FATE
Fate TherapeuticsADocument history
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Related articleQuarter not tagged2026-10-01Fate Therapeutics to Participate in Upcoming Fourth Quarter 2026 Conferences
GlobeNewswire
Fate Therapeutics to Participate in Upcoming Fourth Quarter 2026 Conferences
SAN DIEGO, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that management will participate in the following investor conferences in the fourth quarter of 2026. 2026 Jefferies Global Healthcare Conference Location: London, UK Date: November 16th – 19th Piper Sandler 38th Annual Healthcare Conference Location: New York, NY Date: December 1st – 3rd The Company may participate in a presentation or a fireside chat at these conferences. When available, a live webcast will be accessible under "Events & Presentations" on the Investors section of the Company's website at www.fatetherapeutics.com. An archived replay of the webcast will be available for 30 days following the event. About Fate Therapeutics, Inc. 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 diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Contact: Ryan Douglas Fate Therapeutics, Inc. [email protected]
Related articleQuarter not tagged2026-08-13Fate Therapeutics: Q2 Earnings Snapshot
Associated Press
Fate Therapeutics: Q2 Earnings Snapshot
SAN DIEGO (AP) — SAN DIEGO (AP) — Fate Therapeutics Inc. (FATE) on Thursday reported a loss of $30.2 million in its second quarter. The San Diego-based company said it had a loss of 25 cents per share. The results beat Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for a loss of 28 cents per share. The clinical-stage biotech company that develops stem cell treatments posted revenue of $2.1 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on FATE at https://www.zacks.com/ap/FATE
Related articleQuarter not tagged2026-08-13Fate Therapeutics Reports Second Quarter 2026 Financial Results and Business Updates
GlobeNewswire
Fate Therapeutics Reports Second Quarter 2026 Financial Results and Business Updates
First lupus nephritis patient dosed in RECLAIM-LN, a Phase 2 potentially registrational trial utilizing FT819, an iPSC-derived, off-the-shelf CAR T-cell therapy; patient was treated as an outpatient with same-day discharge FDA clearance of the FT839 IND application advances the Company’s novel dual CD19/CD38 targeting off-the-shelf CAR T-cell product candidate into a Phase 1/2 basket trial in autoimmune disease Preliminary clinical data in SSc presented at the ISSCR 2026 Annual Meeting demonstrate rCRISS25 or greater responses and improvement in mRSS in all four treated patients, with no CRS, ICANS, GvHD, or hypogammaglobulinemia reported Appointment of Laura Hamill to the Board, bringing strong commercial expertise as the Company advances its pipeline toward later-stage development and prepares for its transition to a commercial-stage organization Quarterly change in cash, cash equivalents, and investments is a decrease of $21 million; cash runway expected into 2028 SAN DIEGO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “Dosing of the first patient in RECLAIM-LN, our Phase 2 potentially registrational trial, is an exciting milestone as we work to address significant unmet medical needs in patients with lupus nephritis using our FT819 off-the-shelf CAR T-cell treatment,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. “The use of a clonally engineered master cell bank provided us the unique advantage of producing a FT819 pivotal CAR T-cell drug product batch that is uniform in composition and consistent with previously manufactured batches, a level of manufacturing consistency that can be challenging to achieve with patient- and donor-sourced CAR T-cell therapies. The clinical development of the FT819 franchise is further strengthened through its FDA RMAT designation and CDRP program inclusion. With our first patient treated, multiple clinical sites activated, and pivotal drug product inventory in distribution depots ready to be shipped to clinical sites on demand, we…Read full documentShow less
First lupus nephritis patient dosed in RECLAIM-LN, a Phase 2 potentially registrational trial utilizing FT819, an iPSC-derived, off-the-shelf CAR T-cell therapy; patient was treated as an outpatient with same-day discharge FDA clearance of the FT839 IND application advances the Company’s novel dual CD19/CD38 targeting off-the-shelf CAR T-cell product candidate into a Phase 1/2 basket trial in autoimmune disease Preliminary clinical data in SSc presented at the ISSCR 2026 Annual Meeting demonstrate rCRISS25 or greater responses and improvement in mRSS in all four treated patients, with no CRS, ICANS, GvHD, or hypogammaglobulinemia reported Appointment of Laura Hamill to the Board, bringing strong commercial expertise as the Company advances its pipeline toward later-stage development and prepares for its transition to a commercial-stage organization Quarterly change in cash, cash equivalents, and investments is a decrease of $21 million; cash runway expected into 2028 SAN DIEGO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “Dosing of the first patient in RECLAIM-LN, our Phase 2 potentially registrational trial, is an exciting milestone as we work to address significant unmet medical needs in patients with lupus nephritis using our FT819 off-the-shelf CAR T-cell treatment,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. “The use of a clonally engineered master cell bank provided us the unique advantage of producing a FT819 pivotal CAR T-cell drug product batch that is uniform in composition and consistent with previously manufactured batches, a level of manufacturing consistency that can be challenging to achieve with patient- and donor-sourced CAR T-cell therapies. The clinical development of the FT819 franchise is further strengthened through its FDA RMAT designation and CDRP program inclusion. With our first patient treated, multiple clinical sites activated, and pivotal drug product inventory in distribution depots ready to be shipped to clinical sites on demand, we are building momentum to accelerate the clinical development of RECLAIM-LN. In addition to FT819, our next generation CAR T-cell programs include FT839, a novel 13-point edited CAR T-cell product candidate co-targeting CD19 and CD38, which is advancing to first patient treatment in rheumatoid arthritis and other autoimmune diseases, as well as FT836, CAR T-cell product candidate targeting the stress ligands MICA/B for pan-tumor treatment which is showing early anti-tumor activity in colorectal cancer without conditioning chemotherapy. With these advancements and a strong cash position, we believe Fate is positioned for strong execution across our portfolio.” Clinical Development & Program Updates RECLAIM-LN, FT819 Phase 2 Potentially Registrational Trial in Lupus Nephritis Lupus nephritis (LN) is among the most serious manifestations of systemic lupus erythematosus (SLE). Approximately 100,000 U.S. patients have refractory moderate-to-severe LN, a subset of LN not previously evaluated with currently available therapies. Of these patients, only approximately 10-20% are expected to achieve a complete renal response (CRR), underscoring the substantial unmet need that RECLAIM-LN is designed to address. The RECLAIM-LN trial is an open-label, single-arm study developed following interactions with the FDA under the Company’s Regenerative Medicine Advanced Therapy (RMAT) designation. The Phase 2 potentially registrational clinical trial is expected to enroll approximately 53 patients and evaluate a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with CRR at Week 26 as the primary endpoint. The conditioning regimen selected for RECLAIM-LN is less-intensive than other CAR T-cell clinical trials, which typically incorporate up to three days of co-administration of cyclophosphamide and fludarabine, a combination that was observed as less desirable to patients and clinicians during the Company's Phase 1 clinical study, in part because of the potential increase in adverse events. To date, the Company has achieved the following operational milestones in RECLAIM-LN: First patient dosed in RECLAIM-LN. To the Company's knowledge, this represents the first patient treated with an iPSC-derived off-the-shelf CAR T-cell therapy in a potentially registrational clinical trial in an autoimmune disease. Notably, the patient was treated in an outpatient setting with same-day discharge and with a drug product that was available on-demand, supporting the Company’s goal of broadening patient access to CAR T cells. Additional patients are in process for screening at several activated sites, a reflection of the enthusiasm treating clinicians have for RECLAIM-LN. Received UK MHRA authorization to conduct RECLAIM-LN at UK clinical sites, broadening the reach of the clinical trial. Further supporting broad access to CAR T cells in RECLAIM-LN, the first pivotal drug product batch of FT819 has been successfully manufactured and released, with drug product inventory positioned in depots for immediate, on-demand distribution to participating clinical sites. The potency strategy supporting pivotal drug product release and several other key elements of the Company’s CMC readiness plan have been discussed and aligned with the FDA under the Company’s RMAT designation, with further discussions continuing under the FDA's Chemistry, Manufacturing and Controls Development and Readiness Pilot (CDRP) Program. Based on enrollment cadence observed in the Phase 1 clinical trial, current clinical site engagement, and the on-demand availability of FT819, the Company aims to complete enrollment of RECLAIM-LN in the first half of 2028. Preliminary clinical data in SLE for FT819 presented at the EULAR 2026 Annual Meeting The Company presented Phase 1 data for FT819 in SLE, with 21 patients treated as of the May 14, 2026 data cutoff, including outpatient administration with same-day discharge in community hospital