IO Biotech to announce Phase 3 melanoma treatment results

Published 10/08/2025, 13:06
IO Biotech to announce Phase 3 melanoma treatment results

NEW YORK - IO Biotech (NASDAQ:IOBT), a clinical-stage biotech with a market capitalization of $119 million, will hold a conference call and webcast on Monday at 8:30 AM ET to reveal topline results from its pivotal Phase 3 trial of Cylembio in combination with pembrolizumab for advanced melanoma treatment. The stock has seen significant volatility, dropping 18% in the past week while gaining nearly 100% over six months. InvestingPro data reveals 10+ additional key insights about IOBT’s performance.

The trial (IOB-013/KN-D18) evaluated the company’s investigational immune-modulatory cancer vaccine, Cylembio (imsapepimut and etimupepimut, adjuvant), in combination with pembrolizumab versus pembrolizumab alone as a first-line treatment for patients with unresectable or metastatic melanoma.

Cylembio, IO Biotech’s lead cancer vaccine candidate, is based on the company’s T-win platform, which aims to activate T cells to target both tumor cells and immune-suppressive cells in the tumor microenvironment.

The U.S. Food and Drug Administration previously granted Breakthrough Therapy Designation to IO102-IO103 (Cylembio) in combination with Merck’s KEYTRUDA (pembrolizumab) for advanced melanoma treatment, following positive Phase 1/2 data in first-line metastatic melanoma.

IO Biotech management will discuss the Phase 3 trial results during the webcast, which will be available for replay on the company’s website after the live event.

The clinical-stage biopharmaceutical company is headquartered in Copenhagen, Denmark, with U.S. headquarters in New York, according to the press release statement. The company maintains a strong balance sheet with more cash than debt, though it is currently in a rapid cash-burn phase typical of clinical-stage biotechs.

In other recent news, IO Biotech announced that it has regained compliance with the Nasdaq Global Select Market’s minimum bid price requirement. The company received confirmation from Nasdaq’s Listing Qualifications Staff that its common stock maintained a closing bid price of at least $1.00 for ten consecutive business days. This marks a resolution to the compliance issue reported in December 2024, when the stock price fell below the required threshold. Additionally, IO Biotech disclosed the results of its 2025 Annual Meeting of Stockholders. At the meeting, David Smith was elected as a Class I director with 40,444,898 votes in favor. There were 3,010,542 votes withheld and 8,622,498 broker non-votes. These developments reflect the company’s ongoing efforts to maintain its market standing and governance structure.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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