iTeos Reports Second Quarter 2022 Financial Results and Provides Business Update
August 10 2022 - 4:01PM
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, 2022 and provided corporate highlights.
“In the second quarter of 2022, we have remained focused
expanding our late-stage development efforts for both of our
differentiated 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. “We’re pleased to be enrolling
non-small cell lung cancer patients in a Phase 2 trial for
inupadenant in combination with chemotherapy, which we described in
a trial in progress poster at ASCO in June. We also continue to
further advance our immunotherapy combinations with EOS-448, with
the initiation of the Phase 2 expansion trial evaluating GSK’s
anti-PD-1, Jemperli and EOS-448 in patients with head and neck
squamous cell carcinoma. Notably, we have multiple clinical trials
underway for EOS-448, which will help provide a comprehensive
understanding of the treatment potential of TIGIT as an
immunotherapy target.”
Program
HighlightsEOS-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.
- In collaboration with GSK, iTeos is evaluating the optimal
development pathway to assess EOS-448 as a potential
next-generation immune-oncology agent through multiple combination
studies and emerging data in the field. Recent highlights include:
- The companies have begun enrolling patients with 1L advanced or
metastatic head and neck squamous cell carcinoma (HNSCC) in the
Phase 2 expansion part of a trial assessing the doublet of GSK’s
anti-PD-1, Jemperli (dostarlimab), with EOS-448.
- The companies have initiated the Phase 1b trial evaluating the
novel triplet of EOS-448 with Jemperli and GSK’s investigational
anti-CD96 antibody. The companies also plan to initiate a Phase 1b
trial with EOS-448, Jemperli, and inupadenant in the coming
months.
- Enrollment continues in the monotherapy dose escalation part of
the Phase 1/2 trial evaluating EOS-448 as both a monotherapy and in
combination with Bristol Myers Squibb’s iberdomide in patients with
multiple myeloma.
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 enrolling patients in a randomized 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. The company presented a
description of this trial in a Trial in Progress poster at the 2022
American Society of Clinical Oncology (ASCO) Annual Meeting in
June.
- Enrollment is ongoing for the biomarker-high cohort of IO-001,
the ongoing Phase 1b/2a trial, evaluating 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: iTeos continues to
focus its research programs on novel targets that address pathways
of immunosuppression. This includes its candidate targeting a
first-in-class mechanism in the adenosine pathway which is under
evaluation in Investigational New Drug-enabling studies.
Second Quarter 2022 Financial Results
- Cash Position: The company’s cash and
cash equivalent position was $791.9 million as of June 30, 2022, as
compared to $302.9 million as of June 30, 2021. Cash balance is
expected to provide the company runway into 2026.
- Research and Development (R&D)
Expenses: R&D expenses were $26.9 million for the
quarter ended June 30, 2022, as compared to $14.2 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 $11.5 million for the
quarter ended June 30, 2022, as compared to $15.1 million for the
same quarter of 2021. The decrease was primarily due to one-time
legal and advisory fees incurred by the Company in 2021 associated
with the Collaboration and License Agreement with GSK. This
decrease was partially offset by additional costs related to
increased headcount.
- Net Income/Loss: Net income attributable
to common shareholders was $5.6 million, or net income of $0.16 per
basic share and $ 0.15 per diluted share, for the quarter ended
June 30, 2022, as compared to a net loss of $ 26.5 million, or a
net loss of $ 0.75 per basic and diluted share, for the same
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
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; the potential of our
EOS-448 clinical trials to help provide a comprehensive
understanding of the treatment potential of TIGIT as an
immunotherapy target; our clinical plans and upcoming milestones,
including our plan to initiate a Phase 1b trial with EOS-448,
Jemperli, and inupadenant; and having cash runway into 2026 to
support differentiated clinical programs for EOS-448 and
inupadenant and advance preclinical programs targeting
immunosuppression pathways.
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 June 30, 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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