Paul Arndt – Investor Relastions-LifeSci Advisors Jason Slakter – Chief Executive Officer Sam Backenroth – Chief Financial Officer

Jonathan Aschoff – Brean Capital Elemer Piros – Roth Capital

Greeting and welcome to the Ohr Pharmaceutical Company Fiscal 2015 Financial Results 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] I’d now like to turn the conference over to your host Paul Arndt, Managing Director of LifeSci Advisors. Thank you. You may now begin.

Thank you, operator. Good afternoon everyone. After the market closed today Ohr released financial results and provided a business update for the year ended September 30, 2015. If you did not yet receive this release, it is available on the Investor Relations section of the company’s website at www.ohrpharmaceutical.com. This call is being webcast and you can view slides that accompanying the management discussion on the company’s website. A replay will be available. Before we begin, I’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-K, which will be filed within the next few days, 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; and Mr. Sam Backenroth, Chief Financial Officer. With that, I’d like to turn the call over to Dr. Slakter. Please go ahead, Dr. Slakter.

Thank you, Paul. Good afternoon everyone, and thank you for joining us today. This is my first year-end call as CEO, and I’m pleased to provide you with an update on the progress we have made over the past year. On the call today, I want to spend most of the time talking about OHR-102, our topical multi-target angiogenesis inhibitor. In particular, what we have learned from the Phase 2 IMPACT clinical trial and how that sets the stage for the planned Phase 3 registration program and our regulatory strategy. I will also give an update on the latest developments with our sustained release technology platform and discuss some other corporate highlights. Sam Backenroth, our CFO, will review the financials. This year, we successfully completed the Phase 2 IMPACT study that investigated OHR-102 in patients with wet-AMD. We demonstrated a positive and clinically meaningful treatment effect with OHR-102 combination therapy, demonstrating a benefit in visual acuity outcomes. From a regulatory and patient perspective, vision improvement is what really matters in wet-AMD. In addition to evaluating the primary and secondary endpoints in the overall treatment population, we conducted a series of analyzes of the IMPACT data, which were reported at various large scientific meeting throughout the past year. Based on this work, we believe we now have a clear understanding of how OHR-102 works and which patients are the best candidates most likely to respond to treatment. I’d now like to move to the slide deck for those you who were following along. I’ll begin starting at Slide number 3. Let be begin by summarizing where we stand with OHR-102. We have demonstrated positive visual acuity benefits with OHR-102 used in combination with Lucentis versus Lucentis monotherapy, where Lucentis was given on an as needed basis in patients with wet-AMD. The results of our Phase 2 IMPACT study have identified a patient population with a greatest potential to benefit from OHR-102 combination therapy and this allows us to enrich the population. We will enroll in our Phase 3 program. The Phase 3 SPA was submitted in early November and we anticipate initiating the clinical program upon its completion with the enrollment expected to begin in the first quarter of 2016. Before we go into detail on our clinical program, I think it is worthwhile to give some background on how companies typically approach drug development. One option is to design a targeted Phase 2 study that is of relatively short duration and with a very restricted patient population with a goal of generating positive data early. The subsequent Phase 3 study is therefore longer in duration and typically enrolls a broader patient population than what was included in the Phase 2, resulting in some increased risk for success. On the other hand, an alternative approach and the one we decided was more appropriate in designing the Phase 2 trial is to conduct an exploratory Phase 2 study with a broad inclusive population and longer duration with a goal of identifying the patients that have the greatest benefit from therapy. The resulting Phase 3 can then be enriched using the identified population over similar trial duration. Thus reducing the risk and increasing the likelihood of a positive outcome in the registration trials. This is a schematic representation of these two drug development approaches. The targeted approach enrolls a Phase 2 that is less representative of the larger Phase 3 population being enrolled, thus increasing risk when moving into Phase 3. The opposite is true in the exploratory approach taken by Ohr in our Phase 2 program. Now, let’s look at our Phase 2 study of OHR-102 in which we enroll patients with newly diagnosed wet-AMD with a broad range of lesion characteristics. The wet-AMD population is a very heterogenous group of patients with neovascular lesions varying in size, location, and composition of CNV. These small black and white images are fluorescein angiograms from patients with wet-AMD, showing the variability in the lesion composition, which can range from completely classic to totally occult CNV as well as mixed lesions with both classic and occult components. The IMPACT study was a Phase 2 trial in which only treatment naïve patient with wet-AMD were enrolled at 23 sites in the United States. Eligibility criteria were very inclusive, enrolling all lesion compositions, both classic containing as well as occult only CNV lesions. Lesion size is up to 12 disc areas, as well as a wide range of visual acuity. At baseline all patients received a single Lucentis injection and then were randomized to either active treatment with OHR-102 or placebo drops administered twice a day for the full nine months of the study. All patients return on a monthly basis and were retreated with Lucentis as per strict SD-OCT criteria, similar to those used in the