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spk10: Good afternoon, everyone. Thank you for standing by, and welcome to the ATARA Biotherapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Heilengren, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please go ahead, sir.
spk12: Thank you, Operator. Good afternoon, everyone, and welcome to Atara's third quarter 2022 results conference call. Earlier today, we issued a press release announcing our third quarter financial results and corporate update. This press release and an updated slide deck are available in the Investors and Media section at atarabio.com. On today's call, members from the ATARA executive team will provide an update on our financial results, operational progress and strategy, and also review our upcoming key milestones and objectives. Joining me on today's call are Dr. Pascal Tuchon, President and Chief Executive Officer, Dr. Jacob Dupont, Executive Vice President and Global Head of Research and Development, Dupal Kopikar, Chief Financial Officer, and Dr. A.J. Joshi, Chief Medical Officer. We will begin with prepared comments from Pascal and Jacob, then open the call up for your questions. We would like to remind listeners that during the call, the company's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release, and the company's SEC filings. These statements are made as of today's date, and the company undertakes no obligation to update these statements. Now, I'd like to turn the call over to Pascal. Pascal?
spk05: Thank you, Eric, and thank you all for joining us this afternoon. We are extremely excited that TAPCEL, under the trade name of Edvalo, received a CHMP positive opinion for its first indication and is on track to obtain European Commission approval by the end of this year. This will be the first ever approval for an allogenic of the shell T cell therapy. That cell first indication addresses a very significant unmet medical need as these EBV positive PTLD patients have no approved therapy. and just a few weeks to a few months median survival. The EMA was accordingly very pleased to highlight EBVALO positive opinion in their public release as one of the landmark of the October CHMP meeting. Meanwhile, our commercial partner, Pierre Fabre, is actively preparing for the EBVALO launch in Europe in Q1 2023. We eagerly anticipate this launch, as we believe EBVALO can deliver a compelling value proposition for patients, payers, and European healthcare systems. With significant pricing potential in such an ultra-rare disease and high double-digit royalties, we believe EBVALO commercialization will progressively contribute to ATARA's revenues and cash runaway. I would like now to give an update on our progress with TAPCEL in the U.S. Following constructive discussions with the FDA, including senior leadership, we recently held a Type A CMC meeting with the review team that culminated in clear guidance and agreement on specific CMC Module 3 requirements for a BLA submission. A Type B clinical meeting request has been granted and is being scheduled to discuss and potentially align on the clinical data package requirements to prepare for a pre-BLA meeting. Following this meeting and possible further interactions with the FDA, we expect to give further guidance in Q1 2023 on progress to a BLA submission. At the ASH conference in December, we will present updated interim analysis efficacy and safety results of the phase three allele study in relapse-remitting EBV-positive PTLD, relapse refractory, EBV-positive PTLD, with additional patients and longer follow-up, confirming the transformative potential of TAP cells. We will also present exciting new data in patients with EBV-positive leiomyosarcoma, a type of EBV-associated solid tumor. Jacob will provide more details on this data in a moment. Finally, for TabCell, we have started to seek a commercial partner in the US. Entering into such a partnership will avoid further investment and could provide additional cash inflows further extend our cash runway. We are confident in a significant business opportunity that TAP cells represent in the U.S., with potential for peak sales over $500 million per year across multiple indications. Now on to ATA-188, or Potentially Transformative Therapy for Those Suffering from Progressive Forms of Multiple Sclerosis. At the ECTRIMS 2022 conference, we presented new MRI biomarker imaging and open-label extension clinical data from the Phase I study of ATA-188 in progressive MS. New biomarker imaging data suggests patients who achieved confirmed disability improvement, or CDI, demonstrated significantly less brain atrophy over time and increased NMTR in unenhancing chronic T2 lesions. support that brain structural changes, including potential remyelination, may underlie