Financial Data and Key Metrics Changes - For Q3 2022, Atara Biotherapeutics ended with approximately $265 million in cash, which is expected to fund operations into Q1 2024 [20] - The company anticipates a reduction in future operating cash burn following a recent restructuring [20] Business Line Data and Key Metrics Changes - The tab-cel therapy, under the trade name Ebvallo, received a positive opinion from the CHMP for its first indication, with a launch planned in Europe for Q1 2023 [5][6] - The overall response rate for the Phase 3 ALLELE study in EBV-positive PTLD was reported at 51.2%, with a median overall survival of 18.4 months [13][62] Market Data and Key Metrics Changes - The company is preparing for the launch of Ebvallo in Europe, which is expected to have significant pricing potential in an ultra-rare disease market [6] - The U.S. market for tab-cel is projected to have peak sales potential over $500 million per year across multiple indications [8][71] Company Strategy and Development Direction - Atara is seeking a commercial partner in the U.S. to avoid further investment and to extend its cash runway while maximizing the value of tab-cel [8][57] - The company is focused on leveraging its clinical data and regulatory discussions to facilitate a BLA submission without the need for new clinical trials [67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformative potential of tab-cel and ATA188, particularly in addressing significant unmet medical needs in their respective markets [5][15] - The company is optimistic about the upcoming data readout from the Phase 2 EMBOLD study for ATA188, expected in October 2023, which could serve as a significant value inflection point [71] Other Important Information - Atara has treated over 400 patients with tab-cel in clinical settings, which is expected to support the BLA submission process [68] - The company has received fast track designations from the FDA for both tab-cel and ATA188, indicating regulatory support for their development [10] Q&A Session Summary Question: Guidance on EU tab-cel revenues and logistical hurdles - Management is not planning to provide revenue guidance for Europe at this stage but will discuss pricing at the time of launch [24] - Logistical hurdles are minimal as the company has experience in delivering allogeneic cell therapies efficiently [25] Question: Number of patients treated with commercial formulation for tab-cel - Management did not disclose specific numbers but confirmed constructive dialogues with the FDA regarding the clinical data from patients treated with commercial material [31] Question: Data presentation at ESMO for ATA2271 - Safety and PK data will be presented, including details on the fatal SAE that led to the pause in enrollment [40] Question: Clinical data package requirements for tab-cel - The upcoming Type B meeting with the FDA will discuss clinical data package requirements, with a focus on leveraging existing clinical experience [66] Question: Strategic rationale for U.S. partnership - A partnership is seen as beneficial to avoid commercialization costs and to leverage existing commercial structures in the U.S. [57]

Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q2 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Eric Hyllengren - VP of IR and Finance Pascal Touchon - President and CEO Utpal Koppikar - CFO Jakob Dupont - EVP and Global Head of Research and Development AJ Joshi - Chief Medical Officer Conference Call Participants Salim Syed - Mizuho Tessa Romero - JPMorgan John Newman - Canaccord Ernesto Rodriguez Dumont - Cowen & Co. Michael DiFiore - Evercore ISI Tommie Reerink - Goldman Sachs C ...

Tab-cel® Program - Atara submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for tab-cel® in November 2021, with potential European Commission (EC) approval anticipated in Q4 2022[10, 34] - Phase 3 ALLELE study data presented at ASH 2021 demonstrated a 50% Objective Response Rate (ORR) across Hematopoietic Cell Transplant (HCT) and Solid Organ Transplant (SOT) cohorts[38] - In responders from the Phase 3 ALLELE study, the Overall Survival (OS) at 1 year was 100% for HCT and 82.5% for SOT[38] - Atara received an upfront payment of $45 million and is eligible to receive up to ~$320 million in milestones, plus tiered royalties from Pierre Fabre for commercializing Tab-cel® in Europe, Middle East, Africa, and other select emerging markets[52] ATA188 Program - Up to ~1.2 million Multiple Sclerosis (MS) patients worldwide have a progressive form of the disease (PMS)[23, 64] - A longitudinal analysis identified Epstein-Barr Virus (EBV) as the required trigger for multiple sclerosis, with the risk of MS increasing 32-fold after EBV infection[75] - Atara is planning for two Phase 3 randomized pivotal studies focused on non-active progressive MS, with the primary endpoint of confirmed EDSS (Expanded Disability Status Scale) improvement at 12 months[74, 107, 109] CAR T Portfolio - Atara received $60 million in cash upon signing and is eligible to receive up to $610 million in development, regulatory, and commercial milestone payments, plus tiered royalties up to low double-digit percentage of net sales from Bayer for the mesothelin CAR T program (ATA3271) and autologous program (ATA2271)[137] - In an Investigator Sponsored Trial (MSKCC), 83% (5/6) of R/R B-ALL, NHL and CLL patients had durable Complete Response (CR) with median follow up of 26.9 months after receiving partially HLA matched EBV CD19 CAR T cells manufactured from third-party donors[145] - ATA3271 IND Submission is expected in Q4 2022[22, 138, 142]

Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q1 2022 Results Conference Call May 5, 2022 4:30 PM ET Company Participants Eric Hyllengren - VP of IR and Finance Pascal Touchon - President and CEO Utpal Koppikar - Chief Financial Officer Jakob Dupont - EVP and Global Head of Research and Development AJ Joshi - Chief Medical Officer Kristin Yarema - Chief Commercial Officer Conference Call Participants Salim Syed - Mizuho Tessa Romero - JPMorgan John Newman - Canaccord Marc Frahm - Cowen and Company Ben Burnett - ...

ATA188 and Multiple Sclerosis (MS) - ATA188 is an allogeneic T cell therapy targeting Epstein-Barr virus (EBV), the underlying cause of MS[6] - Phase 1 data supports the safety and potential for transformative disability improvement in progressive MS with ATA188[6] - Recent publications identify EBV as the leading cause of MS[7] - In a Phase 1/OLE study, 20 out of 24 patients with non-active progressive MS showed improvement or stability with EDSS[7] - The company plans to conduct a formal interim analysis in Q2 2022 to optimize the likelihood of success in Phase 2[7] EBV and MS - Up to 100% of MS patients are EBV seropositive[55] - A 2022 study showed a 32-fold increase in the risk of MS after EBV infection[58] - EBV proteins bind risk loci mapped to many autoimmune diseases, including MS[114] Clinical Trial and Data - In Phase 1 study, 33% confirmed EDSS improvement in Cohorts 3 – 4 at 12 Months[75] - Analysis of placebo data shows limited placebo-driven EDSS improvement, around 5% in non-active PMS[100] - The company is currently enrolling 80 non-active progressive MS patients in the ATA188 Phase 2 Randomized, Placebo-Controlled Study (EMBOLD)[99] Manufacturing and Commercial Potential - Scaled-up manufacturing process planned to result in the ability to produce up to ~20,000 doses from one donor collection[108] - Current inventory model projects coverage of ~95% of MS patients with ~10 HLA specific product lots[108] - ATA188 has the potential to be a transformative multi-billion dollar opportunity[122]

Financial Data and Key Metrics Changes - Atara Biotherapeutics ended Q4 2021 with $371 million in cash, which includes $48 million from the sale of common stock and $45 million from a commercialization agreement [20][21] - The company believes that its cash position, along with an anticipated $100 million from a strategic transaction, will be sufficient to fund operations into Q4 2022 [21] Business Line Data and Key Metrics Changes - The company is focusing on three strategic priorities: ATA188 for multiple sclerosis and next-generation allogeneic CAR T programs [6] - The tab-cel product is undergoing a review for regulatory approval in Europe, with an anticipated approval in Q4 2022 [9] - The FDA has recommended a clinical study for tab-cel, indicating that comparability has not been demonstrated, which was unexpected for the company [11][54] Market Data and Key Metrics Changes - There is increasing interest from the medical and investor community regarding ATA188, particularly following recent publications linking EBV to multiple sclerosis [15][24] - The company is hosting an EBV and MS Day to discuss the implications of recent findings and the potential of ATA188 [16] Company Strategy and Development Direction - Atara is committed to finding a reasonable pathway for BLA submission for tab-cel in collaboration with the FDA, emphasizing the product's potential to address urgent medical needs [13][29] - The company is also exploring the development of an EBV vaccine, leveraging its knowledge of the link between EBV and autoimmune diseases [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of tab-cel and ATA188, despite regulatory challenges, and emphasized the importance of ongoing dialogue with the FDA [11][70] - The company is optimistic about the upcoming interim analysis for ATA188 and its implications for future studies [17][25] Other Important Information - Atara announced a strategic partnership with FUJIFILM Diosynth Biotechnologies to acquire a manufacturing facility, which is expected to enhance its production capabilities [19] - The company is actively treating patients with commercial tab-cel products in clinical trials, gathering valuable clinical data [10][70] Q&A Session Summary Question: Concerns about the interim analysis for ATA188 - Management acknowledged the concerns and stated that they will communicate decisions related to study sample size and rationale following the interim analysis [32][33] Question: Comparability of tab-cel materials - Management confirmed that EMA has accepted comparability between pivotal and commercial materials, while the FDA has raised concerns about specific attributes [42][43] Question: Data sharing from interim analysis - Management intends to share interim analysis data with potential partners and the FDA under confidentiality agreements [48] Question: Fatal serious adverse events in ATA2271 study - Management is investigating the events and will provide updates as more information becomes available [62][64] Question: Confidence in ATA188's progress - Management expressed confidence that ATA188 will not be adversely affected by the ongoing discussions regarding tab-cel [70]