Summary of Arcellx (NasdaqGS:ACLX) Update / Briefing Company Overview - Arcellx is focused on developing a new class of CAR T therapy, specifically targeting multiple myeloma, with a product named anito-cel [1][2][4] Industry Context - The discussion centers around the evolving landscape of multiple myeloma treatments, particularly the comparison between CAR T therapies and bispecific antibodies [2][9] Key Points and Arguments Efficacy and Safety of Anito-cel - Anito-cel has shown a 100% response rate in phase one studies, with a 79% stringent complete response (sCR) rate and a median progression-free survival (PFS) of 30.2 months [38] - The therapy is positioned as superior to bispecifics in terms of efficacy and safety, with lower rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity (ICANS) [10][12][44] - Anito-cel demonstrated a 96% overall response rate and a 74% stringent sCR rate in a phase two study with a patient population that was heavily pre-treated [41][42] Market Potential - The company estimates a $12 billion market for second-line+ therapies and a $20+ billion market for frontline+ therapies, with conservative class share assumptions that allow for significant market opportunity even with competition from bispecifics [24][25] - The potential for anito-cel to redefine the CAR T category is emphasized, likening its impact to that of the iPhone in the smartphone market [19][22] Commercial Launch Strategy - Arcellx plans to launch anito-cel with a robust commercial strategy, including partnerships with Kite for manufacturing and distribution, aiming for a large footprint and rapid patient access [23][26][32] - The company has engaged 82% of account treatment centers (ATCs) pre-approval, indicating strong interest and readiness for launch [33] Clinical Trials and Future Studies - The iMMagine-3 trial is designed to include a real-world control arm and is enrolling rapidly, with expectations for significant data to support the therapy's efficacy in a broader patient population [17][30] - Future studies, including iMMagine-4 and iMMagine-5, are planned to further explore the therapy's potential in frontline settings and community practices [30][31] Additional Important Insights - The safety profile of anito-cel is highlighted as a key differentiator, with no reported cases of delayed neurotoxicity or secondary malignancies, which are common concerns with other CAR T therapies [46][48] - The discussion includes anecdotal evidence from physicians about the positive impact of anito-cel on patients' quality of life, emphasizing the therapy's potential to allow patients to return to normal activities [59][60] Conclusion - Arcellx is poised to make a significant impact in the treatment of multiple myeloma with anito-cel, which is believed to be a game-changer in terms of efficacy, safety, and market potential [34][35]

Core Insights - Arcellx, Inc. announced positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel) for relapsed or refractory multiple myeloma (RRMM) [1][5] - The study demonstrated a high overall response rate (ORR) of 96% and a complete response/stringent complete response (CR/sCR) rate of 74% [3] - Anito-cel has shown a manageable safety profile with no delayed or non-ICANS neurotoxicities reported [4][5] Study Details - The data presented includes results from 117 patients with a median follow-up of 15.9 months, where 87% were triple refractory and 41% were penta refractory [2] - Patients received a median of three prior lines of therapy, with 56% having received three prior lines [2] Efficacy Metrics - The study reported a very good partial response or higher (VGPR) rate of 88% and 95% of evaluable patients achieved overall minimal residual disease (MRD) negativity [3] - Six-month progression-free survival (PFS) and overall survival (OS) rates were 93.1% and 95.7%, respectively, with 12-month PFS and OS rates at 82.1% and 94.0% [3] Safety Profile - No delayed or non-ICANS neurotoxicities, including Parkinsonism or Guillain-Barré syndrome, have been observed in patients dosed more than 12 months ago [4][5] Future Plans - The company plans for a commercial launch of anito-cel in 2026 and is building a commercial and medical affairs organization to support this [6][11] - The collaboration with Kite, a Gilead Company, aims to co-develop and co-commercialize anito-cel for multiple myeloma [11] Presentation Information - The updated results from the iMMagine-1 study will be presented at the 67th American Society of Hematology (ASH) Annual Meeting on December 6, 2025 [1][7]

