Q2 2025 Ocular Therapeutix Inc Earnings Call
Good morning and welcome to the ocular therapeutix. Second quarter 2025 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. 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. I would now like to turn the call over to ocular vice president of investor relations Bill flattery Junior, please. Go ahead Mr. Flattery
Good morning, everyone. Thank you for joining us today.
Earlier this morning, we issued a press release and filed our quarterly report on form. 10q outlining our financial results and business updates for the second quarter of 2025 along with several updates to our registration program for exp, paxley and wet, AMD
Oculars executive chairman president and CEO. Dr. Pravin Dougall will summarize recent business highlights before we move to our question and answer session.
Joining Dr. Dugle for the Q&A, portion of the call will be Donald nman Chief Financial Officer and Chief. Operating Officer Sanjay neach Chief strategy officer and Steve Meyers Chief commercial officer
We refer everyone to this morning's press release and our form 10q for a comprehensive update of second quarter, 2025 financial and business results.
During today's call certain statements, we will be making constitute forward-looking statements under the Safe Harbor. Provisions of the private Securities, litigation Reform, Act of 1995,
Actual results May differ materially as a result of a variety of risk factors, including risks and uncertainties identified in the risk factor section of our annual report on form, 10 K, and our other SEC filings.
With that, I'd like to hand the call over to Dr. Praveen Duggal to review our recent updates.
Good morning, everyone. And thank you for joining us today.
2025 is shaping up to be a defining year for ocular therapeutix.
As we look back on the progress made over the first half of the year.
I'm proud to say. We are continuing to execute with precision speed and scientific integrity.
Last month, we updated our corporate branding to reflect who we are today.
These changes represent more than a new look.
They marked the next chapter in our evolution as a retina-focused company at the forefront of innovation.
Our mission remains unchanged.
To redefine the retina experience in hopes of preserving vision.
For the long term.
For millions of patients around the world wet, AMD remains a Relentless Progressive disease.
Despite recent advances in therapy, the burden of frequent injections remains unmanageable for many with nearly 40% of patients in the US discontinuing treatment within the first year.
This is unacceptable to us.
And it's exactly why we're advancing expats late, a treatment designed to offer best-in-class durability, meaningful efficacy, and real-world flexibility.
Our registration program for expats actually includes the sole 1 and soar studies.
These are thoughtfully crafted complimentary trials with bespoke patient populations designed to de-risk outcomes and answer key questions. Physicians will have on the durability, flexibility, and repeatability of EXP Paxlovid.
If approved.
We Believe XP actually has the potential to be the first product.
For wet AMD with a superiority claim, based on the sole 1 trial.
This trial is designed in alignment with the fda's guidance for conducting, a superiority study, which has enabled us to secure a special protocol assessment or spa spa agreement.
For soul 1.
Recently approved anti-Vella products and current competitive phase 3 wet AMD trials are all based on non-inferiority to a fluiver set, 2 milligrams.
To our knowledge.
Soul 1 is the only phase 3 superiority trial being conducted in wet AMD.
and before successful in gaining FDA approval,
We will potentially be the only wet AMD product with a superiority claim in the label for the foreseeable future.
Combined with our non-inferiority trial soar.
We Believe exactly has the potential to unlock unprecedented durability with dosing of at least 6 months in potentially, as in frequently as every 12 months.
We believe this dynamic will allow us a unique and potentially dominant position compared to all other products in the commercial landscape. This could enable an opportunity that spans millions of patients worldwide, addressing the critical needs for a more sustainable, less burdensome treatment with improved long-term outcomes.
This morning.
We're excited to share several updates across our sole 1 and solar programs. Including initial plans to incorporate a single long-term open label extension study for both Soul trials.
And updates to our rescue criteria for soar.
These updates are designed to further enhance XPAX Lee's commercial profile and underscore the confidence we have in this program.
We'll also provide a financial update that highlights the flexibility and optionality, we've secured.
As we approach the sole 1, topline data readout in the first quarter of 2026,
Continued to advance our manufacturing and Commercial infrastructure and evaluate expansion opportunities for expats, actually in non-proliferative diabetic, retinopathy and diabetic macular edema.
Finally.
We are pleased to announce that, we will be hosting an investor day on September 30th in New York City.
Which we encourage everyone to join.
Either virtually or in person.
Let's first discuss. Our soul studies.
I am pleased to report that both Soul 1 and solar trials. Continue to move forward expeditiously.
Investigators and the quality of our operational planning.
Let me start with soul 1.
Our superiority trial for exactly.
Following the successful randomization of 344 patients in December 2024.
The trial has maintained exceptional retention as we prepare for Topline data in the first quarter of 2026.
As part of the ordinary course.
