Ocuphire Pharma Files 2023 Annual Report on Form 10-K

TL;DR

<b>Ocuphire Pharma, Inc. has filed its 2023 10-K report detailing its operations and financial status.</b>

AI Summary

Ocuphire Pharma, Inc. (IRD) filed a Annual Report (10-K) with the SEC on March 8, 2024. Ocuphire Pharma, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal executive offices are located at 37000 Grand River Ave., Suite 120, Farmington Hills, MI 48335. Ocuphire Pharma, Inc. was formerly known as Rexahn Pharmaceuticals, Inc. and Corporate Road Show Dot Com Inc. The company operates in the Pharmaceutical Preparations industry (SIC code 2834).

Why It Matters

For investors and stakeholders tracking Ocuphire Pharma, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Ocuphire Pharma's business, financial condition, and risk factors for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. Understanding the company's historical structure, including its former names, offers context for its evolution and potential strategic shifts.

Risk Assessment

Risk Level: medium — Ocuphire Pharma, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and high R&D costs, posing inherent risks to financial performance and market success.

Analyst Insight

Investors should review the detailed risk factors and financial statements within the 10-K to understand the specific challenges and opportunities facing Ocuphire Pharma in the pharmaceutical sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-08 — Filing Date (Filed as of date)

Key Players & Entities

• Ocuphire Pharma, Inc. (company) — Filer name
• 2023 (date) — Fiscal year end
• December 31, 2023 (date) — Conformed period of report
• March 8, 2024 (date) — Filed as of date
• Farmington Hills, MI (location) — Business address city and state
• Rexahn Pharmaceuticals, Inc. (company) — Former company name
• Corporate Road Show Dot Com Inc (company) — Former company name
• 2834 (industry_code) — Standard Industrial Classification

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government agencies, which can impact product development, approval, manufacturing, and marketing.
• Financing and Liquidity Risks [high — financial]: The company may require additional financing to fund its operations and development activities, and there is no assurance that such financing will be available on favorable terms.
• Research and Development Risks [high — operational]: The success of the company depends on its ability to successfully develop and commercialize its product candidates, which involves significant risks and uncertainties.

Industry Context

Ocuphire Pharma operates within the pharmaceutical preparations sector, focusing on the development of novel therapies for ophthalmic conditions.

Regulatory Implications

The pharmaceutical sector is heavily regulated by bodies like the FDA, requiring rigorous clinical trials and adherence to strict manufacturing standards for drug approval and market access.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management discussion.
2. Analyze the risk factors section to understand potential challenges to Ocuphire Pharma's business model.
3. Research Ocuphire Pharma's product pipeline and clinical trial progress mentioned in the report.

Year-Over-Year Comparison

This filing is the annual report for the fiscal year ended December 31, 2023, superseding previous filings and providing updated financial and operational information.

Key Financial Figures

• $0.0001 — ange on which registered Common Stock, $0.0001 par value per share OCUP The Nasdaq
• $4 — ed on the closing price on that date of $4.34, was approximately $ 89,224,159 . As
• $35 million — ire received an upfront cash payment of $35 million and a $10 million license agreement mil
• $10 million — front cash payment of $35 million and a $10 million license agreement milestone payment for
• $120 m — potential additional payments of up to $120 million, in the aggregate, upon achieving
• $20 million — t activities, and simultaneously raised $20 million through an offering of common shares an

