Fate Therapeutics, Inc. (FATE) Business Model Canvas

Fate Therapeutics, Inc. (FATE): Business Model Canvas [Dec-2025 Updated]

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You're looking at Fate Therapeutics, Inc.'s strategy right now, and honestly, it boils down to whether their proprietary iPSC platform can deliver on the promise of off-the-shelf cell therapies, especially with that big pivot toward autoimmune diseases like SLE. As of Q3 2025, they are burning cash-spending $25.8 million on R&D against $1.7 million in collaboration revenue-but they still hold a war chest of $225.7 million and over 500 patents to fund the journey, even after that recent 12% headcount cut. The real question is if their potential low cost of goods, perhaps around $3,000 per dose, can truly disrupt the market and turn that massive R&D into the revenue streams that partners like Ono Pharmaceutical are banking on. Dive into the full Business Model Canvas below to see how all these moving pieces-from clinical sites to their IP fortress-fit together for this next phase.

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Key Partnerships

Fate Therapeutics, Inc. relies on a network of external entities to drive its clinical and preclinical pipeline forward, spanning commercial development, academic research, and non-dilutive funding sources.

Ono Pharmaceutical Co., Ltd. for solid tumor CAR T development

The collaboration with Ono Pharmaceutical Co., Ltd. is central to developing FT825/ONO-8250, a HER2-targeted CAR T-cell product candidate aimed at solid tumors. Fate Therapeutics is jointly developing and commercializing this candidate in the U.S. and Europe, while Ono holds exclusive rights for the rest of the world. Fate Therapeutics recognized revenue of $1.7 million for the third quarter of 2025, derived from preclinical development activities for a second collaboration candidate under this agreement with Ono Pharmaceutical. Fate Therapeutics expects to continue receiving co-funding from Ono for the preclinical development of this second candidate through at least June 2026.

The ongoing Phase 1 study for FT825 / ONO-8250 in advanced solid tumors is actively enrolling patients. As of the September 22, 2025 data cut-off, dose escalation was ongoing at the third dose level of 900 million cells. At that time, nine patients had been treated in the monotherapy arm and seven patients in the combination arm.

Collaboration Aspect Product Candidate Target Indication Development Status (as of late 2025)
Joint Development/Commercialization FT825 / ONO-8250 HER2-expressing advanced solid tumors Phase 1 dose escalation ongoing
Preclinical Co-Development Second Candidate Undisclosed solid tumor antigen Preclinical development continuing with co-funding

Academic research collaborations (e.g., University of Minnesota)

Fate Therapeutics, Inc. actively forges research collaborations with leading academic institutions to accelerate product development. A notable example is the ongoing research collaboration with the University of Minnesota, led by Jeffrey S. Miller, M.D. This partnership focuses on the research and development of off-the-shelf, iPSC-derived CAR NK cell cancer immunotherapies. This specific academic work was instrumental in advancing the first-ever iPSC-derived cell therapy, FT500, and the first-ever engineered iPSC-derived cell therapy, FT516, into clinical development in the United States.

  • Collaboration with the University of Minnesota on CAR NK cell immunotherapies.
  • Advanced FT500 into clinical development.
  • Advanced FT516 into clinical development.

Clinical trial sites and investigators for patient enrollment

Patient enrollment for clinical programs like the FT819 Phase 1 study is supported by an expanding network of clinical sites across the U.S. and internationally. Fate Therapeutics, Inc. has received regulatory authorization from the UK MHRA and EU authorities to activate ex-US clinical trial sites for FT819, which is being investigated for autoimmune diseases. The FT825-101 study for solid tumors is also a multi-center Phase 1 study.

The Phase 1 study for FT819 in Autoimmune Diseases includes sites in the following locations:

  • Fullerton, California, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Minneapolis, Minnesota, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Memphis, Tennessee, United States
  • New York, New York, United States
  • San Francisco, California, United States
  • Manchester, United Kingdom
  • Cambridge, United Kingdom

California Institute of Regenerative Medicine (CIRM) for funding

The California Institute of Regenerative Medicine (CIRM) provides significant non-dilutive funding to Fate Therapeutics, Inc. to support pipeline advancement. As of late 2025, Fate Therapeutics has secured a total of 3 awards from CIRM, totaling $15,934,448 in award value.

