Good afternoon, and thank you for joining us for the Virtual Investor CEO Spotlight event featuring Outlook Therapeutics. My name is Jenene Thomas. I am CEO of JTC, and I will be the moderator for today's event. We are very excited to have Russ Trenary, President and CEO of Outlook Therapeutics for today's spotlight event. Before we get started, I wanna remind our audience that Outlook Therapeutics is publicly listed on Nasdaq and trades under the ticker OTLK. During today's discussion, 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. Welcome, Russ. We're so excited to have you join our virtual investor platform again. Thanks so much. Thanks for having us back, Janene. It's a real pleasure. Oh, absolutely. To begin, let's start with your background. Would you mind telling our audience a little bit about yourself? Yeah. I've been in the healthcare industry for about 40 years. About half that time I've been with some of the bigs like Allergan and Advanced Medical Optics, multi-billion dollar companies, sat on those executive committees. I've seen what companies look like and how they're run, from that standpoint and have been a part of running those. The other half of my career has really been with smaller companies like Outlook Therapeutics that have oftentimes either a single product or a single technology, but a tremendous opportunity. I think both of those are great experiences to have. Both those environments I've enjoyed, but this opportunity at Outlook, I've never seen one like this before. This one's really has me revved up. Excellent. Well, I can't wait to dive into the story and really get to some good questions since we have you. A lot has happened since the last time you joined us, Russ, namely the submission of the ONS-5010 BLA submission for wet AMD. Congratulations on that. Thank you. Absolutely. It certainly has been a challenging time for the biotech sector, and I'd love to hear your thoughts on how this has impacted Outlook Therapeutics. I think, look, it's been tough for companies of all sizes and in more sectors than just ours. I think biotech has been particularly beaten up. I think a lot of investors who are in this space, I think historically, are looking for that big one or two out of a hundred home run that's gonna turn into a multi-billion dollar opportunity. As we know, the batting average on those is quite low. Most people would acknowledge the fact that 95% of the molecules, if not more, that go into development don't make it out on the other side. I think biotech investors kinda get excited about finding those gems. The reason I'm so excited about or one of the reasons I'm so excited about our opportunity is bevacizumab is a molecule that's been well proven. It's been in use for well over a decade. It's trusted. It gets the job done as an anti-VEGF in treating wet AMD, which is our first trial. Also it's been used successfully off-label in DME and BRVO, a couple of studies that we'll be doing in the future. You know, I think that although the markets have been hammered, maybe it's time for biotech investors to look at something that's de-risked, instead of trying to find that home run, because I think if you look at our opportunity and the impact that we can make in a $13 billion market cap arena, you know, I think we've got something that, because of its lack of risk and because of the expertise we have inside the company in launching big products, this is something that really deserves people's attention, I think. I'm not worried about the rest of the space. In fact, if anything, maybe people will look at this, a very unique opportunity, in the face of what looks like choppy waters out there for a lot of other people. Great point of view, Russ. Appreciate that. Now I think it's time to just dive in. You've given us some good nuggets, and an insight into why people should be excited about Outlook Therapeutics, and so let's just kind of drill down here. Why don't we start really just take a step back, and for those new to the story and as a refresher for those that have been following, can you provide an overview of ONS-5010 and its use in wet AMD? Yeah. ONS-5010 is bevacizumab. This is a biologic drug solution that ends up getting injected in patients' eyes for the treatment of wet AMD, or DME or BRVO. All those things that I just mentioned have been conditions that have been treated off-label by a product that has been procured by compounding pharmacies. They repackage it, rehandle it, put it into small volume vials and syringes, hope nothing goes wrong during that process, and then it ends up getting used for those aforementioned conditions. What we're doing is we're getting an honest-to-goodness FDA approval in ophthalmology for bevacizumab. Although it's been used successfully off-label in ophthalmology, there have been no ophthalmic conditions for which this molecule has been approved. We're going. We're doing the hard work. We've done, you know, three studies in order to prove to FDA that we can get results as good as or better than the bevacizumab that's come before us. It's, you know, the great thing about this is the space is $13 billion worldwide and about $7 billion just in the United States. So it's a big opportunity. It's mostly, you know, the dollar volume is mostly dominated by just a small handful of brands that are very expensive, do a great job, but they're only 50% of the injections. The other 50% of the market is occupied by these or it's served by these compounding pharmacies who, you know, are buying a product that exists, that was developed and exists to treat other conditions. They're buying it, repackaging it, and then reselling it into ophthalmology. We expect to go into that segment with a differentiated product and provide a value proposition that is currently not available just due to the standards that we have to meet in order to earn the right to inject this product in somebody's eye with an FDA approval in ophthalmology. You talked about the $13 billion market opportunity for wet AMD. What are the current treatment options available for patients in wet AMD? Right now, you know, it is a condition that the conditions of