8-K
false000160446400016044642023-02-032023-02-03

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 3, 2023

 

 

Atara Biotherapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-36548

46-0920988

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

2380 Conejo Spectrum Street

Suite 200

 

Thousand Oaks, California

 

91320

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (805) 623-4211

 

 

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

ATRA

 

The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

On February 8, 2023, Atara Biotherapeutics, Inc., a Delaware corporation (the “Company”) announced certain financial results for the fourth quarter and year ended December 31, 2022. A copy of the Company’s press release, titled “Atara Biotherapeutics Announces Fourth Quarter and Full Year 2022 Financial Results and Operational Progress” is furnished as Exhibit 99.1 hereto.

The information set forth in this Item 2.02 and in the press release included as Exhibit 99.1 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended, and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such filing.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On February 3, 2023, Utpal Koppikar, the Company’s Executive Vice President, Chief Financial Officer, notified the Company of his intention to resign from the Company, effective March 31, 2023, to pursue an external opportunity.

On February 3, 2023, the Company appointed Eric Hyllengren, the Company’s Senior Vice President, Finance, to serve as the Company’s Senior Vice President, Chief Financial Officer, effective as of April 1, 2023. Mr. Hyllengren will also serve as the Company’s Principal Financial Officer and Principal Accounting Officer.

Mr. Hyllengren, 47, joined the Company in 2018 as Vice President, Financial Planning and Analysis and added the role of Head of Investor Relations in April 2020. Previously, Mr. Hyllengren spent 15 years at Amgen Inc. in several finance roles with increasing responsibilities, including corporate finance and investor relations. Mr. Hyllengren holds a B.B.A. in finance and Russian from the University of Notre Dame and an M.B.A. in finance from the Kellogg School of Management at Northwestern University.

Mr. Hyllengren’s base salary is $455,000 and his bonus target is equal to 40% of his base salary. The Company and Mr. Hyllengren have entered into the Company’s standard form of Executive Employment Agreement and the Company’s standard form of Indemnification Agreement

The forms of Executive Employment Agreement and Indemnification Agreement are qualified in their entirety by reference to the full text of such forms, each of which are exhibits to the Company’s Form 10-K filed on February 8, 2023.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

 

Description

 

 

99.1

 

Press Release, dated February 8, 2023

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

ATARA BIOTHERAPEUTICS, INC.

 

 

 

 

Date:

February 8, 2023

By:

/s/ Utpal Koppikar

 

 

 

Utpal Koppikar
Chief Financial Officer

 

 

Exhibit 99.1

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2022 Financial Results and Operational Progress

 

Ebvallo™ EU Launch Activities Led by Pierre Fabre to Commence in Q1 2023

 

Discussions with FDA Progressing on Potential U.S. BLA for Tab-cel®

 

ATA188 Phase 2 EMBOLD Study Primary Data Readout On-Track for October 2023

 

Cash Runway Extended into Q2 2024

 

 

THOUSAND OAKS, Calif.—February 8, 2022—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 fourth quarter and full year 2022, recent business highlights and key upcoming catalysts for 2023.

 

“Following the landmark approval of EbvalloTM in Europe, we had productive discussions with the FDA about their requirements for a tab-cel BLA. We welcome the opportunity to further discuss the topic of comparability that may advance our progress towards a BLA submission,” said Pascal Touchon, President and Chief Executive Officer of Atara. "Meanwhile we are on track for the results of our Phase 2 EMBOLD study this October, a key catalyst that could progress ATA188 towards becoming the first ever targeted and transformative therapy in multiple sclerosis (MS) following the landmark scientific discovery of EBV as the leading trigger of MS.”

 

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

•
Atara recently held a productive meeting with FDA on clinical aspects for a potential biologics license application (BLA) submission for tab-cel
•
Atara and the FDA are expected to hold another meeting to further discuss chemistry, manufacturing, and controls (CMC) matters relating to a potential BLA for tab-cel, including aspects related to comparability that may support pooling clinical data from different process versions
○
Atara expects to provide a further update in Q2 2023
•
In December 2022, Atara announced that the European Commission (EC) granted marketing authorization for the first-of-its-kind off-the-shelf allogeneic T-cell therapy, Ebvallo™ (tabelecleucel) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy
•
In February 2023, Atara completed the transfer of the EC marketing authorization to Pierre Fabre, who is now leading all commercialization, distribution, medical, and regulatory activities in Europe, Middle East, Africa and other selected markets
○
Pierre Fabre is planning to launch Ebvallo™ in the first European countries during Q1 2023
•
Atara anticipates investigating label expansion opportunities with its ongoing Phase 2 multi-cohort study with initial data expected in 2023
•
Atara is engaged in discussions with potential U.S. commercialization partners

