IO Biotech, Inc. (IOBT): Business Model Canvas [Dec-2025 Updated]

You're looking at IO Biotech, Inc. (IOBT), and honestly, the business model is a pure play on clinical success: everything rests on their T-win immune-modulatory platform delivering for Cylembio in advanced melanoma. As of late 2025, they are funding significant R&D-$13.7 million in Q3 alone-while sitting on about $30.7 million in cash, making that Merck partnership and the EIB loan facility essential lifelines. Dive into the full canvas below to see exactly how this pre-revenue biotech manages its cost structure and customer engagement while betting big on enhancing checkpoint inhibitor efficacy.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Key Partnerships

The operational backbone of IO Biotech, Inc. relies on strategic external collaborations to advance its T-win^® platform candidates, particularly the lead asset IO102-IO103 (Cylembio^®).

Merck (MSD) Collaboration for IO102-IO103 Development

• Merck Sharp & Dohme LLC (MSD outside the US and Canada) supplies KEYTRUDA^® (pembrolizumab) for combination clinical trials.
• IO Biotech sponsors the trials, including the pivotal Phase 3 trial IOB-013/KN-D18, while Merck supplies the anti-PD-1 therapy.
• IO Biotech maintains global commercial rights to Cylembio^®.

European Investment Bank (EIB) Non-Dilutive Financing

The European Investment Bank provided a significant debt facility to support late-stage development and pre-commercialization efforts, extending the cash runway.

The EIB support validates the technology, and the loan is unsecured with no minimum cash covenants.

Global Clinical Trial Site Network

• The pivotal Phase 3 trial (IOB-013/KN-D18) enrolled 407 patients.
• Enrollment occurred across over 100 centers globally.
• Geographic sites included the United States, Europe, Australia, Turkey, Israel, and South Africa.
• Enrollment for the Phase 3 trial was completed by December 2023.

Academic and Scientific Collaborators

Preclinical pipeline advancement involves external scientific engagement, supporting candidates beyond the lead program.

• Pre-clinical data for IO112 (targeting arginase 1) and IO170 (targeting Transforming Growth Factor (TGF)-β) were presented at the SITC 40th Annual Meeting in November 2025.
• The company anticipates filing an Investigational New Drug Application (IND) for IO112 in 2026.
• An investigator-initiated Phase 1 trial for IO112 was conducted at the University of Copenhagen.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Key Activities

You're looking at the core engine driving IO Biotech, Inc. (IOBT) right now, which is heavily weighted toward clinical execution and strategic regulatory navigation following the Q3 2025 data readout. The focus is clearly on pivoting the Cylembio program after the initial Phase 3 results.

Pivotal Phase 3 Clinical Trial Execution for Cylembio in Advanced Melanoma

The execution of the pivotal Phase 3 trial, IOB-013/KN-D18, for Cylembio in first-line advanced melanoma was a massive undertaking. Enrollment for this trial was completed rapidly by December 2023, involving a total of 407 patients who were treated with Cylembio in combination with Merck's KEYTRUDA (pembrolizumab) versus pembrolizumab alone. The topline results were reported in the third quarter of 2025, presenting a complex picture for the primary endpoint.

Here's the quick math on the key efficacy numbers from that trial:

What this estimate hides is the strong signal in a specific patient group. The data showed a profound effect in patients with PD-L1 negative tumors, where the mPFS was 16.6 months compared to only 3.0 months for the control arm, achieving a nominal p-value of 0.006. This demonstration of a clinically relevant benefit across subgroups is what management is leaning on as they move forward.

Research and Development (R&D) of the Proprietary T-win Platform

The R&D activity is shifting from the late-stage trial execution to pipeline advancement, evidenced by the financial reporting for Q3 2025. The company is clearly tightening its belt, which impacts the pace of discovery work. Research and development expenses for the three months ended September 30, 2025, were $13.7 million, a noticeable reduction from the $20.2 million reported for the same period in 2024. Still, the T-win platform remains the core intellectual property, designed to activate T cells against both tumor cells and immune-suppressive cells in the tumor microenvironment.

Key R&D activities and pipeline progression include:

• Advancing next-generation candidates from preclinical work.
• Presenting pre-clinical data for IO112 (targeting arginase 1) and IO170 (targeting transforming growth factor (TGF)-β) at the SITC 2025 conference.
• Planning to file an Investigational New Drug (IND) Application for IO112 in 2026.

