iTeos Reports Third Quarter 2023 Financial Results and Provides Business Updates
07 Novembro 2023 - 9:00AM
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 third quarter ended
September 30, 2023 and provided a business update.
“We have seen great progress over the third
quarter with the initiation of GALAXIES H&N-202, a Phase 2
trial evaluating the belrestotug and dostarlimab doublet as well as
novel IO combinations including a triplet in head and neck squamous
cell carcinoma, enrollment completion of the belrestotug
monotherapy arm in the Phase 2 TIG-007 trial, and enrollment
completion of the first dose cohort in the Phase 1 trial of
EOS-984,” said Michel Detheux, Ph.D., president and chief executive
officer of iTeos. “Furthermore, we remain encouraged that the
belrestotug + dostarlimab doublet represents a high quality
TIGIT:PD-1 combination. Belrestotug demonstrated meaningful
clinical benefit as a monotherapy in solid tumors in the Phase 1
trial and data presented at ESMO this year from GSK's PERLA trial
showed dostarlimab and pembrolizumab had similar efficacy in 1L
metastatic non-squamous NSCLC, with a positive numerical trend in
OS outcomes favoring dostarlimab plus chemotherapy compared to
pembrolizumab plus chemotherapy. With this continued progress
across our programs, our ambitions are high and we look forward to
providing updates on data readouts in 2024, including the Phase 2
GALAXIES LUNG-201, Phase 2 TIG-006 HNSCC, Phase 2 A2A-005 and
EOS-984's Phase 1 trial.”
Program Highlights
Belrestotug (EOS-448/GSK4428859A):
- In collaboration with GSK, multiple
combination studies evaluating late-stage development of
belrestotug as a potential next-generation immuno-oncology (IO)
agent are progressing as expected.
- Trial updates include:
- Initiation of GALAXIES H&N-202,
a Phase 2 platform study assessing the belrestotug + dostarlimab
doublet and novel IO combinations including a CD96 triplet in
first-line patients with PD-L1 positive recurrent / metastatic head
and neck squamous cell carcinoma (HNSCC).
- Completed enrollment of monotherapy
dose escalation arm in a Phase 1/2 trial evaluating belrestotug and
in combination with Bristol Myers Squibb’s iberdomide in multiple
myeloma.
- Preparation underway for Phase 3
registrational studies that will evaluate the belrestotug +
dostarlimab doublet combination.
- Ongoing randomized GALAXIES
LUNG-201 Phase 2 platform trial assessing the belrestotug +
dostarlimab doublet and CD96 in previously untreated advanced /
metastatic non-small cell lung cancer (NSCLC).
- Ongoing Phase 2 TIG-006 expansion
study assessing the belrestotug + dostarlimab doublet in first line
PD-L1 positive advanced or metastatic HNSCC.
- Ongoing Phase 1b TIG-006 expansion
study assessing the triplet of belrestotug, dostarlimab, and
chemotherapy in previously untreated advanced / metastatic
NSCLC.
- Continued advancement of Phase 1b
trials exploring the addition of two novel triplets in selected
advanced solid tumors: belrestotug with dostarlimab and GSK’s
investigational anti-CD96 antibody, and belrestotug with
dostarlimab and GSK’s investigational anti-PVRIG antibody.
Adenosine Pathway
Inupadenant (EOS-850):
- Continued progression of the
two-part A2A-005 Phase 2 trial with inupadenant and
platinum-doublet chemotherapy in post-IO metastatic non-squamous
NSCLC. Topline data from Phase 2 A2A-005 are anticipated in late
2024.
EOS-984:
- Completed enrollment of the first
dose cohort and continued advancement in the dose escalation of the
Phase 1 trial in advanced malignancies. Topline data from the Phase
1 trial are anticipated in late 2024.
Third Quarter 2023 Financial
Results
- Cash and Investment
Position: The Company’s cash, cash equivalents, and
investments position was $644.9 million as of September 30, 2023,
as compared to $752.2 million as of September 30, 2022. The Company
continues to expect its cash balance to provide runway through
2026.
