Io Biotech, Inc. Stock Price, News & Analysis

IO Biotech (NASDAQ: IOBT) announced topline results from its pivotal Phase 3 trial of Cylembio® plus KEYTRUDA® for first-line advanced melanoma treatment. While the combination showed clinical improvement in progression-free survival (19.4 months vs. 11.0 months), it narrowly missed statistical significance with HR=0.77 (p=0.056).

Notable findings include a profound effect in PD-L1 negative patients (16.6 vs. 3.0 months, HR: 0.54, p=0.006) and improved results in patients without prior anti-PD-1 treatment (24.8 vs. 11.0 months, HR: 0.74, p=0.037). The combination demonstrated a positive safety profile with no new safety signals. A trend toward improved overall survival was observed (HR=0.79), though data is not yet mature.

IO Biotech plans to meet with the FDA this fall to discuss potential regulatory submission.

IO Biotech (NASDAQ:IOBT), a clinical-stage biopharmaceutical company, has scheduled a conference call and webcast for August 11, 2025, at 8:30 AM ET to reveal topline results from its pivotal Phase 3 trial (IOB-013/KN-D18). The trial evaluates Cylembio, an investigational immune-modulatory cancer vaccine, in combination with KEYTRUDA® versus KEYTRUDA® alone for first-line treatment of advanced melanoma.

The study focuses on patients with unresectable or metastatic melanoma, with management hosting a live discussion of the results. A replay will be available on the company's website after the event.

IO Biotech (IOBT), a clinical-stage biopharmaceutical company focused on developing immune-modulatory therapeutic cancer vaccines, has announced its participation in two upcoming investor conferences. The company's leadership team, including CEO Mai-Britt Zocca, CFO Amy Sullivan, and CMO Qasim Ahmad, will participate in a fireside chat at the TD Cowen 6th Annual Oncology Summit on May 27, 2025. Additionally, Dr. Zocca will present at the Jefferies Global Healthcare Conference on June 4, 2025, where the team will also conduct one-on-one investor meetings.

IO Biotech (IOBT) reported Q1 2025 financial results and business updates. The company's pivotal Phase 3 trial for Cylembio®, their lead therapeutic cancer vaccine for advanced melanoma, remains on track for readout in Q3 2025. The net loss increased to $22.4M from $19.5M YoY, with R&D expenses at $16.4M and G&A expenses at $6.2M. Cash position stood at $37.1M as of March 31, 2025. The company drew €10M from EIB loan facility and expects sufficient funding into Q2 2026. IO Biotech completed enrollment in its Phase 2 solid tumor trial and was recognized by Fast Company as the 9th most innovative biotech company globally. They plan to submit a BLA to FDA in 2025 and potentially launch Cylembio in 2026.

IO Biotech (Nasdaq: IOBT) showcased its scientific leadership at the 2025 AACR Annual Meeting through an educational session on cancer vaccines. The company's scientific co-founder, Dr. Mads Hald Andersen, chaired and presented at the session, focusing on immune-modulatory vaccines (IMVs).

Dr. Andersen's presentation highlighted the dual mechanism of action of IO102-IO103, IO Biotech's most advanced therapeutic cancer vaccine. The vaccine targets both tumor cells and host immune suppressive cells by activating T cells against IDO+ and PDL1+ cells. Recent data suggests it can reprogram the tumor microenvironment (TME) through inflammatory cytokine induction and macrophage phenotypic changes, promoting a more immune-permissive environment.

IO Biotech (IOBT) presented new preclinical data for two cancer vaccine candidates at the AACR Annual Meeting 2025 in Chicago. The company showcased findings for:

1. IO102-IO103: Their lead therapeutic vaccine targeting IDO1 and PD-L1 demonstrated strong T-cell responses and unique tumor microenvironment modulation in mouse models, with effects distinct from conventional PD-1/PD-L1 inhibitors.

2. IO170: Their TGF-β-directed vaccine showed significant tumor growth inhibition in breast and prostate cancer models, increasing CD8+ T-cell density and reducing suppressive cells like M2 macrophages.

Both vaccines, developed using IO Biotech's T-win® platform, showed promising results in reshaping the tumor microenvironment to enhance anti-tumor immunity.

IO Biotech (IOBT) announced the acceptance of two abstracts for presentation at the 2025 AACR Annual Meeting in Chicago. The presentations will showcase new non-clinical data for their cancer vaccine candidates:

1. Data demonstrating how IO102-IO103, their lead candidate currently in Phase 3 trials for advanced melanoma, controls tumor growth through target-specific T-cell activation.

2. Preclinical data for IO170, their pipeline candidate targeting TGF-beta, showing promising antitumor activity.

Additionally, Dr. Mads Hald Andersen, the company's scientific co-founder, will chair and speak at an educational session on cancer vaccines, exploring the latest advances in cancer vaccine research.

IO Biotech (Nasdaq: IOBT) has been recognized as the 9th most innovative company in biotechnology on Fast Company's World's Most Innovative Companies of 2025 list. The clinical-stage biopharmaceutical company earned this distinction for its innovative approach to immune-modulatory cancer vaccines.

The company's T-win® platform develops off-the-shelf therapeutic cancer vaccines designed to target and kill both tumor cells and immune-suppressive cells in the tumor microenvironment. Their lead candidate, Cylembio®, is currently in:

• A global Phase 3 trial for advanced melanoma with primary endpoint readout expected in Q3 2025
• Phase 2 trials combining with pembrolizumab for non-small cell lung cancer and head and neck cancer
• Phase 2 trials as neoadjuvant and adjuvant treatment for resectable melanoma and head and neck cancer

The recognition by Fast Company highlights IO Biotech's potential to transform the oncology treatment paradigm with products designed to be available at diagnosis.

IO Biotech (IOBT) reported key developments in Q4 2024 for its therapeutic cancer vaccine Cylembio®. The company's pivotal Phase 3 trial completed enrollment ahead of schedule with 407 patients, with primary endpoint readout expected in Q3 2025. A Biologics License Application (BLA) submission to FDA is planned by year-end 2025.

The company's Phase 2 basket trial for resectable melanoma and head and neck cancer completed enrollment with 95 patients, with initial data expected in H2 2025. The Phase 2 trial IOB-022/KN-D38 met its primary endpoint of overall response rate in head and neck cancer, with promising activity in lung cancer treatment.

Financial position shows $60.0 million in cash and equivalents at Q4 2024 end, supplemented by up to €57.5 million in EIB debt financing. The committed tranches are expected to extend cash runway into Q2 2026.