On November 13, 2023 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, reported financial results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Ocuphire Pharma, NOV 13, 2023, View Source [SID1234637559]).
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"We achieved important regulatory and clinical milestones in recent months, particularly in advancing oral APX3330 towards a registrational Phase 3 program in diabetic retinopathy," said Chief Executive Officer George Magrath, M.D., M.B.A., M.S., "We now have agreement with the FDA on the Phase 3 primary endpoint of 3-step worsening (measuring delay or prevention of progression) on a binocular Diabetic Retinopathy Severity Scale, and plan to finalize the protocol and statistical analysis plan with the FDA through a Special Protocol Assessment submission. If approved, APX3330 has the potential to be the first non-invasive, early treatment to delay or prevent vision-threatening complications in millions of patients with non-proliferative DR. We are very pleased to have recently received FDA approval of RYZUMVI (phentolamine ophthalmic solution) 0.75% eye drops for the reversal of pharmacologically induced mydriasis and look forward to our partner Viatris’ commercial launch in the first half of 2024. We are also excited to share that the VEGA-2 Phase 3 trial in presbyopia met its primary endpoint, and Viatris is expected to continue the Phase 3 development in the first half of 2024."
Key Anticipated Future Milestones
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APX3330: Special Protocol Assessment ("SPA") submission and agreement with U.S. Food and Drug Administration ("FDA")
Recent Business Highlights
Clinical and Regulatory Updates
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In October 2023, Ocuphire had a successful End-of-Phase 2 ("EOP2") meeting with the FDA for oral APX3330 in Diabetic Retinopathy and agreed on the Phase 3 primary endpoint of 3-step worsening (measuring delay or prevention of progression) on a binocular diabetic retinopathy severity scale. The Company plans to submit a SPA to the FDA to agree on the protocol and statistical analysis plan of the first Phase 3 trial.
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In September 2023, Ocuphire and Viatris announced FDA approval of RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). Ocuphire received a $10 million milestone payment from Viatris upon the approval. RYZUMVI is expected to be commercially available in the U.S. in the first half of 2024.
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The VEGA-2 Phase 3 study evaluating phentolamine ophthalmic solution 0.75% in presbyopia achieved its primary endpoint. Viatris is expected to continue Phase 3 development for this indication in the first half of 2024.
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The Company has submitted a SPA to the FDA for night vision disturbances or dim light vision and Viatris is expected to continue Phase 3 development of phentolamine ophthalmic solution 0.75% for this indication in the first half of 2024.
Corporate
On August 10, 2023, Ocuphire entered into a common share purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"). Subject to the terms and conditions of the purchase agreement, Ocuphire has the right to sell, and LPC is obligated to purchase, up to $50 million of Ocuphire’s common shares over a 30-month period at prices per share as computed under the purchase agreement. Ocuphire, in its sole discretion, controls the timing and amount of all sales of common shares within a pre-specified range. There are no warrants or other share classes associated with the purchase agreement. Proceeds from share sales are expected to fund the future development of APX3330 and to be used for general corporate purposes.
Presentations, Publications, and Conferences
Beginning in the third quarter of 2023, several presentations at medical meetings featured previously announced data from the ZETA-1 Phase 2 trial of APX3330 in diabetic retinopathy. Highlights include:
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A presentation at the Eyecelerator American Academy of Ophthalmology 2023 Retina Showcase by Jay Pepose, M.D. Ph.D., Chief Medical Advisor, highlighting the agreement of Phase 3 registration endpoint at the EOP2 FDA meeting.
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A paper presentation delivered by Veeral Sheth, M.D., at the 23rd Euretina Congress in October 2023.
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An oral presentation delivered by Anat Lowenstein, M.D., at the 56th Annual Retina Society Scientific Meeting in October 2023.
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An oral presentation delivered by Priya Vakharia, M.D., at the Women in Ophthalmology Summer Symposium in August 2023. The abstract was rated as one of the top three scoring abstracts out of nearly 600 submissions and received the Joanne Angle Abstract of Distinction Award.
Third Quarter ended September 30, 2023, Financial Highlights
As of September 30, 2023, Ocuphire had cash and cash equivalents of approximately $42.4 million. Based on current projections, management believes the present cash on hand will be sufficient to fund operations into 2025.
License and collaborations revenue was $11.9 million and $17.4 million for the three and nine months ended September 30, 2023, respectively. There was no license and collaborations revenue during the three and nine months ended September 30, 2022. Revenue during the three and nine months ended September 30, 2023, was derived from the achievement of a $10.0 million milestone attributed to the FDA’s approval of RYZUMVI for reversal of mydriasis and from the reimbursement of research and development services under the License Agreement with Viatris in the amount of $1.9 and $7.4 million, respectively.
General and administrative expenses for the three and nine months ended September 30, 2023, were $2.1 million and $8.7 million, respectively, compared to $1.7 million and $5.2 million, respectively, for the three and nine months ended September 30, 2022. The increases from the comparable periods in 2022 were attributable to professional services and personnel related and other costs. General and administrative expenses included stock-based compensation expenses.
Research and development expenses for the three and nine months ended September 30, 2023, were $3.5 million and $13.8 million, respectively, compared to $2.8 million and $10.8 million, respectively, for the three and nine months ended September 30, 2022. The increases from the comparable periods in 2022 were primarily attributable to increased drug manufacturing, toxicology services and payroll and consulting related costs. Research and development expenses also included stock-based compensation expenses.
Income (loss) from operations for the three and nine months ended September 30, 2023, was $6.4 million and ($5.1) million, respectively, compared ($4.5) million and ($16.0) million, respectively, for the three and nine months ended September 30, 2022.
Net income (loss) for the three and nine months ended September 30, 2023, was $5.6 million and ($5.2) million, respectively, compared to ($4.5) million and ($16.1) million, respectively, for the three and nine months ended September 30, 2022. Basic net income (loss) per share for the three and nine months ended September 30, 2023, was $0.26 and ($0.25) per share, respectively, compared to ($0.22) and ($0.82) per share, respectively, for the three and nine months ended September 30, 2022.
For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, to be filed with the Securities and Exchange Commission.
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