Q4 2024 EyePoint Pharmaceuticals Inc Earnings Call
Michelle: Good morning. My name is Michelle and I will be your conference operator today. At this time I would like to welcome everyone to the EyePoint fourth quarter and full year 2024 financial results and recent corporate development conference call. There will be a question and answer session to follow the completion of the prepared remarks. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of EyePoint.
George Elston: The safe Harbor provisions under the private Securities Litigation Reform Act of $19 95.
George Elston: These include statements about our future expectations clinical developments and regulatory matters and timelines the potential success of our products and product candidates financial projections, and our plans and prospects.
George Elston: <unk> results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings that we have made or may make with the SEC in the future.
George Elston: Any forward looking statements represent our views as of today only while we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change.
George Elston: Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today.
Jay: I'll now turn the call over to Dr. Jay <unk>, President and Chief Executive Officer of high point.
Speaker Change: Thanks George.
Speaker Change: Everyone and thank you for joining us <unk>.
Speaker Change: 2024 was a Europe continued execution and exceptional results for I point on all fronts.
Speaker Change: Bringing us closer to delivering on our goal of bringing life changing treatments to patients with severe retinal diseases on today's call. We will review why we're the leader in ocular sustained drug delivery and how we are uniquely positioned to improve patients' lives with strong data into potential multi.
Speaker Change: Billion dollar blockbuster indications.
We've advanced our best in class therapy, do review into phase III clinical trials in wet age related macular degeneration or wet AMD and we've reported positive 24 week phase II results in diabetic macular edema, or <unk> supporting a second phase III opportunity.
Speaker Change: <unk> is the only sustained delivery program with robust data for an investigational six months therapy in both of these indications highlighting our differentiated teekay AI with a new mechanism of action may improve patient outcomes compared to the standard of care.
I want to emphasize the safety of Arcturus or technology, beginning with the four products already approved by the FDA and continuing with the strong safety data from the four clinical trials of bio erodible to Richard E consisting of over 190 patients treated.
Speaker Change: With that review.
Speaker Change: This superb safety profile, coupled with the excellent efficacy data we saw in <unk>, the largest interventional phase II sustained delivery clinical trial in wet AMD to date has driven significant patient and physician interest in our ongoing pivotal trials with both.
Speaker Change: Our phase III wet AMD trials, Lugano, and lucci, surpassing enrollment expectations.
Speaker Change: I am pleased to report that we are exceeding historical enrollment rates of comparable wet AMD trials by a substantial margin.
Speaker Change: The Lugano trial is now well over 50% enrolled and the Lucci trial is tracking ahead of schedule as well.
Speaker Change: We continue to expect completion of enrollment in both trials in the second half of 2025 with top line data anticipated in 2026.
Speaker Change: The tried and true non inferiority trial design at Lugano, and Lucci in wet AMD represents a clear pathway to regulatory approval should the results be positive.
Speaker Change: And the sustained release space, we anticipate being the first investigational six month interim picture wet AMD program to submit a new drug application or NDA, allowing us to potentially reach patients first.
Speaker Change: Our patient centric trial design should enable a broad product label with an optimal dosing interval, thereby providing physicians flexibility and allowing us to capture more of the market share.
Speaker Change: As part of our preparation for success, our commercial manufacturing facility in North Bridge, Massachusetts is now online with to review registration batch manufacturing underway to support an NDA filing.
Speaker Change: We recently reported positive efficacy safety and subgroup data from our phase II <unk> clinical trial for Dura view in DNA.
Speaker Change: <unk> met primary and key secondary endpoints firmly establishing <unk> as the only sustained release Teekay program with an active <unk> program.
Speaker Change: <unk> is currently a large market, but has a significant need for sustained delivery options.
Speaker Change: I will discuss the Verona data in more detail later in this call, but based on the compelling phase II data, we expect to hold an end of phase II meeting with the FDA around pivotal trial design and the second quarter of this year.
Speaker Change: We remain in a solid financial position, we ended 2024 with a noteworthy balance sheet of $371 million in cash and investments and no debt.
Speaker Change: This was bolstered by a $161 million oversubscribed follow on equity offering in the fourth quarter.
Speaker Change: Turning to our science to review consists of <unk>, which is a patent protected best in class tyrosine kinase inhibitor or TK, I formulated and proprietary bio erodible <unk> E D.
Speaker Change: <unk> has been safely delivered to tens of thousands of ice across four FDA approved products.
Speaker Change: Both patients and physicians are exceptionally comfortable with this delivery system and its established safety record.
Speaker Change: <unk> uses a bio erodible matrix that allows for the sustained delivery of drug via zero order kinetic release for at least six months.
Speaker Change: As your order kinetics means that the drug is delivered at a steady rate. So thats small payloads can give an extended therapeutic effect with constant tissue exposure.
Speaker Change: In addition, <unk> allows for immediate bioavailability and by design prevents uncontrolled release of free drug floating in the eye.
Speaker Change: We're rolling it is not another anti VEGF and day review is not just another anti VEGF program.
<unk> is a potent and selective teekay <unk> brings a new mechanistic approach to the treatment of VEGF mediated retinal diseases through intra cellular blocking up all that Jeff receptors.
Speaker Change: Therefore blocks, all isoforms event, Jeff, including debt UFC and D. A.
