Sun Pharma Advanced Research Company Limited (SPARC.NS) Earnings Call Transcript & Summary

Ladies and gentlemen, good day, and welcome to SPARC Conference Call. [Operator Instructions] Please note that this conference is being recorded. I now hand the conference over to Mr. Jaydeep Issrani. Thank you, and over to you, sir.

Thank you, Michelle. Good evening, ladies and gentlemen. My name is Jaydeep Issrani. I head the Business Development and Investor Relations at SPARC. On behalf of SPARC, I welcome you to today's call and appreciate you for taking the time out on a Saturday evening to attend the call. I am joined by our CEO, Mr. Anil Raghavan; and the senior management team at SPARC. Anil will walk you through the presentation, which we have shared earlier. And after his presentation, we will open the call for questions. Before we start, I would like to remind you that our discussion today includes forward-looking statements that are subject to risks and uncertainties associated with our business. Hence, the actual results may be different from those projected in the presentation today. I will now hand it over to Mr. Anil Raghavan for his presentation. Over to you, Anil.

Thank you, Jaydeep. Good evening, everybody. Good morning and good afternoon, if you're joining internationally. Thank you for taking this call on short notice. It's been a very short notice for this call. I have 4 key objectives for this call. Wanted to provide an update on the Vodabatinib program. I want to set up our immediate priorities going into [ '24-'25 ] financial year for Vodabatinib, particularly after the data events that we are expecting. And also want to provide some perspective in terms of how to look at this program in balanced way. We're spoken about the opportunity extensively in our investor call earlier this year. Also want to give a sense of some of the risks that we're seeing in the program or customary to this kind of programs. And probably most importantly, this is an opportunity to answer any questions that you may have before we go into a quiet period on the interim analysis. So with that, let's move to Slide 3. So Slide #3, we have a recap of the status of the program. We have touched upon some of this in our earlier call. Vodabatinib, a [ Poc ] program, which is called PROSEEK, completed its enrollment target earlier this year around October of 2023. Our target was 506 evaluable patients. We ended up with 513 patients globally and the independent analysis as communicated earlier is planned with [indiscernible] patients. That's the patient cut off. Enrollment cut off was May of 2023. So we have 441 patients going into this interim analysis and that is planned for late March, early April of 2024. As we communicated earlier, the broader organizations will be blinded. Not just the broader organization, the external ecosystem or investigators and others who are participating in the trial will also be blinded because we will still have around 70-odd patients in different stages of treatment and protecting the integrity of data from those patients is an important consideration for the trial and also the regulators in different countries. In that sense, we are committed with maintaining the blind and protecting this information to ensure that we don't induce unnecessary bias in conduct of the trial. So I spoke to the design of the program. We have covered that in many earlier conversations. But just to kind of give a very brief overview, this is 2 doses of Vodabatinib with 168 patients each, in the original design intent, we meant more than that, 384 milligram on the top dose and 192 milligram on the lower dose against a placebo arm. As we've spoken about in the past, MDS-UPDRS Part III is the primary endpoint, and we have a host of secondary endpoints and biomarker reads which are mostly exploratory. And the study also has Part 2, which is a long term extension study where patients are on the drug for another 40 weeks. That's another roughly around 10 months. These patients are around Part A and Part B combined for almost 80 weeks, and those patients go through this 80-week period without any symptomatic therapy. So that's the design of the program. And I have already talked about some of the milestones, like interim analysis in April. The full top line data for PROSEEK is expected in August, September of 2024. That's when we will have a full disclosure on the data. Now, moving on to the next slide. Has a listing of our near term priorities post availability of data from PROSEEK. The primary objective at that time in 2024, '25 financial year is to ensure that we move on to the next phase of development without a phase lag, if we're fortunate to have positive data and data in line with expectations of the hypothesis. That requires several steps. Most importantly, in agreement with regulatory agencies globally in terms of the nature of registrational studies required. So that would happen during the end of Phase 2 consultations with U.S. FDA and other important regulatory agencies globally. We hope to do that in short order after the September data core break. And in parallel, we will be continuing the long term extension study of PROSEEK. And as soon as we have clarity