Financial Performance - The company reported that it has not generated significant revenue from product sales and expects to incur losses for the foreseeable future[152]. - The company reported a net loss of $17.5 million for the three months ended September 30, 2025, compared to a net loss of $7.5 million for the same period in 2024[189]. - As of September 30, 2025, the company had an accumulated deficit of $172.1 million[189]. - The net loss for the three months ended September 30, 2025, was $17.5 million, compared to a net loss of $7.5 million in the same period of 2024, an increase of $9.9 million[205]. - For the nine months ended September 30, 2025, net cash used in operating activities was $25.4 million, attributed to a net loss of $33.1 million[256]. - For the nine months ended September 30, 2024, cash used in operating activities was $18.1 million, with a net loss of $22.4 million[258]. Clinical Development - OPGx-LCA5 is currently in a Phase 1/2 clinical trial, with six participants treated, all showing improvements in vision[160]. - The FDA provided constructive feedback on the registration strategy for OPGx-LCA5, acknowledging the significant unmet medical need for LCA5-related blindness[163]. - The Phase 3 trial for OPGx-LCA5 is expected to begin dosing in the second half of 2026, with topline clinical data anticipated approximately one year later[165]. - OPGx-BEST1 received FDA clearance for an IND application, with initial data expected in the first quarter of 2026[167]. - The company has five programs in pre-clinical development, with three currently in IND-enabling studies supported by grants[168]. - The company anticipates increased research and development expenses as it advances clinical trials for LCA5, BEST1, and PS[198]. - The company intends to file a Supplemental New Drug Application for the treatment of presbyopia with PS in Q4 2025[172]. - The FDA granted RMAT designation to OPGx-LCA5, facilitating expedited development and review for the investigational gene therapy[183]. Revenue and Funding - The company raised approximately $23.0 million in a registered direct offering that closed on November 7, 2025[176]. - The August 2025 private placement generated gross proceeds of $3.5 million from the issuance of 3,138,338 shares of common stock[177]. - The November 2025 Registered Direct Offering generated gross proceeds of approximately $23.0 million, with the intention to advance LCA5 and BEST-1 gene therapy programs[228]. - The company raised approximately $94.9 million through various equity offerings and $8.5 million from convertible notes, including a one-time non-refundable cash payment of $35.0 million in Q4 2023 related to the Viatris License Agreement[227]. - The RDF Agreement provides for nondilutive funding of up to $2.0 million for the development of the MERTK Program, with $1.0 million already disbursed[179]. - License and collaborations revenue decreased to $3.1 million for the three months ended September 30, 2025, down from $3.9 million in 2024, a decline of $0.8 million attributed to reduced PS research and development services[206]. - For the nine months ended September 30, 2025, license and collaborations revenue increased to $10.3 million from $6.7 million in 2024, a rise of $3.6 million due to increased PS research and development services[216]. - License and collaborations revenue to date includes a one-time non-refundable payment of $35 million and a milestone payment of $10 million[262]. - The company anticipates recognizing revenue as it earns reimbursement for research and development services under the Viatris License Agreement[262]. - The company expects to satisfy its short-term and long-term obligations through cash on hand, future equity and debt financings, and reimbursement payments[279]. Stock and Market Activity - The market price of the company's common stock is expected to be volatile, with potential risks of delisting from the Nasdaq Capital Market[152]. - The company has sold an aggregate of 9,479,494 shares under the ATM program, resulting in gross proceeds of $28.5 million[264]. - The company established an at-the-market equity offering program with an aggregate offering price of up to $40.0 million[245]. - As of September 30, 2024, 1,538,461 RDO Warrants were still outstanding from a previous offering that raised $15.0 million[247]. - The Series A Warrants, issued on November 19, 2020, have an initial exercise price of $4.4795 per share and 5,665,838 warrants were still outstanding as of September 30, 2025[253]. Expenses - General and administrative expenses increased to $5.0 million in Q3 2025 from $2.9 million in Q3 2024, an increase of $2.1 million primarily due to public company costs and legal fees[207]. - Research and development expenses for Q3 2025 were $6.4 million, down from $9.0 million in Q3 2024, a decrease of $2.6 million mainly due to lower APX 3330 expenses[210]. - General and administrative expenses for the nine months ended September 30, 2025, were $17.1 million compared to $10.9 million in 2024, an increase of $6.2 million driven by various operational costs[217]. - Research and development expenses for the nine months ended September 30, 2025, totaled $20.4 million, slightly up from $19.8 million in 2024, an increase of $0.6 million primarily due to higher IRD program expenses[221]. - The fair value change in warrant and other derivative liabilities was $9.5 million for Q3 2025, reflecting fluctuations in common stock fair value[211]. - The fair value change in warrant and other derivative liabilities for the nine months ended September 30, 2025, was $5.8 million, attributed to the March 2025 Warrants[222]. Corporate Developments - The Opus Acquisition expanded the product pipeline significantly, issuing 5,237,063 shares of common stock and 14,145.374 shares of Series A preferred stock[157]. - The company relocated its headquarters to Durham, North Carolina, and amended its lease for the headquarters on a month-to-month basis[269].
Opus Genetics, Inc.(IRD) - 2025 Q3 - Quarterly Report