Q2 2024 Outlook Therapeutics Inc Earnings Call

Operator: 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. If anyone requires operator assistance during the event, please press star zero on your telephone keypad.

Hello, and welcome to the outlook Therapeutics inaugural quarterly update conference call and webcast.

Speaker Change: As a brief reminder, all participants are currently in a listen only mode. If anyone require operator assistance during the event. Please press star zero on your telephone keypad.

Operator: Following the presentation, there will be a question and answer session. Please 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 Janine Thomas of Investor Relations. Thank you, Daryl.

Speaker Change: 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 web site. Following the end of the event.

Speaker Change: It is now my pleasure to turn the call over to Janine Thomas from Investor Relations.

Janine Thomas: 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.

Janine Thomas: Thank you Darryl at this time I would like to remind our listeners that remarks made during this webcast may state managements 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.

Janine Thomas: Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in 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 SEC's website.

Janine Thomas: Based on the outlook therapeutics current expectation 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 that.

Janine Thomas: Fiscal year ended September 32023, 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 website. We encourage you to review these documents carefully. Additionally, certain information contained in this bad cats relates to orders.

Janine Thomas: Additionally, certain information contained in this webcast relates 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 these third-party sources to be reliable as of the date of this presentation, it has not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of that information or that any independent source has verified any information that comes from third-party sources. During the call, the company will discuss non-GAAP financial measures, which are not prepared in accordance with U.S. generally accepted accounting principles.

Speaker Change: Based on studies publications surveys and other data obtained from third party sources and the company's estimates and research while the company believes that these third party sources to be viable as of the date of this presentation. It has not independently verified it makes no representation as to the adequacy fairness accuracy or completeness of that.

Speaker Change: Or is that any independent sources verified any information from third party source it.

Janine Thomas: The definition of these non-GAAP financial measures, along with reconciliations to the most directly comparable GAAP financial measures, is 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 I would now like to turn the call over to Russ.

Speaker Change: On the call the company will discuss non-GAAP financial measures, which are not prepared in accordance with U S. Generally accepted accounting principle definition of these non-GAAP financial measures along with reconciliations at the most directly comparable GAAP financial measures are included in our earnings.

Speaker Change: Our earnings release, which has been furnished to the SEC and is available on the company's website.

Trevor: Our outlook Therapeutics Dot com joining us on the call from outlook therapeutic leadership team, our basketball generic President and Chief Executive Officer, and Laura Kenyan Chief Financial Officer of outlook Therapeutics, I would now like to turn the call over to Trevor. Please proceed.

Russell Trenary: Please proceed. Thank you, Janine. And thank you to everyone joining us for the company's first earnings call and webinar. To begin, I feel it's important to restate our mission and what we're 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, ONS5010, could provide people afflicted with wet AMD an effective form of Bevacizumab that meets the FDA and EU's stringent efficacy, safety, and quality standards.

Trevor: Thank you Janine and thank you to everyone joining us for the company's first earnings call and webcast.

Trevor: To begin I feel it's important to restate, our mission and what we're working to accomplish.

Trevor: Our goal is to enhance the standard of care in the retina anti VEGF space by achieving the first approval for it.

Trevor: Formulation of Bevacizumab for the treatment of retinal diseases in the United States and Europe.

Trevor: Accomplishing this with our product candidate O&M 50, 10 could provide people afflicted with wet AMD.

Trevor: Active form of Bevacizumab.

Trevor: The F D a N E U Street.

Trevor: Engine.

Trevor: Can see safety and quality standards.

Russell Trenary: Well, 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 have also submitted our MAA, or Marketing Authorization Application, to the Medicine and Healthcare Products Regulatory Agency in the United Kingdom.

Trevor: This is not a distant long term goal for.

Speaker Change: Following our recent positive opinion from the <unk>. We believe we are on the cusp of receiving a potential approval for Rowan is 50 10 in Europe.

Speaker Change: Which we expect this court 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.

Russell Trenary: 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, and in the EU in the first quarter of calendar 2025.

Speaker Change: 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 U K and.

Speaker Change: And in the EU in the first quarter of calendar 2025.

Russell Trenary: 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 NORS-8, our ongoing 90-day non-inferiority trial for which we will inspect 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.

Speaker Change: Regarding the United States, we have been actively engaged with the FDA and we'll continue to do so leading up to our expected BLA resubmission.

Speaker Change: As part of these interactions earlier this year, we reached agreement with the FDA on a special protocol assessment or Spa for Norse eight are ongoing 90 day non inferiority study for which we expect top line data in the fourth calendar quarter of this year 2020 for.

Speaker Change: Shortly thereafter, our goal is to resubmit, our BLA by the end of this calendar year.

Speaker Change: Turning to our financial picture, we believe were strongly positioned.

Russell Trenary: 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 is accompanied by warrants to purchase shares of common stock, and that's already been received; an additional $107 million, which will be available upon the full cash exercise of the warrant.

Speaker Change: We recently closed a private placement with gross proceeds of up to $172 million.

Speaker Change: Of that.

$65 million in cash from the issuance and sale of common stock.

Speaker Change: Which are accompanied by warrants to purchase shares of common stock and that's already been received plus.

Speaker Change: An additional $107 million, which.

Speaker Change: Which will be available on the full cash exercise of the warrants.

Russell Trenary: 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, 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, and additional fundamental healthcare-focused institutional investment. Larry will speak to that a little bit later. I'd like to drill down a little bit more on our activities in the EU and UK.

Speaker Change: Sumit the forecast exercise of the warrants, we expect our accessible capital to fund the business through our potential approval and commercial launch in parts of Europe.

Speaker Change: And through the completion of North Sea.

Speaker Change: Plus a potential FDA approval and subsequent launch in the United States.

