Fate Therapeutics(FATE)
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Fate Therapeutics (FATE) Soars 25.4%: Is Further Upside Left in the Stock?
Zacks Investment Research· 2024-01-30 13:56
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 ...
Billionaire Steve Cohen Is Betting Big on Fate Therapeutics (FATE) Stock
InvestorPlace· 2024-01-29 19:53
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 ...
Fate Therapeutics(FATE) - 2023 Q3 - Earnings Call Transcript
2023-11-09 02:12
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]
Fate Therapeutics(FATE) - 2023 Q3 - Quarterly Report
2023-11-07 16:00
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 ...
Fate Therapeutics(FATE) - 2023 Q2 - Quarterly Report
2023-08-07 16:00
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(FATE) - 2023 Q1 - Earnings Call Transcript
2023-05-04 00:34
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 ...
Fate Therapeutics(FATE) - 2023 Q1 - Quarterly Report
2023-05-02 16:00
Financial Performance - The company has incurred net losses since inception, with significant losses attributed to research and development costs and general administrative expenses [125]. - The company has not generated any revenues from therapeutic product sales or royalties to date, relying instead on collaboration agreements and government grants [128]. - The company anticipates continued operating losses for the foreseeable future as it invests in research and development activities [125]. - As of March 31, 2023, the company had an accumulated deficit of $1.1 billion and anticipates continued net losses for the foreseeable future [154]. - The company expects to incur losses for the foreseeable future as it continues research and development activities, with potential increases in losses anticipated [177]. Collaboration Agreements - Collaboration revenue for the three months ended March 31, 2023, was $52.3 million under the Janssen Agreement, compared to $15.9 million for the same period in 2022 [132]. - The company recognized $6.7 million of collaboration revenue under the Ono Agreement for the three months ended March 31, 2023, up from $2.5 million in the same period in 2022 [139]. - The company has entered into multiple collaboration agreements, including a $100 million agreement with Janssen, which included a $50 million upfront cash payment [129]. - Collaboration revenue increased to $58.98 million for the three months ended March 31, 2023, compared to $18.41 million for the same period in 2022, reflecting a $40.57 million increase attributed to the recognition of deferred revenue from the Janssen contract termination [150]. - Under the Ono Agreement, the company received an upfront payment of $10 million and is eligible for up to $40 million in additional payments based on preclinical milestones [160]. - The company is entitled to receive up to $843.0 million in milestone payments for each candidate under the Ono Agreement, with $10.0 million received in December 2020 and $12.5 million in November 2022 [166]. Research and Development - The company plans to increase research and development expenses to support ongoing clinical trials and the development of its iPSC product platform [141]. - The company has discontinued its FT516, FT596, FT538, and FT536 NK cell programs to focus on more innovative projects [123]. - The company has a research collaboration with the University of Minnesota and Memorial Sloan Kettering Cancer Center to develop engineered NK and T-cell cancer immunotherapies [120]. - Research and development expenses decreased to $65.63 million for the three months ended March 31, 2023, down from $72.14 million in the same period in 2022, a reduction of $6.51 million [151]. Expenses and Cash Flow - General and administrative expenses rose to $21.94 million for the three months ended March 31, 2023, compared to $20.74 million in the same period in 2022, an increase of $1.20 million primarily due to higher patent and legal expenses [151]. - Cash used in operating activities decreased to $28.9 million for the three months ended March 31, 2023, compared to $64.6 million for the same period in 2022, primarily due to a decrease in net loss [155]. - The company incurred $17.1 million in sublicense fees related to the Janssen Agreement, with $15.6 million paid as of March 31, 2023 [159]. - The company reversed the liability associated with the CIRM Award, recording it as other income during the three months ended March 31, 2023, following the discontinuation of the FT516 program [147]. - Other income increased to $9.71 million for the three months ended March 31, 2023, compared to $8.78 million in the same period in 2022, including $4.0 million from the CIRM Award [152]. Capital and Funding - The company may require additional capital for research and development and may seek funds sooner than expected due to various risks, including inflation and global economic conditions [179]. - The company has entered into a sales agreement for an at-the-market offering program, allowing it to sell up to $350.0 million in common stock [176]. - The company received $100 million from the Janssen Agreement, which included a $50 million upfront cash payment and a $50 million equity investment [156]. Market and Economic Factors - Inflationary factors may adversely affect the company's operating results, although no material impact has been observed to date [185]. - The company is exposed to interest rate risk, but a 10% change in market interest rates would not have a material impact on its financial condition [186]. - The company has no material contractual obligations not fully recorded or disclosed in its financial statements [184].
Fate Therapeutics(FATE) - 2022 Q4 - Earnings Call Transcript
2023-03-01 03:57
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 ...
Fate Therapeutics(FATE) - 2022 Q4 - Annual Report
2023-02-27 16:00
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 ...
Fate Therapeutics (FATE) Investor Presentation - Slideshow
2022-11-12 13:53
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 ...