Ocuphire Pharma Announces Financial Results for Third

NDA Submission for Nyxol for RM and Initiation of VEGA-2 on Track for This autumn 2022

Topline Data from ZETA-1 Phase 2b Trial of Oral APX3330 Expected in Early 2023

FARMINGTON HILLS, Mich., Nov. 04, 2022 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical firm centered on growing and commercializing therapies for the therapy of refractive and retinal eye issues, proclaims monetary outcomes for the third quarter ended September 30, 2022 and offers a company replace.

“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,” stated 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 This autumn 2022, with potential approval and business launch as first dilation reversal drop in 2023.
• Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Plan to report top-line outcomes from the ZETA-1 Phase 2b trial of APX3330 in early 2023. APX3330 is a novel oral remedy with a twin mechanism of motion in validated pathways, lowering each irregular angiogenesis and irritation. 
• Presbyopia: Plan to provoke VEGA-2 Phase 3 trial in This autumn 2022 investigating Nyxol alone and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive remedy. In addition, VEGA-3 (2^nd Phase 3) and LYRA-1 (1-year security) trials are deliberate to start in 2023.

Third Quarter and Recent Business Highlights

Clinical and Regulatory Development

• In September, the Company introduced that the final of the 103 enrolled sufferers within the ZETA-1 Phase 2b trial of oral APX3330 for the therapy of diabetic retinopathy (DR) accomplished the ultimate go to of the 24-week research.
• In September, the Company introduced that U.S. Food and Drug Administration (FDA) has granted a small-business waiver of the Prescription Drug User Fee Act (PDUFA) payment of $3.1 million for the 505(b)(2) NDA for Nyxol.

Presentations, Publications, and Conferences

• Year up to now, Ocuphire was represented at a number of key ophthalmological conferences with updates on Nyxol in RM, presbyopia and night time imaginative and prescient disturbances, in addition to masked security information for APX3330 in DR. In complete, greater than 25 papers, posters, and panel talks had been introduced over 20 medical and business conferences. Highlights in October and early November 2022:
  • Mitchell Jackson, MD introduced a poster highlighting presbyopia information on the American Academy of Ophthalmology Annual Meeting in Chicago, IL.
  • Prominent optometry thought leaders and medical trial investigators Justin Schweitzer, OD, Mitch Ibach, OD, Leslie O’Dell, OD, Shane Foster, OD, Doug , Devries, OD and Shane Kannarr, OD introduced six posters on Nyxol and APX3330 on the American Academy of Optometry Annual Meeting in San Diego, CA.
  • The Company introduced publication of an earlier Phase 2 medical trial in sufferers with extreme night time imaginative and prescient disturbances within the BMC Ophthalmology peer-reviewed journal. The publication may be accessed right here.

• In October, the Company held a Key Opinion Leader (KOL) webinar on oral APX3330. The occasion featured shows 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 dialogue highlighted the unmet want and present therapy panorama for DR/DME and included new information on research demographics and 24-week masked security information from the ZETA-1 trial. A replay of the occasion may be discovered on the corporate’s company web site right here.

Corporate

• On August 2, 2022, Ocuphire was granted prolonged mental property safety for Nyxol with the issuance of U.S. Patent No. 11,400,077 with claims directed to strategies for mydriasis therapy utilizing phentolamine, prolonged by 5 years into 2039.
• In September, the Company appointed seven new Key Opinion Leaders (KOLs) throughout 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 money and money equivalents of roughly $13.9 million. Based on present projections, administration believes the present money readily available shall be ample to fund operations into the fourth quarter of 2023. Net money utilized in working actions within the third quarter of 2022 was $4.5 million, with a cumulative complete for the 9 months ended September 30, 2022, of $14.5 million.

General and administrative bills for the three and 9 months ended September 30, 2022, had been $1.7 million and $5.2 million, respectively, in comparison with $1.6 million and $6.7 million, respectively, for the three and 9 months ended September 30, 2021. The improve from the comparable quarter in 2021 was largely attributed to a rise in authorized prices on a web foundation. The lower from the comparable 9 months in 2021 was largely attributed to a non-cash settlement with sure buyers within the comparable prior yr interval, offset by a slight improve basically and administrative bills attributed to increased payroll and different working prices within the present yr interval when in comparison with the comparable prior yr interval.

