Ocuphire Pharma Announces Financial Results for First Quarter 2022 and Provides Corporate Update
Nyxol Posts 5 Positive Clinical Data Readouts Including Presbyopia in Last 12 Months
Successfully Enrolled 4 Late-Stage Trials for Nyxol and APX3330 in First Quarter
NDA Filing on Track for Late 2022 for Potential 2023 Approval of Nyxol as Only Dilation Reversal Drop
Data Expected in 2H22 from Phase 2b Trial of Oral APX3330 for Diabetic Retinopathy
FARMINGTON HILLS, Mich., May 13, 2022 (GLOBE NEWSWIRE) -- 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, today announced financial results for the first quarter ended March 31, 2022 and provided a corporate update.
“We have kicked off 2022 with a high level of productivity and execution resulting in multiple positive clinical data readouts across our late-stage programs,” said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma. “Year to date, we presented at 10 conferences and met with many KOLs, reinforcing the growing awareness and enthusiasm for our programs, particularly among doctors anticipating an eye drop treatment to reverse dilation. We recently reported positive data from the MIRA-3 and MIRA-4 trials, marking completion of the clinical activities to support the planned NDA filing for Nyxol in the Reversal of Mydriasis (RM) indication later this year. In our retinal program, we look forward to reporting top-line Phase 2b data in the second half of the year for APX3330, an novel oral treatment option for the large unmet need of over 7 million diabetic retinopathy patients who are generally asymptomatic with a progressive vision-threatening disease and are not routinely treated with approved anti-VEGF injections. With the approval of the first artificial-intelligence-based screening of diabetic retinal diseases, we expect an increase in the identification of DR patients.”
Key Anticipated Future Milestones
First Quarter and Recent Business Highlights
Presentations, Publications, and Conferences
First Quarter Ended March 31, 2022 Financial Highlights
As of March 31, 2022, Ocuphire had cash and cash equivalents of approximately $19.2 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations into the second quarter of 2023. Cash and cash equivalents as of March 31, 2022 was $5.3 million lower than on December 31, 2021.
General and administrative expenses were $1.7 million for each of the three months ended March 31, 2022 and March 31, 2021.
Research and development expenses for the three months ended March 31, 2022 were $4.8 million compared to $3.5 million for the three months ended March 31, 2021. The $1.3 million increase was primarily attributable to an increased activity level associated with clinical trials and manufacturing activities for Nyxol and APX3330 period over period as well as additional preclinical and other development activities during the current period.
The loss from operations for the quarter ended March 31, 2022 was $6.5 million, compared to $5.2 million for the quarter ended March 31, 2021.
Net loss for the quarter ended March 31, 2022 was $6.6 million or ($0.35) per share, compared to $39.0 million or ($3.57) per share for the quarter ended March 31, 2021 which included a non-cash fair value change in warrant liabilities of $33.8 million.
For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 to be filed with the Securities and Exchange Commission.
About Ocuphire Pharma
Ocuphire is a publicly-traded (NASDAQ: OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting refractive and retinal indications. The company’s lead product candidate, Nyxol® eye drops (0.75% phentolamine ophthalmic solution) is a once-daily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications, including reversal of pharmacologically-induced mydriasis (RM), presbyopia and dim light or night vision disturbances (NVD), and has been studied in 11 completed clinical trials. Ocuphire has reported positive data from MIRA-2 and MIRA-3 registration trials and MIRA-4 pediatric safety trial for the treatment of RM. Ocuphire also reported positive top-line data from a Phase 2 trial of Nyxol for treatment of presbyopia, both Nyxol as a single agent and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive therapy. The company recently completed enrollment in its Phase 3 trial of Nyxol for NVD (LYNX-1). Ocuphire’s second product candidate, APX3330, is an oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy (DR) and diabetic macular edema (DME) and has been studied in 11 Phase 1 and 2 trials. The company recently announced the completion of enrollment in a Phase 2b clinical trial of APX3330 to treat DR/DME (ZETA-1). Please visit www.clinicaltrials.gov to learn more about Ocuphire’s recently completed Phase 3 registration trial in RM (NCT05134974), pediatric safety study in RM (NCT05223478), Phase 3 registration trial in NVD (NCT04638660), and Phase 2b trial in DR/DME (NCT04692688). Ocuphire previously completed the first Phase 3 registration trial in RM (NCT04620213) and Phase 2 trial in presbyopia (NCT04675151). As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development, regulatory preparation, and commercialization of drugs in key global markets. For more information, visit www.ocuphire.com.
Forward Looking Statements
Corey Davis, Ph.D.
Ocuphire Pharma, Inc.
Ocuphire Pharma, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
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