On February 27, 2020 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, 2019 and recent business highlights (Press release, Atara Biotherapeutics, FEB 27, 2020, View Source [SID1234554921]).
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"2019 was a year of strategic prioritization and significant advancement of our T-cell immunotherapy programs," said Pascal Touchon, President and Chief Executive Officer of Atara. "In 2020 we plan to deliver on key milestones across our pipeline and further establish Atara as a leader in off-the-shelf, allogeneic T-cell immunotherapies through our innovative EBV T-cell platform, next-generation CAR T technologies and state-of-the-art manufacturing capabilities. This work underpins our mission to transform the lives of patients with serious medical conditions through pioneering science, teamwork and a commitment to excellence."
Recent Highlights and Anticipated Upcoming Milestones
Tab-cel (tabelecleucel)
Atara continues to progress tab-cel Phase 3 development for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (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
Atara plans to discuss the totality of tab-cel results 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, 38 sites are available for enrollment and the Company is preparing to open additional sites in the U.S., Canada and Europe
Atara submitted clinical trial applications (CTAs) to several European countries in November and December 2019 to enable the opening of EU clinical sites in 2020. The Company’s CTAs in the United Kingdom, Spain and Austria were recently approved
Atara recently 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 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
In December 2019, Atara presented long-term clinical results for 61 patients with diverse EBV-associated diseases, including efficacy and safety data for 26 patients with relapsed/refractory EBV+ PTLD and safety findings for 35 patients with other EBV-associated diseases, from a multicenter EAP study of tab-cel at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition
Results from this analysis suggest a high overall response rate (ORR), short time to response and favorable estimated long-term overall survival (OS) rates for tab-cel in patients with EBV+ PTLD following hematopoietic cell transplant (HCT) or solid organ transplant (SOT) who have failed rituximab-based therapy
Tab-cel was shown to be generally well-tolerated in all patients with EBV+ PTLD and other EBV-associated diseases
Studies supporting potential additional tab-cel indications are also advancing
Atara expects to initiate enrollment in a tab-cel Phase 2 multi-cohort study including up to six additional ultra-rare EBV+ diseases in the second half of 2020 based on previous clinical data treating these patients
Atara enrolled the final planned patient in the Phase 1b portion of a Phase 1b/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)
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 six- and 12-month ATA188 Phase 1a clinical results for cohorts 3 and 4 in the first and second halves of 2020, respectively
Atara retreated the first patients in the open label extension (OLE) portion of the Phase 1a study; OLE design allows patients who complete one year in the Phase 1a dose-escalation portion of the study to be retreated annually using the cohort 3 dose for up to four years
Atara plans to initiate enrollment of a randomized, double-blind, placebo-controlled Phase 1b study in patients with progressive MS in the second or third quarter of 2020
Activation of clinical study sites for the Phase 1b is ongoing with an increased number of leading MS centers expected to participate in the U.S. and Australia
EBV CAR T Platform
In February 2020, an academic off-the-shelf, allogeneic CD19 CAR T clinical study using an EBV T-cell construct for patients with relapsed/refractory B-cell malignancies was presented at the 2020 Transplantation and Cellular Therapy (TCT) Meetings
No cytokine release syndrome or neurotoxicity above Grade 2, and dose-limiting toxicities were observed post-infusion with multiple EBV CD19 CAR T doses administered
No confirmed GvHD was observed in patients who received partially HLA matched third-party donor EBV CD19 CART cells
Investigators observed durable complete responses (CR) with median follow up of 26.9 months for 83 percent (5/6) of patients who received partially HLA matched EBV CD19 CAR T cells manufactured from third-party donors including
100 percent (4/4) response in patients with non-Hodgkin’s lymphoma (NHL)
100 percent (1/1) response in patient with chronic lymphocytic leukemia (CLL)
Findings from this study provide initial clinical proof-of-principle that an EBV T-cell platform has the potential to generate off-the-shelf, allogeneic CAR T immunotherapies with high and durable responses, low risk of toxicity and that can be rapidly delivered to patients
ATA2271/ATA3271 and ATA3219 CAR T Programs
Atara is developing a mesothelin-targeted autologous CAR T (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 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
Started preclinical IND-enabling studies for ATA3219 and ATA3271
Operational
Atara named Kristin Yarema as Chief Commercial Officer; Dr. Yarema brings extensive hematology, oncology, neuroscience and autoimmune disease commercialization experience to Atara as the Company advances commercialization activities for tab-cel
Atara created a Chief Operations Officer role to continue to drive operational excellence across the Company’s programs and platform; Joe Newell, Atara’s current Chief Technical Operations Officer, was appointed to this new role
Atara is executing on its planned commercial supply strategy with continued positive progress on commercial production qualification activities with the Company’s contract manufacturing partner and dedicated, state-of-the-art T cell manufacturing facility in Thousand Oaks, Calif.
