NeuBase Therapeutics, Inc.
Q3 2015 Earnings Call Transcript

Published: 9 Aug 2015

[Operator:]

Welcome to the Ohr Pharmaceutical Third Quarter 2015 Financial Results Conference Call. [Operator Instructions]. At this time I would like to turn the call over to Mr. Michael Wood of LifeSci Advisors. Please go ahead, sir.

[Michael Wood:]

Thank you, Operator. Good afternoon everyone. After the market closed today Ohr released financial results and provided a business update for the third quarter ended June 30, 2015. 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 on the company's website. Before we begin, we'd like to remind you that 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-Q filed today, 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. Irach Taraporewala, Dr. Jason Slakter, and Mr. Sam Backenroth. With that, I'd like to turn the call over to Dr, Taraporewala. Please go ahead, sir.

[Irach Taraporewala:]

Thank you, Michael. Good afternoon everyone and thanks for joining us on the call. We have had a very productive quarter and we will give you an update today on continued progress with our lead candidates Squalamine eye drops or OHR-102 which we’re developing for treating retinal diseases. By now most of you will have read the press release we issued yesterday morning stating that I will be stepping down as Chief Executive Officer of Ohr Pharmaceutical. The new CEO will be Dr. Jason Slakter, our current Chief Medical Officer. It has been my privilege to serve as CEO and President of the company for the last 5.5 years seeing us grow from pleasant startup with two employees with a dream into a full fledge NASDAQ listed and focused organization with an internally first in class product for retinal disease about to enter Phase 3 registration clinical trials. Through the acquisition of SKS Ocular last year we also added a novel sustained release technology platform and have expanded our pipeline to include preclinical sustained release drug for our product candidates. It has been a great experience of corporate growth and the development of valuable therapeutic pharmaceutical product. But corporations living organism [ph] have much evolved and change as they grow. Ohr Pharmaceutical has evolved two point where it's most advanced clinical program that was Squalamine eye drops is about to enter Phase 3 trials and will truly benefit from the guidance and leadership of a leading clinical expert in ophthalmological drug development. Dr. Jason Slakter or as new CEO is an internationally renowned expert in ophthalmology. He has played a critical role in many companies that have successfully brought blockbuster Ocular drug to market and to the patients who need them. He has been involved with Ohr Pharmaceutical since the inception of our ophthalmology program. As he has additionally being a member of our Board of Directors and will continue to be on that Board going forward. Many of you have in fact had the opportunity to meet and interact with Jason since joined us last year and I think you will agree with me that he is the right person at the right time and with the appropriate combination of leadership, experience and vision to maintain, to manage the next phase of the company's development. I will myself continue to actively serve Ohr Pharmaceutical as both a member of the corporate Board of Directors and in my new position as Chief Technology Officer. In this new role I shall be spear heading our corporate research and development efforts to advance Ohr Pharmaceuticals technologies and to accelerate the further product development of our robust pipeline of sustained release of [indiscernible] drug candidates. As we have outlined earlier these include experimental treatment for ocular allergy and glaucoma, protein drugs for retinal diseases and also new topical treatments or back of the eye disorders. It is our intent to elevate our pharmaceutical to the forefront as the leading pharmaceutical company to address unmet medical needs in Ocular disease treatment. I want to thank the Board of Directors, management and staff and the shareholders of the company for all their support during my tenure. I will now like to welcome Dr. Jason Slakter the new leader of our corporation to address all of you. With that I will turn the call over to Jason.