Speaker Change: <unk> has demonstrated neuro protection in a validated retinal detachment animal model and May have an anti fibrotic benefit as it blocks the PDGF receptor.
Speaker Change: At tissue exposure achieved with Doe review Rolling It does not block tied to.
Speaker Change: Blockage of the tie to receptor is associated with retinal vascular instability.
Speaker Change: To review is packaged in a pre filled sterile syringe injector.
Speaker Change: It is administered by a standard <unk> injection in the physician's office similar to the current standard of care anti VEGF biologic treatments and consistent with current retinal practice dynamics.
Speaker Change: Unlike currently approved biologics and other sustained release programs in development. However, the review can be shipped and stored at ambient temperature.
Speaker Change: We have strong patent protection for <unk> in both the United States and outside of the U S.
Speaker Change: This allows us to protect our innovation and provides us flexibility with our strategic partnerships.
Speaker Change: In summary, with an excellent safety profile a distinct mechanism of action zero order kinetics that allows for sustained micro dose delivery for at least six months, great patent protection and convenience for physicians, we believed to review as well positioned as an excellent treatment option for patients.
Jeff: Vet, Jeff mediated retinal diseases.
Jeff: Turning to the phase II <unk> clinical trial in GMA, We recently announced positive 24 week safety and efficacy data for Dura view with both to review arms meeting the primary endpoint of longer time to first supplement versus control.
Jeff: <unk> $2 seven milligram demonstrated an early sustained and clinically meaningful improvement in best corrected visual acuity or <unk> with a gain of $7 one letters compared to baseline in our central subfield thickness or CST improvement of $75 nine Mike.
<unk> on OCD measurement.
Speaker Change: This represents 74% more drawing effect versus the a flipper set control.
Speaker Change: Visual and anatomic gains were observed as early as week four and we're much more robust than those achieved by the <unk> control wise, demonstrating the immediate bioavailability of Dura view and its differentiated profile as a sustained release PKI.
Speaker Change: Both to review treatment arm showed a favorable safety and Tolerability profile with no dearth view related ocular or systemic serious adverse events reported to date.
Speaker Change: Yesterday, we presented subgroup analysis from the phase II Corona clinical trial of the supplement pre patients through week 24.
Speaker Change: The data demonstrated that for those eyes that went 24 weeks with no supplementation <unk> $2 seven milligram had a significantly better improvement in CVA and anatomic control compared to the a flipper set control group.
Speaker Change: <unk> improved 10, three letters compared to baseline versus only three letters improvement for the Flipper set control group.
Speaker Change: To review $2 seven milligram also demonstrated concomitant structural improvement with CST improvement of 117 microns versus only 31 microns for the Flipper set control.
Speaker Change: This result confirms that the positive data from the phase II Verona trial were driven by the review as an active agent continuously released over six months and Thats. The unsub lamented eyes had improved visual acuity of about two lines on the chart.
Speaker Change: The highly positive phase two data supports our plans to engage in discussions with the U S and ex U S regulatory agencies to solidify the plans around a pivotal program.
Speaker Change: As a company we are highly focused on the successful completion of our phase III wet AMD program for Dura view.
Speaker Change: In wet AMD. Our goal is to provide a product that maintains stabilization at retinal anatomy for the majority of wet AMD patients with an every six month label.
Speaker Change: This could represent a significant improvement compared to the current anti VEGF treatments that are typically dosed on average every two months in the United States and it may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual outcomes.
Speaker Change: As previously mentioned enrollment is ongoing in both of our pivotal phase III wet AMD trials Lugano in Lucia with rapid enrollment rates that are exceeding our expectations enrollment completion in both trials is expected in the second half of 2025, both trials have received exceptional invest.
Speaker Change: <unk> and patient enthusiasm to date, driven by an established and familiar trial design.
Speaker Change: The two essentially identical non inferiority trials with six months re dosing provide a clear and recognize pathway for global regulatory and commercial success.
Speaker Change: <unk> reviewed to become a potential blockbuster franchise.
Speaker Change: To close I'd like to thank the entire <unk> team for an incredible year and a strong start to 2025.
Speaker Change: The dedication and execution capabilities demonstrated by our team to reach these milestones reflects the entire organization's commitment to improving patients' lives.
Speaker Change: On that note I'd also like to thank the patients and the clinical investigators for their participation in our ongoing trials without you all of the progress we've made advancing d'oeuvre you would not be possible.
Speaker Change: With our compelling clinical pipeline, representing multi billion dollar product opportunities are best in class sustained ocular delivery to Richard E technology, along with our strong balance sheet. We have further established our role as the leader and sustained ocular drug delivery and are well on our way to bring.
Speaker Change: <unk> impactful therapies to patients suffering from serious retinal diseases.
Speaker Change: I will now turn the call over to George to review the financials George.
George Elston: Thank you Jay as.
George Elston: As Jay noted we ended 2024 with a very strong balance sheet driven by continued stewardship of our cash in an oversubscribed $161 million follow on financing in October ending the year with $371 million in cash and investments.
George Elston: As the financial results for the three months and full year ended December 31, 2024 were included in the press release issued this morning. My comments today will be focused on a high level review for the quarter.
George Elston: For the quarter ended December 31, 2024, total net revenue was $11 6 million compared to $14 million for the quarter ended December 31 2023.
George Elston: Net product revenue for the quarter ended December 31, 2024 was $1 8 million compared to net product revenue for the quarter ended December 31 $2023.