durable CDI or confirmed disability improvement associated with ATA-188. Also, updated results from the ongoing Open Label Extension with up to 46 months total follow-up in patients achieving CDI demonstrate durability of improvement once achieved. Remarkably, patients with stable disease, meaning no decline in EDSS, have maintained such stability for up to four years, which would also represent a transformational profile relative to the expected natural course of the disease. As a reminder, based on enrollment at the end of July for Phase II EMBAL study evaluating AT188 versus placebo in non-active PMS patients. Approximately 90 patients are planned to be included in the readout of the study Primary Endpoint of Confirmed Disability Improvement by EDSS at 12 months. We expect to communicate this final data readout in October of 2023. All in all, these new extremes data from our Phase I study and OLE, Open Label Extension, together with the two landmark studies published this year in Science and Nature, and our two fast-track designations with the FDA, further support our confidence in the possibility for 80188 to deliver transformational clinical improvement to progressive MS patients. We are truly excited. by 8188 potential as a unique game changer in MS, and we are eager to reach the unbold primary endpoint readout in October 2023. Meanwhile, we'll continue to be opportunistic in exploring potential partnering opportunities with biopharma companies that could maximize the value creation potential of 8188. Now, I would like to hand over to Jacob to provide more details on our pipeline portfolio and strategy before I give you an update on our financials. Jacob?
spk09: Thank you, Pascal. As Pascal mentioned, we are extremely excited about the recent positive CHMP opinion for Abvalo in Europe. We are advancing ever closer to receiving European Commission approval for this first of its kind off-the-shelf T cell therapy. We also believe that this positive decision provides clinical validation for our overall EBV T cell platform and portfolio, which now has treated more than 500 patients with clear evidence of efficacy and safety, the most of any allogeneic cell therapy company to date. We're also encouraged by the steady progress we're making on the US regulatory front and expect to have more to say in Q1 of next year. Looking ahead to the upcoming 2022 ASH meeting in December, we will present updated efficacy and safety results of the phase three allele study in relapsed refractory EBV positive PTLD, now with additional patients and longer follow-up. The data to be presented that was published in the ASH abstracts last week are consistent with the transformative potential of TAB cell in EBV-positive PTLD. Specifically, the overall response rate by independent oncologic and radiographic assessment was 51.2% in a sample size of 43 patients. The response rate after HCT was 50%. and after SOT was 51.7%. The median time to response was very rapid at one month, and this urgent response is needed for these patients with such an oncologic emergency as EBV-positive PTLD. The duration of response was an impressive 23 months, and the median overall survival was 18.4 months with patients who received with patients who responded having longer survival than non-responders. These new allele clinical trial data were impactful for the positive CHMP opinion that we just received. Additionally, at ASH, we will present updated efficacy and safety data from two single center open label studies and multi-center expanded access program in patients with EBV positive leiomyosarcoma. who have received at least one therapy. Now, the clinical benefit rate from TAB cell was 77.8%, with an objective response rate of 22.2% in this rare and difficult-to-treat solid tumor, and the estimated median overall survival was 77.4 months. In all these studies, the safety profile of TAB cell remains consistent with previously reported data with no new reports of tumor flora reactions, cytokine release syndrome, transmission of infectious diseases, graft-versus-host disease, or infusion reaction related to treatment. We believe these data continue to support the benefit of TabCell and its potential to transform the lives of thousands of patients each year across multiple indications and geographies. Now on to ATA-188 or potentially transformative therapy for those patients with progressive multiple sclerosis. We believe that targeting EBV-infected B cells is a validated approach towards finding a transformative treatment for this debilitating disease. The recent publications in Nature showed that EBV-infected B cells mature into antibodies secreting plasma cells that generate brain reactive antibodies. In addition, EBV-infected B cells can stimulate autoreactive T cells and