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Greetings. And welcome to the Outlook Therapeutics Corporate Third Quarter Fiscal Year 2024 Update Conference Call and Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Jenene Thomas, Investor Relations. Thank you. Please go ahead.

Thank you, Donna. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations for future projections, including but not limited to our expectations about the timing of clinical trials and commercial launch and the sufficiency of our cash resources. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws and are based on Outlook Therapeutics current expectations, and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic report, Outlook Therapeutics files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast release to or is based on studies, publications, surveys and other data obtained from third-party sources and the company's own estimates and research. While the company believes that these third-party sources to be reliable, as of the date of this presentation that has not independently verified and makes no representation as to the adequacy, fairness, accuracy or completeness of that or that any independent source has verified any information from third-party sources. During the call, management will discuss non-GAAP financial measures, which are not prepared in accordance with US generally accepted accounting principles. Definition of these non-GAAP financial measures, along with reconciliations of the most directly comparable GAAP financial measures are included in Outlook Therapeutics third quarter earnings release which has been furnished to the SEC and is available on the company's website at ir.outlooktherapeutics.com. Joining us on the call from Outlook Therapeutics leadership team are Russell Trenary, President and Chief Executive Officer; and Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics. I’d now like to turn the call over to Russ Trenary. Please proceed.

Thank you, Jenene, and thank you to everyone joining us for our third quarter fiscal year 2024 conference call and webcast. As we begin today's call, I think it's important for me to start with our mission, and that is quite simply to achieve the first-ever approval for an ophthalmic formulation of bevacizumab for the treatment of retina diseases, initially in the EU, UK, and US. We're working toward achieving that mission in real time. We already received marketing authorization in both the European Union and the United Kingdom and are advancing toward the launch of the first approved ophthalmic bevacizumab approved for the treatment of wet AMD in those key markets. We're also making good progress here in the United States with our ongoing NORSE EIGHT clinical trial, which, if successful, will serve as the basis for resubmitting our BLA with the FDA, which we expect to occur in the first calendar quarter of 2025. More on that in a minute. Focusing on the European Union and the United Kingdom, we're very pleased with the decisions from both regulatory bodies and believe this is a culmination of all the hard work our colleagues and partners have been striving to achieve these past several years. I think it also speaks to and validates the data we have generated, the clinical studies we have conducted, and the CMC work we have completed. We are going to do everything we can to bring this important drug to as many patients as possible in these two territories, which combined represent the second largest market for wet AMD in the world. Now, turning to commercialization, we're continuing with market access work and inventory planning for Germany and the UK, and expected product availability in those markets in the first half of calendar 2025. Additionally, we're continuing discussions with organizations that have established EU infrastructure and will continue to evaluate potential partners in the EU. Turning to the US, we continue to make progress on our NORSE EIGHT study, a three-month noninferiority study with an eight-week efficacy end point. NORSE EIGHT is progressing as planned, and we currently have 359, that's 359 of the planned 400 subjects enrolled. We continue to expect a complete enrollment before the end of the third quarter. Top line results from NORSE EIGHT are expected in the fourth quarter of this year and if positive should provide sufficient clinical data to resubmit our BLA with the US FDA in the first calendar quarter 2025. In addition, we've completed our planned Type C and Type D meetings with the FDA and believe we have addressed the open CMC items that were received in the CRL. And now it's my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer. Larry?

Thank you, Russ. Good morning, everyone. During the most recent quarter, we saw a further reduction in the balance of our outstanding convertible note. Additional conversions of the note into common stock have continued in July, and the outstanding balance is approximately $30.3 million as of today. While the remaining balance, another $5.5 million is convertible at $7 per share, with the remaining balance convertible at $40 per share. Our June 30, 2024 cash position of $32 million when combined with the expected $107 million of proceeds from the full exercise of warrants to purchase shares of common stock, subject to meeting requirements for calling these warrants, should be sufficient to support our operations through calendar 2025. Moving on to our financial results for the third fiscal quarter of 2024, I can report that we saw a reduction in adjusted net loss from fiscal quarter two of 2024. R&D expenses decreased during the current fiscal quarter versus Q2 of this year after we completed the majority of the NORSE EIGHT initiation activities in fiscal Q1. Previously, we had reported that we estimated a total cost of $30 million to complete NORSE EIGHT, with most of these expenses to be incurred during the first three calendar quarters of 2024. We have not changed our estimates for NORSE EIGHT and expect that overall R&D expenses will continue to run at these levels for the next quarter. The fiscal Q3 G&A expenses increased compared to fiscal Q2, as we did incur pre-launch expenses for Europe in the most recent quarter. I will now turn the call back over to the operator for the Q&A portion.

[Operator Instructions] Today's first question is coming from Julian Harrison of BTIG.

