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, 2020 and recent business highlights.
“The completion of our successful IPO in July was a major
milestone for iTeos and further supports the advancement of our
highly differentiated immunotherapy pipeline, including our two
lead product candidates, our adenosine A2a receptor
antagonist, EOS-850, and TIGIT antagonist, EOS-448,” said Michel
Detheux, PhD, President and Chief Executive Officer of iTeos. “With
trials ongoing for our two lead product candidates, we anticipate
that 2021 will be a data-rich year and we hope to continue to
leverage our deep understanding of immune pathways and the tumor
microenvironment to identify additional novel product candidates
that can improve the clinical benefit for patients suffering from
cancers.”
Recent Business Highlights
EOS-850: Designed as a highly selective small
molecule antagonist of the adenosine A2a receptor, or A2AR, to
inhibit the adenosine triphosphate, or ATP, adenosine pathway, a
key driver of immunosuppression in the tumor microenvironment
across a broad range of tumors.
- Enrollment continues in Phase 1/2a clinical trial in
adult patients with advanced solid tumors: The EOS-850
monotherapy trial in adult patients with advanced solid tumors is
ongoing and the company expects to report initial data from
monotherapy and combination therapy cohorts in the first half of
2021.
- AACR data presentation showed encouraging safety and
efficacy signals in Dose Escalation: The Company presented
initial data from the monotherapy, dose escalation portion of the
Phase 1/2a clinical trial of EOS-850 in 21 heavily pre-treated
cancer patients with advanced solid tumors at the American
Association of Cancer Research (AACR) Virtual Annual Meeting in
April 2020. The data showed that EOS-850 was reported to be
generally well tolerated with no dose-limiting toxicities observed.
EOS-850 showed preliminary single-agent clinical benefit in two
patients with confirmed partial response and an additional five
patients with stable disease.
EOS-448: Antagonist specifically designed to
target T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a
checkpoint that has a role in both inhibitory and stimulatory
pathways in the immune system. EOS-448 was also designed to engage
the Fc gamma receptor, or FcgR, to promote antibody-dependent
cellular cytotoxicity (ADCC) activity, including the elimination of
tumor-infiltrating regulatory T cells.
- Patient enrollment continues in Phase 1/2a clinical
trial: The dose escalation portion of the Phase 1/2a
clinical trial of EOS-448 was initiated in February 2020. Initial
safety and efficacy data are expected to be reported in the
first half of 2021. Following dose escalation and determination of
the recommended Phase 2 dose, the study design allows for the
expansion of patient cohorts to evaluate the anti-tumor activity of
EOS-448 in specific tumor types.
- AACR preclinical data presentation demonstrating an
encouraging preclinical therapeutic index: In June 2020,
the company presented data for EOS-448 showing potent
antitumor activity and a favorable tolerability profile in
preclinical studies at the American Association of Cancer Research
II Virtual Annual Meeting.
Corporate Updates
- Completed Initial Public Offering (IPO) raising $229.7
million in gross proceeds: In July 2020, iTeos completed
its IPO of 10,586,316 shares of common stock at a public offering
price of $19.00 per share. In August 2020, the underwriters
exercised their option to purchase an additional 1,505,359
shares.
- Strengthened leadership team with key
appointments: In June 2020, iTeos announced the
appointments of Matthew Gall as Chief Financial Officer, Dr. Yvonne
McGrath as Vice President of Research and Development and Philippe
Brantegem as Vice President of Human Resources. Matthew Gall joins
iTeos Therapeutics from Sarepta Therapeutics, Inc. where he was the
Senior Vice President of Corporate Development and
Treasurer. Dr. Yvonne McGrath joins iTeos Therapeutics from
Complix N.V. where she served as the Chief Scientific
Officer. Philippe Brantegem has delivered human resources
support to biopharmaceutical companies such as Merck Sharp &
Dohme, Besins Healthcare, Sanofi Pasteur MSD and Korn Ferry for
over 20 years.
- Added Ann D. Rhoads to Board of
Directors: In June 2020, iTeos announced the appointment
of Ann D. Rhoads to its Board of Directors. Ms. Rhoads
brings over 25 years of corporate and financial expertise in the
life sciences and healthcare industry.
Second Quarter 2020 Financial Results
- Cash Position: Cash was
$136.9 million as of June 30, 2020, as compared to $19.9
million as of December 31, 2019.
- Research and Development (R&D)
Expenses: R&D expenses were $6.1
million for the quarter ended June 30, 2020, as compared to $3.9
million for the second quarter of 2019. The increase was
primarily due to an increase in activities related to clinical
trials for EOS-850 and EOS-448.
- General and Administrative (G&A)
Expenses: G&A expenses were $2.4 million for the
quarter ended June 30, 2020, as compared to $2.1 million for the
second quarter of 2019. The increase was primarily due to an
increased payroll and related costs, including recruiting fees, due
to the hiring of additional executives in the second quarter of
2020.
