Precigen Announces Q1 2024 Financial Results and Business Updates

Precigen, Inc., a biopharmaceutical company specializing in gene and cell therapies, announced promising results and upcoming plans for their key projects. The company will present pivotal Phase 2 study data for PRGN-2012, a therapy for recurrent respiratory papillomatosis (RRP), at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The results will be detailed in a late-breaking oral presentation on June 3rd, followed by a conference call to discuss the findings and provide business updates. The company anticipates a rolling Biologics License Application (BLA) submission for PRGN-2012 in the latter half of 2024, under an accelerated approval pathway, with potential commercial launch activities slated for 2025.

Dr. Helen Sabzevari, President and CEO of Precigen, expressed confidence in PRGN-2012's advantages, including its administration method, safety profile, and clinical efficacy. Internal research indicates that healthcare providers and key opinion leaders find PRGN-2012's benefits compelling, suggesting it could become the primary treatment for RRP if approved.

CFO Harry Thomasian Jr. emphasized the company's focus on financial management and exploring various financing options to support the potential commercial launch of PRGN-2012. Precigen reported cash, cash equivalents, and short-term investments totaling $44.8 million as of March 31, 2024.

Key highlights for PRGN-2012 include its design as an off-the-shelf AdenoVerse gene therapy targeting HPV 6 and HPV 11 to treat RRP. The therapy has received Breakthrough Therapy Designation and an accelerated approval pathway from the FDA, as well as Orphan Drug Designation from both the FDA and the European Commission. The Phase 1/2 study demonstrated significant efficacy, with 50% of patients achieving Complete Response, meaning no surgeries were needed during the 12-month period following treatment. Additionally, 83% of patients saw a reduction in RRP surgeries in the year after treatment compared to the previous year.

The upcoming ASCO presentation will underscore the immunological responses and overall safety benefits observed in the PRGN-2012 Phase 2 study. The FDA has confirmed that the current Phase 1/2 single-arm study will serve as pivotal, negating the need for an additional randomized, placebo-controlled trial for BLA submission. Preparations for a potential commercial launch in 2025 are already in motion.

In addition to PRGN-2012, Precigen will present two trial-in-progress studies for PRGN-2009 in combination with pembrolizumab at ASCO. These studies focus on treating HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) and recurrent/metastatic cervical cancer. PRGN-2009, another off-the-shelf AdenoVerse gene therapy, aims to activate the immune system to target HPV-associated cancers.

The company, in collaboration with the Recurrent Respiratory Papillomatosis Foundation, will co-sponsor the first RRP Awareness Day on June 11th. The event aims to increase awareness and build a community among individuals living with RRP, caregivers, clinicians, and government officials. The event will be held both in-person at the National Press Club in Washington DC and virtually.

Financially, Precigen reported an increase in research and development expenses by $2.1 million (17%) in the first quarter of 2024 compared to the same period in 2023. This rise is attributed to hiring additional employees and higher fees paid to consultants and contract research organizations. However, selling, general, and administrative costs decreased by 13%, primarily due to reduced stock compensation and insurance expenses. Despite a decrease in total revenues by $0.8 million (43%) compared to the previous year, the company remains committed to advancing its clinical development activities, with a reported net loss of $23.7 million for the first quarter of 2024.

Looking ahead, Precigen is poised to make significant strides in gene and cell therapy, leveraging its innovative AdenoVerse and UltraCAR-T platforms to address complex diseases and improve patient outcomes.