George Elston: $7 million.
George Elston: We expect net product revenue to continue at immaterial levels as we will no longer be supplying Utica to Eni pharmaceuticals, our U S partner as of May 31, 2025.
George Elston: This follows the non renewal of a supply agreement that accompany the sale of UT commercialization rights to <unk> Sciences now Eni in 2023.
George Elston: Consistent with our strategy our forward manufacturing focus is on our <unk> program to support clinical trials, and NDA filing and future commercial launch.
George Elston: Net revenue from royalties and collaborations for the fourth quarter ended December 31, 2024 totaled $10 8 million compared to $13 $3 million in the corresponding period in 2023 the.
George Elston: The decrease was primarily driven by lower recognition of deferred revenue from the license of unique product grades.
George Elston: Operating expenses for the quarter ended December 31, 2024 totaled $56 8 million compared to $30 4 million in the prior year period.
George Elston: This increase was primarily driven by the two ongoing phase III trials for <unk>.
George Elston: Net non operating income totaled $3 9 million and net loss was $41 4 million or <unk> 64 per share.
Compared to a net loss of $14 1 million or <unk> 33 per share for the prior year period.
George Elston: Turning to the full year ended December 31, 2024, total net revenue was $43 3 million compared to $46 million for the year ended December 31 2023.
George Elston: Net product revenue for the full year ended December 31 2024.
George Elston: It was $3 2 million compared to net product revenues for the full year ended December 31, 2023 of $14 2 million.
George Elston: This decrease was driven by the license the beauty product rates sold in May 2023, completing I points exit from its commercial business.
George Elston: Net revenue from royalty and collaborations for the full year ended December 31, 2024 totaled $40 1 million compared to $31 8 million in the corresponding period in 2023.
George Elston: The increase was primarily driven by full year recognition of deferred revenue in 2024 from the license of Youtube product rates versus a partial year in 2023.
George Elston: Operating expenses for the full year ended December 31, 2024 totaled $189 1 million versus $121 1 million in the prior year period.
George Elston: This increase was attributed primarily to a $26 6 million increase in clinical trial costs related to the phase III clinical trials of <unk>.
George Elston: $28 million of increased personnel costs across the organization, including $24 7 million increase of noncash stock compensation.
George Elston: $16 7 million in <unk>, non clinical and license expense.
George Elston: These increases were offset by $3 $3 million decrease in other sales and marketing expenses due to discontinuation of Ut commercialization in 2023.
George Elston: Net non operating income totaled $15 1 million and net loss was $139 million or $2 32 per share compared to a net loss of $70 8 million or $1 82 per share for the prior year period.
George Elston: Cash cash equivalents and investments in marketable securities on December 31, 2024 totaled $371 million compared to $331 million as of December 31, 2023.
George Elston: We expect the cash and investments on December 31, 2024 will enable us to fund operations into 2027 beyond topline phase III data for <unk> in wet AMD expected in 2026.
George Elston: Accordingly based on our solid cash position. We currently have no plans to access the equity capital markets. This year.
George Elston: In conclusion, we are incredibly pleased with <unk> progress in 2024 and are well capitalized to advance our <unk> program.
George Elston: Two phase III trials in wet AMD.
Jay: I will now turn the call back over to Jay for closing remarks.
Jay: Thank you George.
As we've discussed I point continues to be a story of a superior product strong execution and focus leadership in the retinal disease space, we've accomplished our clinical milestones efficiently and aligned with our guidance and we plan to continue this in 2025 and beyond.
Key upcoming catalysts include in.
Jay: Enrollment completion in the phase III Lugano, and lucci of clinical trials of <unk> in wet AMD in the second half of 2025.
Jay: Topline data for these phase III trials in 2026.
Jay: And an end of phase II meeting with the U S. FDA to discuss the first pivotal phase III trial of <unk> in Dnb.
Jay: This remains an incredibly exciting time for <unk> as we are well positioned to execute on our upcoming milestones and continue to transform the treatment landscape with innovative long term solutions to improve both the vision and the lives of patients with serious retinal diseases.
Jay: Thank you all very much for listening. This morning, I will now turn the call over to the operator for questions.
Jay: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced.
Jay: Your question. Please press star one again, we ask that you. Please limit the number of questions that you ask at once it will get that there is a fair chance to participate.
Jay: And that will be comparable or Q&A roster.
Jay: Yes.
Speaker Change: Our first question is going to come from the line of course Ramiro with Jpmorgan. Your line is open. Please go ahead.
Speaker Change: Hi, gentlemen, and thank you for taking our questions. This morning.
Speaker Change: For your wet AMD pivotal program.
Speaker Change: Clinical sites have been activated across the trials of your overall target. So far I think you are at over 100 sites activated across the trials as of our conference in January.
Speaker Change: And for lithium can you remind us how many sites do you have open.
Speaker Change: To open thanks, so much.
Speaker Change: Good morning tests, thanks for your questions.
Speaker Change: Like to introduce our Chief Medical Officer, Ramiro Ribeiro Who's also on the call.
Speaker Change: Dr. <unk> do you want to answer those questions first of all.
Speaker Change: About our wet AMD trials, the current sites open and Blue ex U S sites planned.
Speaker Change: Yeah, no. Thanks, Jan good morning, everybody and thanks for the question Jess.
