Fate Therapeutics Conference Call Summary Company Overview - **Company**: Fate Therapeutics (FATE) - **Industry**: Biotechnology, specifically focusing on CAR T cell therapies for oncology and autoimmune diseases - **Tagline**: "Making transformative medicine accessible to all" [2] Key Points and Arguments CAR T Cell Technology - Fate Therapeutics is pioneering CAR T cell therapies, emphasizing the unique ability of CAR T to expand upon antigen engagement, making it a "living drug" [3] - The company utilizes stem cells to produce nearly unlimited amounts of CAR T cells, aiming for an "off the shelf" solution that enhances accessibility [3][4] Competitive Landscape - The company acknowledges competition in the autoimmune space, particularly with CD19 CAR T therapies and other modalities like T cell engagers (TCEs) [5] - Fate's FT819 is positioned as superior due to its accessibility and unique mechanism, which does not rely on the patient's immune system as heavily as other therapies [6][8] Efficacy and Safety - FT819 has shown promising preclinical results, with a 40% complete response (CR) rate in aggressive lymphoma patients [13] - The company aims to balance safety and efficacy, with a focus on operational feasibility, including reducing hospitalization requirements to potentially none by year-end [16][29] Treatment Regimens - Two treatment regimens are being explored: - **Regimen A**: Light conditioning with cyclophosphamide, which is familiar to rheumatologists [18][20] - **Regimen B**: Administering FT819 on top of maintenance therapy, with ongoing dose-finding studies [22][24] - The company has received RMAT designation from the FDA for both regimens, indicating a collaborative relationship with regulatory bodies [27] Enrollment and Site Activation - Fate has activated eight sites within four months, with expectations to reach around 20 sites by year-end, significantly improving patient enrollment rates [30][34] - The company is experiencing a shift from low patient enrollment per site to a more traditional model of higher patient numbers per site [32] Future Data and Trials - Upcoming data presentations are expected at ACR, with a focus on the efficacy and safety of FT819 and the removal of hospitalization requirements [37] - The company is also expanding its pipeline to include other autoimmune diseases beyond lupus, with positive discussions with the FDA regarding additional indications [39] Manufacturing and Capacity - Fate has established a master cell bank capable of producing 400 vials, each yielding trillions of CAR T cells, indicating a robust manufacturing capability [42][44] - The company can produce approximately 50,000 doses per year and is exploring options for increased production without additional capital investment [44][45] Financial Position - Fate has extended its cash runway to 2027, with a focus on prioritizing the FT819 program while also advancing next-generation products [59] - The company is strategically managing its resources to ensure successful completion of pivotal studies and continued development of its pipeline [59] Additional Important Insights - The CEO emphasized the importance of operational feasibility and patient experience, aiming to minimize the burden on patients undergoing treatment [15][16] - The company is leveraging its unique manufacturing capabilities to differentiate itself from competitors in the CAR T space [45][46]

Fate Therapeutics (FATE) came out with a quarterly loss of $0.29 per share versus the Zacks Consensus Estimate of a loss of $0.35. This compares to a loss of $0.33 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +17.14%. A quarter ago, it was expected that this clinical-stage biotech company that develops stem cell treatments would post a loss of $0.39 per share when it actually produced a loss of $0.32, delivering a surprise ...

[SUMMARY OF RISK FACTORS](index=3&type=section&id=SUMMARY%20OF%20RISK%20FACTORS) This section provides a high-level overview of the principal factors that make an investment in the Company's common stock speculative or risky, covering aspects such as product development, funding, competition, manufacturing, intellectual property, and market conditions - Product candidates are novel, may cause undesirable side effects, and face risks in preclinical/clinical development, regulatory approval, and commercial potential[9](index=9&type=chunk) - **Substantial additional funding is required** for product development, which may cause dilution to stockholders[9](index=9&type=chunk) - The Company utilizes proprietary induced pluripotent stem cell (iPSC) and gene-editing technologies, which are critical for the creation of its product candidates[9](index=9&type=chunk) - Clinical trials may face delays in initiation, conduct, or completion due to various factors, including patient recruitment and manufacturing of adequate clinical supplies[9](index=9&type=chunk) - The Company operates in a highly competitive environment with rapid technological change, and failure to compete effectively could harm operating results[9](index=9&type=chunk) - Manufacturing and distribution of product candidates are complex and subject to risks, potentially limiting supply and increasing costs[9](index=9&type=chunk) - The Company has a **limited operating history**, has **incurred significant losses** since inception, and anticipates continued losses for the foreseeable future[10](index=10&type=chunk) - Dependence on strategic partnerships and collaboration arrangements for development and commercialization of certain product candidates[10](index=10&type=chunk) - Inability to protect intellectual property or obtain/maintain patent protection could reduce demand for products and harm the business[10](index=10&type=chunk) - The Company lacks experience in marketing products and does not have a sales force or distribution capabilities[10](index=10&type=chunk) - Global economic and market conditions, public health emergencies, and geopolitical tensions could adversely impact various aspects of the business[10](index=10&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the Company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of cash flows, and accompanying notes, providing a detailed financial overview for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the Company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $41,249 | $36,056 | | Accounts receivable | $1,395 | $3,539 | | Short-term investments | $181,581 | $243,012 | | Prepaid expenses and other current assets | $6,172 | $9,302 | | Total current assets | $230,397 | $291,909 | | Long-term investments | $26,097 | $27,657 | | Property and equipment, net | $61,097 | $64,384 | | Operating lease right-of-use assets | $43,814 | $46,508 | | Restricted cash | $10,227 | $10,227 | | Other assets | $0 | $9 | | **Total assets** | **$371,632** | **$440,694** | | **Liabilities and Stockholders' Equity** | | | | **Current liabilities:** | | | | Accounts payable | $4,040 | $9,365 | | Accrued expenses | $18,182 | $21,348 | | CIRM award liability, current portion | $795 | $0 | | Deferred revenue | $0 | $393 | | Operating lease liabilities, current portion | $5,656 | $7,416 | | Total current liabilities | $28,673 | $38,522 | | CIRM award liability, net of current portion | $5,600 | $5,070 | | Operating lease liabilities, net of current portion | $75,675 | $77,849 | | Stock price appreciation milestones | $320 | $527 | | **Total liabilities and stockholders' equity** | **$371,632** | **$440,694** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the Company's financial performance over specific periods, including revenue, expenses, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $1,907 | $6,772 | $3,536 | $8,697 | | Research and development | $27,430 | $34,604 | $56,566 | $66,742 | | General and administrative | $11,445 | $17,251 | $25,218 | $38,106 | | Total operating expenses | $38,875 | $51,855 | $81,784 | $104,848 | | Loss from operations | $(36,968) | $(45,083) | $(78,248) | $(96,151) | | Interest income | $2,921 | $4,827 | $6,257 | $8,976 | | Change in fair value of stock price appreciation milestones | $(73) | $1,556 | $207 | $162 | | Other income | $50 | $273 | $93 | $582 | | Total other income | $2,898 | $6,656 | $6,557 | $9,720 | | Net loss | $(34,070) | $(38,427) | $(71,691) | $(86,431) | | Unrealized loss on available-for-sale securities, net | $(129) | $(228) | $(206) | $(437) | | Comprehensive loss | $(34,199) | $(38,655) | $(71,897) | $(86,868) | | Net loss per common share, basic and diluted | $(0.29) | $(0.33) | $(0.61) | $(0.79) | | Weighted-average common shares used to compute basic and diluted net loss per share | 118,528,046 | 117,468,124 | 118,452,214 | 109,286,235 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the Company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Operating activities** | | | | Net loss | $(71,691) | $(86,431) | | Depreciation and amortization | $6,611 | $9,542 | | Stock-based compensation | $14,535 | $20,611 | | Net cash used in operating activities | $(58,396) | $(65,656) | | **Investing activities** | | | | Purchases of investments | $(99,437) | $(215,001) | | Maturities of investments | $164,137 | $179,079 | | Net cash provided by (used in) investing activities | $62,264 | $(36,059) | | **Financing activities** | | | | Proceeds from FT836 CIRM award | $1,325 | $0 | | Proceeds from public offering of common stock, net | $0 | $74,531 | | Proceeds from issuance of pre-funded warrants, net | $0 | $19,996 | | Net cash provided by financing activities | $1,325 | $96,762 | | Net change in cash, cash equivalents and restricted cash | $5,193 | $(4,953) | | Cash, cash equivalents and restricted cash at end of the period | $51,476 | $52,094 | [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering significant accounting policies, collaboration agreements, CIRM awards, investments, fair value measurements, accrued expenses, leases, and stockholders' equity [1. Organization and Summary of Significant Accounting Policies](index=9&type=section&id=Note%201.