FT819 continues to demonstrate meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus (SLE) patients now treated; first systemic sclerosis (SSc) patient treated First ex-U.S. SLE patient treated with FT819 expands enrollment capacity and supports unique ability of FT819 for broad, on-demand patient accessibility Preclinical studies show FT836 chimeric antigen receptor (CAR) T cells uniquely targeting stress antigens MICA/B, combined with daratumumab, provide a c ...

Summary of Fate Therapeutics FY Conference Call Company Overview - **Company**: Fate Therapeutics (NasdaqGM:FATE) - **Focus**: Development of induced pluripotent stem cells (iPSC)-derived cell therapies for immune diseases and oncology [1][2] Key Points and Arguments iPSC Technology - **Unique Properties**: iPSCs can grow indefinitely and differentiate into any of the 200 cell types in the body, allowing for the creation of a master cell bank [3][4] - **Off-the-Shelf Concept**: iPSCs enable the production of consistent and uniform drug products, reducing costs and improving accessibility [4][5] Transition to CAR iT Cells - **Shift from T Cells to CAR iT Cells**: The company transitioned from developing T cells to CAR iT cells due to the latter's superior response to stimulation and expansion, which is crucial for treating aggressive diseases [6][7][8] FT819 Development - **Target**: FT819 is a CD19 CAR iT cell therapy initially aimed at aggressive DLBCL, showing a 40% complete response (CR) rate in CAR-T naive patients [10][11] - **Lupus Indication**: The therapy has been adapted for lupus, demonstrating a favorable safety profile and significant efficacy improvements in various clinical metrics [12][13] Market Potential - **Patient Population**: The potential patient population for lupus is significantly larger than for DLBCL, with estimates of 200 million individuals affected [13][14] - **Manufacturing Capacity**: The company projects the ability to produce approximately 50,000 doses per year, with a cost of goods around $3,000 per dose [15][16] Clinical Development and Future Plans - **Next Steps**: The company aims to initiate pivotal registration studies for FT819 in lupus by 2026 and explore additional autoimmune diseases [20][21] - **Pipeline Expansion**: Future therapies include FT839 for more complex diseases and FT836 targeting MICA/MICB in oncology [21][27] Innovations in Treatment - **Reduced Conditioning**: The company is working towards outpatient treatment options with lighter conditioning regimens, enhancing patient experience and accessibility [24][26] - **Sophisticated Edits**: FT839 will include additional edits to target CD38, aiming for a broader approach in treating autoimmune diseases [22][23] Financial Position - **Cash Reserves**: Fate Therapeutics reported a cash position of approximately $226 million, extending its runway through the end of 2027, allowing for continued development of its therapies [35] Additional Important Information - **Partnerships**: The company is collaborating with Ono for the development of FT825, a HER2 CAR iT therapy, which has faced challenges in patient enrollment due to prior treatments affecting HER2 expression [33][34] - **Patient Enrollment**: The company is experiencing faster enrollment rates in lupus compared to competitors, with nearly 14 clinical sites activated [19][20] This summary encapsulates the critical insights and developments discussed during the Fate Therapeutics FY Conference Call, highlighting the company's innovative approaches and future directions in cell therapy.

Core Insights - Fate Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies for cancer and autoimmune diseases [1][3] Company Overview - The company utilizes a proprietary iPSC product platform to create multiplexed-engineered master iPSC lines and manufacture off-the-shelf, iPSC-derived cell products [3] - Fate Therapeutics has established a leadership position in the clinical development of iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to deliver multiple therapeutic mechanisms [3] - The company is headquartered in San Diego, California [3] Upcoming Events - Fate Therapeutics will present at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, in New York [1] - Company management will participate in a fireside chat at 9:00 AM ET and a cell therapy panel discussion at 12:00 PM ET [1]

Core Insights - Fate Therapeutics reported a quarterly loss of $0.27 per share, which is better than the Zacks Consensus Estimate of a loss of $0.29, and an improvement from a loss of $0.40 per share a year ago [1][2] - The company achieved a revenue of $1.74 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 104.82%, although this is a decline from $3.07 million in the same quarter last year [3] Financial Performance - The earnings surprise for the quarter was +6.90%, and over the last four quarters, the company has consistently surpassed consensus EPS estimates [2] - Fate Therapeutics has also topped consensus revenue estimates four times in the last four quarters [3] Stock Performance - Since the beginning of the year, Fate Therapeutics shares have declined by approximately 37%, contrasting with a 16.5% gain in the S&P 500 [4] - The current Zacks Rank for the stock is 4 (Sell), indicating expectations of underperformance in the near future [7] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$0.29 on revenues of $0.85 million, and for the current fiscal year, it is -$1.14 on revenues of $4.38 million [8] - The outlook for the Medical - Biomedical and Genetics industry is relatively strong, ranking in the top 35% of over 250 Zacks industries, which may positively influence stock performance [9]

