Serina Therapeutics (SER) 38th Annual Roth Conference summary

Platform technology and strategic focus

• POZ platform enables next-generation drug delivery for small molecules, improving bioavailability and reducing dosing frequency to once-weekly injections using poly(2-oxazoline).

• Founders previously developed PEGylation, now standard for protein drugs; POZ aims to be the equivalent for small molecules, a much larger market.

• Three platform programs: small molecules (primary focus), RNA therapeutics, and ADC/AOC, with small molecules targeting CNS disorders.

• RNA and ADC programs are in preclinical stages, with early data suggesting potential for novel payloads and gene editing applications.

• Capital constraints have limited progress in non-small molecule programs, but recent deals aim to address funding needs.

Lead programs and clinical development

• SER-252 targets advanced Parkinson's disease, currently in a phase I-B registrational study, with first patient dosed.

• Clinical trial design includes single and multiple ascending dose studies, with a head-to-head comparison against an approved drug, aiming for NDA submission without a phase III trial.

• Polymer conjugation is expected to eliminate injection site reactions and improve tolerability, based on preclinical and early clinical data.

• Market modeling estimates a $1.7–$2.5 billion peak sales opportunity for SER-252 in the U.S. and EU, targeting 250,000 patients.

• Commercial launch is expected with a partner, leveraging a compressed regulatory pathway (505(b)(2)) to accelerate approval.

Pipeline expansion and market opportunities

• SER-270 addresses tardive dyskinesia, a $4 billion market in 2024, expected to grow to $6 billion by 2030; aims to capture share through long-acting injectable formulation.

• SER-270 may follow a similar regulatory and clinical path as SER-252, with potential for co-development partnerships.

• SER-290 is an undisclosed CNS indication, believed to be a major opportunity, with advisory panel formation underway.

• Business model is opportunistic, balancing wholly owned development with potential co-development or licensing deals.

• Real-world evidence and clinician feedback are expected to further define product positioning and market expansion.