Please note that this conference is being recorded. I now hand the conference over to Mr. Jaydeep Israni. Thank you, and over to you, sir.
Thank you, Sagar. Good evening, ladies and gentlemen. My name is Jaydeep. I head the Business Development and Investor Relations at SPARC. On behalf of SPARC, I welcome you for the update on the Interim Analysis of PROSEEK study. I have with me Mr. Anil Raghavan, CEO of SPARC. Anil will provide brief update on the outcome of the PROSEEK study, following which we will open the call for question and answer. Before I hand it over to him, I would like to remind you that our discussion may include forward-looking statements that are subject to risks and uncertainties associated with our business. I will now hand it over to Mr. Anil Raghavan for his presentation. Over to you, Anil.
Hello, everybody. Thank you for joining the call today. Thanks, Jaydeep, for the introduction and setup for the call. As he mentioned, we plan to provide an update on the Interim Analysis of our PROSEEK study and briefly talk about the next steps and the way forward for SPARC. The primary objective, though, is to try and address your questions and concerns as much as possible today. So I'll keep my opening comments brief. But before I begin, I would like to apologize for the delay in convening this call. We received data from the PROSEEK Interim Analysis last week and made a disclosure of the results through a press release immediately, within a day. Our intent was to provide an update and talk to you as soon as possible.
However, the immediate focus thereafter shifted to initiating the closeout activities which mandated and thinking through the near-term priorities, which took a few days to complete. We believe it is important to map out key next steps toward that before we can have a productive conversation with you. Again, we understand the sensibility and sincerely apologize for not following up the release immediately with the call. You may recall that our initial plan was not to disclose the interim results before completing the review of all the 513 patients randomized on the trial. However, in the interest of patients, our investigator community, and the larger investor group, we decided to unblind the study and share the results immediately, given the trendlines that we have seen.
As we disclosed, we completed the review of 442 out of 513 patients, 442 who finished the first part of the study, Part 1 of the study, by March of 2024.
Alexa, set the timer when timer starts at 71.
Sir, can you put your line on mute, please?
Okay.
The data suggested that the Vodobatinib arms, that is, the low-dose and high-dose arms, did not meet the primary endpoint of change in score from baseline in MDS-UPDRS part III at week 40. Key secondary endpoints have also shown a similar trend. Overall incidence of serious adverse events was low in this trial, indicating an acceptable safety profile. That was indeed a disappointing outcome and certainly not what we hoped for our patients, especially after having generated significant body of evidence in preclinical model systems in collaboration with some of the most important thought leaders in this space, demonstrating the neuroprotective role of Vodobatinib in multiple preclinical experiments. Based on our statistical projections that suggested that the study is unlikely to show clinical benefit in the overall study population, we decided to close the trial.
Having said that, we will review the full dataset, which is not expected to change the primary endpoint of the study. However, it can provide meaningful insights on the mechanism, the drug, and the trial. We will keep you informed as we complete this planned analysis. Once we have reviewed the full data, we will also evaluate the expectations for and the value of Lewy Body Dementia investigator-initiated trial at Georgetown and preclinical programs for the backup series of Vodobatinib as they target the same mechanism of action as Vodobatinib did at PROSEEK. But as of now, we have parked all activities in these studies. Obviously, these results represent a setback for SPARC, which will pose questions on certain parts of our portfolio and challenge our ability to pursue an aggressive R&D agenda.
As we complete the data analysis for PROSEEK, we will also work towards resetting our portfolio, optimizing our operating model, and cost structure. This is really important, considering the additional costs that we have got to charge. As we have indicated previously, SPARC's pipeline has significant optionality, including multiple clinical assets and a late-stage preclinical program, which is expected to enter the clinical testing phase in the last quarter of this financial year. So please allow me to take a minute to highlight these assets with short to medium-term milestone visibility. The most advanced program is K0706, as you may know, which is Vodobatinib oncology arm for treatment of CML. We have completed the phase 2 study, and the data provides clear validation for the third-line disease in leukemia with excellent response rate, even in patients who have exhausted all available therapeutic options.