settings. Among the 16 patients receiving FT819 with less-intensive conditioning (Regimen A), the therapy was well tolerated, with no dose-limiting toxicities, no Grade >2 cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS), and no graft-versus-host disease (GvHD). FT819 drove rapid and sustained improvements across key disease measures, including clinical Systemic Lupus Erythematosus Disease Activity Index (cSLEDAI)-2K, urine protein-to-creatinine ratio (UPCr), Physician Global Assessment (PGA), and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, with bendamustine conditioning demonstrating the deepest and most durable responses and supporting its selection as the conditioning regimen for the RECLAIM-LN trial. Among 10 evaluable patients on background glucocorticoids, 7 achieved a dose of ≤5 mg/day, including 5 who discontinued steroids entirely. Treatment also produced deep and durable B-cell depletion, with a 74–96% reduction in the most expanded baseline B-cell clones that did not reappear through 12 months of follow-up, while protective vaccine titers were preserved. Preliminary clinical data in systemic sclerosis for FT819 presented at the ISSCR 2026 Annual Meeting In July, the Company presented preliminary clinical data from the systemic sclerosis (SSc) arm of the FT819-102 Phase 1 basket trial at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting. The SSc cohort enrolls a treatment-refractory patient population, with eligibility requiring both prior treatment failure and ongoing active disease and permits enrollment of patients with up to 15 years of disease duration. As of the June 12, 2026 data cutoff, four SSc patients had been treated: three under Regimen A with less-intensive conditioning chemotherapy (cyclophosphamide or bendamustine alone) and one under Regimen B with no conditioning chemotherapy. Participants demonstrated preliminary clinical activity in multiple disease scoring categories, including a revised Composite Response Index in Systemic Sclerosis (rCRISS) of 25 or higher and meaningful mean improvement in the modified Rodnan Skin Score (mRSS) for all patients at three months post-treatment. Treatment was well tolerated, with no CRS, ICANS, GvHD, or hypogammaglobulinemia reported in SSc participants on study. The Company believes these data reinforce the favorable profile of FT819 in SSc and is exploring the opportunity to accelerate the advancement of its clinical development in this rare disease indication with high unmet medical needs. FT839: Next-generation off-the-shelf dual-CAR T-cell product candidate co-targeting CD19 and CD38 advancing in Phase 1/2 Trial Also in July, the FDA cleared the Company’s IND application for FT839, a next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38. FT839 has been engineered with 13 targeted genetic edits that together are intended to confer multi-antigen targeting, immune evasion, enhanced functional persistence, and an enhanced safety profile. By co-targeting CD19 and CD38, FT839 is designed to eliminate broad spectrum of aberrant, disease-driving immune cells, including B cells, plasma cells, macrophages and activated T cells, that underlie multicellular disease in many autoimmune disorders as well as in hematologic malignancies. FT839 incorporates the Company’s patented Sword & Shield™ technology, which is designed to support durable activity without dependence on conditioning chemotherapy, as well as a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor and a CD3ε fusion receptor enabling combination with approved therapeutic monoclonal antibodies and T-cell engagers, respectively. Uniquely, FT839 is derived from a clonal iPSC master cell bank that has been precisely engineered to consistently and uniformly express the suite of genetic edits. The iPSC master cell bank serves as the starting cell source to manufacture FT839, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. COMPLETE (FT839-101) is a single-arm, open-label Phase 1/2 basket trial designed to evaluate FT839 across multiple autoimmune indications in combination with background therapy without the requirement for conditioning chemotherapy, with a starting dose level of 900 million cells. The Phase 1/2 design is intended to enable simultaneous assessment of safety and efficacy in a single trial to shorten the transition from Phase 1 to Phase 2. Following IND clearance, the Company has several clinical sites participating in accelerated activation, reflecting strong investigator interest for an off-the-shelf CAR T-cell with the potential to tackle complex autoimmune diseases. The Company plans to evaluate additional investigator-initiated trials of FT839 in multiple myeloma, diffuse large B-cell lymphoma, and type 1 diabetes. We look forward to providing an enrollment update later this year. FT836: Next-generation off-the-shelf CAR T-cell product candidate targeting MICA/B demonstrates preliminary anti-tumor activity in colorectal cancer At the American Society of Clinical Oncology (ASCO) Annual Meeting in June, the Company presented preliminary Phase 1 data for FT836, its multiplex-engineered CAR T-cell product candidate uniquely targeting major histocompatibility complex class I chain-related proteins A (MICA) and B (MICB). As of the April 20, 2026 data cutoff, nine patients had been enrolled across two regimens administered without conditioning chemotherapy (Regimen C: FT836 plus cetuximab, n=6; Regimen E: FT836 plus trastuzumab, n=3), with all patients evaluable for safety and five evaluable for initial efficacy assessment. Key findings included a favorable safety profile with no dose-limiting toxicities, CRS, ICANS, or GvHD observed across any patient or dose level; first-in-human evidence of FT836 trafficking to and persisting within tumor tissue without the use of conditioning chemotherapy, along with evidence of remodeling of the tumor immune microenvironment; and preliminary anti-tumor activity in two efficacy-evaluable, heavily pre-treated KRAS wild-type (KRASwt) metastatic colorectal cancer (mCRC) patients, each with seven prior lines of therapy, including meaningful reductions in target lesion size and decreases in tumor biomarkers such as carcinoembryonic antigen (CEA). Based on these preliminary clinical results, the Company intends to focus subsequent clinical development of FT836 on the KRASwt colorectal cancer population. With the clinical dose established at 900M, in the next cohort the Company plans to combine FT836 multi-dosing with standard of care chemotherapy with the intent to drive further reduction of tumor volume and achieve higher overall response rates in KRASwt CRC patients. The Company expects to provide the next clinical update on FT836 in the first half of 2027. Separately, the FDA has cleared an IND for an investigator-initiated trial of FT836 in combination with daratumumab in multiple myeloma, to be conducted at the Medical College of Wisconsin. Corporate Updates Fate appointed Laura Hamill to its Board of Directors, adding more than three decades of global commercial and strategic leadership across the biopharmaceutical industry. Ms. Hamill’s appointment brings deep launch, market-access, and commercial-scaling expertise as the Company advances its pipeline toward later-stage development and initiates preparations for the potential transition to a commercial-stage company. Second Quarter 2026 Financial Results Cash & Investment Position: Cash, cash equivalents, and investments as of June 30, 2026 were $153.8 million, a quarterly decrease of $21 million. Total Revenue: Revenue was $2.1 million for the second quarter of 2026, compared to $1.9 million for the second quarter of 2025. Revenue was derived from the conduct of preclinical development activities under the Company’s collaboration with Ono Pharmaceutical. Total Operating Expenses: Total operating expenses were $33.2 million for the second quarter of 2026, including research and development expenses of $24.4 million and general and administrative expenses of $8.8 million. Such amount included $3.5 million of non-cash stock-based compensation expense. Year-to-Date Operating Expense Reduction: Total operating expenses for the six months ended June 30, 2026 decreased by $14.3 million compared to the same period in 2025, reflecting a $7.5 million, 13% reduction in research and development expenses and a $6.8 million, 27% reduction in general and administrative expenses. Net Loss: Net loss was $30.2 million, or $(0.25) per share, for the second quarter of 2026, compared to $34.1 million, or $(0.29) per share, for the second quarter of 2025. Shares Outstanding: As of June 30, 2026, common shares outstanding were 116.7 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares. Financial Guidance Operating runway into 2028 driven by improvements to the expense structure of the organization, along with $153.8 million in cash, cash equivalents, and investments. About FT819 FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303) About FT839 FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate, designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and a second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is a 13-point edited CAR T cell and the second program to incorporate the Company’s Sword & Shield™ technology. The FDA cleared the IND application for FT839 in July 2026, and the Company is conducting COMPLETE (FT839-101), a Phase 1/2 basket clinical trial evaluating FT839 across autoimmune indications in combination with standard-of-care therapy, without the requirement for conditioning chemotherapy . About FT836 FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex class I chain-related proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. FT836 is the Company’s first product candidate to incorporate the novel Sword & Shield™ technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout, to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from the California Institute for Regenerative Medicine (CIRM) to support IND-enabling activities for FT836. About Fate Therapeutics’ iPSC Product Platform Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s results of operations, financial condition, anticipated operating expenses and cash runway, and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to the Company’s product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the activation of clinical sites and the pace of patient screening and enrollment, the manufacture, release, distribution and availability of drug product supply, including the Company’s expectations regarding the adequacy of drug product inventory to support clinical trial demand, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, and the Company’s expectations regarding progress and timelines, the objectives, plans and goals of its collaboration with Ono, and the Company’s expectations regarding the receipt of funding under the collaboration. These and any other forward-looking statements in this release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk that alignment with the FDA on potency or other CMC matters may not be maintained or may not result in acceptance of the Company’s approach at the time of a marketing application, the risk of a delay or difficulties in the manufacturing, release, or supply of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that clinical site activation and patient screening may not proceed as anticipated, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, risks relating to regulatory interactions and the outcome of such interactions, the risk that the Company may not comply with its obligations under and otherwise maintain its collaboration agreement with Ono, the risk that research funding and milestone payments received by the Company under its collaboration may be less than expected, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact: Ryan DouglasFate Therapeutics, [email protected]
Related articleQuarter not tagged2026-07-01Fate Therapeutics to Participate in Upcoming Third Quarter 2026 Conferences
GlobeNewswire
Fate Therapeutics to Participate in Upcoming Third Quarter 2026 Conferences
SAN DIEGO, July 01, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that management will participate in the following investor conferences in the third quarter of 2026. Leerink Partners Therapeutics Forum Location: Boston, MA Date: July 14th & 15th Wells Fargo 21st Annual Healthcare Conference Location: Boston, MA Date: September 8th – 10th 12th Annual Cantor Fitzgerald Global Healthcare Conference Location: New York, NY Date: September 9th – 11th H.C. Wainwright 28th Annual Global Investment Conference Location: New York, NY Date: September 14th – 16th The Company may participate in a presentation or a fireside chat at these conferences. When available, a live webcast will be accessible under “Events & Presentations” in the Investors section of the Company’s website at www.fatetherapeutics.com. An archived replay of the webcast will be available for 30 days on the Company’s website following the event. About Fate Therapeutics, Inc. 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 diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Contact: Ryan DouglasFate Therapeutics, [email protected]
Related articleQuarter not tagged2026-05-13Fate Therapeutics: Q1 Earnings Snapshot
Associated Press
Fate Therapeutics: Q1 Earnings Snapshot
SAN DIEGO (AP) — SAN DIEGO (AP) — Fate Therapeutics Inc. (FATE) on Wednesday reported a loss of $31.2 million in its first quarter. On a per-share basis, the San Diego-based company said it had a loss of 26 cents. The results topped Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 29 cents per share. The clinical-stage biotech company that develops stem cell treatments posted revenue of $1.3 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on FATE at https://www.zacks.com/ap/FATE
Related articleQuarter not tagged2026-05-13Fate Therapeutics Reports First Quarter 2026 Financial Results and Business Updates
GlobeNewswire
Fate Therapeutics Reports First Quarter 2026 Financial Results and Business Updates
RECLAIM – LN, a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis, on schedule to initiate in the 2nd half of 2026 FDA selects FT819 into the CDRP (CMC Development and Readiness Pilot) program enabling early and enhanced communication with the FDA to ensure CMC readiness for accelerated clinical timelines Clinical data presented at Pediatric Rheumatology Symposium 2026 and Congress of Clinical Rheumatology – East 2026 highlights safety and efficacy of single dose of FT819 with reduced conditioning in SLE Preclinical data presented at the American Association for Cancer Research 2026 demonstrates the unique ability of FT839 for comprehensive targeting of hematological malignancies and autoimmune diseases without the use of conditioning chemotherapy Operating runway extended into 2028, driven by a 20% reduction in operating expenses in the first quarter of 2026 compared to the first quarter of 2025 SAN DIEGO, May 13, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. "We are incredibly excited and focused on initiating RECLAIM-LN, our Phase 2 potentially registrational clinical trial of FT819 for the treatment of lupus nephritis to provide eligible trial patients a truly accessible CAR T-cell treatment option," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "Our acceptance into the FDA's highly competitive CDRP Program, combined with our RMAT designation, reflects a recognition of the strength of our initial Phase 1 clinical data and provides a powerful regulatory foundation as we advance FT819 along an accelerated clinical pathway. With planned clinical advancement of FT819 on multiple fronts, next generation CAR T-cell programs entering clinical trials, a strong cash balance supporting our runway into 2028 and a team that continues to execute at the highest level, we believe 2026 will be a defining year for Fate Therapeutics." Clinical Development & Program Updates RECLAIM-…Read full documentShow less
RECLAIM – LN, a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis, on schedule to initiate in the 2nd half of 2026 FDA selects FT819 into the CDRP (CMC Development and Readiness Pilot) program enabling early and enhanced communication with the FDA to ensure CMC readiness for accelerated clinical timelines Clinical data presented at Pediatric Rheumatology Symposium 2026 and Congress of Clinical Rheumatology – East 2026 highlights safety and efficacy of single dose of FT819 with reduced conditioning in SLE Preclinical data presented at the American Association for Cancer Research 2026 demonstrates the unique ability of FT839 for comprehensive targeting of hematological malignancies and autoimmune diseases without the use of conditioning chemotherapy Operating runway extended into 2028, driven by a 20% reduction in operating expenses in the first quarter of 2026 compared to the first quarter of 2025 SAN DIEGO, May 13, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. "We are incredibly excited and focused on initiating RECLAIM-LN, our Phase 2 potentially registrational clinical trial of FT819 for the treatment of lupus nephritis to provide eligible trial patients a truly accessible CAR T-cell treatment option," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "Our acceptance into the FDA's highly competitive CDRP Program, combined with our RMAT designation, reflects a recognition of the strength of our initial Phase 1 clinical data and provides a powerful regulatory foundation as we advance FT819 along an accelerated clinical pathway. With planned clinical advancement of FT819 on multiple fronts, next generation CAR T-cell programs entering clinical trials, a strong cash balance supporting our runway into 2028 and a team that continues to execute at the highest level, we believe 2026 will be a defining year for Fate Therapeutics." Clinical Development & Program Updates RECLAIM-LN, Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe SLE with lupus nephritis The Company anticipates commencing patient dosing in FT819-201, RECLAIM – LN (NCT07570862), a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe SLE with lupus nephritis, in the second half of 2026. The planned open-label, single-arm study was developed during interactions with the FDA under the RMAT designation for FT819, and is expected to enroll approximately 53 patients, evaluating a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response (CRR) at six months as the primary endpoint. The conditioning regimen selected for RECLAIM – LN is unique and less-intensive than most CAR T-cell clinical trials that incorporate up to 3 days of co-administration of cyclophosphamide and fludarabine, a combination that was perceived as less desirable to patients and clinicians during the Company’s Phase 1 clinical study. Based on enrollment cadence in the Phase 1 clinical trial and current clinical site engagement, the unique on-demand availability of FT819, and the option for outpatient treatment with reduced conditioning chemotherapy requirements, the Company aims to complete the enrollment of the RECLAIM – LN clinical study approximately 15 months from commencement. CDRP program selection for FT819 to align CMC plans with the FDA early in the development process FT819 has been selected for participation in the FDA’s Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program, a highly selective initiative designed to accelerate development of investigational therapies for serious diseases with unmet medical need through enhanced FDA engagement on CMC-related activities. Participation in the program enables increased interaction with the Agency, including additional CMC-focused Type B meetings with FDA review staff intended to help clarify development strategies, address key manufacturing questions, align CMC readiness and support a more efficient regulatory review process. The Company believes participation in the CDRP Program, in addition