Financial Performance - The company has incurred net losses since inception, with significant expenses expected to continue due to ongoing research and development activities[111]. - Collaboration revenue for the three months ended September 30, 2025, was $1.7 million, down from $3.1 million in the same period in 2024, a decrease of 44%[142]. - For the nine months ended September 30, 2025, collaboration revenue was $5.3 million, down from $11.8 million in 2024, a decrease of 55%[146]. - The company incurred a net loss of $103.9 million for the nine months ended September 30, 2025, compared to a net loss of $134.1 million in 2024[153]. - As of September 30, 2025, the company had an accumulated deficit of $1.5 billion and cash and cash equivalents of $225.7 million[152][158]. Research and Development - The total estimated research and development fees under the Ono Agreement have increased to $44.5 million following multiple amendments[123]. - The company plans to continue significant investments in research and development activities over the next twelve months[127]. - The company has a pipeline of iPSC-derived CAR-targeted T-cell and NK cell product candidates currently under development[108]. - Research and development expenses decreased to $25.8 million for the three months ended September 30, 2025, from $34.7 million in 2024, a reduction of 25%[143]. - The company anticipates continued significant losses as it progresses with research and development of its product candidates, which have not yet achieved regulatory approval[162]. Collaboration and Funding - Collaboration revenue recognized during the three and nine months ended September 30, 2025, was $1.7 million and $5.3 million, respectively[125]. - The company received an upfront payment of $10.0 million from Ono Pharmaceutical Co., Ltd. as part of the collaboration agreement[115]. - The company has entered into research collaborations and license agreements with academic institutions to support the development of its iPSC product platform[108]. - The company was awarded $7.9 million from the California Institute for Regenerative Medicine (CIRM) for the Phase 1 study of FT819, with disbursements based on development milestones from April 1, 2024, to March 31, 2028[131]. - The company was awarded $4.0 million from CIRM for pre-clinical activities for FT836, with disbursements based on milestones from May 1, 2025, to October 31, 2025[135]. Expenses and Financial Obligations - General and administrative expenses are expected to remain significant as the company focuses on innovation and compliance with regulatory requirements[129]. - General and administrative expenses decreased to $10.6 million for the three months ended September 30, 2025, from $20.8 million in 2024, a decrease of 49%[143]. - The company has a milestone payment obligation of up to $75.0 million to MSKCC, contingent on stock price increases, with an initial payment of $20.0 million already made[168]. - Additional capital will be required for ongoing research and development, with potential funding sources including public or private equity and debt securities[164]. Market and Economic Conditions - The company is closely monitoring inflation and global economic conditions, which may impact its financial condition and capital raising efforts[166]. - The forecast for cash adequacy to support operations involves significant risks and uncertainties, with actual results potentially varying materially from expectations[165]. - The company is subject to risks in the development of therapeutic products, including potential additional regulatory requirements that could increase costs and extend timelines[163]. Securities and Offerings - The company has a shelf registration statement allowing the issuance of up to $300.0 million in securities, with an additional at-the-market offering program of up to $100.0 million through Jefferies[159]. - In March 2024, the company sold 14,545,454 shares of common stock at $5.50 per share, raising approximately $80.0 million[160]. - Concurrently, the company sold pre-funded warrants for 3,636,364 shares at $5.499 each, totaling approximately $20.0 million in a private placement[161]. Contractual Obligations - The company has no material contractual obligations not fully recorded or disclosed in its financial statements[169].

