Ocular Therapeutix, Inc. (OCUL) Q4 2017 Earnings Report, Transcript and Summary

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutix Q4 and Year-end Earnings Conference Call. [Operator Instructions]. It is now my pleasure to turn the conference over to Mr. Donald Notman, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.

Thank you, Brian. Good morning, everyone, thank you for joining us on our Fourth Quarter and Year-end 2017 Financial Results and Business Update Conference Call. This morning, we issued a press release providing an update on the company's product development programs and details of the company's financial results for the quarter ended December 31, 2017. The press release can be accessed on the investor's portion of our website at investors.ocutx.com. Before we begin, I would like to lay out a brief agenda for the call. Leading the call today will be Antony Mattessich, our President and Chief Executive Officer, who will provide a summary of our recent clinical and corporate developments; Dr. Dan Bollag, our Senior Vice President of Regulatory Affairs and Quality, will provide an update on our progress in manufacturing and quality systems; Dr. Michael Goldstein, our Chief Medical Officer, will then provide an update on the pipeline. Following Michael's remarks, I will provide an overview of the financial highlights for the fourth quarter and for the year ended 2017 before turning the call back to Antony for a summary and questions. For Q&A, we will also be joined by Kevin Hanley, our Senior Vice President of Technical Operations; and Scott Corning, our Senior Vice President of Marketing and Commercial Operations. As a reminder, during today's call, we will be making certain forward-looking statements. Various remarks that we make during this call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which was filed with the SEC earlier this morning. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. I will now turn the call over to Antony.

Thanks, Donald. It gives me great pleasure to be able to turn the page on 2017 and look forward to a 2018 with the rebuild team in place and exciting set of opportunities that can be realized before the end of the year. As I took over as CEO, I'd been looking forward to this moment when the rebuilding is done and we are equipped to move forward to a future that holds great promise. Despite the setback that extends the Complete Response Letter in July, 2017 has also been very productive, particularly in the more recent months as we have gained significant momentum in making the changes necessary to resubmit for DEXTENZA and advance our pipeline. By far the most important order of business since the CRL was to rebuild a senior leadership team with the necessary experience to bring forward a late stage biopharmaceutical pipeline while preserving our core competence in the formulation of breakthrough delivery technologies using the company's hydrogel platform. To remind everyone, since July 2017 when we received the CRL for DEXTENZA, in addition to adding myself as CEO, we have brought in a new Senior Vice President of Regulatory Affairs and Quality, a Vice President of Quality, a new Chief Financial Officer, a new Chief Medical Officer and a Senior Vice President of Technical Operations. These new appointments of six of the top nine executives bringing over 100 years of biopharma experience. We are now not only more capable of advancing our current pipeline, we we're also able to refocus our highly experienced polymer chemists on improving and innovating our formulation capabilities. While all of the new and retained teams performed vital functions, possibly the most important new additions, ensuring our ability to bring DEXTENZA through FDA approval, are Naymisha Patel, Vice President of Quality and Kevin Hanley, Senior Vice President of Technical Operations. Naymisha brings with her over 20 years of experience in blue-chip biotechs with a proven record in quality management, process improvement, regulatory submissions and regulatory compliance. Kevin joins us from Pfizer and brings to Ocular over 30 years of experience, managing biopharmaceutical technical operations with demonstrated success in technology transfer and process scale-up for the manufacturing of proteins from development through manufacturing approval. We are working diligently to ensure that we not only respond to specific issues outlined in the most recent Form 43, but more importantly, to upgrade all of the quality systems and operating procedures, so if we come into full GMP in compliance and improve our overall instruction ratings, not only for the approval of DEXTENZA but also for the rest of our pipeline. Clearly, none of the changes we have made in either people or process matter if we cannot expeditiously bring DEXTENZA to the market. With this understanding, the resubmission of DEXTENZA has been and remains the top priority of everyone at Ocular. Based on the momentum we have enabled to achieve, we are able to reaffirm our guidance and we continue to anticipate the resubmission in the first half of 2018. This time we'll require that we continue to progress well on our manufacturing activities and quality improvement initiatives. To give you a detailed overview of the progress to date, I would like to turn the call over to Dan Bollag, Senior Vice President of Regulatory and Quality. Dan?