The company was recognized in 2025 by Fast Company as the 9th most innovative company in the world in the biotechnology category for this platform.

Regulatory Strategy and Meetings with the FDA for a New Phase 3 Design

This is the most critical near-term activity, directly resulting from the IOB-013 data. IO Biotech had a pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) on September 29, 2025. The outcome was that the FDA recommended IO Biotech not submit a BLA based on the existing IOB-013 trial data. Consequently, the strategy immediately pivoted to designing a new registrational study. You should expect the company to continue dialogue with the FDA in December 2025 to align on the design for this potential new Phase 3 trial. They also plan to discuss the IOB-013 data with European regulators to determine a path to submission in the EU.

Manufacturing and Supply Chain Management for Off-the-Shelf Vaccines

For Cylembio, the key supply chain activity identified is the collaboration with Merck. Merck is supplying pembrolizumab for the ongoing clinical trials, while IO Biotech maintains global commercial rights to Cylembio. As the product is an 'off-the-shelf' vaccine, the development of a scalable manufacturing process is inherent to the platform's value proposition, though specific 2025 manufacturing capacity or cost figures aren't detailed in the latest reports. The restructuring announced in late September 2025, which included a workforce reduction of approximately 50 percent, will certainly impact the internal resources dedicated to scaling up manufacturing and supply chain readiness for commercialization, should a new Phase 3 be successful.

Finance: draft 13-week cash view by Friday.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Key Resources

You're looking at the core assets IO Biotech, Inc. (IOBT) relies on to drive its business forward, especially given the recent Phase 3 data readout. These aren't just concepts; they are the tangible and intangible things that make the business run.

Proprietary T-win® Immune-Modulatory Cancer Vaccine Platform

The foundation here is the T-win® platform. It's an off-the-shelf technology, which is a key differentiator from personalized neoantigen vaccines that require custom manufacturing for each patient. The platform's design centers on a dual mechanism of action.

• Activates and expands T cells to target both tumor cells and immune-suppressive cells in the tumor microenvironment (TME).
• Targets established, widely expressed immune-suppressive antigens like IDO1 and PD-L1, rather than rare tumor-specific antigens.
• Modulates the TME to potentiate anti-tumor activity by unleashing tumor killing by effector T cells.
• Mission is to establish these vaccines as the backbone of combination therapy for multiple cancer types.

Lead Investigational Candidate: Cylembio® (IO102-IO103)

Cylembio®, also known as IO102-IO103, is the lead asset utilizing the T-win® platform. It's a dual-antigen vaccine targeting IDO1+ and PD-L1+ cells. The recent data from the pivotal Phase 3 trial in first-line advanced melanoma is critical context for this resource.

Here's a breakdown of the key data points from the IOB-013/KN-D18 trial presented in Q3 2025:

IO Biotech, Inc. maintains global commercial rights to Cylembio®.

Financial Resources

Liquidity is a primary resource, especially for a clinical-stage company. You need to know exactly what's in the bank to fund operations until the next milestone or financing event. The company secured proceeds from the European Investment Bank (EIB) Tranche B loan and an at-the-market (ATM) program during the third quarter of 2025.

• Cash and cash equivalents as of September 30, 2025: approximately $30.7 million.
• Cash position was $60.0 million at December 31, 2024.
• Cash used in operating activities for the three months ended September 30, 2025, was $19.4 million in total operating expenses.
• The company guided that its cash is sufficient to run the company through the first quarter of 2026.
• Net cash position, including debt of $18.12 million, was $12.55 million as of the last reported balance sheet data.

Intellectual Property Protecting IDO/PD-L1 Peptide Antigens

The core technology is protected by granted patents, which provide a barrier to entry for competitors trying to replicate this specific approach to immune modulation via peptide epitopes.

Key granted patents in 2025 include:

• Patent number 12233103, granted February 25, 2025, relating to Indoleamine 2,3-dioxygenase (IDO) peptide fragments for anti-cancer immune responses.
• Patent number 12187782, granted January 7, 2025, concerning a PD-L1 peptide fragment for use in cancer therapies.
• Patent number 12215135, granted February 4, 2025, covering PDL2 compounds.