in terms of the nature of the registrational studies required, we hope to initiate the pivotal program, the Phase 3 programs, globally. And our strategic intent would be to minimize that lag between end of Phase 2 and initiation of Phase 3. And we will also be using this time, right from the availability of interim analysis data, to explore and finalize and execute a [indiscernible] strategy, so that as we move into a late stage development post PROSEEK, we can do that with a partner who we may be going with for commercialization of the assets. And as I said, the regulatory agreement is an important element in triggering this, and it is not just about additional clinical studies required. We may also require additional preclinical studies, particularly toxicity studies, and also additional steps to be taken for ensuring manufacturing raw business, particularly given size and potential of this product. So let's go to the next slide. So, when we met you in the last quarter of 2023 for our annual investor update, we have spoken extensively about the program, the potential of the hypothesis and its implications on the standard of care of Parkinson's disease, and also more broadly about the possibilities of diseases driven by alpha-synuclein and in the outer run of possibility, diseases that are driven by other proteins impacted by oxidative stress and [indiscernible] activation. So we have spoken about the opportunity clearly. We thought that it is important, given some of the communication and coverage that we are seeing on this program recently. It's important to also highlight some of the risks which are inherent in programs like this, especially in translation programs in neuroscience. So we want to highlight 3, 4 major risks that you may want to keep in mind as you kind of think about these programs. One is the translatability of animal models in diseases like this. If you've seen these animal models have built on intent to mimic underlying mechanism and create the manifestation of disease which can be addressed with the trial. While they are found from a science standpoint, their true validation will come when programs which are developed with these models go on to clinic and get validating clinical data and go into market. So in diseases like Parkinson's, we haven't seen significant clinical translation in a long time, especially in disease modifying therapies which are designed to bend the neurodegenerative arc. So we are one of the early companies which are trying to translate the oxidative stress pathway, and therefore these models carry a certain level of risk. And it is important to keep that in mind as you kind of evaluate this program. A couple of other risks that I want to highlight. One is about target engagement and dose. We have used, if you've been following this program, we used the top dose in our animal models that is fortified and expected as a marker for deciding our dose into the Phase 2 clinical program. We matched the brain exposure associated with the top dose in animal studies, which is the most efficacious dose in animal studies. And in early clinical studies, we matched that exposure in Parkinson's patients' CSF, which we believe is a good proxy for free levels in the brain. So even though the translational process is sound, this field clearly lacks a target engagement marker because we cannot open the brain and see what happens. There are challenges in terms of clearly getting appropriate dose in humans. There is a certain level of approximation that is done by extrapolating animal data that may create certain level of risk which needs to be factored. And the third point that I want to highlight is the reproducibility of early clinical studies, clinical proof of concept study as we think about repeating those results in later stage clinical settings. Typically, if you look at companies which are doing early proof of concept studies, they are more smaller pilot studies, and the [indiscernible] comes from inadequate powering of early studies. And we have tried to address some of that in the design of the PROSEEK trial. PROSEEK is for a Phase 2 program. It is an extensive study with 500-plus patients, which is powered at around 80% power. So in that sense, even though we have tried to address some of the translation risk, that is, some of the risks associated with reproducibility of early stage clinical results in late stage clinical programs, that is still a risk in the sense that it needs to be reproduced in the larger study in Phase 3 setting. And the last point is this will require extensive additional work in terms of Phase 3 programs, and resourcing that and actually executing that in a timely manner is the last point that I want to make [indiscernible]. We have also, in the earlier presentations, talked about opportunities for Vodabatinib beyond Parkinson's disease, and that would require additional preclinical and clinical work. And we are in the process of doing some of that. These are mainly in 2 buckets. Diseases which are driven by alpha-synuclein, like Lewy body dementia, MSA. You may know that we have an investigative initiative trial going on.

I'm sorry to interrupt. Sir, can you speak a little bit louder, please?

