EyePoint Pharmaceuticals Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 5, 2025

There are 13 speakers on the call.

Operator

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 twenty twenty four Financial Results and Recent Corporate Developments 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.

Operator

I would now like to turn the call over to George Elston, Executive Vice President and Financial Officer of EyePoint. Please go ahead, sir.

Speaker 1

Thank you, and thank you all for joining us on today's conference call to discuss EyePoint's fourth quarter and full year twenty twenty four financial results and recent corporate developments. With me today is Doctor. Jay Duker, President and Chief Executive Officer. Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for DuraView. I will close with commentary on the fourth quarter and full year twenty twenty four financial results, and we will then open the call for your questions.

Speaker 1

Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found in the Investor Relations tab on the company website, www.eyepointpharma.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. 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. Actual 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.

Speaker 1

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. Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Doctor. Jay Duker, President and Chief Executive Officer of EyePoint.

Speaker 2

Thanks, George. Good morning, everyone, and thank you for joining us. 2024 was a year of continued execution and exceptional results for EyePoint on all fronts, 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 in two potential multibillion dollar blockbuster indications. We've advanced our best in class therapy DuraView into Phase III clinical trials in wet age related macular degeneration or wet AMD and we've reported positive twenty four week Phase II results in diabetic macular edema or DME supporting a second Phase III opportunity.

Speaker 2

DuraView is the only sustained delivery program with robust data for an investigational six month therapy in both of these indications, highlighting how a differentiated TKI with a new mechanism of action may improve patient outcomes compared to the standard of care. I want to emphasize the safety of our DuraceRD technology, beginning with the four products already approved by the FDA and continuing with the strong safety data from the four clinical trials of bioerodible DuraSert E, consisting of over 190 patients treated with DuraView. This superb safety profile coupled with the excellent efficacy data we saw in DAVIO2, the largest intravitreal 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 of our Phase three wet AMD trials Lugano and Lucia surpassing enrollment expectations. I'm pleased to report that we are exceeding historical enrollment rates of comparable wet AMD trials by a substantial margin. The Lugano trial is now well over 50% enrolled and the LUCIA trial is tracking ahead of schedule as well.

Speaker 2

We continue to expect completion of enrollment in both trials in the second half of twenty twenty five with top line data anticipated in 2026. The tried and true non inferiority trial design of Lugano and Lucia and wet AMD represents a clear pathway to regulatory approval should the results be positive. In the sustained release space, we anticipate being the first investigational six month intravitreal wet AMD program to submit a new drug application or NDA, allowing us to potentially reach patients first. 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. As part of our preparation for success, our commercial manufacturing facility in Northbridge, Massachusetts is now online with DuraView registration batch manufacturing underway to support an NDA filing.

Speaker 2

We recently reported positive efficacy, safety and subgroup data from our Phase II VIRONA clinical trial for DuraView in DME. VIRONA met primary and key secondary endpoints, firmly establishing DuraView as the only sustained release TKI program with an active DME program. DME is currently a large market, but has a significant need for sustained delivery options. I will discuss the VIRONA 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 in the second quarter of this year. We remain in a solid financial position.

Speaker 2

We ended 2024 with a noteworthy balance sheet of $371,000,000 in cash and investments and no debt. This was bolstered by a $161,000,000 oversubscribed follow on equity offering in the fourth quarter. Turning to our science, DuraView consists of virolinib, which is a patent protected best in class tyrosine kinase inhibitor or TKI formulated in proprietary bioerodible DuraSert E. DuraSert has been safely delivered to tens of thousands of eyes across four FDA approved products, meaning both patients and physicians are exceptionally comfortable with this delivery system and its established safety record. DuraSert E uses a bioerodible matrix that allows for the sustained delivery of drug via zero order kinetic release for at least six months.

Speaker 2

Zero order kinetics means that the drug is delivered at a steady rate, so that small payloads can give an extended therapeutic effect with constant tissue exposure. In addition, DuraSert E allows for immediate bioavailability and by design prevents uncontrolled release of free drug floating in the eye. Varoninib is not another anti VEGF and DuraView is not just another anti VEGF program. Varoninib is a potent and selective TKI that brings a new mechanistic approach to the treatment of VEGF mediated retinal diseases through intracellular blocking of all VEGF receptors. It therefore blocks all isoforms of VEGF, including VEGF C and D.

