NeuBase Therapeutics, Inc.
Q2 2016 Earnings Call Transcript

Published: 11 May 2016

[Operator:]

Greetings and welcome to the Ohr Pharmaceutical Company Second Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Michael Wood, LifeSci Advisors. Thank you. You may begin.

[Michael Wood:]

Thank you, operator and good afternoon everyone. After the market today, Ohr released financial results and provided a business update for the quarter ended March 31, 2015. If you did not yet receive it, it’s available on the Investor Relations section of the website at ohrpharmaceutical.com. This call is being webcast and a replay will be available. Before we begin, I would like to remind you some of the information contained in the 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 believe, intend, expect, plan, 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 are described in detail in the company’s 10-K, 10-Q as well as additional filings with the SEC. These forward-looking statements speak only as of the date of this release and the conference call and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the circumstances after the date of this release. Participating in today’s call from the company are Dr. Jason Slakter, CEO, Mr. Sam Backenroth, CFO; and Dr. Avner Ingerman, Chief Clinical Officer. With that, I would like to turn the call over to Dr. Slakter. Please go ahead.

[Jason Slakter:]

Thank you, Michael. Good afternoon and thank you for joining us today. The first half of fiscal 2016 has been extremely productive at Ohr. On the call today, I am going to give you an update on our lead development candidate, topical Squalamine also referred to as OHR-102, which is now in a Phase 3 registration trial for patients with neovascular age-related macular degeneration also known as wet AMD. I will also spend some time discussing the ARVO meeting which ended last week and talk about some of the exciting new data we presented there both on Squalamine and one of our pipeline programs. Sam Backenroth, our CFO, will then review the financials. Let’s begin with the Squalamine registration program. By now, I am sure you saw the news on April 18 that we enrolled the first patient in the first of two Phase 3 clinical trials of Squalamine for wet AMD. The agreement with the FDA on a special protocol assessment, or SPA for the overall registration program and the initiation of the first study are obviously very important milestones for the company. I have been over the Phase 3 trial design before. So, let me briefly remind you of some of the details. There will be two double-masked, placebo-controlled, multi-center international studies of Squalamine lactate ophthalmic solution 0.2% administered twice a day in combination with Lucentis injections in patients with newly diagnosed wet AMD. The primary endpoint will be an evaluation of visual acuity gains at 9 months with subjects followed to 2 years for safety. You recall we chose this endpoint, because visual acuity is the most meaningful clinical measurement of efficacy in this setting. Furthermore, the primary endpoint on the Phase 3 studies is aligned with the visual acuity benefits we observed at a similar 9-month time point in the Phase 2 IMPACT study, which allows us to better power and de-risk the Phase 3 program. The eligibility criteria for the trials are based on our analyses of the Phase 2 trial, in which we identified the subject with choroidal neovascularization, or CMV secondary to AMD who had the greatest visual acuity benefits from Squalamine combination therapy. The neovascular lesions in these eligible subjects may contain classic and/or occult CMV provided that the occult CMV component of these lesions measures less than 10 square millimeters as assessed unforeseen angiography. Each trial is designed with a target enrollment of 650 patients with the first study expected to include approximately 165 clinical centers in the U.S. and Canada. As mentioned, these trials are covered by a special protocol assessment, or SPA, that we finalized with the FDA in March. The SPA provides us with a binding agreement on the design of the trials. In conjunction with the initiation of our Phase 3 program, last week we announced the appointment of Dr. David Brown, Clinical Professor of Ophthalmology at Baylor College of Medicine as Chair of the Steering Committee for this program. Dr. Brown is a world-renowned retinal specialist, investigator and thought leader on the research and treatment for age-related macular degeneration. I have personally worked with David on previous studies and I am very excited to have someone of his caliber to provide strong support and leadership as we advance Squalamine through this key phase of development. As we have previously stated, we are seeking a strategic partner to collaborate with us on the development and commercialization of Squalamine, most likely a pharmaceutical company with an established presence in ophthalmic care. Discussions with potential partners are ongoing and we have made good progress. I can say that there is recognition from potential partners with respect to the positive clinical attributes of Squalamine and the significant size of the market opportunity. You can appreciate there is relatively little else we can say at this point, but look forward to providing a further update at the appropriate time. Let me now turn to the ARVO meeting, which took place in Seattle from May 1 to 5 or had two poster presentations, one on Squalamine and one on our sustained release technology. Before we discuss the posters, I want to say that we were extremely encouraged by the overall level of interest in Squalamine from physicians and industry representatives at the ARVO conference. A lot of physicians we talk to are now familiar with the Phase 2 data and we are getting great feedback from the investigators at the site in the Phase 3 program. I think this interest speaks to the quality of the program as well as the dedication of our team here at Ohr. In the clinical and industry communities, there is clear recognition that improvements in vision beyond what can be achieved with our standard of care for wet AMD patients are needed. They understand that a drug with the profile of Squalamine can change the way these patients are treated and offer them an efficacious drug in a convenient topical formulation. If the Phase 3 trials produce the results that we expect to see and then I think we are going to have a very successful new treatment to meet this unmet medical need. Turning to the ARVO posters, we presented new data from the prior Phase 2 study of Squalamine combination therapy specifically a post-talk analysis of enrolled patients looking at both the size and composition of their AMD lesions and how this determined visual outcomes. The analysis showed that it was the size of the occult CMV irrespective of a classic CMV component that was most important in predicting treatment success with a combination of Squalamine plus Lucentis. It was demonstrated that combination therapy with Squalamine was most effective in those patients [Technical Difficulty] square millimeters. This size effect was not seen in the [indiscernible] therapy arm. This research adds to the greatest literature that points to put vascular biology and positive treatment in classic versus occult lesions, particularly with combination therapy. This is clearly important of the Squalamine registration program, because with this information in hand, we were able to optimize the inclusion criteria of the Phase 3 development program to enroll a patient population with the highest likelihood of significant visual acuity gains. The second poster at ARVO was on our proprietary sustained release technology. Two, recall we acquired when we bought the asset of SKS ocular. This technology uses micro-fabrication techniques to create micro-particle drug formulations by sustained and predictable release of a therapeutic drug over a multi-month period. Our goal is to use this technology to develop a portfolio of best in class drug formulations for ocular disease that can enhance patient compliance, reduce treatment burden and improve visual outcomes. The poster presentation detailed a pre-clinical pharmacokinetic study in which we dose rabbits with a single intravitreal dose of a sustained release formulation of OHR3031, which is a novel small molecule anti and angiogenic compound and then followed these animals over a six week period. We show that sustained supratherapeutic level of active drug could be achieved in the retina and choroids which are the target ocular tissues for back of the eye disease. These observations were made at all time points in the study, demonstrating a prolonged pharmacokinetic profile. Furthermore, vitreous concentrations remained at a stable high level throughout the six week study indicating that the true durations affect is likely much longer. We are excited by these data because they serve as an important validation for our SKS sustained release technology which holds the promise of improving the standard of care in a number of ocular conditions by allowing for physician administration of drugs at convenient treatment intervals. We currently have four active pipeline programs underway in glaucoma, steroid induced glaucoma, allergic conjunctivitis and retinal diseases. We will give updates periodically as we move forward with these and expect to present additional preclinical studies at scientific conferences this year. Now, I would like to have Sam provide additional detail on the financial results we just reported. Sam?

