UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 11, 2017
Ohr Pharmaceutical, Inc. |
(Exact Name of Registrant as Specified in Its Charter)
Delaware | 333-88480 | 46-5622433 | ||
(State or Other Jurisdiction | (Commission | (I.R.S. Employer | ||
of Incorporation) | File Number) | Identification No.) |
800 Third Avenue, 11th Floor, New York, NY | 10022 |
(Address of Principal Executive Offices) | (Zip Code) |
(212) 682-8452 |
(Registrant’s Telephone Number, Including Area Code)
Not Applicable |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 | Results of Operations and Financial Condition. |
On May 11, 2017, Ohr Pharmaceutical, Inc., a Delaware corporation (the “Company”), issued a press release announcing its results for the second quarter ended March 31, 2017. This press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information set forth or incorporated by reference in this Item 2.02 of this Current Report on Form 8-K, including the applicable portion of the press release attached as Exhibit 99.1 hereto, is being furnished to the Securities and Exchange Commission, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities thereof, nor shall it be deemed to be incorporated by reference into any filing under the Exchange Act or under the Securities Act of 1933, as amended, except to the extent specifically provided in any such filing.
Item 8.01 | Other Events. |
On May 11, 2017, the Company issued a press release announcing the election of the Hon. Michael A. Ferguson as a director and Chairman of the Board of Directors of the Company, and the resignation of Ira Greenstein as a director of the Company. This press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits: |
99.1 | Press release, dated May 11, 2017 |
99.2 | Press release, dated May 11, 2017 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
OHR PHARMACEUTICAL, INC | ||
(Registrant) | ||
Date: May 11, 2017 | By: | /s/ Sam Backenroth |
Sam Backenroth | ||
Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. | Description | |
99.1 | Press release, dated May 11, 2017 | |
99.2 | Press release, dated May 11, 2017 |
Exhibit 99.1
Ohr Pharmaceutical Announces Fiscal Second Quarter 2017 Earnings
Management to Host a Conference Call and Webcast at 5:00pm Eastern Time Today
NEW YORK, New York – May 11, 2017 – Ohr Pharmaceutical, Inc. (NASDAQ: OHRP), a clinical-stage pharmaceutical company developing novel therapies for ophthalmic diseases, today reported results for its second quarter ended March 31, 2017.
“We are focused on completing our ongoing multi-center, randomized clinical study (the MAKO study), designed to determine the benefits of Squalamine combination therapy in the treatment of wet AMD,” stated Jason Slakter, MD, Chief Executive Officer of Ohr. “We recently amended this study in order to provide top-line data by year end 2017 or early calendar 2018. Our goal is to confirm the visual acuity benefits observed in the patient population most likely to benefit from treatment, based on what was seen in the prior Phase 2 IMPACT study. Our confidence in the clinical and commercial potential of Squalamine remains high. We see it as a differentiated, topical, multi-target angiogenesis inhibitor with the potential to change the standard of care in wet AMD. Following the closing of the recent financing, we are now funded through the top-line data readout and into 2018.”
Second Quarter and Recent Corporate Highlights
● | Raised approximately $12.7 million in net proceeds from a public offering of common stock and warrants. |
○ | Transaction led by existing investors and included the participation of management and the Board of Directors. |
○ | Company funded into 2018, including the completion of the ongoing clinical trial and data readout. |
● | Amended the ongoing clinical trial investigating Squalamine in wet-AMD (the MAKO Study) to enable top-line data by the end of calendar 2017 or early 2018. |
○ | MAKO remains double-masked and no interim efficacy or futility analysis has been performed. |
○ | The data safety monitoring board has confirmed that there are no safety concerns and recommended the study continue as planned. |
○ | More than 200 subjects have been enrolled in the MAKO study. The patient population is the same as that identified from the prior IMPACT study as having the greatest potential to benefit from Squalamine combination therapy. |
○ | Patients enrolled in the study continue to receive their assigned study treatment of monthly Lucentis® and either topical Squalamine or placebo twice daily, and undergo scheduled visits and assessments through nine months. The primary endpoint is an assessment of visual acuity at nine months. |
Financial Results for the Second Quarter ended March 31, 2017
● | For the quarter ended March 31, 2017, the Company reported a net loss of approximately $7.7 million, or ($0.21) per share, compared to a net loss of approximately $5.3 million, or ($0.17) per share in the same period of 2016. |
● | For the quarter ended March 31, 2017, total operating expenses were approximately $7.7 million, consisting of $1.4 million in general and administrative expenses, $6.0 million of research and development expenses, and $0.3 million in depreciation and amortization. This compares to total operating expenses of $6.6 million in the same period of 2016, comprised of approximately $3.0 million in general and administrative expenses, $4.0 million in research and development expenses, $0.3 million in depreciation and amortization, and a gain on settlement of accounts payable of $0.7 million. |
● | At March 31, 2017, the Company had cash and cash equivalents of approximately $9.5 million, compared to cash and equivalents of approximately $12.5 million at September 30, 2017. This does not include the approximately $12.7 million in net proceeds from the public offering of common stock received in April 2017. |
Financial Results for the Six Months Ended March 31, 2017
● | For the six months ended March 31, 2017, the Company reported a net loss of approximately $14.7 million, or ($0.43) per share, compared to a net loss of approximately $11.4 million, or ($0.37) per share in the same period of 2016. |
● | For the six months ended March 31, 2017, total operating expenses were approximately $14.7 million, consisting of $3.2 million in general and administrative expenses, $10.9 million of research and development expenses, and $0.6 million in depreciation and amortization. This compares to total operating expenses of $10.2 million in the same period of 2016, comprised of approximately $4.2 million in general and administrative expenses, $6.1 million in research and development expenses, $0.6 million in depreciation and amortization, and a gain on settlement of accounts payable of $0.7 million. |
Conference Call & Webcast | |
Thursday, May 11, 2017 at 5:00pm Eastern Time | |
Domestic: | 877-407-0789 |
International: | 201-689-8562 |
Conference ID: | 13661723 |
Webcast: | http://public.viavid.com/index.php?id=124321 |
Replays – Available through May 25, 2017 | |
Domestic: | 844-512-2921 |
International: | 412-317-6671 |
Conference ID: | 13661723 |
About
Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. (OHRP) is a clinical-stage
pharmaceutical company developing novel therapies for ophthalmic diseases. The company’s lead drug candidate, Squalamine
lactate ophthalmic solution, 0.2% (also known as OHR-102), is currently being studied using an eye drop formulation in a clinical
trial for the treatment of the wet form of age-related macular degeneration. In addition, Ohr has a sustained release micro
fabricated micro-particle ocular drug delivery platform technology. Additional information on the company may be found at www.ohrpharmaceutical.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and we undertake no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to raise sufficient funds to perform and conclude clinical trials, the financial resources available to us, the ability to negotiate and conclude a strategic partnership, the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, and general economic conditions. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing; and no assurance or warranty can be made that the FDA will approve final testing or marketing of any pharmaceutical product. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition.
