On November 7, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the third quarter of 2019 and recent business highlights (Press release, Atara Biotherapeutics, NOV 7, 2019, View Source [SID1234550652]).
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"I am pleased with our recent clinical, operational and strategic progress," said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. "Following a comprehensive strategic portfolio review, we will focus our resources going forward on innovative off-the-shelf, allogeneic T-cell immunotherapy programs, specifically tab-cel, ATA188, ATA2271/ATA3271 and ATA3219. In parallel, we will continue to leverage the capabilities and expertise of external partners for development of autologous CAR T immunotherapies."
Following a six-month assessment of patients with progressive multiple sclerosis (MS) enrolled in cohort 3 of an ATA188 Phase 1a study, Atara selected this cohort 3 dose to initiate the randomized, double-blind, placebo-controlled Phase 1b part of this study.
"We are encouraged by the safety profile and early findings of potential efficacy for people living with progressive MS, as shown in our Phase 1a study data presented at ECTRIMS in September," said AJ Joshi, MD, Senior Vice President and Chief Medical Officer of Atara Biotherapeutics. "The decision to initiate the Phase 1b was based on achieving in cohort 3 our pre-determined criteria of a continued well-tolerated safety profile and at least 50 percent of patients achieving clinical improvement from more than one clinical study site using the criteria we defined at ECTRIMS. Recognizing these are early data, and incorporating input from external experts, we believe these results merit the acceleration of ATA188 development for progressive MS patients who have limited treatment options and in whom continual clinical decline is expected."
Recent Highlights and Anticipated Upcoming Milestones
61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting
Announced four abstracts highlighting robust off-the-shelf, allogeneic T-cell immunotherapy pipeline and next-generation CAR T technologies to be presented at the 61st ASH (Free ASH Whitepaper) Annual Meeting, December 7-10, 2019 in Orlando, Florida
Among these data are tab-cel long-term clinical outcomes from a multicenter expanded access protocol (EAP) study for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD)
— 26 relapsed/refractory EBV+ PTLD patients were treated in a multicenter tab-cel EAP study including a subgroup of 22 patients who would have likely met eligibility criteria for Atara’s ongoing tab-cel Phase 3 studies
— An overall response rate (ORR) of 55 and 82 percent was observed in this subgroup of patients with EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) and solid organ transplant (SOT), respectively
— Estimated 2-year overall survival (OS) in this subgroup was 79 and 81 percent for HCT and SOT, respectively
Atara will present additional findings describing the hospitalization burden of patients with EBV+ PTLD
Atara’s Moffitt Cancer Center collaborators to present two abstracts detailing next-generation CAR T technologies
Tab-cel (tabelecleucel)
Atara continues to progress tab-cel Phase 3 development for patients with EBV+ PTLD
— Atara remains on track to initiate a tab-cel biologics license application (BLA) submission for patients with EBV+ PTLD in the second half of 2020
— In the U.S. and Australia, 35 sites are available for enrollment and the company is preparing to open additional sites in the U.S. and Canada
— Atara plans to submit a clinical trial application (CTA) to several European countries by the end of 2019 to enable opening EU clinical sites next year
Atara continues to see strong tab-cel investigator, physician and patient interest, and in cases where the company is not able to enroll patients in its EBV+ PTLD Phase 3 clinical studies, Atara is providing tab-cel to patients in need under its early access and single patient use programs
Atara is in discussions with the European Medicines Agency (EMA) and the outcome of these discussions will determine the timing of the tab-cel EU conditional marketing authorization (CMA) application for patients with EBV+ PTLD
Studies supporting potential additional tab-cel indications are also advancing
— A Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) is currently enrolling
— Atara expects to initiate enrollment in a Phase 2 multi-cohort study including patients with other EBV+ cancers in the second half of 2020
ATA188 for Multiple Sclerosis (MS)
Following a six-month assessment of patients with progressive MS enrolled in cohort 3 of an ATA188 Phase 1a study, Atara selected this dose to initiate the randomized, double-blind, placebo-controlled Phase 1b part of this study
In September, Atara presented safety and early findings of potential efficacy from a Phase 1a study of ATA188 in patients with progressive MS at the 35thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)
— Completed enrollment in the fourth and final planned Phase 1 dose escalation cohort
— Atara expects to present additional efficacy and safety results from this study in 2020, including six and twelve-month assessments from cohorts 3 and 4
— Safety results showed across the 4 planned dose cohorts, ATA188 was well tolerated in patients with progressive forms of MS with no evidence of cytokine release syndrome, graft versus host disease or dose-limiting toxicities
Atara will not initiate a randomized study of autologous ATA190 in progressive MS at this time and will evaluate strategic options for this program
— Atara’s ATA190 portfolio decision is based on continued encouraging ATA188 results, acceleration of the ATA188 randomized Phase 1b study and the Company’s strategic focus on off-the-shelf, allogeneic T-cell immunotherapies
ATA2271/ATA3271 and ATA3219 CAR T Programs
Atara is developing a mesothelin-targeted autologous CAR T (ATA2271) for patients with advanced mesothelioma with an IND planned in 2020
— ATA2271 is designed using a novel 1XX CAR co-stimulatory domain and PD-1 dominant negative receptor (DNR) intrinsic checkpoint inhibition technology
Atara is also developing off-the-shelf, allogeneic CAR T immunotherapies targeting mesothelin (ATA3271) and CD19 (ATA3219) using its next generation technologies and EBV T cell platform
Operational
Facility commissioning and qualification activities to support clinical development at ATOM (Atara T-cell Operations and Manufacturing) are complete
— Commercial production qualification activities are progressing well and, together with our contracted manufacturing partner, are aligned with our planned commercial strategy
The Company is focused on aligning the current leadership to the Company’s new strategic priorities and actively searching for a new Global Head of Research and Development, Head of Commercial and General Counsel
Third Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments as of September 30, 2019 totaled $282.9 million, which includes $140.7 million in net proceeds from an underwritten public offering completed in July 2019
The Company believes that its current cash, cash equivalents and short-term investments are sufficient to fund planned operations into 2021
The Company reported a net loss of $71.9 million, or $1.31 per share, for the third quarter of 2019 as compared to $58.4 million, or $1.29 per share, for the same period in 2018
Total operating expenses include non-cash stock-based compensation and depreciation and amortization expenses of $13.9 million for the third quarter of 2019 as compared to $10.4 million for the same period in 2018
Research and development expenses were $53.5 million for the third quarter of 2019 as compared to $43.4 million for the same period in 2018. The increase in the third quarter of 2019 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
— Clinical study, manufacturing and outside service costs related to our MS programs
— Research and process development costs related to our CAR T programs
— Higher employee-related and overhead costs from increased headcount and operations
Research and development expenses include $7.0 million of non-cash stock-based compensation expense for the third quarter of 2019 as compared to $4.7 million for the same period in 2018
General and administrative expenses were $19.0 million for the third quarter of 2019 as compared to $16.9 million for the same period in 2018. The increase in the third quarter of 2019 was primarily due to increases in employee-related costs driven by increased headcount to support the Company’s expanding operations
General and administrative expenses include $5.1 million of non-cash stock-based compensation expense for the third quarter of 2019 as compared to $4.6 million for the same period in 2018
Conference Call and Webcast Information
Atara will host a live conference call and webcast today at 8:00 a.m. EST to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 6069034. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.