Ocular Therapeutix Inc (OCUL) 2014 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Ocular Therapeutix third-quarter 2014 earnings conference call. (Operator Instructions). As reminder, this conference call is being recorded.

I'll now introduce your host for today's conference, Brad Smith, Chief Financial Officer. Please go ahead, sir.

Thank you, and good morning, everyone. Welcome to Ocular Therapeutix third-quarter 2014 earnings conference call. This morning we issued a press release providing details of the Company's financial results for the third quarter ended September 30, 2014. We also announced the first patients enrolled this morning in our Phase IIb clinical trial for OTX-TP, a sustained release travoprost, filed with -- an IND with the FDA for this product back in September. We also announced this morning topline results from our Phase II clinical trial for OTX-DP for the treatment of allergic conjunctivitis. These press releases are available on the Investor portion of our website, at investors.ocutx.com.

Leading the call today will be Dr. Amar Sawhney, our President and Chief Executive Officer, who will review recent clinical developments for our lead programs, along with a discussion on some of our upcoming milestones. I will then provide an overview of the financial highlights for the third quarter before opening the call up for questions. Also joining us on the call this morning is Scott Corning, Vice President of Sales and Marketing; and Eric Ankerud, our Executive Vice President of Clinical, Regulatory and Quality.

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 quarterly report on Form 10-Q on file with the SEC.

In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views 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. These forward-looking statements should not be relied upon as representing our views as of any subsequent date to today.

I will now turn the call over to Amar.

Thank you, Brad, and good morning everyone, and thank you for joining us today for our third-quarter 2014 earnings call. Before we begin, I would like to welcome all of our new shareholders. If we have not yet had a chance to meet you personally, we look forward to having that opportunity in the near term.

For those of you who may be new to our story, Ocular Therapeutix is focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, including both front-of-the-eye and back-of-the-eye, using our proprietary bioabsorbable hydrogel technology platform.

Our product candidates are designed to provide sustained delivery of therapeutic agents to the eye. The products we currently have in development address a $9 billion market opportunity in the US, and a market that is growing rapidly. For front-of-the-eye diseases and conditions, we are developing therapies to replace the standard of care, eye drop regimens, with our innovative drug eluting punctum plugs. These plugs are [non-invasively] inserted into a natural opening of the punctum located in the inner portion of the eyelid near the nose, and reside comfortably in the canaliculus below the punctal opening.

Eye drop therapy represents numerous limitations, including significant peaks and valleys of drug concentration, lack of patient compliance, difficulty in administration, and side effects due to high concentrations of drug and presence of preservatives. We believe that our candidates will improve the compliance due to long-term, sustained delivery; provide a more uniform amount of drug presence on the surface of the eye; and ultimately increase treatment efficacy and reduce disease progression associated with patient noncompliance.

We also believe that our product candidates can provide an improved safety profile compared to eye drop regiments, due to the lack of preservatives as well as our ability to avoid the peaks associated with high dosage and valleys associated with low dosage with topical eye administration.

We have a late stage product pipeline, with several product candidates in Phase II in Phase III clinical development. Our lead sustained relief product candidate, OTX-DP, is in Phase III clinical development for the treatment of post-surgical ocular inflammation and pain.

We recently enrolled the first patient in our Phase IIb trial for our OTX-TP product candidate for the treatment of glaucoma and ocular hypertension, with the first patients enrolled in the trial this past week. Additionally, we just completed a Phase II trial for OTX-DP for the treatment of allergic conjunctivitis, and I will discuss those results in a moment.

We are also in the early stages of evaluating sustained release injectable anti-VEGF drug depots for back-of-the-eye diseases, including wet age-related macular degeneration, or wet AMD. These development efforts are at an early stage, but if our upcoming feasibility studies are successful this could represent another exciting opportunity for Ocular.

Our first product, ReSure Sealant, received FDA approval earlier this year for sealing corneal incisions following cataract surgery. The product is marketed to a select network of independent sales agents. We have not been investing the resources to build out a commercial organization in support of ReSure, and do not anticipate making this investment until we are closer to an approval for our first sustained-release punctum plug drug candidate, assuming favorable clinical results.