thus drive chronic inflammation. Taken together, these recent scientific advances support our excitement around the potential of this therapy. Now, as Pascal noted, the new MRI data and updated OLE data presented at ECTRIMS on top of previous Phase I data further reinforce our belief in the transformative potential of ATA-188. We look forward to the final data readout from the approximately 90 patients who will be included in the primary analysis of the randomized, double-blinded, placebo-controlled Phase II EMBOLD study in October of next year. Now, I want to provide an update on our CAR-T therapies as well. With respect to ATA2271, which as a reminder, is our autologous mesothelin product candidate being currently developed by our partner Memorial Sloan Kettering Cancer Center, and we are pleased to report that the phase one dose escalation clinical study conducted by MSK has resumed enrollment after the voluntary pause earlier this year due to a fatal serious event in one patient. Additionally, for this program, we expect MSK to provide a phase one data update for ATA 2271 in December of this year at the ESMO I-O conference. In addition, we are advancing ATA 3219, which is our potentially best-in-class allogeneic CAR T for B-cell malignancies expressing CD19. Now, the manufacturing process optimization is progressing to ensure appropriate scale-up while maintaining a unique memory T-cell phenotype. Following completion of process optimization and manufacturing runs in the GMP manufacturing suites of our strategic manufacturing partner, Fujifilm DioSynth Biotechnologies, we now anticipate an IND filing in Q2 of next year. As a reminder, we're using an optimized manufacturing process to ensure enrichment for a memory T cell phenotype, which has shown robust activity in preclinical studies, as shown on slide 55 of our updated investor deck, where ATA3219 outperforms an autologous CAR-T benchmark on overall survival in a preclinical model. This manufacturing approach is part of the overall optimization of ATA3219 to differentiate it from the existing products and to address the high unmet medical need. Our focus on memory T cell phenotype for ATA3219 product candidate is supported by recent preclinical and clinical presentations of autologous CAR T therapy. Upcoming clinical data at this year's ASH meeting of an autologous CD19 CAR T therapy showed that CAR T phenotype with more stemness is associated with improved response rate and durability of response. Additionally, clinical data from another ASH 2022 abstract with the autologous CD19 CAR T containing The new 1XX co-stimulatory domain invented by Dr. Michelle Sadling is associated with favorable response rates, durability, and safety. As a reminder, the 1XX co-stimulatory domain that we have licensed from MSK is incorporated into the ATA3219 construct. We are particularly excited to bring ATA3219 to the clinic since this allogeneic CD19 CAR T has several key points of differentiation. These include the safety of the EBV CAR T cells, potential best-in-class efficacy, persistence, and off-the-shelf accessibility. And the ATA3219 program does not require TCR or HLA gene editing. Before I turn the call back to Pascal, I would like to extend my gratitude to the ATARA staff, our collaborators, and the patients involved in our studies. Together, we hope to bring to patients in need of allogeneic T-cell therapy some with curative potential. Pascal?
spk05: Thanks, Jacob. Now on to our financials. In September 2022, we announced an additional near-term milestone payment under an updated TAPCEL commercialization agreement with Pierre Fabre. Under this agreement, ATARA will receive an additional $30 million upon EC approval and subsequent filing of the MAA transfer to Pierre Fabre. For the third quarter of 2022, with regard to our cash position and runway, we ended this third quarter with approximately $265 million in cash. We believe that this cash balance, together with potential cash inflows from Pierre Sabré and the expected reduction in future operating cash burn, will be sufficient to fund the company plan operations into Q1 of 2024. Following our recent restructuring that is now fully implemented, we are on track to reduce our operating cash burn in 2023 and beyond according to plan. I would like to conclude by extending my sincere gratitude to all ATARA staff for their unwavering commitment to patient lives we seek to transform and their significant contributions in advancing truly innovative medicine for patients in need. Thank you all for what you have done. I will now turn the call over to the operator for the Q&A part of the call. Operator?
spk10: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question is from Saleem Syed with Mizuho Group. Please proceed with your question.
