Serina Therapeutics (SER) Status update summary

Clinical and product development update

• SER-252, a long-acting treatment for advanced Parkinson's, showed sustained pharmacokinetics and preliminary clinical activity at the lowest dose in Cohort one of the phase Ib study, supporting advancement to higher doses.

• The study design is randomized, double-blind, placebo-controlled, with both single and multiple ascending dose arms, focusing on safety, tolerability, pharmacokinetics, and exploratory efficacy in advanced patients.

• SER-252 leverages the POZ platform for controlled release, aiming to eliminate the burdens of current device-assisted therapies by offering twice-weekly, 10-minute, push-button administration without surgery or daily setup.

• No significant safety or tolerability issues have been observed so far, and the safety monitoring committee has recommended advancing to the next cohort.

• The regulatory pathway is aligned with the FDA for a 505(b)(2) NDA, potentially allowing for an accelerated submission based on existing apomorphine data.

Market opportunity and competitive landscape

• The target market includes approximately 250,000 advanced Parkinson's patients in the US and EU5, with current device-assisted therapy penetration below 10%.

• Recent launches of device-assisted therapies, such as Vyalev, validate demand but highlight significant usability and tolerability gaps, which SER-252 aims to address.

• Vyalev's rapid US revenue growth post-reimbursement changes demonstrates strong market demand, with AbbVie now guiding to a $1 billion annual run rate by early 2027.

• SER-252's differentiated profile could expand the market by attracting patients unwilling to use pumps or undergo surgery, with a base case peak sales estimate of $1.8 billion and upside to $2.7 billion.

Financial and capital structure

• As of June 30, 2026, there are approximately 25 million shares outstanding, with a large insider ownership led by Greg Bailey and Juvenescence, who together own about 25%.

• The company raised $21 million in a PIPE funding and $10 million via ATM in Q1 2026, ending June with $23 million in cash and a clean payables profile.

• The capital structure includes a $5 million convertible note and about 965,000 warrants; float is around 30%.