On March 1, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), 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 diseases, reported financial results for the fourth quarter and full year 2020, recent business highlights and key catalysts over the next 18 months (Press release, Atara Biotherapeutics, MAR 1, 2021, View Source [SID1234575843]).
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"Atara had a very strong year in 2020, delivering on key milestones across the Company’s three strategic priorities," said Pascal Touchon, President and Chief Executive Officer of Atara. "We anticipate several additional key catalysts over the next 18 months, especially the completion of the tab-cel BLA filing in Q3 2021, significant advancement on the ATA188 program – including long-term clinical data update from the Phase 1 study as well as enrollment progress in the Phase 2 RCT enabling an interim analysis, and preclinical and clinical progress on both the mesothelin and CD19 CAR T programs."
Tabelecleucel (tab-cel) for Post-transplant Lymphoproliferative Disease (PTLD)
The Company has completed the preclinical module 4 and is ready to initiate a rolling BLA with this module once the FDA decides on a procedural question related to how the historical non-pivotal data should be presented in the BLA submission
Atara is making progress through active and productive discussions with FDA on the final content of the CMC module 3
Atara is on track to complete a rolling BLA submission for patients with EBV+ PTLD with the clinical module in Q3 2021
Atara plans to submit an EU Marketing Authorization Application (MAA) for patients with EBV+ PTLD in Q4 2021
Data from the Phase 3 ALLELE study will be presented at an appropriate congress in Q4 2021
The Company recently presented transcriptional data for tab-cel demonstrating consistency of the product’s activation profile irrespective of donor and consistent enrichment of receptors targeting EBV-driven diseases, at the 2021 Transplantation & Cellular Therapy (TCT) Meeting
The Company has confirmed an HLA match for 89 percent of patients eligible for screening in the Phase 3 ALLELE study over the last 12 months and continues to build a robust inventory for clinical studies and commercialization
The Company is investing further in U.S. commercial readiness activities in anticipation of planned tab-cel approval and launch in H1 2022
In addition, Atara is seeking a partner for the commercialization of tab-cel outside the U.S.
Tabelecleucel (tab-cel) for Potential Additional Indications
Atara is actively opening sites in the Phase 2 multi-cohort study including patients with other EBV-driven cancers
ATA188 for Progressive Forms of Multiple Sclerosis (MS)
Atara continues to make progress with enrollment in the ATA188 Phase 2 randomized, double-blind, placebo-controlled trial (RCT) following enrollment of its first patient in June 2020
The Company discussed updates to the design of the RCT with the FDA and gained alignment on the following for this RCT, as well as potential registrational studies:
A disability improvement endpoint is appropriate, with the FDA articulating a preference for EDSS improvement
The criteria used to enroll the study population of non-active secondary progressive MS (SPMS) and non-active primary progressive MS (PPMS) are appropriate
This Phase 2 RCT should run for at least 12 months, and a properly conducted interim analysis is appropriate
Based on this alignment, the Company has amended the study protocol, changing the primary endpoint of the study to EDSS disability improvement and increasing the number of patients to 80 to account for this change, while maintaining the biological and functional endpoints
Atara will conduct an interim analysis (IA) in H1 2022 including efficacy and safety from the Phase 2 RCT in patients with progressive forms of MS, and following the IA, expects to complete enrollment of the study in H1 2022
The Company plans to present translational data from the Phase 1a study and long-term two-year clinical data from the Phase 1a open-label extension (OLE) in H2 2021
Atara presented a poster on an innovative testing solution that enables detection and quantification of non-engineered allogeneic T-cell therapies for use in ATA188 clinical development, at the recent 2021 TCT Meeting
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
Atara announced and has initiated a strategic collaboration with Bayer through an exclusive worldwide license agreement and research, development and manufacturing collaboration for its mesothelin-directed CAR T-cell therapies (ATA2271 and ATA3271) for the treatment of solid tumors
