during Cohort 1, patients were withdrawn from background Parkinson’s medications under the protocol, so that investigators could characterize pharmacokinetics and motor function with limited contribution from other dopaminergic therapy. Cohort 1 was eight patients at the lowest dose, randomized 3:1 to SER-252 or placebo.
The record since the hold
The FDA places a clinical hold on the SER-252 IND. It asked for more information on a commonly used excipient in the formulation, not on the active drug or its mechanism. 8-K, Nov 3, 2025
Serina submits its complete response to the FDA’s clinical hold letter dated Nov 25, 2025, and announces it on Dec 10. 8-K, Dec 10, 2025
Serina announces that the FDA has cleared the IND. 8-K, Jan 28, 2026
The first patient is enrolled and dosed in the Phase 1b study. 10-K, Mar 25, 2026
Sentinel dosing in Cohort 1 is complete, per the company’s news release. News index
Enrollment and dosing in Cohort 1 are complete, per the company’s news release. News index
After a blinded review, the independent Safety Monitoring Committee recommends the study advance to Cohort 2. 8-K, Sep 9, 2026
Expected: topline data from the single-ascending-dose part of the study. The company says so; it is not a result.
Partners and the platform beyond SER-252
Serina’s business is largely a wholly owned pipeline of POZ-enabled drug candidates, and it intends to take other uses of POZ forward through out-licensing, co-development and other partnerships. 10-K, Mar 25, 2026
Delivery partner · May 2024
In May 2024 Serina entered a partnership with Enable Injections, Inc. to develop and commercialize SER-252 together with enFuse, a wearable drug delivery system for at-home self-administration. The company describes enFuse as designed to overcome the shortcomings of IV infusion and of other subcutaneous methods. 10-K, Mar 25, 2026
Earlier candidate
POZ-rotigotine for early Parkinson’s disease and restless legs syndrome. It completed a Phase Ia study in 19 subjects as a proof of principle for POZ in humans, is not being advanced internally, and may be out-licensed.
License · October 2023
A non-exclusive license to use POZ in lipid nanoparticle drug delivery formulations, for a specific POZ polymer structure in one field. It followed two years of work, from early 2021, with several large pharmaceutical and biotechnology companies under agreements the 10-K calls FSAs, on POZ-lipids as a replacement for PEG-lipids in mRNA vaccines.
Other uses · intent to license
The company intends to license POZ to others developing lipid nanoparticle approaches in infectious diseases, cancer immunology and gene therapy, and describes POZ as applicable to antibody-drug conjugates. None of these programs is the company’s own.
The company’s 8-K press releases, most recently on Mar 25, 2026, describe SER-270 as an investigational once-weekly VMAT2 inhibitor for tardive dyskinesia and say the company is also exploring Huntington’s disease chorea. The Nov 13, 2025 release said it was on track to complete formulation optimization and pre-IND activities in 2026, while the investor site still says it is anticipated to enter IND enabling studies in the fourth quarter of 2025. The 10-K does not name it, so it is not counted in the pipeline above. 8-K, Nov 13, 2025 8-K, Mar 25, 2026
Financials
Serina has no product revenue. Its revenue is grant revenue: $130 thousand in 2025 and none in the first half of 2026. In the six months to Jun 30, 2026 it used $11.3 million in operating activities and raised $21.1 million net in a private placement and $10.2 million net in at-the-market sales. 10-Q, Aug 13, 2026
| 2025 | 2024 | |
|---|---|---|
| Grant revenues | 130 | 56 |
| 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) |
| Net loss attributable to Serina | (19,182) | (11,141) |
| 2026 | 2025 | |
|---|---|---|
| Grant revenues | 0 | 130 |
| Research and development | 7,015 | 6,103 |
| General and administrative | 6,049 | 5,450 |
| Total operating expenses | 13,064 | 11,553 |
| Loss from operations | (13,064) | (11,423) |
| Net loss | (13,254) | (11,284) |
| Cash used in operating activities | (11,252) | (8,072) |
| Jun 30, 2026 | Dec 31, 2025 | |
|---|---|---|
| Cash and cash equivalents | 23,024 | 3,056 |
| Total assets | 25,814 | 6,951 |
| Convertible note, net | 3,087 | 2,946 |
| Total liabilities | 7,084 | 6,988 |
| Total stockholders’ equity (deficit) | 18,730 | (37) |
| Accumulated deficit | (76,754) | (63,500) |
Inside the numbers
Disclosures
Seven matters a reader should have in front of them. Each is in the company’s own filings, and each carries its source.
“Management believes that its cash and cash equivalents of $23.0 million as of June 30, 2026 are not expected to be sufficient to satisfy the Company’s anticipated operating and other funding requirements for the twelve months from the issuance of these unaudited condensed consolidated interim financial statements. As such, there is substantial doubt about the Company’s ability to continue as a going concern.”
