Enrollment Ongoing with FT819 1XX CAR T-cell Product Candidate in Phase 1 Autoimmunity Study; Singleagent Cyclophosphamide Included as Alternative Conditioning Regimen First Patient Treated with FT522 CAR NK Cell Product Candidate in Conditioning-free Arm of Phase 1 B Cell Lymphoma Study FT522 Multi-indication IND Application for Conditioning-free Treatment of Autoimmune Diseases to be Submitted in 3Q24 Enrollment Ongoing with FT825 / ONO-8250 CAR T-cell Product Candidate as Monotherapy in Phase 1 Solid Tum ...

Fate Therapeutics is 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. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off- the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-deri ...

Financial Data and Key Metrics Changes - The company reported a net loss of $48 million for Q1 2024, equating to $0.47 per share, with total operating expenses increasing by 7% to $53 million compared to Q4 2023 [14][26][70] - Cash, cash equivalents, and investments at the end of Q1 2024 were approximately $391 million, bolstered by an $80 million stock offering and a $20 million private placement [14][26] Business Line Data and Key Metrics Changes - FT819, the off-the-shelf CD19-targeted CAR T-cell program, demonstrated rapid, deep, and sustained B-cell depletion in preclinical studies, showing clinical responses without the use of fludarabine as a conditioning agent [11][22][24] - FT522, the CAR NK cell program, showed enhanced persistence and activity in preclinical studies, with plans to submit an IND application for various B-cell mediated autoimmune diseases [12][24] Market Data and Key Metrics Changes - The company is focusing on the autoimmune disease market, particularly with FT819 and FT522, aiming to redefine treatment paradigms by eliminating the need for conditioning chemotherapy [13][24][73] - The competitive landscape includes T-cell engagers, which may address similar challenges as the company's off-the-shelf programs, indicating a need for differentiation in safety and efficacy [36][62] Company Strategy and Development Direction - The company plans to amend the current clinical protocol for FT819 to allow administration with single-agent cytoxan, aiming to enhance patient experience and safety [11][29][73] - The strategic direction emphasizes the value proposition of iPSC-derived therapies and off-the-shelf cell therapies for improved patient safety, convenience, and cost-effectiveness [13][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of FT819 to demonstrate disease-modifying effects in autoimmune diseases, with initial clinical data expected by the end of 2024 [41][74] - The focus on safety and efficacy in the autoimmune space is critical, with management acknowledging the challenges posed by traditional conditioning regimens [36][73] Other Important Information - The company has completed dose escalation in its FT819 Phase I study, treating 43 patients with a single dose of up to 1 billion cells without HLA matching [11][12] - The first lupus patient has been treated in the FT819 autoimmunity study, with no notable adverse events reported during a three-day hospitalization [22][53] Q&A Session Summary Question: Can you discuss the impact of allowing single-agent cytoxan in the autoimmune study? - Management believes this amendment will enhance patient enrollment and treatment outcomes, as it simplifies the conditioning regimen [29][73] Question: How does FT522 compare to other therapies in terms of efficacy? - Management acknowledges the importance of efficacy but emphasizes that safety will be prioritized in the autoimmune setting, differentiating from oncology approaches [36][62] Question: What are the expectations for patient enrollment in the FT819 studies? - Management anticipates that the amendment to allow alternative conditioning regimens will drive traction with site investigators and improve enrollment rates [56][73]

Fate Therapeutics (FATE) came out with a quarterly loss of $0.47 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this clinical-stage biotech company that develops stem cell treatments would post a loss of $0.57 per share when it actually produced a loss of $0.45, delivering a surprise of 21.05%.Over the last four quarters, the company has surpassed consensus EPS es ...

