Full Press Release Details
IO Biotech Announces 2022 Fourth-Quarter and Year-End Results
New York, NY March 14, 2023: IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel,
immune-modulating cancer vaccines based on its T-win technology platform, today announced financial results for the fourth quarter and year-ended
December 31, 2022. The company continues to advance its lead cancer vaccine candidate, IO102-IO103, with two company-sponsored clinical studies currently recruiting, as well as five investigator-initiated trials contracted with leading cancer
institutions in the United States and Europe.
We continue to build on the progress made in 2022, advancing development of IO102-IO103, our novel,
investigational immune-modulating cancer vaccine, across multiple programs, said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. In our global Phase 3 pivotal trial for patients with
advanced melanoma, the positive enrollment trends we observed at the end of last year have continued, putting us on track to reach 75% enrollment in this trial by mid-2023. The study protocol calls for an
interim analysis of overall response rate one year after 75% of patients have been randomized. If these data are supportive, we could then prepare and submit a Biologics License Application for accelerated approval in the US.
Dr. Zocca continued, For the balance of 2023, we remain keenly focused on executing on the development of IO102-IO103 through both our own clinical
trials as well as the five investigator-initiated trials currently underway in the United States and Europe. I am very excited that we are working with Memorial Sloan Kettering Cancer Center on a trial that may provide additional data to help
position IO102-IO103 as the potential backbone of combination therapy for patients with melanoma. Our balance sheet is strong and we expect our cash runway to be sufficient to carry us through the third quarter of 2024.
Highlights for Fourth Quarter 2022 and Recent Weeks
Fourth Quarter and Year End 2022 Financial Results
IO102-IO103 is an investigational
immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and
IOB-013/KN-D18 Phase 3 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized
Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment
is 300 patients from centers spread across the United States, Europe, Australia, Israel and South Africa. 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.
IOB-022/KN-D38 Phase 2 Solid Tumor Basket Study
IOB-022/KN-D38 is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with
pembrolizumab in each of the following first-line indications: non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (UBC). The clinical trial
is sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its
T-win vaccine platform. The T-win platform is a novel approach to cancer vaccines designed to activate T cells
to target the most important immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing in clinical studies its lead cancer vaccine candidate, IO102-IO103, targeting IDO and PD-L1, and
through preclinical development its other pipeline candidates. 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 analysis of our 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.
| Company Contact: | Investor Contact: | |
| Amy Sullivan, Chief Financial Officer | Corey Davis, Ph.D., LifeSci Advisors | |
| IO Biotech, Inc. | 212-915-2577 | |
| asu@iobiotech.com | cdavis@lifesciadvisors.com |
Condensed 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, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 14,433 | $ | 16,440 | $ | 46,986 | $ | 30,152 | ||||||||
| General and administrative | 5,955 | 4,955 | 24,438 | 11,082 | ||||||||||||
| Total operating expenses | 20,388 | 21,395 | 71,424 | 41,234 | ||||||||||||
| Loss from operations | (20,388 | ) | (21,395 | ) | (71,424 | ) | (41,234 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Currency exchange gain, net | 521 | 10 | 130 | 319 | ||||||||||||
| Interest income | 782 | 4 | 1,411 | |||||||||||||
| Interest expense | (155 | ) | (302 | ) | (361 | ) | ||||||||||
| Fair value adjustments on preference shares tranche obligations | 295 | (26,535 | ) | |||||||||||||
| Total other income (expense), net | 1,303 | 154 | 1,239 | (26,577 | ) | |||||||||||
| Loss before income tax expense | (19,085 | ) | (21,241 | ) | (70,185 | ) | (67,811 | ) | ||||||||
| Income tax expense | 987 | 69 | 1,273 | 68 | ||||||||||||
| Net loss | (20,072 | ) | (21,310 | ) | (71,458 | ) | (67,879 | ) | ||||||||
| Cumulative dividends on class B and C preference shares | (1,102 | ) | (7,108 | ) | ||||||||||||
| Net loss attributable to common shareholders | (20,072 | ) | (22,412 | ) | (71,458 | ) | (74,987 | ) | ||||||||
| Net loss per common share, basic and diluted | $ | (0.70 | ) | $ | (1.34 | ) | $ | (2.48 | ) | $ | (17.30 | ) | ||||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 28,815,267 | 16,675,317 | 28,815,267 | 4,335,629 | ||||||||||||
| Other comprehensive loss | ||||||||||||||||
| Net loss | (20,072 | ) | (21,310 | ) | (71,458 | ) | (67,879 | ) | ||||||||
| Foreign currency translation | 3,775 | (2,192 | ) | (8,652 | ) | (3,450 | ) | |||||||||
| Total comprehensive loss | (16,297 | ) | (23,502 | ) | (80,110 | ) | (71,329 | ) |
Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share amounts)
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 142,590 | $ | 211,531 | ||||
| Prepaid expenses and other current assets | 5,629 | 10,207 | ||||||
| Total current assets | 148,219 | 221,738 | ||||||
| Restricted cash | 268 | 268 | ||||||
| Property and equipment, net | 741 | 155 | ||||||
| Right of use lease asset | 2,493 | |||||||
| Other non-current assets | 84 | 127 | ||||||
| Total non-current assets | 3,586 | 550 | ||||||
| Total assets | $ | 151,805 | $ | 222,288 | ||||
| Liabilities, convertible preference shares and stockholders equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 4,004 | $ | 3,928 | ||||
| Lease liability current | 515 | |||||||
| Accrued expenses and other current liabilities | 6,157 | 6,377 | ||||||
| Total current liabilities | 10,676 | 10,305 | ||||||
| Lease liability noncurrent | 2,275 | |||||||
| Other long-term liabilities | 59 | |||||||
| Total non-current liabilities | 2,275 | 59 | ||||||
| Total liabilities | 12,951 | 10,364 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preference shares | ||||||||
| 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, 2022 and 2021 | ||||||||
| Common stock, par value of $0.001 per share; 300,000,000 shares authorized, 28,815,267 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively | 29 | 29 | ||||||
| Additional paid-in capital | 326,705 | 319,665 | ||||||
| Accumulated deficit | (177,739 | ) | (106,281 | ) | ||||
| Accumulated other comprehensive loss | (10,141 | ) | (1,489 | ) | ||||
| Total stockholders equity | 138,854 | 211,924 | ||||||
| Total liabilities, convertible preference shares and stockholders equity | $ | 151,805 | $ | 222,288 |