As next steps, we are discussing the registration strategy design and expectations with the USFDA, in fact, later today, to decide future development strategy for K0706. Since K0706 has established human POCs, we may explore licensing the asset to a partner to raise non-dilutive capital for developing other late-stage assets. That's SCD-153 and SBO-154. SCD-153 is under Phase 1 evaluation in India, and we hope to complete the Phase 1 study by financial year 2025 and subsequently an early patient study in Alopecia Areata in India by financial year 2026, at which point we would have established human POC for SCD-153. Similarly, for SBO-154, our antibody-drug conjugate targeting a novel epitope of MUC1, we have initiated IND-enabling studies, and we expect to file the IND by the end of the current financial year. Both these opportunities represent first-in-class potential for SPARC across multiple indications.
Additionally, SCD-044 is under Phase 2 assessment, and the top-line results of the Atopic Dermatitis, that is, atopic dermatitis study, is expected in quarter four of calendar year 2024. This, as you know, is licensed to Sun Pharma, and the development costs are borne by the partner. Continued development of these programs will require additional resourcing, and our current cash balance and approved credit may be sufficient to cover the expenses for 12-15 months if, in fact, we're in expected cost savings from the Vodobatinib and related deprioritizations. We are also eligible for additional milestones from SCD-044 and SEZABY, depending on certain outcomes that can increase our runway further for SPARC. We may require additional resources to get to the next set of milestones in certain scenarios.
We will tightly manage the portfolio and our spend to get to this next set of data events soon. As I indicated earlier, we will review our current clinical and preclinical portfolio to identify and prioritize high-value programs and optimize the cost base to extend our runway. Let me summarize. While PROSEEK interim results set us back, for sure, we have several additional assets, especially the clinical assets that carry significant value, which we will pursue using appropriate resourcing models, which may involve partnering early, if that makes sense. We will keep you posted as we make progress with the full analysis of the PROSEEK data and complete our strategy review. Thanks again for joining us today. And at this point, I would like to open up the call for questions, concerns you may have, suggestions, if you have any. And thank you again for your time today.
Thank you very much. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their touch-tone phone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handset only while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. Again, participants, you may press star and one to ask a question. The first question is from the line of Ketan Gandhi from Gandhi Securities. Please go ahead.
Yeah. So due to this disappointment, in the November call, you said we have a few options for Vodobatinib for CML. So in terms of timeline, when can we expect the licensing deal to happen, and what are the opportunity size for this molecule?
Thanks, Ketan. I think, as we have explained in the last investor call, we have parked the CML opportunity till we have the results of the Vodobatinib study, so as in the preclinical and the Parkinson's disease study. So we will now initiate I mean, that is the reason why we have these conversations with the FDA, to have a clear visibility to the regulatory pathway. And we are now in the process of reinitiating potentially this development activity on the CML part of the program. In terms of giving you a specific timeline for closing out of that licensing transaction, I think probably we are a little too early in the process. We just started this process now, and we may need additional time to kind of scan and go through the process and conclude a transaction for Vodobatinib.
In terms of the opportunity size, I think we haven't disclosed the specific sales potential, but it is significantly lower than the Parkinson's disease opportunity. I mean, here we are talking about potentially $several hundred million up against $several billion in the case of the Parkinson's disease.
Sir, I want the timeline in terms of whether it will happen this financial year or next financial year or a year after the next financial year. Can you give some sort of ballpark understanding so that we can model that into our?
We are definitely targeting this financial year, and that's our objective.
Okay. So in terms of cash burn, we are enough cash position to go ahead for other programs, or we need to raise some equity in near term?
We are not contemplating any near-term equity raise. I mean, if I look at our current cash balance, it should be in the range of around $20 million. We also have access to approved credit. If I actually look at both approved credit and the current available cash, we should be able to basically go beyond the current financial year. We are looking at a burn window of around 12-15 months. This also factors in some of the cost savings from the reprioritization. I mean, if you're not spending on the SCD-044 clinical program, Vodobatinib clinical program, and also the backup program that we have, that is a significant amount of I mean, it's a significant part of our budget for this year.
