IO Biotech, Inc.

IO Biotech, Inc. is a clinical-stage biopharmaceutical company developing therapeutic cancer vaccines, with its lead program IO102-IO103 now referred to in the U.S. as Cylembio® (imsapepimut and etimupepimut, adjuvanted). The company is focused on advancing oncology immunotherapy candidates through clinical trials and regulatory approval, with no approved products or product revenue to date.

3.33

3.33

— IO Biotech, Inc.
%
Lead therapeutic cancer vaccine0% Clinical-stage vaccine program targeting oncology indications, including Cylembio®/IO102-IO103.
Pipeline development programs0% Earlier-stage preclinical and discovery assets intended to expand the oncology pipeline.
Clinical and regulatory development100% Internal R&D, trial execution, and regulatory work needed to advance candidates toward approval.

IO Biotech does not yet sell approved products, so it currently has no commercial customer base...

  • Oncology treatment providersprimary

    Hospitals, cancer centers, and physicians would buy or administer approved therapies if the pipeline succeeds.

  • Patients with solid tumorsprimary

    End users of the therapy, especially in indications addressed by IO102-IO103/Cylembio®.

  • Regulatory authoritiessecondary

    FDA and foreign agencies evaluate the clinical package and determine whether products can be commercialized.

  • Strategic collaboratorssecondary

    Pharma partners may fund, co-develop, or commercialize programs and provide non-dilutive capital.

The company is headquartered in the United States, but its operating footprint is international, with references to...

  • •United States is the key market for clinical and future commercialization
  • •Denmark is an important operating base for the company
  • •European Union exposure includes EIB financing and cross-border operations
  • •Clinical and regulatory work spans U.S. and foreign jurisdictions
  • •Future sales would depend on reimbursement systems in multiple countries

IO Biotech’s strategy is to advance Cylembio® through late-stage clinical development and generate the data needed for...

01
Complete clinical development of Cylembio®short-term

Approval depends on positive late-stage data and successful trial execution.

02
Secure additional capitalshort-term

Current cash is not sufficient to fund all planned development activities.

03
Prepare for commercializationmedium-term

If approved, the company must build or outsource sales, marketing, and distribution.

IO Biotech is a pre-revenue oncology developer with substantial clinical, regulatory, financing, and commercialization...

critical

Clinical development failure

The lead candidate is still in development and early results may not predict later outcomes.

Scope
Cylembio® / IO102-IO103
Materiality
High
critical

Going concern and financing risk

The company expects to need additional capital to fund future clinical and preclinical work.

Scope
All programs and operations
Materiality
High
high

Commercialization execution risk

The company has no sales, marketing, or distribution infrastructure.

Scope
Future approved products
Materiality
High
high

Manufacturing and supply chain risk

Specialty materials and contract manufacturing are needed for clinical and commercial supply.

Scope
API and product supply
Materiality
High
high

Competitive and technological obsolescence

Oncology is crowded and faster or better therapies could reduce market opportunity.

Scope
Oncology immunotherapy market
Materiality
High
Going concern
Affects financial statement presentation and investor assessment of survival risk
Research and development expense recognition
Drives reported loss and masks underlying progress until commercialization
Valuation allowance on deferred tax assets
Prevents tax benefits from reducing reported losses
Equity and warrant fair value accounting
Can materially affect equity and non-cash expense recognition

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: 28/04/2026