[Jason Slakter:]

Thank you, Irach. Good afternoon everyone and let me begin my thanking Irach for his kind words of support and his years of inspired leadership. I too I'm glad that we will continue working together here at Ohr. Of course I'm honored to become Ohr Pharmaceutical's next CEO, and I look forward to leading our dedicated and talented team as we continue to advance the development of first in-class drugs for unmet needs in a wide variety of chronic [ph] diseases. As Irach noted we had a productive quarter with significant announcements in the clinical development of OHR-102 and I will give you some more detail on those accomplishments. We have now accumulated a substantial body of evidence, demonstrating that OHR-102 has a potential to be game changing treatment option for patients with various retinal diseases. Many of you know are by now familiar with our clinical data but let me reiterate some of the important features of OHR-102 and explain why it is that we’re so confident in the drug and why we think it has such great potential. As you will recall the Phase 2 IMPACT study was in all commerce trial that enrolled 142 patients at 23 sites across the United States. We focused exclusively on treatment naïve patients with either classic containing or occult only lesions with sizes upto 12 disc areas and a wide range of visual acuity. In those patients with classic containing choroidal neovascularization, a mean gainable 11 letters was shown in those receiving in the combination treatment versus the gain of only five letters, but the group treated with Lucentis monotherapy a difference of six letters. In addition 44% of patients treated with OHR-102 combination therapeutic gained three or more lines of vision by comparison, only 29% of that Lucentis monotherapy patients reported similar outcome. These differences became evident as early as four weeks after first initiating treatment. A similar treatment effect was seen when patients with smaller occult C and D lesions were analyzed at the end of the study. The drug was well-tolerated throughout the clinical development process. These data clear indicate that OHR-102 is reaching it's target tissue in the back of the eye and providing a clinically meaningful visual benefit when used in combination with an [indiscernible]. As a result we’re now actively preparing a Phase 3 clinical program for OHR-102 with patient selection criteria based on the outcome of our analysis of the impact study data. The information we have gathered has helped to optimize the patient population for this trial in order to maximize the likelihood of a positive outcome. The visual acuity primary end point is at nine months for regulatory submission. Subjects will be followed for 24 months for safety. Our goal as we have stated is to begin enrolling patients in the second half of this year. In parallel with these preparations for the Phase 3 program we’re also in the process of enrolling patients with wet AMD in a small exploratory Phase 2 trial utilizing OHR-102 in combination of anti-VEGF therapy. We’re conducting this study to further evaluate the functional and anatomical effects of combination therapeutic for OHR-102 with Lucentis administered monthly we will be utilizing advanced retinal imaging modalities in these patients to identify the best means to demonstrate the anatomic changes associated with combination therapy and to differentiate the effects of our comparable ocular agent. We at Ohr are interested to see the results of this study but I think it's important to stress that the completion of this trial is not a gating factor for commencing our planned Phase 3. As I said we remain on track and expect to begin the Phase 3 trial in the second half of this year. We achieved another important milestone in July with the release of positive final results from the Phase 2 investigator led study of OHR-102 in macular edema secondary to retinal vein occlusion. Those results demonstrated that following an initial 10 week combination therapeutic treatment period patients who were randomized to continue receiving combination of comparable OHR-102 twice a day plus Lucentis achieved greater visual acuity gained than the control group received with Lucentis alone. At week 38, patients receiving the combination of comparable OHR-102 plus Lucentis reported mean gain in visual acuity of 27.8 letters from baseline, this compared with a gain of only 23.3 letters in the control group for a clinically meaningful difference in digital gain of 4.5 letters. We’re greatly encouraged by these positive results and believe that they weren't further study of OHR-102 in a larger controlled clinical trial in this additional retinal disease. Furthermore these data win strong support for the ability of topically applied OHR-102 to a disease modifying effect on a variety of retinal conditions. As we look to the remained of 2015 we will have a continued presence at the major medical conferences. You will hear additional data presentations from the impact study at the [indiscernible] in September, the Annual Meeting of the Retinal Society in October and the America Academy of Ophthalmology meeting in November. Before I turn the call over to Sam, I want to reiterate my excitement over my new role at Ohr. The management and clinical team of the company share my vision of developing new treatment to address unmet needs in ophthalmology. Together we’re focused on improving the quality of life for people affected by sight threatening ocular diseases. I see in Ohr the ideal combination of innovation, experience and drive to accomplish this goal and that is why I accepted the role of CEO. As part of my new position I will also put in a 10D51 plan that will allow me to purchase equity in Ohr on an ongoing basis something which I intend to take advantage of. I would now like to take the opportunity to turn the call over to Sam who will provide additional detail on the financial results we have just reported. Sam?

