Le Lézard
Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Atara Biotherapeutics Announces Second Quarter 2020 Financial Results and Operational Progress


Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases including solid tumors, hematologic cancers and autoimmune disease, today reported financial results for the second quarter ended June 30, 2020 and recent business highlights.

"I am proud of the continued tremendous progress made by Atara's team in delivering on our strategic priorities and on our mission to bring transformative therapies to patients with severe diseases," said Pascal Touchon, President and Chief Executive Officer of Atara. "We remain on track to initiate a BLA submission for tab-cel® for patients with EBV+ PTLD by the end of 2020, despite the COVID-19 outbreak. During the quarter we also reported positive ATA188 clinical data in progressive multiple sclerosis at EAN, successfully completed a follow-on financing, made key executive and board hires, and progressed our CAR T programs closer to the clinic."

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel® (tabelecleucel)

Post-transplant lymphoproliferative disease (PTLD)

Tab-cel Potential Additional Indications

ATA188 for Progressive Multiple Sclerosis (MS)

CAR T Programs

ATA2271/ATA3271 (Solid tumors)

ATA3219 (B-cell)

Operations

Executive and Board Appointments

Second Quarter 2020 Financial Results

About Atara Biotherapeutics, Inc.

Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other severe diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® (tabelecleucel) in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD); ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients' lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.

Conference Call and Webcast Information

Atara will host a live conference call and webcast today at 4:30 p.m. EDT 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 9355679. 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 14 days following the live webcast.

Forward-Looking Statements

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: Atara's ability to deliver on key milestones relating to tab-cel®, including (i) conducting an interim analysis of the tab-cel® Phase 3 study and discussing the totality of tab-cel® data with the FDA prior to initiating the BLA submission, (ii) discussions with the EMA regarding a PIP under the PRIME mechanism for the EMA,, (iii) the timing and plan of submitting an EU MAA, (iv) initiating enrollment in a Phase 2 multi-cohort study and potentially expanding tab-cel® into other indications, (v) the timing and results of additional clinical data, and (vi) the timing of BLA submissions for tab-cel® for patients with EBV+ PTLD; the potential benefits and efficacy of Atara's drug candidates; the timing, enrollment and results of additional data from Atara's clinical trials; and the sufficiency of our cash, cash equivalents and short-term investments for our operations into 2022. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the COVID-19 pandemic, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturers, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara's cash resources and need for additional capital; and other risks and uncertainties affecting Atara's and its development programs, including those discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

Financials

ATARA BIOTHERAPEUTICS, INC.
Consolidated Balance Sheets
(Unaudited)
(In thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

74,511

 

 

$

74,317

 

Short-term investments

 

 

273,201

 

 

 

184,792

 

Restricted cash - short-term

 

 

194

 

 

 

194

 

Prepaid expenses and other current assets

 

 

11,081

 

 

 

13,689

 

Total current assets

 

 

358,987

 

 

 

272,992

 

Property and equipment, net

 

 

53,587

 

 

 

54,176

 

Operating lease assets

 

 

13,321

 

 

 

14,007

 

Restricted cash - long-term

 

 

1,200

 

 

 

1,200

 

Other assets

 

 

1,016

 

 

 

567

 

Total assets

 

$

428,111

 

 

$

342,942

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,106

 

 

$

7,963

 

Accrued compensation

 

 

12,657

 

 

 

14,706

 

Accrued research and development expenses

 

 

8,244

 

 

 

8,341

 

Other current liabilities

 

 

5,677

 

 

 

5,733

 

Total current liabilities

 

 

31,684

 

 

 

36,743

 

Operating lease liabilities - long-term

 

 

13,420

 

 

 

14,136

 

Other long-term liabilities

 

 

1,882

 

 

 

1,282

 

Total liabilities

 

 

46,986

 

 

 

52,161

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock

 

 

7

 

 

 

6

 

Additional paid-in capital

 

 

1,349,234

 

 

 

1,108,516

 

Accumulated other comprehensive income

 

 

810

 

 

 

220

 

Accumulated deficit

 

 

(968,926

)

 

 

(817,961

)

Total stockholders' equity

 

 

381,125

 

 

 

290,781

 

Total liabilities and stockholders' equity

 

$

428,111

 

 

$

342,942

 

ATARA BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per share amounts)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

61,560

 

 

$

52,251

 

 

$

119,219

 

 

$

100,919

 

General and administrative

 

 

16,392

 

 

 

23,284

 

 

 

33,430

 

 

 

42,507

 

Total operating expenses

 

 

77,952

 

 

 

75,535

 

 

 

152,649

 

 

 

143,426

 

Loss from operations

 

 

(77,952

)

 

 

(75,535

)

 

 

(152,649

)

 

 

(143,426

)

Interest and other income, net

 

 

497

 

 

 

1,207

 

 

 

1,685

 

 

 

2,841

 

Loss before provision for income taxes

 

 

(77,455

)

 

 

(74,328

)

 

 

(150,964

)

 

 

(140,585

)

Provision for income taxes

 

 

1

 

 

 

?

 

 

 

1

 

 

 

?

 

Net loss

 

$

(77,456

)

 

$

(74,328

)

 

$

(150,965

)

 

$

(140,585

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities

 

 

606

 

 

 

135

 

 

 

590

 

 

 

513

 

Comprehensive loss

 

$

(76,850

)

 

$

(74,193

)

 

$

(150,375

)

 

$

(140,072

)

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(1.14

)

 

$

(1.60

)

 

$

(2.34

)

 

$

(3.04

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding used to calculate basic and diluted net loss per common share

 

 

67,975

 

 

 

46,426

 

 

 

64,592

 

 

 

46,276

 

 


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