Precigen Inc Stock Price, News & Analysis

Precigen (Nasdaq: PGEN), a biopharmaceutical company focused on innovative gene and cell therapies, announced its participation in the 2024 Cantor Global Healthcare Conference. Helen Sabzevari, PhD, President and CEO of Precigen, will engage in a fireside chat on September 18, 2024, from 9:45 to 10:15 AM ET in New York.

The conference, scheduled for September 17-19, 2024, provides a platform for Precigen to showcase its advancements in precision medicine. Precigen specializes in developing therapies for immuno-oncology, autoimmune disorders, and infectious diseases using cutting-edge gene and cell therapy technologies. Interested parties can access event details through Precigen's website in the Events & Presentations section.

Precigen (PGEN) reported Q2 and H1 2024 financial results, highlighting key developments for its lead program PRGN-2012 in recurrent respiratory papillomatosis (RRP):

- Pivotal study data showed 51% of RRP patients achieved Complete Response
- Rolling BLA submission anticipated in H2 2024
- Confirmatory trial enrollment initiated
- Appointed new CCO to lead potential 2025 commercial launch
- Raised $31.4M via public offering

The company is prioritizing PRGN-2012 advancement and streamlining other programs. Q2 net loss was $58.8M vs $20.3M in Q2 2023, impacted by $32.9M impairment charge. R&D expenses increased 32% YoY to $15.7M. Cash expected to fund operations into early 2025.

Precigen (Nasdaq: PGEN), a biopharmaceutical company focused on innovative gene and cell therapies, has announced it will release its second quarter and first half 2024 financial results on August 14, 2024. The company will host a conference call at 4:30 PM ET on the same day to discuss the results and provide a business update. Investors can access the call by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (International). Participants are advised to dial in 10-15 minutes early. Event details are available on Precigen's website in the Events & Presentations section.

Precigen (Nasdaq: PGEN) has announced the pricing of a public offering of 35,294,118 shares of its common stock at $0.85 per share. The company expects to raise approximately $30.0 million in gross proceeds. Underwriters have a 30-day option to purchase up to an additional 5,294,117 shares. The offering is set to close on August 9, 2024. Precigen plans to use the net proceeds for advancing PRGN-2012 to regulatory approval and commercial readiness, clinical development of other pipeline assets, and for working capital. Combined with recent strategic reprioritization, the funds are expected to support operations into early 2025.

Precigen (Nasdaq: PGEN) has announced a proposed $30 million public offering of its common stock. The company intends to grant underwriters a 30-day option to purchase up to an additional $4.5 million of common stock. Stifel is acting as the sole book-running manager for the offering. The offering is subject to market conditions, and there's no assurance regarding its completion or final terms.

The public offering will be made pursuant to a shelf registration statement on Form S-3, effective since January 17, 2024. A preliminary prospectus supplement and accompanying base prospectus will be filed with the SEC. The offering's final terms will be disclosed in a final prospectus supplement to be filed with the SEC.

Precigen (PGEN) announced a strategic reprioritization of its clinical portfolio, focusing on the potential commercialization of PRGN-2012 AdenoVerse® gene therapy for recurrent respiratory papillomatosis (RRP). The company plans to submit a rolling BLA under an accelerated approval pathway in H2 2024, with a potential launch in 2025. Key points include:

- Workforce reduction of over 20%
- Continuation of PRGN-2009 Phase 2 trials with NCI for certain cancers
- Pausing of other UltraCAR-T clinical programs except PRGN-3006 for AML
- Shutdown of ActoBio subsidiary operations
- Pause of all preclinical programs

These changes aim to streamline resources and focus on PRGN-2012's potential commercialization, including BLA submission, confirmatory clinical trial, and manufacturing of commercial product.

Precigen (Nasdaq: PGEN) has appointed Phil Tennant as Chief Commercial Officer to lead commercial strategy and execution for potential launch of PRGN-2012 AdenoVerse gene therapy in recurrent respiratory papillomatosis (RRP). Tennant brings 30+ years of experience from biotech and pharma companies, including Merck, AstraZeneca, Bristol Myers Squibb, and Astellas Pharma. His expertise spans oncology, rare diseases, and global markets. At Astellas, he drove double-digit growth for a $5B oncology portfolio. Tennant will report to CEO Helen Sabzevari and join the executive leadership team, focusing on commercial readiness for PRGN-2012's potential US launch.

Precigen announced positive results from its Phase 1/2 pivotal study for PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP). In the study, 51% of patients achieved complete response, with no surgeries required post-treatment. Additionally, 86% of patients saw reduced surgical interventions. The treatment was well-tolerated, with no severe adverse events reported. The study showed significant improvements in patient quality of life and reduced disease severity. Precigen plans to submit a Biologics License Application (BLA) under an accelerated approval pathway in the second half of 2024, aiming for a potential launch in 2025.

Precigen (Nasdaq: PGEN) will host a webcast on June 3, 2024, at 6:00 PM CT/7:00 PM ET to discuss pivotal study results of PRGN-2012 for treating recurrent respiratory papillomatosis (RRP). The data will be presented earlier that day at 8:30 AM CT during the 2024 ASCO Annual Meeting. This Phase 2 study, led by Dr. Scott M. Norberg, demonstrates that PRGN-2012, a gorilla adenovirus-based immunotherapy, provides complete and durable responses in RRP patients. Participants can register and access the webcast via Precigen's website, and an archived recording will be available post-event. Precigen focuses on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases, leveraging its AdenoVerse platform for advanced gene delivery and therapy development.