IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical
company developing novel, immune-modulating cancer vaccines based
on its T-win® technology platform, today announced financial
results for the second quarter ended June 30, 2023.
“We have made a great deal of progress during
the first half of the year in the development of our novel,
investigational immune-modulating cancer vaccine, IO102-IO103,”
said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “We
have achieved the important recruitment milestone of having
enrolled 225 patients in our pivotal Phase 3 trial for patients
with advanced melanoma. We now look forward to the interim analysis
which, per the protocol, is to be conducted one year after 225
patients have been randomized. If the data from this interim
analysis are supportive, we anticipate submitting a Biologics
License Application for accelerated approval in the US. We are
continuing to see enrollment in this trial accelerate and remain on
track to reach full enrollment by the end of this year. We continue
to be encouraged by the strong interest from investigators and
patients in our clinical studies.”
Dr. Zocca continued, “With a very strong balance
sheet and executives now hired into critical roles, we are well
prepared for the key activities necessary to continue progressing
our lead candidate cancer vaccine, IO102-IO103, towards the market.
I look forward to a very productive second half of the year.”
Second Quarter 2023 and Recent Business
Highlights:
- In June 2023, the company achieved
a significant recruitment milestone of having enrolled 225 patients
in its Phase 3 ‘IOB-013/KN-D18’ trial. The Phase 3 trial protocol
calls for an interim analysis of the overall response rate one year
after 225 patients have been enrolled. If the data are supportive,
this interim analysis could allow for submission of a Biologics
License Application for accelerated approval in the US.
- Full enrollment for the Phase 3
IOB-013/KN-D18 trial was increased from 300 to 380 patients with
the aim of accelerating the time to reach the primary endpoint of
progression free survival (PFS). The company expects the trial to
be fully enrolled with 380 patients by the end of 2023.
- 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, recurrent or metastatic head and neck cancer continued
enrolling patients. The company will be closing the metastatic
bladder cancer cohort of this basket trial due to the changing
treatment landscape in this indication and the possibility of
further exploring the safety and efficacy of IO Biotech products in
this indication in a separate IIT. Data from the lung cohort of
this basket trial will be presented in a mini oral presentation at
the IASLC 2023 World Conference on Lung Cancer (WCLC) in September
2023 and in a poster presentation at the ESMO Congress in October
2023.
- Three of five
investigator-initiated trials (IITs) that the company is supporting
have recently started enrolling patients. These three IITs include:
(1) a Phase 1 trial to investigate IO102-IO103 in combination with
pembrolizumab for BCG-unresponsive or intolerant, non-muscle
invasive bladder cancer (NMIBC), (NCT05843448); (2) the Phase 2
KIEO (Keytruda-IO102-IO103
Extended-pre-Operative) trial to
investigate neoadjuvant pembrolizumab and IO102-IO103 prior to
curative-intent surgical care for squamous cell carcinoma of the
head and neck (SCCHN), (NCT05977907); and (3) a Phase 2 trial
evaluating IO102-IO103 and a fixed-dose combination of
nivolumab-relatlimab in treatment-naïve patients with unresectable
Stage III/IV melanoma, (NCT05912244).
- The company strengthened its
executive team with the appointments of Christine Richter, PhD,
MBA, as Senior Vice President, Commercial and Program Lead; Qasim
Ahmad, MD, as Chief Medical Officer; and the promotion of Eric
Faulkner from Sr. Vice President, CMC to Chief Technical
Officer.
- The Company appointed Heidi Hunter
to its Board of Directors.
- On August 7, 2023, the company
entered into a definitive securities purchase agreement. Under the
securities purchase agreement, the investors have agreed to
purchase 37,065,647 shares of the company’s common stock and
accompanying warrants to purchase up to an aggregate of 37,065,647
shares of common stock, at a combined purchase price of $2.025 per
share and accompanying warrant. Each accompanying warrant will
represent the right to purchase one share of the company’s common
stock at an exercise price of $2.47 per share. The warrants will be
exercisable for a period of three years and six months following
the date of issuance.
Second Quarter 2023 Financial
Results
- Net loss for the three months ended
June 30, 2023 was $21.2 million, compared to $18.5 million for the
three months ended June 30, 2022.
- Research and development expenses
were $16.5 million for the three months ended June 30, 2023,
compared to $12.2 million for the three months ended June 30, 2022.
The increase was primarily related to clinical trial-related
activities for our IO102-IO103 product candidate, including the
continued execution of our Phase 3 clinical trial. The Company
recognized $0.9 million in research and development equity-based
compensation for the three months ended June 30, 2023, compared to
$0.5 million for the three months ended June 30, 2022.
