Precigen(PGEN) - 2024 Q3 - Quarterly Results

Regulatory and Clinical Developments - Precigen completed a pre-BLA meeting with the FDA and is aligned on the content for the BLA submission for PRGN-2012, expected in Q4 2024[1] - The pivotal clinical study for PRGN-2012 showed that 51% of patients achieved a Complete Response, with a median follow-up duration of 20 months[5] - The company is preparing for an end of Phase 1b meeting with the FDA for PRGN-3006 in AML in early 2025[1] Financial Performance - Total revenues decreased by $0.4 million, or 31%, compared to the same period in 2023, primarily due to reductions in product and service revenues at Exemplar[20] - Net loss for Q3 2024 was $24.0 million, or $(0.09) per share, compared to a net loss of $19.8 million, or $(0.08) per share, in Q3 2023[20] - Total revenues for Q3 2024 were $953,000, a decrease of 30.8% compared to $1,379,000 in Q3 2023[30] - Product revenues in Q3 2024 were $66,000, down from $82,000 in Q3 2023, representing a decline of 19.5%[30] - Service revenues decreased to $886,000 in Q3 2024 from $1,296,000 in Q3 2023, a drop of 31.6%[30] - The net loss for Q3 2024 was $23,978,000, compared to a net loss of $19,795,000 in Q3 2023, reflecting an increase in losses of 11.0%[30] - The accumulated deficit increased to $(2,070,979,000) as of September 30, 2024, from $(1,964,471,000) at the end of 2023[29] Expenses and Liabilities - Research and development expenses increased by $5.7 million, or 16%, compared to the nine months ended September 30, 2023, driven by costs associated with PRGN-2012[22] - SG&A expenses increased by $0.6 million, or 7%, in Q3 2024, attributed to increased focus on PRGN-2012 and severance costs from workforce reduction[17] - Total operating expenses for Q3 2024 were $22,215,000, slightly down from $22,316,000 in Q3 2023[30] - Current liabilities decreased slightly to $21,216,000 from $22,985,000 at the end of 2023[29] Asset Management - Cash and cash equivalents rose to $24,725,000 as of September 30, 2024, compared to $7,578,000 at the end of 2023[29] - Total assets decreased to $83,474,000 as of September 30, 2024, down from $151,043,000 at the end of 2023[29] - The weighted average shares outstanding increased to 275,881,170 in Q3 2024 from 248,520,724 in Q3 2023[30] Strategic Initiatives - Precigen's UltraCAR-T platform is positioned to potentially be best-in-class for CD19-targeting treatments in oncology and autoimmune diseases[2] - The company is exploring various financing options, including strategic partnerships, to support the commercialization of PRGN-2012[2] - The company recorded $34.5 million in impairment charges related to goodwill and long-lived assets due to the suspension of ActoBio's operations[24]