Outlook Therapeutics, Inc. (OTLK) Earnings Call Transcript & Summary

Good morning and thank you for joining us for the virtual investor KOL roundtable. My name is Jenene Thomas, CEO of JTC, and I will be the moderator for today's event. For the lineup and schedule of today's presenting companies for the KOL roundtable event, visit www.virtualinvestorco.com. All the roundtables being held October 27 through 29 will have a video webcast replay available on this website as well as each presenting company's sites. For our first roundtable of the day, I'm pleased to be joined by the Outlook Therapeutics management team, Lawrence Kenyon, President, CEO and CFO; Terry Dagnon, Chief Operating Officer; and Jeff Evanson, Chief Commercial Officer. We are also joined by Dr. Firas Rahhal, Partner at Retina Vitreous Associates Medical Group in Los Angeles and Associate Clinical Professor of Ophthalmology at the UCLA School of Medicine. Thank you all for joining us today.

Thank you.

Thanks, Jenene.

Thank you.

Great. So before we get started...

Thank you.

Thank you. And before we get started, I just want to remind our audience that Outlook Therapeutics is publicly listed on the NASDAQ and trades under the ticker OTLK. During today's discussions, we will be making forward-looking statements, and I encourage everyone to view the company's latest SEC filings on their website at outlooktherapeutics.com for the latest information.

So Larry, we're going to start with you. If you could give us a brief introduction to Outlook Therapeutics and what you're currently working on to develop.

Sure thing. Thanks, Jenene, and thank you, Firas, for joining us today. Terry, Jeff and I are all very much looking forward to the conversation. Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010 / LYTENAVA as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If approved, we expect to commercialize LYTENAVA as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, Europe and other markets. Currently unapproved, repackaged bevacizumab, also known as Avastin, is the most frequently used treatment for wet AMD in the United States. If the outcome from our ongoing, fully enrolled pivotal trial of ONS-5010 is as successful as we expect next summer, we believe we are in great position to finally be able to provide patients and physicians with the responsibly priced, approved bevacizumab that has been missing in the market. Because bevacizumab has not previously been approved for use in retina diseases, we cannot use the biosimilar pathway and will instead seek approval as a new drug with 12 years of regulatory exclusivity. Outlook Therapeutics is very excited about LYTENAVA and what it represents for wet AMD patients. Jenene?

Thank you, Larry. Great overview. Now I'd like to turn it over to Dr. Rahhal. Dr. Rahhal, we're so glad you could join us today. We'd love it if you could tell us a little bit about your background and maybe touch a bit on your experience with retinal diseases and wet AMD in particular.

Thanks, Jenene, and thanks for having me. I enjoy talking with all these guys, and it's been fun. I'm a vitreoretinal surgeon. I'm in a busy, high-volume-type retina practice in Los Angeles. We have multiple offices, multiple doctors, and we're very active in clinical trials. So I have a long history, as does this group, in clinical trials. I treat wet AMD countless -- dozens to hundreds of times a week. Obviously, that's one of the big conditions that we manage in vitreoretinal diseases. Depending on the demographic of the SIFI work in, it's certainly at least 1/5 of your practice. It might be more than that, given the volume of injections we do. And I use all the 3 major drugs repeatedly and frequently, and Avastin is a big part of that. For me, it's probably at least half of the patients that I treat are treated with Avastin versus the other 2, which also I use quite frequently.

Excellent. Appreciate that. Can you expand a little bit on what anti-VEGF therapies are, and why they are valuable in treating retinal disease?