Speaker 2

Varoninib has demonstrated neuroprotection in a validated retinal detachment animal model and may have an anti fibrotic benefit as it blocks the PDGF receptor. At tissue exposure achieved with DuraVu, virolinib does not block TY2. Blockage of the TY2 receptor is associated with retinal vascular instability. DUREVU is packaged in a prefilled sterile syringe injector. It is administered by a standard intravitreal 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 2

Unlike currently approved biologics and other sustained release programs in development, however, DuraView can be shipped and stored at ambient temperature. We have strong patent protection for DuraView in both The United States and outside of The U. S. This allows us to protect our innovation and provides us flexibility with our strategic partnerships. In summary, with an excellent safety profile, a distinct mechanism of action, zero order kinetics that allows for sustained microdose delivery for at least six months, great patent protection and convenience for physicians, we believe DuraView is well positioned as an excellent treatment option for patients with VEGF mediated retinal diseases.

Speaker 2

Turning to the Phase II VIRONA clinical trial in DME, we recently announced positive twenty four week safety and efficacy data for DuraView with both DuraView arms meeting the primary endpoint of longer time to first supplement versus control. DuraView two point seven milligram demonstrated an early sustained and clinically meaningful improvement in best corrected visual acuity or BCVA with a gain of 7.1 letters compared to baseline and a central subfield thickness or CST improvement of 75.9 microns on OCT measurement. This represents 74% more drying effect versus the Aflibrcept control. Visual and anatomic gains were observed as early as week four and were much more robust than those achieved by the Aflibrcept control eyes, demonstrating the immediate bioavailability of DuraView and its differentiated profile as a sustained release TKI. Both DuraView treatment arms showed a favorable safety and tolerability profile with no DuraView related ocular or systemic serious adverse events reported to date.

Speaker 2

Yesterday, we presented subgroup analyses from the Phase II VIRONA clinical trial of the supplement free patients through week twenty four. The data demonstrated that for those eyes that went 24 with no supplementation, DuraView two point seven milligram had a significantly better improvement in BCVA and anatomic control compared to the eflibercept control group. BCVA improved 10.3 letters compared to baseline versus only three letters improvement for the eflibercept control group. DuraView two point seven milligram also demonstrated concomitant structural improvement with CST improvement of 117 microns versus only 31 microns for the Aflibrasep control. This result confirms that the positive data from the Phase II VIRONA trial were driven by DuraView as an active agent continuously released over six months and that the unsupplemented eyes had improved visual acuity of about two lines on the eye chart.

Speaker 2

The highly positive Phase II 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 2

As a company, we are highly focused on the successful completion of our Phase three wet AMD program for DuraView. In wet AMD, our goal is to provide a product that maintains stable vision and retinal anatomy for the majority of wet AMD patients within every six month label. 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. As previously mentioned, enrollment is ongoing in both of our pivotal Phase three wet AMD trials, Lugano and Luchia, with rapid enrollment rates that are exceeding our expectations.

Speaker 2

Enrollment completion in both trials is expected in the second half of twenty twenty five. Both trials have received exceptional investigator and patient enthusiasm to date, driven by an established and familiar trial design. The two essentially identical non inferiority trials with six month redosing provide a clear and recognized pathway for global regulatory and commercial success, positioning DuraView to become a potential blockbuster franchise. To close, I'd like to thank the entire EyePoint team for an incredible year and a strong start to 2025. The dedication and execution capabilities demonstrated by our team to reach these milestones reflects the entire organization's commitment to improving patients' lives.

Speaker 2

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, the progress we've made advancing DERAVU would not be possible. With our compelling clinical pipeline representing multibillion dollar product opportunities, our best in class sustained ocular delivery Durasert E technology, along with a strong balance sheet, we have further established our role as the leader in sustained ocular drug delivery and are well on our way to bringing impactful therapies to patients suffering from serious retinal diseases. I will now turn the call over to George to review the financials. George?

