This drug has now been in over a 130 subjects, including initial clinical development, which demonstrated proof of concept in patients with cutaneous T-cell lymphoma, and then our study that we recently completed in alopecia areata. We do have orphan drug designation around this program for CTCL, and we own worldwide rights to this. Going forward, we would intend to transition to subcutaneous delivery of this product, and explore dose optimization in the next phase of development and looking to get this back into the clinic during 2025. The second program that we're working on from this platform, our multi-cytokine inhibitor EQ302, which is a peptide therapeutic targeting IL-15 and IL-21.
We have recently sort of repositioned this program with the stapled version of the peptide that we've demonstrated can be orally delivered, is stable in the gut, for effectively a local topical delivery to the gut for a range of GI diseases, with a focus on celiac disease and/or IBD as target indications. Our goal is to initiate first-in-man development of this program during H2 of 2025 . And we are doing some work with our platform that underpins these programs, developing additional sort of discovery programs, which could include programs that not only inhibit but agonize select cytokines. So we have a range of activities going on around the multi-cytokine programs and platform. Shifting our focus a bit to itolizumab for today's conversation.
Again, this was our foundational asset, our CD6 antibody. We are currently more than halfway through a pivotal study in acute graft-versus-host disease, first-line treatment. We have FDA Fast Track and Orphan Drug Designations around this program. The second study that we recently completed is our study of itolizumab in lupus nephritis patients. We reported full top-line data on that program earlier this year, and both of these datasets underpin the Ono partnership, and I'll take you through that structure in more detail. In addition, our partner, Biocon, is completing a study of itolizumab in ulcerative colitis. This is a study that we helped design and we're co-funding. Biocon is conducting the study entirely in India. It's an interesting study in that it's a robust study design, testing itolizumab in biologic-naive patients in India.
These are patients that have otherwise gotten standard of care, but naive to biologics, and evaluating itolizumab head-to-head against placebo, as well as adalimumab, Humira, which is standard of care as a biologic treatment for ulcerative colitis. 30 patients per arm, a 12-week study with a crossover after 12 weeks for an additional 12-week evaluation on drugs. Very robust study design. We're expecting to have that data later during Q4. Interesting data read coming up there. In terms of the partnership with Ono, this was a very important relationship for us that we entered into in 2022. As you recall, the capital markets were very challenging, so we were looking at ways to fully fund the program through to potential approval and extend Equillium's overall operating runway significantly.
And so we were very pleased to bring in Ono as a strategic partner around the development of itolizumab. This was structured again as sort of a traditional option-style agreement. We received closing consideration of about $38 million at the time of the transaction in December 2022, and importantly, Ono agreed to fully fund the entirety of the R&D program for itolizumab going forward through the end of their option period. And that has had a budget of approximately $8 million per quarter that started in Q3 2022. So Ono's got a pretty significant investment into this program. Currently, I think, north of around or approximately $90 million since we initiated this strategic partnership with Ono. And we agreed to give them two datasets, which we've now delivered.
The first dataset was the top-line data from the EQUALISE study in LN. We viewed that data to be very favorable, and generally in line with standard of care today, which is mycophenolate, cyclosporine, as one of the few approved drugs to treat LN, and then the second dataset we more recently delivered at the end of July was the interim data from the EQUATOR study. Again, this is our pivotal study in acute graft-versus-host disease. This was a blinded dataset to Equillium and which we shared with Ono and included an unblinded review by our data monitoring committee, who gave us a recommendation to proceed with the study based on predefined stopping criteria for totality and efficacy.
So we effectively landed sort of where we had hoped and expected to land, which was to proceed with the study to completion. I'm happy to say that we're progressing quite well in terms of enrollment. We have over a hundred sites now worldwide recruiting patients, and so we are, you know, tracking to complete enrollment in the near term here and very much looking forward to this full dataset, which we believe can have a significant impact for patients in this first-line treatment setting, where these patients are entering the study quite severe. These are grade three, four patients and grade two patients with lower GI disease, and these patients have a very high mortality rate in the near term. If Ono does elect to opt in...
Now, I should add importantly, the option period expires October 30th. They have a three-month window from when we delivered that second dataset, so establishing October thirtieth as the option expiration date, and Ono is running their internal process very consistent with what they had previously prescribed to us, so we do expect to have that decision no later than October 30th, so right around the corner, we'll be hearing from Ono on how they plan to proceed. If they do opt in, the program will become theirs. We are expected to continue to conduct the EQUATOR study through to completion and prepare the BLA submission. They've indicated that to us. At that point, from the moment of their opt-in, we would continue to get reimbursed for R&D.
