Atara Biotherapeutics Announces Third Quarter 2018 Financial Results and Recent Operational Progress
“We made important progress in the third quarter advancing our off-the-shelf, allogeneic T-cell immunotherapy pipeline,” said
Atara continues to advance its tab-cel® (tabelecleucel) Phase 3 studies for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) and anticipates initial tab‑cel® Phase 3 results in the first half of 2019. The Company is in ongoing discussions with the
Atara continues to build its pipeline and operational capabilities as well as prepare for the launch of its first commercial product. Initial results from the off-the-shelf, allogeneic ATA188 multiple sclerosis program are anticipated in the first half of 2019. In addition, the Company is rapidly advancing its next-generation chimeric antigen receptor T-cell (CAR T) pipeline across multiple therapeutic areas and expects to highlight results at upcoming events.
Recent Highlights and Anticipated Upcoming Milestones
- Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel® (tabelecleucel) 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 26 locations available for enrollment in
the United Statesand Australiawith additional sites expected to open in the United Statesand other geographies.
- Initiated 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).
- Scheduled to present new tab-cel® efficacy and safety results in patients with EBV-associated leiomyosarcoma (EBV+ LMS) solid tumors at the
European Society for Medical Oncology (ESMO) Immuno-Oncology Congressin December 2018.
- Announced eight abstracts highlighting robust off-the-shelf, allogeneic T-cell immunotherapy pipeline and next-generation CAR T technologies to be presented at the 60th ASH Annual Meeting in
Moffitt Cancer Centercollaborators to present next-generation CAR T technology that increases T cell persistence and decreases exhaustion.
- Memorial Sloan Kettering (MSK) collaborators to present tab‑cel® Phase 2 clinical results for patients with EBV+ PTLD involving the central nervous system (CNS).
- Current PTLD patient health outcomes and treatment patterns are described in additional ASH abstracts.
Next-Generation CAR T Development Pipeline
- Announced a strategic collaboration with
Moffitt Cancer Centerto develop multi-targeted CAR T immunotherapies for patients with AML and B cell malignancies.
- Along with prior CAR T collaboration with MSK, furthers Atara’s strategy to develop next‑generation CAR T immunotherapies across multiple therapeutic areas and leverage the Company’s off-the-shelf, allogeneic T-cell immunotherapy platform.
- Research supporting the novel CAR T co-stimulatory domain findings were recently published in the
September 2018issue of the Journal of Clinical Investigation.
- CAR T preclinical activities ongoing, with initial IND expected Q4 2019 to Q1 2020.
- Hosting CAR T Breakfast Teach-In on
November 29, 2018in New York, NYfocused on Atara’s next-generation CAR T immunotherapy pipeline for patients with hematologic and solid tumors, autoimmune and infectious diseases as well as off-the-shelf, allogeneic CAR T development using EBV-specific T cell platform.
- Featured experts: Michel Sadelain, M.D., Ph.D., MSK and
Marco Davila, M.D., Ph.D., Moffitt Cancer Center.
ATA188 & ATA190 for Multiple Sclerosis (MS)
- A Phase 1 clinical study to evaluate off-the-shelf, allogeneic ATA188 in patients with progressive MS is underway across clinical sites in
the United Statesand Australia.
- Initial results from the ongoing study are expected in the first half of 2019.
- Plan to initiate a randomized autologous ATA190 study in progressive MS patients in 2019.
- Recent positive published results support Atara’s continued development of ATA621, targeting both JC and BK viruses for patients with progressive multifocal leukoencephalopathy (PML). The Company is currently conducting IND enabling manufacturing process development for this program.
- Strengthened the Company’s Board of Directors with the appointment of
Roy Baynes, M.D., Ph.D. Dr. Baynes currently serves as Senior Vice President Global Clinical Development and Chief Medical Officer at Merck Research Laboratories.
- Additional appointments include the promotion of Manher (AJ) Joshi, M.D., to Chief Medical Officer, the appointment of
Renu Vaishas Atara’s Senior Vice President, Global Regulatory Affairs, as well as Jose Vidal’s appointment as Atara’s Senior Vice President, Head of GMP Quality and Process Sciences.
- Continued to increase manufacturing activities at Atara T Cell Operations & Manufacturing (ATOM) facility with completion of licensure to support clinical production expected in 2019.