Speaker Change: So we have most of this site already activated in the U S.
Speaker Change: The ones that are not activated yet.
Speaker Change: Usually the ones that have more process like academic centers that takes a little bit longer to be activated.
Speaker Change: But I think as we show we fall enrollment numbers.
Speaker Change: We are very pleased with the progress of the studies and we have most of the sites already activated, especially the strong ones.
Speaker Change: In terms of ex U S.
Speaker Change: We are planning to have.
Speaker Change: Between 60 and 80 sites.
Speaker Change: Our study.
Speaker Change: Which should be coming.
Speaker Change: <unk>.
Speaker Change: This year.
Speaker Change: Thank you.
Speaker Change: Can you just clarify youre.
Speaker Change: Numbers of active sites currently.
Speaker Change: And its trial.
Speaker Change: So we have approximately active about 60 sites.
Speaker Change: Yes.
Speaker Change: Okay. Thanks, so much.
Speaker Change: Thank you and one moment as we move on to the next question.
Speaker Change: Our next question comes from the line of Yigal <unk> with Citigroup. Your line is open. Please go ahead.
Speaker Change: Hi, Jay and team. Thank you for taking my questions I just had one on the analysis, we presented yesterday on the supplement.
Speaker Change: It was interesting that you got a very very.
Speaker Change: <unk> separation with the $2 seven milligram.
Speaker Change: Versa flavor.
Speaker Change: No for the one three it seems like it didn't separate as much one may have expected I'm just curious if you could comment on the trend there.
Speaker Change: Relative to what was observed with the overall population of 26 patients.
Speaker Change: Thanks, Hugo terrific question and again I think.
Speaker Change: Evaluation of the subgroup analysis in particular this subgroup of the non supplemented patients really shows you how powerful the review was in this <unk> population.
Speaker Change: So these are the eyes that made it the whole 24 weeks without anything else other than to review and.
Speaker Change: Our group.
Speaker Change: And they improved over 10 letters and had 117 microns less fluid, which was significantly better than the unsub lamented is in the control.
Speaker Change: I think what we're seeing essentially is evidence of dose response between the two 7% to $1 three doses and of course, the two seven doses what were using in the current pivotal trials, what we plan on using in the pivotal trials in <unk>.
Speaker Change: And what our go to market doses, but we interpreted.
Speaker Change: There are some individual variability within those numbers, but we think this represents a dose response.
Speaker Change: What it shows you is that when to review works in this population it works exceedingly well.
Speaker Change: In the supplement free rates that were achieved by the $2 seven milligram dose.
Speaker Change: Not.
Speaker Change: Clouded by the fact that those supplementary eyes, we're slowly losing vision, we're slowly gaining fluid but didn't meet the criteria. In fact, when you look at those curves they are flat.
So the size that we're supplementary were extremely well controlled.
Speaker Change: I will bring up the point to that.
Speaker Change: This supplements in the $2 seven group.
Speaker Change: With one exception didn't really seem to change division, where the fluid much suggesting that we had reached perhaps a ceiling affected most of these eyes.
Speaker Change: So yes that analysis is very strong and I think too.
Speaker Change: Try to explain the differences I think again it's.
Dose response between the two doses with a little bit of individual variability there.
Speaker Change: Okay. Thanks, and just one very quick one.
Speaker Change: The timing of the phase III will there come a point, perhaps later this year, where you would be able to provide a little bit more granularity on.
Speaker Change: Sort of which half of 2026, we may expect.
Speaker Change: The phase III topline data.
Speaker Change: The phase III top line data sure I think we will be able to give you more granularity.
Speaker Change: Certainly as we approach last patient into Lucia.
Speaker Change: That will be obvious so so yes, we do expect.
Speaker Change: Some time.
Speaker Change: I suspect early second half of the year to give you some more granularity around that.
Speaker Change: Alright, perfect. Thank you so much.
Speaker Change: Thank you and one moment as we move on to the next question.
Speaker Change: Our next question comes from the line of.
Speaker Change: <unk> <unk> with Guggenheim. Your line is open. Please go ahead.
Speaker Change: Hey, guys. Thank.
Speaker Change: Thank you for taking my question.
Speaker Change: Now that the <unk>.
Speaker Change: Study is 50% enrolled are you able to characterize the <unk>.
Speaker Change: <unk> of patients you are able to recruit right now how they might be.
Speaker Change: I know that.
Speaker Change: I know that our differentiated versus davita too but.
Speaker Change: Anything you can just comment on.
Speaker Change: So thats one the second one is on the Dms side I mean, now that you have little bit more time to analyze the data.
Speaker Change: Could you maybe talk about the development, especially the phase III. How you are thinking about what sort of a lowered we should expect from center of cab.
Thank you.
Speaker Change: Thanks Scott.
Speaker Change: First the first question.
Speaker Change: About the patient population.
Speaker Change: I think a high level.
Speaker Change: We have.
Speaker Change: Said that we're capping the previously treated patients had approximately 25%.
Speaker Change: And we have reached that cap in Lugano.
Speaker Change: So.
Speaker Change: The majority of patients obviously at this point since we're over 50% enrolled are.
Speaker Change: Our treatment naive patients.
We don't expect that trial to be enrolling any more previously treated patients. So that's really kind of a high level understanding of where we're at.
With with the type of patients we have recruited.
