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]

Financial Performance - The company reported a net loss of $340.1 million for the year ended December 31, 2021[155]. - As of December 31, 2021, the company had total cash, cash equivalents, and short-term investments of $371.1 million[165]. - The company expects to incur significant operating losses for the foreseeable future as it continues to invest in research and development[156]. - The anticipated $100.0 million from FUJIFILM Diosynth Biotechnologies California Inc. is expected to fund operations into the fourth quarter of 2023[165]. - The company currently has no approved products and thus has no product revenues[161]. - Future capital requirements will depend on the costs of research, regulatory approvals, and commercialization activities[164]. - The company has a limited operating history, making it difficult to assess future viability[158]. - The company may need to raise additional capital through equity or debt financing, which could dilute existing stockholders[168]. Impact of COVID-19 - The ongoing COVID-19 pandemic continues to impact the company's operations and may affect future clinical programs[172]. - The ongoing COVID-19 pandemic continues to adversely affect the company's business operations, impacting manufacturing capabilities and supply chains due to government restrictions and health concerns[173]. - Clinical trials have experienced delays in site initiation and patient enrollment, particularly for the Phase 3 clinical trial of tab-cel® due to COVID-19 related restrictions[174]. - The ongoing COVID-19 pandemic has caused transient interruptions in the supply of raw materials, impacting manufacturing capabilities[223]. Regulatory Challenges - The company has not yet obtained regulatory approval for any product candidates, with a significant dependency on the timely approval of tab-cel® and ATA188 for future success[176]. - The FDA's approval process is unpredictable and may take many years, with the company facing challenges due to the novel nature of its T-cell immunotherapy product candidates[178]. - The company may need to conduct additional clinical trials to establish comparability for tab-cel®, which could significantly delay the BLA submission process[180]. - Regulatory authorities may impose limitations on approved product candidates, affecting commercialization and revenue generation potential[184]. - The company relies on CROs and other third parties for clinical studies, which introduces risks related to their performance and compliance with regulations[199]. - Delays in regulatory approvals for product candidates could limit the company's ability to generate revenues[226]. - Regulatory approval in international jurisdictions is necessary for the company to market its products abroad, and the approval process varies significantly among countries[214]. Clinical Trials and Product Development - The company has not yet demonstrated the ability to successfully complete Phase 2 or Phase 3 clinical studies[158]. - Tab-cel® is being evaluated in the ALLELE study, with a primary endpoint of an overall response rate (ORR) exceeding 20% to be considered successful[190]. - An observed ORR above approximately 37% in a cohort of 33 patients would meet the primary endpoint for that cohort in the ALLELE study[190]. - The company may file a marketing application based on interim data, which could impact the required ORR and approved indications[190]. - The company has experienced slower-than-anticipated enrollment in Phase 3 studies of tab-cel® for patients with EBV+ PTLD, affecting clinical timelines[198]. - Delays in clinical studies may arise from various factors, including patient enrollment challenges and regulatory authority feedback[195]. - Any delays or quality issues in clinical studies could harm the approval and commercial prospects of product candidates[200]. Manufacturing and Supply Chain Risks - The company faces challenges in manufacturing processes for T-cell immunotherapy products, including ensuring a reliable supply and addressing variability in donor T cells[186]. - Manufacturing processes must evolve to support advanced clinical studies and commercialization, with risks of cost overruns and process reproducibility issues[222]. - Manufacturing cellular therapies is susceptible to contamination and equipment failure, which could lead to product defects and supply disruptions[224]. - The company relies on third-party manufacturers and suppliers, which poses risks to maintaining clinical and commercial timelines[232]. - Transitioning manufacturing to a CMO or own facility is necessary to meet projected supply needs for product candidates[233]. - Disruptions in supplier relationships could considerably delay clinical studies and regulatory approvals, impacting revenue generation[239]. Intellectual Property and Competition - The company faces risks related to intellectual property, including potential challenges to the validity and enforceability of patents[246]. - The patent life for products is limited, generally expiring 20 years after filing, which could reduce exclusive marketing time[254]. - The company may face significant competition in forming strategic alliances and may not achieve desired outcomes from such efforts[244]. - The company faces significant risks related to patent infringement claims from third parties, which could impede the development and commercialization of its product candidates[258]. - There is a possibility that third-party patents or applications may cover materials or methods related to the company's product candidates, potentially leading to infringement claims[259]. Market Acceptance and Reimbursement - Market acceptance of the company's product candidates is crucial for commercial success, influenced by factors such as efficacy, safety, and reimbursement availability[275]. - The company may struggle to secure adequate coverage and reimbursement from third-party payors, which is essential for successful commercialization[276]. - The healthcare industry is experiencing a primary trend of cost containment, with government authorities and third-party payors limiting coverage and reimbursement levels for medications[277]. - There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, which could adversely affect the commercialization of these products[279]. Corporate Governance and Compliance - The company is highly dependent on its executive officers and key employees, and losing any of them could impede corporate objectives[320]. - Compliance with healthcare laws and regulations is critical, as violations could lead to significant penalties and harm to the company's reputation[325]. - The company currently holds product liability insurance, but it may not be adequate to cover all potential liabilities[330]. - Noncompliance with environmental, health, and safety laws could result in fines or penalties that adversely affect business success[331]. Data Privacy and Cybersecurity - The company acknowledges potential vulnerabilities in its data protection efforts, which could lead to significant operational disruptions and reputational harm[349]. - Unauthorized access or breaches could result in legal claims and liabilities under privacy and data protection laws, potentially harming the company's competitive position[351]. - The company has implemented security measures, but data remains accessible through multiple channels, increasing the risk of breaches[350]. - Any significant data breach could compel the company to comply with breach notification laws, leading to further reputational damage and financial exposure[351].

Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Q3 2021 Earnings Conference Call November 4, 2021 8:30 AM ET Company Participants Eric Hyllengren - VP of IR and Finance Pascal Touchon - President and CEO Jakob Dupont - EVP and Global Head of Research and Development Utpal Koppikar - CFO AJ Joshi - Chief Medical Officer Kristin Yarema - Chief Commercial Officer Conference Call Participants Salim Syed - Mizuho Matt Phipps - William Blair John Newman - Canaccord Tessa Romero - JPMorgan Phil Nadeau - Cowen Jonathan M ...