Q2 2024 Ocular Therapeutix Inc Earnings Call
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Speaker Change: Who'd A Handful of Bells!
Operator: Please stand by, your program is about to begin. If you need assistance with today's program, please press star zero. Good morning and welcome to the Ocular Therapeutix second quarter 2024 earnings conference call. At this time, all participants are in a listen only mode. To ask a question, please press star 1.
Speaker Change: Please stand by, your program is about to begin. If you need assistance on today's program, please press star zero.
Speaker Change: Good morning and welcome to the Ocular Therapeutix second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question and answer session. To ask a question, please press star 1.
Operator: As a reminder, this conference call is being recorded and will be available for replay in the Investor Relations section of the Ocular Therapeutix website. I would now like to turn the call over to Ocular's Vice President of Investor Relations, Bill Slattery. Please go ahead, Mr. Slattery.
Speaker Change: As a reminder, this conference call is being recorded and will be available for replay on the Investor Relations section of the Ocular Therapeutix website.
Speaker Change: I would now like to turn the call over to Ocular's Vice President of Investor Relations, Bill Slattery. Please go ahead, Mr. Slattery.
Bill Slattery: Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release outlining our financial results for the second quarter of 2024. To make the best use of your time today, Ocular's Executive Chairman, President, and CEO, Dr. Pravin Dugel, will briefly provide a summary of recent business highlights so we can quickly get to your questions. Joining Dr. Dugel for the Q&A portion of the call will be Donald Notman, Chief Financial Officer; Dr. Nadia Wahid, Chief Medical Officer; Dr. Sanjay Nayak, Chief Strategy Officer; and Steve Meyers, Chief Commercial Officer.
Bill Slattery: Good morning, everyone, and thank you for joining us today.
Speaker Change: Earlier this morning, we issued a press release outlining our financial results for the second quarter of 2024. To make the best use of your time today, Ocular's Executive Chairman, President, and CEO , Dr. Pravin Dugel, will briefly provide a summary of recent business highlights so we can quickly get to your questions.
Speaker Change: Joining Dr. Dugel for the Q&A portion of the call will be Donald Notman, Chief Financial Officer, Dr. Nadia Wahid, Chief Medical Officer, Dr. Sanjay Nayak, Chief Strategy Officer, and Steve Meyers, Chief Commercial Officer.
Bill Slattery: We refer everyone to this morning's press release in our Form 10-Q for a comprehensive update on second quarter financial and business results. During today's call, we will be making certain forward-looking statements, and our actual results may differ materially. Please see the Risk Factors section of our annual report on Form 10-K and our other SEC filings for details on the risks and uncertainties relating to our business. With that, I'd like to hand the call over to Dr. Pravin Dugel to review our recent updates. Pravin? Thank you.
Speaker Change: We refer everyone to this morning's press release in our Forum 10 queue for a comprehensive update of second quarter financial and business results.
Speaker Change: During today's call we will be making certain forward-looking statements and our actual results may differ materially. Please see the risk factors section of our annual report on Form 10-K and our other SEC filings for details on the risks and uncertainties relating to our business.
Speaker Change: With that, I'd like to hand the call over to Dr. Pravin Dugel to review our recent updates. Pravin?
Pravin Dugel: Thank you, Bill, and thank you to everyone for joining us today. We know this is a very busy time of year for everyone, so let's jump right in.
Speaker Change: Thank you, Bill, and thank you to everyone for joining us today.
Praveen Dugal: We know this is a very busy time of year for everyone, so let's jump right in.
Pravin Dugel: When I assumed responsibility as Ocular's Chairman of the Board, President, and CEO in mid-April, the goal was simple: transform this organization into a retina-focused company and execute, execute, execute. Ocular's number one priority today is to bring Expansy to market for wet AMD as soon as possible, given the large market size and the unmet need, both in terms of the need for a more sustainable treatment option and the need to improve long-term outcomes.
Praveen Dugal: When I assumed responsibility as Ocular's Chairman of the Board, President, and CEO in mid-April, the goal was simple, transform this organization into a retina-focused company and execute, execute, execute.
Praveen Dugal: Ocular's number one priority today is to bring expaxly to market for wet AMD as soon as possible given the large market size and the unmet need, both in terms of the need for a more sustainable treatment option and the need to improve long-term outcomes.