wet macular degeneration and diabetic macular edema and branch retinal vein occlusion are all conditions that are treated with anti-VEGF drugs. You know, there have really been two molecules, ranibizumab and aflibercept, that have kinda dominated the space over the last 10+ years. They are the ones that have basically garnered, you know, over $6.5 billion of sales just in the United States. There have been a couple of recent entrants to the space, but clearly the two molecules, aflibercept and ranibizumab, are currently the ones that dominate that space. The mechanisms of actions for all of these are pretty similar. You know, these anti-VEGFs are all introduced. They're all injected into the eye to try to tamp down those, you know, aggressive vascular processes that are creating a wetness, if you will, at the macula and at the retina. That has a very deleterious effect to central vision. These anti-VEGFs like bevacizumab, ranibizumab, and aflibercept are all molecules that are used to treat these conditions and keep that proliferation of vascular endothelial growth from continuing at the same pace that it has before. Can you speak to the current process in which physicians source repackaged bevacizumab? From what I understand, aren't there certain safety concerns? Yeah. What's going on is there are a group of compounding pharmacies in the United States who buy Avastin. Avastin is bevacizumab that was developed to treat oncology. It was designed to go into a drip IV and treat the patient systemically. Some very smart ophthalmologists determined that, you know, ranibizumab, which was a molecule that was under development for treating wet macular degeneration in DME and BRVO, is a fragment of bevacizumab, so wouldn't bevacizumab work as well? Some doctors did some experiments with it, and then ultimately that turned into or morphed into over time the CATT study that was you know the National Eye Institute under the auspices of the National Eye Institute, the CATT study was performed. What it showed with over 2,000 patients was that bevacizumab was non-inferior to ranibizumab in treating these retinal conditions. Because bevacizumab wasn't approved in ophthalmology, some compounding pharmacies saw an opportunity to get hold of this product, bring it into their own facilities, rehandle it, repackage it into smaller volumes of, you know, smaller volume vials and syringes, and then resell that to either retinal surgeons or hospitals or, you know, whatever the business entity was that was procuring these. Over time, what the doctors learned, what we've all learned, is that bevacizumab works, and it's allowed the compounding pharmacies to garner a 50% market share, albeit all off-label, in treating these retinal conditions. Off-label use of repackaged bevacizumab represents approximately 50% of the U.S. wet AMD market. Why do physicians continue to use it, even if there are other FDA-approved options available? Well, I think you know there are a number of reasons. I think the first reason that they would cite is the CATT trial, you know, where you know those results that were published in 2011 looked pretty convincing that bevacizumab was non-inferior to ranibizumab, so it became de facto an option for them. Economically, you know it was an opportunity for doctors and hospitals to procure an anti-VEGF for a markedly different price than what they were paying for ranibizumab and aflibercept. I think you know there were a number of factors that went into it. I think first and foremost was the doctor's trust in the data that show that bevacizumab is a great molecule in treating these retinal conditions. Excellent. Great background on ONS-5010, the market. Now I want to turn to the regulatory pathway. Your recent BLA submission was an amazing accomplishment. Congratulations again on that, Russ. Thank you. Sure. From a regulatory perspective, can you outline what steps will take place between now and a decision from the FDA? We filed the BLA, and it was an impressive document or series of electronic transfers. It was about 160 pages of information that we or 160,000 pages that we end up transferring to FDA of tables and graphs and explanations for trial design, our inclusion/exclusion criteria. You know, all of the trial design, all of the factors that go into helping the FDA understand what we did, how we did, why we did it, and what those clinical results are. FDA will be poring over that data, looking at our clinical data. Fortunately, all of our primary and secondary endpoints were met. The safety data, you know, turned out to be extraordinarily good. I think, you know, one of the things that FDA is gonna see in those data that we sent them, was we had about almost 42% of our patients were three-line gainers. That was our primary endpoint. What we showed was not only did we have 42% of our patients gain three lines of vision, but the p-value of that was 0.0052. It was highly statistically significant. In addition to that, we had about almost 57% of our patients gain two lines of vision, and almost 70% of our patients gained at least a line of vision. All of them had impressive p-values and statistical significance associated with that. They will see that, but if they've got questions on the data or if they're wondering how some of the statistics were calculated or they wanna see our programming for doing stuff like that, they'll ask questions, we'll give answers. A lot of this is gonna be back and forth between us and FDA on just parsing through all those data and all of our explanations on what is in there. We love the data that went in there. We had only one ocular inflammation from a safety standpoint. That was one out of we now have about 370 patients that are being filed with well over 1,000 injections. An incredible safety measure in this study for this molecule. We're very, very proud of that. As FDA, you know, just kinda, you know, has additional information that they need, we're there for them. Some other things that they'll do is they'll engage in some level of inspection on some of our clinical sites to ensure that they were all following the protocol appropriately. They'll likely