NIH monitored CAT study. In this diverse population of patients completing the study, we achieved better efficacy with OHR-102 used in combination with Lucentis versus Lucentis monotherapy across all visual, functional endpoints. A pre-specified analysis of patients with classic containing lesions was conducted. Note, that classic containing lesions are a subset of the overall AMD population, defined as a lesion with any visible classic components. This would include patients with lesions only with classic only lesions as well as those with the combination of classic and occult CNV even with the vast majority of the lesion is occult in nature. In these patients with classic containing CNV, we again see better efficacy with OHR-102 combination therapy across all visual outcomes but with greater benefits noted in this group of patients than in the overall population. Looking in more detail, we see that there are clinically significant gains in mean visual acuity with OHR-102 combination therapy versus Lucentis monotherapy with a six-letter increased gain in vision by month-nine. These gains were seen early and continue to increase throughout the study. Similarly, when looking at the clinically meaningful endpoint of three or more lines of vision improvement, better efficacy was seen in the combination therapy group throughout the entire nine months of the trial. Given the strength of this data we could have stopped here and move forward with the classic containing population of our Phase 3 program. Notice on this slide, these classic containing lesions account for only a subset of the overall AMD population. Furthermore, the classic containing CNV sub group itself is a heterogeneous population with respect to size, as well as lesion composition. Remember, that a lesion is classified as classic containing as long as any portion of the lesion is identified as being classic CNV. Thus you can have a small 100% classic lesion, as well as a very large lesion with nearly all occult CNV and just a small spot of visible classic CNV and anything in-between. Let’s look more closely at two of these classic containing lesions that were enrolled in the IMPACT study to understand just how diverse this group can be. Here we see the early and late fluorescein angiograms of these two patients along with their accompanying OCT images. On the left are the early angiogram images, showing classic CNV in each patient, designed by the yellow arrow. In the second frame in each row, we see the late angiogram images with an occult CNV component identified by the green arrow. Note the differences between these two patients with respect to the size of these different CNV components. Note also the differences in the appearance of the OCT scans. Clearly, the classic containing category encompasses a very diverse population that may have a varied response to treatment. Given the marked heterogeneity of the classic containing CNV subgroup, and the variability of response to treatment, we felt that it was logical to move beyond this analysis and determine if there are more important factors driving treatment response in combination therapy. The data from the IMPACT study have identified the size of the occult CNV at baseline as the most important determinate of visual benefits in this study. The mean change in visual acuity at month-nine was plotted as a function of the baseline occult CNV size, regardless of the presence or size of any classic component. This analysis reveals that the occult CNV size was directly and very strongly correlated with visual gains in patients treated with combination therapy. Looking at various categories of occult CNV size, it was determined that the smaller the occult CNV at baseline, the greater the mean change in visual acuity throughout the study for the OHR-102 combination therapy group. Note, that the larger the occult CNV size, the smaller the gains in visual acuity. This size responsive effect was not seen in the patients treated with Lucentis monotherapy. A similar size response affect was seen when looking at the proportion of patients gaining three or more lines of vision. Again, for the combination treated patients, the size of the occult CNV at baseline, regardless of the presence of a classic CNV component, was found to determine the visual benefits of this therapy. Looking back at the correlation of vision gains as a function of occult CNV size, we determine that consistent, positive visual acuity benefits were noted in those patients treated with combination therapy, when the occult CNV was less than 10 square millimeters or approximately four disc areas in size. This particular size cutoff for positive treatment benefits is not a new observation. In the early 2000s it was found that treatment occult only or minimally classic CNV lesions with Visudyne photodynamic therapy produced consistent positive benefits when the lesion sizes were less than 4.0 MPS disc area which corresponds to an area of 10 square millimeters. It is not a coincidence that this is the same size cutoff that is noted in the IMPACT study for occult CNV to achieve consistent, positive treatment benefits. So let’s think about this, mechanistically, photodynamic therapy resulted in photochemical closure of the neovascular vessels in AMD. We believe that OHR-102 used in conjunction with anti-VEGF injections induces CMDB stabilization due to its multi-target inhibition of neovascular growth factors. In both cases the closer of larger, more established occult CNV that only recently cause visual symptoms in a patient, may not be desirable. On the other hand, smaller or less established neovascular complexes whether classic or occult may best be treated by combination therapy to restore normal macular architecture. When this 10 square millimeter limit of the occult CNV was applied to the IMPACT study, it was found that 94 of the 128 patients completing the study met the criteria. A larger proportion of patients have been classified as classic containing in the prior analysis. In this rich patient population regardless of whether there was any classic CNV