Speaker 1

Thank you, Jay. As Jay noted, we ended 2024 with a very strong balance sheet driven by continued stewardship of our cash and an oversubscribed $161,000,000 follow on financing in October ending the year with $371,000,000 in cash and investments. As the financial results for the three months and full year ended 12/31/2024, were included in the press release issued this morning, my comments today will be focused on a high level review for the quarter. For the quarter ended 12/31/2024, total net revenue was $11,600,000 compared to $14,000,000 for the quarter ended 12/31/2023. Net product revenue for the quarter ended 12/31/2024, was $800,000 compared to net product revenue for the quarter ended 12/31/2023, of $700,000 dollars We expect net product revenue to continue at immaterial levels as we will no longer be supplying YUTIQ to ANI Pharmaceuticals, our U.

Speaker 1

S. Partner, as of 05/31/2025. This follows the non renewal of a supply agreement that accompanied the sale of UT commercialization rights to Alimero Sciences, now ANI, in 2023. Consistent with our strategy, our forward manufacturing focus is on our DuraView program to support clinical trials and NDA filing and future commercial launch. Net revenue from royalties and collaborations for the fourth quarter ended 12/31/2024, totaled $10,800,000 compared to $13,300,000 in the corresponding period in 2023.

Speaker 1

The decrease was primarily driven by lower recognition of deferred revenue from the license of YUTIQ product rights. Operating expenses for the quarter ended 12/31/2024, totaled $56,800,000 compared to $30,400,000 in the prior year period. This increase was primarily driven by the two ongoing Phase III trials for DORAVU. Net non operating income totaled $3,900,000 and net loss was $41,400,000 or $0.64 per share compared to a net loss of $14,100,000 or $0.33 per share for the prior year period. Turning to the full year ended 12/31/2024, total net revenue was $43,300,000 compared to $46,000,000 for the year ended 12/31/2023.

Speaker 1

Net product revenue for the full year ended 12/31/2024 was $3,200,000 compared to net product revenues for the full year ended 12/31/2023, of $14,200,000 This decrease was driven by the license of YUTIQ product rights sold in May 2023, completing EyePoint's exit from its commercial business. Net revenue from royalty and collaborations for the full year ended 12/31/2024, totaled $40,100,000 compared to $31,800,000 in the corresponding period in 2023. The increase was primarily driven by full year recognition of deferred revenue in 2024 from the license of YUTIQ product rights versus a partial year in 2023. Operating expenses for the full year ended 12/31/2024, totaled $189,100,000 versus $121,100,000 in the prior year period. This increase was attributed primarily to a $26,600,000 increase in clinical trial costs related to the Phase III clinical trials of DuraView, twenty eight million dollars of increased personnel costs across the organization, including $24,700,000 increase of non cash stock compensation, 16,700,000 in DuraView non clinical and license expense.

Speaker 1

These increases were offset by $3,300,000 decrease in other sales and marketing expenses due to discontinuation of YUTI commercialization in 2023. Net non operating income totaled $15,100,000 and net loss was $130,900,000 or $2.32 per share compared to a net loss of $70,800,000 or $1.82 per share for the prior year period. Cash, cash equivalents and investments in marketable securities on 12/31/2024 totaled $371,000,000 compared to $331,000,000 as of 12/31/2023. We expect the cash and investments on 12/31/2024 will enable us to fund operations into 2027 beyond top line Phase III data for DuraView and wet AMD expected in 2026. Accordingly, based on our solid cash position, we currently have no plans to access the equity capital markets this year.

Speaker 1

In conclusion, we are incredibly pleased with EyePoint's progress in 2024 and are well capitalized to advance our DuraView program through Phase III trials in wet AMD. I will now turn the call back over to Jay for closing remarks.

Speaker 2

Thank you, George. As we've discussed, EyePoint continues to be a story of a superior product, strong execution and focused 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 enrollment completion in the Phase III Lugano and Lucia clinical trials of DuraView and wet AMD in the second half of twenty twenty five top line data for these Phase III trials in 2026 and an end of Phase II meeting with the U. S.

Speaker 2

FDA to discuss the first pivotal Phase three trial of DuraView in DME. This remains an incredibly exciting time for EyePoint 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. Thank you all very much for listening this morning. I will now turn the call over to the operator for questions.