spk01: Great. Good afternoon, guys. Thanks for the color and the question. I guess a couple from me on TABCEL. So, Pascal, I'm curious if you plan on providing any sort of guidance on the EU TABCEL revenues at any point in 23, maybe the first part of 23, or what format would that take place in, and also maybe some of the logistical hurdles that you plan on having for having the first Allo T-cell product in Europe. And then also just on the U.S. side, just curious what the gating factors are around finalizing discussions for potential partnership for U.S. commercialization. Thank you.
spk05: Thank you, Salim. So regarding Europe, We are not planning at this stage to give any guidance on revenues coming from Europe. Of course, at the time of the launch, which, as I said, is planned for Q1 2023 after we receive the approval and we transfer that to Pierre Fabre, we will have more to say about pricing, which is a very important starting point in any type of launch. At this stage, we have aligned with Pierre Fabre and we understand what is their pricing strategy, which we think is very relevant to and fully aligned with the idea to price according to the value brought to patients, physicians, society, and the healthcare system. But it's too early to make any comment on pricing. We will be able to do so after the product or the time the product is being launched into 1.23. Now, we will, at the time, give more details if needed on that launch. But regarding what you call logistical hurdles, we don't see that many on our side. in a sense that this is really like a biologic launch. It is, of course, cell therapy, but it is allogenic cell therapy, off-the-shelf cell therapy, which is basically having the ability to deliver a product to the institutions or the physicians where the patient is being treated within just a few days from an inventory of product that has already been made. So there is, of course, some aspect of logistics that we have already tested time and time again since we started now a couple of years ago to do clinical trials in Europe as well as expanded access program. We've treated across Europe, in most of the key countries, a number of patients. So we are used to that type of logistic and the ability to deliver within a few days to the patient in need the treatment. And we have transferred that knowledge, that know-how to Pierre Fabre. So we're very confident that he will be able to handle that very efficiently. Now, on the US partnering front, As I said, we are starting to seek for a partner. I think to be able to finalize and execute on a partnership is not only a question about finding the right type of partner and negotiating the right type of value split and financials, it's also to be clear about the timing of the BLS submission and the approval for the product to prepare for the launch. So there is some ability to run in parallel the process of finding the right commercial partner that could maximize the value of TAPCEL in the U.S., which we believe is very significant, while we are also progressing with the FDA in terms of fine-tuning the exact timing of the BLA submission. And in some ways, they're risking that BLA submission with all these activities of interactions and meetings that we have with the FDA. Does it answer your question?
spk01: Yes, very helpful. Thanks so much. Thank you, Salim.
spk10: Thank you. Our next question is from John Newman with Canaccord. Please proceed with your question.
spk08: Hi there, team. Thanks for taking my question. Just curious if you could comment a little bit more regarding the number of patients that you currently have treated with the commercial formulation for TabCell and also how much follow-up time you might have there. Just kind of curious as to how the patient distribution looks across commercial product versus the clinical study material. Thanks.
spk05: Thank you, John. Jacob, do you want to take that one?
spk09: Sure, Pascal. And John, thanks for the question. So as you know, we filed this IMD amendment last year to put the intended commercial material into the clinic, and then we had good discussions with the FDA, and they're certainly interested to see the clinical data for these patients treated with the intended commercial material. So that's going well. We are not going to comment at the present time on the number of patients that we've treated and the amount of follow-up. But I will say, and, you know, we mentioned this previously, but we've had constructive dialogues with the FDA about a possible path forward. to BLA submission without the need for new clinical trial, and that we could use these commercial processed treated TAB cell patients. And again, the FDA was supportive of not conducting a new clinical trial, and we've previously announced that. And again, we are proceeding ahead, and we're treating patients in the clinic, but I At this point, we're not going to give specifics as to how many patients have been treated with the commercial material or the duration of follow-up at this point. Pascal?
spk05: Yeah, no, nothing to add on my side. I mean, in terms of duration of follow-up, the typical one that has been done with the FDA in the past was to have response and to have the patient followed for six months following response. But at this stage, we are not going to comment about what the exact requirements regarding this population of patients with the commercial product. So, it's nice to say that things are posing well and we are treating new patients in different settings with the commercial product with time.