Speaker Change: Beyond that just really been no kind of analysis done yet.
Speaker Change: And.
Speaker Change: We don't expect to be doing any analysis before the studies are done on any kind of other details around that.
Speaker Change: With respect to the phase III <unk> trial, we have a lot of options here.
Riveros: I think probably riveros the best person to two.
Speaker Change: Give you a little bit more specifics, but the truth is we don't know yet exactly what we're going to do we really need to get some important questions answered by the agency around this.
Riveros: <unk>.
Riveros: The top line here is the data was so robust I think we have a lot of options that.
Riveros: Wood.
Riveros: Give us a pathway to approval so ramiro any more detail you want to add on that.
Ramiro Ribeiro: Yes, I think as you mentioned Jay.
The data from the Phase III study this show immediate benefit on the CPA on day one.
Ramiro Ribeiro: So that type of result gives us flexibility why are we think about designing the phase III studies for <unk>.
Ramiro Ribeiro: The first option of course is always going to be similar to what we're doing for wet AMD right. We have the loading dose which for the in this case. These five loading dose of <unk> and then we would give to you.
Ramiro Ribeiro: But again based on the results from the Phase III study I think we might have an opportunity to design a study that is more efficient.
Ramiro Ribeiro: Many.
Ramiro Ribeiro: We would dose to review earlier.
Ramiro Ribeiro: So a study that could be a little bit shorter.
Ramiro Ribeiro: Overall the results sooner.
Speaker Change: Okay. That's helpful. One more question this finished for George.
Ramiro Ribeiro: Could you maybe help us model the R&D expense.
Ramiro Ribeiro: Going forward at least in 2025.
Ramiro Ribeiro: Pardon me, yes, sure yet and so remember.
Ramiro Ribeiro: Didn't see that.
Speaker Change: Fairly meaningful increase in Q4.
Ramiro Ribeiro: And that was really related to the.
Ramiro Ribeiro: <unk>.
Ramiro Ribeiro: Initiation of both the Lugano and leukemia trials and in the fourth quarter.
Ramiro Ribeiro: I think thats, probably a good barometer of how you roll forward 2024, as we clarified yesterday and again today, we are laser focused on execution of those trials and thats going to be the focus for our burn.
Ramiro Ribeiro: On the R&D side in 2025.
Ramiro Ribeiro: Thank you.
Ramiro Ribeiro: Thank you one moment as we move to the next question.
Speaker Change: Our next question comes from the line of Ken <unk> with Jefferies. Your line is open. Please go ahead.
Ken <unk>: Good morning, and team congratulations on the enrollment progress.
Speaker Change: While the CN Lugano remains laser focused near term I was wondering if you have considered any opportunities to conduct post marketing studies for <unk> long term.
Ken <unk>: If so what information would be valuable to glean from such studies.
Ken <unk>: To help further differentiate <unk> in the wet AMD marketplace. Thank you so much.
Speaker Change: Thanks, <unk> for that question and obviously, we've already started to think about what.
Ken <unk>: What other studies might.
Speaker Change: Hence the value of day review in wet AMD.
Ken <unk>: And the one we've talked about I think for a while.
Speaker Change: That is most obvious wood.
Speaker Change: Post approval to run the study in wet AMD of Dura view against.
Speaker Change: Whatever the.
Speaker Change: Current industry leader for like an blocker is at the point, whether it's high dose eylea or a buy small in this study instead of the primary endpoint being change in visual acuity as a primary endpoint would be supplement free rate up to six months or percentage wise on supplemental ore.
Speaker Change: To further supplement that sort of thing.
Speaker Change: Obvious reason for doing that is we're going up against two milligram eylea into pivotal trials, which is a regulatory requirement.
Speaker Change: And while two milligram eylea remains a very very.
Speaker Change: Good treatments as a ligand Walker.
Speaker Change: With terrific short term efficacy.
Speaker Change: The market seems to be moving into <unk> and suspect high dose that we eventually so it makes sense to prove our longevity against those two products. We think we would do very well against that.
Speaker Change: And obviously then give us some more strength in the marketing argument.
I'm going to ask Romero any other thoughts you might have on on.
Speaker Change: Post approval studies that would be interesting and helpful.
Speaker Change: Yes, I think we were just Lenny.
Speaker Change: About the effect of CPI in wet AMD.
Speaker Change: The phase III studies are a major focus on getting our regulatory approval, but as Jay mentioned, we're going to do studies compared to other ligand blockers, but also.
Speaker Change: Exploring additional benefits that ATK inhibitor.
Speaker Change: Could have such as.
Speaker Change: Prevention of <unk>.
Speaker Change: <unk> fee in these type of wet AMD patients. So that's something that we're also going to be looking for as a post marketing study.
Speaker Change: Thank you and one moment as we move on to the next question.
Speaker Change: Our next question comes from the line of Jennifer <unk> with Cantor Fitzgerald. Your line is open. Please go ahead.
Jennifer <unk>: Hi, Thanks for taking my question and congrats on all the strong execution, maybe first to start and Danny can you give us some more color on your plans to meet with both U S and ex U S agencies next quarter, including what Youre, hoping to take away from those.
Jennifer <unk>: Should we expect an update by next quarter or would that contrary after and then.
Jennifer <unk>: Understanding that wet AMD take center stage, what was sort of trigger a decision to advance the pivotal program is it contingent on sort of that accelerated pathway that premier was talking about.