Pravin Dugel: As of this morning, we can now confirm that the FDA has advised us that the two wet AMD studies in which we are currently enrolling patients, SOL1 and SOLAR, are both appropriate as registration-enabling studies. This is a momentous achievement for the ocular team that has been working diligently to surpass all expectations in a few short moments. This team has achieved four tremendous accomplishments that I'd like to outline today. We set a decisive vision for the company and streamlined the organization. This year, we've invested in the areas of the business that are most value-creating and are aligned with our vision to be a leading retina company.
Praveen Dugal: As of this morning.
Speaker Change: We can now confirm that the FDA has advised us that the two wet AMD studies in which we are currently enrolling patients, SOL1 and SOLR, are both appropriate as registration enabling studies.
Speaker Change: This is a momentous achievement for the ocular team that has been working diligently to surpass all expectations.
Speaker Change: In a few short months, this team has achieved four tremendous accomplishments that I'd like to outline today.
Speaker Change: Thank you very much. Thank you.
Speaker Change: We set a decisive vision for the company and streamlined the organization.
Speaker Change: This year we've invested in the areas of the business that are most value creating and are aligned with our vision to be a leading retina company.
Speaker Change: We've invested in highly credentialed retina experts with unmatched experience in clinical development, regulatory affairs, biostatistics, and other key functions.
Speaker Change: to put this dream team in context.
Speaker Change: Members of the ocular team have played a role in nearly every major advancement in retinal diseases over the past three decades.
Speaker Change: We are fortunate today to be well financed with approximately $460 million in cash at the end of the second quarter.
Speaker Change: Based on our current operating plans, we believe this gives us a cash runway into 2028 beyond the anticipated top-line readouts for both the SOL1 and SOLAR studies in wet AMD.
Speaker Change: Our commitment to the investment community is to stay financially disciplined.
Speaker Change: which included making the difficult decision earlier this quarter to reduce headcount in areas of the business that are not aligned with the vision of the company.
Speaker Change: Our second significant accomplishment relates to the SOL1 study, where the rate of enrollment continues to accelerate and exceed our expectations.
Speaker Change: Soil 1 is the first of two registration studies for expactly and wet AMD
Speaker Change: The single biggest challenge I saw when I first came to Ocular was how to effectively communicate the benefits and advantages of the SOL1 study to the retinal community as well as patients.
Speaker Change: In our June Investor Day, we shared the success of our communication campaign by announcing that 60 sites had been activated and over 150 patients were in various stages of loading and randomization.
Pravin Dugel: As many of you know, enrollment in clinical trials is not always linear, and today we believe we're in that exciting phase of enrollment in the SOL1 study. In short, with enrollment following our Investor Day announcement, and an Activated Study Site in just three months. When we talk about SOHL 1 and SOHL-R, What's most important for everyone to understand is how well these studies complement each other and how much thought has gone into patient selection and study design to reduce disease variability when taken in its totality versus the 20 to 30 percent year-over-year historic rate. In other words, not a single patient.
Speaker Change: As many of you know, enrollment in clinical trials is not always linear.
Speaker Change: When you hit a critical mass of sites activated, enrollment starts to accelerate in an exponential fashion.
Speaker Change: And today we believe we're in that exciting phase of enrollment in the SOLE1 study.
Speaker Change: In short, we continue to be delighted with the enrollment following our Investor Day announcement.
Speaker Change: The Third Substantial Accomplishment.
Speaker Change: is the initiation of our repeat dosing study STOLAR or WET-AMD.
Speaker Change: over the course of just three months.
Speaker Change: The ocular team developed the concept for SOLAR, activated study sites,
Speaker Change: and as of last week began enrolling patients.
Speaker Change: To take it one step further, we can now share that the FDA has officially confirmed to us in writing
Speaker Change: that SOLAR is acceptable as a registrational study for ex-PASLI in wet AMD.
Speaker Change: Let me say that again.
Speaker Change: SOLAR was taken from concept to clinic.
Speaker Change: in just three months.
Speaker Change: This is simply exceptional, and in my experience, unprecedented.
Speaker Change: When we talk about SOL1 and SOLR, what's most important for everyone to understand is how well these studies complement each other and how much thought has gone into patient selection and study design to reduce disease variability.
Speaker Change: de-risked the patient population and improved the likelihood of a successful outcome in both pivotal studies.
