THE-630 Phase 1/2 clinical trial actively
enrolling patients with advanced gastrointestinal stromal tumors
(GIST); initial data expected in 1H 2023
On track to nominate development candidate for
fourth-generation epidermal growth factor receptor (EGFR) program
targeting non-small cell lung cancer (NSCLC) in Q3 2022; IND
expected in 2023
$237.0 million
in cash, cash equivalents, and investments as of March 31, 2022, expected to fund operations into
the second half of 2024
CAMBRIDGE, Mass., May 12, 2022
/PRNewswire/ -- Theseus Pharmaceuticals, Inc. (NASDAQ: THRX)
(Theseus or the Company), a clinical-stage biopharmaceutical
company focused on improving the lives of cancer patients through
the discovery, development and commercialization of transformative
targeted therapies, today announced business highlights and
reported financial results for the first quarter ended March 31, 2022.
"We are pleased by the progress achieved in the first quarter of
2022 as we continue to make strides in advancing our pipeline of
novel pan-variant targeted therapies. Notably, we began the year by
enrolling patients in our first clinical trial of THE-630 in
advanced GIST, and more recently presented encouraging preclinical
data on our EGFR program at AACR that support our approach of
pan-variant inhibition in a single molecule," said Tim Clackson, Ph.D., President and Chief
Executive Officer of Theseus. "Over the next 12 months we have a
robust set of milestones, including the nomination of a development
candidate for our EGFR program and the expansion of our pipeline
with a third TKI program. We look forward to seeing these
developments over the remainder of 2022, and to sharing initial
clinical data from THE-630 in the first half of 2023."
Recent Business Highlights and Upcoming Milestones:
- Enrollment ongoing in Phase 1/2 clinical trial evaluating
THE-630, targeting the receptor tyrosine kinase KIT, in patients
with advanced GIST. In January
2022, the first patient was treated in a Phase 1/2 dose
escalation and expansion clinical trial of THE-630 in patients with
advanced GIST, a disease that remains largely KIT-dependent even
after multiple lines of therapy. THE-630 is a single molecule
pan-variant inhibitor of KIT, designed for patients whose cancer
has developed resistance to earlier lines of therapy. The Company
continues activating sites and enrolling patients in this study,
with initial data from the Phase 1 portion of the clinical trial
expected to be presented at a scientific conference in the first
half of 2023.
- Presented preclinical data supporting nomination of a
development candidate for fourth-generation EGFR program, expected
in the third quarter of 2022. At the 2022 American Association
for Cancer Research (AACR) Annual Meeting in April, Theseus
presented preclinical data demonstrating that pan-variant
inhibition of all major single-, double-, and triple-EGFR mutants,
including T790M and C797S, with selectivity over wild-type and
central nervous system (CNS) penetration, can be achieved with a
single molecule. Theseus expects to nominate a fourth-generation
EGFR inhibitor designed to inhibit the full range of EGFR variants
found in the tumors of patients with EGFR-mutant NSCLC that have
developed C797S-mediated resistance to first- or later-line
osimertinib treatment. Additional preclinical data on the
development candidate are expected to be presented at a scientific
conference in the fourth quarter of 2022 and Theseus expects to
submit an IND for this program in 2023.
- Additional TKI program expected to be disclosed by year-end
2022. Theseus continues advancing its preclinical discovery
pipeline and expects to introduce a new kinase target program by
the end of 2022.
- Continued to strengthen leadership team. Theseus
recently appointed Claire Coleman,
Ph.D., as Vice President, Program Management. Dr. Coleman joined
the Company from Allena Pharmaceuticals, where she served as
Executive Director, Program Management, and earlier in scientific
and program management roles of increasing responsibility at
Momenta Pharmaceuticals. She will play an integral role in
shepherding Theseus' programs through preclinical and
clinical-stage development.
First Quarter Financial Results:
- Cash Position: As of March 31,
2022, Theseus had cash, cash equivalents and short-term and
long-term investments of $237.0
million. Theseus expects its cash, cash equivalents, and
investments to fund operations and capital expenditures into the
second half of 2024 based on its current operating plan.
- R&D Expenses: Research and development expenses were
$6.5 million for the first quarter of
2022, as compared to $3.8 million for
the same period in 2021. This increase was primarily due to
$1.8 million of increased
employee-related costs, and $0.8
million in increased expenses for clinical and preclinical
studies.
- G&A Expenses: General and administrative expenses
were $4.0 million for the first
quarter of 2022, as compared to $0.7
million for the same period in 2021. This increase was
primarily due to $2.1 million of
increased employee-related costs, as well as $1.1 million of increased general expenses,
primarily driven by public company-related costs.
- Net Loss: Net loss was $10.5
million for the first quarter of 2022, as compared to a net
loss of $4.5 million for the same
period in 2021.
About Theseus Pharmaceuticals, Inc.
