Does it answer your question?
John Newman: It does. I just had one additional question on ATA188. Just curious, obviously, the data will be coming here shortly, but wondered if you could discuss your thoughts on the commercial plans for that product if you’re considering a partnership, if you’re planning on marketing the product on your own, if perhaps partnership is being considered for only Europe. Just curious there.
Dr. Pascal Touchon: Yes. No, thank you for your question. So it depends on the next step. But if indeed, we are — to the point where the next step is to move to Phase III, as we disclosed in the past, we have already discussed with the FDA about the type of Phase III that they would like to see when we obtain our 2 Fast Track designation and that’s where the agency mentioned 2 Phase III, one in nonactive PPMS, one in nonactive SPMS. And the reason they offered 2 instead of just 1 is mainly because the medical need is slightly different in the U.S. in these 2 potential indication because in nonactive SPMS, which is, by the way, the vast majority of the patients with SPMS, with secondary progressive MS. In that particular population, there is no approved therapy in the U.S., whereas in nonactive PPMS, there is officially 1 approved therapy — recently approved therapy, which is OCREVUS.
So that’s why there is a slight medical need from the Fast Track and potential BTD as a type of status later on. So we’ll discuss with the agency. These 2 Phase III studies will be also put together with a Phase II program to go in earlier stage of MS and maybe some other autoimmune indications. All that will be a very significant clinical development program that we believe will benefit from having a strategic partner that could bring financial and operational capabilities to be able to run all of these studies in parallel. So at this stage, the idea will be to consider partnership but not a pure licensing out, more of a strategic co-development, maybe with some options for other activities, especially in the U.S. And that’s really the aim being to activate rapidly this next stage of the development.
At the same time, to retain significant value for — within Atara. And we’ve discussed in the past that the type of partnership with profit split, particularly in the U.S., which is about 75% to 80% of the world market for MS, could make sense for the company and our shareholders. So too early to say what type of partnership and how we will implement that. But certainly it’s something that we have been actively considering and discussing with a large number of big pharma companies over the last couple of years.
Operator: Our next question is from Phil Nadeau with Cowen & Company.
Phil Nadeau: Let us add our congratulations on the expanded partnership. A couple of questions from us. First, in terms of the royalty that you’re going to get from Pierre Fabre, any — can you give us any more information on the magnitude of that royalty? Is it a greater royalty in any sense of the royalty range? And then second, a follow-up on the EMBOLD trial. Could you talk us through your current thought process as you — as to how you would frame the go/no-go decision post the EMBOLD data? What do you need to see in EMBOLD to advance 188 into those 2 Phase III trials?
Dr. Pascal Touchon: Thank you for your question. So the first one, unfortunately, we cannot say more than significant double-digit tiered royalties, and it’s an agreement with our partner, Pierre Fabre, that is not willing for us to disclose the royalty level. So we cannot say more than significant double-digit tiered royalties. And let’s say that we are very pleased with that deal. Now on your second question, the way we see the different scenarios, as we explained in the past, is as follows. We believe that if we have a significant statistical results on top of an impactful clinical result in terms of showing a percentage of CDI or confirmed disability improvers in active versus placebo, in that case, we would be — with a significant p, we’ll be considering moving into Phase III.
But it could be also the case if this is not a significant p, but a very strong trend, supported by a number of additional data from other clinical measures, from imaging biomarkers such as MTR, magnetization transfer ratio, or some additional fluid biomarkers. So having a strong trend, supported by this type of biomarkers and additional clinical data could also make the case for moving into Phase III. So that’s the type of scenario where we’ll move to Phase III. A scenario where we will not move to Phase III in this specific indication of nonactive positive MS will be a scenario where we have evidence of effect, but that there is a need either to continue to study [indiscernible] 2-year study or to be able to have data, for example, on stability on a larger number of patients.
We’ll have already data on stability of the disability and the ability to limit promotion of disability, but we might want to have more patients and to have all the patients reaching a 2 years’ time point. We might also have some particular signal — strong signal in subgroups of patients based on the data. So all that could lead to the need to continue some additional work for EMBOLD, expansion of EMBOLD or just the continuation of EMBOLD or some other studies that we could do to be able then to be in a stage where we could move to Phase III. So that’s the best way probably to answer your question right now is, if it is a statistical significance or very strong trend backed by biomarkers and other data, there is a clear path to move into Phase III following end of Phase II meeting with the agency and scientific advice in Europe.
If it is something that shows evidence of effect, which, by the way, will be a big first and truly transformational already because nobody has ever shown in such a large study that there is evidence of effect versus placebo that could be of a significant signal to be able to explore further or continue the study until its end. So that particular scenario will require some additional work, but we are well positioned to do that work.
Phil Nadeau: That’s very helpful. Congratulations again.
Operator: Our next question is from Jonathan Miller with Evercore ISI.
Jonathan Miller: Congrats on the tab-cel deal. We’re really looking forward to the MS data coming out, obviously. I would love to get a little bit deeper into the, I guess, the pipeline and the runway from here. So you mentioned there are certain anticipated payments included in the cash runway to ‘25 there. Is BLA approval included in that runway? For instance, what are the certain anticipated payments that you’re counting explicitly? And what are you not counting? And secondly, how much of the CAR-T program, the oncology program trial initiations are counted in the runway? And how much of those trials are covered versus not covered with your current expectations?
Dr. Pascal Touchon: No, thank you for your question, Jon. So in terms of the expected payment from the deal, this is really around the regulatory milestone. It’s not only a milestone at approval, it’s through approval we have a number of steps that, if successfully achieved, will be linked with payments. So that’s why we say $100 million regulatory milestone through BLA approval. That includes the BLA approval, by the way, but it’s not the only milestone. There are a number of milestone before the BLA approval that could lead to payment from Pierre Fabre based on the progress we’re making on a regulatory front. So that’s to answer your first question. On your second question, what we are putting together in this cash runway expectation is the start, as we were doing right now, of our study in lymphoma with ATA3219.
