NEW YORK – Precigen on Tuesday announced it was laying off 20 percent of its workforce, reprioritizing its clinical portfolio, and streamlining its resources so it can focus on commercializing its investigational gene therapy, PRGN-2012 AdenoVerse, for recurrent respiratory papillomatosis (RRP).
The Germantown, Maryland-based company further said it was offering $30.0 million of its common stock at $1.31 per share. Underwriters will also have 30 days to purchase another $4.5 million shares of Precigen's common stock.
Precigen said it will record noncash impairment charges of approximately $32.9 million in Q2 2024 and severance costs of around $3.0 million between Q2 and Q3 2024.
As of June 30, 2024, Precigen had $19.5 million in cash, cash equivalents, and short-term investments. The company expects that the cost savings from the strategic reprioritization, the proceeds of the offering, plus the cash it has on hand to fund operations until early 2025.
Before then, in the second half of this year, Precigen hopes to initiate a rolling biologics license application for PRGN-2012 with the US Food and Drug Administration, seeking its accelerated approval in RRP while conducting a confirmatory trial and manufacturing the commercial product. Precigen's new Chief Commercial Officer Phil Tennant will lead commercialization efforts in anticipation of launching a marketed product next year.
Under the strategic reprioritization, the company said it will still continue the Phase II trials it is conducting under a cooperative R&D agreement with the National Cancer Institute, which are testing the off-the-shelf immunotherapy PRGN-2009 in recurrent cervical cancer and newly diagnosed HPV-associated oropharyngeal cancer. However, Precigen said it will stop enrolling patients into PRGN-2009 trials at non-NCI trial sites.
The firm is preparing to have an end of Phase Ib meeting with the FDA to discuss clinical development plans for the autologous cell therapy PRGN-3006 in acute myeloid leukemia. But it will pause all other UltraCAR-T programs, including PRGN-3005 and PRGN-3007, and look to advance these assets through strategic partnerships.
Precigen is also pausing all preclinical programs and shutting down its Belgian-based ActoBio subsidiary, including laying off personnel and selling the firm's intellectual property.
"These prioritization steps enhance our ability to rapidly prepare for potential commercialization of PRGN-2012, which if approved, we believe has the safety, efficacy, and route of administration profile to be the first and best-in-class therapy for RRP patients," Precigen President and CEO Helen Sabzevari said in a statement.