Full Press Release Details
IO Biotech Announces First Quarter Results for 2022
Updated Data from Phase 1/2 study of IO102-IO103 in Combination with Nivolumab Showing High Response Rates in Metastatic Melanoma
Presented at AACR in April
Announced initiation and dosing of first patient in Phase 2 Trial of IOB102-IOB103 in
combination with KEYTRUDA (pembrolizumab) as first line treatment in multi-arm basket trial
Strong Balance Sheet with ~$188 million Cash Runway to Support Multiple Data readouts into
New York, New York May 16, 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 ended March 31, 2022.
During our first quarter and in recent weeks we continued to advance our promising
pipeline of immune-modulating cancer therapies, highlighted by the initiation of our IOB-022 / KN-D38 Phase 2 Trial, said
Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. This trial will evaluate IOB102-103 with KEYTRUDA (pembrolizumab) in previously untreated patients with three different tumor types in the first line setting, and we look forward to expanding our data set in these additional indications. We were
also pleased to see the presentation of updated efficacy data and subgroup analyses from our MM1636 Phase 1/2 clinical trial evaluating IO102-IO103 as investigational agents in metastatic melanoma at the AACR annual meeting in April. These data
further demonstrate the three-year survival probability of 73% for 3% for IO102-IO103 in combination with nivolumab for these patients, and we are encouraged by the clinical activity demonstrated in this trial. As previously disclosed, we expect to
provide guidance regarding the timing for the interim readout for our IOB-013/KN-D18 Phase 3 trial towards the middle of this year. We believe our platform and product
candidates may represent a paradigm shift in the management of cancer, and with a solid balance sheet we have a substantial cash runway to carry us through multiple data readouts into mid-2024.
Highlights for First Quarter 2022 and Recent Weeks
First 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 trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line indications: NSCLC, SCCHN, and mUBC. 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-dehydrogenase (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 clinical and preclinical development its other pipeline candidates. IO
Biotech is headquartered in Copenhagen, Denmark and has additional offices within the United States (New York, New York and Rockville, Maryland) and United Kingdom (Monmouthshire).
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, 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.
Mai-Britt Zocca, Ph.D.
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)
| For the Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 10,306 | $ | 2,848 | ||||
| General and administrative | 6,704 | 965 | ||||||
| Total operating expenses | 17,010 | 3,813 | ||||||
| Loss from operations | (17,010 | ) | (3,813 | ) | ||||
| Other income (expense) | ||||||||
| Currency exchange gain (loss), net | (20 | ) | 137 | |||||
| Interest income | 15 | |||||||
| Interest expense | (123 | ) | (72 | ) | ||||
| Total other income (expense), net | (128 | ) | 65 | |||||
| Loss before income tax expense | (17,138 | ) | (3,748 | ) | ||||
| Income tax expense | 66 | |||||||
| Net loss | (17,204 | ) | (3,748 | ) | ||||
| Cumulative dividends on class B and C preference shares | (1,839 | ) | ||||||
| Net loss attributable to common shareholders | (17,204 | ) | (5,587 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.60 | ) | $ | (31.53 | ) | ||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 28,815,267 | 177,200 | ||||||
| Other comprehensive loss | ||||||||
| Net loss | (17,204 | ) | (3,748 | ) | ||||
| Foreign currency translation | (2,647 | ) | (1,766 | ) | ||||
| Total comprehensive loss | (19,851 | ) | (5,514 | ) |
See accompanying notes to the financial statements.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| March 31, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 187,904 | $ | 211,531 | ||||
| Prepaid expenses and other current assets | 11,344 | 10,207 | ||||||
| Total current assets | 199,248 | 221,738 | ||||||
| Restricted cash | 268 | 268 | ||||||
| Property and equipment, net | 271 | 155 | ||||||
| Right of use lease asset | 2,248 | |||||||
| Noncurrent assets | 136 | 127 | ||||||
| Total assets | $ | 202,171 | $ | 222,288 | ||||
| Liabilities, convertible preference shares and stockholders equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,087 | $ | 3,928 | ||||
| Lease liability current | 345 | |||||||
| Accrued expenses and other current liabilities | 3,998 | 6,377 | ||||||
| Total current liabilities | 6,430 | 10,305 | ||||||
| Lease liability noncurrent | 2,048 | |||||||
| Other long-term liabilities | 59 | |||||||
| Total liabilities | 8,478 | 10,364 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| 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 March 31, 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 March 31, 2022 and December 31, 2021 | 29 | 29 | ||||||
| Additional paid-in capital | 321,285 | 319,665 | ||||||
| Accumulated deficit | (123,485 | ) | (106,281 | ) | ||||
| Accumulated other comprehensive loss | (4,136 | ) | (1,489 | ) | ||||
| Total stockholders equity | 193,693 | 211,924 | ||||||
| Total liabilities, convertible preference shares and stockholders equity | $ | 202,171 | $ | 222,288 |
See accompanying notes to the financial statements