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Atara Biotherapeutics, Inc. Q2 FY2022 Earnings Call

Atara Biotherapeutics, Inc. (ATRA)

Earnings Call FY2022 Q2 Call date: 2022-08-08 Concluded

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Operator

Greetings, and welcome to Atara Biotherapeutics Q2 2022 Financial Results Conference Call. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Mr. Eric Hyllengren, Vice President of Investor Relations and Finance. Thank you, sir. You may begin.

Eric Hyllengren Head of Investor Relations

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 Touchon, President and Chief Executive Officer; Dr. Jakob Dupont, Executive Vice President and Global Head of Research and Development; Utpal Koppikar, Chief Financial Officer; and Dr. AJ Joshi, Chief Medical Officer. We will begin with prepared comments from Pascal and Jakob 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 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.

Thank you, Eric, and thank you all for joining us this afternoon. Today, we announced plans to further focus our company's activity as a leaner research and development-centered organization designed to advance our innovative pipeline while, at the same time, reducing future cash burn. This includes a reduction of staff by approximately 20% across the organization and a reduction in planned annual cash burn of over 20% versus last year. These actions are expected to extend our cash runway into Q1 of 2024 while still delivering on key milestones for most advanced strategic assets in terms of potential value creation, tab-cel, ATA188, and ATA3219. Leveraging our differentiated allogeneic T-cell therapy platform and Atara's 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 ATA188 or potentially transformative Phase 2 asset for progressive multiple sclerosis; second, the EU and potential U.S. regulatory filings and approval for tab-cel while seeking a commercial partner for tab-cel in the U.S., including all related activities and costs, which is expected to further extend the company's cash runway; finally, the anticipated Q4 2022 IND filing for ATA3219, a potential best-in-class allogeneic CD19 CAR T, which could address a significant opportunity in this field for improving durable clinical response in hard-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 Diosynth 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 nondilutive funding, and it optimizes resources to advance development for lead clinical and pipeline assets. Let me now detail our progress and plans for key strategic priorities. As we announced in July, we have completed the interim analysis of the ATA188 Phase 2 EMBOLD study, and following the IDSMC recommendation, and importantly, our own 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 EMBOLD study and are confident in the possibility for ATA188 to deliver significant clinical improvement to non-active MS patients. Indeed, targeting EBV-infected B cells 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 the 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 ATA188 to address the disease at its core by 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 1 and open-label extension study so far. As a reminder, in the Phase 1 study, 33% of the 12 patients in the ATA188 cohorts achieved confirmed EDSS improvement at the 12-month time point, an FDA registration-appropriate and primary endpoint of EMBOLD. Furthermore, the Phase 1 study and its open-label extension showed that 20 out of 24 patients have had either confirmed EDSS improvement or EDSS stability for 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 OAD and new Phase 1 MRI data providing further evidence of the potential clinical impact of ATA188 in progressive MS patients. Also, we continue to plan for Phase 3 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 ATA188. Following the EMBOLD IA, a number of companies have confirmed interest in a potential partnership and we plan to have further discussions in the future with a keen focus on generating significant value. Another key strategic priority to create value is tab-cel. I would like now to give an update on tab-cel starting with our recent progress on the U.S. regulatory front. Indeed, 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 BLA submission at our next quarterly earnings call. We believe that tab-cel can become potentially life-saving options for those EBV-positive PTLD patients in need with poor prognosis and no approved treatment options. We also believe tab-cel can deliver compelling value proposition for payers and the healthcare system. We already knew that physicians had strong interest in tab-cel based upon the clinical data presented last year at ASH. More recently, our U.S. payer market research and payer advisory boards have shown us that payers and treating institutions clearly see tab-cel as an important therapeutic improvement for the high need previously treated EBV-positive PTLD patient population. Atara's belief in tab-cel sales value proposition has been recently supported by the CMS decision in its newly released 2023 IPPS rule to formally assign tab-cel to DRG-18, which is a diagnosis-related group that links CAR T.

Operator

Ladies and gentlemen, we do apologize for our technical difficulties. The event will resume momentarily. Again, please stand by. The event will resume momentarily.

