Fate Therapeutics (FATE) came out with a quarterly loss of $0.40 per share versus the Zacks Consensus Estimate of a loss of $0.42. This compares to loss of $0.46 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 4.76%. A quarter ago, it was expected that this clinical-stage biotech company that develops stem cell treatments would post a loss of $0.47 per share when it actually produced a loss of $0.33, delivering a surprise of 2 ...

Initial Clinical Data from Phase 1 Autoimmunity Study of FT819 1XX CAR T-cell Product Candidate to be Presented in 4Q24; Second Treatment Arm Adding FT819 to Maintenance Therapy without Conditioning Chemotherapy Opened for Enrollment FT522 Multi-indication IND Application for Conditioning-free Treatment of B Cell-mediated Autoimmune Diseases Allowed by FDA; Initial Phase 1 Clinical Data in B-cell Lymphoma to be Presented at ACR Convergence Initial Low-Dose Cohort of FT825 / ONO-8250 Shows Favorable Safety P ...

It has been about a month since the last earnings report for Fate Therapeutics (FATE) . Shares have added about 18.7% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Fate Therapeutics due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. FATE Q2 Earnings Beat on Lower Ex ...

Investors might want to bet on Fate Therapeutics (FATE) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. Since a changing e ...

Fate Therapeutics (FATE) reported a loss of 33 cents per share in the second quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 47 cents. The company reported a loss of 54 cents per share in the year-ago period. The loss narrowed year over year due to higher collaboration revenues and lower R&D expenses. The company earned collaboration revenues of $6.8 million, which beat the Zacks Consensus Estimate of $1 million. The figure also increased from $0.9 million reported in the year-ago q ...

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].