Atara Biotherapeutics Announces Fourth Quarter and Full Year 2017 Financial Results and Recent Operational Progress
– Initiated two Phase 3 clinical studies to evaluate tab-cel™ (tabelecleucel) in patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab and opened six MATCH and eight ALLELE study sites for enrollment in the U.S. –
– Announced positive interim results from a multicenter expanded access study of tab-cel™ in patients with EBV+ PTLD who have no other approved alternative therapies at the 59th
– Received FDA clearance to proceed with patient enrollment at U.S. sites for ongoing multinational Phase 1 clinical study to evaluate ATA188 in patients with progressive or relapsing-remitting multiple sclerosis –
“Atara continues to advance its leadership in T-cell immunotherapy innovation, highlighted by our recent initiation of the first Phase 3 clinical studies of an off-the-shelf, allogeneic T-cell technology, tab‑cel™, in the U.S.,” said
Recent Highlights and Anticipated Upcoming Milestones
- Initiated two Phase 3 clinical studies (MATCH and ALLELE) to evaluate tab-cel™ in patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
° Six clinical sites for the MATCH and eight for the ALLELE pivotal studies are now open for enrollment in the U.S. and the studies continue to expand to additional U.S. sites as well as sites in other countries including EU,
° Results from the first tab-cel™ Phase 3 study to reach the primary endpoint are expected to be announced in the first half of 2019. Atara also plans to submit a Conditional Marketing Authorization (CMA) application for tab-cel™ in the EU for patients with EBV+ PTLD who have failed rituximab following HCT during the first half of 2019.
- Received clearance of an Investigational New Drug (IND) application from the
U.S. Food and Drug Administration( FDA) to proceed with patient enrollment at U.S. sites for the Company's ongoing multinational Phase 1 clinical study to evaluate ATA188 in patients with progressive or relapsing-remitting multiple sclerosis (MS).
° 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.
° We believe that ATA188 may allow for a more consistent reactivity against target EBV antigens, which correlated with clinical improvements in a previous autologous ATA190 Phase 1 study in patients with progressive MS.
° The first results from the ATA188 Phase 1 study in patients with progressive MS are expected in the first half of 2019.
- Presented positive interim tab-cel™ results from a multicenter expanded access protocol (EAP) study for patients with EBV associated cancers at the 59th
American Society of Hematology(ASH) Annual Meeting.
° In 6 patients with EBV+ PTLD who have failed rituximab following SOT, the Objective Response Rate (ORR) was 83%, with 5 of 6 patients responding to treatment.
° Additionally, in 5 patients with EBV+ PTLD who have failed rituximab following allogeneic HCT, an ORR of 80% was observed, with 4 of 5 patients responding to treatment.
° Safety findings were reported for a total of 23 patients and demonstrated that tab-cel™ was generally well-tolerated in this study population, which comprised ill, mostly immunosuppressed patients with multiple comorbidities. Five patients experienced treatment-related serious adverse events (SAEs).
- Continue to build core commercial and clinical development capabilities in preparation for the expected submission of the tab-cel™ CMA in the EU and potential launch.
° Appointed Dr.
Derrell Porteras Senior Vice President, Global Commercial Head, who brings extensive oncology and specialty commercialization experience to the management team.
° Appointed Dr.
Kanya Rajangamas Senior Vice President and Chief Medical Officer, who has leadership experience advancing multiple global, early- and late-stage oncology programs.
° Identified Atara’s EU headquarters in Zug,
Switzerlandand began recruiting key global functional leadership and staff.
° Plan to announce partner for Atara MatchMeTM, our off-the-shelf T-cell immunotherapy delivery solution, in the first half of 2018.
- Plan 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.
- Plan to communicate development strategy for CMV and other viral disease programs in the second half of 2018.
- Expect operations to commence at Atara T Cell Operations & Manufacturing (ATOM) facility in 2018, with clinical production anticipated in 2019.
Fourth Quarter and Full Year 2017 Financial Results
- Cash, cash equivalents and short-term investments as of
December 31, 2017totaled $166.1 million, which the Company believes, along with the $131.4 millionnet proceeds from the sale of 7,675,072 shares of common stock in an underwritten public offering completed in January 2018, will be sufficient to fund planned operations into the first half of 2020.
- The Company reported net losses of
$35.3 million, or $1.15per share and $119.5 million, or $4.00per share, for the fourth quarter and fiscal year 2017, as compared to $18.2 million, or $0.63per share and $79.0 million, or $2.75per share, for the same periods in 2016.
- Research and development expenses were
$24.8 millionand $81.2 millionfor the fourth quarter and fiscal year 2017, as compared to $13.5 millionand $56.5 millionfor the same periods in 2016. The increases in the fourth quarter and fiscal year 2017 were due to costs associated with the Company’s continuing expansion of research and development activities, including:
° manufacturing and outside service costs related to the preparation for the two tab-cel™ Phase 3 clinical studies in patients with EBV+ PTLD who have failed rituximab;
° ongoing costs for the Company’s EAP clinical study for tab-cel™, which was initiated in mid-2016;
° clinical manufacturing and preparations for the Phase 1 clinical study of allogeneic ATA188, which was initiated in
° higher payroll and related costs from increased headcount, and
° an increase in allocated facilities and information technology expenses.
