ATA-2271

Atara CEO Pascal Touchon/Courtesy of Atara Biotherapeutics The promised layoffs at Atara Biotherapeutics have begun weeks after the Bay Area company announced plans to terminate 20% of its staff under a new corporate strategy focused on the innovation within the company’s pipeline. Notices of job cuts totaling 77 employees at three company sites across California have been filed with the state, according to Endpoints. Atara first announced its plans earlier this month in its quarterly call. The company said the cuts are part of a broader strategy that will make the organization leaner and focus its attention on research and development. Additionally, it will build out manufacturing and commercialization collaborations established with FUJIFILM Diosynth Biotechnologies (FDB) and Pierre Fabre. When the company announced its intentions to cut staff, Atara had approximately 430 employees. The decision to terminate one-fifth of the company’s headcount comes about a month after it hit a snag with its multiple sclerosis drug ATA188. In July, the company reported that an interim analysis from the Phase II EMBOLD trial assessing ATA188 in patients with progressive multiple sclerosis revealed inconclusive data. The study will continue with a data readout planned for October 2023. Atara noted in its earnings call that it is preparing to conduct a Phase III study with the asset. The company also saw a setback in May when Bayer terminated a two-year-old collaboration to develop an off-the-shelf T cell immunotherapy for high mesothelin-expressing tumors. That partnership focused on two CAR-T assets, ATA3271, an armored allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer. The termination of the agreement comes about two months after Atara announced a study of ATA2271 was paused following the revelation of a patient death. While this sets back plans for an investigational new drug application, Atara said it intends to continue supporting the clinical development of ATA2271 through its collaboration with Merck. In addition to ATA3271, Atara is progressing the development of ATA3219, a CAR-T program aimed at B-cell malignancies. The company anticipates a possible IND in the fourth quarter of the year. Atara also said it intends to focus its resources on the development of its cell therapy tabelecleucel (tab-cel) for Epstein-Barr virus-driven post-transplant lymphoproliferative disease. Pascal Touchon, president and CEO of Atara, said that according to the FDA there is a potential path toward a BLA that does not require a new clinical trial. The company stated it will provide guidance on the progress of tab-cel at its next quarterly call. Outside of the United States, Atara anticipates that tab-cel will be approved for use in Europe by the end of 2022. Atara closed out the quarter with cash and cash equivalents of $331.3 million. With the projected savings of more than 20% of its cash burn due to the layoffs, Atara reported that its current finances are enough to fund its operations into the first quarter of 2024. “Atara’s R&D-centered strategy, clear portfolio prioritization, and purposeful partnerships are positioning us for success in reaching critical value-generating milestones for our key pipeline assets,” Touchon said during the quarterly call. “I would like to extend my sincere gratitude and thanks to Atara’s staff for their significant contributions and unwavering commitment to advancing truly innovative medicines for patients in need.”

Atara to Focus on R&D Activities Prioritizing Upcoming Milestones for Key Pipeline Assets ATA188 Phase 2 EMBOLD Study Interim Analysis Completed with Target Enrollment Achieved; Primary Endpoint Data Read Out Planned for October 2023 FDA Recommended Pathway to Potential Tab-cel BLA Filing Without Need for New Clinical Trial; European Commission Approval on Track for Q4 2022 ATA3219 on Track for Q4 2022 IND Submission Conference Call and Webcast Today at 1:30 p.m. PDT / 4:30 p.m. EDT SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the second quarter 2022, an update to its corporate strategy, recent business highlights, and key upcoming catalysts. “We are excited about the transformative potential of ATA188 in MS and are pleased that as a result of our significant and constructive engagement, the FDA has recommended a possible path towards a tab-cel BLA filing without the need for a new clinical study,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Atara’s R&D-centered strategy, clear portfolio prioritization, and purposeful partnerships are positioning us for success in reaching critical value-generating milestones for our key pipeline assets. I would like to extend my sincere gratitude and thanks to Atara’s staff for their significant contributions and unwavering commitment to advancing truly innovative medicines for patients in need." Corporate Strategy Update Atara announced plans to focus its activities as a leaner organization centered on R&D to further advance the Company’s innovative pipeline, while reducing cash burn Staff will be reduced by approximately 20% across the organization Future annual cash burn is anticipated to be reduced by over 20%, extending Atara’s cash runway into Q1 2024 Leveraging its differentiated allogeneic T-cell therapy platform and unique clinical experience in over 500 patients treated, Atara will prioritize R&D activities over the next 18 months on three core priorities: Clinical development of ATA188, our potentially transformative Phase 2 asset for progressive multiple sclerosis EU and potential U.S. regulatory filings and approvals 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 Anticipated Q4 2022 IND filing for ATA3219, a potential