On May 6, 2020 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 severe diseases including solid tumors, hematologic cancers and autoimmune disease, reported financial results for the first quarter ended March 31, 2020 and recent business highlights (Press release, Atara Biotherapeutics, MAY 6, 2020, View Source [SID1234557139]).
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"It is with tremendous pride that I acknowledge the commitment and resiliency of our entire Atara team. We have remained focused on our mission to serve patients and implemented industry-leading practices to ensure safety while mitigating the impact of COVID-19 on our business," said Pascal Touchon, President and Chief Executive Officer of Atara. "We have made great progress in Q1 toward accomplishing our key objectives and are well-poised to achieve significant milestones throughout the year as we expect to initiate the tab-cel biologics license application (BLA) submission in the second half of 2020 and are eager to present further results from the ATA188 Phase 1a study in progressive multiple sclerosis in Q2. Such momentum in developing innovative off-the-shelf allogeneic T-cell immunotherapies has also supported our ability to attract top talent including a non-executive board chair and general counsel."
Recent Highlights and Anticipated Upcoming Milestones
Operational
COVID-19 Response and Actions
Atara continues to deliver product to patients from our inventory of off-the-shelf, allogeneic tab-cel and ATA188.
Prior to the COVID-19 outbreak, as part of our routine supply planning and operational risk management strategies, the Company had already manufactured significant inventories of tab-cel and process intermediates and procured the required starting materials needed to maintain long-term product supply across tab-cel, ATA188 and other programs.
The Atara clinical study and operational teams have been working closely with sites to ensure the safety of site staff and patients as well as preserve data integrity and access to treatment as appropriate. Where needed, they have established remote study visits, leveraged tele-medicine, home health care, and other methods to ensure continuity of care for patients while preserving key endpoint data.
Atara is closely monitoring the evolving COVID-19 pandemic and continues to assess potential impact on the business and operations, including the timing and execution of clinical and preclinical studies.
Board and Executive Appointments
Atara recently announced the appointment of a Chair of the Board and executive with extensive leadership and management experience in the life sciences industry:
Atara appointed Ron Renaud as Chairman of the Board of Directors. Mr. Renaud has served as Translate Bio’s chief executive officer since 2014 and brings deep and broad experience in strategic and corporate development, partnering, financing, and industry and Wall Street relationships. He has significant prior board experience having served on the boards of both public and private companies.
K. Amar Murugan was named Senior Vice President, General Counsel. Mr. Murugan brings significant expertise in M&A, corporate finance, securities, life science transactions and corporate governance. Mr. Murugan was most recently Senior Vice President and General Counsel of Assertio Therapeutics.
Tab-cel (tabelecleucel)
Atara continues to progress tab-cel Phase 3 development for patients with EBV-associated post-transplant lymphoproliferative disease (EBV+ PTLD).
Atara remains on track to initiate a tab-cel BLA submission for patients with EBV+ PTLD in the second half of 2020.
Atara plans to discuss the totality of tab-cel data with the U.S. Food and Drug Administration (FDA) in a pre-BLA meeting prior to initiating the BLA submission.
In the U.S. and Australia, most of the current 40 clinical study sites are available for enrollment and the Company is preparing to open additional sites in the U.S., Canada and Europe.
The Company’s clinical trial applications (CTAs) in the United Kingdom, Spain, France, and Austria were recently approved, the first European clinical site has opened for enrollment, and we expect to open additional European Phase 3 clinical sites in 2020.
Atara has submitted a Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMA).
Following EMA approval of the PIP, Atara plans to submit a tab-cel EU marketing authorization application (MAA) for patients with EBV+ PTLD in 2021.
Atara continues to see strong tab-cel investigator, physician and patient interest and, for cases in which the Company is not able to enroll patients in its EBV+ PTLD Phase 3 clinical study, Atara is providing tab-cel to patients in need under its expanded access protocol (EAP) and single patient use (SPU) programs.
Studies supporting potential additional tab-cel indications are also advancing.
