iTeos Reports Second Quarter 2021 Financial Results and Provides Business Update
August 12 2021 - 07:00AM
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
second quarter ended June 30, 2021 and provided recent business
highlights.
“The last few months have been a transformative time for iTeos,
as we achieved significant milestones that will shape the future of
our company and help us in our mission to discover, develop and
deliver therapies that will improve the lives of people with
cancer. I am incredibly proud of our continued execution with our
clinical programs and strategic initiatives,” said Michel Detheux,
PhD, president, and chief executive officer of iTeos. “For our
TIGIT program, we announced a transformational strategic
collaboration with GSK that will allow us to combine our resources
and expand and accelerate the development program for EOS-448
through rapid evaluation of dostarlimab and triplet combinations
beginning in the coming months. With the rights iTeos retained, we
can maximize the value of EOS-448 for patients and our
shareholders. In addition to expanding our TIGIT program, the GSK
collaboration is also an important validation for our team’s
ability to identify and pursue best-in-class anti-tumor drug
candidates. To that end, we are excited to advance inupadenant, our
second clinical-stage program, which has demonstrated in a Phase 1
trial durable responses in two patients with checkpoint inhibitor
resistant tumors, good tolerability and a potentially predictive
biomarker which will help to drive tumor and patient selection in
upcoming trials. In the coming months, we look forward to advancing
inupadenant into proof-of-concept trials in several
indications.”
Program Highlights
EOS-448: IgG1 anti-TIGIT monoclonal antibody
designed to engage the Fc gamma receptor (FcγR) and to enhance
anti-tumor responses through a multifaceted mechanism of
action.
- In June 2021, iTeos and GSK announced an agreement to
co-develop and co-commercialize EOS-448. As part of the agreement,
iTeos received a $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.
GSK is responsible for 60% of expense in the global development
plan. The companies will co-commercialize and equally split profits
in the U.S. iTeos will be eligible to receive royalties on sales
outside of the U.S.
- In April 2021, 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.
These preliminary data show 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 early signs of anti-cancer activity in Phase 1,
including one partial response in a pembrolizumab-resistant
metastatic melanoma patient.
- The Company is working with GSK to rapidly initiate trials of
EOS-448 in combinations including with Jemperli (dostarlimab).
- iTeos will also advance EOS-448 in combination with
pembrolizumab and with 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 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.
- In June 2021, the company presented updated data from 43
patients in both the single-agent dose-escalation and expansion
portions of the ongoing open-label Phase 1/2a clinical trial,
including results from pre-treatment tumor biopsy analyses, as part
of an e-poster at the 2021 American Society of Clinical Oncology
(ASCO) Annual Meeting. Preliminary tumor biopsy analyses
demonstrate that A2AR expression assessed using a proprietary
assay, in patients with solid tumors treated with single agent
inupadenant is associated with clinical outcomes. Results also
provide evidence of durable antitumor activity in patients with
advanced solid tumors and indicate a safety and tolerability
profile consistent with previously reported data.
- Based on the encouraging monotherapy results, iTeos plans to
initiate inupadenant proof-of-concept trials in several indications
and will continue to use A2AR and other potential biomarkers to
select indications and patients most likely to benefit from
treatment.
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. iTeos expects to nominate
an additional product candidate which inhibits a novel target in
the adenosine pathway for Investigational New Drug-enabling studies
before the end of 2021.
Upcoming Events
- KBC Securities Life Sciences Conference, September 7
- Wells Fargo Healthcare Conference, September 9-10
- Morgan Stanley Global Healthcare Conference, September 9-10 and
13-15
- H.C. Wainwright Global Investment Conference, September
13-15
- Cantor Fitzgerald Global Healthcare Conference, September
27-30
Second Quarter 2021 Financial Results
- Cash Position: The Company had cash and
cash equivalents of $302.9 million as of June 30, 2021, compared to
$136.9 million as of June 30, 2020. Following receipt of the
upfront payment from GSK pursuant to the Company’s Collaboration
and License Agreement earlier in August 2021, the Company believes
that its existing cash and cash equivalents would enable it to fund
operating expenses and capital expenditure requirements into
2026.
- Research and Development (R&D)
Expenses: R&D expenses were $14.2 million for the
quarter ended June 30, 2021, compared to $6.1 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 and increased headcount.
- General and Administrative (G&A)
Expenses: G&A expenses were $15.1
million for the quarter ended June 30, 2021, compared to $2.4
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, along with
one-time legal and advisory fees incurred by the Company associated
with the Collaboration and License Agreement with GSK to co-develop
and co-commercialize EOS-448.
- Net Loss: Net loss attributable to common
shareholders was $26.5 million, or a net loss of $0.75 per basic
and diluted share, for the quarter ended June 30, 2021, as compared
to $10.3 million, or a net loss of $29.49 per basic and diluted
share, for the same quarter of 2020.
Conference Call Details:iTeos Therapeutics will
host a conference call and webcast today at 8:00am ET. To access
the live event, please use the following link and you will receive
access details via email:
https://www.incommglobalevents.com/registration/q4inc/8354/iteos-therapeutics-q2-2021-earnings-conference-call/
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.
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.
Forward-Looking StatementsIn order to provide
iTeos’ investors with an understanding of its current results and
future prospects, this press release contains statements that are
forward-looking. Any statements contained in this press release
that are not statements of historical fact may be deemed to be
forward-looking statements. Words such as “believes,”
“anticipates,” “plans,” “expects,” “will,” “may,” “intends,”
“prepares,” “looks,” “potential,” “possible” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements include statements relating to our
future operations, financial performance and projections, business
plans, market opportunities, priorities and research and
development programs and expected plans and milestones, including
milestones and royalty payments from GSK pursuant to the
collaboration agreement; GSK’s obligation to share responsibility
and costs for the global development of EOS-448; the collaboration
with GSK allowing us to combine our resources and expand and
accelerate the development program for EOS-448 through rapid
evaluation of dostarlimab and triplet combinations; the plan to
initiate studies for EOS-448 in the coming months; the
collaboration with GSK allowing us to maximize the value of EOS-448
for patients and our shareholders; our plan to initiate inupadenant
proof-of-concept trials in several indications and to continue to
use A2AR and other potential biomarkers to select indications and
patients most likely to benefit from treatment; our plan to
nominate an additional product candidate which inhibits a novel
target in the adenosine pathway for Investigational New
Drug-enabling studies before the end of 2021; and the expectation
that iTeos’ existing cash and cash equivalents would enable iTeos
to fund its operating expenses and capital expenditure requirements
into 2026.
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, 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
iTeos Therapeutics (NASDAQ:ITOS)
Historical Stock Chart
From Feb 2024 to Mar 2024
iTeos Therapeutics (NASDAQ:ITOS)
Historical Stock Chart
From Mar 2023 to Mar 2024