Serina Therapeutics (SER) Status update summary

Program and market opportunity

• SER-252 is a POZ-enabled apomorphine candidate intended to provide long-acting continuous dopaminergic stimulation for advanced Parkinson’s disease.

• An estimated 250,000 advanced patients across the U.S., EU4 and U.K. have inadequate control on oral therapy; only 5%-10% of eligible patients are estimated to use device-assisted therapy.

• Vyalev U.S. revenue reached $128 million in Q2 2026; AbbVie guided to a $1 billion U.S. annual run rate by early 2027, with uptake accelerating after Medicare billing and coverage access improved.

• Peak annual sales opportunity estimated at $1.8 billion in the base case and $2.7 billion if SER-252 expands the market.

Product profile

• Target profile: twice-weekly administration with about 10 minutes of wear time, no tubing or daily pump setup, and no surgery; delivery uses a compact mechanical on-body device.

• POZ is designed to control apomorphine release until it reaches plasma, potentially reducing exposure of the subcutaneous compartment to the active drug and related skin reactions.

• FDA alignment supports a 505(b)(2) NDA pathway that can rely on existing apomorphine data alongside the clinical program.

Clinical progress

• Phase I-B registrational study is randomized, double-blind and placebo-controlled in advanced Parkinson’s patients; Cohort one of the single ascending dose arm completed in July 2026.

• Blinded Cohort one observations showed sustained PK consistent with prolonged apomorphine exposure and periods of motor-function improvement in individual patients on exploratory measures.

• Study remains blinded; findings are preliminary and exploratory in a small cohort, may not indicate a treatment effect, and the lowest-dose cohort was not expected to establish therapeutic activity.

• Safety monitoring committee recommended dose escalation; Cohort two is underway, and the trial has not been halted for safety or tolerability issues.

• Key readouts include safety, tolerability, PK, skin response and exploratory motor assessments; Cohort two SAD top-line data are targeted for H1 2027.