also visit our factories. We've got two great factory partners. One is Ajinomoto in San Diego, California, and the other is FUJIFILM Diosynth in College Station, Texas. These are two very experienced companies. They deal with FDA. Some of them have been involved in Operation Warp Speed, so they're used to seeing FDA in and out of their facilities a lot. We're very confident that their ability to withstand FDA inspections is well at hand for them as well. A lot of hardcore clinical and regulatory back and forth and inspections and things like that will be occurring. It's something FDA does every day. Wiley Chambers and his group are monstrously effective and experienced at engaging in this functionality. I think we expect that they're gonna see some good things in our file. If they've got any questions for us, we're ready to answer them. Well, I now see what you mean when you started saying this was a de-risked opportunity because you've been through so many hoops and hurdles and so forth, just making it through the clinical development strategy and clinical program. Now on the other side of it's the regulatory piece. You've, you know, accomplished so much that, you know, a lot of life sciences companies, you know, aren't able to make it to this point. That's right. This is a huge accomplishment. I understand you're enrolling subjects in your NORSE-7 clinical study. Can you please provide an overview of the study and what it means for this overall program? Yeah. NORSE-7 is the study that we're doing in order to show equivalence between the drug substance and results that you would get out of a vial. The vial was the container that was used for all of our clinical trials that, you know, NORSE-1, -2, and -3, that are gonna add up to the ultimate, you know. Those are the data that FDA is gonna look for. It's all drug product that came out of vials. What NORSE-7 is all about is we want to show equivalence between the drug solution that goes into vials and the drug solution that goes into a pre-filled syringe. That is gonna be a three-month study that's gonna compare the safety of ONS-5010 in vials versus pre-filled syringes. We've already enrolled the vial arm, so we're just waiting to get started on enrolling the arm that will be treated with our pre-filled syringe. There will be about 120 patients that are treated in this, and we are gonna be treating wet AMD, BRVO, and DME. But basically, for this kind of an approval, it will be a supplemental application once we get our original BLA approval, assuming we get that. But that supplemental filing will be basically what FDA is gonna focus on is safety, and so they're gonna be looking for safety signals. Is there anything untoward about the drug solution that comes out of syringes versus that which comes out of vials? We're really excited to be able to start that after our anticipated FDA approval. Ultimately, we'll take those trial results and put those into a supplemental filing once we get the original approval. You've talked about the leadership team and the commercial expertise that you have around the table. I'm sure you're planning for success with respect to the commercialization of ONS-5010. High level, what is your commercial strategy? Do you intend to partner with a large pharma company, utilize a contract sales organization, or if approved, are you planning to commercialize on your own? Yeah. High level, our strategy is to launch ourselves in the United States. What we're doing right now, people have seen some announcements from us around hiring. You know, we've hired an executive from Amgen to head up commercial operations for us. We hired a former Genentech executive to manage marketing and market access for us. We're going through the process of recruiting in the medical affairs area, and we'll be bringing on a head of medical affairs and then ultimately management in charge of the medical scientific liaisons. Ultimately, you know, other levels of market access, marketing, sales management, and then ultimately a sales team once we get closer to what we would anticipate would be a successful communication with FDA around approval. All of that is underway. It's very exciting. We're spending a lot of time interviewing, finding super top talent in this area 'cause this is a really cool opportunity. People are not having trouble understanding the value proposition here. Outside of the United States, Janene, we're open to partnering. I think in the United States, one of the things that makes it easier to launch today than, say, 15 years ago is there are distribution partners out there who can take your product from your factory all the way through delivery to the customer, inclusive of front office, back office, volume-based discount and rebating calculations, pharmacovigilance. There are entities out there that can perform all that functionality for you and do that for other companies. That's available to us in the United States. Of course, we've got all of our factory work is outsourced in the United States with our great factory partners. Likewise, there are some geographies like Europe where that same functionality is developing rather quickly. We could potentially be able to launch directly in Europe as well. We're kind of looking at that. Having said that, it would be difficult to launch everywhere simultaneously for us right now. We're open to looking at partnerships outside of the United States. As you know, in this space, everybody else has done that. You know, for right or wrong, everyone else has tended to be in charge of their own destiny in the United States while they out-license OUS, and so, you know, we'll consider that as a strategy as well. Great clarification there, Russ. Thank you. In order to support a successful launch, what pre-commercial activities have you begun thus far? Aside from the aforementioned, you know, in terms of all the hiring that we're doing for all of the sales and marketing and medical affairs and the whole medical science liaison group that we'll be bringing on. We're still doing a lot of final market research to verify what we learned earlier around product positioning, the value proposition