IO Biotech, Inc., a clinical-stage biopharmaceutical company, develops immune-modulating cancer therapies based on the T-win technology platform. The company's lead product candidate, IO102-IO103, which is designed to target immunosuppressive proteins, such as Indoleamine 2,3-dehydrogenase (IDO), and programmed death-ligand (PD-L1) that is in phase 2 clinical trial to treat melanoma, as well as in phase 1 clinical trial to treat lung, head and neck, bladder, and melanoma cancer. It also develops IO112, a product candidate that contains a single Arginase 1-derived peptide designed to target T cells that recognize epitopes derived from Arginase 1 for the treatment of cancers. The company was incorporated in 2014 and is based in Copenhagen, Denmark.
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IO Biotech is like a clinical-stage BioNTech or Moderna, but exclusively focused on developing cancer vaccines and immunotherapies.
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- IOB-018 (danesept t): A novel investigational anti-cancer immunotherapy designed to target the immunosuppressive enzyme IDO in the tumor microenvironment.
- IOB-035: A preclinical stage immunotherapy candidate targeting PD-L1, aimed at activating the immune system against cancer by disrupting a key immunosuppressive pathway.
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IO Biotech (IOBT) is a clinical-stage biopharmaceutical company focused on developing novel cancer immunotherapies. As such, the company does not currently have any approved commercial products on the market. Consequently, it does not have major customers in the traditional sense of selling products or services to other companies or individuals.
However, the business model for clinical-stage biopharmaceutical companies like IO Biotech typically involves developing drug candidates through clinical trials with the eventual goal of licensing them to larger pharmaceutical companies for commercialization, or entering into co-development and co-commercialization partnerships. In this context, potential future "customers" or strategic partners are other pharmaceutical companies.
The company currently has a significant clinical collaboration that could be considered a key corporate relationship:
- Merck & Co., Inc. (NYSE: MRK) - This collaboration involves the clinical development of IO Biotech's lead product candidate, IO102-IO103, in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with advanced melanoma. While this is a clinical collaboration rather than a direct sales relationship where Merck is purchasing a commercial product from IO Biotech, Merck represents a critical corporate partner in the advancement of IO Biotech's pipeline, aligning with the "sells primarily to other companies" category for future commercialization potential.
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Mai-Britt Zocca, Ph.D. Founder, President & CEO
Dr. Zocca has served as the founder and Chief Executive Officer of IO Biotech since January 2015. She also founded and served as Chief Executive Officer of OncoNOx ApS from 2011 to 2019. Prior to founding IO Biotech, she was the Chief Executive Officer at LevOss ApS from 2012 to 2017 and led DanDrit Biotech A/S as its Chief Executive Officer from 2007 to 2010. Dr. Zocca has almost two decades of experience in biotech, focusing on translational and clinical immuno-oncology, and has participated in the founding and co-founding of several biotech companies. She currently serves on the board of directors for Dansk Biotek and Valo Therapeutics Ltd.
Amy Sullivan, M.B.A. Chief Financial Officer
Ms. Sullivan is a seasoned life sciences professional with over 25 years of experience in capital raising and managing corporate biotechnology and life sciences brands. She joined IO Biotech from TABA, BV, where she served as Chief Financial Officer. Previously, Ms. Sullivan was Chief Strategy Officer for Euronext-listed Kiadis Pharma, where she was responsible for fundraising and capital formation strategy, repositioning the company, and played a critical role in its sale to Sanofi. She also served as Senior Vice President of Corporate Affairs at Keryx Biopharmaceuticals, a period that included a merger. Her experience also includes leadership roles in corporate communications and investor relations at AMAG Pharmaceuticals, Idenix Biopharmaceuticals, and Genencor International.
Qasim Ahmad, M.D. Chief Medical Officer
Dr. Ahmad is a trained internist and clinical oncologist with over two decades of experience in strategic clinical development, medical affairs, and marketing authorization. He joined IO Biotech from Novartis, where he most recently served as Senior Vice President, US Head of Clinical Development & Medical Affairs for the Novartis Oncology business unit.
Devin Smith General Counsel
Mr. Smith joined IO Biotech from Yumanity Therapeutics, Inc., where he was Senior Vice President and General Counsel. At Yumanity, he played a key role in the sale of the company's neuroscience assets to Johnson & Johnson and a reverse merger. Prior to Yumanity, he served as Senior Vice President and General Counsel of Minerva Neurosciences, Inc., where he led the sale of potential royalties to Royalty Pharma.
