NeuBase Therapeutics, Inc.
Q3 2017 Earnings Call Transcript

Published: 10 Aug 2017

[Operator:]

Greetings. And welcome to the Ohr Pharmaceutical Company Third Fiscal Quarter 2017 Earnings Conference 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, LifeSci Advisors.

[Michael Wood:]

Yeah. Thank you, and good afternoon, everyone. This afternoon Ohr released financial results and provided a business update for the quarter ended June 30, 2017. If you did not yet receive the release, it is available on the Investor Relations section on the company's website at ohrpharmaceutical.com. This call is being webcast and a replay will be available. Before I 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 these statements. Such factors that could cause or contribute to such differences include the Company’s ability to raise additional funds to perform and conclude clinical trials, the financial resources available to the Company, their ability to negotiate and conclude any strategic partnership agreements, the future success of scientific studies, and the Company’s ability to successfully develop products, rapidly -- rapid technological change in the marketplace, changes in demand for their future products, legislative, regulatory and competitive developments. These factors are described in detail in the Company's most recently filed Annual Report on Form 10-K and subsequently filed on Form 10-Q, as well as an additional filings with the SEC. These forward-looking statements speak only as of the date of today's call, Tuesday, August 8, 2017. The Company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding these circumstances after the date of the release. Participating in today's call from the Company are Dr. Jason Slakter, the Chief Executive Officer; and Mr. Sam Backenroth, Chief Financial Officer. With that, I like to call -- turn this call over to Dr. Slakter. Jason, please go ahead.

[Dr. Jason Slakter:]

Thank you, Michael. Good afternoon, everyone, and thank you for joining us today. Everyone at Ohr remains committed to the development of Squalamine and is excited about its potential to be an innovative and clinically valuable therapy for wet-AMD and other retinal diseases. Our primary focus has and continues to be the successful completion of the MAKO study, which is our ongoing clinical trial being conducted to evaluate the efficacy and safety of Squalamine in combination with Lucentis for treatment naïve patients with wet-AMD. Our goal for the MAKO study is to confirm the visual acuity benefits of Squalamine seen in the prior Phase II impact study. We believe that Squalamine is well-positioned to succeed based on a number of unique properties of the drug, including its intracellular side of action, it’s activity against multiple androgenic targets, it’s topical route of delivery, and importantly, the sustained suppressive nature of its activity by virtue of daily topical administration. In addition, in the MAKO study, we have enrolled a targeted population identified in the Phase II study, which demonstrated the optimal response Squalamine combination therapy and is consistent with the mechanism of action of Squalamine and the vascular biology of wet-AMD. We believe that the strategic targeted approach significantly enhances the chances of success of this trial. Finally, we confirmed that the Lucentis monotherapy group in the Phase II impact trial behaved as expected for Lucentis PRN treatment, which further increases the chances for success in the ongoing MAKO study. As you know, earlier this year we made the strategic decision to amend the MAKO study in order to complete, analyze and report topline data from the study by early in calendar 2018, almost a year earlier than previously planned. I'm happy to report that we remain on track for the topline data readout. There are currently more than 200 subjects in the trial who undergo scheduled visits and assessments, as well as receive the assigned study treatment through month nine. This is more than twice the number of patients analyzed in the impact study in this targeted population. Recall this group demonstrated improvements in both mean visual acuity and the proportion of three line gainers and we look to confirm these benefits with the MAKO study readout. In April, we raised approximately $12.7 million in new capital from a public offering of common stock and warrants. As a result, we are now fully funded into 2018, including the completion of the MAKO clinical trial and the data readout. This successful offering was led by existing investors and included the participation of senior management and members of our Board of Directors. Over the next several months we expect to continue our active ongoing discussions with potential partners in preparation for the data readout. We are also spending a lot of time meeting with investors throughout the United States, as well as internationally to update them on our progress, outline expectations for the MAKO study readout and walk through our strategic plan moving forward. The other important news we announced early in the quarter was the appointment of the Honorable Mike Ferguson to the Board of Directors of Ohr as our new Chairman. We are honored to have Mike onboard and believe his experience as a former member of Congress, public policy expert and public health advocate will be invaluable. With that, I’d like to handover the call to Sam for the financial results. Sam?

[Sam Backenroth:]

Thank you, Jason. For the third quarter ended June 30, 2017, total operating expenses were approximately $3.9 million, consisting of $1.4 million in general and administrative expenses, $2.2 million of research and development expenses and $0.3 million in depreciation and amortization. This compares to total operating expenses of approximately $7.6 million, consisting of approximately $1.7 million in general and administrative expenses, $5.6 million in research and development expenses and $0.3 million in depreciation and amortization in the same period of 2016. For the quarter ended June 30, 2017, the Company reported a net loss of approximately $3.9 million or $0.07 per share, compared to a net loss of approximately $7.7 million or $0.24 a share in the same period of 2016. At June 30th, we had cash and cash equivalents of approximately $18.1 million, this compares to approximately $12.5 million at September 30, 2016. For a more detailed description of the financials, including the financial results of the nine-months period ended June 30, 2017, please refer to our 10-Q which will be filed shortly. That completes my review of the financials. I'd like to now open up the call for questions. Operator?

[Operator:]

[Operator Instructions] Our first question is from Sam Slutsky of LifeSci Capital. Please proceed with your question.

[Sam Slutsky:]

Hi, everyone. Thanks for taking my questions. Regarding the amendments of the MAKO study, how do you anticipate this will affect the statistics for the data?

[Dr. Jason Slakter:]

That's a really good question. I think, as you know, in our Phase II study, we did all the analyses necessary to identify the population is most likely to demonstrate visual acuity benefits of Squalamine combination therapy over Lucentis monotherapy. And when we identify this population this is the group that we enrolled in the current MAKO study. If you look back at the data, based on the strength and consistency of the visual gains that we saw in this population in the Phase II study, we feel strongly that there are enough patients enrolled in the MAKO study, that's more than twice the number in the group that was analyzed in the Phase II study to provide us with the ability to confirm the visual acuity benefits of Squalamine treatment in wet-AMD. Operator, do we have more questions.

[Operator:]

[Operator Instructions] Ladies and gentlemen, we have reached the end of the question-and-answer session and I would now like to turn the call back to Jason Slakter for closing remarks.

[Dr. Jason Slakter:]

Thanks, Operator. The second half of the year looks to be very exciting for Ohr as we complete the MAKO study and prepare for topline efficacy data in early 2018. 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. I personally want to thank the entire team at Ohr for working so diligently to achieve our corporate strategic goals and our shareholders for their continued support and I want to wish everyone a good evening. Thank you very much.

[Operator:]

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