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Serina Therapeutics — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Total revenues for the three months ended September 30, 2026, were $125,000, compared to $0 in the same period in 2025; contract revenues were $125,000.
    • Operating expenses for the three months ended September 30, 2026, were $8.0 million, an increase from $6.4 million in the prior year period.
    • Research and development expenses were $4.6 million for the quarter, up from $3.6 million in 2025, driven by increased clinical activities, contract manufacturing, and compensation, partially offset by lower amortization and consultant spend.
    • General and administrative expenses were $3.3 million for the quarter, up from $2.7 million in 2025, primarily due to increased legal, compensation, and recruiting expenses.
    • Net loss attributable to common stockholders was $7.9 million ($0.31 per share) for the quarter, compared to a net loss of $4.7 million ($0.45 per share) in 2025.
    • For the nine months ended September 30, 2026, net loss attributable to common stockholders was $23.8 million ($1.32 per share), compared to $16.1 million ($1.60 per share) in 2025.
    • Cash and cash equivalents totaled $19.4 million as of September 30, 2026, compared to $3.1 million as of December 31, 2025.
    • Net cash used in operating activities was $16.7 million for the nine months ended September 30, 2026, compared to $11.9 million in 2025.
    • Net cash provided by financing activities was $33.1 million for the nine months ended September 30, 2026, compared to $16.9 million in 2025.
    • Convertible Note, net, increased to $3.2 million as of September 30, 2026, from $2.9 million as of December 31, 2025.
    • Warrant liability was eliminated (reduced to $0) for the current period from $88,000 in the prior year period.
  • Guidance and Future Outlook:

    • Topline single-ascending-dose data for the SER-252 registrational study is expected in the first half of 2027.
    • The company intends to advance additional applications of the POZ platform via out-licensing, co-development, or partnership arrangements.
  • Business Segments and Product Lines:

    • SER-252 advanced to Cohort 2 of its registrational study in Parkinson's disease following an independent Safety Monitoring Committee review of Cohort 1 data.
    • Dosing in Cohort 2 is currently underway to evaluate a higher dose level as part of the single-ascending-dose portion of the trial.
    • Cohort 1 blinded pharmacokinetic observations showed sustained drug exposure consistent with the design, and blinded exploratory clinical assessments identified sustained periods of improvement in motor function in individual patients.
    • The SER-252 study is a randomized, double-blind, placebo-controlled trial with single-ascending-dose (five cohorts) and multiple-ascending-dose components in adults with Parkinson's disease and motor fluctuations.
    • The company holds a non-exclusive license agreement with Pfizer, Inc. to use Serina's POZ polymer technology for lipid nanoparticle drug (LNP) delivery formulations.
  • Market and Competitive Landscape:

    • SER-252 is designed to provide continuous dopaminergic stimulation (CDS) 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, addressing limitations of current apomorphine therapies regarding pharmacokinetic profiles and toxicity.
    • The POZ Platform™ is designed to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics, and antibody-based drug conjugates.
  • Risks and Challenges:

    • Cohort 1 data are preliminary, blinded, and exploratory, involving a small number of patients, and may not be evidence of treatment effect or predictive of future results.
    • Risks include the uncertainties inherent in research and development, the ability to meet anticipated clinical endpoints, and potential regulatory holds or unfavorable data interpretations.
    • The company faces risks regarding its ability to continue as a going concern and the potential need for additional financing.
    • Forward-looking statements regarding future revenue, expenses, and clinical program commencement dates are subject to uncertainty and changes in circumstances.
  • Management Commentary and Tone:

    • CEO Steve Ledger expressed excitement about advancing SER-252 to the next stage of dose escalation following the independent Safety Monitoring Committee recommendation.
    • Management highlighted that blinded pharmacokinetic observations confirmed the sustained drug exposure the treatment was designed to achieve.
    • The Company stated the study focuses on demonstrating SER-252's potential as a differentiated treatment option to improve consistent symptom control for patients with advanced Parkinson's disease.
  • Other Key Points:

    • The company is a clinical-stage biotechnology firm headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology.
    • Serina's proprietary POZ technology utilizes a synthetic, water-soluble, low-viscosity polymer called poly(2-oxazoline) to provide greater control in drug loading and precision in release rates via subcutaneous injection.
    • The registrational study for SER-252 will be conducted across sites in the U.S. and Australia.
    • The company reported a significant increase in cash balances, rising from $3.1 million at year-end 2025 to $19.4 million in Q3 2026, driven by financing activities.
Company
SERINA THERAPEUTICS INC
Sector
Healthcare
Industry
Biotechnology