- Research and Development
(R&D) Expenses: R&D expenses were $30.6 million
for the quarter ended September 30, 2023, as compared to $23.9
million for the same quarter of 2022. The increases in each
comparative period were primarily due to increases in activities
related to the belrestotug, inupadenant, and EOS-984 programs.
- General and Administrative
(G&A) Expenses: G&A expenses were $12.6 million
for the quarter ended September 30, 2023, as compared to $10.8
million for the same quarter of 2022. The increases were primarily
due to increases in headcount and related costs compared to the
same quarter and nine months last year.
- Net Income/Loss:
Net loss attributable to common shareholders was $32.2 million, or
net loss of $0.90 per basic and diluted share for the quarter ended
September 30, 2023, as compared to a net income of $1.0 million, or
a net income of $0.03 per basic and diluted share for the same
quarter of 2022.
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 three clinical-stage
programs targeting novel, validated immuno-oncology pathways
designed with optimized pharmacologic properties for improved
clinical outcomes, including the TIGIT:CD226 axis and the adenosine
pathway. iTeos Therapeutics is headquartered in Watertown, MA with
a research center in Gosselies, Belgium.
About Belrestotug (EOS-448/
GSK4428859A)Belrestotug is an anti-TIGIT human
immunoglobulin G1, or IgG1, antibody with a functional Fc domain,
designed to enhance the anti-tumor response through a multifaceted
immune modulatory mechanism. The drug has an optimized affinity and
potency to inhibit the suppressive function of TIGIT and to
activate T cell and NK cell killing of tumor cells. The therapeutic
candidate is currently progressing in multiple indications in
collaboration with GSK.
About Inupadenant (EOS-850) Inupadenant is
next-generation adenosine A2A receptor antagonist optimized for
activity at high adenosine concentrations in solid tumors and
designed to inhibit the ATP-adenosine pathway by specifically
targeting A2AR, which is the primary adenosine receptor on immune
cells with a high affinity for adenosine. It has the potential for
enhanced antitumor activity as compared to other A2AR antagonists
currently in clinical development. The therapeutic candidate is
currently in Phase 2 studies.
About EOS-984EOS-984 is a first-in-class small
molecule program we are developing to inhibit the immunosuppressive
activity of adenosine, targeting a novel mechanism in the adenosine
pathway. The therapeutic candidate has the potential to fully
reverse the profound immunosuppressive action of adenosine on T and
B cells and is currently in Phase 1 development. Preclinical
studies have demonstrated enhanced effects by combining EOS-984
with inupadenant in addition to other standards of care.
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 StatementsThis press release
contains forward-looking statements. Any statements that are not
solely statements of historical fact are 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
belrestotug, inupadenant, and EOS-984; our belief that belrestotug
+ dostarlimab doublet represents a high quality TIGIT:PD-1
combination; our plan to provide updates on data readouts in 2024,
including GALAXIES LUNG-201, TIG-006 HNSCC, A2A-005 and EOS-984's
Phase 1 trial; our plan to have topline data from the Phase 2
A2A-005 trial and the Phase 1 trial in EOS-984 in late 2024; our
plan to initiate Phase 3 registrational studies that will evaluate
the belrestotug + dostarlimab doublet combination; and iTeos having
cash runway through 2026 through a number of impactful milestones
across our portfolio.
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 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 or more slowly 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 to move into later stage trials or to
commercialize products; 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, negative
developments in the field of immuno-oncology, such as adverse
events or disappointing results, including in connection with
competitor therapies, and 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
those risks identified under the heading “Risk Factors” in iTeos’
Quarterly Report on Form 10-Q for the quarter ended September 30,
2023 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 other
than as required by law.
For further information, please contact:
Investor Contact:Carl MauchiTeos Therapeutics,
Inc.carl.mauch@iteostherapeutics.com
Media Contact:media@iteostherapeutics.com
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