Speaker Change: The bottom line is, when taken in its totality,
Speaker Change: Solar One and Solar are designed to meet our regulatory requirements while providing commercially meaningful data.
Speaker Change: The Fourth Accomplishment
Speaker Change: is the presentation of results from our Phase 1 Helio study in Non-Proliferative Diabetic Retinopathy, or NPDR.
Speaker Change: What's remarkable about these results is that every single metric and parameter favored x-PAXly.
Speaker Change: These data show that with a single expaxillary implant, literally zero patients in the trial were observed to have developed vision-threatening complications at 48 weeks.
Speaker Change: versus the 20 to 30 percent year-over-year historic rates.
Speaker Change: In other words, not a single patient, after a single injection of Axpaxly, developed a potentially blinding complication after 48 weeks.
Speaker Change: These impressive results have been well noted by our retina colleagues. In fact, they were viewed as significant enough to warrant a late break of presentation at the recent ASRS meeting.
Speaker Change: Ultimately, we believe the positive initial data from Helios not only provide us a remarkable opportunity in NPDR but also build on our U.S. and Australia studies in wet AMD.
Speaker Change: giving us further data-based confidence for the success of both the SOL1 and SOLAR pivotal studies.
Pravin Dugel: I'd like to leave you with these key messages. SOLAR1 and SOLAR are strategically designed to provide meaningful data, exceeding our highest expectations based on the enrollment pace for SOLAR I and the rapidity of initiation of enrollment in SOLAR.
Speaker Change: As we conclude the prepared remarks in today's call, I'd like to leave you with these key messages.
Speaker Change: We are dedicated to becoming a leader in the treatment of retinal disease and improving vision in the real world.
Speaker Change: We have assembled an expert retina team to accelerate the development of AXPAX leaf or wet AMD, which now includes two registration enabling studies that are enrolling patients.
Speaker Change: We have very thoughtfully designed both SOL1 and SOLR with an emphasis on enriching the patient selection appropriately for each trial and on de-risking each study to improve the probability of success.
Speaker Change: SOL1 and SOLAR are strategically designed to provide meaningful data.
Speaker Change: for both regulatory and commercial purposes.
Speaker Change: We are executing extremely well.
Speaker Change: exceeding our highest expectations based on the enrollment pace for SOAR 1 and the rapidity of initiation of enrollment in SOAR.
Speaker Change: We believe, based on our current operating plans, that our cash runway takes us into 2028 and fully funds Go1 and Solar top-line results.
Speaker Change: We look forward to updating you on our progress.
Speaker Change: With the sincerest thanks for your engagement and ongoing support.
Speaker Change: Operator, I would now like to open the call for questions.
Speaker Change: Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad.
Speaker Change: Thank you.
Operator: Our first question comes from Tazeen Ahmad of Bank of America. Your line is open.
Speaker Change: Our first question comes from Tazeen Ahmad of Bank of America. Your line is open.
Tazeen Ahmad: Hi, good morning, guys. Thanks so much for taking the time to answer my questions. Congratulations on getting the alignment with FDA. Pravin, I wanted to maybe ask you, with that now in tow, your SOAR 1 study has been recruiting much faster than expected. And at your R&D day, you talked about how that could also feed into the speed with which the SOAR study could recruit. Have you had a chance to talk to FDA about whether both studies would need to be submitted at the same time when you do apply for approval, or could a potential rolling submission be on the table? That's my first question. And then, secondly, as you think about the time period between inserts that might be needed for the SOAR 1 study, you're talking about an average of maybe every 9 months.
Tazeen Ahmad: Hi. Good morning, guys. Thanks so much for taking my questions.
Tazeen Ahmad: Congrats on getting the alignment with the FDA. Pravin, I wanted to maybe ask you, with that now in tow, your Cell 1 study has been recruiting much faster than expected, and at your R&D day you talked about how that could also feed into the speed with which
Speaker Change: Have you had a chance to talk to FDA about whether both studies would need to be submitted at the same time when you do apply for approval or could a potential rolling submission be
Speaker Change: beyond the table? That's my first question. And then secondly, as you think about the time period between inserts that might be needed for the SOAR 1 study, you've talked about an average of maybe every nine months.