Speaker Change: Oh no. This financing included participation by a couple longtime supporters of the company as well as a good number of additional one mental health care focused institutional investors.

Speaker Change: Larry will speak to this a little bit later in the call.

Russell Trenary: 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're working with Sincora, formerly Amerisource, and their European partners to leverage their existing infrastructure and expertise to support launching ONS 5010 ourselves in Europe. I'd like to emphasize the importance of this opportunity in Europe, which is the second largest market for wet AMD globally.

Larry: I would like to drill down a little bit more on our activities in the EU and U K.

Speaker Change: In the EU, we expect potential approval this quarter and then in the U K, we expect potential approval in the third quarter of calendar 2024. This year with initial launches in the first quarter of calendar 2025.

Speaker Change: We await potential approval in the EU, we're working with Suncor, formerly Amerisourcebergen.

Speaker Change: And their EU units to leverage their existing infrastructure and expertise to support launching a windows 50 10 ourselves in Europe.

Speaker Change: I'd like to emphasize the importance of the opportunity in Europe, which is the second largest market for wet AMD globally.

Russell Trenary: 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 done. First, it will validate our entire development program for ONS 5010. Include it, the positive safety and efficacy data we generated in our pivotal NORS2 trial, plus the learnings from NORSE 1, which informed our NORSE 2 study design. Also, the additional patient exposures established in Nourse 3 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.

Speaker Change: 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 done to date.

Speaker Change: It'll validate our entire development program for <unk> is 50 10, including.

Speaker Change: The positive safety and efficacy data, we generated in our pivotal north to trial.

Speaker Change: Plus the learnings from the first one which informed our north to study design.

Speaker Change: Also the additional patient exposures established endorsed three to meet Fda's required safety population size.

Speaker Change: And it also puts an exclamation point on the entire team and the quality of our CMC work.

Russell Trenary: Now turning to the U.S. We reached agreement with the FDA on our SPA and launched NORSATE, a three-month non-inferiority study with an eight-week efficacy endpoint. This study is progressing as planned, and we have already enrolled over 30% of the patients today. 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.

Speaker Change: Now turning to the U S.

Speaker Change: We reached agreement with the FDA on our Spa and launch North Sea, a three month non inferiority study with an eight week efficacy endpoint.

Speaker Change: This study has progressed as planned.

Speaker Change: And we've already enrolled over 30% of the patients to date.

Speaker Change: 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.

Russell Trenary: Additionally, we're meeting with the FDA in Type C and Type D meetings in order to discuss the resolution of the CFA questions and comments that were received in the CRL last year. The type C and D meetings are not required by FDA.

Speaker Change: Additionally, we're meeting with the FDA type C type D meetings in order to discuss the resolution of the CMC questions and comments that were received in the C. I R. L last year.

Speaker Change: The type C and D meetings are not required by FDA. These.

Russell Trenary: These interactions are our... 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 C&C items will be resolved in calendar Q2 and Q3 this year, 2024, in advance of the North State Data Readout. I'd also like to reiterate that the CMC comments from the CRL do not have any impact on our current supply of ONS 5010.

Speaker Change: These interactions are our request with the goal of doing everything in our power to address the FDA CMC questions, while streamlining the process for resubmitting our BLA.

Speaker Change: Importantly, we anticipate these open CMC items will be resolved in calendar Q2, and Q3. This year 2024 in advance of the North Sea data readout.

Speaker Change: I'd also like to reiterate that the CMC comments from the CRA will do not.

Speaker Change: Any impact on our current supply of Boeing is 50 10.

Russell Trenary: We're working with reputable manufacturers and are actively using ONS5010 from these partners in the ongoing NORSATE study. We believe that if successful, these activities will be sufficient for potential approval in the United States in calendar 2025. Now, it's my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer.

Speaker Change: We're working with reputable manufacturers that are actively using Owen. It's 50 10 from these partners in the ongoing North Sea study.

Speaker Change: We believe that if successful these activities will be sufficient for a potential approval in the United States in calendar 2025 and.

Speaker Change: And now it's my pleasure to turn the call over to Larry Kenyon, Our Chief Financial Officer.

Speaker Change: Larry.

Lawrence A. Kenyon: 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 EU approval and complete the 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 U.S.

Lawrence A. Kenyon: Thank you Ross good morning, everyone.

Lawrence A. Kenyon: 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 our goal to receive approval for and launch O N S 50 times.

Lawrence A. Kenyon: We still are waiting to receive EU approval and compete for our BLA submission at the end of calendar 2024.

We believe our successful type financing that closed in March and April provides the necessary cash resources to support launches in the U S and Europe.

Lawrence A. Kenyon: The Outlook Therapeutics team is grateful to GMS Ventures and Investments and Syntone for their continued support of our mission. We also welcome the significant new institutional healthcare funds that 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.

Lawrence A. Kenyon: Outlet Therapeutics team is grateful to Gm's ventures in investments and central them for their continued support of our mission. We also welcomed a significant new institutional health care funds that see the opportunity here to upgrade the standard of care for treating wet AMD and patients around the world.

Lawrence A. Kenyon: Our current cash position when combined with the expected proceeds from the full exercise of warrants to purchase shares of common stock.

Lawrence A. Kenyon: Jack to meeting the requirements for calling the warrants should be sufficient to support our operations through calendar 2025.

Lawrence A. Kenyon: 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.

Lawrence A. Kenyon: Moving onto 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 noncash 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.

Lawrence A. Kenyon: 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 North State and also began enrolling patients. Previously, we had reported that we estimated we could complete Norse 8 for a total of $30 million, with most of these expenses to be incurred during the first three calendar quarters of 2024.

Lawrence A. Kenyon: 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 North Sea and also began enrolling patients.