Faiçal Miyara, Ph.D. Chief Business Officer
Dr. Miyara is an executive with nearly two decades of experience in the pharmaceutical and biotechnology industry, with a strong track record in deals and partnerships across various therapeutic areas. He previously served as Vice President, Head of Business Development Oncology, and then Head of External Innovation Oncology, Lead on Venture Capital Activities at Ipsen Biosciences. Before Ipsen, he was Senior Vice President, Head of Business Development and External Research at Kadmon Corporation, and earlier in his career, held leadership roles at Pfizer and Eli Lilly and Company.
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The key risks to IO Biotech's (IOBT) business are primarily centered around the uncertainty of regulatory approval for its lead product candidate, its precarious financial position requiring significant additional funding, and intense competition within the biotechnology industry.
- Regulatory Approval Uncertainty and Clinical Trial Failure: IO Biotech's primary asset, Cylembio (IO102-IO103), a therapeutic cancer vaccine, recently faced a significant setback. The company's pivotal Phase 3 trial for Cylembio in combination with pembrolizumab for advanced melanoma narrowly missed its primary endpoint of progression-free survival (PFS), achieving 19.4 months versus 11.0 months for the control arm but failing to meet the prespecified statistical significance threshold. Consequently, the U.S. Food and Drug Administration (FDA) has recommended against submitting a Biologics License Application (BLA) based on the current data and advised a new Phase 3 trial. This significantly delays the potential launch timeline for Cylembio, now projected for 2029 instead of 2026, and has led to reduced probability of success estimates for its various indications. As a clinical-stage company, all of IO Biotech's product candidates are in development and require extensive preclinical and clinical testing, and regulatory approval, prior to commercialization.
- Financial Position and Need for Additional Financing: IO Biotech operates with a limited cash runway and has incurred consistent and significant losses since its inception, with an accumulated deficit of $416.3 million as of September 30, 2025. The company currently generates no revenue, which is typical for a clinical-stage entity. Its existing cash and equivalents are projected to fund operations only into the first quarter of 2026. This critical cash position, exacerbated by the regulatory setback, necessitates securing substantial additional funding to continue operations and complete clinical trials. The company has openly disclosed substantial doubt about its ability to continue as a going concern without further capital, indicating a high likelihood of a dilutive cash raise.
- Intense Competition: The biotechnology sector, especially the immuno-oncology space in which IO Biotech operates, is highly competitive. The company faces significant competition from larger, well-established, and better-capitalized pharmaceutical and biotechnology companies. This competitive landscape is continuously intensifying, posing a challenge for IO Biotech to establish and maintain a market presence, even with its off-the-shelf approach for Cylembio.
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The most clear emerging threat for IO Biotech is the advancement and demonstrated efficacy of **mRNA-based personalized cancer vaccines**, particularly exemplified by the candidate mRNA-4157/V940 being developed by Moderna and Merck. This product, also targeting melanoma in combination with a PD-1 inhibitor (pembrolizumab), has shown positive results in Phase 2b trials and is progressing to Phase 3. This represents a distinct technological platform for cancer vaccination that could prove to be more efficacious, versatile, or rapidly scalable than IO Biotech's peptide-based vaccine approach, directly threatening its market position and potential for adoption in the same therapeutic area.
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IO Biotech (IOBT) is a clinical-stage biopharmaceutical company focusing on novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win® platform. The company's lead investigational cancer vaccine candidate is Cylembio™ (also known as IO102-IO103), which is currently in clinical trials for several cancer indications. IO Biotech also has other pipeline candidates, including IO112 and IO170, in preclinical development.
Addressable Markets for Cylembio (IO102-IO103)
Cylembio (IO102-IO103) is being developed for advanced melanoma, non-small cell lung cancer (NSCLC), and head and neck cancers.
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Melanoma:
- The global melanoma therapeutics market was estimated at approximately USD 5.83 billion in 2024 and is projected to reach about USD 10.26 billion by 2030. Another estimate places the global advanced melanoma market at USD 8.7 billion in 2024, with a projection to reach USD 22.5 billion by 2034.
- In the U.S. alone, the melanoma market was valued at approximately USD 7.24 billion in 2024, expected to reach USD 7.66 billion in 2025, and projected to grow to USD 11.98 billion by 2033.