that we're bringing to this. We've already spent a lot of time with, you know, surveying. We had a big survey of 152 doctors, half of which were in Europe and half of which were in the United States, just kinda going through our target product profile, making sure that it was something that the doctors were interested in. Boy, were they. You know, 84% of them said they were interested or very interested in having an FDA-approved version of bevacizumab, so that was great news for the company. We also did a lot of research and are continuing to do research with payers, because, you know, once we got the green light from the doctors on, "Yeah, this is something I actually want," even though I've had access to off-label bevacizumab for a long time, 84% of them said they really wanted us to continue doing what we were doing. We took that information and went to payers, similarly and said, "Hey, you know, we've got a signal from the doctors. They think this is good, but would you pay for it?" And the answer was a resounding yes. We asked them, you know, what do you think we should pay for it? They gave us some answers. I think the good news for us was, the payers, they had a level of understanding beyond what we thought they might around some of the safety and efficacy issues associated with an off-label product, something that's never been approved in ophthalmology, and they know that costs money. On the one hand, they liked the price point that they were getting for off-label bevacizumab compared to the on-label brands that are pretty expensive. They also know it costs money. When you've got safety problems and efficacy problems, they inherently knew that. Their counsel to us was, "Look, we like this idea. We'd like to see the whole space, on label, and we're willing to pay something for it." You know, we're going back and doing some continued research with the payers. By the way, the payers that we talked to, it wasn't just our best friend on the street corner. You know, we had UnitedHealthcare, Aetna, Humana. You know, we had payers in there that represented 270 million lives, so America. I think we got some really good feedback from them. We're continuing to make sure that we've got a pristine understanding of the likes and dislikes for the customers, for the doctors, and for the payers, and make sure that, when we get out there, we've got something that looks like it's a white hat opportunity. It should make payers happy, doctors happy, and patients happy. I want to kind of dive in a little bit deeper to the survey you described. With your ongoing efforts to grow awareness, how has physician engagement been going, and how receptive are ophthalmologists to an FDA-approved formulation of bevacizumab? What is their willingness to prescribe it? Great question. We just got some market research back on that. I'd like to show the audience that screen because this was kind of a flash survey. It wasn't done by us, so we were really interested in it. You know, any great marketer who's really trying to find the truth tries to engage in the type of market research that doesn't bias the outcome. You're trying to find out where the customers really live. Where do the payers really live? What are they really thinking without us going on and trying to, you know, sprinkle pixie dust on something and make it look like it's not. We think we've done an incredible job with the payers and with the doctors in terms of just giving a right down the middle description of what we have, what we're bringing to the market. When we found that 84% of the doctors were interested and very interested, that was a great signal. When we found out the payers were willing to pay for this, that was a great signal. We were still engaged in market research even though we were behind the curtain, and people didn't know who we were. This survey that just recently came out we thought was very interesting. Janene, this flash research was done within a week of the time we filed the BLA. We didn't even know who these people were at the time, but there's a group called Spherix who went out and surveyed, I think it was 70 or 80 doctors. There was a large survey on a number of things, but one of them was about ONS-5010 specifically. As you'll see from this, about 80% of the doctors surveyed indicated that they believed ONS-5010 was an advancement over other technologies that were available. We're assuming that what they were referencing was an off-label brand of. We think that was in response to our bevacizumab versus off-label bevacizumab, which means they've got an inherent level of understanding around what the differences are in turn you have to do to meet FDA requirements on lack of particulates, on pH levels, on endotoxin levels or lack thereof. Our packaging has to be approved. Osmolarity specifications are important. We have to prove hold times and shelf life and stability. There's a bunch of hurdles that Wiley Chambers and the group at FDA require for you to get an honest-to-goodness approval in ophthalmology that are not necessarily required by something that was designed to go into a drip IV and then ends up getting repackaged and rehandled in a compounding pharmacy. It looks like from this survey's results, the doctors get that. They either knew it before we got here or have learned something about our program to convince them, 80% of them feeling like this is an advancement. On top of that, 77% of those surveyed thought that an FDA approval in ophthalmology was important in wet AMD. Mm-hmm. The market research that we have done and over 71% of them said, yeah, they're likely to prescribe it. If you can get these kind of market research results, you know, on the eve of a launch, that's pretty good news. We were really excited to see that. We had no opportunity to bias it except by virtue of the fact that we're doing what we're doing, how we're doing it. I think again, this just corroborates the fact that what the doctors told us previously in our market research, it matters. They want an FDA-approved form of bevacizumab. Oh, I love how you came prepared, and that slide was so helpful. Thanks for sharing it with the