Exhibit 99.1
Atara Biotherapeutics Announces Second Quarter 2022 Financial Results and Corporate Strategy Update
Atara to Focus on R&D Activities Prioritizing Upcoming Milestones for Key Pipeline Assets
ATA188 Phase 2 EMBOLD Study Interim Analysis Completed with Target Enrollment Achieved; Primary Endpoint Data Read Out Planned for October 2023
FDA Recommended Pathway to Potential Tab-cel BLA Filing Without Need for New Clinical Trial; European Commission Approval on Track for Q4 2022
ATA3219 on Track for Q4 2022 IND Submission
Conference Call and Webcast Today at 1:30 p.m. PDT / 4:30 p.m. EDT
SOUTH SAN FRANCISCO, Calif.--August 8, 2022--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the second quarter 2022, an update to its corporate strategy, recent business highlights, and key upcoming catalysts.
“We are excited about the transformative potential of ATA188 in MS and are pleased that as a result of our significant and constructive engagement, the FDA has recommended a possible path towards a tab-cel BLA filing without the need for a new clinical study,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Atara’s R&D-centered strategy, clear portfolio prioritization, and purposeful partnerships are positioning us for success in reaching critical value-generating milestones for our key pipeline assets. I would like to extend my sincere gratitude and thanks to Atara’s staff for their significant contributions and unwavering commitment to advancing truly innovative medicines for patients in need."
Corporate Strategy Update
ATA188 for Progressive Multiple Sclerosis (MS)
Tabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD)
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
ATA3219 (B-cell Malignancies)
Second Quarter 2022 Financial Results
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Monday, August 8, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13730293. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company's website for 30 days following the live webcast.
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 in Phase 3 clinical development and currently under review to support registration 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® (tabelecleucel) in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD); 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 South San Francisco, 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) the Company’s updated corporate strategy to focus as a leaner, R&D-centered organization, including (i) the staff reduction; and (ii) seeking a commercial partner for tab-cel in the U.S; (2) the potential benefits, safety and efficacy of tab-cel®; the timing and progress of tab-cel®, including (i) data and analyses from ALLELE study; (ii) 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®, (iii) the timing and outcome of the MAA for tab-cel®, (iv) the potential timing of the initiation or submission of the BLA for tab-cel®, and (iv) the timing of the EMA’s review of the MAA for tab-cel®; (3) the potential benefits, safety and efficacy of ATA188; the timing and progress of ATA188, including (i) regulatory designations for ATA188 granted by FDA and the impact thereof; (ii) data and analyses from ATA188 OLE study; (iii) ATA188 clinical trials, (iv) data and analyses from the planned interim analysis for the EMBOLD study, potential next steps for the program and planned discussions with FDA; and (v) Atara’s ability to successfully advance the development of ATA188; (4) the timing and progress of its CAR T programs, and the safety and efficacy of product candidates emerging from such programs, including (i) ATA2271 clinical trial, (ii) ATA3271 and ATA3219 preclinical development, (iii) termination of the strategic collaboration with Bayer for ATA2271 and ATA3271, and (iv) Atara’s ability to successfully advance the development of its CAR T programs; (5) Atara’s research and development activities; (6) Atara’s ability to reach critical value-generating milestones for its key pipeline assets or to generate value from such assets; and (7) Atara’s ability to advance development of its other programs. 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 South San Francisco and Southern California 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 (SEC), 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)