Speaker Change: Can you talk about, as you experience as a retina physician, the variability that physicians or flexibility that physicians
Speaker Change: may choose to have maybe some dosing more frequently and some dosing less frequently, and where you think at the end of the day the average dosing frequency for the insert will be. Thanks.
Speaker Change: Good morning, Tazeen, and thank you for the questions. I appreciate the thoughtfulness of your questions.
Speaker Change: First of all, let me make it very clear, we are absolutely thrilled with the written FDA response.
Speaker Change: It validates what we've been saying to the street all along, which is that our thinking is absolutely in line with the FDA requirements.
Speaker Change: And now we have this in writing, and this absolutely validates everything that we've told you.
Speaker Change: We also have in writing that these two studies will potentially qualify for approval.
Speaker Change: One is a non-inferiority study and the other one is a superiority study.
Speaker Change: These two studies are very thoughtfully, very carefully designed to answer not only the regulatory requirement questions, but also have a commercial impact.
Speaker Change: And very importantly, as I've been saying all along,
Pravin Dugel: The Solar Study is specifically designed to actually increase recruitment in SOAR 1. Having said that, I must tell you that we are very pleased with the continued pace of recruitment in SOAR 1. As you know, recruitment is not necessarily linear. Treatment Regimen with potentially a better long-term outcome. Thank you for your question.
Speaker Change: The SOLAR study is specifically designed to actually increase the recruitment in SOLAR. Having said that, I must tell you that we're very pleased.
Speaker Change: with the continued pace of recruitment in SOAR 1. As you know, recruitment is not necessarily linear.
Speaker Change: after you hit a certain critical mass.
Speaker Change: It becomes exponential, and we clearly are in that phase. We are very pleased with the recruitment of SOL1.
Speaker Change: Now, in regards to your question about the clinical, the potential clinical use of expaselate, you know, our goal, as you know, is to get this drug to patients as soon as possible.
Speaker Change: Patients will be treated in a personalized fashion, I believe, as they are being with the anti-VEGFs today.
Speaker Change: But the important part is that given the totality of these two studies, it answers many questions while providing a clear regulatory pathway and gives the physicians the flexibility in terms of personal treatment and having a...
Speaker Change: Sustainable treatment regimen with potentially a better long-term outcome. Thank you for your question.
Speaker Change: We'll take our next question from Biren Amin of Piper Sandler.
Biren Amin: Yeah, hi guys. Thanks for taking my questions and congrats on the regulatory update. Maybe, Pravin, if I could start with Sol1. I think the company previously guided to patient enrollment completing in the trial in the first half of 2025.
Speaker Change: Do you have an update on this timeline? And then, you know, second question is, you know, you've got FDA feedback, and I know
Speaker Change: There's been some discussions with EMA. Any update there in terms of the EMA's thoughts on the design of SOLAR and SOL1?
Pravin Dugel: Biren, thank you for your question and good morning to you. Thank you. So, first of all, you're right. We did guide in our previous filings.
Pravin: Thank you for your question and good morning to you. Thank you. So, first of all, you're right. We did guide in our previous filings.
Speaker Change: effective recruitment. So, just heart-wrenching. We talked a lot about Donald and Dr. Mattessich. The school's career as an academic body of both education and recruitment as part of the Anthony whispering experiment. It's very important that he дисcusses how what happens to
Speaker Change: for SOL1 being the end of the first quarter of 2025.
Speaker Change: We did also say that given the pace of KINREL support, goal one...
Speaker Change: We have not changed any official guidance since then. It is too early to do so. When appropriate, we certainly will update you with the proper model.
Speaker Change: In regards to the EMA, Clear is a global drug, and we are in conversations with the EMA. We're very, very pleased with our conversations, and when the time is appropriate, we certainly will update you as to that as well.
Speaker Change: And if I could have one follow-up on the SOLAR, what are the retreatment criteria that you're using for the trial?
Speaker Change: As you know, this is a non-inferiority study. My expectation is that the retreatment criteria will be different than SOA-1.
Speaker Change: and in line with other non-inferiority studies. As of now, we're still discussing this with the FDA and when it is finalized, we'll certainly update you.
Speaker Change: Great, thank you.
Speaker Change: Thank you. We'll take our next question from Tara Bancroft of TD Cowen.
