IO Biotech

IOBT

Market cap $43.2M

Always be cautious before investing in a penny stock. While some will turn out to be explosive winners, like Advanced Micro Devices, others turn out to be expensive duds.

FDA recommends that IO Biotech not submit a Biologics License Application (BLA) based on the data from the IOB-013 clinical trial Company plans to design new registrational study for Cylembio for the treatment of first-line patients with advanced melanoma Company implementing a restructuring, reducing its workforce by approximately 50 percent NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today provided an update on the regulatory pathway for Cylembio® (imsapepimut and etimupepimut, adjuvanted) following a pre-BLA meeting with the U.S. Food and Drug Administration (FDA).

Oral presentation will highlight the results from the randomized Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 cancer vaccine plus pembrolizumab for first-line (1L) advanced melanoma Poster presentation will share final data from Phase 2 basket trial (IOB-022/KN-D38) of IO102-IO103 cancer vaccine plus pembrolizumab for 1L treatment of solid tumors NEW YORK, Sept. 23, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announces a late-breaking abstract has been accepted and selected as a Proffered Paper oral presentation at the 2025 European Society for Medical Oncology (ESMO) Congress taking place in Berlin, Germany from October 17-21, 2025.

IO Biotech, Inc. (NASDAQ:IOBT ) Morgan Stanley 23rd Annual Global Healthcare Conference September 9, 2025 7:45 AM EDT Company Participants Mai-Britt Zocca - Founder, President, CEO, Principal Financial Officer & Director Qasim Ahmad - Chief Medical Officer Amy Sullivan - Chief Financial Officer Conference Call Participants Michael Ulz - Morgan Stanley, Research Division Presentation Michael Ulz Equity Analyst All right. Good morning, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference.

NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, announced today that members of its senior management team will provide a corporate update and participate in one-on-one meetings at the following upcoming investor conferences: Event: Morgan Stanley 23rd Annual Global Healthcare ConferenceLocation: New York, New YorkFireside Chat Date & Time: Tuesday, September 9, 2025 at 7:45 am ETPresenters: Mai-Britt Zocca, PhD, President and CEO, Amy Sullivan, CFO, and Qasim Ahmad, MD, CMOWebcast Link: Here Event: H.C.

IO Biotech, Inc. (IOBT) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Announced clinical improvement in progression free survival observed in pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (pembrolizumab) for the treatment of first-line advanced melanoma, but statistical significance narrowly missed; company plans to meet with FDA this fall to discuss data and next steps for a potential regulatory submission Ended second quarter with approximately $28.1 million in cash and cash equivalents; the company expects that our cash position, together with €12.5 million in proceeds from the second tranche of the European Investment Bank (EIB) loan facility received on July 4, 2025, will be sufficient to continue funding our operations into the first quarter of 2026 Corporate presentations are planned for the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, and the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025 NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today reported financial results and business highlights for the second quarter of 2025.

IO Biotech's phase 3 melanoma trial showed a strong PFS benefit, especially in true 1st-line and PD1-negative patients, despite narrowly missing statistical significance. I believe the FDA should accept a submission based on these compelling, double-blind, randomized trial results, which show consistent benefits across subgroups. Key risks include potential FDA rejection, a dilutive cash raise, and limited US patient enrollment, but upcoming catalysts could strengthen IOBT's position.

IO Biotech said on Monday its experimental cancer vaccine, in combination with Merck's Keytruda, showed improvement in a late-stage study goal, but was not statistically significant.

Patients treated with Cylembio (imsapepimut and etimupepimut, adjuvanted) plus pembrolizumab achieved improvement in progression free survival (PFS) compared to patients treated with pembrolizumab monotherapy, HR=0.77 (CI 0.58-1.00), (p=0.056), with median PFS (mPFS) of 19.4 months vs. 11.0 months, respectively; the results on the primary endpoint narrowly missed the study's statistical significance threshold of p≤0.045 In patients enrolled in this study without prior neo-adjuvant/adjuvant anti-PD-1 treatment (n=371), patients treated with Cylembio plus pembrolizumab achieved improvement in PFS, HR: 0.74 (CI 0.56-0.98) (nominal p=0.037), with mPFS of 24.8 months vs.