NEW YORK, August 14, 2025 — Leads & Copy — IO Biotech (Nasdaq: IOBT) announced clinical improvement in progression free survival in a pivotal Phase 3 trial of Cylembio® plus KEYTRUDA® for first-line advanced melanoma treatment, though statistical significance was narrowly missed. The company plans to meet with the FDA this fall to discuss data and potential regulatory submission steps. The second quarter ended with approximately $28.1 million in cash; together with €12.5 million from the European Investment Bank loan received on July 4, 2025, funding is expected to continue into the first quarter of 2026. Corporate presentations are scheduled for the Morgan Stanley 23rd Annual Global Healthcare Conference on Sept. 9, 2025, and the H.C. Wainwright 27th Annual Global Investment Conference on Sept. 10, 2025.
Mai-Britt Zocca, PhD, President and CEO of IO Biotech, noted the achievement of a significant milestone with the Phase 3 trial readout for Cylembio. The company is focused on discussing the results with the FDA and determining the next steps for a potential submission of a Biologics License Application (BLA) for the treatment of advanced melanoma, citing the notable safety profile and clinical improvement observed.
The Phase 3 trial (IOB-013/KN-D18) evaluated Cylembio® (imsapepimut and etimupepimut, adjuvanted) with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for advanced melanoma treatment. The trial included 407 patients, comparing Cylembio plus pembrolizumab vs. pembrolizumab alone. While Cylembio plus pembrolizumab showed clinical improvement in progression-free survival (PFS), statistical significance was narrowly missed.
The company anticipates initial data from the perioperative Phase 2 solid tumor basket trial (IOB-032/PN-E40) and longer-term data from the Phase 2 basket trial IOB-022/KN-D38 in the second half of 2025, with presentations planned for a medical meeting in 2026.
Upcoming Investor Conferences Participation:
Morgan Stanley 23rd Annual Global Healthcare Conference: Mai-Britt Zocca, PhD, President and CEO, Amy Sullivan, CFO, and Qasim Ahmad, MD, CMO, will participate in a fireside chat beginning at 7:45 AM ET on September 9, 2025.
H.C. Wainwright 27th Annual Global Investment Conference: Mai-Britt Zocca, PhD, President and CEO, will give a company presentation beginning at 8:00 AM ET on September 10, 2025.
The webcasts for these two upcoming conferences will be available from the Investors section of the company’s website at https://investors.iobiotech.com.
Net loss for the three months ended June 30, 2025, was $26.2 million, compared to $20.7 million for the three months ended June 30, 2024.
Cash and cash equivalents as of June 30, 2025 were $28.1 million, compared to $60.0 million at December 31, 2024.
Contact:
Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com
Source: IO Biotech
