Full Press Release Details
IO Biotech Announces Third Quarter Results for 2022
November 9, 2022: IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, announced today financial results for the quarter ending September 30, 2022.
During the last three months, we have made significant progress with the activation of clinical sites participating in our global Phase 3 combination
trial of IOB102-IO103 with pembrolizumab as a potential first-line treatment in advanced melanoma, said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. We ended October
with 55 sites actively enrolling in study, compared to 19 actively enrolling sites at the end of July. We view the pace of site activation as a leading indicator of patient enrollment, and we are very pleased with our progress.
Dr. Zocca continued, Additionally, enrollment in our second ongoing clinical study, the Phase 2 basket trial of IO102-IO103 in combination with
pembrolizumab, is progressing nicely and we continue to expect to receive preliminary data in one indication this quarter with additional data in 2023. We believe that our T-win platform and its novel approach to activate naturally occurring T cells to target immunosuppressive mechanisms has the potential to benefit patients in need of more treatment options
and look forward to reporting our progress in the coming months.
Highlights for Third Quarter 2022 and Recent Weeks
Third Quarter Financial Results
About the IOB-013/KN-D18 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
will be 300 patients from centers spread across Europe, Australia, and the United States. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global
commercial rights to IO102-IO103.
About IOB-022/KN-D38
IOB-022/KN-D38 is a non-comparative,
open label Phase 2 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, squamous cell carcinoma of the head and neck, and
metastatic urothelial bladder cancer. The clinical trial will be sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.
IO102-IO103 is an investigational
cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its
T-win technology platform. The T-win platform is a
novel approach to cancer immunotherapy designed to activate naturally occurring T cells to target immunosuppressive mechanisms. IO Biotech is advancing in clinical studies its lead immuno-oncology 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 future clinical
trials, trials results and clinical site activation, 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.
Chief Financial Officer
LifeSci Communications
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 10,022 | $ | 4,128 | $ | 32,553 | $ | 13,712 | ||||||||
| General and administrative | 5,843 | 2,914 | 18,482 | 6,127 | ||||||||||||
| Total operating expenses | 15,865 | 7,042 | 51,035 | 19,839 | ||||||||||||
| Loss from operations | (15,865 | ) | (7,042 | ) | (51,035 | ) | (19,839 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Currency exchange (loss) gain, net | (87 | ) | 17 | (392 | ) | 309 | ||||||||||
| Interest income | 457 | 631 | ||||||||||||||
| Interest expense | (78 | ) | (67 | ) | (305 | ) | (210 | ) | ||||||||
| Fair value adjustments on preference shares tranche obligations | 2,630 | (26,830 | ) | |||||||||||||
| Total other income (expense), net | 292 | 2,580 | (66 | ) | (26,731 | ) | ||||||||||
| Loss before income tax expense | (15,573 | ) | (4,462 | ) | (51,101 | ) | (46,570 | ) | ||||||||
| Income tax expense | 115 | 286 | ||||||||||||||
| Net loss | (15,688 | ) | (4,462 | ) | (51,387 | ) | (46,570 | ) | ||||||||
| Cumulative dividends on class B and C preference shares | (2,073 | ) | (6,006 | ) | ||||||||||||
| Net loss attributable to common shareholders | (15,688 | ) | (6,535 | ) | (51,387 | ) | (52,576 | ) | ||||||||
| Net loss per common share, basic and diluted | $ | (0.54 | ) | $ | (36.88 | ) | $ | (1.78 | ) | $ | (296.70 | ) | ||||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 28,815,267 | 177,200 | 28,815,267 | 177,200 | ||||||||||||
| Other comprehensive loss | ||||||||||||||||
| Net loss | (15,688 | ) | (4,462 | ) | (51,387 | ) | (46,570 | ) | ||||||||
| Foreign currency translation | (5,400 | ) | (681 | ) | (12,427 | ) | (1,256 | ) | ||||||||
| Total comprehensive loss | (21,088 | ) | (5,143 | ) | (63,814 | ) | (47,826 | ) |
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| September 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 151,168 | $ | 211,531 | ||||
| Prepaid expenses and other current assets | 6,583 | 10,207 | ||||||
| Total current assets | 157,751 | 221,738 | ||||||
| Restricted cash | 268 | 268 | ||||||
| Property and equipment, net | 640 | 155 | ||||||
| Right of use lease asset | 2,612 | |||||||
| Noncurrent assets | 886 | 127 | ||||||
| Total assets | $ | 162,157 | $ | 222,288 | ||||
| Liabilities, convertible preference shares and stockholders equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,345 | $ | 3,928 | ||||
| Lease liability current | 492 | |||||||
| Accrued expenses and other current liabilities | 3,484 | 6,377 | ||||||
| Total current liabilities | 6,321 | 10,305 | ||||||
| Lease liability noncurrent | 2,347 | |||||||
| Other long-term liabilities | 59 | |||||||
| Total liabilities | 8,668 | 10,364 | ||||||
| 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 September 30, 2022 and December 31, 2021 | ||||||||
| Common stock, par value of $0.001 per share; 300,000,000 shares authorized, 28,815,267 shares issued and outstanding as of September 30, 2022 and December 31, 2021 | 29 | 29 | ||||||
| Additional paid-in capital | 325,044 | 319,665 | ||||||
| Accumulated deficit | (157,668 | ) | (106,281 | ) | ||||
| Accumulated other comprehensive loss | (13,916 | ) | (1,489 | ) | ||||
| Total stockholders equity | 153,489 | 211,924 | ||||||
| Total liabilities, convertible preference shares and stockholders equity | $ | 162,157 | $ | 222,288 |