Thank you, Antony. On the DEXTENZA front, we have been continuing our work to improve the manufacturing processes and quality systems in preparation for an NDA resubmission and facility reinspection. For example, since receiving the CRL last July, we've made equipment modifications and have conducted multiple DEXTENZA manufacturing runs. In addition, quality system improvements are being implemented for several key systems and we are making advances every day on this ambitious project. Of course, the most important new developments, as Antony mentioned, have been the additions of Kevin Hanley and Naymisha Patel. I can't overstate what an important difference they are making for Ocular. As described previously, we have several ongoing work streams leading to manufacturing preparedness and NDA resubmission. These are, one, completing modifications to equipment and implementing enhancements to our manufacturing and production process; two, upgrading our quality processes, this is the quality systems improvement plan I described on the third quarter earnings call; three, walking down the particulate control plan; and four, conducting additional manufacturing runs to increase our confidence levels in the improvements we have made. These manufacturing runs will also support some acceptance limits, which need to be updated in our NDA resubmission, most notably, limits on particulates. All of these work streams have been progressing well. Kevin's and Naymisha's experience and insights are improving the robustness of our documentation and our manufacturing effectiveness, and will enhance our inspection readiness. We continue to push forward while taking the time to make additional improvements if they are essential to meet our compliance and manufacturing commitments. As we mentioned on the last earnings call, we requested and obtained a meeting with the FDA to describe our activities and NDA resubmission plans and to seek feedback. The meeting was granted in January and preliminary written responses from the FDA to our questions fully addressed our meeting objectives. Based on the completeness of the FDA's response, we decided that the meeting would no longer be necessary. We feel that we have a good plan in place for NDA resubmission and the FDA's comments have not required any substantial change in our manufacturing or regulatory plans. So as we speak today, we have made important progress towards of DEXTENZA resubmission and we now have well-defined activities and time lines in place to execute on that plan. Ultimately, our goal is to ensure a high-quality submission package and the right team is in place to reach that goal. So to discuss our pipeline, I'll turn the call over to Michael Goldstein, our Chief Medical Officer. Michael?