Of our trial monitoring. We periodically review rescue data on a massed basis,
And what we look at are primarily 3 things first. The number of rescues, we need patients to be rescued to demonstrate a difference between the Flubber set and exp paxley second. The Cadence of rescues, whether they occur in a distribution that is consistent with our hypotheses as to, how a flip patients would behave and how exactly patients would behave.
And third whether the rescues are on protocol or not as this goes to trial conduct and the reliability of data we are generating.
I am pleased to share that the vast majority of rescue events remain fully aligned with the pre-specified criteria outlined in the sole 1 protocol.
simply put patients are staying in the trial and Physicians are waiting until patients meet
The predefined threshold of a 15 letter loss in visual Acuity from Baseline before, administering rescue treatment in the vast majority of cases.
That's not just a procedural win.
It's also a powerful Testament to the integrity and reliability of the data. We are building.
And this reinforces our confidence in the quality of the data set, we intend to deliver to the FDA.
And when we step back and look at the number and Cadence of rescues, again, under masking, we are also thrilled with what we're seeing.
This is based on our expectations of the difference in how the 2 agents would perform over time.
We look forward to hopefully confirming that hypothesis. Once we are able to unmask the study in q1 of next year and Report Topline data.
We are also excited to announce plans to incorporate a long-term open-label extension study for both Soul 1 and solar.
Which patients will be eligible to enter a following the completion of the 2-year safety follow-up period in each trial.
This extension study is a strategic initiative, not a regulatory requirement.
We believe it will generate valuable real world insights into the potential long-term benefits of using a non pulsatile treatment like xpac in addition to providing long-term safety data.
The study is designed to assess key outcomes, such as vision preservation.
anti-fibrotic activity and the potential consequences of delaying xactly treatment in control armed patients,
our hypothesis is straightforward.
If nonpulsatile dosing reduces the risks of fibrosis and atrophy, the axle arm patients will have the potential for better long-term visual outcomes than the control arm patients, who have a 2-year delay before they initiate xactly treatment.
Importantly.
We expect this extension study will have significant commercial implications.
In today's evolving, landscape Retina Specialists and payers alike are seeking long-term data that validates durability.
We believe this study will enhance confidence and expects. These sustained performance and support broader adoption upon launch.
We're extremely excited.
To take on this effort as part of our commitment to delivering a long-lasting flexible and non-political solution that could potentially deliver improved long-term visual outcomes on a treatment regimen. That is sustainable for patients, caregivers and Physicians.
Our non-inferiority trial, comparing those to every 24 weeks to Flippers set dosed every 8 weeks.
We continue to advance this study with strong momentum and unwavering conviction in both our strategy and execution.
This trial was deliberately designed with a 6-month, screening and loading ramp to identify and exclude patients, who demonstrate, unstable Anatomy. Particularly those with high fluctuations in central subfield, thickness.
These are precisely the patients who could introduce variability and compromise outcomes in a non-inferiority trial.
Excluding them.
Is a strategic choice.
Because a failed trial due to noise is not a risk we're willing to take.
With enrollment complete in solar, we expect to have Topline data in the first half of 2027 and we believe the structure of this trial gives us key advantages needed to succeed by de-risking the patient population.
The primary endpoint for solar.
to demonstrate non-inferiority in the mean change in best corrected visual acuity at week 56.
Which is a highly favorable time point.
It falls.
2 months after both the last xaxy dose and the correspondent of flipper set injection for the control arm.
Importantly, this endpoint is at a singular time point.
It is not Blended over multiple visits.
Separately, as part of our ongoing effort to ensure SOLAR reflects real-world clinical decision-making, we've streamlined and simplified the rescue criteria.
The rescue criteria in solar is now based on a greater than 5-letter loss in visual acuity, plus a greater than or equal to 75 micron increase in central subfield thickness.
This change aligns the trial more closely with how physicians determine when to intervene in the real world and simplifies the criteria for investigators to reflect their everyday clinical practice.
This also reflects our confidence.
In xpac based on what we are seeing under masking in Soul 1.
This is critically important, so let me reiterate.
The change in solar rescue criteria, reflects a thoughtful and proactive effort.
To further bridge, the gap between clinical trial design and clinical practice.
This is not an FDA requirement.
But rather a strategic decision we have made from a position of confidence in exp, Pack's ability to deliver meaningful outcomes in a trial setting.
That is more clinically relevant for Physicians.
Solar remains robustly powered at 90%.
To meet the non-inferiority margin of minus 4.5 letters.
At week 56, based on our written FDA feedback and alignment.
Let me step back a moment.
In just over 1 year, we have built a world-class team.
Advanced a groundbreaking program and wet AMD.
And we enrolled in advanced 2, complimentary registrational trials for expats.
All the while maintaining excellent quality.
Speed.
And operational, precision.
From inception.
These trials were intentionally designed to be complimentary, not redundant.
Each addressing distinct yet sooner just a clinical question.
That together form the foundation of our registrational strategy for expat.
