ATRA Atara Biotherapeutics Inc

Discussions With FDA Progressing on Potential BLA Submission for Tab-cel® With Meeting Scheduled To Resolve Remaining Topic of Comparability

ATA188 Phase 2 EMBOLD Study Primary Analysis and Communication Will Now Occur in Early November To Include the Last Patient Visits From More Than 90 Patients

IND Cleared for Atara's First Allogeneic CAR T, ATA3219, in Relapsed/Refractory B-Cell NHL

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the second quarter 2023, recent business highlights and key upcoming catalysts.

“We are pleased to announce IND clearance for ATA3219, our first allogeneic CAR-T cell product candidate expected to enter the clinic in the coming months as a potential best-in-class treatment for patients with certain B-cell malignancies,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Building on this momentum, our discussions with FDA and potential commercial partners for tab-cel in the U.S. are progressing well and we are excited to soon conduct the primary analysis of the EMBOLD Phase 2 study in progressive MS, with clinical and biomarker data from more than 90 patients.”

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

• Continued productive discussions between Atara and FDA have addressed outstanding chemistry, manufacturing, and controls (CMC) questions. A meeting is scheduled to resolve the remaining topic of comparability between clinical and intended commercial process versions which should provide clarity on timing for a potential BLA submission
• Following significant levels of engagement, discussions with potential U.S. commercialization partners are advancing
• Patients in Europe are now receiving treatment with EBVALLO in the commercial setting, as Pierre Fabre is progressively launching on a country-by-country basis
• Atara is investigating label expansion opportunities with its ongoing Phase 2 multi-cohort study with initial data expected in Q4 2023

ATA188 for Progressive Multiple Sclerosis (MS)

• Atara plans to communicate data from the primary analysis of the double-blind placebo-controlled Phase 2 EMBOLD study in progressive MS in early November
• This communication will include data from more than 90 patients, covering the primary endpoint of confirmed disability improvement (CDI) based on expanded disability status scale (EDSS) at 12 months, other clinical endpoints, and additional biomarkers
• In addition, the Company anticipates sharing longer-term results for patients that have completed study visits beyond the 12-month primary endpoint
• Atara will present new biomarker analyses from its ongoing Phase 1 trial of ATA188 at the International Society of Neuroimmunology (ISNI) congress taking place August 20-24. The data show ATA188-treated patients who achieved CDI by EDSS exhibited reduced accumulation of plasma Glial Fibrillary Acidic Protein (GFAP), a potential biomarker of disease progression in MS. Additionally, a novel application of TCRβ-sequencing allowed for detection of ATA188-derived EBV-specific TCRβ clonotypes in patients

ATA3219: Allogeneic CD19 CAR T for Various Indications

• A Phase 1 study in relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) is expected to start in the coming months following Atara’s receipt of a Safe to Proceed letter from FDA in response to an Investigational New Drug Application (IND) submitted for ATA3219. ATA3219 is an allogeneic CD19-1XX CAR+ EBV T cell immunotherapy that incorporates multiple clinically validated technologies designed for T-cell memory, robust expansion and persistence, and potent anti-tumor efficacy
• A large unmet medical need remains for CD19-directed CAR T products that can be reliably manufactured at scale, are available in advance of patient need, and are enabling more complete and durable responses with favorable safety

Second Quarter 2023 Financial Results

• Cash, cash equivalents and short-term investments as of June 30, 2023, totaled $153.6 million, as compared to $205.4 million as of March 31, 2023
• Net cash used in operating activities was $52.8 million for the second quarter 2023, as compared to $64.0 million in the same period in 2022
• Atara believes that its cash and investments as of June 30, 2023, will be sufficient to fund the Company’s planned operations into second quarter 2024
• Atara reported a net loss of $71.1 million, or $0.68 per share for the second quarter 2023, as compared to net income of $18.5 million, or $0.18 per share for the same period in 2022. Second quarter 2022 net income included $50.9 million of deferred revenue recognized due to the termination of the Bayer Collaboration Agreements and a gain on the sale of the ATOM facility of $50.2 million.
• Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $13.8 million for the second quarter 2023, as compared to $15.6 million for the same period in 2022
• Research and development expenses were $56.1 million for the second quarter 2023, as compared to $64.9 million for the same period in 2022
  • Research and development expenses include $7.2 million of non-cash stock-based compensation expenses for the second quarter 2023 as compared to $7.9 million for the same period in 2022
• General and administrative expenses were $13.3 million for the second quarter 2023, as compared to $18.8 million for the same period in 2022
  • General and administrative expenses include $5.4 million of non-cash stock-based compensation expenses for the second quarter 2023, as compared to $6.2 million for the same period in 2022

