Good morning, and welcome to Ocugen Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session for research analysts and institutional investors will follow the presentation [Operator Instructions]. Please note this conference is being recorded. I would now like to conference over to Kelly Beck, Vice President of Investor Relations and Administration at Ocugen. You may begin.

Thank you, operator. I'd like to welcome you to our conference call. With me today are our Chairman and CEO Dr. Shankar Musunuri and CFO, Sanjay Subramanian. Earlier this morning, we issued a press release with highlights of our business results and third quarter financial results. We encourage listeners to review the press release, which is available on the Ocugen Web site www.com ocugen.com. This call is also being recorded, and a replay will be available on the investor section of the Ocugen Web site for approximately 45 days. Before we begin our formal comments, I'll remind you that various remarks we make today constitute forward looking statements pursuant to the Safe Harbor provisions of the private securities litigation Reform Act of 1995, including statements related to our financial outlook, our ability to raise capital on terms acceptable to us, our ability to close the NeoCart asset sale and the timeframe associated with such closing, and our product development plans for our product candidates, including the results and timing of any future preclinical studies and clinical trials for such product candidates. These forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from our expectations and forecasts, and can be identified by words, such as expect, plan will, may, anticipate, believe, estimate, upcoming, should, intend and other words of similar meaning. Any such forward looking statements are not guarantees of future performance and involve certain risks and uncertainties. These risks are described in the risk factors section in the registration statement on form S4, registration number 333-232147 as amended, filed by Ocugen Incorporated with the Securities and Exchange Commission and available on the SEC's Web site. Any information we provide on this conference call is provided only as of the day of this call, November 8, 2019 and we undertake no obligation to update any forward looking statements we may make on this call on account of new information, future events or otherwise. In addition, any audited or pro forma financial information that may be provided is preliminary and does not purport to project financial positions or operating results of the company. Actual results may differ materially. I will now turn the call over to our Chairman and CEO, Shankar Musunuri.

Thank you, Kelly. Good morning, everyone. And thank you for joining us this morning. As this is our first conference call as a public company, I would like to take this opportunity to share with you more about our mission, our pipeline programs and the opportunity to create needed new therapies for the treatment of debilitating eye diseases. I'll review our pipeline and the progress we have made since our reverse merger in September. Sanjay will then recap our recently completed reverse merger transaction and discuss our current quarter financial results before the Q&A. The entire management team and our advisors have been strongly focused on creating long term value for our shareholders. Our company was founded upon a mission to develop innovative therapies to address rare and underserved eye diseases. Our most advanced program is OCU300 for the treatment of ocular graft versus host disease or oGVHD for short. oGVHD is a severe chronic autoimmune disease that occurs in up to 60% of allogeneic bone marrow transplantations and represents the critical unmet medical need. By 2020, it is expected that there will be 53,000 patients suffering from oGVHD. Of which, there is no approved FDA treatment. These cancer patients experienced severe and debilitating pain and discomfort, which significantly diminishes their quality of life and restricts daily activities leading to disability in many cases. One patient described this disease like putting hot sauce directly into your eye and rolling your eyeball in the sand, imaging the pain that must feel like for patients who have already undergone so much in their cancer treatment. For some patients, this disease can lead to vision loss and irreparable damage to the ocular surface. Our product, OCU300, is brimonidine 0.18% developed in our proprietary OcuNanoE nanoemulsion formulation. Our OcuNanoE formulation was designed to deliver…

Thank you, Shankar and good morning everyone. As you are aware, we closed our merger with Histogenics on Friday, September 27th, and changed the company to Ocugen. We began trading under the symbol OCGN on Monday, September 30th. Immediately prior to the merger, we completed a private placement financing, or what we refer to as our premerger financing of approximately $25 million under the terms of the securities purchase agreement announced in June 2019. We do see net proceeds of $17.2 million from the pre merger financing after factoring in fees, expenses and repayment of bridge loans. I'd like to take a few minutes to describe this transaction and a bit more detail. At the closing of the premerger financing, we issues approximately 2.2 million shares of our common stock to new investors. Our common stock outstanding as of September 30th was approximately 10 million shares. On October 4th, we issued an additional 2.2 million shares of common stock to these new investors. This brought our total common stock outstanding to 12.2 million shares. In addition, on October 4th as part of the premerger financing, we issued three sets of warrants to these investors, which we amended on Wednesday November 6th; Series A, Series B and Series C warrants. We issued 8.8 million Series A warrants, which have an initial exercise price per share of $7.13 and a term of five years. These warrants were amended to reflect the re-closing equity financing on or before May 31, 2020 with the research our nonprofit foundation our organization in an amount up to $10 million. This financing will be excluded from the anti-dilution adjustment. The Series B warrants have an exercise price per share of $0.01. The Series B warrants were also amended, so that they are not exercisable until the completion…

