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): November 08, 2024

 

 

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

 

(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 November 12, 2024, Atara Biotherapeutics, Inc. (the “Company”) announced certain financial results for the third quarter ended September 30, 2024. A copy of the Company’s press release, titled “Atara Biotherapeutics Announces Third Quarter 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 (the "SEC"), 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 November 8, 2024, it was agreed that the employment of Amar Murugan, the Company’s Chief Legal Officer, would end effective November 8, 2024. In connection with Mr. Murugan’s departure from the Company, Mr. Murugan is entitled to receive severance benefits under the terms of his employment agreement, which are described in the Company’s Definitive Proxy Statement filed with the SEC on April 26, 2024. In addition, the Company and Mr. Murugan entered into a Consulting Agreement dated November 8, 2024 (“Consulting Agreement”) pursuant to which Mr. Murugan will provide consulting services to the Company for up to 10 hours per month from November 8, 2024 through July 11, 2025 at an hourly rate of $250. The Consulting Agreement provides for (i) Mr. Murugan to relinquish to the Company all of Mr. Murugan’s vested and unvested stock option awards and (ii) the continued vesting during the consulting term of Mr. Murugan’s outstanding restricted stock unit awards. In addition, subject to Mr. Murugan’s continued service during the applicable date, Mr. Murugan will be entitled to receive (1) a bonus of $150,000 upon the approval by the United States Food and Drug Administration of a biologics license application for tabelecleucel and (2) a bonus $150,000 upon the earlier of to occur of (a) the successful transition, as determined by the Compensation Committee of the Board of Directors of the Company, of certain tabelecleucel manufacturing activities from the Company to Pierre Fabre Medicament (“Pierre Fabre”) or its affiliates, as contemplated by that certain Amended and Restated Commercialization Agreement dated October 31, 2023 and related agreements, between Pierre Fabre and the Company, and (b) July 11, 2025.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release, dated November 12, 2024
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:	November 12, 2024	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 Third Quarter 2024 Financial Results and Operational Progress

 

 

Tab-cel® U.S. BLA On-Track With PDUFA Target Action Date of January 15, 2025

 

First Patient Dosed for ATA3219 Non-Hodgkin’s Lymphoma Study; Initial Clinical Data Expected Q1 2025

 

ATA3219 Lupus Nephritis and Extrarenal Systemic Lupus Erythematosus Study Initiation Expected by End of Year; Initial Clinical Data Expected Mid-2025

 

Cash Runway Into 2027 Enables Key Pipeline Readouts

 

 

THOUSAND OAKS, Calif.—November 12, 2024—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 third quarter 2024, recent business highlights, and key upcoming milestones.

 

“With the first patient now enrolled in our Phase 1 NHL trial of ATA3219, we have taken an important step in applying our proven Epstein-Barr virus platform to the significant opportunity in allogeneic CAR T,” said Cokey Nguyen, Ph.D., President and Chief Executive Officer of Atara. “The first quarter of 2025 is positioned to be transformational for the company, with the potential for FDA approval of tab-cel and transition of this business to our partner Pierre Fabre, repositioning Atara as a fully focused allogeneic CAR-T company with multiple near-term data milestones for our lead program in oncology and autoimmune indications.”

 

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

 

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

ATA3219: CD19 Program in Lupus Nephritis (LN)

 

ATA3219: CD19 Program in Extrarenal Systemic Lupus Erythematosus (ERL) Without Lymphodepletion (LD)

 

ATA3431: CD19/CD20 Program for B-Cell Malignancies

 

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Leadership and Board of Directors Update

 

Third Quarter 2024 Financial Results

 

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About ATA3219

ATA3219 combines the natural biology of unedited T cells with the benefits of an allogeneic therapy. It consists of allogeneic Epstein-Barr virus (EBV)-sensitized T cells that express a CD19 CAR construct for the treatment of CD19+ relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin’s lymphoma and B-cell mediated autoimmune diseases including systemic lupus erythematosus. ATA3219 has been optimized to offer a potential best-in-class profile, featuring off-the-shelf availability. It incorporates multiple clinically validated technologies including a modified CD3ζ signaling domain (1XX) that optimizes expansion and mitigates exhaustion, enrichment during manufacturing for a less differentiated phenotype for robust expansion and persistence and retains the endogenous T-cell receptor without gene editing as a key survival signal for T cells contributing to persistence.

 

About ATA3431

ATA3431 is an allogeneic, bispecific CAR directed against CD20 and CD19, built on Atara’s EBV T-cell platform. The design consists of a tandem CD20-CD19 design, with binders oriented to optimize potency. Dual targets address the limitations of single antigen loss and tumor variability. ATA3431 features a novel 1XX signaling domain, memory phenotype, and retained, unedited T-cell receptor. Preclinical data have demonstrated early evidence of antitumor activity, long-term persistence, and superior tumor growth inhibition compared to an autologous CD19/CD20 CAR T benchmark.