spk08: And also, do you – just curious if you've discussed with the agency or perhaps you've thought about – utilizing patients in the future or currently in the multi-cohort study, if those patients were to receive the commercial product, might that satisfy FDA's requests as well as perhaps give the opportunity to potentially broaden the label a bit?
spk05: Yeah, maybe I start, and Jacob, you might want to chime in. I mean, there are two aspects. One is from a safety database point of view for the intended commercial product, any type of use of that product in terms of indication, in terms of setting, be it in the pivotal study, the allele study, or be it in expanded access program or even single patient use, all that is, of course, not only useful but required for a safety assessment, and that will be useful there. From an efficacy point of view, as you can imagine, the FDA is looking more at the specific indications we are pursuing with the future potential BLA filing. So that's where we will need to focus on the efficacy data in that specific indication. Jacob, anything to add?
spk09: Yeah, I think that's well summarized, Pascal, but I do think the spirit is right. You know, we are treating patients in a variety of settings with the intended commercial material. And all of this is certainly going to be informative for the FDA as that they would ultimately make a risk benefit assessment for these patients treated with Tapsil.
spk08: Okay, great. Thank you.
spk10: Thank you. Our next question is from Tessa Romero with JP Morgan. Please proceed with your question.
spk03: Hey guys, this is Taylor on for Tess. Thanks for taking the question. So we were just curious, what is the size and the scope of the data that will be presented on ATA 2271 at ESMO next month? And in particular, will we get more details on the fatal SAE that was reported earlier this year? And what factors led to the MSK study resuming?
spk05: Jacob, do you want to take that one?
spk09: Yeah, absolutely. So the intended target and the presentation will be made to the ESMAL-IO conference here coming up before the end of the year, and certainly clinical data will be presented there. Now, because of the hold on enrollment, there will be patients presented here up to, that first patient in the third dose escalation cohort. So we anticipate, and again, the presenting author is still putting together the slide presentation, but we fully expect there's going to be safety data presented. There's going to be some degree of PK data, potentially also some information on this particular patient. There was an extensive workup, as we've previously detailed, including an autopsy for that patient. And that type of translational work will also be part of the presentation, we suspect. And in terms of the factors that were assessed by the FDA, where the FDA was in agreement that enrollment should start once again, included the information on that patient who was treated on the clinical trial who had very refractory mesothelioma and a lot of other comorbid illnesses. And that... where the protocol amendment was created by the investigators at Memorial Sloan Kettering. They submitted it to the FDA, and again, the FDA was accepting of the workup of that patient, the data provided, and the proposed amendment as well that really led to the FDA agreement that enrollment could start once again for that particular trial.
spk03: Okay, and are you able to provide any more details on the protocol amendment that was accepted?
spk09: Yeah, so in terms of the protocol amendment, some of the details were that the study would be started once again. What was agreed was that the study treatment of the patients would resume at the cohort two dose. So there would be a return to the second cohort that had already been cleared and treat a couple more patients at that dose of three times 10 to the six CAR T cells per kilogram. So we'll see information from a couple of more patients treated there. And there is also a little bit of... of the eligibility criteria here were, as I mentioned, this was quite a confounded patient who'd received a lot of different treatment, including checkpoint inhibitors, COVID vaccines, and so forth. So there was a requirement that there was a bit longer of a washout of checkpoint inhibitor therapy before the patient was treated on the clinical trial with the CAR T therapy. I would say those were the predominant changes that were made.
spk03: Okay, great. Thank you so much.
spk09: Absolutely.
spk10: Thank you. Our next question is from Phil Nadu with Cowan & Company. Please proceed with your question.
spk07: Good afternoon. Thanks for taking our questions. A few clarifying questions. First, on your guidance about meeting with the FDA, are we correct that the next meeting is a Type B meeting, and that's simply to prepare for the pre-BLA meeting? The pre-BLA meeting will happen at some time after the Type B meeting.