So in that sense, if I take out that from the provision, this cash balance and access to credit is sufficient to take us to a 12-15 months runway. But we are taking a deeper look at our portfolio priorities. Clearly, the assets that I spoke about in the call earlier are important, and we have clinical validations coming from mostly in India-based trials in these cases, except MUC1. And so we may require, beyond that, we may need to have additional cash infusions. But that's depending on how some of these outcomes I mean, we have milestone visibility on SCD-044, which is maturing later this year. And SEZABY, we can also provide additional milestones. So there are additional milestone opportunities which can augment this beyond the 12-15 months window.
We will take a call as we kind of move towards that. We will take a hard look at the portfolio and our cost structure in the interim.
Fair enough. Sir, can you throw some light on the SEZABY? What happened there? Because I believe we have filed some case in District of Columbia on the 2nd of April. So what is that about, and where are we in terms of launching it?
No, no. The case that we have filed against the HHS and the FDA has nothing to do with the launch of the product. The product is launched, and the takeoff is expected when we get the exclusivity established. There is a whole workstream going on. Our expectation right from the beginning is that by the end of the second year or beginning of third year of launch, we will be able to establish the exclusivity or enforce the exclusivity and take out the unapproved products from the market. But the case is about a different matter. We believe we are entitled to get a Pediatric Rare Disease Voucher. That Pediatric Rare Disease Voucher was denied because of certain interpretations of statutes involved, and we disagree with that. I cannot dwell into this matter more than that since this is sub judice at the moment.
I don't want to talk a lot about our position and the specific nature of our disagreement, but we believe that we have a defensible case, and that's the reason why we initiated this process.
Thank you, sir. I have some more questions. I'll join back in the queue.
Sure.
Thank you. A reminder to all the participants, you may please press star and one to ask a question. Our next question is from the line of Ashutosh from Zydus Investments. Please go ahead.
Sir, for the.
Hello?
For PROSEEK Studies, sir, when can we expect full analysis results?
Sorry. I couldn't follow the question. So did you ask the availability of the full analysis results of PROSEEK?
Yes, sir.
Okay. We are looking to complete the full analysis of PROSEEK by the second quarter of this financial year.
Okay.
Ashutosh, do you have any further questions?
No, no, sir.
Thank you. The next question comes from the line of Tushar Bohra from MK Ventures. Please go ahead.
Thanks for the opportunity. Sir, I just want to understand, are there any qualitative data points that you can share further on the PROSEEK trials? Or while we did not meet the primary endpoint, was there actually no efficacy outcome at all, no response at all, or was the response there but not sufficient to cross the hurdles? What was the case here?
In the PROSEEK Interim Analysis, we looked at the primary endpoint, which is part three of the MDS-UPDRS, and a few secondary endpoints, which is part two plus part three and the time to event, as in the time to systematic therapy. So this was a subset of the secondary endpoints we had in the trial. Plus, we also looked at three biomarkers, which is neurofilament light. And we've looked at a binary alpha-synuclein assay, which essentially diagnoses the disease. And then we, in CSF fluid, look at the trending of alpha-synuclein. So in the primary endpoint, and as you indicated, we did not meet the significance between placebo and our treated arms. And we have a similar trending for these subset of secondary endpoints that we've looked at. In both these cases, what I can say at this point is that we have an extraordinarily high placebo response.
In fact, the placebo curve stayed flat for almost the study period. But we are not disclosing the specific data at this point. And we will take a look at all the secondary endpoints and also all the biomarker endpoints. In biomarkers, we have conflicting data points coming from that biomarker study. So we will take a look at both the clinical outcomes across all secondary endpoints. We have looked at the first nine-month period data in this analysis. We also have an additional nine-month data for a subset of this patient pool. And we will also take a look at how this trajectory kind of pan out. That's obviously an uncontrolled; it doesn't have a placebo control in the second part of this trial.
We will take a look at both the 9-month period, the second 9-month period, all biomarkers, and make a final view on both the target and the trial and the trial.
