Pascal Touchon
Analyst · Mizuho. You may proceed with your question
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 of 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 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 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, 9-0, 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 cell is now a well-supported therapeutic hypothesis towards finding a transformative treatment for this debilitating disease. The recent publication in Natures 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 in targeting this 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 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 discussion 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 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 BLA submission at our next quarterly earnings call. We believe that tab-cel can become potentially life-saving options or 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 health care 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 cell to DRG 18, which is a diagnosis-related. [technical difficulty]