When billionaire investors step into a particular smaller-cap under-the-radar name, investors take notice. That appears to be the case with Fate Therapeutics (NASDAQ:FATE) today. At the time of writing, FATE stock has soared more than 17% on news that Steve Cohen and his Point 72 hedge fund have taken a 5% passive stake in the biotech company.Fate Therapeutics is working on developing drugs and treatments for patients with various cancers and autoimmune diseases. The early-stage oncology and immune biotech ...

Financial Data and Key Metrics - Revenue for Q3 2023 declined to $1.9 million compared to $15 million in the same period last year, driven exclusively by the collaboration with ONO Pharmaceutical [59] - General and administrative expenses decreased by 12% to $18.9 million, primarily due to reduced salaries and benefits, including share-based compensation [16] - Total operating expenses declined by 47% to $53.2 million, including $10.1 million of non-cash share-based compensation expense [16] - Net loss for the quarter was $45.2 million or $0.46 per share [60] - Cash, cash equivalents, and investments at the end of Q3 were approximately $350 million [59] Business Line Data and Key Metrics - FT522, the off-the-shelf CD19-targeted CAR-NK cell program, has opened enrollment for its Phase 1 study in relapsed refractory B-cell lymphoma, with two regimens: one with conditioning chemotherapy and one without [6][7] - FT825, a multiplexed engineered iPSC-derived CAR T-cell program, received FDA clearance for clinical investigation in solid tumors, incorporating seven novel synthetic controls of cell function [8][9] - FT819, the off-the-shelf CD19-targeted CAR T-cell program, initiated Phase 1 studies in SLE (systemic lupus erythematosus) with multiple sites starting enrollment [30][31] - FT576, a CAR T-cell program for multiple myeloma, is enrolling patients in three-dose treatment cohorts at 1 billion cells per dose, both as monotherapy and in combination with CD38-targeted monoclonal antibody therapy [32] Market Data and Key Metrics - The company is expanding its iPSC product platform into solid tumors and autoimmunity, with significant clinical readouts expected in 2024 across multiple programs [24] - The collaboration with ONO Pharmaceutical for FT825 in solid tumors has resulted in $2.1 million of contra R&D expense recognized in Q3 [34] - The company is exploring the potential of off-the-shelf cell therapy in autoimmunity, with FT819 showing promise in SLE and other autoimmune diseases [31][66] Company Strategy and Industry Competition - The company is focused on advancing its iPSC-derived cellular immunotherapies, with a strong emphasis on reducing or eliminating the need for conditioning chemotherapy, which could significantly improve patient access and safety [25][26] - The ADR (alloimmune defense receptor) technology in FT522 is designed to mitigate rejection and promote NK cell proliferation, potentially enabling clinical responses without intense conditioning chemotherapy [25] - The company is positioning itself as a leader in off-the-shelf cell therapy, with a differentiated approach that leverages multiple mechanisms of action to target both cancer and autoimmune diseases [58][66] Management Commentary on Operating Environment and Future Outlook - Management remains confident in the company's ability to achieve important clinical readouts in 2024, particularly in oncology and autoimmunity [24] - The company is well-positioned to extend its operating runway into the second half of 2025, thanks to significant cost control measures and reduced cash utilization [24] - Management highlighted the potential for FT522 to demonstrate proof-of-concept without conditioning chemotherapy, which could be a game-changer in the field of cell therapy [65] Other Important Information - The company has a contingent milestone payment of $700,000 related to the development of FT819, with up to two additional milestone payments possible based on the company's stock performance [16] - The Phase 1 study of FT819 in SLE allows for assessment of higher dose levels and multiple dose expansion cohorts, with a favorable review from the Lupus Therapeutics Protocol Design Committee [31] Q&A Session Summary Question: What is the threshold for acceptable drop-off in engraftment or activity for FT522 between patients with and without preconditioning? [61] - The focus is on patient benefit, with the potential for no conditioning being a key element of FT522's unique profile [62] Question: How does FT825 compare to other CAR T-cell therapies in solid tumors? [45] - FT825 is a multiplexed engineered iPSC-derived CAR T-cell therapy with a fine-tuned binding domain against HER2, showing early promise in solid tumors [45] Question: Why start with FT819 in autoimmunity rather than FT522? [68] - FT819 has human clinical experience, a differentiated safety profile, and strong proof-of-concept for autologous CAR T-cell therapy, making it a strong candidate for autoimmunity [69] Question: What are the major value-creating events expected in the next 6-12 months? [65] - Key events include demonstrating proof-of-concept for FT522 without conditioning chemotherapy, advancing FT825 in solid tumors, and expanding into autoimmunity with FT819 [65][66] Question: What is the rationale for choosing lupus as the initial autoimmune indication for FT819? [73] - There is strong clinical precedent for CD19-targeted therapy in lupus, and significant enthusiasm from the lupus community for cell therapy [84] Question: How does the company view the competitive landscape for CD19 CAR-T therapies? [63] - The company believes there is a significant need for off-the-shelf cell therapies, particularly in post-auto CAR-T patients, and sees opportunities to combine with standard immunotherapy regimens [63][64] Question: What is the expectation for T-cell removal with the starting dose of FT522? [86] - The starting dose of 300 million cells is expected to remove a significant portion of T-cells, with potential for dose escalation based on anti-tumor activity [86] Question: How does FT819 compare to other emerging assets in systemic lupus? [87] - Preclinical data for FT819 shows distinct and specific elimination of the B-cell compartment, with strong in vitro and in vivo evidence of durable activity [88][89] Question: How many sites will be involved in the autoimmune study for FT819? [93] - The company is working with 12-15 sites that are already familiar with FT819 from oncology studies, aiming to partner with oncologists and rheumatologists for effective patient treatment [93]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION From the transition period from to . Commission File Number 001-36076 FATE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 Delaware 65-1311552 (State or other jurisdiction of i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to . Commission File Number 001-36076 FATE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 65-1311552 (State or other jurisdiction of incorp ...