So 1 is focused on durability with redosing after the 9-month primary endpoint at Weeks, 52 and 76.
Soar is focused on repeatability of XP, actually every 6 months and real world applicability.
For both trials, leverages a rigorous screening and loading phase to select bespoke de-risked.
Patient populations for randomization.
This is a critical differentiator.
and 1 that we believe could meaningfully reduce
Patient, variability in each trial, and strengthen the probability of success in both trials.
Together. These trials seek to address the most important questions, Physicians and patients will have about a tax lease durability repeatability and flexibility.
If successful, these trials, May support an unprecedented and potentially the first and only superiority label in retina that enables dosing every 6 to 12 months in a chronic disease where most patients currently require monthly or bi-monthly treatment.
Perhaps most importantly, both trials are built on the foundation of FDA alignment with clear guidance around endpoints and trial design.
And neither study uses sham comparators consistent with fda's stated preference to avoid introducing bias in Mass studies.
This has been clearly stated.
In the fda's guidelines.
which they have reiterated in person and in writing numerous times.
This thoughtful strategic design gives us confidence, not only in our clinical program but also in our ability to bring forward a product that redefines what’s possible in a retinal disease.
Pending successful outcomes, we plan to submit our NDA shortly after.
The solar 56 week primary endpoint.
This strategy allows us to deliver a comprehensive package to the FDA that intends to address the durability, repeatability, flexibility, and safety of xpax.
Notably because excited is already FDA approved for non-op indications.
We plan to Leverage The 505 B2.
NDA review pathway which has the potential to shorten the review timeline for xactly by 2 months compared to the traditional review pathway for new molecular entities.
Moreover, both trials have been designed in close alignment with the latest FDA guidance.
So 1 under a spa agreement.
And solar.
Informed by written formal feedback.
With a strong clinical and Regulatory foundation in place for wet AMD. We're now preparing to expand our reach towards the next Horizon.
Diabetic eye disease.
Earlier this year, we received positive FDA feedback on our proposed trial design for patients with diabetic retinopathy
The unmet need here is immense.
Despite available therapies, fewer than 1% of NPD patients are treated, and yet...
With XP, we may be able to offer a long-acting solution that reduces the risk of progression with just 1 or 2 treatments per year.
Recall that in our Helio study at zero, patients developed a vision threatening complication with a single injection of x-axis at 48 weeks compared to almost 40%.
In the control arm.
Additionally, all patients in the exactly arm.
That had diabetic macular edema.
Saw Improvement at week 48.
Although these results are from a relatively small Phase 1 study.
We Believe.
This is an area where xaxis profile could drive real change. Not just in patient outcomes but also in how Retina Specialists approached disease prevention.
With virtual access available.
This will be an important event.
We'll walk through how Soul trials work together to support. What we expect will be a differentiated exposed label in wet, AMD.
We'll share new insights on the extension study design for both of our SOUL trials.
We'll introduce our next steps in npdr and DME, including the clinical trial design informed by recent FDA feedback and will begin to articulate the global commercial opportunity. For exp paxley, both in wet, AMD and Beyond.
You can register or our investor Day by visiting the events page on the investor relations section of our website.
We believe this event will clearly demonstrate the breadth and depth of our strategy and why we believe is poised to redefine the standard of care in retinol treatment.
Let me now turn to our financial position.
we ended the second quarter with over 390 million in cash and cash equivalents
In June, we opportunistically raised gross proceeds of approximately $97 million through our existing at-the-market (ATM) facility.
Opening the ATM. This quarter was a deliberate decision to provide us.
With maximum financial flexibility as we head into the most significant data readout in Ocular’s history.
We expect this increased Capital will support several key initiatives.
Will be speaking more about in our upcoming investor day including investments in commercial infrastructure, preparation for the soul 1 and solar extension study and planning.
For FDA aligned future studies in npdr and DME.
Importantly, we remain disciplined stewards of capital.
We remained well financed with expected Runway into 2028 which is well beyond anticipated, Topline data readouts for both Soul 1 and solar.
Our cash guidance does not yet factored in the full impact of potential clinical trial activities for expats actually in npdr or the long-term extension study in wet AMD as we remain at the planning phases.
For these programs.
2025 is already proving to be a breakout year for ocular therapeutix.
In just the past few months.
We have advanced two complimentary registrational trials.
Aligned with FDA, on next steps, in diabetic, eye disease.
And laid the groundwork for commercial Readiness in wet AMD.
If approved.
We Believe xactly has the potential to be the first product.
For wet, AMD, with a superiority label.
This would likely be the only product with a superiority label for the foreseeable future with redosing potentially as infrequently as every 12 months.
This profile would provide XP, actually, with a unique and potentially dominant position compared to all other products in the commercial landscape.
Unlocking, an opportunity in wet, AMD alone, that spans millions of patients worldwide.
To summarize the updates on today's call First.
