Exhibit 99.1

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In January 2023, Ocuphire reported top-line efficacy and safety results from the ZETA-1 Phase 2 trial conducted in 103 subjects with DR, including moderately severe and severe non-proliferative DR (“NPDR”) and mild proliferative DR (“PDR”), as well as patients with diabetic macular edema without loss of central vision. Trends toward efficacy were seen on the ≥3-step worsening on a binocular diabetic retinopathy severity scale (“DRSS”) Person Scale. APX3330 also demonstrated favorable safety and tolerability in diabetic patients.

•	In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.

•	In February 2024, Ocuphire submitted a Special Protocol Assessment (“SPA”) to seek agreement on the clinical trial protocol and statistical analysis plan for Phase 3. Specifics on the study design and the anticipated timing will be shared if and when an agreement is reached with the FDA.

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In September 2023, Ocuphire and Viatris, Inc. (“Viatris”) announced FDA approval of PS under the brand name RYZUMVI™ for the treatment of pharmacologically-induced mydriasis. In 2023, the Company received a cash payment in the amount of $10 million from Viatris upon achieving this regulatory approval milestone in connection with its license agreement with Viatris. RYZUMVI is expected to launch in the first half of 2024.

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The Company received an agreement from the FDA under a SPA for the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial to evaluate PS for the proposed indication for the treatment of decreased visual acuity under dim (mesopic) light conditions after keratorefractive surgery. Viatris is expected to continue Phase 3 development of this indication in the first half of 2024.

•	The VEGA-2 Phase 3 study achieved a primary endpoint in presbyopia. Viatris is expected to continue Phase 3 development in the first half 2024.

•	Development of PS in treatment of presbyopia and in decreased visual acuity under dim (mesopic) light conditions after keratorefractive surgery is expected to be funded by Viatris, under terms of the license agreement with Viatris.

•	In August 2023, Ocuphire entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which Ocuphire has the sole right, but not the obligation, to direct LPC to purchase up to $50 million of shares of our common stock.

•	In November 2023, Ocuphire appointed George Magrath, M.D., M.B.A., M.S., as Chief Executive Officer and as a member of the Board of Directors. Dr. Magrath succeeded Rick Rodgers, M.B.A., Interim Chief Executive Officer and President. Mr. Rodgers remains a member of the Board of Directors.

•	In November 2023, Ocuphire appointed Joseph (Joe) K. Schachle, M.B.A., as Chief Operating Officer.

•	In February 2024, Ocuphire appointed Nirav Jhaveri, C.F.A, M.B.A. as Chief Financial Officer and Ashwath (Ash) Jayagopal, Ph.D., M.B.A. as Chief Scientific and Development Officer.

For more information, visit www.ocuphire.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 concerning the End-of-Phase 2 meeting with the FDA to align on late-stage registration endpoints and study parameters, the launching of RYZUMVI, the continued development of PS and LDP, the sufficiency of cash on hand to meet future funding needs, and the potential of APX3330 as an oral treatment for patients with non-proliferative diabetic retinopathy.

 

These forward-looking statements relate to 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 Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “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.

 

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The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts;

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Regulatory requirements or developments;

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Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways;

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Delays or difficulties in the enrollment of patients in clinical trials;

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Substantial competition and rapid technological change;

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Our development of sales and marketing infrastructure;

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Future revenue losses and profitability;

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Our relatively short operating history;

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Changes in capital resource requirements;

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Risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs;

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Domestic and worldwide legislative, regulatory, political and economic developments;

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Employee misconduct;

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Changes in market opportunities and acceptance;

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Reliance on third-parties;

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Future, potential product liability and securities litigation;

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System failures, unplanned events, or cyber incidents;

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The substantial number of shares subject to potential issuance associated with our Equity Line of Credit arrangement with LPC;

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Risks that our partnership with Viatris, or our other licensing arrangements, may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates;

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Future fluctuations in the market price of our common stock;

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The success and timing of commercialization of any of Ocuphire’s product candidates; and

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Obtaining and maintaining Ocuphire’s intellectual property rights.

Ocuphire Pharma, Inc.

Balance Sheets

(in thousands, except share amounts and par value)

 

Ocuphire Pharma, Inc.

Statements of Comprehensive (Loss) Income

(in thousands, except share and per share amounts)

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