Earnings summaries and quarterly performance for IO Biotech.
Executive leadership at IO Biotech.
Board of directors at IO Biotech.
Research analysts covering IO Biotech.
Recent press releases and 8-K filings for IOBT.
IO Biotech Engages Financial Advisor and Announces Workforce Reduction
IOBT
Layoffs
Management Change
M&A
- IO Biotech has retained Raymond James & Associates, Inc. as its exclusive financial advisor to assist in the exploration of strategic alternatives.
- The company is implementing cost-containment and cash conservation measures, including a significant reduction of its workforce globally.
- In connection with the workforce reduction, IO Biotech expects to incur one-time charges and cash expenditures in a range of approximately $2.4 million to $2.6 million, primarily during the first quarter of 2026.
- Qasim Ahmad, M.D., the Chief Medical Officer, will depart the company effective February 15, 2026.
7 days ago
IO Biotech Engages Financial Advisor and Implements Workforce Reduction
IOBT
M&A
Layoffs
- IO Biotech has retained Raymond James & Associates, Inc. as its exclusive financial advisor to assist in the previously announced exploration of strategic alternatives.
- The company is implementing cost-containment and cash conservation measures, including a significant reduction of its workforce, to reduce operating expenses while exploring strategic alternatives.
8 days ago
IO Biotech Explores Strategic Alternatives
IOBT
M&A
Layoffs
- IO Biotech is exploring a range of strategic alternatives to maximize stockholder value, which may include a merger, a business combination, a sale of assets, or a liquidation and dissolution.
- The company is also evaluating a further reduction-in-force and other efforts to significantly reduce operating expenses.
- No timetable has been established for the completion of this process, and there are no assurances that any transaction will be pursued or completed on attractive terms.
Jan 21, 2026, 10:30 AM
IO Biotech Provides Updates on Clinical Trials, Regulatory Path, and Financial Position
IOBT
New Projects/Investments
Guidance Update
- IO Biotech's lead program, IO102-IO103, in combination with pembrolizumab, demonstrated clinically meaningful results in its Phase III trial for first-line metastatic melanoma, with a hazard ratio in PFS of 0.77 and median PFS of 19.4 months versus 11 months in the control arm; however, the FDA recommended against BLA submission due to a "slight miss" on the p-value for statistical significance.
- In response to FDA feedback and the evolving standard of care, IO Biotech is proposing a new global adaptive Phase II/III clinical trial for IO102-IO103 in combination with Opdualag for first-line advanced melanoma.
- The company plans to discuss the pivotal study data with EU regulators for a potential MAA submission, guided for 2026, with feedback expected within the next couple of months.
- IO Biotech ended the third quarter with just over $30 million in cash, providing a cash runway through Q1 2026, and plans to raise capital in the coming months.
Dec 3, 2025, 8:00 PM
IO Biotech Provides Update on Melanoma Program and Financial Position
IOBT
Guidance Update
New Projects/Investments
- IO Biotech's Phase 3 trial for its lead program, IO102-IO103, in combination with Pembro for first-line metastatic melanoma patients, demonstrated a hazard ratio in PFS of 0.77 and a median PFS of 19.4 months versus 11 months in the control arm, but a "slight miss on the primary endpoint" due to the P-value led the FDA to recommend against a BLA submission.
- The company is now planning a new global adaptive Phase 2-3 clinical trial evaluating IO102-IO103 in combination with Opdualag in first-line advanced melanoma, a design influenced by FDA discussions and an investigator-initiated trial.
- Discussions are underway with EU regulators for a potential MAA submission in 2026, with the company believing EU guidelines may allow for filing in certain subgroups despite the FDA's recommendation.
- IO Biotech ended Q3 with just over $30 million (almost $31 million) in cash, providing a runway through Q1 2026, and intends to raise capital in the next few months to support the upcoming Phase 3 trial.
Dec 3, 2025, 8:00 PM
IO Biotech Discusses Phase 3 Melanoma Trial Results and Future Plans
IOBT
New Projects/Investments
Product Launch
- IO Biotech's lead product, Xylembio (IO-102, IO-103), in combination with pembrolizumab, achieved a hazard ratio of 0.77 or 0.76 in progression-free survival (PFS) in its Phase 3 trial for melanoma, despite a narrow miss on the P-value.
- The company observed a dramatic effect in the PD-L1 negative subgroup, showing over 16 months median PFS in the experimental arm compared to 3 months in the control arm.
- IO Biotech plans a new, larger Phase 3 trial, estimated to enroll 550 to 800 patients, with a futility sample size reassessment after the first 400 patients are enrolled and 150 PFS events are hit.
- The company has cash until the end of the first quarter and will seek to raise "a couple of hundred million" to fund the new Phase 3 study after aligning with the FDA on the trial design.