Operator

Thank you. Our first question is going to come from the line of Tess Romero with JPMorgan. Your line is open. Please go ahead.

Speaker 3

Hi, Jay and team. Thank you for taking our questions this morning. For your wet AMD pivotal program, how many 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. And for LUTIA, can you remind us how many ex U.

Speaker 3

S. Sites do you have open and are you aiming to open? Thanks so much.

Speaker 2

Good morning, Tess. Thanks for your questions. I'd like to introduce our Chief Medical Officer, Ramiro Ribeiro, who's also on the call. Doctor. Ribeiro, do you want to answer those questions?

Speaker 2

First of all, about our wet MD trials, the current sites open and blue ex U. S. Sites planned?

Speaker 4

Yes. Thanks, Jay, and good morning, everybody. Thanks for the question, Jess. So we have most of the sites already activated in The U. S.

Speaker 4

The ones that are not activated yet are usually the ones that have more length process like academic centers that takes a little bit longer to be activated. But I think as we show with our enrollment numbers, we are very pleased with the progress of the studies and we have most of the sites already activated, especially the strong ones. In terms of ex U. S, we are planning to have between sixty and eighty sites per study, which should be coming later this year.

Speaker 5

Thank

Speaker 3

you. Can you just clarify your numbers of active sites currently in each trial?

Speaker 4

So we have approximately active about 60 sites per study.

Speaker 3

Okay. Thanks so much.

Operator

Thank you. And one moment as we move on to the next question. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is open. Please go ahead.

Speaker 6

Hi, Jay and team. I just had one on the analysis you presented yesterday on the supplement free. It was interesting that you got a very, very strong separation with the two point seven milligram versus Aflibercept. Though for the one point three, it seems like it didn't separate as much as one may have expected. I'm just curious if you could comment on the trend there relative to what was observed with the overall population of the twenty six patients?

Speaker 6

Thanks.

Speaker 2

Thanks, Yigal. Terrific question. And again, I think that evaluation of the subgroup analysis, in particular, the subgroup of the non supplemented patients really shows you how powerful DuraView was in this DME population. So these were the eyes that made it the whole twenty four weeks without anything else other than DuraView in our group. And they improved over 10 letters and had 117 microns less fluid, which was significantly better than the unsupplemented eyes in the control.

Speaker 2

I think what we're seeing essentially is evidence of dose response between the two point seven and the one point three doses. And of course, the two point seven dose is what we're using in the current pivotal trials, what we plan on using in the pivotal trials at DME and what our go to market dose is. But we interpret it with there is some individual variability within those numbers, but we think this represents a dose response. So what it shows you is that when DuraView works in this population, it works exceedingly well. And the supplement free rates that were achieved by the two point seven milligram dose were not clouded by the fact that those supplement free eyes were slowly losing vision or slowly gaining fluid, but didn't meet the criteria.

Speaker 2

In fact, when you look at those curves, they are flat. So these eyes that were supplementary were extremely well controlled. I will bring up the point too that the supplements in the two point seven group, with one exception didn't really seem to change the vision or the fluid much suggesting that we had reached perhaps a ceiling effect in most of these eyes. So yes, that analysis is very strong and I think to 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 6

Okay, thanks. And just one very quick one on the timing of the Phase III. Will there come a point perhaps later this year where you'd be able to provide a little bit more granularity on sort of which half of '20 '20 '6 we may expect the Phase III top line data?

Speaker 2

Well, the Phase III top line data, sure. I think we will be able to give you more granularity certainly as we approach last patient in in Lucia. I think that will be obvious. So yes, we do expect sometime, I expect early the second half of the year to give you some more granularity around that.

Speaker 6

Perfect. Thank you so much.

Operator

Thank you. And one moment as we move on to the next question. Our next question comes from the line of Yatin Suneha with Guggenheim. Your line is open. Please go ahead.

Speaker 7

Hey, guys. Thank you for taking my question. I mean, now that the study is 50% enrolled, are you able to characterize the type of patients you are able to recruit right now? How they might be? I know there are differences versus W2, but anything you can just comment on?