Yes. So just a little historical background. For us, it's become sort of a daily thing. But every now and then, I have to remind myself when I'm talking to folks who are learning about our specialty, anti-VEGF drugs and anti-VEGF therapy absolutely revolutionized what we do in our space in the back of the eye approximately 15 or so years ago. Prior to that, these conditions that we treat now quite commonly and very successfully, many of them had no treatment or they had very poor and limited treatment. And so anti-VEGF therapy -- and there, again, are a few drugs in this space, Avastin being one, and that was one of the first ones. In fact, for me, it was the first one I used, again, off-label in those days, and now have revolutionized how we can treat wet AMD patients and diabetic retinopathy patients, and to an extent, vein occlusion patients, which are also not so rare, but the more common things are diabetic retinopathy and wet macular degeneration. And what these drugs do, essentially, and I explain this to patients every day in this way, these diseases have abnormal blood vessels either growing from the retina or are inherent into your own retina and they're leaking fluid and blood into the retinal space, into the macula, which is the geographic center of the retina, and that damages vision quite significantly and rapidly. And what these drugs do are 2 things: they can slow the leakage from your own damaged blood vessels, such as in diabetic retinopathy and diabetic macular edema; and they can block the growth or cause shrinkage of the abnormally growing blood vessels in, say, macular degeneration. And I like in that part, and this is the part for patients, sort of like weeds growing through a sidewalk. That's kind of really on an angiogram what these abnormal veins look like. And they leak and the drug becomes sort of the equivalent of a weed killer, and we repeatedly inject it into the vitreous. And it's remarkable how well these drugs work.

So is bevacizumab an anti-VEGF medication?

Yes. I don't know the exact history, but it was one of the first, maybe it's the first. There was a number of drugs in this class in those days. And I think much of the research early in this space were for cancer therapy. And the idea in cancer with an anti-VEGF drug is cancers induce the growth of blood vessels into their own tissue to feed themselves, and so they're causing the sprouting of blood vessels off of your own blood vessels to feed the cancer. And so anti-VEGF therapy was originally conceived and utilized now to cause these vessels to shrivel up or stop working so that the tumor gets cut off from its circulation supply. So these drugs are not just in the eye, but in other spaces, and they were brilliant discoveries when they first came on.

Can you describe for us how bevacizumab is currently used in the treatment of retinal diseases?

Yes. And I'll add that it's used so frequently, I think Larry mentioned the amount of Avastin, not exactly, but the proportion, it's very commonly used throughout the country. There's not a retina doctor I can imagine almost anywhere in the world that has not used a lot of it at this point in our process. And some of us use it more than others. In this state, we use it a fair amount. I'm in California. It's approved by the payer systems here, the federal and state payer systems, so everyone is using it. The way it's used is through compounding pharmacies, essentially. Since it is off-label, you can't just order it and get a dose made for the eye, no such thing exists. That's what we're talking about here for Outlook. But essentially, I think the way it's generally done is the compounding pharmacy obtains the large vials that are used for cancer, which is the labeled indication for Avastin, and then they use their techniques to individualize eye level doses into small syringes that we then use directly into the eye. I don't think any physicians are doing this for themselves, although I don't know that for a fact. It's supposed to be done through compounding pharmacies. And so we order it from the compounding pharmacy and receive these bags -- bag fulls of individuals syringes that they've loaded with the drug that they've obtained through the cancer vial.

Understood. We appreciate you walking us through this. I think it is very -- it's providing great information for our participants. Can you describe the typical way to administer it? And do you use it in your practice?

So all intra-vitreal injections are -- which is the name of this, some will call it intra-vitreous injection to be sort of technically correct, but they're done similarly. We numb the eye. There's various ways to anesthetize the eye, either topically or with a small injection of anesthetic into the thin layer on the surface of the eye. I use topical anesthetic myself and don't inject. And then the eye is prepped with Betadine and maybe antibiotic drops to sterilize the field. And then using, most of us, a 30 or 32 gauge needle, which is a very small needle. I think 32 gauge is about as small as there is in health care, maybe there's some tinier ones, but that's at the small end, is used to inject the drug directly into the vitreous through the sclera. And we pick a very specific area on the white of the eye, as I explain it to patients, to inject directly into the middle compartment of the eye where the vitreous is. And then the patient is -- it takes a few minutes to do. We do thousands of these a year each. And the patient goes home either with eye drops or with nothing at all, depending on the physician's preference, to go about their normal activities. Very few limitations are put on these patients for the day of treatment other than having to come in and get the treatment.

