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NEW YORK - IO Biotech (NASDAQ:IOBT), a clinical-stage biopharmaceutical company with a current market capitalization of approximately $57 million, announced it is on schedule with its plan to submit a Biologics License Application (BLA) for its therapeutic cancer vaccine, Cylembio®, to the U.S. Food and Drug Administration (FDA) by the end of 2025. The company’s pivotal Phase 3 trial for Cylembio®, in combination with pembrolizumab, reached full enrollment in December 2023, with 407 patients participating. The primary endpoint of this trial is progression-free survival (PFS), and the company now expects to report the primary endpoint data in the third quarter of 2025.
The trial is evaluating the efficacy of Cylembio® in patients with advanced melanoma. IO Biotech also reported that its Phase 2 basket trial of Cylembio® as a neoadjuvant/adjuvant treatment for resectable melanoma or head and neck cancer completed enrollment ahead of schedule. Initial data from this trial is anticipated in the second half of 2025.
Financially, IO Biotech ended the fourth quarter of 2024 with approximately $60.0 million in cash and cash equivalents. Additionally, the company secured up to €57.5 million in debt financing from the European Investment Bank (EIB). This financing is expected to extend the company’s cash runway into the second quarter of 2026. InvestingPro data shows the company maintains a strong current ratio of 5.37, with liquid assets well exceeding short-term obligations. However, the company is rapidly burning through cash, which is typical for clinical-stage biotech firms.
The company’s CEO, Mai-Britt Zocca, Ph.D., expressed optimism about the potential for Cylembio® to address unmet medical needs in advanced melanoma, metastatic head and neck cancer, and metastatic lung cancer. The therapeutic cancer vaccine is designed to target both immune-suppressive cells in the tumor microenvironment and cancer cells.
IO Biotech will present at the TD Cowen’s 45th Annual Health Care Conference on March 5, 2025. The company’s progress includes meeting the primary endpoint of overall response rate (ORR) and encouraging PFS data from its Phase 2 basket trial investigating Cylembio® in combination with pembrolizumab as first-line treatment for squamous cell carcinoma of the head and neck. According to InvestingPro analysis, analyst price targets for IOBT range from $6 to $12, suggesting significant potential upside despite the stock’s recent 12% decline over the past week. The company’s next earnings report is scheduled for March 27, 2025, which could provide additional insights into its clinical progress and financial position.
The information in this article is based on a press release statement from IO Biotech.
In other recent news, IO Biotech has made several noteworthy advancements. The company has published promising preclinical study results for its cancer vaccine candidate, IO112, targeting the enzyme arginase 1. These findings, which appeared in the Journal for ImmunoTherapy of Cancer, suggest potential improvements in anti-tumor immunity. In financial developments, IO Biotech secured a €57.5 million loan from the European Investment Bank to support its cancer vaccine initiatives, including IO102-IO103, with plans to submit a Biologics License Application in 2025.
Jefferies analyst Roger Song has maintained a Buy rating for IO Biotech with a price target of $8.00, highlighting the anticipated progression-free survival data from their Phase 3 trial of IO102-IO103 in advanced melanoma. Despite not meeting an interim objective response rate, the company remains optimistic about achieving significant progression-free survival outcomes. Additionally, IO Biotech is addressing a compliance issue with Nasdaq due to its stock price falling below the $1.00 minimum bid requirement. The company has until June 2025 to rectify this issue or risk delisting.
Furthermore, IO Biotech has amended its corporate bylaws and maintained its fiscal year-end on December 31, as disclosed in a recent SEC filing. These amendments aim to streamline stockholder meetings and align with recent changes in Delaware corporate law. These developments reflect IO Biotech’s ongoing efforts to advance its clinical pipeline and strengthen its financial and corporate governance standing.
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