As a result, we expect sales growth of ReSure Sealant to be modest for the next several quarters. We are a clinical development organization at present, and are investing the majority of our resources on our drug delivery platform and related product candidates. Speaking of which, I'm pleased with the progress that we have made this quarter in advancing our lead clinical programs.

Last month we announced the completion of enrollment in two Phase III clinical trials evaluating our OTX-DP product candidate for the sustained-release of the corticosteroid dexamethasone for treatment of ocular inflammation and pain following cataract surgery.

These are not only our first Phase III clinical trials for a sustained release pharmaceutical, but we believe that these are the first Phase III trials ever to be conducted for a sustained release drug eluting punctum plug. We expect to have results from these trials in the first quarter of 2015; and, assuming favorable results, expect to submit an NDA to the FDA in the second quarter of 2015.

At the American Academy of Ophthalmology meeting in October this year, Dr. Thomas Walters from Austin, Texas, an investigator on our recent Phase II OTX-DP clinical trial, had the opportunity to present data from this Phase II trial of our OTX-DP product candidate for the treatment of ocular inflammation and pain following cataract surgery.

The data showed that the patients who were treated with OTX-DP experienced significantly less pain and inflammation compared to placebo. We were pleased that following the presentation, the AAO issued a press release summarizing the data presented by Dr. Walters. This release can be found on the AAO website at AAO.org/newsroom.

Ocular Therapeutix presented three posters, two papers, and a video from our sustained-release dexamethasone plug and our ReSure Sealant. For additional details on our presence at the meeting, please refer to the 2014 AAO annual meeting section on the AAO website.

As I mentioned earlier, our clinical pipeline continues to advance. This morning we announced topline data for our Phase II clinical trial for OTX-DP, a sustained release dexamethasone product for the treatment of allergic conjunctivitis. The prospective market center randomized double-masked study evaluated OTX-DP versus a placebo vehicle at two clinical sites in the United States. The Company used a modified conjunctival allergen, or CAC, model to accommodate for the longer therapeutic effect of a one-time administered sustained-release drug product.

The well-controlled trial enrolled 68 patients with the intent to treat for reactions to a variety of allergens over a 42-day period. The primary effect of this measure was ocular itching and conjunctival redness at 14 days post-insertion. OTX-DP treated patients presented statistically significantly lower ocular itching and conjunctival redness scores than the placebo group at all three time points, measured on day 14, 28, and 42 after insertion.

As compared to placebo, patients in the OTX-DP treatment group achieved a mean difference of more than 0.5 units on a 5-point scale -- which went from 0 to 4 -- at day 14 for both ocular itching and conjunctival redness. The trial did not achieve a mean difference of 1.0 units at the majority of time points for ocular itching and conjunctival redness. OTX-DP met one of the two criteria for treatment success previously established by the FDA for anti-allergy drops in the traditional CAC model. There were no serious treatment-related adverse events noted. OTX-DP treatment was well tolerated overall.

Although we are continuing to analyze the available data from this trial, we believe that these topline results support the continued development of this drug product candidate for the treatment of allergic conjunctivitis. By year end, we expect to fully analyze additional data regarding secondary efficacy measures and safety results, including more detailed adverse event information. Thereafter, we plan to submit this clinical data and meet with the FDA to discuss next steps for this clinical program.

Although effective for treatment of allergic conjunctivitis, topical corticosteroids are often limited in use due to potential side effects such as increased intraocular pressure. A low-dose, sustained-release corticosteroid may alleviate the symptoms of allergic conjunctivitis without unwanted side effects. The Phase II trial provided valuable insight into the advantages of utilizing a Modified CAC model, which we may incorporate into future trial design.

As I mentioned previously, we also just announced the first patients enrolled in our Phase IIb clinical trial of OTX-TP sustained-release travoprost, a prostaglandin analog for the treatment of glaucoma. We expect to have data from the study in the third quarter of 2015. This Phase IIb trial is a prospective, randomized, parallel-arm, double-masked active controlled study, consisting of approximately 80 patients who will receive either OTX-TP and placebo drugs, or a placebo punctum plug and timolol drops.

In the first quarter of 2015, we also are anticipating completion of feasibility studies for our anti-VEGF hydrogel depot. Ocular Therapeutix has had ongoing agreements with three pharmaceutical companies to evaluate the feasibility of using our hydrogel depot to achieve sustained release of their anti-VEGF drugs in early stage preclinical models.