to its previously received Regenerative Medicine Advanced Therapy (RMAT) designation, has the potential to accelerate the registration pathway of FT819 in SLE. FT819-102 Phase 1 clinical trial now enrolling in 18 clinical sites globally The Company's ongoing multi-center Phase 1 clinical trial of FT819 (NCT06308978) evaluates the safety, pharmacokinetics, and efficacy of FT819 administered under either Regimen A, a fludarabine-free less-intensive conditioning regimen consisting of bendamustine or cyclophosphamide, or Regimen B, where FT819 is added to background maintenance therapy without conditioning chemotherapy. The study is enrolling patients across four autoimmune disease indications: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myositis (IIM), and anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). As of May 5, 2026, enrollment stands at: Nineteen SLE patients across the two regimens have been treated Eight patients have been treated across SSc, IIM and AAV Of these 27 patients, 8 have been treated in an outpatient setting Clinical enrollment across the study indications continues to accelerate with a focus on bringing on-demand accessibility of FT819 and outpatient treatment to community hospitals and infusion centers, and advancing the clinical development of various autoimmune indications and study cohorts, including Regimen B of SLE, where FT819 is uniquely demonstrating meaningful reduction in lupus disease activity and improvement in quality of life without the use of conditioning chemotherapy. This week at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, the Company showed in Regimen B of the FT819-102 Phase 1 study that a single dose of FT819 without the use of conditioning chemotherapy demonstrated meaningful clinical responses at dose level 1 (360 million cells) in patients with active SLE, with 3 of 3 patients achieving systemic lupus erythematosus responder index (SRI-4) and 2 of 3 patients achieving lupus low disease activity state (LLDAS) (data cutoff of April 9, 2026). The Company is now treating patients at dose level 2 (900 million cells) in Regimen B and exploring a repeat-dose paradigm without the use of conditioning chemotherapy. The Company anticipates providing further updates on its clinical progress at European Alliance of Associations for Rheumatology (EULAR) Annual Congress in June of 2026 as well as in other scientific conferences in the second half of 2026. Clinical Data Presented at Pediatric Rheumatology Symposium (PRSYM) and Congress of Clinical Rheumatology CCR-East continue to demonstrate meaningful and durable clinical responses, broad accessibility, and a favorable emerging safety profile of FT819 in SLE Highlights of the presentation included clinical safety, efficacy and translational data from 13 SLE patients with a data cutoff of December 23, 2025, with data showing clinically meaningful improvements in disease activity and patient-reported outcome measures following treatment with FT819 using less-intensive conditioning chemotherapy in Regimen A. These responses were observed early and were maintained over time, as demonstrated by i) SLEDAI-2K: Scores decreased by 13 points (mean) from baseline at Month 6, ii) PGA: Scores decreased by 1.75 points (mean) from baseline at Month 6 ; iii) UPCr: Levels decreased by 0.90 and 1.14 mg/mg (mean) from baseline at Months 3 and 6, respectively, and iv) FACIT-Fatigue: Scores improved by 23.4 points (mean) from baseline at Month 3 with continued meaningful improvement over time. The data presented continue to support the clinical advancement of FT819. The Company believes the strength of its FT819 Phase 1 clinical data, combined with two significant regulatory recognitions, provides a compelling foundation for the RECLAIM – LN study and future pivotal programs. FT819 has demonstrated progressive and durable reductions in disease activity, clinically meaningful reductions in urine protein-to-creatinine ratio in patients with lupus nephritis, effective B-cell depletion with immune remodeling, a notable drop in FACIT-Fatigue score resulting in profound improvements in quality of life for treated patients, and a favorable tolerability profile. FT839: Next-generation Off-the-Shelf CAR T-cell Program Designed to co-target CD19 and CD38 and Armed with Novel Sword & Shield™ Technology Designed to Eliminate the Need for Conditioning Chemotherapy The Company plans to submit an Investigational New Drug (IND) application to the FDA to support a Phase 1 basket autoimmune study to evaluate FT839 in combination with standard of care therapies across SLE, SSc, AAV, IIM, and rheumatoid arthritis (RA), including without the use of conditioning chemotherapy, and expects to commence enrollment in the Phase 1 study in the second half of 2026. Preclinical data for FT839 was presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2026, highlighting the ability of FT839 to simultaneously target and eliminate multiple pathogenic immune cell types across a broad range of autoimmune diseases and hematologic malignancies. FT839 preclinical data in autoimmune disease are expected to be presented at the 2026 American Society of Gene and Cell Therapy Annual Meeting and at the 2026 EULAR Annual Congress, further discussing the scientific rationale for the differentiated dual-CAR approach of FT839 in conditions where complex, multi-compartment immune dysregulation has resulted in hard-to-treat diseases. The breadth of the therapeutic potential of FT839 is reflected in the range of clinical collaboration opportunities in discussion with leading academic centers, including in autoimmune disease and in hematological malignancies, including multiple myeloma and diffuse large B-cell lymphoma. The Company believes this growing network of academic partnerships underscores the scientific community's recognition of the potential of FT839 to address serious diseases across both autoimmune and oncology settings. The Company will provide further updates on FT839 at American Society of Gene and Cell Therapy Annual Meeting in May of 2026. FT836 Next-generation Off-the-Shelf CAR T-cell Program Designed to Uniquely Target Broadly Expressed Stress Cancer Antigens MICA/B and Armed with Novel Sword & Shield™ Technology The Company is currently enrolling patients in a Phase 1 study of FT836, its multiplex-engineered CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB) which are expressed on many types of cancer cells with limited detection on healthy tissue. The Phase 1 study is designed to assess the tolerability and activity of FT836 without administration of conditioning chemotherapy for the treatment of advanced solid tumors. As of April 20, 2026, nine patients have been treated with FT836 in the Phase 1 basket solid tumor study, including patients in the cetuximab combination (Regimen C) and trastuzumab combination (Regimen E) arms. To date, FT836 has been well-tolerated with no ICANS, GvHD, CRS, or dose-limiting toxicities at dose level 1 of Regimen C, supporting its potential as a broadly accessible treatment with a favorable emerging safety profile. The Company expects to present updated FT836 clinical data across a larger patient cohort at the American Society of Clinical Oncology Annual Meeting in June 2026. Additionally, the FDA has cleared an IND for an investigator-initiated trial for FT836 in combination with daratumumab for a novel treatment strategy in multiple myeloma to be conducted at the Medical College of Wisconsin. Patient treatment in this IIT is expected to commence in mid-2026. The Company plans to provide further updates on FT836 at American Society of Gene and Cell Therapy Annual Meeting and at American Society of Clinical Oncology in May of 2026. First Quarter 2026 Financial Results Cash & Investment Position: Cash, cash equivalents, and investments as of March 31, 2026 were $174.8 million. Total Revenue: Revenue was $1.3 million for the first quarter of 2026, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical. Total Operating Expenses: Total operating expenses were $34.3 million for the first quarter of 2026, including research and development expenses of $24.7 million and general and administrative expenses of $9.6 million. Such amount included $3.9 million of non-cash stock-based compensation expense. Shares Outstanding: As of March 31, 2026, common shares outstanding were 116.3 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares. Financial Guidance Operating runway into 2028, supported by $174.8 million in cash, cash equivalents, and investments. About FT819 FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303) About FT839 FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate that is designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and the second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is the second program to contain the Company’s Sword and ShieldTM technology. At the 2025 ASH Annual Meeting, the Company presented preclinical data demonstrating the ability of FT839, with its dual-CAR mechanism and unique ability to synergize with monoclonal antibodies and T-cell engagers through its incorporated hnCD16 Fc receptor and CD3 fusion receptor, respectively, to specifically eliminate a variety of pathogenic immune cell types without requiring conditioning chemotherapy, suggesting its potential to broadly treat complex autoimmune diseases and hematologic malignancies. The Company has created the FT839 master cell bank and is completing IND-enabling activities to support initial clinical investigation of FT839 for the treatment of autoimmune diseases and hematologic malignancies in 2026. About FT836 FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. At the Society for Immunotherapy of Cancer (SITC) 40th Annual meeting held in November 2025, the Company presented preclinical data showing FT836 exhibited potent and durable CAR-dependent antigen-driven proliferation with robust activity across diverse solid tumors and that FT836 can be combined with standard of care chemotherapy to induce MICA/B surface expression for enhanced target recognition and additive antitumor activity. In addition, the Company presented immunohistochemistry analysis showing that MICA/B is expressed throughout tumor tissue in biopsy samples obtained from patients with various cancers, including colorectal cancer. FT836 is also the Company’s first product candidate to incorporate the novel Sword & ShieldTM technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout (KO), to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from the California Institute of Regenerative Medicine (CIRM) to support IND-enabling activities for FT836. About Fate Therapeutics’ iPSC Product Platform Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s results of operations, financial condition, anticipated operating expenses and cash runway, and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to complete IND-enabling studies and to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT819, and the Company’s expectations regarding progress and timelines, the objectives, plans and goals of its collaboration with Ono, and the Company’s expectations regarding the receipt of funding under the collaboration. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, risks relating to regulatory interactions and the outcome of such interactions, the risk that the Company may not comply with its obligations under and otherwise maintain its collaboration agreement with Ono, the risk that research funding and milestone payments received by the Company under its collaboration may be less than expected, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact: Ryan Douglas Fate Therapeutics, Inc. [email protected]
Related articleQuarter not tagged2026-05-06Foghorn Therapeutics Inc. (FHTX) May Report Negative Earnings: Know the Trend Ahead of Q1 Release
Zacks
Foghorn Therapeutics Inc. (FHTX) May Report Negative Earnings: Know the Trend Ahead of Q1 Release
The market expects Foghorn Therapeutics Inc. (FHTX) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.28 per share in its upcoming report, which represents a year-over-year change of +6.7%. Revenues are expected to be $9.24 million, up 55.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 3.53% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A p…Read full documentShow less
The market expects Foghorn Therapeutics Inc. (FHTX) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.28 per share in its upcoming report, which represents a year-over-year change of +6.7%. Revenues are expected to be $9.24 million, up 55.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 3.53% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Foghorn Therapeutics, the Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Foghorn Therapeutics will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Foghorn Therapeutics would post a loss of$0.28 per share when it actually produced a loss of -$0.34, delivering a surprise of -21.43%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Foghorn Therapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Fate Therapeutics (FATE), is soon expected to post loss of $0.29 per share for the quarter ended March 2026. This estimate indicates a year-over-year change of +9.4%. This quarter's revenue is expected to be $1.75 million, up 7.4% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Fate Therapeutics has been revised 1.3% up to the current level. Nevertheless, the company now has an Earnings ESP of +4.00%, reflecting a higher Most Accurate Estimate. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP indicates that Fate Therapeutics will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Foghorn Therapeutics Inc. (FHTX) : Free Stock Analysis Report Fate Therapeutics, Inc. (FATE) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Related articleQuarter not tagged2026-04-09Fate Therapeutics to Participate in Upcoming Second Quarter 2026 Conferences
GlobeNewswire
Fate Therapeutics to Participate in Upcoming Second Quarter 2026 Conferences
SAN DIEGO, April 09, 2026 (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 with cancer and autoimmune diseases, today announced that management will participate in five upcoming investor conferences in the second quarter of 2026. 25th Annual Needham Virtual Healthcare Conference Location: Virtual Date: April 14th Bank of America Healthcare Conference 2026 Location: Encore at the Wynn - Las Vegas, NV Date: May 13th H.C. Wainwright 4th Annual BioConnect Investor Conference Location: Nasdaq - New York, NY Date: May 19th 2026 Jeffries Global Healthcare Conference Location: Marriott Marquis - New York, NY Date: June 4th Goldman Sachs 47th Annual Global Healthcare Conference Location: Loews Miami Beach Hotel - Miami Beach, FL Date: June10th The Company may participate in a presentation or a fireside chat at these conferences. When available, a live webcast will be accessible under “Events & Presentations” in the Investors section of the Company’s website at www.fatetherapeutics.com. An archived replay of the webcast will be available for 30 days on the Company’s website following the event. About Fate Therapeutics, Inc. 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 diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Contact: Ryan Douglas Fate Therapeutics, Inc. [email protected]
Related articleQuarter not tagged2026-02-26Fate Therapeutics: Q4 Earnings Snapshot
Associated Press Finance
Fate Therapeutics: Q4 Earnings Snapshot
SAN DIEGO (AP) — SAN DIEGO (AP) — Fate Therapeutics Inc. (FATE) on Thursday reported a loss of $32.4 million in its fourth quarter. On a per-share basis, the San Diego-based company said it had a loss of 27 cents. The results matched Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was also for a loss of 27 cents per share. The clinical-stage biotech company that develops stem cell treatments posted revenue of $1.4 million in the period. For the year, the company reported a loss of $136.3 million, or $1.15 per share. Revenue was reported as $6.6 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on FATE at https://www.zacks.com/ap/FATE
Related articleQuarter not tagged2026-02-26Fate Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates
GlobeNewswire
Fate Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates
Outpatient treatment enabled under FT819-102 autoimmune basket protocol with patients now treated with FT819 off-the-shelf CAR T-cell therapy as same-day hospital discharge Four systemic sclerosis patients and the first idiopathic inflammatory myopathy patient treated with FT819; First systemic sclerosis patient reaching 3-month evaluation timepoint shows meaningful disease improvement using less-intensive conditioning chemotherapy FT819 Phase 1 enrollment expanded across 16 clinical sites in the U.S., U.K. and EU, with 15 systemic lupus erythematosus patients enrolled to date, supported by increased interest in FT819 safety, efficacy and on-demand accessibility profile Colorectal cancer patient shows greater than 50% reduction in CEA levels with tumor reduction across all target lesions after treatment with FT836, a MICA/B-targeted off-the-shelf CAR T-cell therapy with Sword and Shield™ technology, highlighting early activity at DL1 without the use of conditioning chemotherapy Projected operating runway through year-end 2027, supported by $205 million in cash, cash equivalents, and investments, and driven by a 30% reduction in operating expenses in 2025 compared to 2024, enabling the achievement of key clinical and collaboration milestones SAN DIEGO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “I am extremely proud of the progress the Fate team delivered in 2025, including bringing to fruition the treatment of FT819 off-the-shelf CAR T cells as outpatient therapy, eliminating the need for extended hospital stay requirements seen today with other CAR T-cell programs, which now uniquely expands autoimmune patient access, including in underserved regions, while significantly improving health system economics,” said Bob Valamehr, M.B.A., Ph.D., President and Chief Executive Officer of Fate Therapeutics. “I’m also pleased to note that we are continuing to progress towards the commencement of our first planned Phase 2 clinical trial in lupus nephritis, and we are actively recruiting patients in the…Read full documentShow less
Outpatient treatment enabled under FT819-102 autoimmune basket protocol with patients now treated with FT819 off-the-shelf CAR T-cell therapy as same-day hospital discharge Four systemic sclerosis patients and the first idiopathic inflammatory myopathy patient treated with FT819; First systemic sclerosis patient reaching 3-month evaluation timepoint shows meaningful disease improvement using less-intensive conditioning chemotherapy FT819 Phase 1 enrollment expanded across 16 clinical sites in the U.S., U.K. and EU, with 15 systemic lupus erythematosus patients enrolled to date, supported by increased interest in FT819 safety, efficacy and on-demand accessibility profile Colorectal cancer patient shows greater than 50% reduction in CEA levels with tumor reduction across all target lesions after treatment with FT836, a MICA/B-targeted off-the-shelf CAR T-cell therapy with Sword and Shield™ technology, highlighting early activity at DL1 without the use of conditioning chemotherapy Projected operating runway through year-end 2027, supported by $205 million in cash, cash equivalents, and investments, and driven by a 30% reduction in operating expenses in 2025 compared to 2024, enabling the achievement of key clinical and collaboration milestones SAN DIEGO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “I am extremely proud of the progress the Fate team delivered in 2025, including bringing to fruition the treatment of FT819 off-the-shelf CAR T cells as outpatient therapy, eliminating the need for extended hospital stay requirements seen today with other CAR T-cell