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. ...

FARMINGTON HILLS, Mich., May 03, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of retinal and refractive eye disorders, today announced that George Magrath, M.D. M.B.A., M.S., Chief Executive Officer of Ocuphire, will present a company overview at the Aegis Virtual Conference being held May 7-9, 2024. Company management will also be participating in one-on-one meetings throughout the conference ...

FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the Fiscal Year Ended December 31, 2023 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-34079 Ocuphire Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3516358 (State or other jurisdiction of i ...

FARMINGTON HILLS, Mich., March 8, 2024 (GLOBE NEWSWIRE) – Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update. "Ocuphire had a successful 2023, with notable achievements on the regulatory and development fronts, paving the way fo ...

Ocuphire Pharma, Inc. Corporate Update Call Summary Company Overview - **Company**: Ocuphire Pharma, Inc. (NASDAQ: OCUP) - **Date of Call**: December 5, 2023 - **Participants**: - Dr. George Magrath - CEO - Michael Wood - LifeSci Advisors - Charlie Hoffmann - SVP of Corporate Development - Ronil Patel - Chief Business Officer Key Points Industry and Company Focus - Ocuphire is focused on the ophthalmology sector, particularly in developing treatments for diabetic retinopathy, which is a leading cause of blindness in working-age Americans [9][12][14]. - The company has two main ophthalmic assets, with a strong emphasis on APX3330, an oral treatment for non-proliferative diabetic retinopathy [10][11]. Leadership and Strategy - Dr. George Magrath, the newly appointed CEO, has extensive experience in ophthalmology and drug development, previously leading Lexitas Pharma Services [6][8]. - The immediate priority is to develop and implement a strategy to advance Ocuphire's assets, particularly APX3330, towards commercialization [10][18]. Product Development and Clinical Trials - APX3330 has shown promise in treating diabetic retinopathy and is expected to enter Phase 3 trials in the second half of 2024 [15][17]. - The FDA has agreed on the primary endpoint for the Phase 3 trials, focusing on a three-step worsening on a binocular diabetic retinopathy severity scale [15][34]. - The company aims to address the significant market of approximately 8 million patients in the U.S. with progressive diabetic retinopathy who are currently asymptomatic [14][25]. Market Opportunity - There is a compelling commercial opportunity for APX3330, as current treatments involve invasive injections that many patients are reluctant to receive [14][20]. - The oral formulation of APX3330 is expected to be well-received due to its convenience compared to intravitreal injections [21][23]. Financial Position - As of September 30, 2023, Ocuphire reported over $42 million in cash and no debt, with a $10 million milestone payment received from Viatris [17]. - The company anticipates that its current financial position will support operations into 2025 while exploring additional financing options for further development [17]. Management and Team Development - The company is in the process of filling key management positions, including a Chief Medical Officer and a Chief Financial Officer, to strengthen its leadership team [16][18]. Future Outlook - Ocuphire is committed to advancing its pipeline and engaging with the investment community to provide updates on its progress [18][40]. - The strategic focus includes not only the development of APX3330 but also potential partnerships with large pharmaceutical companies interested in the product [17][31]. Additional Insights - The company is exploring the potential systemic benefits of APX3330 beyond ophthalmology, considering its implications for broader diabetic complications [28][31]. - Market research indicates a favorable reception for oral therapies in ophthalmology, as evidenced by the acceptance of AREDS vitamins among patients with intermediate dry AMD [24][25]. This summary encapsulates the critical insights and strategic direction of Ocuphire Pharma as discussed during the corporate update call.

(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q 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 J ...

Washington, DC 20549 Form 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 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 Jurisd ...

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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 Delaware 11-3516358 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification Number) 37000 Grand River Avenue, Suite 120 (Address of Principal Executive Offi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2022 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-34079 Ocuphire Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3516358 (State or other jurisdiction of i ...

