Exhibit 99.1
Atara Biotherapeutics Announces Second Quarter 2024 Financial Results, Operational Progress and Leadership Update
Tab-cel® U.S. BLA Accepted Under Priority Review With PDUFA Action Date of January 15, 2025
ATA3219 Lupus Nephritis and Severe Systemic Lupus Erythematosus Study Initiation Expected Q4 2024; Initial Clinical Data Expected Mid-2025
Enrolling ATA3219 Non-Hodgkin’s Lymphoma Study; Initial Clinical Data Expected Q1 2025
Effective September 9, 2024, Pascal Touchon To Assume Role of Chairman of the Board of Directors of Atara; Cokey Nguyen, Ph.D., Currently Chief Scientific and Technical Officer, To Be Appointed President and CEO
Cash Runway Into 2027 Enables Key Pipeline Readouts
THOUSAND OAKS, Calif.—August 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 second quarter 2024, recent business highlights, and key upcoming milestones for 2024.
“Building on the recent BLA acceptance with Priority Review for tab-cel, we are making significant progress with the agency towards the target action date of January 15, 2025, while supporting our partner Pierre Fabre with their U.S. launch preparation,” said Pascal Touchon, President and Chief Executive Officer of Atara. “During the quarter we continued to advance the clinical development of our lead CAR T program, ATA3219, and remain on track to deliver key value creating milestones within the next 12 months. This is highlighted by initial data from our non-Hodgkin’s lymphoma study anticipated in the first quarter of 2025, which we believe will provide a read-through for ATA3219’s potential in autoimmune disease. On that front, we plan to initiate our ATA3219 Systemic Lupus Erythematosus trial in the fourth quarter, including the cohort without lymphodepletion, with initial data expected in mid-2025.”
Dr. Touchon continued, “Following the landmark milestone of the world’s first-ever approval of an allogeneic T-cell therapy and with the potential first U.S. approval approaching, we are advancing our differentiated allogeneic CAR-T programs into the clinic. With the Company in a strong position, I have decided to move into the role of Chairman for personal reasons to dedicate more time to my family. I look forward to having a very active and strategic advisory role as board chair and continuing to help Atara create value with the potential tab-cel U.S. approval and initial clinical data with ATA3219. I believe the future of Atara is bright under the leadership of Cokey Nguyen, Ph.D. who will be promoted to the role of President and CEO. Cokey is a visionary leader in the cell therapy field, and our Board of Directors values his deep commitment to our staff and to patients as well as his expertise across the breadth of our business.”
“I admire the strong foundation we built under Pascal’s leadership. I am honored to serve as Atara’s CEO at this pivotal time to continue our journey to get tab-cel approved in the U.S. and to unlock the disruptive potential of our allogeneic CAR-T platform,” said Cokey Nguyen, Ph.D. “I look forward to working alongside our world-class and innovative teams to rapidly innovate and strive to develop better cell therapy treatment options for patients.”
Exhibit 99.1
Tabelecleucel (tab-cel® or EbvalloTM) for Post-Transplant Lymphoproliferative Disease (PTLD)
ATA3219: CD19 Program in Lupus Nephritis (LN)
ATA3219: CD19 Program in Severe Systemic Lupus Erythematosus (SLE) Without Lymphodepletion
Exhibit 99.1
ATA3219: CD19 Program in Non-Hodgkin’s Lymphoma (NHL)
ATA3431: CD19/CD20 Program for B-Cell Malignancies
Leadership Updates
Second Quarter 2024 Financial Results
Exhibit 99.1
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.
Exhibit 99.1
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.
Exhibit 99.1
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.
