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 fourth quarter and year-ended December 31, 2023.
“In 2023, we reached a significant milestone in
our pivotal Phase 3 trial evaluating our lead therapeutic cancer
vaccine, IO102-IO103, in combination with KEYTRUDA, completing
enrollment in this trial in mid-November,” said Mai-Britt Zocca,
Ph.D., President and CEO of IO Biotech. “The acceleration in
enrollment observed in this study in the second half of 2023 is a
testament to the need that exists today for more efficacious and
better tolerated first-line treatment options for patients with
advanced melanoma.”
Dr. Zocca continued, “The coming months will
prove to be a critical period in the development of IO Biotech,
with the outcome of the pivotal Phase 3 interim analysis expected
in the third quarter of 2024, and, more importantly, the primary
endpoint of progression free survival estimated to follow in the
second half of 2025. Our team is dedicated to continuing our
diligent work to efficiently bring IO102-IO103 to patients in need,
potentially as early as 2025.”
Fourth Quarter 2023 and other Recent
Highlights
- In November 2023, the company
completed enrollment of 380 patients in its pivotal Phase 3 trial
(IOB-013/KN-D18) of IO102-IO103 in combination with Merck’s
anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in advanced melanoma.
The primary endpoint of the pivotal Phase 3 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 second half of 2025.
Additionally, a planned interim analysis of overall response rate
(ORR) will be conducted when the first 225 randomized patients
reach one year of treatment in June 2024. The outcome of this
analysis is expected in the third quarter of 2024.
- In December 2023, the first patient
was dosed in the company’s Phase 2 solid tumor basket trial
(IOB-032/PN-E40) studying treatment with IO102-IO103 in combination
with pembrolizumab given before (neo-adjuvant) and after (adjuvant)
surgery with curative intent in patients with resectable melanoma
or squamous cell carcinoma of the head and neck (SCCHN).
- The company’s Phase 2 basket trial
(IOB-022/KN-D38) evaluating IO102-IO103 in combination with
pembrolizumab in patients with metastatic non-small cell lung
cancer (NSCLC) or recurrent or metastatic SCCHN is ongoing.
Encouraging preliminary data that support the potential of
IO102-IO103 in combination with pembrolizumab as first-line
treatment in NSCLC and SCCHN were presented at the IASLC 2023 World
Conference on Lung Cancer (WCLC) in September 2023 and at the
European Society of Medical Oncology (ESMO) annual meeting in
October 2023.
- Progress continued in several
investigator-initiated trials the company is supporting including
dosing of the first patient in the Phase 2 trial evaluating its
lead therapeutic cancer vaccine candidate, IO102-IO103, and
pembrolizumab as neoadjuvant followed by adjuvant treatment of
patients with SCCHN (NCT05977907), as well as continuing enrollment
in both the Phase 2 trial of IO102-IO103 given in combination with
nivolumab-relatlimab in patients with untreated, unresectable Stage
III/IV melanoma (NCT05912244) and the Phase 1 study of the
IO102-IO103 vaccine in combination with pembrolizumab for patients
with BCG-unresponsive or intolerant high-risk non-muscle invasive
bladder cancer (NCT05843448).
- Three posters were presented at the
Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting in
November 2023 with data providing further evidence of the
differential biological impact of therapeutic vaccines IO102, IO103
and IO112.
- The company expanded its Board of
Directors with the appointment of Helen Collins, MD in November
2023.
Fourth Quarter 2023 Financial
Results
- Net loss for the three months ended
December 31, 2023, was $26.2 million, compared to $20.1 million for
the three months ended December 31, 2022.
- Research and development expenses
were $21.8 million for the three months ended December 31, 2023,
compared to $14.4 million for the three months ended December 31,
2022. The increase was primarily related to clinical trial-related
activities for the company’s IO102-IO103 therapeutic cancer vaccine
candidate, including the continued execution of the company’s Phase
3 clinical trial. The company recognized $0.5 million in research
and development equity-based compensation for the three months
ended December 31, 2023, compared to $0.6 million for the three
months ended December 31, 2022.
- General and administrative expenses
were $6.4 million for the three months ended December 31, 2023,
compared to $6.0 million for the three months ended December 31,
2022. The increase was primarily related to personnel costs due to
an increase in head count that was offset by a decrease in
professional services, consultant and other costs. The company
recognized $1.0 million in general and administrative equity-based
compensation for the three months ended December 31, 2023, compared
to $1.1 million for the three months ended December 31, 2022.
- Cash and cash equivalents as of
December 31, 2023 were $143.2 million, compared to $142.6 million
at December 31, 2022. During the three months ended December 31,
2023, the company used cash, cash equivalents and restricted cash
of $22.9 million from operating and investing activities.
About IO102-IO103
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) and/or programmed death-ligand 1 (PD-L1)
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 and Merck is supplying
pembrolizumab. IO Biotech maintains global commercial rights to
IO102-IO103.
KEYTRUDA® is a 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 clinical trial of
IO102-IO103 in combination with pembrolizumab versus pembrolizumab
alone in patients with previously untreated, unresectable or
metastatic (advanced) melanoma, being conducted in collaboration
with Merck. Patients have been enrolled from centers across the
United States, Europe, Australia, Turkey, Israel and South Africa.
The primary endpoint of the study is progression free survival.
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.
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
second 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.