Yes, hi. Good morning. Congrats on all the progress and thanks for taking my questions. First, just on enrollment in NORSE EIGHT, are you able to provide any more granular details with regards to how far along you are? I understand completion is still on track for later in the third quarter, calendar quarter of this year, but any more details there you could share at this point?

Yes, I think it's worth noting, Julian, that in this five minutes we've got dozens of people that are in screening, and of course we track that screening rate to see how many of those convert to actual enrollments, and we believe that right now we've got enough in screening to take us to 380 patients. On top of, and of course today or yesterday we were at 359, so we continue to see a good level of screening and expect that to continue so that we can comfortably finish enrollment before the end of the third quarter.

Okay, excellent, very helpful. And then when enrollment completion is confirmed in NORSE EIGHT, does it become easier to guide to specifically when you expect BLA resubmission? I understand your updated guidance for 1Q ‘25, but does it become easier to be more precise than that guidance once enrollment completion is confirmed?

Yes, because I think there's the amount of time between the last patient treated and when their last visit is scheduled is known and the amount of time to lock and clean the databases is predictable. So yes, we will be in a good position, in a better position to nail that down once we know when enrollment completion has occurred.

The next question is coming from Will Hidell of Brookline Capital Markets.

Hey, thank you for taking the questions. Quick question about the UK process with NICE. I know I think they're going to have a tech assessment delivered by maybe December. Are there any updates on that process?

I think really the only update we have is that we believe we put together a well-informed dossier to NICE and we're going through the process with them. They've accepted our application and so we're going through that process and we'll know later in the year just exactly what that looks like in terms of the type of pricing that we'll be utilizing in that market.

The next question is coming from Timothy Chiang of Capital One.

Hi, thanks. Russell, could you just talk a little bit about what came out of the Type C and D meetings that you had with the FDA? I noticed the timing of the filings and extend it to 1Q of next year. So I just -- is there any correlation between your discussions with the FDA and the push out in the filing?

None. Really the timing of the filing is really associated with our prediction on completion of enrollment. It's solely focused on that. After we had the first Type A meeting with FDA, they encouraged us aside from having discussions around what the additional clinical trial design would look like, they also encouraged us during that meeting to come back and meet with them during the course of the trial to talk to their CMC group around what the questions that they had in there. So we took them up on that offer, and so I think we would characterize our discussions with FDA's have been very positive. And I think we've now reviewed with FDA every single question that they had on the CMC list, and so we're happy to say we've completed those meetings, and we'll continue to finish up some of the work, but we're really at a point where we're just going to publishing on answers to those CMC questions, so we're quite satisfied with how that turned out.

The next question is coming from Douglas Tsao of HC Wainwright.

Hi, good morning. Thanks for taking the questions. Just curious, so in terms of the timing of the BLA filing, as has been noted, you sort of now got into the first quarter versus the fourth quarter. Just curious exactly what led to that. And my guess is maybe patient enrollment is a little behind where you expected, and was that the result of just the pace of patients coming in, or just did you not quite get as many sites up and running as quickly as you may be anticipated? Thank you.

Yes, thanks, Doug. Yes, I think for us to be able to hit that end-of-year enrollment timing, or to be able to resubmit the BLA by the end of the year, we would have had to finish enrollment by the end of July. Our current enrollment pace is about two times faster than the industry average. Most people talk about in the industry that it takes a patient per doctor per site, that's what should be predicted. And so if that were the case, then it would have taken us all the way to the end of the year to enroll. Instead, we're going to finish enrollment by the end of the third quarter. So I think it was just a really aggressive goal that we're almost going to hit. But I think it does, because we did not hit end of July, it puts us into the beginning of next year in terms of BLA submission.

Okay, great. And in terms of the European launch, I'm just curious, what kind of investments are you making in terms of inventory for the European launch? And is that going to potentially provide supply for the US launch as well? Thank you.

Yes, it could. We actually went into; we had some inventory ready for August 29 of last year when we expected approval from FDA. So that inventory is still sitting there. And it's going to be available for sale in the European area and or in the United States. And I think one of the nice things about having built that inventory is we're continuing to be able to extend the shelf life of that product. So I think by the end of the year, we're expecting to have between 30 and 36 months of dating on that product. So I think that's kind of the work that's being done on inventory right now is really just tracking stability and extending shelf life.

Our next question is coming from Daniil Gataulin of Chardan.

Hi. Good morning, guys. Thanks for taking the question and congrats on all the progress. I have a quick one, so we still have kind of approval in the EU and the UK. How does the off-label use dynamics change there between now and launch and shortly after launch? And as a follow-up, what are the current assumptions or checklist items on your list for the commercial launch in Europe in the first half? Thank you.

