Precigen(PGEN) - 2025 Q1 - Quarterly Results

Business and Financial Highlights Precigen advanced PRGN-2012 for RRP with FDA priority review (PDUFA August 2025), ending Q1 2025 with $81 million cash, funding operations into 2026 - The company is highly focused on advancing PRGN-2012, which could become the first FDA-approved therapeutic for RRP, with a PDUFA target action date of August 27, 2025[3][6] - Precigen and the Recurrent Respiratory Papillomatosis Foundation will host the 2025 International RRP Awareness Day on June 11 to engage with patients, caregivers, and the healthcare community[3][4] Financial Position | Financial Position | Amount ($) | Note | | :--- | :--- | :--- | | Cash, cash equivalents, and investments | $81.0 million | As of March 31, 2025 | | Cash Runway Expectation | Into 2026 | Excludes potential PRGN-2012 revenue | Clinical Program Updates Precigen's clinical pipeline is led by PRGN-2012 nearing FDA approval, with other candidates like PRGN-2009 and PRGN-3006 also advancing PRGN-2012 AdenoVerse Gene Therapy in RRP PRGN-2012, an RRP gene therapy, is under FDA priority review (PDUFA August 2025), showing 51% complete response in pivotal study, with 2025 commercial launch preparations underway - The FDA accepted the BLA for PRGN-2012, granted priority review, and set a PDUFA target action date for August 27, 2025 An advisory committee meeting is not currently planned[6][7] - Pivotal study results showed 51% of patients (18 of 35) achieved a Complete Response, requiring no surgeries after treatment, with durable responses observed for up to three years[7][8] - 86% of patients (30 of 35) experienced a decrease in surgical interventions post-treatment, with median surgeries dropping from 4 to 0[15] - Commercial and manufacturing readiness campaigns are advancing in anticipation of a potential 2025 launch, supported by commercialization partner EVERSANA[6][15] PRGN-2009 AdenoVerse Gene Therapy in HPV-associated Cancers PRGN-2009, an investigational gene therapy for HPV-associated cancers, is undergoing Phase 2 clinical trials in partnership with the NCI - Phase 2 clinical trials are ongoing for recurrent/metastatic cervical cancer and newly diagnosed HPV-associated oropharyngeal cancer in partnership with the NCI[9] PRGN-3006 UltraCAR-T in AML and MDS PRGN-3006, an autologous CAR-T therapy for AML and MDS, has completed Phase 1b enrollment for AML and received FDA Orphan Drug and Fast Track designations - The company has completed patient enrollment in the Phase 1b trial for PRGN-3006 in AML[10] - PRGN-3006 has been granted Orphan Drug Designation for AML and Fast Track Designation for relapsed/refractory (r/r) AML by the FDA[10] First Quarter 2025 Financial Results Precigen's Q1 2025 revenues rose 26% to $1.3 million, while R&D decreased 27% and SG&A increased 22%, resulting in a $54.2 million net loss primarily due to warrant liabilities Financial Performance Summary | Metric | Q1 2025 ($) | Q1 2024 ($) | Change (%) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $1.3M | $1.1M | +26% | Increased volume at Exemplar | | R&D Expenses | $10.5M | $14.2M | -27% | Closure of ActoBio operations and asset prioritization | | SG&A Expenses | $12.4M | $10.2M | +22% | PRGN-2012 commercial readiness activities | | Net Loss | $54.2M | $23.7M | +129% | Primarily a $32.5M non-cash change in fair value of warrant liabilities | | Net Loss Per Share | $(0.18) | $(0.10) | +80% | Increased net loss and higher share count | - Total other expense was $31.6 million, a significant shift from an income of $0.6 million in Q1 2024 This was driven by a $32.5 million non-cash increase in the fair value of warrant liabilities due to a higher stock price[14] Consolidated Financial Statements Precigen's unaudited consolidated financial statements for Q1 2025 show total assets of $128.8 million, total liabilities of $113.3 million, and a net loss of $54.2 million Consolidated Balance Sheets Precigen's balance sheet as of March 31, 2025, shows total assets of $128.8 million and total liabilities of $113.3 million, driven by increased warrant liabilities Balance Sheet Summary | (Amounts in thousands) | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $6,058 | $29,517 | | Short-term investments | $74,184 | $68,393 | | Total Assets | $128,787 | $145,266 | | Liabilities & Equity | | | | Warrant liabilities | $83,018 | $50,537 | | Total Liabilities | $113,329 | $78,535 | | Total shareholders' (deficit) equity | $(14,060) | $38,513 | Consolidated Statements of Operations Precigen's Q1 2025 statement of operations shows $1.34 million in revenues, a $22.6 million operating loss, and a $54.2 million net loss due to warrant liabilities Statements of Operations Summary | (Amounts in thousands, except per share data) | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Total revenues | $1,341 | $1,065 | | Total operating expenses | $23,937 | $25,475 | | Operating loss | $(22,596) | $(24,410) | | Change in fair value of warrant liabilities | $(32,481) | $— | | Net loss | $(54,153) | $(23,738) | | Net loss per share, basic and diluted | $(0.18) | $(0.10) |