Ocuphire Pharma Announces Financial Results for Second Quarter 2024 and Provides Corporate Update
Rhea-AI Summary
Ocuphire Pharma (Nasdaq: OCUP) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. VEGA-3 Phase 3 study of phentolamine ophthalmic solution for presbyopia is recruiting patients, with top-line data expected in 2025.
2. LYNX-2 Phase 3 study for dim light disturbances continues enrollment, with top-line data expected in 2025.
3. Preparations for Phase 2/3 study of APX3330 in diabetic retinopathy are ongoing.
4. Cash position of $41.4 million, providing runway into mid-2025.
5. Q2 2024 revenue was $1.1 million, including a $19,000 royalty payment from RYZUMVI™ sales.
6. Net loss for Q2 2024 was $7.8 million or $(0.30) per share.
Positive
- VEGA-3 Phase 3 study for presbyopia and LYNX-2 Phase 3 study for dim light disturbances are progressing with expected top-line data in 2025
- Strong cash position of $41.4 million, providing runway into mid-2025
- Received first royalty payment of $19,000 from RYZUMVI™ sales
Negative
- Net loss increased to $7.8 million in Q2 2024 from $5.0 million in Q2 2023
- License and collaborations revenue decreased to $1.1 million in Q2 2024 from $3.7 million in Q2 2023
- Research and development expenses increased to $6.1 million in Q2 2024 from $4.7 million in Q2 2023
Insights
Ocuphire Pharma's Q2 2024 results reveal a mixed financial picture. The company's cash position of
Ocuphire's pipeline progress is encouraging, particularly for APX3330 in diabetic retinopathy (DR). The ongoing discussions with the FDA regarding the Special Protocol Assessment for Phase 2/3 trials indicate regulatory engagement. The potential for APX3330 to be the first non-invasive, early treatment for DR is significant, addressing a large untreated patient population. For phentolamine ophthalmic solution, the initiation of the VEGA-3 Phase 3 trial in presbyopia and strong enrollment in the LYNX-2 Phase 3 study for dim light disturbances post-keratorefractive surgery are positive developments. However, with top-line data for both studies expected in 2025, investors should be prepared for a wait before potential commercialization.
The ophthalmic market presents significant opportunities for Ocuphire. Presbyopia affects millions globally and the lack of non-invasive treatments creates a substantial market potential for phentolamine ophthalmic solution. Similarly, the dim light disturbances market is underserved, offering another niche opportunity. For APX3330, targeting early-stage diabetic retinopathy could be a game-changer, potentially expanding the treatable patient pool significantly. However, the company faces challenges with increased R&D costs and declining revenue. The partnership for phentolamine development helps offset costs, but Ocuphire needs to carefully manage its cash burn rate to reach key milestones in 2025 without additional financing.
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
FARMINGTON HILLS, Mich., Aug. 13, 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 financial results for the second quarter ended June 30, 2024, and provided a corporate update.
“APX3330 has potential to be the first non-invasive, early treatment to delay vision-threatening complications in millions of patients with non-proliferative diabetic retinopathy (“DR”) who otherwise remain untreated, and we are pleased with the progress on our preparations for the next clinical study. We continue to work collaboratively with the U.S. Food and Drug Administration (the “FDA”) on our submitted Special Protocol Assessment (“SPA”) for Phase 2/3 and the overall clinical development plan for APX3330,” said George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire.
Dr. Magrath continued, “We are also making progress on additional indications for phentolamine ophthalmic solution. The VEGA-3 Phase 3 trial in presbyopia, funded by our commercial partner, has begun recruiting. Phentolamine ophthalmic solution has demonstrated a differentiated product profile in prior presbyopia studies, and we believe it could be a promising and convenient treatment option for the growing number of people with this condition. The LYNX-2 Phase 3 study in dim light disturbances (“DLD”) has seen strong enrollment and could provide a differentiated product for patients.”
Clinical and Regulatory Updates
APX3330
- Data from studies with APX3330 in DR were featured at multiple medical meetings throughout the second quarter, including at the Association for Research in Vision and Ophthalmology Special Interest Group panel, the American Society of Retina Specialists 42nd Annual Scientific Meeting, the Clinical Trials at the Summit meeting and the Retinal Imaging Biomarkers & Endpoints Summit meeting. Presentations featured results from a subset analysis that evaluated the efficacy of APX3330 in slowing DR progression using a binocular DR severity person-level scale in high-risk non-proliferative DR patients.
- Discussions with the FDA are ongoing regarding the SPA and the development pathway of APX3330 for the treatment of DR.
Phentolamine Ophthalmic Solution
- The VEGA-3 Phase 3 trial evaluating phentolamine ophthalmic solution
0.75% for the treatment of presbyopia is now recruiting. This randomized, double-masked, placebo-controlled, multi-center Phase 3 trial is expected to enroll up to 545 subjects with presbyopia at up to 40 U.S. sites. Participants will be randomized 3:2 to receive phentolamine ophthalmic solution0.75% or placebo. The primary endpoint is the percentage of subjects with 15-letter improvement in photopic binocular distance-corrected near visual acuity (DCNVA) on the eighth day following their first visit. Topline results are expected in 2025. - Enrollment has been strong for the LYNX-2 Phase 3 registration study evaluating phentolamine ophthalmic solution
0.75% for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery. The LYNX-2 trial is being conducted under conditions of an SPA with the FDA. - The Company is also planning an additional Phase 3 study for decreased vision under mesopic (low) light conditions following keratorefractive surgery, LYNX-3, in 2024.