Both sold 1 and solar continue to advance with exceptional retention.
Trial integrity and physician adherence to protocol, we enforcing our confidence in the quality of data.
We are generating.
Second.
In Soul 1, the vast majority of rescue treatments remain aligned with the protocol defined 15-letter loss threshold.
Third, building, on this momentum, we plan to incorporate a long-term open-label extension study for both Soul trials.
Generate long-term safety and visual outcomes data with a nonpulsatile treatment that could meaningfully support physician confidence and market adoption.
Forth.
We have high confidence in the success of solar and we expect Topline data.
in the first half of 2027,
With a 6-month, screening and loading phase design to exclude unstable patients.
And a primary endpoint at week, 56 timed 2 months after the most recent x-axi, and a flipper set injections.
We believe we have taken steps to de-risk the patient population and maximize the opportunity for success.
Fifth.
We've streamlined and simplified.
The solar rescue criteria to a greater than 5 letter loss plus a greater than or equal to 75 Micron increased in central subfield, thickness.
We believe this change enhances solar's, real world relevance and reflects our continued confidence.
In xpax.
6, we're preparing to expand into npdr and DME.
Following positive FDA feedback.
We Believe exactly could redefine treatment in diabetic, eye disease, offering durable protection with just 1 or 2 injections per year.
Seventh.
We remain well-capitalized, with over $390 million in cash.
And expected Runway into 2028 well beyond anticipated. Topline data for both Soul 1 and solar.
Our recent sale.
Of $97 million of common stock under the ATM, it provides financial flexibility.
To support both near-term execution and long-term strategic investments.
and finally,
we look forward to hosting our investor day on September 30th in New York City.
Where we will provide deeper insights.
Into the soul trials and the sole trials extension study.
Our diabetic eye disease strategy.
And our global commercial vision.
At ocular.
We're not just developing a drug.
We're redefining the retina experience with confidence.
Clarity.
And conviction.
We hope you all plan to join us at our investor day on September 30th.
Thank you again for your time and continued support.
Operator.
We are now ready to take questions.
As a reminder, if you would like to ask a question, please.
Your first question comes from Byron. Amen. With Piper Sandler, please go ahead.
Hey yeah. Hi guys, thanks for taking my questions and congrats on all the progress. I have a multi-part question for solar. Um, so I guess first question, when do you expect to complete randomization of the 555 patients that are required for the trial?
Um second question, what drove the change in the rescue criteria for the study and I think you remove the 10th for, um, the rescue criteria. So if you could just confirm that
And um third I guess, you know, was there anything like on a mass basis that you saw in solar that basically drove the that change in um the rescue criteria? And I guess why, why was that? Why was this changed on at this time. So those are I guess um the 3 questions that I have on solar, thanks.
Darren good morning and uh, thank you for your questions. So let me just answer answer that in order. Uh, first of all, as far as randomization is concerned, uh, look, we will, um, we will update you when appropriate what we've said, very clearly is that our enrollment has, has been completed. And that the trial conduct where is going superbly. We're very, very happy with the way uh, that, uh, the conduct of solar and solar 1 for that matter is going on.
This modification of the solar rescue criteria was based purely for a strategic Advantage, purely for strategic Advantage, it was not required by the FDA and it was based on a position of confidence as far as what we're seeing in the mass data. And so 1 is concerned.
Um, to put a very simply if you step back and if you look at 3 studies and I say 3 because I include the sole extension study. There's a purpose. Again this is this is simplistic but it's actually quite effective. There's a purpose for each study. The purpose for soul 1 is a superiority label. That's a very important to us the purpose for. So large is clinical use and clinical relevance the purpose for the sole extension. Study is data generation that supports the superiority label as well as the long-term clinical advantage and what we have done from a position of confidence
Is to go ahead and modify the rescue criteria for so large to better get it towards its goal, which is the data generation for clinical use and clinical relevance, and why. Now it's really quite simple. Uh, it's because of 2 things. 1 is again. It's, it's from a position of confidence. Uh, 1 is because we see the sole 1 Mass data, and we're very, very excited by it, we're very confident our confidence continues to grow as we see the mass data. And the second reason is the feedback that we
We get from our from our investigators. What we want to do is we want to set this drug up to be adopted immediately upon its approval and by reflecting rescue criteria that are that are going on. In the community, currently will make it much more adaptable, immediately, and answer all the questions that need to be answered for full acceptance. And that's really, the reason again, this is a decision that's made from a position of confidence, um, and it reflects a strategic advantage that we will enjoy. Thank you for your question. Very
next question.
Cousin, namat with Bank of America, please go ahead.