Sorry for all this technical difficulty. We'd like to resume the call and just starting at tab-cel. As I said, another key strategic priority to create value with tab-cel. I would like now to give an update on tab-cel 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 earnings call. We believe that tab-cel 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 tab-cel can deliver a compelling value proposition for payers and the health care system. We already knew that physicians have strong interest in tab-cel based upon the clinical data presented this year at ASH. More recently, our U.S. payer market research and payer advisory boards have shown us that payers and treating institutions clearly see tab-cel as an important therapeutic improvement for the high need previously treated EBV-positive PTLD patient population. Atara's belief in tab-cel value proposition has been recently supported by the CMS decision in its newly released 2023 IPPS rule to formally assign tab-cel to DRG-18, which is a diagnosis-related group that links 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 life-saving therapy for patients with EBV-positive PTLD. Once tab-cel is approved, this will improve access to reimbursement for patients in need. As we have said before, we believe that the tab-cel 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 tab-cel value for patients and the health care system, we believe that tab-cel has the potential to deliver peak sales in the U.S. of over $500 million coming from sales in EBV-positive PTLD following previous therapy or first indication that we attend - and potential label expansion from the multi-cord study. To realize such significant value opportunities, we have decided to seek a partner for merchandising tab-cel in the U.S. that could invest appropriately into commercialization activities while Atara will focus on getting tab-cel field 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 tab-cel once approved. Moving on to Europe. We passed all pre-approval inspection for GMP compliance required to support the marketing authorization application for tab-cel in Europe. This is excellent progress and the UN Medicine Agency or EMA review of tab-cel 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 tab-cel launch in Europe, and we have already manufactured more than one year of commercial product inventory. I'm excited that we, along with our partners at Pierre Fabre are very close to bringing tab-cel to the market, thereby generating value for patients and shareholders. Now I would like to hand over to Jakob to provide more details on our CAR T portfolio and strategy before I give you an update on our financials.

Speaker 3

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, ATA2271, an autologous version; and ATA3271, an armored allogeneic T-cell immunotherapy. The product rights for these differentiated and innovative mesothelin CAR T programs have now been returned and that are wholly owned by Atara. 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 1 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 that 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 resumes. Additionally, for this program, we expect to provide a Phase 1 data update for ATA2271 in the fourth quarter of this year. Meanwhile, we have decided to temporarily pause our activities towards the IND of the allogeneic mesothelin-targeted CAR T program, ATA3271. This pause will occur until additional funding is available as Bayer was planned to fund the IND filing and the clinical development starting in Phase 1. However, our conviction remains strong behind 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. Michel Sadelain, 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 Atara staff, our collaborators and the patients involved in our studies. I am 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 to 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.

Thanks, Jakob. 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 Bayer collaboration agreements. We anticipate that license and collaboration revenues will decrease substantially in the future quarters due to the termination of the Bayer 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 operations 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 Atarans. I would like to extend my sincere gratitude to all Ataran staff, including those departing as well as 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

Our first question comes from Salim Syed with Mizuho. You may proceed with your question.

Speaker 4

Great. Good afternoon, everyone. Thank you for the questions. I have three for you regarding ATA188. First, could Pascal and Jakob confirm if you saw the IA data and if it influenced your decision to continue the study? A simple yes or no would be helpful. Second, there seems to be a bare thesis that's emerged suggesting there might have been some EDSS baseline creep in the Phase 1 data and that's why we observed a drop. Can you provide any reassurance on how we can be confident that there wasn't actually any EDSS baseline creep for the Phase 1? Lastly, regarding the predictability threshold, did you disclose what threshold you used for the IA? We were considering 85% based on the Phase 1 data, but did you actually use 85% for the IA or a lower number? If possible, please share that number. Thank you.

Thank you, Salim. So I'll start answering the first question together with Jakob, and then AJ will answer the other two. So following the IDSMC recommendation and their detailed comments on that recommendation, a few people within Atara, including myself, Jakob, 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?

Speaker 5

Sure. Thanks, Salim. Regarding the EDSS for Phase 1 and the concept of baseline creep, I have two points to make. First, it's important to note that the EDSS has some variability. When we observe an improvement, it has been sustained at each consecutive time point for up to 39 months. This suggests that baseline creep is unlikely to cause a random drop followed by gains later on. The second point, which is equally important, is the MTR data that aligns with the improvement in EDSS we observed. Even if there's speculation about potential measurement decreases, which we do not believe occur, the MTR data will not reflect any such measurement creep. Additionally, Pascal has mentioned that there are other MRI data we will discuss that further confirm that something significant is happening with patients who experience EDSS improvement. All of these factors lead us to conclude that there's no concern in this regard. As for specific thresholds relating to the IA, we haven't provided any details beyond the rationale regarding the 85% productivity, and we haven't commented on any specific thresholds used for the IA.