 

ATA188 for Progressive Multiple Sclerosis (MS)

•
Following target enrollment in the Phase 2 EMBOLD study, the primary analysis data read out is on track for October 2023

 

 

 

ATA3219: CD19 Program for B-Cell Malignancies

•
IND for ATA3219 anticipated for Q2 2023
•
ATA3219 is an allogeneic CD19-1XX CAR+ EBV T cell that incorporates multiple clinically-validated technologies designed for T-cell memory, robust expansion, and potent anti-tumor efficacy
•
Currently, the majority of eligible patients are not receiving approved autologous CD19 CAR T treatment due to technical, operational and access challenges. Within the minority of diffuse large B-cell lymphoma (DLBCL) patients who do receive CAR T treatment, only 30-40% have durable response at 6 months, representing a significant opportunity for ATA3219 to potentially expand patient access and deliver durable, safe responses

 

Chief Financial Officer Transition

•
Utpal Koppikar, who has served as the Company’s Chief Financial Officer since 2018, will depart Atara to pursue an external career opportunity effective March 31, 2023
•
Effective April 1, 2023, Eric Hyllengren will assume the role of Senior Vice President, Chief Financial Officer. Mr. Hyllengren will also serve as the Company’s Principal Financial Officer and Principal Accounting Officer
•
Mr. Hyllengren joined Atara in 2018 as Vice President, Financial Planning and Analysis and added the role of Head of Investor Relations in April 2020. Previously, Mr. Hyllengren spent 15 years at Amgen Inc. in several finance roles with increasing responsibilities, including corporate finance and investor relations

 

Fourth Quarter and Full Year 2022 Financial Results

•
Atara sold a portion of its right to receive royalties and certain milestones in Ebvallo under the Pierre Fabre Commercialization Agreement to HCR Molag Fund L.P (HCRx) for $31.0 million, which was received in December 2022. Total royalties and milestones payable to HCRx are capped between 185% and 250% of the $31.0 million, depending upon the timing of such payments to HCRx
•
Cash, cash equivalents and short-term investments as of December 31, 2022 totaled $242.8 million, as compared to $371.1 million as of December 31, 2021
•
Atara believes that its cash and investments as of December 31, 2022, together with the $40.0 million received in January 2023 for achievement of certain milestones under the Pierre Fabre Commercialization Agreement, will be sufficient to fund the Company’s planned operations into Q2 2024
•
Atara reported net losses of $74.6 million, or $0.72 per share, and $228.3 million, or $2.24 per share, for the fourth quarter and fiscal year 2022, respectively, as compared to $93.3 million, or $0.96 per share, and $340.1 million, or $3.63 per share, for the same periods in 2021
•
Total operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $12.6 million and $59.5 million for the fourth quarter and fiscal year 2022, respectively, as compared to $16.5 million and $63.0 million for the same periods in 2021
•
Research and development expenses were $62.5 million and $272.5 million for the fourth quarter and fiscal year 2022, respectively, as compared to $79.1 million and $282.0 million for the same periods in 2021
o
Research and development expenses include $7.0 million and $31.4 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2022, respectively, as compared to $8.4 million and $32.1 million for the same periods in 2021

 

 

•
General and administrative expenses were $13.2 million and $71.6 million for the fourth quarter and fiscal year 2022, respectively, as compared to $21.8 million and $78.8 million for the same periods in 2021
o
General and administrative expenses include $4.4 million and $22.5 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2022, respectively, as compared to $5.6 million and $21.8 million for the same periods in 2021

 

 

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 receiving marketing authorization 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 for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; 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 Southern 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) 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 potential benefits, safety and efficacy of ATA188; (5) the timing and progress of ATA188, including (i) data and analyses from ATA188 OLE study; (ii) ATA188 clinical trials, (iii) data and analyses from the EMBOLD study and the timing of when such data will be received and communicated; and (iv) Atara’s ability to successfully advance the development of ATA188; (6) the timing and progress of Atara’s CAR T programs, and the safety and efficacy of product candidates emerging from such programs, including ATA3219, a potential IND for ATA3219 and the timing thereof; (7) Atara’s cash runway; and (8) Pierre Fabre’s activities relating to the commercialization of Ebvallo™ in Europe and the timing thereof. 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 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)

