Precigen is throwing everything behind a push to bring a noncancerous tumor gene therapy to market, driving it to lay off 20% of its employees and pause a raft of other programs to stretch its limited funds.
The Maryland-based biotech reported phase 1/2 data on its PRGN-2012 gene therapy and outlined plans to file for accelerated approval in June. Precigen’s commitment to seeking approval posed a problem to the biotech. With $19.5 million to its name at the end of June, there were substantial doubts about the company's ability to continue as a going concern, let alone to bankroll the regulatory approval process.
Precigen has responded to the cash crunch by simultaneously raising money and reducing its costs. The cost-cutting plan involves a more than 20% reduction in the workforce of Precigen, which ended last year with 134 employees, and a pullback from multiple programs.
The biotech is minimizing spend on its CAR-T programs. Enrollment in a phase 1b trial of PRGN-3006 in acute myeloid leukemia is complete, and Precigen is preparing to discuss the next steps with the FDA. But management is pausing all other CAR-T clinical programs, including PRGN-3005 and PRGN-3007, and will focus on partnering to advance assets.
A phase 2 trial of cancer gene therapy PRGN-2009 will continue under an agreement with the National Cancer Institute (NCI). However, Precigen will pause enrollment at non-NCI sites. PRGN-2009 is in four active studies, three of which are sponsored by the NCI.
Precigen has paused all preclinical programs and started to shutter its Belgian subsidiary ActoBio. The biotech plans to lay off everyone at ActoBio, a developer of microbe-based biopharmaceuticals, and put its intellectual property up for sale.
In parallel, Precigen has begun a $30 million stock offering. The biotech is predicting the combination of the cuts and the financing will extend its cash runway into 2025. Precigen plans to file for FDA approval of PRGN-2012 this year. Having extended its runway just beyond the filing, the biotech is now “exploring a number of potential non-dilutive financings for future liquidity.”
Speaking when Precigen presented the clinical data in June, Chief Financial Officer Harry Thomasian said the company had “fielded a number of inbound inquiries in support of our efforts to commercialize PRGN-2012” and was “considering all strategic options.”