Welcome to our dedicated page for Precigen news (Ticker: PGEN), a resource for investors and traders seeking the latest updates and insights on Precigen stock.
Overview of Precigen Inc (PGEN)
Precigen Inc is a clinical stage biopharmaceutical company that develops and refines innovative gene and cell therapies using cutting-edge synthetic biology and precision technology. With proprietary platforms such as UltraCAR-T and AdenoVerse, the company designs, builds, and regulates complex gene expression programs to address intractable diseases. Its expertise in non-viral gene transfer methods and advanced DNA construction techniques positions the company as a significant innovator across multiple therapeutic areas including immuno-oncology, autoimmune disorders, and infectious diseases.
Core Business and Technological Platforms
Precigen leverages a comprehensive suite of technologies to discover and develop next generation therapeutics. The company utilizes an advanced UltraVector platform for DNA construction, facilitating the design and assembly of gene components. Its UltraCAR-T platform, which employs a non-viral Sleeping Beauty system, enables the rapid manufacturing of personalized cell therapies with an improved safety profile and simplified logistics. Additionally, the AdenoVerse platform uses a library of engineered adenovector serotypes that efficiently deliver gene therapies aimed at modulating immune responses.
Business Model and Collaborations
The business model of Precigen is centered on leveraging its proprietary technology platforms through strategic collaborations with industry experts who bring extensive development, manufacturing, and commercial capabilities. These partnerships generate revenue primarily via technology access fees, milestone payments, royalties, and reimbursement of collaborative costs. This model provides a stable framework for continuous innovation and the effective translation of preclinical discoveries into viable clinical therapies.
Market Position and Competitive Landscape
In the competitive biotechnology arena, Precigen distinguishes itself through its robust research capabilities and a diversified portfolio of therapeutic candidates. Its unique non-viral gene transfer methods and rapid manufacturing techniques set it apart from traditional gene and cell therapy developers. By focusing resources on technologies with high clinical and commercial potential, the company addresses critical unmet needs in the therapeutic landscape, thereby reinforcing its market significance.
Operational Focus and Expertise
Precigen’s operations are built on years of scientific expertise in genetic engineering and computational model integration for therapeutic design. The company’s detailed approach to tailoring gene expression programs allows for improved functional characteristics of immune cells and precise control over therapeutic outcomes. Its methodical approach and dedication to iterative clinical development underscore its commitment to advancing medicine with precision.
Summary of Value Proposition
Precigen excels in translating complex genetic information into transformative therapies with the potential to modify the disease course in challenging therapeutic areas. By continually streamlining its research and operational models, the company ensures that its innovative techniques remain at the forefront of scientific excellence and commercial relevance. The integrated approach of technology, clinical expertise, and strategic partnerships makes Precigen a notable entity within the biopharmaceutical industry.
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.
Precigen announced its Q1 2024 financial results and business updates, including pivotal Phase 2 data for PRGN-2012 to be presented at the ASCO Annual Meeting on June 3, 2024. A rolling BLA submission for PRGN-2012 is anticipated in the second half of 2024, with commercial readiness activities underway for a potential 2025 launch. Financially, the company reported $44.8 million in cash, cash equivalents, and short-term investments as of March 31, 2024, with a net loss of $23.7 million or $(0.10) per share. R&D expenses increased by 17%, while SG&A costs decreased by 13%. Key initiatives include PRGN-2009 trials for HPV-associated cancers and PRGN-3006 and PRGN-3005 trials for AML/MDS and ovarian cancer, respectively.
Precigen, Inc. (Nasdaq: PGEN) will report first quarter 2024 financial results on May 14, 2024, with a conference call on June 3, 2024. The company will discuss pivotal Phase 2 study data of PRGN-2012 for recurrent respiratory papillomatosis (RRP) at the 2024 ASCO Annual Meeting. Precigen focuses on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases.
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