- General and administrative expenses
were $5.3 million for the three months ended June 30, 2023,
compared to $5.9 million for the three months ended June 30, 2022.
The decrease was related to lower professional services and
consulting costs, offset by an increase in headcount. The Company
recognized $0.7 million in general and administrative equity-based
compensation for the three months ended June 30, 2023, compared to
$0.8 million for the three months ended June 30, 2022.
- Cash and cash equivalents as of
June 30, 2023 were $110.1 million, compared to $142.6 million at
December 31, 2022. During the three months ended June 30, 2023, the
Company used cash, cash equivalents and restricted cash of $18.3
million from operating and investing activities with an additional
decrease of $0.1 million in cash due to the effects of foreign
currency exchange rates.
- Cash on hand is expected to support
operations into the fourth quarter of 2025.
Upcoming events
Morgan Stanley 21st Annual Global
Healthcare Conference. New York City. September 11-13,
2023. Dr. Zocca and Ms. Sullivan will participate in a fireside
chat and one-on-one meetings on Tuesday, September 12.
H.C. Wainwright 25th Annual Global
Investment Conference. New York City. September 11-13,
2023. Dr. Zocca will present a corporate overview and Dr. Zocca and
Ms. Sullivan will participate in one-on-one meetings on Wednesday,
September 13.
A live audio webcast of each presentation will
be available on the Investors section of the IO Biotech website at
www.iobiotech.com. A webcast replay of the presentations will be
available on IO Biotech’s website for 90 days following the
presentation.
IASLC 2023 World Conference on Lung
Cancer (WCLC). Singapore, September 9-12, 2023. One
abstract has been accepted for a Mini Oral presentation.
- Abstract Title: Ph 2 Trial of
IO102-IO103 Vaccine Plus Pembrolizumab: Preliminary Results for the
First-line Treatment of Lung AdenocarcinomaSession: MA15 - Bringing
New Discoveries into Early Phase Clinical TrialsSession Date &
Time: September 12, 2023 at 10:45 AM - 11:45 AMPresenter: Jonathan
Riess, MD
ESMO Congress 2023. Madrid, October
20-24, 2023. One abstract has been accepted for a poster
presentation.
- Abstract Title: A Phase 2 trial of
the IO102-IO103 vaccine plus pembrolizumab: preliminary analysis
for first line (1L) treatment of Non-Small Cell Lung Cancer (NSCLC)
and Squamous Cell Carcinoma of the Head and Neck
(SCCHN)Presentation number: 1038PPresenter: Jonathan Riess, MD
About IO102-IO103
IO102-IO103 is an investigational
immune-modulating cancer vaccine designed to target the
immunosuppressive mechanisms mediated by the proteins indoleamine
2,3-dioxygenase (IDO) and PD-L1. The company is currently
conducting a Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating
IO102-IO103 in combination with pembrolizumab in first-line
advanced melanoma patients, and a Phase 2 basket trial
(IOB-022/KN-D38; NCT05077709).
About the IOB-013/KN-D18 Phase 3
Clinical Trial
IOB-013/KN-D18 (NCT05155254) is an open label,
randomized Phase 3 clinical trial being conducted in collaboration
with Merck of IO102-IO103 in combination with pembrolizumab versus
pembrolizumab alone in patients with previously untreated,
unresectable or metastatic (advanced) melanoma. Target enrollment
is 380 patients from centers spread across the United States,
Europe, Australia, Israel and South Africa. Biomarker analyses will
also be conducted. IO Biotech is sponsoring the Phase 3 trial and
Merck is supplying pembrolizumab. IO Biotech maintains full global
commercial rights to IO102-IO103.