Hi. Good morning. Um thanks for taking my question. Um Perrine I just wanted to um clarify how you're thinking about any potential for a shortened review timeline. Um given that you're going to file um your application. After a solar reads out, you had any pro a preliminary feedback from the agency or with this piece something that you would need to discuss with them. And would you need the full solar study fee to enhance in order to to get any kind of clarity or could you start a process before that in terms of filing and then? Um, secondly when should we think about the the pace with which you'll start for preparing for the potential launch of drugs? Thanks.
It is in good morning and thank you for your question. First of all, uh, look, our expectation of what the FDA wants has not changed and the FDA has been very clear in stating that they want to well-controlled, well, Mass studies with positive results. Uh, they are well, aware of what we're doing, you, you, you remember that? We do have a spa for soul 1. Uh, we have a written type-c confirmation uh for soar. Uh and we expect to be able to submit for for approval immediately following a positive result for solar which is at 56 weeks. Now what we also said was that we do have a drug here uh that will qualify for a 505 D2. Now remember the typical pathway that most people are used to is the 505 D1 which is a new molecular entity. Uh this is this is usually reserved for drugs that have never been approved.
Uh with drug particles that have never been approved or drug drug uh API that has never been approved in our case because xpack slate has been previously approved. We believe uh that the 505 B2 path will will shorten our time period by at least 2 months. Um, in regards to launch activities, look, you will be seeing some uh, discussion uh, in our investor day and I hope everybody
To attend our investor day, uh, we will outline for you, our Outlook in terms of, ah, uh, ah, ah, National as well as a global commercial strategy at that time.
Thank you to zoom for your question.
Next question, Tara frankoff with TD Cal and please go ahead.
Theme of Baron's questions. But uh, so for the updated rescue criteria, can you just help us to better understand how the the number and timing of the rescues will be viewed by the FDA when evaluating the um the primary endpoint for solar and how that differs from the previous criteria.
Yeah, so Tara, good morning and thank you for your question. Uh, there's really no change whatsoever in in in the how the FDA would look at this in terms of the primary endpoint or anything else like that. Again, as I stated earlier, on this modification, was based purely on getting a strategic advantage and making this drug immediately adoptable, uh, because it reflects what is being done? Clinically there's absolutely no FDA requirement whatsoever and we expect no change in terms of the way the FDA regards the study. Thank you.
Go ahead.
Great, thanks. Good morning. Thanks for sharing your question, and congrats on the progress, understand this change in retro. Criteria is not a regular regulatory decision. But did you speak with the FDA about this change and criteria? Or would you plan to do so? Um, and then can you just confirm? I think the rescue criteria that you're no longer using is the just a pure 10-letter loss with no food stipulation. Um, and so, how do you think, removing that criteria would impact the primary end point?
Yeah, good morning. Uh Colleen and thank you again for a question. Just like I said to Tara get a previously. This has nothing to do with the FDA whatsoever. It's a purely strategic decision. It will have no issue whatsoever with the primary endpoint. This is really not an FDA discussion. This is a pure strategic, strategic decision that we've made to better reflect the purpose of solar which is to completely define. This drug to be adoptable immediately for clinical use. There will be, uh, this is, this is again, I'll reiterate has nothing to do with any kind of an FDA requirement. It's a pure strategic decision. Thank you, Colleen.
Got it that's helpful and 1 follow up. If I can just from an operational standpoint, um obviously solar is already kind of up and up and running and the changes happening in mid trial. So can you speak to what percent of rescues in solar were for the other criteria? And does this change by chance delay, the primary endpoint readout
So, Colleen again, uh, this doesn't do anything for the time before the end point, uh, at all that this does not delay or change the timing of solar 1 bit. Uh, recall that 1 of the great benefits that we have in solar is the trial design. The trial design is unique in completely de-risking. The patient population as much as we can. Uh, recall that what we have here is a very well-thought-out ramp um, where we have 5.
Loading Phase 5, loading injections and we have a unique design and having 2 opportunities to observe patients for instability. So it's quite a long ramp. Um and it really doesn't change uh, anything in terms of the patient outcomes whatsoever. Thank you for your question.
Next question, Kelly shy with Jeffrey, is please proceed.
Uh, congrats on the great progress and thanks for taking my questions. Maybe, for the first 1, um,
For the single long term extension status, for both trials. Maybe, could you explain to us the rationale and the purpose of such designed how much uh long-term data, do you think you need to collect for commercial and meaningful impact and also have a follow up? Thanks.
So Kelly, good morning and thank you for your question. Um, it's it's an important question. So let me kind of step back a little bit and and answer this in a more holistic way. Uh, you know, especially at this time in appropriately. Um it's it's important to sort of reflect what these trials are doing, and why they fit in and how they fit in. And what I'm about to say, I want to meet very, very, very clear. Um, I am, I'm, I'm going to talk from a different position of confidence.