Thanks, Dan. Beyond DEXTENZA is a deep pipeline consisting of 4 products targeting both the front and back of the eye and multiple ocular diseases with markets that exceed $7 billion in United States alone. Like DEXTENZA, each of the products in our pipeline is formulated using our proprietary hydrogel technology platform. These hydrogels have been shown to be generally safe and well tolerated in millions of patients across many different therapeutic areas. This platform is programmable from days to many months with a wide range of release profiles and offers tremendous versatility by allowing it to be formulated with both small molecules as well as with larger proteins and biologics. We have leveraged the advantages of our hydrogel formulation platform and created a differentiated pipeline that we believe will produce drugs that offer significant benefits to existing drugs on the market today. Now, let me provide an update on our pipeline. OTX-TP is a long-acting, preservative-free formulation of travoprost for patients with mild to moderate primary open-angle glaucoma and ocular hypertension. Our product is an intracanalicular insert designed to release drug over three months. One of the biggest unmet needs in ophthalmology and in glaucoma, in particular, is solving the problem of noncompliance. What differentiates OTX-TP from currently marketed products is that the extended-release profile reduces the number of drops patients are required to take, which improves compliance and ultimately, the benefit of the drug. This program is currently enrolling patients in our first Phase III clinical trial with OTX-TP. We are targeting enrollment of 550 subjects and remain pleased with the pace of enrollment. As a reminder, the primary efficacy endpoint is the statistically superior reduction of intraocular pressure from baseline with OTX-TP compared to placebo inserts of two, six and 12 weeks following insertion. These include statistically superior IOP reductions at three diurnal time points of 8 a.m., 10 a.m. and 4 p.m. at each of these weeks. In addition, while not a primary endpoint, the IOP reduction will also need to be clinically meaningful for regulatory approval. We expect top line efficacy data from the first Phase III trial to be available on the second half of 2018. We intend to initiate the second Phase III trial after we get the results from the first Phase III trial. OTX-TIC is our second glaucoma program and it targets a more severe patient population. We are developing OTX-TIC as our bioresorbable travoprost containing hydrogel implant delivered via an intracameral injection and as a drug that targets patients with moderate to severe glaucoma, we need a higher level of interactive pressure reduction. In preclinical studies, OTX-TIC has demonstrated a good safety of favorable pharmacokinetic profile in the aqueous humor, a marked reduction in intraocular pressure and a sustained zero-order release profile supporting human dosing with a duration of up to six months. We have initiated a pilot human clinical trial of OTX-TIC outside the United States. This study is a prospect of single-center study designed to evaluate the safety, efficacy, and tolerability of OTX-TIC compared to travoprost eye drops in patients with primary open-angle glaucoma or ocular hypertension. We also filed a U.S. IND in the first quarter of 2018, allowing us to conduct a multicenter, open label clinical trial evaluating the safety, efficacy, durability and tolerability of OTX-TIC in patients in the same indication. Based on the results from these trials, we plan to advance OTX-TIC into a full development program. Moving to OTX-TKI, moving to our efforts in the back of the eye, we continue to advance our tyrosine kinase inhibitor implant program, OTX-TKI, which is being developed to treat patients with wet age-related macular degeneration. OTX-TKI is a bioresorbable hydrogel fiber implant with antiangiogenic properties delivered by intravitreal injection. Preclinical data have demonstrated the ability to deliver an efficacious dose of OTX-TKI to the posterior segment of the eye for the treatment of VEGF-induced retinal leakage for an extended duration of up to 12 months. We are currently planning for a Phase I clinical trial to begin outside the United States in the first half of 2018. The study will be a multicenter, open label, dose escalation study to test the safety, durability and tolerability of OTX-TKI. We also plan to evaluate biological activity by following visual acuity over time and measuring retinal thickness using standard optical coherence tomography. Along with our partner Regeneron, we also continue to progress the development of a sustained-release formulation of the VEGF trap aflibercept or Eylea for the treatment of serious retinal diseases such as wet age-related macular degeneration. We value our partnership with Regeneron and believe it speaks to the innovative nature of our technology. I would now like to turn the call back over to Donald, who will review our fourth quarter and year-end 2017 financial results.