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 each of the following first-line
advanced cancers: non-small cell lung cancer (NSCLC), squamous cell
carcinoma of the head and neck (SCCHN), and urothelial bladder
cancer (UBC). The clinical trial is sponsored by IO Biotech and
conducted in collaboration with Merck. IO Biotech maintains global
commercial rights to IO102-IO103.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical
company developing novel, immune-modulating 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 most important immunosuppressive cells in the tumor
microenvironment. IO Biotech is advancing in clinical studies its
lead cancer vaccine candidate, IO102-IO103, targeting IDO and
PD-L1, and through preclinical development its other pipeline
candidates. 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 Statements
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 Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
16,504 |
|
|
$ |
12,226 |
|
|
$ |
28,404 |
|
|
$ |
22,531 |
|
General and administrative |
|
|
5,348 |
|
|
|
5,935 |
|
|
|
11,372 |
|
|
|
12,639 |
|
Total operating expenses |
|
|
21,852 |
|
|
|
18,161 |
|
|
|
39,776 |
|
|
|
35,170 |
|
Loss
from operations |
|
|
(21,852 |
) |
|
|
(18,161 |
) |
|
|
(39,776 |
) |
|
|
(35,170 |
) |
Other
income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Currency exchange gain (loss), net |
|
|
10 |
|
|
|
(286 |
) |
|
|
268 |
|
|
|
(305 |
) |
Interest income |
|
|
1,196 |
|
|
|
158 |
|
|
|
2,224 |
|
|
|
173 |
|
Interest expense |
|
|
— |
|
|
|
(102 |
) |
|
|
— |
|
|
|
(226 |
) |
Total other income (expense), net |
|
|
1,206 |
|
|
|
(230 |
) |
|
|
2,492 |
|
|
|
(358 |
) |
Loss
before income tax expense |
|
|
(20,646 |
) |
|
|
(18,391 |
) |
|
|
(37,284 |
) |
|
|
(35,528 |
) |
Income
tax expense |
|
|
532 |
|
|
|
104 |
|
|
|
938 |
|
|
|
171 |
|
Net
loss |
|
|
(21,178 |
) |
|
|
(18,495 |
) |
|
|
(38,222 |
) |
|
|
(35,699 |
) |
Net loss
attributable to common shareholders |
|
|
(21,178 |
) |
|
|
(18,495 |
) |
|
|
(38,222 |
) |
|
|
(35,699 |
) |
Net loss
per common share, basic and diluted |
|
$ |
(0.74 |
) |
|
$ |
(0.64 |
) |
|
$ |
(1.33 |
) |
|
$ |
(1.24 |
) |
Weighted-average number of shares used in computing net loss per
common share, basic and diluted |
|
|
28,815,267 |
|
|
|
28,815,267 |
|
|
|
28,815,267 |
|
|
|
28,815,267 |
|
Other
comprehensive (loss) income |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(21,178 |
) |
|
$ |
(18,495 |
) |
|
$ |
(38,222 |
) |
|
$ |
(35,699 |
) |
Foreign
currency translation |
|
|
(141 |
) |
|
|
(4,379 |
) |
|
|
376 |
|
|
|
(7,026 |
) |
Total
comprehensive loss |
|
$ |
(21,319 |
) |
|
$ |
(22,874 |
) |
|
$ |
(37,846 |
) |
|
$ |
(42,725 |
) |
|
IO BIOTECH, INC. |
|
Condensed Consolidated Balance Sheets |
(In thousands, except share and per share
amounts) |
(unaudited) |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
110,095 |
|
|
$ |
142,590 |
|
Prepaid expenses and other current assets |
|
|
2,941 |
|
|
|
5,629 |
|
Total current assets |
|
|
113,036 |
|
|
|
148,219 |
|
Restricted cash |
|
|
268 |
|
|
|
268 |
|
Property
and equipment, net |
|
|
826 |
|
|
|
741 |
|
Right of
use lease asset |
|
|
2,534 |
|
|
|
2,493 |
|
Other
non-current assets |
|
|
891 |
|
|
|
84 |
|
Total non-current assets |
|
|
4,519 |
|
|
|
3,586 |
|
Total assets |
|
$ |
117,555 |
|
|
$ |
151,805 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,464 |
|
|
$ |
4,004 |
|
Lease liability - current |
|
|
613 |
|
|
|
515 |
|
Accrued expenses and other current liabilities |
|
|
5,799 |
|
|
|
6,157 |
|
Total current liabilities |
|
|
10,876 |
|
|
|
10,676 |
|
Lease
liability - non-current |
|
|
2,159 |
|
|
|
2,275 |
|
Total non-current liabilities |
|
|
2,159 |
|
|
|
2,275 |
|
Total liabilities |
|
|
13,035 |
|
|
|
12,951 |
|
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, 2023
and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, par value of $0.001 per share; 300,000,000 shares
authorized, 28,815,267 shares issued and outstanding as of June 30,
2023 and December 31, 2022 |
|
|
29 |
|
|
|
29 |
|
Additional paid-in capital |
|
|
330,217 |
|
|
|
326,705 |
|
Accumulated deficit |
|
|
(215,961 |
) |
|
|
(177,739 |
) |
Accumulated other comprehensive loss |
|
|
(9,765 |
) |
|
|
(10,141 |
) |
Total stockholders’ equity |
|
|
104,520 |
|
|
|
138,854 |
|
Total
liabilities and stockholders’ equity |
|
$ |
117,555 |
|
|
$ |
151,805 |
|
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