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 (
Clinical data presented at Pediatric Rheumatology Symposium 2026 and
Preclinical data presented at the
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
"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
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
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
- 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
The Company anticipates providing further updates on its clinical progress at
Clinical Data Presented at Pediatric Rheumatology Symposium (PRSYM) and
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
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
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
The Company plans to provide further updates on FT836 at
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
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
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
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.
| Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) |
||||||||
| Three Months Ended | ||||||||
| 2026 | 2025 | |||||||
| Collaboration revenue | $ | 1,299 | $ | 1,629 | ||||
| Operating expenses: | ||||||||
| Research and development | 24,703 | 29,136 | ||||||
| General and administrative | 9,596 | 13,773 | ||||||
| Total operating expenses | 34,299 | 42,909 | ||||||
| Loss from operations | $ | (33,000 | ) | $ | (41,280 | ) | ||
| Other income (expense): | ||||||||
| Interest income | 1,867 | 3,336 | ||||||
| Change in fair value of stock price appreciation milestones | (80 | ) | 280 | |||||
| Other income | — | 43 | ||||||
| Total other income, net | 1,787 | 3,659 | ||||||
| Net loss | $ | (31,213 | ) | $ | (37,621 | ) | ||
| Other comprehensive loss: | ||||||||
| Unrealized loss on available-for-sale securities, net | (193 | ) | (77 | ) | ||||
| Comprehensive loss | $ | (31,406 | ) | $ | (37,698 | ) | ||
| Net loss per common share, basic and diluted | $ | (0.26 | ) | $ | (0.32 | ) | ||
| Weighted–average common shares used to compute basic and diluted net loss per share | 120,030,638 | 118,375,540 | ||||||
| Condensed Consolidated Balance Sheets (in thousands) (unaudited) |
||||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 39,570 | $ | 46,628 | ||||
| Accounts receivable | 704 | 916 | ||||||
| Short-term investments | 135,252 | 157,029 | ||||||
| Prepaid expenses and other current assets | 4,000 | 4,131 | ||||||
| Total current assets | 179,526 | 208,704 | ||||||
| Long-term investments | — | 1,472 | ||||||
| Operating lease right-of-use asset | 41,078 | 41,609 | ||||||
| Other long-term assets | 64,312 | 67,152 | ||||||
| Total assets | $ | 284,916 | $ | 318,937 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 16,919 | $ | 22,680 | ||||
| CIRM award liability, current portion | 8,448 | 8,448 | ||||||
| Deferred revenue | 582 | 381 | ||||||
| Operating lease liability, current portion | 4,740 | 4,562 | ||||||
| Total current liabilities | 30,689 | 36,071 | ||||||
| CIRM award liability, net of current portion | 2,112 | 2,112 | ||||||
| Operating lease liability, net of current portion | 72,045 | 73,287 | ||||||
| Stock price appreciation milestones | 363 | 283 | ||||||
| Stockholders’ equity | 179,707 | 207,184 | ||||||
| Total liabilities and stockholders’ equity | $ | 284,916 | $ | 318,937 | ||||
Contact:
IR@fatetherapeutics.com
Source: Fate Therapeutics, Inc.