Atara Biotherapeutics(ATRA)
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Atara Biotherapeutics(ATRA) - 2025 Q3 - Quarterly Report
2025-11-12 14:10
Regulatory Approvals and Commercialization - Atara Biotherapeutics received marketing authorization approval for its lead program, Tab-cel (Ebvallo), for commercial sale in the European Economic Area, the UK, and Switzerland[148]. - Tab-cel, under the name Ebvallo, is approved for commercial sale in the EEA, UK, and Switzerland, with ongoing Phase 3 trials in the U.S. for EBV+ PTLD patients[165]. - The Prescription Drug User Fee Act target action date for the tab-cel BLA is set for January 10, 2026[169]. Financial Performance - Commercialization revenue for the nine months ended September 30, 2025, was $119.2 million, a decrease of $36.7 million compared to $96.2 million in the same period of 2024[185]. - The cost of commercialization revenue for the nine months ended September 30, 2025, was $21.1 million, a decrease of $7.5 million from $14.2 million in the same period of 2024[186]. - Research and development expenses for the nine months ended September 30, 2025, totaled $37.7 million, a decrease of $85.1 million compared to $122.8 million in the same period of 2024[187]. - The accumulated deficit as of September 30, 2025, was $2.0 billion, with net losses of $72.7 million for the nine months ended September 30, 2024[173]. - General and administrative expenses decreased to $4.0 million in Q3 2025 from $10.4 million in Q3 2024, a reduction of 61%[190]. - Interest income fell to $0.2 million in Q3 2025 from $0.5 million in Q3 2024, a decrease of 60%[191]. - Total cash, cash equivalents, and short-term investments decreased to $13.7 million as of September 30, 2025, down from $42.5 million as of December 31, 2024, a decline of 68.6%[199]. - Cash and cash equivalents as of September 30, 2025, were $5.7 million, down from $25.0 million as of December 31, 2024, a decrease of 77.2%[199]. - Net cash used in operating activities was $45.2 million for the nine months ended September 30, 2025, compared to $44.2 million in the same period of 2024, an increase of 2.3%[201]. - Net cash provided by financing activities was $16.1 million in the nine months ended September 30, 2025, down from $59.6 million in the same period of 2024, a decrease of 73%[200]. - As of September 30, 2025, the company had $87.2 million of common stock remaining to be sold under the 2023 ATM Facility[195]. - The company expects a $40 million milestone payment from Pierre Fabre upon approval of the tab-cel BLA, which will provide significant cash runway[204]. - The company incurred losses and negative cash flows from operations since inception and anticipates needing additional capital to fund operations[197]. - The company may need substantial additional funding to complete the regulatory approval process for tab-cel in the US[207]. Workforce and Restructuring - The company executed workforce reductions of approximately 30% in November 2023, resulting in restructuring charges of $6.7 million[156]. - A further workforce reduction of approximately 50% was announced in January 2025, with total severance and related benefits recognized at approximately $7.1 million[158]. Strategic Alternatives and Collaborations - The company has engaged a financial advisor to assess strategic alternatives, including potential acquisitions or mergers, following the pause in CAR-T asset development[164]. - The company has entered into research collaborations with leading academic institutions to acquire rights to novel technologies and programs[152]. Program Developments and Changes - The company announced a pause in the development of its allogeneic CAR T cell programs, including ATA3219 and ATA3431, and has completed nearly all wind-down activities for these programs[148]. - The FDA lifted the clinical hold on the ATA3219 program in May 2025 after compliance issues were addressed[166]. - The company returned rights to the ATA188 and EBV Vaccine programs to QIMR in May 2025, and discontinued other programs[168]. - Manufacturing responsibilities for tab-cel were transferred to Pierre Fabre as of March 31, 2025, following an amendment to the A&R Commercialization Agreement[170]. - The Fujifilm Master Services and Supply Agreement was assigned to Pierre Fabre as part of the transition of manufacturing responsibility for Tab-cel[153]. Risks and Future Considerations - The company anticipates no material impact from the recent U.S. corporate tax legislation changes on its business operations[162]. - No material changes to interest rate risk, market risk, and foreign currency exchange rate risk disclosures during the nine months ended September 30, 2025[212]. - The company is subject to the timing of proceeds from the A&R Commercialization Agreement and the HCRx Agreement[212]. - Future commercialization, collaboration, licensing, and partnering arrangements may impact financial performance[212]. - The company may incur costs related to licensing, filing, prosecution, maintenance, defense, and enforcement of patents[212]. - The extent of in-licensing or acquisition of other products and technologies will influence growth strategies[212]. - Timing of qualification for partner's CMOs' manufacturing facilities is critical for operational success[212].
Atara Biotherapeutics(ATRA) - 2025 Q3 - Quarterly Results
2025-11-12 14:05
Financial Performance - Atara reported total revenues of $3.5 million for Q3 2025, a decrease of 91.3% compared to $40.2 million in Q3 2024[7] - The net loss for Q3 2025 was $4.3 million, or $0.32 per share, significantly improved from a net loss of $21.9 million, or $2.93 per share, in Q3 2024[7] - Total costs and operating expenses for Q3 2025 were $7.0 million, down from $61.9 million in Q3 2024, marking a decrease of 88.7%[15] Cash and Investments - Cash, cash equivalents, and short-term investments totaled $13.7 million as of September 30, 2025, down from $22.3 million as of June 30, 2025[7] - Atara's accumulated deficit as of September 30, 2025, was $2.02 billion, compared to $2.05 billion at the end of 2024[13] Research and Development - Research and development expenses decreased to $2.9 million in Q3 2025 from $43.9 million in Q3 2024, reflecting a year-over-year reduction of 93.4%[7] - The company anticipates a full-year 2025 operating expense reduction of at least 60% compared to 2024 due to the transition of tab-cel activities to Pierre Fabre[11] Milestones and Future Expectations - Atara expects to receive a $40 million milestone payment from Pierre Fabre Laboratories contingent upon FDA approval of the tab-cel BLA[4] - The FDA has set a PDUFA target action date of January 10, 2026, for the tab-cel BLA, which has been granted Priority Review[3] - The company completed the transfer of substantially all tab-cel activities to Pierre Fabre Laboratories in October 2025[5]
Atara Biotherapeutics (ATRA) Surges 10.0%: Is This an Indication of Further Gains?
