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)

[Report Overview and Company Information](index=1&type=section&id=Report%20Overview%20and%20Company%20Information) This section details Arcellx, Inc.'s corporate information, including its incorporation, executive offices, and Nasdaq stock listing as of August 7, 2025 - The report is a **Form 8-K Current Report** filed by Arcellx, Inc. with a report date of August 7, 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - Arcellx, Inc. is incorporated in **Delaware** with principal executive offices in **Redwood City, California**[2](index=2&type=chunk) Securities Registration | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :--- | :--- | :--- | | Common Stock, $0.001 par value per share | ACLX | The Nasdaq Stock Market LLC | [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Arcellx, Inc. announced its Q2 2025 financial results via a press release, furnished but not filed with the SEC - The company issued a press release on **August 7, 2025**, announcing financial results for the fiscal quarter ended **June 30, 2025**[6](index=6&type=chunk) - The press release is attached as **Exhibit 99.1** to this Form 8-K[6](index=6&type=chunk) - Information under Item 2.02, including the exhibit, is **furnished** not **filed**, limiting liabilities under Section 18 of the Securities Exchange Act of 1934[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section details the exhibits filed with the Form 8-K, primarily the financial results press release and interactive data file Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release dated August 7, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL Document) | [Signatures](index=4&type=section&id=Signatures) The report is formally concluded and authenticated by the signature of the company's Chief Executive Officer - The report was duly signed on **August 7, 2025**, on behalf of Arcellx, Inc.[11](index=11&type=chunk)[13](index=13&type=chunk) - The signatory is **Rami Elghandour**, Chief Executive Officer of Arcellx, Inc.[13](index=13&type=chunk)

Company Overview - Arcellx, Inc. (NASDAQ: ACLX) is advancing its lead CAR-T cell therapy, anitocabtagene Autoleucel (anito-cel), aimed at treating patients with relapsed/refractory multiple myeloma (r/r MM) [2] Industry Insights - The article highlights the importance of deep-dive analysis in the pharmaceutical sector, particularly for investors interested in biotech companies [2]

Anito-cel Product Profile and Clinical Data - Anito-cel, a BCMA-directed CAR T-cell therapy, utilizes a novel D-Domain binder, potentially offering a best-in-class efficacy profile, differentiated safety, and rapid manufacturing[7, 8, 9, 15] - Phase 1 data showed a median Progression-Free Survival (PFS) of 30.2 months[17] - In the iMMagine-1 pivotal trial, the Overall Response Rate (ORR) was 97%, with a stringent Complete Response/Complete Response (sCR/CR) rate of 68%[92] - iMMagine-1 demonstrated a 6-month PFS rate of 91.9% and a 12-month PFS rate of 79.3%[98] - iMMagine-1 showed a favorable safety profile, with 85% of patients experiencing < Grade 1 Cytokine Release Syndrome (CRS) and 92% experiencing no Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)[17, 108, 118] Market Opportunity and Commercial Strategy - The Multiple Myeloma (MM) CAR T market is projected to reach approximately $12 billion in the 2L+ setting[7, 19, 21, 55, 61] - Arcellx anticipates a high gross margin of ≥70% at launch for anito-cel, with profitability achievable before reaching $1 billion in anito-cel sales[51, 55] - Post-approval, 90% of US Healthcare Professionals (HCPs) are motivated to prescribe anito-cel[30] - Anito-cel is expected to launch with a large Authorized Treatment Center (ATC) network, projected to be 160+ ATCs, leveraging Kite's infrastructure[17, 33, 62] - Payer coverage for anito-cel is projected to be >80% of US lives within 30 days and >90% within 90 days post-launch[45]