Specific funding allocations include:

Program/Candidate CIRM Award Amount Award Purpose/Date
FT819 (Phase 1 Study in SLE) $7,934,448 Clinical Trial Stage Projects
FT836 (IND-enabling activities) $4,000,000 Secured in January 2025
FT516 (IND enabling development) $4,000,000 Late Stage Preclinical Projects

The $4 million award for FT836 was secured in January 2025 to support its Investigational New Drug (IND) application enabling activities. This non-dilutive funding helps advance the MICA/B-targeted CAR T-cell program.

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Key Activities

You're looking at the core engine driving Fate Therapeutics, Inc.'s strategy-the things they absolutely must do well to deliver on their promise of off-the-shelf cell therapies. These aren't just tasks; they are the high-stakes activities that consume the bulk of their resources.

Research and development (R&D) of iPSC-derived cell therapies

The R&D focus is squarely on advancing their induced pluripotent stem cell (iPSC) product platform. This is where the science gets translated into tangible drug candidates. To give you a sense of the investment here, for the third quarter ended September 30, 2025, Research & Development (R&D) expense was reported at $\mathbf{\$25.8}$ million. Year-to-date through Q3 2025, the cumulative R&D spend reached $\mathbf{\$82.4}$ million. Honestly, looking at the last twelve months (LTM) ending September 2025, the total R&D was $\mathbf{\$116.0}$ million. This level of spending supports the development of their pipeline, which includes T-cell and natural killer (NK) cell product candidates designed with novel synthetic controls of cell function.

The company's current financial health, with $\mathbf{\$225.7}$ million in cash, cash equivalents, and investments as of September 30, 2025, is projected to fund operations through the Year-End 2027, which covers the critical milestones expected from these R&D efforts.

Conducting and managing global clinical trials (e.g., FT819, FT825)

Managing the clinical pipeline is a major activity, especially for their lead candidates, FT819 and FT825. These trials are designed to prove both efficacy and the unique off-the-shelf nature of the products, which should allow for broad patient accessibility. Here's a snapshot of where things stood as of late 2025:

  • The Phase 1 clinical trial for FT819 in moderate-to-severe Systemic Lupus Erythematosus (SLE) is actively enrolling and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA in April 2025.
  • As of the September 25, 2025 data cut-off, $\mathbf{10}$ patients with treatment-refractory, moderate-to-severe SLE had been treated with a single dose of FT819.
  • The trial is evaluating doses including a single dose of $\mathbf{360}$ million cells and $\mathbf{900}$ million cells.
  • Dose expansion cohorts for FT819 are now active for anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc).
  • Regulatory clearance was received from the UK MHRA and EU EMA to activate ex-US clinical trial sites for FT819.
  • The company held approximately $\mathbf{600}$ cryopreserved drug product bags of FT819 in inventory available for treatment.

For FT825, targeting solid tumors, the Phase 1 study is ongoing, with dose escalation continuing at the third level of $\mathbf{900}$ million cells. As of the September 22, 2025 cut-off, $\mathbf{9}$ patients were treated in the monotherapy arm and $\mathbf{7}$ in the combination arm.

The goal of these trials is to support a potential pivotal study in 2026 for FT819. That's a clear action item for the clinical team.

Manufacturing of off-the-shelf cell products from a master cell bank

A critical activity underpinning the entire model is the ability to manufacture these products consistently and at scale. Fate Therapeutics, Inc. operates a custom-designed, cGMP-compliant manufacturing facility in San Diego, California. This facility is specifically set up to use clonal master iPSC lines as the starting cell source to produce off-the-shelf product candidates. The facility has been commissioned, qualified, and holds drug manufacturing licenses from the State of California. This operational capability positions the company to support manufacturing through all phases of clinical development and for initial commercialization, which is key for an 'off-the-shelf' product that needs to be readily available.

