On November 4, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, announces financial results for the third quarter ended September 30, 2022 and provides a corporate update (Press release, Ocuphire Pharma, NOV 4, 2022, View Source [SID1234623106]).
"During the third quarter, Ocuphire continued to execute elements of our strategic plan to bring innovative treatments to patients with highly prevalent refractive and diabetic retinal diseases," said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma. "With enrollment and 24-week treatment completed in over 100 patients in our ZETA-1 Phase 2b trial of APX3330, we look forward to sharing topline results in early 2023, bringing us closer to delivering a potential oral option for diabetic retinopathy patients. We are on track for NDA submission for Nyxol for reversal of mydriasis in the fourth quarter 2022. We have strong momentum and are poised to deliver on multiple catalysts going forward that we believe will create significant value for our company and shareholders."
Key Anticipated Future Milestones
Reversal of Mydriasis (RM): Plan to submit New Drug Application (NDA) with the FDA for Nyxol in RM indication in Q4 2022, with potential approval and commercial launch as first dilation reversal drop in 2023.
Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Plan to report top-line results from the ZETA-1 Phase 2b trial of APX3330 in early 2023. APX3330 is a novel oral therapy with a dual mechanism of action in validated pathways, decreasing both abnormal angiogenesis and inflammation.
Presbyopia: Plan to initiate VEGA-2 Phase 3 trial in Q4 2022 investigating Nyxol alone and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive therapy. In addition, VEGA-3 (2nd Phase 3) and LYRA-1 (1-year safety) trials are planned to begin in 2023.
Third Quarter and Recent Business Highlights
Clinical and Regulatory Development
In September, the Company announced that the last of the 103 enrolled patients in the ZETA-1 Phase 2b trial of oral APX3330 for the treatment of diabetic retinopathy (DR) completed the final visit of the 24-week study.
In September, the Company announced that U.S. Food and Drug Administration (FDA) has granted a small-business waiver of the Prescription Drug User Fee Act (PDUFA) fee of $3.1 million for the 505(b)(2) NDA for Nyxol.
Presentations, Publications, and Conferences
Year to date, Ocuphire was represented at multiple key ophthalmological conferences with updates on Nyxol in RM, presbyopia and night vision disturbances, as well as masked safety data for APX3330 in DR. In total, more than 25 papers, posters, and panel talks were presented over 20 medical and industry conferences. Highlights in October and early November 2022:
Mitchell Jackson, MD presented a poster highlighting presbyopia data at the American Academy of Ophthalmology Annual Meeting in Chicago, IL.
Prominent optometry thought leaders and clinical trial investigators Justin Schweitzer, OD, Mitch Ibach, OD, Leslie O’Dell, OD, Shane Foster, OD, Doug , Devries, OD and Shane Kannarr, OD presented six posters on Nyxol and APX3330 at the American Academy of Optometry Annual Meeting in San Diego, CA.
The Company announced publication of an earlier Phase 2 clinical trial in patients with severe night vision disturbances in the BMC Ophthalmology peer-reviewed journal. The publication can be accessed here.
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In October, the Company held a Key Opinion Leader (KOL) webinar on oral APX3330. The event featured presentations by KOLs Peter Kaiser, MD, from the Cleveland Clinic, Caroline Baumal, MD, from Tufts Medical Center, and David Lally, MD, from New England Retina Consultants. KOL. The discussion highlighted the unmet need and current treatment landscape for DR/DME and included new data on study demographics and 24-week masked safety data from the ZETA-1 trial. A replay of the event can be found on the company’s corporate website here.
Corporate
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On August 2, 2022, Ocuphire was granted extended intellectual property protection for Nyxol with the issuance of U.S. Patent No. 11,400,077 with claims directed to methods for mydriasis treatment using phentolamine, extended by 5 years into 2039.
In September, the Company appointed seven new Key Opinion Leaders (KOLs) across retina, cornea/refractive, and medical optometry to its Medical Advisory Board (MAB): Anat Loewenstein, MD, PhD, Caroline Baumal, MD, Zaina Al-Mohtaseb, MD, Inder Paul Singh, MD, Leslie O’Dell, OD, Selina McGee, OD, Justin Schweitzer, OD.
Third Quarter Ended September 30, 2022, Financial Highlights
As of September 30, 2022, Ocuphire had cash and cash equivalents of approximately $13.9 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations into the fourth quarter of 2023. Net cash used in operating activities in the third quarter of 2022 was $4.5 million, with a cumulative total for the nine months ended September 30, 2022, of $14.5 million.
General and administrative expenses for the three and nine months ended September 30, 2022, were $1.7 million and $5.2 million, respectively, compared to $1.6 million and $6.7 million, respectively, for the three and nine months ended September 30, 2021. The increase from the comparable quarter in 2021 was largely attributed to an increase in legal costs on a net basis. The decrease from the comparable nine months in 2021 was largely attributed to a non-cash settlement with certain investors in the comparable prior year period, offset by a slight increase in general and administrative expenses attributed to higher payroll and other operating costs in the current year period when compared to the comparable prior year period.
Research and development expenses for the three and nine months ended September 30, 2022, were $2.8 million and $10.8 million, respectively, compared to $3.1 million and $10.4 million, respectively, for the three and nine months ended September 30, 2021. The decrease from the comparable quarter in 2021 was primarily attributable to the completion of clinical trials and the timing of manufacturing activities for Nyxol and APX3330. The increase from the comparable nine months in 2021 was primarily attributable to the timing of clinical trials and manufacturing activities for Nyxol and APX3330 as well as regulatory, preclinical and other development activities.
The total loss from operations for the three and nine months ended September 30, 2022, was $4.5 million and $16.0 million, respectively, compared to $4.2 million and $16.6 million, respectively, for the three and nine months ended September 30, 2021.
Net loss for the three and nine months ended September 30, 2022, was $4.5 million and $16.1 million, respectively, compared to $4.2 million and $50.4 million, respectively, for the three and nine months ended September 30, 2021. Net loss per share for the three and nine months ended September 30, 2022, was ($0.22) and ($0.82) per share, respectively, compared to ($0.25) and ($3.64) per share, respectively, for the comparable periods in 2021.
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, 2022, to be filed with the Securities and Exchange Commission.