On May 8, 2018 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, today reported financial results for the first quarter of 2018 and recent operational highlights (Press release, Atara Biotherapeutics, MAY 8, 2018, View Source [SID1234526197]).
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"During the first quarter of 2018, we continued to advance our T-cell immunotherapy pipeline and platform," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Our two Phase 3 pivotal studies of tab-cel are progressing, and we remain focused on building Atara’s global commercial and operational capabilities in anticipation of the first tab-cel Phase 3 results and submission of an EU conditional marketing authorization application in the first half of 2019. We are also excited to have recently expanded our collaboration with Memorial Sloan Kettering Cancer Center to develop next generation chimeric antigen receptor T cell (CAR T) technologies, marking our entry into genetically engineered T-cells and furthering our leadership position in off-the-shelf, allogeneic T-cell immunotherapy. I am pleased with our strong operational and strategic execution in the first quarter and look forward to both continuing this momentum and updating you on our progress throughout the rest of the year."
Recent Highlights and Anticipated Upcoming Milestones
Two Phase 3 clinical studies are underway (MATCH and ALLELE) to evaluate tab-cel (tabelecleucel) in patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
9 clinical sites for the MATCH and 12 for the ALLELE studies are now open for enrollment in the U.S. with additional sites expected to open in the U.S. and other geographies.
Continued to expand research and development, operational and commercial leadership as we advance our pipeline, leverage the potential of our technology platform and prepare for the expected tab-cel CMA submission in the EU and potential launch.
Biotech industry veteran Dietmar Berger, M.D., Ph.D., most recently a senior R&D leader at Roche/Genentech, joined Atara as Global Head of Research and Development.
Appointed Mina Kim as Senior Vice President and General Counsel, who has nearly 20 years of corporate legal experience.
Expanded commercial leadership team with the appointment of Manuela Maronati as General Manager, Europe, who brings extensive European commercial launch and operations experience in the oncology and rare disease areas.
Expanded T-cell immunotherapy collaboration with Memorial Sloan Kettering Cancer Center (MSK) to advance next-generation CAR T technologies in oncology, autoimmune and other diseases.
Gained access to several of MSK’s innovative enabling technologies, including a novel CAR T construct that Atara believes has physiologic T cell activation properties, as well as methods for designing CAR T immunotherapies.
Entered into an exclusive research collaboration for multiple targets with Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering at MSK, to employ next-generation technologies in developing novel CAR T immunotherapies.
Plan to rapidly advance novel gene-edited CAR T development programs leveraging our existing off-the-shelf T-cell immunotherapy technology platform, manufacturing expertise and research and development capabilities.
Strengthened cash position with the completion of two underwritten public offerings in the first quarter of 2018 with net proceeds of approximately $293.3 million. Cash, cash equivalents and short-term investments as of March 31, 2018 totaled $407.3 million, which we believe enable us to expand our near-term pipeline and accelerate pre-commercial activities as well as fund our previously planned operations to mid-2020.
Partnered with TrakCel, an industry-leading software provider for cell and gene therapy supply chain tracking and orchestration, to develop Atara MatchMe, the first commercial product delivery solution designed to achieve streamlined supply and delivery of an off-the-shelf, allogeneic T-cell immunotherapy.
Atara MatchMe is being designed to provide a compelling customer experience across a diverse range of treatment centers, partners, systems and geographies to ensure tab-cel is safely and effectively ordered and delivered, globally to patients in the minimum possible time.
At the 44th Annual Meeting of the European and Marrow transplantation (EBMT) in March 2018, Atara and its collaborating investigator at the University of North Carolina at Chapel Hill presented findings from a comprehensive literature review of the mortality burden of PTLD following HCT.
Based on a review of studies published since 2005, the research showed that 42.5% of PTLD patients diagnosed following HCT died as a result of the disease, and in the patients who died, the median time from initial diagnosis of PTLD to death for children and adults was under 8 weeks.
A multinational Phase 1 clinical study to evaluate ATA188 in patients with progressive or relapsing-remitting multiple sclerosis is also underway across clinical sites in the U.S. and Australia.
The primary objective of the Phase 1 study is to assess the safety of ATA188 in patients followed for at least one year after the first dose. Key secondary endpoints in the study include measures of clinical improvement such as expanded disability status scale (EDSS) and annualized relapse rate (ARR), as well as MRI imaging.
The first interim results from the ongoing ATA188 Phase 1 study in patients with progressive MS are expected in the first half of 2019.
Atara plans to initiate 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) in the second half of 2018.
Expect to present updated tab-cel results in patients with EBV+ cancers in the second half of 2018.
Expect operations to commence at Atara T Cell Operations & Manufacturing (ATOM) facility in the second quarter of 2018, with completion to support clinical production in 2019.
First Quarter 2018 Financial Results
Cash, cash equivalents and short-term investments as of March 31, 2018 totaled $407.3 million, which includes $293.3 million in net proceeds from the two underwritten public offerings completed in the first quarter of 2018.
The Company reported net losses of $41.4 million, or $1.05 per share, for the first quarter of 2018, as compared to $25.7 million, or $0.88 per share, for the same period in 2017.
Research and development expenses were $28.5 million for the first quarter of 2018, as compared to $17.5 million for the same period in 2017. The increase in the first quarter of 2018 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
clinical trial, manufacturing and outside service costs related to the initiation of the two tab-cel Phase 3 clinical studies in patients with EBV+ PTLD who have failed rituximab;
clinical manufacturing and the initiation of the Phase 1 clinical study of allogeneic ATA188, which was initiated in October 2017;
higher payroll and related costs from increased headcount, and
an increase in allocated facilities and information technology expenses.
Research and development expenses include $2.9 million and $2.1 million of non-cash stock-based compensation expenses in the first quarters of 2018 and 2017, respectively.
General and administrative expenses were $14.0 million for the first quarter of 2018, as compared to $8.6 million for the same period in 2017. The increase in the first quarter of 2018 was primarily due to increases in payroll and related costs driven by increased headcount to support the Company’s expanding operations and higher professional services costs. General and administrative expenses include $4.1 million and $3.2 million of non-cash stock-based compensation expenses in the first quarters of 2018 and 2017, respectively.