spk05: Yes, that's the case. The pre-BLA meeting will be after the type B, and the type B is really to discuss and align on the number of patients and the duration of follow-up that he wants to see in the clinical data package. That will allow then to move to the pre-BLA meeting.
spk07: Good. In the update in Q1 of next year, that's after the type B meeting, presumably not after the pre-BLA meeting.
spk05: Yeah, at this stage, what we're talking about, the meeting that is being scheduled as we speak, is a Type B meeting.
spk07: Got it. Okay. And do you have a sense of how long it's going to take for you to complete the CMC Module 3 based on the requirements that have been agreed upon with the FDA? Or is that dependent upon the outcomes of the Type B meeting with how many patients of clinical data you're going to need?
spk05: No, it is independent from the clinical meeting. I mean, we have now a very clear view about what's needed for the BLE filing, what type of information needs to be gathered and so on. Nothing surprising here. So it's aligned with our expectations. So we are not giving any guidance for the time, but that's a reasonable timeframe in line with our expectations regarding that CMC part. So we think that the Now, the main next item to clarify before we can give a guidance on the timing of a BLA filing is really the clinical part. CMC is very clear.
spk07: And do you think the clinical part is gating, or is that likely to be gating for the filing?
spk05: We cannot comment on whether it's going to be gating until we have that meeting with the FDA, because that's really the key aspect to discuss with them is about how many patients for how long and the How do we relate to the other type of patients and so on?
spk07: Got it. Okay. Then last question from us, just on the partnership in the U.S. Can you talk a little bit more about the strategic rationale for signing a partner at this point in development? It sounds like getting close to the U.S. filing, we wouldn't imagine the commercial spend is too large for a disease like PTLD. So can you talk a little bit more about why you think a partnership would be wise?
spk05: Yeah, I think we believe that there is a clear business case for TAPSEL in the U.S. in its first indication, then followed by additional indication as part of the labor expansion that we are already planning, as you know, for the multi-core study in particular. So the business case is very clear. As you know, we have done a significant level of work to prepare for that future launch in terms of pricing reimbursement. We discussed with payers. We know the price level that will be an acceptable one in that particular healthcare system. We have already achieved a very unique situation of having the product, in fact, into the DRG18 that will be implemented next year. So payers, reimbursement, all that has been well prepared. We've also well prepared the mapping of all the centers where we believe the focus of key account management and medical affairs work should be really at the launch time. So all that is ready. And it's true that the launch of a product like that in an ultra rare disease with significant unmet medical need, no competition, and very clearly identified patients as post-transplant patients now are all being tested for EBV. And when there is a lymphoma in this patient, it's really clearly linked with an EBV positive PTLD in most of the cases. Physicians are aware about that. So the awareness of physicians is going to be the key at the time of the launch. And this is progressing as we speak. And, for example, the new data will present that ash in a couple of weeks, a bit more than a couple of weeks, a few weeks. It's going to be very important, again, to stimulate that awareness of physicians about the ability of a treatment like that cell to transform the life of these patients with significant benefits. data in terms of efficacy and safety. So all that preparation of the launch has been done by ATARA and we continue to make sure that there is the proper communication of scientific data that are very convincing, we believe. Now, this being said, implementing a launch will still require an investment to create the full commercial and medical team and to be able then to handle the launch before you start to have some break-even and then profitability. Typical situation there, even though we believe that the penetration of that population could be relatively happy due to the unmet medical need and the lack of competition. So we think that from a corporate strategy point of view, it is better to rely on a partner that has already a structure, a commercial structure in the U.S. that they could leverage with that launch. And the advantage for us at the corporation level will be to avoid to have to further compromise invest from a commercialization point of view and therefore to allocate some resources to that commercialization. And then we can also get some cash inflows based on that partnership, as we've proven when we signed that deal for Europe with a 45 million upfront. And as you know, the U.S. is a much larger market than Europe for several aspects in that particular disease area. So we are confident that we have the possibility here, the opportunity to avoid allocating resource to commercializations, to get some cash inflows that will help us to extend our cash runway and also to continue our creation of value for especially the allogeneic CAR T programs that we are developing. Does it answer your question?