In addition, we recently signed an early-stage agreement with another pharmaceutical company to discuss the likelihood of achieving sustained-release of several of their drugs in our hydrogel depot. We have additional interest from other pharmaceutical companies in our drug delivery program.

Depending on the outcome of these studies, we will determine our forward development path; and, assuming a positive outcome, we would potentially explore broader strategic alliance with one of these partners. Again, we have not established any expectations for this program, as it is at an early stage of development, and still carries high risk. But given the market size, it could be a potentially large opportunity.

Since our closing of our IPO in July, we have had an exciting and busy few months as a company. We are pleased with the progress that we have made with the lead product candidates in our pipeline, and look forward to the coming months.

I will now turn the call back over to Brad, who will review the third-quarter 2014 financials.

Thanks, Amar. As Amar mentioned previously, during the third quarter of 2014 we closed our initial public offering and raised $75 million in gross proceeds, including the exercise of the overallotment option. After all fees and expenses, we received over $67 million in net proceeds. We were pleased to have secured Morgan Stanley, Cowen, RBC Capital, and Oppenheimer as the underwriters of our IPO. Including the proceeds from the IPO, we had $81 million in cash and cash equivalents as of September 30, 2014.

Our operating cash burn for the third quarter was $6.4 million. We expect our cash burn to increase over the next several quarters as we continue to advance our clinical development programs and expand our personnel to support the business. We continue to believe that we have sufficient cash and cash equivalents to fund the Company through at least the first half of 2016, and through several important clinical and commercial milestones with our product development programs, including the initial commercialization of our lead OTX-DP program for post-surgical inflammation and pain, assuming favorable clinical results in the Phase III trials; and the continued clinical development of our OTX-TP product for the treatment of glaucoma and ocular hypertension, which is currently in Phase IIb trials. And we expect to advance into Phase III trials with that program in the first half of 2016, assuming favorable results in the Phase II trials. So we expect to have the money last us through some very important milestones for the Company.

For the third quarter ended September 30, 2014, we reported a net loss of $7.3 million or a loss of $0.48 per share. This compares to a net loss of $3.5 million or a loss of $1.34 per share for the third quarter of 2013. The net loss for the third quarter of 2014 included $600,000 in non-cash charges for stock-based compensation compared to $100,000 in the comparable quarter in 2013.

Revenues from the sale of ReSure Sealant product told $143,000 in the third quarter of 2014. We are selling this product through a small network of independent sales agents. The ReSure Sealant was launched in the first quarter of 2014, so there were no product revenues in the same quarter in 2013.

Total operating expenses during the third quarter of 2014 were $6.9 million compared to $3.4 million for the third quarter of 2013. Research and development expenses increased to $4.5 million in the third quarter of 2014 compared to $2.8 million in the same period in 2013. The increase is due to additional clinical trials associated with the advancement of our clinical programs.

In the third quarter of 2014, we had ongoing clinical trials for our Phase III dexamethasone punctum plug product for the post-operative treatment of inflammation and pain, and our Phase II clinical trials for our dexamethasone punctum plug product for the treatment of allergic conjunctivitis.

For the nine months ended September 2014, we reported a net loss of $20.7 million or a loss of $2.93 per share compared to a net loss of $9.8 million or a loss of $3.79 per share for the same period in 2013. The net losses for the nine-month period ended September 2014 included $4 million in charges for stock-based compensation expense, as well as licensing and consulting fees paid in common stock, compared to $400,000 for the same period in 2013. Revenues from the sale of the ReSure Sealant product totaled just over $300,000 for the nine months ended September 30, 2014, and there were no product revenues in the same period in 2013.

Research and development expenses were $13.7 million for the nine-month period ended September 2014 compared with $7.7 million for the same period in 2013, again due to the increased clinical trial activities for our sustained-release drug delivery programs, and also due to the licensing fees that were paid in stock relating to the expansion of our intellectual property rights.

This concludes my comments on the third-quarter financial results, so I'd like to turn it back over to Amar.

Thank you, Brad. We're now ready to take your questions. In addition to Brad and myself, Scott Corning, Vice President of Sales and Marketing; and Eric Ankerud, Executive Vice President of Clinical, Regulatory and Quality, are also available to take your questions.

Operator, can you please take our first question?

