Key Program Highlights
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PRGN-2012 AdenoVerse® Gene Therapy in RRP: PRGN-2012, an investigational gene therapy targeting HPV 6 or HPV 11 for RRP treatment, showed promising results with 51% of patients achieving Complete Response. The therapy was well-tolerated, with significant improvements in quality of life scores and a reduction in surgical interventions.
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Strategic Prioritization: Precigen announced a strategic reprioritization of its pipeline to focus on PRGN-2012, including workforce reduction and streamlining resources. The company anticipates a rolling Biologics License Application (BLA) submission under an accelerated approval pathway in the second half of 2024.
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Financial Highlights: The company raised approximately $31.4 million through a public offering of common stock in August 2024. However, it reported a net loss of $58.8 million for the second quarter and $82.5 million for the first half of 2024, compared to net losses of $20.3 million and $43.1 million in the respective periods of 2023.
Clinical Trials and Future Plans
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Precigen has initiated enrollment in the confirmatory clinical trial for PRGN-2012, in line with FDA guidance. The company plans to continue PRGN-2009 Phase 2 clinical trials in cervical cancer and oropharyngeal cancer under a CRADA with the National Cancer Institute.
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The company has completed enrollment for the Phase 1b trial of PRGN-3006 in acute myeloid leukemia (AML) and is preparing for an end of Phase 1b meeting with the FDA. It will pause the PRGN-3005 and PRGN-3007 clinical trials and minimize spending on UltraCAR-T programs to focus on strategic partnerships.
Corporate Updates
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Precigen has initiated the shutdown of its Belgium-based ActoBio subsidiary, resulting in non-cash impairment charges of $32.9 million and severance charges of $3.0 million. The company's portfolio of intellectual property from ActoBio will be made available for prospective transactions.
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The company remains committed to advancing its gene and cell therapies, focusing on immuno-oncology, autoimmune disorders, and infectious diseases, with an emphasis on innovation and strategic partnerships to bring affordable biotherapeutics to market.