programs, which now uniquely expands autoimmune patient access, including in underserved regions, while significantly improving health system economics,” said Bob Valamehr, M.B.A., Ph.D., President and Chief Executive Officer of Fate Therapeutics. “I’m also pleased to note that we are continuing to progress towards the commencement of our first planned Phase 2 clinical trial in lupus nephritis, and we are actively recruiting patients in the Phase 1 basket study of FT819 across the U.S., U.K. and E.U., with the ultimate goal to advance FT819 to commercialization in various autoimmune diseases. Last year’s accomplishments are further highlighted by strong fourth-quarter clinical site activation, accelerated patient enrollment, expansion of FT819 into additional autoimmune diseases, the advancement of our next generation CAR T-cell programs, and continuation of our scientific leadership through quality conference presentations and manuscript publications. Importantly, additional clinical signals across autoimmune disease and in oncology without the use of conditioning chemotherapy are further validating the breadth of our platform. We have a well-capitalized balance sheet ensuring runway through 2027 and believe we are uniquely positioned to drive long-term value creation.” Clinical Development & Program Updates FT819 Off-the-Shelf CAR T-cell Program in Autoimmune Disease for Broad Patient Accessibility FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. FT819-102 Phase 1 clinical trial now enrolling in 16 clinical sites across the U.S., U.K. and E.U. The Company’s ongoing multi-center, Phase 1 clinical trial of FT819 (NCT06308978) is designed to evaluate the safety, pharmacokinetics, and efficacy of a single dose of FT819 following either i) Regimen A, a fludarabine (flu)-free less-intensive conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone, or ii) Regimen B, added to maintenance therapy without the use of conditioning chemotherapy. The disease indications in the basket study include systemic lupus erythematosus (SLE), anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). Fifteen SLE patients across the two regimens have been treated, as of February 25th; Four SSc patients have also been treated in the two regimens as of February 25th, with the first SSc patient treated with FT819 and less-intensive conditioning chemotherapy (Regimen A) exhibiting improvements in health assessment questionnaire (HAQ), clinician global assessment (CGA), patient global assessment (PtGA) and modified Rodnan skin score (mRSS) at the 3-month follow-up, as of February 9th data cut off; and One IIM patient has also been treated, as of February 25th. Clinical site expansion and enrollment across the study indications continue to accelerate with a focus on bringing on-demand accessibility of FT819 and outpatient treatment to community hospitals and infusion centers. The Company expects to provide clinical, regulatory, and operational updates in the second half of 2026. Successfully treated patients in FT819-102 clinical trial as outpatient treatment. This achievement represents a major clinical milestone: the successful dosing of autoimmune patients with FT819 off-the-shelf CAR T-cell therapy in an outpatient setting, without the need for extended hospitalization and observation. By eliminating the need for extended hospitalization and reducing or eliminating the use of conditioning chemotherapy, FT819 removes key logistical and clinical barriers that have limited autoimmune patient access to CAR T-cell therapies, facilitating broad patient access to such potentially transformative medicine. This unique ability for outpatient treatment of CAR T cells in autoimmune disease reflects meaningful clinical progress. Enabling a feasible treatment option in community hospital-based settings and plans for treatment in infusion centers has the potential to expand access to FT819 off-the-shelf CAR T cells to a broader patient population, facilitate service to underserved regions, reduce burden on healthcare infrastructure, and improve the scalability and practical delivery of CAR T-cell therapy. Data presented at the American Society of Hematology (ASH) Annual Meeting demonstrate meaningful and durable clinical responses, broad accessibility, and favorable safety profile of FT819 in SLE. At the 2025 ASH Annual Meeting, the Company reported that 12 patients had been treated in the FT819-101 Phase 1 study, and provided clinical data for 10 patients with greater than 1 month follow-up as of a data cut off date of October 22, 2025, showing progressive and durable reductions in disease activity, including mean SLEDAI-2K score reductions of up to 78% by six months from the dose level 2 (DL2) cohort, complete renal responses in lupus nephritis, and sustained B-cell depletion with immune cell remodeling. FT819 was well tolerated with no dose limiting toxicities, no immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and only low-grade incidences of cytokine release syndrome (CRS), supporting outpatient, on-demand treatment. Next-generation off-the-Shelf CAR T-cell Program with Novel Sword & Shield™ Technology Designed to Eliminate the Need for Conditioning Chemotherapy Preclinical data demonstrates potent activity and functional persistence of FT836 across a broad array of cancers. FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. At the Society for Immunotherapy of Cancer (SITC) 40th Annual meeting held in November 2025, the Company presented preclinical data showing FT836 exhibited potent and durable CAR-dependent antigen-driven proliferation with robust activity across diverse solid tumors and that FT836 can be combined with standard of care chemotherapy to induce MICA/B surface expression for enhanced target recognition and additive antitumor activity. In addition, the Company presented immunohistochemistry analysis showing that MICA/B is expressed throughout tumor tissue in biopsy samples obtained from patients with various cancers, including colorectal cancer. FT836 is also the Company’s first product candidate to incorporate the novel Sword & ShieldTM technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout (KO), to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from the California Institute of Regenerative Medicine (CIRM) to support IND-enabling activities for FT836. FT836 demonstrates clinical activity in CRC without the use of conditioning chemotherapy. In July, the FDA allowed the Company’s investigational new drug (IND) application to initiate Phase 1 clinical testing of FT836 off-the-shelf CAR T cells. The Phase 1 study is designed to assess the safety and activity of FT836 as monotherapy and in combination with standard of care therapies without administration of conditioning chemotherapy for the treatment of advanced solid tumors. The Company has now treated three colorectal cancer (CRC) patients with FT836 at DL1 of 300 million cells, given on Days 1 and 15, with the first dose requiring 24-hour hospitalization and the second dose being given as outpatient. FT836 was well-tolerated with no ICANS, GvHD, CRS or dose-limiting toxicities reported at DL1, supporting its potential as a broadly accessible treatment with a favorable safety profile. As of the January 23rd 2026 data cut off, one of the three CRC patients treated in combination with cetuximab at DL1, a heavily pretreated 45 year old male who was refractory to cetuximab and had received 7 prior lines of therapy, demonstrated early evidence of anti-tumor activity, including a greater than 50% reduction in carcinoembryonic antigen (CEA) levels and significant reduction in lactate dehydrogenase (LDH) levels at Day 29 post treatment, with tumor reduction seen across all target lesions of approximately 20% decrease in the sum of diameters at the 46-day evaluation scan. Notably, these observations were achieved without conditioning chemotherapy, a capability of FT836 attributed to its Sword and ShieldTM Technology. The clinical response is assessed on Day 56 and the patient is under consideration for a second treatment cycle. The ongoing clinical protocol trial is open to enrollment for treatment of patients with breast, colorectal, ovarian, head and neck, endometrial, gastric/gastroesophageal junction, and non-small cell lung cancers. The Company expects to provide additional clinical data updates in the second half of 2026. FT839 preclinical data presented at 2025 ASH Annual Meeting demonstrates broad targeting capacity across autoimmune diseases and hematologic malignancies without the need for conditioning chemotherapy. FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate that is designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and the second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is the second program to contain the Company’s Sword and ShieldTM technology. At the 2025 ASH Annual Meeting, the Company presented preclinical data demonstrating the ability of FT839, with its dual-CAR mechanism and unique ability to synergize with monoclonal antibodies and T-cell engagers through its incorporated hnCD16 Fc receptor and CD3 fusion receptor, respectively, to specifically eliminate a variety of pathogenic immune cell types without requiring conditioning chemotherapy, suggesting its potential to broadly treat complex autoimmune diseases and hematologic malignancies. The Company has created the FT839 master cell bank and is completing IND-enabling activities to support initial clinical investigation of FT839 for the treatment of autoimmune diseases and hematologic malignancies in 2026. Fourth Quarter 2025 Financial Results Cash & Investment Position: Cash, cash equivalents, and investments as of December 31, 2025 were $205.1 million. Total Revenue: Revenue was $1.4 million for the fourth quarter of 2025, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical. Total Operating Expenses: Total operating expenses were $36.1 million for the fourth quarter of 2025, including research and development expenses of $25.4 million and general and administrative expenses of $10.7 million. Such amount included $5.5 million of non-cash stock-based compensation expense. Shares Outstanding: As of December 31, 2025, common shares outstanding were 115.4 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares. About Fate Therapeutics’ iPSC Product Platform Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s results of operations, financial condition, anticipated operating expenses and cash runway, and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to complete IND-enabling studies and to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT819, and the Company’s expectations regarding progress and timelines, the objectives, plans and goals of its collaboration with Ono Pharmaceutical, and the Company’s expectations regarding the receipt of funding under the collaboration. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, risks relating to regulatory interactions and the outcome of such interactions, the risk that the Company may not comply with its obligations under and otherwise maintain its collaboration agreement with Ono Pharmaceutical, the risk that research funding and milestone payments received by the Company under its collaboration may be less than expected, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact: Ryan Douglas Fate Therapeutics, Inc. [email protected]