Tara Bancroft: Hi, good morning, and it's great to see the news on the FDA feedback here. So my question is, if you can elaborate on the term that you put in the press release that's generally acceptable in the written response, and if you believe there's any remaining risk to both studies satisfying the NDA requirements, and really, if so, if there's anything that you're doing to mitigate that proactively. Thank you.
Pravin Dugel: Good morning, Tara, and thank you for your question. You know, look, the term that we used is a term that the FDA uses, and it's a term that's generally used. There's really nothing to read into that. The take-home message here is that we are absolutely thrilled with the alignment that the FDA has, and we have that now in writing, and I repeat, in writing. So this is not subject to any interpretation.
Tara Bancroft: Good morning, Tara, and thank you for your question.
Speaker Change: You know, look, the term that we use is a term that the FDA uses, and it's a term that's generally used. There's really nothing to read into that. The take-home message here is that we are absolutely thrilled.
Speaker Change: with the alignment that the FDA has and we have that now in writing and I repeat in writing so there's this is not subject to any Interpretation it is in writing
Pravin Dugel: It is in writing that they think that their requirements are absolutely aligned with what we've been saying. So, for example, we have been saying, and this is aligned with the FDA, and we have this in writing, that sham is not recommended, that it does not constitute complete masking. It has the ability to introduce bias, and any study done with a sham will be subject to review. That is what we've been saying all along, and now we have that in writing from the FDA in a type C response.
Speaker Change: that they're thinking that their requirements are absolutely aligned with what we've been saying. For example,
Speaker Change: and that sham is not recommended.
Speaker Change: that it does not constitute complete masking. It has the ability to introduce bias.
Speaker Change: and any study done with a sham will be subject to review. That is what we've been saying all along and now we have that in writing from the FDA in a type C response.
Pravin Dugel: As you know, we don't have any sham in any of our studies. We are not willing to do any of our studies at risk, and we believe that we're in absolute alignment with what the FDA requirements are as of just a few days ago.
Speaker Change: As you know, we don't have any sham in any of our studies. We are not willing to do any of our studies at risk. We believe that we're in absolute alignment with what the FDA requirements are as of just a few days ago.
Speaker Change: Great, thank you.
Speaker Change: So, with the FDA written feedback, would you expect to also plan to pursue a SPA for SOLAR? And then, based on the feedback that you received, are there any changes that you plan to make to the SOLAR study, and can you just confirm how the FDA is viewing the role of the comparator arm? Do you need any sort of statistical significance?
Speaker Change: Colleen, good morning and again thank you for your question. It's important to state that we requested a type C meeting and the FDA responded by saying that they know us and our drug well enough to have a written response. As you know, we have a SPA for the SOLE1 study.
Pravin Dugel: To answer your question directly, you know, look, we believe we are in complete alignment with the FDA, as we've been saying. We believe that everything that we've said, and I've just given you the example regarding sham, is absolutely validated in this written response. In regards to the potential for a spawn, the answer is, I honestly don't know at this point.
Speaker Change: To answer your question directly, you know, look, we are, we believe we are in complete alignment with the FDA, as we've been saying, we believe that everything that we've said, and I've just given you the example regarding sham is absolutely validated in this written response.
Speaker Change: In regards to the potential for a spawn, the answer is I honestly don't know at this point, we've just received this written response a few days ago.
Pravin Dugel: We just received this written response a few days ago. What I will tell you is that our goal here is to get this drug to patients as quickly as possible. We will not do anything that will jeopardize that or will delay it in any way, whether it be the use of resources or time. We will give you an answer regarding the spa discussion at this point. I simply don't know as yet. Colleen, does that answer your question, or was there another one that I missed?
Speaker Change: What I will tell you is that our goal here...
Speaker Change: is to get this drug to patients as quickly as possible.
Pravin Dugel: And then just, yeah, that's helpful on the spot, and then can you just confirm, were there any other changes that you plan to make to the trial design and what the role of the comparator arm is? https://oculartherapeutixinc.com
Speaker Change: And then just yeah that's helpful on the spot and then can you just confirm were there any other changes that you plan to make to the trial design and what the role of the comparator arm is whether you need any
Pravin Dugel: So, we don't really anticipate any large changes whatsoever. The FDA has been very clear in its written response saying that this trial is acceptable as a registration study. We really do not anticipate any great changes whatsoever here.
Speaker Change: and statistics around that.
Speaker Change: Oh, yeah.