Yes, so in terms of off-label use, the situation in Europe is a really different market-by-market. There are some markets where off-label use is close to zero because it's not allowed, and in those markets, people are following the law, and they're not repackaging or compounding. In other markets, it's also unlawful, but it's tolerated for now. And I think the thing that we hear from doctors and from payers is that they like having a source of bevacizumab available. It's the only molecule of its kind. And so they'll turn a blind eye for a little bit of time, at least on offering off-label products. So I think once we're approved, I think the market research and the customer conversations that we've had indicate that doctors and payers, they get it. They understand that the standards that we have to live to and the standards that we have lived to with the product that was used in our clinical trial are different for that bevacizumab that we have versus the bevacizumab that was originally developed and designed to treat oncology and be delivered through a drip IV. So those standards for oncology don't meet ophthalmic standards for things like utter lack of particulates. They don't have the same requirements for pH levels. They don't have the same requirements for endotoxin levels. They don't have the same requirements for approved packaging for use in ophthalmology and validation that the vial or syringe that the oncologic version comes from meet ophthalmic standards. So there are a whole host of things that off-label bevacizumab doesn’t provide the payer and the customer compared to an ophthalmic approved version of bevacizumab. So we think that we'll be in a great position to go in those markets where it takes a while for the off-label to go away, we think we can compete with them based on quality, based on clinical data and ophthalmology, based on meeting all the GMP standards and based upon having the right amount of drug protein concentration vial by vial, syringe by syringe that is never validated. From a product that comes out of the repackaging effort. So I think the right product profile, the right level of quality and the right price point will put us in a position where we'll be a very able competitor against off-label bevacizumab. But it's a little different market by market.

Thank you. In terms of the assumptions and the checklists for launch in this first half of ‘25?

Yes, it's really the, whether we're hiring our own, so basically the work that we're engaged in right now is market access. So we're in hot pursuit of the health technology assessment groups and we're talking to NICE, we're talking to that same counterpart in Germany to establish with the payer community what it is that they're looking for in terms of pricing and availability. So the HTA work comes first. That market access work has to be done. In addition to that, we're going through the process of showing up at trade shows, conducting symposia with doctors and really doing some of the good communication that's required with the retina community to help them understand what the real difference is between an ophthalmic approved bevacizumab versus what they've had available to them today. We love having those conversations. The doctors do have a preference for a regulatory approved ophthalmic version. All the market research points to that so we're continuing to engage in all of that work. And then the final step will be whether it's with a partner or whether it's our own would be to make the decision to put a salesforce and a group of medical scientific liaisons so-called MSLs on the ground so that the appropriate conversations can take place with the customers.

At this time, I would like to turn the floor back over to Mr. Trenary for closing comments.

Great, thank you so much. Well, look, we believe this is a really exciting time for Outlook Therapeutics. And the next few months have the potential to continue to transform the profile of our company. So to summarize what we've talked about today, in Europe the second largest market for wet AMD, we received marketing authorization in the EU and the United Kingdom. And we're actively advancing market access initiatives, preparing product inventory, and are in discussions with potential partners to launch in these key markets. In the U.S., we remain on track with enrollment for NORSE EIGHT and expect to report top line results this calendar year and resubmit our BLA early in first calendar quarter 2025. We look forward to continuing this progress and the opportunity to bring an enhanced level of care to the retina anti VEGF space. Thanks so much for joining us today.

Ladies and gentlemen, this concludes today's event. You may disconnect your lines at this time or log off the webcast. And enjoy the rest of your day.

Hello, and welcome to the Outlook Therapeutics Inaugural Quarterly Update Conference Call and Webcast. As a brief reminder all participants are currently in a listen-only mode. [Operator Instructions] Following the presentation, there will be a question-and-answer session. Note that this webcast is being recorded at the company's request and a replay will be made available on the company's website following the end of the event. It is now my pleasure to turn the call over to Jenene Thomas of Investor Relations.

Thank you, Darryl. At this time, I would like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws and are based on Outlook Therapeutics current expectations, and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the Outlook Therapeutics Annual Report on Form 10-K for the fiscal year ended September 30, 2023 and in other reports filed with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast release to or is based on studies, publications, surveys and other data obtained from third-party sources and the company's own estimates and research. While the company believes that these third-party sources to be reliable, as of the date of this presentation that has not independently verified and makes no representation as to the adequacy, fairness, accuracy or completeness of that or that any independent source has verified any information from third-party sources. During the call, the company will discuss non-GAAP financial measures, which are not prepared in accordance with US generally accepted accounting principles. Definition of these non-GAAP financial measures, along with reconciliations of the most directly comparable GAAP financial measures are included in our second quarter earnings release which has been furnished to the SEC and is available on the company's website at ir.outlooktherapeutics.com. Joining us on the call from Outlook Therapeutics leadership team are Russell Trenary, President and Chief Executive Officer; and Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics. I’d now like to turn the call over to Russ. Please proceed.

