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 first quarter ended March 31, 2024.
“This will be a transformative year for IO
Biotech as we approach the interim analysis of our pivotal Phase 3
study in first-line advanced melanoma, which, if supportive, could
allow for a submission of a Biologics License Application (BLA) to
the United States (US) Food and Drug Administration (FDA) this
year,” said Mai-Britt Zocca, Ph.D., President and CEO of IO
Biotech. “Last year, we expanded our Phase 3 study to potentially
bring in the time to reach the primary endpoint of progression free
survival and we concluded enrollment in the fourth quarter of 2023
with 407 patients. As we prepare for the interim analysis, we now
have greater visibility to estimate the timing of reaching 226
events needed for the PFS analysis, which we now project will occur
in the first half of 2025.”
Dr. Zocca continued, “With continued execution
of our Phase 3 study and its planned interim analysis as our main
priorities this year, we also continue both of our Phase 2 basket
studies: completing enrollment in our IOB-022 study; and rapidly
enrolling and expanding our newest basket study, IOB-032, in the
neo-adjuvant/adjuvant settings of melanoma and squamous cell
carcinoma of the head and neck (SCCHN). Finally, as we prepare for
potential commercialization and partnering, I am very pleased with
the strength of expertise we have added to our leadership team with
the additions of Marjan Shamsaei as Senior Vice President,
Commercial and Portfolio Lead, and Faiçal Miyara as Chief Business
Officer. I founded IO Biotech 10 years ago and couldn’t be more
proud of all that we have accomplished, and, with such a strong
team in place, confident in what lies ahead.”
Recent Business Highlights
- The company recently completed
enrollment of 407 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 Phase 3 trial is PFS. The PFS analysis
will be conducted when 226 events have occurred in the trial,
which, based on the expanded trial size, reaching full enrollment
ahead of schedule and the events to date in the study, the company
now projects will occur in the first half of 2025. Additionally, a
planned interim analysis of 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 and, if supportive, we believe could allow for submission of a
BLA for accelerated approval in the US.
- The independent data monitoring
committee (IDMC) for the company’s IOB-013/KN-D18 Phase 3 trial
convened its fourth meeting in March 2024 and recommended that the
trial continue without modifications.
- 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 squamous cell carcinoma
of the head and neck (SCCHN) completed enrollment; the company
plans to submit abstracts with updates from this study to medical
meetings in the fall of 2024.
- 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 SCCHN has been enrolling patients since
December 2023 in cohorts A (melanoma) and B (SCCHN) in the US,
European Union (EU) and Australia. Cohort A is now fully enrolled
and the company recently expanded the study to include a randomized
cohort C in melanoma, in which patients are randomized either to
IO102-IO103 in combination with pembrolizumab or to pembrolizumab
alone.
- In April, a poster presentation of
new non-clinical data further supporting the dual mechanism of
action of the company’s lead cancer vaccine, IO102-IO103, was
delivered at the American Association for Cancer Research (AACR)
Annual Meeting 2024 in San Diego, California. While further studies
are needed to fully discern the relationship between IDO1+/PD-L1+
target populations within the TME and the impact of IDO1/PD-L1
targeted vaccination, we believe the data presented support the use
of a dual antigen approach to reduce the immunosuppression and
enhance anti-tumor effect.
- In April, the company strengthened
its executive team with the appointments of Faiçal Miyara, Ph.D.,
as Chief Business Officer, and Marjan Shamsaei, Pharm.D., as Senior
Vice President, Commercial and Portfolio Lead.
First Quarter 2024 Financial
Results
- Net loss for the three months ended
March 31, 2024, was $19.5 million, compared to $17.0 million for
the three months ended March 31, 2023.
- Research and development expenses
were $14.3 million for the three months ended March 31, 2024,
compared to $11.9 million for the three months ended March 31,
2023. 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
pivotal Phase 3 clinical trial. The company recognized $0.6 million
in research and development equity-based compensation for the three
months ended March 31, 2024, compared to $0.7 million for the three
months ended March 31, 2023.
- General and administrative expenses
were $5.9 million for the three months ended March 31, 2024,
compared to $6.0 million for the three months ended March 31, 2023.
The company recognized $1.0 million in general and administrative
equity-based compensation for the three months ended March 31,
2024, compared to $1.2 million for the three months ended March 31,
2023.
- Cash and cash equivalents as of
March 31, 2024 were $118.0 million, compared to $143.2 million at
December 31, 2023. During the three months ended March 31, 2024,
the company used cash, cash equivalents and restricted cash of
$24.9 million. The increase in cash use was primarily driven by
milestone payments and payment of other accrued expenses associated
with clinical trials, as well as the payment of year-end bonuses.