So if bevacizumab is not currently approved, then how are you able to use it?

So this is what's so-called off-label usage, which is common in medicine and very common in ophthalmology, or has been. Until anti-VEGF drugs came online at all, and now I'm speaking about the label drugs, EYLEA and Lucentis initially, there essentially were very few, if any, on-label drugs for the eye. Almost everything we've ever done in the eye over the decades earlier in my career, injections of antibiotics and various other drugs into the eye, antifungals for infections, those are all sort of considered off-label. So off-label means that a drug is licensed to be used in the United States but maybe originally intended for other indications. And then the physician has the right to administer it to -- for other indications under their direction. But that said, off-label has its own cadre of potential pitfalls, and that's how we're using it now. It's basically off-label, an indication we've created, but the original indication was cancer therapy.

Understood. Are there any risks associated with that?

There's risks, yes, absolutely. And with regard to the medical risks, it relates -- the medical risks relate to the preparation and the technique. Compounding pharmacies do a very good job, and they -- like any other industry in medicine or industry in anything, there are variable different quality levels in what might come out of a compounding pharmacy. And there have been some issues several years ago where regulatory bodies had to close down some compounding pharmacies because of the quality of the drugs that were coming out or the prepared syringes that were coming out. That was specific to Avastin, and it's been specific to some other drugs as well. But with regard to medical risk, the obvious is if the preparation is done poorly and unsterily, that's a very dangerous problem. And fortunately, that has not come up much, although there were a few batches over the years that led to some cluster of problems in that regard. But then there's some more common things, like the quality of the syringe. And you can -- we've seen many times, this has been across the country, a little droplets in the vitreous that turned out to be the silicone on the -- liquefied or liquid type silicone on the inside lining of the syringe. And it starts to accumulate after multiple injections, and the patients can see that as what they would call large floaters, and that's been very bothersome. In my hands, I think the biggest problem I've noticed with compounding pharmacy drug preparation is the dosing is a bit erratic. I get the sense frequently that I may have too little drug being administered as compared to what I think is the intended amount.

So is unapproved bevacizumab typically administered monthly versus quarterly?

So typically, we start most people on monthly dosing for bevacizumab or Avastin, same as we would, say, for Lucentis, which is the drug it was compared to in a very important trial years ago that I participated in called CATT. We may have a chance to talk about this later. But monthly is the initial intended dosing for it. But like the other drugs, we tend to see how the patient responds in those early months and then, from my practice, taper down to lower frequency, if we can and the patient is doing well.

Perfect. That was a great overview, and really appreciate your input there. We're going to bring Terry into the mix now. Terry, can you tell us a little bit about ONS-5010 / LYTENAVA and the development and regulatory pathway you've established?

Yes, Jenene. So our journey began with the ANDA Phase II pre-IND meeting with the USFDA where we confirmed that we are, in fact, a PHS 351, a new biologic application for an ophthalmic formulation of bevacizumab. In that meeting, we also confirmed our clinical program, which consists of a clinical experience study, a pivotal trial and a safety study. We're excited to say that the clinical experience study has been completed. We've reported those results. And the anticipated proof of concept, both from a safety and clinical efficacy standpoint, was seen. The pivotal trial is fully enrolled. It's a U.S.-based study. And we're anticipating results in mid-2021, so we're very excited about that. Additionally, that safety study, which was also confirmed in the ANDA Phase II meeting, is ongoing and more than 50% enrolled at this time. So we're very excited. We're on track for filing and our potential approval in 2022.

Very exciting. So if you can let us know how LYTENAVA compares to bevacizumab.