Thank you, Jenene and thank you to everyone joining us for the company's first earnings call and webcast. To begin I feel it is important to restate our mission and what we are working to accomplish. Our goal is to enhance the standard of care in the retina anti-VEGF space by achieving the first approval for an ophthalmic formulation of bevacizumab for the treatment of retina diseases in the United States and Europe. Accomplishing this with our product candidate ONS-5010 could provide people afflicted with wet AMD, an effective form of bevacizumab that meets the FDA and EU stringent efficacy, safety and quality standards. So this is not a distant long-term goal for us. Following our recent positive opinion from the CHMP, we believe we are on the cusp of receiving a potential approval for ONS-5010 in Europe, which we expect this quarter, calendar Q2 2024 and we are making significant potential progress for approval in the United States as well. We also submitted our MAA or Marketing Authorization Application to the Medicines and Healthcare Products Regulatory Agency in the United Kingdom. So in Europe which represents a significant market opportunity for us, we're making tremendous progress and expect to be in a position to launch in the UK and in the EU in the first quarter of calendar 2025. Regarding the United States, we have been actively engaged with the FDA and will continue to do so, leading up to our expected BLA resubmission. As part of these interactions, earlier this year, we reached agreement with the FDA on a Special Protocol Assessment, or SPA, for NORSE EIGHT, our ongoing 90-day non-inferiority study for which we expect top-line data in the fourth calendar quarter of this year 2024. Shortly thereafter, our goal is to resubmit our BLA by the end of this calendar year. Turning to our financial picture. We believe we're strongly positioned. We recently closed a private placement with gross proceeds of up to $172 million. Of that $65 million is in cash from the issuance and sale of common stock, which are accompanied by warrants to purchase shares of common stock and that's already been received, plus an additional $107 million which will be available upon the full cash exercise of the warrants. Assuming the full cash exercise of the warrants, we expect our accessible capital to fund the business through our potential approval and commercial launch in parts of Europe and through the completion of NORSE EIGHT plus a potential FDA approval and the subsequent launch in the United States. Of note, this financing included participation by a couple long-time supporters of the company, as well as a good number of additional fundamental health care-focused institutional investors. Larry will speak to this a little bit later in the call. I would like to drill down a little bit more on our activities in the EU and UK. In the EU, we expect potential approval this quarter and in the UK, we expect potential approval in the third quarter of calendar 2024 this year, with initial launches in the first quarter of calendar 2025. As we await potential approval in the EU, we are working with Cencora, formerly AmerisourceBergen and their EU units to leverage their existing infrastructure and expertise to support launching ONS-5010 ourselves in Europe. I'd like to emphasize the importance of the opportunity in Europe, which is the second-largest market for wet AMD globally. So not only will it potentially be where we start generating revenue in the first half of calendar 2025, but it will validate all the hard work we've to-date. First, it will validate our entire development program for ONS-5010 including the positive safety and efficacy data we generated in our pivotal NORSE TWO trial plus the learnings from NORSE ONE, which informed our NORSE TWO study design. Also, the additional patient exposures established in NORSE THREE to meet FDA's required safety population size. And it also puts an exclamation point on the entirety and the quality of our CMC work. Now turning to the US. We reached agreement with the FDA on our SPA and launched NORSE EIGHT, a three month non-inferiority study with an eight week efficacy endpoint. This study has progressed as planned and we have already enrolled over 30% of the patients to-date. We continue to expect to complete enrollment in the third quarter of this year as planned and be in a position to report top-line data and resubmit our BLA in the fourth quarter of this year. Additionally, we are meeting with the FDA in Type C and Type D meetings in order to discuss the resolution of the CMC questions and comments that were received in the CRL last year. The Type C and D meetings are not required by FDA. These interactions are our request with the goal of doing everything in our power to address the FDA's CMC questions while streamlining the process for resubmitting our BLA. Importantly, we anticipate these open CMC items will be resolved in calendar Q2 and Q3 this year 2024, in advance of the NORSE EIGHT data readout. I would also like to reiterate the CMC comments from the CRL do not have any impact on our current supply of ONS-5010. We are working with reputable manufacturers and are actively using ONS-5010 from these partners in the ongoing NORSE EIGHT study. We believe that if successful, these activities will be sufficient for potential approval in the United States in calendar 2025. And now it is my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer. Larry?

