On December 15, 2017 Ohr Pharmaceutical, Inc. (Nasdaq: OHRP), a clinical-stage pharmaceutical company developing novel therapies for ophthalmic disease, reported financial results for its fiscal year ended September 30, 2017 (Press release, Ohr Pharmaceutical, DEC 15, 2017, View Source [SID1234522662]).
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"Our primary focus at Ohr continues to be the successful completion of the MAKO study, our ongoing clinical trial being conducted to evaluate the efficacy and safety of Squalamine in combination with Lucentis for treatment-naive patients with the wet form of age-related macular degeneration (wet-AMD)," said Dr. Jason Slakter, chief executive officer of Ohr Pharmaceutical. "The MAKO study enrolled a targeted population identified in the prior Phase 2 study which we believe is best suited for Squalamine combination therapy and is consistent with the mechanism of action of Squalamine and the vascular biology of the disease. We remain on track to receive and report top-line efficacy data from the MAKO study in early calendar 2018."
Corporate Highlights for the Fiscal Year Ended September 30, 2017
● Continued progress of the ongoing clinical study in wet-AMD, entitled the MAKO study. The study is a multi-center, randomized, double-masked, placebo controlled clinical trial designed to investigate Ohr’s lead candidate Squalamine in combination with Lucentis in wet-AMD.
○ Topline data from the study are expected in early calendar year 2018.
○ In April 2017, the Company made a strategic decision to amend the MAKO study from the original agreed-upon design to enable efficacy analyses at an earlier date than originally anticipated.
○ More than 200 patients were enrolled in the MAKO study. Patients received monthly Lucentis and either topical Squalamine or placebo eye drops twice daily. The primary endpoint is an assessment of visual acuity gain at nine months.
○ The MAKO study prospectively enrolled the patient population identified from the prior Phase 2 IMPACT study that had the greatest potential to benefit from Squalamine combination therapy.
● Raised approximately $19.5 million in combined net proceeds, after deducting placement agent fees and offering expenses payable, from two public offerings of common stock and warrants that closed on December 13, 2016 and on April 10, 2017.
● In May, the Company appointed the Honorable Mike Ferguson as a Director and Chairman of the Board of Directors.
○ Mr. Ferguson served for nearly a decade in the House of Representatives. As Vice Chairman of the House health subcommittee, he led policy reforms including the creation of the Medicare Part D prescription drug benefit and pharmaceutical and medical device user fee reauthorizations. He is also Senior Advisor and Leader of the Federal Policy Team at Baker Hostetler LLP, one of the nation’s largest law firms.
Financial Results for the Fiscal Year ended September 30, 2017
● For the year ended September 30, 2017, the Company reported a net loss of approximately $23.8 million, or ($0.53) per share, compared to a net loss of approximately $25.8 million, or ($0.82) per share, in the same period of 2016.
● For the year ended September 30, 2017, total operating expenses were approximately $23.8 million, consisting of $5.3 million in general and administrative expenses, $17.4 million of research and development expenses, and $1.2 million in depreciation and amortization. This compares to total operating expenses of approximately $24.6 million, consisting of approximately $7.7 million in general and administrative expenses, $16.5 million in research and development expenses, and $1.2 million in depreciation and amortization in the same period of 2016.
● At September 30, 2017, the Company had cash and cash equivalents of approximately $12.8 million, compared to cash and cash equivalents of approximately $12.5 million at September 30, 2016.
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