Speaker 4

Got it. Super helpful. Thank you so much.

Operator

Our next question comes from the line of Tessa Romero with JPMorgan. You may proceed with your question.

Speaker 6

Hi, guys. Thank you so much for taking our question. The first one is on the cash side. So you ended Q2 with about $331 million in cash and you are guiding to a runway to Q1 '24. 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 tab-cel, if I could.

Sure. Tessa, it's Utpal. Thanks for the question. I think one of the key things that Pascal mentioned is burn reduction. We mentioned a 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 Pierre Fabre 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 nondilutive financing that we can talk a little bit more about, particularly related to European and U.S. tab-cel as an opportunity for us.

Speaker 6

Okay. And any milestones there that we should be reflecting?

Yes. There are milestones associated with Pierre Fabre in Europe, but we have not commented on them.

Speaker 6

Okay. And then one more from me on tab-cel. 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? Thank you so much.

Yes. Jakob, you want to address that one?

Speaker 3

Absolutely. Thank you for the question, Tessa. As Pascal mentioned in our prepared comments, we've had productive discussions with the FDA, which recommend a possible path to a BLA submission without needing new clinical trials. This represents a change from their earlier recommendation. This pathway aligns with the proposal we shared during our last quarterly call, which involves using patients currently treated with a commercial product in the pivotal study. Looking ahead, we have meetings planned, including one scheduled and another to follow, to finalize the content for the potential BLA. We intend to provide more details about this path toward a potential BLA in our next quarterly call.

Speaker 6

Okay. Thanks so much for taking our questions.

Thank you, Tessa.

Operator

Our next question comes from the line of John Newman with Canaccord. You may proceed with your question.

Speaker 8

Hi, everyone. Thank you for addressing my question. Congratulations on the progress with the FDA regarding tab-cel. I have a follow-up inquiry about tab-cel. If the FDA is asking for some additional data, we believe our ongoing clinical activities can meet those requests in a reasonable timeframe. I am curious, for instance, if the agency is seeking more clinical data, is it feasible to gather that from the existing clinical structure without taking too long? Thank you.

Jakob, do you want to address that one?

Speaker 3

Yes. As we report today, a significant development is that the FDA suggests a possible pathway to BLA without requiring a new clinical trial. We are currently engaged in negotiations, with one meeting scheduled and another to follow, where we will discuss the details of that potential BLA filing. The expectation is that the necessary data will not come from a new clinical trial.

Yes. 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.

Speaker 8

Okay. Great. And then just one additional question on ATA3219. Actually really exciting to hear that planning on 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'll 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 study?

No, thank you. Our focus will be, although we are not providing details today about the first-in-human study, on addressing medical needs. We recognize various medical needs that currently remain unmet by existing therapies and many of those in development. For lymphoma, one significant need is ensuring durability of clinical response. Many other therapies, including both autologous and allogeneic CAR T, achieve about a 40% complete remission rate at six months. In lymphoma, it is crucial to examine the complete response rate at six months and beyond. Thus, there is a demand for a higher percentage of patients experiencing good safety and enhanced safety compared to autologous CAR T in this context. Another medical need pertains to patients who have relapsed and are not well-controlled after prior CD19 therapy. This issue is often not solely related to the target but also involves insufficient persistence of the therapy, whether CAR T or other treatments, which results in the lack of durable remission, leading to relapses. We intend to address these two types of medical needs in our clinical development, with more details to be shared later.

Speaker 8

Okay. Great. Thank you.

Operator

Our next question comes from the line of Phil Nadeau with Cowen & Co. You may proceed with your question.

Speaker 9

Hi, thank you for taking our question. This is Ernie for Phil. I have two questions, if that's alright. First, I would like some clarification on ATA188. I understand that your executive team reviewed the data for the interim analysis after making the decision. However, based on your prepared remarks, it seems that your internal assessment supports that decision. Is my interpretation correct? If so, was that agreement based on your initial assumptions going into the interim analysis? Thank you.