ZACKS· 2025-11-07 12:45
Company Overview - Atara Biotherapeutics (ATRA) shares increased by 10% to close at $11.82, following a notable trading volume compared to typical sessions, despite a 32.2% loss over the past four weeks [1][2] Product Development - The rise in stock price is linked to growing investor optimism regarding Atara's lead product candidate, tabelecleucel (tab-cel), which is a T-cell immunotherapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) [2] - Atara has resubmitted its biologics license application for tab-cel, which is currently under priority review by the FDA, with a decision expected on January 10, 2026 [2] Financial Performance - The company is projected to report a quarterly loss of $0.83 per share, reflecting a year-over-year increase of 71.7%, while revenues are expected to be $1.29 million, down 96.8% from the same quarter last year [3] - The consensus EPS estimate for Atara has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Atara Biotherapeutics is part of the Zacks Medical - Biomedical and Genetics industry, where another company, CervoMed Inc. (CRVO), experienced a 0.7% decline in its stock price, with a return of -17.5% over the past month [4] - CervoMed's consensus EPS estimate has also remained unchanged at -$0.68, representing a 23.6% decline from the previous year [5]
Pierre Fabre Pharmaceuticals Announces Transfer from Atara Biotherapeutics of the Biologics License Application (BLA) for Tabelecleucel as Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
Prnewswire· 2025-11-03 14:00
Tabelecleucel BLA currently under U.S. Food and Drug Administration (FDA) Priority Review as potentially the first approved therapy in the U.S. for EBV+ PTLD with a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026 First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment Accessibility StatementSkip Navigation EBV+ PTLD is an ultra-rare, acute, ...
4 Biotechnology Stocks That Outshine In Momentum Amid Strong Technicals - Arrowhead Pharma (NASDAQ:ARWR), Assembly Biosciences (NASDAQ:ASMB)
Benzinga· 2025-09-29 11:11
Core Insights - Four biotechnology stocks have surged into the top 10th percentile for momentum ranking, indicating strong technical strength and price action [1][2] Group 1: Momentum Ranking - Arrowhead Pharmaceuticals Inc. (ARWR), Assembly Biosciences Inc. (ASMB), Atara Biotherapeutics Inc. (ATRA), and Corcept Therapeutics Inc. (CORT) have shown significant momentum percentile increases, making them stand out in the competitive biotech sector [2][5] - Joining the top decile for momentum ranking means these stocks are outperforming 90% of all tracked stocks in terms of price appreciation and volatility-adjusted returns [5] Group 2: Individual Stock Performance - ARWR's momentum percentile increased from 89.87 to 93.79, with a week-on-week gain of 3.92 percentage points; the stock has risen by 66.92% year-to-date and 69.33% over the year [7] - ASMB moved from 87.58 to 93.13, posting a 5.55 percentage point increase; it is up 43.85% YTD and 62.95% over the year [7] - ATRA climbed from 88.24 to 92.76, translating to a weekly gain of 4.52 percentage points; the stock has declined 2.97% YTD but advanced 69.00% over the year [8] - CORT advanced from 88.05 to 90.50, achieving a week-on-week improvement of 2.45 percentage points; it has risen by 67.84% YTD and 81.22% over the year [8]
Atara Biotherapeutics (ATRA) Soars 10.0%: Is Further Upside Left in the Stock?