The manufacturing activity supports the product attributes:

Product Attribute Description Supported by Manufacturing
Composition Well-defined and uniform
Availability Can be stored in inventory for off-the-shelf, on-demand use
Scalability Supports manufacturing for all phases of clinical development

Securing and maintaining intellectual property (IP) portfolio

Protecting the proprietary iPSC product platform is non-negotiable. This activity involves continuous filing and maintenance of patents covering their technology, which is what differentiates their cell products from others. As of early 2025, Fate Therapeutics, Inc.'s intellectual property portfolio was reported to include over $\mathbf{500}$ issued patents and $\mathbf{500}$ pending patent applications. This large and active portfolio is the legal moat around their core technology, which includes multiplexed-engineering of human iPSCs and single-cell selection to create clonal master iPSC lines.

Finance: review Q4 2025 R&D spend against budget by end of January 2026.

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Key Resources

When we look at the core assets that power Fate Therapeutics, Inc.'s business engine, it really boils down to proprietary science and the financial runway to execute on it. You're looking at a company whose primary value is locked up in its technology and its intellectual property fortress.

The foundation is definitely the Proprietary iPSC product platform and multiplexed-engineering technology. This isn't just standard cell therapy; it's about using human induced pluripotent stem cells (iPSCs) which have that dual ability to renew themselves infinitely and turn into any cell type. Fate Therapeutics combines this with multiplexed-engineering of those iPSCs, plus single-cell selection, to create what they call clonal master iPSC lines. Think of it like creating a perfect, standardized master blueprint for every cell product they make.

This technology directly supports the Clonal Master Cell Bank (MCB) for consistent, scalable supply. These master iPSC lines act as the starting material, much like a master cell line for producing monoclonal antibodies. The benefit here is huge: the resulting engineered cell products are well-defined, uniform, can be stored in inventory for that crucial off-the-shelf availability, and can be given alongside other treatments. This is how they aim to overcome the major hurdles of patient- or donor-sourced cell therapies.

To protect all this foundational work, the intellectual property is substantial. Fate Therapeutics, Inc.'s IP portfolio includes over 500 issued patents. That's a significant barrier to entry for competitors trying to replicate their approach to off-the-shelf cellular immunotherapies.

Now, let's talk about the fuel in the tank. As of the end of the third quarter of 2025, the company reported its liquidity position. Cash, cash equivalents, and investments stood at $225.7 million as of September 30, 2025. This level of capital is key because it directly translates to operational time. Fate Therapeutics, Inc. projected this cash position would support the achievement of key clinical and collaboration milestones through the end of 2027. That runway gives you, the analyst, a clear timeline to watch for clinical readouts and partnership progress.

Here's a quick breakdown of the financial and IP anchors:

  • Proprietary platform: iPSC-derived off-the-shelf cellular immunotherapies.
  • Intellectual Property: Over 500 issued patents.
  • Liquidity (Q3 2025): Cash, cash equivalents, and investments of $225.7 million.
  • Operational Runway: Projected through Year-End 2027.

You can see the tangible assets supporting the business model in this table:

Key Resource Component Metric/Status Date/Source Context
Cash & Investments $225.7 million September 30, 2025 (Q3 2025)
Issued Patents Over 500 Reported throughout 2025 filings
Technology Platform Proprietary iPSC and multiplexed-engineering Core to manufacturing process
Cell Supply Asset Clonal Master Cell Bank (MCB) Enables off-the-shelf inventory
Financial Projection Operating Runway through Year-End 2027 Based on November 2025 cash position

The ability to manufacture these complex, engineered cell products consistently from a defined MCB, all while being protected by a large patent estate and funded well into the future, defines the resource side of Fate Therapeutics, Inc.'s canvas. Finance: confirm the Q4 2025 cash position update by February 15, 2026.

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Value Propositions

You're looking at the core value Fate Therapeutics, Inc. is trying to deliver with its pipeline, especially FT819. It's all about making advanced cell therapy something you can actually use broadly, not just in highly specialized centers. The fundamental shift here is moving from patient-specific, time-consuming manufacturing to an off-the-shelf, inventory-based model.