Um, and let me explain that what you see now in this field is really a morass of me to drugs, um, and that's based on non-inferiority, studies. As far as I know, Soul 1 is the only superiority study that's active. And in fact, I don't even know if another superiority study that's that's planned. Um, so so what does that do? In terms of the advantage that we would have right? If we're fortunate enough to get a superiority, a label. So what I would say is let me answer that question in terms of the doctor and let me answer that question in terms of the uh of of the company itself as far as the doctors concerned, the doctor wants to be in a position to choose the drug. The best drug possible for the patient and if there's a pressure based on competition based on pricing and so on and so forth and step therapy,
the doctor may have to wait until the patient is actually worse on a lesser drug before being able to switch to a better drug or the drug that's desired. And often times what happens in this case as has been shown in previous diseases uh in retina is that the patient really never recovers? There's damage done that's irreversible now why have we extended the the the the the the sole studies and why have we put in the the the questions that we want to answer? Well 1 of the questions very clearly is what happens to patients when there's a delayed adoption to X paxley.
Um, and we want to be able to see if that causes any damage that's irreversible. Uh, if there's an advantage, we believe there will be to starting exponentially right away. So from a doctor's point of view, that extension study question is very, very important from a company's point of view, having a superiority label, puts a great deal of value on the drug as well as the as well as the company. It puts the drug in an entirely different orbit. Again, I don't know if any other drug that is currently being investigated based on superiority. So getting the superiority label putting these studies together to answer the proper questions to support that superiority label. Particularly the sole extension study uh, is going to be very important in terms of the value of the drug and value of this company. Thank you for your question.
Thank you for helpful. Uh, I also have a follow-up if you find
uh, so besides
meeting the regulatory bar for as approximately 2 pivotal trials. In what? I'm the curious, what is the commercial bar in your mind for expect to gain dominant position in what AMD market in terms of how many letters of bcva loss from Baseline? Maybe at a 36 weeks of 52 weeks? Thanks.
Yes, so Kelly, it's it's it's a great question and it's appropriate question, thank you for the question. First of all, look, you know, the, the most important thing for us to do is to conduct a study in a way that, uh, we will allow this drug to show itself and we're very, very firmly committed to doing that. And our confidence, in this drug has always been great and continues to grow every day. Uh, in terms of meeting the primary endpoint, that's what we have to do. From that point on what we intend will have a lot of data. And what we intend to show, uh, is is, is data that will show a clear profile of this drug. We'll have data regarding, uh, the the Delta we'll have data regarding the visual Acuity regarding Anatomy. So on and so forth. And what we also intend to do is to show the data in a way that maximizes the confidence in the translation of a positive Soul, 1 Study to solar, we realized how important that is and I hear that uh it is very important. Although we realize that the patient
Population is different, uh, in a bespoke manner and intentionally shows. So, the drug is the same and I totally get the fact that when we show the positive Soul 1 data, it has to be shown in a way that allows you and everybody else to be very confident, the translation of that success to solar, and we will do that. So, based on all of those things and based on us, uh, having the potential to get a superiority label. I think we'll have
Sean Makati. And with Raymond James, please go ahead.
Hi, thanks for the question.
12-month follow-up for SOUL 1 as a reader to SOUL. And whether you anticipate having visibility into a meaningful proportion of patients out to say 15 or 18 months on SOUL 1 at that point to get a read on the impact of redosing. Thanks.
Thank you. It's a great question and I appreciate the question. Um, you know, I think as I say we will be providing we'll have a lot of data right away and we'll be providing data in a way that we will absolutely head on address that issue. Uh, as of now I I, I can't tell you that we've advised you to what data costs will be providing. But look, I hear you, I hear everybody, the company hears everybody and saying we need to provide you with that link from Soul 1 to solar. We're absolutely going to be set up to do that. Thank you for your question.
Next question, Lisa Walter with RBC Capital markets, please proceed.
Oh good morning. Thanks so much for taking our questions. Um, maybe a first, 1 on on Soul 1. Uh, just wondering if you can clarify a detail for us, on, uh, off a protocol rescues. Um, you know, for the on protocol rescue injection criteria. Very clear that uh, patients must lose 15 letters or more. Um, but wondering what where patients who have Hemorrhage fall into uh whether they fall into the off protocol or on protocol? Uh, rescue criteria.
Yeah. Good morning Lisa and thank you for your question. Uh, look in every single study and having done clinical trials, for 30 years before, uh, before this job, and the job. Before, what I'll tell you is that in every single clinical trial. Uh, there's a section there that says that the patient may be rescued per the doctor's discretion, and that has to be there to pass the, uh, the, the IRB, um, that is to protect the patient. Um, and the doctor can rescue the patient based on his or her decision, if they feel that that is the safest thing for the patient, as far as the protocol for soul 1 is concerned clearly states, uh, that the that the primary endpoint is based, um, on the rescues. Um, and the rescues consists of 15 letters or more of loss of vision, uh, or any kind of hemorrhage that threatens the, the masculine. Now, what I will say, and what we've been saying over and over again, is that the vast vast majority of patients here are being rescued based on the
Loss of 15 letters of vision and the protocol is being followed and that's very important. Thank you Lisa, for a question.
