Latest news with #Atara
Yahoo
15-05-2025
- Business
- Yahoo
Atara Biotherapeutics Announces First Quarter Financial Results and Operational Progress
Atara has transferred all manufacturing responsibility to Pierre Fabre Laboratories, including all costs associated with the manufacturing and supply of tabelecleucel for development and commercialization worldwide Atara expects to reduce its operating expenses year-over-year by approximately 65% in 2025 as a result of implemented cost reduction initiatives Atara has entered into an underwriting agreement for an offering with expected gross proceeds of $16 million that Atara believes is sufficient to fund the ongoing activities required to achieve potential BLA approval THOUSAND OAKS, Calif., May 15, 2025--(BUSINESS WIRE)--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 2025 and business updates. "We are pleased that we have secured additional financing that is expected to extend our cash runway through the first quarter of 2026," said Cokey Nguyen Ph.D., President and Chief Executive Officer of Atara. "This enables Atara to continue to work to reduce costs and liabilities while maintaining the required support to achieve potential BLA approval." Tabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD) The FDA has lifted the clinical holds on EBVALLO™ studies. Atara plans to resume enrollment in the Phase 3 ALLELE clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) and the Phase 2 label-expansion multi-cohort clinical study. The FDA has granted a date in the second quarter of 2025 for a Type A meeting to discuss the plan to address the issues raised by the FDA in the Complete Response Letter (CRL) issued in January 2025, and the path forward for resubmission of the EBVALLO™ BLA. In March 2025, the Company completed the transfer of all worldwide manufacturing and supply responsibility, including all associated costs, to Pierre Fabre Laboratories, and the Company is in active discussions on accelerating the transfer of all remaining operational activities related to tab-cel to Pierre Fabre, except the BLA sponsorship, which the Company expects to be completed as early as June 2025. Atara remains eligible for significant milestone payments from Pierre Fabre Laboratories upon FDA approval of the EBVALLO™ BLA and related commercial sales of EBVALLO™, as well as significant royalties as a percentage of net sales. Pierre Fabre Laboratories holds worldwide Commercialization rights to EBVALLO™. CAR T Programs Discontinued Atara has paused development of its CAR T programs (ATA3219 and ATA3431), with anticipated completion of wind-down activities in the second quarter of 2025. Corporate Updates Strategic Option Evaluation: As communicated in January and March, Atara engaged a well-known financial advisor to support the assessment of a range of strategic options, which may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. In April 2025, Atara paused its review of strategic options, pending the Type A meeting with the FDA which is scheduled in the second quarter of 2025, to discuss the plan to address the issues raised by the FDA in the CRL and the path forward for resubmission of the EBVALLO™ BLA. Organizational Restructuring: In May 2025, Atara implemented a strategic restructuring to further reduce operating expenses and due to the wind down of the CAR T programs. This restructuring resulted in a company-wide workforce reduction of approximately 30%, retaining approximately 23 personnel essential to execute on its remaining transition responsibilities under the EBVALLO™ collaboration with Pierre Fabre Laboratories, including as the BLA holder until approval. Financial Update: Atara has entered into an underwriting agreement for the issuance and sale of 834,237 shares of its common stock at a purchase price of $6.61 per share and the issuance and sale of pre-funded warrants to purchase up to 1,587,108 shares of its common stock at a purchase price of $6.6099 per share, representing fair market value based on closing, to entities affiliated with Adiumentum Capital Management, EcoR1 Capital, Panacea Venture and Redmile Group. The proceeds to Atara from the offering are expected to be $16 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Atara. Atara currently intends to use the net proceeds from the offering to fund its ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, and for working capital and general corporate purposes. The offering is expected to close on May 16, 2025, subject to the satisfaction of customary closing conditions. First Quarter 2025 Financial Results Cash, cash equivalents and short-term investments as of March 31, 2025 totaled $13.8 million, as compared to $42.5 million as of December 31, 2024. Net cash used in operating activities was $28.1 million for the first quarter 2025, as compared to $29.6 million in the same period in 2024. Total revenues were $98.1 million for the first quarter 2025, as compared to $27.4 million for the same period in 2024. Total revenues increased by $70.7 million year over year, primarily due to revenue recognized as a result of the completion of certain performance obligations under our Pierre Fabre agreement following the transfer of manufacturing responsibilities to Pierre Fabre as of March 31, 2025. Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $6.0 million for the first quarter 2025, as compared to $9.8 million for the same period in 2024. Research and development expenses were $27.4 million for the first quarter 2025, as compared to $45.5 million for the same period in 2024. Research and development expenses include $8.3 million in restructuring charges comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act for the January and March 2025 reductions in force. Research and development expenses also include $1.4 million of non-cash stock-based compensation expenses for the first quarter 2025, as compared to $4.7 million for the same period in 2024. General and administrative expenses were $11.5 million for the first quarter 2025, as compared to $11.1 million for the same period in 2024. General and administrative expenses include $1.5 million in restructuring charges comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act for the January and March 2025 reductions in force. General and administrative expenses include $2.8 million of non-cash stock-based compensation expenses for the first quarter 2025, as compared to $3.7 million for the same period in 2024. Atara reported net income of $38.0 million, or $3.53 basic earnings per share and $3.50 diluted earnings per share, for the first quarter 2025, as compared to a net loss of $31.8 million, or $5.65 basic and diluted loss per share, for the same period in 2024. 2025 Outlook and Cash Runway Atara transitioned all tab-cel manufacturing costs and responsibilities to Pierre Fabre in the first quarter of 2025. Pierre Fabre continues to reimburse Atara for costs related to the remaining tab-cel operation activities. In addition to reducing its headcount by approximately 85% since December 31, 2024, Atara continues to pursue additional initiatives aimed at enhancing operational efficiency. Following the recognition of most of the one-time restructuring costs in the first quarter of 2025, we anticipate operating expenses to decrease continuously throughout the remainder of the year, with the largest reduction expected in the second quarter of 2025. In total, we expect full year 2025 operating expenses to decrease by approximately 65% from 2024. Atara projects that cash, cash equivalents and short-term investments as of March 31, 2025, combined with the $16M gross proceeds from the May 2025 offering, in total will enable funding of planned operations into the first quarter of 2026. 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. Atara is headquartered in Southern California. For more information, visit 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 the anticipated resubmission of the BLA to the FDA; (2) Atara's cash runway, receipt of potential milestone payments, and operating expenses, including Atara's ability to fund its planned operations into the first quarter of 2026; and (3) Atara's planned transition of substantially all remaining activities relating to EBVALLO to Pierre Fabre and the timing thereof; (4) Atara's planned cost reduction strategies; and (5) the anticipated closing of the underwritten offering, as well as the proceeds and anticipated use of proceeds therefrom. 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 related with the timing of the transfer of all operational activities related to EBVALLO to Pierre Fabre, with any delay creating additional expenses and cash needs for Atara; risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA feedback and the ability of Atara, Pierre Fabre and Pierre Fabre's third-party manufacturer to address issues identified in the CRL; our ability to access capital, and the sufficiency of Atara's cash resources and access to additional capital on favorable terms or at all; and other risks and uncertainties affecting Atara, 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. Consolidated Balance Sheets (Unaudited) (In thousands) March 31, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 13,841 $ 25,030 Short-term investments — 17,466 Restricted cash 146 146 Accounts receivable 8,875 1,482 Inventories — 10,655 Other current assets 4,320 10,115 Total current assets 27,182 64,894 Property and equipment, net 285 1,294 Operating lease assets 31,727 39,807 Other assets 2,844 3,103 Total assets $ 62,038 $ 109,098 Liabilities and stockholders' equity (deficit) Current liabilities: Accounts payable $ 1,384 $ 4,367 Accrued compensation 4,599 6,589 Accrued research and development expenses 1,783 7,984 Deferred revenue 15,983 95,092 Other current liabilities 24,143 20,542 Total current liabilities 47,892 134,574 Deferred revenue - long-term — — Operating lease liabilities - long-term 26,708 29,914 Liability related to the sale of future revenues - long-term 39,383 38,624 Other long-term liabilities 3,127 3,269 Total liabilities $ 117,110 $ 206,381 Stockholders' (deficit) equity: Common stock 1 1 Additional paid-in capital 1,961,470 1,957,261 Accumulated other comprehensive loss — 8 Accumulated deficit (2,061,543 ) (2,054,553 ) Total stockholders' (deficit) equity (55,072 ) (97,283 ) Total liabilities and stockholders' (deficit) equity $ 62,038 $ 109,098 ATARA BIOTHERAPEUTICS, INC. Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except per share amounts) Three Months EndedMarch 31, 2025 2024 Commercialization revenue $ 98,149 $ 27,357 Costs and operating expenses: Cost of commercialization revenue 20,439 1,985 Research and development expenses 27,443 45,506 General and administrative expenses 11,475 11,113 Total costs and operating expenses 59,347 58,604 Income (loss) from operations 38,802 (31,247 ) Interest and other income, net (792 ) (481 ) Total other income (expense), net (792 ) (481 ) Income (loss) before provision for income taxes 38,010 (31,728 ) Provision for income taxes — 24 Net income (loss) $ 38,010 $ (31,752 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities (8 ) 149 Comprehensive income (loss) $ 38,002 $ (31,603 ) Basic net income (loss) per common share $ 3.53 $ (5.65 ) Diluted net income (loss) per common share $ 3.50 $ (5.65 ) Basic weighted-average shares outstanding 10,764 5,623 Basic and diluted weighted-average shares outstanding 10,851 5,623 View source version on Contacts Investor and Media Relations Amber DaughertySr. Director, Strategy and Operationsadaugherty@
Business Wire
15-05-2025
- Business
- Business Wire
Atara Biotherapeutics Announces First Quarter Financial Results and Operational Progress
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--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 2025 and business updates. 'We are pleased that we have secured additional financing that is expected to extend our cash runway through the first quarter of 2026,' said Cokey Nguyen Ph.D., President and Chief Executive Officer of Atara. 'This enables Atara to continue to work to reduce costs and liabilities while maintaining the required support to achieve potential BLA approval.' Tabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD) The FDA has lifted the clinical holds on EBVALLO™ studies. Atara plans to resume enrollment in the Phase 3 ALLELE clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) and the Phase 2 label-expansion multi-cohort clinical study. The FDA has granted a date in the second quarter of 2025 for a Type A meeting to discuss the plan to address the issues raised by the FDA in the Complete Response Letter (CRL) issued in January 2025, and the path forward for resubmission of the EBVALLO™ BLA. In March 2025, the Company completed the transfer of all worldwide manufacturing and supply responsibility, including all associated costs, to Pierre Fabre Laboratories, and the Company is in active discussions on accelerating the transfer of all remaining operational activities related to tab-cel to Pierre Fabre, except the BLA sponsorship, which the Company expects to be completed as early as June 2025. Atara remains eligible for significant milestone payments from Pierre Fabre Laboratories upon FDA approval of the EBVALLO™ BLA and related commercial sales of EBVALLO™, as well as significant royalties as a percentage of net sales. Pierre Fabre Laboratories holds worldwide Commercialization rights to EBVALLO™. CAR T Programs Discontinued Atara has paused development of its CAR T programs (ATA3219 and ATA3431), with anticipated completion of wind-down activities in the second quarter of 2025. Corporate Updates Strategic Option Evaluation: As communicated in January and March, Atara engaged a well-known financial advisor to support the assessment of a range of strategic options, which may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. In April 2025, Atara paused its review of strategic options, pending the Type A meeting with the FDA which is scheduled in the second quarter of 2025, to discuss the plan to address the issues raised by the FDA in the CRL and the path forward for resubmission of the EBVALLO™ BLA. Organizational Restructuring: In May 2025, Atara implemented a strategic restructuring to further reduce operating expenses and due to the wind down of the CAR T programs. This restructuring resulted in a company-wide workforce reduction of approximately 30%, retaining approximately 23 personnel essential to execute on its remaining transition responsibilities under the EBVALLO™ collaboration with Pierre Fabre Laboratories, including as the BLA holder until approval. Financial Update: Atara has entered into an underwriting agreement for the issuance and sale of 834,237 shares of its common stock at a purchase price of $6.61 per share and the issuance and sale of pre-funded warrants to purchase up to 1,587,108 shares of its common stock at a purchase price of $6.6099 per share, representing fair market value based on closing, to