Related articleQuarter not tagged2025-11-13Fate Therapeutics Reports Third Quarter 2025 Financial Results and Business Updates
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Fate Therapeutics Reports Third Quarter 2025 Financial Results and Business Updates
Authorization Received from UK and EU Authorities to Activate ex-US Clinical Trial Sites Supporting the Ongoing Patient Enrollment of FT819, an Off-the-Shelf CD19-targeted CAR T-cell Product Candidate that Utilizes Less-intensive or No Conditioning, Enabling Broad Patient Accessibility First Systemic Sclerosis Patient treated in Phase 1 Study of FT819 Following Fludarabine-free Conditioning; Dose Expansion Designed to Evaluate Patient Outcome with Less-intensive or No Conditioning First Patient Treated with FT836, a MICA/B-targeted Off-the-Shelf CAR T cell with Sword and ShieldTM Technology for Conditioning-free Treatment of a Broad Array of Solid Tumors Projected Operating Runway Through Year-End 2027 to Enable Achievement of Key Clinical and Collaboration Milestones with $226 Million in Cash, Cash Equivalents, and Investments SAN DIEGO, Nov. 13, 2025 (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 off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. “The potentially transformative impact of FT819 in lupus is at an inflection point as we enter the final quarter of the year with accelerated advancements in our autoimmune and oncology programs,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “The meaningful therapeutic and favorable safety profile of FT819 seen to date in preliminary clinical data combined with its broad patient accessibility demonstrates that CAR T-cell therapy can be delivered in a community setting, broadening reach for a wide range of patients with limited treatment options. Our focus remains on driving enrollment and expanding access for patients with lupus and other autoimmune diseases as we advance toward our planned registration study in 2026. In parallel, we continue to strengthen our iPSC platform and next-generation CAR T-cell programs, leveraging our Sword and Shield™ technology to expand the reach of off-the-shelf cell therapies, including FT836 with its unique ability to target a broad array of cancers. Operationally, we remain disciplined, with a well-capitalized balance sheet that is intended to fun…Read full documentShow less
Authorization Received from UK and EU Authorities to Activate ex-US Clinical Trial Sites Supporting the Ongoing Patient Enrollment of FT819, an Off-the-Shelf CD19-targeted CAR T-cell Product Candidate that Utilizes Less-intensive or No Conditioning, Enabling Broad Patient Accessibility First Systemic Sclerosis Patient treated in Phase 1 Study of FT819 Following Fludarabine-free Conditioning; Dose Expansion Designed to Evaluate Patient Outcome with Less-intensive or No Conditioning First Patient Treated with FT836, a MICA/B-targeted Off-the-Shelf CAR T cell with Sword and ShieldTM Technology for Conditioning-free Treatment of a Broad Array of Solid Tumors Projected Operating Runway Through Year-End 2027 to Enable Achievement of Key Clinical and Collaboration Milestones with $226 Million in Cash, Cash Equivalents, and Investments SAN DIEGO, Nov. 13, 2025 (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 off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. “The potentially transformative impact of FT819 in lupus is at an inflection point as we enter the final quarter of the year with accelerated advancements in our autoimmune and oncology programs,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “The meaningful therapeutic and favorable safety profile of FT819 seen to date in preliminary clinical data combined with its broad patient accessibility demonstrates that CAR T-cell therapy can be delivered in a community setting, broadening reach for a wide range of patients with limited treatment options. Our focus remains on driving enrollment and expanding access for patients with lupus and other autoimmune diseases as we advance toward our planned registration study in 2026. In parallel, we continue to strengthen our iPSC platform and next-generation CAR T-cell programs, leveraging our Sword and Shield™ technology to expand the reach of off-the-shelf cell therapies, including FT836 with its unique ability to target a broad array of cancers. Operationally, we remain disciplined, with a well-capitalized balance sheet that is intended to fund the company’s operations through 2027.” R&D Highlights and Updates FT819 Off-the-Shelf CAR T-cell Program in Autoimmune Disease for Broad Patient Accessibility FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC line serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to potentially reach a broad patient population. Authorization received from Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) to initiate clinical trials of FT819. Fate Therapeutics has now received regulatory clearance from the United Kingdom (UK) MHRA to proceed with clinical evaluation of FT819 in autoimmune diseases. This authorization represents a significant step in the Company’s international expansion and highlights global interest in the unique ability of FT819 to enable broad patient accessibility of CAR T cells without the requirement of intensive conditioning. The first of several planned UK clinical sites is now active and open to patient enrollment. The Company also received regulatory authorization from the European Union (EU) EMA to initiate the FT819 clinical trial across multiple EU countries. Data presented at American College of Rheumatology (ACR) Convergence 2025 continues to demonstrate robust clinical activity with preferable tolerability; translational data demonstrates sustained B-cell depletion and immune remodeling after treatment with FT819. The Company presented new data demonstrating encouraging enrollment in its ongoing clinical study, reflecting growing physician and patient interest in FT819 for autoimmune diseases. The preliminary clinical data highlighted robust activity in patient responses, and favorable tolerability, reinforcing the potential of FT819 as a transformative therapy for lupus and other autoimmune disorders. Data was presented across both regimens: (i) Regimen A, with either bendamustine alone or cyclophosphamide alone, followed by a single FT819 dose, and (ii) Regimen B, no chemotherapy conditioning, with a single FT819 dose given in combination with stable maintenance standard of care. Updated Phase 1 data were presented for 10 patients with treatment-refractory, moderate-to-severe Systemic Lupus Erythematosus (SLE) treated with a single dose of FT819 with less-intensive or no conditioning chemotherapy. The overall data, for which 8 patients had completed greater than one month of follow-up, showed meaningful reductions in disease activity and improvements in fatigue and physician assessments across both regimens. As of a September 25, 2025 data cut-off-date, three patients with ≥ 3 months follow up on Regimen A demonstrated a significant mean SLEDAI-2K score decrease of 10.7 points at 3 months and 14 points at 6 months; while the one Regimen B patient with ≥ 3 months follow up had their SLEDAI-2K score decrease by 6 points. Both Regimen A patients with active lupus nephritis who had ≥ 6 months follow up on Regimen A demonstrated renal responses, marked by decreases in their UPCR to < 0.5 mg/mg. Most notably, the lupus nephritis patient with the longest follow up of 15 months (Regimen A, dose level 1) achieved a 16-point SLEDAI-2K score reduction from baseline, discontinued steroids and maintained both DORIS (definition of remission in SLE) and complete renal response (CRR). Furthermore, depletion and reconstitution of B cells after treatment with FT819 in Regimen A continued to demonstrate successful remodeling of the immune system with the effective depletion of pathogenic B cells and the recovery of naïve subtypes. Importantly, FT819 was well tolerated with no dose limiting toxicities, no immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and only low-grade incidences of cytokine release syndrome (CRS), supporting its potential as a broadly accessible treatment without over-night hospitalization. First systemic sclerosis (SSc) patient treated in Phase 1 autoimmunity study. The multi-center, Phase 1 clinical trial is designed to evaluate the safety, pharmacokinetics, and anti-B-cell activity of FT819 in four autoimmune diseases, including with less-intensive or no conditioning chemotherapy: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and idiopathic inflammatory