Finance: draft 13-week cash view by Friday.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Value Propositions

IO Biotech, Inc. (IOBT) offers an off-the-shelf therapeutic cancer vaccine, Cylembio® (imsapepimut and etimupepimut, adjuvanted), which is based on its T-win® platform, designed for broad use across various cancer types.

The core value is derived from its dual-pronged mechanism, which is designed to activate T cells to fight cancer in two distinct ways within the tumor microenvironment (TME).

• T cells are primed to target cells expressing IDO1 (via IO102) and PD-L1 (via IO103).
• The action kills tumor cells.
• The action sets loose effector T cells to create an anti-tumor, proinflammatory TME.

The clinical evidence supporting this mechanism comes from the Phase 3 trial (IOB-013/KN-D18) in first-line advanced melanoma, which involved 407 patients.

This represents a clinically relevant improvement in mPFS of 8.4 months (19.4 months minus 11.0 months).

The vaccine is positioned to enhance the efficacy of existing checkpoint inhibitors, notably KEYTRUDA (pembrolizumab), as demonstrated in combination studies. For instance, in a Phase 2 trial for advanced squamous cell carcinoma of the head and neck (SCCHN), the combination delivered an objective response rate of 44.4%.

Financially, as of September 30, 2025, IO Biotech, Inc. (IOBT) held $30.7 million in cash and cash equivalents, with this position expected to fund operations through the first quarter of 2026. The company reported Q3 2025 operating expenses of $19.4M, with Research and development expenses at $13.7M for the same period.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Customer Relationships

You're managing the narrative for IO Biotech, Inc. (IOBT) as they navigate the post-Phase 3 readout period in late 2025. Customer relationships here mean the critical interactions with the gatekeepers of approval and capital. We need to be precise about the data shared and the outcomes.

Direct, high-touch engagement with regulatory bodies (FDA, EMA)

Engagement with the U.S. Food and Drug Administration (FDA) has been central following the Phase 3 IOB-013 trial results for Cylembio®. IO Biotech, Inc. had a pre-BLA meeting with the FDA, after which the agency recommended against submitting a Biologics License Application (BLA) based on the data from that trial, as the primary progression-free survival (PFS) endpoint narrowly missed statistical significance (p=0.0558). The median PFS in the combination arm was 19.4 months versus 11.0 months for pembrolizumab alone in that trial.

The company respects the FDA's feedback but remains confident in the drug's potential, noting benefits across most subgroups, such as a median PFS of 16.6 months versus 3.0 months for patients with PD-L1-negative tumors. IO Biotech, Inc. is now focused on continuing dialogue with the FDA, with a meeting scheduled for December 2025 to align on the design for a potential new Phase 3 registrational study for first-line advanced melanoma patients.

Scientific communication via presentations at major oncology congresses (ESMO, SITC)

Scientific communication is how IO Biotech, Inc. validates its T-win® platform to the broader medical and research community. This involves presenting clinical and preclinical data at key industry events.

In the latter half of 2025, the scientific engagement was high-profile:

• Presented Phase 3 results for Cylembio® plus pembrolizumab at the ESMO Congress 2025 (October 17-21, 2025).
• Presented pre-clinical data for additional therapeutic cancer vaccine candidates at the 2025 annual meeting of the Society for Immunotherapy of Cancer (SITC) (November 7, 2025).

The Phase 3 trial, IOB-013/KN-D18, involved 407 patients. Furthermore, enrollment for the two ongoing company-sponsored Phase 2 clinical trials is now complete.

Investor relations and corporate presentations for capital markets

Keeping the capital markets informed is vital, especially given the recent cash position and the need for alignment with the FDA on the next registrational trial. IO Biotech, Inc. reported its Third Quarter 2025 financial results on November 14, 2025.

Here is a snapshot of the financial relationship status as of the Q3 2025 filing:

Investor engagement included participation by senior management in conferences such as the Jefferies Global Healthcare Conference on November 18, 2025. The Director of Investor Relations & Corporate Communications is Maryann Cimino. The company is defintely facing near-term funding requirements based on the runway projection.

The company's recent investor communications highlighted key activities:

• Discussions planned with the FDA in December 2025.
• Participation in investor conferences in November 2025.
• Presentation of preclinical data at SITC 2025.

Finance: draft 13-week cash view by Friday.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Channels

You're looking at how IO Biotech, Inc. gets its science and its financial story out to the world, which for a clinical-stage company means researchers, doctors, and investors. The channels are all about data dissemination and stakeholder communication as of late 2025.