Lawrence A. Kenyon: Previously we had reported that we estimated we could complete north say for a total of $30 million with most of these expenses to be incurred during the first three calendar quarters of 2024, we.

Operator: We have not changed our estimates for North 8th 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 prepare for the anticipated approvals in the EU and UK and plan for a launch there in early calendar 2025. I will now turn the call back over to the operator for the Q&A portion.

Lawrence A. Kenyon: We have not changed our estimates for north Sea and expect that overall R&D expenses will continue to run at these levels for the next two quarters.

Lawrence A. Kenyon: 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 EU and U K and plan for a launch there in early calendar 2025.

Speaker Change: Now I'll turn the call back over to the operator for the Q&A portion.

Speaker Change: Yeah.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question.

Speaker Change: Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

Speaker Change: A confirmation tone will indicate your line is in the question queue you.

Speaker Change: You May press star two if he would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys one.

Speaker Change: One moment, please while we poll for your questions.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we poll for your question. Our first questions come from the line of Julian Harrison with BTIG. Please proceed with your, "Hello, good morning." Congratulations 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 de-risking for NORSE-8.

Speaker Change: Our first questions come from the line of Julian Harrison with BTG I G. Please proceed with your questions.

Julian Reed Harrison: Hi, good morning, Congrats on all the progress and thank you for taking my questions first.

Russell Trenary: And second, great to see the positive CHNP opinion back in March. I'm curious how large the European market opportunity for ONS 5010 is relative to the U.S., and sorry if I missed it, but is this something you could pursue alone, or is a partner there the most likely path forward? I'll go ahead and take the market size first, a really great looking opportunity for us. If you look at the number of injections for off-label Bevacizumab in Europe, they're quite similar to the United States. They get close to about three million injections per year.

Julian Reed Harrison: First I'm wondering if there are any preceding datasets in particular, you would highlight as being especially Derisking for North Asia.

Julian Reed Harrison: And second great to see the positive C. H N P opinion back in March I'm curious, how large the Europe market opportunity for <unk> 50 tenants relative to the U S and sorry, if I missed it is this something you could pursue alone or as a partner there the most likely path forward.

Julien: Yeah. Thanks, Julien I'll go ahead and take the the the market size first Europe as a as really Super looking opportunity for us if you look at the number of injections.

Julien: For off label Bevacizumab in Europe, they are quite similar to the United States. They they they get close to about 3 million injections per year.

Russell Trenary: There's 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 Amerisource Bergen, which has units that 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 U.S., they have GPO contracting services.

Julien: There's a little bit of price compression in Europe, compared to the United States, but it still looks like a very enticing opportunity.

Julien: And we look forward to capitalizing on that we are planning to work.

Julien: Work in conjunction with Suncor, a formerly Amerisourcebergen, who have units who are fully capable of not only conducting all of the three P. L activities, but they have great H T. A payer connectivity, they've got pharmacovigilance, which will be utilizing in the U S. They've got GPO contracting.

Julien: Services, they've got medical literature, distributional, we'll be utilizing all of that functionality.

Russell Trenary: 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'll be our sales reps and MSLs that we hire. It will be an Outlook launch. The, you know, turning back to the data set that you mentioned that might portend the relative success of NORS 8 and why we are so confident in that, that's a great question because in our NORS 2 pivotal trial, which had spectacular data associated with that year-long trial.

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'll be you know Oliver the sales reps and M. S. L that we hire will be will be so it'll it will be an outlook launch.

Julien: The you know turning back to the to the dataset that you mentioned that might portend, the relative success of North Sea and why we are so confident in that.

Speaker Change: That's a great question because.

Speaker Change: In our north two pivotal trial, which had spectacular spectacular data associated with that year long trial.

Russell Trenary: There's a detail in there that not everybody remembers, and that is that the first 90 days of our NORS2 pivotal trial had an identical dosing regimen to our current NORS8 trial. So in other words, In both NORS 8, the current trial, as well as NORS 2, our very successful initial pivotal trial, there was dosing of either ONS5010 or Ranibizumab or Lucentis at day 0, day 30, and day 60. And so when we go back and we look at the data during that period of time in the NORS2 trial, we see non-inferiority between the ONS5010 line and the Lucentis line.

Speaker Change: There's a detailed in there that not everybody remembers.

That is that the the first 90 days of our north to pivotal trial were had an identical dosing regimen to our current north trial. So in other words in both North Sea. The current trial as well as north to our very successful initial pivotal trial.

Speaker Change: There was dosing of either O&M, 50, 10, or Ranibizumab or Lucentis at day Zero day, 30, and day 60, and so when we go back and we look at those data during that period of time in the north to trial, we see non inferiority between the O N S 50 10.

Speaker Change: Line and the Lucentis a line so in terms of best corrected visual acuity, which is the primary endpoint for North Sea.

Russell Trenary: So in terms of best corrected visual acuity, which is the primary endpoint for NORS8, and because there was such a small difference in letters gained between Lucentis and ONS5010 in NORS2 during that day zero, day 30, day 60 timeframe, we certainly do expect to see the same thing duplicated in NORS8. Julian, did you have a follow-up question? That was it for me.

Speaker Change: No because there was such a small difference in letters gained between Lucentis and O&M 50, 10 endorsed to during that day Zero Day 30 day 60 timeframe. We certainly do expect to see the same thing duplicated in normal state.

Speaker Change: Okay.

Speaker Change: Uh huh.

Speaker Change: Yeah.

Speaker Change: Okay.

Speaker Change: Yeah.

Speaker Change: Julian did you have a follow up question.

Russell Trenary: Very helpful. Thank you very much. Great. Thanks, Julie.