Sir, a couple of related questions. So just to understand, so we are seeing that the trial did not fail because of a poor outcome or a poor data on Vodobatinib, but more because your placebo response was extraordinarily good. So could it be a case of maybe a trial design or an externality? Do you think that there is a possibility that you may want to look at a retrial with maybe a revised trial design or a revised endpoint and look at the trial again? Is there a possibility for that, sir?
Well, I wouldn't frame the way you framed it. I think then the study was designed for showing a 35% difference between placebo and our trial, a 35% improvement over placebo. Obviously, the analysis that we have seen so far did not show that difference. And we had to wait till the full analysis of the data for any additional steps that we may have to take. In terms of actually factoring in Vodobatinib into the model, our advice at this point is to discount Vodobatinib fully based on the trend lines that we have seen. And if there is a room for any kind of reframing this hypothesis or reframing based on any additional trials, we will definitely come back and advise you on the basis of additional review that we are going to take.
Maybe I just want to frame the question differently. In terms of Vodobatinib for the PROSEEK trial next steps, is a retrial one of the possibilities, sir? Even if it is, let's say, a 1% possibility, is that one of the options that is still available to us, or that is completely closed out?
No, I cannot close out anything at this point because we haven't seen the full data set. Unless we see the full data set and we understand what happened in the trial fully, all of these options are possible. But there are very remote options based on what we've seen on the primary endpoint and secondary endpoint. That's why we are advising you to discount the program in the market.
Got it, sir. And what is the backup option you said? I think was it referring to the Alzheimer's thing, or are you referring to backup as Vodobatinib for CML and LBD?
So the hedge for Vodobatinib, as in the hedge for PROSEEK, was essentially CML. Even though we had other preclinical programs for Vodobatinib and its backup series in neurodegenerative diseases, we always considered that as one package, one battery, which will come alive if we have a positive response in PROSEEK. In the absence of that, the real alternative for Vodobatinib is its leukemia program, which is what we just discussed.
Got it, sir. Thank you so much. I'll join back in the queue. Thanks for your questions.
Thank you. The next question is from the line of Manish Jain from GormalOne LLP. Please go ahead.
Yeah, hi. I just wanted to understand that in CML, given that the way Asciminib has been ramping up to $450 million sales already at an annualized run rate, does it make sense for us to take it all the way to the final approval?
Yeah. Hello, Manish. I mean, the question is about SPARC spending the resources to take this to the clinical—I mean, regulatory—approval in the US. The answer may not be yes. We may not—it may not be an appropriate use of SPARC's capital to take that all the way to regulatory approval in the US, given other options or opportunities that we have in the portfolio. But there may be other mid-sized pharmaceutical companies, for sure, who may be interested in a program like this, which can give a significant enough opportunity from a commercial standpoint for a smaller sales force and with opportunities to go up against a product which is ramping up fast.
I mean, there are not very many options, especially the safety profile that we have seen for the product and the activity that we have seen for late-line patients makes it a developable option. We are seeing validation for that. Even after we kind of deprioritize the program, we get several requests for off-trial access for that drug because of its activity in patients who are exhausted or lines of therapy. So that's an interesting proposition for someone who is looking to build a $200-$300 million product. That may not be a right opportunity to kind of prioritize our capital over the ADC or over the potentially first-in-class dermatology product.
Perfect. And my second question was that in phenobarbital, given that we have licensed it to an external party, should we win the PRV case? The entire PRV value belongs to us, or we have to share some proceeds with a partner as well?
The PRV is with SPARC.
Yes. So 100% value of PRV is with SPARC, right?
Yep.
All right. Thanks. I had a few other clarifications. I'll join back the queue.
Thank you. The next question is from the line of Chandpal Singh, who's an individual investor. Please go ahead.
Hello. Good evening, sir.
Hello.
Sir, I just wanted to ask you a question that is this the end of the c-Abl hypothesis for other drugs that are in trial for Parkinson's?
Well, I don't think PROSEEK at the moment the interim analysis is certainly not the last word for the mechanism. It's a serious setback for the mechanism. But we need to basically look at the full data set. We are practically sitting at a threshold of information in terms of how the mechanism actually behaves. So in that sense, whether it is a tractable hypothesis is something that needs to be determined based on the full analysis of the data set.