Speaker Change: Thanks, Jennifer.
Jennifer <unk>: Terrific questions as usual.
Speaker Change: So.
I'm going to let Ramiro give a little more details around what type of interaction, we would expect and hope for with the regulatory agencies.
Speaker Change: Typically what we've done in the past and I suspect what we'll do for this as well as after we get the written minutes, we would have a public announcement about about what.
Speaker Change: What our plans are and how on how they obviously sync with what the agencies have told us.
Speaker Change: As for acceleration of Dnb.
Speaker Change: That again.
Speaker Change: We do not at this point as a company want to put anything at risk with wet AMD.
Speaker Change: We really are delighted with how it's going.
Speaker Change: We want to continue to make sure that we have the resources within the company both people resources and financial resources to have a.
Speaker Change: Our strong cash runway after the.
Speaker Change: Got AMD data.
Speaker Change: And therefore decisions about the structure of <unk> after regulatory meetings and the timing of D&B is really going to be secondary to this first principle, which is make sure that wet AMD is successful.
Speaker Change: So over to Ramiro again any color on.
How what we really hope to accomplish with the two.
Speaker Change: <unk> meeting with the agencies.
Speaker Change: Yes. So we are planning to have a meeting both with the FDA as well.
Speaker Change: We have made to ensure we get regulatory feedback globally.
Speaker Change: In the end of the day the questions are going to be around the design of the study.
Speaker Change: So of course.
Speaker Change: We're going to propose something that as I mentioned before we would make a steady efficient and then get feedback from the agency they agree with that approach.
Speaker Change: Okay, and if I could ask one question on the wet AMD programs since you talked about the six to eight sites per study roughly.
Speaker Change: Should we think about just.
Speaker Change: Given the enrollment we have seen with O'connor should we think about this year in the same way or is there sort of a split and high end <unk> tapping into legato before they move into this year and I'm just trying to think through what the cadence looks like.
Speaker Change: So.
Speaker Change: Yeah.
Speaker Change: <unk>.
Speaker Change: The number of sites in Lugano at this point is slightly higher than lucida.
Speaker Change: Do expect more lucci as sites to come on overtime remember Lucci has started.
Speaker Change: Approximately I think it was perhaps first patient in six seven weeks after Lugano, so there's naturally going to be.
Speaker Change: I wouldn't call it delay, but little separation between the.
Speaker Change: The ryzen into recruit.
Speaker Change: So what we're seeing though in recruitment rise in leukemia is mirroring what we saw at the beginning.
Speaker Change: The Lugano trial, so we are optimistic and confident that the type of enrollment we saw on the <unk>.
Speaker Change: Not all will be matched by the chip.
Speaker Change: Alright Thats helpful. Thanks, guys.
Speaker Change: Thank you one moment as we move on to the next question.
Speaker Change: Our next question comes from the line of Greg <unk> with Mizuho Securities. Your line is open. Please go ahead.
Greg <unk>: Good morning, Thanks for taking my question and congrats on the progress in the year.
Speaker Change: Quarter, just wanted to ask a question about your North Bridge Manny.
Speaker Change: Manufacturing facility manufacturing, obviously, it's something that we on the sell side don't get a lot of.
Speaker Change: Visibility into but maybe can you talk about.
Speaker Change: How.
Speaker Change: You are anticipating the manufacturing progress to continue and maybe some color on I guess kind of.
Speaker Change: The quality of the site that you've built out there and potentially.
Speaker Change: Potentially.
Speaker Change: Anticipating any potential.
Speaker Change: CMC issues, which obviously, we always worry about because we can't get visibility to that thanks.
Speaker Change: Thanks, Greg at George do you want to answer that question.
George Elston: Yes sure Marty.
Marty: How we did it and how it's going.
Speaker Change: Yes, Greg really great question and thanks for that because we've been out ahead of this for several years I think just to remind the audience.
Speaker Change: We opened our North bridge facility last fall state of the art 41000 square foot facility.
Speaker Change: We're focused not just on clinical execution, but being ready for registration batches pre approval inspections and ultimately commercialization. The team has really done a remarkable job getting that site up and running and.
Speaker Change: And we will we really pivoted all day review manufacturing forward to that site.
Speaker Change: And the team has already started.
Speaker Change: Activities to get ready to start registration batches this year to support an NDA filing.
Speaker Change: The site was actually built.
Speaker Change: To our specifications by the landlord did involve any cash investments. So it's really worked out incredibly well for us and importantly to your point, we've had FDA involved early in.
Speaker Change: And the design and execution of that site.
Speaker Change: And our quality team has had that in mind the entire way. So we're feeling really positive and really prepared as we get on the other side of data that we're going to have not just product for late clinical but also be able to support.
Speaker Change: Successful commercial launch with positive data.
Speaker Change: If I may tell a little anecdote about the site to which I think reflects the team that we have and how focused we are.
Speaker Change: <unk>, obviously been out there many times.
Speaker Change: Right before we were ready to have an official opening I went out to inspect.
Speaker Change: And I walked around the site, it's in the middle of the Woods access a beautiful area walk around the site and Theres a sidewalk all the way around the building.
Speaker Change: I went to the head of the building and I said why did we put a sidewalk all the way around the building and his response was so when the FDA comes to inspect us if it's a rainy day, they will have a sidewalk to work on.