(Operator Instructions). Yigal Nochomovitz, Oppenheimer.

Congrats on the progress. I just wanted to clarify one aspect on the allergic conjunctivitis study. The press release stated that you didn't achieve a 1.0 unit difference on the majority of time points. But I just wanted to understand if we should take that to mean that you did hit the 1.0 unit threshold on one of them, since obviously there were three -- and if you could say which one.

No. Yigal, this is Amar. No, the effect was close to a 1.0, but not [over] 1.0. And, remember, that these endpoints are basically with the guidance that the FDA has done in the past for eye drop-related therapies, and not for sustained-release therapies. And, remember, we are dosing only once through the whole 42-day duration compared to drops that need to be dosed frequently. So, we did hit the 0.5, I think. But what we need to do is to take these results and discuss with the FDA as to how and what the hurdles are for sustained-release therapy, and how should we go about that process.

So, we have to be careful in interpreting anything beyond that, because this is just guidance that the FDA has given in the past for the CAC Challenge, which is not the Modified CAC Challenge that we are using, where we are repeatedly challenging over the long duration.

Okay, so that sort of led into my question, which I guess you've sort of answered, in terms of whether you need to hit on the 1.0 versus the 0.5. But it seems like you need to have the discussion with the FDA.

I was just wondering also, you mentioned in your remarks, would you consider another allergen challenge model -- for example, the Environmental Exposure Chamber model -- to potentially increase the chances of having better data? How would you view that option?

No, I don't think we will go to the environmental model. We are actually quite excited by these results, and these are well within the expectations that we have. Remember that there are therapies that have been approved with less than a 1.0 treatment level. And there have been therapies that have been approved only for itching and not for redness, for example, the leading therapy -- Pataday, right now.

So I think we feel that these are right in track with our expectations, and we just need to have a discussion with the Agency as to how to regulate a product of this sort and how to label it. So, once we have those discussions, we will keep you all apprised.

Okay, great. And then on the Phase IIb glaucoma which you just initiated, can you discuss a bit what you're looking for in terms of retention rates there to feel comfortable with the product profile moving into Phase III? And would you expect to do another round of [bug] technology refinements after the Phase IIb, even if you hit your retention rate goals in this current study? Thanks.

So, we are -- as you know, we've described this previously, that the retention rates that we are expecting over here will be in the 80% range for 60 days, which is going to be the primary endpoint. We will be evaluating out 90 days also, and we expect that retention to be probably obviously below that number, but maybe in the 60%-plus kind of range. So we would be comfortable with getting to those in that domain.

We are also looking at repeat administrations, should the plug be lost by virtue of it being visualized by the patients, and using the blue light technique that we have, which allows the florescent plug to be visualized by the patients themselves. So in this study, the plugs will be replaced in the event that they are noticed by the patient to have been lost.

So, we are continuing to do studies to further improve the retention. And those studies are ongoing, but those don't have to be drug studies. Those are device-only studies that are done as nonsignificant risk studies. So we continue to iterate, but as we've discussed in the past, that the drug studies use an earlier version compared to the latest studies that we might be doing in optimizing the plug performance.

So it's an ongoing effort to improve the retention, but we feel that this study should, at a minimum, tell us whether we have reasonable levels of efficacy compared to timolol, which is the bar that the FDA has set for approval of a product of this nature; and also evaluate repeat administrations in the event that the plug is lost.

So those of the key factors that we're seeking to evaluate, as well as seeing if we can go to 60 days as a primary endpoint on efficacy, as well as go longer than that. So those are three objectives we are looking to realize from this study.

Okay, thanks very much.

Ken Cacciatore, Cowen.

Sorry, guys, I'm a little bit like getting on, so I don't know if this was discussed -- but just wanted to understand the clinical relevance of that delta between 1.0 and 0.5 on the results. Understanding that the Agency historically, how they've looked at it, but just trying to frame it in the perspective of how a clinician would view it, in your opinion. And then I have a couple follow-up questions.

These studies were conducted with a Modified CAC Challenge Model with the support of Ophthalmic Research Associates, which is an organization that has approved, or helped get probably a dozen of the last 15 allergy products through the market. So they have a fairly good sense for the performance. And based on their feedback, they were highly encouraged to see a clinically meaningful level of effect which was sustained, and not only at the 14-day duration of the first evaluation period, but at 28 and 42 days.