Julian Reed Harrison: That was it for me very helpful. Thank you very much.

Speaker Change: Great. Thanks, Julie.

Julian Reed Harrison: Yeah.

Operator: Thanks. Our next questions come from the line of Eddie Hickman with Guggenheim Securities. Please proceed with your question. Hi, good morning.

Speaker Change: Our next questions come from the line of Eddie Hickman with Guggenheim Securities. Please proceed with your question.

Russell Trenary: Congratulations on all the progress. Just a couple questions for me. Can you talk about how many sites you currently have enrolling patients and what the goal of coming online will be?

Eddie Hickman: Hi, good morning, Congrats on all the progress just a couple of questions for me can you talk about how many sites do you currently have enrolling patients and what the goal is or cadence of that at 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 you know will be a little bit.

Russell Trenary: And then, could you remind us of your pricing discussions with both commercial and government plans? I know that the landscape will be a little bit different next year than it was last year given some of the new. I'd be curious if you could update us. Yeah, so I think 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.

Eddie Hickman: 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.

Yeah. 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.

Russell Trenary: 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're pretty much at full strength right now. So for us to have just reached mostly full-strength in April, be in full-strength in May, and with March having been a partially full-strength month, to already have 30% of the patients enrolled really encourages sites are very happy about the study design, and the ease with which recruiting is.

Eddie Hickman: <unk>, where we were kind of full bore.

Eddie Hickman: I think we've got one more site that still needs to be activated, but we're 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 pull strength month, so already at 30%.

Speaker Change: <unk> of the patients enrolled really encouraging on this.

Speaker Change: Sites are very happy about the study design.

Speaker Change: The ease with which on recruiting is no patients get either a product that the doctors have been using for several decades or O&M 50, 10. So they feel like it's a win win no matter, which arm. The patient is randomized into them. So it's very encouraging start and we're going to try to keep.

Russell Trenary: You know, patients get either a product that 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 it's a very encouraging start, and we're gonna try to keep the pedal to the metal and get this thing enrolled by the third quarter of this year. In terms of pricing, we really like how it's shaping up because, you know, I think if you looked at 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.

Speaker Change: The pedal to the metal and get this thing.

Speaker Change: Hum.

Speaker Change: Inside the third quarter of this year.

Speaker Change: In terms of pricing, we really like how it's shaping up.

Because you know I think if you if you looked over last year and the year before you started to see some some relatively speaking some price declines among the major brands.

Speaker Change: Hum in the United States and in Europe.

Russell Trenary: And now with the launches, some of the super-high-priced brands, that ASP for the anti-vegetative states, 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's always been a low-cost emphasis in that segment, albeit one that was off-label, didn't meet ophthalmic standards, and didn't really have the type of quality that 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.

Speaker Change: And now with the launches.

Speaker Change: Some of the the Super high priced brands that a S. P for the anti VEGF space, we expect to go up.

Speaker Change: And I think the important thing for people to understand about this space is the following.

It's always been a two segment market.

Speaker Change: There are old Theres always been a low cost bevacizumab segment, albeit one that was off the table.

Speaker Change: It didn't 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 that was multiples more expensive than the off label. So.

Russell Trenary: So, that part of the market that almost 50% of the injections have always been there, and it's been, I'm sure we're 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. You know, they're switching a lot of their own customers to their higher-priced brands, or they're taking market share from others with their products to a higher price.

Speaker Change: That's part of the market that almost 50% of the injection has always been there and it's been untouchable.

Speaker Change: We're gonna come along.

Speaker Change: The rest of the Pip the other 50% it's been the battleground for the Biosimilars the major brands and now the the new launches that have come out from the other companies the new launches from the other companies are driving V. A S. P up you know, they're switching a lot of their own customers to their higher priced brand or they're taking market share from others.

Speaker Change: <unk>.

Speaker Change: From their product into a higher price. So we like how the pricing is working for us. So we think the the paradigm of having a two segment market will continue there will still be a lower cost services in that market. It's about half of the injection and then the other half being the battleground for forever.

Russell Trenary: So, we like how the pricing's working for us, and we think the paradigm of having a two-segment market will continue. There will still be a lower-cost emphasis in that market. It's about half of the injections, and then the other half being the battleground for everybody else. Is that everything you were looking for, Eddie?

Speaker Change: The body else.

Is that everything you were looking for Eddie Yeah, No very very helpful. And then just 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.

Russell Trenary: Yeah, no, very helpful. And is this only a three-month study? And sort of what are these doctors saying about what they would do to those patients after they're finished with three months? Um, you know, they obviously wouldn't want to go back to like a non...

Speaker Change: Obviously I wouldn't want to go back to like a non.

Russell Trenary: I'm just sort of curious, like, how you're thinking about recruiting those doctors for a future launch. Yeah, well, I think the best way to recruit those doctors for a future launch is to have them be 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, you know, I think that's setting up for us rather nicely. But you are correct.

Speaker Change: Branded version, so I'm, just sort of curious like how how youre thinking about recruiting those docs for future launch.

Speaker Change: Yeah, well I think the best way to recruit those law those doctors for future launches 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.

Speaker Change: So that's you know 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 injection that would create a zero day of randomization and then day 30, and then day 60, and the peso will exit the study.

Russell Trenary: It is a 90-day study, and the injections will occur daily. There are three injections that will occur at day zero, 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'll be best corrected visual acuity, and we'll be looking for a non-inferiority margin of three and a half letters to Lucentis, which was, again, achieved in NORS2, It wasn't necessary for the outcomes of that study.

Speaker Change: Good day 90, so the.

Speaker Change: The primary endpoint is that day 60, and that'll be best corrected visual acuity and we'll be looking for a non inferiority margin of three and a half letters to Lucentis, which was again achieved in north too although that was not a pre specified.