So in our clinical experience study, what we were looking for as a proof-of-concept was definitely a similar safety profile to what was seen in previously published studies for bevacizumab, which we did see. There were no ocular inflammation events, which was very exciting for us. We're happy to see that. We saw the same magnitude of increase in mean visual acuity and 3-line gainers that were anticipated. Our Phase III studies are unique in design, and they're based on the results from the CATT trial, which is a very famous, very large study conducted by the National Eye Institute and the Genentech Lucentis peer study. So those 2 designs combined are essentially the design of our trials, which are monthly ONS-5010 versus a quarterly injection of Lucentis.

Very helpful. So Terry, it sounds like ONS-5010 is being intentionally developed as an ophthalmic formulation of bevacizumab, not a biosimilar. Are there currently any ophthalmic formulations of bevacizumab?

Jenene, no, there are not. So as Dr. Rahhal has explained to everyone, the only available bevacizumab that is used in ophthalmology is off-label. So it's an IV formulation. It was not approved to meet the ophthalmic specifications that are necessary to be an ophthalmic solution. Our product, ONS 5010, was deliberately developed to meet those criteria and be a GMP-sourced ophthalmic bevacizumab.

Excellent. So back to you, Dr. Rahhal. And looking at the risks associated with how unapproved bevacizumab is currently used, do you think having an improved bevacizumab will make a difference?

Yes, absolutely. There's no question. That would be the main purpose in my mind. I'll make the assumption, which I think is a safe one, that it'll be same efficacy and safety profiles for the drug itself because we have a lot of experience there and understand the drug efficacy and safety profile meeting bevacizumab. But the delivery of it with an ophthalmic preparation would have to be, with certainty, safer and more predictable because, again, I think the dosing can be quite erratic from a compounding pharmacy, and/or the management of these syringes, the way they're loaded and the handling of them in the clinic by the technician and myself and in the travel and so forth, a lot of things can change about the dosing and how it was loaded into the syringe itself. It sounds pretty mundane, but this is really on the frontline, something that we deal with kind of regularly. And for the other things I mentioned, like the silicone oil droplets, the purification, I don't know the technical term exactly, the particulates that would be removed for an eye preparation as opposed to another preparation like an intravenous. As safe and clean as intravenous drugs, I'm sure, are prepared for the eye, it's an even higher standard, I think, to put drugs into that space in the body. So for all those reasons and others, yes, I don't see why one wouldn't choose to use it and find it to be more predictable and safe.

Great. And you both mentioned the CATT trial, Dr. Rahhal. As you know, the CATT trial was run under very strict conditions where bevacizumab was controlled and managed through a central source, but that's not how it's been provided in medical practice. What issues have surfaced as a result of this?

So I'll preface by saying I was in the CATT trial, and I helped to coauthor a couple of those papers. We've still been publishing out of that as recently as a couple of years ago, even though the study itself was many years ago. I guess, we're bleeding that maybe a long time. But it was, as Terry said, it really -- it was a milestone for retina and ophthalmology. That study was gigantic in terms of numbers of patients and the predictability that came out of that and really helped us to shape as-needed treatment versus regular monthly dosing, Avastin versus Lucentis, a lot of questions were asked and answered. But again, the data that comes out of these trials do have to be interpreted with the context of what happens in a clinical trial versus what happens in real life. And yes, those were prepared -- those injections were prepared by very high-level professionals in selected compounding pharmacies, I'm sure, maybe even one single one, I don't recall. Terry might know. But in the real world, that's not how drug is prepared and brought to the clinic. It is still -- I want to be fair here to the compounding pharmacies, they're doing their best and they're trying, all of them, to meet the highest standards. But it's very difficult to do that when you have so many different sources and so many different variables going into the preparation of the drug and the syringe and so forth. So in real life, we have countless different compounding pharmacies in different cities and states around the country with different habits and travel or shipping policies and preparation policies. It's hard to make this homogeneous and hard to make it equally high standard among all those different places. So I think in the real world, the variability of the syringes and the drug is much higher than you would see in a clinical trial like that.

