Maryland biotech Precigen said it will lay off more than 20% of its workforce, pause multiple CAR-T clinical programs, halt all preclinical R&D, and try to raise $30 million in a public offering.
It will also shutter a Belgian-based subsidiary named ActoBio, which was working on a type 1 diabetes program that went through Phase 1/2.
All those updates came after the market closed Tuesday afternoon. The company’s shares $PGEN were down about 11% after hours.
Precigen expects to record nearly $33 million in non-cash impairment charges in connection with the moves, and about $3 million in severance costs, according to an SEC filing. The company had 202 employees, including 177 supporting its “healthcare operations,” at the end of 2023, according to its annual report.
It anticipates the pullbacks will allow it to keep the lights on into early 2025 so that later this year it can submit a rolling BLA for its gene therapy, dubbed PRGN-2012, according to the SEC filing. Precigen is developing the therapy for recurrent respiratory papillomatosis, targeting a commercial launch next year.
Helen Sabzevari“We are on track toward our goal of submitting a rolling BLA for PRGN-2012 in the second half of this year and we are pleased to announce that the confirmatory clinical trial, an important step guided by the FDA to support an accelerated approval, has already been initiated and is actively enrolling patients,” CEO Helen Sabzevari said in a statement.
It plans to continue testing another therapy, PRGN-2009, in Phase 2 studies in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer with the help of the National Cancer Institute. But it will pause non-NCI clinical sites.
Its CAR-T PRGN-3006 has completed enrollment in a Phase 1b for acute myeloid leukemia, and Precigen plans to meet with the FDA to talk through next steps. But it will pause all other CAR-T clinical programs, including PRGN-3005 in ovarian cancer and PRGN-3007 in hematological cancers and solid tumors, and instead will “focus on strategic partnerships” for those assets.