However, we would also start to get reimbursed for our pro rata share of our G&A expense and all of that at which is currently being reimbursed at cost, would then get a markup. So we would expect this to actually further reduce our overall operating burn, significantly if this carries forward. We would also, at that time, get an option exercise payment of JPY 5 billion, which is approximately $35 million based on recent exchange rates. So that would significantly bolster our current balance sheet, which we reported $33 million in cash at the end of Q2 this year.
In addition to that, the rest of the economics to Equillium would are represented here in the milestone payments of just over $100 million, a significant portion of which are tied to the first two clinical study starts and the most of the balance tied to the first two regulatory approvals. It is our belief that if Ono opts in, we could reasonably expect that additional studies would be initiated. We're doing quite a bit of study preparedness for advanced LN as a follow-on indication, and we're also having discussions about other areas in GVHD to pursue. As the acute GVHD indication is successful, we'll represent our first approval, so sort of an exciting time coming up for us related to the Ono option decision.
I should comment, if for some reason they do not carry this forward, one, we do not think it's because of the data. We think the data is very solid on both the datasets, really achieving sort of the results we had hoped for. But as we've seen, you know, pharma companies do change direction for various reasons. So if they don't opt in, we will have the program at that point, completely unencumbered again, roughly two years ahead of where it was, and significant milestones achieved with the full top-line data from our LN study and having cleared the interim. So, you know, at that point, we will have a study that's rapidly approaching complete enrollment in a potentially registrational study.
So that would be an interesting position to be in, in terms of having itolizumab unencumbered again, would be sort of an interesting outcome, but we are expecting Ono to proceed. But we'll see. They've got a decision to make in the immediate future here. Feel free to reach out if anybody has any questions on the Ono partnership and, you know, what we're expecting going forward. Just to touch briefly on the multi-cytokine programs with a focus on EQ101. So this is the program around which we recently reported our top-line data from the alopecia areata study. We do know that IL-2 and IL-15 are very important to CD8 and NK cell biology, and IL-9 contributes to inflammation in the skin. We...
You know, based on the earlier data around CTCL, which gave us some indication that this could work, sort of in diseases broadly here, we decided to move ahead with our alopecia areata study. Other areas that we think would be interesting to pursue in the future would be vitiligo, which we believe has a read from the AA data, and then potentially atopic dermatitis. Obviously, a little bit more competition in the AD landscape, much bigger patient population, but really not a tremendous amount of competition currently in AA or vitiligo, where the only drugs that are approved for these two indications are JAK inhibitors, and most of the pipeline in development are other JAK inhibitors.
What's interesting is that, you know, what we've shown is that, and this is looking at ruxolitinib, looking at the JAK-STAT pathway, does a very good job of blocking that pathway but is insufficient in other pathways that couldn't be involved in disease, so you know, really what we're trying to do and achieve with our multi-cytokine programs is to dial in or out the pathways that are really responsible for disease pathogenesis, but not affect the pathways that may not be so involved. As mentioned, this drug had already been through a proof-of-concept evaluation in patients with CTCL, showing some very good data compared to the current drugs that are available for these patients. This is data shown from the MAVERICK phase lll trial of mogamulizumab.
And we saw some response rates, albeit in a much smaller patient population, that stacked up favorably here. Very large unmet need here for patients with AA. JAK inhibitors are quite effective, but obviously, they all carry black box warnings. So not necessarily, I think, the best drug to be dosing long term in a chronic indication that's not life-threatening. And independent research has established that, of physicians surveyed, roughly 80%, 79% believe there's a high unmet medical need, and that's largely based around trying to find a drug that would be viewed more favorably for long-term chronic dosing. Again, from a mechanistic standpoint, we believe EQ101 is very well targeted in terms of IL-2, 9, and 15 inhibition. Pre-clinically, our prior colleagues showed some very nice data.
This is a rodent model of hair regrowth, comparing EQ101 at two mgs per kg to ruxolitinib at 30 mgs per kg. This was a dose that we took forward in the recently completed study. You also see on the right side very nice cell-based data in a CD8-positive cytotoxic T cell activation marker, NKG2D. In terms of comparative datasets, we view that the recently completed study is comparable to a low-dose product. Here we're showing low- and high-dose baricitinib and the data, SALT less than or equal to 20 response rate. What's important to call out is that the dose level matters, the duration of treatment matters, and the severity of disease matters in terms of patient outcomes, so what you're seeing here is low- and high-dose baricitinib.
