Serina Therapeutics Secures Up to $20 Million to Advance Registrational Trial of SER-252 in Parkinson鈥檚 Disease
Serina Therapeutics (NYSE American: SER) has secured access to up to $20 million in financing through a convertible note agreement to advance its SER-252 clinical program for advanced Parkinson's disease. The funding, led by Board Director Greg Bailey, includes five tranches tied to clinical milestones and features 100% warrant coverage that could provide an additional $20 million if exercised.
The convertible notes have a 5-year maturity, 10% annual interest rate, and are convertible at $5.18 per share. The company plans to submit its U.S. IND application in Q4 2025 and begin patient dosing in Australia as part of its global registrational program. The SER-252-1b study is designed as a randomized, double-blind, placebo-controlled Phase 1b trial evaluating safety, tolerability, and pharmacokinetics in Parkinson's patients.
Serina Therapeutics (NYSE American: SER) ha ottenuto accesso fino a 20 milioni di dollari di finanziamento tramite un accordo di nota convertibile per portare avanti il programma clinico SER-252 per il Parkinson avanzato. Il finanziamento, guidato dal membro del consiglio Greg Bailey, 猫 strutturato in cinque tranche collegate a tappe cliniche e include una copertura di warrant al 100%, che potrebbe generare ulteriori 20 milioni di dollari se esercitati.
Le note convertibili hanno una scadenza di 5 anni, un tasso d'interesse annuo del 10% e sono convertibili a 5,18 dollari per azione. La societ脿 prevede di presentare la domanda IND negli Stati Uniti nel 4掳 trimestre 2025 e di avviare la somministrazione ai pazienti in Australia nell'ambito del programma registrativo globale. Lo studio SER-252-1b 猫 disegnato come uno studio randomizzato, in doppio cieco e controllato con placebo di Fase 1b per valutare sicurezza, tollerabilit脿 e farmacocinetica nei pazienti con Parkinson.
Serina Therapeutics (NYSE American: SER) ha asegurado acceso a hasta 20 millones de d贸lares en financiaci贸n mediante un acuerdo de pagar茅s convertibles para impulsar su programa cl铆nico SER-252 en Parkinson avanzado. La financiaci贸n, liderada por el director del consejo Greg Bailey, consta de cinco tramos ligados a hitos cl铆nicos e incluye una cobertura de warrants del 100%, que podr铆a aportar otros 20 millones de d贸lares si se ejercen.
Los pagar茅s convertibles tienen un vencimiento a 5 a帽os, un inter茅s anual del 10% y son convertibles a 5,18 d贸lares por acci贸n. La compa帽铆a planea presentar su solicitud IND en EE. UU. en el 4.潞 trimestre de 2025 y comenzar la dosificaci贸n de pacientes en Australia como parte de su programa registracional global. El estudio SER-252-1b est谩 dise帽ado como un ensayo aleatorizado, doble ciego y controlado con placebo de Fase 1b para evaluar seguridad, tolerabilidad y farmacocin茅tica en pacientes con Parkinson.
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鞝勴櫂 靷眲電� 毵岅赴 5雲�, 鞐办澊鞛� 10%鞚措┌ 欤茧嫻 5.18雼煬鞐� 鞝勴櫂 臧�電ロ暕雼堧嫟. 須岇偓電� 氙戈淡 IND 鞁犾箔鞚� 2025雲� 4攵勱赴鞐� 鞝滌稖頃橁碃 鞝� 靹戈硠 霌彪 頂勲攴鸽灗鞚� 鞚柬櫂鞙茧 順胳＜鞐愳劀 頇橃瀽 韴棳毳� 鞁滌瀾頃� 瓿勴殟鞛呺媹雼�. SER-252-1b 鞐瓣惮電� 韺岉偍鞀硲 頇橃瀽霌れ棎靹� 鞎堨爠靹�, 雮挫暯靹� 氚� 鞎诫彊頃欖潉 韽夑皜頃橁赴 鞙勴暅 氍挫瀾鞙勲鞍鞝�, 鞚挫毵龟瞼, 鞙勳暯雽�臁办潣 1b靸� 鞁滍棙鞙茧 靹り硠霅橃棃鞀惦媹雼�.
Serina Therapeutics (NYSE American: SER) a obtenu un acc猫s 脿 jusqu'脿 20 millions de dollars de financement via un accord d'obligations convertibles pour faire avancer son programme clinique SER-252 pour la maladie de Parkinson avanc茅e. Le financement, men茅 par le directeur du conseil Greg Bailey, est structur茅 en cinq tranches li茅es 脿 des jalons cliniques et comporte une couverture de bons de souscription 脿 100%, susceptible de fournir 20 millions de dollars suppl茅mentaires en cas d'exercice.
