Full Press Release Details
IO Biotech Announces 2023 Fourth-Quarter and Year-End Results
New York, NY March 5, 2024: IO Biotech (Nasdaq:
IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win platform, today
reported financial results for the fourth quarter and year-ended December 31, 2023.
In 2023, we reached a significant milestone in our pivotal
Phase 3 trial evaluating our lead therapeutic cancer vaccine, IO102-IO103, in combination with KEYTRUDA, completing enrollment in this trial in mid-November, said
Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. The acceleration in enrollment observed in this study in the second half of 2023 is a testament to the need that exists today for more efficacious
and better tolerated first-line treatment options for patients with advanced melanoma.
Dr. Zocca continued, The coming months will prove
to be a critical period in the development of IO Biotech, with the outcome of the pivotal Phase 3 interim analysis expected in the third quarter of 2024, and, more importantly, the primary endpoint of progression free survival estimated to follow in
the second half of 2025. Our team is dedicated to continuing our diligent work to efficiently bring IO102-IO103 to patients in need, potentially as early as 2025.
Fourth Quarter 2023 and other Recent Highlights
Fourth Quarter 2023 Financial Results
IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine
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 (IDO) and/or programmed
death-ligand 1 (PD-L1) cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254)
investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38;
NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial
(IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of
patients with solid tumors.
The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck and Merck is supplying
pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About the IOB-013/KN-D18
Pivotal Phase 3 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial of IO102-IO103 in
combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma, being conducted in collaboration with Merck. Patients have been enrolled from centers across the United
States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.
IO Biotech maintains global commercial rights to IO102-IO103.
About the IOB-013/KN-D18 Clinical Trial Endpoints
The primary endpoint of the IOB-013/KN-D18 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events
have occurred in the trial, which the company estimates will take place in the second half of 2025. Additionally, there is a planned per-protocol interim analysis of overall response rate when the first 225 randomized patients reach one year of
treatment in mid-2024. The outcome of this analysis is expected in the third quarter of 2024. There is a high statistical bar for the Phase 3 interim analysis (p 0.005), which was set to preserve most of the alpha for the primary endpoint of
PFS. Regardless of the outcome of the interim analysis, the trial is designed to continue to the primary PFS endpoint.
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating 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 the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase
1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered
in Copenhagen, Denmark and has US headquarters in New York, New York.
For further information, please visit www.iobiotech.com.
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 regarding the timing of the
interim and primary analyses of the company s Phase 3 trial, current or future clinical trials, their 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.
Maryann Cimino, Director of Investor Relations
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited in thousands, except share and per share amounts)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 21,770 | $ | 14,433 | $ | 67,829 | $ | 46,986 | ||||||||
| General and administrative | 6,413 | 5,955 | 23,614 | 24,438 | ||||||||||||
| Total operating expenses | 28,183 | 20,388 | 91,443 | 71,424 | ||||||||||||
| Loss from operations | (28,183 | ) | (20,388 | ) | (91,443 | ) | (71,424 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Currency exchange gain, net | 405 | 521 | 331 | 130 | ||||||||||||
| Interest income | 1,949 | 782 | 5,881 | 1,411 | ||||||||||||
| Interest expense | (302 | ) | ||||||||||||||
| Total other income (expense), net | 2,354 | 1,303 | 6,212 | 1,239 | ||||||||||||
| Loss before income tax expense | (25,829 | ) | (19,085 | ) | (85,231 | ) | (70,185 | ) | ||||||||
| Income tax expense | 353 | 987 | 852 | 1,273 | ||||||||||||
| Net loss | (26,182 | ) | (20,072 | ) | (86,083 | ) | (71,458 | ) | ||||||||
| Net loss attributable to common shareholders | (26,182 | ) | (20,072 | ) | (86,083 | ) | (71,458 | ) | ||||||||
| Net loss per common share, basic and diluted | $ | (0.40 | ) | $ | (0.70 | ) | $ | (1.98 | ) | $ | (2.48 | ) | ||||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 65,880,914 | 28,815,267 | 43,539,976 | 28,815,267 | ||||||||||||
| Other comprehensive (loss) income | ||||||||||||||||
| Net loss | $ | (26,182 | ) | $ | (20,072 | ) | $ | (86,083 | ) | $ | (71,458 | ) | ||||
| Foreign currency translation | 204 | 3,775 | 472 | (8,652 | ) | |||||||||||
| Total comprehensive loss | $ | (25,978 | ) | $ | (16,297 | ) | $ | (85,611 | ) | $ | (80,110 | ) |
Consolidated Balance Sheets
(Unaudited in thousands, except share and per share amounts)
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 143,193 | $ | 142,590 | ||||
| Prepaid expenses and other current assets | 4,062 | 5,629 | ||||||
| Total current assets | 147,255 | 148,219 | ||||||
| Restricted cash | 268 | 268 | ||||||
| Property and equipment, net | 847 | 741 | ||||||
| Right of use lease asset | 2,259 | 2,493 | ||||||
| Other non-current assets | 89 | 84 | ||||||
| Total non-current assets | 3,463 | 3,586 | ||||||
| Total assets | $ | 150,718 | $ | 151,805 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,878 | $ | 4,004 | ||||
| Lease liability - current | 655 | 515 | ||||||
| Accrued expenses and other current liabilities | 11,184 | 6,157 | ||||||
| Total current liabilities | 15,717 | 10,676 | ||||||
| Lease liability - non-current | 1,839 | 2,275 | ||||||
| Total non-current liabilities | 1,839 | 2,275 | ||||||
| Total liabilities | 17,556 | 12,951 | ||||||
| Stockholders equity | ||||||||
| Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of December 31, 2023 and 2022 | ||||||||
| Common stock, par value of $0.001 per share; 300,000,000 shares authorized at December 31, 2023 and December 31, 2022; 65,880,914 and 28,815,267 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively | 66 | 29 | ||||||
| Additional paid-in capital | 406,587 | 326,705 | ||||||
| Accumulated deficit | (263,822 | ) | (177,739 | ) | ||||
| Accumulated other comprehensive loss | (9,669 | ) | (10,141 | ) | ||||
| Total stockholders equity | 133,162 | 138,854 | ||||||
| Total liabilities and stockholders equity | $ | 150,718 | $ | 151,805 |