Thanks, Michael. Let me begin by summarizing our capitalization as of year ended December 31, 2017. At that time, we had $41.5 million in cash and cash equivalents and approximately 29.7 million shares issued and outstanding. After the completion of the January 2018, $37.4 million common stock offering, we have approximately 37.3 million shares issued and outstanding. With respect to operations during Q4, our operating cash burn was $10.4 million in 2017 compared to $7.6 million for the fourth quarter of 2016. The increase of $2.8 million was due to the increased personnel cost, associated with supporting our ongoing development programs and facilities costs associated with the relocation of company headquarters. Based on our current plans and forecasted expenses, we believe that existing cash and cash equivalents and including the proceeds from the January 2018 offering will fund operating expenses, debt service obligations and capital expenditures through the first quarter of 2019, exclusive of the potential $10 million option payment from our Regeneron partnership. This is, of course, subject to a number of assumptions about our clinical development programs and other aspects of the business. With respect to financial results for the fourth quarter ended December 31, 2017, we recorded a net loss of $13.1 million or a loss of $0.44 per share. This compares to a net loss of $12.8 million or a loss of $0.52 per share for the fourth quarter of 2016. The net loss for the fourth quarter of 2017 included $2.6 million in noncash charges for stock-based compensation and depreciation compared to $2 million in similar noncash charges for the comparable quarter in 2016. For the full year ended December 31, 2017, we reported a net loss of $63.4 million or a loss of $2.20 per share. This compares to a net loss of $44.7 million or a loss of $1.80 per share for the full year 2016. The net loss for 2017 included $8.9 million in noncash charges for stock-based compensation and depreciation compared to $6.8 million in similar charges in 2016. Research and development expenses for the quarter ended December 31, 2017, were $7.9 million compared to $7.3 million for the quarter ended December 31, 2016, and reflect an increase in personnel costs and facilities expenses associated with increased plant space at our corporate headquarters. Overall, R&D expenses for the full year ended December 31, 2017, increased $3.8 million to $30.9 million from $27.1 million in 2016, reflecting increased spending for OTX-TP offset by lower DEXTENZA related expenses. Selling and marketing expenses for the quarter ended December 31, 2017, were $0.9 million as compared to $2.5 million in the fourth quarter of 2016. This decrease primarily relates to a reduction in precommercial activities as a result of the delay in the planned launch of DEXTENZA. Overall, however, selling and marketing expenses increased $10.3 million to $17 million for the full year ended December 31, 2017, from $6.7 million in 2016, driven primarily by increased expenses associated with the anticipated DEXTENZA launch before the company received its second CRL in July and moved quickly to contain and reduce expenses. Going forward, we expect the selling and marketing costs to remain relatively constant over the next couple of quarters until we have greater visibility on the potential approval of DEXTENZA. General and administrative expenses were $4.2 million for the quarter ended December 31, 2017, as compared to $3 million in the fourth quarter of 2016. This increase in expenses stemmed largely from increases in personnel costs, professional fees and facilities expenses. For the year ended December 31, 2017, G&A expenses increased $4.5 million to $15.5 million, from $11 million in 2016 reflecting the same themes. Revenues for the fourth quarter and year of 2017 were driven almost excessively by ReSure Sealant. Fourth quarter revenues totaled by approximately $487,000 compared with $511,000 in the same period for 2016. Annual revenues for the year ended December 31, 2017, totaled $1.9 million versus $1.8 million in 2016. As noted in the past, we are not currently providing promotional support through ReSure and do not expect product revenues to be material in 2018. This concludes my comments on the fourth quarter and year-end December 31, 2017, financial results. Now I would like to turn the call back to Antony for some summary comments.

Thanks, Donald. I trusted this call has been helpful in giving more granular level of detail on the work we are doing and what it still needed to accomplish for a timely, successful resubmission of DEXTENZA. As I mentioned in the beginning of the call, it was extremely gratifying to be able to start the future with a team of individuals, which I have full confidence and have proven track records in biopharma space in their respective areas. There are no shortcuts in getting a production unit to full GMP compliance and we realized the key goal we are working towards is the earliest as possible FDA approval for DEXTENZA and not simply an early resubmission. As a team, we are extremely excited about what to expect in 2018. After an intensive period of rebuilding and capitalizing the company, we have a lot to look forward to over the next three quarters. First and foremost, we expect to resubmit DEXTENZA in the first half of 2018 and anticipate receiving a decision from the FDA before the end of the year. With OTX-TP, our intracanalicular insert for the treatment of glaucoma, we expect to complete our first Phase III pivotal and provide top line efficacy results in the fourth quarter of 2018. With both of our Phase I programs, OTX-TIC, our intracameral implant for the treatment of glaucoma and OTX-TKI, our intravitreal implant for the treatment of wet AMD, we expect to collect data before the end of 2018 that will give us a read not only of the safety and tolerability of these products but also on their potential efficacy. Finally, with OTX IVT, our collaboration with Regeneron on extending the dosing interval for Eylea, we expect continued progress. Since we do not control the pace of the clinical and preclinical work, we cannot give guidance on expectations for 2018. However, with the emphasis of the VEGF competitive landscape on longer-acting drug delivery and the excitement of both parties in this collaboration, we remain hopeful of a disclosable news flow in 2018. With all that we anticipate to happen in 2018, we expect Ocular to be a very different company by the end of the year. The issues Ocular has faced in the past have been purely executional in nature, while the hydrogel drug delivery technology upon which the company is based has continued to perform. I hope it is clear with the changes made to the leadership team that we have no intention of doing what was done in the past and expecting a different result. We understand clearly that the proof will be in how we execute going forward. With that, I thank you for your attention and will make myself and the team available for your questions.

