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spk10: Greetings, and welcome to Atara Biotherapeutics Q2 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A 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. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Mr. Eric Hellengrand, Vice President of Investor Relations and Finance. Thank you, sir. You may begin.
spk04: Thank you, Operator. Good afternoon, everyone, and welcome to ATARA's second quarter 2022 results conference call. Earlier today, we issued a press release announcing our second 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, Upal Kopikar, Chief Financial Officer, and Dr. A.J. Joshi, Chief Medical Officer. We will begin with prepared comments from Pascal and Jacob, then open up the call 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 filing. 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.
spk07: Thank you, Eric, and thank you all for joining us this afternoon. Today, we announce plans to further focus our company's activities as a leaner research and development centered organization designed to advance our innovative pipeline while at the same time reducing our future cash birth. This includes a reduction of staff by approximately 20% across the organization and a reduction in planned annual cash burn of over 20 percent versus last year. These actions are expected to extend our cash on the way into Q1 of 2024, while still delivering on key milestones for most advanced strategic assets in terms of potential value creation, , 81-88, and . Deveraging or differentiated allogeneic T-cell therapy platform and ATARA unique clinical experience in more than 500 patients treated. We will prioritize R&D activities over the next 18 months on three core priorities. First, the clinical development of ATA-188, a potentially transformative phase two asset for progressive multiple sclerosis. the EU and potential U.S. regulatory filings and approval for TAPCEL, while seeking a commercial partner for TAPCEL in the U.S., including all related activities and cost, which is expected to further extend the company cash runway. Finally, the anticipated Q4 2022 IND filing for ATA3219, a potential best-in-class halogenic CD19 CAR-T, which could address significant opportunity in this field for improving durable clinical response in how to treat B-cell malignancies. We believe these three product candidates could have meaningful impact on patients in great need and could deliver significant value for ATARA and our shareholders. These actions are part of a strategy to focus the organization on research and development and build on the previously announced strategic partnership on manufacturing with Fujifilm Dioxin Biotechnologies and our commercialization collaboration with Pierre Fabre. The prioritization and actions announced today are a continuation of this strategy. We believe this strategy is well-suited for the current position of the company today. It includes new opportunities for future strategic partnerships and non-dilutive funding, and it optimizes resources to advance development for lead clinical and pipeline assets. Let me know detail of progress and plans for key strategic priorities. As we announced in July, we have completed the interim analysis of the ATA-188 Phase II EMBOLD study, and following the IDSMC recommendation, and importantly, or on internal assessment, we determined that no sample size adjustment or modification will be made to the study. Based on enrollment at the end of July, 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, which the FDA recommended as a primary endpoint. We expect to communicate this final data readout in October of 2023. We are pleased with the progress made on the EMBOL study and are confident in the possibility for AT188 to deliver significant clinical improvement to non-active progressive MS patients. Indeed, targeting EBV-infected B-cell is now a well-supported therapeutic hypothesis towards finding a transformative treatment for this debilitating disease. The recent publication in Nature showed how EBV-infected B cells drive pathology in MS by stimulating autoreactive T cells and by differentiating into autoreactive plasma cells. These EBV-infected B cells present in a CNS can drive chronic inflammation in the brain and the generation of reactive antibodies against some brain proteins. We are therefore excited about the potential of 8188 to address the disease at its core in targeting these EBV-infected B cells and plasma cells. In addition to this robust scientific rationale, our confidence and leadership in pursuing our EBV-targeted approach is reinforced by the encouraging clinical data shown in our phase one and open-label extension studies so far. As a reminder, in the phase one study, 33% of the 12 patients in the IDALS 8188 cohorts achieved confirmed EDSS improvement at the 12-month time point, an FDA registration appropriate and primary endpoint framework. Furthermore, the Phase I study in its open-label extension showed that 20 out of 24 patients have had either confirmed EDSS improvement or EDSS stability throughout their observation in the study or open-label extension for up to 42 months. In Q4 of this year, we plan to present at a conference updated data from the OLE and new Phase I MRI data, providing further evidence of the potential clinical impact of 8188 in progressive MS patients. Also, we continue to plan for Phase III readiness, including interacting with the FDA based on our two fast-track designations. Importantly, we're also continuing to further develop and scale up our proprietary bioreactor