Ohr Pharmaceutical, Inc. (NASDAQ:OHRP)
Q3 2016 Earnings Conference Call
August 09, 2016, 17:00 ET
Michael Wood - LifeSci Advisors, IR
Jason Slakter - CEO
Sam Backenroth - CFO
Avner Ingerman - Chief Clinical Officer
Welcome to the Ohr Pharmaceutical Company Third Quarter 2016 Earnings Conference Call. [Operator Instructions]. It is now my pleasure to introduce my host, Mr. Michael Wood, LifeSci Advisors. Thank you. Mr. Wood, you may begin.
Thank you, Operator and good afternoon everybody. After the market today, Ohr released financial results and provided a business update for the quarter ended June 30, 2015. If you did not yet receive the release 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 on the company's website following.
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 is also on the line for Q&A session.
With that, I would like to turn the call over to Dr. Slakter. Please go ahead.
Thank you, Michael. Good afternoon and thank you for joining us today. It's been a very busy and exciting year so far at Ohr. We have accomplished many of our corporate and strategic objectives. I will focus my discussion primarily on our lead development candidate, topical Squalamine also referred to as OHR-102, which is now in a registration clinical program for neovascular age-related macular degeneration also known as wet AMD. In March, we announced the achievement of a special protocol assessment or SPA from the FDA which provides us with a binding agreement on the design of the trial. This was closely followed in April with the commencement of the first of two phase three clinical trials of Squalamine an AMD. We’re very excited to have this program underway and are very pleased with the interest we continue to see in the clinical community.
We can report that patients are being treated on the clinical study program at dozens of sites across the United States. As you know patients with wet AMD are in need of new more efficacious treatment that can improve on the vision gain scene with current therapy. There's also a great unmet medical need for topical noninvasive treatment options for this patient population. We feel Squalamine, a topical multi target anti-antigen agent used in combination with anti-ANTI-VEGF treatment could meet these critical patient needs and establish a new standard of care.
This is a very significant market opportunity and we are committed to advancing Squalamine through Phase 3 development and registration as quickly as possible. We have discussed the design of the Phase 3 trials before, but I think it's worthwhile to go over some of the details. The registration clinical program incorporates two double math placebo controlled multi-center study of Squalamine lactate ophthalmic solution 0.2%. The drug is being administered topically twice a day in combination with Lucentis injections in patients with newly diagnosed wet AMD. The primary endpoint is an evaluation of visual acuity gains at 9 months with patients then followed out to 2 years for safety. We chose this endpoint, because visual acuity is the most meaningful clinical measurement of efficacy in this setting. Furthermore, the primary endpoint in the Phase 3 studies is aligned with the visual acuity benefits we observed at a similar 9-month time point in our prior Phase 2 IMPACT study. This allowed us to better power and de-risk the Phase 3 program.
The patient population we’re enrolling was defined based on the extensive analysis we conducted on the Phase 2 data in which we identified those subjects having the greatest visual acuity benefit from Squalamine combination therapy. The neovascular lesions in these eligible patients may contain any type of CMV, classic and/or occult provided the occult CMV component of these lesions measures less than 10 square millimeters as assessed on fluorescein angiography. The target enrollment number for each trial is 650 patients with the first study expected to include more than a 125 clinical centers in North America.
As we have previously stated we’re seeking a strategic partner to collaborate with us on the development and commercialization of Squalamine. Discussions with these potential partners are ongoing. I can say that there is recognition among the people we're talking to with respect to the positive clinical attributes of Squalamine and the significant size of the commercial opportunity. I think you can appreciate there's relatively little else we can discuss at this point beyond what is in our 10Q. but I look forward to updating you when we have further news.
Now let me spend a minute talking about the progress we have made with our proprietary sustained release technology. As you know we have a pipeline of preclinical sustained release drug product candidate that addressed ocular indications including glaucoma, ocular-allergy and retinal disease among other ophthalmic condition. These candidates together with our proprietary sustained release drug delivery platform or ocular drugs were acquired with the asset of SKS ocular in 2014. There is a particular challenge in achieving sustained levels of a therapeutic drug in the ophthalmic setting and our goal here is to provide sustained and predictable release of a drug both small molecules and biologics over a three to six month time period.