audience. Very encouraging feedback. It just leads me to kind of think back to how we started this conversation with that de-risk comment that you made. Another opportunity here, with this feedback that you've received and I understand very clearly now why you're so excited moving forward. However, in practice, what incentive is there for physicians to use a new FDA formulation when they're already comfortable with their current sourcing methods through compound pharmacies? I think the main incentive, Janene, is quality. I think that the doctors are there for their patients, and they're trying to make sure that the treatments that they provide their patients are as good as they can possibly be. I think that is the primary incentive for them to be moving in our direction. Having said that, there is, I think, something else to take into consideration, and that is that there is U.S. law that kind of regulates, if you will, what compounding pharmacies are allowed to do and what they're not allowed to do. One of the things that, you know, just happens to be a matter of fact is that once a drug or biologic is FDA approved and commercially available, then compounding is no longer authorized. What this law talks about is if a company and FDA have gone through the trouble of doing everything that you have to do in order to earn an FDA approval, then a compounding pharmacy can't just come along and provide the same thing. What they've been doing is repackaging bevacizumab. We're getting FDA approval for bevacizumab. We believe that the law is clear that once we get approval, the earth tilts. Now all of a sudden there is an approved and commercially available product. Compounding is no longer authorized except on a specific patient name basis per prescription. In those exceptions, you know, it would still be authorized, but we don't think doctors are gonna be writing individual prescriptions for, you know, for this. There's no reason for them to be avoiding our drug versus something that would come out of a compounding pharmacy unless there was an ingredient in our formulation that a patient was known to be allergic to, but that's a pretty low incidence occurrence. Understood, Russ. Thanks so much for that. You touched on pricing and reimbursement strategy. I wanna dive into that just a little bit. There's a broad range in the cost of medications to treat wet AMD, from less than $100 a dose for off-label products to over $2,000 a dose for branded products. Thinking about potential pricing, if approved, where do you see ONS-5010 fitting into the overall spectrum? Yeah. I think what we're doing right now, Janene, is we're finalizing the research that we're doing with payers and with doctors, and ensuring that everybody's got a pristine understanding of the value proposition that we're bringing. Once all of that is understood, inclusive of you know some of the potential safety and efficacy issues that emanate from the compounding pharmacy process, I think we'll be in a position you know at launch to be able to you know not only know what that price is gonna be, but know that it's gonna be a good one that is well accepted. You know, one of the things that I think You know, I think there's a silent thief that's been in this whole compounded pharmacy arrangement, and that is, you know, it was kind of elucidated in a JAMA article that was done by Yannuzzi et al. In fact, Szilard Kiss was one of the doctors that was part of this paper that we've recently talked to. What they found in this study, Janene, and it was published in JAMA, was that 80% of the samples that they looked at had insufficient drug protein concentration. What that should do is put a question in the doctor's mind around dosing. So, regardless of the volume of drug that I'm putting in the patient's eye, you know, if even if I believe that the vial or syringe came with the right volume of drug in it, was the protein concentration that comes along with that, you know, up to ophthalmic standards? We have to prove that. We certainly did have to meet that, you know, jump over that hurdle in order to provide the drug solution that was used in our clinical trial. Our clinical trial had great results with it from an efficacy and a safety standpoint. If part of the value proposition is I'm going to know what kind of efficacy I should expect, and I should get a pristine level of safety, something similar to what was shown in the clinical trial, then, you know, I think that's all part of the value proposition. I think when you look at folks like OMIC, who's the number one medical malpractice insurer in ophthalmology. They seem to be paying attention to this because we've been informed that OMIC won't necessarily cover the second eye of a patient who is receiving, you know, in close proximity, off-label Avastin in one eye and now the second eye is to be treated. We've had reports that OMIC won't cover that second eye because it's also gonna be off-label. There's something in there that may be detriment to them that is an increased risk associated with that. I think, you know, I think that the bottom line is the value associated with meeting FDA standards and getting an FDA approval is meaningful. It will ultimately be baked into the price. I think at the end of the day, doctors will have an opportunity to look at what our value proposition is compared to what's in the compounding pharmacies, even if they were allowed to be there, which we think by law they're not allowed to be there. Relative to the other molecules that are in existence today that are, you know, currently priced within shouting distance of $2,000. You touched on this, a few times, but just to ask directly. What about reimbursement? Can you speak to your strategy to convey the value proposition to ensure coverage by payers? Yeah. This is a pretty standard playbook that CMS runs and they'll look at our wholesale acquisition cost over the first couple of months that we're out in the marketplace. Then we'll initially launch with a temporary J-code, and that will turn into a permanent J-code once the system has a chance to see what is the actual price that the molecule is being sold at. I