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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.
“In the second quarter, we achieved a significant milestone advancing our pipeline of novel cancer therapies with the readout of the topline results of the Phase 3 trial for Cylembio, our potentially first-in-class, immune-modulatory, off-the-shelf therapeutic cancer vaccine, being investigated in advanced melanoma,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “With the notable safety profile and clinical improvement observed in this trial, we are 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.”
Recent Business Highlights
Upcoming Investor Conferences Participation
The webcasts for these two upcoming conferences will be available from the Investors section of the company’s website at https://investors.iobiotech.com.
Second Quarter 2025 Financial Results
About Cylembio®
Cylembio® (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is now complete.
The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio.
Cylembio® is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada).
About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial
IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.
About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial
IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) or metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.
About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial
IOB-032/PN-E40 (NCT05280314) is a multicenter Phase 2 basket trial investigating Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) as neo-adjuvant/adjuvant treatment of patients with solid tumors at sites in Australia, the United States, France, Germany, Spain, and Denmark. The study completed enrollment in all cohorts: 18 patients with melanoma in cohort A and 16 patients with SCCHN in cohort B, both as single arm cohorts receiving combination of Cylembio with pembrolizumab. In cohort C, 61 melanoma patients were randomized 1:1 to either the combination of Cylembio with pembrolizumab or pembrolizumab alone. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery (≤10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio®, in clinical trials, and additional pipeline candidates through preclinical development. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.
For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including statements regarding the timing or outcome of communications with regulatory authorities including the FDA, the timing or outcome of the submission of marketing applications, including a BLA, for Cylembio, the timing or outcome of the launch of Cylembio, and statements regarding other current or future clinical trials, their timing, progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Contact:
Investors
Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
[email protected]
Media
Julie Funesti
Edelman
917-498-1967
[email protected]
| IO BIOTECH, INC. Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 16,652 | $ | 15,848 | $ | 33,027 | $ | 30,159 | ||||||||
| General and administrative | 6,518 | 5,685 | 12,727 | 11,571 | ||||||||||||
| Total operating expenses | 23,170 | 21,533 | 45,754 | 41,730 | ||||||||||||
| Loss from operations | (23,170 | ) | (21,533 | ) | (45,754 | ) | (41,730 | ) | ||||||||
| Other (expense) income | ||||||||||||||||
| Currency exchange loss, net | (374 | ) | (90 | ) | (479 | ) | (552 | ) | ||||||||
| Interest income | 285 | 1,311 | 699 | 2,928 | ||||||||||||
| Interest expense | (253 | ) | — | (253 | ) | — | ||||||||||
| Change in fair value of warrants | (2,587 | ) | — | (2,587 | ) | — | ||||||||||
| Total other (expense) income, net | (2,929 | ) | 1,221 | (2,620 | ) | 2,376 | ||||||||||
| Loss before income tax expense | (26,099 | ) | (20,312 | ) | (48,374 | ) | (39,354 | ) | ||||||||
| Income tax expense | 118 | 374 | 264 | 789 | ||||||||||||
| Net loss | (26,217 | ) | (20,686 | ) | (48,638 | ) | (40,143 | ) | ||||||||
| Net loss attributable to common shareholders | (26,217 | ) | (20,686 | ) | (48,638 | ) | (40,143 | ) | ||||||||
| Net loss per common share, basic and diluted | $ | (0.40 | ) | $ | (0.31 | ) | $ | (0.74 | ) | $ | (0.61 | ) | ||||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 65,880,914 | 65,880,914 | 65,880,914 | 65,880,914 | ||||||||||||
| Other comprehensive loss | ||||||||||||||||
| Net loss | $ | (26,217 | ) | $ | (20,686 | ) | $ | (48,638 | ) | $ | (40,143 | ) | ||||
| Foreign currency translation | (220 | ) | (151 | ) | 39 | 43 | ||||||||||
| Total comprehensive loss | $ | (26,437 | ) | $ | (20,837 | ) | $ | (48,599 | ) | $ | (40,100 | ) | ||||
| IO BIOTECH, INC. Consolidated Balance Sheets (In thousands, except share and per share amounts) (unaudited) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 28,131 | $ | 60,031 | ||||
| Prepaid expenses and other current assets | 10,849 | 4,920 | ||||||
| Total current assets | 38,980 | 64,951 | ||||||
| Restricted cash | 268 | 268 | ||||||
| Property and equipment, net | 603 | 638 | ||||||
| Right of use lease asset | 1,470 | 1,725 | ||||||
| Other non-current assets | 1,005 | 117 | ||||||
| Total non-current assets | 3,346 | 2,748 | ||||||
| Total assets | $ | 42,326 | $ | 67,699 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 5,537 | $ | 4,661 | ||||
| Lease liability - current | 768 | 717 | ||||||
| Accrued expenses and other current liabilities | 13,592 | 14,108 | ||||||
| Total current liabilities | 19,897 | 19,486 | ||||||
| Lease liability - non-current | 868 | 1,198 | ||||||
| Term loan debt, net | 6,720 | — | ||||||
| Common stock warrants | 13,249 | — | ||||||
| Total non-current liabilities | 20,837 | 1,198 | ||||||
| Total liabilities | 40,734 | 20,684 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of June 30, 2025 and December 31, 2024 | — | — | ||||||
| Common stock, par value of $0.001 per share; 300,000,000 shares authorized at June 30, 2025 and December 31, 2024; 65,880,914 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | 66 | 66 | ||||||
| Additional paid-in capital | 416,289 | 413,113 | ||||||
| Accumulated deficit | (407,951 | ) | (359,313 | ) | ||||
| Accumulated other comprehensive loss | (6,812 | ) | (6,851 | ) | ||||
| Total stockholders’ equity | 1,592 | 47,015 | ||||||
| Total liabilities and stockholders’ equity | $ | 42,326 | $ | 67,699 | ||||
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