Okay. Thank you, sir. Thanks for your time.
Thank you. A reminder to all the participants, you may press star and one to ask a question. The next question comes from the line of Rohan Parekh from OHM Stock Brokers. Please go ahead.
Hi. This is Jigar Valia. Thanks for this call. My question is, while Voda failed on the primary and secondary, did it cross the blood-brain barrier through? And so it's a question. Did it actually go through with regards to the 442 patients, or is that anything of value for the clinic?
So that's an important question that you're.
Therapy. Yeah.
Sorry. I mean, I came in before you finished. Can you just repeat the last line of the question?
Yeah. So my question was that did the results show a successful crossing of the blood-brain barrier while it did not meet the primary, secondary endpoints? And if it did, then is that of value for either us or as far as the therapy or a study is concerned, generally?
No, that's an important question, Rohan, because the interim analysis did not include a PK analysis. So even though we have access to both blood draws from all patients and also CSF data for an appropriate number of patients, we haven't analyzed that to determine the exposure that we have both peripherally and in the brain. So that is an important part of the analysis that we will be doing as part of the final review.
Okay. Okay. So if it was not a part of it, then it can't be okay. Second question is, with regards to the CML, the failure that happened for the PD thing, those primary, secondary endpoints would be entirely distinct as far as the CML is concerned, and it would be completely—this is completely linked to PD, and that would be linked to CML. But yeah, is it fair that there is no correlation between the two?
Primary and secondary endpoints of the Parkinson's trial is very specific to Parkinson's and the progression of that neurodegenerative condition. And it has nothing to do with leukemia. And the proof of concept for leukemia, it's already available from our earlier patient I mean, earlier study, phase II study. And if anything, the safety data from this trial is supportive of its dose in leukemia, which is actually lower than the doses that we have used in the Parkinson's trial. So we don't see any negative fallout of PROSEEK in the leukemia program. If anything, it is possible because of the safety profile.
That's good. For the leukemia program, we continue with the phase II asciminib plus one more as a third-line product, right?
No, it will be. We are essentially in the process of having the conversations with the FDA. An actual treatment line for the trial will be decided based on the feedback that we receive from FDA. But the study that we have done so far was in three-line failed patients. That is the original proof of concept. And that is probably the most difficult setting to go after because they've exhausted all available lines of therapy. If we have an opportunity to move up and test a different line, it would be a function of what we hear from the agency.
Understood. Last question from my side. As far as the fundraisers concerned, it would have nothing to do with the timelines for the final study, which will be with you two. And it would also be a function of you having the discussion with FDA or basically condition?
No, no. Fundraise is not a function of our conversations with FDA because, as I explained earlier to another question, we are not looking to allocate our capital for developing this program in leukemia. We are initiating a process to actively look for licensing partners for leukemia. So in that sense, from a cash flow funding standpoint, these conversations and our actual plans for leukemia, they're not the major factor.
Yeah. Thank you very much, best wishe s. Thank you.
Thank you. Participants, if you wish to ask questions, you may please press star and one now. The next follow-up question is from the line of Ashutosh from Zydus Investments. Please go ahead.
Sir, I wanted to ask hello?
Yes, you're audible.
Hello?
Please go ahead.
Yeah, we can hear you, Ashutosh.
I wanted to ask, please, what did the trial cost for them?
We may have spent roughly in the range of 45 and the overall budget for PROSEEK was in the range of $45 million. But we may not end up spending all of $45 million because that assumed completion of the trial all the way to visit level. That's 40 weeks for the part one and completion of the part two study. So now, because of the early termination, we may be able to have some savings on that $45 million original allocation.
Sir, can I ask you how much you have spent?
Currently, it may be in excess of $35 million. The original budget was $45 million, maybe.
Currently, how much?
35+. I don't have an exact number right at the moment, but it is certainly between 35 and 40. But closer to 35 than 40.
Okay. Yeah. Thanks.
Thank you. As there are no further questions from the participants, I would now like to hand the conference over to Mr. Jaydeep Israni for closing comments.
Sagar, there are a couple of additional questions. If you could, yes, please.