[Sam Backenroth:]

I would also like to take the opportunity to congratulate Jason on his new role. Beginning with the results for the third quarter ended June 30, 2015, general and administrative expenses in the quarter were 1.6 million up from approximately 786,000 in the same period of 2014, the increase as a result of decreases in corporate overhead additional hiring and stock option expense and compensation. Research and development expenses were 1.5 million in the quarter as compared to 1.2 million in the same period in 2014. The increase is as a result of the ongoing clinical trials and ophthalmic indications, increased costs associated with the acquisition of SKS Ocular, as well as stock option expense. For the three months ended June 30, 2015 we had a net loss of 3.4 million or $0.11 per diluted share compared to a net loss of 2.1 million or $0.09 per share in the third quarter of 2014. Turning briefly to the nine month period ending June 30, 2015 G&A expenses were 5.7 million and R&D expenses were 7.4 million. For this nine months period we recorded a net loss of 11.3 million or $0.41 per share compared to a net loss of 6 million or $0.28 per share for the same period of 2014. As of June 30, 2015 we had cash and cash equivalents of approximately $31 million as due to 13.2 million as of September 30, 2014. For more detailed description of the financials I would encourage investors to refer to our 10Q which should be filed shortly today. That completes my review, we will now open up the call to questions. Operator?

[Operator:]

[Operator Instructions]. And we will now take a question from Tyler Van Buren with Cowen & Company.

[Tyler Van Buren:]

First question for Sam, maybe, on the Phase 3 what are your updated thoughts on how much it will cost and given that you’ve 30 million cash on hand, what are the kind of options about for funding it and what are you kind of leading towards? And then situation on the new small scale study perhaps if you elaborate on what caused you all to kind of start investigating, was there any indication from the impact study data to maybe look at Lucentis monotherapy versus PRN and is there anything else that you’re looking at besides just the frequency of dosing and I guess how can we wrap our heads around the fact that it's not a gating factor for Phase 3. Thank you.

[Sam Backenroth:]

In terms of the cost of the Phase 3 clinical program it's widely appreciated that a Phase 3 clinical program in this condition can cost as much as a $100 million or more and we would expect our program to be in-line with that estimate. Now in terms of the funding options available to us we have multiple options that are available to us as we have stated in our 10Q for an active ongoing discussions with several parties regarding license or partnership of 102 which would provide for the funding of the clinical program in a non-dilutive manner. We’re also open to raising capital in the future if necessary.

[Jason Slakter:]

As far as your clinical question, as I’ve stated earlier as we are working toward with the Phase 3 program we have made decision to run this small exploratory Phase 2 trial to look at monthly dosing of anti-VEGF therapy, to accomplish we are utilizing an advance [indiscernible] imaging modality so we’re not used in the Phase 3 trial so we can determine the best means to demonstrate the anatomic change the anatomic changes associated with OHR-102 combination therapy and also Tyler to differentiate the effects of our topical ocular agent in these patients. In addition we may take advantage of the opportunity to explore other anti-VEGF agents used in combination with OHR-102 in this exploratory Phase 2 trial but I do want to reiterate that the completion of this trial is not a gating factor for commencing our Phase 3 plan. It's not a regulatory requirement either and we do remain on track and expect to begin by the second half of this year.

[Operator:]

We will now take our next question from Jonathan Aschoff with Brean Capital.

[Jonathan Aschoff:]

I was wondering the anti-VEGFs that you would need more than 20 patients or you would be redoing it with the same patients?

[Jason Slakter:]

This study, I mean the way we have designed the study it's a small study but it gives us an opportunity to get an idea of the effects of the OHR-102 and combination with these other agents and use the taking advantage of small study, you can do a lot of different imaging techniques that will allow you to learn a lot about the effective combination therapy in a small study like this that you can then make determinations for the ongoing Phase 3 program.

[Jonathan Aschoff:]

So you will do several different anti-VEGFs within those 20 patients?

[Jason Slakter:]

The first 20 patients as we have indicated will be with Lucentis and then we have the option within the trial design to do additional patients with other anti-VEGF agent.