ZACKS· 2025-09-25 14:31
Company Overview - Atara Biotherapeutics (ATRA) shares increased by 10% to close at $14.26, with notable trading volume compared to typical sessions, and a 2.6% gain over the past four weeks [1][2] Product Development - The rise in stock price is linked to growing investor optimism regarding Atara's lead product candidate, tabelecleucel (tab-cel), a T-cell immunotherapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) [2] - Atara has resubmitted its biologics license application for tab-cel, which is currently under priority review by the FDA, with a decision expected on January 10, 2026 [2] Financial Performance - Atara is projected to report a quarterly loss of $0.83 per share, reflecting a year-over-year increase of 71.7%, while revenues are expected to be $1.29 million, down 96.8% from the same quarter last year [3] - The consensus EPS estimate for Atara has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Atara Biotherapeutics is part of the Zacks Medical - Biomedical and Genetics industry, which includes Amicus Therapeutics (FOLD), another stock in the same sector that closed 2.3% higher at $8.35 and has returned 8.5% over the past month [5] - Amicus Therapeutics has a consensus EPS estimate of $0.12 for its upcoming report, representing a year-over-year change of 20%, and also holds a Zacks Rank of 3 (Hold) [6]
Atara Biotherapeutics, Inc. (NASDAQ:ATRA) Leads in Capital Efficiency Among Biotech Peers
Financial Modeling Prep· 2025-09-05 15:00
Core Insights - Atara Biotherapeutics, Inc. is a biotechnology company focused on immunotherapy for serious diseases, distinguishing itself with innovative approaches and strong financial metrics [1] Financial Performance - Atara's Return on Invested Capital (ROIC) is 36.19%, significantly higher than its Weighted Average Cost of Capital (WACC) of 6.53%, resulting in a ROIC to WACC ratio of 5.54, indicating effective capital utilization and strong potential for value creation [2][6] - In contrast, G1 Therapeutics, Inc. has a negative ROIC of -17.42% and a WACC of 12.24%, leading to a ROIC to WACC ratio of -1.42, highlighting inefficiencies in capital use [3] - Allogene Therapeutics, Inc. shows a ROIC of -57.03% against a WACC of 4.85%, resulting in a ROIC to WACC ratio of -11.77, further emphasizing capital inefficiency [3] - MacroGenics, Inc. and AnaptysBio, Inc. exhibit negative ROIC to WACC ratios of -3.98 and -2.27, respectively, indicating challenges in capital management [4] - CytomX Therapeutics, Inc. has a ROIC of 30.37% and a WACC of 13.35%, resulting in a ROIC to WACC ratio of 2.27, which, while positive, is less efficient than Atara [5][6] Competitive Landscape - Atara Biotherapeutics leads its peers in capital efficiency within the biotechnology sector, showcasing a strong position compared to competitors with negative or lower ROIC to WACC ratios [5][6]
Atara Biotherapeutics(ATRA) - 2025 Q2 - Quarterly Report
2025-08-11 20:10
[Forward-Looking Statements](index=3&type=section&id=NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines the scope of forward-looking statements, covering strategic alternatives, program expectations, regulatory approvals, commercialization, market opportunities, financing, intellectual property, financial performance, workforce reductions, and manufacturing - Forward-looking statements cover strategic alternatives, program expectations, regulatory approvals (tab-cel BLA), commercialization (Ebvallo/Pierre Fabre), market opportunities, financing needs, intellectual property, financial performance, workforce reductions, and manufacturing[10](index=10&type=chunk) - These statements involve risks and uncertainties, with many discussed in detail under "1A. Risk Factors"[11](index=11&type=chunk) [Summary Risk Factors](index=4&type=section&id=Summary%20Risk%20Factors) This section highlights key risks including the uncertainty of strategic alternatives, substantial losses, product development challenges, regulatory scrutiny, and potential disruptions from workforce reductions - Strategic alternatives review may not yield expected benefits or enhance stockholder value, potentially leading to **liquidation**[13](index=13&type=chunk) - The company has incurred **substantial losses since inception** and may never achieve sustained profitability, requiring substantial near-term financing[13](index=13&type=chunk) - **Ebvallo is the only approved product** (EEA, UK, Switzerland); allogeneic CAR T programs have been paused[13](index=13&type=chunk) - T-cell immunotherapy product candidates face heightened regulatory scrutiny, and clinical trial results are not necessarily predictive of future success[13](index=13&type=chunk) - **Workforce reductions** may not result in anticipated savings and could disrupt business operations[15](index=15&type=chunk) PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive income (loss), statements of changes in stockholders' equity (deficit), statements of cash flows, and accompanying notes, providing a detailed financial overview for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and equity at specific points in time, reflecting its financial position Condensed Consolidated Balance Sheets (Selected Items, in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $16,903 | $25,030 | | Short-term investments | $5,420 | $17,466 | | Inventories | $— | $10,655 | | Total current assets | $24,772 | $64,894 | | Total assets | $36,902 | $109,098 | | Deferred revenue | $1,607 | $95,092 | | Total current liabilities | $14,563 | $134,574 | | Total liabilities | $71,943 | $206,381 | | Total stockholders' equity (deficit) | $(35,041) | $(97,283) | - **Total assets decreased significantly from $109.1 million** at December 31, 2024, to **$36.9 million** at June 30, 2025, primarily due to reductions in current assets like cash, short-term investments, and inventories[17](index=17&type=chunk) - **Total liabilities decreased from $206.4 million to $71.9 million**, largely due to a substantial reduction in deferred revenue[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) This statement details the company's revenues, expenses, and net income or loss over specific reporting periods, indicating operational performance Condensed Consolidated Statements of Operations (Selected Items, in thousands, except per share amounts) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Commercialization revenue | $17,575 | $28,640 | $115,724 | $55,997 | | Total costs and operating expenses | $14,378 | $46,871 | $73,725 | $105,475 | | Income (loss) from operations | $3,197 | $(18,231) | $41,999 | $(49,478) | | Net income (loss) | $2,387 | $(19,049) | $40,397 | $ (50,801) | | Basic earnings (loss) per common share | $0.20 | $(3.10) | $3.52 | $(8.64) | | Diluted earnings (loss) per common share | $0.19 | $(3.10) | $3.49 | $(8.64) | - For the six months ended June 30, 2025, the company reported a **net income of $40.4 million**, a significant improvement from a **net loss of $(50.8) million** in the prior year period[19](index=19&type=chunk) - This turnaround was driven by a substantial increase in **commercialization revenue ($115.7 million vs. $56.0 million)** and a considerable reduction in **total costs and operating expenses ($73.7 million vs. $105.5 million)**[19](index=19&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) This statement tracks changes in the equity section of the balance sheet, including net income, stock issuances, and other comprehensive income or loss Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Selected Items, in thousands) | Item | January 1, 2025 | June 30, 2025 | | :--------------------------------- | :-------------- | :-------------- | | Balance as of January 1, 2025 | $(97,283) | N/A | | Issuance of pre-funded warrants to purchase common stock | N/A | $14,843 | | Stock-based compensation expense | N/A | $7,010 | | Net (loss) income | N/A | $40,397 | | Balance as of June 30, 2025 | N/A | $(35,041) | - The **total stockholders' deficit improved from $(97.3) million** at January 1, 2025, to **$(35.0) million** at June 30, 2025[21](index=21&type=chunk) - This improvement was primarily due to **net income of $40.4 million** and additional paid-in capital from equity offerings and stock-based compensation[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities, illustrating liquidity and solvency Condensed Consolidated Statements of Cash Flows (Selected Items, in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(35,456) | $(40,257) | | Net cash provided by investing activities | $12,129 | $21,913 | | Net cash provided by financing activities | $15,054 | $23,817 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(8,273) | $5,473 | | Cash, cash equivalents and restricted cash at end of period | $16,903 | $31,460 | - **Net cash used in operating activities decreased to $35.5 million** for the six months ended June 30, 2025, from **$40.3 million** in the prior year, primarily due to changes in net working capital following the transfer of manufacturing responsibilities[201](index=201&type=chunk) - **Financing activities provided $15.1 million**, primarily from **$15.3 million in proceeds** from the issuance of prefunded warrants and shares in an underwritten registered direct offering[203](index=203&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide additional detail and context to the financial statements, explaining accounting policies, significant transactions, and other relevant information [Note 1. Description of Business](index=10&type=section&id=1.%20Description%20of%20Business) This note describes the company's core business, key products, strategic partnerships, and significant operational changes including workforce reductions - Atara Biotherapeutics is a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr Virus (EBV) T-cell platform[27](index=27&type=chunk) - **Tab-cel (Ebvallo™) has received marketing authorization** in the EEA, UK, and Switzerland, and is currently in Phase 3 development in the US[28](index=28&type=chunk) - In March 2025, **all manufacturing responsibility for tab-cel was transferred to Pierre Fabre**, and in July 2025, all clinical and development responsibility was also transferred[29](index=29&type=chunk) - The company executed multiple **workforce reductions** in November 2023 (~30%), January 2024 (~25%), January 2025 (~50%), March 2025 (~50%), and May 2025 (~30%), retaining approximately **23 employees**[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the critical accounting principles and methods used in preparing the financial statements, including details on a reverse stock split and going concern considerations - A **1-for-25 reverse stock split** was effected on June 20, 2024, with all equity-related information retroactively adjusted[36](index=36&type=chunk) - The company has incurred substantial operating losses since inception and expects existing capital to be insufficient for at least 12 months, raising **substantial doubt about its ability to continue as a going concern**[38](index=38&type=chunk)[39](index=39&type=chunk) - The business operates as one operating and reportable segment, focused on developing therapeutics, with substantially all assets located in the U.S. and commercialization revenue from Pierre Fabre (a French company)[41](index=41&type=chunk) [Note 3. Net Income (Loss) per Common Share](index=12&type=section&id=3.%20Net%20Income%20(Loss)%20per%20Common%20Share) This note details the calculation of basic and diluted earnings per share, including the treatment of potential dilutive securities Weighted-Average Shares Outstanding (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Weighted average shares outstanding – Basic | 12,197 | 6,143 | 11,484 | 5,883 | | Weighted average shares outstanding – Diluted | 12,310 | 6,143 | 11,576 | 5,883 | - Potential dilutive securities (unvested RSUs, options, ESPP rights) were excluded from diluted EPS calculation when their effect was antidilutive, resulting in the same denominator for basic and diluted net earnings (loss) per common share during net loss periods[46](index=46&type=chunk) [Note 4. Financial Instruments](index=13&type=section&id=4.%20Financial%20Instruments) This note provides information on the company's financial assets and liabilities, including available-for-sale securities and fair value measurements Total Available-for-Sale Securities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Money market funds (Level 1) | $14,444 | $13,718 | | U.S. Treasury obligations (Level 2) | $6,415 | $27,458 | | Total available-for-sale securities | $20,859 | $41,176 | - **Total available-for-sale securities decreased from $41.2 million** at December 31, 2024, to **$20.9 million** at June 30, 2025[52](index=52&type=chunk) - **No impairment losses were recognized** on investments, and no transfers between Level 1, Level 2, and Level 3 within the fair value hierarchy occurred during the periods presented[49](index=49&type=chunk)[52](index=52&type=chunk) [Note 5. Out-license Agreements](index=15&type=section&id=5.