Full Press Release Details
Opus Genetics Announces Financial Results for
Full Year 2025 and Provides Corporate Update
- Favorable early safety and initial efficacy data from BEST1 program highlighted at premier gathering of global retinal experts with additional data expected mid-year
- Reauthorization of FDA's Rare Pediatric Disease Priority Review Voucher (PRV) program provides opportunity for Opus' deep pipeline in rare inherited retinal diseases -
- FDA Prescription Drug User Fee Act (PDUFA) date in October 2026 for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia -
- Funding from prominent healthcare investors expected to extend cash runway into 2028 -
RESEARCH TRIANGLE PARK, N.C. - March 10, 2026 - Opus Genetics, Inc. (Nasdaq: IRD) (the "Company" or "Opus Genetics"), a clinical-stage biopharmaceutical company
developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the year ended December 31, 2025, and provided a corporate update.
"We are delivering a steady cadence of data and milestones across our pipeline," said George Magrath, M.D., Chief Executive Officer, Opus Genetics. "With positive clinical
results from both our BEST1 and LCA5 gene therapy programs, new funding for our MERTK program and an upcoming FDA PDUFA date for Phentolamine Ophthalmic Solution 0.75% in presbyopia, we are advancing therapies with both scientific promise and
compelling commercial potential. The reauthorization of the U.S. Rare Pediatric Disease Priority Review Voucher program further strengthens our work, reinforcing long term
incentives that support sustainable investment in rare gene therapy development. With multiple catalysts ahead and a capital efficient operating model, we believe Opus is
positioned to create significant long term value for shareholders."
OPGx-BEST1 - Gene Therapy for BEST1-Related IRD
OPGx-LCA5 - Gene Therapy for Leber Congenital Amaurosis (LCA5)
Preclinical Gene Therapy Pipeline
Phentolamine Ophthalmic Solution 0.75% (PS)
Recent Medical Publications and Presentations
Financial Results for the Year Ended December 31, 2025
Cash Position: As of December 31, 2025, Opus Genetics had cash and cash equivalents
of $45.1 million. Subsequent to the end of the fourth quarter, the Company raised approximately $25.0 million in gross proceeds through a private placement of equity securities. Based on current operating plans, the Company believes its aggregate
cash resources of $70.1 million will fund operations into the first half of 2028, excluding any potential proceeds from callable warrants or future milestone payments.
Revenue: License and collaborations revenue totaled $14.2 million for the year
ended December 31, 2025, compared to $11.0 million for the same period in 2024. Revenue in both periods was driven by the Company's collaboration with Viatris, Inc. from reimbursement of research and development (R&D) services.
Research and Development (R&D) Expenses: R&D expenses were $30.8 million
for the year ended December 31, 2025, compared to $26.9 million for the same period in 2024. The increase was primarily attributable to higher costs related to clinical research, toxicology, payroll, professional services and other operating
expenses, partially offset by lower manufacturing and regulatory costs. R&D expenses included $1.0 million in stock-based compensation expense during each of the years ended December 31, 2025 and 2024.
General and Administrative (G&A) Expenses: G&A expenses were $22.0 million
for the year ended December 31, 2025, compared to $18.2 million for the same period in 2024. The increase was primarily attributable to higher legal and patent-related costs, payroll and public company-related costs, and professional service fees. G&A expenses included $2.4 million in stock-based compensation expense during each of the years ended December 31, 2025 and 2024.