spk07: Yeah, that's very helpful. Thanks for taking our questions.
spk05: You're welcome.
spk10: Thank you. Our next question is from Ben Burnett with Stifel. Please proceed with your question.
spk02: Hi, this is Kaylee Breeza on for Ben Burnett. Thanks for taking our questions. I just had a quick question about the phase 3 allele update that's slated for ASH. I was just curious if you guys could give us an idea of how many patients there are going to be at this update as opposed to the previous update that we had received I think actually maybe a couple years ago on this program. And then maybe how many of these new patients that are in this update, how many of these patients are also new to the FDA? Thank you.
spk05: Okay, maybe I start, and Jacob, you can chime in. Just to clarify one point, the last update we gave on ALIL was, in fact, just a year ago. It was ASH 2021, so it was not a couple of years ago. It was just a year ago. And now this new update is based on the abstract that was released last week, So maybe, Jacob, you can comment on the number of patients. And what I would say regarding the regulatory aspect, sorry, that these data were extremely important in getting the European positive opinion at the CHMP level because that way part of the submitted data. Jacob?
spk09: Yeah, absolutely. So just to give a little granularity, and this is also captured in our press release, from today, but when you look at it in the phase three allele study, obviously in relapsed refractory EBB positive PTLD patients, we're now presenting data from a total of 43 patients that are evaluable here, and as I mentioned in my initiating remarks, we do have that overall response rate of 51.2% response rate, and of those, 14 of those patients had been post-HCT. So again, and the response rate here was 50%. So seven out of those 14 patients were responders. And then if you look particularly at the SOT patients, we had 29 patients and 15 of those patients were responders for an overall response rate of 51.7% response rate, which again is, is a remarkably high response rate in this particular population of patients that have a very high unmet need. And as Pascal mentioned, you know, these data from the allele study were really the crown jewel in the MAA filing that led to the positive CHMP opinion just a few weeks ago. And then obviously we had median overall survival data of 18.4 months, which again is quite remarkable when you consider that for these patients post-SOT or HCT, you're looking at a median overall survival of somewhere between 0.7 months and four months median survival. So again, these are really pretty remarkable data.
spk02: Thank you.
spk10: Sure. Thank you. Our next question is from John Miller with Evercore. Please proceed with your question.
spk04: Hi, this is Jessica Hui on for John. A couple questions for me. First on TabCell, could you just give a little bit more color on this new meeting plan with the FDA to discuss clinical data? So you just said now that a new phase three may not necessarily be required for BLA submission. But what are the range of possibilities for clinical data package requirements for TAP cell? And then also, how much could you expect to extend cash runway with a potential U.S. commercialization partner? And then lastly, just a question on ATA-188. Are there any updates on potential large pharma partnership interests? Thank you very much.
spk05: Thank you. Jacob, do you want to take the first one? I'll take the next two.
