iTeos Reports First Quarter 2023 Financial Results and Provides Business Updates
10 Mayo 2023 - 6:01AM
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 first quarter ended March
31, 2023 and provided business updates on belrestotug, its
anti-TIGIT antibody; inupadenant, its adenosine A2A receptor
antagonist; and EOS-984, a first-in-class small molecule program
targeting a novel mechanism in the adenosine pathway.
“iTeos is entering 2023 from a position of strength. We are
thoughtfully and methodologically advancing both our lead programs
through clinical development to fully unlock their potential.
Notably, we’re focused on progressing our multiple clinical studies
with belrestotug and GSK’s Jemperli (dostarlimab), with continuing
clinical development with both doublet and novel triplets. This
includes the ongoing preparations for our first Phase 3 study in
first line non-small cell lung cancer with the doublet of
belrestotug and dostarlimab, which we are targeting for study
initiation by the end of the year. For our adenosine pathway
programs, we also remain on track with our first-in-class small
molecule program EOS-984, as it enters the clinic in the near term.
These advancements follow recently presented biomarker data at the
American Association for Cancer Research (AACR) meeting, which have
expanded our understanding of the mechanisms of adenosine-mediated
immunosuppression, opening up avenues to new patient selection
strategies,” said Michel Detheux, Ph.D., president and chief
executive officer of iTeos. “Looking ahead, we will continue to
leverage our expertise in tumor biology alongside our ability to
evaluate novel combinations with our therapeutic candidates, as we
continue to execute on our mission to bring a new generation of
treatment options to those living with cancer.”
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 agent
through multiple combination studies is on track. Highlights
include:
- Ongoing randomized Phase 2 trial assessing the doublet of
dostarlimab with belrestotug in previously untreated advanced /
metastatic non-small cell lung cancer (NSCLC).
- Ongoing Phase 2 expansion study assessing the doublet of
dostarlimab with belrestotug in first line advanced or metastatic
head and neck squamous cell carcinoma.
- Phase 1b trials ongoing exploring 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.
- 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.
- Data describing a novel mechanism of action of inupadenant in
tumor tissue was presented at the American Association for Cancer
Research meeting in April 2023. Translational analysis of tumor
material from inupadenant clinical trials demonstrated that the
predominant cell type in tumor tissue expressing high levels of the
target A2A receptor were in fact antibody secreting cells.
Additionally, these cells were shown in vitro to be suppressed by
adenosine and that such suppression could be reversed by
inupadenant.
EOS-984: First-in-class small molecule program
targeting a novel mechanism in the adenosine pathway.
- 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.
- The company completed Investigational New Drug / Clinical
Trials Application-enabling activities, including toxicity studies,
and anticipates initiating clinical studies for EOS-984 mid-year
2023.
First Quarter 2023 Financial Results
- Cash and Investment Position: The company’s
cash, cash equivalents, and investments position was $706.6 million
as of March 31, 2023, as compared to $824.0 million as of March 31,
2022. The company continues to expect its cash balance to provide
runway into 2026.
- Research and Development (R&D) Expenses:
R&D expenses were $25.6 million for the quarter ended March 31,
2023, as compared to $21.1 million for the same quarter of 2022.
The increase was primarily due to an increase in activities related
to belrestotug and inupadenant clinical trials.
- General and Administrative (G&A) Expenses:
G&A expenses were $11.9 million for the quarter ended March 31,
2023, as compared to $10.6 million for the same quarter of 2022.
The increase was primarily due to an increase in headcount and
related costs compared to the same quarter last year.
- Net Income/Loss: Net loss attributable to
common shareholders was $15.6 million, or net loss of $0.44 per
basic and diluted share, for the quarter ended March 31, 2023, as
compared to a net income of $69.6 million, or a net income of $1.96
per basic share and $1.82 per diluted share, for the same quarter
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 two clinical-stage programs
targeting novel, validated immuno-oncology pathways designed with
optimized pharmacologic properties for improved clinical outcomes.
The first antibody product candidate, belrestotug, is a high
affinity, potent, anti-TIGIT antibody with a functional Fc domain,
designed to enhance the anti-tumor response through a multifaceted
immune modulatory mechanism, currently progressing in multiple
indications in collaboration with GSK. The Company is also
advancing inupadenant, a next-generation adenosine
A2A receptor antagonist tailored to overcome cancer
immunosuppression, in proof-of-concept trials. 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 potential of our
biomarker data to open avenues to new patient selection strategies;
our plan to continue executing on our mission to bring a new
generation of treatment options to those living with cancer; our
clinical plans and upcoming milestones for 2023, including our
expectation that EOS-984 will enter the clinic in mid-2023 and our
plan to initiate a phase 3 study in 1L NSCLC with the doublet of
belrestotug and dostarlimab by the end of 2023; 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, 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 March 31, 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:Matthew GalliTeos
Therapeutics, Inc.matthew.gall@iteostherapeutics.com
Media Contact:media@iteostherapeutics.com
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