Atara Biotherapeutics Announces First Quarter 2024 Financial Results and Operational Progress

 

 

Tab-cel® U.S. BLA on Track for Submission in Q2 2024

 

Initiation of ATA3219 Lupus Nephritis Study Expected in Q4 2024, with Initial Clinical Data Expected in H1 2025

 

Initiation of New ATA3219 Cohort Without Lymphodepletion in Severe Systemic Lupus Erythematosus Planned for Q4 2024, with Initial Clinical Data Expected in H2 2025

 

Enrolling ATA3219 Non-Hodgkin’s Lymphoma Study, with Initial Clinical Data Expected in Q4 2024

 

Cash Runway Into 2027 Enables Key Pipeline Readouts

 

 

THOUSAND OAKS, Calif.—May 9, 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 first quarter 2024, recent business highlights, and key upcoming milestones for 2024.

 

"Our lead CAR T program, ATA3219, is advancing as a promising new therapeutic option for oncology and autoimmune diseases, where it is positioned to benefit from the unique characteristics of our proven allogeneic EBV T-cell platform,” said Pascal Touchon, President and Chief Executive Officer of Atara. “This is anticipated to provide multiple near-term clinical milestones for ATA3219, including initial non-Hodgkin’s lymphoma data expected in the fourth quarter 2024, and initial lupus nephritis data in the first half of 2025, with plans to expand into a new SLE cohort without lymphodepletion. In addition, our partnership with Pierre Fabre continues to generate value, as we received our first milestone payment related to tab-cel regulatory progress in the U.S. in April, with the potential for additional near-term payments related to the BLA acceptance and approval.”

 

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

ATA3219: CD19 Program in Lupus Nephritis (LN)

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ATA3219: CD19 Program in Severe Systemic Lupus Erythematosus (SLE) Without Lymphodepletion

 

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

 

ATA3431: CD19/CD20 Program for B-Cell Malignancies

 

First Quarter 2024 Financial Results

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2024 Outlook and Cash Runway

 

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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 (SLE) with kidney involvement (lupus nephritis [LN]). 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 costimulatory 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 promote 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 costimulatory 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.

 

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 a potential BLA and potential indications, the potential characteristics and benefits of tab-cel®, and the progress and results of, and prospects for, the expanded global partnership with Pierre Fabre Laboratories involving tab-cel®, and the potential financial benefits to Atara as a result of the expanded global partnership with Pierre Fabre Laboratories, including the receipt, timing and amount of any payments 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 submissions of regulatory applications, and the potential benefits, safety and efficacy of such product

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candidates or product candidates emerging from such programs; (3) Atara’s cash runway, the timing and receipt of potential milestone 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.

Consolidated Balance Sheets

(Unaudited)

(In thousands)

		March 31,				December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	35,087			$	25,841
Short-term investments			11,152				25,884
Restricted cash			146				146
Accounts receivable			35,834				34,108
Inventories			16,084				9,706
Other current assets			8,131				6,184
Total current assets			106,434				101,869
Property and equipment, net			2,989				3,856
Operating lease assets			51,981				54,935
Other assets			3,868				4,844
Total assets		$	165,272			$	165,504
Liabilities and stockholders’ equity (deficit)
Current liabilities:
Accounts payable		$	2,854			$	3,684
Accrued compensation			5,707				11,519
Accrued research and development expenses			15,928				17,364
Deferred revenue			123,154				77,833
Other current liabilities			33,047				31,826
Total current liabilities			180,690				142,226
Deferred revenue - long-term			719				37,562
Operating lease liabilities - long-term			42,197				45,693
Liability related to the sale of future revenues - long-term			35,573				34,623
Other long-term liabilities			4,401				4,631
Total liabilities		$	263,580			$	264,735
Stockholders’ (deficit) equity:
Common stock			12				11
Additional paid-in capital			1,902,637				1,870,112
Accumulated other comprehensive loss			(55	)			(204	)
Accumulated deficit			(2,000,902	)			(1,969,150	)
Total stockholders’ (deficit) equity			(98,308	)			(99,231	)
Total liabilities and stockholders’ (deficit) equity		$	165,272			$	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 March 31,
		2024				2023
Commercialization revenue		$	27,357			$	884
License and collaboration revenue			—				342
Total revenue			27,357				1,226
Costs and operating expenses:
Cost of commercialization revenue			1,985				216
Research and development expenses			45,506				62,156
General and administrative expenses			11,113				13,872
Total costs and operating expenses			58,604				76,244
Loss from operations			(31,247	)			(75,018	)
Interest and other income (expense), net			(481	)			269
Loss before provision for income taxes			(31,728	)			(74,749	)
Provision for income taxes			24				22
Net loss		$	(31,752	)		$	(74,771	)
Other comprehensive gain (loss):
Unrealized gain (loss) on available-for-sale securities			149				830
Comprehensive loss		$	(31,603	)		$	(73,941	)
Basic and diluted net loss per common share		$	(0.23	)		$	(0.72	)
Basic and diluted weighted-average shares outstanding			140,587				103,969

 

 

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

 

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