Outlook Therapeutics Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 16, 2024

There are 10 speakers on the 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. 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 Jeanine Thomas of Investor Relations.

Speaker 1

Thank you, Daryl. 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.

Speaker 1

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 ks 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 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 that these 3rd 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 or that any independent source has verified any information obtained from third party sources.

Speaker 1

During the call, the company will discuss non GAAP financial measures, which are not prepared in accordance with U. S. Generally Accepted Accounting Principles. Definition of these non GAAP financial measures along with reconciliations at the most directly comparable GAAP financial measures are included in our Q2 earnings release, which has been furnished to the SEC and is available on the company's website at ir. Outlooktherapeutics.com.

Speaker 1

Joining us on the call from Outlook Therapeutics leadership team are Russell Trenier, President and Chief Executive Officer and Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics. Would now like to turn the call over to Russ. Please proceed.

Speaker 2

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

Speaker 3

To begin,

Speaker 2

I feel it's 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-five thousand and ten 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. 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-five thousand and ten 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.

Speaker 2

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 United States, we've 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 NORS8, our ongoing 90 day non inferiority study for which we expect top line data in the 4th calendar quarter of this year 2024. Shortly thereafter, our goal is to resubmit our BLA by the end of this calendar year.

Speaker 2

Turning to our financial picture, we believe we're strongly positioned. We recently closed a private placement with gross proceeds of up to $172,000,000 Of that, $65,000,000 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 107,000,000 dollars 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 Norsane, 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 healthcare focused institutional investors. Larry will speak to this a little bit later in the call.

Speaker 2

I'd 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 U. K, we expect potential approval in the Q3 of calendar 2024 this year with initial launches in the Q1 of calendar 2025. As we await potential approval in the EU, we're working with Syncora, formerly AmerisourceBergen and their EU units to leverage their existing infrastructure and expertise to support launching ONS-five thousand and ten ourselves in Europe. I'd like to emphasize the importance of the opportunity in Europe, which is the 2nd largest market for wet AMD globally.

Speaker 2

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. First, it will validate our entire development for ONS-five thousand and ten, including the positive safety and efficacy data we generated in our pivotal NORS2 trial, plus the learnings from NORS1, which informed our NORS2 study design. Also the additional patient exposures established in NORS3 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 U. S.

Speaker 2

We reached agreement with the FDA on our SPA and launched Norsate, a 3 month non inferiority study with an 8 week efficacy endpoint. This study has progressed as planned and we've already enrolled over 30% of the patients to date. We continue to expect to complete enrollment in the Q3 of this year as planned and be in a position to report top line data and resubmit our BLA in the Q4 of this year. Additionally, we're meeting with the FDA in Type C and Type D meetings in order to discuss the resolution of the C and C questions and comments that were received in the CRL last year. The Type C and D meetings are not required by FDA.

Speaker 2

These interactions are at 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. Importantly, we anticipate these open CMC items will be resolved in calendar Q2 and Q3 this year 2024 in advance of the Norsaite data readout. I'd also like to reiterate the CMC comments from the CRL do not have any impact on our current supply of ONS-five thousand and ten. We're working with reputable manufacturers that are actively using ONS-five thousand and ten from these partners in the ongoing NORSAFE study. We believe that if successful, these activities will be sufficient for potential approval in the United States in calendar 2025.

Speaker 2

And now, it's my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer.

Speaker 4

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-five thousand and ten. 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 type financing that closed in March April provides the necessary cash resources to support launches in the U.

Speaker 4

S. And Europe. 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.

Speaker 4

Moving on to our financial results for the 2nd 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 and L and balance sheet. For the 2nd fiscal quarter of 2024, I can report that we remain on track with our spending plan for the year. The increase in our R and D expenses during fiscal Q2 versus Q1 of this year came in as expected as we began recruiting and initiating clinical trial sites for NORS8 and also began enrolling patients. Previously, we had reported that we estimated we could complete NORS8 for a total of $30,000,000 with most of these expenses to be incurred during the 1st 3 calendar quarters of 2024. We have not changed our estimates for North8 and expect that overall R and D expenses will continue to run at these levels for the next two quarters.

Speaker 4

Fiscal Q2 G and A expenses were in line with fiscal Q1 and we also expect this to continue for the next 2 fiscal quarters as we prep 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 and A portion.

Operator

Thank you. We will now be conducting a question and answer Our first questions come from the line of Julian Harrison with BTIG. Please proceed with your questions.

Speaker 5

Hi, good morning. Congrats on all the progress and thank you for taking my questions. First, I'm wondering if there are any preceding datasets in particular you would highlight as being especially derisking for NORS8. And second, great to see the positive CHMP opinion back in March. I'm curious how large the Europe market opportunity for ONAS-five thousand and ten is relative to the U.

Speaker 5

S? And sorry if I missed it, is this something you could pursue alone? Or is a partner there the most likely path forward?

Speaker 2

Yes. Thanks, Julien. 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're quite similar to the United States.

Speaker 2

They get close to about 3,000,000 injections per year. 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 Centora, 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 U.