manufacturing process, which we expect to enable biologic-like cost of goods manufactured. Finally, we will continue to be opportunistic in exploring potential partnering opportunities with biopharma companies that could maximize the value creation potential of ATA-188. Following the EMBOLD IA, A number of companies have confirmed interest in a potential partnership, and we plan to have further discussion in the future with a keen focus on generating significant value. Another key strategic priority to create value is TAPSEL. I would like now to give an update on TAPSEL, starting with our recent progress on the U.S. regulatory front. Indeed, following constructive discussion with the FDA, including senior leadership, The agency recommended a potential path to BLA submission without the need for a new clinical trial. We are very pleased with this outcome, and following additional upcoming scheduled interactions with the FDA, we will give further guidance on progress to a BLA submission at our next quarterly earning call. We believe that TAP-Cell can become a potentially life-saving option for those EBV-positive PTLD patients in need with poor prognosis and no approved treatment options. We also believe TAP-Cell can deliver compelling value proposition for payers and the healthcare system. We already knew that physicians have strong interest in TAP-Cell based upon the clinical data presented last year at ASH. More recently, our US payer market research and payer advisory boards have shown us that payers and treating institutions clearly see TAP-Cell as an important therapeutic improvement for the high-need, previously treated, EBV-positive PTLD patient population. Atara's belief in TAP-Cell value proposition has been recently supported by the CMS decision in its newly released 2023 IPPS rule to formally assign TAP-Cell to DRG18, which is a diagnosis-related story of this technical difficulty, would like to resume the call and just starting at TAP-Cell. As I said, another key strategic priority to create value is TAP-Cell. I would like now to give an update on TAP-Cell, starting with our recent progress on the U.S. regulatory front. Following constructive discussions with the FDA, including senior leadership, the agency recommended a potential path to BLA submission without the need for a new clinical trial. We are very pleased with this outcome. And following additional upcoming scheduled interactions with the FDA, we will give further guidance on progress to a BLA submission at our next quarterly earnings call. We believe that TabCell can become a potentially life-saving option for those EPV-positive PTLD patients in need with poor prognosis and no approved treatment options. We also believe TAP-Cell can deliver a compelling value proposition for payers and the healthcare system. We already knew that physicians have strong interest in TAP-Cell based upon the clinical data presented last year at ASH. More recently, our U.S. Payer Market Research and Payer Advisory Board have shown us that payers and treating institutions clearly see TAP-Cell as an important therapeutic improvement for the high-need previously treated EBV-positive PTLD patient population. ATARA's belief in TAP-cell value proposition has been recently supported by the CMS decision in its newly released 2023 IPPS rule to formally assign TAP-cell to DRG18, which is a diagnosis-related group that includes CAR-T. Obtaining such assignment in advance of BLA filing is extremely rare and is based on compelling value arguments developed by our team for such a potentially lifesaving therapy for patients with EBV-positive PTLD. Once TAP-Cell is approved, this will improve access to reimbursement for patients in need. As we have said before, we believe that the TAP-Cell EBV-positive PTLD market is an attractive, ultra-rare opportunity with several hundred addressable patients in the U.S. who could benefit from this therapy. When considering pricing in line with TAP-Cell's value for patients and the healthcare system, we believe that TAP-Cell has the potential to deliver peak sales in the U.S. of over $500 million. coming from cells in EBV-positive PTLD following previous therapy, or first indication that we are intent, and potential labor expansion from the multicore study. To realize such significant value opportunities, we have decided to seek a partner for commercializing TAP cells in the U.S. that could invest appropriately into commercialization activities, while ATARA will focus on getting TAP cell fields approved in the near term. and on expanding the label in the future. At this stage, I want to thank our team at ATARA who have devoted tremendous effort in order to establish a solid foundation for the launch of TAPCEL once approved. Moving on to Europe, we passed all pre-approval inspection for GMP compliance required to support the marketing authorization application for TAPCEL in Europe. This is excellent progress. And the European Medicine Agency, or EMA, review of TAP-Cell is on track, following our submission of answers to all Day 120 questions. We anticipate European Commission approval in Q4 2022. Our commercial partner, Pierre Fabre, is actively preparing for the TAP-Cell launch in Europe, and we have already manufactured more than one year of commercial product inventory. I am excited that we, along with our partners at Pierre Fabre, are very close to bringing TAP cells to the market, thereby generating value for patients and shareholders. Now, I would like to hand over to Jacob to provide more details on our CAR-T portfolio and strategy before I give you an update on our financials. Jacob?