We have previously reported positive results from our sustained release technology demonstrated sustained therapeutic concentrations of OHR3031 and anti-angiogenic agent which acted over a prolonged time in multiple invivo study. I'm pleased to report that we have followed up on these successful pharmacokinetic studies with a positive invivo study with OHR3031 demonstrating sustained pharmacological anti-angiogenic activity in a rabid model of laser induced CMV. We were able to show that a single intravitreal injection of micro particles containing OHR3031 produced clinically meaningful and statistically significant efficacy six weeks after dose administration in this model which was the latest time point to evaluate. We saw a dose response in the reduction of average CMV lesion area with OHR3031 compared to vehicle treatment with the highest dose exhibiting a statistically significant effect at week six. Furthermore the magnitude of difference in average CMV lesion size of a high dose of OHR3031 compared to vehicle treatment at six weeks was comparable to that seen at two weeks with the currently approved anti-VEGF agent conducted in the previous study.
These ongoing studies serve as important validation of our SKS sustained release technology which we believe holds the promise of improving the standard of care in a number of ocular conditions by allowing for position administration of drugs at convenient treatment intervals. We anticipate presenting additional invivo proof of concept data on our internal program in the second half of calendar 2016 and in 2017.
Now I'd like to have Sam provide additional details on the financial results we just reported. Sam?
Thank you, Jason. For the third quarter ended June 30, 2016 we reported a net loss of approximately $7.7 million or $0.24 a share compared to a net loss of $3.3 million or $0.11 a share in the same period of 2015. Total operating expenses were approximately 7.6 million consisting of 1.7 million in general and administrative expenses, 5.6 million in research and development expenses and 0.3 million in depreciation and amortization. This compares to a total operating expense in the same period of 2015 of approximately 3.3 million consisting of 1.6 million in general and administrative expenses, 1.5 million in research and development expenses and 0.3 million in depreciation and amortization.
For the nine month period ended June 30, 2016 we reported a net loss of approximately 19.1 million or $0.61 a share compared to a net loss of approximately 11.3 million or $0.41 a share in the same period of 2015. For the nine months ended June 30, 2016 total operating expenses were approximately 17.8 million consisting of 5.8 million in general and administrative expenses, 11.8 million of research and development expenses and 0.9 million in depreciation and amortization. This compares to total operating expenses of 14.3 million in the same period of 2015 comprised of approximately 5.7 million in general and administrative expenses, 7.4 million in research and development expenses and 0.9 million in depreciation and amortization.
At June 30, 2016 the company had cash and cash equivalents of approximately 17.6 million this compares to cash and equivalence of approximately 28.7 million at September 30, 2015. For additional details on our financials I would refer you to 10Q just filed with the SEC as well as our prior filings.
That completes my review. We will open up the call to questions. Operator?
[Operator Instructions]. Our first question comes from [indiscernible], a private investor. Please go ahead.
In July of 2015, OHR started the 20 patient six month treatment Phase 2 study number, 1501 in three cities, Maryland, Texas and California. I want to get an update on this. Has the study completed enrollment and if so when?
The study is ongoing as planned and we don’t provide specific information about studies other than [Technical Difficulty].
So you cannot indicate if the patients have been completed the enrollment?
The study as [indiscernible] mentioned the study is ongoing. Over the last few months we have been focused on getting our Phase 3 developmental program up and running and now the enrollment is moving along nicely in the Phase 3. We will be paying more attention to this program and to other of our developmental plan and we will be able to update you in the future.
Gentlemen, there are no further questions at this time. I would like to turn the floor back over to Dr. Slakter for any closing remarks.
Thank you, Operator and thanks all of you for joining. In closing the third quarter of fiscal 2016 was another very productive period for Ohr and we’re very excited to have the Phase 3 Squalamine program now underway. I look forward to updating you as we continue to make progress both with Squalamine and our sustained release therapeutic pipeline. Thank you again for joining us and have a very good day.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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