And it was quite encouraging to see a one single-dose administration lasting that long and having such a long-lasting effect on both itching and redness being statistically lower in the treatment group at all time points and at all days. So, from that standpoint, it was very encouraging.

And remember that usually these studies are done with eye drops, where you're looking at the onset of action and the duration of effect after the challenge is made, and looking to see how long the drop might last. And typically these drops would last for eight hours or maybe 16 hours, or something of that duration, compared to the 42-day type of duration that we are seeing over here. So, from that standpoint, very encouraging.

The effect, however, did not reach the 1.0 level, which for eye drops has been in the past set up as something that people needed to meet for a majority of the time points, so not all time points but a majority of the time points. So this study was meant to get sort of a sizing up of the effect and exploration of the endpoints. While we did stage some of these endpoints, these are meant to explore what our study design for a product like this needs to look like, and that discussion needs to be had with the FDA. And it was not possible to have that discussion prior to having some results.

So we expect to take these Phase II results and have the conversation with the Agency as to how to regulate a product of this sort, and what is the right ways to look at this modified CAC Challenge Model, and where the bar will and should be set.

Okay. And again, I apologize if I'm going to go over anything that you've talked about. But just also on the hydrogel depot, the anti-VEGF program, clearly there's multiple potential partners here. Can you just give us a sense of what we should be thinking about? When you say feasibility studies, what possible information could you disclose to us when you release those results? What does that look like in terms of -- how should we be doing analysis? Clearly, duration is important. But can you frame it, ahead of us seeing those results?

We have limited ability to release the results over there, owing to the confidential nature of these discussions with the potential partners. Clearly, they don't want to be identified at this stage, given that this could be a process where they have a sizable amount of competition. So, we have a limited ability to disclose those results; I will just preface my remarks with that. (multiple speakers)

So when you say -- let's just pretend the answer is, these six studies were successful. Let's just say that you use the word successful. Clearly, what would one imagine successful looks like? You are seeing a level of duration you're happy with. You are clearly seeing a level of efficacy. Without being able to give us the exact nuance, can you just frame what the word successful would mean in the context, if you did say the feasibility studies were successful?

Sure. The success would be in three different dimensions. One is that we are seeing drug release out to a meaningful duration. And meaningful is in the 4- to 6-month kind of range, probably closer to six months. Second thing would be that these are well tolerated by the animals, in whichever animal model that the potential partners seeks to evaluate them. Some of them are doing it in rabbit models; some are doing it in primate models. And the third would be that these materials are giving a meaningful amount of drug in the various tissues of the eye that are being evaluated.

So for example, retinal concentrations are at a meaningful level compared to what people expect to see for efficacy. So, folks have a pretty good idea as to what levels of anti-VEGF drugs give efficacy. And if they see that, or above that, I think that would qualify as success. So those would be (multiple speakers).

Okay. That's helpful context. And then in terms of -- again, this is always difficult to predict -- but in terms of the rapidity into the clinic from there, do you think that we could see the initiation of clinical studies in 2015, if, again, successful?

Remember that if you have a six-month duration product, a preclinical study with at least one dosing, it will take six months, and will take some time to start and will take some time to analyze. And then there is a submission to the Agency, et cetera. So when you add up all of those timelines, this is why I think controlled release systems is more challenging, because it takes longer to do the product validations, and longer to do the preclinical studies. But the rewards of creating category-dominating types of products is that you have a much bigger upside.

So, given the length of these therapies, it will be hard to pull off initiating a clinical trial in 2015. So we would expect, if these are to be successful, to only initiate studies in the 2016 time.

Okay. Yes, that makes a lot of sense. And then lastly, the last question was on the question I asked you about the next maybe generation devices -- or, I'm sorry, plugs that you may be working on. And so, just wondering, I didn't hear what's in there. I know what we're going with, but should we just assume there's constant innovation -- that you are constantly refining? Or do we feel that this is the last generation that you're dealing with?

No, we are constantly refining, would be the short answer.

Okay, perfect.

That is an ongoing iteration process and an ongoing quest. So we will continue to iterate, but we do want to see if we get adequate levels of effect out for reasonable durations of time. And that's what we're seeking to evaluate in this Phase IIb study.

Great. Thank you so much.