[Operator Instructions]. And our first question will come from the line of Adnan Butt with Guggenheim Securities.

This is Blair Cohen on for Adnan. Just two questions for you. What is the minimum level of IOP lowering that can be statistically significant but still be considered clinically meaningful? And then is there anything you can learn from the first PIII study that can help you improve the design for the second PIII study?

Yes. Thanks for those two questions. So in order to get regulatory approval, you need to meet two criteria. So one, we need to be statistically significant, compare it to the comparator, which in this case is a vehicle and that needs to happen at all nine time points. So that's looking at two weeks, six weeks and 12 weeks and then for each of those time points, there's actually diurnal measurements that are made of 8 a.m., 10 a.m. and 4 p.m. So that's criteria one. The second is that the change from baseline that you'll see with the OTX-TP must be a clinically meaningful change. And there, there's more flexibility. The determination of clinical meaningfulness is not as well defined and it's up to looking at sort of the totality of all of the data in determining over those nine time points mentioned in the case for what is clinically meaningful. The second part of your question is what can you learn from the first Phase III trial and how can you apply that to the second Phase III trial? So I think it's good clinical development to always look at all the data you have at hand and constantly make small modifications to future trials so you can optimize the trials and optimize the chances of success. And so there are a number of assumptions that were made moving from the Phase II trial to the Phase III trial in terms of changes to baseline, in terms of, which patients to enroll, in terms of how to best look at endpoints and obviously once we have the bigger data set with the Phase III trial, we'll be looking at all of those different aspects and be making small, potentially small changes for the second Phase III. But as we sit here right now, we don't anticipate any large changes. I think overall that second Phase III will look very similar to what the first Phase III trial looks like.

And our next question will come from the line of Bill Maughan with Cowen and Company.

So I have two for you. First of all, regarding the resolution of the FDA's and special observations and demonstrating consistency, can you give us any details on what is left to do that - as far as, are there more batches to be made? And how much time might that take? Following up with that, when might we expect an FDA reinspection? And when might we expect to know the outcome of that reinspection? And then finally, is there an update on the allergic conjunctivitis DEXTENZA program?

Okay, thanks. This is Dan, I'll take the first couple of questions and then Michael can take the third one. Your first question about what remains to be done to address the FDA's concerns from the last inspection, I think we've put a number of improvements in place. Again, we've made modifications to the manufacturing equipment and process, not extremely substantial ones but ones to address some of the concerns around the generation of particles and also we've been working to increase the reproducibility of our results from batch to batch. So we've made those modifications and we also, in our communications with the agency, explained what we were planning to do and got useful feedback, which didn't really change our plans. So at this stage, we are in the process of conducting additional manufacturing campaigns with two main purposes. One is just to generate additional confidence in those manufacturing runs and also to generate some additional data, which we need to put into our submission, most specifically around confidence limits for the particulates that are observed. So that's what is in process. Maybe - if you can remind me your second question that you had?

Sure. Yes. Just following up on the FDA reinspection. When might that occur? And when might we know the outcome?

Okay, good. Thanks. That's a good question as well. Normally, the FDA works to schedule the inspection, after they've had a chance to take an initial look at the materials that we've sent in and then that's based on the availability of an inspector. Typically this would occur probably three or so months into the review. Again, it's very difficult to predict but we are working to be ready for an inspection right after we resubmit because they could show up the day after, that certainly is a theoretical possibility. So we will be ready. We would expect it to be occurring sometime in the middle of our six-month review. And as regards to outcomes, that will be difficult to judge directly because the FDA really only communicates the final outcomes when they issue their decision at the end of the whole process. So we really anticipate that we'll only really know the outcome at the time that we get a decision from the FDA.