Speaker 7

So that's one. The second one is on the DME side. I mean, now that you have a little bit more time to analyze the data, could you maybe talk about the development plan, especially the Phase III, how you are thinking about what sort of a load we should expect from standard of care? Thank you.

Speaker 2

Thanks, John. First, the first question about the patient population. I think at a high level, we have said that we're capping the previously treated patients at approximately twenty five percent. And we have reached that cap in Lugano. So the majority of patients obviously at this point since we're over fifty percent enrolled are treatment naive patients.

Speaker 2

But we don't expect in that trial to be enrolling any more previously treated patients. So that's really kind of the high level understanding of where we're at with the type of patients we've recruited. Beyond that, there's really been no kind of analysis done yet and we don't expect to be doing any analysis before the studies are done on any kind of other details around that. With respect to the Phase three DME trial, we have a lot of options here. I think probably Romero is the best person to give you a little bit more specifics.

Speaker 2

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. But the top line here is the data was so robust. I think we have a lot of options that would give us a pathway to approval. So Ramiro, any more detail you want to add on that?

Speaker 4

Yes. I think as you mentioned, Jade, the data from the Phase two study does show immediate benefit on BCVA on day one. So that type of result give us flexibility while we think about designing the Phase three studies for DME. The first option, of course, is always going to be something similar to what we're doing for wet MD, right? We have the loading dose, which for DME in this case is five loading dose of a flubrcept and then we would give to review.

Speaker 4

But again, based on the results from the Phase two study, I think we might have an opportunity to design a study that is more efficient, meaning we would dose to review earlier, do a study that could be a little bit shorter and overall have the results sooner.

Speaker 7

Got it. Helpful. One more question. This one is for George. Could you maybe help us model the R and D expense going forward at least in 2025?

Speaker 1

Pardon me, yes, sure, Jatin. So remember, you did see that fairly meaningful increase in Q4 and that was really related to the initiation of both the Lugano and Lucia trials in the fourth quarter. I think that's 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 that's going to be the focus for our burn on the R and D side in 2025.

Speaker 7

Thank you.

Operator

Thank you. One moment as we move to the next question. Our next question comes from the line of Cam Bijazi with Jefferies. Your line is open. Please go ahead.

Speaker 8

Good morning and team. Congratulations on the enrollment progress. While LUCIA and Lugano remain the laser focused near term, I was wondering if you have considered any opportunities to conduct post marketing studies for DuraView long term? If so, what information would be valuable to glean from such studies and help further differentiate DuraView in the wet AMD marketplace? Thank you so much.

Speaker 2

Thanks, Kembe, for that question. And obviously, we've already started to think about what other studies might enhance the value of DuraView in wet AMD. And the one we've talked about, I think for a while, that is most obvious, would post approval to run a study in wet AMD of DuraView against whatever the current industry leader for Ligand blocker is at the point, whether it's high dose SEGLEA or VABYSMO. In the study, instead of the primary endpoint being change in visual acuity, the primary endpoint would be supplement free rate up to six months or percentage of eyes on supplemented or time to first supplement, that sort of thing. The obvious reason for doing that is we're going up against two milligram Eylea in the pivotal trials, which is a regulatory requirement.

Speaker 2

And while two milligram Eylea remains a very, very good treatment as a Ligand blocker with terrific short term efficacy. The market seems to be moving into VAVISMO and suspect high dose early eventually. So it makes sense to prove our longevity against those two products. We think we would do very well against that and obviously then give us some more strength in the marketing argument. I can ask, Ramiro, any other thoughts you might have on post approval studies that would be interesting and helpful?

Speaker 4

Yes. I think we are just learning about the effect of TKI in wet AMD. And of course, the Phase III studies are laser focused on gaining our regulatory approval. But as Jay mentioned, we're going to do studies comparing to other ligand blockers. But also, exploring additional benefits that ATK inhibitor could have such as prevention of atrophy in this type of wet AMD patients.

Speaker 4

So that's something that we're also going to be looking for as a post market study.

Operator

Thank you. And one moment as we move on to the next question. Our next question comes from the line of Jennifer Kim with Cantor Fitzgerald. Your line is open. Please go ahead.