spk03: Thank you, Pascal. First, I want to provide an update on our mesothelin-directed CAR-T cell therapies. we have terminated with Bayer the exclusive worldwide licensing agreement for our next-generation mesothelin-directed CAR T-cell therapies, ATA-2271, an autologous version, and ATA-3271, an armored allogeneic T-cell immunotherapy. The product rights for these differentiated and innovative mesothelin CAR T programs have now been returned and thus are wholly owned by Atarum. With respect to ATA2271, which is being currently developed by a partner, Memorial Sloan Kettering Cancer Center, we continue to be supportive of the phase one dose escalation clinical study conducted by MSK. And I'd like to provide an update regarding the recent fatal serious adverse event in a patient treated in this study. Over the last several months, MSK has generated significant autopsy-based and correlative data analyses which they have shared with us. The autopsy established a specific end organ adverse event as the cause of death. This AE is a rare but recognized complication associated independently with two of the non-CAR T therapies that this patient received. Based on the data that MSK has shared with us, we see no evidence in the tissues in question of on- or off-target toxicities from the CAR T. As such, our assessment is that the CAR T is not directly associated with the unfortunate adverse event. We appreciate the detailed correlative analyses performed by MSK to help shed light on this complex case of an unfortunate and very ill patient. We appreciate MSK will be communicating these assessments to the FDA along with their plan for resuming patient enrollment via protocol amendment per their policies. We intend to continue to support the development of 2271 through our collaboration with MSK once the study resumed. Additionally, for this program, we expect to provide a phase one data update for ATA 2271 in the fourth quarter of this year. Meanwhile, we have decided to temporarily pause our activities towards the IMD of the allogeneic mesothelin-targeted CAR T program, ATA 3271. This pause will occur until additional funding is available as Bayer was planned to fund the IMD filing and the clinical development starting in phase one. However, our conviction remains strong beyond the potential of our mesothelin programs. We believe they target a high unmet medical need in several key solid tumors, and the CAR-T has a unique and differentiated design using next-generation PD-1 dominant negative receptor and 1XX co-stimulatory domain CAR technologies. Importantly, Atara's approach to CAR-T does not require any TCR or HLA gene editing and retains the endogenous T cell receptor. Our non-gene edited format, co-stimulatory domain, and armoring approaches have been shown in academic studies to increase persistence, durability, and trafficking. We also believe having an allogeneic approach to this target is a unique differentiator in this space, particularly since this allogeneic format utilizes our EBV T-cells, where we have, as Pascal mentioned, over 500 patients' worth of clinical experience. In addition, we are advancing ATA3219 as a potential best-in-class allogeneic CAR T for B-cell malignancies expressing CD19 and are on track to submit an IND in Q4 of this year. We're using an optimized manufacturing process, which is enriched for memory T-cell phenotype, as well as 1XX co-stimulatory domain invented by Dr. Michelle Sadlane, and this program continues to show robust activity in preclinical studies. This manufacturing approach is part of the overall optimization of ATA3219 to differentiate it from the existing products and to address a significant unmet medical need in advanced B-cell malignancies, especially lymphoma. Some of the key points of differentiation are the safety of the EBV CAR T cells, potential best-in-class efficacy, persistence to potentially increase response durability, and off-the-shelf accessibility. Before I turn the call back to Pascal, I'd like to extend my gratitude to the ATAR staff our collaborators, and the patients involved in our studies. I'm thankful for the progress our R&D team has delivered thus far. Going forward, we continue to have a very talented team in R&D and technical operations who will focus on advancing our three key assets, work constructively with our collaborators and academic teams, bring forward our early research programs, and have an unwavering commitment to bring to patients In need, allogeneic T-cell therapies, some with curative potential. Pascal?
