AgeX Therapeutics(AGE) - 2024 Q4 - Annual Results

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 oral 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 3Q 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]. - The small molecule pipeline includes SER-252 for Advanced Parkinson's and other candidates in CNS and cardiology indications[50]. Drug Development and Partnerships - The partnership with Pfizer in the RNA vaccine field represents a strategic collaboration to enhance the development of RNA-based therapeutics[34]. - The company has a strong history of 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 partnerships in the therapeutic landscape[34]. - POZ platform partnerships in RNA and ADCs are anticipated to be established by 2025/26[47]. - Company is exploring partnering opportunities in RNA delivery/targeting and ADC optimization[48]. POZ Platform and Technology - The POZ platform enables optimized drug delivery with reduced immunogenicity and improved safety profiles, addressing limitations of existing biocompatible polymers[7]. - Anticipated regulatory pathway for SER-252 includes a potential 505(b)(2) NDA submission, which could expedite the approval process[10]. - Preclinical data for POZ platform optimization of ADCs is expected in 1Q 2025[47]. - POZ-RNA and POZ-ADCs are under research and development with partners for RNA therapeutics and oncology, respectively[51]. Financial Position - 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 4Q 2024 eliminates all corporate debt[49]. - Lead IND candidate SER-252 has a peak sales potential of $2.1 billion to $3.3 billion[48].