think whatever our wholesale acquisition cost is upon launch, that should be, you know, relatively speaking, within a range of what the reimbursement amount should be. Turning to the potential commercialization of ONS-5010, what is your vision for the commercial rollout, and how large of a sales force do you expect you will need? Yeah, the nice thing about this one, because, you know, there are a lot of- bottom line is our sales force is gonna be dozens rather than hundreds. You know, a lot of investors who have dealt with other companies who have, for example, small molecule launches coming up, and they've got audiences that are, you know, if it was in ophthalmology, for example, and you were trying to cover all of ophthalmology, there are 15,000 ophthalmologists in the United States. Well, only 3,000 of them are retina surgeons, and only about 800 of them comprise about 90% of the injections that take place. So how many reps do you need to cover 800 doctors? It's a couple of dozen. The nice thing for us is we're gonna have a, you know, pretty cost-effective, I think, sales and marketing effort coming in just by virtue of the fact that it's really the retina community that we're targeting, and that's it. It's just the retina community that's doing, you know, for the most part, the largest volume of injections. We're covering a lot today. We are going to open it up for Q&A for our audience. I have a few more questions, though, that I'm dying to ask. I know from our past events you've had some very excited and engaged KOLs. How do you intend to leverage them in the early stages of launch? Yeah. Frankly, we're getting a lot of volunteers. You know, I think we've you know, You never have 100% of the doctors loving or hating what you do. You know, it always segments out. You can tell from the survey data, and you can tell from the data we showed today, that 80% of the doctors out there view this as an advancement. I think as doctors look at the opportunity to be engaged and be a part of having this anti-VEGF space go from 50% on-label to kind of 100% on-label. You know, I think there are a lot of doctors that are eager to help with that process. We have not had any trouble putting together scientific advisory board meetings, medical advisory board meetings. When we've gotten together, whether it was over Zoom or whether it was at some of the local congresses, we have not had any difficulty getting some of the largest names in all of retina involved in helping us look at everything from what is the value proposition, you know, for this. You know, should this product be positioned? What are the attributes of an FDA-approved bevacizumab versus what's available today? The new delivery systems that we're developing had a lot of excitement around that. One of the coolest advisory board meetings I've ever been in. We were trying to show them two generations of syringes, and once we got done talking about the first generation and actually demonstrated the first generation, they were ready for the meeting to end. They said, "This is what we need." We made them stay and help us. Is there anything we can do to make this better? That was the first time I've ever been to an advisory board meeting where people said, "Stop thinking. You've given us what we need." Regardless, we made them keep on thinking, and maybe we'll be able to one-up ourselves on the second generation. I think the doctors are bringing a level of energy and excitement commensurate with what we're feeling at the company. We'll continue to conduct these advisory board meetings with, you know, as many of them as we can, as we can get hold of, to just kinda continue to help the company think through what are all of the things that we can do right here, and how can we avoid doing things wrong as we roll this thing out. Excellent. Beyond your initial beachhead opportunity in wet AMD in the United States, can you speak to your strategy to target additional indications? You mentioned this in your opening comments, DME and BRVO. Also, what is your plan for entering markets outside the US here? Yeah. Regarding additional indications. Fortunately, wet AMD is, you know, two-thirds to three-quarters of the total anti-VEGF space. If we get an approval, that will be the lion's share of the market right there. Having said that, we have gone through the process of designing what the clinical trials would look like for DME and BRVO. We have met with FDA and gotten a nod on, yes, those are approved spaces, and that is the proper way to conduct those trials. If you do that and the data are good, then, you know, that could ultimately lead to an approval in DME and BRVO as well. We won't start those studies until after we've got FDA approval. Those will be two efforts that we're definitely looking at engaging in. Then outside of the United States, you know, we'll again be mindful of the magnitude of this opportunity in the various geographies outside of the United States and respond to potential out-licensing opportunities with that. Being mindful of the fact that, again, I think there are some geographies we can get there by ourselves. We'll continue to, you know, kinda weigh those opportunities for out-licensing versus doing it ourselves. Right now, the focus, Janene, we are laser-focused on the United States, and we're gonna stay there until we till we get out there and have a successful launch. Certainly hear you loud and clear there, Russ. Thank you so much for that. With our spotlight event, at this point in time in the conversation, I usually ask the CEO what you're most excited about and what you see as the biggest opportunity. I think in this case, we all know that it's the outcome of the decision from the FDA on the approval of ONS-5010. I'm going to ask you another question. What are your top priorities leading up to that decision, and what do you see as mission-critical in supporting a potential commercial launch? The first part I mentioned is focus. You know, we talk about focus a lot, and we'll continue to talk about that. And our mission is clear. Launch, you know, getting the FDA approval, all the things that we have to do to do that