Sure. So I was talking about additional indications for Vodabatinib, which will require additional preclinical studies and clinical studies. And some of those studies are currently underway. You may note that we have been working with Georgetown in investigative initiative trial to explore this program smaller proof of concept study for Lewy body dementia. We are also working in early stage preclinical work in Alzheimer's disease with this mechanism with academic investigators. So there is additional work that needs to be done to fully explore the potential of this program in other indications and other diseases, but also in other settings in Parkinson's. If you look at the design of Vodabatinib's PROSEEK trial, we are looking at early stage Parkinson's patients who are presymptomatic therapy. Those are patients who are very early in their disease process before they get into symptomatic therapies like L-DOPA. So if you demonstrate disease modification or bending of the neurodegenerative arc in this setting, clearly there is justification for exploring this program in other settings. In Parkinson's disease, like [ base case ] disease is the companion for symptomatic therapy and also precursor conditions. In both these settings, that would require additional studies. So success on PROSEEK would be the beginning of an extensive journey which would then validate the program in the early setting, which would be our first registrational program, but also it will initiate a significant number of opportunities outside. But all of that would require additional investment and additional exploration from a preclinical and clinical standpoint. That takes me to my last slide. Just wanted to highlight a few market-related risks here In this slide. We have seen recent coverage on Vodabatinib, which in our view captures some aspects of the program, not all aspects of the program, comprehensively. So, for investors who intend to price in Vodabatinib's potential to their decisions, deliberate analysis of the potential of the program, both from a sales standpoint and also extension into other possibilities standpoint, along with an understanding of cost, risk and also time to market. It's important before you take those calls. In a setting like this, when early stage biotechs go into data events like this, there is significant risk of price volatility, and that is somewhat magnified in the market like India, in the absence of informed analyst coverage, which looks at these programs carefully. So when you look at this reporting that is coming in, we urge you to take a balanced view on the program, which balances both the potential of the program as well as the risk of the program. And finally, I want to reaffirm our commitment to this area. We are going to see significant data coming from this program in the rest of this year, interim analysis and also in the final analysis. That's going to teach us a lot about [indiscernible] role in neurodegeneration. It's going to teach us about how moderation in oxidative stress pathway is going to have a role in treating neurodegenerative diseases. And there is a significant number of possibilities in these data events. You can have a clear validation of this hypothesis, you can also have a clear debunking of this hypothesis, but there's also lot of gray space in between. So this data, we are looking forward to contextualizing what we are going to learn and then finding ways to move forward with continuing exploration of this program, and not just in this area as in this hypothesis, we also want to reaffirm our commitment to neurodegenerative diseases. In fact, if we go back several years, that was a bet that we have taken that neurodegeneration, in spite of conventional wisdom going the other way, we believe that the neurodegeneration is an area is maturing from a science standpoint, and that has also been validated recently with several transactions happening in this space. So we will continue to be interested and continue to be excited about making a bend on these difficult diseases in the neurodegenerative spectrum. So with that, I will conclude my comments and open up this call for questions that you may have. Thank you very much again for attending this call on short notice.

[Operator Instructions] We'll take the first question from the line of Ketan Gandhi from Gandhi Securities.

In the November 2 presentation, you indicated on Slide 19 that approximately 87% of the eligible patients enrolled in Part 2 from Part 1. However, in current presentation, there is no update. Do you have any update on that, sir?

No. That is true, 85% to 87% of eligible patients are in patients who are completing Part 1 of the study and eligible for continuation into phase and long term extension study, is enrolling in the long term extension study. We don't have additional data. That trend continues.

Do you interpret the rollover rate to Part 2 as indicative of patients positively embracing the treatment, or is it possibly a result of patients not experiencing the desired improvement? What is your thought process on that?

It's very difficult to conclusively say that because we have significant number of patients on placebo, they may also want to have, even if they are not improving, they may want to access the drug in the long term extension setting. So there are lot of motivations, patients are feeling better and they may want to continue. Patients feel that they're not feeling better, that they may be on placebo and they may want to transition to drug. So there are significant number of different motivations that may be driving that conclusion. So while it may be encouraging, it's difficult to draw any definitive conclusions based on that.

And on Slide 5, under the section, Expanding Evaluation of Vodabatinib, it is mentioned that SPARC would explore initialization in an early treatment and night setting. Can you throw some light on regulatory pathway post announcement of PROSEEK topline data in August '24? Whether we would go for regulatory approval or we would go after Phase 3? Can FD help us in getting approval post EOP 2?