- Net Loss: Net loss attributable to common
shareholders was $10.3 million, or a net loss of $29.49 per basic
and diluted share, for the quarter ended June 30, 2020, as compared
to $6.8 million, or a net loss of $36.49 per basic and diluted
share, for the second quarter of 2019.
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 the tumor
microenvironment and immunosuppressive pathways to design novel
product candidates with an aim to improve the clinical benefit of
oncology therapies. The innovative pipeline includes two
clinical-stage programs targeting novel, validated immuno-oncology
pathways designed to build on prior learnings in the field to have
differentiated pharmacological and clinical profiles. The most
advanced product candidate, EOS-850, is designed as a highly
selective small molecule antagonist of the adenosine A2a receptor,
in the adenosine triphosphate adenosine pathway, a key driver of
immunosuppression in the tumor microenvironment across a broad
range of tumors. EOS-850 is being investigated in an open-label
Phase 1/2a clinical trial in adult patients with advanced solid
tumors and encouraging preliminary single-agent activity were
observed in the dose escalation portion of the trial. The lead
antibody product candidate, EOS-448, is an antagonist of TIGIT, or
T-cell immunoreceptor with Ig and ITIM domains, a checkpoint that
has a role in both inhibitory and stimulatory pathways in the
immune system. EOS-448 was also designed to engage the Fc gamma
receptor, or FcγR, to promote antibody-dependent cellular
cytotoxicity, or ADCC, activity, including the elimination of
tumor-infiltrating regulatory T cells, or Tregs. An open-label
Phase 1/2a clinical trial of EOS-448 was recently initiated in
adult patients with advanced solid tumors. Therapeutics is
headquartered in Cambridge, MA with a research center in Gosselies,
Belgium.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of 1995
and other federal securities laws, including express or implied
statements regarding iTeos’ future expectations, plans and
prospects, which are based on currently available information. All
statements other than statements of historical facts contained in
this press release, including statements regarding our strategy,
future financial condition, future operations, prospects, plans,
objectives of management and expected growth, are forward-looking
statements. In some cases, you can identify forward-looking
statements by terminology such as ‘‘aim,’’ ‘‘anticipate,’’
‘‘assume,’’ ‘‘believe,’’ ‘‘contemplate,’’ ‘‘continue,’’ ‘‘could,’’
‘‘design,’’ ‘‘due,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘goal,’’
‘‘intend,’’ ‘‘may,’’ ‘‘objective,’’ ‘‘plan,’’ ‘‘predict,’’
‘‘positioned,’’ ‘‘potential,’’ ‘‘seek,’’ ‘‘should,’’ ‘‘target,’’
‘‘will,’’ ‘‘would’’ and other similar expressions that are
predictions of or indicate future events and future trends, or the
negative of these terms or other comparable terminology and similar
expressions that constitute forward-looking statements under the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include statements about the initiation,
timing, progress and results of our current and future clinical
trials and current and future preclinical studies of our product
candidates, including our clinical trials of EOS-850, our clinical
trials of EOS-448 and of our research and development programs;
uncertainties inherent in clinical studies and in the availability
and timing of data from ongoing clinical trials; whether interim
results from a clinical trial will be predictive of the final
results of the trial; whether results from preclinical studies or
earlier clinical studies will be predictive of the results of
future clinical trials; our ability to successfully establish or
maintain collaborations or strategic relationships for our product
candidates; the expected timing for submissions for regulatory
approval or review by governmental authorities; our financial
performance; whether our cash resources will be sufficient to fund
our foreseeable and unforeseeable operating expenses and capital
expenditure requirements; risks, uncertainties and assumptions
regarding the impact of the continuing COVID-19 pandemic on our
business, operations, strategies and anticipated timelines,
including mitigation efforts and economic effects, including but
not limited to our preclinical studies and future clinical trials;
and our plans to develop and commercialize our current product
candidates and any future product candidates and the implementation
of our business model and strategic plans for our business, current
product candidates and any future product candidates, and other
risks concerning iTeos’ programs and operations that are described
in additional detail in our Quarterly Report on Form 10-Q and our
other filings made with the Securities and Exchange Commission from
time to time. Although our forward-looking statements reflect the
good faith judgment of management, these statements are based
solely on facts and circumstances currently known to iTeos. As a
result, you are cautioned not to rely on these forward-looking
statements. Any forward-looking statement made in this press
release speaks only as of the date on which it is made. iTeos
undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
the occurrence of certain events or otherwise.
For further information, please contact:
Investor Contacts:Sarah McCabe, Zofia Mita
Stern Investor Relations, Inc. + 1 212 362 1200
iTeos@sternir.com
Media Contacts: Amber Fennell, Paul Kidwell
Consilium Strategic Communications +44 203 709 5700
iteos@consilium-comms.com
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