(Operator Instructions). Adnan Butt, RBC Capital Markets.

Couple of questions for you here. First, on the OTX-DP inflammation and pain study, is there a way to measure safety differences along with the efficacy outcome from the ongoing Phase III program?

So, is your question related to the allergy study, or is it related to the pain and inflammation study?

Amar, it's the Phase III pain and inflammation post-operative study. Yes, for that study. So for the Phase III that's ongoing, that will read out in the first quarter, is there a way in that study to show safety differences along with measuring efficacy?

Yes. As we analyze the data, we will be analyzing both efficacy and safety results for the Phase III program.

And what are the safety parameters that are typically looked at? So I think the higher-dose steroids obviously cause -- have had side effects associated with them. This is a much lower-dose product, so what kind of safety differences could manifest in this Phase III?

Well, we'll be looking with some focus on the adverse event profile for both the treatment group and the control group through predefined analyses in our study protocol.

Adnan, this is Amar. What we would look at would be all the standard safety measures that are done post-cataract surgery, which would include slit lamp exams, ocular surface exams, periocular tissue exams, et cetera. These are standard tests that people look at. And anything nonstandard would obviously also be reported, if there were an unexpected or any serious adverse events, ocular or even non-ocular in nature. So we would collect all of that adverse event information, and look at the two groups and try to see if there are any major differences. And FDA will be provided all of that information.

Okay, Amar. Historically, do steroids -- what kind of side effects do you expect from them in a study like this?

Chronic use of steroids can give intraocular pressure spikes, for example. So, if you -- you'll get -- there are two types of pressure increases, just so that we know, post-cataract surgery: one that would happen in the first day or two, which is usually associated with the presence of the viscoelastic that has not been taken out adequately from the eye. And that happens at a rate of about 8% to 9%, 10% or so. But that will only happen in the first day or two because that is associated with surgery.

And then there is the more chronic intraocular pressure spike that comes from high-dose and chronic use of steroids that may happen in the outer periods of time, typically after two weeks, end of duration. So we would be looking at those post-two-week duration spikes with a degree of interest, because literature has indicated that up to 20% spike rates might happen with post-surgical use of steroids. And remember that in our Phase II study, we did not see many of those at all. And that was one of the more exciting developments, so we're going to be watching that with interest.

Okay, great. Great. The next question I have is on OTX-TP for glaucoma, the Phase II that's starting. Is this study powered to show a difference between TP and timolol?

It is. It does have statistical power built in. It is a Phase II study, however; and so we are going to be analyzing it for statistical differences between the treatment group with OTX-TP and placebo drops, compared to the placebo punctum plug and timolol drops.

Okay. But the trial is sized to show a treatment difference.

Yes.

Okay.

Or non-inferiority. It's basically not a study to look at superiority. It's a study to look at non-inferiority.

Okay. That's helpful. And then the last question I have is that in terms of the hydrogel depot for anti-VEGFs, what's the technical hurdle here? You mentioned three things; its durability, its activity. So which one is the one that is the toughest to overcome, if you can say something about that?

Sure. I think we are fairly comfortable that we can entrap these anti-VEGF compounds within our materials and not change them -- not denature them, not cause the protein activity to be compromised, or the protein to be abnegated or structurally compromised.

We are also reasonably comfortable that these will be released in a meaningful duration. We have seen that in in vitro studies. We hope to replicate that in in vivo studies. The biggest challenge is about having tolerability over a long period of time of an implant, which is being placed intravitreally. So that is a higher hurdle, and that is something that we are trying to understand also. It is a little complex, since putting in a human protein into an animal can create an immune response, in any case, through no fault of the depot itself.

So how to analyze that vis-a-vis tolerability that may be a biocompatibility question versus tolerability that is an immune reaction kind of question. Those are things that we are trying to parse through over here and understand. And our partners have some insights into that. But I think we are treading new ground over here, because this is not something that anybody has ever done before.

Thank you. I'm not showing any further questions in queue.

I'd like to turn the call back over to Amar Sawhney for any further remarks.

Thank you, everyone, for your time this morning to join the Ocular Therapeutix third-quarter 2014 earnings review and business update. On behalf of the entire Ocular Therapeutix team, we appreciate your support and look forward to communicating our progress in the coming months. Have a great day.

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone have a great day.