Research and improvement bills for the three and 9 months ended September 30, 2022, had been $2.8 million and $10.8 million, respectively, in comparison with $3.1 million and $10.4 million, respectively, for the three and 9 months ended September 30, 2021. The lower from the comparable quarter in 2021 was primarily attributable to the completion of medical trials and the timing of producing actions for Nyxol and APX3330. The improve from the comparable 9 months in 2021 was primarily attributable to the timing of medical trials and manufacturing actions for Nyxol and APX3330 in addition to regulatory, preclinical and different improvement actions.

The complete loss from operations for the three and 9 months ended September 30, 2022, was $4.5 million and $16.0 million, respectively, in comparison with $4.2 million and $16.6 million, respectively, for the three and 9 months ended September 30, 2021.

Net loss for the three and 9 months ended September 30, 2022, was $4.5 million and $16.1 million, respectively, in comparison with $4.2 million and $50.4 million, respectively, for the three and 9 months ended September 30, 2021. Net loss per share for the three and 9 months ended September 30, 2022, was ($0.22) and ($0.82) per share, respectively, in comparison with ($0.25) and ($3.64) per share, respectively, for the comparable intervals in 2021.

For additional particulars on Ocuphire’s monetary outcomes, consult with 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.

About Ocuphire Pharma

Ocuphire is a publicly traded (Nasdaq: OCUP), clinical-stage, ophthalmic biopharmaceutical firm centered on growing and commercializing small-molecule therapies for the therapy of refractive and retinal eye issues.

The Company’s lead product candidate, Nyxol^® eye drops (0.75% phentolamine ophthalmic answer), is a once-daily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to cut back pupil measurement and is being developed for three indications, together with reversal of pharmacologically induced mydriasis (RM), presbyopia and dim mild or night time imaginative and prescient disturbances (NVD). Nyxol has been studied in 12 accomplished medical trials, together with lately reported optimistic information from the next trials:

• MIRA-2 (NCT04620213), MIRA-3 (NCT05134974), and MIRA-4 (NCT05223478 pediatric security trial) registration trials for the therapy of RM
• VEGA-1 (NCT04675151) Phase 2 trial of Nyxol for therapy of presbyopia, which evaluated each Nyxol as a single agent and Nyxol with low dose pilocarpine (“LDP”) 0.4% as adjunctive remedy
• LYNX-1 (NCT04638660) Phase 3 trial of Nyxol for night time imaginative and prescient disturbances (NVD)

Ocuphire’s second product candidate, APX3330, is an oral pill designed to inhibit angiogenesis and irritation pathways related to retinal and choroidal vascular ailments, comparable to diabetic retinopathy (DR) and diabetic macular edema (DME). APX3330 has been studied in 11 Phase 1 and a pair of trials. The Company introduced the completion of final affected person final go to in late August in ZETA-1 (NCT04692688).

For extra info, go to www.ocuphire.com. 

Forward Looking Statements

Statements contained on this press launch relating to issues that aren’t historic info are “forward-looking statements” inside the that means of the Private Securities Litigation Reform Act of 1995. Such statements embody, however aren’t restricted to, statements regarding medical and regulatory milestones for Ocuphire’s indications, together with Ocuphire’s potential NDA submission, initiation of sure trials, and receipt of topline information, Ocuphire’s business technique and potential progress, and commercialization of Ocuphire’s product candidates. These forward-looking statements are primarily based upon Ocuphire’s present expectations and contain assumptions that will by no means materialize or might show to be incorrect. Actual outcomes and the timing of occasions may differ materially from these anticipated in such forward-looking statements because of varied dangers and uncertainties, together with, with out limitation: (I) the success and timing of regulatory submissions and pre-clinical and medical trials, together with enrollment and information readouts; (ii) regulatory necessities or developments; (iii) adjustments to medical trial designs and regulatory pathways; (iv) adjustments in capital useful resource necessities; (v) dangers associated to the shortcoming of Ocuphire to acquire ample further capital to proceed to advance its product candidates and its preclinical applications; (vi) legislative, regulatory, political and financial developments, (vii) adjustments in market alternatives, (viii) the consequences of COVID-19 on medical applications and business operations, (ix) the success and timing of commercialization of any of Ocuphire’s product candidates and (x) the upkeep of Ocuphire’s mental property rights. The foregoing assessment of necessary elements that might trigger precise occasions to vary from expectations shouldn’t be construed as exhaustive and ought to be learn at the side of statements which might be included herein and elsewhere, together with the chance elements detailed in paperwork which were and could also be filed by Ocuphire once in a while with the SEC. All forward-looking statements contained on this press launch converse solely as of the date on which they had been made. Ocuphire undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they had been made.

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