Precigen (PGEN) Q2 2024 earnings summary

Executive summary

• PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP), is the primary focus, with pivotal study data showing over 51% Complete Response and 86% reduction in surgeries, aiming for the first FDA approval in this indication.

• Strategic reprioritization in August 2024 led to a workforce reduction of over 20%, pausing non-core and preclinical programs, and shutting down the ActoBio subsidiary.

• Recent $31.4 million equity raise in August 2024 extends cash runway into early 2025, but substantial doubt remains about going concern.

• Appointment of new Chief Commercial Officer to lead commercialization efforts for PRGN-2012.

Financial highlights

• Q2 2024 net loss was $58.8 million ($0.23/share), up 189% year-over-year, driven by $34.5 million in impairment charges and strategic restructuring.

• Revenues fell 59% year-over-year to $0.7 million in Q2 2024, mainly due to lower Exemplar service revenues.

• R&D expenses rose 32% to $15.7 million in Q2 2024, driven by PRGN-2012 trial costs and severance charges.

• SG&A expenses increased 11% in Q2 2024, reflecting severance and commercial readiness costs.

• Cash and investments at June 30, 2024, totaled $19.5 million; cash and cash equivalents were $9.3 million.

Outlook and guidance

• BLA submission for PRGN-2012 expected by end of 2024 under accelerated approval, with potential commercial launch in 2025.

• Confirmatory trial for PRGN-2012 is underway, with strong patient interest and rapid enrollment anticipated.

• Operations funded into early 2025 after equity raise; additional capital needed for ongoing operations, with further cost reductions and non-dilutive financings under consideration.

• Global commercialization plans are in progress, including ex-U.S. markets.