Financial Performance - Fate Therapeutics reported total revenue of $1.7 million for Q3 2025, derived from preclinical development activities[12] - Collaboration revenue for Q3 2025 was $1.741 million, down from $3.074 million in Q3 2024, representing a decrease of 43.4%[17] - Total operating expenses for Q3 2025 were $36.5 million, including R&D expenses of $25.8 million and G&A expenses of $10.6 million[12] - Total operating expenses for Q3 2025 were $36.476 million, a reduction of 34.2% compared to $55.451 million in Q3 2024[17] - Net loss for Q3 2025 was $32.250 million, compared to a net loss of $47.678 million in Q3 2024, indicating an improvement of 32.3%[17] - The company reported total other income of $2.485 million for Q3 2025, compared to $4.699 million in Q3 2024, a decrease of 47.2%[17] - Comprehensive loss for the nine months ended September 30, 2025, was $104.056 million, down from $133.289 million in 2024, indicating a reduction of 21.9%[17] Cash and Assets - Cash, cash equivalents, and investments as of September 30, 2025, were $225.7 million, providing a projected operating runway through year-end 2027[12] - Cash and cash equivalents increased to $40.622 million as of September 30, 2025, up from $36.056 million at the end of 2024[19] - Total assets decreased to $343.671 million as of September 30, 2025, down from $440.694 million at the end of 2024, reflecting a decline of 22%[19] Research and Development - FT819, an off-the-shelf CAR T-cell product, has shown promising clinical activity in treating systemic lupus erythematosus (SLE), with a mean SLEDAI-2K score decrease of 10.7 points at 3 months and 14 points at 6 months for patients on Regimen A[5] - The first patient with systemic sclerosis was treated in a Phase 1 study, demonstrating the potential for FT819 to address significant unmet medical needs in autoimmune diseases[5] - The company received regulatory authorization from the UK and EU to initiate clinical trials for FT819, marking a significant step in international expansion[4] - FT836, a MICA/B-targeted CAR T-cell, was administered to the first patient without conditioning chemotherapy, showcasing the potential for broad accessibility in solid tumor treatments[8] - The ongoing Phase 1 study for FT825/ONO-8250 in advanced solid tumors is currently at the third dose level of 900 million cells, with no dose-limiting toxicities observed[7] - The company plans to present data on FT836's applicability against multiple myeloma at the upcoming ASH Annual Meeting, supported by a $4 million award from CIRM[8] - Research and development expenses for the nine months ended September 30, 2025, were $82.404 million, down from $101.392 million for the same period in 2024, a decrease of 18.7%[17] - General and administrative expenses for the nine months ended September 30, 2025, were $35.856 million, compared to $58.907 million in 2024, a reduction of 39.1%[17] Leadership Changes - Kamal Adawi was appointed as Chief Financial Officer, bringing over 20 years of financial leadership experience in the life sciences industry[10] Share Information - The weighted-average common shares used to compute basic and diluted net loss per share for Q3 2025 were 118,998,693, compared to 117,769,161 in Q3 2024[17]

Core Insights - Fate Therapeutics has received authorization from UK and EU authorities to activate clinical trial sites for FT819, an off-the-shelf CD19-targeted CAR T-cell product candidate, aimed at improving patient accessibility with less-intensive or no conditioning [1][3] - The company reported promising preliminary clinical data for FT819, showing significant reductions in disease activity in patients with systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) [5][6] - Fate Therapeutics has a strong financial position with $226 million in cash and equivalents projected to fund operations through the end of 2027 [1][12] R&D Highlights and Updates - FT819 is designed to be a cost-effective, off-the-shelf CAR T-cell therapy that can be stored for on-demand availability, overcoming limitations of traditional patient-sourced therapies [3][11] - The first patient with systemic sclerosis has been treated in a Phase 1 study, demonstrating the potential of FT819 to address significant unmet medical needs in autoimmune diseases [5][6] - FT836, another CAR T-cell candidate targeting solid tumors, has also begun patient treatment without conditioning chemotherapy, showcasing the versatility of the company's technology [7][8] Financial Results - For Q3 2025, the company reported total revenue of $1.7 million, primarily from preclinical development activities [12][17] - Total operating expenses for the same period were $36.5 million, with research and development expenses accounting for $25.8 million [12][17] - The net loss for Q3 2025 was $32.3 million, reflecting ongoing investments in R&D and operational activities [12][17] Corporate Updates - Kamal Adawi has been appointed as Chief Financial Officer, bringing over 20 years of financial leadership experience in the life sciences sector [9] - The company continues to strengthen its iPSC platform and next-generation CAR T-cell programs, focusing on expanding access to innovative therapies for patients [2][3]

Core Viewpoint - Fate Therapeutics (FATE) is anticipated to report a year-over-year increase in earnings despite lower revenues, which could significantly influence its stock price depending on the actual results compared to estimates [1][3]. Financial Expectations - The upcoming earnings report is expected to show a quarterly loss of $0.29 per share, reflecting a year-over-year change of +27.5% [3]. - Revenues are projected to be $0.85 million, down 72.3% from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised 3.57% lower in the last 30 days, indicating a reassessment by analysts [4]. - The Most Accurate Estimate for Fate Therapeutics is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -7.02% [12]. Earnings Surprise Prediction - A positive Earnings ESP is a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1, 2, or 3 [10]. - Fate Therapeutics currently holds a Zacks Rank of 4, making it challenging to predict an earnings beat [12]. Historical Performance - In the last reported quarter, Fate Therapeutics was expected to post a loss of $0.35 per share but actually reported a loss of -$0.29, resulting in a surprise of +17.14% [13]. - Over the past four quarters, the company has beaten consensus EPS estimates four times [14]. Industry Context - In the Zacks Medical - Biomedical and Genetics industry, Arcturus Therapeutics (ARCT) is expected to report a loss of $1.25 per share, indicating a year-over-year change of -380.8% [18]. - Arcturus Therapeutics' revenue is expected to be $11.39 million, down 72.7% from the previous year [18].