Global network of clinical research organizations (CROs) and trial sites

The execution of the clinical strategy relies on a network that has already completed enrollment for key studies. For instance, the Phase 3 trial (IOB-013) involved 407 patients across 100+ global sites before enrollment finished in December 2023. Ongoing Phase 2 trials, like IOB-022/KN-D38, are actively using sites located in the United States, Spain, and the United Kingdom to test Cylembio® in combination with pembrolizumab for NSCLC and SCCHN.

Scientific publications and medical conferences for data dissemination

IO Biotech, Inc. uses major medical meetings to communicate clinical progress directly to the scientific community. The company presented topline results from its Phase 3 trial (IOB-013) at ESMO 2025. Furthermore, pre-clinical data for pipeline candidates IO112 and IO170 were presented at the SITC 2025 Annual Meeting, which took place November 5-9, 2025. This scientific output is critical for establishing the validity of the T-win® platform.

Direct communication with investors via press releases and SEC filings

Investor relations are driven by mandatory filings and targeted presentations. The company reported its Q3 2025 financial results and business highlights via a press release on November 14, 2025, following its 10-Q filing. IO Biotech, Inc. also uses investor conferences as a primary channel for direct engagement, with corporate presentations scheduled for the Jefferies Global Healthcare Conference on November 18, 2025, and the Piper Sandler 37th Annual Piper Sandler Healthcare Conference on December 3, 2025.

Here's a quick look at the latest financial snapshot provided through these channels as of the Q3 2025 report:

The company is actively using these channels to manage expectations following the Phase 3 readout, noting that while the primary endpoint was narrowly missed, the results support the mechanism of action and have de-risked the program. The next concrete step communicated to investors is the December meeting with the FDA.

The key communication events used by IO Biotech, Inc. in late 2025 included:

• ESMO 2025 presentation of Phase 3 topline data.
• SITC 2025 presentation of pre-clinical IO112/IO170 data.
• Q3 2025 earnings release on November 14, 2025.
• Upcoming investor calls at Evercore and Piper Sandler conferences.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Customer Segments

You're looking at the customer base for IO Biotech, Inc. (IOBT) as of late 2025, which is heavily concentrated around the clinical development and potential commercialization of their T-win platform vaccines, primarily Cylembio (IO102-IO103).

The first segment involves Oncologists and specialized cancer treatment centers globally. These are the treating physicians and institutions where the combination therapy of Cylembio plus Merck's KEYTRUDA (pembrolizumab) is being tested or will eventually be prescribed. IO Biotech maintains global commercial rights to Cylembio, suggesting a broad, international target market for future sales, though current activity is centered around trial sites in the United States, Europe, Australia, Turkey, Israel, and South Africa. The company is actively collaborating with Merck, which supplies the necessary anti-PD-1 therapy for these trials.

The most immediate patient segment centers on Patients with advanced melanoma (first-line treatment). This group was the focus of the pivotal Phase 3 trial, IOB-013/KN-D18. This trial evaluated Cylembio in combination with pembrolizumab versus pembrolizumab alone in a cohort of 407 patients with unresectable or metastatic (advanced) melanoma. Although topline data presented at ESMO 2025 showed clinically relevant improvement in progression-free survival (PFS), statistical significance on the primary endpoint was narrowly missed. IO Biotech is meeting with the FDA in December to align on the design of a potential new Phase 3 registrational trial for this indication, which will define the next wave of this customer segment.

The next group includes Patients with metastatic NSCLC and SCCHN in Phase 2 trials. These patients are being treated in the IOB-022/KN-D38 Phase 2 basket trial. Furthermore, a separate Phase 2 basket trial, IOB-032/PN-E40, targeted patients with resectable tumors receiving Cylembio plus pembrolizumab as neo-adjuvant/adjuvant treatment. Initial data from this trial is expected in the second half of 2025, with presentation planned for 2026. The enrollment for the resectable melanoma cohort (Cohort A) was 18 patients, and the SCCHN cohort (Cohort B) enrolled 16 patients.