Next question, you Chen with HC winright, please repeat.
Thank you for taking my question. Uh, could you please remind us what was the rescue criteria for solar before the change? And how do you expect to change to impact the number of patients being rescued? And also, could you comment on whether their, uh, was a change in railroad. Railroad, practice in terms of rescue criteria during the past several years. Thank you.
Yes, so thank you for the question and good morning. Um, so as I say the, the reason that we made the change is that I keep saying, is that it was made purely for strategic reasons, there was no FDA issue whatsoever. Um, as far as the practice patterns are concerned, what what what I can tell you is when we spoke with the RPI, and when we saw, what we saw based on a mass basis with soul 1, we felt that we did not want any questions whatsoever as to the relevance of the rescue criteria, we wanted to make it as a liberal as possible be work because we were very confident, uh, in the drugs. And remember, we have the patient population here. That is the risk, um, and selected after a 6-month loading phase with 2 Opportunity. So we will be randomizing patients that we feel are about as de-risked as we can have them. Uh, based on the uh, the the uh, the ramp that we have. So
Having seen what we've seen. And having heard the piss, our decision was to say, you know, we have enough confidence in this drug now that we can go ahead and allow the rescue criteria to be as liberal as possible. So there'll be no question in terms of adoption or whatsoever. Again, it was made purely for that strategic reason, and we believe that that will allow for a a significant strategic Advantage. Thank you for your question.
Next question, John Wallen been with citizens. JP, please proceed.
The criteria is different. So wondering. You know what was the specific feedback you received to to prompt this change? And then um a second 1 you mentioned your expectation um was in line on. And so 1 for the Cadence of rescues wondering what what is your expectation for the case of rescues for Aliyah versus X packs. Like, thanks.
Yeah, John good morning and thank you for your questions. Um, so so again, going back to the to, to the, to the, to the, to the rescue, uh, criteria. The this, the feedback, you know, really we, we got was was very, very simple. It was look, I I want this drug. I want this, uh, as soon as it's out there and I want to make sure that my rescue criteria now, in terms of what I do for patients is aligned with what I see from solar and you know, people have different rescue criteria in real life but we wanted to make it so that, uh, even folks, that will be rescuing, based on the most liberal of criteria are able to basically have a translation directly from solar. And again, this reflects our level of confidence in this drug uh that we see in a massed fashion. Um,
As far as your question regarding the Cadence of, uh, of of rescue in in, in Soul, 1 is concerned. Let me go back to what we're looking at. We're looking at 3 things, as I've said, the first 1 is the number of rescues. We're looking at the Cadence of rescues, which means that we want to make sure that we see a pattern of, of rescues that we expect. Um, and we absolutely do. We have
Great confidence that we're seeing the kind of rescues that we would expect again in a massed fashion. And the third thing that we look for is we look to make sure that these rescues are being done on protocol. And on all 3 of those parameters, uh, we are very, very, very happy and we continue to see a consistency, um, in those patterns, as I've said, from the very beginning that gives us a great deal of confidence uh, in the results of so on, thank you for your question.
Greg Harris. And with Scotia Bank, please go ahead.
Hey everybody. This is Joe Thomas after Greg Harrison. Thank you for taking our question. Just 1 based on the updates today. Just how should we? And investors? Be thinking about the interplay of the eventual time to market for exactly with the potential Superior label to competitors who might possibly answer the market, you know slightly sooner. Thank you.
Yeah, good morning, and thank you. Um, you know, you know, look, I I, I keep on emphasizing that that's 1 thing that I think is really quite underappreciated which is the position that we will potentially have with a superiority label. Um, again, I'll reiterate if you can just kind of step back and look at this Market, um, every drug is based on a non-inferiority study. Uh, the difference between these drugs are very slight if any at all. Um, and when you have a situation like that, when you have a massive drugs, that pretty much look the same,
Name. The competition is basically based off and on pricing with very little to distinguish the drugs and as someone who's practiced for for 30 years, uh, I realized that the downstream pressures of something like that. And the downstream pressures of something like that. Is that the relationship that a doctor has with a patient is, is, is taken away, or at least impacted because the choices that are that are made for the drug are being forced to make be made based on pricing.
Um, and often times the consequences of that are are really very bad for the patients. Again, we have studies in chronic diseases and retina where, uh, if the patient is started on the proper drug in a delayed fashion. The vision, never recovers the vision May improve, but really never recovers to the extent that it should have been. And again, as I said earlier on, this is a major point of study for extension. Um, our sole extension study. Um, we will have unique data there where we're able to see what happens to patients, who are started on. Actually, after a 2-year delay, we'll have an opportunity to see if that catches up or not. And when we, when we see something like that happening, where there's irreversible visual loss from a delay in treatment, uh, that has a tremendous impact on patients, uh chronically. Um, so with a superior order that label our expectation is that we'll be in a different
Different orbit we will be immunized, you know, from the, the rest of the drugs, and the rest of the pressures, that they may feel this, a lot of great deal of value to um to the drug to the company and most importantly uh we believe that this will allow for better better. Patient care and better long-term outcomes. Thanks for the question.