Speaker Change: So we don't anticipate really any large changes whatsoever. The FDA has been very clear in its written response of saying that this trial is acceptable as a registration study.
Pravin Dugel: This is absolute, complete alignment with the FDA. In regards to the comparator arm, again, I say this, as I said before, we have followed the guidelines to the T. As you know, the comparator, or the requirement of the comparator arm, is that the comparator arm have the same dosing frequency and the same rescue requirements as the treatment arm. This is purely for masking purposes; it is not for statistical analysis. And that has not changed, I believe, with the FDA at all. That has been absolutely in line with what we've done.
Speaker Change: We really do not anticipate any great changes whatsoever here.
Speaker Change: This is absolute complete alignment with the FDA. In regards to the comparator arm, again, I say this as I said before, we have followed the guidelines to the T.
Speaker Change: As you know, the comparator or the requirement of the comparator arm is that the comparator arm have the same dosing frequency and the same rescue requirements as the treatment arm. It is purely for masking purposes. It is not for statistical analysis.
Operator: Great. Thanks for taking your questions.
Speaker Change: Great. Thanks for taking our questions.
Operator: Our next question is from Kelly Shee of Jefferies.
Speaker Change: Thank you.
Speaker Change: Congrats on the great progress.
Speaker Change: Maybe could you walk us through your expectations on how the two compare to your arms?
Speaker Change: might perform in SOAR based on historical trial data and how the real world dosing frequency of ILEA for both high dose and the low dose might differ in YAMD. Thank you.
Speaker Change: Kelly, good morning and thank you for your question. You know, I don't want to predict.
Speaker Change: in terms of our arms that we have selected, as you know.
Speaker Change: SOLAR is a trial design where the statistical analysis will be done versus the 2mg effilibrosate arm.
Speaker Change: I believe the best comparator that you can look for is our U.S. study. In our U.S. study, as you recall, in a patient population that was not super selective or enriched as we have in SOLAR,
Speaker Change: At the six-month point, per protocol, 100% of patients were rescued free. And again, I repeat, per protocol, at six months, 100% of patients were rescued free in the expat alarm.
Speaker Change: So this gives us a great deal of confidence based on our data that in this patient population, which has been de-risked.
Speaker Change: and Selected and Enriched.
Speaker Change: that those numbers will not only stand, but actually will be even better. As I said earlier on, there is one comparator arm, and that is not for a statistical analysis, that is purely for masking purposes. But given the data that we have from the U.S. study,
Speaker Change: We are very confident in the non-inferiority outcome of SOAR.
Speaker Change: makes sense thank you and maybe I can add a follow-up here
Speaker Change: So now you're aware that AMD trials are well on track to advance wandering.
Speaker Change: How should we think about the next step of expertly in diabetic retinopathy? What would be the key learnings on trial design from your discussion with FDA on YAMD trial designs and also the DR trial designs in the space overall? Thanks.
Pravin Dugel: Kelly, thank you again for that question. I want to be very clear. We, as a company, have made our priorities about as transparent and about as clear as possible. Our priority is SOLE1 and SOLAR. Our priority is to get this drug to patients as quickly as possible and have the potential to be approved as quickly as possible. We are thrilled with the Helios data set. This comes as the next priority. To be clear, we have not had a formal meeting with the FDA regarding the non-proliferative diabetic retinopathy study. However, our intention is to do so.
Speaker Change: Kelly, thank you again for that question. I want to be very clear. We as a company have made
Speaker Change: are priorities about as transparent and about as clear as possible.
Speaker Change: Our priority is SOLA-1 and SOLAR. Our priority is to get this drug to patients as quickly as possible and have the potential to be approved as quickly as possible.
Speaker Change: We are thrilled with the Helios dataset.
Speaker Change: This comes as the next priority. To be clear, we have not had
Speaker Change: a meeting with the FDA, a formal meeting with the FDA regarding
Speaker Change: at the Non-Proliferative Diabetic Retinopathy Study. However, our intention is to do so.
Pravin Dugel: The take-home messages from Helios are two. The first one is that the results of Helios, which I think are quite remarkable, which is that, as we mentioned earlier, every single metric, every single parameter is absolutely aligned in favor of the drug. And that's quite remarkable given the variability of this patient population, is that there is a great line of sight into the database that should give us confidence based on Helios for the success of SOL1 and SOLR in terms of the activity of this drug. So I think those are the two take-home messages.