Understood. If there were an approved bevacizumab such as ONS-5010 / LYTENAVA, would you prescribe it?

Definitely. I'm smiling because I don't see why anybody wouldn't who uses Avastin already. It's an easy decision. I'm already a fan of the drug and used it, again, for at least 50% of my patients with these conditions. So if one were to offer me a prepared ophthalmic version that I could have even a higher degree of confidence in, and I already feel great confidence in its efficacy and safety profile of the drug, yes, with certainty and, I think, with regularity.

So how does a GMP-approved bevacizumab solve some of the issues that you could experience with compounding pharmacies?

I think the dosing to me -- would be, for me, the most critical because I think that's the more commonly observed problem with some of the different -- and I see this from different -- we've ordered for many different places. And I can tell that some get the dosing more consistent and some get the dosing maybe less consistently. Then there's the obvious particulate issues. And the syringe issue should be solved as well pretty easily. Even if you're not yet to a point that you're going to have a prepackaged syringe, and that may be an excellent goal to have as well, as some of the other preparations have come, that resolves the syringe issue, but that can be resolved in other ways as well. But the dosing, the particulate, the sterility for safety profile should be solved.

Thank you so much for that. Now Jeff, we're going to bring you into the mix. So let's move more towards the current treatment landscape and commercialization strategy. Jeff, could you talk a little bit about what's currently available for the treatment of wet AMD?

Yes. Thanks, Jenene. And Dr. Rahhal really set up the answer to that question very well. His practice, in fact, is what we see nationwide in the U.S. in terms of the available therapies and how the retina community has used and utilized them. So off-label, unapproved bevacizumab is the majority share of treated patients at this point at more than north of 50%, followed by EYLEA and Lucentis. And so those are the currently available treatment options. And as Dr. Rahhal had shared, it really did revolutionize care. We talk about that in terminology like standard of care. Anti-VEGF has been established as a standard of care. It's remarkable what it does for patients after all this time, but also what is viewed to be the future. So as we think of the current marketplace, those are the 3 main options that we have.

Excellent. So Dr. Rahhal, what are you using on a regular basis to treat your patients?

I use all 3 drugs that were just mentioned: EYLEA from Regeneron, and Lucentis and Avastin both from Genentech. And I use, I mean, about the proportions mentioned by coincidence, but I think this is a common proportion, to be honest, that we take polls at the Vitreous Society, now known as the American Society of Retina Specialists. This is dating myself because that name changed about 10 or 12 years ago, I think, at least now. But the poll shows a lot of consistency among how people are practicing around the country. And so for me, a little bit over 50% receive bevacizumab. We're talking about wet AMD and diabetic retinopathy. Although there may be some subtle differences between those 2 conditions for you, but pretty similar. And then the -- of the other 45% or 50%, I'd say, for me, I use a greater proportion of EYLEA, maybe 2/3 of that remaining half, and then 1/3 of that remaining half are in the Lucentis category. There's a lot of factors that go into these decisions that are sometimes complicated and nuanced and sometimes somewhat arbitrary, but cost matters a lot, and that ends up factoring into these decisions quite regularly. I also use steroid medications for these conditions over and above anti-VEGF. It's infrequent that I would use steroid alone, there's some rare exceptions, but I'll also use steroid injectable medications as adjunct therapy to these drugs.

Okay. So Jeff, why is there a need for ONS-5010? If it were approved, how do you see it fitting into the overall treatment landscape for retinal diseases?

