Precigen(US:PGEN)2025-11-13 21:20Financial Performance - Total revenues for the three months ended September 30, 2025, were $2,922,000, a significant increase from $953,000 in the same period of 2024, representing a growth of 206%[23] - The company reported a net loss of $146,344,000 for the three months ended September 30, 2025, compared to a net loss of $23,978,000 for the same period in 2024, indicating a substantial increase in losses[23] - For the nine months ended September 30, 2025, the company reported a net loss of $227,139,000, compared to a net loss of $106,508,000 for the same period in 2024, representing an increase in loss of approximately 113%[38] - The company experienced a net loss of $23,978,000 for the quarter ending September 30, 2024, compared to a net loss of $106,508,000 for the previous quarter, indicating a significant reduction in losses[33] - Net loss attributable to common shareholders reached $325.3 million, compared to $24.0 million in the same period last year, reflecting an increase of less than 200%[191] - Net loss per share attributable to common shareholders increased to $1.06 from $0.09, primarily due to changes in fair value of warrant liabilities and a deemed dividend[198] Revenue Sources - The company reported collaboration and licensing revenue of $1,818,000 for the three months ended September 30, 2025, compared to no revenue in the same period of 2024[23] - Total revenues increased by $2.0 million, or over 200%, primarily driven by collaboration and licensing revenues, with $1.8 million recognized from a terminated agreement[192] - Product revenues rose to $162,000, a 145.5% increase from $66,000 in the prior year[191] - Service revenues increased by 6.3%, reaching $942,000 compared to $886,000 in the previous year[191] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2025, were $34,343,000, down from $41,312,000 in the same period of 2024, reflecting a decrease of 17%[23] - Selling, general and administrative expenses surged by $14.2 million, or 144%, driven by costs associated with Papzimeos commercial readiness[195] - Operating loss for the three months ended September 30, 2025, was $34.5 million, a 62.2% increase from $21.3 million in the prior year[191] - The company reported stock-based compensation of $2,061,000 for the quarter ending September 30, 2024, reflecting ongoing investment in employee incentives[30] - The company recognized a significant increase in stock-based compensation expense, which rose to $8,703,000 in 2025 from $6,606,000 in 2024, reflecting a 32% increase[38] Assets and Liabilities - Cash and cash equivalents decreased to $14,322,000 as of September 30, 2025, from $29,517,000 as of December 31, 2024, a decline of 51%[17] - Total assets increased to $171,264,000 as of September 30, 2025, compared to $145,266,000 as of December 31, 2024, representing a growth of 18%[19] - The company’s total liabilities rose to $129,396,000 as of September 30, 2025, up from $78,535,000 as of December 31, 2024, an increase of 65%[20] - The accumulated deficit increased to $(2,317,845,000) as of September 30, 2025, compared to $(2,090,706,000) as of December 31, 2024, indicating a worsening financial position[20] Stock and Equity - The weighted average shares outstanding for the three months ended September 30, 2025, were 307,170,490, compared to 275,881,170 for the same period in 2024, reflecting an increase in shares[23] - The total common stock shares outstanding increased to 292,869,097 as of September 30, 2024, up from 252,656,151 shares at June 30, 2024, representing a growth of approximately 15.9%[30] - Precigen, Inc. issued 39,878,939 shares in public offerings, net of issuance costs, contributing to the increase in total equity[33] - The company converted all holders of preferred stock to common stock in the third quarter of 2025, impacting the equity structure[75] Financing Activities - The company’s net cash provided by financing activities was $90,562,000 for the nine months ended September 30, 2025, compared to $32,179,000 for the same period in 2024, showing a substantial increase in financing[41] - The company entered into a Loan Agreement on September 3, 2025, securing a senior secured term loan facility of up to $125 million, with net proceeds of $92,818 after expenses[108] - The effective interest rate for the Term Loan was 12.5% for the three months ended September 30, 2025, with total interest expense of $902[112] Regulatory and Clinical Developments - The company received FDA approval for Papzimeos™ (Zopapogene Imadenovec) in August 2025, marking its transition from a development-stage to a commercial-stage company[44] - The FDA granted full approval of Papzimeos in August 2025, marking it as the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP)[167] - Papzimeos demonstrated a 51% complete response rate in a pivotal clinical trial, with 18 out of 35 patients requiring no surgeries in the 12 months post-treatment[169] - The FDA granted priority review for the company's BLA for PRGN-2012, with a target action date set for August 27, 2025[152] Strategic Initiatives - The company has initiated a strategic prioritization of its clinical portfolio, including a workforce reduction of over 20% to focus on the commercialization of Papzimeos[48] - The company is focusing on strategic partnerships to advance its UltraCAR-T programs, including PRGN-3006 in AML[173] - The proprietary UltraPorator device is designed to streamline and ensure rapid manufacturing of UltraCAR-T therapies, representing a significant advancement in the field[172] Other Financial Metrics - The company recorded a cumulative catch-up adjustment of $2,266 for stock-based compensation upon FDA approval of the BLA[140] - The total lease liabilities as of September 30, 2025, amounted to $5,302,000, with a current portion of $1,123,000[145] - The company had no outstanding balance on its $5 million revolving line of credit as of September 30, 2025, which bore interest at 8.00% per annum[114]