Speaker Change: The take-home messages from Helios O2. The first one...
Speaker Change: is that the results of Helios, which I think are quite remarkable, which is that, as we mentioned earlier, that every single metric, every single parameter is absolutely aligned in favor of the drug. And that's quite remarkable, given the variability of this patient population.
Speaker Change: I don't think there's any doubt whatsoever that the drug is active, that it's safe, and that it is absolutely working at 48 weeks with a single injection in patients with non-proliferative diabetic retinopathy. The take-home message is that we have a clear path forward.
Speaker Change: to target this disease for which right now, effectively, there is no drug and patients are going blind. The vision-threatening complication rate, as you know, is 20 to 30 percent year upon year. So the first take-home message is that there's a clear path forward for us into this target.
Speaker Change: The second importance is that there is a great line of sight that is database that should give us confidence based on Helios for the success of SOL1 and SOLAR in terms of the activity of this drug. So I think those are the two take-home messages.
Prave: Thanks again, Prave.
Operator: Our next question is from Sean McCutcheon of Raymond James.
Kelly: Thank you, Kelly.
Speaker Change: Our next question is from Sean McCutcheon of Raymond James.
Sean McCutcheon: Hi guys, thanks for the question. So maybe to pick on the SOL-R comparator arm a bit more and understand that the 8-megapoliver set...
Speaker Change: Hi guys, thanks for the question. So maybe to pick on the SOL-R comparator arm a bit more and understanding that the 8-megapolyper set...
Speaker Change: is for masking only, but what strategic significance do you think it plays that you will have these data at hand?
Speaker Change: Your competitors presumably will not. Does this give you optionality on the marketing front, or maybe...
Speaker Change: Tom, thank you. Good morning and thank you for your question. The first goal here is to make sure that from a regulatory point of view
Speaker Change: We're about as clear as possible and as aligned as possible with the FDA requirements. I believe we've achieved that with the comparator arm. And as you rightly stated, the comparator arm is purely for masking, not for statistical analysis.
Speaker Change: That is the first goal.
Speaker Change: In terms of the read-through from a commercial point of view, we will be able to show here a comparison with what may be considered the next generation of ILEA product, which is high-dose ILEA.
Speaker Change: And I think that will be very valuable.
Speaker Change: for Physicians. Most importantly, when taken in its totality, when you look at SOL1 and SOLAR, SOL1 is a superiority study. SOL1 will give us a great deal of information as to the durability of the single injection of AXPAC sleep.
Speaker Change: So LAR is a non-inferiority study. It gives us information regarding repeatability, it allows for flexibility of dosing, and it gives us commercial information in regards to how our drug does, which we are very confident about with both
Speaker Change: And we'll take our next question from Yi Chen of H.C. Wainwright.
Yi Chen: Thank you for taking my questions. With respect to the SOAR trial, do you currently have an estimate as to when the trial could complete enrollment? And also, for the five loading doses, does that apply to both patients who failed at randomization in the SOAR 1 trial as well as patients who directly enrolled into the SOAR trial? Thank you.
Yi Chen: Thank you for taking my questions. With respect to the SOAR trial, do you currently have an estimate as to when the trial could complete enrollment?
Speaker Change: And also for the five loading doses, does that apply to both patients who failed at randomization in the SOAR1 trial as well as patients who directly enrolled into the SOAR trial?
Pravin Dugel: Yi, thank you again. Good morning, and thank you for your question.
Pravin Dugel: We have not given any guidelines as to when we expect SOLAR to be recruited. It will absolutely increase the traffic and the recruitment of SOLAR1. Once we are certain that SOLAR1 is either recruited or about to be recruited, we control the switch, and this is really important. We control the switch so that patients who are being recruited for SOLAR no longer need to come from SOLAR1 screen failures but may come from the outside.
Speaker Change: Thank you again, good morning, and thank you for your question. We have not given any guidelines as to when we expect SOLAR to be recruited.
Speaker Change: One of the really important requirements that I had for SOLAR was that not only it's not cannibalized,
Speaker Change: Now, we're recruiting extraordinarily well, and so, one, I want to emphasize that.
Speaker Change: Why may they screen fail? Well, the most common reason may be that they simply may not get, for instance, a 10-letter game. They may only get an 8- or 9-letter game, and then there will be a place for them to go, which is SOLAR.