[Operator instructions] Our first question comes from Swayampakula Rama with H.C. Wainwright.

So I have two questions. So to start off, I'd like to understand a little bit more on the on the Phase 3 study of the OCU200 program, especially trying to figure out some of the time points regarding the Phase 3data. And obviously, you had a great day at the oGVHD -- [oGHD] event which we -- which was held at the University of Chicago. And trying to -- and also the third part of this questions is to trying to understand the potential regulatory pathway that you are taking this drug through?

Our OCU300 programs in patients with ocular GHD is progressing well, continues to enroll patients. We are on track for our statistical review when we reach 50% of client enrollment in first half of next year. That means those -- 50% of those patients have to go through the treatment. Since we are the first company to ever conduct a Phase 3 study in this population, we have worked out with FDA to reach an agreement that we have a blinded review when the data are available on the first 50% of enrolled subjects to ensure sample size was appropriate. And any more details on the clinical trials are available on clinicaltrials.gov, and we expect to have top line results in the second half of next year. Coming back to oGVHD conference, yes, it was a great conference. And once again, I would like to point out some takeaways from that. And again this is a conference, which is organized at University of Illinois Chicago Medical School by Dr. James. It's sponsored by NIH. And it's held every other year and the attendees include oncologists with an expertise in systemic GVHD, and ophthalmologists specialized in oGVHD, as well as economic researchers. Key takeaways from this conference are, oGVHD is often looked among providers as the focus is usually on other organs. Patients are in tremendous pain as there is no medication approved for this indication. Prior markers are also being developed, which could be used in future clinical trials. Clinical trials are few in number and enrollment is slow. oGVHD requires an interdisciplinary approach where oncologists and ophthalmologists work as a team. So once again, based on the conference, there was a FDA attendance at the conference and the general session, and that there was a general discussion about complicity and challenges in the disease itself and some approaches for clinical trials. And they discussed about dialog around appropriate end points, number of studies needed, benefits of having orphan drug designation, prior approval in animal indication. Obviously, based on what FDA shared during the meeting, our Phase 3 program is in alignment with the general principles. We do have orphan drug designation from the FDA for this product. We also have 505(b) (2) pathway.

Talking about the 505(b) (2), obviously, you are actually formulating brimonidine, which is generic at this point into your OcuNano emulsion proprietary formulation system. But at the same time, the question with probably in some investors is. Is it still possible for people to utilize brimonidine, which is available generically or contrary? I mean, otherwise, I can ask the question like, what sort of fences have you folks does, such that the generic brimonidine will not have an impact on your OCU300?

Starting with -- or again, as you pointed out, our brimonidine formulation is in proprietary OcuNanoE emulsion formulation. It's at 0.18% and that dose is not available in the market for currently available generic product, which is available at the higher concentration. And also the market product has benzalkonium chloride, which can be irritating in the patients with ocular surface diseases, such as ocular oGVHD. And we are shown in animal studies head-to-head our OcuNanoE formulation is superior in efficacy compared to normal eye drops. We also have strong patent portfolio, covering our brimonidine formulation and the patents cover major factors. They cover IT related method of treatment, as well as our OcuNanoE proprietary formulation. And typically when you use a generic, there are multiple things you have to look into, including [AB] criteria. You look into is the molecule? Yes, it’s the same molecule. Is the dosing the same? In this case, it's not. And is it actually -- has it gone through controlled clinical trials for a specific disease indication? So we are going through a controlled clinical study for ocular GVHD, and generic obviously was approved for pro forma. And with dosing regimen the same, currently, the other medication it's been used three times a day and we use it twice a day. So that will also restrict pharmacies to take any substitutions at the pharmacy level. So therefore, I think to address again just to sum it up, we have strong IT. We have superior formulation, which improves [indiscernible] for the eye drops. We do not have preservatives in that, which could be irritating, like such as benzalkonium chloride and everything -- and we are doing controlled clinical studies in these patients with ocular GVHD to get a very specific indication for specific drug product, OCU300.

