Form 8-K Atara Biotherapeutics, For: Aug 02
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
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Trading |
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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. ☐
Item 1.01 Entry into a Material Definitive Agreement
As previously disclosed, on May 13, 2022, Atara Biotherapeutics, Inc. (the “Company”) received written notice of termination from Bayer AG (“Bayer”) of the Research, Development and License Agreement dated December 4, 2020 by and between the Company and Bayer (the “License Agreement”), pursuant to which the Company granted Bayer an exclusive, field-limited license under the applicable patents and know-how owned or controlled by the Company and its affiliates covering or related to ATA2271 and ATA3271. On August 2, 2022, the Company and Bayer entered into a Termination, Amendment and Program Transfer Agreement (the “Termination Agreement”). The Termination Agreement terminates the License Agreement and each of the Manufacturing and Supply Agreement, the Pharmacovigilance Agreement, the Quality Agreement and the Technology Transfer Agreement, entered into between the Company and Bayer in March 2022, effective as of July 31, 2022.
Under the terms of the Termination Agreement, Bayer will pay the Company $4.2 million in cash for certain contractual activities performed by the Company until effectiveness of the termination and return all rights and licenses granted by the Company to Bayer under the License Agreement to the Company, with the exception of an internal research license to certain know-how granted under the License Agreement. The Company has full rights to continue the clinical development and future commercialization of the programs worldwide.
The foregoing summary of the Termination Agreement does not purport to be complete and is qualified in its entirety by reference to the Termination Agreement, a redacted version of which will be filed with the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2022.
On August 2, 2022, the Company and Charles River Laboratories entered into an Amendment No. 3 to the Commercial Manufacturing Agreement (the “Amendment”). The Amendment, among other things, extended the term of the Commercial Manufacturing Agreement through January 31, 2023, effective as of July 1, 2022.
The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, a redacted version of which will be filed with the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2022.
Item 2.02 Results of Operations and Financial Condition.
On August 8, 2022, the Company announced certain financial results for the second quarter ended June 30, 2022. A copy of the Company’s press release, titled “Atara Biotherapeutics Announces Second Quarter 2022 Financial Results and Corporate Strategy Update” is furnished as Exhibit 99.1 hereto.
The information (including Exhibit 99.1) is being furnished in this Item 2.02 “Results of Operations and Financial Condition” and 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 2.05 Costs Associated with Exit or Disposal Activities
On August 8, 2022, the Company announced a reduction in its workforce plan that will impact approximately 20% of its current employees. The Company expects to substantially complete the workforce reduction by October 7, 2022.
The Company expects to recognize approximately $6.0 million in total for severance and related benefits for employees laid off under the reduction in workforce plan. These charges are primarily one-time termination benefits and are all cash charges. The Company may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the workforce reduction.
Additional details will be provided in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
In connection with the reduction in workforce, the employment of Kristin Yarema, the Company’s Senior Vice President and Chief Commercial Officer, will terminate effective as of November 15, 2022. Pursuant to the terms of the Executive Employment Agreement dated as of January 2, 2020 between Dr. Yarema and the Company, Dr. Yarema will be entitled to receive severance benefits of 12 months of base salary continuation and, subject to her timely election of coverage, payment by the Company of up to 12 months of continued health care benefits.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
Forward-Looking Statements
This Current Report on Form 8-K 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. Forward-looking statements include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the Company’s future activities, or future events or conditions, including plans related to the reduction in the Company’s workforce. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of the Company 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 the Company’s cash resources and need for additional capital; and other risks and uncertainties affecting the Company’s and its development programs, including those discussed in the Company’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, the Company 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.
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 thereunto duly authorized.