Speaker 2

S, they've got GPO contracting services, they got medical literature distribution. 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 a customer facing arm in both markets where it'll be our the sales reps and MSLs that we hire will be so it will be an outlook launch. Turning back to the data set that you mentioned that might portend the relative success of NARS8 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, there's a detail in there that not everybody remembers.

Speaker 2

And that is that the 1st 90 days of our NORS2 pivotal trial were had an identical dosing regimen to our current NORS8 trial. So in other words, in both NORS8, the current trial as well as NORS-two, our very successful initial pivotal trial, there was dosing of either ONS-five thousand and ten 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 NORSCH-two trial, we see non inferiority between the ONS-five thousand and ten line and the Lucentis line. So in terms of best corrected visual acuity, which is the primary endpoint for Norsa. So because there was such a small difference in letters gained between LUCENTIS and ONS-five thousand and ten in NORS-two during that day 0, day 30, day 60 time frame.

Speaker 2

We certainly do expect to see the same thing duplicated in NORS-eight.

Operator

Julian, did you have a follow-up question?

Speaker 5

That was it for me. Very helpful. Thanks very much.

Speaker 2

Great. Thanks, Julien.

Operator

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

Speaker 6

Congrats on all the progress. Just a couple of questions from me. Can you talk about how many sites you currently have enrolling patients and what 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 that the landscape will be a little bit different next year than it was last year given some of the new approvals.

Speaker 6

So I'm just sort of curious if you could update us on those discussions. Thanks.

Speaker 2

Yes. So I think the this is the 1st 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 got one more site that still needs to be activated, but we're pretty much at full strength right now.

Speaker 2

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. So already at 30% of the patients enrolled is really encouraging. The sites are very happy about the study design, the ease with which recruiting is. Patients get either a product that the doctors have been using for several decades or ONS-five thousand and ten. So they feel like it's a win win no matter which arm the patient gets randomized into.

Speaker 2

So it's very encouraging start. And we're going to try to keep the pedal to the metal and get this thing enrolled inside the Q3 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.

Speaker 2

It's always been a 2 segment market. There's always been a low cost sevices in that segment, albeit one that was off label, 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 multiples more expensive than the off label. So that part of the market, that almost 50% of the injection has always been there and it's been untouchable until 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.

Speaker 2

They're switching a lot of their own customers to their higher priced brand or they're taking market share from others from their product into a higher price. So we like how the pricing is working for us. So we think the paradigm of having a 2 segment market will continue. There will still be a lower cost sebicizumab market. It's about half of the injections and then the other half being the battleground for everybody else.

Speaker 2

Is that everything you were looking for Eddie?

Speaker 6

Yes. No, very helpful. And is this only a 3 month study and sort of what's the what are these doctors saying about what they would do to patients after they're finished with 3 months? Would they they obviously wouldn't want to go back to like a non branded version. So I'm just sort of curious like how you're thinking about recruiting those docs for a future launch?

Speaker 2

Yes. Well, I think the best way to recruit those doctors for a future 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.

Speaker 2

There are 3 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'll be looking for a non inferiority margin 3.5 letters to Lucentis, which was again achieved in NORS2, although that was not a pre specified statistic for that particular study. It 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's really up to the doctors and the payers to determine what happens next and what therapy they move them to next.

Operator

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

Speaker 7

Just Russ, I just want to clarify a couple of things. Was the 30% enrollment as of today or was that as of March 31?

Speaker 2

That was as of yesterday.

Speaker 7

And what was the number so you said there are 60 sites up now. What was the number of sites that like the progression like through start to say in March and April?

Speaker 2

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 pretty either 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 and of course May will be also.

Speaker 7

Okay, great. Thanks. 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 Bravo indication? Thank you.

Speaker 2

Yes. It's a great question, Doug. We do have in our pipeline studies for DME and BRPL planned. It's interesting today that DME and BRBO are also treated with off label Avastin. So we don't know how that will develop necessarily in the future.

Speaker 2

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-five thousand and ten, 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 anti bedding space.

Speaker 7

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 NORTHAID, 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 a 8 week endpoint DME or BRVO would be sufficient? Thank you.

Speaker 2

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 NORSCH-two and what our expected success will be on NORS8, given that platform as well as the safety exposures that were generated in NORS3, we will want to ensure that we and FDA have a pristine understanding of what all the requirements will be for a DME and a BRBO study and we'll evaluate our we'll evaluate continuing the game plan that we've used in the past to use Type A meetings and potentially SPA approval to ensure that we have the air on the same page regarding those studies.

Speaker 7

Okay, great. I'll jump back into the queue.

Operator

Thank you. Our next questions come from the line of Tim Chiang with Capital

Speaker 8

1. As you guys prepare for the launch in Europe, you talk a little bit about what some of your contract manufacturers, your partnerships with those, your packaging partners, what they're doing to prepare for the launches in Europe and also in the U. S. Next year?