Speaker Change: Statistics for that particular study it wasn't necessary for the outcomes of that study. So we expect this one to.

Speaker Change: To show non inferiority again.

Russell Trenary: So we expect this one to show non-inferiority again. And then after the patient exits the study, you know, I think it's really up to the doctors and the payers to determine what happens next and what therapy they move them to. Thank you. Our next question has come from the line of Douglas Tsao with H.C. Wainwright. Please proceed with your question. Hi, good morning.

Speaker Change: And then.

Speaker Change: After the pace of exit to exit the study I think it's really up to the to the doctors and payers to determine what you know what happens next and what what therapy. They moved them to next.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: Thank you. Our next question is coming from the line of Douglas Tsao with H C. Wainwright. Please proceed with your question.

Russell Trenary: Thanks for taking the question. Russ, I just want to clarify a couple things. Was the 30 percent enrollment as of today, or was that as of March 31? That was as of yesterday.

Speaker Change: Hi, good morning, Thanks for taking the question.

Douglas Dylan Tsao: I just wanted to clarify a couple of thing was the 30% enrollment as of today or was that as of March 31st.

Speaker Change: So that was as of yesterday.

Russell Trenary: Um, and what was the number, so you said there were 60 sites up now, what was the number of sites at, like, you know, the progression, like, through the start of, say, March and 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 by the end of March or the beginning of April. So we kind of felt that April was sort of a full strength month for us.

Speaker Change: And what was the number you said, there's 60 site up now what was the number of sites like you know the progression here you started in March.

Speaker Change: Paul.

Paul: Probably and in March we probably got about half of the sites enrolled at that point.

Paul: And then in April we pretty much got the rest of them enrolled.

Paul: They either by the end of March or the beginning of April. So we kind of felt that April was sort of a full strength.

Paul: For us and of course may will be also.

Russell Trenary: And of course, May will also be. Okay, great, thanks. And then, I'm just curious, have you, you know, given the progress in the wet AMD market as well as the funding, what's the latest thinking in terms of DME and browser authentication? Thank you. Yeah, it's a great question, Doug.

Okay, great. Thanks, and then I'm just curious have you.

Speaker Change: Given the progress.

Speaker Change: In the wet AMD market as well as the funding you know what's the latest thinking in terms of D E and F and the ballpark indication. Thank you.

Speaker Change: Yes, it's a great question Doug.

Russell Trenary: We do have in our pipeline studies for DME and BRBO planned. You know, it's interesting today that DME and BRBO are also treated with off-label avastin. So we don't know how that'll develop necessarily in the future, but for us,

Doug: Doug we do have in our pipeline study.

Speaker Change: Studies for DNA and the RVO planned you know it's it's it's interesting today that <unk> be RVO, where also treated with off label Avastin. So we don't know how that'll that'll developed necessarily in the future, but for US we want to make sure that our sales organization.

Russell Trenary: 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 GME and BRBO, but 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 wet and anti-vegetative space. Yeah, absolutely.

Speaker Change: Has always been the safest position to promote.

Speaker Change: Across the full breadth of the capabilities of O&M 50, 10, which we believe will include G. M. N V. R. B O, but we're gonna have to do those studies to prove that so initially are.

Speaker Change: First approval will be what it was in wet AMD, which as you know Doug as you know up to about 70% of the market.

Speaker Change: Yeah.

Speaker Change: Space.

Speaker Change: Yeah, absolutely and just yeah.

Russell Trenary: Given some of 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 that is, obviously, with NORTH8, you got a fairly, I would argue, favorable study to align with you on a fairly favorable study, certainly in duration. Do you think something like an eight-week endpoint in DMV or DRVO would be sufficient?

Speaker Change: Given you know 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 north they you got a fairly I would argue favorable study.

Speaker Change: So aligned with you on a fairly favorable study certainly a duration do you think something like a you know eight week end point D. N E. R V. R V O would be sufficient.

Russell Trenary: Yeah, 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 talking with FDA, given the real success of Norse 2 and what our expected success will be on NORCE 8, given that platform as well as the safety exposures that were generated in NORCE 3. We will want to ensure that we in FDA have a clear understanding of what all the requirements will be for a DME and a BRBO study, and 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 FDA are on the same page regarding those studies. Okay, great. I'll jump back out into the queue.

Speaker Change: Yeah, I think we are in discussions with F. D. A pretty constantly now are our relationship has really grown to have an excellent level and we do plan on.

Speaker Change: On addressing with the FDA given the the the <unk>.

Speaker Change: Real.

Speaker Change: Success of north to and what our expected successful be on North sea given that platform as well as the safety exposures that were generated in north three.

Speaker Change: We will want to to ensure that we in F. D. A M. Kristine understanding of what all of the requirements will be for the D. M D and a b or B O study and will evaluate oh.

Speaker Change: Well evaluate continuing the game plan that we've used in the past to use type a meetings and potentially spa approvals to ensure.

Speaker Change: We ended up the air on the same page regarding those studies.

Speaker Change: Okay, great I'll jump back out into the queue.

Operator: Thank you. Our next questions come from the line of Tim Chang with Capital One. Please proceed with your question. Hi, thanks. You know, as you guys prepare for the launch in Europe... Could you talk a little bit about, you know, some of your contract manufacturers, your partnerships with them, your packaging partners, you know, what they're doing to prepare for the launches in Europe and also in the U.S. next year? Yeah, I mean, well, we've got inventory now.

Speaker Change: Thank you. Our next question is come from the line of Tim Chiang with capital. One. Please proceed with your questions.

Speaker Change: I think so you know as you guys prepare for the launch in Europe.