spk07: Thanks, Jacob. Now on to our financials. For the second quarter of 2022, we reported license and collaboration revenue of $51.6 million, primarily consisting of deferred revenue recognized due to the termination of the buyer collaboration agreements. We anticipate that license and collaboration revenues will decrease substantially in the future quarters due to the termination of the buyer agreements. We also reported a net gain of $18.9 million for the second quarter. This amount included a gain on the sale of the Atom facility of $50.2 million. With regard to our cash position and runway, we ended the second quarter of 2022 with approximately $331 million in cash. This includes the impact of net proceeds of approximately 95 million from the sale of the ATOM facility during the second quarter. We believe our second quarter cash balance, together with the expected benefit from reductions in operating cash burn, will be sufficient to fund our planned operation into the first quarter of 2024. Finally, while I believe the actions we announced today will best position ATARA to be successful in advancing our pipeline of potentially innovative therapies. I also want to acknowledge that it is also a challenging day for Atarians. I would like to extend my sincere gratitude to all Atara staff, including those departing as well as those staying with Atara, for their unwavering commitment to the patient lives we seek to transform and their significant contribution in advancing truly innovative medicines for patients in need. Thank you for all that you have done. I will now turn the call over to the operator for the Q&A part of the call. Operator?
spk10: At this time, we will 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 will indicate your line is in the question queue. You may press star 2 to remove your question from the queue. For participants using speaker equipment, it may be necessary for you to pick up your hands up before pressing the star keys. One moment while we poll for questions. Our first question comes from the line of Salim Saeed with Mizuho. You may proceed with your question.
spk08: Great. Good afternoon, guys. Thanks for the questions. Three for me, if I can, on ATA 188. One, just for, just because I think there's some confusion on this, Pascal and Jacob, can you guys just confirm for us if you guys actually saw the IAEA data and if that factored into your decision to continue the study, just a yes, no, that would be great. On the bare thesis that's sort of arisen post the data that perhaps it was actually the phase one, perhaps there was some EDSS baseline creep in the phase one data and that's why we saw a drop in the phase one. Could you give us any sense of comfort that, or how do we get comfortable that there wasn't actually an EDSS baseline creep for the phase one? And then the last question just is on the predictability threshold. I don't know if you guys ever disclosed what predictability threshold you used for the IA. I know we were looking at 85% because that's what we saw in the phase one, but did you actually use 85% for the IA, or did you use a lower number? And if you could tell us what that number was. Thank you.
spk07: Thank you, Sanim. So I'll start answering the first question together with Jacob, and then AJ will answer the other two. So, following the IDSMC recommendation and their detailed comment on that recommendation, a few people within ATARA, including myself, Jacob, and AJ, have seen the top line data. And our decision has been based on that as much as on the IDSMC recommendation. So, we've seen the top line data. AJ, do you want to address the second question, please?
spk05: Sure. Thanks, Salim. And, you know, in terms of the EDSS for the phase one, The, this concept of baseline creep, I think it's one of, there's two things I'd probably comment on there. One is that we know EDSS has some variability to it. So once you have an improvement, you've seen it maintained at every consecutive time point for all the way up to 39 months. That in general would argue a little bit against some kind of baseline creep giving you a random, you know, drop and then you taking advantage of it later on. I think probably the second thing though that is just as important is the MTR data that correlates with that EDSS improvement we saw. So whatever measurement creep you think may or may not happen, which we don't believe happened, but let's say if you think something might have happened, there's no measurement creep that's going to happen on the MTR piece. And then you've also heard from Pascal that there's some other MRI data that we're going to be talking about that continue to support that whole notion that there's something happening in those patients that's different when they have the EDSS improvement. So those are all the reasons to really think that that's not really an issue here. And in terms of, you know, we haven't really commented on any specific thresholds related to the IA, apart from that rationale that you articulated about the 85% predictivity, but we haven't commented on any specific thresholds that were used for the IA.
spk08: Got it. Super helpful. Thank you so much.
spk05: Sure.
spk10: Our next question comes from the line of Tessa Romero with JP Morgan. You may proceed with your question.
spk06: Hey, guys. Thanks so much for taking our question. The first one is on the cash side. So you ended 2Q with about $331 million in cash, and you are guiding to a runway to 1Q24. So can you provide some further detail on what assumptions are in that runway? including in terms of any milestones that you're expected to receive from your partnerships. And what are the levers that ATARA could pull to further extend that runway if necessary? And then I have one more on TACCEL if I could.
spk07: The first question, Uthpal, do you want to address this?