Speaker 5

Hi. Thanks for taking my question and congrats on all the strong execution. Maybe first to start in DME. Can you give us a bit more color on your plans to meet with both U. S.

Speaker 5

And ex U. S. Agencies next quarter, including what you're hoping to take away from both? Should we expect an update by next quarter or will that come shortly after? And then understanding that when AMD takes center stage, what would sort of trigger a decision to advance the pivotal program?

Speaker 5

Is it contingent on sort of that accelerated pathway that Ramiro was talking about?

Speaker 2

Thanks, Jennifer. Terrific questions as usual. So I'm going to let Ramiro give a little more details around what type of interaction we'd expect and hope for with the regulatory agencies. Typically, what we've done in the past and I suspect what we'll do for this as well is after we get the written minutes, we would have a public announcement about what our plans are and how they obviously sync with what the agencies have told us. As for acceleration of DME, that again, we do not at this point as a company want to put anything at risk with wet AMD.

Speaker 2

We really are delighted with how it's going. We want to continue to make sure that we have the resources within the company, both people resources and financial resources to have a strong cash runway after the wet AMD data. And therefore, decisions about the structure of DME after regulatory meetings and the timing of DME is really going to be secondary to this first principle, which is make sure that wet AMD is successful. So over to Ramiro again, any color on how what we really hope to accomplish with the 2Q meeting with the agencies?

Speaker 4

Yes. So we are planning to have a meeting both with the FDA as well as with the EMA to ensure we get our regulatory feedback globally. In the end of the day, the questions are going to be around the design of the study. So of course, I think we're going to propose something that, as I mentioned before, would make a study efficient and then get feedback from the agencies if they agree with that approach.

Speaker 5

Okay. And if I could ask one question on the wet AMD programs. Since you talked about the 60 sites per study roughly, should we think about I guess given the enrollment we've seen with Lugano, should we think about Lucia in the same way? Or is there sort of a split in high enrollers tapping into Lugano before they move into Lucia? I'm just trying to think through what the cadence looks like.

Speaker 2

So the number of sites in Lugano at this point is slightly higher than Lucia. We do have expect more LUCIA sites to come on over time. Remember, LUCIA started approximately, I think it was perhaps first patient in six, seven weeks after Lugano. So there's naturally going to be, I wouldn't call it delay, but a little separation between the rise in the recruitment. So what we're seeing though in recruitment rise in Luchia is mirroring what we saw at the beginning of the Lugano trial.

Speaker 2

So we are optimistic and confident that the type of enrollment we saw in the Lugano will be matched by LUCIA.

Speaker 5

All right. That's helpful. Thanks guys.

Operator

Thank you. One moment as we move on to the next question. Our next question comes from the line of Gregg Sivanovich with Mizuho Securities. Your line is open. Please go ahead.

Speaker 9

Good morning. Thanks for taking my question. Congrats on the progress in the year and the quarter. Just wanted to ask a question about your Northbridge manufacturing facility. Manufacturing obviously is something that we on the South Side don't get a lot of visibility into, but maybe can you talk about how you are anticipating the manufacturing progress to continue and maybe some color on I guess, kind of the quality of the site that you've built out there and potentially anticipating any potential CMC issues, which obviously we always worry about because we can't get visibility into that.

Speaker 9

Thanks.

Speaker 2

Thanks, Greg. George, do you want to answer that question?

Speaker 1

Yes, sure.

Speaker 9

Why are

Speaker 2

you creating how we did it and how it's going?

Speaker 1

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, we opened our Northbridge facility last fall, state of the art 41,000 square foot facility. 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 we will we really pivoted all DuraView manufacturing forward to that site.

Speaker 1

And the team has already started activities to get ready to start registration batches this year to support an NDA filing. The site was actually built to our specifications by the landlord and didn't involve any cash investment. So it's really worked out incredibly well for us. And importantly, to your point, we've had FDA involved early in the design and execution of that site 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 a successful commercial launch with positive data.