present a positive visual acuity benefit was seen in mean gain of vision from base line in the OHR-102 combination treated group versus the monotherapy treated patients. This difference was seen early in the study and persisted to the nine-month endpoint with a meaningful additional benefit of 5.3 letters in favor of the OHR-102 combination arm. The positive benefits of OHR-102 combination therapy were also seen in the proportion of patients gaining three or more lines of vision. This efficacy was seen consistently throughout the entire nine months of the clinical trial. This has obvious implications for the treatment of patients with AMD, since occult CNV less than 10 square millimeters in size represents approximately 75% to 80% of the overall AMD population seen in clinical practice today. Recall, we saw that in classic containing CNV OHR-102 combination therapy resulted in greater vision gains across all measures of visual function versus Lucentis monotherapy. In patients with occult CNV less than 10 square millimeters we see this same consisted visual benefits but in a much larger more inclusive patient population. We have received guidance from the FDA which gave us the go-ahead and insight to proceed to Phase 3 with a primary efficacy endpoint for filing at nine months. Importantly, the nine month primary endpoint is the same duration as our Phase 2 study which we believe further reduces risks in the Phase 3 program. Each of these two Phase 3 trials will involve approximately 650 patients with newly diagnosed treatment naive CNV randomized one-to-one to receive either topical OHR-102 twice a day or placebo eye drops twice a day for the full two years of the study. All patients will receive monthly Lucentis injections from first year and then criteria based PRN Lucentis injections in the second year. The primary endpoint of the study will be a visual acuity parameter at nine months. We are extremely pleased with the results of our development plan to-date and the path forward. We successfully enrolled a broad inclusive patient population in our Phase 2 study that allowed us to identify those patients with the greatest potential to achieve a treatment benefit from OHR-102 combination therapy. We have used this knowledge to enrich the Phase 3 program and we’ll enroll this patient population in the trials, which supports a greater likelihood of success. This slide is a summary. We have demonstrated positive visual acuity benefits with OHR-102 used in combination with Lucentis in patients with wet-AMD versus Lucentis monotherapy. The results of our Phase 2 IMPACT study have identified patient population with the greatest potential for benefit and allows us to enrich the patient population we enroll on our Phase 3 program. The Phase 3 FDA was submitted in early November and we expect the program will be initiated upon its completion. Enrollment for the Phase 3 program is expected to begin in the first quarter of calendar 2016. This ends the slide presentation portion of the call. One of the other indications we have been exploring with OHR-102 is macular edema secondary to retinal vein occlusion. In July, we announced positive final results for Phase 2 investigator sponsored clinical trial at the Annual Meeting of the American Society of Retina Specialists in Vienna, Austria. The data presented included the final analysis of patients that following 10-week initial combination treatment period were randomized proceed either continued OHR-102 plus Lucentis PRN therapy or Lucentis monotherapy PRN through 38 weeks. At week 38, we saw a clinically meaningful difference in visual acuity of 4.5 letters in favor of the OHR-102 group. Furthermore, by the end of the study, 80% of the patient in the OHR-102 plus Lucentis combination arm had a gain in visual acuity, compared with only 50% of the patients treated with Lucentis alone. This trial is important I think for two reasons. First, these results indicate an opportunity to serve this patient population and the consistency of the efficacy data in the study definitely wants further study in a larger controlled clinical trial. Second, this positive outcome adds to the overall body of data we have on OHR-102, demonstrating that the drug is clinically active and it’s able to produce a treatment effect in the back of the eye. Now turning to our SKS sustained release platform. We have a pipeline of preclinical sustained release drug product candidates, that address a number of ocular conditions, including glaucoma, steroid-induced glaucoma, ocular allergy, and retinal disease among other ophthalmic disorders. These candidates together with our proprietary sustained release drug delivery platform, we’re acquired with the asset of SKS ocular last year. The SKS sustained release technology employs micro fabrication techniques to create nano and microparticle drug formulations that can provide sustained and predictable release of a therapeutic drug over a 3-month to 6-month period. It has been developed to circumvent many of the challenges associated with current drug delivery approaches with the ability to sustain therapeutic drug levels for both small molecules and biologics for extended durations. Our goal with this platform technology is to develop a pipeline of drug candidates that can enhance patient compliance, reduce treatment burden and improve visual outcomes. We announced last week, positive preclinical results with one of these drug candidates in an animal model use to evaluate ophthalmic compounds. We were able to show that sustained supratherapeutic levels of active drug could be achieved in target ocular tissues and demonstrated that these active levels were present at all time points in the study, indicating a prolonged pharmacokinetic profile. We see the results of this study as an important validation for our SKS sustained release technology. We plan to present the results in medical meeting during 2016 and will keep you posted, as we move forward with these programs. Now I would like to have Sam, provide additional detail on the financial results, we’ve just reported. Sam?