And then going on to CanSinoBIO. Could you help us understand why or how this transaction is a real meaningful one, especially when you're not even initiated as in a clinical study at or basically are trying to get into the clinical study soon? So why is this a big transaction for you at this point?

As we all know, gene therapy manufacturing is very complex, capital intensive and requires specialized expertise. With increasing number of companies entering in gene therapy space, manufacturing demands continue to increase there is limited supply of high quality contract manufacturing organizations who can meet the current demand. This can become rate limiting step in advancing a gene therapy program into the clinic. We start with a partner who had state-of-the-art manufacturing capabilities for viral vectors and produced this commercial product to meet global needs. CanSino was a perfect fit. The key takeaways from this partnership are; it ensures we have the reliable manufacturing path to the clinic; CanSinoBIO fund all costs associated with CMC development and clinical supplies; we will be responsible for focusing on toxicology and clinical studies. In [indiscernible], they have granted CanSino commercialization rights in Greater China where we retain commercialization rights for the rest of the world; we will receive high single digit royalties, as I mentioned before, on sales in Greater China and CanSino will receive low single digit royalties on sales for the rest of the world. So this partnership overall provides a greater flexibility with our capital resources and extensive cash runway.

And couple more questions. The next one is you know when we think of gene therapies for inherited eye diseases, Spark comes to mind and especially with their recent success with Luxturna. So how should the inventors think about Ocugen when we think with regards Luxturna and how different or similar is your technology compared to Spark?

Good question. Once again, we're pretty excited about our modified gene therapy platform. The difference between the current gene therapies, such as Luxturna and ours is, our modifier gene therapy platform is, if you take the Luxturna, the current approaches followed by Spark and other gene therapy companies. So they're using one gene therapy product to address one disease, because you're targeting a specific genetic mutation. This means when you are targeting a new disease, the new product has to be developed from scratch, including manufacturing of the clinical supply and IND enabling studies for each disease. This process requires significant capital and time to get to the clinic. With our modifier gene therapy platform, these nuclear hormone receptor genes have the potential to address many different functions with the retina and to restore normal cell function to the retina. So what it means is we can develop one product that can address many retinal diseases. From the product development perspective, once you have one product in the clinic, you can more quickly move to clinical study for additional diseases, because you already have completed toxicology studies for the product. This is the same product completed the manufacturing process and you will have some safety data on the product, so one product versus one disease versus one product versus multiple diseases.

Yes, that's great. That's really time -- it really saves a lot of time, energy and money, I can see that. Regarding the recent restructuring of warrants that you announced about, two questions on there. Why did you need to do that and the other peace is like what as a management, what are you folks trying to tell investors when you have to do this restructuring deal?

Thanks. I'll take that question. I appreciate that. I think this is in a lot of investors' mind. So we want to take this opportunity to expand the rationale behind this warrant restructuring. As part of the pre-merger financing, as you probably recall, we had three warrants within place, Series A, Series B and Series C warrants. And the Series C warrants were 15 million warrants that were exchangeable for shares 1:1 if the stock drops below $1.20 for any five days during the life of the warrant. And that's overhang in our capital structure which concerning a lot of investors, and we had a lot of questions around that. And the management and the Board was also concerned about it. So we have been having some really productive discussions with our investors, and we were successful in doing the restructuring of these warrants. And the headline is that we were able to reduce the potential valuation by 30 million shares. Essentially, we restructured the Series C warrants from the 50 million that was previously there to just 20 million of warrants, which are exchangeable for shares. Apart from that, we also restructured our Series A warrants to give us more flexibility, whereby we could raise up to $10 million in financing from a not for profit organization or a foundation, which are triggering any anti-value provisions under these warrants. You know, we also had a few other minor tweaks to our Series B warrants. But essentially, between the previous structure to the new structure, we are reducing our dilution from a potential $83 million that was previously possible to now anywhere from 40 million to 53 million shares, which is at least a reduction of 30 million shares in the dilution, which we believe is a huge positive for all our shareholders.