Thank you, Russ. Good morning everyone. To begin I'm very pleased to report that for the first time in the history of Outlook Therapeutics, we have secured access to the capital to potentially fully execute on our goal to receive approval for and launch ONS-5010. While we still are waiting to receive the EU approval and complete work for our BLA submission at the end of calendar 2024 we believe our successful pipe financing that closed in March and April provides the necessary cash resources to support launches in the US and Europe. The Outlook Therapeutics team is grateful to GMS Ventures and investments and [indiscernible] for their continued support of our mission. We also welcome the significant new institutional health care fund with see the opportunity here to upgrade the standard of care for treating wet AMD in patients around the world. Our current cash position, when combined with the expected proceeds from the full exercise of warrants to purchase shares of common stock, subject to meeting the requirements for calling the warrants should be sufficient to support our operations through calendar 2025. Moving on to our financial results for the second fiscal quarter of 2024. I want to note that going forward, we are and will be using non-GAAP adjusted results to eliminate the noise caused by the non-cash quarterly fair value changes for our warrants and convertible notes that are reflected in the P&L and balance sheet. For the second fiscal quarter of 2024, I can report that we remain on track with our spending plan for the year. The increase in our R&D expenses during the fiscal second quarter versus Q1 of this year came in as expected as we began recruiting and initiating clinical trial sites for NORSE EIGHT and also began enrolling patients. Previously, we had reported that we estimated we could complete NORSE EIGHT for a total of $30 million with most of these expenses to be incurred during the first three calendar quarters of 2024. We have not changed our estimates for NORSE EIGHT and expect that overall R&D expenses will continue to run at these levels for the next two quarters. Fiscal Q2 G&A expenses were in line with fiscal Q1, and we also expect this to continue for the next two fiscal quarters as we prep for the anticipated approval in the EU and UK and planned for a launch there in early calendar 2025. I’ll now turn the call back over to the operator for the Q&A portion.

Thank you we will now be conducting a question-and-answer session. [Operator Instructions] Our first questions come from the line of Julian Harrison with BTIG. Please proceed with your questions.

Hi good morning. Congrats on all the progress and thank you for taking my questions. First, I'm wondering if there are any preceding data sets, in particular you would highlight as being especially derisking for NORSE EIGHT? And second great to see the positive CHMP opinion back in March. I'm curious how large the Europe market opportunity for ONS-5010 is relative to the US? And sorry if I missed it. Is this something you could pursue alone, or is a partner there the most likely path-forward?

Yes. Thanks, Julian. I'll go ahead and take the market size first. Europe is a really super looking opportunity for us. If you look at the number of injections for off-label bevacizumab in Europe, they are quite similar to the United States. They get close to about 3 million injections per year. There is a little bit of price compression in Europe compared to the United States, but it still looks like a very enticing opportunity and we look forward to capitalizing on that. We are planning to work in conjunction with Cencora formerly AmerisourceBergen, who have units who are fully capable of not only conducting all of the 3PL activities, but they have great HTA payer connectivity, they've got pharmacovigilance, which we'll be utilizing. In the US, they've got GPO contracting services, they’ve got medical literature distribution. And we'll be utilizing all of that functionality in both the United States and in Europe. And then what we'll be doing is we'll be the customer-facing arm in both markets, where it will be our -- the sales reps and MSLs that we hire will be -- so it will be an Outlook launch. The -- turning back to the data set that you mentioned that might portend the relative success of NORSE EIGHT and why we are so confident in that. That's a great question because in our NORSE TWO pivotal trial, which had spectacular data associated with that year-long trial. There is a detail in there that not everybody remembers, and that is that the first 90-days of our NORSE TWO pivotal trial where had an identical dosing regimen to our current NORSE EIGHT trial. So in other words, in both NORSE EIGHT, the current trial, as well as NORSE TWO our very successful initial pivotal trial. There was dosing of either ONS-5010 or ranibizumab or Lucentis at day 0, day 30 and day 60. And so when we go back and we look at those data during that period of time in the NORSE TWO trial, we see non-inferiority between the ONS-5010 line and the Lucentis line. So in terms of best corrected visual acuity, which is the primary endpoint for NORSE EIGHT. So because there was such a small difference in letters gained between Lucentis and ONS-5010 in NORSE TWO during that day 0, day 30, day 60 time frame. We certainly do expect to see the same thing duplicated in NORSE EIGHT.

Julian, did you have a follow-up question?

That was it from me. Very helpful. Thank you very much.

Great. Thanks Julian.

Thank you. Our next questions come from the line of Eddie Hickman with Guggenheim Securities. Please proceed with your question.

Hi good morning. Congrats on all the progress. Just a couple of questions for me. Can you talk about how many sites you currently have enrolling patients? And what's the goal and sort of cadence of that site coming online will be? And then if you could remind us of your pricing discussions with both commercial and government plans. I know the landscape will be a little bit different next year than it was last year given some of the new approvals. So I'm just sort of curious if you could update us on those discussions. Thanks.

