IO Biotech Announces 2023 Third Quarter Results
13 Novembre 2023 - 2:12PM
IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical
company developing novel, immune-modulating therapeutic cancer
vaccines based on its T-win® technology platform, today reported
financial results for the third quarter ended September 30, 2023.
“Our focus for 2023 has been to successfully
execute multiple clinical trials for our novel, investigational
therapeutic cancer vaccine, IO102-IO103. We recently achieved
several milestones, completion of enrollment in our pivotal Phase 3
trial in patients with advanced melanoma, the presentation of
encouraging preliminary data from the Phase 2 basket trial of
IO102-IO103 at WCLC and ESMO, and expanding into earlier stages of
melanoma treatment with the initiation of an additional Phase 2
basket study in the neoadjuvant/adjuvant setting,” said Mai-Britt
Zocca, PhD, President and CEO of IO Biotech. “With our strengthened
balance sheet as a result of our $75 million private placement and
key additions to both our management team and board of directors,
we are in a strong position as we work diligently to bring our lead
therapeutic cancer vaccine candidate, IO102-IO103, toward the
market, potentially as early as 2025.”
Recent Business Highlights and
Anticipated Milestones
- The company completed enrollment of
380 patients in its pivotal Phase 3 trial (IOB-013/KN-D18) in
November 2023. 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, there is a per-protocol interim analysis of
overall response rate (ORR) planned 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.
- The Phase 2 basket trial
(IOB-022/KN-D38) evaluating IO102-IO103 in combination with
pembrolizumab in patients with metastatic non-small cell lung
cancer, or recurrent or metastatic squamous cell cancer of the head
and neck (SCCHN) also continued to enroll patients. Encouraging
preliminary data from this basket trial were presented at the IASLC
2023 World Conference on Lung Cancer (WCLC) in September 2023 and
at the ESMO Congress in October 2023. [https://bit.ly/3uhelje;
https://bit.ly/3MxPWwg]
- The company presented three posters at the Society for
Immunotherapy of Cancer’s (SITC) 38th Annual Meeting. Non-clinical
data presented demonstrate the clear impact of therapeutic vaccines
targeting IDO1 and PD-L1 on several tumoral immune escape
mechanisms in the tumor microenvironment leading to enhanced
anti-tumor effect and support the clinical observations observed to
date with the company’s lead therapeutic vaccine candidate,
IO102-IO103. [https://bit.ly/469Lvyy]
- On August 7, 2023, the company
completed a $75 million private placement with participation from
both new and existing healthcare-dedicated investors, extending the
company’s cash runway into the fourth quarter of 2025.
[https://bit.ly/3QSyaXl]
- The company appointed a new member,
Helen Collins, MD, to the company’s board of directors. Dr. Collins
is currently the Chief Medical Officer at Enliven Therapeutics.
Prior to joining Enliven, Helen served as Chief Medical Officer and
Executive Vice President at Five Prime Therapeutics, a
clinical-stage biotechnology company focused on oncology that was
acquired by Amgen, Inc. She serves as a member of the board of
directors of Kura Oncology. [https://bit.ly/3uaqwOV]
Third Quarter 2023 Financial
Results
The company ended the third quarter with
approximately $165.5 million in cash and cash equivalents, which is
expected to fund the company’s operations into the fourth quarter
of 2025.
- Net loss for the three months ended
September 30, 2023, was $21.7 million, compared to $15.7 million
for the three months ended September 30, 2022.
- Research and development expenses
were $17.7 million for the three months ended September 30, 2023,
compared to $10.0 million for the three months ended September 30,
2022. The increase was primarily related to clinical trial-related
activities for our IO102-IO103 therapeutic vaccine candidate,
including the continued execution of our Phase 3 clinical trial.
The company recognized $2.1 million in research and development
equity-based compensation for the three months ended September 30,
2023, compared to $1.0 million for the three months ended September
30, 2022.
- General and administrative expenses
were consistent at $5.8 million for the three months ended
September 30, 2023 and 2022, respectively. The company recognized
$0.9 million in general and administrative equity-based
compensation for the three months ended September 30, 2023,
compared to $1.4 million for the three months ended September 30,
2022.
- Cash and cash equivalents as of
September 30, 2023, were $165.5 million, compared to $142.6 million
at December 31, 2022. During the three months ended September 30,
2023, the company used cash, cash equivalents and restricted cash
of $16.0 million from operating and investing activities, obtained
$71.9 million in estimated net cash proceeds from our private
placement and incurred an additional decrease of $0.5 million in
cash due to the effects of foreign currency exchange rates.
Upcoming Events
Jefferies London Healthcare
Conference from November 14-16, 2023 in London. Mai-Britt
Zocca, PhD, President and CEO, and Amy Sullivan, CFO, will
participate in one-on-one meetings on Wednesday, November 15.
Piper Sandler
35th Annual Healthcare
Conference from November 28-30, 2023 in New York. Dr.
Zocca will present a corporate overview and Dr. Zocca and Ms.
Sullivan will participate in one-on-one meetings on Wednesday,
November 29.
About IO102-IO103
IO102-IO103 is an investigational
immune-modulating therapeutic cancer vaccine designed to target the
immunosuppressive mechanisms mediated by the proteins indoleamine
2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1). The
company is currently conducting a pivotal Phase 3 trial
(IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination
with pembrolizumab in first-line advanced melanoma patients, a
Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating
IO102-IO103 in combination with pembrolizumab in first-line
advanced non-small cell lung cancer and squamous cell cancer of the
head and neck (SCCHN), and a Phase 2 basket trial (IOB-032/PN-E40;
NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a
perioperative treatment in solid tumors including melanoma and
SCCHN.