One last housekeeping question, if I may. Sanjay, you talked about $15.5 million at the end of the quarter. I just want to make sure this does not assume the $7.7 million of the asset purchase agreement with Medavate. Is that right?

Correct. The cash that we had at the end of third quarter 2019 is approximately $15.5 million. It does not include the assets that we have held for sale, which we are continuing the discussions with Medavate to close. And as I've mentioned before, any delay in that closings would increase the value purchase price of that asset by 10% each calendar month. The cash that we have as of the end of the quarter is sufficient to fund our operation into mid-2020. During which time, we expect to compete our Phase 3 clinical trials for patients with oGVHD and to continue development of our modifier gene therapy program.

Our next question comes from [indiscernible] with Chardan.

Couple questions for you, one coming out of the GvHD meeting in Chicago. Is there things that you've learned in terms of best practices that you think could be helpful in terms of helping to increase the rate of enrollment?

I think as I mentioned before, this is a difficult patient population, tough patients dealing with cancer. So what do we need, the best practices are interdisciplinary approach. Many of the academic bone marrow transplant centers are included in our clinical trials. And each of these centers, the oncologist who is taking care of the patient up for allogeneic bone morrow transplants, they closely work with a specialized ophthalmologist in those clinics. And so that's the first thing, the interaction between the company and the people who are treating these patients, and those specialized clinics we have contacted many of them and over 10 centers are included in our clinical trials today. And second thing is there are also approaches, which we have taken reaching out to bone marrow transplant conferences and reaching out to the patients. And we are putting some measures in place and to directly contact them and get the information out there. And obviously, some of the specialized ophthalmology city centers. For example, in some of the cities if there is -- the specific bone morrow center doesn't have enough commodities, we are also encouraging some of these ophthalmologists for an investigators' clinical trial to contact those bone marrow centers in the nearby where the patients can be referred to. So once again, based on the conference as you have seen, the ocular GvHD is completely different than the cGVHD, and it's a difficult process. All we are trying to do is educate as much as we can working through these oncologists in these cancer bone morrow centers and ophthalmologists.

And for Sanjay, based on what you just reported in terms of your expenses and cash burn in Q3. How should we be thinking about that trajectory over the next couple of quarters relative to what you just recorded?

Yes, as I mentioned, we have sufficient cash to go until mid of 2020. And in our financials, we reported our R&D and G&A expenses, which will be pretty consistent in that form, that could be an indication for you to factor that in. And as a public company, those costs that we had an increase in our G&A relative to the prior year, are kind of -- broadly representative of what will be our G&A expenses for the upcoming quarters.

And as you get to the assessment of the interim data for Phase 3 for GvHD and possible additional recruitment, do you expect the R&D cost to increase in a meaningful way from where we are currently standing?

We have sufficient cash to complete the Phase 3 clinical trial for patients with oGVHD. Our enrolment for this Phase 3 trial is progressing very well. And we will have top-line results by the second half of next year.

And just another question on Medavate, just the latest restructuring of that agreement. Is there currently a hard stop termination date for them to come up with the funding?

The way we structured our amendment with Medavate, is that we set up an incentive for them to close as soon as possible. They are actively working with their investors to close their financing. We have been very in-close discussions with them and the discussions have been productive, and they're keeping us updated. The way we have structured the deal is we didn't put a hard stop in terms of this transaction, but price will increase 10% every month for the delay. And if this deal does not close, we will then freak out other buyers' interest in the NeoCart asset.

[Operator Instructions] And I am not showing any further questions at this time. I'd like to turn the call back over to Kelly.

Thank you. Thanks everyone for taking the time to join this call this morning. Here at Ocugen, we are committed on developing breakthrough therapies for patients suffering from certain debilitating eye diseases. We believe our fundamentals are strong and we expect to generate long term value for all of our shareholders. We look forward to providing further update in the coming months. Thank you.

Thank you. Ladies and gentlemen, this concludes today's conference. You may now disconnect your lines at this time. Thank you for your participation and have a wonderful day.