Summary of Arcellx (ACLX) Investor Relations Event - June 13, 2025 Company Overview - **Company**: Arcellx (ACLX) - **Event**: Investor Relations event held in Milan - **Focus**: Development of a novel cell therapy, Anitosel, targeting multiple myeloma Key Industry Insights - **Market Size**: - The second line plus market for multiple myeloma is estimated at **$12 billion** - The frontline market is projected to reach **$20 billion** - The fourth line plus population is approximately **$3.5 billion** [7][8][9] - **Market Research**: - Conducted with over **300 hematologists and oncologists** to assess market share and therapy adoption [11] - Anitosel is expected to capture a **58% market share** in 2024, increasing to **83%** in 2025 [12][13] Product Development and Clinical Trials - **Anitosel**: - A novel synthetic binder developed to address limitations of biologic-based binders, focusing on safety, scale, and manufacturability [5][6] - Strong clinical data in relapsed and refractory myeloma populations [6] - **IMMAGINE-one Study**: - Phase 2 study with **129 patients** enrolled, showing a **97% overall response rate** and **68% complete response rate** [31][33] - Median progression-free survival (PFS) of **30.2 months** and no delayed neurotoxicities reported [32][39] Launch Strategy - **Launch Timeline**: Anticipated launch of Anitosel in the U.S. in **mid to late 2026** [5] - **Market Access**: - Plans to access **80% of covered lives** within **30 days** of launch and **90% within 90 days** [21][22] - **Manufacturing Capacity**: - Expected to cover the majority of the fourth line plus population at launch, with a global potential of over **24,000 doses** [17][19] Operational Excellence - **Turnaround Time**: Expected turnaround time for Anitosel is less than **17 days**, with a high in-spec rate of **96%** [18][19] - **Partnership with Kite**: - Collaboration with Kite to leverage their expertise in cell therapy, enhancing operational efficiency and reducing costs [24][21] Financial Outlook - **Profitability**: Expected gross margins of **≥70%** at launch, with profitability anticipated at less than **$1 billion** in Anitosel sales [23][24] - **Capital Management**: As of Q1, the company has **$565 million** remaining on its balance sheet, reflecting operational efficiency [23] Safety and Efficacy - **Safety Profile**: - Anitosel demonstrated a predictable and manageable safety profile with no delayed neurotoxicities observed [39][40] - **85%** of patients experienced grade one or less cytokine release syndrome (CRS) [36] Conclusion - **Market Positioning**: Anitosel is positioned to be a leading CAR T therapy in the myeloma space, with a strong focus on patient safety, operational excellence, and market access strategies [28][29]

Summary of the Conference Call Company and Industry - The conference call involved **Arcelix**, a company in the **biotechnology** sector, specifically focusing on therapies for **multiple myeloma**. Core Points and Arguments 1. **Data Release and Efficacy**: Arcelix presented data from their **IMGIGINE-one** registrational trial, highlighting a **68% complete response rate** with a median follow-up of **12.5 months**. This positions their therapy, **anitosella**, as a leading option in the myeloma community [5][7][8]. 2. **Safety Profile**: The company emphasized that no cases of delayed events, such as **Parkinsonism** or **enterocolitis**, have been observed, suggesting a superior safety profile compared to competitors like **Carvicti** [8][9][16]. 3. **Manufacturing and Scalability**: Kite is responsible for manufacturing, and the company is confident in their ability to deliver the product reliably and at scale, with manufacturing times within the commercial specifications of **14 to 17 days** [41][42]. 4. **Regulatory Filing Timeline**: Arcelix aims for a **BLA filing** by mid to late **2026**, with productive discussions with the FDA ongoing [36][39]. 5. **Market Positioning**: The company plans to differentiate its launch strategy from previous CAR T therapies by ensuring better availability and reliability, addressing physician concerns about therapy access [43][44]. Additional Important Content 1. **Comparison with Competitors**: The company believes that the safety and efficacy data do not support the notion of a class effect among CAR T therapies, indicating that their product is distinct [9][19][31]. 2. **Patient Enrollment Challenges**: It was noted that excluding patients with peripheral neuropathy from trials would be impractical, as a significant percentage of patients experience this condition post-treatment [24]. 3. **ALC Monitoring**: The company does not monitor **Absolute Lymphocyte Count (ALC)** as a treatment intervention but captures it for analysis. They believe that ALC levels do not correlate directly with safety profiles as suggested by competitors [21][51][54]. 4. **Future Data Updates**: The next data update is expected at the **ASH** conference in December, which will provide additional follow-up data [34]. This summary encapsulates the key points discussed during the conference call, focusing on the company's product, its competitive advantages, and future plans in the biotechnology sector.