- Research and development expenses include
$2.5 millionand $8.8 millionof non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2017, as compared to $0.4 millionand $7.6 millionfor the same periods in 2016.
- General and administrative expenses were
$11.0 millionand $40.3 millionfor fourth quarter and fiscal year 2017, as compared to $5.3 millionand $24.7 millionfor the same periods in 2016. The increases in the fourth quarter and fiscal year 2017 were 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 $3.6 millionand $14.3 millionof non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2017, as compared to $1.3 millionand $9.2 millionfor the same periods in 2016.
About EBV+ PTLD
Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection. In immunocompromised patients, such as those undergoing allogeneic hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV associated post-transplant lymphoproliferative disorder (EBV+ PTLD), represents a life-threatening condition. Median overall survival in patients with EBV+ PTLD following HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV+ PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One- and two-year survival in patients with high-risk EBV+ PTLD following SOT is 36% and 0%, respectively.
About tab-cel™ (tabelecleucel; formerly known as ATA129)
Atara's most advanced T-cell immunotherapy in development, tab-cel™, is a potential treatment for patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). In
About Multiple Sclerosis (MS)
MS is a chronic neurological autoimmune disease that affects an estimated 2.3 million people around the world. Relapsing-remitting MS (RRMS) is the most common form of MS and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Despite available disease-modifying treatments, most individuals with RRMS continue to experience disease activity and disability progression.
Progressive MS (PMS) is a severe form of the disease with few therapeutic options. PMS comprises two conditions, both characterized by persistent progression and worsening of MS symptoms and physical disability over time. Primary Progressive MS (PPMS) occurs when continuous progressive disease is present at diagnosis and occurs in approximately 15% of newly diagnosed cases. Secondary Progressive MS (SPMS) initially begins as RRMS and develops into a progressive form. Up to 80% of people with RRMS will eventually develop SPMS. There is substantial unmet medical need for new and effective therapies for patients with PPMS and SPMS. Most treatment options that work well in reducing flares in RRMS have not been shown to be effective in slowing or reversing disability in PMS.
About allogeneic ATA188 and autologous ATA190
Epstein-Barr Virus (EBV) is associated with a wide range of hematologic malignancies and solid tumors, as well as certain autoimmune conditions such as multiple sclerosis (MS). T-cells are a critical component of the body's immune system and can selectively target specific EBV antigens believed to be important for the potential treatment of MS. Off-the-shelf ATA188 and autologous ATA190, using the Company’s complementary T-cell immunotherapy technology developed by Professor
In patients with weakened immune systems, including bone marrow and solid organ transplant recipients, newborns with immature immune systems and those with human immunodeficiency virus (HIV), cytomegalovirus (CMV) can cause potentially life-threatening disease or may result in blindness, brain damage, and deafness. While small molecule antiviral drugs are approved to treat and prevent CMV infection, there remains a high unmet need due to viral resistance, modest neurodevelopmental activity and adverse effects, such as toxicity and reduction in white blood cell count impairing the ability to fight other infections, with these agents.
ATA230, an allogeneic T-cell immunotherapy targeting antigens expressed by cytomegalovirus (CMV), has been investigated in one Phase 1 and two Phase 2 clinical studies in immunocompromised patients with CMV viremia or disease who are refractory or resistant to antiviral drug treatment in the post-transplant setting. In
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 the Company's enrollment, later expansion of additional sites in the U.S. and sites in the EU,
|Atara Biotherapeutics, Inc.|
|Consolidated Balance Sheets|
|December 31,||December 31,|
|Cash and cash equivalents||$||79,223||$||47,968|
|Prepaid expenses and other current assets||5,900||4,677|
|Total current assets||172,190||260,553|
|Property and equipment, net||44,129||3,259|
|Restricted cash, long term||1,200||—|
|Liabilities and stockholders’ equity|
|Accrued research and development expenses||4,006||2,408|
|Other accrued liabilities||3,265||744|
|Total current liabilities||27,646||9,675|
|Commitments and contingencies|
|Additional paid-in capital||474,662||431,075|
|Accumulated other comprehensive loss||(151||)||(183||)|
|Total stockholders’ equity||177,864||253,736|
|Total liabilities and stockholders’ equity||$||217,779||$||263,914|
|Atara Biotherapeutics, Inc.|
|Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended
|Research and development||$||24,771||$||13,474||$||81,206||$||56,514|
|General and administrative||11,031||5,280||40,326||24,728|
|Total operating expenses||35,802||18,754||121,532||81,242|
|Loss from operations||(35,802||)||(18,754||)||(121,532||)||(81,242||)|
|Interest and other income, net||473||519||2,027||2,203|
|Loss before provision for income taxes||(35,329||)||(18,235||)||(119,505||)||(79,039||)|
|Provision (benefit) for income taxes||(16||)||-||(14||)||10|
|Other comprehensive loss:|
|Unrealized gain (loss) on available-for-sale securities||(63||)||(218||)||32||335|
|Net loss per common share:|
|Basic and diluted net loss per common share:||$||(1.15||)||$||(0.63||)||$||(4.00||)||$||(2.75||)|
|Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share||30,651||28,915||29,863||28,732|
INVESTOR & MEDIA CONTACTS:
Source: Atara Biotherapeutics, Inc.