Finally, the strategic customer segment comprises Pharmaceutical companies for potential future licensing or acquisition. These entities represent potential partners for co-development, commercialization, or outright acquisition, especially given the need to fund the next registrational trial following the Phase 3 outcome. IO Biotech ended the third quarter of 2025 with approximately $31 million in cash and cash equivalents, which is expected to support operations through the first quarter of 2026. This tight runway definitely signals a near-term need to secure external capital or a strategic partnership to advance the pipeline beyond the planned December FDA alignment meeting.

• Oncology Research Institutions are also key partners for preclinical data presentation, such as the recent presentation of IO112 (arginase 1) and IO170 (TGF-β) candidates at the 2025 SITC annual meeting.
• The company was recognized as one of the most innovative biotechnology companies in the world by Fast Company in 2025.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Cost Structure

You're looking at the expense side of IO Biotech, Inc. (IOBT)'s operations as of late 2025, which is heavily weighted toward advancing its clinical pipeline. The main cost drivers reflect the capital-intensive nature of late-stage biopharma development. For the third quarter ended September 30, 2025, the total operating expenses clocked in at $19.4 million.

Here's a quick look at how those operating expenses broke down for the quarter:

Research and Development (R&D) is definitely the primary cost driver here, hitting $13.7 million for Q3 2025. This figure directly funds the core value creation-the clinical trials and the science behind the T-Win platform. Honestly, this is where the bulk of your investment capital is going to support the next milestones.

Within that R&D spend, you have significant, though not itemized separately in the public filings, expenses related to clinical trial execution. This includes things like patient enrollment, site management, and data monitoring for ongoing studies. The Phase 3 trial (IOB-013) for Cylembio in advanced melanoma had its enrollment completed by December 2023, but ongoing monitoring and data analysis still consume resources. Also factored in are manufacturing costs for clinical trial materials, which are necessary to supply the ongoing trials, including the two Phase 2 studies that completed enrollment.

The status of those key clinical activities impacting R&D spend includes:

• Phase 3 (IOB-013) topline data presented at ESMO in Q3 2025.
• Meeting scheduled with the FDA in December 2025 to align on a potential new Phase 3 registrational trial design.
• Enrollment complete for two ongoing company-sponsored Phase 2 clinical trials.
• Pre-clinical data presented for pipeline candidates IO112 and IO170.

General and Administrative (G&A) expenses were $5.6 million for the same three-month period. This covers the overhead necessary to run the business-things like executive salaries, legal fees, finance operations, and corporate compliance. To be fair, for a clinical-stage company, keeping G&A at this level while advancing late-stage trials shows a degree of operating discipline, especially considering the cash position was guided to last only through the first quarter of 2026 with $30.7 million in cash on hand as of September 30, 2025.

Finance: draft 13-week cash view by Friday.

IO Biotech, Inc. (IOBT) - Canvas Business Model: Revenue Streams

You're looking at the financial engine for IO Biotech, Inc. (IOBT) as of late 2025. Since they are still in the clinical development phase, the revenue streams are focused on financing operations rather than product sales.

Currently, IO Biotech, Inc. is pre-revenue from product sales. The company ended the third quarter of 2025 with approximately $30.7 million in cash and cash equivalents, which is expected to support operations through the first quarter of 2026.

The financing structure relies heavily on non-dilutive debt and recent equity raises to bridge the gap until potential commercialization of Cylembio.

The non-dilutive financing from the European Investment Bank (EIB) loan facility is a major component:

• Total facility size is up to €57.5 million.
• The facility is structured with committed tranches totaling €37.5 million and an uncommitted accordion tranche of €20 million.
• Tranche A of €10.0 million was drawn on May 6, 2025.
• Tranche B of €12.5 million in gross proceeds was drawn on July 4, 2025.

Equity financing has also been active to supplement the runway. Specifically, the company secured net proceeds from its At-The-Market (ATM) program in Q3 2025.

Looking ahead, the primary potential revenue streams are tied directly to the success of the lead candidate, Cylembio, and the T-win platform:

• Future product sales of Cylembio upon regulatory approval, following alignment with the FDA on a potential new Phase 3 registrational trial design scheduled for December 2025.
• Potential future milestone payments or royalties derived from any existing or future licensing deals for its pipeline candidates, including IO112 and IO170.

The current cash position of $30.7 million as of September 30, 2025, was bolstered by the $6.6 million ATM proceeds and the EIB drawdowns, but the company is still operating under a timeline that necessitates securing further capital.