iTeos Reports Third Quarter 2021 Financial Results and Provides Corporate Updates
November 10 2021 - 4:01PM
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
third quarter ended September 30, 2021 and provided recent business
highlights.
“We continued to make significant clinical progress advancing
our next-generation immunotherapies in multiple cancer indications.
We officially closed our transformational collaboration with GSK,
allowing us to initiate novel immunotherapy combinations with the
potential to improve outcomes for patients. This includes pairing
GSK’s recently approved anti-PD-1, Jemperli (dostarlimab) with our
anti-TIGIT monoclonal antibody, EOS-448, and with both EOS-448 and
our highly differentiated clinical-stage A2A adenosine receptor
antagonist, inupadenant,” said Michel Detheux, Ph.D., president and
chief executive officer of iTeos. “We are pleased to have started
executing our accelerated clinical development plans, initiating
dosing in cohorts evaluating EOS-448 in combination with
pembrolizumab and with inupadenant. We have also begun dosing
patients with PD-1 resistant melanoma in a trial evaluating
inupadenant plus pembrolizumab. We remain focused on converting our
scientific innovation into improved clinical outcomes for patients
and plan to initiate multiple trials of additional combinations in
the coming months.”
Program Highlights
EOS-448: IgG1 anti-TIGIT monoclonal
antibody designed to engage the Fc gamma receptor (FcγR) and to
enhance the anti-tumor response through a multifaceted
mechanism.
- In July 2021, iTeos closed its
development and commercialization collaboration agreement with GSK
for EOS-448 which was first announced in June 2021. iTeos received
the full $625 million upfront payment and is eligible to receive up
to $1.45 billion in potential milestone payments upon the
achievement of certain development and commercial milestones as
part of the agreement.
- iTeos and GSK are advancing various
novel combinations of potential next generation immuno-oncology
agents. Two trials will be initiated in the coming months. The
first, assessing the doublet of GSK’s anti-PD-1, (dostarlimab),
with EOS-448 and the second, a triplet of this combination adding
inupadenant.
- In September, iTeos dosed the first
patients in a clinical trial of EOS-448 in combination with
pembrolizumab and in combination with inupadenant in patients with
solid tumors.
- The company will initiate a clinical
trial in the first quarter of 2022 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 has completed patient
enrollment in the cohort evaluating the safety of inupadenant in
combination with chemotherapy and with pembrolizumab as well as the
monotherapy expansion cohort in prostate cancer.
- The company has initiated an
expansion cohort evaluating inupadenant in combination with
pembrolizumab in patients with PD-1-resistant melanoma.
- Based on results presented at
ASCO in June 2021, demonstrating that A2A receptor expression is
associated with clinical outcomes in patients with solid tumors
treated with single agent inupadenant, iTeos plans to explore a
patient selection biomarker in the ongoing Phase 1b/2a trial.
- The company plans to advance
inupadenant into randomized controlled trials in combination based
on the established safety and tolerability profile in combinations
and encouraging clinical data observed to date.
Preclinical programs: iTeos continues to
progress research programs focused on additional targets that
address pathways of immunosuppression and complement the mechanism
of action of the A2AR and TIGIT programs. As previously guided,
iTeos has nominated an additional candidate targeting a new
mechanism in the adenosine pathway for Investigational New
Drug-enabling studies.
Upcoming Events
- Piper Sandler 33rd Annual Healthcare
Conference, November 30 – December 2, 2021
Third Quarter 2021 Financial Results
- Cash
Position: The Company had cash and cash equivalents
of $899.8 million as of September 30, 2021, compared to $340.0
million as of September 30, 2020. This cash balance provides a
runway into 2026.
- License Revenue:
License revenue was $104.3 million for the quarter ended September
30, 2021, compared with $0 million for the same quarter of 2020.
This revenue was due to the recognition of a portion of the upfront
payment received as a result of the license and collaboration
agreement with GSK during the quarter. Additional information
regarding revenue recognition related to the collaboration
agreement will be included in the company’s Form 10-Q for the
quarter ended September 30, 2021.
- Research and Development
(R&D) Expenses: R&D expenses were $16.1
million for the quarter ended September 30, 2021, compared to $8.7
million for the same quarter of 2020. This increase was
primarily due to an increase in activities related to clinical
trials for EOS-448 and inupadenant, increased spending for the
company’s preclinical programs and increased headcount.
- General and Administrative
(G&A) Expenses: G&A expenses were $8.8
million for the quarter ended September 30, 2021, compared to
$4.8 million for the same quarter of 2020. This increase was
primarily due to increased headcount, professional fees and other
costs associated with becoming a public company
- Net
Income/Loss: Net income attributable to common
shareholders was $69.6 million, or a net income of $1.98 per basic
share and $1.86 per diluted share, for the quarter ended September
30, 2021, as compared to a net loss attributable to common
shareholders of $11.6 million, or a net loss of $0.48 per basic and
diluted share, for the same quarter of 2020.
Conference Call Details:iTeos Therapeutics will
host a conference call and webcast today, Wednesday, November 10th,
at 4:30 p.m. ET. To access the live conference call, please dial
833-927-1758 (domestic) or 929-526-1599 (international) and refer
to conference access code 861337. A live audio webcast of the event
will also be accessible from the News and 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 one week following the
call.
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 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 Cambridge, MA with a
research center in Gosselies, Belgium.
Internet Posting of Information
iTeos 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 Statements In 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 our
clinical plans and upcoming milestones, including our plans to
initiate a clinical trial with the doublet of GSK’s anti-PD-1,
Jemperli (dostarlimab), and EOS-448 and a triplet of this
combination adding inupadenant, to initiate multiple trials of
additional combinations in the coming months, to initiate a
clinical trial in the first quarter of 2022 evaluating EOS-448 as
both a monotherapy and in combination with BMS’ iberdomide in
patients with multiple myeloma, to explore a patient selection
biomarker in the ongoing Phase 1b/2a trial evaluating inupadenant,
and to advance inupadenant into randomized controlled trials in
combination; having cash runway into 2026 to support clinical
development plans for EOS-448 and inupadenant and growing pipeline
of preclinical programs; the potential benefits of our
collaboration with GSK, including planned clinical trials and the
potential milestone payments under the agreement; and the potential
benefits of our product candidates.
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 September 30, 2021 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 Contacts:Ryan BakeriTeos Therapeutics,
Inc.Ryan.Baker@iteostherapeutics.com
Media Contacts:media@iteostherapeutics.com
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