So first, let me give you a little bit of context to this statement in this presentation, which is explore initial registration in early treatment, treatment-naive setting. And that is the most logical way to plan a registration leg for this program given the evidence that we are likely to see from PROSEEK, assuming PROSEEK was the patients who are coming into PROSEEK are early stage patients who are treatment naive from a L-DOPA and symptomatic therapy standpoint. So if you're getting a positive readout from that trial, the least risk option from a registrational standpoint is to repeat those studies and reproduce those results which will become the basis of registration. The intent of that statement is that the early or the initial registrational setting would be a repeat of what we have explored and studied in PROSEEK. Now the second part of your question in terms of what would be an actual registrational program and regulatory ask? That is subject to the discussions that we need to have with regulatory agencies. We're going to have end of Phase 2 conversations as soon as we have data, and there are very many possibilities. Traditionally, agencies would require 2 additional Phase 3 studies and that's that classical ask in these kind of settings. But there are also other possibilities of factoring PROSEEK into a registrational package in some form of fashion. But that is all strategies that would require validation and agreement with agencies around the world, and we intend to do that as soon as we have data from the PROSEEK program.

Sure. So final shape on the registrational package can only be clear after we have these discussions with the agency. Sure. If I may squeeze one more question. Is my understanding right that we will be starting partnership program as soon as between interim data analysis and the topline data between that period?

That is true, yes. We expect to initiate conversations with potential partners. We may not be able to conclude that before a final data disclosure in August, September, but we intend to kind of use this time to engage and create interest and work towards a partnership as we kind of get to September.

[Operator Instructions] We'll take the next question from the line of Ishita Jain from Ashika Stock Broking.

Am I audible?

Yes, ma'am. Please proceed.

Thanks for the update. I appreciate this reiteration of the risks associated to drug development. My first question is, so our enrollment concluded in October 2023. Was the enrollment time line as anticipated, or did we face any challenges in recruiting?

There was a big muffle. I couldn't hear you.

Okay. So my question is that our enrollment concluded in October 2023. Was the enrollment time line as anticipated, or did we face any challenges in recruiting?

See, if you remember, Ishita, we started this program even though technically in 2019 and with actual doses we started the program in early part of 2020, exactly when health systems around the world started shutting down because of pandemic. The initial couple of years had been rough for the program because most of the hospitals were not seeing patients in person in hospital settings, and many of our endpoints require practitioners' reassessment at site. So in that sense, we clearly have seen slower than anticipated recruitment in the first part of this study. But it was clearly picked up in the last 18 months or so, which helped us conclude this program almost in line with the revised time lines, we did a revision of the time line during the COVID phase. COVID induced certain delays, but other than that, in the last 18 months, the program has been tracking [indiscernible].

Understood. So what I'm trying to understand is that if we go into, let's say, Phase 3, what would Phase 3 terms of size and then enrollment concerns in Phase 3, is that significant? I mean, obviously, notwithstanding existing drug development concerns.

I won't be able to comment on the actual size of the Phase 3 program. There are significant number of statistical considerations that go into defining that size, and it will also be informed by the data that we are seeing in PROSEEK in terms of the doses that are effective, what is registrational dose that we want to carry, and the effect size that we are seeing in the Phase 2 settings. So there are a lot of variables which can only be informed by data from the PROSEEK trial. I won't be able to clearly indicate a size of the Phase 3 program, but we expect to maintain the momentum that we had in the later part of PROSEEK in terms of recruitment going into the Phase 3 program, because we have built relationships with investigators across and other service providers in this ecosystem, and we understand this space probably better than we started off. So I think we are confident that we can maintain the momentum that we had in the second half of this trial from an actual recruitment rate standpoint. But actual size of the program in terms of the number of patients that's required is a function of where we land [indiscernible]. It would be difficult to extrapolate that now.

Makes sense. And I think, I'm not sure if you already mentioned it and did I miss it? But meeting with the agency would only be post final data, right? There would be no agency meeting with interim data.

Yes, the agencies would require completion of trial and data from the ITT population before we can have the interface to meeting.

Okay, if I may just ask one more. You mentioned that we may require additional preclinical studies. What kind of studies would these be? I know it would be around efficacy, concentration of drug in the brain, or checking for specific biomarker. What kind of additional preclinical studies would be required?

So there are several toxicity studies which are expectations from standard expectations in a registration package. To give you an example, customer genetic studies, for example, is a standard expectation in the registration package. And there may be additional clinical trials like drug-drug interaction studies or other toxicity studies in clinical setting. So there are path of customary expectations in a registrational setting, both preclinical studies and certain additional clinical studies. Clinical studies are not major clinical studies, but they are either PK studies or studies which explore safety endpoints.