Yes. So I think the -- this is the first month, Eddie that we have 60 sites or more that are enrolling patients. And we had almost that same number in April. So we kind of look at April as the first month where we were kind of full bore. I think we've got one more site that still needs to be activated, but we are pretty much at full strength right now. So for us to have just reached mostly full strength in April, being full strength in May and with March having been a partial -- partially full-strength month to already have 30% of the patients enrolled is really encouraging. The site are very happy about the study design, the ease with which on recruiting is, patients get either a product that the doctors have been using for several decades or ONS-5010. So they feel like it's a win-win no matter which arm the patient gets randomized into. So very encouraging start. And we are going to try to keep the pedal to the metal and get this thing enrolled inside the third quarter of this year. In terms of pricing, we really like how it's shaping up because I think if you looked over last year and the year before, you started to see some relatively speaking, some price declines among the major brands in the United States and in Europe. And now with the launches of some of the super high-priced brands, that ASP for the anti-VEGF space we expect to go up. And I think, the important thing for people to understand about this space is the following. It's always been a two segment market. There is always been a low-cost bevacizumab segment albeit one that was off table, given – meet Ophthalmic standards, didn't really have the type of quality that the doctors were necessarily looking for, but it was oftentimes mandated by payers to start with that before moving on to something that was multiples more expensive than the off-label. So that part of the market, that's almost 50% of the injections has always been there and it's been untouchable until we are going to come along. The rest of -- the other 50% has been the battleground for the biosimilars, the major brands and now the new launches that have come out from the other companies. The new launches from the other companies are driving the ASP up, they're switching a lot of their own customers to their higher-priced brand or they are taking market share from others from their product into a higher price. So we like how the pricing is working for us. And we think the paradigm of having a two segment market will continue. There will still be a lower cost bevacizumab market, that is about half of the injections and then the other half being the battleground for everybody else. Is that everything you were looking for Eddie?

Yes. No, very helpful. And is this only a three month study? And sort of what's the -- what are these doctors saying about what they would do to those patients after they're finished with three months? They obviously wouldn't want to go back to like a non-branded versions. So I'm just sort of curious like how you're thinking about recruiting those docs for a future launch.

Yes. Well, I think the best way to recruit those doctors for a huge launch is having them part of the study, and then see what kind of clinical results emerge from our study, which again, we expect to show non-inferiority to Lucentis. So that's I think that's setting up for us rather nicely. But you are correct. It is a 90 day study. The injections will occur -- there are three injections that will occur at day 0, the day of randomization and then day 30 and then day 60 and the patient will exit the study at day 90. So the primary endpoint is at day 60, and that will be best corrected visual acuity and we will be looking for a non-inferiority margin of 3.5 letters to Lucentis, which was again achieved in NORSE TWO. Although that was not a prespecified statistic for that particular study wasn't necessary for the outcomes of that study. So we expect this one to show non-inferiority again. And then after the patient exits the study, I think it is really up to the doctors and the payers to determine what happens next and what therapy they move them to next.

Thank you. Our next question comes from the line of Douglas Tsao with HC Wainwright. Please proceed with your question.

Hi, good morning. Thanks for taking the question. Just -- I just want to clarify a couple of things. Was the 30% enrollment as of today? Or was that as of March 31?

So that was as of yesterday.

And what was the number -- so you said there are 60 sites up now? What was the number of sites like the progression like [you] (ph) started, say, in March in April?

Probably in March, we probably had about half of the sites enrolled at that point. And then in April, we pretty much got the rest of them enrolled -- either by the end of March or at the beginning of April. So we kind of felt that April was sort of a full strength month for us and of course, May will be also.

Okay. Great. And then I'm just curious, have you -- given the progress in the wet AMD market as well as the funding, what's the latest thinking in terms of DME and the BRVO indication? Thank you.

Yes, it's a great question, Doug. We do have in our pipeline studies for DME and BRVO planned. It's interesting today that DME and BRVO were also treated with off-label Avastin. So we don't know how that will develop necessarily in the future. But for us, we want to make sure that our sales organization is always in the safest position to promote across the full breadth of the capabilities of ONS-5010, which we believe will include DME and BRVO we're going to have to do those studies to prove that. So initially, our first approval will be in wet-AMD, which as you know, Doug is up to about 70% of the market in that – pipeline for the space.

Yes, absolutely. And just given some of the -- maybe the changes within the FDA division, do you think it's necessary to go back and revisit sort of what would be needed to get those approvals? And what I mean by it is obviously with NORSE EIGHT, you got a fairly, I would argue favorable study then to align with you on a fairly favorable study, certainly in duration. Do you think something like an 8 week endpoint DME or BRVO would be sufficient? Thank you.

Yes, I think we are in discussions with FDA pretty constantly now. Our relationship has really grown to an excellent level and we do plan on addressing with FDA given the real success of NORSE TWO and what our expected success will be on NORSE EIGHT that platform as well as the safety exposures that were generated in NORSE THREE, we will want to ensure that we and FDA have a pristine understanding of what all the requirements will be for DME and BRVO study, and we will evaluate our -- we'll evaluate continuing the game plan that we've used in the past to use Type A Meetings and potentially SPA approvals to ensure that we and the FDA are on the second page regarding those studies.