Next question, Lachlan Hamburg.
Brown with William.
Hey guys, thanks for the question. Uh, I was curious on the reason for starting the open label extensions Now versus having them up and running previously, you know, prevent you mentioned that, you know, obviously you've been in the space for for a while, seeing the data from all these studies showing long-term benefits. So
Knowing the value that that can provide like, why?
Why did you not originally start with? Why? Why did that change now?
That. Yeah again, thank you. Good morning and thank you for your question. There's really no no reason other than a logistic. Um, you know, at a at a certain point, uh, you know, you start these studies with with, uh, with what you see, under a masking with again, with a great deal of confidence and you step back and you say, what questions can we answer with this drug and what questions would be most clinically relevant to be answered? Um, and and that's, that's, that's the question, is that we're asking again we'll have a lot more detail regarding what the extension study will look like, um, and further questions that we'll be asking in the extension study in our investor Day on, on September 30th. Thank you for the question.
Bill man with clear Street, please go ahead.
Good morning and thanks. Uh, so you mentioned excluding patients with high flux rations and ocp from the, uh, from The Trial to, to reduce noise, which makes sense. But I just looking down the road. Do you expect any, um, any impact on the commercial effort? Um, either by uh, uh, restrictive label discussing, uh, excluding these patients or just understanding
Among the prescribing community that uh these patients were excluded from The Trial. Thank you.
Yeah, good morning. And thank you for the question. No, quite the opposite. Quite honestly. So let's just speak from the doctor's point of view as well as from the label point of view, from a physician's point of view. What we're providing is is is a pure patient population by reducing the noise. We're actually providing much more valid scientific data. So from a physician's point of view or a clinician's point of view, the data that we're providing that, providing it, pure scientific patient population provides for a pure comparison. So so quite the opposite. As far as a a clinician is concerned from a labeling point of view that's never ever been the case. And the most recent example that I have from a personal Viewpoint is my last company, uh, and and I have Eric bio. The same question was asked about labor restrictions or if you recall all the studies were done with patients with extra foval Geographic, atrophy, in fact, not a single patient with phobia involving, Geographic. Atrophy was ever studied and this question was always
Was brought up. And as you can see in the label, there are no restrictions at all. And there are numerous examples of that going all the way back to Anchor and Marina and visual acue to restrictions in terms of patient enrollment to Panorama for instance, look, looking at diabetic retinopathy and only a certain group of patients. So history has shown that. As long as you conduct a proper scientific study that
WellMed. Well conducted. There really will be no label restrictions.
Thank you for your question.
Sir, it's Ballinger with Native and Company. Please go ahead.
Hi, good morning. This is John on percentage today. Uh, congrats on all the progress. Pine, um just to touch on again, the the translation of Soul 1 data, the solar uh considering the distinct purposes and criteria you noted for each trial. Um do you view the readout of so on as a de-risking event for solar or more? So complimentary considering their answering different questions
Good morning, and thank you for your question. It's a great question. So what I will tell you is look, um, it's it's like it's clearly both.
Um, again, I'll repeat this. I know there's a great deal of interest in looking at the SOUL 1 results and seeing the translation into SOLAR. That, in my mind, is completely appropriate and understandable. The patient populations are deliberately different; the drug is the same, and we will address that. Um, I hear you. I appreciate it. We will address that in the data cuts that we will release to give you confidence in the translation of a positive SOUL 1 study to SOLAR. Now, having said that...
Opportunities to look for instability. So, the patients that wear randomizing are about as de-risked as we can make them so that in itself should give a great deal of confidence in terms of patient selection. The second thing in regards to clinical trial design,
Remember that our primary endpoint is at week 56, it's a singular endpoint, it's not a blended endpoint, it's a singular endpoint. This, in our opinion, is an optimal endpoint because it's 2 months after the last x-axis injection and the last, uh, a flubber set injection. Um, so given those 2 things, you already should have, you know, quite a, quite a bit of confidence in the success of solar. But having said that, I completely understand and hear that, the sole 1. Positive results will have to allow you to translate that success into solar. We hear you. We understand you and we intend to address that.
Thank you for question.
This concludes our question and answer session. I will now turn the call back over to Dr. Pine dugle for closing remarks.
Thank you very much.
Once again, 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 contact Bill Slattery our vice president of investor relations. Please also register for our investor day. Have a great day everybody. Thank you.
This concludes today's teleconference. You may disconnect your line at this time and thank you for your participation.