On February 26, 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 fourth quarter and full year ended December 31, 2018, and recent operational highlights (Press release, Atara Biotherapeutics, FEB 26, 2019, View Source [SID1234533690]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"2018 was a year of pipeline expansion and strong operational execution for Atara as we advanced our T-cell immunotherapy programs across all three of our major value drivers: tab-cel, multiple sclerosis and next-generation CAR T," said Isaac Ciechanover M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Notably, we successfully executed on our strategy to build a leading next-generation and off-the-shelf, allogeneic CAR T portfolio. Our collaborations with academic leaders leverage technologies at the forefront of CAR T innovation for hematologic malignancies and solid tumors. We also opened a state-of-the-art T-cell operations and manufacturing facility and expanded our R&D, operational and commercial leadership. I am extremely gratified with where the Company is today and wish to acknowledge the many extraordinary contributions by Atara employees that enabled us to reach this point. I anticipate 2019 to be another pivotal year with multiple clinical and regulatory milestones, moving Atara closer to realizing our mission of transforming the lives of patients with serious medical conditions."
Atara continues to progress tab-cel (tabelecleucel) Phase 3 studies for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD) and anticipates initial tab-cel Phase 3 results to be available to the company in the first half of 2019.
Discussions with the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA) regarding the development of tab-cel are ongoing and Atara’s intention is to align on a global regulatory strategy for patients with EBV+ PTLD. Outcomes of these discussions are expected in the first half of 2019.
Atara plans to submit a tab-cel EU conditional marketing authorization (CMA) application in the second half of 2019. To ensure the integrity of the ongoing, open-label tab-cel Phase 3 studies, the Company anticipates disclosing initial top-line EBV+ PTLD results in the second half of 2019 following submission of the EMA CMA application.
Atara expects initial safety results from the ongoing off-the-shelf, allogeneic ATA188 Phase 1 study in patients with progressive multiple sclerosis (MS) in the first half of 2019. Additional safety and efficacy results from this study are expected in the second half of 2019.
The Company is also rapidly advancing its next-generation chimeric antigen receptor T-cell (CAR T) pipeline across multiple therapeutic areas and expects results to be presented at upcoming scientific conferences.
Recent Highlights and Anticipated Upcoming Milestones
Tab-cel (tabelecleucel)
Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel for patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
Expanded MATCH and ALLELE study sites, with 30 sites available for enrollment in the United States and Australia, and with additional sites expected to open in the United States and other geographies.
ATA188 & ATA190 for Multiple Sclerosis (MS)
A Phase 1 clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the United States and Australia.
Atara also plans to initiate a randomized autologous ATA190 study in progressive MS patients in the second half of 2019.
Next-Generation CAR T Development Pipeline
Licensed worldwide rights to a mesothelin-targeted chimeric antigen receptor T-cell (CAR T) immunotherapy for solid tumors from Memorial Sloan Kettering Cancer Center (MSK).
Development with MSK will focus on a next-generation, mesothelin-targeted CAR T using novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies for patients with mesothelin-associated solid tumors.
Expect clinical and preclinical results supporting Atara’s next-generation CAR T programs to be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 to be held March 29 to April 3 in Atlanta, Georgia.
First IND submission for Atara’s next-generation CAR T program expected in the fourth quarter of 2019 or first quarter of 2020.
Other Pipeline
Conducting IND-enabling manufacturing process development for ATA621, targeting both JC and BK viruses for patients with progressive multifocal leukoencephalopathy (PML).
Corporate
Atara’s Board of Directors is currently conducting a search for a new Chief Executive Officer following Dr. Ciechanover’s transition plan announced in January. Dr. Ciechanover will remain in his role as President and CEO until the earlier of the appointment of his successor or June 30, 2019.
Fourth Quarter and Full Year 2018 Financial Results
Cash, cash equivalents and short-term investments as of December 31, 2018 totaled $309.6 million, which we believe will be sufficient to fund planned operations to mid-2020. The balance excludes the impact of one-time license fees of $12.5 million paid in the first quarter of 2019 for worldwide rights to the next-generation allogeneic CAR T program targeting mesothelin.
The Company reported net losses of $80.0 million, or $1.75 per share, and $230.7 million, or $5.27 per share, for the fourth quarter and fiscal year 2018, respectively, as compared to $35.3 million, or $1.15 per share, and $119.5 million, or $4.00 per share, for the same periods in 2017.
Total operating expenses include total non-cash expenses of $11.0 million and $37.5 million for the fourth quarter and fiscal year 2018, respectively, as compared to $6.4 million and $24.1 for the same periods in 2017.
Research and development expenses were $62.3 million and $167.5 million for the fourth quarter and fiscal year 2018, respectively, as compared to $24.8 million and $81.2 million for the same periods in 2017. The increases in the fourth quarter and fiscal year 2018 were 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 the two Phase 3 clinical studies of tab-cel in patients with EBV+ PTLD and the Phase 1 clinical study of allogeneic ATA188 in patients with progressive MS;
one-time license fees of $12.5 million incurred in the fourth quarter of 2018 for exclusive rights to a next-generation allogeneic CAR T program targeting mesothelin from MSK;
higher employee-related and overhead costs from increased headcount and operations, and
an increase in facilities and information technology expenses that are allocated to our research and development function.
Research and development expenses include $5.2 million and $16.2 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2018, respectively, as compared to $2.5 million and $8.8 million for the same periods in 2017.
General and administrative expenses were $19.6 million and $69.7 million for the fourth quarter and fiscal year 2018, respectively, as compared to $11.0 million and $40.3 million for the same periods in 2017. The increases in the fourth quarter and fiscal year 2018 were primarily due to increases in professional services costs and employee-related costs driven by increased headcount to support the Company’s expanding operations.
General and administrative expenses include $4.3 million and $17.6 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2018, respectively, as compared to $3.6 million and $14.3 million for the same periods in 2017.