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

Atara Biotherapeutics Announces Second Quarter 2022 Financial Results and Corporate Strategy Update


Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the second quarter 2022, an update to its corporate strategy, recent business highlights, and key upcoming catalysts.

"We are excited about the transformative potential of ATA188 in MS and are pleased that as a result of our significant and constructive engagement, the FDA has recommended a possible path towards a tab-cel BLA filing without the need for a new clinical study," said Pascal Touchon, President and Chief Executive Officer of Atara. "Atara's R&D-centered strategy, clear portfolio prioritization, and purposeful partnerships are positioning us for success in reaching critical value-generating milestones for our key pipeline assets. I would like to extend my sincere gratitude and thanks to Atara's staff for their significant contributions and unwavering commitment to advancing truly innovative medicines for patients in need."

Corporate Strategy Update

ATA188 for Progressive Multiple Sclerosis (MS)

Tabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD)

CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

ATA3219 (B-cell Malignancies)

Second Quarter 2022 Financial Results

Conference Call and Webcast Details

Atara will host a live conference call and webcast today, Monday, August 8, 2022, 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 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13730293. 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 30 days following the live webcast.

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 serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development and currently under review to support registration in Europe, 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 serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform, which does not require TCR or HLA gene editing, 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, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.

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: (1) the Company's updated corporate strategy to focus as a leaner, R&D-centered organization, including (i) the staff reduction; and (ii) seeking a commercial partner for tab-cel in the U.S; (2) the potential benefits, safety and efficacy of tab-cel®; the timing and progress of tab-cel®, including (i) data and analyses from ALLELE study; (ii) tab-cel® clinical trials, and the occurrence, timing and outcome of Atara's interactions and discussions with the FDA regarding a BLA submission for tab-cel®, (iii) the timing and outcome of the MAA for tab-cel®, (iv) the potential timing of the initiation or submission of the BLA for tab-cel®, and (iv) the timing of the EMA's review of the MAA for tab-cel®; (3) the potential benefits, safety and efficacy of ATA188; the timing and progress of ATA188, including (i) regulatory designations for ATA188 granted by FDA and the impact thereof; (ii) data and analyses from ATA188 OLE study; (iii) ATA188 clinical trials, (iv) data and analyses from the planned interim analysis for the EMBOLD study, potential next steps for the program and planned discussions with FDA; and (v) Atara's ability to successfully advance the development of ATA188; (4) the timing and progress of its CAR T programs, and the safety and efficacy of product candidates emerging from such programs, including (i) ATA2271 clinical trial, (ii) ATA3271 and ATA3219 preclinical development, (iii) termination of the strategic collaboration with Bayer for ATA2271 and ATA3271, and (iv) Atara's ability to successfully advance the development of its CAR T programs; (5) Atara's research and development activities; (6) Atara's ability to reach critical value-generating milestones for its key pipeline assets or to generate value from such assets; and (7) Atara's ability to advance development of its other programs. Because such statements deal with future events and are based on Atara's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara 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, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the ongoing COVID-19 pandemic and the war in Ukraine, 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 manufacturer, 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 Atara's filings with the Securities and Exchange Commission (SEC), including in the "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.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

70,688

 

 

$

106,084

 

Short-term investments

 

 

260,623

 

 

 

264,984

 

Restricted cash

 

 

1,346

 

 

 

194

 

Accounts receivable

 

 

637

 

 

 

986

 

Prepaid expenses and other current assets

 

 

13,690

 

 

 

12,373

 

Total current assets

 

 

346,984

 

 

 

384,621

 

Property and equipment, net

 

 

8,328

 

 

 

53,780

 

Operating lease assets

 

 

73,582

 

 

 

26,159

 

Restricted cash - long-term

 

 

?

 

 

 

1,200

 

Other assets

 

 

7,227

 

 

 

2,367

 

Total assets

 

$

436,121

 

 

$

468,127

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

12,799

 

 

$

17,368

 

Accrued compensation

 

 

16,317

 

 

 

25,150

 

Accrued research and development expenses

 

 

15,125

 

 

 

13,451

 

Deferred revenue

 

 

1,671

 

 

 

40,760

 

Other current liabilities

 

 

19,776

 

 

 

9,057

 

Total current liabilities

 

 

65,688

 

 

 

105,786

 

Deferred revenue - long-term

 

 

43,329

 

 

 

55,708

 

Operating lease liabilities - long-term

 

 

63,999

 

 

 

25,518

 

Other long-term liabilities

 

 

5,626

 

 

 

1,501

 

Total liabilities

 

$

178,642

 

 

$

188,513

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock?$0.0001 par value, 500,000 shares authorized as of June 30,2022 and December 31, 2021; 94,356 and 91,671 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

 

 

9

 

 

 

9

 

Additional paid-in capital

 

 

1,794,449

 

 

 

1,744,695

 

Accumulated other comprehensive (loss) income

 

 

(2,618

)

 

 

(368

)

Accumulated deficit

 

 

(1,534,361

)

 

 

(1,464,722

)

Total stockholders' equity

 

 

257,479

 

 

 

279,614

 

Total liabilities and stockholders' equity

 

$

436,121

 

 

$

468,127

 

ATARA BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(Unaudited)

(In thousands, except per share amounts)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

License and collaboration revenue

 

$

51,579

 

 

$

3,870

 

 

$

58,893

 

 

$

7,422

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

64,898

 

 

 

68,475

 

 

 

139,861

 

 

 

132,534

 

General and administrative

 

 

18,813

 

 

 

19,397

 

 

 

39,384

 

 

 

37,135

 

Total operating expenses

 

 

83,711

 

 

 

87,872

 

 

 

179,245

 

 

 

169,669

 

Loss from operations

 

 

(32,132

)

 

 

(84,002

)

 

 

(120,352

)

 

 

(162,247

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain on sale of ATOM Facility

 

 

50,237

 

 

 

?

 

 

 

50,237

 

 

 

?

 

Interest and other income, net

 

 

361

 

 

 

225

 

 

 

476

 

 

 

135

 

Total other (expense), net

 

 

50,598

 

 

 

225

 

 

 

50,713

 

 

 

135

 

Income (loss) before provision for income taxes

 

 

18,466

 

 

 

(83,777

)

 

 

(69,639

)

 

 

(162,112

)

Provision for income taxes

 

 

?

 

 

 

16

 

 

 

?

 

 

 

16

 

Net income (loss)

 

$

18,466

 

 

$

(83,793

)

 

$

(69,639

)

 

$

(162,128

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

(726

)

 

 

(99

)

 

 

(2,250

)

 

 

(234

)

Comprehensive income (loss)

 

$

17,740

 

 

$

(83,892

)

 

$

(71,889

)

 

$

(162,362

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net earnings (loss) per common share

 

$

0.18

 

 

$

(0.91

)

 

$

(0.69

)

 

$

(1.77

)

Diluted net earnings (loss) per common share

 

$

0.18

 

 

$

(0.91

)

 

$

(0.69

)

 

$

(1.77

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average basic shares outstanding

 

 

101,601

 

 

 

92,152

 

 

 

101,166

 

 

 

91,806

 

Weighted-average diluted shares outstanding

 

 

101,866

 

 

 

92,152

 

 

 

101,166

 

 

 

91,806

 

 


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