Opus Genetics sets up $40,000,000 at-the-market program with Leerink Partners

Opus Genetics, Inc. (Nasdaq: IRD) entered into a sales agreement with Leerink Partners LLC under which it may sell common stock with an aggregate offering price of up to $40,000,000. The company filed the prospectus supplement on January 13, 2025, under a shelf registration statement declared effective January 23, 2024. Leerink may act as agent or principal, and it is not required to sell any specific amount. The company says sales, if any, will be made as at-the-market offerings into Nasdaq at prevailing prices.

Leerink will receive 3.0% of gross proceeds from any shares it sells. The supplement says Leerink's compensation counts as underwriting commissions and discounts, and that the company agreed to provide indemnification and contribution.

Ending the earlier program

When it signed the Leerink agreement, the company terminated its Capital on Demand Sales Agreement dated March 11, 2021 with JonesTrading Institutional Services LLC. That earlier program also covered up to $40,000,000 of common stock. The supplement says an aggregate gross sales price of approximately $26.4 million of shares had been sold under it. The filing does not say how much of the stock was sold at each price, or when most of it was sold.

Advisers

Sidley Austin LLP, New York, passes on the legal matters for Opus. Duane Morris LLP, New York, represents Leerink in the offering. The supplement names no other placement agent or underwriter.

Dilution and share count

The supplement says that as of December 31, 2024, 1,420,288 shares were reserved for future issuance under the company's stock incentive plans, and options to purchase 5,406,536 shares were outstanding. Options with an exercise price below the offering price will increase dilution to investors in this offering. The company also says it cannot predict how many shares it will sell under the agreement or the aggregate proceeds from those sales.

The supplement says that as of September 30, 2024 the company had $36.6 million in cash and cash equivalents, which it believes is enough to fund planned expenditures and meet its obligations into 2026. It gives no net loss figure. It says the net proceeds, if any, will go to general corporate purposes and working capital, including preclinical studies, clinical trials and the advancement of product candidates.

The company and its pipeline

Opus Genetics was formerly known as Ocuphire Pharma, Inc. It acquired a private company also operating as Opus Genetics on October 22, 2024, under a merger agreement of the same date. The company is based in Durham, North Carolina, and calls itself a clinical-stage ophthalmic biotechnology company developing gene therapies for inherited retinal diseases.

Its most advanced gene therapy, OPGx-LCA5, targets mutations in the LCA5 gene, which causes an early-onset retinal degeneration. It is in an open-label, dose-escalation Phase 1/2 trial. The company reports six-month data showing visual improvement in three out of three adult patients, all with late-stage disease. That is a group of three patients. First pediatric enrollment was expected in the first quarter of 2025, with first data expected in the third quarter of 2025.

OPGx-LCA5 has Rare Pediatric Disease and Orphan Drug designations, which make it eligible for a priority review voucher if a biologics license application is approved by September 30, 2026. The supplement notes that Congress could extend that deadline, but that there is no guarantee it will.

The company also has OPGx-BEST1, a gene therapy acquired from Iveric Bio in late 2022 for Best disease. Its phentolamine ophthalmic solution is in Phase 3 trials for presbyopia and for dim-light vision disturbances. APX3330, an oral small-molecule inhibitor of Ref-1 for diabetic retinopathy, reached agreement with the FDA on a Special Protocol Assessment for a Phase 3 trial in December 2024. The company says the capital needs of that program led it to seek a strategic partner and to redirect its resources toward the gene therapies.

What comes next

The company's stated cash runway reaches only into 2026, and the proceeds from the Leerink program depend on prices and volumes the company does not control. Its next visible dates are the priority review voucher deadline of September 30, 2026 and the pediatric and LCA5 data timelines it gave for 2025.

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