In collaboration with Atara, Memorial Sloan Kettering Cancer Center (MSK) has enrolled several patients into the open-label, single-arm Phase 1 clinical study of ATA2271, the Company’s second-generation autologous CAR T therapy targeting mesothelin (MSLN) that incorporates for the first time both a novel 1XX co-stimulatory domain for improving functional persistence and a PD-1 DNR (dominant-negative programmed death-1 receptor) for intrinsic check-point inhibition for the treatment of advanced mesothelioma
Atara and MSK expect to present first Phase 1 data for ATA2271 in Q4 2021
The Company presented preclinical findings that demonstrate potent antitumor activity, functional persistence, and low toxicity profile of ATA3271 supporting further clinical investigation, at the November 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (SITC) (Free SITC Whitepaper)
ATA3219 (B-cell Malignancies)
Atara plans to submit an IND for ATA3219, its allogeneic CAR T for patients with B-cell malignancies, in Q4 2021 or Q1 2022
The Company presented promising preclinical data showing potent antitumor activity both in vitro and in vivo, with long-term functional persistence and no evidence of allocytoxicity in vivo, at the December 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting
Fourth Quarter and Full Year 2020 Financial Results
Cash, cash equivalents and short-term investments as of December 31, 2020 totaled $500.7 million, as compared to $259.1 million as of December 31, 2019
The December 31, 2020 cash balance included $164.5 million of net proceeds from the sale of 5,102,041 shares of common stock and pre-funded warrants to purchase 2,040,816 shares of common stock in an underwritten public offering in December 2020, $52.9 million in payments from the Bayer collaboration (excluding $7.1 million of refundable withholding taxes), and $10.9 million from the sale of 675,530 shares of common stock through the Company’s ATM facility, partially offset by other operating cash burn
Atara believes that its cash as of December 31, 2020 together with projected revenue from U.S. tab-cel sales is sufficient to fund its operations into 2023, including expenses related to the BLA filing and commercial launch of tab-cel in the U.S.
Net cash used in operating activities was $4.1 million and $180.8 million for the fourth quarter and fiscal year 2020, respectively, as compared to $58.7 million and $235.6 million for the same periods in 2019; the reduction in operating cash usage in the fourth quarter of 2020 was primarily due to $52.9 million of payments received from Bayer
Atara reported net losses of $81.3 million, or $0.95 per share, and $306.6 million, or $4.15 per share, for the fourth quarter and fiscal year 2020, respectively, as compared to $78.5 million, or $1.36 per share, and $291.0 million, or $5.67 per share, for the same periods in 2019
Total operating expenses include non-cash expenses of $13.6 million and $59.4 million for the fourth quarter and fiscal year 2020, respectively, as compared to $14.0 million and $58.8 million for the same periods in 2019
Research and development expenses were $65.6 million and $244.7 million for the fourth quarter and fiscal year 2020, respectively, as compared to $61.6 million and $216.1 million for the same periods in 2019
The increase in the fourth quarter 2020 was primarily due to sublicense fees related to the Bayer license agreement and higher employee-related and overhead costs from increased headcount
The increase in fiscal year 2020 was primarily due to higher employee-related and overhead costs from increased headcount, sublicense fees related to the Bayer license agreement and increased spending on tab-cel clinical trials, process performance qualification activities and preparations for our tab-cel BLA filing
Research and development expenses include $7.2 million and $31.5 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2020, respectively, as compared to $7.0 million and $26.8 million for the same periods in 2019
General and administrative expenses were $16.1 million and $64.4 million for the fourth quarter and fiscal year 2020, respectively, as compared to $18.1 million and $79.6 million for the same periods in 2019; the decreases in the fourth quarter and fiscal year 2020 were primarily due decreases in outside services costs and lower non-cash stock-based compensation expenses
General and administrative expenses include $4.3 million and $19.8 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2020, respectively, as compared to $5.0 million and $24.9 million for the same periods in 2019