Thanks, Jenene. Yes, the utility and our excitement really comes from the future and what we are solving for with ONS-5010. And Dr. Rahhal outlined very well as well as Larry and Terry, we're trying to solve important problems for a product that's highly utilized and trying to give the community what they know and trust in efficacy, but solve a number of safety considerations with particulates and with silicone oil droplets and syringe malfunction. And the underreported notion, and Dr. Rahhal was mentioning, just the 50 microliters is a very precise measure of dose. And not only is there the issue of volume, but there's the issue of potency. So if the -- if you could assure physicians and patients that the continuity of drug is provided all the way to the injection into the eye, then you can be assured that you get a safe and effective outcome for the patients. So that is really what excites us about the future landscape in providing this product that we -- it isn't convincing the community of the efficacy, they know it to be effective and they've used it in great numbers. And so by adding the FDA element, GMP-approved portion of that, we're really thrilled to provide that in the market, ultimately. And as we've done our homework, we've done global market research, quantitative market research to really understand the compelling nature of a product, as we intend to provide it. And we've been -- it has been a very, very strong response in terms of what we call share preference. So we know physicians in great numbers are wanting this product because it allows them to, again, give the patient something they know and trust in a better FDA-approved solution. So that's kind of the general point about ONS-5010. There have been other changes that the payers have influenced the community in terms of their requirements of first-line therapies that Outlook is not driving a strategy, but in terms of what is commonly known as step edit, there's a requirement to try a lower-cost alternative before being authorized for something down the line, and even ASRS has well documented that requirement. And we're excited because as a commitment to a responsibly priced option, we feel great about ONS-5010 fitting in that first bucket. So that first patient that's diagnosed or when they're initially diagnosed, ONS-5010 can be an important tool to begin the therapy. A good number of them can continue on ONS-5010 over the course of the treatment requirements. But even as you think of longer term, if there was an adjunct therapy in the market that would be paired with an anti-VEGF, we feel that's a perfect pairing with a responsibly priced, safe, FDA-approved alternative in our 5010. Because of cost considerations, they can use the 2 together if those options come to market. And then the last point would be even if there was a device-based, longer-acting anti-VEGF, they will initially require proof of response to an anti-VEGF, which we can provide that solution. And they may need intermittent dosing beyond. And this will be for a subset of patients perhaps at a device-based, long-acting solution would occur. But even in that case, we see great utility in 5010 being an available option in almost any scenario we can imagine in the future.

Excellent. Dr. Rahhal, is there anything that you'd like to add to that?

Yes. I do. I like that Jeff brought up combination therapy and extended-duration therapy. This is really, if we're talking about real time, what are retina doctors thinking, talking about doing in their practices now or want to do in their practices in the near term, the demand for longer-acting products and for smart, useful, efficacious and cost-effective combination therapy is really going to be probably the way the next decade will unfold. We've had an unbelievable 1.5 decades of, again, revolutionizing the treatment of these conditions. The next frontier, in my mind and I think in the mind of many, there's no secret here, is extending the durability of these treatments. And I think that -- I like his term, I think the cost effectiveness of a drug is going to matter a lot, especially in this context of combination therapy and/or long-acting therapy to get payers to back the treatment and cover the treatment for patients and for patients who are paying out of pocket, the cost containment is going to be huge. And if you're using 2 or 3 drugs, and that may be necessary to get the best results, we're going to have to think about ways to do it in a cost-conscious way, to quote from Jeff, which -- and I like that term. And for a drug that's going to be extended release, let's say, if you need another molecule, a carrier molecule or a surgical device or some adjunct to make these drugs last longer, again, that's going to add a lot of cost. So the greater the cost containment for each individual component of these treatment paradigms, the better it will be for everyone involved, patients in particular.

Certainly appreciate those thoughts. Jeff, what presentation will ONS-5010 / LYTENAVA be provided in? Can you tell us a little bit about the rationale behind that decision? And what are the advantages you believe exists with that approach?