%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note describes the Company's business, its reliance on collaboration agreements, and its significant accounting policies and estimates - Fate Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on off-the-shelf, multiplexed-engineered, iPSC-derived cellular immunotherapies. The company has not generated revenue from product sales and relies on collaboration agreements and government grants[22](index=22&type=chunk)[23](index=23&type=chunk) Cash, Cash Equivalents, and Restricted Cash Reconciliation (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $41,249 | $36,917 | | Restricted cash | $10,227 | $15,177 | | Total cash, cash equivalents, and restricted cash | $51,476 | $52,094 | - The company's financial statements are unaudited and prepared in accordance with U.S. GAAP, requiring management estimates for items like stock price appreciation milestones, leases, and accrued expenses[24](index=24&type=chunk) - Revenue recognition follows a five-step approach under ASC 606 for customer transactions within collaboration arrangements[33](index=33&type=chunk) - Operating leases are recognized as right-of-use assets and lease liabilities, with short-term leases (**12 months or less**) expensed on a straight-line basis[34](index=34&type=chunk)[35](index=35&type=chunk) - Stock-based compensation expense is recognized over the vesting period, with fair value estimated using Black-Scholes or lattice-based models[36](index=36&type=chunk)[37](index=37&type=chunk) Net Loss Per Common Share, Basic and Diluted (in thousands, except share and per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(34,070) | $(38,427) | $(71,691) | $(86,431) | | Weighted-average common shares outstanding | 114,634,372 | 113,574,450 | 114,558,540 | 107,010,943 | | Weighted-average pre-funded warrants | 3,893,674 | 3,893,674 | 3,893,674 | 2,275,292 | | Weighted-average common shares used to compute basic and diluted net loss per share | 118,528,046 | 117,468,124 | 118,452,214 | 109,286,235 | | Net loss per share, basic and diluted | $(0.29) | $(0.33) | $(0.61) | $(0.79) | Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share (as of June 30, in thousands) | Security Type | 2025 | 2024 | | :--- | :--- | :--- | | Convertible preferred stock | 13,775,430 | 13,805,540 | | Outstanding options to purchase common stock | 12,694,556 | 12,572,603 | | Outstanding restricted stock units | 7,047,968 | 3,259,692 | | Total | 33,517,954 | 29,637,835 | [2. Collaboration and License Agreements](index=13&type=section&id=Note%202.%20Collaboration%20and%20License%20Agreements) This note details the Company's key collaboration and license agreements, including their financial terms and impact on revenue and expenses - The Ono Agreement, initiated in September **2018**, involves joint development and commercialization of iPSC-derived CAR T-cell product candidates (Candidate **1**, **2**, and **3**). Candidate **1** development was terminated, while Candidate **2** and **3** development continues, expanded to include CAR NK cell candidates[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - Ono exercised its option for Candidate **2** in November **2022**, leading to a **$12.5 million** payment. The Company co-develops and co-commercializes Candidate **2** in the US and Europe, sharing profits and losses[45](index=45&type=chunk) - Aggregate estimated research and preclinical development fees from Ono for Candidate **3** have **increased to $44.5 million** through June **2026**, following several amendments (**2022**, **2023**, **2024**, **2025** Ono Amendments)[44](index=44&type=chunk)[46](index=46&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk) - The Company is eligible to receive **up to $843.0 million** in clinical, regulatory, and commercial milestones for Candidate **2** and **3**, plus tiered royalties (mid-single to low-double digits) on net sales in Ono's exclusive territories[50](index=50&type=chunk) Collaboration Revenue and Contra-R&D Expense from Ono Arrangement (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $1,907 | $6,772 | $3,536 | $8,697 | | Contra-research and development expense | $1,300 | $1,100 | $3,300 | $2,000 | - The Amended MSKCC License grants the Company rights to iPSC-derived cellular immunotherapy. The Company is obligated to pay annual license maintenance fees, milestone payments (**up to $75.0 million** based on stock price appreciation), and royalties on net sales[58](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk) Stock Price Appreciation Milestones under Amended MSKCC License (in millions) | Common stock multiple | Ten-trading day trailing average common stock price | Stock price appreciation milestone payment | | :--- | :--- | :--- | | 5.0x | $50.18 | $20.0 | | 10.0x | $100.36 | $30.0 | | 15.0x | $150.54 | $25.0 | - The Company achieved the first clinical milestone in July **2021**, **remitting $20.0 million** to MSKCC. Remaining milestones are fair valued using a Monte Carlo simulation, with changes recognized in other income (expense)[62](index=62&type=chunk)[63](index=63&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) [3. California Institute for Regenerative Medicine Awards](index=19&type=section&id=Note%203.%20California%20Institute%20for%20Regenerative%20Medicine%20Awards) This note describes the CIRM awards received, their financial treatment, and potential repayment obligations - The Company received a **$7.9 million** FT819 CIRM Award in February **2024** to support its Phase **1** study of FT819 for systemic lupus erythematosus. As of June **30**, **2025**, **$5.1 million** has been received and recorded as a non-current liability[67](index=67&type=chunk)[69](index=69&type=chunk)[128](index=128&type=chunk)[131](index=131&type=chunk) - The Company received a **$4.0 million** FT836 CIRM Award in January **2025** for pre-clinical and IND-enabling activities. As of June **30**, **2025**, **$1.3 million** has been received, with **$0.8 million** classified as current and **$0.5 million** as non-current liability[70](index=70&type=chunk)[72](index=72&type=chunk)[132](index=132&type=chunk)[153](index=153&type=chunk) - Both CIRM awards can be treated as a loan or a grant at the Company's discretion after the award period. If treated as a grant, a low single-digit royalty on commercial sales (**up to nine times** the awarded amount) is payable[68](index=68&type=chunk)[71](index=71&type=chunk)[130](index=130&type=chunk)[133](index=133&type=chunk) [4. Investments](index=19&type=section&id=Note%204.%20Investments) This note provides details on the Company's investment portfolio, including classification and fair value of available-for-sale securities - The Company invests excess cash in U.S. treasuries, commercial paper, non-U.S. government securities, municipal securities, and corporate debt securities, classified as available-for-sale and categorized as short-term or long-term based on maturity[73](index=73&type=chunk) Available-for-Sale Securities (in thousands) | Investment Type | Maturity | Amortized Cost (June 30, 2025) | Fair Value (June 30, 2025) | Amortized Cost (Dec 31, 2024) | Fair Value (Dec 31, 2024) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Current Assets:** | | | | | | | Money market fund | 1 or less | $33,770 | $33,770 | $29,491 | $29,491 | | U.S. Treasury debt securities | 1 or less | $34,724 | $34,736 | $40,206 | $40,291 | | Non-US government securities | 1 or less | $1,715 | $1,716 | $2,994 | $2,995 | | Corporate debt securities | 1 or less | $113,049 | $113,098 | $170,169 | $170,327 | | Commercial paper | 1 or less | $32,049 | $32,031 | $26,903 | $26,907 | | **Total short-term investments** | | **$215,307** | **$215,351** | **$272,253** | **$272,503** | | **Non-Current Assets:** | | | | | | | Municipal securities | Greater than 1 | $2,500 | $2,500 | $0 | $0 | | Corporate debt securities | Greater than 1 | $23,579 | $23,597 | $17,887 | $17,912 | | U.S. Treasury debt securities | Greater than 1 | $0 | $0 | $9,752 | $9,745 | | **Total long-term investments** | | **$26,079** | **$26,097** | **$27,639** | **$27,657** | [5. Fair Value Measurements](index=22&type=section&id=Note%205.%20Fair%20Value%20Measurements) This note explains the fair value hierarchy used for financial assets and liabilities, and changes in Level 3 measurements Fair Value Measurements at Reporting Date Using (in thousands) | Asset/Liability | Total (June 30, 2025) | Level 1 (June 30, 2025) | Level 2 (June 30, 2025) | Level 3 (June 30, 2025) | Total (Dec 31, 2024) | Level 1 (Dec 31, 2024) | Level 2 (Dec 31, 2024) | Level 3 (Dec 31, 2024) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Financial assets:** | | | | | | | | | | Money market funds | $33,770 | $33,770 | $0 | $0 | $29,491 | $29,491 | $0 | $0 | | U.S. Treasury debt securities | $34,736 | $34,736 | $0 | $0 | $50,036 | $50,036 | $0 | $0 | | Non-US government securities | $1,716 | $0 | $1,716 | $0 | $2,995 | $0 | $2,995 | $0 | | Municipal securities | $2,500 | $0 | $2,500 | $0 | $2,492 | $0 | $2,492 | $0 | | Corporate debt securities | $136,695 | $0 | $136,695 | $0 | $188,239 | $0 | $188,239 | $0 | | Commercial paper | $32,031 | $0 | $32,031 | $0 | $26,907 | $0 | $26,907 | $0 | | **Total financial assets** | **$241,448** | **$68,506** | **$172,942** | **$0** | **$300,160** | **$79,527** | **$220,633** | **$0** | | **Financial liabilities:** | | | | | | | | | | Stock price appreciation milestones | $320 | $0 | $0 | $320 | $527 | $0 | $0 | $527 | | **Total financial liabilities** | **$320** | **$0** | **$0** | **$320** | **$527** | **$0** | **$0** | **$527** | - Level **1** assets include money market funds and U.S. Treasury securities. Level **2** assets include corporate debt securities, commercial paper, municipal securities, and non-U.S. government securities. Level **3** liabilities consist of stock price appreciation milestones[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) Changes in Fair Value of Level 3 Stock Price Appreciation Milestones Liability (in thousands) | Period | Balance at Beginning | Changes in Fair Value | Balance at End | | :--- | :--- | :--- | :--- | | Six Months Ended June 30, 2025 | $527 (Dec 31, 2024) | $(280) (Q1 2025) | $247 (Mar 31, 2025) | | | $247 (Mar 31, 2025) | $73 (Q2 2025) | $320 (June 30, 2025) | | Six Months Ended June 30, 2024 | $1,346 (Dec 31, 2023) | $1,394 (Q1 2024) | $2,740 (Mar 31, 2024) | | | $2,740 (Mar 31, 2024) | $(1,556) (Q2 2024) | $1,184 (June 30, 2024) | [6. Accrued Expenses](index=23&type=section&id=Note%206.%20Accrued%20Expenses) This note provides a breakdown of the Company's current accrued expenses, including payroll, clinical trial costs, and other liabilities Current Accrued Expenses (in thousands) | Accrued Expense Type | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Accrued payroll and other employee benefits | $7,119 | $9,710 | | Accrued clinical trial related costs | $6,191 | $5,279 | | Accrued other | $4,872 | $6,359 | | **Total current accrued expenses** | **$18,182** | **$21,348** | [7. Leases](index=23&type=section&id=Note%207.