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Precigen, Inc. (Nasdaq: PGEN) is a pioneering biopharmaceutical company dedicated to discovering and developing next-generation gene and cellular therapies in the United States. Specializing in disease-modifying therapeutics, Precigen has been at the forefront of genetic engineering and synthetic biology solutions. The company excels in creating innovative therapies for some of the most challenging diseases in areas such as immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen's core technologies include:
- UltraVector® Platform: This platform incorporates advanced DNA construction technologies and computational models to design and assemble genetic components into complex gene expression programs.
- UltraCAR-T® Cell Therapies: These therapies address limitations of conventional CAR-T therapies by improving in vivo CAR-T expansion and persistence, adding safety features, and reducing manufacturing costs.
- AdenoVerse™ Technology Platform: A library of engineered adenovector serotypes, including gorilla adenovectors, which is used for gene delivery, and modulating immune responses.
- RheoSwitch® Inducible Gene Switch: This technology allows for precise control over gene expression, making therapies safer and more efficient.
Recent achievements include the Phase 2 pivotal study data for PRGN-2012 in treating recurrent respiratory papillomatosis (RRP), a rare and debilitating disease. The study showcased promising results, with 51% of patients achieving Complete Response, defined as no need for surgical interventions in the 12-month period following treatment.
Precigen is also actively developing UltraCAR-T therapies, which have demonstrated significant preliminary efficacy and safety advantages over existing CAR-T therapies. These therapies are currently being evaluated in clinical trials for various hematological and solid tumors.
Financially, Precigen has shown resilience, focusing on sound fiscal management while advancing its clinical pipeline. Despite experiencing fluctuations in research expenses and revenues, the company remains committed to achieving its milestones and maintaining a strong balance sheet.
Precigen's business model involves commercializing its technologies through collaborations with industry partners who possess specialized expertise, development resources, and sales capabilities. This collaborative approach enables Precigen to bring new and improved products to market efficiently.
For the latest updates on Precigen's innovative gene and cell therapies, visit their official website and follow them on social media platforms like X (formerly Twitter), LinkedIn, and YouTube.
Precigen (PGEN) has completed its BLA submission for PRGN-2012, potentially the first FDA-approved treatment for Recurrent Respiratory Papillomatosis (RRP). The company starts 2025 with approximately $100 million cash on-hand and runway extending well into 2026, beyond the anticipated launch in second half of 2025.
The market opportunity for PRGN-2012 includes approximately 27,000 adult RRP patients in the US and over 125,000 patients ex-US. The therapy has shown promising results with over 50% of patients achieving Complete Response and more than 85% experiencing decreased surgical interventions in clinical trials.
The company sees significant potential in expanding their AdenoVerse platform to other HPV-related conditions, including genital warts (4+ million annual global incidence) and HPV16/18-driven cancers. Manufacturing readiness is progressing with a 100% success rate to date at their in-house commercial facility.
Precigen (Nasdaq: PGEN), a biopharmaceutical company focused on innovative gene and cell therapies, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Dr. Helen Sabzevari, the company's President and CEO, will deliver a presentation on Thursday, January 16, 2025, at 9:00 AM PT in San Francisco, California.
The company specializes in developing next-generation gene and cell therapies using precision technology, targeting three core therapeutic areas: immuno-oncology, autoimmune disorders, and infectious diseases. Their approach focuses on creating affordable biotherapeutics through controlled innovation, with an active preclinical and clinical pipeline progressing toward clinical proof-of-concept and commercialization.
Precigen (PGEN) has completed its Biologics License Application (BLA) submission to the FDA for PRGN-2012, a potential first FDA-approved treatment for adults with Recurrent Respiratory Papillomatosis (RRP). The therapy received Breakthrough Therapy Designation and Orphan Drug Designation from both FDA and European Commission. The BLA submission includes compelling Phase 1/2 pivotal study results where over 50% of patients achieved Complete Response and more than 85% experienced decreased surgical interventions in the year following treatment. The company has requested priority review, which could reduce the FDA review timeline from 10 to 6 months. PRGN-2012 demonstrated strong safety profile with no treatment-related adverse events above Grade 2.
Precigen (PGEN) has announced a private placement offering of 8.00% Series A Convertible Perpetual Preferred Stock, expecting to raise $79.0 million in gross proceeds. The deal includes warrants to purchase 52,666,669 shares at $0.75 per share. The placement was led by Patient Capital Management affiliates, with participation from Bill Miller and Randal J. Kirk.
The Preferred Stock is convertible into common stock at $1.125 per share after six months and shareholder approval. Dividends will be paid annually, with the first two years paid in kind. The company expects this financing to extend its cash runway well into 2026, beyond the anticipated commercial launch of PRGN-2012 in the second half of 2025.
Precigen (PGEN) reported Q3 2024 financial results and key updates. The company completed pre-BLA meetings with FDA and is aligned for Q4 2024 rolling BLA submission of PRGN-2012 for RRP under accelerated approval. Commercial and manufacturing preparations are underway for potential 2025 launch. Q3 net loss was $24.0 million ($0.09 per share) compared to $19.8 million ($0.08 per share) in Q3 2023. The company raised $30.9 million through a public offering in August 2024 and implemented strategic prioritization, including 20% workforce reduction, to focus on PRGN-2012 commercialization.
Precigen (Nasdaq: PGEN) has announced its participation in the Stifel 2024 Healthcare Conference in New York. Helen Sabzevari, PhD, President and CEO, will engage in a fireside chat on Tuesday, November 19, 2024, from 10:55 to 11:25 AM ET. The conference is scheduled for November 18-19, 2024.
Precigen is a discovery and clinical stage biopharmaceutical company focused on developing next-generation gene and cell therapies. The company specializes in precision technology targeting immuno-oncology, autoimmune disorders, and infectious diseases, working to create affordable biotherapeutics through controlled innovation.
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.
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