Thank you, Jason. For the fiscal year ended September 30, 2015, the company reported a net loss of approximately $15.2 million or $0.54 per share. This compares to a net loss of approximately $9.1 million or $0.41 per share in the same period, in 2014. Total operating expenses for the year were approximately $17.8 million, consisting of $7.4 million in general and administrative expenses $8.8 million in research and development expenses, $1.2 million in depreciation and amortization and $0.3 million in impairment of intangibles. This compared to approximately $9.1 million in 2014, consisting of $4.3 million in general and administrative expenses. $4.4 million in research and development expenses, $0.5 million in depreciation and amortization and no impairment of intangibles. At September 30, 2015 we had cash and cash equivalents totaling approximately $28.7 million. This compares to cash and cash equivalents of approximately $13.2 million at September 30, 2014. For a more detailed description of the financials, I would encourage you to refer to our 10-K, which should be filed on Monday morning. That completes my review of the financials. I will now open up the call to questions. Operator?

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Jonathan Aschoff from Brean Capital.

Hi, good afternoon and thanks for taking my question, guys. I was wondering how far along are you with those small studies that you have started in wet-AMD?

We are progressing along nicely and expect to be able to report results in 2016.

Anything more granular than – just like, first half, first quarter or something later?

Not any more granular than that.

Okay, given the roughly $29 million and the cost of the trial. Can you maybe give us a bit of a more of a description of how you are going to finance the Phase 3s and will you start them with or without in SPA, now sounds like the SPA negotiation is the overwhelming reason for 1Q versus the end of the year? And I’m just kind of curious, will you go with or without it and how you are going to plan to finance them?

Jonathan, we have multiple financing options available to us. As we stated in our previous filings, we are active in ongoing discussions with several parties regarding a partnership for licensing of OHR-102. We’re confident based on the positive data from the Phase 2 study. The population we’ve identified with a greatest potential for benefit and the risk mitigation we have in our Phase 2 program to move forward with the initiation of the Phase 3 program and that our business development process will yield the successful outcome.

Okay. And then with or without the SPA you’ll start?

The SPA process as you know provides us with an opportunity to gain concurrence with the FDA on the specifics of our Phase 3 program. So since the SPA leads to a binding agreement and further reduces risk of our registration trials we’ll complete the SPA process before we begin the enrollment in the trial.

Right, if you don’t get an SPA sometimes the companies ask and they won’t get it, would you still start the trials?

We have a high level of confidence that we will get an SPA with the FDA.

Okay, while you are enrolling these trials can you maybe help us understand the enrollment competition environment?

