- Reached an agreement on a Special Protocol Assessment (SPA) with the US FDA on the design of Phase 3 trials for Squalamine lactate ophthalmic solution, 0.2% ("Squalamine", also known as OHR-102) for patients with wet AMD.
- Appointed David M. Brown, MD to serve as the chair of the Steering Committee for the Phase 3 clinical program of Squalamine in wet-AMD.
- Closed a public offering of shares of common stock and warrants resulting in net proceeds of approximately $6.9 million.
- In September, presented new data from the Phase 2 IMPACT study at the American Society of Retina Specialists (ASRS). Subjects with occult CNV <10mm 2 achieved final mean visual acuity outcomes of 71.7 letters with Squalamine combination therapy compared to 67.4 letters with Lucentis® monotherapy. The final mean visual acuity outcomes in the combination therapy group translates to approximately 20/40 vision (Snellen equivalent). This underscores the potential of Squalamine combination therapy to allow patients to reach higher levels of visual function and improve their overall quality of life.
- In May, presented two posters on the Squalamine Phase 2 IMPACT study and OHR3031 sustained release in vivo studies at the Association for Research in Vision and Ophthalmology (ARVO) Conference.
- In April, commenced enrollment in the Phase 3 clinical development program investigating Squalamine as a treatment to improve visual acuity for patients with wet AMD.
- The Phase 3 program includes two double-masked, placebo-controlled, multicenter, international studies of Squalamine administered topically twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis ® injections.
- The primary endpoint in both studies is a measurement of visual acuity gain at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
- In November 2015, presented new data from the Phase 2 IMPACT Study in Wet-AMD at American Academy of Ophthalmology (AAO) Annual Meeting.
- Data showed that the size of occult CNV at baseline, irrespective of a classic CNV component, was the most important factor in predicting treatment success with the combination of Squalamine plus Lucentis®. This correlation was not seen in the Lucentis® monotherapy group.
- Also in November 2015, announced positive preclinical data in proprietary SKS sustained release technology.
- In an animal model used to evaluate ophthalmic compounds, sustained supratherapeutic levels of active drug were achieved in target ocular tissues at all time points in the study.
- The results serve as an important validation for the company's SKS sustained release technology which holds the promise of improving the standard of care in a number of ocular conditions.
- For the year ended September 30, 2016, the Company reported a net loss of approximately $25.8 million, or ($0.82) per share, compared to a net loss of approximately $15.2 million, or ($0.54) per share in the same period of 2015.
- For the year ended September 30, 2016, total operating expenses were approximately $24.6 million, consisting of $7.7 million in general and administrative expenses, $16.5 million of research and development expenses, and $1.2 million in depreciation and amortization. This compares to total operating expenses of $17.8 million in the same period of 2015, comprised of approximately $7.5 million in general and administrative expenses, $8.8 million in research and development expenses, and $1.2 million in depreciation and amortization.
- At September 30, 2016, the Company had cash and cash equivalents of approximately $12.5 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.
- On December 7, 2016, the Company sold in a public offering, an aggregate of approximately 3,885,000 shares of its common stock, together with Series A common stock purchase warrants exercisable for up to an aggregate of approximately 1,942,500 shares of common stock and Series B common stock purchase warrants exercisable for up to an aggregate of approximately 3,885,000 shares of common stock. Net proceeds from the offering were approximately $6.9 million, after deducting placement agent fees and estimated offering expenses payable but excluding the proceeds, if any, from the exercise of the Series A and Series B Warrants issued in the offering.
