Atara Biotherapeutics(ATRA) - 2025 Q2 - Quarterly Report

Forward-Looking Statements 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] - These statements involve risks and uncertainties, with many discussed in detail under "1A. Risk Factors"[11] Summary Risk Factors 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] - The company has incurred substantial losses since inception and may never achieve sustained profitability, requiring substantial near-term financing[13] - Ebvallo is the only approved product (EEA, UK, Switzerland); allogeneic CAR T programs have been paused[13] - T-cell immunotherapy product candidates face heightened regulatory scrutiny, and clinical trial results are not necessarily predictive of future success[13] - Workforce reductions may not result in anticipated savings and could disrupt business operations[15] PART I. FINANCIAL INFORMATION Item 1. Financial Statements (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 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] - Total liabilities decreased from $206.4 million to $71.9 million, largely due to a substantial reduction in deferred revenue[17] Condensed Consolidated Statements of Operations and Comprehensive Income (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] - 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] Condensed Consolidated Statements of Changes in Stockholders' Equity (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] - 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] Condensed Consolidated Statements of Cash Flows 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] - 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] Notes to Condensed Consolidated Financial Statements 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 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] - Tab-cel (Ebvallo™) has received marketing authorization in the EEA, UK, and Switzerland, and is currently in Phase 3 development in the US[28] - 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] - 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][32][33] Note 2. Summary of Significant Accounting Policies 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] - 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][39] - 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] Note 3. Net Income (Loss) per Common Share 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] Note 4. Financial Instruments 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] - 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][52] Note 5. Out-license Agreements 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] - All manufacturing responsibility for tab-cel was transferred to Pierre Fabre by March 2025, and all clinical and development responsibility by July 2025[60][64] - 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] 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 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][79] - The liability is amortized using the effective interest method, with an annual effective interest rate of approximately 9% as of June 30, 2025[81] 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 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] - 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] - 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] 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 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][94][96][97] 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 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][105] - A dispute with MSK regarding $6.0 million in sub-licensing fees was settled in March 2025, with MSK returning $3.0 million[103][104] - Rights to the ATA188 and EBV Vaccine programs were returned to QIMR in May 2025[105] - 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][109][111] Note 10. Stockholders' Equity (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][118][120][122][124] - 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][129] 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 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 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 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] - Development of allogeneic CAR T cell programs (ATA3219, ATA3431) and ATA188 for MS has been paused or discontinued[146] - All manufacturing, clinical, and development responsibility for tab-cel was transferred to Pierre Fabre by July 2025[149] - 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] Financial Overview 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] - Accumulated deficit as of June 30, 2025, was $2.0 billion[171] 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] 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] - 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] Cost of Commercialization Revenue 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] - 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] Research and Development Expenses 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] - 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] General and Administrative Expenses 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] Other Income (Expense), Net 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] - 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] Liquidity and Capital Resources 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] 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] - 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][207] Cash Flows 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] - 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] Operating Capital Requirements and Plan of Operations 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][206] - 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][209][214] - The company anticipates generating losses for the foreseeable future and will need substantial additional funding in the near term[204] Contractual Obligations and Commitments 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] - 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] Item 3. Quantitative and Qualitative Disclosures about Market Risk 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] Item 4. Controls and Procedures 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] - No material change in internal control over financial reporting was identified during the three months ended June 30, 2025[216] PART II. OTHER INFORMATION Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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][226] - The company has incurred substantial losses since inception, and future profitability is uncertain, requiring significant near-term financing to continue operations[229][237] - 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][270][278] - 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] - Inability to obtain and maintain sufficient intellectual property protection or defend against infringement claims could adversely affect commercialization efforts[333][344] - Market acceptance and adequate reimbursement for products are uncertain, facing intense competition from existing and new therapies[361][381] - 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][390][433][449] Item 5. Other Information 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] Item 6. Exhibits 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] - 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] 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]