Precigen Reports Q3 2024 Progress and Financial Insights

Key Developments in Q3 2024

Precigen, Inc. (NASDAQ: PGEN) recently reported its financial results for the third quarter of 2024, along with critical business updates that highlight the company's strategic direction and innovative developments in gene and cell therapies.

Regulatory Progress and Clinical Updates

The company successfully completed a pre-BLA meeting with the FDA, achieving full alignment on the Biologics License Application (BLA) content, including pivotal chemistry, manufacturing, and controls (CMC) modules. This positions the company for a rolling BLA submission for PRGN-2012, an investigational therapy for recurrent respiratory papillomatosis (RRP) under the accelerated approval pathway.

Moreover, Precigen has initiated a confirmatory clinical trial for PRGN-2012, following FDA guidance, to commence prior to the BLA submission. The campaign for commercial and manufacturing readiness for PRGN-2012 is currently underway, aiming for a potential launch in 2025.

Strengthening Platforms for Future Growth

In addition to PRGN-2012, Precigen is gearing up for an end of Phase 1b meeting with the FDA in early 2025 to discuss PRGN-3006, a treatment for acute myeloid leukemia (AML). Data from preclinical studies on PRGN-3008, a next-generation UltraCAR-T therapy targeting CD19, was recently presented at a leading oncology conference, cementing its position as a competitive therapy for oncology and autoimmune diseases.

Helen Sabzevari, PhD, President and CEO of Precigen, highlighted the strategic reprioritization of resources to advance PRGN-2012 and emphasized continued innovations through their UltraCAR-T platform.

Financial Highlights of Q3 2024

During this quarter, Precigen reported an increase in selling, general, and administrative (SG&A) expenses by 7% compared to the previous year. This rise is mainly due to the heightened focus on advancing PRGN-2012 in preparation for its commercial launch. R&D costs saw a 2% decrease thanks to strategic resource allocation and streamlining operations.

The company closed a public offering of common stock with net proceeds of about $30.9 million, aiding its financial stability during this critical phase. However, net losses amounted to $24 million, compared to $19.8 million for the same period last year, attributed to investments in crucial therapies and workforce restructuring.

Pipeline and Future Directions

Precigen's ongoing work in the RRP field, along with its commitment to developing cutting-edge therapies like PRGN-2009 for HPV-associated cancers, showcases its dedication to harnessing innovative treatments to address pressing health challenges. The company remains focused on its confirmatory trials and is exploring partnerships that can enhance its capabilities while reducing financial burdens.

About Precigen

Precigen, Inc. (NASDAQ: PGEN) is a clinical-stage biopharmaceutical company dedicated to the development of innovative gene and cell therapies. With a focus on immuno-oncology, autoimmune disorders, and infectious diseases, the company aims to advance the next generation of targeted therapies that provide affordable biotherapeutics in a controlled manner. For more detailed information, potential partners and patients can visit Precigen's official website.

Frequently Asked Questions

What is the strategic focus of Precigen moving forward?

Precigen is concentrating on advancing therapies like PRGN-2012 for RRP and exploring partnerships to enhance its resource allocation during potential commercialization efforts.

What are PRGN-2012 and PRGN-3006?

PRGN-2012 is an investigational therapy for recurrent respiratory papillomatosis, while PRGN-3006 is a treatment targeting acute myeloid leukemia, both representing key advancements in Precigen's pipeline.

How did Precigen's financial performance compare year-on-year?

Precigen reported a net loss of $24 million in Q3 2024, compared to $19.8 million in Q3 2023, reflecting increased investment in R&D and workforce adjustments.

What recent data was presented for PRGN-3008?

Preclinical data for PRGN-3008, targeting CD19, indicated promising results that may position it as a best-in-class therapy, with potential applications in oncology and autoimmune diseases.

How significant is the FDA's involvement for Precigen?

The FDA's alignment on the BLA submissions and its ongoing guidance for clinical trials greatly supports Precigen's efforts to bring innovative therapies to market effectively.

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