%20Leases) This note details the Company's operating lease arrangements, including right-of-use assets, lease liabilities, and future payment obligations - The Company has operating leases for office, laboratory, and manufacturing spaces with terms **up to 16 years**. In October **2024**, the Company exercised an early termination right for its Torrey Pines lease, **effective** October **31**, **2025**, resulting in a **$2.5 million** payment and a reduction in ROU assets and lease liabilities[82](index=82&type=chunk)[83](index=83&type=chunk) Future Undiscounted Minimum Lease Payments (in thousands) | Period | Operating Lease Payments | | :--- | :--- | | Remaining 2025 | $6,875 | | 2026 | $11,050 | | 2027 | $11,382 | | 2028 | $10,293 | | 2029 | $10,602 | | 2030 | $10,920 | | Thereafter | $65,056 | | **Total undiscounted lease payments** | **$126,178** | | Less: imputed interest | $(44,847) | | **Total lease liability** | **$81,331** | - As of June **30**, **2025**, the **remaining weighted-average lease term is 10.4 years**, with a **weighted-average discount rate of 8.4%**[84](index=84&type=chunk) [8. Convertible Preferred Stock and Stockholders' Equity](index=25&type=section&id=Note%208.%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity) This note describes the Company's convertible preferred stock, pre-funded warrants, and activity related to stock options and restricted stock units - The Company issued **2,819,549** shares of Class A Convertible Preferred Stock in November **2016**, convertible into **five** shares of common stock each. As of June **30**, **2025**, **2,755,086** shares of Class A Preferred Stock remain outstanding[87](index=87&type=chunk) - Pre-funded warrants to purchase **3,893,674** shares of common stock were outstanding as of June **30**, **2025**, issued in January **2021** and March **2024** public offerings. These warrants are exercisable at a nominal price and are classified in equity[89](index=89&type=chunk)[90](index=90&type=chunk)[92](index=92&type=chunk) Stock Option Activity (Period Ended June 30, 2025) | Metric | Number of Options | Weighted Average Price | | :--- | :--- | :--- | | Balance at December 31, 2024 | 10,722,674 | $10.99 | | Granted | 3,555,400 | $1.30 | | Exercised | (832) | $1.32 | | Cancelled | (1,582,686) | $7.83 | | **Balance at June 30, 2025** | **12,694,556** | **$8.67** | Restricted Stock Unit Activity (Period Ended June 30, 2025) | Metric | Number of Restricted Stock Units | Weighted Average Grant Date Fair Value per Share | | :--- | :--- | :--- | | Balance at December 31, 2024 | 6,214,064 | $15.50 | | Granted | 2,298,070 | $1.31 | | Vested | (725,956) | $23.34 | | Cancelled | (738,210) | $9.22 | | **Balance at June 30, 2025** | **7,047,968** | **$10.72** | Stock-Based Compensation Allocation (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,821 | $5,237 | $7,698 | $10,953 | | General and administrative | $3,333 | $4,393 | $6,837 | $9,658 | | **Total** | **$7,154** | **$9,630** | **$14,535** | **$20,611** | - As of June **30**, **2025**, **unrecognized compensation cost for outstanding options was $8.6 million** (**1.6 years** weighted-average period) and **for restricted stock units was $21.8 million** (**1.6 years** weighted-average period)[93](index=93&type=chunk)[94](index=94&type=chunk) Weighted-Average Assumptions for Black-Scholes Model | Assumption | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Risk-free interest rate | 4.4% | 3.9% | | Expected volatility | 90.2% | 87.1% | | Expected term (in years) | 6.2 | 6.4 | | Expected dividend yield | 0.0% | 0.0% | [9. Segment Reporting](index=29&type=section&id=Note%209.%20Segment%20Reporting) This note clarifies that the Company operates as a single reportable segment and provides a breakdown of its operational results - The Company operates as a single reportable segment, with its Chief Executive Officer managing operations on an integrated basis for resource allocation. Revenues are primarily derived from research and development collaborations[97](index=97&type=chunk)[98](index=98&type=chunk) Segment Profit or Loss and Expenses (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $1,907 | $6,772 | $3,536 | $8,697 | | Less: | | | | | | Personnel costs | $10,682 | $10,654 | $22,386 | $22,958 | | Clinical programs | $5,778 | $6,512 | $12,061 | $11,698 | | Research activities | $1,870 | $3,807 | $4,306 | $6,529 | | Facilities costs | $5,884 | $7,028 | $11,964 | $13,662 | | Other segment expenses | $14,661 | $23,854 | $31,067 | $50,001 | | **Total operating expenses** | **$38,875** | **$51,855** | **$81,784** | **$104,848** | | **Loss from operations** | **$(36,968)** | **$(45,083)** | **$(78,248)** | **$(96,151)** | | Interest income | $(2,921) | $(4,827) | $(6,257) | $(8,976) | | Change in fair value of stock price appreciation milestones | $73 | $(1,556) | $(207) | $(162) | | Other income | $(50) | $(273) | $(93) | $(582) | | **Total other income** | **$(2,898)** | **$(6,656)** | **$(6,557)** | **$(9,720)** | | **Net loss** | **$(34,070)** | **$(38,427)** | **$(71,691)** | **$(86,431)** | [10. Subsequent Events](index=29&type=section&id=Note%2010.%20Subsequent%20Events) This note discloses significant events that occurred after the reporting period, including a corporate restructuring and associated costs - In August **2025**, the Company initiated a corporate restructuring, **reducing its workforce by approximately 12%** to streamline operations and extend cash runway. This is expected to result in **$0.9 million** to **$1.2 million** in severance and termination costs during Q**3** **2025**[99](index=99&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition and results of operations, highlighting key financial performance drivers, liquidity, capital resources, and future outlook, including the impact of collaboration agreements and R&D expenses [Overview](index=30&type=section&id=Overview) This overview describes the Company's business as a clinical-stage biopharmaceutical company and its ongoing need for substantial funding - Fate Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf cellular immunotherapies using a proprietary induced pluripotent stem cell (iPSC) product platform[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) - The Company has **incurred significant net losses** since inception and expects this to continue due to substantial investments in R&D, preclinical and clinical trials, GMP production, and intellectual property protection[107](index=107&type=chunk)[108](index=108&type=chunk) - Future operations will require **additional funding** through equity, debt, or collaborations, as meaningful product sales are not expected until regulatory approval, which is years away[109](index=109&type=chunk) [Financial Operations Overview](index=32&type=section&id=Financial%20Operations%20Overview) This overview highlights key trends in collaboration revenue, research and development, general and administrative expenses, and other income - Collaboration revenue **decreased by $4.9 million** (**72%**) for the three months ended June **30**, **2025**, and **by $5.2 million** (**59%**) for the six months ended June **30**, **2025**, primarily due to a **$5.0 million** clinical development milestone recognized in Q**2** **2024**[138](index=138&type=chunk)[142](index=142&type=chunk) - Research and development expenses **decreased by $7.2 million** (**20.7%**) for the three months ended June **30**, **2025**, and **by $10.2 million** (**15.2%**) for the six months ended June **30**, **2025**, driven by reductions in laboratory materials, depreciation, stock-based compensation, and sub-licensing fees[139](index=139&type=chunk)[143](index=143&type=chunk)[144](index=144&type=chunk)[98](index=98&type=chunk) - General and administrative expenses **decreased by $5.8 million** (**33.6%**) for the three months ended June **30**, **2025**, and **by $12.9 million** (**33.8%**) for the six months ended June **30**, **2025**, mainly due to lower patent and legal expenses and employee compensation[139](index=139&type=chunk)[146](index=146&type=chunk) - Other income (expense), net, **decreased by $3.8 million** (**56.5%**) for the three months ended June **30**, **2025**, and **by $3.2 million** (**32.5%**) for the six months ended June **30**, **2025**, primarily due to changes in fair value of stock price appreciation milestones and interest income[140](index=140&type=chunk)[141](index=141&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=37&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section discusses management's reliance on estimates and judgments for financial reporting, noting no material policy changes - Management's financial analysis relies on estimates and judgments, particularly for stock price appreciation milestones, leases, accrued expenses, stock-based compensation, and collaboration agreement costs. **No material changes** to critical accounting policies occurred during the six months ended June **30**, **2025**[135](index=135&type=chunk)[136](index=136&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) This section provides a detailed analysis of the Company's financial performance, including revenue and expense trends over specific periods Summary of Operations (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $1,907 | $6,772 | $(4,865) | | Research and development expense | $27,430 | $34,604 | $(7,174) | | General and administrative expense | $11,445 | $17,251 | $(5,806) | | Total other income | $2,898 | $6,656 | $(3,758) | Summary of Operations (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $3,536 | $8,697 | $(5,161) | | Research and development expense | $56,566 | $66,742 | $(10,176) | | General and administrative expense | $25,218 | $38,106 | $(12,888) | | Total other income | $6,557 | $9,720 | $(3,163) | - **Net loss** for the three months ended June **30**, **2025**, was **$(34.1) million**, compared to **$(38.4) million** for the same period in **2024**. For the six months, **net loss** was **$(71.7) million** in **2025**, compared to **$(86.4) million** in **2024**[16](index=16&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the Company's cash position, historical cash flows, and future capital requirements for