spk13: Sure, Tessa, it's Uthpal. Thanks for the question. I think one of the key things that TACCEL mentioned is burn reduction. We mentioned 20% reduction versus what we had incurred last year. Now, it's something that's going to take some time to occur. Some burn reduction has happened with the FDB deal, and as we reduce staff, the burn will continue to go down. And you can look forward, as we get into 2023, when we wrap up all the filing and approval activities with Tier 5 in Europe, the burn will continue to decrease. So that's the first key thing you have to keep in mind. The second thing that you asked about in terms of how could we further extend the cash runway, we're continuing to look at other opportunities to do some non-dilutive financing that we can talk a little bit more about, but particularly related to European and U.S. cap cell is an opportunity for us.
spk06: Okay. And any milestones there that we should be reflecting?
spk13: Yeah, there are milestones associated with PeerFob in Europe, but we have not commented on them.
spk06: Okay. Okay. And then one more from me on TabCell. Just can you provide any more detail on the scenarios that we should be considering for a possible path to a BLA submission here in the U.S. that has been recommended by the FDA or that you're discussing with the FDA? Thanks so much.
spk03: Yeah. Jacob, do you want to address that one? Absolutely. So, Tessa, thanks for the question. So, as Pascal mentioned in our prepared comments, we've had constructive discussions with the FDA. And they do, as you allude to, recommend a possible path to BLA submission without the need for new clinical trials. So, that is an adjustment from their previous recommendation. This path is consistent with the proposal that we made, as you may recall from our previous quarterly call, leveraging patients currently treated with commercial product in the pivotal study. In terms of next steps, meetings are planned. There's one that's scheduled, and there's one more to follow to align on the content of the potential BLA. So we do plan on giving additional color to this path towards a potential BLA at our next quarterly call.
spk06: Okay. Thanks so much for taking our questions.
spk07: Thank you, Tessa.
spk10: Our next question comes from the line of John Newman with Canaccord. You may proceed with your question.
spk02: Hi, guys. Thanks for taking my question. Congrats on the progress of the FDA EBSL. Just had a follow-up question on TabCell. Assuming that the FDA will be requesting some type of additional data, do you believe that ongoing clinical activities will be able to satisfy those types of requests without getting into details to what they are in a reasonable amount of time? I'm just curious, for example, if the agency is looking for more clinical data I feel like the existing clinical structure is going to pull that together in a long time. Thank you.
spk07: Jacob, do you want to address that one?
spk03: You know, as we're reporting today, I think the significant outcome is that the FDA recommends a possible path to BLA without the need for a new clinical trial. And then in terms of negotiations, that's what we are involved in now. And I mentioned, you know, one scheduled meeting and another to follow after that. But that's where we're going to be speaking about the content of that potential BLA filing. But again, the expectation here is that that data will not be coming from a new clinical trial.
spk07: Yeah, and I may add, John, as well, that we are treating patients with a commercial product not only in the pivotal study, the allele study, but also in other studies, and in particular in the EAP program. So we are basically accumulating a number of clinical data efficacy and safety using the commercial product. And all that is really going to be important for the BLA submission.
spk02: Okay, great. And then just one additional question on ATA 3219. Actually really exciting to hear that planning and filing an IND there near term. I had a question on clinical design here. I'm curious. Going forward, think about the patient population or the potential patient population. Do you think that you'd be focusing on patients that were naive to other CD19-focused therapies, or would there be some types of CD19 therapies that you might think about allowing in the studies?
spk07: No, thank you. Our focus will be, even though we are not giving details today about the first in human study, but we can say our focus will be around the medical need. And we see different type of medical need today that are not being fulfilled by the existing and even most of the therapy in development. One in NIFOMA is to have durability of clinical response. We see most of the other therapies, even CAR-T, autologous or allogeneic CAR-T, giving usually up to 40% complete remission at six months. And really, in nymphoma in particular, it's important to look at the CR rate at six months and beyond. So there is a need here to have a higher percentage of patients with good safety and ideally improved safety compared with autologous CAR-T in these type of populations. So that's one type of clinical need. The other type of clinical need is, as you say, patients that have been relapsing and not being controlled after a previous CD19 therapy. And we know that this is not only due to a particular issue with the target, but very often due to a lack of persistence of the therapy, the CAR-T, or other type of therapy that doesn't lead to this durable remission. Hence, they are relapsing. So there are these two types of medical needs that we plan to address somehow in our clinical development, but more detail about that at a later stage.