[Operator Instructions] We'll take the next question from the line of Bino Pathiparampil from Elara Capital.

Could you please make some comments around the IP estate around Vodobatinib. Do you have a drug substance patent? How long does it run et cetera?

So I don't have the exact dates in front of me, but I can indicate the ranges with composition of matter and regulatory compensation for the development time. We will go into late second half of '30 from IP coverage standpoint. And we may also have some additional patents which are covering the states, the method of treatment patents and also potentially formulation patents. So we are confident that we may go into late second half of 2030s for sure.

[Operator Instructions] Ladies and gentlemen, as there are no further questions, I would now like to hand the conference over to the management for their closing. Sir, can we take one question? As I can see, one participant right now joined in the conference. We'll take the question from the line of [ Tushar Vohar ] from [ SK Ventures ].

That's Tushar Bohra from MK Ventures. Just a couple of points. So, while the end of Phase 2 discussions with FDA would happen only after the final data, but fair to assume that the interim data analysis, whatever the readouts that we would have, the same would be shared with FDA as well. And that may be useful whenever we have the final discussions. This would be something like a preread or an advanced discussion item that is shared with them.

We do not have current plans of sharing in the interim analysis outlook. I mean, the data with agencies. Our next planned interaction with the agency on PROSEEK data would be post full data disclosure in September of 2024.

Okay. And in the November interaction you had mentioned regards to my question only about 2 or 3 drugs, especially in the case of Alzheimer's, where FDA has shown inclination for a faster registration pathway. Is it fair to assume that a similar pathway is potentially one of the options for SPARC as well as in PROSEEK trial is large enough and pivotal enough that FDA may in one of the situations have that as an option, that this can itself be used as a registrational study?

Yes. If I answer that it should be speculative because it require agreement with the agencies. But I want to highlight a couple of points. We have a significant number of endpoints in PROSEEK, both clinical endpoints and biomarker endpoints. The possibility of an accelerated approval would require significantly in terms of how the data comes in, where all the [indiscernible], especially, I mean, if you look at the precedents in Alzheimer's or ALS recently, they have used a conditional approval pathway which was based on validated biomarkers in those areas. So Alzheimer's and ALS, Alzheimer's because of the [indiscernible] because of the validation of a neuronal death marker called neurofilament light had significantly more clarity in terms of the correlation of these biomarkers with clinical outcome. So we may see similar trends and similar correlation in PROSEEK, but in the field at the moment, we don't have validated markers like Alzheimer's had going into those events. So in that sense, there are some challenges inherent in the indication which kind of differentiates with AD or ALS setting. But there may be possibility then I think it is highly speculative to indicate that as a possibility at this point. It's a function of what we see in the trial and also how the regulatory agencies interpret that.

Fair enough, sir. And at different points in previous discussions, it has been mentioned, at one point I think we mentioned that there is a backup compound to Vodobatinib that we are looking at potentially for Alzheimer's as well. And I think in a previous discussion in November, it was highlighted that Vodobatinib can also work for Alzheimer's, the alpha-synuclein pathway, if I get that right. So which one is it? It's maybe a bit early, but just to understand the thought process, whether it is Vodobatinib itself that we may look for Alzheimer's also at some point, or is there another compound, maybe similar domain that we may look for Alzheimer's?

I think if we continue to see preclinical data coming in expected lines, we think Vodobatinib can be explored in Alzheimer's disease because of its activity in alpha-synuclein. But in mechanistic studies, mechanistic studies in vitro or in [ IPSC ] derived [indiscernible], we have seen proteins like activated [indiscernible] Tau or A Beta 40 and 42 moving in a positive direction with Vodobatinib. So this mechanism of [indiscernible] inhibition may have legs in diseases which are driven by other proteins other than alpha- synuclein. And that is a key part of the data that we have already presented and disclosed. And that is what gives us confidence to look at these other indications like [indiscernible] disease or ALS. But from an actual development strategy standpoint, we have spoken about this in the past. We have a backup program for Vodobatinib. There are additional assets in that package and we may develop an additional compound, backup compound which will give us a longer IP life from a composition matter standpoint for additional indications. So we may choose to develop a backup compound in alternative indications driven by other proteins.