operations and development - The Company has **incurred continuous losses** since inception, with an **accumulated deficit of $1.5 billion** as of June **30**, **2025**, and expects to continue incurring losses[149](index=149&type=chunk)[255](index=255&type=chunk) - As of June **30**, **2025**, **cash, cash equivalents, and investments totaled $248.9 million**, intended to fund R&D, clinical development, and general corporate purposes[155](index=155&type=chunk)[252](index=252&type=chunk) Cash Flow Summary (Six Months Ended June 30, in millions) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(58.4) | $(65.7) | | Net cash provided by (used in) investing activities | $62.3 | $(36.1) | | Net cash provided by financing activities | $1.3 | $96.8 | - In March **2024**, the Company raised **approximately $80.0 million** gross proceeds from a public offering of common stock and issued pre-funded warrants in a concurrent private placement[154](index=154&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - Additional capital will be required for future R&D, manufacturing, and regulatory approvals, which may involve equity or debt financings, potentially leading to dilution or increased obligations[160](index=160&type=chunk)[162](index=162&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk) - The Company leases office, laboratory, and manufacturing spaces, with future undiscounted minimum contractual payments of **$126.2 million** as of June **30**, **2025**[165](index=165&type=chunk)[86](index=86&type=chunk) - The Company has a contingent obligation to MSKCC for **up to $75.0 million** in stock price appreciation milestones, with **$20.0 million** already **remitted** in **2021**[166](index=166&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for smaller reporting companies, indicating the Company's status and reduced disclosure obligations regarding market risk - **Not required** for smaller reporting companies[169](index=169&type=chunk) [Item 4. Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the Company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025, with no material changes in internal control over financial reporting during the latest fiscal quarter - **Disclosure controls and procedures were effective** at the reasonable assurance level as of June **30**, **2025**[170](index=170&type=chunk) - **No material changes in internal controls** over financial reporting occurred during the latest fiscal quarter[171](index=171&type=chunk) [PART II. OTHER INFORMATION](index=47&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, detailed risk factors, and other required disclosures [Item 1. Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The Company is involved in a securities class action lawsuit (Hadian v. Fate Therapeutics, Inc. et al.) and a consolidated derivative action (In re Fate Therapeutics, Inc. Derivative Litigation), both alleging federal securities law violations and breach of fiduciary duties related to a terminated collaboration agreement. The Company intends to vigorously defend against these actions - A securities class action lawsuit (Hadian v. Fate Therapeutics, Inc. et al.) was filed in January **2023**, alleging false/misleading statements regarding the Janssen Agreement and its termination. The court granted a motion to dismiss the amended complaint in September **2024**, with leave to refile[173](index=173&type=chunk) - A consolidated derivative action (In re Fate Therapeutics, Inc. Derivative Litigation) was filed in June **2023** and June **2024**, naming board members and officers, asserting claims for breach of fiduciary duty, unjust enrichment, and waste of corporate assets, among others. This action is stayed pending the securities action's motion to dismiss[174](index=174&type=chunk) - The Company **intends to vigorously defend** against both the securities class action and the derivative action[173](index=173&type=chunk)[174](index=174&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) This section details various risks that could significantly harm the Company's business, financial condition, and operating results, categorized into risks related to product development, financial condition, reliance on third parties, intellectual property, commercialization, business and industry, and common stock ownership [Risks Related to the Discovery, Development and Regulation of Our Product Candidates](index=47&type=section&id=Risks%20Related%20to%20the%20Discovery,%20Development%20and%20Regulation%20of%20Our%20Product%20Candidates) This section outlines risks associated with the preclinical and clinical development, regulatory approval, and manufacturing of product candidates - All product candidates are in early development; failure to complete preclinical/clinical development or obtain regulatory approval would significantly harm the business. The Company has limited experience in autoimmune diseases, a new focus area[178](index=178&type=chunk) - Clinical trials face potential delays or termination due to difficulties in dose optimization, manufacturing, patient recruitment, regulatory agreement, unexpected safety issues, and competition[179](index=179&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) - Manufacturing and distribution of cell product candidates are complex, costly, and subject to regulatory risks, potentially limiting supply and delaying commercialization. The Company has limited experience in commercial-scale manufacturing[184](index=184&type=chunk)[185](index=185&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk) - Product candidates are based on novel iPSC and genome-editing technologies, which are unproven and subject to technological uncertainty, with unknown immunogenicity profiles and potential for undesirable side effects[197](index=197&type=chunk)[198](index=198&type=chunk) - Development of combination therapies depends on access to third-party drugs/biologics, over which the Company has limited control, posing risks to development timelines and costs[200](index=200&type=chunk)[201](index=201&type=chunk)[202](index=202&type=chunk) - Difficulties in patient enrollment, especially for autoimmune diseases where cell therapies are novel, could delay or adversely affect clinical development activities[206](index=206&type=chunk)[207](index=207&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk) - Regulatory authorities may require unanticipated studies or impose restrictions, causing delays, increased costs, or preventing regulatory approval. Preliminary and interim clinical data may not be predictive of final results[210](index=210&type=chunk)[211](index=211&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk)[227](index=227&type=chunk) - The Company may pursue next-generation product candidates, potentially rendering existing ones obsolete, and limited resources may lead to abandoning or delaying other promising programs[215](index=215&type=chunk) - Regulatory approval for novel cell therapies is uncertain, potentially more expensive and time-consuming, with evolving requirements and potential for stricter standards or new safety warnings (e.g., T-cell malignancies)[220](index=220&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) - RMAT designation for FT819 does not guarantee faster development or approval, and orphan drug status may not confer sufficient marketing exclusivity[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk) - The Company may be subject to healthcare fraud and abuse laws, physician payment transparency laws, anti-bribery laws, and health information privacy laws, with non-compliance leading to significant penalties[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk)[244](index=244&type=chunk) - International operations and clinical trials abroad expose the Company to various risks, including differing regulatory requirements, economic instability, and potential non-acceptance of foreign data by the FDA[245](index=245&type=chunk)[248](index=248&type=chunk) - Changes in patent law, such as the overruling of the Chevron doctrine, could diminish patent value and delay regulatory review[250](index=250&type=chunk) [Risks Related to Our Financial Condition](index=77&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition) This section details financial risks including the need for additional funding, accumulated losses, and potential limitations on tax benefits - **Substantial additional funding is required** for ongoing operations and product development. Failure to raise capital on favorable terms could significantly delay or discontinue programs[251](index=251&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk) - The Company has a **limited operating history**, **incurred $1.5 billion in accumulated deficit** as of June **30**, **2025**, and anticipates continued **significant losses** for the foreseeable future due to R&D and operational costs[255](index=255&type=chunk)[256](index=256&type=chunk) - Management has broad discretion over capital use, and ineffective allocation could adversely affect results or stock value. Investments may not produce income or could lose value[257](index=257&type=chunk) - The ability to use net operating loss carryforwards and other tax benefits may be limited by ownership changes, potentially increasing future tax liability[288](index=288&type=chunk)[289](index=289&type=chunk) [Risks Related to Our Reliance on Third Parties](index=80&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section describes risks arising from dependence on third parties for manufacturing, partnerships, and clinical trial execution - The Company relies on third parties for manufacturing certain product components and potentially for later-stage clinical and commercial manufacturing, posing risks related to regulatory compliance, quality, and supply disruptions[259](index=259&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk) - Dependence on strategic partnerships (e.g., Ono Agreement) means delays or termination of these arrangements could significantly harm development, manufacturing, and commercialization efforts, impacting milestone and royalty payments[263](index=263&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk) - Availability of specialized reagents, materials, and equipment from third-party suppliers is critical. Disruptions in the supply chain due to public health crises, natural disasters, or geopolitical tensions could delay clinical trials and