[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%201%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $4.5 million for Q3 2022 and $16.1 million for the nine months ended September 30, 2022, with cash and cash equivalents decreasing to $13.9 million by September 30, 2022, primarily due to operating activities [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Balance Sheet Highlights (in thousands) | Balance Sheet Highlights (in thousands) | Sep 30, 2022 (unaudited) | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,855 | $24,534 | | Total current assets | $14,561 | $26,067 | | **Total assets** | **$14,568** | **$26,077** | | **Liabilities & Equity** | | | | Total current liabilities | $2,691 | $3,855 | | **Total liabilities** | **$2,691** | **$3,855** | | Total stockholders' equity | $11,877 | $22,222 | | **Total liabilities and stockholders' equity** | **$14,568** | **$26,077** | [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Income Statement Highlights (in thousands, except per share) | Income Statement Highlights (in thousands, except per share) | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | **2022** | **2021** | **2022** | **2021** | | Collaborations revenue | $0 | $489 | $0 | $589 | | General and administrative | $1,703 | $1,595 | $5,215 | $6,707 | | Research and development | $2,835 | $3,126 | $10,769 | $10,437 | | Loss from operations | $(4,538) | $(4,232) | $(15,984) | $(16,555) | | **Net loss** | **$(4,531)** | **$(4,230)** | **$(16,053)** | **$(50,380)** | | **Net loss per share (basic and diluted)** | **$(0.22)** | **$(0.25)** | **$(0.82)** | **$(3.64)** | - The significant net loss in the nine months ended Sep 30, 2021, was primarily driven by a **$33.8 million** non-cash expense related to the fair value change of warrant liabilities, which did not recur in 2022[12](index=12&type=chunk)[168](index=168&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,477) | $(13,724) | | Net cash used in investing activities | $0 | $0 | | Net cash provided by financing activities | $3,798 | $19,575 | | **Net (decrease) increase in cash** | **$(10,679)** | **$5,851** | | Cash and cash equivalents at end of period | $13,855 | $22,250 | - Net cash from financing activities in 2022 primarily came from the at-the-market (ATM) program (**$4.4 million** gross proceeds)[16](index=16&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk) In contrast, 2021 financing activities were significantly higher due to proceeds from a Registered Direct Offering (**$15.0 million**) and the ATM program (**$5.8 million**) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on its two clinical-stage ophthalmic product candidates, Nyxol® and APX3330, reporting a net loss of $16.1 million for the first nine months of 2022, and noting a going concern uncertainty despite sufficient funds into Q4 2023 [Overview and Recent Developments](index=27&type=section&id=Overview%20and%20Recent%20Developments) - **Nyxol® (phentolamine mesylate):** The lead product candidate, a once-daily eye drop, with an anticipated NDA submission to the FDA in Q4 2022 for the Reversal of Mydriasis (RM) indication[125](index=125&type=chunk) - **APX3330:** The second product candidate, an oral tablet for diabetic retinopathy (DR) and diabetic macular edema (DME), with top-line results from the ZETA-1 Phase 2b trial expected in early 2023[126](index=126&type=chunk)[127](index=127&type=chunk)[131](index=131&type=chunk) - **Presbyopia Program:** The company submitted a Phase 3 protocol (VEGA-2) to the FDA for Nyxol for presbyopia, with trial initiation anticipated in Q4 2022[132](index=132&type=chunk) - **Regulatory Update:** The FDA granted a small business waiver for the **$3.1 million** PDUFA fee for the Nyxol NDA submission[136](index=136&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Operating Results Comparison (in thousands) | Operating Results Comparison (in thousands) | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | **2022 vs 2021** | **2022 vs 2021** | | Collaborations Revenue | $(489) | $(589) | | General & Administrative Expenses | $108 | $(1,492) | | Research & Development Expenses | $(291) | $332 | | **Net Loss** | **$(301)** | **$34,327** | - G&A expenses for the nine months ended Sep 30, 2022 decreased by **$1.5 million** compared to the prior year, primarily due to a one-time **$1.6 million** non-cash settlement with investors in 2021[166](index=166&type=chunk) - R&D expenses for Q3 2022 decreased by **$0.3 million** compared to Q3 2021, mainly due to the completion of certain clinical trials and the timing of manufacturing activities for Nyxol and APX3330[160](index=160&type=chunk) - The significant decrease in net loss for the nine-month period is primarily due to a **$33.8 million** non-cash fair value change in warrant liabilities recorded in 2021, which did not recur in 2022[164](index=164&type=chunk)[168](index=168&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2022, the company had cash and cash equivalents of **$13.9 million**[173](index=173&type=chunk) - Management believes current cash will be sufficient to fund operations into the fourth quarter of 2023, but the company's financial statements include a going concern warning, indicating substantial doubt about its ability to continue without raising additional capital[173](index=173&type=chunk)[201](index=201&type=chunk) - Through September 30, 2022, the company has raised **$17.9 million** in gross proceeds from its At-The-Market (ATM) program established in March 2021[175](index=175&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company is a smaller reporting company - Not applicable for smaller reporting companies[223](index=223&type=chunk) [Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2022, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of September 30, 2022, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[226](index=226&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended September 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[227](index=227&type=chunk) [PART II – OTHER INFORMATION](index=48&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any legal proceedings that management believes are likely to have a material adverse effect on the business[229](index=229&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2021 - Risk factors have not changed materially from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2021[230](index=230&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) None reported for the period - None[231](index=231&type=chunk) [Defaults Upon Senior Securities](index=48&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None reported for the period - None[232](index=232&type=chunk) [Mine Safety Disclosures](index=48&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable to our Company[234](index=234&type=chunk) [Other Information](index=49&type=section&id=Item%205.%20Other%20Information) None reported for the period - None[235](index=235&type=chunk) [Exhibits](index=50&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, a lease amendment, and certifications by the Principal Executive Officer and Principal Financial Officer - A Fourth Lease Amendment, dated October 17, 2022, was filed as an exhibit[236](index=236&type=chunk) - Certifications pursuant to Section 302 and 906 of the Sarbanes-Oxley Act of 2002 were filed[236](index=236&type=chunk)