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
70,688 |
|
|
$ |
106,084 |
|
Short-term investments |
|
|
260,623 |
|
|
|
264,984 |
|
Restricted cash |
|
|
1,346 |
|
|
|
194 |
|
Accounts receivable |
|
|
637 |
|
|
|
986 |
|
Prepaid expenses and other current assets |
|
|
13,690 |
|
|
|
12,373 |
|
Total current assets |
|
|
346,984 |
|
|
|
384,621 |
|
Property and equipment, net |
|
|
8,328 |
|
|
|
53,780 |
|
Operating lease assets |
|
|
73,582 |
|
|
|
26,159 |
|
Restricted cash - long-term |
|
|
— |
|
|
|
1,200 |
|
Other assets |
|
|
7,227 |
|
|
|
2,367 |
|
Total assets |
|
$ |
436,121 |
|
|
$ |
468,127 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
12,799 |
|
|
$ |
17,368 |
|
Accrued compensation |
|
|
16,317 |
|
|
|
25,150 |
|
Accrued research and development expenses |
|
|
15,125 |
|
|
|
13,451 |
|
Deferred revenue |
|
|
1,671 |
|
|
|
40,760 |
|
Other current liabilities |
|
|
19,776 |
|
|
|
9,057 |
|
Total current liabilities |
|
|
65,688 |
|
|
|
105,786 |
|
Deferred revenue - long-term |
|
|
43,329 |
|
|
|
55,708 |
|
Operating lease liabilities - long-term |
|
|
63,999 |
|
|
|
25,518 |
|
Other long-term liabilities |
|
|
5,626 |
|
|
|
1,501 |
|
Total liabilities |
|
$ |
178,642 |
|
|
$ |
188,513 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock—$0.0001 par value, 500,000 shares authorized as of June 30,2022 and December 31, 2021; 94,356 and 91,671 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively |
|
|
9 |
|
|
|
9 |
|
Additional paid-in capital |
|
|
1,794,449 |
|
|
|
1,744,695 |
|
Accumulated other comprehensive (loss) income |
|
|
(2,618 |
) |
|
|
(368 |
) |
Accumulated deficit |
|
|
(1,534,361 |
) |
|
|
(1,464,722 |
) |
Total stockholders’ equity |
|
|
257,479 |
|
|
|
279,614 |
|
Total liabilities and stockholders’ equity |
|
$ |
436,121 |
|
|
$ |
468,127 |
|
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(Unaudited)
(In thousands, except per share amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
License and collaboration revenue |
|
$ |
51,579 |
|
|
$ |
3,870 |
|
|
$ |
58,893 |
|
|
$ |
7,422 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
64,898 |
|
|
|
68,475 |
|
|
|
139,861 |
|
|
|
132,534 |
|
General and administrative |
|
|
18,813 |
|
|
|
19,397 |
|
|
|
39,384 |
|
|
|
37,135 |
|
Total operating expenses |
|
|
83,711 |
|
|
|
87,872 |
|
|
|
179,245 |
|
|
|
169,669 |
|
Loss from operations |
|
|
(32,132 |
) |
|
|
(84,002 |
) |
|
|
(120,352 |
) |
|
|
(162,247 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of ATOM Facility |
|
|
50,237 |
|
|
|
— |
|
|
|
50,237 |
|
|
|
— |
|
Interest and other income, net |
|
|
361 |
|
|
|
225 |
|
|
|
476 |
|
|
|
135 |
|
Total other (expense), net |
|
|
50,598 |
|
|
|
225 |
|
|
|
50,713 |
|
|
|
135 |
|
Income (loss) before provision for income taxes |
|
|
18,466 |
|
|
|
(83,777 |
) |
|
|
(69,639 |
) |
|
|
(162,112 |
) |
Provision for income taxes |
|
|
— |
|
|
|
16 |
|
|
|
— |
|
|
|
16 |
|
Net income (loss) |
|
$ |
18,466 |
|
|
$ |
(83,793 |
) |
|
$ |
(69,639 |
) |
|
$ |
(162,128 |
) |
Other comprehensive gain (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities |
|
|
(726 |
) |
|
|
(99 |
) |
|
|
(2,250 |
) |
|
|
(234 |
) |
Comprehensive income (loss) |
|
$ |
17,740 |
|
|
$ |
(83,892 |
) |
|
$ |
(71,889 |
) |
|
$ |
(162,362 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net earnings (loss) per common share |
|
$ |
0.18 |
|
|
$ |
(0.91 |
) |
|
$ |
(0.69 |
) |
|
$ |
(1.77 |
) |
Diluted net earnings (loss) per common share |
|
$ |
0.18 |
|
|
$ |
(0.91 |
) |
|
$ |
(0.69 |
) |
|
$ |
(1.77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average basic shares outstanding |
|
|
101,601 |
|
|
|
92,152 |
|
|
|
101,166 |
|
|
|
91,806 |
|
Weighted-average diluted shares outstanding |
|
|
101,866 |
|
|
|
92,152 |
|
|
|
101,166 |
|
|
|
91,806 |
|
INVESTORS & MEDIA:
Investors
Eric Hyllengren
805-395-9669
ehyllengren@atarabio.com
Media
Alex Chapman
805-456-4772
achapman@atarabio.com