Precigen Inc Stock Price, News & Analysis

Precigen (PGEN) and the Recurrent Respiratory Papillomatosis Foundation (RRPF) announced they will co-host the annual RRP Awareness Day on June 11, 2025, in Washington DC. The international event aims to raise awareness about recurrent respiratory papillomatosis (RRP), a rare chronic disease affecting both children and adults.

RRP, mainly caused by HPV 6/11 infection, leads to papilloma growth in respiratory tracts, causing voice disturbance, compromised airways, and potential post-obstructive pneumonias. The disease affects approximately 27,000 adult patients in the US and over 125,000 patients globally. Currently, there is no FDA-approved treatment, with patients requiring multiple surgeries throughout their lifetime.

The event will feature an in-person panel discussion with patients, caregivers, and physicians, broadcast globally via webcast. It will focus on patient experiences, disease burden, and the need for new treatment options. Interested participants can register at www.RRPAwareness.org.

Precigen (PGEN) announced its full year 2024 financial results and significant progress with its lead therapy PRGN-2012. The FDA granted priority review for PRGN-2012's BLA with a PDUFA date of August 27, 2025, potentially making it the first FDA-approved treatment for recurrent respiratory papillomatosis (RRP).

Key clinical highlights include:

• 51% of patients achieved Complete Response with no required surgeries after treatment
• 86% of patients showed decreased surgical interventions
• Median duration of response was 2 years, with some patients surgery-free beyond 3 years

Financial position:

• Ended 2024 with $97.9 million in cash and investments
• Raised $87.5 million through preferred stock offering and asset sale
• Extended cash runway into 2026
• Net loss of $126.2 million ($0.47 per share) compared to $95.9 million in 2023

Precigen (PGEN), a biopharmaceutical company focused on gene and cell therapies, has scheduled the release of its full year 2024 financial results for March 19, 2025. The company will host a conference call at 4:30 PM ET to discuss the results and provide business updates.

Investors can access the conference call by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (International). Participants should dial in 10-15 minutes before the scheduled call time. Additional event details are available on Precigen's website under the Events & Presentations section.

Precigen specializes in developing next-generation gene and cell therapies targeting immuno-oncology, autoimmune disorders, and infectious diseases using precision technology. The company focuses on creating affordable biotherapeutics through controlled innovation.

Precigen, Inc. (PGEN) announced that the FDA has granted priority review to its biologics license application (BLA) for PRGN-2012 (zopapogene imadenovec), an investigational AdenoVerse gene therapy for treating adults with recurrent respiratory papillomatosis (RRP).

The FDA set a PDUFA target action date of August 27, 2025, with no advisory committee meeting currently planned. If approved, PRGN-2012 would become the first and only FDA-approved therapy for RRP, a rare and devastating chronic disease caused by HPV 6 or HPV 11 infection.

The BLA is supported by pivotal Phase 1/2 clinical study data showing impressive results:

• Over 50% of patients achieved Complete Response
• More than 85% experienced decreased surgical interventions
• Some patients have remained surgery-free for over three years
• The treatment was well-tolerated with no serious adverse events

RRP currently has no cure, with patients relying on repeated surgeries that don't address the underlying cause and can lead to cumulative laryngeal injury. The US adult RRP patient population is estimated at more than 27,000.

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.