Core Insights - Arcellx, Inc. (NASDAQ:ACLX) is recognized as a promising investment opportunity due to its CAR-T therapy, which is expected to perform well in the multiple myeloma market [2][3] Financial Performance - For Q3 2025, Arcellx reported a net loss of $55.8 million, an increase from $25.9 million in Q3 2024 [4] - The company ended the quarter with $576 million in cash, providing operational runway until 2028 [4] - Collaboration revenue significantly decreased from $26 million in Q3 2024 to $4.9 million in Q3 2025 due to the completion of dosing in the iMMagine-1 trial [4] Market Position and Growth Potential - The management is optimistic about capturing a significant share of the second-line to third-line (2L-3L) global multiple myeloma market, particularly in large healthcare enterprises and academic centers [3] - Upcoming data presentations at the ASH meeting are anticipated to validate the durability and efficacy of the company's CAR-T therapy, potentially driving stock upside [3] Analyst Sentiment - Morgan Stanley's analyst Judah Frommer maintained a "Buy" rating for Arcellx, citing the safety profile and high potential for minimal residual disease negativity rates of the CAR-T therapy [2]

Core Insights - Arcellx, Inc. reported a quarterly loss of $0.99 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.96, and a significant increase from a loss of $0.48 per share a year ago [1] - The company posted revenues of $4.95 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 66.2%, and a decline from $26.03 million in the same quarter last year [2] - The stock has gained about 15% since the beginning of the year, closely matching the S&P 500's gain of 15.1% [3] Earnings Outlook - The future performance of Arcellx's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4] - Current consensus EPS estimate for the upcoming quarter is -$0.86 on revenues of $28.28 million, and for the current fiscal year, it is -$3.86 on revenues of $58.58 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Arcellx belongs, is currently ranked in the top 40% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - The correlation between near-term stock movements and earnings estimate revisions suggests that tracking these revisions can provide insights into stock performance [5][6]

Financial Performance - The company reported a net loss of $170.8 million for the nine months ended September 30, 2025, compared to a net loss of $60.3 million for the same period in 2024, resulting in an accumulated deficit of $667.7 million[80]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $152.1 million, compared to $37.4 million in 2024[118]. - The company expects to incur substantial additional losses in future periods as it continues product development and seeks regulatory approvals[116]. Revenue and Expenses - Collaboration revenue decreased to $4.949 million for the three months ended September 30, 2025, down from $26.030 million in 2024, reflecting a change of $21.081 million[103]. - For the nine months ended September 30, 2025, collaboration revenue was $20.6 million, down from $92.7 million in the same period of 2024, a decrease of $72.0 million[110]. - Total operating expenses increased to $66.725 million for the three months ended September 30, 2025, compared to $59.646 million in 2024, an increase of $7.079 million[103]. - General and administrative expenses rose to $31.637 million for the three months ended September 30, 2025, compared to $20.473 million in 2024, an increase of $11.164 million[103]. - General and administrative expenses for the nine months ended September 30, 2025, rose to $86.5 million from $64.6 million in 2024, an increase of $21.9 million[112]. - Research and development expenses were $35.088 million for the three months ended September 30, 2025, down from $39.173 million in 2024, a decrease of $4.085 million[103]. - Total research and development expenses for the nine months ended September 30, 2025, were $123.5 million, an increase of $11.1 million from $112.4 million in 2024[111]. Cash Position - The company sold 1,905,715 shares of common stock in at-the-market offerings for total net proceeds of $131.6 million in 2025[82]. - As of September 30, 2025, the company had cash and cash equivalents and marketable securities totaling $576.0 million[115]. - The company believes its current cash and cash equivalents are adequate to fund operations into 2028[83]. - The company expects to continue incurring significant operating losses and increasing expenses in the foreseeable future due to ongoing research and development activities[80]. Product Development - The company has received FDA clearance for the IND application for ACLX-004, targeting CD33 and CD123 in relapsed or refractory acute myeloid leukemia[78]. - The company is developing a BCMA-targeting ddCAR product candidate called "anito-cel," currently in pivotal Phase 2 and Phase 3 trials for relapsed or refractory multiple myeloma[76].