Speaker 2

If I may tell a little anecdote about the CYC2, which I think reflects the team that we have and how focused we are. I've obviously been out there many times and right before we were ready to have an official opening, I went out to inspect and I walked around the site. It's in the middle of the woods, actually. It's a beautiful area. Walked around the site and there's a sidewalk all the way around the building.

Speaker 2

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 walk on. That is the type of foresight that the team has, putting it together to make sure that this site will be up and running on time into both FDA and EMA specifications. And we expect from a commercial perspective to be able to slot a supply, the entire global supply for DuraView from this site.

Speaker 9

Thanks for the anecdote, Jay, and thanks, George.

Operator

Thank you. One moment as we move on to the next question. Our next question comes from the line of Colleen Tussi with Baird. Your line is open. Please go ahead.

Speaker 5

Great. Good morning. Thanks for taking our questions and congrats on all the progress. We've seen with other retina studies talking about GA studies, a difference in results in ex U. S.

Speaker 5

Versus U. S. Sites. Can you speak to whether you'd expect a meaningful difference in the type patients you're enrolling in Lugano and Lucia? Any differences in the standard deviation for patients and how that might impact the top line results?

Speaker 2

Great question, Colleen. And I have the best person next to me to answer that question, Doctor. Ribero, who of course was quite involved in one of the international GA studies. So Ribero, what do you think?

Speaker 4

Yeah. No, good question. And I think if we go back on the GA trials, I think that was something that could be one of the hypothesis, but I'm not sure if it was truly confirmed that the geographical difference were one of the reasons for the difference in the results. Regardless, we WestMD studies are much more mature than GA trials across the globe, right? So clinical sites have been doing these WestMD studies for many, many years.

Speaker 4

I think we nail down our inclusion exclusion criteria to accommodate a global study. So I don't expect to see baseline characteristics being much different between The U. S. And ex U. S.

Speaker 4

Side.

Speaker 5

Great. That's helpful. And one quick one, if I can. On DME, does the FDA have the same non inferiority margin of minus 4.5 letters on the lower bound of the confidence interval as they do in wet AMD?

Speaker 2

Ramiro, do you know historically how the non inferiority margin has been calculated in DME?

Speaker 4

Yes. So for DME, of course, it's going to be part of our discussion with the FDA EMA. But I think if you look back of some of the previous studies, they tend to use four letters instead of 4.5, but of course it's going to be one of the questions we ask in our interactions.

Speaker 5

Great. Thanks for taking our questions and congrats on the forecast.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Divanjana Chatterjee with Jones. Your line is open. Please go ahead.

Speaker 10

Hi. Thanks for taking my question. So in terms of future market positioning, how would DuraView's potential every six months label compared to Xpact three's potentials every six months, every twelve months label that Ocular has guided to?

Speaker 2

Thanks for the question. I think in every six months label is what the physicians, I think prefer. I think that's been made clear, not only by us, but by quite a bit of market research. And of course, that's how we design DuraView to consistently deliver therapeutic levels of virolinib for six months in virtually everybody. So that we like our label, we like our study design, and 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 drying effect, while minimizing the necessary visits and injections.

Speaker 10

Thank you. As a quick follow-up, the way things are stacking up, DuraView could still be the first to market durable TKI. How would you use this lead time over excise lead to capture the market?

Speaker 2

Well, that's a really interesting question because it's quite broad. And of course, first to market, there is an advantage as I think you all know, and we strongly 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. In saying that, we've had an early program work done here for the past two years on exactly how we are going to position DuraView. And it is a shift in the market, a true six month repeatable safe tolerable treatment for VEGF mediated disease is you could argue there really is nothing like that right now. So that the idea of how to get physicians comfortable with it is a process that we are doing right now and it will certainly accelerate internally as we get closer and closer to data and closer to eventual launch.

Speaker 2

So I think we could spend two hours on the details of what that might entail. But suffice it to say that just like we've been on the forefront of figuring out manufacture for commercial, we've been testing the market, interviewing KOLs, talking to payers, talking to the business people at the retina groups in order to best position ourselves.

Speaker 10

Thank you. Thanks for the insights.

Operator

Thank you. And one moment as we move to the next question. Our next question is going to come from the line of Greg Harrison with Scotiabank. Your line is open. Please go ahead.