spk02: Okay, great. Thank you.
spk10: Our next question comes from the line of Phil Nadu with Cowan & Co. You may proceed with your question.
spk11: Hi, Stephen. Thanks for taking our question. This is Ernie for Phil. Two questions, if I may. The first one is a clarification on ATA-188. So as I understand now, your team, your executive team, did see the data for the interim analysis after the decision was made. But it sounds from your prepared remarks that your internal assessment agreed with that decision, and I was wondering if that interpretation is correct. And if so, was that agreement based on your – assumptions, initial assumptions going into the interim analysis? Thanks.
spk07: Thank you for your question. So what we have clarified today is that as planned by the charter of this interim analysis, a few individuals initially, not myself, Jacob, were informed of the data to be able to put the data to the IDSMC that then reviewed the data fully independently, full unblinded data. Then after they put their recommendation, a few of us, including Jacob and myself and AJ, had access to the top line data, not the full unblinded data, just the top line data, to be able to see whether the recommendations is aligned with the best way to create value for this asset. And we do indeed confirm that in our assessment, These top line data have led us to confirm that we can follow the recommendation from the IDSMC and have no changes in the sample size of that study based on the data we've seen.
spk11: I see. Thanks. Thank you. And then, sorry.
spk07: Go ahead, please.
spk11: Okay. And then on TAPCEL, do you have an estimate on how long will the proposed pathway delay the BLA filing? And also, did the decision to partner TAPCEL, was the FDA feedback factor in that decision? Did it have something to do with it? Thanks.
spk07: You want to take the first part of the question, Jacob?
spk03: Yeah, so as I mentioned earlier, The next steps are clear from the perspective that we have an upcoming meeting that is scheduled, and then there will be another meeting after that. So, these will occur in the not-too-distant future, and I think we'll be able to provide more detail on the timeline for the BLA submission and the content of the BLA submission at our next quarterly call.
spk07: And on your second question, I think the decision to look for commercial partner for TAPCEL in the U.S. is really to make sure that we have greater financial flexibility that will position us well to fully realize the value and key catalyst and milestone for most advanced and promising asset TAPCEL 8188 and 883219. So, it's really around finding the possibility for partnering to have all the related activity and cost to prepare and launch the product taken care by this partnering strategy and enabling us to potentially extend further our cash runway. And we think that we've demonstrated that with the European deal that we can create very significant value in partnering, and that allows us to focus on where we believe our resource allocation could create most value for shareholders around creating, reaching key milestone and catalyst for all priority asset.
spk11: Great. Very helpful. Thank you again for taking my question.
spk10: Our next question comes from the line of Michael DeFiore with Evercore ISI. You may proceed with your question.
spk12: Hi, guys. Thanks so much for taking my question. A few for me, both about TadCell. You keep on referring to this registration as a potential path that was recommended by the FDA. that implies that it may not even happen. What needs to be discussed with the agency at this point, and what could possibly result in it not being, not there being a potential path forward here? You know, are they expecting post-marketing studies on this as well? Because it does sound like, from your comments, it does sound like they are willing to accept expanded access patients. um for this and and the second part of my question is just on on the us commercial partnership like it sounds like you know this has been fueled by a desire to extend cash runway what led to this this decision now um and how much additional runway could be achieved if a new partner opts in to share costs thank you yeah let me address both questions here i mean on on the
spk07: As usual, you always talk about potential. We haven't had a pre-BLA meeting. We have not filed a BLA yet. So that's why we always talk about potential. We have now clearly a recommendation that allows us to work constructively, as we've done over the last few months with the FDA, to get to this point of moving forward to a BLA submission. But we have some steps to achieve, and that's what are the planned interactions for before we can confirm the exact timing. And again, as Jacob has said, this particular path is fundamentally based on what we've discussed with them and also what we propose to them, as we said at our previous quarterly call. So, there is no major differences there. On the second aspect, it's always a decision to be made about resource allocation between investing in commercialization or partnering for commercialization. At this stage, we believe that with all the key value-creating assets that we have and we are developing at the clinical stage, it makes sense for us to look for partnering there because, again, partnering, when it is done in the right way, allows to have a significant share of the NPV that remains in the company, and that's where we can really create further value for our shareholders. So we think it makes sense to consider that right now and to be able to focus our activities, but also, again, to have a partnership that will create significant value for ATARA and our shareholders.