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ATARA BIOTHERAPEUTICS, INC. |
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Date: |
August 8, 2022 |
By: |
/s/ Utpal Koppikar |
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Utpal Koppikar |
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)
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June 30, |
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December 31, |
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2022 |
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2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
70,688 |
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$ |
106,084 |
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Short-term investments |
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260,623 |
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264,984 |
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Restricted cash |
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1,346 |
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194 |
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Accounts receivable |
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637 |
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986 |
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Prepaid expenses and other current assets |
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13,690 |
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12,373 |
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Total current assets |
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346,984 |
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384,621 |
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Property and equipment, net |
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8,328 |
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53,780 |
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Operating lease assets |
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73,582 |
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26,159 |
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Restricted cash - long-term |
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— |
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1,200 |
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Other assets |
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7,227 |
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2,367 |
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Total assets |
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$ |
436,121 |
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$ |
468,127 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
12,799 |
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$ |
17,368 |
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Accrued compensation |
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16,317 |
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25,150 |
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Accrued research and development expenses |
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15,125 |
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13,451 |
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Deferred revenue |
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1,671 |
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40,760 |
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Other current liabilities |
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19,776 |
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9,057 |
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Total current liabilities |
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65,688 |
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105,786 |
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Deferred revenue - long-term |
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43,329 |
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55,708 |
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Operating lease liabilities - long-term |
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63,999 |
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25,518 |
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Other long-term liabilities |
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5,626 |
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1,501 |
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Total liabilities |
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$ |
178,642 |
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$ |
188,513 |
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Stockholders’ equity: |
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Common stock—$0.0001 par value, 500,000 shares authorized as of June 30,2022 and December 31, 2021; 94,356 and 91,671 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively |
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9 |
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9 |
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Additional paid-in capital |
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1,794,449 |
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1,744,695 |
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Accumulated other comprehensive (loss) income |
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(2,618 |
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(368 |
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Accumulated deficit |
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(1,534,361 |
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(1,464,722 |
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Total stockholders’ equity |
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257,479 |
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279,614 |
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Total liabilities and stockholders’ equity |
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$ |
436,121 |
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$ |
468,127 |
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Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(Unaudited)
(In thousands, except per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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License and collaboration revenue |
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$ |
51,579 |
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$ |
3,870 |
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$ |
58,893 |
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$ |
7,422 |
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Operating expenses: |
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Research and development |
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64,898 |
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68,475 |
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139,861 |
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132,534 |
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General and administrative |
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18,813 |
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19,397 |
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39,384 |
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37,135 |
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Total operating expenses |
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83,711 |
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87,872 |
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179,245 |
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169,669 |
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Loss from operations |
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(32,132 |
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(84,002 |
) |
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(120,352 |
) |
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(162,247 |
) |
Other income (expense), net: |
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Gain on sale of ATOM Facility |
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50,237 |
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— |
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50,237 |
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— |
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Interest and other income, net |
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361 |
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225 |
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476 |
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135 |
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Total other (expense), net |
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50,598 |
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225 |
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50,713 |
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135 |
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Income (loss) before provision for income taxes |
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18,466 |
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(83,777 |
) |
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(69,639 |
) |
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(162,112 |
) |
Provision for income taxes |
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— |
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16 |
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— |
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16 |
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Net income (loss) |
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$ |
18,466 |
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$ |
(83,793 |
) |
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$ |
(69,639 |
) |
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$ |
(162,128 |
) |
Other comprehensive gain (loss): |
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Unrealized gain (loss) on available-for-sale securities |
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(726 |
) |
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(99 |
) |
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(2,250 |
) |
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(234 |
) |
Comprehensive income (loss) |
|
$ |
17,740 |
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|
$ |
(83,892 |
) |
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$ |
(71,889 |
) |
|
$ |
(162,362 |
) |
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Basic net earnings (loss) per common share |
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$ |
0.18 |
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$ |
(0.91 |
) |
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$ |
(0.69 |
) |
|
$ |
(1.77 |
) |
Diluted net earnings (loss) per common share |
|
$ |
0.18 |
|
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$ |
(0.91 |
) |
|
$ |
(0.69 |
) |
|
$ |
(1.77 |
) |
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Weighted-average basic shares outstanding |
|
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101,601 |
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|
|
92,152 |
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|
|
101,166 |
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|
|
91,806 |
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Weighted-average diluted shares outstanding |
|
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101,866 |
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|
92,152 |
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|
|
101,166 |
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|
|
91,806 |
|
INVESTORS & MEDIA:
Investors
Eric Hyllengren
805-395-9669
Media
Alex Chapman
805-456-4772
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