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Non-Small Cell Lung Cancer (NSCLC):
- The global non-small cell lung cancer therapeutics market was valued at approximately USD 21.85 billion in 2024 and is anticipated to reach around USD 72.42 billion by 2034. Other estimates for the global market in 2024 include USD 21.45 billion and USD 33.90 billion, with projections to reach USD 43.89 billion by 2030 and USD 66.04 billion by 2032, respectively.
- North America held a dominant share of the global NSCLC therapeutics market, with an estimated revenue of USD 15.07 billion in 2024. The U.S. NSCLC market alone reached approximately USD 8.2 billion in 2024.
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Head and Neck Cancer:
- The global head and neck cancer therapeutics market was estimated at approximately USD 2.58 billion in 2024 and is projected to grow to USD 7.68 billion by 2034. Other reports indicate the global market size at USD 2.27 billion in 2024, expected to reach USD 6.25 billion by 2033, or USD 6.07 billion in 2024, potentially increasing to USD 10.2 billion by 2035. The global head and neck cancer drugs market revenue was valued at USD 18.78 billion in 2025 and is expected to reach around USD 32.65 billion by 2033.
- In the U.S., the head and neck cancer therapeutics market was valued at approximately USD 0.83 billion in 2024 and is expected to reach USD 1.91 billion by 2032. North America accounted for the largest share of the global market in 2024, at 44.8%.
Addressable Markets for IO112 and IO170
IO112 is being developed for difficult-to-treat tumors including renal cell carcinoma, head and neck, breast, pancreatic, ovarian, colorectal, and prostate cancers. IO170 is being explored for solid tumors, including pancreatic adenocarcinoma and prostate cancer. However, specific addressable market sizes for these preclinical candidates are not yet available. Therefore, market sizing for these products would be null at this time.
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Below are 3-5 expected drivers of future revenue growth for IO Biotech (IOBT) over the next 2-3 years:
- Regulatory Approval and Commercial Launch of Cylembio (IO102-IO103) in Melanoma: IO Biotech's lead asset, Cylembio, is an investigational therapeutic cancer vaccine for advanced melanoma. While its pivotal Phase 3 trial (IOB-013/KN-D18) in combination with pembrolizumab narrowly missed statistical significance for its primary endpoint, the company plans to design a new registrational study for Cylembio for first-line patients with advanced melanoma. Additionally, IO Biotech intends to discuss the data from the IOB-013 study with European regulators to determine a path to submission in the EU. A successful regulatory approval and subsequent commercial launch of Cylembio in the U.S. and/or Europe, potentially in 2026, would be the most significant driver of initial revenue growth.
- Expansion of Cylembio into New Indications: Beyond advanced melanoma, IO Biotech's T-win® platform, on which Cylembio is based, has the potential to address other solid tumors. Positive results from ongoing or planned clinical trials exploring Cylembio in additional cancer types, such as Non-Small Cell Lung Cancer (NSCLC) and Head & Neck cancer (currently in Phase 2 trials), could significantly broaden its market opportunity and contribute to revenue growth.
- Advancement and Clinical Development of Pipeline Candidates (IO170 and IO112): IO Biotech's T-win® platform is generating additional candidates, IO170 and IO112, which are currently in preclinical development. IO112, an Arginase-1-targeting vaccine, is expected to have an Investigational New Drug (IND) filing in 2026, initiating its clinical development. IO170, a TGF-β-directed vaccine, has shown tumor growth inhibition in preclinical models of pancreatic and prostate cancer. Successful progression of these candidates into and through clinical trials could diversify the company's pipeline and create new revenue streams in the longer term.
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Share Issuance
- IO Biotech completed its Initial Public Offering (IPO) in November 2021, issuing 8,222,500 shares of common stock at $14.00 per share, resulting in gross proceeds of approximately $115.1 million.
- In August 2023, the company executed a private placement financing, generating gross proceeds of approximately $75 million. This involved the sale of 37,065,647 shares of common stock and accompanying warrants.
Inbound Investments
- In December 2024, IO Biotech secured a loan facility of up to €57.5 million from the European Investment Bank (EIB). This facility includes three committed tranches totaling €37.5 million and an uncommitted accordion tranche of €20 million.
- The company drew down Tranche A (€10.0 million) in May 2025 and Tranche B (€12.5 million) in July 2025 from the EIB loan facility.
Capital Expenditures
- For the last 12 months (as of November 2025), IO Biotech's capital expenditures were -$75,000.
- The company anticipates that its capital expenditures will continue to increase in the future, primarily focused on supporting research and development expenses and general and administrative expenses.