%20Out-license%20Agreements) This note details the company's licensing agreements, particularly with Pierre Fabre for tab-cel, including milestone payments, royalties, and deferred revenue - Pierre Fabre's exclusive rights to research, develop, manufacture, commercialize, and distribute tab-cel (Ebvallo) were **expanded worldwide in October 2023**[58](index=58&type=chunk) - **All manufacturing responsibility for tab-cel was transferred to Pierre Fabre** by March 2025, and all clinical and development responsibility by July 2025[60](index=60&type=chunk)[64](index=64&type=chunk) - Atara is eligible to receive up to **$308.0 million in remaining milestone payments** for the Initial Territory and up to **$550.0 million for the Additional Territory**, plus double-digit tiered royalties[62](index=62&type=chunk) Deferred Revenue Activity (in thousands) | Item | Amount | | :--------------------------------------- | :------- | | Deferred revenue, January 1, 2025 | $95,092 | | Additions | $21,914 | | Recognized into commercialization revenue | $(115,399) | | Deferred revenue June 30, 2025 | $1,607 | [Note 6. Liability Related to the Sale of Future Revenues](index=18&type=section&id=6.%20Liability%20Related%20to%20the%20Sale%20of%20Future%20Revenues) This note explains the liability arising from the sale of future Ebvallo royalties and milestone payments to HCRx, including its amortization and interest accretion - Atara sold a portion of future Ebvallo royalties and milestone payments to HCRx for **$31.0 million**, subject to a repayment cap between **185% and 250%** of the investment amount[78](index=78&type=chunk)[79](index=79&type=chunk) - The liability is amortized using the effective interest method, with an annual **effective interest rate of approximately 9%** as of June 30, 2025[81](index=81&type=chunk) Liability Related to Sale of Future Revenues (in thousands) | Item | Amount | | :--------------------------------------- | :------- | | Liability balance, January 1, 2025 | $39,006 | | Accretion of interest expense on liability related to sale of future revenues | $1,809 | | Repayment of the liability | $(51) | | Liability balance, June 30, 2025 | $40,793 | [Note 7. Leases](index=19&type=section&id=7.%20Leases) This note provides details on the company's lease arrangements, including right-of-use assets, lease liabilities, and the impact of lease terminations and assignments - The company vacated its Thousand Oaks office in February 2025, resulting in a **$1.0 million acceleration of amortization expense** on the abandoned right-of-use asset[83](index=83&type=chunk) - A non-cash **impairment of $4.1 million** was recorded for the Atara Research Center (ARC) lab's right-of-use asset due to pausing CAR-T research and development activities[84](index=84&type=chunk) - The Fujifilm MSA, containing embedded operating and finance leases, was novated to Pierre Fabre in March 2025, leading to **derecognition gains of $0.7 million (operating) and $0.5 million (finance)**[86](index=86&type=chunk) Present Value of Lease Liabilities (in thousands) | Item | June 30, 2025 | | :--------------------------------------- | :-------------- | | Total lease payments | $24,409 | | Less: amount representing interest | $(6,741) | | Present value of lease liabilities | $17,668 | [Note 8. Restructuring](index=21&type=section&id=8.%20Restructuring) This note outlines the restructuring activities, primarily workforce reductions, and the associated charges and liabilities incurred by the company - The company announced significant **workforce reductions** in January 2025 (~50%), March 2025 (~50%), and May 2025 (~30%), incurring total **restructuring charges of $11.3 million** for the six months ended June 30, 2025[93](index=93&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) Total Restructuring Charges (in thousands) | Item | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Research and development expense | $944 | $9,293 | | General and administrative expense | $579 | $2,043 | | Total restructuring charges | $1,523 | $11,336 | Restructuring Liability Activity (in thousands) | Item | Amount | | :--------------------------------------- | :------- | | Liability balance, January 1, 2025 | $63 | | Restructuring charges | $11,336 | | Cash payments | $(7,450) | | Non-cash settlements/adjustments | $(1,105) | | Liability balance, June 30, 2025 | $2,844 | [Note 9. Commitments and Contingencies](index=22&type=section&id=9.%20Commitments%20and%20Contingencies) This note describes the company's contractual obligations, in-license agreements, legal disputes, and manufacturing commitments - Atara has in-license agreements with Memorial Sloan Kettering Cancer Center (MSK) and QIMR Berghofer, involving milestone and tiered royalty payments[99](index=99&type=chunk)[105](index=105&type=chunk) - A dispute with MSK regarding **$6.0 million in sub-licensing fees was settled** in March 2025, with MSK returning **$3.0 million**[103](index=103&type=chunk)[104](index=104&type=chunk) - Rights to the ATA188 and EBV Vaccine programs were **returned to QIMR** in May 2025[105](index=105&type=chunk) - Manufacturing agreements with Charles River Laboratories (CRL) and FUJIFILM Diosynth Biotechnologies California, Inc. (Fujifilm) were **assigned to Pierre Fabre** by March 2025, relieving Atara of related obligations and minimum commitments[108](index=108&type=chunk)[109](index=109&type=chunk)[111](index=111&type=chunk) [Note 10. Stockholders' Equity (Deficit)](index=24&type=section&id=10.%20Stockholders'%20Equity%20(Deficit)) This note details changes in stockholders' equity, including pre-funded warrants, stock-based compensation, and activity under the at-the-market facility - **Pre-funded warrants were issued** in July 2019, May 2020, December 2020, January 2024, and May 2025, contributing to additional paid-in capital[116](index=116&type=chunk)[118](index=118&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk)[124](index=124&type=chunk) - No shares of common stock were sold under the 2023 ATM Facility during the six months ended June 30, 2025, with **$88.7 million remaining available**[128](index=128&type=chunk)[129](index=129&type=chunk) RSU Activity (Shares) | Item | Shares | | :--------------------------------------- | :------- | | Balance as of December 31, 2024 | 414,470 | | Granted | 386,068 | | Forfeited | (13,910) | | Vested | (282,988) | | Balance as of June 30, 2025 | 503,640 | Stock-based Compensation Expense (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $2,340 | $8,027 | | General and administrative | $4,670 | $6,706 | | Total stock-based compensation expense | $7,010 | $14,733 | [Note 11. Supplemental Balance Sheet Information](index=28&type=section&id=11.