Okay, great. I will jump back into the queue.

Thank you. Our next questions come from the line of Tim Chiang with Capital One. Please proceed with your question.

Hi thanks. As you guys prepare for the launch in Europe, can you talk a little bit about what some of your contract manufacturers, your partnerships with those, your packaging partners, what they are doing to prepare for the launches in Europe and also in the US next year?

Yes. I mean, well we've got inventory now. So we have already been through the process of developing the -- producing the drug substance out of FUJIFILM Diosynth and College Station, Texas as well as the fill-and-finish operation that occurs with Ajinomoto Biopharma in San Diego, California and then our packaging takes place and labeling and serialization takes place with PCI. So we have got inventory sitting on the shelf. We are going to have to wait for final approval and final labeling before we get that product into final packaging and labeling. So we've got the -- the beginning of the pipeline stope, and we just need to get that product in the final packaging and labeling. And then -- from there on, it's just really just continuing to place orders with our manufacturers and be in a position to have enough to ship to both Europe, as well as the United States.

Okay. Super. Is there anything else that you think you need to remediate or update leading up to your meeting with the FDA, the Type A meeting?

Yes. We actually don't have any more Type A meetings planned with them on this particular product. We are conducting Type C and Type D meetings, but those are either one or a number of agenda items pertaining to CMC that we meet with FDA to go through with them the studies that we've conducted the analysis that we've done, the statistics that we have and the data pertaining to answering all of the questions that they had in the CRL. We've already had one of those meetings. We have got another one on the calendar schedule. We've had a very successful run with them. And I think, what it allows us to do is first of all, ensure that we and the FDA are hearing each other and so far so good and ensure that the data we have produced to answer the CMC questions are being looked at by the FDA and to ensure that by the time we resubmit this BLA, they will then be seeing our CMC data for the third time, the initial application, then again in the Type C and D meetings and in the resubmission. So we believe that this is not only streamlines our submission process but also streamlines the review process for FDA. So we've had a -- this came at the suggestion of the FDA, it was a requirement. But in our first Type A meeting with them last year, they made note of the fact that it might be a good idea. And so we have been following orders -- and I think that our relationship with the FDA has grown to a very healthy place by engaging with them relatively constantly during this process.

Okay, that’s very helpful. Thanks Russell.

Our next questions come from the line of Douglas Tsao with H.C. Wainright. Please proceed with your questions. Douglas, could you check up -- your on mute, please?

Thanks for taking the questions again. Just to clarify, Russ, your comments earlier about how you're thinking about commercialization in Europe, is it the plan now to in [indiscernible] deal for? Or are you still contemplating potential partnerships with companies that have [indiscernible] pricing already? Thanks.

Yes. Thanks, Doug. Yes, we're focused on executing the things that we can do ourselves. We will always entertain conversations with other partners. And if we ever come to a determination that they can do it better than we can. Our job is to maximize shareholder value and ensure that we do the best job of creating great top-line and a great bottom-line on behalf of our shareholders. So right now, we are focused on what we can do, but we are not close minded. And we will listen to people who might want to feel like they can be helpful to us.

Okay, thank you.

Thank you. Our next questions come from the line of Kemp Dolliver with Brookline Capital Markets. Please proceed with your question.

Great. Thank you. How does the EU differ from the US in the context of how the health plans will position your product versus all the other options? Because in the US, it's pretty -- they're pretty much going to have you at a [full] (ph) position initially until patients fail therapy and then move on to something else. Focusing on the EU 5, how do they differ if at all?

Yes, Kemp they not only differ -- in five different ways, but even within countries. There are regional differences within the countries. In the UK, for example, there is just a trace of off-able bevacizumab. So I think it gives us an opportunity to establish ourselves as a great brand that is priced according to what doctors and payers want which is the same strategy that we used in the United States. Unlike a lot of -- probably unlike everybody who came before us in the United States, the pricing strategy that we took was to ensure that doctors and payers understood our value proposition. Of course, they understand what the rest of the landscape looks like. They understand how much switching goes on from off-label bevacizumab to a brand. And now they understand why some of that switching is going on and a lot of that is due to the inability of off-label bevacizumab to meet the characteristics that would be required for a regulatory approval in ophthalmology. So in educating the audience on that, then the last question really was how would you like us to price this? What do you think is fair? And be mindful of the fact that even though you start with an off-label price, you don't finish there a lot of the time. So your average price per injection per patient over a three year period of time, taking switching into account is a lot closer to $1,000 per injection than it is to what you are paying for off-label at $100 for injection or less. So that same paradigm generally speaking, exists throughout Europe as well. In most markets, there is off-label. In most markets, there is a group a cabal of high-priced brands that are out there. And so although the price is compressed a bit from the United States -- the United States, the brands are priced. Their wholesale acquisition costs in some cases exceed $2,600 per injection. There are also high prices in Europe, but just not that high. So we see the paradigm in Europe in terms of number of injections being very similar to the United States and the thought process around what payers and doctors are looking for to be pretty similar to the US, albeit with a little bit of price compression.

