GERMANTOWN, Md. - Precigen, Inc. (NASDAQ:PGEN), a biopharmaceutical company, has announced significant changes to its operations, including a workforce reduction of over 20%, to prioritize the development and potential commercialization of its gene therapy PRGN-2012. This therapy is aimed at treating recurrent respiratory papillomatosis (RRP), a rare condition caused by human papillomavirus (HPV) infections.
The company's strategic reprioritization will concentrate resources on PRGN-2012, including the submission of a rolling biologics license application (BLA) expected in the latter half of 2024 and the initiation of a confirmatory clinical trial. These steps are in line with the U.S. Food and Drug Administration's (FDA) accelerated approval pathway. The trial has already begun enrolling patients.
In addition to the focus on PRGN-2012, Precigen will continue Phase 2 trials of PRGN-2009 for cervical cancer and HPV-associated oropharyngeal cancer in a partnership with the National Cancer Institute (NCI). However, enrollment at non-NCI sites will be paused. The company has also completed the Phase 1b trial enrollment for PRGN-3006, targeting acute myeloid leukemia, and will engage in discussions with the FDA on the future steps. Other UltraCAR-T clinical programs and preclinical activities will be put on hold, and the Belgium-based ActoBio subsidiary will be shut down.
PRGN-2012 has been designated as a Breakthrough Therapy by the FDA and has received Orphan Drug Designation in both the U.S. and Europe. Its development is part of Precigen's broader AdenoVerse platform, which utilizes proprietary adenovectors for efficient gene delivery.
The company's President and CEO, Helen Sabzevari, PhD, expressed confidence in the potential of PRGN-2012 to become the first and best-in-class therapy for RRP patients. Precigen aims to prepare for a potential market launch in 2025, with efforts led by the newly appointed Chief Commercial Officer, Phil Tennant.
In other recent news, Precigen Inc. has initiated a public offering of its common stock, intending to raise $30 million. Stifel is serving as the exclusive book-running manager for this offering, which is contingent on market conditions and other factors. Meanwhile, the biopharmaceutical company has appointed Phil Tennant as Chief Commercial Officer, a move that comes as Precigen prepares for the potential launch of PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP).
In addition to these developments, Precigen has reported positive results from a Phase 1/2 pivotal study of PRGN-2012. The therapy led to 51% of participants experiencing a complete response, requiring no surgeries for RRP in the 12 months following treatment. These results are expected to support a Biologics License Application submission, anticipated in the second half of 2024.
Investment firm Stifel has responded positively to these recent developments, upgrading Precigen's price target from $7.00 to $10.00 following the presentation of Phase 2 data for PRGN-2012. JMP Securities has also maintained a "Market Outperform" rating for Precigen. These are among the recent developments in Precigen's journey towards bringing new treatments to market.
InvestingPro Insights
As Precigen, Inc. (NASDAQ:PGEN) navigates through strategic changes to bolster its gene therapy programs, the company's financial health and market performance provide essential context for investors. According to InvestingPro data, Precigen holds a market capitalization of approximately $340.77 million. Despite the company's focus on advancing its PRGN-2012 therapy, it's worth noting that analysts have recently revised their earnings expectations downwards for the upcoming period, reflecting the challenges ahead.
InvestingPro Tips reveal that Precigen is quickly burning through cash, which is a critical factor to consider given the company's need to fund ongoing clinical trials and prepare for potential commercialization. Moreover, the stock has experienced volatility, dropping by around 13.82% over the last week, indicating that investors may be reacting to the company's current cash burn rate and the recent downsizing announcement.
On the balance sheet front, Precigen does hold more cash than debt, which could provide some financial flexibility in the short term. However, the company's gross profit margin over the last twelve months as of Q1 2024 stands at a concerning -936.35%, underscoring the financial pressures it faces. With no dividends paid to shareholders and a high revenue valuation multiple, the company's stock may not appeal to income-focused investors but rather to those willing to take on higher risk for potential long-term gains.
For those interested in a deeper dive into Precigen's financials and future outlook, InvestingPro offers additional insights and tips, which can be found at https://www.investing.com/pro/PGEN.
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