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 IO Biotech
IO Biotech is a clinical-stage biopharmaceutical
company developing novel, immune-modulating therapeutic cancer
vaccines based on its T-win® vaccine platform. The T-win platform
is 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 advanced melanoma data, IO102-IO103, in combination
with pembrolizumab, has been granted a breakthrough therapy
designation for the treatment of unresectable / metastatic 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 analysis of our 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. Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share
amounts)(unaudited) |
|
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
17,655 |
|
|
|
$ |
10,022 |
|
|
$ |
46,059 |
|
|
$ |
32,553 |
|
General and administrative |
|
|
5,829 |
|
|
|
|
5,843 |
|
|
|
17,201 |
|
|
|
18,482 |
|
Total operating expenses |
|
|
23,484 |
|
|
|
|
15,865 |
|
|
|
63,260 |
|
|
|
51,035 |
|
Loss
from operations |
|
|
(23,484 |
) |
|
|
|
(15,865 |
) |
|
|
(63,260 |
) |
|
|
(51,035 |
) |
Other
income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency exchange loss, net |
|
|
(342 |
) |
|
|
|
(87 |
) |
|
|
(74 |
) |
|
|
(392 |
) |
Interest income |
|
|
1,708 |
|
|
|
|
457 |
|
|
|
3,932 |
|
|
|
631 |
|
Interest expense |
|
|
— |
|
|
|
|
(78 |
) |
|
|
— |
|
|
|
(305 |
) |
Total other income (expense), net |
|
|
1,366 |
|
|
|
|
292 |
|
|
|
3,858 |
|
|
|
(66 |
) |
Loss
before income tax benefit (expense) |
|
|
(22,118 |
) |
|
|
|
(15,573 |
) |
|
|
(59,402 |
) |
|
|
(51,101 |
) |
Income
tax (benefit) expense |
|
|
(439 |
) |
|
|
|
115 |
|
|
|
499 |
|
|
|
286 |
|
Net
loss |
|
|
(21,679 |
) |
|
|
|
(15,688 |
) |
|
|
(59,901 |
) |
|
|
(51,387 |
) |
Net loss
attributable to common shareholders |
|
|
(21,679 |
) |
|
|
|
(15,688 |
) |
|
|
(59,901 |
) |
|
|
(51,387 |
) |
Net loss
per common share, basic and diluted |
|
$ |
(0.43 |
) |
|
|
$ |
(0.54 |
) |
|
$ |
(1.66 |
) |
|
$ |
(1.78 |
) |
Weighted-average number of shares used in computing net loss per
common share, basic and diluted |
|
|
50,168,303 |
|
|
|
|
28,815,267 |
|
|
|
36,011,162 |
|
|
|
28,815,267 |
|
Other
comprehensive (loss) income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(21,679 |
) |
|
|
$ |
(15,688 |
) |
|
$ |
(59,901 |
) |
|
$ |
(51,387 |
) |
Foreign
currency translation |
|
|
(108 |
) |
|
|
|
(5,400 |
) |
|
|
268 |
|
|
|
(12,427 |
) |
Total
comprehensive loss |
|
$ |
(21,787 |
) |
|
|
$ |
(21,088 |
) |
|
$ |
(59,633 |
) |
|
$ |
(63,814 |
) |
|
IO BIOTECH, INC.Condensed Consolidated
Balance Sheets (In thousands, except share and per
share amounts) (unaudited) |
|
|
|
September 30,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
165,501 |
|
|
$ |
142,590 |
|
Prepaid expenses and other current assets |
|
|
2,753 |
|
|
|
5,629 |
|
Total current assets |
|
|
168,254 |
|
|
|
148,219 |
|
Restricted cash |
|
|
268 |
|
|
|
268 |
|
Property
and equipment, net |
|
|
797 |
|
|
|
741 |
|
Right of
use lease asset |
|
|
2,367 |
|
|
|
2,493 |
|
Other
non-current assets |
|
|
867 |
|
|
|
84 |
|
Total non-current assets |
|
|
4,299 |
|
|
|
3,586 |
|
Total assets |
|
$ |
172,553 |
|
|
$ |
151,805 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
6,645 |
|
|
$ |
4,004 |
|
Lease liability - current |
|
|
627 |
|
|
|
515 |
|
Accrued expenses and other current liabilities |
|
|
5,713 |
|
|
|
6,157 |
|
Total current liabilities |
|
|
12,985 |
|
|
|
10,676 |
|
Lease
liability - non-current |
|
|
1,976 |
|
|
|
2,275 |
|
Total
non-current liabilities |
|
|
1,976 |
|
|
|
2,275 |
|
Total liabilities |
|
|
14,961 |
|
|
|
12,951 |
|
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 September 30,
2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, par value of $0.001 per share; 300,000,000 shares
authorized at September 30, 2023 and December 31, 2022; 65,880,914
and 28,815,267 shares issued and outstanding as of September 30,
2023 and December 31, 2022, respectively |
|
|
66 |
|
|
|
29 |
|
Additional paid-in capital |
|
|
405,039 |
|
|
|
326,705 |
|
Accumulated deficit |
|
|
(237,640 |
) |
|
|
(177,739 |
) |
Accumulated other comprehensive loss |
|
|
(9,873 |
) |
|
|
(10,141 |
) |
Total stockholders’ equity |
|
|
157,592 |
|
|
|
138,854 |
|
Total
liabilities and stockholders’ equity |
|
$ |
172,553 |
|
|
$ |
151,805 |
|
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