Speaker Change: That is the type of foresight.
Speaker Change: Putting it together to make sure that this site will be up and running on time.
Speaker Change: To both FDA and EMEA specifications, and we expect from a commercial perspective to be able to supply the entire global supply for Derby from this site.
Speaker Change: Thanks for the anecdote J and thanks George.
Speaker Change: Thank you one moment as we move on to the next question.
Speaker Change: Our next question comes from the line of calling Kelsey with Baird. Your line is open. Please go ahead.
Kelsey Baird: Great. Good morning, Thanks for taking our questions and congrats on all the progress we've seen with other retina study is talking about GI studies, a difference in results and X U S versus the U S side can you speak to whether you would expect a meaningful difference in the type of patients you're enrolling in Lugano Lithia any differences in the thinner deviation for patients and how that might impact the top line.
Speaker Change: Yourself.
Speaker Change: Great question Choline and I have the best person next to me to answer that question.
Ramiro Ribeiro: Dr. <unk>, who of course was quite involved in one of the international Ghw's. So Ramiro what do you think.
Ramiro Ribeiro: Yeah, No. Good question and I think if we go back on the <unk>.
Ramiro Ribeiro: Sure.
Ramiro Ribeiro: Something that could be one of the hypotheses, but I'm not sure if it was truly confirm that the geographically.
Ramiro Ribeiro: One of the reasons for the difference in the results.
Ramiro Ribeiro: Regardless, we wet AMD study.
Ramiro Ribeiro: Studies are.
Ramiro Ribeiro: <unk> more matured MGA trials across the globe right. So clinical sites have been doing this.
Ramiro Ribeiro: <unk> studies for many many years.
Ramiro Ribeiro: I think we may have down our inclusion exclusion criteria to accommodate a global study so I don't expect to see.
Ramiro Ribeiro: The baseline characteristics being much different between the U S and ex U S sites.
Speaker Change: Great. That's helpful and one quick one if I can on Dnb does you have to have the same non inferior non inferiority margin of minus four and a half later its on a lower bound of the confidence interval as they do in wet AMD.
Roberto: Roberto do you know historically.
Speaker Change: Manav your margin has been calculated indeed, yes.
Speaker Change: Yes, so forgive me.
Speaker Change: It's going to be part of our discussion with the FDA, but I think if you look back of some of the previous studies.
They tend to use four letters.
Speaker Change: Center footprint five but a question it's going to be one of the questions. We asked in our direction.
Speaker Change: Great. Thanks for taking my questions and congrats on that bucket.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Next.
Speaker Change: Comes from the line of Dan Donlan Chatterji with Jones. Your line is open. Please go ahead.
Speaker Change: Hi, Thanks for taking my question. So in terms of future market positioning how would you view as potential every six months labor compared to at Barclays. But then says every six months every 12 month label that ocular had guided too.
Speaker Change: Thanks for the question I think in every six months label is what these physicians.
Speaker Change: I think prefer I think thats been made clear not only by us, but by quite a bit of market research and of course, that's how we designed to review to consistently deliver therapeutic levels of rolling it for six months.
Speaker Change: Virtually everybody.
Speaker Change: We like our label.
Speaker Change: We like our study design.
Speaker Change: We think the six month label will deliver that flexibility to patients and physicians to help tailor their individual treatment to maximize the vision maximize the drawing effect, while minimizing the unnecessary visits injections.
Speaker Change: Thank you a quick follow up the way things are stacking up.
Speaker Change: You could still be the first to market do you have a TGI, Colorado use based on need.
Speaker Change: Tying overexcites lead to capture the market.
Speaker Change: Wow.
Speaker Change: It's a really interesting question, because it's quite broad and in of course first to market. There is an advantage as I think you all know and we.
Speaker Change: We believe that we are still in a position to be first to market, especially driven by this great enrollment that we've talked about today.
Speaker Change: In saying that we've had.
Speaker Change: An early program.
Speaker Change: Work done here for the past two years on exactly how we're going to position to review.
Speaker Change: It is.
Speaker Change: A shift in the market.
Speaker Change: A true six months.
Speaker Change: Repeatable safe tolerable.
Speaker Change: Treatment for VEGF mediated diseases, you could argue with there really is nothing like that right now so that the idea.
Speaker Change: Of how to get physicians comfortable with it is a process that we are doing right now and it will certainly accelerate internally.
Speaker Change: As we get closer and closer to data.
Speaker Change: Closer to eventual launch so.
Speaker Change: I think we could spend two hours on the details of what that might entail, but suffice it to say that that just like we've been on the forefront of figuring out manufacture.
Speaker Change: For commercial.
Speaker Change: Testing the market.
Speaker Change: Interviewing kols talking to payers talking to the business people at the.
Speaker Change: Retina.
Speaker Change: <unk> in order to best position ourselves.
Speaker Change: Thank you thanks for the insight.
Speaker Change: Thank you and one moment as we move to the next question.
Speaker Change: Our next question is going to come from the line of Greg Harrison with Scotiabank. Your line is open. Please go ahead.
Speaker Change: Hey, good morning, Thanks for taking the question.
Speaker Change: Wanted to ask about your cash runway guidance and whether that includes.
Speaker Change: Assumptions for or what assumptions that includes for.
Speaker Change: Work.
Speaker Change: The EMEA in the earlier pipeline and then separately.