manufacturing[267](index=267&type=chunk)[270](index=270&type=chunk)[271](index=271&type=chunk)[272](index=272&type=chunk) - Reliance on third parties (CROs, medical institutions) for R&D and clinical trials means their failure to perform or meet deadlines could extend or terminate development, impacting regulatory approval and commercialization[273](index=273&type=chunk)[274](index=274&type=chunk)[275](index=275&type=chunk) - Conflicts with collaborators or strategic partners could lead to adverse actions, competition, or termination of agreements, limiting the Company's ability to implement strategies[277](index=277&type=chunk)[278](index=278&type=chunk) - Reliance on China-based vendors for non-clinical/clinical trials or lab services poses risks due to geopolitical relationships, potentially causing delays or requiring costly vendor changes[279](index=279&type=chunk) [Risks Related to Our Intellectual Property](index=86&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section covers risks related to obtaining, maintaining, and enforcing intellectual property rights, and potential infringement issues - Inability to obtain and maintain patent protection for technology and product candidates could allow competitors to exploit discoveries, reducing demand and harming business. Patent scope, validity, and enforceability are uncertain[280](index=280&type=chunk)[281](index=281&type=chunk) - Government funding for certain patent rights may result in the government retaining rights, including march-in rights, which could harm the Company's competitive position[282](index=282&type=chunk) - Reliance on licensors to prosecute and maintain material patents means their failure to protect these rights could adversely affect the business[283](index=283&type=chunk) - Failure to comply with license agreement obligations, including payment obligations, could lead to loss of rights to product candidates or key technologies[284](index=284&type=chunk) - Involvement in intellectual property litigation is costly, time-consuming, and unpredictable, potentially diverting resources and risking invalidation or unenforceability of patents[285](index=285&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk) - Risk of infringing third-party intellectual property rights could prevent or delay product development and commercialization, or increase costs, potentially leading to substantial damages or injunctions[288](index=288&type=chunk)[289](index=289&type=chunk)[290](index=290&type=chunk)[291](index=291&type=chunk) - Difficulty in obtaining or maintaining necessary rights to product components and processes from third parties could lead to higher costs or abandonment of programs[293](index=293&type=chunk)[294](index=294&type=chunk)[295](index=295&type=chunk) - Intellectual property rights may not cover all competitive threats, and trade secrets are vulnerable to unauthorized disclosure or misappropriation, eroding competitive advantage[296](index=296&type=chunk)[300](index=300&type=chunk)[302](index=302&type=chunk) - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may offer less protection, allowing competitors to use technologies in other jurisdictions[303](index=303&type=chunk)[304](index=304&type=chunk) - Changes in U.S. patent law, including Supreme Court rulings, could diminish patent value and impair the ability to protect product candidates and technology[305](index=305&type=chunk) - Limited patent lifespan may not **effectively** protect market position, leading to increased competition once patents expire[306](index=306&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=97&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) This section addresses challenges in marketing, sales, market acceptance, pricing, and reimbursement for future product candidates - The Company lacks experience in marketing and sales; failure to develop internal capabilities or **effective** partnerships could hinder product revenue generation if products are approved[308](index=308&type=chunk) - Commercial success depends on market acceptance by physicians, patients, and third-party payers, which is uncertain, especially for novel cell therapies in autoimmune diseases where risk tolerance is lower[309](index=309&type=chunk)[310](index=310&type=chunk)[311](index=311&type=chunk) - Significant uncertainty exists regarding pricing for novel cellular immunotherapies, and intense political/societal pressures on drug pricing could adversely affect commercial viability[313](index=313&type=chunk) - Failure to obtain or maintain adequate insurance coverage and reimbursement from third-party payors (government, private insurers) could limit product revenues and commercial success[314](index=314&type=chunk)[315](index=315&type=chunk) - Market opportunities may be restricted or smaller than anticipated, especially for rare diseases and specific patient populations, requiring significant market share capture for profitability[316](index=316&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk) - Healthcare legislative or regulatory reforms (e.g., ACA, IRA, Executive Orders on drug pricing) could negatively impact business by delaying approvals, restricting post-approval activities, or reducing profitability[319](index=319&type=chunk)[320](index=320&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk)[326](index=326&type=chunk) [Risks Related to Our Business and Industry](index=102&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) This section discusses broader business and industry risks, including competition, key personnel, product liability, and cybersecurity - Success is highly dependent on developments in cellular immunotherapy and genome-edited cells, which are novel and unproven fields, subject to evolving regulatory requirements and potential safety risks (e.g., T-cell malignancies)[327](index=327&type=chunk)[328](index=328&type=chunk) - Intense competition from biotechnology and pharmaceutical companies with greater resources and more advanced product candidates could adversely affect the Company's ability to develop and commercialize products[329](index=329&type=chunk)[330](index=330&type=chunk)[331](index=331&type=chunk)[332](index=332&type=chunk)[333](index=333&type=chunk) - Loss of senior management or inability to attract/retain key personnel and consultants could adversely affect business, especially given intense competition for talent and recent management transitions[334](index=334&type=chunk)[335](index=335&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk) - Engaging in acquisitions, reorganizations, or business combinations carries risks such as dilution, debt, integration challenges, and diversion of resources[338](index=338&type=chunk) - Potential product liability exposure from clinical trials and commercial sales far exceeds limited insurance coverage, risking substantial damages and adverse impact on business[340](index=340&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk) - Insurance policies are expensive and may not cover all risks, leaving the Company exposed to significant uninsured liabilities[343](index=343&type=chunk) - Risk of employee or third-party service provider misconduct, including non-compliance with regulations and insider trading, could lead to regulatory sanctions and reputational harm[345](index=345&type=chunk) - Potential liability related to privacy of personal information, including health data, under various federal, state, and foreign data protection laws (e.g., HIPAA, CCPA, GDPR). Non-compliance or data breaches could result in fines, litigation, and reputational damage[346](index=346&type=chunk)[348](index=348&type=chunk)[349](index=349&type=chunk)[350](index=350&type=chunk)[351](index=351&type=chunk)[352](index=352&type=chunk)[353](index=353&type=chunk)[354](index=354&type=chunk) - Increasing use of AI-based software presents risks of flawed algorithms, biased data, inadvertent release of confidential information, and evolving regulatory scrutiny (e.g., EU AI Act, FDA guidance), potentially leading to reputational harm or liability[355](index=355&type=chunk)[356](index=356&type=chunk)[357](index=357&type=chunk) - Internal computer systems and those of third parties are vulnerable to cybersecurity risks (e.g., cyberattacks, ransomware), which could lead to data loss, operational disruption, and significant costs, despite security measures[358](index=358&type=chunk)[359](index=359&type=chunk)[360](index=360&type=chunk)[361](index=361&type=chunk)[362](index=362&type=chunk)[363](index=363&type=chunk) - Inadequate funding or disruptions to government agencies (FDA, SEC, NIH), including government shutdowns or policy changes, could hinder regulatory review and approval processes, negatively impacting business[364](index=364&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk)[368](index=368&type=chunk) [Risks Related to the Ownership of Our Common Stock](index=118&type=section&id=Risks%20Related%20to%20the%20Ownership%20of%20Our%20Common%20Stock) This section highlights risks associated with the Company's common stock, including price volatility, dilution, and corporate governance provisions - The Company's stock price has been and may continue to be volatile due to clinical trial results, regulatory developments, competition, management changes, financing efforts, and general economic conditions. Stock price changes can also trigger financial obligations under licensing agreements[369](index=369&type=chunk)[370](index=370&type=chunk)[371](index=371&type=chunk)[372](index=372&type=chunk) - Delisting from Nasdaq Global Market due to failure to meet minimum requirements (e.g., **$1.00** bid price) would adversely affect liquidity and market price[373](index=373&type=chunk) - Principal stockholders and management own a **significant percentage** (**approx. 