[Sam Backenroth:]

Thank you, Jason. For the second quarter ended March 31, 2016, we reported a net loss of approximately $5.3 million or $0.17 per share loss compared to a net loss of approximately $3.4 million or $0.12 per share loss in the same period of 2015. Total operating expenses in the second quarter were approximately $6.7 million consisting of approximately $3 million in general and administrative expenses, $4 million in research and development expenses, $0.7 million in gain on settlement of accounts payable and $0.3 million in deprecation and amortization. This compares to a total operating expenses in the same period of 2015 of approximately $6.8 million consisting of $3.3 million in general and administrative expenses, $3.2 million in research and development expenses and $0.3 million in depreciation and amortization. At March 31, 2016, our cash and cash equivalents stood at approximately $21.9 million. This compares to approximately $28.7 million at September 30, 2015. For additional details on our financials I would refer you to the 10-Q just filed with the SEC as well as our prior filings. That completes my review. We will now open up the call to questions. Operator?

[Operator:]

Thank you. At this time we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Tyler Van Buren from Cowen & Company. Please go ahead.

[Tyler Van Buren:]

Hi there, congratulations on the addition of Dr. Brown. With respect to enrollment, can you tell us roughly how many or what percentage of the patients for the trials have been enrolled and I guess what percentage of those patients have been dosed, how long is the time between enrolment and dosing just kind of curious to get some granularity there as well as you are obviously using fluorescein angiogram in your ongoing trials, there are some others that are using alternative imaging techniques such as SD OCT which is commonly used in practice now a days, I was curious to get your thoughts there and upon potential success and approval how that could potentially have an impact? Thank you.

[Avner Ingerman:]

Hi. Thank you for the questions. This is Avner Ingerman, I will try and address, there are several questions there and I will try and address the questions. In terms of patient enrollment what we just started maybe two and a half weeks ago enrollment of the study, first patient was enrolled in the study as we have – as Dr. Slakter presented the design of the study patients are going to have monthly Lucentis injections in the first year and year end criteria based Lucentis injections in the second year will have either Squalamine or placebo eye drops for the two years of the study. In terms of the actual details of the study design, I would just say that all the images – all the performance and all the imaging criteria that we are using are on par with all the modern retina studies. So, they are not different than any other studies that you would expect in that view.

[Jason Slakter:]

As far as the imaging criteria as we have mentioned and we have talked about extensively the inclusion criteria defining both classic and occult CNV as long as the occult component is less than 10 square millimeter, these are criteria that are based on fluorescein angiographic imaging. There is no other method for distinguishing between classic and occult based upon all the clinical trials that we have done in the past. So as far as alternative imagining, while we are employing imaging such as fundus photography and OCT imaging to look at various features of the lesions at baseline and follow-up, the only effective way to distinguish being clean classic and occult is through the use of fluorescein angiography.

[Tyler Van Buren:]

Just a follow-up since you will using fundus photography will you be looking at fibrosis in these trials?

[Jason Slakter:]

We will be looking at all of the different parameters fibrosis as well as all the other features that can be qualitatively and quantitatively evaluated on those images.

[Tyler Van Buren:]

Thanks so much.

[Operator:]

[Operator Instructions] And if there are no further questions I would like to turn the call back over to management for any closing remarks.

[Jason Slakter:]

Thank you very much, operator. And thank you all for joining us on the call today. The first half of the year I think you will agree reflects improvement accomplishments in our Squalamine program and with our pipeline sustained release technology as we work towards our mission of bringing new treatments to patients with ocular disease. We look forward to continue progress during the remaining part of 2016. I wish you all good evening.

[Operator:]

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