Speaker 9

Hi, good morning. Thanks for taking the question. Wanted to ask about your cash runway guidance and whether that includes assumptions for or what assumptions that includes for work in DME and the earlier pipelines? And then separately, what is the current status of the rasiprotofib program and when could we see additional data there?

Speaker 2

Thanks, Greg. I'm going to let George take both those questions.

Speaker 1

Sure. So Greg, our cash guidance is into 2027. And I think as Jay said, we want to have meaningful cash on hand on the other side of the Phase three data. And so our guidance includes obviously everything associated with DuraView and wet AMD, it includes our ongoing work in preparation internally for an eventual DME study, but not the study itself. As far as rasoprotofib goes, our pre clinical activities will continue there.

Speaker 1

Obviously, with our focus on wet AMD, that's gone to a lower priority, but it continues to move forward as we look at some additional enabling studies to move that ultimately move that forward for an IND. But I would say that's on percolation mode. The organization remains laser focused on wet AMD execution this year and really conserving cash.

Speaker 9

Okay. Thanks. That's helpful.

Operator

Thank you. One moment as we move on to the next question. Our next question comes from the line of Yale Jen with Laidlaw and Co. Your line is open. Please go ahead.

Speaker 11

Great. Thanks for taking the question and congrats on all the progress. Just two of them. The first one is that you suggested that you guys might be the first to market. And given the ocular sort of mentioned a few days ago, they may have the top line result in the first quarter of twenty twenty six.

Speaker 11

Any read through from these two statements? And then I have a follow-up questions.

Speaker 2

Sure. First to market, of course, is going to be highly dependent on that last patient in the second trial. Whether the first trial, which was not run concurrently reads 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 for Lucia. Once again, as we look at the rate that we're recruiting, we remain confident that Lucia will recruit as rapidly as Lugano is.

Speaker 2

And therefore, we think that taken in total, we are confident we will be first to market.

Speaker 11

Okay, great. That's very helpful. And maybe one follow-up here, which is that a few days ago, you reported that the supplement three patients subgroup analysis. I know the numbers are small, but just curious, have you guys dissected the patient, which do not need supplement versus those needs? Any characteristic differences and be able to maybe apply to your current Phase III study?

Speaker 2

Yes. Great question, Yale. I'm going to let Ramiro answer that.

Speaker 4

Yes. No, good question. And I think you already mentioned the limitation of this study being a small study. So I think with this sample size, it's a little bit hard to predict which patients are going to be supernatopically. Of course, once we have a larger database with the Phase III program, then that's something that we might be able to look at.

Speaker 11

Okay, great. That's very helpful. Again, congrats on all the progress. Thank you.

Operator

Thank you. And one moment for our next question. Our next question comes from the line of Yi Chen with H. C. Wainwright.

Operator

Your line is open. Please go ahead.

Speaker 12

Thank you for taking my question. Could you talk about whether you currently have a plan to initiate a Phase III trial in DME at this point potentially late twenty twenty five or 2026? If not, do you plan to find a partner potentially moving this indication forward? And what would be the target enrollment suggested by the Varona results in a potential Phase III trial set? Thank you.

Speaker 2

All great questions, Yi. And I can say that we have currently no plans to initiate the pivotal trial in DME in 2025. We believe that it will be a 2026 event at this point. And we would certainly welcome a potential partner, but we're not going to partner an indication individually. A partnership that might include clinical program development in DME would have to be a much larger partnership or we really wouldn't be interested in it.

Speaker 2

So that's something that I think we would consider at the right time. But as I said, it would have to be a much larger structured partnership than just DME. As for the target, again, I think maybe Ramiro, you might be able to answer that better about how we would approach the targets.

Speaker 4

Yes. And I think we have a great benefit of having the wet MD study and a lot of the learnings as well as the relationship we're building with the sites now. So we know that for DME's clinical sites, they would be very likely the same ones as we are using for RETIMD trial. So I think in terms of enrollment rates, we would also be optimistic for a DME trial.

Speaker 12

Thank you.

Operator

Thank you. I am 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.

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Earnings Conference Call
EyePoint Pharmaceuticals Q4 2024
00:00 / 00:00