%20Supplemental%20Balance%20Sheet%20Information) This note provides additional breakdown for specific balance sheet items such as inventories, property and equipment, and other current liabilities Inventories (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Raw Materials | $— | $964 | | Work-in-process | $— | $9,691 | | Total inventories | $— | $10,655 | Property and Equipment, Net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Property and equipment, net | $176 | $1,294 | Other Current Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Accrued operating expenses | $4,783 | $6,027 | | Current portion of operating lease liabilities | $2,242 | $12,879 | | Current portion of finance lease liabilities | $— | $1,038 | | Other accrued liabilities | $646 | $598 | | Total other current liabilities | $7,671 | $20,542 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting key business developments, financial performance, liquidity, and capital resources [Overview](index=30&type=section&id=Overview) This overview summarizes the company's strategic focus, product pipeline status, key partnerships, and recent regulatory developments for its lead product - Atara is a T-cell immunotherapy leader with **tab-cel (Ebvallo) approved in EEA, UK, and Switzerland**, and in Phase 3 development in the U.S. for EBV+ PTLD[146](index=146&type=chunk) - Development of allogeneic CAR T cell programs (ATA3219, ATA3431) and ATA188 for MS has been **paused or discontinued**[146](index=146&type=chunk) - All manufacturing, clinical, and development responsibility for tab-cel was **transferred to Pierre Fabre by July 2025**[149](index=149&type=chunk) - The FDA issued a **Complete Response Letter for tab-cel BLA** in January 2025 due to GMP issues, but clinical holds were lifted in May 2025, and the BLA was resubmitted in July 2025 with a target action date of January 10, 2026[168](index=168&type=chunk) [Financial Overview](index=34&type=section&id=Financial%20Overview) This section provides a high-level summary of the company's financial performance, including net income, accumulated deficit, and primary revenue sources - **Net income was $40.4 million** for the six months ended June 30, 2025, compared to a **net loss of $(50.8) million** for the same period in 2024[171](index=171&type=chunk) - **Accumulated deficit as of June 30, 2025, was $2.0 billion**[171](index=171&type=chunk) Cash, Cash Equivalents and Short-term Investments (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Total cash, cash equivalents and short-term investments | $22,323 | $42,496 | - Commercialization revenue is primarily from Pierre Fabre, derived from upfront license fees, milestone payments, and inventory sales, subject to the HCRx Agreement[172](index=172&type=chunk) [Revenues](index=34&type=section&id=Revenues) This section analyzes the company's commercialization revenue, detailing changes and the factors influencing them, particularly from collaboration agreements Commercialization Revenue (in thousands) | Period | 2025 | 2024 | Increase (Decrease) | | :--------------------------------------- | :------- | :------- | :------------------ | | Three Months Ended June 30, | $17,575 | $28,640 | $(11,065) | | Six Months Ended June 30, | $115,724 | $55,997 | $59,727 | - The six-month increase was primarily due to **revenue recognized from the transfer of manufacturing responsibilities to Pierre Fabre** as of March 31, 2025[184](index=184&type=chunk) - The three-month decrease was due to **no remaining revenue associated with the Initial Territory Obligation** in 2025, as it was fully recognized by March 31, 2025[184](index=184&type=chunk) [Cost of Commercialization Revenue](index=34&type=section&id=Cost%20of%20Commercialization%20Revenue) This section discusses the costs directly associated with generating commercialization revenue, explaining fluctuations based on operational changes Cost of Commercialization Revenue (in thousands) | Period | 2025 | 2024 | Increase (Decrease) | | :--------------------------------------- | :------- | :------- | :------------------ | | Three Months Ended June 30, | $554 | $4,627 | $(4,073) | | Six Months Ended June 30, | $20,993 | $6,612 | $14,381 | - The six-month increase was primarily due to the **cost of inventory sold to Pierre Fabre** on March 31, 2025, according to the A&R Commercialization Agreement Amendment[185](index=185&type=chunk) - The three-month decrease is primarily due to there being **no manufacturing activities in the 2025 period** following the transfer of such activities to Pierre Fabre as of March 31, 2025[185](index=185&type=chunk) [Research and Development Expenses](index=34&type=section&id=Research%20and%20Development%20Expenses) This section details the company's research and development expenditures, explaining changes driven by program transitions and workforce adjustments Research and Development Expenses (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Technical operations and quality expenses | $2,537 | $21,519 | $21,810 | $49,038 | | Medical and safety expenses | $3,628 | $8,302 | $8,963 | $21,828 | | Regulatory expenses | $1,145 | $3,511 | $3,970 | $7,972 | | Total research and development expenses | $7,310 | $33,332 | $34,743 | $78,838 | - **Decreases in R&D expenses** were primarily due to the transition of tab-cel manufacturing activities to Pierre Fabre and reduced headcount following workforce reductions[186](index=186&type=chunk) - Medical and safety expenses also decreased due to a **$3.0 million MSK sublicensing fee refund** and a decrease in CAR T research and development activities[187](index=187&type=chunk) [General and Administrative Expenses](index=35&type=section&id=General%20and%20Administrative%20Expenses) This section analyzes general and administrative expenses, highlighting the impact of cost-saving measures and workforce reductions General and Administrative Expenses (in thousands) | Period | 2025 | 2024 | Increase (Decrease) | | :--------------------------------------- | :------- | :------- | :------------------ | | Three Months Ended June 30, | $6,514 | $8,912 | $(2,398) | | Six Months Ended June 30, | $17,989 | $20,025 | $(2,036) | - The **decrease in general and administrative expenses** was primarily due to reduced headcount following the January and March 2025 reductions in force[189](index=189&type=chunk) [Other Income (Expense), Net](index=35&type=section&id=Other%20Income%20(Expense),%20Net) This section reports on non-operating income and expenses, including interest income and expense, and their contributing factors Other Income (Expense), Net (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Interest income | $143 | $450 | $379 | $1,054 | | Interest expense | $(972) | $(1,262) | $(1,989) | $(2,415) | | Other income (expense), net | $(807) | $(818) | $(1,599) | $(1,299) | - **Interest income decreased** due to lower average balances of cash, cash equivalents, and available-for-sale securities[190](index=190&type=chunk) - **Interest expense decreased** primarily due to decreased interest expense recognized on the liability related to the sale of future revenues under the HCRx Agreement[191](index=191&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, detailing funding sources and future capital needs - The company has historically funded operations primarily through equity financings, pre-funded warrants, and upfront fees and milestone payments from collaboration agreements[193](index=193&type=chunk) Cash, Cash Equivalents and Short-term Investments (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $16,903 | $25,030 | | Short-term investments | $5,420 | $17,466 | | Total cash, cash equivalents and short-term investments | $22,323 | $42,496 | - Existing cash, cash equivalents, and short-term investments as of June 30, 2025, are **insufficient to fund planned operations for at least 12 months**, raising substantial doubt about the company's ability to continue as a **going concern**[206](index=206&type=chunk) - The company plans to secure additional capital through public or private security offerings, debt, and/or strategic transactions, and anticipates a **$40 million milestone payment** from Pierre Fabre upon tab-cel BLA approval[204](index=204&type=chunk)[207](index=207&type=chunk) [Cash Flows](index=38&type=section&id=Cash%20Flows) This section analyzes the company's cash inflows and outflows from operating, investing, and financing activities, explaining significant changes Net Cash Flows (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(35,456) | $(40,257) | | Net cash provided by investing activities | $12,129 | $21,913 | | Net cash provided by financing activities | $15,054 | $23,817 | - **Net cash used in operating activities decreased by $4.8 million**, primarily due to changes in net working capital following the transfer of manufacturing responsibilities to Pierre Fabre in the first quarter of 2025[201](index=201&type=chunk) - **Net cash provided by financing activities** in the six months ended June 30, 2025, primarily consisted of **$15.3 million in proceeds** from the issuance of prefunded warrants and shares in an underwritten registered direct offering[203](index=203&type=chunk) [Operating Capital Requirements and Plan of Operations](index=39&type=section&id=Operating%20Capital%20Requirements%20and%20Plan%20of%20Operations) This section outlines the company's projected funding needs and strategies to secure additional capital to support future operations and development - The company expects that existing cash, cash equivalents, and short-term investments as of June 30, 2025, combined with an anticipated **$40 million milestone payment**, will provide significant cash runway, but is **insufficient for the next 12 months**[204](index=204&type=chunk)[206](index=206&type=chunk) - Future funding requirements depend on clinical study outcomes, regulatory approvals, commercialization success, and the ability to raise additional capital through equity, debt, or strategic partnerships[208](index=208&type=chunk)[209](index=209&type=chunk)[214](index=214&type=chunk) - The company anticipates generating **losses for the foreseeable future** and will need substantial additional funding in the near term[204](index=204&type=chunk) [Contractual Obligations and Commitments](index=40&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details the company's significant contractual obligations and commitments, including leases and manufacturing agreements - Contractual obligations primarily consist of non-cancellable operating and finance leases and agreements with CROs and CMOs[211](index=211&type=chunk) - No material changes were reported since the Annual Report on Form 10-K for the year ended December 31, 2024, other than those discussed in this document (e.g., assignment of manufacturing agreements to Pierre Fabre)[211](index=211&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section states that there were no material changes to the company's market risk disclosures, including interest rate risk and foreign currency exchange rate risk, during the six months ended June 30, 2025, compared to the previous annual report - **No material changes** to interest rate risk, market risk, or foreign currency exchange rate risk disclosures were reported during the six months ended June 30, 2025[212](index=212&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and reports no material changes in internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Accounting Officer concluded that **disclosure controls and procedures were effective** as of June 30, 2025[215](index=215&type=chunk) - **No material change in internal control over financial reporting** was identified during the three months ended June 30, 2025[216](index=216&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently involved in any material legal proceedings - The company is **not currently involved in any material legal proceedings**[217](index=217&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section details the significant risks associated with investing in the company, covering financial stability, product development, manufacturing, reliance on third parties, intellectual property, market acceptance, regulatory compliance, and general operational challenges - Activities to review strategic alternatives may not result in a transaction or deliver expected benefits, potentially leading to **liquidation and dissolution**[220](index=220&type=chunk)[226](index=226&type=chunk) - The company has incurred **substantial losses since inception**, and future profitability is uncertain, requiring significant near-term financing to continue operations[229](index=229&type=chunk)[237](index=237&type=chunk) - Development and commercialization of T-cell immunotherapies face heightened regulatory scrutiny, lengthy and expensive clinical trials with uncertain outcomes, and potential for undesirable side effects[259](index=259&type=chunk)[270](index=270&type=chunk)[278](index=278&type=chunk) - Dependence on Pierre Fabre for manufacturing and commercialization of tab-cel worldwide poses risks if they fail to meet contractual, regulatory, or other obligations[327](index=327&type=chunk) - Inability to obtain and maintain sufficient intellectual property protection or defend against infringement claims could adversely affect commercialization efforts[333](index=333&type=chunk)[344](index=344&type=chunk) - Market acceptance and adequate reimbursement for products are uncertain, facing intense competition from existing and new therapies[361](index=361&type=chunk)[381](index=381&type=chunk) - The company is subject to complex and changing healthcare laws and regulations (e.g., BPCIA, ACA, IRA, GDPR, HIPAA) and cybersecurity risks, which could lead to fines, liabilities, and reputational harm[367](index=367&type=chunk)[390](index=390&type=chunk)[433](index=433&type=chunk)[449](index=449&type=chunk) [Item 5. Other Information](index=88&type=section&id=Item%205.%20Other%20Information) This section confirms that no Rule 10b5-1 trading arrangements were adopted or terminated by the company's directors or executive officers during the three months ended June 30, 2025 - None of the company's directors or executive officers adopted or terminated any **Rule 10b5-1 trading arrangements** during the three months ended June 30, 2025[468](index=468&type=chunk) [Item 6. Exhibits](index=89&type=section&id=Item%206.