The manufacturing strategy is a big part of this value. Fate Therapeutics has engineered its process for reliability and scale, which directly impacts the economics. They cite a low estimated Cost of Goods Sold (COGs) of approximately $3,000 per dose. This is supported by a renewable manufacturing process using a precisely engineered clonal master induced pluripotent stem cell (iPSC) line, which eliminates donor variability and supports inventory-based economics. The current site has a GMP-scale capacity of around 50,000 doses.

This off-the-shelf nature is key to achieving broad access and on-demand availability, which is a major departure from traditional autologous CAR T-cell therapies. This approach is designed to allow for repeat dosing and administration in a community setting, reducing patient burden significantly.

The potential to reduce or eliminate intensive pre-treatment is a massive value driver for both patients and the healthcare system. For FT819 in Systemic Lupus Erythematosus (SLE), the clinical strategy explicitly tests less-intensive options. Here's what the Phase 1 trial is exploring regarding conditioning:

  • Administering FT819 following a fludarabine-free conditioning regimen (using bendamustine or cyclophosphamide alone).
  • Assessing FT819 as an add-on to maintenance therapy without conditioning chemotherapy.
  • Early data showed a patient on maintenance therapy achieved Low Lupus Disease Activity State (LLDAS) at 3- and 6-months following FT819 administration in the absence of conditioning.

The regulatory environment is recognizing this potential. Fate Therapeutics, Inc. received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for FT819 specifically for the treatment of moderate to severe SLE in April 2025. This designation is intended to expedite development and review, signaling the FDA sees the therapy as promising for a serious condition with unmet need.

To put the core product attributes side-by-side, look at this comparison for the FT819 program:

Value Proposition Attribute FT819 Program Detail Status/Data Point
Therapy Type iPSC-derived CAR T-cell therapy Off-the-shelf product candidate
Target Indication Systemic Lupus Erythematosus (SLE) Phase 1 clinical trial ongoing
Regulatory Milestone RMAT Designation granted by FDA April 2025
Conditioning Regimen Fludarabine-free or No Conditioning Under evaluation in Phase 1 study
Manufacturing Economics Estimated Cost of Goods Sold (COGs) Approximately $3,000/dose

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Customer Relationships

Fate Therapeutics, Inc. maintains relationships characterized by deep scientific exchange with clinical partners and proactive engagement with regulatory bodies and the investment community to support its pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies.

High-touch, direct engagement with clinical investigators and sites

The company drives engagement through active clinical trial execution, which necessitates close collaboration with investigators at participating sites. This relationship is critical for demonstrating the potential of their off-the-shelf products.

  • FT819 Phase 1 study for Systemic Lupus Erythematosus (SLE) continues enrolling patients.
  • The FT819 Phase 1 trial is testing two dose levels: a single dose of 360 million cells and a single dose of 900 million cells.
  • As of a September 25, 2025 data cut-off, 10 patients with treatment-refractory, moderate-to-severe SLE were treated with FT819.
  • For the FT825 / ONO-8250 trial in advanced solid tumors, as of a September 22, 2025 data cut-off, nine patients were treated in the monotherapy arm and seven patients in the combination arm.
  • The FT819 product is positioned with a cost of approximately $3,000 per dose.
  • The company is focused on driving enrollment to demonstrate therapeutic differentiation, which directly involves site management and investigator support.

Close regulatory collaboration with the FDA and ex-US authorities

Regulatory relationships are central to advancing clinical candidates, particularly through expedited pathways and geographic expansion. Fate Therapeutics, Inc. works to align development plans with regulatory expectations.

  • Fate Therapeutics, Inc. received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for FT819 in April 2025.
  • In August 2025, the company met with the FDA under the RMAT designation to seek preliminary feedback on a proposed registrational study design for FT819 in moderate-to-severe SLE and refractory Lupus Nephritis (LN).
  • Authorization was received from UK and EU authorities, specifically the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), to activate ex-US clinical trial sites for FT819.
  • The Phase 1 SLE study was amended following a Type D meeting with the FDA to explore FT819 in additional B cell-mediated autoimmune diseases.

Investor relations and communication via conferences (e.g., Piper Sandler)

Direct communication with the financial community is managed through participation in key industry and investor conferences to provide updates on clinical progress and financial standing. The company projects an operating runway through Year-End 2027.

