Atara Biotherapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Recent Operational Progress
“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
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
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
- 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 Statesand Australia, and with additional sites expected to open in the United Statesand other geographies.
- Expanded MATCH and ALLELE study sites, with 30 sites available for enrollment in
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 Statesand 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) Annual Meeting 2019 to be held March 29 to April 3in 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.
- Conducting IND-enabling manufacturing process development for ATA621, targeting both JC and BK viruses for patients with progressive multifocal leukoencephalopathy (PML).
- 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, 2018totaled $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 millionpaid 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 $1.75per share, and $230.7 million, or $5.27per share, for the fourth quarter and fiscal year 2018, respectively, as compared to $35.3 million, or $1.15per share, and $119.5 million, or $4.00per share, for the same periods in 2017.
- Total operating expenses include total non-cash expenses of
$11.0 millionand $37.5 millionfor the fourth quarter and fiscal year 2018, respectively, as compared to $6.4 millionand $24.1for the same periods in 2017.
- Research and development expenses were
$62.3 millionand $167.5 millionfor the fourth quarter and fiscal year 2018, respectively, as compared to $24.8 millionand $81.2 millionfor 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 millionincurred 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 millionand $16.2 millionof non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2018, respectively, as compared to $2.5 millionand $8.8 millionfor the same periods in 2017.
- General and administrative expenses were
$19.6 millionand $69.7 millionfor the fourth quarter and fiscal year 2018, respectively, as compared to $11.0 millionand $40.3 millionfor 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 millionand $17.6 millionof non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2018, respectively, as compared to $3.6 millionand $14.3 millionfor the same periods in 2017.
Consolidated Balance Sheets
|December 31,||December 31,|
|Cash and cash equivalents||$||60,698||$||79,223|
|Restricted cash - short-term||194||194|
|Prepaid expenses and other current assets||11,664||5,900|
|Total current assets||321,489||172,190|
|Property and equipment, net||68,576||44,129|
|Restricted cash - long-term||1,200||1,200|
|Liabilities and stockholders’ equity|
|Accrued research and development expenses||19,210||4,006|
|Other current liabilities||6,414||3,265|
|Total current liabilities||39,979||27,646|
|Commitments and contingencies|
|Additional paid-in capital||866,541||474,662|
|Accumulated other comprehensive loss||(340)||(151)|
|Total stockholders’ equity||338,857||177,864|
|Total liabilities and stockholders’ equity||$||391,839||$||217,779|
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||$||62,255||$||24,771||$||167,457||$||81,206|
|General and administrative||19,561||11,031||69,654||40,326|
|Total operating expenses||81,816||35,802||237,111||121,532|
|Loss from operations||(81,816||)||(35,802||)||(237,111||)||(121,532||)|
|Interest and other income, net||1,757||473||6,368||2,027|
|Loss before income taxes||(80,059||)||(35,329||)||(230,743||)||(119,505||)|
|Benefit from income taxes||(47||)||(16||)||(44||)||(14||)|
|Other comprehensive gain (loss):|
|Unrealized gain (loss) on available-for-sale securities||109||(63||)||(189||)||32|
|Net loss per common share:|
|Basic and diluted net loss per common share||$||(1.75||)||$||(1.15||)||$||(5.27||)||$||(4.00||)|
|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 achieve clinical and regulatory milestones in 2019; tab-cel® Phase 3 results; discussions with the EMA and
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Source: Atara Biotherapeutics, Inc.