That’s a very question Jonathan. Clearly there are a lot of clinical trials going on in the wet-AMD space we’ve had feedback from perspective clinical investigators that have indicated enthusiasm for involvement in our Phase 3 program. Partly because it includes a non-invasive topical agent in combination with an anti-VEGF injection but also based on the strength and consistency of the Phase 2 data that we just went over just now.

All right, that’s it from me. Thank you, guys.

Thank you.

Thank you.

Thank you. Our next question comes from Elemer Piros from Roth Capital.

Yes, good evening gentleman. What I’d like to expand a little bit on is the SPA itself. Before the data was released, you were fairly confident that you have an agreement with the FDA. Once the data was released and its totality, you have repeated that level of confidence. Which aspects of the protocol that you would like to gain additional comfort by going through the SPA process?

I kind of partly answered that with Jonathan’s question. I think to keep in mind an SPA is not a fact finding activity, it’s a process that leads to a formal binding agreement. So as I think you gathered from the presentation that I just completed our goal here was to move forward in the most de-risked manner possible, we moved into our Phase 3. That included the design of the Phase 2, the analysis we conduct at the Phase 2, the search for and identification of an optimal broad patient population that we can enroll that could give us the best chance of success. And in addition to that is the SPA process and that process as you know goes along through an evaluation and an agreement that leads to a binding process with the FDA. Once you have that in place you are essentially working the FDA hand-in-hand for a successful clinical trial. So it allows us to have enhanced interaction with them and have the clear endpoint at the end of the process without any questions.

Okay, would you indicate what would be a follow-up indication beyond wet-AMD that you would as a company pursue as opposed to investigator sponsored trials?

Obviously, we as a company our self have kind of our wish list for where we’d like to take the compound forward. But obviously in partnership with another company they would have some input into the development process. Clearly, we have seen that vein occlusion data is very supportive of moving forward in that indication. Those trials tend to be faster to enroll and shorter to completion. So that would be a compelling area to move. But in addition to that, an agent that’s selling as dramatic in effect in visual outcomes as we’ve seen in this clinical study that we’ve just reported opens the possibility for a non-evasive therapy as a risk producing agent. So the idea of moving into the study that would involve reducing the risk of converting from dry to wet-AMD would be another compelling area that would be looked at. And again a lot would depend upon the situation of the partnership that we have.

Okay, and maybe just a couple of more, if I may. How expensive do you think these trials would be? And how far apart would you initiate them from each other?

So I’ll take the first one with regard to cost. It’s widely appreciated that our Phase 3 program for this indication is going to cost as much as $100 million or more. Through the completion of the Phase 2 to the Phase 3 two year follow-up and we would expect our program to be in line with that.

All right. Thanks.

I think you also were asking about how much the other studies would runs is that how I interpret that.

How far behind the first one, yes?

Yes, it would all again, would all depend upon the position of the company and the partner that we are working with. And it also depends upon the indication. It’s interesting that the clinical trials that I just mentioned with time wise be similar or shorter and would actually that potential cost would be lower than what we are talking about. But again it would all have to do with the strategic position we were in at that time. And can give you more guidance on that.

Yes, I’m sorry Jason I wasn’t probably perhaps clear. What would be the planned delay between the first Phase 3 trial in wet-AMD and the second Phase 3 trial in wet-AMD?

I’m sorry. As far as starting the studies we intend to start the studies as closely and possible with each other as we can. It’s very likely the global study will begin after the North American study

Thank you so much for it.

Sure.

Thank you. That’s all the time we have for today’s call. I’d now like to hand the call over to Ohr for final comments.

Thank you very much. In closing, this is an exciting time for Ohr Pharmaceutical. We are moving into registration trials with our lead clinical compound topical OHR-102. And at the same time, we are advancing a number of our sustained delivery compounds through the development process that represent additional opportunities to further our goal of being an ophthalmic company that addresses meaningful unmet needs in the ophthalmic space. In closing, I want to thank the entire team at Ohr for their continued commitment and drive to our mission, and look forward to an even more exciting 2016. Thank you all for listening, and I want to wish you all a happy and healthy holiday season. Good evening.

Thank you. This does conclude the teleconference. You may disconnect your lines at this time. Thank you for your participation.