Precision BioSciences(US:DTIL)2025-11-03 12:00Financial Performance - Revenue for the three months ended September 30, 2025, was $13,000, a significant decrease of 97.7% compared to $576,000 for the same period in 2024[24]. - Operating loss for the nine months ended September 30, 2025, was $65,857,000, compared to a net income of $24,912,000 for the same period in 2024[24]. - The company reported a net loss of $21,772,000 for the three months ended September 30, 2025, compared to a net loss of $16,425,000 for the same period in 2024[24]. - For the nine months ended September 30, 2025, the company reported a net loss of $65.857 million compared to a net income of $24.912 million for the same period in 2024[27]. - Revenue for the nine months ended September 30, 2025, was $60,000, a significant decrease from $68.058 million in the same period of 2024[87]. - The net loss for Q3 2025 was $21.772 million compared to a net loss of $16.425 million in Q3 2024, representing a 32.5% increase in losses[81]. - The company reported a net loss of $65.9 million for the nine months ended September 30, 2025, with an accumulated deficit of $548.3 million[183]. Assets and Liabilities - Total current assets decreased from $94,989,000 as of December 31, 2024, to $51,705,000 as of September 30, 2025, a decline of approximately 45.4%[22]. - Cash and cash equivalents decreased from $85,899,000 as of December 31, 2024, to $44,870,000 as of September 30, 2025, a reduction of approximately 47.8%[22]. - Total liabilities decreased from $79,995,000 as of December 31, 2024, to $76,876,000 as of September 30, 2025, a decline of about 2.7%[22]. - Stockholders' equity decreased from $56,393,000 as of December 31, 2024, to $16,634,000 as of September 30, 2025, a drop of approximately 70.5%[22]. - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $71.212 million, down from $121.328 million at the end of 2024[27]. - The company had a restricted cash balance of $26.342 million as of September 30, 2025, up from $22.576 million at the end of 2024[36]. Expenses - Research and development expenses for the three months ended September 30, 2025, were $13,352,000, slightly up from $13,084,000 in the same period of 2024[24]. - Total operating expenses for the nine months ended September 30, 2025, were $64.716 million, down from $69.374 million in 2024[87]. - General and administrative expenses decreased to $7.3 million for the three months ended September 30, 2025, down approximately $1.4 million from $8.8 million in 2024[129]. - General and administrative expenses for the nine months ended September 30, 2025, were $25.0 million, down $0.7 million from $25.7 million in 2024[141]. - Employee share-based compensation expense for Q3 2025 was $2.386 million, down 25.4% from $3.199 million in Q3 2024[69]. Financing Activities - The company reported a net cash provided by financing activities of $17.646 million for the nine months ended September 30, 2025, compared to $44.530 million in the prior year[27]. - The company entered into a public offering on March 1, 2024, resulting in approximately $37.0 million of net proceeds after expenses[56]. - The company issued 1,818,886 shares through an ATM facility, net of issuance costs, contributing $9,516,000 to additional paid-in capital[25]. - The company entered into a loan agreement in July 2024, securing a term loan of $22.5 million[191]. - The outstanding principal balance on the 2024 Term Loan was $22.5 million as of September 30, 2025, with a stated interest rate of 5.75%[163]. Research and Development - The company plans to expand the ELIMINATE-B clinical trial and file an investigational new drug application for the PBGENE-DMD program[30]. - PBGENE-HBV is in a global first-in-human clinical trial aimed at treating chronic Hepatitis B, with multiple ascending dose levels being investigated[95]. - The ELIMINATE-B trial for PBGENE-HBV is recruiting patients in the U.S., Moldova, Hong Kong, New Zealand, and the U.K.[95]. - PBGENE-DMD received Rare Pediatric Disease designation from the FDA in June 2025 and Orphan Drug Designation in July 2025[99]. - The Company anticipates filing for an investigational new drug (IND) for PBGENE-DMD by the end of 2025, with Phase 1 initiation expected in the first half of 2026[102]. - The ongoing OTC-HOPE study for neonatal onset ornithine transcarbamylase deficiency is expected to yield data in the first half of 2026[105]. Market and Competition - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying instead on collaboration and license agreements[108]. - The company faces significant competition from larger pharmaceutical and biotechnology companies with greater resources and expertise[216]. - Adverse public perception of genome editing may negatively impact the developmental progress or commercial success of the company's products[212]. - The company may experience delays in achieving development milestones, which could harm its business and credibility[211]. Future Outlook - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through development and clinical trials[83]. - The company believes existing cash and cash equivalents will be sufficient to fund operations into the second half of 2027, pending supportive Phase 1 data readouts for ongoing studies[166]. - The company may need to seek additional funding sooner than planned due to various factors, including clinical trial outcomes and regulatory approvals[188]. - The company has incurred significant operating losses and does not expect to achieve profitability in the foreseeable future[183]. - The company expects its cash runway to be sufficient to fund operating expenses and capital expenditures into the second half of 2027[188]. Risks and Challenges - Investment in biopharmaceutical product development is highly speculative, with significant risks that product candidates may fail to demonstrate efficacy or safety, obtain regulatory approvals, or become commercially viable[200]. - The company faces challenges in forecasting accuracy, resource allocation, and gaining market acceptance in the rapidly evolving gene editing field[201]. - Limited prior experience in commercialization may hinder market penetration and revenue potential[219]. - Compliance with complex and changing regulatory requirements poses significant challenges[220]. - Economic weaknesses, such as inflation and political instability, could impact market performance[220]. - Production shortages may arise from disruptions in raw material supply or manufacturing capabilities[220]. - Longer accounts receivable collection times could affect cash flow[220]. - Foreign currency exchange rate fluctuations may impact financial results[220].