Financial Performance - The company has incurred net losses since its inception in 2007, with significant losses expected to continue in the foreseeable future[112]. - The company had an accumulated deficit of $1.3 billion as of March 31, 2024, and anticipates continued net losses[143]. - Cash used in operating activities increased to $33.4 million in Q1 2024 from $28.9 million in Q1 2023, driven by a higher net loss[144]. - Other income (expense), net was $3.1 million in Q1 2024, down from $9.7 million in Q1 2023, impacted by changes in fair value of stock price appreciation milestones[141]. Collaboration Revenue - Collaboration revenue for the three months ended March 31, 2024, was $1.9 million, a decrease from $6.7 million in the same period in 2023[123]. - The company recognized $52.3 million of collaboration revenue under the Janssen Agreement during the three months ended March 31, 2023[127]. - Collaboration revenue decreased to $1.9 million in Q1 2024 from $59.0 million in Q1 2023, primarily due to the termination of the Janssen contract[139]. Research and Development - Research and development expenses include costs related to the development of product candidates and are expected to remain significant as the company continues its activities[128]. - The company plans to invest significantly in research and development activities over the next twelve months, focusing on clinical and preclinical development[129]. - Research and development expenses were $32.1 million in Q1 2024, down from $65.6 million in Q1 2023, reflecting a decrease in clinical trial and consulting expenses[140]. - The company has a deep pipeline of iPSC-derived CAR-targeted NK and T-cell product candidates currently under development with multiple clinical trials ongoing[109]. - The company has entered into collaborations with academic institutions and pharmaceutical companies to support the development of its iPSC product platform[109]. Cash Flow and Financing - Investing activities provided cash of $17.3 million in Q1 2024, compared to $9.3 million in Q1 2023, due to increased net maturities of investments[145]. - Financing activities generated $95.5 million in Q1 2024, primarily from the issuance of 14,545,454 shares at $5.50 per share[146]. - As of March 31, 2024, the company had cash and cash equivalents of $391.1 million, sufficient to fund projected operating requirements for at least the next twelve months[148]. - The company anticipates needing additional capital for research, manufacturing, and development of product candidates due to potential changes in business conditions and global economic factors[154]. Obligations and Risks - The company has a milestone payment obligation to MSKCC totaling up to $75 million, with a recent payment of $20 million made after achieving a specified clinical milestone[159]. - The company may need to adjust its business operations if it cannot secure sufficient capital, which could materially affect its financial condition and prospects[157]. - The company has no material contractual obligations not fully recorded on its balance sheets or disclosed in financial statement notes[160]. - Inflation rates and global political conditions, including conflicts, are being closely monitored as they may negatively impact the company's financial condition and operational results[156]. - Inflation has persisted and may continue to rise, potentially affecting operating results, although no material impact has been observed to date[161]. - The company may face challenges in raising additional capital on reasonable terms, which could lead to delays or discontinuation of product development[154]. Operational Considerations - The company is evaluating the costs and timing of clinical trials and regulatory approvals, which are critical for its product candidates[156]. - Future funding requirements will depend on various factors, including the progress and costs associated with clinical trials and manufacturing activities[155]. - The company is assessing its operating capital requirements and may make necessary adjustments to its business operations[156].

Exhibit 99.1 Enrollment Initiated with FT522 CAR NK Cell Product Candidate in Conditioning-free Treatment Arm of Phase 1 B Cell Lymphoma Study First Patient Treated with FT825 / ONO-8250 CAR T-cell Product Candidate in Phase 1 Solid Tumor Study $391 Million in Cash, Cash Equivalents, and Investments San Diego, CA – May 9, 2024 – Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived ce ...

Pre-treatment Sample of Patient's Blood Showed Rapid and Potent Depletion of CD19+ B Cells in Ex Vivo Cytotoxicity Assay with FT819 Translational Data from FT819 Phase 1 B Cell Malignancies Study Support Key Therapeutic Mechanisms of Activity for B Cell-mediated Autoimmune Diseases Initial Clinical Observations of FT522 CAR NK Cell Program in Phase 1 B Cell Lymphoma Study Show Rapid, Deep, and Sustained B Cell Depletion and Enhanced Persistence in the Periphery SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Fa ...

SAN DIEGO, May 06, 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 diseases, will host a conference call and live audio webcast on Thursday, May 9, 2024 at 5:00 PM ET to report its first quarter 2024 financial results and highlight operational updates, i ...

Off-the-shelf, CD19-targeted CAR NK Cell Product Candidate Drives Rapid and Deep Depletion of SLE Donor CD19+ B cells ADR Technology Incorporated into FT522 Induces Functional Persistence and Eliminates Alloreactive Host Immune Cells in SLE Donor PBMCs SAN DIEGO, May 03, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (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 ...

Fate Therapeutics’ (FATE) shares have surged 86.4% year to date compared with the industry’s growth of 1.5%. This can be attributed to the overall positive sentiment across the company’s innovative pipeline and recent pipeline progress.FATE is a clinical-stage biopharmaceutical company, building a pipeline of programmed cellular immunotherapies for cancer and autoimmune diseases. The company is using cell programming to create better cell therapies. It creates and engineers human induced pluripotent stem ce ...