Atara continues to scale its EBV T-cell manufacturing platform with current yields of approximately 400 tab-cel doses from a single donor leukapheresis
Fourth Quarter and Full Year 2019 Financial Results
Atara believes that its cash, cash equivalents and short-term investments as of December 31, 2019, together with the net proceeds from the "at-the-market" (ATM) facility in January 2020, are sufficient to fund planned operations into the second quarter of 2021
Cash, cash equivalents and short-term investments as of December 31, 2019 totaled $259.1 million, as compared to $282.9 million as of September 30, 2019
Net cash used in operating activities was $58.7 million and $235.6 million for the fourth quarter and fiscal year 2019, respectively, as compared to $57.4 million and $179.8 million for the same periods in 2018
In the fourth quarter of 2019, the Company sold 2,449,216 shares of common stock pursuant to its ATM facility for net proceeds of $36.3 million and in January 2020 sold 1,371,216 shares of common stock for net proceeds of $21.1 million
Proforma cash, cash equivalents and short-term investments as of December 31, 2019, including aggregate ATM and option exercise proceeds of $23.6 million in January 2020, was $282.7 million. The number of outstanding shares of common stock and pre-funded common stock warrants as of February 18, 2020 were 58,571,550 shares and 2,888,526 warrants, respectively
Atara reported net losses of $78.5 million, or $1.36 per share, and $291.0 million, or $5.67 per share, for the fourth quarter and fiscal year 2019, respectively, as compared to $80.0 million, or $1.75 per share, and $230.7 million, or $5.27 per share, for the same periods in 2018
Total operating expenses include non-cash expenses of $14.0 million and $58.8 million for the fourth quarter and fiscal year 2019, respectively, as compared to $11.0 million and $37.5 million for the same periods in 2018
Research and development expenses were $61.6 million and $216.1 million for the fourth quarter and fiscal year 2019, respectively, as compared to $62.3 million and $167.5 million for the same periods in 2018
The decrease in the fourth quarter 2019 was primarily due to one-time license fees of $12.5 million incurred in the fourth quarter of 2018 for exclusive rights to the next-generation CAR T program targeting mesothelin, with no such corresponding costs incurred in fourth quarter of 2019, partially offset by higher employee-related and overhead costs from increased headcount and operating activities
The increase in fiscal year 2019 was primarily 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 MS programs
Research and process development costs related to CAR T programs
Higher employee-related and overhead costs from increased headcount and operating activities
Research and development expenses include $7.0 million and $26.8 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2019, respectively, as compared to $5.2 million and $16.2 million for the same periods in 2018
General and administrative expenses were $18.1 million and $79.6 million for the fourth quarter and fiscal year 2019, respectively, as compared to $19.6 million and $69.7 million for the same periods in 2018. The decrease in the fourth quarter 2019 was primarily due to a decrease in outside services costs, partially offset by an increase in employee-related costs driven by increased headcount. The increase in the fiscal year 2019 was primarily due to an increase in employee-related costs driven by increased headcount to support the Company’s expanding operations
General and administrative expenses include $5.0 million and $24.9 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2019, respectively, as compared to $4.3 million and $17.6 million for the same periods 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 1554668. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.