Financial Results Announcement - Arcellx, Inc. announced its financial results for the fiscal quarter ended September 30, 2025[6] - The press release detailing the financial results was issued on November 5, 2025[6] Company Information - The company is listed on The Nasdaq Stock Market under the symbol ACLX[5]

Core Insights - Arcellx, Inc. (ACLX) is anticipated to report a year-over-year decline in earnings due to lower revenues for the quarter ended September 2025, with a consensus EPS estimate of a loss of $0.96 per share, reflecting a -100% change [1][3] - Revenues are projected to be $14.64 million, down 43.8% from the same quarter last year [3] - The consensus EPS estimate has been revised 12.39% higher in the last 30 days, indicating a reassessment by analysts [4] Earnings Expectations - The upcoming earnings report could lead to a stock price increase if results exceed expectations, while a miss could result in a decline [2] - The Earnings Whisper model suggests that revisions prior to earnings releases provide insights into business conditions [7] Earnings Surprise Prediction - The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, with a positive Earnings ESP indicating a likely earnings beat [8][9] - For Arcellx, the Most Accurate Estimate is higher than the consensus, resulting in an Earnings ESP of +7.60%, suggesting a strong likelihood of beating the consensus EPS estimate [12] Historical Performance - In the last reported quarter, Arcellx was expected to post a loss of $1.03 per share but actually reported a loss of -$0.94, achieving a surprise of +8.74% [13] - Over the past four quarters, Arcellx has beaten consensus EPS estimates two times [14] Industry Context - Another company in the biomedical sector, Geron (GERN), is expected to report a loss of $0.03 per share, indicating a year-over-year change of +25%, with revenues projected at $52.49 million, up 85.7% [18] - Geron's consensus EPS estimate has been revised 7.7% lower, resulting in an Earnings ESP of -32.35%, combined with a Zacks Rank of 4 (Sell), making it challenging to predict an earnings beat [19][20]

Company Overview - Arcellx was founded approximately 10 years ago with the aim of addressing three primary needs in cell therapy: safety, efficacy, and scale, along with reliable manufacturability to enhance accessibility [2] - The company has developed a core technology known as the D-Domain, which is utilized in its lead asset, anito-cel, considered a best-in-class therapeutic option for patients with multiple myeloma [2] Pipeline and Development - Arcellx is actively leveraging its technology in ongoing clinical trials for acute myeloid leukemia (AML) and myasthenia gravis, indicating a commitment to expanding its therapeutic applications [3]

Summary of Arcellx Conference Call Company Overview - **Company**: Arcellx - **Lead Asset**: Anitocabtagene autoleucel (anito-cel), a BCMA-directed CAR-T therapy for multiple myeloma - **Founded**: Approximately 10 years ago - **Core Technology**: D-domain technology aimed at improving safety, efficacy, and manufacturability in cell therapy [2][3] Key Points on Anitocabtagene Autoleucel (anito-cel) - **Efficacy Data**: - Complete response (CR) rate increased from the 60s to the 70s percentage range - Progression-free survival (PFS) rates: 92% at 6 months, 66% at 18 months - Minimal residual disease (MRD) negativity rate in the low 90% range [5][6] - **Safety Profile**: - No cases of delayed neurotoxicity or immune-related enterocolitis observed in patients with at least four months of follow-up - Differentiation from other therapies due to the absence of these adverse events [6][7] - **Market Research**: - Increased confidence among physicians regarding the safety profile of anito-cel, leading to an anticipated increase in market share [9][10] Regulatory Path and Market Opportunities - **Regulatory Confidence**: - Established regulatory paths for approval, with confidence in the FDA's commitment to expedite lifesaving therapies - Anticipated BLA submission in late 2023 to early 2024, with a market launch expected in mid to late 2026 [15][20] - **Unmet Needs**: - Significant unmet needs in late-line multiple myeloma treatment due to safety issues with existing therapies - Access issues persist despite the presence of other CAR-T therapies in the market [17][18] Market Dynamics and Commercial Strategy - **Market Size**: - The second-line market for CAR-T therapies is estimated at $12 billion, with anitocabtagene autoleucel targeting the fourth-line plus setting, representing a $3.5 billion opportunity [22][23] - **Adoption in Community Settings**: - Anticipated rapid adoption in community oncology centers, driven by safety benefits and the need for effective treatment options [27][32] - **Market Share Expectations**: - Research indicates a potential market share of around 80% for anito-cel upon launch, driven by favorable physician preferences [30] Clinical Trials and Future Developments - **Imagen-3 Trial**: - Designed to include a broader patient population and incorporate MRD negative CR as a co-primary endpoint, enhancing the likelihood of regulatory approval [36][37] - **Myasthenia Gravis Study**: - Ongoing phase one study with a focus on eliminating plasma cells to address antibody-driven damage at the neuromuscular junction [41] Financial Position - **Cash Runway**: - Ended Q2 with $538 million in cash, expected to fund operations through 2028, including the launch of anitocabtagene autoleucel [47] Additional Insights - **AI Utilization**: - Leveraging AI for optimizing D-domains and generating binders, enhancing R&D capabilities [53] - **Regulatory Environment**: - No significant impact from recent regulatory changes or tariffs on operational performance [54] This summary encapsulates the critical insights from the Arcellx conference call, highlighting the company's strategic direction, product differentiation, and market potential in the evolving landscape of cell therapies.