About Atara Biotherapeutics, Inc. Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions, including multiple sclerosis, that can be rapidly delivered to patients within days. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile Epstein-Barr virus (EBV) T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of non-EBV-associated liquid and solid tumors. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio 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) dialogue with the FDA regarding a potential BLA submission for tab-cel (2) 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; (3) the potential submission of a BLA for tab-cel; (4) the timing and progress of ATA188, including data and analyses from the EMBOLD study and the timing of when such data will be received and communicated; (5) the timing and progress of Atara’s CAR T programs, including the timing of the start of any clinical trials, and the safety and efficacy of product candidates emerging from such programs, including ATA3219; (6) Atara’s cash runway; (7) Pierre Fabre’s activities relating to the commercialization of Ebvallo™ in Europe and the timing thereof; and (8) the status of discussions with potential U.S. commercialization partners for tab-cel and the potential timing of such a transaction if such a transaction were to occur. 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 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 Southern California and Denver 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 , 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,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

45,898

 

 

$

92,942

 

Short-term investments

 

 

107,744

 

 

 

149,877

 

Restricted cash

 

 

146

 

 

 

146

 

Accounts receivable

 

 

507

 

 

 

40,221

 

Inventories

 

 

7,861

 

 

 

1,586

 

Other current assets

 

 

10,164

 

 

 

10,308

 

Total current assets

 

 

172,320

 

 

 

295,080

 

Property and equipment, net

 

 

5,349

 

 

 

6,300

 

Operating lease assets

 

 

62,195

 

 

 

68,022

 

Other assets

 

 

6,575

 

 

 

7,018

 

Total assets

 

$

246,439

 

 

$

376,420

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,138

 

 

$

6,871

 

Accrued compensation

 

 

12,556

 

 

 

17,659

 

Accrued research and development expenses

 

 

20,737

 

 

 

24,992

 

Deferred revenue

 

 

11,949

 

 

 

8,000

 

Other current liabilities

 

 

25,172

 

 

 

21,394

 

Total current liabilities

 

 

74,552

 

 

 

78,916

 

Deferred revenue - long-term

 

 

75,565

 

 

 

77,000

 

Operating lease liabilities - long-term

 

 

51,754

 

 

 

58,064

 

Liability related to the sale of future revenues - long-term

 

 

32,091

 

 

 

30,236

 

Other long-term liabilities

 

 

5,023

 

 

 

5,564

 

Total liabilities

 

$

238,985

 

 

$

249,780

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock

 

 

10

 

 

 

10

 

Additional paid-in capital

 

 

1,847,280

 

 

 

1,821,721

 

Accumulated other comprehensive (loss) income

 

 

(933

)

 

 

(2,067

)

Accumulated deficit

 

 

(1,838,903

)

 

 

(1,693,024

)

Total stockholders’ equity

 

 

7,454

 

 

 

126,640

 

Total liabilities and stockholders’ equity

 

$

246,439

 

 

$

376,420

 

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,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Commercialization revenue

 

$

793

 

 

$

—

 

 

$

1,677

 

 

$

—

 

License and collaboration revenue

 

 

164

 

 

 

51,579

 

 

 

506

 

 

 

58,893

 

Total revenue

 

 

957

 

 

 

51,579

 

 

 

2,183

 

 

 

58,893

 

Costs and operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of commercialization revenue

 

 

2,895

 

 

 

—

 

 

 

3,111

 

 

 

—

 

Research and development expenses

 

 

56,141

 

 

 

64,898

 

 

 

118,297

 

 

 

139,861

 

General and administrative expenses

 

 

13,335

 

 

 

18,813

 

 

 

27,207

 

 

 

39,384

 

Total costs and operating expenses

 

 

72,371

 

 

 

83,711

 

 

 

148,615

 

 

 

179,245

 

Loss from operations

 

 

(71,414

)

 

 

(32,132

)

 

 

(146,432

)

 

 

(120,352

)

Gain on sale of ATOM Facility

 

 

—

 

 

 

50,237

 

 

 

—

 

 

 

50,237

 

Interest and other income, net

 

 

307

 

 

 

361

 

 

 

576

 

 

 

476

 

Total other income, net

 

 

307

 

 

 

50,598

 

 

 

576

 

 

 

50,713

 

Income (loss) before provision for income taxes

 

 

(71,107

)

 

 

18,466

 

 

 

(145,856

)

 

 

(69,639

)

Provision for income taxes

 

 

1

 

 

 

—

 

 

 

23

 

 

 

—

 

Net income (loss)

 

$

(71,108

)

 

$

18,466

 

 

$

(145,879

)

 

$

(69,639

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

304

 

 

 

(726

)

 

 

1,134

 

 

 

(2,250

)

Comprehensive income (loss)

 

$

(70,804

)

 

$

17,740

 

 

$

(144,745

)

 

$

(71,889

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net earnings (loss) per common share

 

$

(0.68

)

 

$

0.18

 

 

$

(1.40

)

 

$

(0.69

)

Diluted net earnings (loss) per common share

 

$

(0.68

)

 

$

0.18

 

 

$

(1.40

)

 

$

(0.69

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average basic shares outstanding

 

 

105,091

 

 

 

101,601

 

 

 

104,533

 

 

 

101,166

 

Weighted-average diluted shares outstanding

 

 

105,091

 

 

 

101,866

 

 

 

104,533

 

 

 

101,166

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20230808955684/en/

Investors Eric Hyllengren 805-395-9669 ehyllengren@atarabio.com

Media Alex Chapman 805-456-4772 achapman@atarabio.com