Fate Therapeutics, Inc. (NASDAQ:FATE) Q4 2023 Earnings Conference Call February 26, 2024 5:00 PM ET Company Participants Scott Wolchko - President and Chief Executive Officer Edward Dulac - Chief Financial Officer Bob Valamehr - Chief Research and Development Officer Conference Call Participants Michael Yee - Jefferies Yigal Nochomovitz - Citigroup Tara Bancroft - TD Cowen Tazeen Ahmad - Bank of America Daina Graybosch - Leerink Partners Michael Ulz - Morgan Stanley Peter Lawson - Barclays Carolina Ibanez - ...

Fate Therapeutics (FATE) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.57. This compares to loss of $0.58 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 21.05%. A quarter ago, it was expected that this clinical-stage biotech company that develops stem cell treatments would post a loss of $0.59 per share when it actually produced a loss of $0.46, delivering a surprise of ...

CIRM Grant Awarded to Support Phase 1 Autoimmunity Study of FT819 CD19-targeted CAR T-cell Program for Systemic Lupus Erythematosus; Study Start-up Ongoing at Multiple Clinical Sites First Patient Treated in Phase 1 Study of FT522 ADR-armed, CD19-targeted CAR NK Cell Program; Dose Escalation Designed to Assess 3-dose Treatment Schedule with and without Chemotherapy Conditioning Phase 1 Study Initiated of FT825 / ONO-8250 CAR T-cell Program for Solid Tumors; Incorporates Seven Synthetic Controls including No ...

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, 2023 ☐ 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) Delaware 65-1311552 (State or other jurisdiction ...

Exhibit 99.1 Fate Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates CIRM Grant Awarded to Support Phase 1 Autoimmunity Study of FT819 CD19-targeted CAR T-cell Program for Systemic Lupus Erythematosus; Study Start-up Ongoing at Multiple Clinical Sites First Patient Treated in Phase 1 Study of FT522 ADR-armed, CD19-targeted CAR NK Cell Program; Dose Escalation Designed to Assess 3-dose Treatment Schedule with and without Chemotherapy Conditioning Phase 1 Study Initi ...

Fate Therapeutics (FATE) is expected to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended December 2023. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on Feb ...

SAN DIEGO, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (the “Company” or “Fate Therapeutics”) (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today announced that the Company will host a conference call and live audio webcast on Monday, February 26, 2024 at 5:00 PM ET to report its fourth quarter and full year 2023 ...

Fate Therapeutics (FATE) shares rallied 25.4% in the last trading session to close at $5.72. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 21.9% gain over the past four weeks.This suuden rise in the stock price is attributable to positive investor sentiments towards the company’s early-stage cell therapy pipeline consisting of several cellular immunotherapies targeting cancer and aitoimmune disorders. Earli ...

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]