Third Quarter 2018 Financial Results
- Cash, cash equivalents and short-term investments as of
September 30, 2018totaled $364.5 million, which the Company believes will fund planned operations to mid-2020.
- The Company reported net losses of
$58.4 million, or $1.29per share, for the third quarter of 2018, as compared to $31.1 million, or $1.02per share, for the same period in 2017.
- In the third quarters of 2018 and 2017, total operating expenses of
$60.2 millionand $31.7 millionincluded non-cash expenses of $10.4 millionand $6.3 million, respectively.
- Research and development expenses were
$43.4 millionfor the third quarter of 2018, as compared to $20.6 millionfor the same period in 2017. The increase in the third 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 two Phase 3 clinical trials of tab-cel® in patients with EBV+ PTLD and the Phase 1 clinical trial of allogeneic ATA188 in patients with MS, and
- higher employee-related and overhead costs from increased headcount and operations.
- Research and development expenses include
$4.7 millionand $2.1 millionof non-cash stock-based compensation expenses in the third quarters of 2018 and 2017, respectively.
- General and administrative expenses were
$16.9 millionfor the third quarter of 2018, as compared to $11.1 millionfor the same period in 2017. The increase in the third quarter of 2018 was primarily due to increases in professional services costs and employee-related costs from increased headcount to support the Company’s expanding operations. General and administrative expenses include $4.6 millionand $3.9 millionof non-cash stock-based compensation expenses in the third quarters of 2018 and 2017, respectively.
Condensed Consolidated Balance Sheets
|September 30,||December 31,|
|Cash and cash equivalents||$||66,028||$||79,223|
|Restricted cash - short-term||194||194|
|Prepaid expenses and other current assets||8,239||5,900|
|Total current assets||372,976||172,190|
|Property and equipment, net||68,279||44,129|
|Restricted cash - long-term||1,200||1,200|
|Liabilities and stockholders’ equity|
|Accrued research and development expenses||3,803||4,006|
|Other current liabilities||7,932||3,265|
|Total current liabilities||27,000||27,646|
|Commitments and contingencies|
|Additional paid-in capital||850,835||474,662|
|Accumulated other comprehensive loss||(449||)||(151||)|
|Total stockholders’ equity||403,054||177,864|
|Total liabilities and stockholders’ equity||$||442,940||$||217,779|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||43,355||$||20,598||$||105,202||$||56,435|
|General and administrative||16,865||11,062||50,093||29,295|
|Total operating expenses||60,220||31,660||155,295||85,730|
|Loss from operations||(60,220||)||(31,660||)||(155,295||)||(85,730||)|
|Interest and other income, net||1,859||564||4,611||1,554|
|Loss before provision for income taxes||(58,361||)||(31,096||)||(150,684||)||(84,176||)|
|Provision for income taxes||—||—||3||2|
|Other comprehensive loss:|
|Unrealized gain (loss) on available-for-sale securities||56||26||(298||)||95|
|Net loss per common share:|
|Basic and diluted net loss per common share||$||(1.29||)||$||(1.02||)||$||(3.49||)||$||(2.84||)|
|Weighted-average shares outstanding used
to calculate basic and diluted net loss per common share
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: the Company’s ability to expand its pipeline; the timing and results of the Company’s Phase 1/2 study of tab‑cel® in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with platinum-resistant or recurrent EBV-associated NPC; the results and timing of its tab-cel® Phase 3 studies; the Company’s plans to share clinical results and disease incidence with regulatory authorities, including the associated timing; the timing of the Company’s submission of a conditional market authorization application for tab-cel® in the EU; enrollment of patients in the Company’s clinical trials; opening additional clinical sites in the United States and other geographies; the Company’s ability to develop next-generation CAR T immunotherapies across multiple therapeutic areas; the timing of the Company’s initial CAR T IND; the timing and results of the Company’s Phase 1 studies of ATA 188 and ATA190 in patients with progressive MS; the Company’s ability to develop ATA621 targeting JC and BK viruses and develop IND-enabling processes for this candidate; the sufficiency of the Company’s cash, cash equivalents and short-term investments to fund operations to mid-2020; the Company’s ability to leverage its platform in other indications and initiate development of additional immunotherapies; and the potential advantages of its product candidates. Because such statements deal with future events and are based on Atara Biotherapeutics' current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Biotherapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those discussed in Atara Biotherapeutics' filings with the Securities and Exchange Commission (
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Source: Atara Biotherapeutics, Inc.