- The phentolamine ophthalmic solution
0.75% development portfolio is being funded by Ocuphire’s partner in both indications (presbyopia and dim light vision disturbances).
Financial Highlights for the Second Quarter Ended June 30, 2024
As of June 30, 2024, Ocuphire had cash and cash equivalents of
License and collaborations revenue was
General and administrative expenses for the three months ended June 30, 2024 were
Research and development expenses for the three months ended June 30, 2024 were
Net loss for the quarter ended June 30, 2024, was
For further details on Ocuphire’s financial results, including results for the six-month period ended June 30, 2024, refer to the Company’s Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission.
About Ocuphire Pharma
Ocuphire Pharma, Inc. (Nasdaq: OCUP) is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing novel therapies for the treatment of patients with retinal and refractive eye disorders. Ocuphire’s lead product candidate, APX3330, a novel small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein), is in development for diabetic retinopathy. In addition, Ocuphire’s late-stage product candidate Phentolamine Ophthalmic Solution
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 applications of phentolamine ophthalmic solution
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 and in subsequent filings with the U.S. Securities and Exchange Commission. 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.
These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation:
- The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts;
- Regulatory requirements or developments;
- Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways;
- Delays or difficulties in the enrollment of patients in clinical trials;
- Substantial competition and rapid technological change;
- Our development of sales and marketing infrastructure;
- Future revenue losses and profitability;
- Our relatively short operating history;
- Changes in capital resource requirements;
- Risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs;
- Domestic and worldwide legislative, regulatory, political and economic developments;
- Employee misconduct;
- Changes in market opportunities and acceptance;
- Reliance on third-parties;
- Future, potential product liability and securities litigation;
- System failures, unplanned events, or cyber incidents;
- The substantial number of shares subject to potential issuance associated with our equity line of credit arrangement;
- Risks that our partnership with our commercial partner, or our other licensing arrangements, may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates;
- Future fluctuations in the market price of our common stock;
- The success and timing of commercialization of any of Ocuphire’s product candidates; and
- Obtaining and maintaining Ocuphire’s intellectual property rights.
The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. 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 SEC that advise interested parties of the risks and factors that may affect our business. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contacts
| Corporate | Investor Relations |
| Nirav Jhaveri, MBA CFO ir@ocuphire.com | Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com |
| Ocuphire Pharma, Inc. Condensed Balance Sheets (in thousands, except share amounts and par value) | ||||||||
| As of | ||||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 41,409 | $ | 50,501 | ||||
| Accounts receivable | 1,358 | 926 | ||||||
| Contract assets and unbilled receivables | 948 | 1,407 | ||||||
| Prepaids and other assets | 1,114 | 1,099 | ||||||
| Short-term investments | 5 | 15 | ||||||
| Total current assets | 44,834 | 53,948 | ||||||
| Property and equipment, net | — | — | ||||||
| Total assets | $ | 44,834 | $ | 53,948 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 634 | $ | 2,153 | ||||
| Accrued expenses | 3,490 | 1,815 | ||||||
| Derivative liability | 74 | 74 | ||||||
| Total current liabilities | 4,198 | 4,042 | ||||||
| Total liabilities | 4,198 | 4,042 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value | — | — | ||||||
| Common stock, par value | 3 | 2 | ||||||
| Additional paid-in capital | 136,970 | 131,370 | ||||||
| Accumulated deficit | (96,337 | ) | (81,466 | ) | ||||
| Total stockholders’ equity | 40,636 | 49,906 | ||||||
| Total liabilities and stockholders’ equity | $ | 44,834 | $ | 53,948 | ||||
| Ocuphire Pharma, Inc. Condensed Statements of Comprehensive Loss (in thousands, except share and per share amounts) (Unaudited) | ||||||||||||||||
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| License and collaborations revenue | $ | 1,112 | $ | 3,674 | $ | 2,823 | $ | 5,423 | ||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative | 3,354 | 4,340 | 8,024 | 6,625 | ||||||||||||
| Research and development | 6,086 | 4,723 | 10,835 | 10,318 | ||||||||||||
| Total operating expenses | 9,440 | 9,063 | 18,859 | 16,943 | ||||||||||||
| Loss from operations | (8,328 | ) | (5,389 | ) | (16,036 | ) | (11,520 | ) | ||||||||
| Other income, net | 563 | 428 | 1,165 | 768 | ||||||||||||
| Loss before income taxes | (7,765 | ) | (4,961 | ) | (14,871 | ) | (10,752 | ) | ||||||||
| Benefit (provision) for income taxes | — | — | — | — | ||||||||||||
| Net loss | (7,765 | ) | (4,961 | ) | (14,871 | ) | (10,752 | ) | ||||||||
| Other comprehensive loss, net of tax | — | — | — | — | ||||||||||||
| Comprehensive loss | $ | (7,765 | ) | $ | (4,961 | ) | $ | (14,871 | ) | $ | (10,752 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.30 | ) | $ | (0.24 | ) | $ | (0.59 | ) | $ | (0.51 | ) | ||||
| Number of shares used in per share calculations: | ||||||||||||||||
| Basic and diluted | 25,827,265 | 20,959,807 | 25,175,596 | 20,949,763 | ||||||||||||
FAQ
What were Ocuphire Pharma's (OCUP) Q2 2024 financial results?
When are top-line results expected for Ocuphire's (OCUP) VEGA-3 and LYNX-2 Phase 3 studies?
What is the status of Ocuphire's (OCUP) APX3330 development for diabetic retinopathy?
How much royalty did Ocuphire Pharma (OCUP) receive from RYZUMVI™ sales in Q2 2024?