Here's a look at the specific investor engagement events around late 2025:

Conference Name Date in 2025 Format/Activity Location
Piper Sandler 37th Annual Healthcare Conference December 2 Fireside Chat at 9:00 AM ET and Cell Therapy Panel Discussion at 12:00 PM ET New York, New York
Wells Fargo Healthcare Conference September 3 One-on-one meetings Boston, Massachusetts
Cantor Global Healthcare Conference 2025 September 4 Fireside chat at 10:55 AM ET New York, New York
Barclays 27th Annual Global Healthcare Conference March 11 Fireside chat at 8:30 AM ET Miami, Florida

For the third quarter ended September 30, 2025, Fate Therapeutics, Inc. reported Total Revenue of $1.7 million and a Net Loss of $32.25 million, with Cash, cash equivalents, and investments totaling $225.7 million as of that date.

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Channels

The Channels block for Fate Therapeutics, Inc. centers on getting their off-the-shelf cell therapies into clinical investigation across multiple geographies and preparing for potential commercialization by focusing on accessibility.

Global clinical trial sites are the primary channel for product delivery and testing as of late 2025. Fate Therapeutics, Inc. has actively expanded its footprint beyond the initial US sites. Regulatory clearance was received from the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) to initiate clinical trials of FT819 in the United Kingdom and across multiple European Union countries, respectively. The first of several planned UK clinical sites is now active for patient enrollment. The Phase 1 clinical trial for FT819 in autoimmune diseases is continuing to enroll patients across its existing US sites, with plans to initiate independent dose-expansion cohorts in the second half of 2025 for anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The FT825 / ONO-8250 program in solid tumors is also conducting a multi-center, Phase 1 study.

Here's a look at the current geographical scope for clinical product delivery:

Trial/Product Geographic Reach Status/Key Activity in 2025
FT819 (Autoimmune) United States (Multiple Sites) Patient enrollment ongoing; dose-expansion cohorts planned for H2 2025.
FT819 (Autoimmune) United Kingdom (UK) Regulatory clearance received (MHRA); first of several planned sites active.
FT819 (Autoimmune) European Union (EU) Regulatory authorization received (EMA) to initiate trials across multiple countries.
FT825 / ONO-8250 (Solid Tumors) United States (Multi-center) Phase 1 study ongoing; dose escalation at the third dose level.

For post-market or late-stage clinical delivery, the strategy emphasizes accessibility and cost-effectiveness, which dictates the future distribution channel structure. Fate Therapeutics, Inc. is in discussions with the Food and Drug Administration (FDA) to potentially reduce hospitalization requirements for FT819, which could allow for outpatient administration. This shift would significantly alter the required distribution and administration channel from specialized inpatient centers to potentially broader outpatient infusion centers. Financially, FT819 is positioned as a cost-effective alternative to traditional CAR T-cell therapies, with a reported cost of approximately $3,000 per dose as of March 2025.

Scientific and medical conferences serve as a critical channel for disseminating clinical data to the medical community, which drives physician awareness and trial enrollment. Fate Therapeutics, Inc. presented interim Phase 1 data for FT819 at the EULAR 2025 Congress in June. Furthermore, data was presented at the American College of Rheumatology (ACR) Convergence 2025. Looking ahead, management is scheduled to present at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, in New York, New York.

Key data dissemination events in 2025 include:

  • Data presented at EULAR 2025 Congress.
  • Data presented at ACR Convergence 2025.
  • Scheduled presentation at Piper Sandler 37th Annual Healthcare Conference on December 2, 2025.
  • Presentation at Cantor Global Healthcare Conference 2025 on September 4, 2025.
  • Presentation at Leerink Global Healthcare Conference on March 12, 2025.

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Customer Segments

You're looking at the patient populations Fate Therapeutics, Inc. (FATE) is targeting with its off-the-shelf, induced pluripotent stem cell (iPSC)-derived cellular immunotherapies. The segments are clearly defined by severe, often refractory, autoimmune diseases and advanced solid tumors, supported by significant cash reserves and a scalable manufacturing model.

