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 first quarter ended March
31, 2024 and provided a business update.
“After reviewing headline data for an interim
assessment of GALAXIES Lung-201, we are thrilled to announce that
belrestotug + dostarlimab exceeded our pre-defined efficacy
criteria for clinically relevant activity with clinically
meaningful tumor reduction at each dose. The data also indicate an
acceptable safety profile in line with the TIGIT:PD-1 class," said
Michel Detheux, Ph.D., president and chief executive officer of
iTeos. “We believe this early interim assessment supports our view
that quality of components matters and that our TIGIT:PD-1 doublet
has the potential to deliver differentiated clinical data. Our
GALAXIES clinical development plans remain on track, and we look
forward to GSK’s update on the GALAXIES program in June. We are
also excited to present data from GALAXIES Lung-201 at a medical
congress later in 2024.”
“Additionally, we completed enrollment with no
new safety signals observed and passed the futility analysis for
efficacy in both combined positive score (CPS) cohorts in the first
portion of the TIG-006 trial in first-line recurrent/metastatic
PD-L1 positive head and neck cancer. iTeos and GSK have agreed to
not continue beyond stage 1 recruitment in the open-label TIG-006
cohorts 2C & 2D and instead focus on generating randomized,
controlled data in the ongoing Phase 2 GALAXIES H&N-202
platform study to further support a path to late-stage development
in this indication. We are excited to provide an update on the
TIG-006 trial at a medical congress later this year,” concluded Dr.
Detheux.
Program Highlights
Belrestotug (EOS-448/GSK4428859A): IgG1
anti-TIGIT monoclonal antibody targeting first-line non-small cell
lung cancer (NSCLC) and head and neck squamous cell carcinoma
(HNSCC) in collaboration with GSK
- Preparation underway to advance
GALAXIES clinical program that will evaluate the belrestotug +
dostarlimab doublet
- GALAXIES Lung-201:
Interim assessment exceeded pre-defined efficacy criteria for
clinically relevant activity with clinically meaningful tumor
reduction and showed an acceptable safety profile in line with the
TIGIT:PD-1 class. Interim data from Phase 2 platform trial
assessing belrestotug + dostarlimab doublet in first-line advanced
/ metastatic PD-L1 high NSCLC anticipated in second half of
2024.
- GALAXIES
H&N-202: Enrollment ongoing in randomized Phase 2
platform study assessing belrestotug + dostarlimab doublet and a
triplet with GSK’s investigational anti-CD96 antibody, nelistotug,
in first-line patients with PD-L1 positive recurrent / metastatic
HNSCC.
- TIG-006 HNSCC:
Completed enrollment and passed futility analysis for efficacy of
both CPS arms of the first portion of TIG-006 in 1L HNSCC (Cohorts
2C & 2D). iTeos and GSK have agreed to not continue beyond
stage 1 recruitment in these open-label cohorts in order to focus
on the randomized, controlled GALAXIES H&N-202 trial. Topline
data from the first portion of TIG-006 Cohorts 2C & 2D
assessing belrestotug + dostarlimab doublet in first-line PD-L1
positive advanced / metastatic HNSCC anticipated in second half
2024.
- TIG-006 mNSCLC:
Enrollment completed in Phase 1b expansion trial assessing
belrestotug, dostarlimab, and chemotherapy triplet in first-line
advanced or metastatic NSCLC.
- Continued advancement of Phase 1b
trials exploring two novel triplets in advanced solid tumors:
belrestotug + dostarlimab and GSK’s nelistotug (anti-CD96
antibody), and belrestotug + dostarlimab and GSK’s investigational
anti-PVRIG antibody (GSK’562)
Adenosine Pathway
Inupadenant (EOS-850): insurmountable
small molecule antagonist targeting adenosine A2A receptor in
second-line NSCLC
- A2A-005: Completed
enrollment of Phase 2 A2A-005 dose escalation. Data from the dose
escalation portion of the Phase 2 trial with inupadenant and
platinum-doublet chemotherapy in post-IO metastatic non-squamous
NSCLC anticipated in late 2024.