%20Exhibits) This section lists the exhibits accompanying the Quarterly Report on Form 10-Q, including corporate governance documents, warrant forms, commercialization agreement amendments, and regulatory certifications - Exhibits include amendments to the Certificate of Incorporation and Bylaws, form of pre-funded warrant, and Amendment No. 2 to the Amended and Restated Commercialization Agreement with Pierre Fabre[469](index=469&type=chunk) - Certifications by the Chief Executive Officer and Principal Financial and Accounting Officer are included pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002[469](index=469&type=chunk) [Signatures](index=90&type=section&id=Signatures) This section contains the official signatures of the company's President and Chief Executive Officer and Chief Accounting Officer, certifying the submission of the Quarterly Report on Form 10-Q - The report was signed by AnhCo Thieu Nguyen, President and Chief Executive Officer, and Yanina Grant-Huerta, Chief Accounting Officer, on August 11, 2025[472](index=472&type=chunk)
Atara Biotherapeutics(ATRA) - 2025 Q2 - Quarterly Results
2025-08-11 20:05
[Filing Information](index=1&type=section&id=Filing%20Information) This section provides the official identification details and securities information for the registrant, Atara Biotherapeutics, Inc [Registrant Details](index=1&type=section&id=Registrant%20Details) This section provides the official identification details for Atara Biotherapeutics, Inc. as the registrant for this Form 8-K filing, including its incorporation state, address, and contact information - Registrant: Atara Biotherapeutics, Inc.[1](index=1&type=chunk) - Incorporation Jurisdiction: Delaware[1](index=1&type=chunk) - Principal Executive Offices: 2380 Conejo Spectrum Street Suite 200, Thousand Oaks, California 91320[1](index=1&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) This part details the registrant's securities registered under Section 12(b) of the Act, specifically its Common Stock, and confirms its status regarding emerging growth company provisions Securities Registered Under Section 12(b) | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :-------------------------------------- | | Common Stock, par value $0.0001 per share | ATRA | The Nasdaq Stock Market LLC | - The registrant is not an emerging growth company.[5](index=5&type=chunk) [Current Report Items](index=2&type=section&id=Current%20Report%20Items) This section outlines preliminary financial estimates, regulatory and business updates for Tabelecleucel, and lists accompanying exhibits [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Atara Biotherapeutics, Inc. announced preliminary estimates for its cash, cash equivalents, and short-term investments as of June 30, 2025. The company explicitly stated that this is a preliminary estimate and does not provide a complete understanding of its financial condition or results of operations for the second quarter - Preliminary estimate of cash, cash equivalents, and short-term investments as of June 30, 2025, was announced on July 14, 2025.[6](index=6&type=chunk) - The preliminary estimate does not present all necessary information for a complete understanding of the Company's financial condition or results of operations for the second quarter ended June 30, 2025.[6](index=6&type=chunk) [Item 8.01 Other Events](index=2&type=section&id=Item%208.01%20Other%20Events) The Company issued a press release on July 14, 2025, providing updates on the regulatory and business status of its product, Tabelecleucel (Tab-cel®). This press release is filed as an exhibit to the 8-K - On July 14, 2025, the Company issued a press release titled 'Atara Biotherapeutics Provides Regulatory and Business Updates on Tabelecleucel (Tab-cel®)'.[7](index=7&type=chunk) - The press release is filed as Exhibit 99.1 and incorporated by reference.[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits accompanying the Form 8-K filing, which include the press release mentioned in Item 8.01 and the interactive data file for the cover page Exhibits | Exhibit No. | Description | | :------------ | :---------------------------------------------- | | 99.1 | Press release, dated July 14, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | [Signatures](index=3&type=section&id=Signatures) This section formally confirms the authorization and signing of the report by the company's executive leadership [Signatures](index=3&type=section&id=Signatures) The report is formally signed on behalf of Atara Biotherapeutics, Inc. by its President and Chief Executive Officer, AnhCo Nguyen, Ph.D., confirming due authorization for the filing - The report was signed on July 14, 2025.[12](index=12&type=chunk) - Signed by AnhCo Nguyen, Ph.D., President and Chief Executive Officer of ATARA BIOTHERAPEUTICS, INC.[13](index=13&type=chunk)
Pierre Fabre Pharmaceuticals Inc. Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Tabelecleucel for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
Prnewswire· 2025-07-24 12:57
Core Perspective - The acceptance of the Biologics License Application (BLA) for tabelecleucel by the FDA represents a significant advancement for patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who currently have limited treatment options and a very short lifespan following initial treatment failure [1][3] Group 1: Company Developments - Pierre Fabre Pharmaceuticals (PFP) has announced the acceptance of the BLA for tabelecleucel, which is targeted for FDA action by January 10, 2026, marking it as the first approved therapy in the U.S. for EBV+ PTLD [1] - Atara Biotherapeutics resubmitted the tabelecleucel BLA on July 11, 2025, after addressing manufacturing facility observations from a previous Complete Response Letter [2] - PFP has taken over global responsibility for tabelecleucel manufacturing for European markets and clinical trial supply since March 31, 2025, following a transfer of the Investigational New Drug Application from Atara Biotherapeutics [5] Group 2: Product Information - Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells, with data from over 430 patients included in the BLA [3] - The therapy has already received marketing authorization in Europe under the brand name EBVALLO™ in December 2022, and in the UK and Switzerland in May 2023 and May 2024, respectively [4] Group 3: Industry Context - The mission of PFP is to provide breakthrough therapies in oncology and rare diseases, focusing on patient populations with high unmet needs [6] - Pierre Fabre Laboratories, the parent company of PFP, operates in 43 countries with over 10,000 employees and aims to create long-term value for patients through innovative partnerships and acquisitions [7]