Filing Documents

• ef20015277_10k.htm (10-K) — 1932KB
• ef20015277_ex21-1.htm (EX-21.1) — 2KB
• ef20015277_ex23-1.htm (EX-23.1) — 8KB
• ef20015277_ex31-1.htm (EX-31.1) — 11KB
• ef20015277_ex31-2.htm (EX-31.2) — 12KB
• ef20015277_ex32-1.htm (EX-32.1) — 5KB
• ef20015277_ex10-5-5.htm (EX-10.5-5) — 12KB
• ef20015277_ex97.htm (EX-97) — 38KB
• image0.jpg (GRAPHIC) — 186KB
• image1.jpg (GRAPHIC) — 178KB
• image2.jpg (GRAPHIC) — 123KB
• image3.jpg (GRAPHIC) — 194KB
• image4.jpg (GRAPHIC) — 614KB
• image5.jpg (GRAPHIC) — 525KB
• image6.jpg (GRAPHIC) — 6KB
• image7.jpg (GRAPHIC) — 17KB
• 0001140361-24-012399.txt (&nbsp;) — 13290KB
• ocup-20231231.xsd (EX-101.SCH) — 72KB
• ocup-20231231_cal.xml (EX-101.CAL) — 55KB
• ocup-20231231_def.xml (EX-101.DEF) — 322KB
• ocup-20231231_lab.xml (EX-101.LAB) — 867KB
• ocup-20231231_pre.xml (EX-101.PRE) — 516KB
• ef20015277_10k_htm.xml (XML) — 1087KB

BUSINESS

BUSINESS 7 ITEM 1A.

RISK FACTORS

RISK FACTORS 44 ITEM 1B. UNRESOLVED STAFF COMMENTS 83 ITEM 1C. CYBERSECURITY 83 ITEM 2.

PROPERTIES

PROPERTIES 84 ITEM 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 84 ITEM 4. MINE SAFETY DISCLOSURES 84 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 85 ITEM 6. [RESERVED] 85 ITEM 7.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 85 ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 99 ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 100 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 100 ITEM 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 100 ITEM 9B. OTHER INFORMATION 101 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 101 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 102 ITEM 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 102 ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 102 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 102 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 102 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 103 ITEM 16. FORM 10-K SUMMARY 108

SIGNATURES

SIGNATURES Table of Contents Ocuphire Pharma, Inc. Form 10-K In this Annual Report on Form 10-K, unless otherwise specified, references to "we," "us," "our," "Ocuphire" or "the Company" mean Ocuphire Pharma, Inc. Our financial statements are prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP").

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). 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 this 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. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the U.S. Securities and Exchange Commission (the "SEC") that advise interested parties of the risks and factors that may affect our business. SUMMARY RISK FACTORS Our business is subject to a number of risks, as fully described in "Item 1A. Risk Factors" in this Annual Report. The principal factors and uncertainties include, among others: We depend heavily on the

BUSINESS

BUSINESS Overview Ocuphire Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders. The Company's lead retinal product candidate, APX3330, is a small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of transcription factors such as HIF-1 and NF-B. Inhibiting Ref-1 reduces levels of vascular endothelial growth factor ("VEGF") and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet administered once or twice per day in development for the treatment of diabetic retinopathy ("DR"). A Phase 2 study in subjects with DR or diabetic macular edema was completed and results were reported in January 2023. An End-of-Phase 2 ("EOP2") meeting with the U.S. Food and Drug Administration (the "FDA") was held in October 2023 at which the Company obtained agreement on the registration endpoint supporting the advancement of APX3330 into future clinical trials. The Company submitted a special protocol assessment ("SPA") to the FDA in February 2024 to seek agreement on the clinical trial protocol and statistical analysis plan and will share specifics on the study design parameters and anticipated timing if and when a SPA agreement is reached with the FDA. DR affects approximately 10 million diabetics and is projected to impact over 14 million Americans by 2050. DR is classified as either Non-Proliferative Diabetic Retinopathy ("NPDR"), the early stage of the disease in which symptoms may be mild or non-existent or Proliferative Diabetic Retinopathy ("PDR") which is the more advanced stage of diabetic eye disease that can be highly symptomatic with loss of vision. Approximately 8 million DR patients have NPDR that may progress to PDR, if left untreated. Despite the risk for visual loss associated with this disease, over 90% of NPDR patients

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View this 10-K filing on SEC EDGAR