Based on clinical data from treating a variety of ultra-rare EBV+ diseases, Atara expects to initiate enrollment in the second half of 2020 in a tab-cel Phase 2 multi-cohort study including up to six additional ultra-rare EBV+ patient populations.
ATA188 for Progressive Multiple Sclerosis (MS)
A Phase 1a clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the U.S. and Australia.
Atara expects to present ATA188 Phase 1a six-month clinical results for the dose-escalating cohorts 1-4 and 12-month results for cohorts 1-3 in an appropriate forum in the second quarter of 2020 and expects to present 12-month cohort 4 data in the second half of 2020.
Atara is re-treating patients in the open-label extension (OLE) of the Phase 1a study in an appropriate setting and as determined by the treating physician and patient.
Atara has temporarily paused the screening and enrollment of patients in the Phase 1b randomized placebo-controlled study to ensure sites can focus on meeting the needs of patients with COVID-19 and to protect the safety of study participants, investigators and staff.
This action will help to preserve study and data integrity as there are numerous assessments that require a specific clinical setting.
Atara expects this pause to be limited and plans to initiate enrollment in this study in the second or third quarter of 2020.
ATA2271/ATA3271 and ATA3219 CAR T Programs
Atara is developing a next generation mesothelin-targeted autologous CAR T immunotherapy (ATA2271) and expects collaborators at Memorial Sloan Kettering Cancer Center (MSK) to submit an Investigational New Drug (IND) application to the FDA for patients with advanced mesothelioma in the second or third quarter of 2020.
ATA2271 is designed to improve efficacy, persistence, and durability of response using a novel 1XX CAR co-stimulatory domain and cell intrinsic checkpoint inhibition technology with a PD-1 dominant negative receptor (DNR).
Data from IND-enabling studies for ATA2271 have been accepted as a late-breaking e-poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II in June, and the abstract will be released on May 15.
Additional clinical data for the first-generation academic program from MSK are expected to be presented in an upcoming forum in the second half of this year.
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.
The Company has initiated preclinical IND-enabling studies for ATA3271 and ATA3219.
First Quarter 2020 Financial Results
Atara believes that its cash, cash equivalents and short-term investments as of March 31, 2020, are sufficient to fund planned operations into the second quarter of 2021.
Cash, cash equivalents and short-term investments as of March 31, 2020 totaled $214.6 million, as compared to $259.1 million as of December 31, 2019.
The decrease of $44.5 million includes the benefit of the sale of 1,528,216 shares of common stock pursuant to the Company’s at-the-market (ATM) facility in the first quarter of 2020 for net proceeds of $23.1 million.
Net cash used in operating activities was $67.0 million for the first quarter of 2020, as compared to $70.2 million for the same period in 2019.
The number of outstanding shares of common stock and pre-funded common stock warrants as of April 30, 2020 was 58,952,045 shares and 2,888,526 warrants, respectively.
Atara reported net losses of $73.5 million, or $1.20 per share, for the first quarter of 2020 as compared to $66.3 million, or $1.44 per share, for the same period in 2019.
Total operating expenses include non-cash expenses of $14.5 million for the first quarter 2020, as compared to $13.9 million for the same period in 2019.
Research and development expenses were $57.7 million for the first quarter of 2020, as compared to $48.7 million for the same period in 2019. The increase in the first quarter of 2020 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
Clinical study, manufacturing and process performance qualification activities related to tab-cel.
Higher employee-related costs from increased headcount.
Increased facilities and information technology expenses allocated to our research and development function.
Research and development expenses include $7.7 million of non-cash stock-based compensation expenses for the first quarter of 2020, as compared to $6.1 million for the same period in 2019.
General and administrative expenses were $17.0 million for the first quarter of 2020, as compared to $19.2 million for the same period in 2019. The decrease in the first quarter 2020 was primarily due to a decrease in outside services costs and non-cash stock-based compensation expenses, partially offset by an increase in payroll-related costs driven by increased headcount.
General and administrative expenses include $5.0 million of non-cash stock-based compensation expenses for the first quarter of 2020, as compared to $6.2 million for the same period in 2019.