in terms of continuing our interaction with FDA, and then with our factory partners and with our distribution partners. As far, you know, aside from that, the number one priority for us after getting FDA approval or as we go through that process, is to recruit the best people that we can find. People are going to be our strength. They're our strength now. You know, this company came up with a strategy, a product positioning and a clinical trial strategy that nobody else had, because our people were really smart people. We're continuing to build on that. We're only looking for the A players that are out there. Third priority after completing the work with FDA and recruiting the best people is to continue to flesh out all the details associated with our launch. We've got a spreadsheet that has thousands of individual line items associated with it that range from hiring this particular person to, you know, developing advertising campaigns or things like that. This is the most well-thought-out, detailed plan I've ever seen that we had. You know, Jeff Evanson and his commercial team have been hard at work at it, and it's been a delight for me to have input into it. It's very detailed, and so staying focused on each one of those individual line items is very important for us. Then finally, you know, it's really doing all the planning around production control and inventory and, you know, ensuring that we've got the right amount of product being produced, so that we're ready for what we believe is gonna be a world-class launch. Certainly very exciting, Russ. Thank you so much for that. We are going to open it up to our audience. We do have time for a couple of questions. For our audience, if you would like to ask a question, please click on the Q&A button at the bottom of your screen and type in your question, and we will get to as many as time allows. Scroll here. Okay. Our first question is, will you launch with vials or pre-filled syringes, and do you think there are any hurdles that you will need to overcome with the vial? Apparently the question anticipates the answer, and well anticipated. Yes, we will. This does go into business strategy. We will get an original approval for the vial, and we will launch with that, first. There have been companies that have come before us that have done exactly the same thing that we're doing. I would view that as a very smart strategy because the vials are a known quantity. Trying to get an original BLA approval with a pre-filled syringe right out of the gate, you know, has landmines associated with that because the pre-filled syringe, you know, it introduces another variable. We really want the FDA just focused on the drug solution that comes out of our vial. That will be the first approval. Will the doctors love that as much as the pre-filled syringe that we'll follow with? Probably not. But we've gotten some good feedback on the vial, partially because of the amount of drug solution that we're putting in there. They like the volume of drug that we're putting in there. And in addition to that, while they love to tell us that they can't wait for our pre-filled syringe to come out, they do acknowledge the fact that every new product that they tried so far has been introduced in a vial. We will have that follow-on pre-filled syringe as quickly as we can, but we don't expect significant headwinds from that because everybody's done it that way. Okay. Our next question is: what do you see as the potential risks and challenges between now and approval? You know, I guess anytime you've got a file that's going in with the FDA, you're not completely in control of that, right? I mean, once we've sent our 160,000 pages to them, you know, you've got to depend upon them to, you know, to do their work and do it on time. Wiley Chambers and his crew have been, you know, a pretty efficient group, and so we don't expect any speed bumps there. They're very knowledgeable and experienced in this area. I guess that, you know, that might be a potential. You know, another thing that people, you know, tend to worry about, in situations like this is, do you have the expertise and the capacity in your factories to handle a large-scale world-class launch? Frankly, if we had built our own factory and were launching out of our own facility that had never been FDA approved, I'd be laying awake at night telling you I just would. I've been there before, and it doesn't always go smoothly. For us to have great factory partners like Fujifilm Diosynth and Ajinomoto, both who have been there, done that, both who have a lot of experience with FDA. One of whom has been involved in projects with regard to Operation Warp Speed and therefore has had FDA in their facility a lot. That box I'm kind of not nearly as worried about, frankly, as if we were doing it ourselves. You know, another area that, you know, in decades past would have been a problem was how do you know you're hiring the right level of expertise in your front office, back office, in your distribution group? Well, you know, with people like, you know, AmerisourceBergen and McKesson and Cardinal and CuraScript and folks like that I think we can kind of check that box too. They kind of know what they're doing. They're running, you know, all of the branded drugs are going through those channels now. I think we probably don't have to worry about that one as much. The other one that that really ends up biting people, and sometimes it's hard to see it coming, is how is your drug going to perform in the real world when the 10,000th patient, the 100,000th patient and the 1,000,000th patient is treated? Because all these clinical trials are just, you know, hundreds of patients. I don't think we have to worry about that one as much, right? Because bevacizumab has been out there, treating patients for more than 10 years. There have been anti-VEGFs that ended up getting through their clinical trials, getting launched, you know, skin their knee rather significantly because they were seeing everything from increased levels of ocular inflammation to other things, you know, as opposed to the one that we had in our clinical trials. I think that's