Fate Therapeutics Reports Third Quarter 2026 Financial Results and Business Updates
Safety profile presented at ASN Kidney Week 2026 across 29 autoimmune patients treated with a single dose of FT819 and fludarabine-free, less-intensive conditioning continues to be favorable, further supporting RECLAIM-LN
Preliminary Phase 1 clinical data presented at ASN Kidney Week 2026 demonstrated 100% renal response in the bendamustine conditioning regimen selected for RECLAIM-LN
Early activation of multiple clinical sites for Phase 1/2 COMPLETE basket trial in autoimmune disease reflects enthusiasm by the rheumatology community for FT839, a novel dual CD19/CD38 targeting off-the-shelf CAR T-cell product candidate
“The third quarter was defined by steady execution across our portfolio, bringing us closer to our goal of delivering off-the-shelf, master cell bank derived cell therapies to the patients who need them most,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of
RECLAIM-LN, FT819 Phase 2 potentially registrational trial in lupus nephritis
The Company continues to advance RECLAIM-LN, a Phase 2 potentially registrational trial of FT819 in lupus nephritis (LN), with enrollment currently open across 17 active sites. In August, the study was initiated and the first patient was treated in an outpatient setting. New Phase 1 efficacy and safety data presented at
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. Patients will receive a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response (CRR) at Week 26 as the primary endpoint. The conditioning regimen selected for RECLAIM-LN is fludarabine-free and 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, in part because of the potential increase in serious adverse events.
Encouraging safety data demonstrated across all 29 autoimmune patients treated with a single dose of FT819 and less-intensive fludarabine-free conditioning as of a data cutoff date of
- No dose-limiting toxicities and no immune effector cell-associated neurotoxicity syndrome (ICANS), no graft-versus-host disease (GvHD), no immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), and no deaths were reported.
- No cytokine release syndrome (CRS) above Grade 2 was observed; Grade 1–2 CRS occurred in 5 patients (17.2%).
- Grade ≥3 infections occurred in 2 patients (6.9%), both urinary tract infections, and Grade ≥3 cytopenias occurred in 6 patients (20.7%).
The Company believes this encouraging safety profile reflects the distinct molecular design and manufacturing features of FT819, including a tuned CAR motif with targeted insertion into the TRAC locus designed to prevent uncontrolled T-cell expansion, and a well-vetted clonal master iPSC bank that serves as a consistent and uniform starting point for manufacture of drug product for broad patient availability. Additionally, the use of a less-intensive, fludarabine-free conditioning approach is intended to significantly reduce the possibility for adverse events, and the avoidance of fludarabine, which is cleared by the kidneys and requires dose adjustment in patients with impaired renal function, is particularly relevant for patients with LN.
Updated Phase 1 lupus nephritis data presented at ASN Kidney Week 2026 supports RECLAIM-LN
In October, updated Phase 1 data from the ongoing FT819-102 study were featured in an oral presentation at the ASN Kidney Week 2026 by
Encore FT819 clinical data presented at CCR – West 2026
In September, the Company presented encore clinical data from the systemic lupus erythematosus (SLE) arm of its Phase 1 FT819-102 trial at the
FT819 in systemic sclerosis (SSc) and extra renal SLE
Beyond lupus nephritis, the Company continues to advance FT819 in its ongoing Phase 1 autoimmune basket trial, including in SSc and extrarenal SLE. In July, the Company presented preliminary clinical data from the SSc arm of the trial at the
Four upcoming presentations at ACR Convergence 2026
The Company is looking forward to ACR Convergence 2026, being held November 6–11 in
FT839: Next-generation off-the-shelf dual-CAR T-cell product candidate co-targeting CD19 and CD38
In July, the FDA cleared the Company’s IND application for FT839. 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. The Company has now activated multiple clinical sites, reflecting strong investigator interest, and expects to dose patients by year-end, including in rheumatoid arthritis.
FT839 has been engineered with 13 targeted genetic edits that together are intended to confer multi-antigen targeting, immune evasion, and enhanced functional persistence without the requirement for intensive conditioning chemotherapy. FT839 is designed to broaden the reach of off-the-shelf CAR T-cell therapy beyond B-cell depletion by simultaneously targeting CD19 and CD38. The elimination of B-lineage cells, including plasma cells, and CD38-expressing activated and proliferating immune cells (e.g., T cells, macrophages and NK cells) is expected to support comprehensive immune reset across a diverse spectrum of autoimmune conditions.
To support the Phase 1/2 COMPLETE clinical trial, the Company has completed the FT839 manufacturing campaign resulting in a uniform CAR T-cell product. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC bank, consisting of the 13 edits, serves as the starting cell source to uniformly manufacture FT839, overcoming numerous limitations associated with patient and donor-sourced CAR T-cell therapies. FT839 is well-defined, consistent 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.
FT836: Next-generation off-the-shelf CAR T-cell product candidate targeting MICA/B
Enrollment in the Phase 1 solid tumor basket study is continuing, including metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC). FT836 is currently being studied in combination with existing standard-of-care therapies, or with conditioning chemotherapy. The study continues to build preliminary evidence of anti-tumor activity, with meaningful target lesion reductions in heavily pre-treated patients. The investigator-initiated trial of FT836 with daratumumab in multiple myeloma is also ongoing.