- IO Biotech is also engaging with the EMA, expecting feedback in some months, and if positive, plans to seek a European partner for non-dilutive capital.
Dec 2, 2025, 12:55 PM
IO Biotech Outlines Path Forward for Xylembio After Phase 3 Miss and Discusses Funding
IOBT
New Projects/Investments
Guidance Update
Product Launch
- IO Biotech's lead product, Xylembio (IO-102, IO-103), in combination with pembrolizumab, achieved a hazard ratio of 0.77 or 0.76 in progression-free survival (PFS) in its recently completed Phase 3 trial, but narrowly missed its P-value target.
- A notable outcome from the trial was a dramatic effect in the PD-L1 negative subgroup, where the experimental arm showed a median PFS above 16 months compared to 3 months in the control arm.
- Following feedback from the FDA, IO Biotech plans a new Phase 3 trial for Xylembio, expected to enroll between 550 and 800 patients, likely comparing its therapy in combination with Opdualag against Opdualag alone.
- The company has cash to fund operations until the end of Q1 2026 and anticipates needing a couple of hundred million dollars to fund the new Phase 3 study, with potential non-dilutive capital from a European partnership if EMA discussions are favorable.
Dec 2, 2025, 12:55 PM
IO Biotech Discusses Phase III Trial Results and Future Development Plans
IOBT
New Projects/Investments
Guidance Update
- IO Biotech's lead product, Cylembio IO-102/IO-103, in combination with pembrolizumab, narrowly missed its primary endpoint (P-value) in a Phase III trial, despite demonstrating a progression-free survival (PFS) hazard ratio of 0.77 or 0.76.
- A significant effect was observed in the PD-L1 negative subgroup, where patients treated with the experimental arm achieved over 16 months median PFS compared to three months in the control arm.
- The FDA requires another study, leading IO Biotech to plan a larger Phase III trial, expected to enroll 550 to 800 patients and cost a couple of hundred million dollars.
- The company has cash until the end of the first quarter and intends to raise capital to fund the new Phase III study.
- IO Biotech is also engaging with the EMA, and a positive outcome could lead to a European partnership to generate non-dilutive capital.
Dec 2, 2025, 12:55 PM
IO Biotech Provides Update on Xylemio Phase 3 Trial Results and Future Development Plans
IOBT
New Projects/Investments
Guidance Update
- IO Biotech's lead product candidate, Xylemio (IO-102, IO-103), in combination with pembrolizumab, achieved a 19.4 month median PFS in its Phase 3 trial for first-line metastatic melanoma, compared to 11 months in the control arm, but narrowly missed statistical significance with a P-value of 0.056 against a target of 0.045.
- Following discussions with the FDA, the company is planning a new Phase 3 trial combining Xylemio with Opdivo, which is becoming the standard of care in the US metastatic melanoma market.
- Discussions are ongoing with European authorities (EMA) for a potential submission based on the existing Phase 3 data, as European guidelines may offer a different pathway.
- Encouraging data was also reported from basket trials for Xylemio in combination with pembrolizumab, showing an Overall Response Rate (ORR) of 44.4% and median PFS of 6.6 months in head and neck cancer, and an unconfirmed ORR of 55% (confirmed 48%) and median PFS of 8.1 months in lung cancer.
- The company is also developing new targets from its TWIN platform, including IO-122 (targeting Arginase 1) and IO-170 (targeting TGF-β), with an IND for IO-122 planned for 2026.
Nov 18, 2025, 3:00 PM
IO Biotech Provides Update on Xylemio Phase 3 Results and Future Development Plans
IOBT
New Projects/Investments
Guidance Update
- IO Biotech's lead product candidate, Xylemio (IO-102, IO-103), in combination with pembrolizumab, achieved a median PFS of 19.4 months versus 11 months in its Phase 3 trial (IOB-013) for first-line metastatic melanoma, but narrowly missed statistical significance with a P-value of 0.056.
- The company is planning a new global Phase 3 trial (IOB-023) combining Xylemio with Opdivo for first-line metastatic melanoma, following discussions with the FDA. This trial will stratify patients by PD-1 status and prior anti-PD-1 treatment, with an expected enrollment of 550 to 800 patients.
- Discussions are ongoing with European authorities (EMA) for a potential Marketing Authorization Application (MAA) submission in Europe based on the existing Phase 3 data, with an indication expected by early 2026.
- Encouraging data for Xylemio were also reported in first-line head and neck cancer (ORR 44.4%, median PFS 6.6 months) and lung cancer (confirmed ORR 48%, median PFS 8.1 months) from a basket trial (IOB-022).
- IO Biotech plans an Investigational New Drug (IND) application for IO-122 (Arginase 1), a new target from its TWIN platform, in 2026.
Nov 18, 2025, 3:00 PM
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