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Arcellx, Inc.'s unaudited financial statements reflect decreased cash, assets, and collaboration revenue, alongside an increased net loss [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $62,336 | $105,679 | | Marketable securities | $475,269 | $519,973 | | Total current assets | $463,895 | $599,310 | | **Total assets** | **$619,086** | **$711,327** | | **Liabilities & Equity** | | | | Total current liabilities | $121,850 | $125,405 | | Total liabilities | $226,863 | $256,535 | | Total stockholders' equity | $392,223 | $454,792 | | **Total liabilities and stockholders' equity** | **$619,086** | **$711,327** | - Total assets decreased from **$711.3 million** at the end of 2024 to **$619.1 million** as of June 30, 2025, primarily driven by a reduction in cash and marketable securities[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $7,554 | $27,384 | $15,683 | $66,640 | | Research and development | $37,627 | $40,953 | $88,428 | $73,271 | | General and administrative | $28,653 | $21,424 | $54,879 | $44,172 | | Loss from operations | $(58,726) | $(34,993) | $(127,624) | $(50,803) | | **Net loss** | **$(52,771)** | **$(27,202)** | **$(115,041)** | **$(34,400)** | | Net loss per share | $(0.94) | $(0.51) | $(2.06) | $(0.65) | - Net loss for the six months ended June 30, 2025, increased significantly to **$115.0 million** from **$34.4 million** in the prior year period, largely due to a sharp decline in collaboration revenue and increased operating expenses[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(102,876) | $(68,156) | | Net cash provided by (used in) investing activities | $48,525 | $(214,685) | | Net cash provided by (used in) financing activities | $10,800 | $(13,412) | | **Net decrease in cash, cash equivalents, and restricted cash** | **$(43,551)** | **$(296,253)** | - Cash used in operating activities increased to **$102.9 million** in the first six months of 2025, up from **$68.2 million** in the same period of 2024, reflecting the higher net loss adjusted for non-cash items[25](index=25&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - As of June 30, 2025, the company had **$537.6 million** in cash, cash equivalents, and marketable securities, which management believes is sufficient to fund operations and capital expenditures for at least the next twelve months[28](index=28&type=chunk) - The collaboration with Kite involves co-development and co-commercialization of anito-cel. Arcellx is eligible for up to **$530.0 million** in milestones for anito-cel, plus additional milestones for other products. Revenue is recognized using a cost-based input method[43](index=43&type=chunk)[45](index=45&type=chunk)[50](index=50&type=chunk) - The company has potential future milestone payment obligations to vendors, including up to **$25.3 million** for development milestones and up to **$52.0 million** for commercial milestones[53](index=53&type=chunk) - During Q2 2025, the company sold **120,000 shares** of common stock through its at-the-market (ATM) offering program, generating net proceeds of **$7.8 million**[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, highlighting decreased collaboration revenue, increased net loss, and sufficient liquidity to fund operations into 2028 [Overview](index=21&type=section&id=Overview) - Arcellx is a **clinical-stage biotechnology company** focused on developing immunotherapies for cancer and other incurable diseases using its novel **D-Domain synthetic binding scaffold**[73](index=73&type=chunk) - The lead program, **anito-cel**, is being evaluated in a **pivotal Phase 2 trial (iMMagine-1)** and a **Phase 3 trial (iMMagine-3)** for **relapsed or refractory multiple myeloma (rrMM)**, in partnership with Kite Pharma[74](index=74&type=chunk) - Preliminary data from the **iMMagine-1 trial** was presented in **June 2025**. Kite has initiated the global **Phase 3 iMMagine-3 trial** and is manufacturing anito-cel for it[75](index=75&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$611.9 million**, with net losses of **$115.0 million** for the first six months of 2025[78](index=78&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Comparison of Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $7,554 | $27,384 | $(19,830) | | R&D Expenses | $37,627 | $40,953 | $(3,326) | | G&A Expenses | $28,653 | $21,424 | $7,229 | | **Net loss** | **$(52,771)** | **$(27,202)** | **$(25,569)** | - The decrease in **Q2 2025 collaboration revenue** was primarily driven by the completion of dosing and manufacturing for the **iMMagine-1 trial** in **late 