Okay. And Russ, just to be clear, so the practice in those countries where there is activity is they will start a patient on the off-label Avastin and then switch if necessary?

Yes, some of that behavior exists in Europe like it does in the United States. And look, let's be clear. There are -- some patients are high responders. And there are some patients who even with off-label that does not meet ophthalmic requirements for approval in the EU and the United States can sometimes take a patient from start to finish. But if you look at the entire cohort and all of the patients who start on off-label. There is so much switching going on that it drives the price way higher than people might have expected in both the United States, as well as in Europe because they don't necessarily continue to respond to an off-label bevacizumab that does not meet the requirements for regulatory approval. So we believe that by bringing ours on which meets all the same requirements for auto lack of particulates or the right drug protein concentration or approved packaging, the right pH levels, the right endotox level, specifications for osmolarity. We check all of those boxes that are not or cannot be met by an off-label product that ends up being removed from its original packaging and allocated and refiltered back into small volume, syringes and bio. There's things that happen on the molecule during that process that are untoward and tend, we [tried the] (ph) amount of drug protein concentration that is then left available in those small volume syringes and bio. So we believe that by bringing regulatory approved quality. That's why we get regulatory -- why we expect regulatory approval with our safety and efficacy data.

Thank you very much.

Thank you. Our next questions come from the line of Ed Woo with Ascendiant Capital Markets. Please proceed with your questions.

Yeah. Congratulations on the progress. My question is on the manufacturing and supply for Europe. Do you anticipate having to move production there as you commercialize the product there?

We don't need to initially, but we'll always be looking to maximize our global footprint as it pertains to that. So we will look at -- and frankly our partners also have facilities that are located in Europe. So as we look to the future, we will balance the needs of Europe and the United States and the cost associated with landing the product in Europe from either our current locations or other locations that we will look at in the future. But for now we are good to go.

Great. Well thanks for answering my questions. And I wish you guys good luck. Thank you.

Thanks so much Ed.

Thank you. Our next questions come from the line of Daniil Gataulin with Chardan. Please proceed with your questions.

Good morning guys. Thank you for taking the question and congrats on the progress. Can you talk about the timing for the Type C and D meetings for the CMC questions? And do you anticipate to provide a separate communication when the issues have been fully addressed?

Well, we expect all of the Type C and Type D meetings Daniil, to be handled within the second and third quarter of this year. We won't be giving updates because when you go into those meetings -- that would be like giving you an update on my staff meeting. You go into these Type C and Type D meetings. They're very focused, they're very technically oriented. But I can say that we know for a fact, having already been through one of these that FDA has been pleased with our approach and pleased with the data that we've produced and are not unhappy that they are getting a look at this prior to us resubmitting. So our suspicion that this would be helpful to them and would aid them in the review process, I think has been validated.

Okay. Thank you. And one more quick question. Initially with your product was supplied in vials and are you still conducting work for pre-filled syringes?

Yes. We are doing work to our prefilled syringe project does continue to progress. We do have one more arm of a study. Our NORSE SEVEN study. We've already enrolled the first arm which would be a control-arm. We will now -- once we get through the stability work that's required for the syringe, we will enroll that second arm for NORSE 7. We do not expect to apply for approval for prefilled syringe until we have final approval from FDA. As you probably know, we are dealing not only with the pharmaceutical and biologics group, but also with the medical device group at FDA. So you get to talk to those twice on this one. And like the other companies who have learned the hard way, we are going to learn the smart way and make sure that we get our approval under our belt before we apply for the prefilled syringe.

Got it. Thank you for taking the questions.

Thank you. We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Russ Trenary for closing remarks.

Great. Thanks so much. While I believe the future of Outlook Therapeutics has never been brighter. In 2024, has already proven to be a pivotal year for the company. To summarize, in Europe the second largest market for wet AMD, we received a positive CMP opinion already and expect potential approval this quarter. This sets the stage for our first commercial launch expected in the first quarter of calendar 2025. In the United States, we reached agreement with the FDA on a path to potential approval and are targeting resubmission of our BLA this calendar year. Assuming cash exercise of the warrants from our recent pipe financing, we expect to be funded through key anticipated milestones potentially realizing our mission of bringing the first approved ophthalmic formulation of bevacizumab to patients with retina disease. We look forward to continued progress and the opportunity to bring an enhanced level of care to the retina anti-VEGF space. Thanks for joining us today.

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.