Contact: | |
Ohr Pharmaceutical Inc. | LifeSci Advisors, LLC |
Investor Relations | Michael Wood |
888-388-2327 | 646-597-6983 |
ir@ohrpharmaceutical.com | mwood@lifesciadvisors.com |
Exhibit 99.2
Ohr Pharmaceutical Announces Appointment of Hon. Mike Ferguson as Chairman of the Board of Directors
NEW YORK, May 11, 2017 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), a clinical-stage pharmaceutical company developing novel therapies for ophthalmic diseases, today announced the appointment of the Honorable Mike Ferguson as a director and Chairman of the Board following the resignation of Ira Greenstein from the Company’s Board of Directors.
“We are honored to have Mike Ferguson join our Board of Directors as our new chairman and believe his experience as a former member of Congress, public policy expert and public health advocate will be invaluable to our Company,” stated Dr. Jason Slakter, CEO. “Mike has a unique understanding of the importance of medical innovation in our society and has been a tireless advocate for public policy reforms to make new medical treatments more available and affordable. We welcome his guidance and counsel. We also wish to thank Ira Greenstein for his many contributions to our Company during his decade of service as the Chairman of our Board of Directors, and wish him all the best in his future endeavors.”
“This is an exciting point in the development of Ohr’s lead candidate, Squalamine, and I am pleased to be named Chairman of the Board during this important time,” said Mr. Ferguson. “Squalamine is an innovative product which has the potential to set a new standard of care for the many patients afflicted with wet AMD. I look forward to working closely with the Ohr team.”
The Honorable Mike Ferguson is Senior Advisor and Leader of the Federal Policy Team at Baker Hostetler, one of the nation’s largest law firms, and is a member of the Board of Directors of NanoVibronix Inc. He served for nearly a decade in the House of Representatives and was a leader on a number of key healthcare and financial service policy initiatives to remove regulatory roadblocks to innovation. 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 also authored and shepherded passage of the Lifespan Respite Care Act of 2006, which champions pioneering healthcare policies that improve treatment options for patients.
After retiring from Congress, Mr. Ferguson founded Ferguson Strategies, a government affairs and public policy consulting firm that served a wide range of clients, including Fortune 500 companies and start-up firms. Among his many honors and community services, he is currently Chairman of the Board of Commissioners of the New Jersey Sports and Exhibition Authority, a senior fellow at the Center for Medicine in the Public Interest and a board member of the Independent College Fund of New Jersey. Mr. Ferguson received a B.A. in government from the University of Notre Dame and a Master of Public Policy degree from Georgetown University.
About
Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. (OHRP) is a clinical-stage pharmaceutical company developing novel therapies for ophthalmic diseases. The
company’s lead drug candidate, Squalamine lactate ophthalmic solution, 0.2% (also known as OHR-102), is currently being studied
using an eye drop formulation in an ongoing clinical trial for the treatment of the wet form of age-related macular degeneration.
In addition, Ohr has a sustained-release micro fabricated micro-particle ocular drug delivery platform technology. Additional
information on the company may be found at www.ohrpharmaceutical.com.
Safe-Harbor
Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and we undertake
no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise.
Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various
factors and uncertainties, including our ability to raise sufficient funds to perform and conclude clinical trials, the financial
resources available to us, the ability to negotiate and conclude a strategic partnership, the future success of our scientific
studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future
products, legislative, regulatory and competitive developments, and general economic conditions. Shareholders and prospective
investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing;
and no assurance or warranty can be made that the FDA will approve final testing or marketing of any pharmaceutical product. Our
most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors
that may affect our business, results of operations and financial condition.
Contact:
Ohr Pharmaceutical Inc.
Investor Relations
888-388-2327
ir@ohrpharmaceutical.com
LifeSci Advisors, LLC
Michael Wood
646-597-6983
mwood@lifesciadvisors.com