2024**[98](index=98&type=chunk) Comparison of Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $15,683 | $66,640 | $(50,957) | | R&D Expenses | $88,428 | $73,271 | $15,157 | | G&A Expenses | $54,879 | $44,172 | $10,707 | | **Net loss** | **$(115,041)** | **$(34,400)** | **$(80,641)** | - The increase in **R&D expenses** for the **first half of 2025** was mainly due to a **$15.9 million** increase in internal costs, primarily higher personnel-related and share-based compensation expenses[105](index=105&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling **$537.6 million**[109](index=109&type=chunk) - Management believes the current cash position is adequate to fund operations **into 2028**, based on expected operating requirements and capital expenditures[111](index=111&type=chunk) - Net cash used in operating activities was **$102.9 million** for the first six months of 2025, primarily due to the net loss of **$115.0 million**, offset by non-cash share-based compensation of **$41.9 million**[113](index=113&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to U.S. interest rate changes, affecting its $537.6 million portfolio of cash, cash equivalents, and marketable securities - The company is exposed to **interest rate sensitivity risk** on its portfolio of cash, cash equivalents, and marketable securities, which totaled **$537.6 million** as of June 30, 2025[126](index=126&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **effective** as of the end of the period covered by this report[128](index=128&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[129](index=129&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material litigation or legal proceedings expected to adversely affect its business - As of the reporting date, Arcellx is **not involved in any material legal proceedings**[131](index=131&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including limited operating history, clinical development uncertainties, reliance on third parties, intellectual property, regulations, commercialization, and stock volatility [Risks Related to Our Limited Operating History, Financial Condition, and Capital Requirements](index=37&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%2C%20Financial%20Condition%2C%20and%20Capital%20Requirements) - The company has a **limited operating history**, has incurred **significant losses** since inception, and expects losses to continue. As of June 30, 2025, the accumulated deficit was **$611.9 million**[143](index=143&type=chunk)[144](index=144&type=chunk) - **Substantial additional funding** will be required to advance product candidates through clinical development and potential commercialization[145](index=145&type=chunk) [Risks Related to Development of Our Product Candidates](index=39&type=section&id=Risks%20Related%20to%20Development%20of%20Our%20Product%20Candidates) - The company's ddCAR and ARC-SparX platforms are **novel and unproven**, making it **difficult to predict development timing, costs, and regulatory approval**[157](index=157&type=chunk) - The FDA previously issued and lifted a **partial clinical hold** on anito-cel, and there is **no assurance** that another clinical hold will not be issued in the future[152](index=152&type=chunk)[171](index=171&type=chunk) - Product candidates may cause **undesirable side effects**, such as **cytokine release syndrome** and **neurologic toxicities**, which could **halt clinical development or prevent regulatory approval**[187](index=187&type=chunk) - Manufacturing genetically engineered cell therapies is **complex** and subject to risks, including **difficulties in production, sourcing key components, and maintaining quality control**[200](index=200&type=chunk)[201](index=201&type=chunk) [Risks Related to Our Business](index=59&type=section&id=Risks%20Related%20to%20Our%20Business) - The company faces **significant competition** from other biotechnology and pharmaceutical companies with **greater financial and technical resources**[214](index=214&type=chunk)[216](index=216&type=chunk) - The business is **highly dependent on key personnel**, and the **inability to attract and retain qualified individuals** could harm the implementation of its business strategy[229](index=229&type=chunk) - **Global economic conditions**, including **inflation** and **market volatility**, as well as **geopolitical instability**, could **adversely affect the business and financial condition**[218](index=218&type=chunk)[219](index=219&type=chunk) [Risks Related to Reliance on Third Parties](index=72&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) - The company **relies on third