Got it, sir. One last on the Parkinson's beyond PROSEEK. Assuming that we need to do a Phase 3 trial, how prepared are we for launching the trial? Typically Phase 2 to Phase 3, there is a decent lag in a number of programs because of lack of preparedness under trial design or regulatory clarity, or even funding clarity for that matter, assuming we have a very strong positive data on PROSEEK and we are required another trial, how well prepared are we? Have we already started working in that direction, sir?

There are multiple components to that question. If you look at various different variables of preparedness from a late stage [indiscernible], one is what to do in terms of regulatory and scientific clarity about the nature of registrational trial or [indiscernible] program that we want to have, and activities that we need to obtain that clarity, and then an ability to kind of design a trial according to those expectations and execute that. And then there is a competency and scale related aspect, which is substantial in a Phase 2 to Phase 3 transition, because kind of competencies that you require and the scale that you require in a Phase 3 setting may be somewhat different from what control a Phase 2 program. Then, as you rightfully pointed out, the resourcing expectation is significantly more in the Phase 3 standpoint because you may need to conduct multiple global trials to complete the traditional Phase 3 package. So on all these counts, we want to move at risk in the next few months, and we already started working on some of these aspects, thinking about what could be the nature of the Phase 3 program from a science standpoint, and also try to put together sense of the capability gaps that we want to bridge and also the extent of resourcing that is required. So we are actually doing some of those preparatory activities at risk, but we can only get full steam once we have clarity from PROSEEK, both from a data standpoint and also it gives us an ability to discuss this more openly and transparently with other players that we need to discuss this with, for example, for resourcing. So it's a nuanced answer. Yes, to the extent that it's possible now, but we are extremely aware of the extent of work that needs to be done and it will all get enforcing post data in September.

So even in the eventuality that 2 outcomes, one, where unfortunately, let's say we don't get the relevant data outcome in PROSEEK, and 2, where we have a very strong outcome and the trial goes through well, and maybe we go through to a registrational study. In both these situations also, in any case, you will do a trial for Vodobatinib for a symptomatic setting, right, in combination with L-DOPA and the existing regime. So that part, in any case, you would be already working on some kind of a trial setting, which is something that any which way to do.

No. So let's look at the spectrum of possibilities that can come from the PROSEEK trial. On the positive side, you can have a full validation of the hypothesis and data in line with the design expectations of the trial. On the other end, we can have a full rejection of the hypothesis in the sense that the going in assumption about this mechanism, mechanism producing a certain level of difference on the trajectory of neurodegeneration was not correct. There can be a rejection of hypothesis and there can be a host of possibilities in between. That is, it is working in patients with a certain disease severity, or it is working with patients who may have MAO-B inhibitors as a background. So there are a lot of other possibilities in terms of that gray area between a full rejection and a full validation. So your question was pertaining to the full rejection of the hypothesis. If I understand it right here. In that case, we don't believe that there is a justification for exploring this program further in any setting, because it rejects the primary mechanistic hypothesis. But in all the other possibilities, whether it is full validation or validation in parts, in different settings, that difficult gray area, we think there are possibilities to move forward with an appropriate registration package.

Got it. Sir, I was just wondering that if the trial is successful as well, then as you said, that you would look at Vodobatinib for the extension of the entire Parkinson's program. So that part, in any case, you would already be working on, right.

If the program is successful, if Vodobatinib is approving, is validating the [indiscernible] hypothesis in PROSEEK, then there is justification in extending this to other settings in Parkinson's disease. Because if it is slowing down the trajectory of the disease, then it can be a companion for L-DOPA and slow down late stage disease. Or you can think about exploring this precursor condition, but if it is not slowing down, then there is no basis. That's the point I was trying to make.

But if it is slowing down, or if it is having some reaction, but maybe not sufficient enough to meet the trial design, in that case, is there still a scoop or reason to study it in symptomatic setting?

We have to take a close look at the data at that point. What you're indicating is that you are seeing a trend, but you may not be meeting statistical significance because the trend is not as strong as you initially thought. We had to take a close look at that trend and take a call based on the data that you have seen. But that is the possibility. I don't want to reject that possibility.

The next question is from the line of Jigar Valia from Ohm Group.