Speaker 2

Yes. I mean, well, we've got inventory now. So we've already been through the process of developing the and producing the drug substance out of Fujifilm, Diosynth in College Station, Texas as well as the fill and finish operation that occurs with Ajinomoto Biopharm in San Diego, California. And then our packaging takes place and labeling and serialization takes place with PCI. So we've got inventory sitting on the shelf.

Speaker 2

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 pipe the beginning of the pipeline stoked and we just need to get that product to 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.

Speaker 8

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?

Speaker 2

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've got another one on the calendar schedule.

Speaker 2

We've had a very successful run with them. And I think what it allows us to do is, 1st 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 3rd 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.

Speaker 2

So we've had a this came at the suggestion of the FDA. It wasn't a requirement. But in our first Type A meeting with them last year, they made note of the fact that they thought 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.

Speaker 8

Okay. That's very helpful. Thanks, Russell.

Speaker 2

You bet.

Operator

Thank you. Our next questions come from the line of Douglas Tsao with H. C. Wainwright. Please proceed with your questions.

Operator

Douglas, could you check if you're on mute, please?

Speaker 7

Thanks for taking questions again. Just to clarify, Russ, your comments earlier about how you're thinking about commercialization in Europe. Is it the plan now to launch within ONS Steelforce or are you still contemplating potential partnerships with companies that has a deal presence already? Thank you.

Speaker 2

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 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.

Speaker 2

And we will listen to people who might want to feel like they can be helpful to us.

Speaker 7

Okay. Thank you.

Operator

Thank you. Our next questions come from the line of Kempe D'Auber with Brookline Capital Markets. Please proceed with your questions.

Speaker 3

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?

Speaker 3

Because in the U. S, it's pretty they're pretty much going to have you at the pole position initially until patients fail therapy and then move on to something else. Focusing on the EU5, how do they differ, if at all?

Speaker 2

Yes. They not only differ in 5 different ways, but even within countries, there are regional differences within the countries. In the U. K, for example, there is just a trace of off label betacizumab. 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 use in the United States.

Speaker 2

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?

Speaker 2

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 3 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. In most markets, there is off label.

Speaker 2

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, it's 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 U.

Speaker 2

S, albeit with a little bit of price compression.

Speaker 3

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?

Speaker 2

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 in 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'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 requirements for a regulatory approval.

Speaker 2

So we believe that by bringing ours, which meets all the same requirements for utter lack of particulates, or the right drug protein concentration or approved packaging, the right pH levels, the right endotox levels, 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 aliquoted and refiltered back into small volume syringes and bile. 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 services and bile. 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.

Speaker 3

Thank you very much.

Operator

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

Speaker 2

Yes, 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.

Speaker 2

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. But for now, we're good to go. Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you.

Speaker 2

Great. Thanks so much, Ed.

Operator

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

Speaker 9

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?

Speaker 2

We expect all of the Type C and Type D meetings, Sunil, 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'd 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're 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.

Speaker 9

Okay. Thank you. And one more quick question. Initially, will your product be supplied in wireless? And are you still conducting work for upper filled syringes?

Speaker 2

Yes, we are doing work to our prefilled syringe project does continue to progress. We do have one more arm of a study, our NORTH-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 NOR7. We do not expect to apply for approval for prefilled syringe until we have final approval from FDA.

Speaker 2

As you probably know, we're dealing not only with the Pharmaceutical and Biologics Group, but also with 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.

Speaker 9

Got it. All right. Thank you for taking the questions.

Operator

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.

Speaker 2

Great. Thanks so much. Well, I believe the future of outlook therapeutics has never been brighter and 2024 has already proven to be a pivotal year for the company. To summarize, in Europe, the 2nd largest market for wet AMD, we received a positive CMT opinion already and expect potential approval this quarter. This sets the stage for our first commercial launch expected in the Q1 of calendar 2025.

Speaker 2

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 of the warrants from our recent pipe financing, we expect to be funded through key anticipated milestones potentially realizing our mission of bringing the 1st 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.

Operator

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.

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Key Takeaways

  • Outlook received a positive CHMP opinion for ONS-5010 in wet AMD and expects potential EU approval in Q2 2024, with UK approval anticipated in Q3 2024 and a first‐launch in Q1 2025.
  • The FDA has agreed to a Special Protocol Assessment (SPA) for the 90-day non-inferiority NORS8 trial versus Lucentis, with top-line data expected in Q4 2024 and a BLA resubmission planned by year-end.
  • Outlook closed a private placement raising up to $172 million (including $65 million received and $107 million from pending warrants) to fund operations through European launch, NORS8 completion and a potential US launch.
  • The company plans to self-commercialize ONS-5010 in Europe, leveraging Syncora’s 3PL, HTA, pharmacovigilance and GPO capabilities, with inventory ready from Fujifilm-Diosynth, Ajinomoto Biopharm and PCI.
  • Europe represents the second-largest wet AMD market with ~3 million off-label bevacizumab injections annually, and ONS-5010 is positioned to meet stringent quality standards at a competitive two-segment market price.
AI Generated. May Contain Errors.
Earnings Conference Call
Outlook Therapeutics Q2 2024
00:00 / 00:00