iTeos Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
March 23 2022 - 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
fourth quarter and full year ended December 31, 2021 and provided
recent corporate highlights.
“In 2021, we laid a strong foundation for both of our
differentiated clinical-stage immunotherapy programs EOS-448, our
FcγR-engaging anti-TIGIT antibody, and inupadenant, our adenosine
A2A receptor antagonist. The data we shared over the course of the
year validates our excitement around both candidates as potentially
differentiated therapies capable of harnessing the immune system to
improve outcomes for patients with several types of advanced
cancers,” said Michel Detheux, Ph.D., president and chief executive
officer of iTeos. “Anticipating the advancement of both EOS-448 and
inupadenant from early to late-stage clinical development with
novel combinations, we have built a global team to fuel the
execution of our robust clinical development plans throughout 2022.
This year is expected to be critical in terms of data generation
for the TIGIT and adenosine fields, and we’re excited to play a key
role in growing the body of evidence that will inform how these
targets can be harnessed for patients as safely and quickly as
possible.”
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 multifaceted mechanisms.
- In collaboration with GSK, iTeos is initiating various
combinations to advance this next generation immuno-oncology agent:
- Began dosing 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) with EOS-448.
- Planning three registration-directed trials combining EOS-448
with Jemperli in 1L NSCLC PDL1 high, head and neck squamous cell
carcinoma (HNSCC) and a third indication targeting an additional
immune-responsive tumor.
- Initiating Phase 1b trials with novel triplets, including
Jemperli with EOS-448 and inupadenant in patients with advanced
solid tumors and EOS-448 with Jemperli and GSK’s investigational
anti-CD96 antibody in patients with NSCLC.
- 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 trial.
- In December 2021, favorable preclinical data generated in
collaboration with Fred Hutchinson Cancer Research Center were
presented at the 63rd American Society of Hematology (ASH) Annual
Meeting & Exposition. Based on this data, iTeos is advancing an
open-label dose-escalation/expansion Phase 1/2 trial of EOS-448 as
a monotherapy and in combination with Bristol Myers Squibb’s
iberdomide - a novel, potent oral cereblon E3 ligase modulator
(CELMoD®) with or without dexamethasone, in adults with relapsed or
refractory multiple myeloma.
- The company will present 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 presentation at
the upcoming American Association for Cancer Research (AACR) Annual
Meeting taking place April 8-13, 2022 in New Orleans,
Louisiana.
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 to evaluate the
combination of inupadenant with chemotherapy compared to standard
of care in an undisclosed solid tumor indication.
- The Company is also evaluating inupadenant in combination with
pembrolizumab in PD-1 resistant melanoma in an ongoing Phase 2a
trial
- iTeos is evaluating patient and indication selection biomarkers
in an ongoing Phase 1b/2a trial of inupadenant as a monotherapy in
patients with solid tumors.
Preclinical programs: Building on the company’s
successful track record of advancing differentiated programs from
discovery into the clinic, iTeos continues to progress research
programs focused on additional targets that address pathways of
immunosuppression. In 2021, iTeos nominated an additional candidate
targeting a new mechanism in the adenosine pathway for
Investigational New Drug-enabling studies.
Upcoming Events
- AACR Annual Meeting, April 8-13, 2022
- Late-Breaking Abstract Title: Pharmacodynamic
assessment of a-TIGIT mAb EOS-448 highlights multiple FcγR-mediated
mode-of-actions in blood and tumor of patients with advanced solid
tumors; Wednesday, April 13 from 9:00am – 12:30pm CDT
- Session Title: Late Breaking Research:
Experimental and Molecular Therapeutics 2
- Abstract Number: LB189 / Section 16
Fourth Quarter and Full Year 2021 Financial
Results
- Cash Position: The Company’s cash and cash
equivalent position was $848.5 million as of December 31, 2021, as
compared to $336.3 million as of December 31, 2020. Cash balance
provides runway into 2026.
- Research and Development (R&D) Expenses:
R&D expenses were $17.4 million for the quarter and $59.4
million for the full year ended December 31, 2021, as compared to
$9.2 million for the fourth quarter and $29.9 million for the full
year of 2020. The increase was primarily due to an increase in
activities related to clinical trials for EOS-448 and Inupadenant,
as well as preclinical programs.
- General and Administrative (G&A) Expenses:
G&A expenses were $9.6 million for the quarter and $40.5
million for the full year ended December 31, 2021, as compared to
$5.7 million for the fourth quarter and $15.3 million for the full
year of 2020. The increase was primarily due to an increase in
professional fees related to the Company’s collaboration with GSK,
in addition to an increase in professional fees associated with the
Company’s status as a publicly traded company.
- Net Income/Loss: Net income attributable to
common shareholders was $184.9 million, or a net income of $5.24
per basic share and $4.88 per diluted share, for the quarter ended
December 31, 2021, as compared to a net loss of $14.9 million, or a
net loss of $0.43 per basic and diluted share, for the fourth
quarter of 2020. Net income was $214.5 million, or a net income of
$6.10 per basic share and $5.68 per diluted share, for the year
ended December 31, 2021, as compared to a net loss of $43.4
million, or a net loss of $2.88 per basic and diluted share, for
the full year of 2020.
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 with the
goal of improving 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 of EOS-448 and inupadenant to be best-in-class therapies
capable of harnessing the immune system to improve outcomes for
patients with several advanced cancers; our clinical plans and
upcoming milestones, including our plan to start three
registration-directed trials combining EOS-448 with Jemperli in 1L
NSCLC PDL1 high, head and neck squamous cell carcinoma (HNSCC) and
a third indication targeting an additional immune-responsive tumor;
and having cash runway into 2026 to support clinical development
plans for EOS-448 and 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 Annual Report on Form 10-K for the year
ended December 31, 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 Contact:Ryan BakeriTeos Therapeutics,
Inc.Ryan.Baker@iteostherapeutics.com
Media
Contact:media@iteostherapeutics.com
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