Top-line data from VEGA-3 Phase 3 trial expected in first half of 2025 Top-line data from LYNX-2 Phase 3 trial in patients with decreased visual acuity under low light conditions following keratorefractive surgery expected in first quarter of 2025 FARMINGTON HILLS, Mich., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of patients with retinal an ...

Financial Performance - Ocuphire Pharma reported a net loss of $7.8 million and $14.9 million for the three and six months ended June 30, 2024, respectively, compared to a net loss of $5.0 million and $10.8 million for the same periods in 2023[136]. - The company has an accumulated deficit of $96.3 million as of June 30, 2024[136]. - License and collaborations revenue decreased to $1.1 million for the three months ended June 30, 2024, down from $3.7 million in the same period of 2023, primarily due to reduced PS research and development services[150]. - License and collaborations revenue for the six months ended June 30, 2024 was $2.8 million, down from $5.4 million in the same period of 2023, reflecting a decrease in PS research and development services[157]. - General and administrative expenses for the three months ended June 30, 2024 were $3.4 million, a decrease of $1.0 million compared to $4.3 million in the prior year, mainly due to reduced payroll-related costs[151]. - General and administrative expenses for the six months ended June 30, 2024 were $8.0 million, an increase of $1.4 million compared to $6.6 million in the prior year[159]. - Research and development expenses increased to $6.1 million for the three months ended June 30, 2024, compared to $4.7 million in the same period of 2023, driven by higher manufacturing and toxicology costs for APX3330[154]. - Research and development expenses for the six months ended June 30, 2024 were $10.8 million, slightly up from $10.3 million in the same period of 2023, primarily due to increased manufacturing costs for APX3330[160]. - Total operating expenses for the three months ended June 30, 2024 were $9.4 million, slightly higher than $9.1 million in the same period of 2023[150]. - Other income, net for the three months ended June 30, 2024 was $0.6 million, compared to $0.4 million in the same period of 2023, mainly from interest income[155]. - Other income, net for the six months ended June 30, 2024 was $1.2 million, up from $0.8 million in the same period of 2023, primarily due to interest income[161]. - For the six months ended June 30, 2024, the company reported a net cash used in operating activities of $13.0 million, attributed to a net loss of $14.9 million[176]. Product Development - Ocuphire's lead product candidate, APX3330, is in development for diabetic retinopathy, which affects approximately 10 million diabetics and is projected to impact over 14 million Americans by 2050[127]. - The FDA approved Phentolamine Ophthalmic Solution 0.75% (RYZUMVI) in September 2023, triggering a $10 million milestone payment under the Viatris License Agreement[131]. - RYZUMVI was commercialized by Viatris in April 2024, following a comprehensive clinical trial program involving over 600 subjects[131]. - The VEGA-2 Phase 3 study for presbyopia achieved its primary endpoint, and the VEGA-3 Phase 3 clinical trial has begun recruiting[134]. - Ocuphire has in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330, targeting other retinal diseases[129]. - The company anticipates recognizing revenue from the Viatris License Agreement and potential future milestone and royalty payments, but significant revenue generation is uncertain until product sales materialize[179]. - The development of APX3330 is subject to uncertainties, and the company cannot assure future profitability or positive cash flow from operating activities[183]. Funding and Capital Structure - Ocuphire has funded operations primarily through equity financings totaling $67.3 million, including $21.15 million from a merger with Rexahn Pharmaceuticals[136]. - The company expects to finance its cash needs through a combination of equity and debt financings, as well as collaborations and licensing arrangements[135]. - The company raised approximately $67.3 million from various equity offerings and $8.5 million from convertible notes, including a one-time non-refundable payment of $35 million and a $10 million milestone payment related to the Viatris License Agreement[163]. - The company entered into a Purchase Agreement with Lincoln Park Capital Fund, allowing for the purchase of up to $50 million of common stock over a 30-month term[164]. - The company has a shelf registration effective for an aggregate offering price of up to $175 million, with $26 million raised through an At-The-Market program since inception[165]. - The company may face dilution of stockholder ownership if additional capital is raised through equity or convertible debt securities[182]. - The company expects to satisfy short-term and long-term obligations through cash on hand, future equity and debt financings, and reimbursement payments[191]. Legal and Regulatory Matters - The company is not currently a party to any legal proceedings that are likely to materially affect its business or financial results[204]. - The company has a full valuation allowance on net deferred tax assets due to uncertainty of future taxable income[196]. - The company has not triggered any milestone or royalty payments as of the date of the report[187]. Miscellaneous - As of June 30, 2024, the company had cash and cash equivalents of $41.4 million, sufficient to fund operations for at least twelve months[162]. - As of June 30, 2024, the company had 5,665,838 Series A Warrants outstanding, with an initial exercise price of $4.4795 per share[172]. - The company has no significant cash flows from investing activities during the reported periods[178]. - Research and development expenses related to the development of PS are fully reimbursed by Viatris[183]. - The company has potential milestone payments totaling up to $11 million and sales milestone payments of up to $20 million under the Apexian Sublicense Agreement[186]. - The company has a non-cancellable operating lease with a base rent of $3,000 per month expiring on December 31, 2024[185]. - The company recognizes license and collaborations revenue based on the stand-alone price of each performance obligation[194].

