Opus Genetics, Inc.

Item 1A.

Risk Factors

Other than as set forth below, there have been no material changes in our risk factors previously disclosed in Part I, Item 1A Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024. You should carefully consider the risks and uncertainties described below and therein.

If we fail to comply with tOur ability to utilize our common stock to finance future capital needs, or for other purposes, is limited by our authorized shares available for issuance.

Following the November 2025 Registered Direct Offering, we had authority to issue a total of 125.0 million shares of common stock, of which approximately 69.0 million shares had been issued and 54.4 million shares were reserved for issuance pursuant to outstanding stock options, restricted stock units, and warrants.

With the limited shares of common stock presently available for issuance, our ability to secure additional funding through the sale of common stock is very limited. Absent an increase in the shares of common stock authorized to be issued, we will be limited to other financing structures in the continued listing standards of tevent additional financing is required. Such alternative structures may be less favorable or unavailable in which case we may be forced to forego opportunities. We may also be limited in our ability to offer equity awards to incentive our employees if we do not have adequate shares available for issuance.

Instability and operational disruptions at government agencies, such as the FDA, may adversely impact our development and commercialization plans by causing delays and requiring the use of additional, unforeseen resources to obtain regulatory approval for trials or products in our pipeline.

Our business depends largely on the Nasdaq successful clinical development, regulatory approval and commercialization of our product candidates. To advance our candidates, we, along with many of the thirdparties we currently and may in the future work with, must work closely with the FDA and comparable regulatory agencies in foreign jurisdictions. Such authorities play a vital role in the development of our product candidates by providing guidance on our clinical programs and reviewing and approving our regulatory submissions, including IND applications, requests for special designations, such as Orphan Drug Designation and Rare Pediatric Disease Designation, and marketing applications.

If these agencies experience unexpected funding losses or mass layoffs or are otherwise affected by the current or any future shutdown of the U.S. federal government, their oversight and review activities of existing and new submissions, such as IND applications, may be significantly disrupted or delayed. Such disruptions or delays could adversely impact our ability to develop and secure timely approval of our product candidates.

There are also ongoing deliberations within the current presidential administration and Congress over potentially substantial proposed cuts to the overall budget for the U.S. Department of Health and Human Services and funding of the FDA for the 2026 federal fiscal year. These budgetary decisions are unpredictable and remain subject to change. Such decisions could make it more difficult to secure grant funding from government agencies and nongovernmental foundations. Further, there is also instability and uncertainty surrounding how the current U.S. administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates. We may have to expend additional resources to comply with any new policies and to engage with the appropriate agencies.

47

Opus Genetics, Inc.

Form 10-Q

Government shutdowns and funding cuts may also negatively affect the SECapital Mar. In the event of an extended shutdown, the SEC may operate with limited staff or suspend certain functions altogether, which could delay the review or effectiveness of our filings, including registration statements or other financing-related disclosures. Such delays could adversely affect our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue to fund our operations.

If we fail to comply with the continued listing standards of Nasdaq, our common stock may be delisted, and our ability to access the capital markets could be negatively impacted.

Our common stock is listed for trading on the Nasdaq Capital Market (Nasdaq). In order to maintain our listing, we must satisfy Nasdaqs continued listing requirements.  (the Nasdaq Listing Rules). The Nasdaq Listing Rules require that the closing price of our common stock generally remains at or above $1.00 per share (the Minimum Bid Price Requirement). The closing price of our common stock has recently traded below $1.00, and may fall below $1.00 per share in the future. If our common stock closes at a price below $1.00 per share for 30 consecutive business days, we could be delisted from Nasdaq. In the event we do receive notice of deficiency from Nasdaq, we expect that applicable Nasdaq Listing Rules would provide us with an initial period of 180 calendar days to regain compliance with the Minimum Bid Price Requirement, which may be extended by Nasdaq in its discretion.

There are no assurances that we will be able to continue to comply with the Minimum Bid Price Requirement. We intend to monitor the closing price of our common stock and may, if appropriate, consider available options to regain compliance with the Minimum Bid Price Requirement, which could include seeking to effect a reverse stock split. There are many factors outside of our control that may adversely affect our minimum bid price, including those described in the Risk Factors section of our most recent Annual Report on Form 10-K for the year ended December 31, 2024 and in our other filings with the SEC.

Any potential delisting of our common stock from Nasdaq would likely result in decreased liquidity and increased volatility for our common stock and may damage our reputation, adversely affecting our ability to raise additional capital or to pursue our strategic business plans. Additionally, delisting would make it more difficult for our stockholders to sell our common stock in the public market. Further, if the Company seeks to implement a reverse stock split in order to remain listed, the announcement or implementation of such a reverse stock split could negatively affect the price of our common stock.

52

Opus Genetics, Inc.

Form 10-Q