We have the next question from the line of Mr. Tushar Bohra from MK Ventures. Please go ahead.
Sir, if you can highlight the next steps on your specialty pipeline, if you can, just highlight the liquidity events or monetization events there and also what kind of milestones when we look at what next steps across SEZABY and Elepsia and the other one.
Further, the major milestone payment from programs which we already licensed, SEZABY, on clearance of the market, we have additional milestone payments which will happen as we move forward and clear the other products on the market and get our exclusivity established. PDP-716, which is our ophthalmology program, we're going in for refiling in September timeline. We have milestones on approval of that product. SCD-044, which is the phase II program in psoriasis and atopic dermatitis. Successful completion of those programs would have additional milestone events. So those are the three identified milestones for us. Other than that, you have further clinical and developmental and regulatory milestones for SCD-044. We also have these two other programs which I talked to you about, which is the SCD-153 and SBO-154. SCD-153 is a collaboration with Hopkins in Alopecia Areata.
We just started our phase 1 clinical trial in India. We are on a course of escalation. Our intent is to establish a clinical proof of concept for that program in Alopecia Areata before we start looking at partnering options. SBO-154 is, again, an antibody-drug conjugate targeting a new epitope of MUC1. We are in the process of scaling up our manufacturing for the clinical program. And its non-clinical program started. Our hope is that we will be able to do the IND for this program before the term is finished here. So those are the two major programs which is closer to engagement even other than the three I spoke about licensed programs.
But there is not much mentioned in the last couple of presentations about our SCD-044. So yes, yes. So in the call also today, I think you mentioned atopic dermatitis. So can you highlight what the status of psoriasis is then?
Yeah, we haven't been given a timeline by our commercialization partner, Sun Pharma, for the completion of the psoriasis program. The psoriasis program is behind the atopic dermatitis program. So it will follow the result of the atopic dermatitis program. And we don't think that we will have data availability from that program this year. That's why we're not talking about that. But that program also is progressing. And probably, Sun can give us an update on specific timelines for the psoriasis program.
What would be your estimate as to SEZABY? When do we start seeing the commercial revenues coming in initially once we have the exclusivity established? Do you have a timeline sense to it?
Sir, I think we had a Citizen Petition with FDA. FDA came back to us asking more time. They said that this is a complex matter, and it requires additional time. They did not set a specific timeline in terms of when they will act on the Citizen Petition. In this process, we are also adding additional leverage points in terms of working with patient advocacy groups and also directly engaging with some of the unauthorized manufacturers. Our hope I mean, if I look at what happened with other programs which came into a market similar to SEZABY, usually, it takes two to three years before the product gets fully exclusively established. We just completed the first year and then into the second year. I think we have a full-fledged process going.
Our hope is that we will be able to maintain a similar timeline.
Got it. And sir, Elepsia and Xelpros, any further updates you want to highlight?
We are in the process of transitioning Elepsia to a different partner. But we don't have a finalization of that process yet. So we're still in an in-process business there.
Got it, sir. Sure. Thank you very much, sir. Just one more thing on Vodobatinib for CML. In terms of head-to-head, what are the options if you have to go for a front-runner trial? Do you have any specific options earmarked or highlighted or that you have decided that this would be most relevant comparison?
If we were to do a comparative study, which looks like that's what we should do, and most likely, comparative product would be most relevant comparative product would be Bosutinib. But we will take that final call based on the FDA feedback.
Okay. Is it possible for us to do maybe more than one arm of study given that a couple of the other products are more prevalent, whether it's Bosutinib or Nilotinib?
Sorry.
Hello?
Yeah, that's, again, a function of the design which we agree with FDA. I'm assuming your question is about multiple comparators. Is that what you're saying?
Yeah, because Bosutinib being the largest, and it's a $2 billion molecule, my sense is in that ballpark in any case. So would it be not fair for us to target that and run through a head-to-head comparison against something like Bosutinib? And if you're able to do equally well or maybe better, that opens up a much bigger commercialization possibility here than the $200-$400 sort of that ballpark of few hundred million dollars that you've highlighted.