53.2%**) of voting stock, allowing them to exercise significant control and potentially delay or prevent changes in control[374](index=374&type=chunk) - Future sales of additional equity or debt securities, or issuances under equity incentive plans, could result in dilution to stockholders and cause the stock price to fall[375](index=375&type=chunk)[376](index=376&type=chunk) - Sales of a substantial number of shares by existing stockholders could significantly reduce the market price of common stock[377](index=377&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk) - Provisions of Delaware law and charter documents could delay or prevent an acquisition or make it difficult to change management, limiting stockholder liquidity opportunities[380](index=380&type=chunk)[381](index=381&type=chunk)[382](index=382&type=chunk)[383](index=383&type=chunk) - Bylaws designate specific exclusive forums for litigation, potentially limiting stockholders' ability to choose judicial forums and incurring additional costs for the Company[384](index=384&type=chunk) - A sustained decline in stock price could trigger impairment indications, adversely impacting results of operations, as seen in December **2024** with a **$13.4 million** impairment charge on property and equipment[385](index=385&type=chunk) - Qualifying as a 'smaller reporting company' and 'non-accelerated filer' allows reduced reporting, which might make stock less attractive to some investors[386](index=386&type=chunk)[387](index=387&type=chunk) [General Risk Factors](index=126&type=section&id=General%20Risk%20Factors) This section covers overarching risks such as litigation, global economic conditions, geopolitical events, and compliance with various laws - The Company is subject to securities class action litigation and other stockholder litigation, which can be costly, divert management attention, and harm business and financial condition[390](index=390&type=chunk)[391](index=391&type=chunk) - Unfavorable global economic conditions, including inflation, unemployment, and political influences, could adversely affect business by impacting investment, capital raising, and demand for products[392](index=392&type=chunk)[393](index=393&type=chunk) - Significant political, trade, and regulatory developments (e.g., tariffs, U.S. federal administration changes) could have a material adverse effect on financial condition and results of operations[394](index=394&type=chunk) - Volatility in capital markets and lower stock prices may affect the ability to access new capital, limiting business growth, acquisitions, and infrastructure improvements[395](index=395&type=chunk) - Recent volatility in interest rates could impact the cost of new indebtedness, affecting liquidity, working capital, and financial results[396](index=396&type=chunk)[398](index=398&type=chunk) - Increasing scrutiny and changing expectations regarding ESG policies may lead to additional costs, risks, and reputational impact, with potential for regulatory oversight and financial consequences[399](index=399&type=chunk)[400](index=400&type=chunk)[401](index=401&type=chunk) - Adverse developments in the financial services industry (e.g., bank failures, liquidity issues) could impair access to funding, impact cash flows, and lead to losses from collaboration partners or suppliers[402](index=402&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk)[405](index=405&type=chunk)[406](index=406&type=chunk)[407](index=407&type=chunk)[408](index=408&type=chunk) - Geopolitical risks from ongoing wars and armed conflicts could adversely impact business, financial condition, and clinical trials through economic volatility, supply chain disruptions, and cyberattacks[409](index=409&type=chunk)[411](index=411&type=chunk)[412](index=412&type=chunk) - Natural disasters (earthquakes, wildfires, power outages) and public health crises could severely disrupt operations, damage critical infrastructure, and delay clinical trials, with business continuity plans potentially inadequate[413](index=413&type=chunk) - Failure to maintain **effective** disclosure controls and internal controls could impair accurate financial reporting and compliance, potentially leading to material weaknesses and stock price decline[414](index=414&type=chunk)[415](index=415&type=chunk) - Non-compliance with environmental, health, and safety laws, including hazardous materials handling, could result in fines, penalties, or significant costs, harming the business[416](index=416&type=chunk)[417](index=417&type=chunk)[418](index=418&type=chunk) - Changes in tax law (e.g., OBBBA) may adversely affect the Company or investors, potentially increasing tax liability or requiring operational changes[419](index=419&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=135&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The Company made no unregistered sales of securities during the quarter covered by this report that have not been previously disclosed on Form 8-K - **No unregistered sales of securities** occurred during the quarter that were not previously disclosed on Form **8-K**[420](index=420&type=chunk) [Item 3. Defaults Upon Senior Securities](index=135&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reporting period - **None**[421](index=421&type=chunk) [Item 4. Mine Safety Disclosures](index=135&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - **Not applicable**[422](index=422&type=chunk) [Item 5. Other Information](index=135&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, materially modified, or terminated any Rule 10b5-1 trading plans for Company securities during the reporting period - **No directors or officers adopted, materially modified, or terminated any Rule 10b5-1 trading plans** during the quarter[424](index=424&type=chunk) [Item 6. Exhibits](index=138&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, stock certificates, warrant forms, descriptions of securities, the amended 2022 Stock Option and Incentive Plan, an amendment to the Ono Collaboration Agreement, and certifications - Exhibits include Amended and Restated Certificate of Incorporation, Certificate of Designation of Preferences, Rights and Limitations of Class A Convertible Preferred Stock, Amended and Restated Bylaws, Specimen Common Stock Certificate, Form of Pre-Funded Warrant, Description of Securities, Second Amended and Restated **2022** Stock Option and Incentive Plan, Amendment No. **5** to Collaboration and Option Agreement with Ono Pharmaceutical Co., Ltd., and various certifications[426](index=426&type=chunk) [SIGNATURES](index=140&type=section&id=SIGNATURES) This section contains the required signatures certifying the accuracy and completeness of the report - The report was signed on August **12**, **2025**, by Bahram Valamehr, Ph.D., MBA, President, Chief Executive Officer, Principal Financial Officer, and Principal Accounting Officer of Fate Therapeutics, Inc[432](index=432&type=chunk)

[Q2 2025 Business Highlights and CEO Commentary](index=1&type=section&id=Fate%20Therapeutics%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Business%20Updates) The company reported significant clinical progress for FT819 in lupus, received FDA allowance for FT836, and extended its cash runway through 2027 [Q2 2025 Highlights](index=1&type=section&id=Q2%202025%20Highlights) The company reported significant clinical progress for its lead candidate FT819 in lupus, including positive 12-month durability data and initial FDA discussions for a registrational pathway. The FDA also allowed an Investigational New Drug (IND) application for FT836 in solid tumors. Operationally, the company extended its cash runway through year-end 2027, supported by $249 million in cash and investments - Demonstrated durability of response in a severe lupus nephritis patient at 12-month follow-up with FT819[1](index=1&type=chunk) - Held initial discussions with the FDA under FT819's RMAT designation to plan a registrational pathway in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN)[1](index=1&type=chunk) - FDA allowed the IND application for FT836, a MICA/B-targeted CAR T-cell therapy for solid tumors, featuring Sword and Shield™ technology for conditioning-free treatment[1](index=1&type=chunk) - Extended projected operating cash runway through the end of 2027, with **$249 million** in cash, cash equivalents, and investments[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Bob Valamehr highlighted the company's focus on patient enrollment for FT819 in autoimmune diseases, citing encouraging data with less-intensive conditioning. The company aims to start a registrational study for FT819 in 2026 under its RMAT designation. He also noted that proactive resource allocation has extended the company's cash runway, enabling execution across the pipeline - The company's priority is to drive patient enrollment for FT819 in autoimmune diseases to demonstrate its therapeutic differentiation and on-demand availability[2](index=2&type=chunk) - The goal is to commence a registrational study for FT819 in SLE and LN in 2026, following discussions with the FDA under the RMAT designation[2](index=2&type=chunk) - Proactive steps were taken to optimize resource allocation and extend the cash runway, positioning the company to execute on its pipeline goals[2](index=2&type=chunk) [Clinical Program Updates](index=2&type=section&id=Clinical%20Program%20Updates) This section details the progress of FT819 in autoimmune diseases, FT825/ONO-8250 in solid tumors, and next-generation CAR T-cell programs [FT819 Program in Autoimmune Disease](index=2&type=section&id=FT819%20iPSC-derived%20of%20-the-shelf%20CAR%20T-cell%20program%20in%20autoimmune%20disease) The FT819 program is advancing rapidly with ongoing FDA discussions for a registrational study in SLE and LN under its RMAT designation. Interim Phase 1 data showed promising responses, including a 12-month durable remission in one patient using a fludarabine-free regimen. The study is also exploring FT819 as an add-on therapy without conditioning and has been expanded to include other B cell-mediated autoimmune diseases like AAV, IIM, and SSc [FDA Discussions and RMAT Designation](index=2&type=section&id=FDA%20Discussions%20and%20RMAT%20Designation) The company is in discussions with the FDA regarding a potential registrational study design for FT819 in moderate-to-severe SLE and refractory LN. This follows the FDA granting Regenerative Medicine Advanced Therapy (RMAT) designation for this indication in April 2025, which is intended to expedite development and review - Met with the FDA in August under its RMAT designation to get preliminary feedback on a proposed registrational study design for FT819 in SLE and LN[3](index=3&type=chunk) - The RMAT designation, granted in April 2025, was created to expedite the development and review of regenerative medicine therapies for serious conditions[3](index=3&type=chunk) [Phase 1 SLE Interim Data](index=2&type=section&id=Phase%201%20SLE%20Interim%20Data) Interim Phase 1 data presented at EULAR 2025 showed positive results in patients with moderate-to-severe