Fate Therapeutics, Inc. (NASDAQ:FATE) Q1 2023 Earnings Conference Call May 3, 2023 5:00 PM ET Company Participants Scott Wolchko - President and Chief Executive Officer Ed Dulac - Chief Financial Officer Wayne Chu - Chief Medical Officer Bob Valamehr - Chief Research and Development Officer Conference Call Participants Tazeen Ahmad - Bank of America Mara Goldstein - Mizuho Daina Graybosch - SVB Securities Andrea Tan - Goldman Sachs Matthew Biegler - Oppenheimer Operator Welcome to the Fate Therapeutics Firs ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36076 FATE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 65-1311552 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 12278 Scripps Summit Drive, San Diego, CA 92131 (Address of principal executive offices) (Zip Code) ...

Fate Therapeutics, Inc. (NASDAQ:FATE) Q4 2022 Earnings Conference Call February 28, 2023 5:00 PM ET Company Participants Scott Wolchko - President and Chief Executive Officer Wayne Chu - Chief Medical Officer Ed Dulac - Chief Financial Officer Bob Valamehr - Chief Research and Development Officer Conference Call Participants Carly Kenselaar - Citi Daina Graybosch - SVB Securities Tazeen Ahmad - Bank of America Andrea Tan - Goldman Sachs Robyn Karnauskas - Truist Mara Goldstein - Mizuho Matthew Biegler - Opp ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number 001-36076 FATE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...

Better Cells For Better Therapies™ | --- | --- | |----------------------------------------------------------------------------------------------------------------------|-------| | | | | Programmed Cellular Immunotherapies | | | Transforming the Treatment of Cancer with Off-the-shelf, Multiplexed-engineered, iPSC-derived Cellular Immunotherapy | | | November 2022 | | - Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Re ...

Fate Therapeutics, Inc. (NASDAQ:FATE) Q3 2022 Earnings Conference Call November 3, 2022 5:00 PM ET Company Participants Scott Wolchko - President & Chief Executive Officer Ed Dulac - Chief Financial Officer Bob Valamehr - Chief Research & Development Officer Conference Call Participants Tazeen Ahmad - Bank of America Michael Yee - Jefferies Tyler Van Buren - Cowen Yigal Nochomovitz - Citigroup Michael Schmidt - Guggenheim Securities Daina Graybosch - SVB Securities Peter Lawson - Barclays Gil Blum - Needham ...