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 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 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 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
≥30 melanoma patients will be randomized 1:1 to neo-adjuvant
treatment with 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® 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: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) |
|
|
|
Three Months
EndedMarch 31, |
|
|
|
2024 |
|
|
2023 |
|
Operating expenses |
|
|
|
|
|
|
Research and development |
|
$ |
14,311 |
|
|
$ |
11,900 |
|
General and administrative |
|
|
5,886 |
|
|
|
6,024 |
|
Total operating expenses |
|
|
20,197 |
|
|
|
17,924 |
|
Loss from operations |
|
|
(20,197 |
) |
|
|
(17,924 |
) |
Other income (expense) |
|
|
|
|
|
|
Currency exchange (loss) gain, net |
|
|
(462 |
) |
|
|
258 |
|
Interest income |
|
|
1,617 |
|
|
|
1,028 |
|
Total other income (expense) |
|
|
1,155 |
|
|
|
1,286 |
|
Loss before income tax
expense |
|
|
(19,042 |
) |
|
|
(16,638 |
) |
Income tax expense |
|
|
415 |
|
|
|
406 |
|
Net loss |
|
|
(19,457 |
) |
|
|
(17,044 |
) |
Net loss attributable to
common shareholders |
|
|
(19,457 |
) |
|
|
(17,044 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.59 |
) |
Weighted-average number of
shares used in computing net loss per common share, basic and
diluted |
|
|
65,880,914 |
|
|
|
28,815,267 |
|
Other comprehensive loss |
|
|
|
|
|
|
Net loss |
|
$ |
(19,457 |
) |
|
$ |
(17,044 |
) |
Foreign currency
translation |
|
|
194 |
|
|
|
517 |
|
Total comprehensive loss |
|
$ |
(19,263 |
) |
|
$ |
(16,527 |
) |
|
IO BIOTECH, INC.Consolidated Balance
Sheets (Unaudited in thousands, except share and
per share amounts) |
|
|
|
March 31,2024 |
|
|
December 31,2023 |
|
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
117,982 |
|
|
$ |
143,193 |
|
Prepaid expenses and other current assets |
|
|
6,146 |
|
|
|
4,062 |
|
Total current assets |
|
|
124,128 |
|
|
|
147,255 |
|
Restricted cash |
|
|
268 |
|
|
|
268 |
|
Property and equipment,
net |
|
|
788 |
|
|
|
847 |
|
Right of use lease asset |
|
|
2,092 |
|
|
|
2,259 |
|
Other non-current assets |
|
|
883 |
|
|
|
89 |
|
Total non-current assets |
|
|
4,031 |
|
|
|
3,463 |
|
Total assets |
|
$ |
128,159 |
|
|
$ |
150,718 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,840 |
|
|
$ |
3,878 |
|
Lease liability - current |
|
|
666 |
|
|
|
655 |
|
Accrued expenses and other current liabilities |
|
|
6,537 |
|
|
|
11,184 |
|
Total current liabilities |
|
|
11,043 |
|
|
|
15,717 |
|
Lease liability -
non-current |
|
|
1,650 |
|
|
|
1,839 |
|
Total non-current liabilities |
|
|
1,650 |
|
|
|
1,839 |
|
Total liabilities |
|
|
12,693 |
|
|
|
17,556 |
|
Commitments and contingencies
(Note 9) |
|
|
|
|
|
|
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, 2024
and December 31, 2023 |
|
|
— |
|
|
|
— |
|
Common stock, par value of $0.001 per share; 300,000,000 shares
authorized at March 31, 2024 and December 31, 2023; 65,880,914
shares issued and outstanding as of March 31, 2024 and December 31,
2023, respectively |
|
|
66 |
|
|
|
66 |
|
Additional paid-in capital |
|
|
408,154 |
|
|
|
406,587 |
|
Accumulated deficit |
|
|
(283,279 |
) |
|
|
(263,822 |
) |
Accumulated other comprehensive loss |
|
|
(9,475 |
) |
|
|
(9,669 |
) |
Total stockholders’ equity |
|
|
115,466 |
|
|
|
133,162 |
|
Total liabilities and
stockholders’ equity |
|
$ |
128,159 |
|
|
$ |
150,718 |
|
IO Biotech (NASDAQ:IOBT)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
IO Biotech (NASDAQ:IOBT)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024