Speaker Change: It will absolutely increase the traffic and the recruitment of SOAR1.
Speaker Change: to now say patients who are being recruited for SOLAR
Pravin Dugel: But the way the study is designed, the fact that we control that switch is really important to understand, which is that, as required, SOLAR will only help the recruitment of SOLAR1 and never cannibalize from the recruitment of SOLAR1. For study sites, this is really important. It's really important for studies, as you probably saw in that quote from Dr. O, that they're able to tell patients, This is a great study, we'd like you to be recruited for this study, and the study coordinators and the physicians will have the confidence that pretty much all patients will qualify for one or the other study. That is a really important fact for all studies. Thank you for the question. Now, we'll take a question from John Wolleben of Citizens JMP. Hi,
Speaker Change: It's really important to understand, which is that as required, SOAR will only help the recruitment of SOAR 1 and never cannibalize from the recruitment of SOAR 1.
Speaker Change: that they're able to tell patients.
Speaker Change: This is a great study, we'd like you to be recruited for this study, and the study coordinators and the physicians will have the confidence that pretty much all patients will qualify for one or the other study. That is a really important fact for all study centers.
Operator: We'll take a question from John Wolleben of Citizens JMP. Hi.
Catherine Ahn: Hi, this is Catherine Ahn for John . I have a quick question about soil water recruitment, just kind of follow up, soil water recruitment, just to follow up. Have you guys updated how many patients have been randomized? I know there was an update during the Investor Day. And also, any guidance on the screen failure rate?
Pravin Dugel: Thank you for the question and good morning. What we did on Investor Day was to show that this team that we had assembled, what we call the dream team, was not just there in name but was actually functioning extremely well and working extremely hard, and to do so, we provided data. And what we showed was that in two short months, we absolutely exceeded the expectations for recruitment. What we said was that 151 patients had been recruited and were in various stages of loading and randomization.
Speaker Change: Yeah, thank you for the question and good morning. What we did in Investor Day was...
Speaker Change: The team that we had assembled, what we call the dream team, was not just there in name, but was actually functioning extremely well and working extremely hard. And to do so, we actually provided data. And what we showed that in...
Speaker Change: Two short months.
Speaker Change: We absolutely exceeded the expectations of recruitment. What we said was that 151 patients had been recruited and were in various stages of loading and randomization.
Pravin Dugel: We have not given you any further granularity as to that. What we have said also is that the screen failure rate is lower than we anticipated and modeled, and that we're very pleased with that. And given that, our expectation is that most of the patients eventually in SOAR will come from outside and not necessarily from the screen failures of SOAR 1 because the screen failure rate is so low. That guidance also has not changed.
Speaker Change: We have not given you any further granularity as to that.
Speaker Change: What we have said also is that the screening failure rate is lower than we anticipated and modeled and that we're very pleased with that and given that our expectation is that most of the patients eventually in SOLAR
Speaker Change: will come from the outside and not necessarily from the screen failures of SOHL 1 because the screen failure rate is so low. That guidance also has not changed.
Pravin Dugel: As you know, as I said earlier, when you reach a critical mass, you enter an exponential phase of recruitment, and we are in that phase. We are very, very pleased with the recruitment of SOAR 1, and our belief is now, with the execution of SOAR, that the pace of recruitment will be even further accelerated, and we certainly will give you milestones when appropriate. Thanks for your question.
Speaker Change: As you know, as I said earlier...
Speaker Change: When you reach a critical mass
Speaker Change: This concludes our question and answer session. I will now turn the call back to Dr. Pravin Dugel for closing remarks.
Pravin Dugel: Thank you very much, and I'd like to thank everyone for taking the time to join our call today. We look forward to updating you on our progress. If you have any follow-up questions, please reach out to Bill Slattery, our Vice President of Investor Relations. Have a great day, and you may now disconnect. Thank you.
Operator: ?? ?? ?? ?? ??
Pravin Dugel: Thank you very much, and again, I'd like to thank everyone for taking the time to join our call today.
Speaker Change: We look forward to updating you on our progress.
Speaker Change: If you have any follow-up questions, please reach out to Bill Flattery, our Vice President of Investor Relations. Have a great day, and you may now disconnect the call. Thank you.
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