best-in-class allogeneic CD19 CAR T, with the potential to address the significant opportunity in the field for improving durable clinical response in hard-to-treat B-cell malignancies These actions are part of a broader ongoing strategy to focus the organization on R&D, building on the previously announced manufacturing and commercialization collaborations with FUJIFILM Diosynth Biotechnologies (FDB) and Pierre Fabre, respectively, and continuing with the R&D-focused prioritization announced today ATA188 for Progressive Multiple Sclerosis (MS) Atara completed the Phase 2 EMBOLD study Interim Analysis (IA) in patients with progressive MS in June 2022 and the Company determined no sample size adjustment or modification would be made to the study Based on enrollment at the end of July, approximately 90 patients are planned to be included in the read out of the study primary endpoint of confirmed disability improvement by EDSS at 12 months. Communication of these data is planned to occur at an appropriate forum in October 2023 Atara continues to plan for Phase 3 readiness, including interacting with the U.S. Food & Drug Administration (FDA) based on two Fast Track designations, and further developing its proprietary large-scale bioreactor manufacturing process New Phase 1 MRI data providing further evidence of the potential clinical impact of ATA188 in progressive MS patients, as well as updated OLE data, are planned for presentation at an appropriate forum in Q4 2022 Tabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD) Based on constructive discussions with Atara, the FDA recommended a possible path to a Biologics License Application (BLA) submission that does not require a new clinical trial Following planned interactions with FDA, Atara intends to provide further guidance on progress to a BLA submission at our next quarterly call The European Medicines Agency (EMA) review of tab-cel is on-track and Atara anticipates European Commission (EC) approval in Q4 2022 Atara has successfully completed all six pre-approval inspections required to support the Marketing Authorization Application (MAA) for tab-cel in Europe CAR T Programs ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin) Following Bayer’s strategic review and asset-level prioritization of its pipeline, the exclusive worldwide licensing agreement for next-generation mesothelin-directed CAR T-cell therapies ATA2271, an autologous version, and ATA3271, an armored allogeneic T-cell immunotherapy has been terminated Accordingly, the IND for ATA3271 is paused pending funding for clinical development Following the findings of the Memorial Sloan Kettering (MSK)-generated autopsy report and correlative data analyses, Atara intends to continue supporting the clinical development of ATA2271 through our collaboration with MSK and a protocol amendment to be discussed shortly with the FDA ATA3219 (B-cell Malignancies) Atara continues to make progress toward the anticipated IND filing for ATA3219 in Q4 2022. This allogeneic EBV CD19 CAR T program, using an optimized manufacturing process, is enriched for a memory T-cell phenotype and continues to show robust activity in preclinical studies Second Quarter 2022 Financial Results Cash, cash equivalents and short-term investments as of June 30, 2022 totaled $331.3 million, as compared to $301.8 million as of March 31, 2022. The increase includes the impact of net proceeds of $94.8 million from the sale of the ATOM facility during the second quarter Atara believes that its cash and investments as of June 30, 2022, together with the expected reductions in operating cash burn, will be sufficient to fund the Company’s planned operations into the first quarter of 2024 Net cash used in operating activities was $64.0 million for the second quarter 2022, as compared to $61.6 million for the same period in 2021 Atara reported net income of $18.5 million, or $0.18 per share, for the second quarter 2022, as compared to a net loss of $83.8 million, or $0.91 per share, for the same period in 2021. Second quarter 2022 net income included a gain on the sale of the ATOM facility of $50.2 million. License and collaboration revenue was $51.6 million for the second quarter 2022, primarily consisting of deferred revenue recognized due to the termination of the Bayer Collaboration Agreements, as compared to $3.9 million for the same period in 2021. We anticipate that license and collaboration revenues will decrease substantially in future quarters due to the termination of the Bayer Agreements. Total operating expenses include non-cash expenses of $15.6 million for the second quarter 2022, as compared to $16.1 million for the same period in 2021 Research and development expenses were $64.9 million for the second quarter 2022, as compared to $68.5 million for the same period in 2021 The decrease in the second quarter 2022 was primarily due to lower employee-related and overhead costs as a result of the FDB transaction, partially offset by increased spending on the Company’s ATA188 and CAR T programs Research and development expenses include $7.9 million of non-cash stock-based compensation expenses for the second quarter 2022 as compared to $8.3 million for the same period in 2021 General and administrative expenses were $18.8 million for the second quarter 2022, as compared to $19.4 million for the same period in 2021 General and administrative expenses include $6.2 million of non-cash stock-based compensation expenses for the second quarter 2022, as compared to $5.5 million for the same period in 2021 Conference Call and Webcast Details Atara will host a live conference call and webcast today, Monday, August 8, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13730293. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company's website for 30 days following the live webcast. About Atara Biotherapeutics, Inc. Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development and currently under review to support registration in Europe, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform, which does not require TCR or HLA gene editing, to create a robust pipeline including: tab-cel® (tabelecleucel) in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD); ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients’ lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn. Forward-Looking Statements This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the Company’s updated corporate strategy to focus as a leaner, R&D-centered organization, including (i) the staff reduction; and (ii) seeking a commercial partner for tab-cel in the U.S; (2) the potential benefits, safety and efficacy of tab-cel®; the timing and progress of tab-cel®, including (i) data and analyses from ALLELE study; (ii) tab-cel® clinical trials, and the occurrence, timing and outcome of Atara’s interactions and discussions with the FDA regarding a BLA submission for tab-cel®, (iii) the timing and outcome of the MAA for tab-cel®, (iv) the potential timing of the initiation or submission of the BLA for tab-cel®, and (iv) the timing of the EMA’s review of the MAA for tab-cel®; (3) the potential benefits, safety and efficacy of ATA188; the timing and progress of ATA188, including (i) regulatory designations for ATA188 granted by FDA and the impact thereof; (ii) data and analyses from ATA188 OLE study; (iii) ATA188 clinical trials, (iv) data and analyses from the planned interim analysis for the EMBOLD study, potential next steps for the program and planned discussions with FDA; and (v) Atara’s ability to successfully advance the development of ATA188; (4) the timing and progress of its CAR T programs, and the safety and efficacy of product candidates emerging from such programs, including (i) ATA2271 clinical trial, (ii) ATA3271 and ATA3219 preclinical development, (iii) termination of the strategic collaboration with Bayer for ATA2271 and ATA3271, and (iv) Atara’s ability to successfully advance the development of its CAR T programs; (5) Atara’s research and development activities; (6) Atara’s ability to reach critical value-generating milestones for its key pipeline assets or to generate value from such assets; and (7) Atara’s ability to advance development of its other programs. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the ongoing COVID-19 pandemic and the war in Ukraine, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara’s cash resources and need for additional capital; and other risks and uncertainties affecting Atara’s and its development programs, including those discussed in Atara’s filings with the Securities and Exchange Commission (SEC), including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise. Financials ATARA BIOTHERAPEUTICS, INC. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) June 30, December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $ 70,688 $ 106,084 Short-term investments 260,623 264,984 Restricted cash 1,346 194 Accounts receivable 637 986 Prepaid expenses and other current assets 13,690 12,373 Total current assets 346,984 384,621 Property and equipment, net 8,328 53,780 Operating lease assets 73,582 26,159 Restricted cash - long-term — 1,200 Other assets 7,227 2,367 Total assets $ 436,121 $ 468,127 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 12,799 $ 17,368 Accrued compensation 16,317 25,150 Accrued research and development expenses 15,125 13,451 Deferred revenue 1,671 40,760 Other current liabilities 19,776 9,057 Total current liabilities 65,688 105,786 Deferred revenue - long-term 43,329 55,708 Operating lease liabilities - long-term 63,999 25,518 Other long-term liabilities 5,626 1,501 Total liabilities $ 178,642 $ 188,513 Stockholders’ equity: Common stock—$0.0001 par value, 500,000 shares authorized as of June 30,2022 and December 31, 2021; 94,356 and 91,671 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively 9 9 Additional paid-in capital 1,794,449 1,744,695 Accumulated other comprehensive (loss) income (2,618 ) (368 ) Accumulated deficit (1,534,361 ) (1,464,722 ) Total stockholders’ equity 257,479 279,614 Total liabilities and stockholders’ equity $ 436,121 $ 468,127 ATARA BIOTHERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) (In thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 License and collaboration revenue $ 51,579 $ 3,870 $ 58,893 $ 7,422 Operating expenses: Research and development 64,898 68,475 139,861 132,534 General and administrative 18,813 19,397 39,384 37,135 Total operating expenses 83,711 87,872 179,245 169,669 Loss from operations (32,132 ) (84,002 ) (120,352 ) (162,247 ) Other income (expense), net: Gain on sale of ATOM Facility 50,237 — 50,237 — Interest and other income, net 361 225 476 135 Total other (expense), net 50,598 225 50,713 135 Income (loss) before provision for income taxes 18,466 (83,777 ) (69,639 ) (162,112 ) Provision for income taxes — 16 — 16 Net income (loss) $ 18,466 $ (83,793 ) $ (69,639 ) $ (162,128 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities (726 ) (99 ) (2,250 ) (234 ) Comprehensive income (loss) $ 17,740 $ (83,892 ) $ (71,889 ) $ (162,362 ) Basic net earnings (loss) per common share $ 0.18 $ (0.91 ) $ (0.69 ) $ (1.77 ) Diluted net earnings (loss) per common share $ 0.18 $ (0.91 ) $ (0.69 ) $ (1.77 ) Weighted-average basic shares outstanding 101,601 92,152 101,166 91,806 Weighted-average diluted shares outstanding 101,866 92,152 101,166 91,806