one that is probably one of the known unknowns that every company has. I don't lay awake at night about that one because bevacizumab has been used so successfully in tens of millions, if not hundreds of millions of patients now over a 10-year period of time. I think what we're trying to do is we make up every list and check it twice. We look at our list of 5,000 things that need to be done. We track it every week. I mean, somebody's working on it every day, but we as a management team track that stuff every week. We meet on it every week. We're trying to do the best we can to ensure that every box is checked. I think at the end of the day, logically, based on the stuff I just said, this should feel more de-risked than most other new drug applications that you've ever seen. Thanks, Russ. We do have time for a couple more questions. We have great questions coming in for sure. What is the probability of accelerated review? Does Russ believe the FDA wants our product approved to replace an off-label Avastin? Well, yeah, I would hate to speak for FDA, but you know, I but I guess the question you have to ask yourself is what do you think in terms of do you think the FDA is happy that half of the anti-VEGF market is off-label? If you've got a reason to believe that, let me know. You know, I'm not gonna speak for FDA, but it seems like something that they would care about. They've had to issue a lot of warning letters you know to these compounded pharmacies because when things have gone wrong, they've been bad wrong. They've been things like endophthalmitis that can cause blindness or enucleation. I think FDA should care about this and we think they probably do. Priority review, you know, you've got to either show better safety, better efficacy, or that you're solving a public health concern. You know, our safety and efficacy, all of these trials have an element of non-inferiority associated with them. You know, I think that, you know, what FDA would have to go to is does this solve a public health concern? I don't know, half the market's off-label. I don't know how they would look at that. You know, and it's not just it, we think of FDA as one thing, but there are different groups in the FDA. There's the clinical group, and there's the CMC group. They'd all have to agree, "Hey, we think this is a public health concern or deserving of a priority review for some reason, and we've all got time to handle it." I would never wanna make that bet. We're making the assumption that it's gonna be 12 months after filing, you know, in all probability. We don't have to wait long because we'll be getting a PDUFA date. You know, we should be able to announce a PDUFA date in real early June. We'll see how it goes. Okay, we do have time for one more question. Appreciate everyone submitting such great questions. Given bevacizumab is an approved product, what IP or exclusivity do you have, and what is stopping others from entering the market? The one of the things that we will be granted, should be granted upon FDA approval, assuming we achieve FDA approval, is 12 years of regulatory exclusivity in the United States. That would represent the most important part of not seeing competition for bevacizumab in this space beyond, you know, what we have so far. It's that 12 years of regulatory exclusivity. We've got a patent portfolio that covers some methods and some other things, but it's really, I think from an investor standpoint, relying on that 12 years of regulatory exclusivity is really where the proper focus should be on that. If somebody wanted to come in with a bevacizumab for wet AMD or any other conditions that we end up or just if they wanted to come in with bevacizumab and get an ophthalmic approval, they would have to show that they are biosimilar to us. That's 13 years away, if. To get that to make that a sound business proposition, I'd like to see the numbers that would make that make sense. Excellent. Everyone, this is all the time we have for the Q&A. I wanna thank our audience for again being so engaged in today's discussion. Before we conclude, Russ, I'd like to give you an opportunity to share any closing remarks. Well, thanks again for having us, Janene. You know, I think what we have is just a remarkable opportunity. I've never seen, in my first 40 years, a space that's this large, it's almost $7 billion in the United States, where half of the injections are off-label. I mean, they're way off-label. It's not like there's an approval for DME, and now people are using bevacizumab for wet AMD or something. It's approved in oncology, and it was designed to go into a drip IV. I find this so fascinating because on the one hand, bevacizumab's been used in ophthalmology for more than 10 years, and the molecule has proven to be a player. This space is sitting here poorly defended with, well, half of the injections are coming from compounding pharmacies that our read of the U.S. laws, they're not supposed to be there once we have an FDA approval. I think this is a de-risk situation relative to a lot of other situations that you see, and it's a big one, and we've got some really smart, experienced people at the company that are gonna shepherd this through and hopefully see this be something that can legitimately enhance the standard of care in treating retinal disorders. Well, very exciting, Russ. We are definitely going to stay tuned and see how things go. It sounds like in the next few months it's going to be an exciting time for the company. Congratulations on all that you've accomplished and really look forward to keeping our audience apprised of what's going on with the company. Thanks again, Janene. Of course. This does conclude today's Virtual Investor CEO Spotlight event. I'd like to sincerely thank Russ Trenary, President and CEO of Outlook Therapeutics, for joining us today. To our audience, thank you for your time and attention. We look forward to you joining us in the future. As a reminder, you can access the webcast replay from today's event and all the replays from our virtual events at virtualinvestorco.com. Russ, thank you again and wish everyone a great afternoon. Great. Thanks a lot.