parties**, such as CROs and medical institutions, to conduct its clinical trials, which **limits direct control** over timing and execution[271](index=271&type=chunk)[272](index=272&type=chunk) - The company **depends on its collaboration with Kite** for the development, manufacturing, and commercialization of anito-cel and other specified product candidates[284](index=284&type=chunk)[285](index=285&type=chunk) - Reliance on third-party manufacturers exposes the company to risks such as **production delays, quality control issues, and compliance failures** with cGMP regulations[276](index=276&type=chunk) [Risks Related to Our Intellectual Property](index=81&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success is **heavily dependent on patent protection** for its platforms and product candidates, which is an **expensive and uncertain process**[297](index=297&type=chunk)[298](index=298&type=chunk) - The company may face **third-party claims of intellectual property infringement**, which could lead to **costly litigation, delays, or prevent commercialization** of its products[316](index=316&type=chunk) - Changes in U.S. patent law and court decisions have increased **increased uncertainty** regarding the scope and enforceability of patents in the biopharmaceutical industry[327](index=327&type=chunk)[328](index=328&type=chunk) [Risks Related to Government Regulation](index=95&type=section&id=Risks%20Related%20to%20Government%20Regulation) - The FDA regulatory approval process is **lengthy, time-consuming, and unpredictable**, and there is **no guarantee** that any product candidates will be approved[338](index=338&type=chunk)[342](index=342&type=chunk) - Even if approved, the company will be subject to **extensive ongoing regulatory obligations**, and failure to comply could result in **significant penalties or withdrawal of approval**[358](index=358&type=chunk) - **Healthcare reform legislation**, such as the **Inflation Reduction Act**, and other changes in healthcare policy could **adversely affect drug pricing, reimbursement, and profitability**[365](index=365&type=chunk)[384](index=384&type=chunk) [Risks Related to Commercialization of Our Product Candidates](index=107&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates) - Approved products may **fail to gain market acceptance** among physicians, patients, and payors due to factors like perceived safety, efficacy, cost, and competition[370](index=370&type=chunk) - The company currently has **no sales organization** and **limited marketing experience**, which could **hinder its ability to generate revenue** from any approved products[389](index=389&type=chunk) - Successful commercialization depends on **securing adequate coverage and reimbursement** from third-party payors, which is a **complex and uncertain process**[374](index=374&type=chunk)[375](index=375&type=chunk) [Risks Related to Ownership of our Common Stock](index=118&type=section&id=Risks%20Related%20to%20Ownership%20of%20our%20Common%20Stock) - The trading price of the company's common stock has been and is likely to continue to be **highly volatile**[409](index=409&type=chunk) - Future sales of common stock to raise capital will result in **dilution to existing stockholders**[412](index=412&type=chunk)[414](index=414&type=chunk) - Gilead holds approximately **12%** of the company's outstanding common stock, and future sales by Gilead could **negatively impact the stock price**[418](index=418&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=128&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during Q2 2025 that were not previously disclosed in a Form 8-K - **No unregistered sales of equity securities** occurred during the quarter that were not previously reported[431](index=431&type=chunk) [Item 3. Defaults Upon Senior Securities](index=128&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities during the reporting period - None[432](index=432&type=chunk) [Item 4. Mine Safety Disclosures](index=128&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[433](index=433&type=chunk) [Item 5. Other Information](index=128&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the last fiscal quarter - **No directors or officers adopted or terminated a Rule 10b5-1 trading plan** during the quarter ended June 30, 2025[434](index=434&type=chunk) [Item 6. Exhibits](index=129&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including officer certifications - The report includes a list of filed exhibits, such as **officer certifications (31.1, 31.2, 32.1, 32.2)** and **XBRL data files**[435](index=435&type=chunk)[436](index=436&type=chunk)