Sir, if you can help understand the administrative interim approach versus the full interim, and while you still maintain that there might be a requirement for a proper Phase 3, and would certainly go with a partner approach, and there would be challenges in terms of seeking or getting leeway on the Phase 3. So we want to understand with regards to the administrative and is there a slight possibility that it may be thought for a Phase 4 direct so wherein a full-fledged this thing happens, but post approval?

Right. So the difference between the interim analysis or administrative interim analysis and the full data set is the number of patients who are going into the data analysis. We have 441 patients going into the interim analysis in end of March, early April, and 513 patients going into the full data set, which would happen in early September next year. So essentially, we will have practically all of the clinical endpoints and many of the biomarker endpoints in this interim analysis, but not all. Some biomarker endpoints would require additional time in terms of both validating the method and also getting in touch. So we will have all endpoints, the primary endpoints, all the secondary endpoints and all the biomarker endpoints as part of the final readout in September. While we may have a substantial subset of that in the interim analysis, those are the 2 differences, the number of patients and also the extent of data from an endpoint standpoint. The second part of your question is tricky in the sense, I don't want to get into a speculative [indiscernible]. There are possibilities in terms of nature of registrational expectations from different agencies, but giving a guidance in terms of what is possible at this point is dangerous in the sense that it is subject to significant change based on data and how the regulatory agencies interpret that data. I would refrain from taking a position in terms of what could be a possible registration factor. We have those discussions with the agencies.

Since the additional patient subtypes would require additional investment time, future time. So if you can help understand the partnership approach, would it be only for the Parkinson's disease PD right now, or would it also try to cover the additional subtypes?

Yes, so we are getting into this partnership process with a certain level of openness in terms of the kind of partnerships that we want to have. We would like to have a relationship which maintains some level of participation in both development and also commercialization of this program, plus some flexibility in terms of additional indication retained within SPARC. But at the same time, these discussions can take a life of its own once you get into them. So in that sense, we are open minded in terms of approaching our partnership strategy. Baseline expectation is that we will continue to retain our role in some level of role development and commercialization. But an actual nature of partnership would be a function of what we are going to see in this process, but we will explore that fully post the independent analysis data in March.

Got it, sir. Other is to understand, since the partnership is going to be for the PD perspective, et cetera, would you be looking at funding for any other programs or. I mean, only this would be a priority until this is settled. So you also have the fundraise approval, et cetera, those in place apart from the partnership approach.

Right. So I don't want to draw a hard line and say partnership would only be for Parkinson's disease. One of the objectives for partnership or one of the drivers for seeking a partner is to expand this program [indiscernible]. In that sense, we would like to leverage both resources and also competency muscle of larger partner in terms of fully exploring this program in Parkinson's and also in other indications. But how we actually carve out those different spaces in terms of ownership and extent of [ dilution ] is a function of these discussions. So we don't have a fair view that the partnership is only going to be for a limited [indiscernible] setting. SPARC would continue to resource everything else that's not the intent is going into this process.

Right. So just a hypothetical this thing that, God forbid, in case of a negative outcome, does it remain open to pursue the CML indication, given that this would be [Technical Difficulty]

Yes. We already have clinical proof of concept for CML and it would require an additional study. We have some clarity in terms of what the study is. And then we have to take a decision whether SPARC would invest additional resources into conducting those trials or whether we need to see the partner to do that. That's a call that we can take once we have clarity on the data.

The next question is from the line of Bino Pathiparampil from Elara Capital.

If you're not going to share the administrative interim analysis with pretty much anybody, like you said, what is the purpose of this administrative interim analysis?

There are question that we just had. We spoke about the partnership strategy and one of the key objectives of the interim analysis is to engage with potential partners early on so that we can try and minimize the time that we require post the full data in September. So it is not correct that we are not sharing this with anybody. We will share this with potential partners under CDA and appropriate safeguards with a limited number of potential partners. That's the expectation at this point.

Ladies and gentlemen, that was the last question of our question-and-answer session. I would now like to hand the conference over to the management for their closing remarks. Over to you, sir.

Thank you, everyone. Thank you for taking out time for today's discussion. We now end the call. In case you have any follow on questions, you can reach out to us on the email and the numbers provided on our website. Thank you again. Have a nice weekend.

Thank you very much, sir.

Thank you, everybody.

Ladies and gentlemen, on behalf of SPARC, that concludes this conference. We thank you for joining us and you may now disconnect your lines. Thank you.