Company Performance - Ocuphire Pharma reported a quarterly loss of $0.30 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.29, and compared to a loss of $0.24 per share a year ago, indicating a decline in performance [1] - The company posted revenues of $1.11 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 38.22%, and down from $3.67 million in the same quarter last year [2] - Over the last four quarters, Ocuphire Pharma has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [2] Stock Performance - Ocuphire Pharma shares have lost approximately 45% since the beginning of the year, contrasting with the S&P 500's gain of 12.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.29 on revenues of $1.89 million, and for the current fiscal year, it is -$1.16 on revenues of $7.34 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Ocuphire Pharma belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Ocuphire Pharma's stock performance [5]

Exhibit 99.1 Ocuphire Pharma Announces Financial Results for Second Quarter 2024 and Provides Corporate Update VEGA-3 Phase 3 Study of Phentolamine Ophthalmic Solution in Presbyopia is Recruiting Patients with Top-Line Data Expected in 2025 LYNX-2 Phase 3 Study of Phentolamine Ophthalmic Solution Continues Enrollment with Top-Line Data Expected in 2025 Preparatory Steps Towards Phase 2/3 with APX3330 in Diabetic Retinopathy are Ongoing Cash Position of $41.4 million Provides Runway Anticipated into mid-2025 ...

Diabetic retinopathy (DR) affects approximately 10 million of the 38 million Americans with diabetes and is the leading cause of blindness in working-age adults. DR is projected to impact over 14 million Americans by 2050. DR is classified as either non-proliferative DR (NPDR), the early stage of the disease in which symptoms may be mild or non-existent, and proliferative (PDR), the more advanced stage of diabetic eye disease that can be highly symptomatic and is associated with loss of vision. Approximatel ...

CEO to participate in ARVO SIG panel on oral medications for retinal diseases FARMINGTON HILLS, Mich., July 10, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced it will participate in the Association for Research in Vision and Ophthalmology Special Interest Group (ARVO SIG) panel and the ...

FARMINGTON HILLS, Mich., June 06, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) ("Ocuphire"), a clinical-stage biopharmaceutical company focused on developing small molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced that clinical updates on the Company's lead candidate APX3330 for diabetic retinopathy (DR) will be featured in upcoming presentations at the Clinical Trials at the Summit meeting on June 8 in Park City, Utah, and the Retin ...

FARMINGTON HILLS, Mich., June 06, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) ("Ocuphire"), a clinical-stage biopharmaceutical company focused on developing small molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced that clinical updates on the Company's lead candidate APX3330 for diabetic retinopathy (DR) will be featured in upcoming presentations at the Clinical Trials at the Summit meeting on June 8 in Park City, Utah, and the Retin ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ________ Commission File Number: 001-34079 Ocuphire Pharma, Inc. (Exact name of Registrant as specified in its charter) Delaware 11-3516358 (State or Other Juris ...

FARMINGTON HILLS, Mich., May 10, 2024 (GLOBE NEWSWIRE) – Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing small molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update. "Ocuphire has made significant progress in 2024, with important developments for both APX3330 and RYZUMVI™," said George Magrath, M. ...