spk12: Got it. Thanks so much.
spk10: Our next question comes from the line of Salveen Richter with Goldman Sachs. You may proceed with your question.
spk01: Hi. Thanks for taking our question. This is Tommy on for Salveen. We want to know about how the cadence of R&D updates is going to work for the mesothelin programs. So after we have the Phase I update for 2271, how would you plan out your timing for discussions and planning further studies in the context that you're now focusing more on 3219? And can you just explain the rationale behind prioritizing 3219, given that 2271 is more advanced? Thank you.
spk07: So maybe just to clarify about that part, we still plan to continue development of 2271. As Jacob has explained, we are now expecting our collaborators at MSK to make a proposal to the FDA about some amendment to the protocol so the study can resume. That's what we're doing, and we are going to support that. What we have decided to pose is 3271 IND, and just because the funding for that clinical study, this first in-human study and for the clinical development, was supposed to be done by Bayer, and now that we have terminated the program, the collaboration with them, we are really in a situation where we have this fully-owned asset, 3271, that we certainly plan to bring to IND once we have the appropriate funding. And that could come from different sources, but certainly we have a strong belief in the potential of this program to create value. And again, we are continuing 2271. It's just the allogeneic versions. We need to have further funding to be able to bring these to the clinic and to start the clinical development.
spk03: And maybe just one other point. You asked about an update with mesothelin, so as we discussed today as well, we continue to see Q4 this year as an opportunity to provide updated data on that 2271 autologous program with our partners on Kettering.
spk07: Yeah, and maybe also to add to your question about why giving some priority to 3219 instead of 3271 in IND and first human study. This is mainly because we believe that 3219 has truly the potential rapidly to get a level of clinical data that could clarify what is the potential for best-in-class situation in terms of response rate, efficacy aspect, and safety, and then at the same time to create further confirmation that our differentiated allogeneic T cell platform is indeed leading to benefit in patients. So in terms of speed to get clinical data, it's certain that developing an allogeneic CD19 CAR T is getting to faster ability to evaluate responses than going into mesothelioma, lung cancer, and other type of cancer. Again, this being said, we still plan to do that at the proper time. So we are all ready to go into these final IND steps and clinical development 3271. It's just a matter of resource allocation right now, but that will be really our strategy to be able to find funding to move forward with that asset, which we believe has potential value for patients and the company.
spk10: Our next question comes from the line of Yigal Noshomowitz with Citi. You may proceed with your question.
spk09: Hi, this is Carly on Free As All. Thanks for taking our questions. Maybe just to follow up on the prior question, I guess, are you actively looking to repartner the mesothelin programs in order to advance the allogeneic version? And then maybe more generally, what's your level of interest in partnering additional CAR T targets beyond mesothelin?
spk07: Yes, so we have a platform that is extremely versatile and allows us to rapidly develop allogeneic CAR-T on different targets. Now we have to make proper resource allocation, and at this stage, even though we could develop further additional CAR-T, we have decided not to go to IND-enabling studies and clinical development for additional CAR-T. We have an early pipeline that we are pursuing, by the way, with memorial stone capturing, with MoFIT cancer centers, and also with our collaborators at QIMR in Australia. And that allows to have some work done on new design, new construct, new targets for allogeneic RTs and other type of modalities. So that's really an exciting part that we're continuing at the early stage. Now, investing into the IND enabling studies and First in Human is another level of investment And at this stage, we have decided to focus our resources on the most advanced clinical asset, i.e., TAP cell 8188 and 3219. Now, this being said, for 3271, we will be open to different possibilities, one being certainly a new partnering because this potential therapy could address a number of very significant indications in solid tumors. So while we are resuming soon, hopefully, the study on 2271, and we think that's a matter of a few months, we then can have more data coming from this clinical experience with the autologous, but the main focus will be the allogenic, which will be able to go to the clinic as soon as we have the funding available for that, either for partnering or some other ways to fund this development.
spk10: Okay, great. Thank you. Ladies and gentlemen, we have reached the end of today's question and answer session. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation and enjoy the rest of your day.
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