NeuBase Therapeutics, Inc.
Q2 2017 Earnings Call Transcript

Published: 13 May 2017

[Operator:]

Greetings and welcome to the Ohr Pharmaceutical Company's Second Quarter 2017 Earnings Call. At this time, all participants are in a listen-only-mode. A Question-and-Answer Session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Michael Wood of LifeSci Advisors. Thank you. Mr. Wood, please go ahead.

[Michael Wood:]

Thank you and good afternoon everyone. This afternoon Ohr released financial results and provided a business update for the quarter ended March 31, 2017. If you did not yet receive the release, it is available on the Investor Relations section of the company's website at www.ohrpharmaceutical.com. This call is being webcast and a replay will be available. Before we begin, I would like to remind you that some of the information in today’s news release and on this conference call contain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words of expression reflecting optimism, satisfaction with current prospects as well as words such as belief, intend, expect, planned, anticipate, and similar variations identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Such forward-looking statements are not a guarantee of performance and the company's actual results could differ materially from those contained in such statements. Several factors that could cause or contribute to such differences include our ability to raise additional funds to perform and conclude clinical trials, the financial resources available to us, our ability to negotiate and conclude a strategic partnership agreement, the future success of our scientific studies, our ability to successfully develop products, rapid technological change in the marketplace, changes in demand for our future products, legislative, regulatory and competitive developments and general economic conditions. These factors are described in detail in the company's most recently filed annual report on Form 10-K subsequently filed Form 10-Qs as well as additional filings with the SEC. These forward-looking statements speak only as of today's date Thursday, May 11, 2017. The company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding those circumstances after the date of this release. Participating in today's call from the company are Dr. Jason Slakter, CEO; and Mr. Sam Backenroth, the Chief Financial Officer. With that, I like to turn the call over to Dr. Slakter. Please go ahead, sir.

[Jason Slakter:]

Thank you, Michael. Good afternoon everyone, and thank you for joining us today. The past few months have been very busy and exiting at Ohr. This afternoon we announced that the Honorable Mike Ferguson has joined the Board of Directors of Ohr as its new Chairman. We are very excited to have Mike onboard, and believe his experience as a former member of Congress, public policy expert and public health advocate will be invaluable to our company. He served for nearly a decade in Congress and was a leader on a number of key healthcare and financial services policy initiatives, to remove regulatory roadblocks to innovation. As Vice Chairman of the House health subcommittee he lead policy reforms, including the creation of the Medicare Part D prescription drug benefit and pharmaceutical and medical device user fee reauthorization. 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, in particular, for sick and elderly family members and children with special needs. Mike brings to Ohr a unique understanding of the importance of medical innovation on our society and is a strong 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 moving forward. We at Ohr remain focused on the MAKO study, our ongoing large, multi-center clinical trial; designed to determine the benefits of Squalamine combination therapy in the treatment of neovascular age-related macular degeneration also known as wet AMD. With the completion of our recent public offering, we are now fully funded through the data readout for this trial and into 2018. For strategic reasons, earlier this year we decided to amend the clinical study and pause enrollment. There are more than 200 subjects enrolled in the trial, who continue to undergo scheduled visits and assessments and receive the assigned study treatment. This change will allow us to complete, analyze and report top line data from the study at the end of this calendar year or in early 2018, almost a year earlier than previously planned. The primary end point is an assessment of visual acuity at nine months. Our goal is to confirm the visual acuity benefits of Squalamine seen in the Phase 2 IMPACT study, when Squalamine was administered as part of a combination therapy for patients with Wet AMD. Since we began the clinical trial, the competitive landscape for new drugs in AMD has changed; in particular, for combination therapy approaches to treatment. We believe the failure to show additional visual benefits in other combination therapy studies does not impact the promise of Squalamine combination therapy to improve vision in patients suffering from Wet AMD. As you recall, Squalamine is a topically applied drug that inhibits multiple targets involved in ocular angiogenesis, including VEGF, PDGF, and basic FGF. While most therapeutic agents on the market today and in development exert their effect in the extra-cellular space, Squalamine acts intra-cellularly to inhibit the downstream activity of a number of pro-angiogenic receptors. Furthermore, we believe that daily tropical application of Squalamine can provide for sustained biologic activity in the target tissues in the back of the eye, which may result in a better therapeutic effect compared to bolus injections into the vitreous. Perhaps the most important factor in the treatment of AMD with combination therapy is the need for careful patient selection. In our exploratory Phase 2 study, we determined at a retrospective analysis that the visual acuity benefits of Squalamine combination therapy were driven by the size of the occult CNV present at the start of treatment. This analysis allowed us to select an optimized population, most likely to show benefit from Squalamine combination therapy, and it is this population that was enrolled in the current trial. The data readout from the ongoing trial is intended to allow us to confirm that this is the ideal population for Squalamine combination therapy, and reproduce the visual acuity benefits seen in these patients in a pre-specified and prospective manner. We remain very confident about the potential of Squalamine as a differentiated topical multi-target angiogenesis inhibitor to provide improved visual function to patients suffering from wet AMD. At the same time, we continue to pursue discussions with potential pharmaceutical partners regarding Squalamine. In April, we raised approximately $12.7 million in new capital from a public offering. As a result, the company is now fully funded into 2018, including completion of our ongoing clinical trial and top line data readout by the end of calendar 2017 or early 2018. This successful offering was led by existing investors and included the participation of myself, senior management and certain members of the board of directors. With that, I would like to handover the call to Sam for the financial results. Sam?

[Samuel Backenroth:]

Thank you, Jason. For the second quarter ended March 31, 2017, total operating expenses were approximately $7.7 million, consisting of $1.4 million in general and administrative expenses, $6 million in research and development expenses, and $0.3 million in depreciation and amortization. This compares to approximately $6.6 million in total operating expenses in the same period of 2016, consisting of $3 million in general and administrative expenses, $4 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. For the second fiscal quarter of 2017, we 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 last year. At March 31, we had cash and cash equivalents of approximately $9.5 million, not including the $12.7 million in additional net proceeds from our recent public offering, which closed in April. This compares to approximately $13.5 million at December 31, 2016. For a more detailed description of the financials, including the financial results of the six month period ended March 31, 2017 please refer to our 10-Q, which should be filed shortly. That completes my review of the financials. We would like to now open up the call for questions. Operator?

[Jason Slakter:]

Thank you, operator. We are excited about Mike Ferguson joining the Ohr team, and we remain confident about the potential value of Squalamine as a highly differentiated agent to provide improved visual function to patients suffering from wet AMD. We look forward to the top line data from the study in late 2017 or early 2018. The implementation of our strategic plan remains on track, and we believe it will provide the optimal approach to help patients maximize value for shareholders and enhance our ongoing business development efforts. I thank you all for joining us on the call today. Have a good evening.

[Operator:]

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.