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 completed enrollment of 15 patients with melanoma in cohort A and continues to enroll 15 patients with SCCHN in cohort B as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab, whereas in cohort C, 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.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win$(R)$ 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. Follow us on our social media channels on LinkedIn and X (@IOBiotech).
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 or outcome of primary analysis of the company's Phase 3 trial, other 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.
Contact:
Investors
Maryann Cimino, Director of Investor Relations
617-710-7305
mci@iobiotech.com
Media
Julie Funesti
Salutem
917-498-1967
Julie.Funesti@salutemcomms.com
IO BIOTECH, INC.
Consolidated Statements of Operations and Comprehensive
Loss
(Unaudited in thousands, except share and per share
amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------- -------------------------
2024 2023 2024 2023
----------- ----------- ----------- -----------
Operating expenses
Research and
development $ 20,178 $ 17,655 $ 50,337 $ 46,059
General and
administrative 6,326 5,829 17,897 17,201
---------- ---------- ---------- ----------
Total
operating
expenses 26,504 23,484 68,234 63,260
---------- ---------- ---------- ----------
Loss from
operations (26,504) (23,484) (68,234) (63,260)
---------- ---------- ---------- ----------
Other income
(expense)
Currency
exchange gain
(loss), net 1,630 (342) 1,078 (74)
Interest income 1,068 1,708 3,996 3,932
---------- ---------- ---------- ----------
Total other
income
(expense),
net 2,698 1,366 5,074 3,858
---------- ---------- ---------- ----------
Loss before income
tax expense
(benefit) (23,806) (22,118) (63,160) (59,402)
Income tax expense
(benefit) 209 (439) 998 499
---------- ---------- ---------- ----------
Net loss (24,015) (21,679) (64,158) (59,901)
---------- ---------- ---------- ----------
Net loss
attributable to
common
shareholders (24,015) (21,679) (64,158) (59,901)
---------- ---------- ---------- ----------
Net loss per common
share, basic and
diluted $ (0.36) $ (0.43) $ (0.97) $ (1.66)
========== ========== ========== ==========
Weighted-average
number of shares
used in computing
net loss per
common share,
basic and diluted 65,880,914 50,168,303 65,880,914 36,011,162
========== ========== ========== ==========
Other
comprehensive
loss
Net loss $ (24,015) $ (21,679) $ (64,158) $ (59,901)
Foreign currency
translation (1,374) (108) (1,331) 268
---------- ---------- ---------- ----------
Total comprehensive
loss $ (25,389) $ (21,787) $ (65,489) $ (59,633)
========== ========== ========== ==========
IO BIOTECH, INC.
Consolidated Balance Sheets
(Unaudited in thousands, except share and per share
amounts)
September 30, December 31,
2024 2023
--------------- --------------
Assets
Current assets
Cash and cash equivalents $ 80,185 $ 143,193
Prepaid expenses and other
current assets 6,059 4,062
----------- ----------
Total current assets 86,244 147,255
----------- ----------
Restricted cash 268 268
Property and equipment, net 695 847
Right of use lease asset 1,814 2,259
Other non-current assets 924 89
----------- ----------
Total non-current assets 3,701 3,463
----------- ----------
Total assets $ 89,945 $ 150,718
=========== ==========
Liabilities and stockholders'
equity
Current liabilities
Accounts payable $ 5,256 $ 3,878
Lease liability - current 694 655
Accrued expenses and other
current liabilities 10,105 11,184
----------- ----------
Total current liabilities 16,055 15,717
----------- ----------
Lease liability - non-current 1,325 1,839
----------- ----------
Total non-current liabilities 1,325 1,839
----------- ----------
Total liabilities 17,380 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
September 30, 2024 and December
31, 2023 -- --
Common stock, par value of
$0.001 per share; 300,000,000
shares authorized at September
30, 2024 and December 31, 2023;
65,880,914 shares issued and
outstanding as of September 30,
2024 and December 31, 2023,
respectively 66 66
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