Industry Overview - The global cancer treatment market is undergoing a transformative phase due to rising cancer incidence and rapid scientific advancements, with the U.S. projected to report 2.04 million new cancer cases and over 618,000 deaths in 2025 [1] - An aging population and lifestyle-related risks are increasing global cancer prevalence, leading to higher oncology spending by healthcare systems [1] Innovation in Cancer Treatment - Advances in immunotherapies, targeted drugs, and personalized vaccines are expanding treatment options beyond traditional chemotherapy and radiation [2] - Immune-based approaches, such as checkpoint inhibitors and CAR-T therapies, enhance the body's defenses against tumors, while targeted therapies focus on specific genetic mutations to improve precision and reduce side effects [2] - Emerging technologies like genomic sequencing, AI, and machine learning are accelerating biomarker discovery and improving early detection, contributing to better survival rates and quality of life across many cancer types [3] Pharmaceutical Investment - Major pharmaceutical companies, including Novartis, AstraZeneca, Johnson & Johnson, Pfizer, AbbVie, Merck, Bristol Myers Squibb, and Eli Lilly, are aggressively investing in new oncology pipelines, including antibody-drug conjugates and next-generation immuno-oncology agents [4] - Smaller biotech firms are key sources of innovation, driving collaborations, licensing deals, and acquisitions as larger companies seek novel assets [4] Investment Opportunities - The oncology segment is positioned as one of the most attractive and resilient areas for long-term investors due to continued innovation and favorable reimbursement trends [5] - Stocks such as Relay Therapeutics, Fate Therapeutics, and Verastem Oncology are highlighted as potential investment opportunities in the rising cancer treatment trend [6] Company Highlights - **Relay Therapeutics** is developing RLY-2608, a mutant-selective PI3Kα inhibitor, showing potential benefits in clinical studies for advanced breast cancer [7][8] - **Fate Therapeutics** focuses on universal, off-the-shelf cell products and is co-developing FT825/ONO-8250, a CAR T-cell product candidate, with promising safety profiles in early studies [9][10][11] - **Verastem Oncology** received FDA approval for its combination regimen of avutometinib and defactinib for treating KRAS mutant recurrent low-grade serous ovarian cancer, generating $2.1 million in sales shortly after launch [12][13]

Core Insights - Fate Therapeutics has reported promising initial clinical data for FT819, an off-the-shelf CAR T-cell therapy for moderate-to-severe systemic lupus erythematosus (SLE), demonstrating significant clinical activity and a favorable safety profile [2][3] - The company aims to accelerate patient enrollment in its Phase 1 trial and is in discussions with the FDA regarding a registrational study design, with plans to initiate a pivotal study in 2026 [2][8] Clinical Data Summary - As of September 25, 2025, 10 patients have been treated with FT819, with 5 patients showing significant reductions in SLE Disease Activity Index (SLEDAI-2K) scores and improvements in renal response [1][3] - Patients treated with a less-intensive conditioning regimen exhibited notable reductions in SLEDAI-2K scores, with one patient achieving complete renal response and remaining in drug-free remission at 15 months [1][4] - In the conditioning-free regimen, patients on maintenance therapy also showed meaningful reductions in disease activity scores, with one patient achieving low lupus disease activity state by 3 months [5] Safety Profile - The safety profile of FT819 is favorable, with no dose-limiting toxicities observed and a low incidence of low-grade cytokine release syndrome [6][8] - All patients were discharged on the same day post-infusion, supporting the potential for outpatient administration [6][8] Mechanistic Insights - FT819 treatment led to rapid CD19+ B cell depletion and immune remodeling towards a naïve B-cell repertoire, correlating with reductions in disease activity [8] - The unique ability of FT819 to remodel the B-cell compartment without intensive conditioning chemotherapy highlights its transformative potential in treating autoimmune diseases [8] Program Expansion and Future Outlook - Fate Therapeutics is expanding its clinical program to include additional cohorts for other autoimmune diseases and is preparing for a pivotal study in 2026 [8][9] - The company currently has approximately 600 cryopreserved drug product bags of FT819 available for patient treatment [9]