entities affiliated with Adiumentum Capital Management, EcoR1 Capital, Panacea Venture and Redmile Group. The proceeds to Atara from the offering are expected to be $16 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Atara. Atara currently intends to use the net proceeds from the offering to fund its ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, and for working capital and general corporate purposes. The offering is expected to close on May 16, 2025, subject to the satisfaction of customary closing conditions. First Quarter 2025 Financial Results Cash, cash equivalents and short-term investments as of March 31, 2025 totaled $13.8 million, as compared to $42.5 million as of December 31, 2024. Net cash used in operating activities was $28.1 million for the first quarter 2025, as compared to $29.6 million in the same period in 2024. Total revenues were $98.1 million for the first quarter 2025, as compared to $27.4 million for the same period in 2024. Total revenues increased by $70.7 million year over year, primarily due to revenue recognized as a result of the completion of certain performance obligations under our Pierre Fabre agreement following the transfer of manufacturing responsibilities to Pierre Fabre as of March 31, 2025. Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $6.0 million for the first quarter 2025, as compared to $9.8 million for the same period in 2024. Research and development expenses were $27.4 million for the first quarter 2025, as compared to $45.5 million for the same period in 2024. Research and development expenses include $8.3 million in restructuring charges comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act for the January and March 2025 reductions in force. Research and development expenses also include $1.4 million of non-cash stock-based compensation expenses for the first quarter 2025, as compared to $4.7 million for the same period in 2024. General and administrative expenses were $11.5 million for the first quarter 2025, as compared to $11.1 million for the same period in 2024. General and administrative expenses include $1.5 million in restructuring charges comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act for the January and March 2025 reductions in force. General and administrative expenses include $2.8 million of non-cash stock-based compensation expenses for the first quarter 2025, as compared to $3.7 million for the same period in 2024. Atara reported net income of $38.0 million, or $3.53 basic earnings per share and $3.50 diluted earnings per share, for the first quarter 2025, as compared to a net loss of $31.8 million, or $5.65 basic and diluted loss per share, for the same period in 2024. 2025 Outlook and Cash Runway Atara transitioned all tab-cel manufacturing costs and responsibilities to Pierre Fabre in the first quarter of 2025. Pierre Fabre continues to reimburse Atara for costs related to the remaining tab-cel operation activities. In addition to reducing its headcount by approximately 85% since December 31, 2024, Atara continues to pursue additional initiatives aimed at enhancing operational efficiency. Following the recognition of most of the one-time restructuring costs in the first quarter of 2025, we anticipate operating expenses to decrease continuously throughout the remainder of the year, with the largest reduction expected in the second quarter of 2025. In total, we expect full year 2025 operating expenses to decrease by approximately 65% from 2024. Atara projects that cash, cash equivalents and short-term investments as of March 31, 2025, combined with the $16M gross proceeds from the May 2025 offering, in total will enable funding of planned operations into the first quarter of 2026. 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. Atara is headquartered in Southern California. For more information, visit 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 the anticipated resubmission of the BLA to the FDA; (2) Atara's cash runway, receipt of potential milestone payments, and operating expenses, including Atara's ability to fund its planned operations into the first quarter of 2026; and (3) Atara's planned transition of substantially all remaining activities relating to EBVALLO to Pierre Fabre and the timing thereof; (4) Atara's planned cost reduction strategies; and (5) the anticipated closing of the underwritten offering, as well as the proceeds and anticipated use of proceeds therefrom. 