spk09: Yeah, sure. Absolutely. So, and just to sort of summarize the status with the FDA. So, you know, we have had these constructive conversations with the FDA between ATARA, senior management, as well within FDA, and Pascal mentioned this. But again, the feedback that we got here over the summer was, which was really a reversal, I would say of some of the feedback that we got back in February is that there could be a possible path to BLA submission without the need for new clinical trial if we were to use the intended commercial process version of Tab-Cell. And obviously, we did, as I mentioned, put this particular product version into the clinic at the latter part of last year. So we're gaining real clinical experience. What we propose to the agency, which again they are embracing, is this concept that we can leverage the clinical data from patients treated with the intended commercial product as well in the pivotal study, but as we also discussed from other sources as well. The other really impactful meeting that we had with the FDA quite recently was a type A CMC meeting, and Pascal mentioned this as well. But this culminated, and this is very important, in clear guidance from the FDA that we have agreement on the specific CMC model. Module 3 requirements for the potential BLA submission. So again, we feel as if we have really cleared through the CMC hurdle, which has been a major source of discussion over the last couple of years. Now, we also mentioned that we have an upcoming clinical Type B meeting, and this was actually suggested by FDA leadership that we actually have this clinical meeting to discuss and potentially align on the clinical data package requirements leading up to the pre-BLA meeting. So we are actively preparing those arguments. Again, we are going to leverage patients treated with the clinical material, but we certainly have a very large clinical experience, and we've discussed the fact that We've treated over 400 patients with TAB cell in the clinic. And again, this is going to be approved in Europe very shortly. And we have close to 200 patients with PTLD treated as well. So we think that that clinical experience is quite impactful. So again, we are preparing this argument between the intended commercial treated patients as well as our very robust other clinical experience where, again, this is going to be quite an interesting type B clinical meeting coming up where we hope to gain agreement with the FDA on that, the contents of that clinical package. Pascal, anything to further add?
spk05: No, I think that's clear on that. So to your other two questions, Jessica, on the cash fund extension, we're not going to comment on that. We are starting this discussion with potential partners. Maybe what I could say that we had a very successful process in Europe with, I think we received six term sheets at the time on the product, and which was PFR, the best partner, with $45 million up front for Europe, plus a few emerging markets, as well as all the milestones of regulatory and sales, plus very significant double-digit royalties. So we managed to have a very good partner, but also a very good deal for the company. So when you think about the U.S., we'll, of course, try to replicate these type of situations there. And we think there is, as you can imagine, a much larger business opportunity in the U.S. than it is in Europe. And I'll let you decide how large it is compared to Europe. But it is very significant. And we mentioned that particular number of over $500 million of big sales in our views regarding the business opportunity in the U.S. So that's going to be, we hope, significant in line with the value of the product in its first indication and follow-up indications. Now, this being said, we've also said last time that our intent in terms of cash runway is progressively for different types of activities to be able to fund the company into the end, sorry, the Q4 of 24, the end of 24, and the reason is to have one year of cash at some stage beyond the readout of EMBO, which is a very significant potential value inflection point for the company in October of 2023. So that's our intent. We are into Q124 now, but we still have a number of activities that we can manage to support the funding of the company. We have already cashed beyond the onboard readout, which is important to notice, and it's Q124, but we believe we'll have opportunities to go much further than that. Now, on 198 partnering, we are not giving any particular update. We just reiterate what we say that we are, of course, discussing with various companies, but the most important is that it's If we were to consider partnering before the onboard readout, it would have to be of very significant value and value, recognized value as well as potential value split in the future because we want to make sure that all shareholders benefit from the potential value inflection point depending on the readout of onboard in October 23. Thank you very much. Thank you.
spk10: Thank you. Our next question is from Salveen Richter with Goldman Sachs. Please proceed with your question.
spk06: Hi. Thanks for taking the question. This is Mason on for Salveen. On 188, what might give you confidence that one year could be sufficient for the Phase II data there? Thank you.
spk11: AJ, do you want to take that one? Sure. Thanks for the question. The conference for one year being sufficient really drives from the phase one data that we saw where when you look for the disability improvers, so the confirmed disability improvers by EDSS, almost all of them improved within that first 12-month timeframe. As you know, the study is a two-year study, so we are following patients beyond that one-year time point. But because really the large majority of improvers occurred in that first 12-month timeframe, we have confidence that that will be a good endpoint for the in bold readout.
spk06: Okay, thank you.
spk10: This concludes our question and answer session for today. Thank you for joining the ATARA Biotherapeutics Third Quarter 2022 Financial Results Conference Call. You may now disconnect.
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