iTeos Reports First Quarter 2022 Financial Results and Provides Business Update
May 12 2022 - 4:01PM
iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage
biopharmaceutical company pioneering the discovery and development
of a new generation of potentially differentiated immuno-oncology
therapeutics for patients, today reported financial results for the
first quarter ended March 31, 2022 and provided recent corporate
highlights.
“The iTeos team is off to a strong start of the year as we
continue to execute on the robust clinical development plans for
both of our differentiated clinical-stage immunotherapy programs,
EOS-448, our FcγR-engaging anti-TIGIT antibody, and inupadenant,
our adenosine A2A receptor antagonist,” said Michel Detheux, Ph.D.,
president and chief executive officer of iTeos. “Notably, the new
data we shared at AACR in April indicating a decrease of
TIGIT-expressing cells in patient tumor biopsies has heightened our
optimism for our program, as it showcases key evidence of target
engagement within the tumor in patients who were treated with
EOS-448 in a clinical trial. These data support the potential of
our TIGIT program and encourage us to pursue an efficient and
data-driven strategy that will guide future development activities.
We look forward to advancing EOS-448 and inupadenant with a goal of
bringing new and more effective treatment regimens for advanced
cancers.”
Program Highlights
EOS-448/GSK4428859A: IgG1 anti-TIGIT monoclonal
antibody designed to engage the Fc gamma receptor (FcγR) and to
enhance the anti-tumor response through multifaceted
mechanisms.
- The company presented preclinical and clinical analyses
supporting the multifaceted mechanism of action of EOS-448,
including data on pharmacodynamics within the tumor
microenvironment, as part of a late-breaking poster at the AACR
Annual Meeting in April. Data highlights are as follows:
- Cell-based assays demonstrated the higher potency of EOS-448
relative to competitor anti-TIGIT monoclonal antibodies and
provided the basis for its selection as a therapeutic
candidate.
- A decrease in TIGIT+ Tregs and potentially exhausted CD8 T
cells in peripheral blood of patients with advanced cancers
following treatment with EOS-448 provide evidence of target
engagement and of the multifaceted mechanisms of action for
EOS-448.
- Treatment of patients with EOS-448 resulted in a decrease of
TIGIT-expressing cells in the tumor, making EOS-448 the first
anti-TIGIT antibody to demonstrate target engagement in human
tumors.
- Preclinical analyses of different anti-TIGIT antibody isotypes
in combination with an anti-PD1 antibody in a murine cancer model
highlighted the importance of FcyR engagement in the anti-tumor
activity of TIGIT antibodies.
- In collaboration with GSK, iTeos is planning multiple
combination studies to evaluate EOS-448 as a potential
next-generation immuno-oncology agent. We are continuously
evaluating both internal and emerging data in the field to
determine the optimal development pathways:
- Enrollment is ongoing in a Phase 1b clinical trial in patients
with non-small cell lung cancer (NSCLC) assessing the doublet of
GSK’s anti-PD-1 (Jemperli (dostarlimab-gxly)) with EOS-448.
- iTeos is evaluating the doublets of pembrolizumab with EOS-448
and inupadenant with EOS-448 in patients with solid tumors in an
ongoing Phase 1/2 trial.
- Plans to initiate Phase 1b trials with novel triplets are on
track, including:
- Jemperli with EOS-448 and inupadenant in patients with advanced
solid tumors
- EOS-448 with Jemperli and GSK’s investigational anti-CD96
antibody in patients with NSCLC
- Enrollment is underway in a clinical trial evaluating EOS-448
as both a monotherapy and in combination with Bristol Myers
Squibb’s iberdomide in patients with multiple myeloma.
- iTeos is working together with GSK to evaluate how best to
proceed with additional clinical development of EOS-448 in light of
the recent release regarding the Roche SKYSCRAPER-01 study.
Inupadenant (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 different immune cells found in the tumor
micro-environment.