 

Next-Generation Allogeneic CAR T Approach

Atara is focused on applying Epstein-Barr virus (EBV) T-cell biology, featuring experience in over 600 patients treated with allogeneic EBV T cells, and novel chimeric antigen receptor (CAR) technologies to meet the current limitations of autologous and allogeneic CAR therapies head-on by advancing a potential best-in-class CAR T pipeline in oncology and autoimmune disease. Unlike gene-edited approaches aimed at inactivating T-cell receptor (TCR) function to reduce the risk for graft-vs-host disease, Atara’s allogeneic platform maintains expression of the native EBV TCR that promotes in vivo functional persistence while also demonstrating inherently low alloreactivity due to their recognition of defined viral antigens and partial human leukocyte antigen (HLA) matching. A molecular toolkit of clinically-validated technologies—including the 1XX signaling domain designed for better cell fitness and less exhaustion while maintaining stemness—offers a differentiated approach to addressing significant unmet need with the next generation CAR T.

 

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, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn.

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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 BLA and potential indications, the potential characteristics and benefits of tab-cel®, and the progress and results of, and prospects for, the global partnership with Pierre Fabre Laboratories involving tab-cel®, and the potential financial benefits to Atara as a result of the global partnership with Pierre Fabre Laboratories, including the receipt, timing and amount of any payments to be received by Atara thereunder; (2) the development, timing and progress of Atara’s AlloCAR-T programs (including ATA3219 and ATA3431), including the timing of the start of any clinical trials, the timing of the availability of data from such clinical trials, the timing of submissions of regulatory applications, and the potential benefits, characteristics, safety and efficacy of such product candidates or product candidates emerging from such programs; (3) Atara’s cash runway, the timing and receipt of potential milestone and other payments, and operating expenses, including Atara’s ability to fund its planned operations into 2027; and (4) Atara’s planned transition of substantially all activities relating to tab-cel at the time of the BLA transfer to Pierre Fabre 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 COVID-19 pandemic and the wars in Ukraine and the Middle East, 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.

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Financials

Atara Biotherapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

		September 30,				December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	46,453			$	25,841
Short-term investments			20,736				25,884
Restricted cash			146				146
Accounts receivable			1,335				34,108
Inventories			13,980				9,706
Other current assets			9,205				6,184
Total current assets			91,855				101,869
Property and equipment, net			1,661				3,856
Operating lease assets			45,833				54,935
Other assets			3,357				4,844
Total assets		$	142,706			$	165,504
Liabilities and stockholders’ equity (deficit)
Current liabilities:
Accounts payable		$	2,146			$	3,684
Accrued compensation			7,768				11,519
Accrued research and development expenses			6,077				17,364
Deferred revenue			116,344				77,833
Other current liabilities			23,644				31,826
Total current liabilities			155,979				142,226
Deferred revenue - long-term			470				37,562
Operating lease liabilities - long-term			35,243				45,693
Liability related to the sale of future revenues - long-term			37,584				34,623
Other long-term liabilities			3,969				4,631
Total liabilities		$	233,245			$	264,735
Stockholders’ (deficit) equity:
Common stock			1				—
Additional paid-in capital			1,951,298				1,870,123
Accumulated other comprehensive loss			22				(204	)
Accumulated deficit			(2,041,860	)			(1,969,150	)
Total stockholders’ (deficit) equity			(90,539	)			(99,231	)
Total liabilities and stockholders’ (deficit) equity		$	142,706			$	165,504

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Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except per share amounts)

 

		Three Months Ended  September 30,								Nine Months Ended  September 30,
		2024				2023				2024				2023
Commercialization revenue		$	40,190			$	2,020			$	96,187			$	3,697
License and collaboration revenue			—				118				—				624
Total revenue			40,190				2,138				96,187				4,321
Costs and operating expenses:
Cost of commercialization revenue			7,602				2,615				14,214				5,726
Research and development expenses			43,924				56,888				122,762				175,185
General and administrative expenses			10,421				12,247				30,446				39,454
Total costs and operating expenses			61,947				71,750				167,422				220,365
Loss from operations			(21,757	)			(69,612	)			(71,235	)			(216,044	)
Interest and other income (expense), net			(169	)			(204	)			(1,468	)			372
Loss before provision for (benefit from) income taxes			(21,926	)			(69,816	)			(72,703	)			(215,672	)
Provision for (benefit from) income taxes			(17	)			(19	)			7				4
Net loss		$	(21,909	)		$	(69,797	)		$	(72,710	)		$	(215,676	)
Other comprehensive gain (loss):
Unrealized gain (loss) on available-for-sale securities			36				362				226				1,496
Comprehensive loss		$	(21,873	)		$	(69,435	)		$	(72,484	)		$	(214,180	)
Basic and diluted net loss per common share		$	(2.93	)		$	(16.40	)		$	(11.34	)		$	(51.27	)
Basic and diluted weighted-average shares outstanding			7,466				4,256				6,414				4,207

 

 

Investor and Media Relations:
Jason Awe, Ph.D.
Head of Corporate Communications & Investor Relations
(805) 217-2287
jawe@atarabio.com 

 

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v3.24.3

Document And Entity Information	Nov. 08, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 08, 2024
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	2380 Conejo Spectrum Street
Entity Address, Address Line Two	Suite 200
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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