The primary focus for autoimmune diseases is the FT819 program, which targets B cell-mediated conditions. The company is actively enrolling and expanding this trial, aiming for broad accessibility with less-intensive or no conditioning chemotherapy.

  • Patients with moderate-to-severe Systemic Lupus Erythematosus (SLE)
  • Patients with refractory Lupus Nephritis (LN)
  • Patients with Systemic Sclerosis (SSc)
  • Patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV)
  • Patients with idiopathic inflammatory myositis (IIM)

As of the September 25, 2025 data cut-off, Fate Therapeutics had treated 10 patients with treatment-refractory, moderate-to-severe SLE with a single dose of FT819 using less-intensive or no conditioning chemotherapy. For the LN subset of this group, 2 patients surpassing a 3-month post-treatment time point achieved complete renal response (CRR) at 6 months; one of those patients continued in drug-free Definition of Remission in SLE (DORIS) at 15 months follow-up. The company held approximately 450 cryopreserved drug product bags of FT819 in inventory as of June 2025, supporting this inventory-based economic model.

The oncology segment centers on solid tumors, specifically utilizing the FT825/ONO-8250 candidate targeting HER2-expressing cancers, developed in partnership with Ono Pharmaceutical Co., Ltd. This is a Phase 1 study where patient eligibility is confirmed by biopsy for HER2 expression.

Customer Segment Detail Product Candidate Clinical Status/Metric (Late 2025) Patient Count/Dose Level
Advanced Solid Tumors (HER2-expressing) FT825 / ONO-8250 (CAR T-cell) Phase 1 Dose Escalation Ongoing 9 patients in monotherapy arm; 7 patients in combination arm (as of Sep 22, 2025 cut-off)
Advanced Solid Tumors (HER2-expressing) FT825 / ONO-8250 (CAR T-cell) Dose Level Escalation ongoing at third dose level of 900 million cells
Moderate-to-Severe SLE (Treatment-Refractory) FT819 (CAR T-cell) Phase 1 Enrollment/Data Cut-off 10 patients treated (as of Sep 25, 2025 cut-off)
Refractory Lupus Nephritis (LN) FT819 (CAR T-cell) Response Metric 2 patients achieved CRR at 6 months

The strategic pharmaceutical partners represent a key revenue source and validation point for the platform technology, particularly for solid tumor development where Fate Therapeutics leverages external expertise.

The collaboration with Ono Pharmaceutical Co., Ltd. is central to the solid tumor strategy, involving joint development and commercialization rights for FT825/ONO-8250 in the U.S. and Europe, with Ono holding exclusive rights in the rest of the world. This partnership also includes research and development for CAR-targeted Natural Killer (NK) cell candidates against two solid tumor antigen targets.

Financial contributions from this segment directly impact the company's operational runway, which is projected through Year-End 2027 with $225.7 million in cash, cash equivalents, and investments as of September 30, 2025. Collaboration revenue figures for 2025 reflect ongoing preclinical development activities:

  • Q3 2025 Collaboration Revenue: $1.7 million
  • Q2 2025 Collaboration Revenue: $1.9 million
  • Q1 2025 Collaboration Revenue: $1.6 million

The underlying platform economics support the broad accessibility goal; the estimated low Cost of Goods Sold (COGs) for the iPSC-derived Cell Therapy Products is approximately $3,000/dose.

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Cost Structure

You're looking at the cost side of Fate Therapeutics, Inc. (FATE)'s operations as of late 2025. The structure is heavily weighted toward getting their cell therapy pipeline, especially FT819, through the clinic. This means the primary cost drivers are intellectual capital and the physical infrastructure needed for advanced biopharma development.

The biggest chunk of spending is definitely Research and Development (R&D) expenses. For the third quarter of 2025, R&D hit $25.8 million. This covers the bench science, process development, and the direct costs associated with running the clinical trials you're tracking. To be fair, this is down from the $27.4 million reported in Q2 2025, which aligns with the August 2025 restructuring efforts.