Les obligations convertibles ont une 茅ch茅ance de 5 ans, un taux d'int茅r锚t annuel de 10% et sont convertibles 脿 5,18 $ par action. La soci茅t茅 pr茅voit de d茅poser sa demande IND aux 脡tats-Unis au 4e trimestre 2025 et de d茅buter la mise sous traitement des patients en Australie dans le cadre de son programme d'enregistrement mondial. L'茅tude SER-252-1b est con莽ue comme un essai randomis茅, en double aveugle et contr么l茅 par placebo de phase 1b, 茅valuant la s茅curit茅, la tol茅rance et la pharmacocin茅tique chez des patients atteints de Parkinson.
Serina Therapeutics (NYSE American: SER) hat 眉ber ein Wandelanleihe-Abkommen Zugang zu bis zu 20 Millionen US-Dollar Finanzierung erhalten, um sein SER-252-Programm f眉r fortgeschrittenes Parkinson voranzutreiben. Die Finanzierung, angef眉hrt von Board Director Greg Bailey, ist in f眉nf Tranchen an klinische Meilensteine gebunden und beinhaltet eine 100%-Warrantabdeckung, die bei Aus眉bung zus盲tzliche 20 Millionen US-Dollar bringen k枚nnte.
Die Wandelanleihen haben eine F盲lligkeit von 5 Jahren, einen j盲hrlichen Zinssatz von 10% und sind zu 5,18 USD je Aktie wandelbar. Das Unternehmen plant, seinen US-IND-Antrag im 4. Quartal 2025 einzureichen und im Rahmen des globalen Zulassungsprogramms mit der Patientenbehandlung in Australien zu beginnen. Die SER-252-1b-Studie ist als randomisierte, doppelblinde, placebokontrollierte Phase-1b-Studie konzipiert, die Sicherheit, Vertr盲glichkeit und Pharmakokinetik bei Parkinson-Patienten untersucht.
- Secured flexible funding of up to $20 million with potential for additional $20 million through warrants
- Clear regulatory pathway through 505(b)(2) NDA process for potentially efficient approval
- Large market opportunity targeting 180,000 advanced Parkinson's patients in US and Europe
- Strategic milestone-based funding structure aligns capital deployment with clinical progress
- 10% annual interest rate on convertible notes indicates relatively high cost of capital
- Potential dilution from convertible notes at $5.18 per share and warrants at $5.44
- Company still evaluating need for additional funding sources
- Clinical trial success and regulatory approval remain uncertain
Insights
Serina secures flexible $20M financing for Parkinson's drug SER-252, enabling critical registrational trials with potential pathway to FDA approval.
Serina Therapeutics' $20 million financing agreement represents a significant positive development for the clinical-stage biotech company advancing its Parkinson's disease candidate. The funding structure is particularly strategic, with five milestone-linked tranches allowing capital deployment aligned with clinical progress. The initial $5 million becomes available by October 2025, with subsequent tranches tied to patient enrollment and dosing achievements in their Phase 1b registrational trial.
What's especially noteworthy is the 505(b)(2) NDA pathway Serina is pursuing for SER-252, which offers a streamlined regulatory approach compared to traditional approval routes. This pathway allows the company to leverage existing data for similar approved drugs, potentially reducing development costs and timelines while maintaining a clear path to approval. The financing terms - including $5.18 conversion price, 100% warrant coverage, and 10% interest rate - reflect both the current market environment for biotech funding and reasonable investor expectations for a clinical-stage company.
The registrational study design demonstrates scientific rigor, using a randomized, double-blind, placebo-controlled approach with both single and multiple ascending dose components. The global trial spanning U.S. and Australia adds regulatory diversification, with Australian data contributing to the overall regulatory package. With IND submission planned for Q4 2025 and patient dosing beginning shortly thereafter, Serina has established clear near-term catalysts. Lead investor Greg Bailey's continued support signals confidence in the management team and technology platform, while his statement regarding SER-252's potential market - approximately 180,000 advanced Parkinson's patients in the US and Europe with inadequately controlled symptoms - highlights the significant commercial opportunity.
The advancement of SER-252 into registrational trials represents a potentially meaningful development for advanced Parkinson's disease treatment. Most significant is the drug's clinical positioning - targeting the estimated 180,000 patients whose symptoms remain poorly controlled by current therapies, a substantial unmet medical need in the Parkinson's landscape.
The trial design incorporates both single-ascending-dose (five cohorts, n=40) and multiple-ascending-dose components (up to three cohorts, n=48), following established methodologies for evaluating novel neurological compounds. The inclusion of the MDS-UPDRS motor scores as exploratory efficacy endpoints aligns with gold-standard assessment tools in Parkinson's research, while structured motor-state assessments will provide critical data on the drug's impact on motor fluctuations - one of the most debilitating aspects of advanced disease.
