iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage
biopharmaceutical company pioneering the discovery and development
of a new generation of highly differentiated immuno-oncology
therapeutics for patients, today reported financial results for the
first quarter ended March 31, 2021 and provided recent business
highlights.
“Our current clinical strategy includes six studies for our two
clinical programs in different indications and combinations that
are expected to provide meaningful readouts before the end of 2022.
In addition to our recent EOS-448 Phase 1 data presentation at
AACR, we also continue to advance our adenosine A2A receptor
antagonist, inupadenant, and we look forward to reporting updated
data with evidence that expression of the A2A receptor in tumor
biopsy samples is associated with anti-tumor benefit at the
upcoming ASCO meeting in June,” said Michel Detheux, PhD, president
and chief executive officer of iTeos. “In addition to this progress
across our two lead programs, we also remain committed to our
ongoing discovery efforts to identify and advance new novel product
candidates that could expand our pipeline and continue to serve our
mission to improve the lives of people with cancer.”
Program Highlights
EOS-448: EOS-448 is an IgG1 antibody with
the ability to engage the Fc gamma receptor (FcγR) and to enhance
the anti-tumor response through a multifaceted mechanism.
- The company presented initial clinical and safety data from the
monotherapy dose escalation part of the Phase 1 trial in adult
patients with advanced solid tumors at the American Association for
Cancer Research (AACR) Annual Meeting in April 2021. These
preliminary data showed the drug was well-tolerated across dose
levels, caused depletion of TIGIT-expressing Treg cells in the
blood, providing evidence of target and FcyR engagement, and had
encouraging signs of anti-cancer activity.
- The company plans to advance EOS-448 into combination trials in
both checkpoint-naïve and resistant patients in mid-2021. These
Phase 1b trials will assess the safety of EOS-448 in combination
with pembrolizumab and with iTeos’ novel agent inupadenant in
patients with solid tumors, and as a monotherapy and in combination
with an Immunomodulatory Drug (IMiD) in patients with multiple
myeloma.
Inupadenant (EOS-850): Designed as a highly
selective small molecule antagonist of the adenosine A2A receptor.
Inupadenant is currently in an open-label multi-arm Phase 1/2a
clinical trial in adult patients with advanced solid tumors.
- iTeos is currently enrolling patients in three distinct cohorts
in its Phase 1/2a clinical trial as both as a single agent and in
combination. The initial cohort is evaluating inupadenant as a
monotherapy in prostate cancer, and the second cohort is evaluating
the safety of inupadenant in combination with pembrolizumab in
patients with solid tumors with planned expansions in prostate
cancer and melanoma. The final cohort is evaluating inupadenant in
combination with chemotherapy in patients with triple-negative
breast cancer.
- iTeos plans to report updated single-agent data, including
results from tumor biopsy analyses as part of an e-poster at the
upcoming 2021 American Society of Clinical Oncology (ASCO) Annual
Meeting held virtually June 4-8, 2021. The abstract will be
available on Wednesday, May 19th at 5:00 p.m. ET, and the e-poster
will be available for on-demand viewing starting on Friday, June 4
at 9:00 a.m. ET.Abstract Title: Phase 1 trial of
the adenosine A2A receptor antagonist inupadenant (EOS-850): Update
on tolerability, and antitumor activity potentially associated with
the expression of the A2A receptor within the
tumor.Abstract Number: 2562
Preclinical programs: iTeos continues to
progress research programs focused on additional targets that
address additional pathways of immunosuppression and complement the
mechanism of action of A2AR and TIGIT programs. iTeos expects to
nominate an additional product candidate for Investigational New
Drug-enabling studies before the end of 2021.
Upcoming Events
- Corporate presentation at the Jefferies Healthcare Conference,
June 1-4, 2021
- Present on inupadenant in an e-poster at the ASCO Annual
Meeting, June 4-8, 2021
- Corporate presentation at the Citi European Healthcare
Conference, June 15-16, 2021
First Quarter 2021 Financial Results
- Cash Position: The Company had cash and
cash equivalents of $321.4 million as of March 31, 2021, compared
to $147.7 million as of March 31, 2020. This cash balance
provides a runway into 2023.
- Research and Development (R&D)
Expenses: R&D expenses were $11.6 million for the
quarter ended March 31, 2021, compared to $5.8 million for the same
quarter of 2020. This increase was primarily due to an
increase in activities related to clinical trials for inupadenant
and EOS-448 and increased headcount.
- General and Administrative (G&A)
Expenses: G&A expenses were $7.0 million for
the quarter ended March 31, 2021, compared to $2.4 million for
the same quarter of 2020. The increase was primarily due to
increased headcount and professional fees and other costs
associated with becoming a publicly traded company.