They evaluated this program out to 52 weeks. Our study was a 24-week study, so that's shown at the blue line in the middle of the charts. At 24 weeks with low-dose baricitinib, you saw effectively no response. You saw effectively no response at 24 weeks in the very severe patient population. These are SALT-95 or greater, effectively AUAT patients. But you did see a good response rate north of 20% at week 24 in the severe category. And it was not until you got to higher doses, shown on the right, that you saw response rates in the very severe category at week 24. We've done a broader analysis across the JAK inhibitor landscape, looking at phase II and III studies.
So you can refer to our deck if you wanna see this in more detail, but the take-home message is that low dose had a response rate as measured by SALT less than or equal to 20. That's sort of what's in the 10% to 20%, mid-20% range, but it wasn't until you get to the higher doses do you achieve those higher response rates, and so this is a cross-study comparison, and the placebo is shown in blue, and placebo rates averaged around 3.6%. You know, close to no response rate with patients not receiving some form of therapy that's active.
If you look at change from baseline, similar results, effectively, no placebo response rate, and low and high-dose JAK inhibitors showed a sort of a 17% to 45% range in terms of change from baseline. So as we looked at our study, which was, again, a 24-week study, using EQ101, dosed IV bolus push at 2 mg per kg once weekly, we felt that this study met objectives. The treatment, you know, the TEAEs were very in line with our prior safety dataset, which included roughly 100 prior subjects. So nothing really jumped out at us from a safety and tolerability standpoint. We did have a, you know, relatively high rate of discontinuations. We had around a third of the patients discontinue the study.
Most of those discontinued the study early, and we believe that's largely explained by the IV bolus push. We had this formulation available. We wanted to rapidly get through a proof of concept study, recognizing that we did not feel that was the delivery form we would take forward in a more advanced development. We've always had as our strategy to transition to subQ delivery. So if you looked at our datasets, again, these compared quite well to the low-dose JAK inhibitors. We also, I think what was interesting, evaluated a number of patients in the moderate category, defined as SALT-35 to 50. Two out of three of those patients had a very deep response.
You can see it here shown on the right, both in SALT less than or equal to 20, we had two of the patients respond, but importantly, the change from baseline was significant in those two patients, where we had roughly, I think, something close to a 70% change from baseline with those two patients that did respond. As we think about the treatment landscape, JAK inhibitors are only approved for severe patients or worse, and patients who are presenting typically don't show up with severe or very severe disease, are typically coming in once they've reached significant hair loss more in that moderate category, and so this is an optimal place, we think, to sort of intervene in the patient path before they actually get indicated for JAK treatment.
So we think there's a nice opportunity there. EQ302 is a first-in-class inhibitor of IL-15 / 21. Again, this is our orally deliverable peptide. We think IL-15 and 21 again are important for both T- and B-cell biology that's implicated in these diseases in the gut. Nothing really approved today for celiac disease, so you know, very high unmet need there. And in terms of oral treatments for IBD, I think patients and physicians are looking for new mechanisms that are more focused and can be delivered locally. So we're you know, excited about this opportunity.
As it relates to celiac disease as a potential first indication, over seven hundred and fifty thousand patients are not responsive to their general approach of trying to avoid gluten, and you know, suffer significantly from the disease, and IL-15 and 21 are implicated here. IL-15 has been taken into development for celiac disease. What's shown on the right is that these pathways have a lot of redundancy and compensation. What was very interesting is some data looking at IL-15 and IL-21 antibodies, both independently and dosed together, and comparing those dosed together on the far right of the chart to our IL-15, 21 inhibitor. You see very similar data to dosing IL-15 and 21 antibodies together. This is looking at a model for disease.
So, you know, we think this is a very interesting program, but it's preclinical. And again, we're hoping to get this into the clinic towards H2 of 2025 next year. A lot of strategic interest here, despite nothing approved. A lot of efforts got into this. We do know some of the larger pharma companies in the world are very interested in this indication area, and you know, we're looking forward to continuing to work on that. Just to summarize, our cash position again $33 million at the end of June. We have a little over 35.4 million shares outstanding, so currently trading slightly right around cash, give or take.
And so obviously, in the context of some of the potential upcoming milestones, I'd say most important right now is the Ono outcome at the end of October. Obviously, if they opt in, that'll add roughly $1 per share of cash to the balance sheet, with the potential for milestones in the near term. And then again, if they don't opt in, we'll have itolizumab unencumbered at a very advanced stage of development, with a study currently marching towards, you know, near-term completion that could support an approval. So feel free to reach out at any time with any questions or follow-up. And again, thank you to the H.C. Wainwright team for having us today. Great.
I'd like to thank our presenter, and I'd like to open up the floor if anyone has any questions they'd like to ask. Great. Thank you, everybody.