Full Press Release Details
IO Biotech Reports Second Quarter 2024 Financial Results and Provides Business Highlights
August 13, 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 second quarter ended June 30, 2024.
During the first half of this year, we ve continued to execute on our mission of developing breakthrough cancer vaccines that could potentially
change the treatment paradigm for people living with melanoma and other types of cancer, said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. We look forward to the planned interim analysis
of our pivotal Phase 3 trial in first-line advanced melanoma followed by the data readout of the primary endpoint of progression free survival (PFS) in the first half of next year. Strategically, we continue to prepare for a potential launch in 2025
if the interim analysis data supports accelerated approval in the US.
Dr. Zocca continued, We are also focused on progressing our Phase
2 studies of IO102-IO103 in other hard-to-treat cancers and earlier line of treatment in melanoma patient populations, and are excited to share new insights this fall on
the potential of IO102-IO103 in the first-line treatment of SCCHN and metastatic NSCLC.
Recent Business Highlights
Second Quarter 2024 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) positive and
programmed death-ligand 1 (PD-L1) positive 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, which 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 pivotal clinical trial evaluating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. A total of 407 patients have been enrolled from
more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival, an event-driven analysis conducted when 226 events, defined as disease progression or
death, have been reported in the study. Secondary endpoints include overall response rate (ORR), overall survival (OS), durable objective response (DRR), complete response rate (CRR), duration of response (DoR), time to complete response (TTCR),
disease control rate (DCR), and incidence of AEs and SAEs (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.
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 first 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.
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 IO102-IO103 in
combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and
Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial
IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating the IO102-IO103 therapeutic cancer vaccine in combination with pembrolizumab as
neo-adjuvant/adjuvant treatment of patients with solid tumors. The study will enroll approximately 15 patients with melanoma and 15 patients with SCCHN in cohort A and cohort B respectively as single arm
cohorts receiving combination of IO102-IO103 with pembrolizumab, whereas in cohort C 60 melanoma patients will be randomized 1:1 to either the combination of IO102-IO103 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.
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.
Forward-Looking Statement
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
Julie Funesti, National Health Media
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited in thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 15,848 | $ | 16,504 | $ | 30,159 | $ | 28,404 | ||||||||
| General and administrative | 5,685 | 5,348 | 11,571 | 11,372 | ||||||||||||
| Total operating expenses | 21,533 | 21,852 | 41,730 | 39,776 | ||||||||||||
| Loss from operations | (21,533 | ) | (21,852 | ) | (41,730 | ) | (39,776 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Currency exchange (loss) gain, net | (90 | ) | 10 | (552 | ) | 268 | ||||||||||
| Interest income | 1,311 | 1,196 | 2,928 | 2,224 | ||||||||||||
| Total other income (expense), net | 1,221 | 1,206 | 2,376 | 2,492 | ||||||||||||
| Loss before income tax expense | (20,312 | ) | (20,646 | ) | (39,354 | ) | (37,284 | ) | ||||||||
| Income tax expense | 374 | 532 | 789 | 938 | ||||||||||||
| Net loss | (20,686 | ) | (21,178 | ) | (40,143 | ) | (38,222 | ) | ||||||||
| Net loss attributable to common shareholders | (20,686 | ) | (21,178 | ) | (40,143 | ) | (38,222 | ) | ||||||||
| Net loss per common share, basic and diluted | $ | (0.31 | ) | $ | (0.74 | ) | $ | (0.61 | ) | $ | (1.33 | ) | ||||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 65,880,914 | 28,815,267 | 65,880,914 | 28,815,267 | ||||||||||||
| Other comprehensive loss | ||||||||||||||||
| Net loss | $ | (20,686 | ) | $ | (21,178 | ) | $ | (40,143 | ) | $ | (38,222 | ) | ||||
| Foreign currency translation | (151 | ) | (141 | ) | 43 | 376 | ||||||||||
| Total comprehensive loss | $ | (20,837 | ) | $ | (21,319 | ) | $ | (40,100 | ) | $ | (37,846 | ) |
Consolidated Balance Sheets
(Unaudited in thousands, except share and per share amounts)
| June 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 100,747 | $ | 143,193 | ||||
| Prepaid expenses and other current assets | 6,905 | 4,062 | ||||||
| Total current assets | 107,652 | 147,255 | ||||||
| Restricted cash | 268 | 268 | ||||||
| Property and equipment, net | 735 | 847 | ||||||
| Right of use lease asset | 1,936 | 2,259 | ||||||
| Other non-current assets | 876 | 89 | ||||||
| Total non-current assets | 3,815 | 3,463 | ||||||
| Total assets | $ | 111,467 | $ | 150,718 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 5,016 | $ | 3,878 | ||||
| Lease liability - current | 678 | 655 | ||||||
| Accrued expenses and other current liabilities | 8,029 | 11,184 | ||||||
| Total current liabilities | 13,723 | 15,717 | ||||||
| Lease liability - non-current | 1,472 | 1,839 | ||||||
| Total non-current liabilities | 1,472 | 1,839 | ||||||
| Total liabilities | 15,195 | 17,556 | ||||||
| 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, 2024 and December 31, 2023 | ||||||||
| Common stock, par value of $0.001 per share; 300,000,000 shares authorized at June 30, 2024 and December 31, 2023; 65,880,914 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 66 | 66 | ||||||
| Additional paid-in capital | 409,797 | 406,587 | ||||||
| Accumulated deficit | (303,965 | ) | (263,822 | ) | ||||
| Accumulated other comprehensive loss | (9,626 | ) | (9,669 | ) | ||||
| Total stockholders equity | 96,272 | 133,162 | ||||||
| Total liabilities and stockholders equity | $ | 111,467 | $ | 150,718 |