The 10-K for 2025 reached the same conclusion when cash was $3.1M, and its risk factors say the auditor’s report contains a qualification to that effect. The company expects to rely largely on raising money from equity investors. 10-Q, Note 1 10-K, Mar 25, 2026
Shares outstanding rose from about 10.8 million at Dec 31, 2025 to 25,400,473 at Aug 10, 2026. The March 2026 private placement came with redeemable warrants at $5.00 a share and pre-funded warrants, and the company has since agreed an equity line of up to $25.0 million at a discount to market. The company says the exercise of outstanding warrants and other issuances could result in substantial dilution. 10-Q, Aug 13, 2026 8-K, Aug 27, 2026
On Jan 9, 2026 the exchange told the company it was below its stockholders’ equity requirements: about $1.6 million at Sep 30, 2025 against $2.0 million and $4.0 million thresholds. The exchange accepted the company’s compliance plan on Mar 24, 2026, which permits the stock to remain listed during a plan period ending Jul 9, 2027, subject to periodic review including quarterly monitoring. The company says there can be no assurance it will maintain compliance, and that delisting proceedings may follow if it does not. Equity was about $18.7 million at Jun 30, 2026. 8-K, Jan 15, 2026 10-Q
On Aug 10, 2026 Juvenescence Limited beneficially owned about 17% of the common stock and Gregory H. Bailey, a director and Co-Chairman, about 41%, each counting shares issuable on exercising warrants. Dr. Bailey is Juvenescence’s executive chairman and a co-founder, and another director is its chief executive. The company says their interests are closely aligned and that, if they act together, they can control or substantially influence stockholder votes, and that conflicts of interest may arise. The 10-K gave Juvenescence about 33.0% on Mar 1, 2026, before the March 2026 placement. The lead investor in that placement was also a board member. 10-Q, Aug 13, 2026 10-K, Mar 25, 2026
The FDA placed a clinical hold on the SER-252 IND on Nov 3, 2025, and Serina announced on Jan 28, 2026 that the FDA had cleared it. The company says the FDA’s feedback concerned a commonly used excipient and did not relate to the active drug substance or its mechanism. It also warns that the FDA approval process is lengthy and unpredictable, and that delays are possible. The dated record
Serina’s revenue so far is grant revenue: $130 thousand in 2025 and none in the first half of 2026. The company says it is uncertain when, if ever, it will realize revenue from product sales, and that it expects to rely largely on raising capital from equity investors, with some funding possibly from licensing agreements. 10-Q, Aug 13, 2026
Cohort 1 enrolled eight patients, randomized 3:1 to SER-252 or placebo, at the lowest dose of a Phase 1b study. The company says preliminary results from its nonclinical studies and clinical trials may change as more patient data becomes available and the data is audited and verified. 10-K, Mar 25, 2026 8-K, Sep 9, 2026
The record
The left column is the company’s own news list. The right column is the filing behind each item, on EDGAR. Where the two differ, the filing governs.
Registration opens for Tribe Public’s CEO presentation and Q&A webinar on SER-252’s clinical progress.
Serina to present at the H.C. Wainwright 28th Annual Global Investment Conference.
Cohort 1 observations from the SER-252 registrational study, and advance to Cohort 2
Enrollment and dosing in Cohort 1 complete.
Farrell Simon, Pharm.D., appointed to the board and to its Audit and Compensation Committees.
Sentinel dosing in Cohort 1 complete.
Partner news: Enable Injections announces CE certification of the enFuse® system for use with Aspaveli®, distributed by Sobi.
8-K Series A preferred stock eliminated from the charter; none was outstanding.
8-K Cohort 1 observations, the committee’s recommendation, topline expected in the first half of 2027.
8-K Common stock purchase agreement with Roth Principal Investments, up to $25.0 million.
8-K The chief executive’s employment agreement amended and restated.
8-K New director appointed.
8-K Authorized common shares raised from 40,000,000 to 125,000,000.
10-Q First quarter report.
10-K Annual report for 2025.
8-K The March 2026 private placement agreement, at $2.25 a share.
8-K Announces that the FDA cleared the SER-252 IND.
8-K NYSE American notice on stockholders’ equity.
Contact IR
This concept page is not Serina’s. For the company’s official news, presentations, alerts and contact form, use the sources below.
The company’s investor site, investors.serinatx.com, offers sign-up for alerts on news, quarterly and annual reports, SEC filings, events and presentations, and the end-of-day stock quote.
The investor site lists a corporate presentation, “Serina POZ Small Molecule Platform Introduction”, dated Sep 9, 2026. Its filings are on EDGAR.
