Parkinson's Disease Treatment - SER-252 (POZ-Apomorphine) is projected to address a significant unmet need in the advanced Parkinson's disease market, with a commercial opportunity estimated between $2.1 billion and $3.3 billion[10]. - The lead program SER-252 is expected to enter clinical trials in 2025, focusing on continuous dopaminergic stimulation for advanced Parkinson's disease[4]. - The market for advanced Parkinson's disease treatments is growing at approximately 1.5% per year, with around 210,000 patients in the US and 150,000 in the EU and UK inadequately controlled on current therapies[18]. - SER-252 aims to provide a differentiated treatment option with a dosing regimen of twice per week via subcutaneous injection, avoiding the need for electronic infusion pumps[10]. - The product development plan includes a Phase 1b trial in advanced Parkinson's disease patients, with interim data expected in the second half of 2026[30]. - Phase 1 trial of SER-252 in advanced Parkinson's disease is set to initiate in Q3 2025, with interim readouts expected in 1Q 2026[47]. - Phase 1b trial for SER-252 in advanced Parkinson's patients is scheduled for 2H 2025, providing early efficacy readout[49]. Drug Development and Partnerships - The partnership with Pfizer in the RNA vaccine field represents a strategic collaboration to enhance product development and market reach[34]. - The company has a strong track record in drug development, with cumulative sales across 32 FDA-approved PEGylated drugs exceeding $25 billion[4]. - The first license deal for RNA products was executed in Q4 2023, indicating a proactive approach to expanding the company's portfolio in the biotechnology sector[34]. - The company is exploring partnering opportunities in RNA delivery/targeting and ADC optimization[48]. - POZ platform partnerships in RNA and ADCs are anticipated to be established by 2025/26[47]. Financial Position and Projections - Preliminary cash position at year-end 2024 is projected to be $3.4 million, with recent funding of $10 million extending runway through 1H 2025[48]. - Sale of UniverXome subsidiary in Q4 2024 will eliminate all corporate debt[49]. - Lead IND candidate SER-252 has a peak sales potential estimated between $2.1 billion and $3.3 billion[48]. POZ Platform and Technology - The POZ platform enables optimized drug delivery with reduced immunogenicity and improved safety profiles compared to traditional methods[7]. - SER-252 is designed to minimize adverse skin reactions, a common issue with existing therapies, as demonstrated in preclinical studies[13]. - Preclinical data for POZ platform optimization of ADCs is expected in 1Q 2025[47]. - POZ-RNA and POZ-ADCs programs are in R&D with partners for RNA therapeutics and oncology, respectively[51]. - SER-2xx candidates are in proof of concept stages for CNS and cardiology indications[50].
Serina Therapeutics, Inc.(SER) - 2024 Q4 - Annual Results