Serina's utilization of the POZ Platform鈩� drug optimization technology suggests they're applying polymer conjugation to potentially enhance an existing therapeutic compound, likely improving its pharmacokinetic profile. This approach may address the notorious challenges of delivering consistent medication levels to the brain, a persistent problem in managing motor fluctuations. The subcutaneous administration route could offer advantages over oral medications by potentially providing more consistent drug levels compared to the peaks and troughs often seen with oral levodopa regimens. The regulatory strategy employing a 505(b)(2) pathway indicates they're building upon established safety data for a known compound, which substantially de-risks the development process compared to entirely novel mechanisms.
- Transaction structured to provide flexible funding to support Phase 1b registrational clinical study program in advanced Parkinson鈥檚 under the 505(b)(2) NDA pathway
- Evaluating complementary funding including strategic equity and non-dilutive alternatives
HUNTSVILLE, AL, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (鈥淪erina鈥�) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform鈩� drug optimization technology, today announced that it has entered into an agreement to access up to
鈥淭his financing provides the resources to advance SER-252 through critical clinical milestones on the path toward registration," said Steve Ledger, Chief Executive Officer of Serina Therapeutics. 鈥淚mportantly, the structure allows us to deploy capital in step with trial progress, while maintaining flexibility to access additional non-dilutive and strategic funding. We believe SER-252 has the potential to transform treatment for those with advanced Parkinson鈥檚 disease.鈥�
Under the terms of the agreement, Serina may draw on up to
- Multi-Tranche Structure:
- Up to
$5 million available on or before October 1, 2025 - Up to
$2.5 million upon enrollment of Phase 1b first patient on or after December 15, 2025 - Up to
$2.5 million upon enrollment of Phase 1b second patient - Up to
$5 million upon dosing of Phase 1b last patient in Cohort 1 on or after March 15, 2026 - Up to
$5 million upon dosing of Phase 1b first patient in Cohort 2 on or after April 30, 2026
- Up to
- Convertible Note Summary Terms:
- Five-year maturity from initial funding
- Convertible into common stock at
$5.18 per share, equivalent to the closing price of its common stock on September 8, 2025 10% annual interest rate, payable quarterly after the first year- Prepayable at any time without penalty
- Warrant Coverage:
Each tranche drawn carries
鈥淚 continue to invest in Serina because of my confidence in the management team, my enthusiasm for their lead candidate, and the compelling 505(b)(2) approval path for SER-252 and potentially other products enabled by Serina鈥檚 technology. The recent FDA feedback provides a clear and efficient route to registration, positioning SER-252 for a highly capital-efficient NDA submission. This financing will drive pivotal milestones, and most importantly, I believe SER-252 could become a best-in-class therapy for the 180,000 advanced Parkinson鈥檚 patients in the US and Europe whose symptoms remain poorly controlled by current treatments,鈥� said Greg Bailey, MD, Board Member of Serina and Co-Founder and Executive Chairman of Juvenescence.
Upcoming Regulatory and Clinical Milestones
Serina plans to submit the U.S. IND application in Q4 2025 incorporating the FDA鈥檚 recommendations. In parallel, the company expects to begin dosing patients in Australia in Q4 2025 as part of the global registrational program, with data from these patients expected to contribute to the overall data package for regulatory review and potential approval. Following U.S. IND clearance, Serina anticipates initiation of enrollment in the U.S. in Q1 2026.
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鈥檚 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-252 (POZ-apomorphine)
SER 252 is an investigational apomorphine therapy developed with Serina鈥檚 POZ platform and designed to provide continuous dopaminergic stimulation (CDS) via a single or twice-weekly subcutaneous injection. CDS has been shown to reduce the severity of motor fluctuations (which includes levodopa-induced dyskinesia) and enable greater daily on time, with reduced off time, in advanced Parkinson鈥檚 patients. SER-252 leverages strategic partner Enable Injections鈥� enFuse鈩� wearable drug delivery platform to enhance patient comfort and convenience, providing CDS to patients via an easy-to-administer, long-acting subcutaneous injection.
About POZ Platform鈩�
Serina鈥檚 proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina鈥檚 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鈥檚 product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include severe skin reactions, side effects due to peak-trough variations in drug levels and a short half-life. Serina believes that by using POZ technology, drugs with a narrow therapeutic index can be designed to maintain more desirable and stable levels in the blood. Serina鈥檚 POZ platform delivery technology has potential for use across a broad range of payloads and indications.
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鈥檚 POZ Platform鈩� 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. For more information, please visit .
Cautionary Statement Regarding Forward-Looking Statement
This release contains forward-looking statements within the meaning of federal securities laws. These statements are based on management鈥檚 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鈥檚 POZ polymer technology, 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 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; 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鈥檚 benefits outweigh its known risks and determination of the product鈥檚 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; default by the lender or Serina under the convertible note; and lack of availability of additional funding on attractive terms and competitive developments. These risks as well as other risks are more fully discussed in Serina鈥檚 Annual Report on Form 10-K, and Serina鈥檚 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. 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
(256) 327-9630
FAQ
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