Other Corporate Updates
Expansion of executive leadership team with newly created commercial position
The Company appointed
Third Quarter 2026 Financial Results
- Cash & Investment Position: Cash, cash equivalents, and investments as of
September 30, 2026 , were$139.1 million , a quarterly decrease of$14.7 million . Cash position does not include cash from the recently awarded CIRM grant of$15.0 million . - Total Operating Expenses: Total operating expenses were
$32.2 million for the third quarter of 2026, including research and development expenses of$24.2 million and general and administrative expenses of$8.0 million . - Year-to-Date Operating Expense Reduction: Total operating expenses for the nine months ended
September 30, 2026 , decreased by$18.5 million compared to the same period in 2025, reflecting a$9.1 million , 11% reduction in research and development expenses and a$9.4 million , 26% reduction in general and administrative expenses. - Net Loss: Net loss was
$30.7 million , or$(0.25) per share, for the third quarter of 2026, compared to$32.3 million , or$(0.27) per share, for the third quarter of 2025. - Shares Outstanding: As of
September 30, 2026 , common shares outstanding were 121.5 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
- Cash, cash equivalents, and investments of
$139.1 million , along with the newly awarded$15.0 million CIRM grant, extends the cash runway to mid-2028.
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
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
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
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, enrollment, and dosing, including the Company’s expectation to dose multiple patients in COMPLETE by year-end 2026, 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, and the Company’s expectations regarding the receipt of funding under its CIRM grants. 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 preliminary clinical results may change as additional patients are treated and additional data become available and may not predict results in larger or potentially registrational trials, 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, enrollment and dosing 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 milestone payments received by the Company under its collaboration may be less than expected, the risk that the Company may not receive, or may be unable to utilize CIRM grant funding, in the anticipated timeframe or manner due to delays in development activities, failure to achieve applicable milestones, or failure to satisfy grant requirements, 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.
| Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) |
||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Collaboration revenue | $ | — | $ | 1,741 | $ | 3,381 | $ | 5,277 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 24,215 | 25,838 | 73,305 | 82,404 | ||||||||||||
| General and administrative | 8,032 | 10,638 | 26,457 | 35,856 | ||||||||||||
| Total operating expenses | 32,247 | 36,476 | 99,762 | 118,260 | ||||||||||||
| Loss from operations | $ | (32,247 | ) | $ | (34,735 | ) | $ | (96,381 | ) | $ | (112,983 | ) | ||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1,409 | 2,575 | 4,831 | 8,832 | ||||||||||||
| Change in fair value of stock price appreciation milestones | 151 | (90 | ) | (509 | ) | 117 | ||||||||||
| Other income | — | — | — | 93 | ||||||||||||
| Total other income, net | 1,560 | 2,485 | 4,322 | 9,042 | ||||||||||||
| Net loss | $ | (30,687 | ) | $ | (32,250 | ) | $ | (92,059 | ) | $ | (103,941 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized loss on available-for-sale securities, net | (38 | ) | 91 | (271 | ) | (115 | ) | |||||||||
| Comprehensive loss | $ | (30,725 | ) | $ | (32,159 | ) | $ | (92,330 | ) | $ | (104,056 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.25 | ) | $ | (0.27 | ) | $ | (0.76 | ) | $ | (0.88 | ) | ||||
| Weighted–average common shares used to compute basic and diluted net loss per share | 123,656,809 | 118,998,693 | 121,374,895 | 118,636,375 | ||||||||||||
| Condensed Consolidated Balance Sheets (in thousands) (unaudited) |
||||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,942 | $ | 46,628 | ||||
| Accounts receivable | 479 | 916 | ||||||
| Short-term investments | 95,190 | 157,029 | ||||||
| Prepaid expenses and other current assets | 4,647 | 4,131 | ||||||
| Total current assets | 144,258 | 208,704 | ||||||
| Long-term investments | — | 1,472 | ||||||
| Operating lease right-of-use asset | 40,011 | 41,609 | ||||||
| Other long-term assets | 54,006 | 67,152 | ||||||
| Total assets | $ | 238,275 | $ | 318,937 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 18,073 | $ | 22,680 | ||||
| CIRM award liability, current portion | 9,508 | 8,448 | ||||||
| Deferred revenue | — | 381 | ||||||
| Operating lease liability, current portion | 5,110 | 4,562 | ||||||
| Total current liabilities | 32,691 | 36,071 | ||||||
| CIRM award liability, net of current portion | 2,377 | 2,112 | ||||||
| Operating lease liability, net of current portion | 69,383 | 73,287 | ||||||
| Stock price appreciation milestones | 792 | 283 | ||||||
| Stockholders’ equity | 133,032 | 207,184 | ||||||
| Total liabilities and stockholders’ equity | $ | 238,275 | $ | 318,937 | ||||
Contact:
IR@fatetherapeutics.com
Source: Fate Therapeutics, Inc.