Speaker Change: Can you talk a little bit about you know what some of your contract manufacturers your partnerships with those your packaging partners you know.

Speaker Change: What theyre doing to prepare for the launches in Europe and also in the U S next year.

Russell Trenary: So, we've already been through the process of developing and producing the drug substance at Fujifilm Diasynth in College Station, Texas, as well as the fill and finish operation that occurs at Ajinomoto BioPharm in San Diego, California. And then our packaging takes place, and labeling and serialization takes place at PCI. So, we've 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.

Speaker Change: Yeah, I mean, well, we've got inventory that so.

Speaker Change: We've already been through the process of developing the had been producing the drug substance.

Speaker Change: I'm out of Fuji film Diocese in College station, Texas, as well as the fill and finish operation that occurs with origin of Moto Biopharma in San Diego, California, and then our packaging takes place in labeling and serialization on takes place with with PCI. So we've got inventory sitting on the shelf.

Speaker Change: We are gonna have to wait for final approval and final labeling before we we get that product into final packaging and labeling.

Speaker Change: So we've got the the pie at the beginning of the pipeline.

Speaker Change: Stoke and we just need to get that product for the final packaging and labeling and then you know from there from there on it's just you know really just continuing to place a place orders with our manufacturers in and be in a position to have enough to ship to both Europe as well as the United States.

Russell Trenary: So, we've got the beginning of the pipeline stoked, and we just need to get that product to the final packaging and labeling. And then, you know, from there on, it's just, you know, 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, great.

Russell Trenary: You know, 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? Yeah, 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.

Speaker Change: Okay Super.

Speaker Change: Is there anything else that you think you need to Rimini.

Speaker Change: Remediate or or update.

Speaker Change: Leading up to your meeting with the FDA the type a meeting.

Speaker Change: Yeah, we actually don't have any more type a meetings planned with them on this particular product. We are conducting type C. N type D meetings, but those are our either one or a number of agenda items pertaining.

Speaker Change: Pertaining to CMC that we meet with F D a to go through with them.

Russell Trenary: 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've got another one on the calendar.

Speaker Change: Hum the studies that we've conducted the analysis that we've done on the statistics that we have and the data pertaining.

Pertaining to answering all of the questions that they had.

In the a and the C O L. A we've already had one of those meetings. We've got another one on the calendar scheduled.

Russell Trenary: 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, 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.

Speaker Change: We've had a very successful run with them and I think what it what it allows us to do is first of all ensure that we and the FDA are hearing each other.

Speaker Change: So far so good.

Speaker Change: And ensure that the day that the data we have produced.

Speaker Change: To answer the CMC questions are being looked at by by the F. D. A.

Speaker Change: And to ensure that by the time, we resubmit the 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 then.

Russell Trenary: The initial application, then again, in the type C and D meetings, and then again in the resubmission. So we believe that this 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 wasn't a requirement, but in our first meeting with them last year, they made note of the fact that they thought it might be a good idea.

Speaker Change: And in the in the Resubmission.

Speaker Change: So we believe that this is not only streamlines.

Speaker Change: Our submission process, but also streams streamlines the review process for FDA. So we've had a this came at the suggestion of the F. D. A it wasn't a requirement, but in our first type a meeting with them last year.

Speaker Change: They've made note of the fact that they thought it might be a good idea and so.

Russell Trenary: 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.

Speaker Change: We've we have.

Speaker Change: And following orders and I think that our relationship with the F D. A.

Speaker Change: He has grown due to a very healthy.

Speaker Change: A healthy place by engaging with them relatively constantly during this process.

Speaker Change: Okay. That's very helpful. Thanks Russell.

You bet.

Russell Trenary: You bet. Thank you. Our next questions come from the line of Douglas Tsao with HC Wainwright. Please proceed with your questions. Douglas, could you check if you're on mute?

Speaker Change: Thank you our next questions come from the line of Douglas Tsao with H C. Wainwright. Please proceed with your questions.

Speaker Change: Yeah.

Speaker Change: Douglas could you check if you're on mute please.

Operator: Thanks for taking questions again. Just to clarify, Ross, your comments earlier about how you're thinking about commercialization in Europe. Is it the plan now to launch with an ONS field force, or are you still contemplating potential partnerships with companies that have a field presence already? Thank you. Yeah, thanks, Doug.

Speaker Change: Thanks for taking the questions again.

Speaker Change: Just to clarify your comments earlier.

Speaker Change: You got to commercialization in Europe.

Speaker Change: This man now too long.

Or are you still contemplating type of partnership.

Speaker Change: You know companies.

Speaker Change: All right. Thank you.

Russell Trenary: Yeah, we're, 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, you know, our job is to maximize shareholder value and ensure that we do the best job of creating a great top line and a great bottom line on behalf of our shareholders. So right now, we're focused on what we can do, but we're not closed-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. Kemp Dolliver with Brookline Capital Markets. Please proceed with your question.

Doug: Yeah, Thanks, Doug Yeah, where we are.

Doug: We're focused on executing the things that we can do ourselves.

Doug: We will always entertain conversations with with with other partners and if we ever come to a determination that they can do it better.

Doug: Better than we can you know.

Doug: Our job is to maximize shareholder value and ensure that we do the.

Doug: The best job of creating a great top line and a great bottom line on behalf of our shareholders. So right now we're focused on what we can do but we're not close minded and we will listen to people who might want to feel.

Doug: I feel like they can be helpful to us.

Speaker Change: Okay. Thank you.

Speaker Change: Yeah.

Speaker Change: Thank you our next questions come from the line of <unk>.

Oliver: Oliver with Brookline capital markets. Please proceed with your questions.

Speaker Change: Great. Thank you.

