Precigen Inc Stock Price, News & Analysis

Precigen (Nasdaq: PGEN) has secured a significant non-dilutive credit facility of up to $125 million through Pharmakon Advisors, LP. The financing includes $100 million funded at closing and an additional $25 million available through March 31, 2027. The credit facility matures in five years and carries an interest rate of 6.50% plus three-month SOFR with a 3.75% floor.

The funding will support the US commercialization of PAPZIMEOS, Precigen's novel immunotherapy for recurrent respiratory papillomatosis (RRP) in adults. The company plans to use the proceeds for international market expansion and pursuing pediatric and other HPV-related indications. This strategic financing positions Precigen for its transition into a commercial-stage biopharmaceutical company.

Precigen (NASDAQ: PGEN) announced its participation in two upcoming virtual fireside chats to discuss their recently FDA-approved therapy for adult recurrent respiratory papillomatosis. The first event, hosted by Jennifer Kim of Cantor, is scheduled for August 27, 2025, while the second chat, moderated by Dr. Swayampakula Ramakanth of H.C. Wainwright, will take place on September 2, 2025.

Both events will feature presentations from Helen Sabzevari, PhD, President and CEO, and Phil Tennant, Chief Commercial Officer. Investors can access the live webcasts through Precigen's investor relations website.

Precigen (NASDAQ: PGEN) has achieved a historic milestone with the FDA's full approval of PAPZIMEOS (zopapogene imadenovec-drba), the first and only approved therapy for adults with Recurrent Respiratory Papillomatosis (RRP). This groundbreaking treatment targets the root cause of RRP, a rare disease affecting approximately 27,000 adult patients in the US.

The therapy demonstrated remarkable efficacy in clinical trials, with 51% of patients (18 out of 35) achieving Complete Response, requiring no surgeries for 12 months post-treatment. Of these, 15 patients maintained Complete Response at 24 months. PAPZIMEOS is administered via four subcutaneous injections over 12 weeks and showed excellent tolerability with no treatment-related adverse events above Grade 2.

Precigen (PGEN) reported Q1 2025 financial results and significant progress with its lead candidate PRGN-2012. The company's BLA for PRGN-2012, a potential first-in-class treatment for Recurrent Respiratory Papillomatosis (RRP), is under FDA priority review with a PDUFA date of August 27, 2025. Clinical results showed 51% of patients achieved Complete Response, with durable responses beyond 12 months. The company ended Q1 with $81.0 million in cash and investments, expected to fund operations into 2026. Q1 net loss was $54.2 million ($0.18 per share), compared to $23.7 million ($0.10 per share) in Q1 2024. The US market opportunity includes approximately 27,000 adult RRP patients, with over 125,000 patients outside the US. Precigen has partnered with EVERSANA for commercialization and is advancing launch preparations.

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.