myositis (IIM) (NCT06308978). For SSc, the prevalence is greater than 85,000 patients in the US with significant unmet medical need, as currently, there are no existing cures or single disease modifying treatments to stop or reverse overall progression of disease. The first patient, a 31-year-old woman diagnosed with SSc six years ago who has refractory disease, despite having been treated with multiple standard of care therapies, received fludarabine-free conditioning followed by a single dose of FT819 at 900 million cells. The patient was discharged after a three-day hospital stay without any notable adverse events. FT825 / ONO-8250 Off-the-Shelf CAR T-cell Program in Solid Tumors Phase 1 study ongoing for advanced solid tumors. Under the collaboration with Ono Pharmaceutical Co., Ltd. (Ono), the Company is conducting a multi-center, Phase 1 study evaluating FT825 / ONO-8250, a multiplex-engineered CAR T-cell candidate targeting HER2, in patients with advanced solid tumors (NCT06241456). Dose escalation is ongoing at the third dose level of 900 million cells, with each patient receiving conditioning chemotherapy followed by a single dose of FT825 / ONO-8250, administered either as monotherapy or in combination with EGFR-targeted monoclonal antibody therapy. Notably, HER2 expression is now confirmed by biopsy to ensure patient eligibility and appropriate stratification to treatment arms. As of a September 22, 2025 data cut-off, nine patients have been treated in the monotherapy arm and seven patients in the combination arm. Through the data cut-off date, FT825 / ONO-8250 continues to demonstrate a favorable tolerability with no dose-limiting toxicities (DLTs) observed, supporting ongoing dose escalation in late-stage patients. Further evaluation will focus on cohorts of patients with confirmed high levels of HER2 expression in advanced solid tumors, and as warranted into earlier lines of therapy in combination with standard of care treatment. Next-generation Off-the-Shelf CAR T-cell Programs with Novel Sword & Shield™ Technology Designed to Eliminate the Need for Conditioning Chemotherapy First solid tumor patient treated in a Phase 1 basket trial for FT836 MICA/B-targeted CAR T-cell program. FT836 is a multiplex-engineered CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB) which are expressed on many types of cancer cells with limited detection on healthy tissue. Accordingly, a Phase 1 study was designed to assess the safety and activity of FT836 without administration of conditioning chemotherapy for the treatment of advanced solid tumors (NCT07216105). The first patient, a 47-year-old male with stage IV colorectal cancer (CRC) with five prior lines of systemic therapy, was treated with FT836 at 300 million cells in the cetuximab combination arm without any conditioning chemotherapy. The patient was discharged after a one-day hospital stay without any notable adverse events and is expected to be treated with a second dose of FT836 at 300 million cells on Day 15 of the treatment cycle. In parallel, non-clinical datasets underscoring broad solid tumor indication applicability, in combination with multi-antigen targeting, augmented tumor micro-environment adaptation, enhanced allo-protection via Sword and ShieldTM technology, and ability of FT836 to be administered in the absence of conditioning chemotherapy were recently presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2025). The Company plans to present a complimentary dataset establishing the utility of FT836 against multiple myeloma in combination with daratumumab and/or standard of care therapy at the 67th American Society of Hematology (ASH) Annual Meeting. The development of FT836 is supported by a $4 million award from the California Institute of Regenerative Medicine (CIRM). Commencement of Investigational New Drug (IND) application enabling activities for FT839 dual-CAR T-cell program. FT839 is a multiplex-engineered dual CAR T-cell product candidate that co-targets CD19 and CD38 and is designed to eliminate an array of aberrant immune cells contributing to both autoimmunity and hematological malignancies. The Company has previously presented preclinical data demonstrating robust eradication of aberrant CD19+ B cells, CD38+ plasma cells, CD38+ activated T cells, and hematological cancer cell lines by FT839 in completely mismatched allogeneic environments, demonstrating the potential versality of the dual-CAR approach combined with its Sword and ShieldTM technology. At the upcoming ASH Annual Meeting, the Company intends to present updated pre-clinical datasets further supporting multi-disease therapy potential. The Company has now generated a master iPSC bank for conducting IND-enabling studies and is currently evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmune disease in 2026. Other Corporate Updates Kamal Adawi, M.S., M.B.A., appointed to the role of Chief Financial Officer. Mr. Adawi brings to the Company more than 20 years of financial leadership experience in the life sciences industry, including over 10 years serving as CFO across innovative life science companies, with deep domain expertise in autoimmune diseases, including lupus. Third Quarter 2025 Financial Results Cash & Investment Position: Cash, cash equivalents, and investments as of September 30, 2025 were $225.7 million. Total Revenue: Revenue was $1.7 million for the third quarter of 2025, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical. Total Operating Expenses: Total operating expenses were $36.5 million for the third quarter of 2025, including research and development expenses of $25.8 million and general and administrative expenses of $10.6 million. Such amount included $4.9 million of non-cash stock-based compensation expense. Shares Outstanding: As of September 30, 2025, common shares outstanding were 115.3 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares. About Fate Therapeutics’ iPSC Product Platform Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s results of operations, financial condition, anticipated operating expenses and cash runway, and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to complete IND-enabling studies and to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the expansion of the Company’s ongoing and planned clinical trials to enroll additional patients and include additional clinical sites, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s expectations regarding progress and timelines, the objectives, plans and goals of its collaboration with Ono, the Company’s expectations regarding the receipt of funding under the collaboration and the expected effects of the Company’s pipeline prioritization plans, and the timing of these events. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, the risk that the Company may not comply with its obligations under and otherwise maintain its collaboration agreement with Ono, the risk that research funding and milestone payments received by the Company under its collaboration may be less than expected, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact: Christina Tartaglia Precision AQ 212.362.1200 [email protected] Source: Fate Therapeutics, Inc.
Related articleQuarter not tagged2025-11-04Fate Therapeutics (FATE) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
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Fate Therapeutics (FATE) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
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 September 2025. 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. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This clinical-stage biotech company that develops stem cell treatments is expected to post quarterly loss of $0.29 per share in its upcoming report, which represents a year-over-year change of +27.5%. Revenues are expected to be $0.85 million, down 72.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 3.57% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predic…Read full documentShow less
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 September 2025. 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. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This clinical-stage biotech company that develops stem cell treatments is expected to post quarterly loss of $0.29 per share in its upcoming report, which represents a year-over-year change of +27.5%. Revenues are expected to be $0.85 million, down 72.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 3.57% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Fate Therapeutics, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -7.02%. On the other hand, the stock currently carries a Zacks Rank of #4. So, this combination makes it difficult to conclusively predict that Fate Therapeutics will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Fate Therapeutics would post a loss of$0.35 per share when it actually produced a loss of -$0.29, delivering a surprise of +17.14%. Over the last four quarters, the company has beaten consensus EPS estimates four times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Fate Therapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Arcturus Therapeutics (ARCT), is soon expected to post loss of $1.25 per share for the quarter ended September 2025. This estimate indicates a year-over-year change of -380.8%. This quarter's revenue is expected to be $11.39 million, down 72.7% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Arcturus Therapeutics has been revised 4.2% down to the current level. Nevertheless, the company now has an Earnings ESP of -4.59%, reflecting a lower Most Accurate Estimate. When combined with a Zacks Rank of #4 (Sell), this Earnings ESP makes it difficult to conclusively predict that Arcturus Therapeutics will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Fate Therapeutics, Inc. (FATE) : Free Stock Analysis Report Arcturus Therapeutics Holdings Inc. (ARCT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