I think that it's not just a regulatory question. It's also trying to find discussion in terms of how you actually maximize your probability of success with the program. And if you look at the second or third generation trials that happen in leukemia, and if you look at what has been the comparator for those programs, that would give you a clear sense of what is the preferred comparator program for even programs like Asciminib or any of the second or third generation programs that have been pursued. It's a complex question which is driven by both commercial calculus and also probability of success and ability to kind of reduce the risk of the program. So we will take that call based on what we hear from the agency.
Got it, sir. Thank you so much.
Thank you. The next question is from the line of Manish Jain from GormalOne LLP. Please go ahead.
Yeah. I just wanted to understand on SCD-153, till what level will we develop it on our own, and when will we explore partnering SCD-153?
So the development program for SCD-153 has three identified steps so far. One is completing its healthy human volunteer single ascending dose trial, which is where we are at the moment. That establishes early safety for the program. Typically, in a program like this, this would have been followed by a 14-day multiple ascending dose study. So instead of doing that 14-day multiple ascending dose study, we are proposing to do a patient study in multiple ascending setting. In a sense, we will test this trial in ascending doses in Alopecia Areata patients. So that will give us two things. One, it will give us a better sense of safety profile in actual patient setting. And even though we are not powered to detect that, it may provide an early signal on efficacy.
Then we will follow that up with a phase II study to determine the dose and also get proof of concept for the mechanism. We are planning that in two steps. The first part is an India-based study where we will go up to 250 patients in India and do an interim analysis for those India-based patients. If we get a proof of concept for 250 patients, that protocol will have a provision to expand the study to the rest of the world. But that India-based proof of concept for 250 patients is what we believe as an ideal licensing opportunity given where we are.
Perfect. And the second clarification I wanted is for ADC, which manufacturing ramp-up that we're talking about, is it in-house manufacturing capability that we have developed?
No, we are working with a San Diego-based CDMO for scaling up this program.
Got it. Thanks, Sagar.
Sure.
Thank you. The next question is from the line of Rohin Kumra, who's an individual investor. Please go ahead.
Yeah, hello, sir.
Hello.
Rather, just to be sure, when we say that Vodobatinib will not be monetizing in the next two or three years, that means we will also monetizing it for both front-runner program also.
Sorry, Rohin. Your line was very blurred, and I couldn't hear you properly.
Sir, when we say that Vodobatinib will be outlicensing in the next 1 or 2 years?
You're talking about the CML arm of Vodobatinib, right, Rohin?
Yes, sir, CML arm.
Right, right.
Is it a fair assumption to assume that we are totalizing it for our front-runner program also?
Front-runner? I mean, what is front-runner? No, so I understand your question as whether the CML part of Vodobatinib would be outlicensed this year or next year. The answer is that's our objective. We are initiating this process. And as I said earlier, our objective is to finalize that process this year. I didn't quite follow the second part of your question.
I mean that we are also trying Vodobatinib in the front-line settings.
Yeah, yeah, yeah. If it is outlicensed, it will be for all settings of Vodobatinib in leukemia, not just the last line.
Okay, sir. Then that means that milestone payment that we are going to see will be while keeping in mind the potential of both sensitivity?
Yeah, I mean, I think that you need a model. But yes, it will cover both the front-line setting and earlier lines as well as the last line.
Okay, sir. Thank you, sir.
Thank you. The next question is from the line of Ashutosh from Zydus Investments. Please go ahead.
Hello?
Hello.
Sir, for Vodobatinib, is there any corporate presentation deck available on the recent reports?
There's a presentation on the website. You're asking about Vodobatinib, right?
Yes.
Yeah, yeah. It's on the website.
Where it is?
It's on the SPARC website.
Oh, okay. Thanks.
Thank you. As I said, I have no further questions. I would like to hand the conference over to Mr. Jaydeep Israni for closing comments.
Thank you, Father. Thank you, everyone, for joining the call today. In case you have any additional questions, feel free to reach out to us on the email IDs and numbers that are shared on our website. Thank you again for being with us on the call.
Thank you. On behalf of SPARC, that concludes this conference. Thank you for joining us. You may now disconnect your lines.