EOS-984:
potential first-in-class small molecule
inhibiting ENT1, a dominant transporter of adenosine on lymphocytes
involved in T cell metabolism, expansion, effector function, and
survival
- Topline data from the Phase 1 trial
anticipated in the second half of 2024
First Quarter 2024 Financial
Results
- Cash and Investment
Position: The Company’s cash, cash equivalents, and
investments position, which included $13.0 million of receivables
from matured investments recorded in prepaid expense and other
current assets on the balance sheet, was $595.0 million as of March
31, 2024, as compared to $706.6 million as of March 31, 2023. Pro
forma cash, cash equivalents, and investments position were $715.0
million as of May 10, 2024, inclusive of approximately $120 million
in proceeds from the May 2024 registered direct offering. The
Company expects its cash balance to provide runway through 2027,
which includes the potential initiation of multiple Phase 3
registrational trials assessing the belrestotug + dostarlimab
doublet.
- Research and Development
(R&D) Expenses: R&D expenses were $34.5 million
for the quarter ended March 31, 2024, as compared to $25.6 million
for the same quarter of 2023. The increase compared to the
comparative period was primarily due to increases in activities
related to the belrestotug, inupadenant, and EOS-984 programs, and
included the addition of new R&D employees hired to help
advance these programs.
- General and Administrative
(G&A) Expenses: G&A expenses were $12.7 million
for the quarter ended March 31, 2024, as compared to $11.9 million
for the same quarter of 2023. The increase was primarily due to
increases in headcount and related costs and an increase in
stock-based compensation compared to the prior year. The increases
were partially offset by a decrease in recruiting costs.
- Net Income/Loss:
Net loss attributable to common shareholders was $38.2 million, or
net loss of $1.07 per basic and diluted share for the quarter ended
March 31, 2024, as compared to a net loss of $15.6 million, or a
net loss of $0.44 per basic and diluted share for the quarter ended
March 31, 2023.
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
immunosuppressive 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 Fc active human
immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T
cell immunoglobulin and immunoreceptor tyrosine-based inhibitory
motif domains (TIGIT), an important inhibitory receptor which
contributes to the suppression of innate immune responses against
cancer. As an optimized high-affinity, potent anti-TIGIT mAb,
belrestotug is designed to enhance the antitumor response through a
multifaceted immune modulatory mechanism by engaging with TIGIT and
FcγR, a key regulator of immune responses which induces cytokine
release and antibody dependent cellular cytotoxicity (ADCC). The
therapeutic candidate is progressing in multiple indications in
collaboration with GSK.
About Inupadenant (EOS-850)
Inupadenant is a next-generation small molecule antagonist
targeting adenosine A2A receptor (A2AR), the primary receptor on
immune cells whose activation by adenosine suppresses innate and
adaptive immune cell responses leading to inhibition of antitumor
responses. Optimized for potency, high selectivity of A2AR, and
activity at high adenosine concentrations in solid tumors,
inupadenant is uniquely designed with its insurmountable profile to
inhibit the ATP-adenosine pathway and has the potential for
enhanced antitumor activity as compared to other A2AR antagonists
in clinical development. The therapeutic candidate is in Phase 2
development.
About EOS-984EOS-984 is a
potential first-in-class small molecule targeting equilibrative
nucleoside transporter 1 (ENT1) designed to inhibit the
immunosuppressive activity of adenosine and restore immune cell
proliferation. The therapeutic candidate has the potential to fully
reverse the profound immunosuppressive action of adenosine on T and
B cells and is in Phase 1 development.
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
This 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; the
timing and content of the expected update from GSK on GALAXIES
program; the future prospects of belrestotug; our plans and
expected milestones, including initiating additional studies,
having topline data from TIG-006 HNSCC in 2024, presenting data
from GALAXIES Lung-201 and TIG-006 at a medical congresses in 2024,
having topline data from A2A-005 in late 2024, having topline data
from the Phase 1 trial in EOS-984 in the second half of 2024 and
intentions around trial enrollment and recruitment; and our
expectation that our cash balance will provide runway through 2026
across a number of impactful portfolio milestones.
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: interim
and early data may change as more patient data become available and
are subject to audit and verification procedures; 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’
Annual Report on Form 10-Q for the period ended March 31, 2024
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 or if 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 undue 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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