|OHR PHARMACEUTICAL, INC.|
|Consolidated Balance Sheets|
|September 30,||September 30,|
|Prepaid expenses and other current assets||738,118||338,713|
|Total Current Assets||13,285,008||29,036,036|
|Intangible assets, net||15,208,219||16,332,863|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued expenses||$||4,394,068||$||1,592,348|
|Total Current Liabilities||4,481,866||3,880,014|
|Preferred stock, Series B; 6,000,000 shares authorized, $0.0001 par value, 0 shares issued and outstanding, respectively||-||-|
|Common stock; 180,000,000 shares authorized, $0.0001 par value, 32,076,396 and 30,331,309 shares issued and outstanding, respectively||3,207||3,033|
|Additional paid-in capital||109,237,551||100,999,173|
|Total Stockholders' Equity||24,963,147||42,490,793|
|TOTAL LIABILITIES AND|
|OHR PHARMACEUTICAL, INC.|
|Consolidated Statements of Operations|
|For the Year Ended September 30,|
|General and administrative||$||7,656,327||$||7,509,601||$||4,287,205|
|Research and development||16,460,714||8,777,519||4,369,413|
|Depreciation and amortization||1,189,276||1,179,254||466,306|
|Gain on settlement of accounts payable||(710,264||)||-||-|
|Impairment of Intangibles||-||338,906||-|
|OTHER INCOME (EXPENSE)|
|Change in fair value of contingent consideration||(1,185,667||)||2,637,756||-|
|Share in losses on investment in joint venture||-||(103,143||)||(10,643||)|
|Other income and expense||3,419||42,966||8,479|
|Interest income (expense), net||12,103||(5,977||)||(5,576||)|
|Total Other Income (Expense)||(1,170,145||)||2,607,415||(7,740||)|
|LOSS FROM OPERATIONS BEFORE|
|PROVISION FOR INCOME TAXES||-||-||-|
|BASIC AND DILUTED LOSS PER SHARE||$||(0.82||)||$||(0.54||)||$||(0.41||)|
|WEIGHTED AVERAGE NUMBER|
|OF SHARES OUTSTANDING:|
|BASIC AND DILUTED||31,349,223||28,404,405||22,141,538|
|OHR PHARMACEUTICAL, INC.|
|Consolidated Statements of Cash Flows|
|For the Twelve Months Ended|
|Adjustments to reconcile net loss to net cash|
|used by operating activities:|
|Common stock issued for services||1,754,814||635,288||-|
|Warrants issued for services||-||8,559||1,177,095|
|Stock option expense||2,913,626||3,579,788||2,074,487|
|Change in fair value of contingent consideration||1,185,667||(2,637,756||)||-|
|Share in losses on investment in joint venture||-||103,143||10,643|
|Amortization of intangible assets||1,124,644||1,138,631||448,456|
|Impairment of intangibles||-||338,906||-|
|Gain on settlement of accounts payable||(710,264||)||(40,636||)||-|
|Changes in operating assets and liabilities|
|Prepaid expenses and deposits||(64,794||)||7,214||105,823|
|Accounts payable and accrued expenses||3,511,984||1,331,120||(63,822||)|
|Net Cash Used in Operating Activities||(15,985,889||)||(10,692,985||)||(5,360,132||)|
|Acquisition of SKS Ocular's assets||-||-||(3,500,000||)|
|Investment in joint venture||-||(100,000||)||(13,786||)|
|Purchase of property and equipment||(14,510||)||(184,951||)||(1,083||)|
|Net Cash Used in Investing Activities||(14,510||)||(284,951||)||(3,514,869||)|
|Proceeds for issuance of common stock for cash||-||26,582,998||16,876,000|
|Proceeds from warrants exercised for cash||26,041||80,003||260,752|
|Repayments of short-term notes payable||(176,075||)||(208,236||)||(164,152||)|
|Net Cash Provided by/ (Used in) Financing Activities||(150,034||)||26,454,765||16,972,600|
|NET CHANGE IN CASH||(16,150,433||)||15,476,829||8,097,599|
|CASH AT BEGINNING OF PERIOD||28,697,323||13,220,494||5,122,895|
|CASH AT END OF PERIOD||$||12,546,890||$||28,697,323||$||13,220,494|
|SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION||-|
|CASH PAID FOR:|
|NON CASH FINANCING ACTIVITIES:|
|Settlement of contingent consideration||$||3,425,270||$||-||$||-|
|Financing of insurance premiums through issuance of short term notes||215,810||212,400||194,000|
|Subscription receivable from exercise of warrants||118,801||-||-|
|Conversion of preferred for common stock||-||-||50|
|Noncash exercise of options and warrants||-||-||223|
|Common stock issued to acquire intangible assets||-||-||10,180,224|
|Common stock issued to settle accounts payable||-||50,000||50,000|
Contact:Ohr Pharmaceutical Inc. Investor Relations 888-388-2327 firstname.lastname@example.org LifeSci Advisors, LLCMichael Wood646email@example.com