iTeos Reports Second Quarter 2023 Financial Results and Provides Business Updates
2023年8月8日 - 8:00PM
iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage
biopharmaceutical company pioneering the discovery and development
of a new generation of immuno-oncology therapeutics for patients,
today reported financial results for the second quarter ended June
30, 2023 and provided a business update.
“Our team continues to bring forward innovation
in immunotherapy through our differentiated development pipeline,
which is expected to make significant progress in the second half
of 2023,” said Michel Detheux, Ph.D., president and chief executive
officer of iTeos. “To start, with GSK’s anti-PD-1 mAb, dostarlimab,
as the backbone for our ambitious TIGIT-based clinical development
plans, we remain confident that its combination with belrestotug
has the potential to become a best-in-class program. Furthermore,
we are continuing to build our position as a leader unlocking the
adenosine pathway with the announcement of enrolling patients in
the Phase 1 trial of EOS-984. This program will deepen our
understanding of the mechanisms of adenosine-mediated
immunosuppression and potentially reinforce the unique,
insurmountable profile of inupadenant. Based on the progression of
our 9 ongoing clinical trials and solid cash position with runway
into 2026, we believe we are poised for an abundance of opportunity
in 2024, including the presentation of TIGIT data from the Phase 2
clinical trials treating patients with NSCLC and HNSCC.”
Program Highlights:
Belrestotug (EOS-448/GSK4428859A): IgG1
anti-TIGIT monoclonal antibody designed to engage the Fc gamma
receptor (FcγR) and enhance the anti-tumor response through
multifaceted mechanisms.
- In collaboration with GSK, late-stage development of
belrestotug as a potential next-generation immuno-oncology (IO)
agent through multiple combination studies are progressing as
expected. We plan to present related datasets in 2024. Preparation
is underway for Phase 3 registrational studies evaluating
belrestotug and dostarlimab combination.
- The ongoing trials include:
- Randomized Phase 2 trial assessing the doublet of dostarlimab
with belrestotug in previously untreated advanced / metastatic
non-small cell lung cancer (NSCLC).
- Phase 2 expansion study assessing the doublet of dostarlimab
with belrestotug in first line advanced or metastatic head and neck
squamous cell carcinoma (HNSCC).
- Phase 1b trials exploring the addition of chemotherapy and two
novel triplets in selected advanced solid tumors: belrestotug with
dostarlimab and GSK’s investigational anti-CD96 antibody, and
belrestotug with dostarlimab and GSK’s investigational anti-PVRIG
antibody.
- Additional studies include the continued advancement of the
monotherapy dose escalation part of a Phase 1/2 trial evaluating
belrestotug as both a monotherapy and in combination with Bristol
Myers Squibb’s iberdomide in multiple myeloma.
Adenosine
PathwayInupadenant
(EOS-850): Designed as an insurmountable and highly
selective small molecule antagonist of the adenosine
A2A receptor, the only high-affinity adenosine receptor
expressed on multiple immune cells found in the tumor
microenvironment. Highlights include:
- Progression of the ongoing two-part Phase 2 trial in post-IO
metastatic non-squamous NSCLC to evaluate the combination of
inupadenant with platinum-doublet chemotherapy compared to standard
platinum-doublet chemotherapy.
EOS-984: First-in-class
small molecule program targeting a novel mechanism in the adenosine
pathway.
- The company has initiated enrolling patients in its Phase 1
trial of EOS-984.
- This complementary clinical development program has the
potential to fully reverse the profound immunosuppressive action of
adenosine on T and B cells. EOS-984’s effects have been shown
preclinically to be enhanced by combining with inupadenant and
other standards of care.
Second Quarter 2023 Financial
Results
- Cash and Investment Position: The
company’s cash, cash equivalents, and investments position was
$677.5 million as of June 30, 2023, as compared to $791.9 million
as of June 30, 2022. The company continues to expect its cash
balance to provide runway into 2026.
- Research and Development (R&D)
Expenses: R&D expenses were $29.2 million and
$54.9 million for the quarter and six months ended June 30, 2023,
respectively, as compared to $26.9 and $48.0 million for the same
quarter and six months of 2022, respectively. The increases in each
comparative period were primarily due to increases in activities
related to the belrestotug, inupadenant, and EOS-984 programs.
- General and Administrative (G&A)
Expenses: G&A expenses were $13.4 million and
$25.4 million for the quarter and six months ended June 30, 2023,
respectively, as compared to $11.5 million and $22.1 million for
the same quarter and six months of 2022, respectively. The
increases were primarily due to increases in headcount and related
costs compared to the same quarter and six months last year.
