Atara Biotherapeutics, Inc 8-K, filed May 8, 2023
Atara Biotherapeutics, Inc. (ATRA)
About this 8-K
Atara Biotherapeutics, Inc filed this 8-K on May 8, 2023, reporting on events of May 5, 2023.
Items reported
- Item 2.02: Financial results
- Item 5.02: Director or officer change, or executive pay
- Item 9.01: Financial statements and exhibits
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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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 2.02 Results of Operations and Financial Condition.
On May 8, 2023, the Company announced certain financial results for the first quarter ended March 31, 2023. A copy of the Company’s press release, titled “Atara Biotherapeutics Announces First Quarter 2023 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, 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 May 8, 2023, Atara Biotherapeutics, Inc., a Delaware corporation (the “Company”), announced that (i) Jakob Dupont, M.D., the Company’s Executive Vice President, Global Head of Research and Development, on May 5, 2023, notified the Company of his intention to resign from the Company effective as of May 12, 2023, and (ii) Charlene Banard, the Company’s Executive Vice President, Chief Technical Officer, will depart the Company effective as of June 9, 2023.
Pursuant to the terms of the Executive Employment Agreement dated as of March 25, 2022 between Ms. Banard and the Company, upon her departure from the Company, Ms. Banard 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) |
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: |
May 8, 2023 |
By: |
/s/ Eric Hyllengren |
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Eric Hyllengren |
Exhibit 99.1
Atara Biotherapeutics Announces First Quarter 2023 Financial Results and Operational Progress
First Patients Treated in Europe with EBVALLOTM Following Transfer of EC Marketing Authorization to Pierre Fabre; Discussions with FDA Progressing
ATA188 Phase 2 EMBOLD Study Primary Data Readout On-Track for October 2023
ATA3219 IND Filing Anticipated End of Q2 2023
THOUSAND OAKS, Calif.—May 8, 2023—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 2023, recent business highlights and key upcoming catalysts.
“We are entering an important period of potential value-generating milestones for our prioritized pipeline assets and continue to have productive dialogue and senior level engagement with FDA regarding tab-cel,” said Pascal Touchon, President and Chief Executive Officer of Atara. “In parallel, we continue to identify operational efficiencies and reduce cash burn with the goal of further extending our cash runway to best position Atara for future success.”
Tabelecleucel (tab-cel® or EBVALLOTM) for Post-Transplant Lymphoproliferative Disease (PTLD)
ATA188 for Progressive Multiple Sclerosis (MS)
ATA3219: CD19 Program for B-Cell Malignancies
Leadership Changes
First Quarter 2023 Financial Results
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 receiving marketing authorization 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 for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; 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 Southern 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) dialogue with the FDA regarding a potential BLA submission for tab-cel®; (2) 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®; (3) the potential submission of a BLA for tab-cel®; (4) timing and progress of Atara’s marketing authorization application filed with the Medicines and Healthcare Products Regulatory Authority for tab-cel®; (5) the timing and progress of ATA188, including data and analyses from the EMBOLD study and the timing of when such data will be received and communicated (6) the timing and progress of Atara’s CAR T programs, and the safety and efficacy of product candidates emerging from such programs, including ATA3219, a potential IND for ATA3219 and the timing thereof; (7) Atara’s cash runway; and (8) Pierre Fabre’s activities relating to the commercialization of Ebvallo™ in Europe 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 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 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.
Financials
Atara Biotherapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
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March 31, |
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December 31, |
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2023 |
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2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
48,741 |
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$ |
92,942 |
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Short-term investments |
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156,666 |
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149,877 |
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Restricted cash |
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146 |
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146 |
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Accounts receivable |
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397 |
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40,221 |
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Inventories |
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5,340 |
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1,586 |
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Other current assets |
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12,892 |
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10,308 |
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Total current assets |
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224,182 |
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295,080 |
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Property and equipment, net |
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5,852 |
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6,300 |
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Operating lease assets |
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65,143 |
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68,022 |
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Other assets |
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6,906 |
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7,018 |
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Total assets |
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$ |
302,083 |
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$ |
376,420 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
5,068 |
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$ |
6,871 |
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Accrued compensation |
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8,913 |
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17,659 |
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Accrued research and development expenses |
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23,766 |
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24,992 |
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Deferred revenue |
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9,924 |
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8,000 |
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Other current liabilities |
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20,205 |
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21,394 |
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Total current liabilities |
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67,876 |
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78,916 |
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Deferred revenue - long-term |
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78,041 |
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77,000 |
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Operating lease liabilities - long-term |
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54,918 |
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58,064 |
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Liability related to the sale of future revenues - long-term |
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31,111 |
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30,236 |
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Other long-term liabilities |
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5,177 |
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5,564 |
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Total liabilities |
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237,123 |
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249,780 |
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Stockholders’ equity: |
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Common stock |
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10 |
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10 |
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Additional paid-in capital |
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1,833,982 |
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1,821,721 |
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Accumulated other comprehensive (loss) income |
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(1,237 |
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(2,067 |
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Accumulated deficit |
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(1,767,795 |
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(1,693,024 |
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Total stockholders’ equity |
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64,960 |
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126,640 |
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Total liabilities and stockholders’ equity |
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$ |
302,083 |
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$ |
376,420 |
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Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per share amounts)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Commercialization revenue |
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$ |
884 |
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$ |
— |
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License and collaboration revenue |
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342 |
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7,314 |
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Total revenue |
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1,226 |
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7,314 |
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Costs and operating expenses: |
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Cost of commercialization revenue |
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216 |
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— |
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Research and development expenses |
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62,156 |
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74,963 |
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General and administrative expenses |
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13,872 |
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20,571 |
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Total costs and operating expenses |
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76,244 |
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95,534 |
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Loss from operations |
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(75,018 |
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(88,220 |
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Interest and other income (expense), net |
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269 |
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115 |
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Loss before provision for income taxes |
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(74,749 |
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(88,105 |
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Provision for income taxes |
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22 |
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— |
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Net loss |
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$ |
(74,771 |
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$ |
(88,105 |
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Other comprehensive gain (loss): |
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Unrealized gain (loss) on available-for-sale securities |
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830 |
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(1,524 |
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Comprehensive loss |
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$ |
(73,941 |
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$ |
(89,629 |
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Net loss per common share: |
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Basic and diluted loss per common share |
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$ |
(0.72 |
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$ |
(0.87 |
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Basic and diluted weighted-average shares outstanding |
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103,969 |
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100,726 |
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CONTACTS:
Investors
Eric Hyllengren
805-395-9669
ehyllengren@atarabio.com
Media
Alex Chapman
805-456-4772
achapman@atarabio.com
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