- iTeos is initiating a randomized Phase 2 trial mid-year in
metastatic non-small cell lung cancer (mNSCLC) to evaluate the
combination of inupadenant with chemotherapy compared to standard
of care. A description of this trial will be presented in a Trial
in Progress poster at the 2022 American Society of Clinical
Oncology (ASCO) Annual Meeting in June.
- Enrollment is ongoing in a Phase 2a trial evaluating
inupadenant in combination with pembrolizumab in PD-1 resistant
melanoma.
- iTeos has begun enrolling patients for the biomarker cohort of
IO-001, the ongoing Phase 1b/2a trial, which evaluates inupadenant
as a monotherapy in patients with solid tumors selected for high
biomarker expression in four cohorts: NSCLC, endometrial cancer,
head and neck squamous cell carcinoma and other solid tumors.
Preclinical programs: As part of the company’s
ongoing commitment to advancing differentiated programs from
discovery into the clinic, iTeos is focused on research programs
for novel targets that address pathways of immunosuppression,
including its candidate targeting a new mechanism in the adenosine
pathway which is under evaluation in Investigational New
Drug-enabling studies.
Upcoming Events
- American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, IL from June 3-7, 2022
- Abstract Title: Randomized phase 2 study
evaluating efficacy and safety of inupadenant in combination with
chemotherapy in adults with metastatic non–small cell lung cancer
(mNSCLC) who progressed on immunotherapy.
- Date and Time: June 6, 2022, 9:00 a.m.
EDT
- Session Title: Lung Cancer—Non-Small Cell
Metastatic
- Abstract Number: TPS9158
First Quarter 2022 Financial Results
- Cash Position: The company’s cash and cash
equivalent position was $824.0 million as of March 31, 2022, as
compared to $321.4 million as of March 31, 2021. Cash balance
provides the company runway into 2026.
- Research and Development (R&D) Expenses:
R&D expenses were $21.1 million for the quarter ended March 31,
2022, as compared to $11.6 million for the same quarter of 2021.
The increase was primarily due to an increase in activities related
to EOS-448 and inupadenant clinical trials along with increased
spending related to the company’s preclinical programs.
- General and Administrative (G&A) Expenses:
G&A expenses were $10.6 million for the quarter, as compared to
$7.0 million for the same quarter of 2021. The increase was
primarily due to increased headcount, professional fees, including
professional fees attributed to SEC reporting, SOX compliance and
consulting costs related to iTeos’ corporate structure in
Belgium.
- Net Income/Loss: Net income attributable to
common shareholders was $69.6 million, or net income of $1.96 per
basic share and $1.82 per diluted share, for the quarter ended
March 31, 2022, as compared to a net loss of $13.5 million, or a
net loss of $0.39 per basic and diluted share, for the first
quarter of 2021.
About iTeos Therapeutics, Inc.iTeos
Therapeutics is a clinical-stage biopharmaceutical company
pioneering the discovery and development of a new generation of
highly differentiated 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,
EOS-448, 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 into proof-of concept trials in several
indications following encouraging single-agent activity in Phase 1.
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 StatementsIn order to provide
iTeos’ investors with an understanding of its current results and
future prospects, this press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995 and other federal securities laws. Any
statements that are not statements of historical fact may be deemed
to be 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 EOS-448 and inupadenant; our plan to advance
EOS-448 and inupadenant with a goal of bringing new and more
effective treatment regimens for advanced cancers; our clinical
plans and upcoming milestones, including our plan to initiate a
randomized Phase 2 trial in mNSCLC to evaluate the combination of
inupadenant with chemotherapy compared to standard of care; and
having cash runway into 2026 to support clinical development plans
for EOS-448, inupadenant and growing pipeline of preclinical
programs.
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 than expected 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 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;
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, 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 the impact of the
COVID-19 pandemic; and those risks identified under the heading
“Risk Factors” in iTeos’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2022 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 based on events or circumstances
after the date hereof.
For further information, please contact:
Investor Contact:Ryan BakeriTeos Therapeutics,
Inc.Ryan.Baker@iteostherapeutics.com
Media Contact:media@iteostherapeutics.com
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