[Jonathan Aschoff:]

And this experimentation here is in no way to gauge sizing for Phase 3 overhead?

[Jason Slakter:]

Not at all.

[Operator:]

[Operator Instructions]. We will now move to Elemer Piros with Roth Capital Partners.

[Elemer Piros:]

If you could please talk a little bit about the remaining work to be done to actually start this Phase 3 trial, if you could give us some detail there.

[Jason Slakter:]

We really don’t have a lot of detail other than the typical things you’ve, you’ve regulatory in production activities and site selection and certification and other activity is typically of a Phase 3 program there is nothing special about what we’re doing right now other than you would expect with any development process.

[Elemer Piros:]

Do you believe that you would want to see the FDA to finalize protocol before starting the study?

[Jason Slakter:]

As you would expect any Phase 3 program we have ongoing interactions with regulatory authorities. But we currently have all the guidance we need to initiative the Phase 3 clinical program.

[Elemer Piros:]

And how you find it on the target observation for the Phase 3 trial?

[Jason Slakter:]

We have selected a patient population that best needs the goal of maximizing enrollment and ensuring a successful outcome for the Phase 3 program and we made this determination based on the analysis of our data from the IMPACT study.

[Elemer Piros:]

And would you be more specific about that you would target classic only or both?

[Jason Slakter:]

We’re going to be able to provide more details as we get closer to the start of the study but eligibility will be determined in part by the characteristics of both classic and occult [ph] C and D components evolution [ph].

[Elemer Piros:]

And I think you alluded to previously that when you looked at the Phase 2 trial in totality and then analyzed the first half of patients there was a different, were you able to pin point the differences between the patient themselves, characteristics of the patient in the second cohort that made responsible for the first half?

[Jason Slakter:]

I think in any trial you’re always going to find some variability. When you look at different groups of people and we simply saw that because we happen to have prespecificied an interim analysis. I think the best way to look at it and as any statistician would tell the best way to analyze data is look at the totality of the data that gives you the best answer as to what's truly going and that’s why we would base our decisions upon the total patient population in the Phase 2 trial.

[Elemer Piros:]

So Jason just last question if I may please, so now you’re looking at monthly Lucentis plus OHR-102 in 20 patients. We have seen their ability in 142, what I would like to understand is what type of information would you be getting from this 20 patient cohort and if you get that type of information which I don’t know how would that impact the protocol of the Phase 3 trial which has been already begun by the time you had this data if you can just help me understand that a little bit?

[Jason Slakter:]

Yes let me start with the beginning of it and say that we do expect there might be some differences in effect with monthly treatment and we realize that potentially there could be greater visual and anatomic effects achieved with combination therapy using a monthly regimen versus a PRN regimen. We’re going to gather the information and look at it and then make determinations as that would have any effect on the Phase 3 program but as I said we have identified our population and we’re moving forward to initiation.

[Elemer Piros:]

But you already have the Phase 3 protocol that you have currently or what you currently communicated that’s going to be a monthly dosing already?

[Jason Slakter:]

That’s correct. Yes.

[Operator:]

[Operator Instructions]. And it appears there are no further questions. I would like to turn the conference back over to today's presenters for any additional or closing remark.

[Irach Taraporewala:]

Thank you, Operator. In closing this is an exciting time for Ohr Pharmaceutical, the company is at a significant juncture of it's growth. Our accomplishments this quarter and throughout the past year have positioned us well for the next set of milestones, we expect to achieve in the rest of 2015 and beyond. We have a potentially life changing treatment for patients with series of ophthalmic disorders with the OHR-102 topical therapy and a world class clinical team to execute it on the development. In addition we have a pipeline of products that represent additional opportunities to further our goal of meeting unmet needs in the ophthalmic space. I want to take this opportunity to thank my colleague Theodore for their continued commitment and drive and their confidence in supporting me in my new role. They are the key to our success and I'm honored to be leading the company at this time. Thank you all very much.

[Operator:]

And once again that does conclude today's conference. We thank you all for your participation.