Exhibit 99.1
Financials
Atara Biotherapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
31,314 |
|
|
$ |
25,841 |
|
Short-term investments |
|
|
3,978 |
|
|
|
25,884 |
|
Restricted cash |
|
|
146 |
|
|
|
146 |
|
Accounts receivable |
|
|
2,422 |
|
|
|
34,108 |
|
Inventories |
|
|
18,749 |
|
|
|
9,706 |
|
Other current assets |
|
|
5,801 |
|
|
|
6,184 |
|
Total current assets |
|
|
62,410 |
|
|
|
101,869 |
|
Property and equipment, net |
|
|
2,317 |
|
|
|
3,856 |
|
Operating lease assets |
|
|
48,948 |
|
|
|
54,935 |
|
Other assets |
|
|
3,609 |
|
|
|
4,844 |
|
Total assets |
|
$ |
117,284 |
|
|
$ |
165,504 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity (deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
5,253 |
|
|
$ |
3,684 |
|
Accrued compensation |
|
|
7,269 |
|
|
|
11,519 |
|
Accrued research and development expenses |
|
|
2,014 |
|
|
|
17,364 |
|
Deferred revenue |
|
|
107,582 |
|
|
|
77,833 |
|
Other current liabilities |
|
|
26,149 |
|
|
|
31,826 |
|
Total current liabilities |
|
|
148,267 |
|
|
|
142,226 |
|
Deferred revenue - long-term |
|
|
567 |
|
|
|
37,562 |
|
Operating lease liabilities - long-term |
|
|
38,703 |
|
|
|
45,693 |
|
Liability related to the sale of future revenues - long-term |
|
|
36,448 |
|
|
|
34,623 |
|
Other long-term liabilities |
|
|
4,167 |
|
|
|
4,631 |
|
Total liabilities |
|
$ |
228,152 |
|
|
$ |
264,735 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ (deficit) equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
1,909,097 |
|
|
|
1,870,123 |
|
Accumulated other comprehensive loss |
|
|
(14 |
) |
|
|
(204 |
) |
Accumulated deficit |
|
|
(2,019,951 |
) |
|
|
(1,969,150 |
) |
Total stockholders’ (deficit) equity |
|
|
(110,868 |
) |
|
|
(99,231 |
) |
Total liabilities and stockholders’ (deficit) equity |
|
$ |
117,284 |
|
|
$ |
165,504 |
|
Exhibit 99.1
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Commercialization revenue |
|
$ |
28,640 |
|
|
$ |
793 |
|
|
$ |
55,997 |
|
|
$ |
1,677 |
|
License and collaboration revenue |
|
|
— |
|
|
|
164 |
|
|
|
— |
|
|
|
506 |
|
Total revenue |
|
|
28,640 |
|
|
|
957 |
|
|
|
55,997 |
|
|
|
2,183 |
|
Costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of commercialization revenue |
|
|
4,627 |
|
|
|
2,895 |
|
|
|
6,612 |
|
|
|
3,111 |
|
Research and development expenses |
|
|
33,332 |
|
|
|
56,141 |
|
|
|
78,838 |
|
|
|
118,297 |
|
General and administrative expenses |
|
|
8,912 |
|
|
|
13,335 |
|
|
|
20,025 |
|
|
|
27,207 |
|
Total costs and operating expenses |
|
|
46,871 |
|
|
|
72,371 |
|
|
|
105,475 |
|
|
|
148,615 |
|
Loss from operations |
|
|
(18,231 |
) |
|
|
(71,414 |
) |
|
|
(49,478 |
) |
|
|
(146,432 |
) |
Interest and other income (expense), net |
|
|
(818 |
) |
|
|
307 |
|
|
|
(1,299 |
) |
|
|
576 |
|
Loss before provision for income taxes |
|
|
(19,049 |
) |
|
|
(71,107 |
) |
|
|
(50,777 |
) |
|
|
(145,856 |
) |
Provision for income taxes |
|
|
— |
|
|
|
1 |
|
|
|
24 |
|
|
|
23 |
|
Net loss |
|
$ |
(19,049 |
) |
|
$ |
(71,108 |
) |
|
$ |
(50,801 |
) |
|
$ |
(145,879 |
) |
Other comprehensive gain (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on available-for-sale securities |
|
|
41 |
|
|
|
304 |
|
|
|
190 |
|
|
|
1,134 |
|
Comprehensive loss |
|
$ |
(19,008 |
) |
|
$ |
(70,804 |
) |
|
$ |
(50,611 |
) |
|
$ |
(144,745 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per common share |
|
$ |
(3.10 |
) |
|
$ |
(16.91 |
) |
|
$ |
(8.64 |
) |
|
$ |
(34.89 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted-average shares outstanding |
|
|
6,143 |
|
|
|
4,204 |
|
|
|
5,883 |
|
|
|
4,181 |
|
Investor and Media Relations:
Jason Awe, Ph.D.
Head of Corporate Communications & Investor Relations
(805) 217-2287
jawe@atarabio.com
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