SLE. All three LN patients treated with a single 360 million cell dose and a fludarabine-free regimen achieved an objective renal response. Notably, the first LN patient demonstrated a durable remission (DORIS) at the 12-month follow-up - All three refractory active LN patients treated with a single **360 million cell dose** of FT819 following a flu-free conditioning regimen achieved an objective renal response[3](index=3&type=chunk) - The first LN patient achieved DORIS (drug-free definition of remission) and complete renal response at 6 months, which was sustained at the 12-month follow-up[3](index=3&type=chunk) [Add-on Therapy Trial](index=2&type=section&id=Add-on%20Therapy%20Trial) The Phase 1 study is also assessing FT819 as an add-on to standard-of-care maintenance therapy without any conditioning chemotherapy. The first patient treated in this cohort achieved Low Lupus Disease Activity State (LLDAS) at 3 and 6 months, along with a reduction in disease scores and steroid dosage - The first patient treated with FT819 as an add-on to maintenance therapy (without conditioning) achieved LLDAS at 3- and 6-months[3](index=3&type=chunk) - The patient also experienced a reduction in SLEDAI-2K score from 8 to 2 and was able to taper their steroid dose[3](index=3&type=chunk) [Study Expansion](index=3&type=section&id=Study%20Expansion) The Phase 1 trial of FT819 has been expanded to investigate its potential in other B cell-mediated autoimmune diseases. The company plans to initiate dose-expansion cohorts in the second half of 2025 for anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc) - The Phase 1 clinical trial of FT819 has been expanded to include other B cell-mediated autoimmune diseases[4](index=4&type=chunk) - The company plans to initiate dose-expansion cohorts in H2 2025 for AAV, IIM, and SSc[4](index=4&type=chunk) [FT825 / ONO-8250 Program in Solid Tumors](index=3&type=section&id=FT825%20%2F%20ONO-8250%20iPSC-derived%20of%20-the-shelf%20CAR%20T-cell%20Program%20in%20Solid%20Tumors) The Phase 1 study of FT825 / ONO-8250, a HER2-targeting CAR T-cell therapy developed with Ono Pharmaceutical, is ongoing in patients with advanced solid tumors. Dose escalation is proceeding to the third level (900 million cells), and the therapy has shown a favorable safety profile with no dose-limiting toxicities reported to date - A Phase 1 study is ongoing for FT825 / ONO-8250, a HER2-targeting CAR T-cell candidate, in patients with advanced solid tumors[5](index=5&type=chunk) - Dose escalation is currently ongoing at the third dose level of **900 million cells**[5](index=5&type=chunk) - FT825 / ONO-8250 has demonstrated a favorable safety profile with no dose-limiting toxicities (DLTs) to date[5](index=5&type=chunk) [Next-Generation CAR T-cell Programs (Sword & Shield™ Technology)](index=3&type=section&id=Next-generation%20iPSC-derived%20of%20-the-shelf%20CAR%20T-cell%20Programs) The company is advancing its next-generation programs designed to reduce or eliminate the need for conditioning chemotherapy. The FDA has allowed the IND for FT836, a MICA/B-targeted CAR T-cell for solid tumors. Additionally, a master iPSC bank has been created for FT839, a dual CD19/CD38 CAR T-cell candidate, with clinical investigation planned to begin in 2026 - The FDA allowed the IND application for FT836, a MICA/B-targeted CAR T-cell product candidate, for Phase 1 testing in advanced solid tumors without conditioning chemotherapy[6](index=6&type=chunk) - A master iPSC bank has been generated for FT839, a CD19/CD38 dual-CAR T-cell product candidate[6](index=6&type=chunk) - The company is evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmunity, with plans to start in 2026[6](index=6&type=chunk) [Corporate and Financial Updates](index=4&type=section&id=Corporate%20and%20Financial%20Updates) This section covers the extension of the collaboration with Ono Pharmaceutical, strategic operational adjustments, and the company's second quarter 2025 financial performance [Corporate Developments](index=4&type=section&id=Corporate%20Developments) Fate Therapeutics extended its collaboration with Ono Pharmaceutical for a second solid tumor CAR T-cell candidate, securing co-funding through at least June 2026. The company also implemented a tactical operations plan, including a 12% headcount reduction and other cost-saving measures, to extend its cash runway through the end of 2027 - Extended the research term of its collaboration with Ono for a second iPSC-derived CAR T-cell candidate, with co-funding expected to continue through at least June 2026[9](index=9&type=chunk) - Implemented a tactical operations plan, including a **12% reduction in employee headcount**, to extend its cash runway through the end of 2027[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=4&type=section&id=Second%20Quarter%202025%20Financial%20Results) For the second quarter of 2025, Fate Therapeutics reported revenues of $1.9 million, derived from its collaboration with Ono Pharmaceutical. Total operating expenses were $38.9 million. The company ended the quarter with a strong cash, cash equivalents, and investments position of $248.9 million Q2 2025 Financial Highlights | Metric | Value | | :--- | :--- | | **Cash, Cash Equivalents & Investments** | $248.9 million | | **Total Revenue** | $1.9 million | | **Total Operating Expenses** | $38.9 million | | **Research & Development Expenses** | $27.4 million | | **General & Administrative Expenses** | $11.4 million | | **Non-cash Stock-based Compensation** | $7.2 million | [Financial Statements](index=7&type=section&id=Financial%20Statements) This section presents the condensed consolidated statements of operations and balance sheets for the second quarter of 2025 and comparative periods [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $34.1 million, or $0.29 per share, for the three months ended June 30, 2025. This represents an improvement from a net loss of $38.4 million, or $0.33 per share, for the same period in 2024. The reduced loss was primarily driven by lower operating expenses, which decreased from $51.9 million in Q2 2024 to $38.9 million in Q2 2025 Statement of Operations (in thousands, except per share data) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :--- | :--- | :--- | | **Collaboration Revenue** | $1,907 | $6,772 | | **Total Operating Expenses** | $38,875 | $51,855 | | **Loss from Operations** | $(36,968) | $(45,083) | | **Net Loss** | $(34,070) | $(38,427) | | **Net Loss per Share** | $(0.29) | $(0.33) | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Fate Therapeutics had total assets of $371.6 million and total stockholders' equity of $261.4 million. Cash, cash equivalents, and investments totaled $248.9 million, compared to $306.7 million at the end of 2024 Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Cash, Cash Equivalents & Investments** | $248,927 | $306,725 | | **Total Assets** | $371,632 | $440,694 | | **Total Liabilities** | $110,268 | $121,968 | | **Total Stockholders' Equity** | $261,364 | $318,726 | [Company Overview](index=5&type=section&id=Company%20Overview) This section provides an overview of Fate Therapeutics' proprietary iPSC product platform and its focus on developing iPSC-derived cellular immunotherapies [iPSC Product Platform](index=5&type=section&id=About%20Fate%20Therapeutics'%20iPSC%20Product%20Platform) The company's proprietary iPSC product platform utilizes multiplexed-engineered human induced pluripotent stem cells to create clonal master iPSC lines. This innovative approach allows for the mass production of well-defined, uniform, off-the-shelf cell therapy products, aiming to overcome the limitations associated with patient- or donor-sourced therapies. The platform is protected by a robust intellectual property portfolio of over 500 issued patents - The platform uses clonal master iPSC lines as a starting source to manufacture engineered cell products, analogous to master cell lines for biopharmaceuticals[10](index=10&type=chunk) - This method is designed to produce well-defined, uniform products that can be stored for off-the-shelf availability and administered to a broad patient population[10](index=10&type=chunk) - The platform is supported by an intellectual property portfolio of over **500 issued patents** and **500 pending patent applications**[10](index=10&type=chunk) [About Fate Therapeutics, Inc.](index=5&type=section&id=About%20Fate%20Therapeutics%2C%20Inc.) Fate Therapeutics is a clinical-stage biopharmaceutical company based in San Diego, CA, dedicated to developing iPSC-derived cellular immunotherapies. The company's pipeline includes engineered T-cell and natural killer (NK) cell product candidates designed to deliver multiple therapeutic mechanisms to patients - Fate Therapeutics is a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies[11](index=11&type=chunk) - The company's pipeline includes iPSC-derived T-cell and NK cell product candidates with novel synthetic controls[11](index=11&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains standard legal disclaimers regarding forward-looking statements, which involve risks and uncertainties. It cautions that actual results may differ materially from expectations due to various factors, including clinical trial outcomes, regulatory hurdles, manufacturing challenges, and other risks detailed in the company's SEC filings - The release contains forward-looking statements based on management's current expectations, which are subject to a number of risks and uncertainties[13](index=13&type=chunk) - Key risks include product candidates not demonstrating requisite safety or efficacy, delays in clinical trials or manufacturing, and potential failure to maintain collaboration agreements[13](index=13&type=chunk) - Readers are advised to review the company's periodic filings with the Securities and Exchange Commission for a more detailed discussion of risks[13](index=13&type=chunk)