About IO Biotech
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.
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 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.
Contact:Maryann Cimino, Director of Investor
Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com
IO BIOTECH, INC.
Consolidated Statements of Operations and
Comprehensive Loss (Unaudited in thousands, except
share and per share amounts)
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
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Three Months
EndedDecember 31, |
|
|
Year EndedDecember 31, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
21,770 |
|
|
$ |
14,433 |
|
|
$ |
67,829 |
|
|
$ |
46,986 |
|
General and administrative |
|
|
6,413 |
|
|
|
5,955 |
|
|
|
23,614 |
|
|
|
24,438 |
|
Total operating expenses |
|
|
28,183 |
|
|
|
20,388 |
|
|
|
91,443 |
|
|
|
71,424 |
|
Loss from operations |
|
|
(28,183 |
) |
|
|
(20,388 |
) |
|
|
(91,443 |
) |
|
|
(71,424 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
Currency exchange gain, net |
|
|
405 |
|
|
|
521 |
|
|
|
331 |
|
|
|
130 |
|
Interest income |
|
|
1,949 |
|
|
|
782 |
|
|
|
5,881 |
|
|
|
1,411 |
|
Interest expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(302 |
) |
Total other income (expense), net |
|
|
2,354 |
|
|
|
1,303 |
|
|
|
6,212 |
|
|
|
1,239 |
|
Loss before income tax
expense |
|
|
(25,829 |
) |
|
|
(19,085 |
) |
|
|
(85,231 |
) |
|
|
(70,185 |
) |
Income tax expense |
|
|
353 |
|
|
|
987 |
|
|
|
852 |
|
|
|
1,273 |
|
Net loss |
|
|
(26,182 |
) |
|
|
(20,072 |
) |
|
|
(86,083 |
) |
|
|
(71,458 |
) |
Net loss attributable to common
shareholders |
|
|
(26,182 |
) |
|
|
(20,072 |
) |
|
|
(86,083 |
) |
|
|
(71,458 |
) |
Net loss per common share, basic
and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.70 |
) |
|
$ |
(1.98 |
) |
|
$ |
(2.48 |
) |
Weighted-average number of shares
used in computing net loss per common share, basic and diluted |
|
|
65,880,914 |
|
|
|
28,815,267 |
|
|
|
43,539,976 |
|
|
|
28,815,267 |
|
Other comprehensive (loss)
income |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(26,182 |
) |
|
$ |
(20,072 |
) |
|
$ |
(86,083 |
) |
|
$ |
(71,458 |
) |
Foreign currency translation |
|
|
204 |
|
|
|
3,775 |
|
|
|
472 |
|
|
|
(8,652 |
) |
Total comprehensive loss |
|
$ |
(25,978 |
) |
|
$ |
(16,297 |
) |
|
$ |
(85,611 |
) |
|
$ |
(80,110 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IO BIOTECH, INC.
Consolidated Balance Sheets
(Unaudited in thousands, except share and per share
amounts)
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
143,193 |
|
|
$ |
142,590 |
|
Prepaid expenses and other current assets |
|
|
4,062 |
|
|
|
5,629 |
|
Total current assets |
|
|
147,255 |
|
|
|
148,219 |
|
Restricted cash |
|
|
268 |
|
|
|
268 |
|
Property and equipment, net |
|
|
847 |
|
|
|
741 |
|
Right of use lease asset |
|
|
2,259 |
|
|
|
2,493 |
|
Other non-current assets |
|
|
89 |
|
|
|
84 |
|
Total non-current assets |
|
|
3,463 |
|
|
|
3,586 |
|
Total assets |
|
$ |
150,718 |
|
|
$ |
151,805 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,878 |
|
|
$ |
4,004 |
|
Lease liability - current |
|
|
655 |
|
|
|
515 |
|
Accrued expenses and other current liabilities |
|
|
11,184 |
|
|
|
6,157 |
|
Total current liabilities |
|
|
15,717 |
|
|
|
10,676 |
|
Lease liability -
non-current |
|
|
1,839 |
|
|
|
2,275 |
|
Total non-current liabilities |
|
|
1,839 |
|
|
|
2,275 |
|
Total liabilities |
|
|
17,556 |
|
|
|
12,951 |
|
|
|
|
|
|
|
|
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, 2023
and 2022 |
|
|
— |
|
|
|
— |
|
Common stock, par value of $0.001 per share; 300,000,000 shares
authorized at December 31, 2023 and December 31, 2022; 65,880,914
and 28,815,267 shares issued and outstanding as of December 31,
2023 and December 31, 2022, respectively |
|
|
66 |
|
|
|
29 |
|
Additional paid-in capital |
|
|
406,587 |
|
|
|
326,705 |
|
Accumulated deficit |
|
|
(263,822 |
) |
|
|
(177,739 |
) |
Accumulated other comprehensive loss |
|
|
(9,669 |
) |
|
|
(10,141 |
) |
Total stockholders’ equity |
|
|
133,162 |
|
|
|
138,854 |
|
Total liabilities and
stockholders’ equity |
|
$ |
150,718 |
|
|
$ |
151,805 |
|
IO Biotech (NASDAQ:IOBT)
過去 株価チャート
から 11 2024 まで 12 2024
IO Biotech (NASDAQ:IOBT)
過去 株価チャート
から 12 2023 まで 12 2024