Yes. Thanks, Jenene. And perhaps maybe the element around our offering that we are most excited about, upon approval, we intend to have the ONS-5010 option be available in both a vial and a prefilled syringe. And the prefilled syringe is one of the more exciting, if not the most exciting, element of what we're providing because the issues that Dr. Rahhal referred to and that has been well documented even in recent history about the syringe issues, whether it's with compounded drug, the issue of silicone oil and droplets in the eye and the issues of floaters, particulates, syringe malfunction, we are going to be providing the product in an innovative very, very -- it's an ophthalmic-designed syringe for the 50-microliter injection. It's a cyclic olefin polymer syringe that has a siliconized coating, which allows you to get the lubricity that you need without the -- introducing silicone oil, so you remove that issue. The particulate issue more or less goes away. So there's really very exciting elements that we're providing in this prefilled syringe that, at the end of the day, the workhorse of an anti-VEGF is more or less the same, and there can be some subtle differences. But we feel very confident in providing the retina community a best-in-class syringe that really can be a means for a choice in itself. And that's going to be very different for the retina community, we feel. And we're excited, truly excited about that option.

That's great. And I appreciate that. It sounds very exciting and a lot to look forward to here. We covered a lot today. We covered wet AMD, the treatment landscape, the clinical and regulatory pathway for ONS-5010 / LYTENAVA as well as the commercialization strategy and opportunity there. I'd like to give all of you an opportunity for some closing remarks before we end this discussion. Let's start with you, Dr. Rahhal.

Thank you. Yes, this has been fun, and I appreciated hearing the thoughts of the other gentlemen on this panel. My final thought is a bit of a -- it may sound repetitious, but it seems a no-brainer that if we have a drug that we love to use and use with great frequency and great success, yet we have to have it in a, let's call it, maybe not subpar but less than the most optimal delivery and acquisition techniques, and thus have problems with dosing or syringes, syringe malfunction as it's referred to, then it seems a no-brainer that if we could get that drug that we're already confident in, that we already have 15 years of experience with and great success with, if we could get it in the form that we really prefer our ophthalmic preparation, which is as an ophthalmic preparation with the purity and the safety profile that goes along with that, it seems that there'd be no reason not to use it universally, especially if these great syringe advancements that are being talked about, that Jeff mentioned, could be part of that.

Thank you for that Dr. Rahhal. Terry? You might be on mute, Terry.

Thanks, Jenene. And we continue to be very excited, in summary, about our ongoing Phase III clinical program for the wet AMD indication. I do want to say we do have FDA SPA-approved protocols for BRVO and DME as well, and intend to pursue those indications as well. We've partnered with world-class, best-in-class CGMP manufacturing facilities and remain on track for filing and, ultimately, that potential approval in 2022. So we're very, very excited about solving these unmet medical needs that have been discussed today.

Thank you, Terry. Jeff?

Well, I would just echo the excitement that we've all had in doing what seems to be very important work in providing, again, an FDA-approved solution for a known efficacious medication and, ultimately, providing it in not only a vial but a prefilled syringe, I think, is just a great place for us to be. We're excited to provide this in the market and look forward to sharing more results and updates as we go along.

Jeff, thank you. So I'll end with you, Larry.

Sure thing. Thank you, Jenene. Firas, thank you for taking time out of your incredibly busy early morning in Los Angeles to join us on this call and provide your expert point of view on retina diseases and the available treatment landscape. You provided us with some great insights. We strongly believe, and I think today's conversation only reinforces, that a responsibly priced FDA-approved bevacizumab will make an important difference to patients and physicians. I hope that everyone watching today now has a better understanding of how LYTENAVA fits into the broader treatment paradigm and why everyone associated with Outlook Therapeutics is so excited about the future of this opportunity. Perhaps the most exciting detail about LYTENAVA for me is that it has the potential to be approved and available for use in less than 2 years.

Excellent. Gentlemen, we appreciate your time. So grateful for this discussion. And with that, this concludes our KOL roundtable with Outlook Therapeutics. I would like to thank Dr. Rahhal and the Outlook Therapeutics team for joining us today. As a reminder, Outlook Therapeutics trades under NASDAQ under the ticker OTLK. I would also like to thank you for your time and attention and look forward to you joining us again today at 2 p.m. ET for the last presentation of this roundtable event. Once again, as a reminder, all live webcast and replays can be accessed through the event website, www.virtualinvestorco.com. Thank you, and have a great day.