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 related with the timing of the transfer of all operational activities related to EBVALLO to Pierre Fabre, with any delay creating additional expenses and cash needs for Atara; risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA feedback and the ability of Atara, Pierre Fabre and Pierre Fabre's third-party manufacturer to address issues identified in the CRL; our ability to access capital, and the sufficiency of Atara's cash resources and access to additional capital on favorable terms or at all; and other risks and uncertainties affecting Atara, 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. Consolidated Balance Sheets (Unaudited) (In thousands) March 31, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 13,841 $ 25,030 Short-term investments — 17,466 Restricted cash 146 146 Accounts receivable 8,875 1,482 Inventories — 10,655 Other current assets 4,320 10,115 Total current assets 27,182 64,894 Property and equipment, net 285 1,294 Operating lease assets 31,727 39,807 Other assets 2,844 3,103 Total assets $ 62,038 $ 109,098 Liabilities and stockholders' equity (deficit) Current liabilities: Accounts payable $ 1,384 $ 4,367 Accrued compensation 4,599 6,589 Accrued research and development expenses 1,783 7,984 Deferred revenue 15,983 95,092 Other current liabilities 24,143 20,542 Total current liabilities 47,892 134,574 Deferred revenue - long-term — — Operating lease liabilities - long-term 26,708 29,914 Liability related to the sale of future revenues - long-term 39,383 38,624 Other long-term liabilities 3,127 3,269 Total liabilities $ 117,110 $ 206,381 Stockholders' (deficit) equity: Common stock 1 1 Additional paid-in capital 1,961,470 1,957,261 Accumulated other comprehensive loss — 8 Accumulated deficit (2,061,543 ) (2,054,553 ) Total stockholders' (deficit) equity (55,072 ) (97,283 ) Total liabilities and stockholders' (deficit) equity $ 62,038 $ 109,098 Expand ATARA BIOTHERAPEUTICS, INC. Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except per share amounts) Three Months Ended March 31, 2025 2024 Commercialization revenue $ 98,149 $ 27,357 Costs and operating expenses: Cost of commercialization revenue 20,439 1,985 Research and development expenses 27,443 45,506 General and administrative expenses 11,475 11,113 Total costs and operating expenses 59,347 58,604 Income (loss) from operations 38,802 (31,247 ) Interest and other income, net (792 ) (481 ) Total other income (expense), net (792 ) (481 ) Income (loss) before provision for income taxes 38,010 (31,728 ) Provision for income taxes — 24 Net income (loss) $ 38,010 $ (31,752 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities (8 ) 149 Comprehensive income (loss) $ 38,002 $ (31,603 ) Basic net income (loss) per common share $ 3.53 $ (5.65 ) Diluted net income (loss) per common share $ 3.50 $ (5.65 ) Basic weighted-average shares outstanding 10,764 5,623 Basic and diluted weighted-average shares outstanding 10,851 5,623 Expand
Business Wire
15-05-2025
- Business
- Business Wire
Atara Biotherapeutics Announces Pricing of $16 Million Offering
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--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 announced the pricing of an offering of 834,237 shares of its common stock at an offering price of $6.61 per share and pre-funded warrants to purchase 1,587,108 shares of its common stock at an offering price of $6.6099 per pre-funded warrant share in an underwritten registered direct offering to a limited number of existing institutional investors, including entities affiliated with Adiumentum Capital Management, EcoR1 Capital, Panacea Venture and Redmile Group. The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable upon issuance. The offering is expected to close on or about May 16, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be $16 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Atara. Atara currently intends to use the net proceeds from the offering to fund its ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, and for working capital and general corporate purposes. TD Cowen is acting as the sole bookrunner for the offering. The securities described above are being offered by Atara pursuant to a shelf registration statement on Form S-3 (No. 333-275256), including a base prospectus, that was previously filed by Atara with the U.S. Securities and Exchange Commission (the 'SEC') on November 1, 2023 and was declared effective on November 13, 2023. A prospectus supplement containing additional information relating to the offering will be filed with the SEC and will be available on the SEC's website located at Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained by contacting TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Atara Biotherapeutics, Inc. Atara is 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. Atara is headquartered in Southern California. 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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, forward-looking statements include statements regarding the completion, timing and size of the offering and the anticipated use of proceeds of the offering. 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 related to market conditions and satisfaction of customary closing conditions related to the offering, as well as those discussed in Atara's filings with the SEC, including in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of the prospectus supplement and Atara'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.