General and Administrative (G&A) expenses follow, coming in at $10.6 million for Q3 2025. This covers the overhead-legal, finance, executive functions, and keeping the lights on in the corporate offices. It's important to note that the total operating expenses for Q3 2025 were $36.5 million, which included $4.9 million in non-cash stock-based compensation expense. This is a noticeable drop from the $38.9 million in total operating expenses recorded in Q2 2025.

Here's a quick look at how those key operating expenses shifted between the second and third quarters of 2025:

Expense Category Q2 2025 Amount (USD) Q3 2025 Amount (USD)
Research and Development (R&D) 27.4 million 25.8 million
General and Administrative (G&A) 11.4 million 10.6 million
Total Operating Expenses 38.9 million 36.5 million

Clinical trial execution and manufacturing facility maintenance are significant, though often bundled within R&D or capital expenditures. Given the focus on advancing FT819 and FT825, maintaining GMP (Good Manufacturing Practice) standards for the iPSC-derived products and managing the logistics of patient enrollment across expanded geographies are critical, ongoing cash drains. The company's cash, cash equivalents, and investments stood at $225.7 million as of September 30, 2025, which management projects extends the operating runway through 2027, so these costs are being managed tightly.

Personnel costs are a major component of both R&D and G&A, and you saw management take direct action here. Fate Therapeutics, Inc. implemented a reduction in total workforce of approximately 12% in August 2025. This move was designed to streamline operations and reduce operating expenses, with estimated severance and termination costs of $0.9 million to $1.2 million expected to be incurred in Q3 2025. The cost structure reflects this shift toward leaner operations:

  • R&D expense as the largest component of burn.
  • G&A expenses reduced following the August 2025 restructuring.
  • Severance charges of up to $1.2 million booked in Q3 2025.
  • Focus on extending cash runway beyond 2027 via cost discipline.
  • Personnel costs are being optimized after the 12% headcount reduction.

Fate Therapeutics, Inc. (FATE) - Canvas Business Model: Revenue Streams

You're looking at the current financial engine for Fate Therapeutics, Inc. as of late 2025. Honestly, for a clinical-stage company, the revenue streams are almost entirely non-product based right now, which is typical for this phase of development. The focus is on external funding to keep the pipeline moving.

Collaboration revenue from strategic partners is the most immediate source of income. For the third quarter of 2025, this figure stood at exactly $1.7 million. This revenue was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the agreement with Ono Pharmaceutical.

Milestone payments and co-funding from Ono Pharmaceutical are a critical, albeit lumpy, part of the partnership structure. The existing collaboration, which includes the FT825/ONO-8250 program, is structured to provide Fate Therapeutics with committed research funding during the option period, plus eligibility for clinical, regulatory, and commercialization milestone payments upon option exercise and subsequent success. While the Q3 2025 revenue reflects ongoing development support, specific milestone payments achieved in that quarter aren't separately itemized from the total collaboration revenue.

Future product sales upon regulatory approval are currently zero. Fate Therapeutics is still in clinical development, with programs like FT819 advancing through Phase 1 studies, and the company is working toward defining a registrational pathway with the FDA.

Potential government or non-profit grants provide non-dilutive capital support for specific programs. A key example is the $4 million award secured in January 2025 from the California Institute for Regenerative Medicine (CIRM). This funding is specifically designated to support Investigational New Drug (IND)-enabling activities for the FT836 product candidate.

Here's a quick look at the current revenue-generating components as of the last reported quarter:

Revenue Component Latest Reported Amount/Status Period/Date
Collaboration Revenue (Ono) $1.7 million Q3 2025
CIRM Grant Award (FT836) $4 million Awarded January 2025
Future Product Sales Zero Currently

The company's cash position as of September 30, 2025, was $225.7 million, which, combined with operational adjustments, projects an operating runway through the end of 2027, intended to enable the achievement of key clinical and collaboration milestones.

The revenue streams can be summarized by their nature:

  • Collaboration revenue from strategic partners like Ono Pharmaceutical.
  • Eligibility for milestone payments tied to clinical and regulatory achievements under existing agreements.
  • Non-dilutive funding via government/non-profit awards, such as the CIRM grant.
  • Zero revenue from product sales, as all candidates remain in development.

Finance: draft 13-week cash view by Friday.


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