ATRA Atara Biotherapeutics Inc

 

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): March 07, 2025

 

 

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.)
1280 Rancho Conejo Blvd
Thousand Oaks, California				91320
(Address of Principal Executive Offices)				(Zip Code)

 

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

 

(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:

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On March 7, 2025, the Company announced certain financial results for the fourth quarter and year ended December 31, 2024. A copy of the Company’s press release, titled “Atara Biotherapeutics Announces Fourth Quarter and Full Year 2024 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 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release, dated March 7, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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 hereunto duly authorized.

			ATARA BIOTHERAPEUTICS, INC.
Date:	March 7, 2025	By:	/s/ Eric Hyllengren
			Eric Hyllengren Chief Financial Officer and Chief Operating Officer (Duly Authorized Officer and Principal Financial and Accounting Officer)

 

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Atara Biotherapeutics Announces Fourth Quarter and Full Year 2024 Financial Results and Operational Progress

 

Atara is working closely with its partners and the FDA to lift clinical hold and support EBVALLO BLA resubmission in the U.S.

 

Atara remains focused on delivering on the future financial value of EBVALLO and has paused ATA3219 and ATA3431 CAR-T programs and implemented a workforce reduction of approximately 50% to preserve resources

 

Strategic review by financial advisor ongoing

 

THOUSAND OAKS, Calif.—March 7, 2025—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 2024, business updates, and key upcoming milestones for 2025.

 

“We will further narrow our focus on the future financial value of EBVALLO for the benefit of all stakeholders. Atara continues to productively engage with our partner Pierre Fabre Laboratories and the FDA to help the third-party manufacturer adequately address the GMP compliance issues as we continue to work toward an expeditious path to release the clinical hold and resubmit the EBVALLO BLA,” said Cokey Nguyen, President and Chief Executive Officer of Atara. “With the focus on future EBVALLO value paramount, the Company has made the difficult decision to pause development of its allogeneic CAR-T cell programs and to discontinue all CAR-T operations including terminating the clinical trials evaluating ATA3219. The Company’s strategic review is ongoing.”

 

“I would like to convey our gratitude to the patients, investigators, and collaborators for their participation in our CAR-T development efforts. Through this work, we have made important progress and advanced an innovative allogeneic CAR-T platform to the clinical stage, which will serve the scientific community well with key learnings as the field progresses. I also wish to sincerely thank the Atara team members who worked tirelessly on this program, and our stockholders for their commitment to our Company,” added Dr. Nguyen.

 

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

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ATA3219: Paused CD19 Program in Non-Hodgkin’s Lymphoma (NHL)

 

Corporate Updates

 

Strategic Option Evaluation: As previously communicated, Atara engaged a well known financial advisor to support a comprehensive process to explore and assess a range of potential strategic options for the Company. Alternatives may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. This process is ongoing. It is possible that Atara may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, will not be completed on attractive terms, or that a strategic alternative or transaction, may not ultimately be consummated.

 

Organizational Restructuring: Atara has implemented a strategic restructuring to sharpen the Company’s focus on addressing the issues at a third party manufacturing facility outlined in the CRL, lifting the clinical hold, and resubmitting the EBVALLO BLA. This restructuring resulted in a company-wide workforce reduction of approximately 50% of our remaining workforce, retaining approximately 35 personnel essential to execute on its remaining transition responsibilities under the EBVALLO collaboration with Pierre Fabre Laboratories, including as the BLA holder until approval, and certain wind-down activities for the CAR-T programs.

 

EBVALLO Transition Activities: Atara is in active discussions with Pierre Fabre on accelerating the transfer of all operational activities related to EBVALLO, except the BLA sponsorship, to be completed as early as the end of the first quarter of 2025.

 

Financial Update: As previously announced, Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding through an equity line of credit, which Atara believes is sufficient to fund the ongoing activities required to achieve BLA approval, assuming a successful transition of operational activities related to EBVALLO to Pierre Fabre. Atara is also exploring alternative financing options.

 

Fourth Quarter and Full Year 2024 Financial Results

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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 that can be rapidly delivered to patients from inventory. 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 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. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X 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 development, timing and progress of tab-cel®, including the anticipated resubmission of the BLA to the FDA and lift of the FDA’s clinical hold, and the potential financial benefits to Atara as a result of the expanded global partnership with Pierre Fabre Laboratories, including any payments thereunder; (2) Atara’s cash runway, receipt of potential milestone payments, and operating expenses, including Atara’s ability to fund its planned operations; and (3) Atara’s fund raising needs and the sufficiency of additional funding to support operations, and the availability of such funding, including the amount of funding necessary to fund ongoing activities required to achieve BLA approval; (4) Atara’s planned transition of substantially all activities relating to EBVALLO to Pierre Fabre and the timing thereof; (5) Atara’s planned cost reduction strategies; and (6) Atara’s exploration of strategic alternatives and ability to consummate one or more strategic transactions. 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 related with the timing of the transfer of all operational activities related to EBVALLO to Pierre Fabre, with any delay creating additional expenses and cash needs for Atara; uncertainties related to the ongoing discussions with Pierre Fabre, which, among other things, are expected to lead to a reduction in the amount of certain future potential regulatory and commercial milestone payments from Pierre Fabre; risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA feedback and the ability of Atara and its third-party manufacturer to address issues identified in the CRL, our ability to access capital, and the sufficiency of Atara’s cash resources and access to additional capital on favorable terms or at all; risks and