Core Insights - Fate Therapeutics has made significant progress in its clinical programs, particularly with the FT819 CAR T-cell product candidate for autoimmune diseases, showing promising data in systemic lupus erythematosus (SLE) and lupus nephritis (LN) [2][5] - The company is working closely with the FDA under the Regenerative Medicine Advanced Therapy (RMAT) designation to establish a registrational study for FT819 in SLE and LN, aiming to commence this study in 2026 [2][5] - Financially, the company reported a cash position of $248.9 million as of June 30, 2025, and total revenue of $1.9 million for the second quarter of 2025 [17][19] Clinical Developments - The first patient treated with FT819 achieved a durable response and drug-free remission at the 12-month follow-up, indicating the potential effectiveness of the therapy [1] - The Phase 1 clinical trial of FT819 continues to enroll patients, with interim data showing that patients with refractory active LN achieved objective renal responses [5][6] - The company has expanded its Phase 1 study to include additional B cell-mediated autoimmune diseases, with plans to initiate independent dose-expansion cohorts in the second half of 2025 [10] Financial Performance - For the second quarter of 2025, total operating expenses were $38.9 million, with research and development expenses accounting for $27.4 million [17][19] - The net loss for the second quarter was $34.1 million, compared to a net loss of $38.4 million in the same quarter of the previous year [19] - The company has implemented measures to extend its cash runway through the end of 2027, including a 12% reduction in employee headcount [12] Partnerships and Collaborations - Fate Therapeutics has extended its collaboration with Ono Pharmaceuticals for the development of a second solid tumor CAR T-cell product candidate [9] - The company is conducting a Phase 1 study for FT825/ONO-8250, targeting HER2 in advanced solid tumors, with a favorable safety profile reported [7] Regulatory Developments - The FDA has allowed the IND application for FT836, a CAR T-cell program targeting MICA/B for the treatment of solid tumors without conditioning chemotherapy [4][11] - The RMAT designation for FT819 was granted in April 2025, aimed at expediting the development of therapies for serious diseases [5]

iPSC Product Platform - Fate Therapeutics' iPSC product platform is supported by an IP portfolio with over 500 issued patents and over 500 pending patent applications[17] - One iPSC MCB vial has the potential to yield trillions of uniformly-engineered cells[18] - The company has a 40,000 ft2 cGMP manufacturing facility co-located with corporate headquarters[21] FT819 Program (CD19-targeted CAR T-cell) - In a Phase 1 study (n=25), FT819 showed no dose-limiting toxicities (DLTs), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD)[35] - In relapsed/refractory aggressive BCL patients (n=17), FT819 achieved a 47% Overall Response Rate (ORR) and a 24% Complete Response (CR), with 60% ORR and 40% CR in patients naïve to auto CD19-targeted CAR T[35] - In FT819-102, three Lupus Nephritis patients were dosed at DL1 (single dose, 360 million cells) with no dose limiting toxicities (DLTs) observed[45] FT825 Program (HER2-targeted CAR T-cell) - FT825/ONO-8250 is engineered for enhanced solid tumor efficacy, overcoming tumor heterogeneity and improving cell trafficking[62] - Preclinical data shows potent CAR-mediated activity of FT825 that can be further enhanced in combination with mAb[70] FT522 Program (CD19-targeted CAR NK Cell) - Preclinical data shows dose-dependent trafficking, infiltration, & residency in primary, secondary & tertiary tissues without cytokine support at human dose equivalency levels of 250 million & 1 billion cells per dose[112] - FT522 has the unique ability to eliminate both B cells and Plasma Cells Without the Need for Conditioning Chemotherapy[119]

Core Viewpoint - Fate Therapeutics has seen a significant increase in share price, gaining approximately 61.5% over the past month, outperforming the S&P 500, raising questions about the sustainability of this trend leading up to the next earnings report [1] Group 1: Earnings and Estimates - The consensus estimate for Fate Therapeutics has shifted upward by 12.68% in the past month, indicating positive revisions [2] - The stock has a Zacks Rank of 2 (Buy), suggesting expectations for above-average returns in the coming months [4] Group 2: VGM Scores - Fate Therapeutics has a subpar Growth Score of D, a Momentum Score of D, and a Value Score of D, placing it in the bottom 40% for investment strategies, resulting in an overall VGM Score of F [3] Group 3: Industry Performance - Fate Therapeutics is part of the Zacks Medical - Biomedical and Genetics industry, where Novavax has reported a revenue of $666.66 million, reflecting a year-over-year increase of 610.3% [5] - Novavax is expected to report a loss of $0.12 per share for the current quarter, with a year-over-year change of -112.1%, and has a Zacks Rank of 3 (Hold) [6]

Core Insights - Fate Therapeutics announced promising clinical data for FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE), showing all five patients treated achieved significant disease improvement [2][3] - The first patient reached a 12-month follow-up and continues in drug-free remission, indicating the potential for durable treatment effects [2][4] - The company is expanding its clinical trials to include multiple B cell-mediated autoimmune diseases, with plans for independent dose-expansion cohorts in various conditions [8] Clinical Data Summary - A multi-center, Phase 1 clinical trial is evaluating FT819's safety and efficacy in patients with moderate-to-severe SLE, including lupus nephritis and extrarenal lupus [3] - As of May 15, 2025, five patients have been treated, with all showing significant improvements in disease activity scores [3][4] - Three patients with active lupus nephritis achieved primary efficacy renal response, with reductions in SLEDAI-2K scores of 10 points or more [4][5] Treatment Regimens - FT819 was administered under two regimens: a fludarabine-free conditioning regimen and a conditioning-free regimen [3][6] - In the fludarabine-free regimen, three patients with active lupus nephritis showed significant reductions in SLEDAI-2K scores, with one patient achieving a score reduction from 20 to 4 at 12 months [4] - One patient with extrarenal lupus on maintenance therapy achieved low lupus disease activity state (LLDAS) at 3 months, maintained at 6 months, with a reduction in SLEDAI-2K from 8 to 2 [6] B-cell Remodeling - Patients treated with FT819 exhibited rapid B-cell depletion and a shift towards a non-switched, naïve B-cell repertoire within the first 60 days [7] - This remodeling was observed in both treatment regimens, indicating a potential mechanism of action for FT819 [7] Safety Profile - The treatment demonstrated a favorable safety profile, with low incidence of cytokine release syndrome and no events of neurotoxicity or graft-versus-host disease [8][10] - All patients were discharged after a short hospitalization, supporting the potential for outpatient administration [10] Regulatory and Development Plans - Fate Therapeutics has reached an agreement with the FDA to investigate multiple autoimmune diseases under its Phase 1 trial for FT819 [8] - The company plans to discuss registrational strategies with the FDA for FT819 in SLE under its RMAT designation [8]

Industry Overview - The global cancer treatment market is rapidly transforming due to increasing demand for more effective and less toxic therapies, with the U.S. expected to see 2,041,910 new cancer cases and 618,120 cancer-related deaths in 2025 [2] - Advances in early detection and treatment have led to a decline in mortality rates for certain cancers, but the overall rise in cancer incidence is driving higher spending on oncology care globally [2][4] - Innovative treatment approaches such as immunotherapy, targeted therapies, and personalized cancer vaccines are reshaping the oncology landscape [3] Market Dynamics - The rise in cancer prevalence is attributed to aging populations, lifestyle factors, and improved diagnostics, positioning the market for novel oncology drugs and diagnostics for robust growth [4] - Major pharmaceutical companies like Novartis, AstraZeneca, Pfizer, AbbVie, Bristol Myers, and Eli Lilly are actively developing next-generation cancer therapies, including antibody-drug conjugates and immuno-oncology agents [5] - Smaller biotech firms are also making significant advancements in cancer research, leading to increased interest from larger drugmakers in acquiring these companies for their innovative therapies [5] Company Highlights - Pfizer's oncology revenues grew 7% on an operational basis in Q1 2025, driven by drugs like Xtandi, Lorbrena, and Padcev, and it has advanced its oncology clinical pipeline with several candidates entering late-stage development [8][9] - Novartis reported a 24% increase in oncology sales to $3.9 billion in Q1 2025, with significant contributions from drugs like Kisqali and Pluvicto, and is investing in research for both common and rare cancers [11] - Fate Therapeutics is focused on developing universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell platform, with ongoing clinical studies for its CAR T-cell product candidate [12][13][14]

Core Viewpoint - The article discusses the advancements in CAR-T cell therapy, particularly focusing on a new iPSC-derived CAR-T cell targeting HER2, which aims to overcome challenges in treating solid tumors [2][3]. Group 1: Research Development - Fate Therapeutics developed an iPSC-derived CAR-T cell that preferentially targets HER2-positive tumors, addressing multiple barriers to efficacy in solid tumors through gene editing and engineering modifications [2][3]. - The CAR-T cells are designed to distinguish between tumor cells and normal cells, detecting truncated and misfolded HER2, while also knocking out genes that cause immune rejection and T cell exhaustion [3][4]. Group 2: Mechanisms and Enhancements - The CAR-T cells have been engineered to express IL-7R fusion protein for enhanced persistence, TGF-β-IL-18R to resist immunosuppressive tumor microenvironments, and CXCR2 to promote specific migration to solid tumor tissues [4][5]. - The study highlights the CAR's ability to differentiate between tumor and normal cells, and the engineered cells exhibit improved persistence and migration capabilities, along with resistance to TGF-β mediated suppression [5]. Group 3: Results and Implications - The iPSC-derived HER2-targeting CAR-T cells demonstrated strong anti-tumor activity in both in vitro and in vivo environments, with limited cytolytic activity against HER2-positive normal cells [3][5]. - The combination of CAR and high-affinity, non-cleavable CD16a Fc receptor allows for comprehensive multi-antigen targeting, enhancing therapeutic potential [3][5].