Business Wire
05-05-2025
- Business
- Business Wire
Atara Biotherapeutics Provides Regulatory Updates on EBVALLO
THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- 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 announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Atara's active Investigational New Drug (IND) applications for the EBVALLO™ (tabelecleucel) program. 'We are very pleased to have addressed the FDA's questions, and this has enabled the FDA to lift the clinical holds,' said Cokey Nguyen Ph.D., President and Chief Executive Officer of Atara. 'We are working closely with our partner Pierre Fabre Laboratories and our clinical trial sites and anticipate resuming enrollment and treatment of patients as soon as possible.' In January 2025, the EBVALLO™ (tabelecleucel) program was placed on clinical hold. The clinical hold was directly linked to GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO™ that was announced on January 16, 2025. The FDA has lifted the clinical hold on tabelecleucel after reviewing supplemental data on finished drug product. The Company is now allowed to restart the Phase 3 ALLELE clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) and the Phase 2 label-expansion multi-cohort clinical study. The FDA has also granted a date for a Type A meeting to discuss the plan to address the issues raised by the FDA in the CRL from January 2025, and the path forward for resubmission of the EBVALLO™ BLA. 'We are pleased that the FDA has granted our request for a Type A meeting and hope to gain clarity on the timing for resubmitting the tab-cel BLA for review by the FDA,' said Dr. Nguyen. Corporate Update Strategic Option Evaluation: As previously communicated, Atara engaged a well-known financial advisor to support a comprehensive process to explore and assess a range of potential strategic options for the Company. Alternatives may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. We have temporarily paused this strategic option evaluation pending clarity with the FDA on timing of the resubmission of the EBVALLO™ BLA. It is possible that Atara may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, will not be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated. 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 and follow @Atarabio on X and LinkedIn. About tabelecleucel Tabelecleucel is an off-the-shelf allogeneic cell therapy composed of EBV specific cytotoxic T cell lymphocytes expanded from healthy donors and infused into partial HLA matched recipients suffering from EBV-driven malignancies such as post-transplant lymphoproliferative disease. Tab-cel is approved by the EMA, trademarked as EBVALLO™, for use in PTLD. Tab-cel is currently being evaluated in clinical studies and Atara is in the process of filing for approval by the FDA for commercial use in the United States. Pierre Fabre Laboratories holds worldwide Commercialization rights to EBVALLO™. 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 and the timing of resuming enrollment of the tab-cel clinical trials, the outcome of the Type A meeting with the FDA, the timing for FDA review of any resubmission of the BLA, and the potential characteristics and benefits of tab-cel; and (2) Atara's exploration of strategic alternatives and ability to consummate one or more strategic transactions. 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; risks related to FDA feedback and the ability of Atara and its third-party manufacturer to address the issues identified in the CRL; our ability to access capital; the sufficiency of Atara's cash resources and need for and ability to obtain additional capital on favorable terms or at all; risks and uncertainties related to Atara's financial close and audit procedures; the timing of the strategic review process; whether Atara will pursue any strategic alternatives; in the event Atara pursues a strategic alternative, that the strategic alternative may not be attractive or ultimately consummated; whether any strategic alternative will result in additional value for Atara and its shareholders; whether the process will have an adverse impact on Atara; 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.
Associated Press
27-01-2025
- Business
- Associated Press
ATRA Investors Have Opportunity to Join Atara Biotherapeutics, Inc. Securities Fraud Investigation with the Schall Law Firm
LOS ANGELES--(BUSINESS WIRE)--Jan 27, 2025-- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Atara Biotherapeutics, Inc. ('Atara' or 'the Company') (NASDAQ: ATRA) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Atara announced on January 16, 2025, that it had received 'a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLO TM (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen.' According to the Company, 'The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO.' If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. Brian Schall, Esq. 310-301-3335 SOURCE: The Schall Law Firm Copyright Business Wire 2025. PUB: 01/27/2025 10:43 AM/DISC: 01/27/2025 10:43 AM