- Net Income/Loss: Net loss attributable to
common shareholders was $34.3 million, or net loss of $0.96 per
basic and diluted share for the quarter ended June 30, 2023, as
compared to a net income of $5.6 million, or a net income of $0.16
per basic share and $0.15 per diluted share for the same quarter of
2022. Net loss attributable to common shareholders was $49.9
million, or net loss of $1.39 per basic and diluted share for the
six months ended June 30, 2023, as compared to a net income of
$75.2 million, or a net income of $2.12 per basic share and $1.98
per diluted share for the same six months of 2022.
About iTeos Therapeutics,
Inc.iTeos Therapeutics is a clinical-stage
biopharmaceutical company pioneering the discovery and development
of a new generation of immuno-oncology therapeutics for patients.
iTeos Therapeutics leverages its deep understanding of tumor
immunology and immunosuppressive pathways to design novel product
candidates with the potential to restore the immune response
against cancer. The Company’s innovative pipeline includes three
clinical-stage programs targeting novel, validated immuno-oncology
pathways designed with optimized pharmacologic properties for
improved clinical outcomes, including the TIGIT:CD226 axis and the
adenosine pathway. iTeos Therapeutics is headquartered in
Watertown, MA with a research center in Gosselies, Belgium.
Internet Posting of
InformationiTeos routinely posts information that may be
important to investors in the 'Investors' section of its website
at www.iteostherapeutics.com. The Company encourages investors
and potential investors to consult our website regularly for
important information about iTeos.
Forward-Looking StatementsThis
press release contains forward-looking statements. Any statements
that are not solely statements of historical fact are
forward-looking statements. Words such as “believe,” “anticipate,”
“plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,”
“potential,” “possible” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements include statements relating to the potential benefits
of belrestotug, inupadenant, and EOS-984; the expectation
that our development pipeline will make significant progress in the
second half of 2023; the potential of the combination of
dostarlimab with belrestotug to become a best-in-class program; the
expectation that EOS-984 will deepen our understanding of the
mechanisms of adenosine-mediated immunosuppression and EOS-984’s
potential to reinforce the unique, insurmountable profile of
inupadenant; iTeos being poised for an abundance of opportunity in
2024, including the presentation of data from the Phase 2 clinical
trials treating patients with NSCLC and HNSCC; our clinical plans
and upcoming milestones, including initiating Phase 3
registrational studies evaluating belrestotug and dostarlimab
combination; and iTeos having cash runway into 2026 through a
number of impactful milestones across our portfolio.
These forward-looking statements involve risks
and uncertainties, many of which are beyond iTeos’ control. Actual
results could materially differ from those stated or implied by
these forward-looking statements as a result of such risks and
uncertainties. Known risk factors include the following: market
conditions; the expected benefits and opportunities related to the
agreement between iTeos and GSK may not be realized or may take
longer to realize due to a variety of reasons, including any
inability of the parties to perform their commitments and
obligations under the agreement, challenges and uncertainties
inherent in product research and development and manufacturing
limitations; iTeos may encounter unanticipated costs or may expend
cash more rapidly or more slowly than currently anticipated due to
challenges and uncertainties inherent in product research and
development and biologics manufacturing; success in preclinical
testing and early clinical trials does not ensure that later
clinical trials will be successful, and early results from a
clinical trial do not necessarily predict final results; the data
for our product candidates may not be sufficient for obtaining
regulatory approval to move into later stage trials or to
commercialize products; iTeos may not be able to execute on its
business plans, including meeting its expected or planned
regulatory milestones and timelines, research and clinical
development plans, and bringing its product candidates to market,
for various reasons, some of which may be outside of iTeos’
control, including possible limitations of company financial and
other resources, manufacturing limitations that may not be
anticipated or resolved for in a timely manner, negative
developments in the field of immuno-oncology, such as adverse
events or disappointing results, including in connection with
competitor therapies, and regulatory, court or agency decisions
such as decisions by the United States Patent and Trademark Office
with respect to patents that cover our product candidates; and
those risks identified under the heading “Risk Factors” in iTeos’
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023
filed with the Securities and Exchange Commission (SEC) as well as
other SEC filings made by the Company which you are encouraged to
review. Statements regarding the Company’s cash runway do not
indicate when the Company may access the capital markets.
Any of the foregoing risks could materially and
adversely affect iTeos’ business, results of operations and the
trading price of iTeos’ common stock. We caution investors not to
place considerable reliance on the forward-looking statements
contained in this press release. iTeos does not undertake any
obligation to publicly update its forward-looking statements other
than as required by law.
For further information, please
contact:
Investor Contact:Carl
MauchiTeos Therapeutics, Inc.carl.mauch@iteostherapeutics.com
Media
Contact:media@iteostherapeutics.com
iTeos Therapeutics (NASDAQ:ITOS)
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