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, Jakob, were informed of the data to be able to put the data to the IDSMC that then we view the data fully independently full unblinded data. Then after they put their recommendation, a few of us, including Jakob and myself and AJ had access to the top-line data, not the full and binding data, just the top-line data to be able to see whether the recommendations align with the best way to create value for this asset. And we do indeed confirm that in our assessment, this top-line data has 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.

Speaker 9

Thank you. Regarding tab-cel, do you have an estimate on how long the proposed pathway will delay the BLA filing? Also, did the FDA feedback influence the decision to partner with tab-cel? Is there a connection between them? Thank you.

Do you want to take the first part of the question, Jakob?

Speaker 3

Yes. As I mentioned, the next steps are clear as we have an upcoming meeting scheduled followed by another meeting afterward. These will take place soon. I believe we will be able to provide more details on the timeline for the BLA submission and its content at our next quarterly call.

In response to your second question, the decision to seek a commercial partner for tab-cel in the U.S. is intended to enhance our financial flexibility. This approach will better position us to realize the full value and key milestones related to our most advanced and promising assets, including tab-cel, ATA188, and ATA3219. Our goal is to find a partnership that can manage the activities and costs associated with preparing and launching the product, potentially extending our cash runway. We believe our recent European deal demonstrates the significant value that can be generated through partnerships, allowing us to focus our resources on achieving the most value for our shareholders by hitting key milestones for our priority assets.

Speaker 10

Hi everyone. Thank you for taking my question. I have a couple of inquiries regarding tab-cel. You keep mentioning that this registration could be a potential path suggested by the FDA, which suggests it might not happen. What discussions need to take place with the agency at this point, and what might lead to the possibility of no path forward? Are they anticipating post-marketing studies for this as well? It seems your comments indicate they may be open to including expanded access patients for this. The second part of my question pertains to the U.S. commercial partnership. It appears that this decision was driven by a need to extend cash runway. What prompted this decision now, and how much additional runway could be gained if a new partner shares costs? Thank you.

Yes. Let me address both questions. We haven't had a pre-BLA meeting or filed the BLA yet, which is why we talk about potential. We now have a recommendation that allows us to work constructively with the FDA to move forward with a BLA submission, but there are some steps we need to complete before confirming the exact timing. As Jakob mentioned, this path is based on our discussions with them and our previous proposals. There are no major differences from what we have shared before. Regarding resource allocation between commercialization investment and partnering, we believe it makes sense to consider partnerships at this stage. This approach allows us to retain a significant share of the net present value in the company when done correctly, which can create further value for our shareholders. Therefore, we think it is a sensible direction for us to pursue.

Speaker 11

Thank you for taking our question. This is Tommie on for Salveen. I wanted to know about how the cadence of R&D updates is going to work for the mesothelin programs. So after we have the Phase 1 update for 2271, how would you plan out your timing for discussions and planning for their 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.

To clarify, we still intend to proceed with the development of 2271. Our collaborators at MSK are expected to propose an amendment to the protocol to allow the study to resume, and we will support that effort. What we have chosen to pause is 3271 IND due to funding issues for the clinical study, which was to be provided by Bayer. Since we have terminated our collaboration with them, we are currently in a position with fully owned asset 3271, which we plan to progress to IND when we secure the necessary funding from other sources. We firmly believe in the potential of this program to generate value. Regarding 2271, we need additional funding to advance the allogeneic versions to clinical development.

Speaker 3

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.

Yes. And maybe also to add to your question about why we're giving some priority to 3219 instead of 3271 in IND and first-in-human study. This is mainly because we believe that 3219 has truly the potential to rapidly get a level of clinical data that could clarify what is the potential for a 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 types of cancer. Again, this being said, we still plan to do that at the proper time. So we're all ready to go into this 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.

Speaker 12

Hi, this is Carly on for Yigal. 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?

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 Sloan Kettering, with Cancer Centers and also with our collaborators at QIMR in Australia. And that allows us to have some work done on new designs, new constructs, new targets for allogeneic CAR Ts and other types of modalities. So that's really an exciting part that we're continuing at the early stage. Now investing in 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 assets, i.e., tab-cel, ATA188, and 3229. 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, 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 allogeneic which will be able to go to the clinic as soon as we have the funding available for that, either from partnering or some other ways to fund this development.

Operator

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.