This is Mike. I can handle the - I guess, the third part of the question, which was about allergic conjunctivitis and DEXTENZA. So we're very excited about the potential for this indication. This gives us the potential to have an in-office indication for DEXTENZA. Just to remind everyone on the call, we've conducted two Phase III trials with DEXTENZA and allergic conjunctivitis using a conjunctival allergen challenge or CAC model, which is the basis for approval for almost every allergy drug on - currently on the market. And again, just to remind people, in both of those trials, we saw a statistically significant difference with using DEXTENZA compared to placebo at all time points looked at. There is a requirement that you show a one unit separation at a majority of those time points and then it would be 0.5 unit at all of the time points as a definition of what's considered clinically meaningful for this indication. In one of those Phase III trials, we hit those - that degree of separation. And in the other, again, while statistically, significantly different, we didn't show that magnitude of change. And so we are currently evaluating all of our data and we're making plans to move forward in allergic conjunctivitis. We believe that we're - we'd be required to do one additional study and exactly what that study will look like and the exact timing is currently under development.

And our next question will come from the line of Dane Leone with BTIG.

So I just wanted to go back to the resubmission. Two questions there to start. One, so just to be clear, what data has not been generated yet? And could you get down to the granularity of set batches or something like that, that you need to see and produce yourself internally before finalizing the resubmission? And then if you - if I could ask you to speculate a little bit, last year, there was kind of a hope that given the situation, there could be an accelerated review time line. I just want your thoughts in terms of your current assumptions, which seem cautiously optimistic versus the different paths that the FDA could take with your resubmission? So I'd start there.

Great. Thanks, Dane. So this is Dan. With regard to the first question you had about what data still remains to be generated, we are - the only, I guess, additional data that remains to be generated are to - some data coming from additional manufacturing runs, which we are currently conducting. Specifically, in our prior submission, we hadn't defined acceptance limits for particulates. And as we've discussed, we made a number of changes to improve some of our equipment and processes to ensure that those are under control if you will and reproducible. So these additional runs will generate a lot of data but the only data that really is essential to the submission is to provide sort of the historical record of what acceptance limits we will propose for particulates. So that is all in process and, again, should all read out well in time to achieve our first-half guidance around the resubmission. With regard to your question about speculating about the review period, there are two kinds of review approaches that the FDA can take with the resubmission, Type 1 and Type 2. Type 1 is a 2-month review, and Type 2 is a six-month review. And the Type 2 review would involve a reinspection. Given that we've had two preapproval inspections and they haven't been satisfactory to the agency, it would be very difficult for me to speculate that they wouldn't want to inspect this time. So we - our full anticipation is that we will be classified with the Type 2 review, which will involve a reinspection and then that comes with a six-month review time line from the date that the FDA receives our application.

Okay. Great. If I could move onto some of your other programs, maybe all of them together in a two-part question here. One on the effort and collaboration with Regeneron. Now that you've moved into a large animal or, I guess, primate testing, who's actually steering that? So does your team have a slot on the steering committee for the program in terms of driving the development time line? Or is that being completely driven by Regeneron? And then secondly on the TKI program, that is - just want to reconfirm that, that's wholly owned? And just want some more detail on what you need to do, what steps you still need to take to actually get the IND filed and then get into clinical testing?