Operator: Great, thank you. How does the EU differ from the U.S. in the context of how the health plans will position your product versus all the other options? Because in the U.S., they're pretty much gonna have you at the top of the pole position initially until patients fail therapy and then move on to something else. You know, focusing on the EU5. How do they differ, if at all?

Speaker Change: How old is the EU gift for the from the U S. In the context of.

Speaker Change: How old the.

Speaker Change: Health plans.

Position.

Speaker Change: Your product versus <unk>.

Speaker Change: All the other options because you know in the U S. It's pretty they're pretty much gonna have you at the pole position initially until patients failed therapy, and then move on to something else.

Speaker Change: Hum.

Speaker Change: Focusing on the EU five.

Speaker Change: How do they differ if at all.

Russell Trenary: Yeah, they can't 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-label basizumab. 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, 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. And, of course, they understand what the rest of the landscape looks like.

Speaker Change: Yeah, they typically not only different 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 label Bevacizumab. So I think it gives us an opportunity to establish ourselves.

Speaker Change: As is 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 you know unlike a lot of probably unlike everybody who came before us.

In the United States.

Speaker Change: The pricing strategy that we took was to.

Speaker Change: Ensure that doctors and payers understood our value proposition.

Speaker Change: Of course, they understand what the rest of the landscape looks like they understand how much switching goes on from off label Bevacizumab to our brand and now they understand why some of that switching that's going on and a lot of that is due to the inability of.

Russell Trenary: They understand how much switching goes on from off-label Bevacizumab to the brand name, 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 regulatory approval in ophthalmology. So in educating the audience on that, then the last question really was, how would you like us to treat you? What do you think is fair?

Speaker Change: 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 can prices what do you think is fair.

Russell Trenary: 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're paying for off-label at $100 per injection or less. So that same paradigm, generally speaking, exists throughout Europe as well.

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 a lot closer to $1000 per injection than it is to what you're paying for off label at $100 per injection or less.

Speaker Change: So that's the same paradigm generally speaking exist throughout Europe as well.

Russell Trenary: 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, you know, the United States, the brands are priced, their wholesale acquisition costs. There are also high prices in Europe, but just not that high.

Speaker Change: In most markets there is off label and most markets. There is a you know a group of cabal of high priced brands that are out there and so although the price has compressed a bit from the United States.

Speaker Change: The United States. The brands are priced there their wholesale acquisition cost and in some cases exceed $2600 per injection.

Speaker Change: 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.

Russell Trenary: So we see the paradigm in Europe in terms of the number of injections being very similar to the United States, and the thought process around what payers and doctors are looking for is pretty similar to the U.S., albeit with a little bit of price compression. Okay, Russ, just to be clear, the practice in those countries where there is activity is they will start a patient on the off-label version of Aston and then switch if necessary. Yes, some of that behavior exists in Europe like it does in the United States.

Speaker Change: To the United States and the thought process around what payers and doctors are looking for to be pretty similar to the U S, albeit with a little little bit of price compression.

Speaker Change: Okay.

Speaker Change: That's just to be clear so.

Speaker Change: Practice in those countries, where there where there is activity.

Speaker Change: Is they will start a patient on the off label label Avastin and then switch if necessary.

Speaker Change: Yes, some of that behavior existed in Europe like it does in the United States and and look let's be clear there are.

Russell Trenary: And look, let's be clear; there are. Some patients are highly responsive. And there are some patients who, even with off-label treatment that does not meet 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 whole picture and all of the patients who start on off-label, there's 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 requirement for regulatory approval.

Speaker Change: Some patients are hurt our high responders and and there are some patients who even with off label that does not meet.

Speaker Change: 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 an off label. There's so much switching going on that it drives the price way higher than people.

Speaker Change: Might've expected in both the United States as well as in is in Europe, because they don't.

Speaker Change: Necessarily continue to respond to an off label Bevacizumab that does not meet the requirements for a regulatory approval. So we believe that by bringing hours on which meets all the same requirements for utter lack of particulars for the right drug protein concentration.

Russell Trenary: So we believe that by bringing our product, 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 levels, and 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 aliquotted and refiltered back into There are things that happen to the molecule during that process that are untoward and can retard the amount of drug protein concentration that is then left available in those small-volume syringes and vials.

Speaker Change: For approved packaging the right ph levels, the right Endo tox levels specifications for osmolarity, we check all of those boxes that debt or not or cannot be met by an off label product that had ended up being removed.

Speaker Change: Removed from its original packaging and Alec clouded and re filtered back into small volume syringes, and vials or things that happened to the molecule during that process that or untoward in 10 Hum.

Speaker Change: Retard the amount of drug protein concentration that is then left available in those small volume syringes and vials. So we believe that by bringing regulatory approved quality.

Russell Trenary: So we believe that by bringing regulatory-approved quality, That's 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 Wu with Ascendian Capital Markets.

Speaker Change: That's why we get regulatory why we expect regulatory approval with our safety and efficacy data.

Speaker Change: Yes.

Speaker Change: Thank you very much.

Yeah.

Speaker Change: Thank you. Our next question is coming from the line of Ed Woo with <unk> capital markets. Please proceed with your questions.

Operator: Please proceed with your question. Congratulations on the progress. My question is about manufacturing and supply for Europe. Do you anticipate having to move production there as you commercialize the product there?

Speaker Change: Yeah. Congratulations on the progress my question is on the manufacturing that supply for Europe do you anticipate having to move our production there as you commercialize the product there.

Russell Trenary: We don't need to initially, but we'll always be looking to maximize our global footprint as it relates 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'll balance the needs of Europe and the United States and the costs associated with landing the product in Europe from either our current locations or other locations that we'll look at in the future.

Speaker Change: We don't need to initially, but we'll always be looking to.