Theseus is a
clinical-stage biopharmaceutical company focused on improving the
lives of cancer patients through the discovery, development and
commercialization of transformative targeted therapies. Theseus is
working to outsmart cancer resistance by developing pan-variant
tyrosine kinase inhibitors (TKIs) to target all known classes of
cancer-causing and resistance mutations that lead to variants in a
particular protein in a given type of cancer. Theseus' lead product
candidate, THE-630, is a pan-variant KIT inhibitor for the
treatment of patients with advanced gastrointestinal stromal tumors
(GIST), whose cancer has developed resistance to earlier lines of
kinase inhibitor therapy. Theseus is also developing a
fourth-generation, selective epidermal growth factor receptor
(EGFR) inhibitor for C797S-mediated resistance to first- or
later-line osimertinib treatment in patients with non-small cell
lung cancer (NSCLC). For more information,
visit www.theseusrx.com.
Cautionary Statement Regarding Forward Looking
Statements
Certain statements included in this press release
are not historical facts but are forward-looking statements for
purposes of the safe harbor provisions under the United States
Private Securities Litigation Reform Act of 1995. Forward-looking
statements generally are accompanied by words such as "believe,"
"may," "will," "estimate," "continue," "anticipate," "intend,"
"expect," "should," "would," "plan," "on track," "predict,"
"potential," "seem," "seek," "future," "outlook," and similar
expressions that predict or indicate future events or trends or
that are not statements of historical matters, but the absence of
these words does not mean that a statement is not forward-looking.
These forward-looking statements include, but are not limited to,
statements regarding Theseus' strategy, future operations,
prospects and plans, the structure and timing of its preclinical
studies and clinical trials, expected milestones, market
opportunity and sizing and objectives of management, including in
relation to the Phase 1/2 dose escalation and expansion clinical
trial for THE-630, EGFR inhibitor program and other programs and
development candidates.
Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, such as those described from time to time in the reports
Theseus files with the Securities and Exchange Commission (SEC),
including Theseus' Form 10-K for the year ended December 31, 2021 filed with the SEC on
March 10, 2022 and Theseus' Form 10-Q
for the quarter ended March 31, 2022
expected to be filed with the SEC in the second quarter of
2022. However, new risk factors and uncertainties may emerge from
time to time, and it is not possible to predict all risk factors
and uncertainties. Accordingly, readers are cautioned not to place
undue reliance on these forward-looking statements. Any
forward-looking statements contained in this press release are
based on the current expectations of Theseus' management team and
speak only as of the date hereof, and Theseus specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise,
except as required by law.
Media Contact
Amy Jobe,
Ph.D.
LifeSci Communications
315-879-8192
ajobe@lifescicomms.com
Investor Contacts
Christen
Baglaneas
Theseus Pharmaceuticals
857-706-4993
christen.baglaneas@theseusrx.com
Josh Rappaport
Stern Investor Relations
212-362-1200
josh.rappaport@sternir.com
Theseus
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(in thousands, except
share and per share data)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2022
|
|
2021
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
6,548
|
|
$
|
3,825
|
General and
administrative
|
|
|
4,031
|
|
|
664
|
Total operating
expenses
|
|
|
10,579
|
|
|
4,489
|
Loss from
operations
|
|
|
(10,579)
|
|
|
(4,489)
|
Other income,
net
|
|
|
82
|
|
|
16
|
Net loss
|
|
$
|
(10,497)
|
|
$
|
(4,473)
|
Net loss per share
attributable to common
stockholders—basic and diluted
|
|
$
|
(0.27)
|
|
$
|
(4.90)
|
Weighted-average common
stock outstanding—basic
and diluted
|
|
|
38,247,970
|
|
|
912,222
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(10,497)
|
|
$
|
(4,473)
|
Other comprehensive
loss:
|
|
|
|
|
|
|
Unrealized loss on
investments
|
|
|
(129)
|
|
|
-
|
Total comprehensive
loss
|
|
$
|
(10,626)
|
|
$
|
(4,473)
|
|
|
|
|
|
|
|
Theseus
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
Three Months
Ended
|
|
Year Ended
|
March 31,
|
|
December 31,
|
|
|
2022
|
|
2021
|
Assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
146,281
|
|
$
|
244,662
|
Short-term
investments
|
|
|
85,757
|
|
|
-
|
Long-term
investments
|
|
|
4,945
|
|
|
-
|
Other assets
|
|
|
10,522
|
|
|
6,267
|
Total assets
|
|
|
247,505
|
|
|
250,929
|
Liabilities and Stockholders'
Equity
|
|
|
|
|
|
|
Liabilities
|
|
|
9,653
|
|
|
4,495
|
Stockholders'
equity
|
|
|
237,852
|
|
|
246,434
|
Total liabilities and stockholders' equity
|
|
$
|
247,505
|
|
$
|
250,929
|
|
|
|
|
|
|
|
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SOURCE Theseus Pharmaceuticals