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uncertainties related to Atara’s financial close and audit procedures; the timing of the strategic review process; whether Atara will pursue any strategic alternatives; in the event Atara pursues a strategic alternative, that the strategic alternative may not be attractive or ultimately consummated; whether any strategic alternative will result in additional value for Atara and its stockholders; whether the process will have an adverse impact on Atara; and other risks and uncertainties affecting Atara, 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.

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Financials

Atara Biotherapeutics, Inc.

Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

		December 31,				December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	25,030			$	25,841
Short-term investments			17,466				25,884
Restricted cash			146				146
Accounts receivable			1,482				34,108
Inventories			10,655				9,706
Other current assets			10,115				6,184
Total current assets			64,894				101,869
Property and equipment, net			1,294				3,856
Operating lease assets			39,807				54,935
Other assets			3,103				4,844
Total assets		$	109,098			$	165,504
Liabilities and stockholders’ equity (deficit)
Current liabilities:
Accounts payable		$	4,367			$	3,684
Accrued compensation			6,589				11,519
Accrued research and development expenses			7,984				17,364
Deferred revenue			95,092				77,833
Other current liabilities			20,542				31,826
Total current liabilities			134,574				142,226
Deferred revenue - long-term			—				37,562
Operating lease liabilities - long-term			29,914				45,693
Liability related to the sale of future revenues - long-term			38,624				34,623
Other long-term liabilities			3,269				4,631
Total liabilities		$	206,381			$	264,735
Stockholders’ (deficit) equity:
Common stock			1				—
Additional paid-in capital			1,957,261				1,870,123
Accumulated other comprehensive loss			8				(204	)
Accumulated deficit			(2,054,553	)			(1,969,150	)
Total stockholders’ (deficit) equity			(97,283	)			(99,231	)
Total liabilities and stockholders’ (deficit) equity		$	109,098			$	165,504

 

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Atara Biotherapeutics, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except per share amounts)

 

		Three Months Ended December 31,								Twelve Months Ended December 31,
		2024				2023				2024				2023
Commercialization revenue		$	32,753			$	4,189			$	128,940			$	7,886
License and collaboration revenue			—				63				—				687
Total revenue			32,753				4,252				128,940				8,573
Costs and operating expenses:
Cost of commercialization revenue			6,795				3,160				21,009				8,886
Research and development expenses			28,271				49,600				151,483				224,785
General and administrative expenses			9,440				11,454				39,886				50,908
Total costs and operating expenses			44,956				64,214				212,378				284,579
Loss from operations			(12,203	)			(59,962	)			(83,438	)			(276,006	)
Interest and other income, net			(509	)			(477	)			(1,977	)			(105	)
Total other income (expense), net			(509				(477	)			(1,977	)			(105	)
Loss before provision for income taxes			(12,712	)			(60,439	)			(85,415	)			(276,111	)
Provision for income taxes			(19	)			11				(12	)			15
Net loss		$	(12,693	)		$	(60,450	)		$	(85,403	)		$	(276,126
Other comprehensive gain (loss):
Unrealized gain (loss) on available-for-sale securities			(14	)			367				212				1,863
Comprehensive loss		$ (12,707		)	)	$ (60,083		)		$ (85,191		)		$ (274,263		)	)
Basic and diluted net loss per common share		$	(1.19	)		$	(14.00	)		$	(11.41	)		$	(65.19	)
Basic and diluted weighted-average shares outstanding			10,690				4,325				7,488				4,236

 

 

 

Investor and Media Relations:

Jason Awe, Ph.D.

Head of Corporate Communications & Investor Relations

(805) 217-2287

jawe@atarabio.com

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v3.25.0.1

Document And Entity Information	Mar. 07, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 07, 2025
Entity Registrant Name	Atara Biotherapeutics, Inc.
Entity Central Index Key	0001604464
Entity Emerging Growth Company	false
Entity File Number	001-36548
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	46-0920988
Entity Address, Address Line One	1280 Rancho Conejo Blvd
Entity Address, City or Town	Thousand Oaks
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	91320
City Area Code	(805)
Local Phone Number	623-4211
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	ATRA
Security Exchange Name	NASDAQ

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