Okay, great, Dane. I'll handle the Regeneron part and I guess the initial answer to TKI is simple enough that I can respond to as well. With Regeneron, we - they drive the clinical time lines. However, there's a classic management structure in place that involves a joint steering committee on which we have a seat and they do as well. We have certainly recognized in their effort and their - the attention that they've had to that program that it's ramped up quite considerably most recently, I think for obvious competitive reasons. But - so we see what they're doing with their trials, they seem to be adding elements to them and also attempting to accelerate the program. I said we can't speak unilaterally on that program because we have to get agreement with any public statements that we make within the collaboration. So I think that's all I can say on the Regeneron process, but as I mentioned in my comments, we are very hopeful to be able to have something to say more concrete in 2018 as we and they continue to get more excited about this program. As regards to TKI, that is wholly owned. We have freedom to operate with the molecule that we're using, which we will disclose at a future point. It's a - the molecule is currently on patent but by the time we get to commercial activity, it will not be. So that we will have full freedom to operate with it. And we are developing it now as Mike mentioned entering an open label Phase I trial in patients with compromised vascular churn in the retina. So we will be able, hopefully, to be in receipt of data before the end of the year that - in-patients can only tell us about the safety and efficacy, but also it would give us some sense of the biologic activity. As you all know, TKIs are - have a broader spectrum of activity, antiangiogenic activity than VEGFs do, so there's certainly some hope that they would be effective now in the places where VEGFs are effective, potentially also where they are not effective or not optimally effective. So we remain very excited about that program. And hopefully by the end of the year, we'll have some concrete data to be able to bring forward or at least interpret to decide how we go forward with that.

Sorry, so are you through tox work for the IND?

Yes. We're in patients. Mike?

So this is Mike. So the strategy is or it would be - the Phase I trials outside the United States. And so we've completed tox work to be able to allow us to do dose patients outside the United States both. In terms of getting to the U.S. IND, we would want to get data from that trial, and as Antony mentioned, it's an open label trial, so we're getting data in real time. There would be some additional tox work we need to do in animals and then we replanning on submitting a U.S. IND. So there are a couple of steps that have to take place before we can file a U.S. IND for that program.

Okay. Got it. And so that's what you meant by seeing some of the data from the open label Phase I study because that's currently running outside the U.S. so you will have - is that...

It's about to run.

Okay. It's about to start running. And is that a single-ascending dose study or multiple-ascending dose study?

So that will be a single-ascending dose study.

[Operator Instructions]. And our next question will come from the line of Yi Chen with H.C. Wainwright.

My first question is, do you plan to, in the near future, present the full Phase IIb data from the OTX-TP and sort of trying to - if you can deduce what is clinically meaningful just from that dataset alone?

So this is Mike. The OTX-TP Phase II data has already been presented at ARVO last year.

I mean, just from - based on that, I mean, in - for instance, based on interpretation of that data alone, I mean, can you just give us some idea what can be - what the FDA could think as clinically meaningful?

Yes. So I think it's hard to speculate on what the FDA would count as clinically meaningful. And I think in some ways, well, in lots of ways, it's up to the sponsor to make the justification for clinical meaningfulness based on the totality of the data. For example, the huge benefit of our product is that with a single insert, you're getting dosing that can extend out to three months. And it's continuous dosing, so you're not getting the pace and value that you might get with eye drops. So we're not only solving the compliance issue, i.e. it's hard to put eye drops in, but also people are getting a more consistent dose. And so what the FDA's clear on is that there are certain time points that you have to look at and those are what we've described, which is you have to look at two weeks, six weeks and 12 weeks and you have to look at 8 a.m., 10 a.m. and 4 p.m., and make measurements at those time points. So exactly what measurement, what value you need to show to be clinically meaningful, I think again, ultimately, is a calculus of what magnitude of effect you're getting and the additional benefit that you're getting because it's only a single application over that three-month time period.

Okay. And what's the current update regarding the second Phase III trial of OTX-TP?

So I think it's always good - there was a question earlier and I think it's always about this as well, I think it's always good clinical development practice to take all your data at hand in order to optimally design your trial. And as everyone I think is aware of, there's been a number of changes that went from the Phase II trial to the Phase III trial in this particular case. And we would like to be able to look at the data from our Phase III trial, make some small changes and be able to optimize that second Phase III trial.

I'm showing no further questions at this time. I would now like to turn the call back over to Chief Executive Officer, Antony Mattessich for closing remarks.

Yes. Thank you, everybody. There are no additional closing remarks. We look forward to being able to deliver on what we've promised. So thank you very much for your attention.

Ladies and gentlemen, thank you for your participation on today's conference. You now disconnect.