 

 

 

December 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

92,942

 

 

$

106,084

 

Short-term investments

 

 

149,877

 

 

 

264,984

 

Restricted cash

 

 

146

 

 

 

194

 

Accounts receivable

 

 

40,221

 

 

 

986

 

Inventories

 

 

1,586

 

 

 

—

 

Other current assets

 

 

10,308

 

 

 

12,373

 

Total current assets

 

 

295,080

 

 

 

384,621

 

Property and equipment, net

 

 

6,300

 

 

 

53,780

 

Operating lease assets

 

 

68,022

 

 

 

26,159

 

Restricted cash - long-term

 

 

—

 

 

 

1,200

 

Other assets

 

 

7,018

 

 

 

2,367

 

Total assets

 

$

376,420

 

 

$

468,127

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

6,871

 

 

$

17,368

 

Accrued compensation

 

 

17,659

 

 

 

25,150

 

Accrued research and development expenses

 

 

24,992

 

 

 

13,451

 

Deferred revenue

 

 

8,000

 

 

 

40,760

 

Other current liabilities

 

 

21,394

 

 

 

9,057

 

Total current liabilities

 

 

78,916

 

 

 

105,786

 

Deferred revenue - long-term

 

 

77,000

 

 

 

55,708

 

Operating lease liabilities - long-term

 

 

58,064

 

 

 

25,518

 

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

 

 

30,236

 

 

 

—

 

Other long-term liabilities

 

 

5,564

 

 

 

1,501

 

Total liabilities

 

 

249,780

 

 

 

188,513

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock

 

 

10

 

 

 

9

 

Additional paid-in capital

 

 

1,821,721

 

 

 

1,744,695

 

Accumulated other comprehensive (loss) income

 

 

(2,067

)

 

 

(368

)

Accumulated deficit

 

 

(1,693,024

)

 

 

(1,464,722

)

Total stockholders’ equity

 

 

126,640

 

 

 

279,614

 

Total liabilities and stockholders’ equity

 

$

376,420

 

 

$

468,127

 

 

 

 

 

 

Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(Unaudited)

(In thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended
December 31,

 

 

Twelve Months Ended
December 31,

 

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

License and collaboration revenue

 

$

221

 

 

$

7,548

 

 

$

63,573

 

 

$

20,340

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

62,515

 

 

 

79,134

 

 

 

272,533

 

 

 

282,001

 

 

General and administrative

 

 

13,245

 

 

 

21,817

 

 

 

71,553

 

 

 

78,801

 

 

Total operating expenses

 

 

75,760

 

 

 

100,951

 

 

 

344,086

 

 

 

360,802

 

 

Loss from operations

 

 

(75,539

)

 

 

(93,403

)

 

 

(280,513

)

 

 

(340,462

)

 

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain on sale of ATOM Facility

 

 

—

 

 

 

—

 

 

 

50,237

 

 

 

—

 

 

Interest and other income, net

 

 

969

 

 

 

84

 

 

 

1,986

 

 

 

367

 

 

Total other income (expense), net

 

 

969

 

 

 

84

 

 

 

52,223

 

 

 

367

 

 

Loss before provision for income taxes

 

 

(74,570

)

 

 

(93,319

)

 

 

(228,290

)

 

 

(340,095

)

 

Provision for income taxes

 

 

2

 

 

 

30

 

 

 

12

 

 

 

46

 

 

Net loss

 

$

(74,572

)

 

$

(93,349

)

 

$

(228,302

)

 

$

(340,141

)

 

Other comprehensive (loss) gain:

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

892

 

 

 

(392

)

 

 

(1,699

)

 

 

(664

)

 

Comprehensive loss

 

$

(73,680

)

 

$

(93,741

)

 

$

(230,001

)

 

$

(340,805

)

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.72

)

 

$

(0.96

)

 

$

(2.24

)

 

 

(3.63

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted weighted-average shares outstanding

 

 

103,178

 

 

 

97,407

 

 

 

101,990

 

 

 

93,670

 

 

 

 

 

INVESTORS & MEDIA:

Investors

Eric Hyllengren

805-395-9669

[email protected]

 

Media

Alex Chapman

805-456-4772

[email protected]