- Net Loss: Net loss attributable to common
shareholders was $13.5 million, or a net loss of $0.39 per basic
and diluted share, for the quarter ended March 31, 2021, as
compared to $6.5 million, or a net loss of $25.53 per basic and
diluted share, for the same quarter of 2020.
Conference Call Details:iTeos Therapeutics will
host a conference call and webcast today, Thursday, May 13th, at
4:30 p.m. ET. To access the live event, please dial the numbers and
reference the conference ID listed below. A live audio webcast of
the event will also be accessible from the Events page of the
Company’s website at
https://investors.iteostherapeutics.com/news-and-events/events.The
archived webcast will be available approximately two hours after
the completion of the event and for 30 days following the call.
Dial-in Numbers: (833) 607-1661 (US/Canada)
(914) 987-7874 (International)Conference ID: 6160559
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 cancer
immunology and immunosuppressive pathways to design novel product
candidates with the potential to fully 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 initial 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. An open-label
Phase 1/2a clinical trial of EOS-448 is ongoing in adult cancer
patients with advanced solid tumors with preliminary data
indicating preliminary clinical activity as a monotherapy and a
favorable tolerability profile. The Company is also advancing
inupadenant, a next-generation adenosine A2A receptor antagonist
tailored to overcome cancer immunosuppression. iTeos is conducting
an open-label multi-arm Phase 1/2a clinical trial of inupadenant in
adult cancer patients with advanced solid tumors. Preliminary
results indicate encouraging single-agent activity in the dose
escalation portion of the trial. iTeos Therapeutics is
headquartered in Cambridge, MA with a research center in Gosselies,
Belgium.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of 1995
and other federal securities laws, including express or implied
statements regarding iTeos’ future expectations, plans and
prospects, including statements regarding the Company’s future
expectations and plans for presenting clinical data, the
anticipated timing of clinical trials and regulatory filings, and
the development of product candidates and advancement of clinical
programs, which are based on currently available information. All
statements other than statements of historical facts contained in
this press release, including statements regarding our strategy,
future financial condition, future operations, prospects, plans,
objectives of management and expected growth, are forward-looking
statements. In some cases, you can identify forward-looking
statements by terminology such as ‘‘aim,’’ ‘‘anticipate,’’
‘‘assume,’’ ‘‘believe,’’ ‘‘contemplate,’’ ‘‘continue,’’ ‘‘could,’’
‘‘design,’’ ‘‘due,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘goal,’’
‘‘intend,’’ ‘‘may,’’ ‘‘objective,’’ ‘‘plan,’’ ‘‘predict,’’
‘‘positioned,’’ ‘‘potential,’’ ‘‘seek,’’ ‘‘should,’’ ‘‘target,’’
‘‘will,’’ ‘‘would’’ and other similar expressions that are
predictions of or indicate future events and future trends, or the
negative of these terms or other comparable terminology and similar
expressions that constitute forward-looking statements under the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include statements about the initiation,
timing, progress and results of our current and future clinical
trials and current and future preclinical studies of our product
candidates, including our clinical trials of inupadenant, our
clinical trials of EOS-448 and of our research and development
programs; uncertainties inherent in clinical studies and in the
availability and timing of data from ongoing clinical trials; the
expected timing of announcing additional product candidates; the
enrollment of our ongoing clinical trials; whether interim results
from a clinical trial will be predictive of the final results of
the trial; whether results from preclinical studies or earlier
clinical studies will be predictive of the results of future
clinical trials; our ability to successfully establish or maintain
collaborations or strategic relationships for our product
candidates; the expected timing for submissions for regulatory
approval or review by governmental authorities; our financial
performance; whether our cash resources will be sufficient to fund
our foreseeable and unforeseeable operating expenses and capital
expenditure requirements; risks, uncertainties and assumptions
regarding the impact of the continuing COVID-19 pandemic on our
business, operations, strategies and anticipated timelines,
including mitigation efforts and economic effects, including but
not limited to our preclinical studies and future clinical trials;
and our plans to develop and commercialize our current product
candidates and any future product candidates and the implementation
of our business model and strategic plans for our business, current
product candidates and any future product candidates, and other
risks concerning iTeos’ programs and operations that are described
in additional detail in our Annual Report on Form 10-K and our
other filings made with the Securities and Exchange Commission from
time to time. Although our forward-looking statements reflect the
good faith judgment of management, these statements are based
solely on facts and circumstances currently known to iTeos. As a
result, you are cautioned not to rely on these forward-looking
statements. Any forward-looking statement made in this press
release speaks only as of the date on which it is made. iTeos
undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
the occurrence of certain events or otherwise.
For further information, please contact:
Investor Contacts:Ryan BakeriTeos Therapeutics,
Inc.Ryan.Baker@iteostherapeutics.com
Media Contacts:media@iteostherapeutics.com
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