Speaker Change: Maximize our global footprint as it pertains to that so.

Speaker Change: We will look at and frankly are our partners also have.

Speaker Change: Facilities that are located in Europe, so as we look to the future we'll balance.

The needs of Europe, and the United States and the costs associated with landing the product in Europe.

Speaker Change: From either our current locations or other locations that we'll look at in the future but for now we're good to go.

Russell Trenary: But for now, we're good to go. Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you. Thank you so much. Thank you. Our next questions come from the line of Danil Gitalin with Chardin.

Speaker Change: Great well, thanks for answering my questions and I wish you guys. Good luck. Thank you great. Thanks, so much.

Speaker Change: Thank you. Our next question is come from the line of Danielle <unk> with Chardan. Please proceed with your questions.

Operator: Please proceed with your, Good morning, guys. Thank you for taking the question and congratulations on the progress. Can you talk about the timing for the Type C and D meetings for the CMC questions, and do you anticipate providing a separate communication when the issues have been fully addressed? We expect all of the Type C and Type D meetings to be handled within the second and third quarters of this year. We won't be giving updates because, you know, when you go into those meetings, that'd be like giving you an update on my staff meeting.

Danielle: Hi, Good morning, guys. Thank you for taking the question and congrats on the progress.

Danielle <unk>: 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 are the issues have been fully addressed.

Danielle <unk>: Oh.

Neal: We expect all of the type C type D meetings to Neal to be handled within the second and third quarter of this year, we won't be giving updates because you know when you go into those meetings that'd be like giving you an update on my staff meeting.

Russell Trenary: You know, you go into these type C and type D meetings; they're very focused, they're very technically oriented, but I can say for a fact that we know for a fact that FDA has been pleased with our approach and pleased with the data that we've produced and are not unhappy that they're getting a look at this prior to what's resubmitting. So, I think our suspicion that this would be helpful to them and would aid them in the review process has been validated. Okay, thank you. And one more quick question.

Neal: You know you go into these type C. N type D meetings are very focused very tactically oriented.

Neal: Hum, 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 I'm pleased with the data that we produced and are not unhappy that they are getting a look at this prior to resubmitting. So our suspicion that this would be.

Neal: Helpful to them and would aid them in their review process I think has been validated.

Speaker Change: Okay. Thank you.

Speaker Change: One more quick question initially will your product supplied in wireless.

Russell Trenary: Initially, will your product be supplied wirelessly, and are you still conducting work for upper field syringes? Yes, we are. We are doing work on our prefilled syringe project does continue to progress. We do have one more arm of a study, our NORTH7 study. We've already enrolled the first arm, which would be the control arm. Now, once we get through the stability work that's required for the syringe, we will enroll that second arm for NORTH7.

You're still conducting work for our Prefilled syringes.

Speaker Change: Yes, we are we are doing work to.

Speaker Change: Pre filled syringe project does continue to progress we do one more arm of our study or nor seven study. We've we've already enrolled the first arm, which would be a control arm.

Speaker Change: We will now once once we get through the stability work that's required for the syringe, we will enroll that second arm for north seven.

Russell Trenary: We do not expect to apply for approval for the prefilled syringe until we have final approval from FDA. As you probably know, we're dealing not only with the pharmaceutical and biologics group but also with the medical device group at FDA. So, you get to talk with those folks twice on this one. And like the other companies who have learned the hard way, we're going to learn the smart way and make sure that we get our approval under our belt before we apply for the prefilled syringe. I got it.

Speaker Change: We do not expect to apply for approval for pre filled syringe until we have final approval from FDA as you probably know we're dealing not only with the with the.

Speaker Change: Pharmaceutical and Biologics group, but also with the medical device group at FDA. So because you get to talk with those folks twice on this one.

Speaker Change: And like the other companies who have learned the hard way.

Speaker Change: We're gonna learn the smart way and make sure that we get our approval under our belt before we we apply for a for the pre filled syringe.

Russell Trenary: All right, thank you for taking the time to answer the question. 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. Well, I believe the future of Outlook Therapeutics has never been brighter. 2024 has already proven to be a pivotal year for the company. To summarize, in Europe, the second largest market for wet AMD, we already received a positive CMP opinion and expect potential approval this quarter.

Speaker Change: Got it alright, thank you for taking the questions.

Speaker Change: Thank you we have reached the end of our question and answer session I would now like to turn the floor back over to restaurant area for closing remarks.

Great. Thanks, so much.

restaurant area: Well I believe the future of outlook Therapeutics has never been brighter.

restaurant area: 2024.

restaurant area: <unk> already proven to be a pivotal year for the company.

To summarize in Europe.

restaurant area: 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.

Russell Trenary: This sets the stage for our first commercial launch, expected in the first quarter of calendar 2021. In the United States, we reached agreement with the FDA on a path to potential approval and are targeting resubmission of our VLA this calendar year. Assuming cash exercise of the warrants from our recent pipe financing, we expect to be funded through key anticipated milestones potentially realized, and our mission of bringing the first approved ophthalmic formulation of Bevacizumab to patients with retinal disease. We look forward to continued progress and the opportunity to bring an enhanced level of care to the retina anti-VEGF.

restaurant area: 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.

restaurant area: Assuming cash ex us exercise of the warrants from our recent financing.

restaurant area: We expect to be funded through key anticipated milestones potentially realizing our mission of bringing the first approved ophthalmic formulation bevacizumab to patients with retinal disease.

restaurant area: We look forward to continued progress and the opportunity to bring an enhanced level of care to the retina anti VEGF space.

Russell Trenary: 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.

restaurant area: Thanks for joining us today.

Speaker Change: 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.

restaurant area: Okay.

restaurant area: [music].

restaurant area: Yes.

restaurant area: [music].