Net Loss: Net loss for the year ended December 31, 2025 was $49.6 million, or
($0.80) per basic and diluted share, compared to a net loss of $57.5 million, or ($2.15) per basic and diluted share, for the same period in 2024. The year over year decrease in net loss was primarily driven by the absence of the $28.0 million acquired in process research
and development charge recognized in 2024, partially offset by an $11.5 million increase in the fair value of warrant and other derivative liabilities associated with the Company's March 2025 financings and increases to R&D and G&A expense as
Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases
(IRDs). The Company is developing durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders. The Company's pipeline includes seven AAV-based programs, led by OPGx-LCA5 for LCA5-related mutations and
OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RHO, CNGB1, RDH12, NMNAT1, and MERTK. Opus Genetics is also advancing a small-molecule therapy, Phentolamine Ophthalmic Solution 0.75%, beyond its approved use
for pharmacologically induced mydriasis, with a supplemental new drug application under review for presbyopia and an ongoing Phase 3 pivotal trial for mesopic, low contrast conditions after keratorefractive surgery (dim light disturbances). The
Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not
limited to, statements related to cash runway, the clinical development, clinical results, preclinical data and future plans for Phentolamine Ophthalmic Solution 0.75%, OPGx-LCA5, OPGx-BEST1, RDH12 and earlier stage programs, and expectations
regarding us, our business prospects and our results of operations, and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially
from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading "Risk Factors" included in our most recent Annual Report on Form
10-K and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking
statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "aim," "may," "ongoing,"
"plan," "potential," "predict," "project," "should," "will," "would" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any
forward-looking statements in order to reflect events or circumstances that might subsequently arise.
IR Advisory Solutions
-Financial Tables Follow-
Consolidated Balance Sheets
(in thousands, except share amounts and par value)
| As of December 31, | ||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 45,091 | $ | 30,321 | ||||
| Accounts receivable | 1,995 | 3,563 | ||||||
| Contract assets and unbilled receivables (Note 10) | 1,170 | 2,209 | ||||||
| Prepaids and other current assets | 1,788 | 515 | ||||||
| Short-term investments | - | 2 | ||||||
| Total current assets | 50,044 | 36,610 | ||||||
| Property and equipment, net | 199 | 252 | ||||||
| Total assets | $ | 50,243 | $ | 36,862 | ||||
| Liabilities, Series A preferred stock and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,293 | $ | 3,148 | ||||
| Accrued expenses and other liabilities | 4,488 | 8,147 | ||||||
| Total current liabilities | 7,781 | 11,295 | ||||||
| Warrant liabilities | 25,985 | - | ||||||
| Funding agreement, related party | 1,129 | - | ||||||
| Total liabilities | 34,895 | 11,295 | ||||||
| Commitments and contingencies (Note 3 and Note 9) | ||||||||
| Series A preferred stock, par value $0.0001; no shares and 14,146 shares were designated as of December 31, 2025 and 2024, respectively; no shares and 14,145.374 shares issued and outstanding at December 31, 2025 and 2024, respectively. | - | 18,843 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, par value $0.0001; 10,000,000 and 9,985,854 shares authorized as of December 31, 2025 and 2024, respectively; no shares issued and outstanding at December 31, 2025 and 2024. | - | - | ||||||
| Common stock, par value $0.0001; 125,000,000 authorized as of December 31, 2025 and 2024; 69,894,507 and 31,574,657 shares issued and outstanding at December 31, 2025 and 2024, respectively. | 7 | 3 | ||||||
| Additional paid-in capital | 203,930 | 145,719 | ||||||
| Accumulated deficit | (188,589 | ) | (138,998 | ) | ||||
| Total stockholders' equity | 15,348 | 6,724 | ||||||
| Total liabilities, Series A preferred stock, and stockholders' equity | $ | 50,243 | $ | 36,862 |
Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
| For the Year Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| License and collaborations revenue | $ | 14,196 | $ | 10,992 | ||||
| Operating expenses: | ||||||||
| Research and development | 30,812 | 26,851 | ||||||
| General and administrative | 21,983 | 18,215 | ||||||
| Acquired in-process research and development | - | 28,000 | ||||||
| Total operating expenses | 52,795 | 73,066 | ||||||
| Loss from operations | (38,599 | ) | (62,074 | ) | ||||
| Fair value change in warrant and other derivative liabilities | (11,515 | ) | 72 | |||||
| Financing costs | (1,337 | ) | - | |||||
| Interest expense | (129 | ) | - | |||||
| Other income, net | 1,989 | 4,470 | ||||||
| Loss before income taxes | (49,591 | ) | (57,532 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss | (49,591 | ) | (57,532 | ) | ||||
| Other comprehensive loss, net of tax | - | - | ||||||
| Comprehensive loss | $ | (49,591 | ) | $ | (57,532 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted | $ | (0.80 | ) | $ | (2.15 | ) | ||
| Number of shares used in per share calculations: | ||||||||
| Basic and diluted | 62,221,901 | 26,715,526 |
Source: Opus Genetics, Inc.