Precigen Reports Full Year 2024 Financial Results and Business Updates

Core Insights - Precigen, Inc. announced its full year 2024 financial results and business updates, highlighting significant progress in its PRGN-2012 therapy for recurrent respiratory papillomatosis (RRP) and a strengthened financial position for potential commercialization in 2025 [1][2]. Financial Performance - Total revenues for 2024 decreased by $2.3 million, or 37%, compared to 2023, primarily due to reduced product and service volumes at Exemplar [8]. - Research and development expenses increased by $4.5 million, or 9%, mainly due to costs associated with the initiation of the PRGN-2012 confirmatory clinical trial and increased drug manufacturing material costs [9]. - The company recorded a net loss of $126.2 million, or $(0.47) per share, compared to a net loss of $95.9 million, or $(0.39) per share in 2023 [15][22]. Key Developments - The FDA granted priority review to the BLA for PRGN-2012, with a target action date set for August 27, 2025, which could lead to the first FDA-approved treatment for approximately 27,000 adult RRP patients in the US [4][5]. - Results from the pivotal clinical study of PRGN-2012 showed that 51% of patients achieved complete responses, with some remaining surgery-free beyond three years [5][4]. - The company ended 2024 with $97.9 million in cash and equivalents, extending its cash runway into 2026, beyond the potential commercial launch of PRGN-2012 [4][14]. Product Pipeline - PRGN-2012 is an investigational gene therapy designed to target HPV 6 and 11 infections in RRP patients, having received Breakthrough Therapy and Orphan Drug Designations from the FDA [3]. - The company is also advancing PRGN-2009 for HPV-associated cancers and PRGN-3006 for acute myeloid leukemia (AML) [6][7]. Market Opportunity - The market opportunity for PRGN-2012 in RRP is estimated at approximately 27,000 adult patients in the US and over 125,000 patients outside the US [13].