Speaker Change: What is the current status.
Speaker Change: <unk>.
Speaker Change: Graham and what could we see additional data there.
Speaker Change: Thanks, Greg I'm going to let George take both those questions.
Speaker Change: Sure.
Speaker Change: So Greg our cash guidance is into 2027, and I think as Jay said, we want to have meaningful cash.
Speaker Change: One hand on the other side of the phase III data and so our guidance includes obviously everything associated with <unk> and wet AMD includes our ongoing work and preparation.
Speaker Change: <unk> for an eventual DMA study, but not the study itself.
Speaker Change: As far as Reza prototype goes our.
Speaker Change: Clinical activities will continue there.
Speaker Change: Obviously with our focus on wet AMD, that's gone to a lower priority, but it continues to move forward as we look at.
Speaker Change: Some additional enabling studies to move that ultimately move that forward for 90, but.
Speaker Change: I would say that thats on percolation mode. The organization remains laser focused on wet AMD execution, this year and really conserving cash.
Speaker Change: Okay. Thanks Thats helpful.
Speaker Change: Thank you one moment as we move on to the next question.
Speaker Change: Our next question comes from the line of Yale Jen with Laidlaw <unk> co. Your line is open. Please go ahead.
Yale Jen: Great. Thanks for taking the question and congrats on that.
Speaker Change: Progress is just the two of them from the.
Yale Jen: The first one is that.
Speaker Change: A few suggest that.
Yale Jen: You guys might be the first to market.
Yale Jen: And given the ocular so to mentioned a few days ago. They may have the topline results.
Yale Jen: In the first quarter of 2006.
Yale Jen: Any read through from these two statements and.
Yale Jen: And then I have a follow up questions.
Yale Jen: Sure.
Yale Jen: First to market of course is.
Yale Jen: Going to be highly dependent on that last patient in the second trial.
Yale Jen: Whether the first trial, which was not run concurrently readout reach out in the fourth quarter of this year. The first quarter of next year doesn't affect the last patient in the second trial and for US of course last patient in.
Yale Jen: For this year.
Yale Jen: Once again as we look at the rate that we're recruiting.
Yale Jen: We remain confident that with each year, we will recruit as rapidly as Lugano is and therefore.
Yale Jen: We think that taken in total.
Yale Jen: We are confident we will be first to market.
Speaker Change: Okay, Great that's very helpful and maybe one follow up here.
Yale Jen: Yes.
Speaker Change: A few days ago, you reported that the pilgrim and free patients.
Yale Jen: Knowledge this.
Yale Jen: I know the numbers are small, but just curious.
Speaker Change: Have you guys dissect it that patients do not need supplemental versus those needs any characteristic differences and be able to maybe apply to your phase III study, yes, great question, Yes I'm.
Romero: I am going to let Romero answer that.
Speaker Change: Yes, no. Good question and I think you already mentioned the limitation of the study being a smaller study. So I think with <unk> sample size, it's a little bit hard to predict.
Speaker Change: Which patients are going to be super rental fleet.
Speaker Change: Of course, once we have a larger.
Speaker Change: Database.
Speaker Change: The phase III program, then thats something that we might be able to look at.
Speaker Change: Okay, great that's.
Speaker Change: That's very helpful again congrats.
Speaker Change: Mrs.
Speaker Change: Thank you.
Speaker Change: Thank you and one moment for our next question.
Speaker Change: Our next question comes from the line any channel H C. Wainwright. Your line is open. Please go ahead.
Speaker Change: Thank you for taking my question.
Speaker Change: Could you talk about whether you're going to have a plan to.
Speaker Change: Initiate a phase III trial.
Speaker Change: At this point potentially.
Speaker Change: <unk> 2025 or 2026.
Speaker Change: <unk>.
Do you plan to find a partner potentially moving.
Speaker Change: Forward.
Speaker Change: It would be the target enrollment suggested by the rollout results potential say good profit. Thank you.
Speaker Change: All great questions and I can say that we have currently no plans to initiate the pivotal trial in <unk> in 2025.
Speaker Change: We believe that it will be a 2026 event at this point.
Speaker Change: And.
Speaker Change: We would.
Speaker Change: Certainly welcome a potential partner, but we're not going to partner and indication individually.
Speaker Change: A partnership that might include.
Speaker Change: Clinical program development at D&B would have to be a much larger partnership we really wouldn't be interested in it. So that's something that I think.
We would consider at the right time.
Speaker Change: But.
Speaker Change: But as I said it would have to be a much larger structured partnership than just DMA.
Speaker Change: As for the target.
Speaker Change: Again, I think maybe Ramiro you might be able to answer that better about.
Speaker Change: How we would approach the targets.
Speaker Change: Yeah, and I think we have.
Speaker Change: Have a great benefit of having the wet AMD study and a lot of the learnings as well as the relationship we're building with the sites now so.
Speaker Change: So we know that for DMD clinical sites they would be.
Speaker Change: Very likely the same ones that we are using for wet AMD trial. So I think in terms of enrollment rates. We would also be optimistic for <unk>.
Speaker Change: Alright, thank you.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Thank you I'm showing no further questions in the queue at this time, ladies and gentlemen, thank you for participating in today's conference. This does conclude your program and you may now disconnect everyone have a great day.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Great.
Speaker Change: Yes.
Speaker Change: [music].