Bullish indicating open at $55-$60, IPO prices at $37
NEW YORK - IO Biotech (NASDAQ:IOBT), currently valued at approximately $119 million, reported Monday that its investigational cancer vaccine Cylembio, when combined with pembrolizumab, demonstrated improved progression-free survival in advanced melanoma patients compared to pembrolizumab alone, though results narrowly missed statistical significance thresholds. The company’s stock has shown remarkable momentum, gaining over 90% in the past six months.
In the pivotal Phase 3 trial involving 407 patients with unresectable or metastatic melanoma, the combination therapy achieved a median progression-free survival of 19.4 months versus 11.0 months for pembrolizumab monotherapy (HR=0.77, p=0.056).
The combination therapy showed particularly strong results in patients with PD-L1 negative tumors, with median progression-free survival of 16.6 months compared to 3.0 months for the control arm (HR=0.54, nominal p=0.006).
In patients without prior anti-PD-1 treatment, the combination therapy achieved median progression-free survival of 24.8 months versus 11.0 months for pembrolizumab alone (HR=0.74, nominal p=0.037). According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $6 to $14, suggesting significant upside potential. Subscribers can access 8 additional exclusive ProTips about IOBT’s financial health and market position.
"In this study, patients treated with Cylembio in combination with pembrolizumab have achieved the longest median PFS ever observed in a Phase 3 clinical study in advanced melanoma," said Omid Hamid, Director of Clinical Research and Immunotherapy at The Angeles Clinic and Research Institute.
The company also reported a trend toward improved overall survival, though this data is not yet mature.
Cylembio plus pembrolizumab was well tolerated, with injection site reactions being the most commonly reported adverse events in the combination arm.
IO Biotech plans to meet with the FDA this fall to discuss potential regulatory submission based on these results, according to the company’s press release statement. While the company maintains a healthy current ratio of 2.32 and holds more cash than debt, InvestingPro analysis indicates rapid cash burn that investors should monitor. The company’s next earnings report is expected on August 11, 2025.
In other recent news, IO Biotech is set to announce the topline results from its Phase 3 trial of Cylembio in combination with pembrolizumab for treating advanced melanoma. The trial evaluated this combination therapy against pembrolizumab alone as a first-line treatment for patients with unresectable or metastatic melanoma. Additionally, IO Biotech disclosed the outcomes of its 2025 Annual Meeting of Stockholders, where David Smith was elected as a Class I director with a significant majority of votes. The company also announced that it has regained compliance with the Nasdaq Global Select Market’s minimum bid price requirement. This compliance was confirmed after the company’s stock maintained a closing bid price of $1.00 or higher for ten consecutive business days. These developments follow a previous compliance issue when the stock price fell below the required threshold late last year. IO Biotech continues to trade on the Nasdaq Stock Market.
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