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
- The independent data monitoring
committee (IDMC) for the company’s pivotal Phase 3 trial
(IOB-013/KN-D18), which is evaluating IO102-IO103 in combination
with KEYTRUDA® (pembrolizumab) in advanced melanoma, is expected to
independently conduct a review of interim analysis data in the
third quarter of 2024. The primary endpoint of the Phase 3 trial is
PFS, which will be analyzed when 226 events have occurred in the
trial, and the outcome of which the company projects will occur in
the first half of 2025. If the IDMC recommendation after review of
the interim analysis data is supportive, we believe the outcome
could allow for submission of a Biologics License Application (BLA)
in fourth quarter of 2024 for accelerated approval in the US.
- Updated data for the head and neck
cohort of the company’s Phase 2 basket trial (IOB-022/KN-D38)
evaluating IO102-IO103 in combination with pembrolizumab in
patients with metastatic NSCLC or recurrent or metastatic SCCHN was
accepted for poster presentation at the European Society of Medical
Oncology (ESMO 2024) congress taking place September 13-17 in
Barcelona. This presentation will share efficacy and safety data
for the full patient cohort, which completed enrollment earlier
this year. The company plans to share updates from the NSCLC
cohort, which also completed enrollment, at a medical meeting this
fall.
- The company continued to progress
its Phase 2 solid tumor basket trial (IOB-032/PN-E40) studying
treatment with IO102-IO103 in combination with pembrolizumab given
before (neoadjuvant) and after (adjuvant) surgery with curative
intent in patients with resectable melanoma or SCCHN. The single
arm melanoma cohort of the trial, cohort A, is now fully enrolled
and enrollment in the single arm SCCHN cohort, cohort B, continues.
Enrollment is also ongoing in the randomized melanoma cohort,
cohort C, in which patients are randomized either to IO102-IO103 in
combination with pembrolizumab or to pembrolizumab alone.
Second Quarter 2024 Financial
Results
- Net loss for the three months ended
June 30, 2024, was $20.7 million, compared to $21.2 million for the
three months ended June 30, 2023.
- Research and development expenses
were $15.8 million for the three months ended June 30, 2024,
compared to $16.5 million for the three months ended June 30, 2023.
The decrease was primarily related to timing of clinical
trial-related activities for the company’s IO102-IO103 therapeutic
cancer vaccine candidate, including the continued execution of the
company’s pivotal Phase 3 clinical trial. The company recognized
$0.7 million in research and development equity-based compensation
for the three months ended June 30, 2024, compared to $0.9 million
for the three months ended June 30, 2023.
- General and administrative expenses
were $5.7 million for the three months ended June 30, 2024,
compared to $5.3 million for the three months ended June 30, 2023.
The company recognized $1.0 million in general and administrative
equity-based compensation for the three months ended June 30, 2024,
compared to $0.7 million for the three months ended June 30,
2023.
- Cash and cash equivalents as of
June 30, 2024 were $100.7 million, compared to $143.2 million at
December 31, 2023. During the three months ended June 30, 2024, the
company used cash, cash equivalents and restricted cash of $17.0
million. The company continues to expect that it will have
sufficient cash to run the company into the fourth quarter of
2025.
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) 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 neoadjuvant/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.
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 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.
About 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 neoadjuvant/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
neoadjuvant 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 neoadjuvant 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® 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 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:InvestorsMaryann
Cimino, Director of Investor Relations IO Biotech,
Inc.617-710-7305mci@iobiotech.com
MediaJulie Funesti, National Health
MediaEdelman917-498-1967Julie.Funesti@salutemcomms.com
IO BIOTECH, INC. |
|
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited in thousands, except share and per share
amounts) |
|
|
Three Months
EndedJune 30, |
|
|
Six Months
EndedJune 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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IO BIOTECH, INC. |
|
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 |
|
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