CAMBRIDGE, Mass., March 10, 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 fourth quarter and full year ended December 31, 2021.
"2021 was a transformative year for Theseus—we evolved into a
clinical stage company, strengthened our team, and completed a
successful IPO," said Tim Clackson,
Ph.D., President and Chief Executive Officer of Theseus. "In
January 2022 we initiated a Phase 1/2
clinical trial to evaluate our lead candidate, THE-630, in patients
with advanced GIST and continue to drive towards development
candidate nomination for our fourth-generation EGFR program in
non-small cell lung cancer. Over the course of this year, we look
forward to executing across our pipeline, which includes advancing
THE-630 in the clinic, initiating IND-enabling studies of our
second development candidate targeting EGFR, and expanding our
pipeline with one or more additional kinase targets."
Recent Business Highlights and Anticipated
Milestones:
- Initiated Phase 1/2 clinical trial to evaluate THE-630 in
patients with GIST. First patient treated in January 2022 in a Phase 1/2 dose escalation and
expansion clinical trial of THE-630 in patients with advanced GIST.
THE-630 is a pan-variant inhibitor of the receptor tyrosine kinase
KIT designed for patients with advanced GIST whose cancer has
developed resistance to earlier lines of therapy. Initial data from
the Phase 1 portion of the clinical trial is expected to be
presented at a scientific meeting in the first half of 2023.
- Nomination of development candidate for fourth-generation
EGFR program expected in the third quarter of
2022. Theseus expects to nominate an EGFR candidate
designed to inhibit the full range of single-, double-, and
triple-mutant EGFR variants found in the tumors of patients with
EGFR-mutant NSCLC that have developed resistance to osimertinib,
including the C797S mutation. Preclinical data is expected to be
presented at the American Association for Cancer Research (AACR)
Annual Meeting in April and at a scientific conference in the
second half of 2022. IND submission is expected in 2023.
- One or more additional kinase targets expected to be
nominated by the end of 2022.
- Successfully completed initial public offering (IPO). In
October 2021, the Company completed a
successful IPO, raising $178.8
million in aggregate gross proceeds, and listed on the
Nasdaq Global Select Market.
Fourth Quarter and Full Year Financial Results:
- Cash Position: As of December 31,
2021, Theseus had cash and cash equivalents of $244.7 million. Theseus expects its cash and cash
equivalents, including proceeds from the IPO, 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 $5.0 million for the fourth
quarter of 2021, as compared to $2.5
million for the fourth quarter of 2020. This increase was
primarily due to $1.6 million of
increased employee-related costs, and $0.9
million in increased expenses for clinical and preclinical
studies. Research and development expenses were $18.3 million for the full year 2021, as compared
to $6.0 million for the full year
2020.
- G&A Expenses: General and administrative expenses
were $3.6 million for the fourth
quarter of 2021, as compared to $0.4
million for the fourth quarter of 2020. This increase was
primarily due to $1.6 million of
increased employee-related costs, primarily due to increases in our
headcount, as well as $1.7 million of
increased general expenses, primarily driven by public
company-related costs. General and administrative expenses were
$9.0 million for the full year 2021,
as compared to $0.9 million for the
full year 2020.
- Net Loss: Net loss was $8.7
million for the fourth quarter of 2021, as compared to a net
loss of $2.9 million for the fourth
quarter of 2020. Net loss was $27.3
million for the full year 2021, or a net loss per share of
$2.84, as compared to a net loss of
$12.0 million for the full year 2020,
or a net loss per share of $21.10.
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," "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 planned
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.
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-Q for the quarter ended September 30, 2021 filed with the SEC on
November 15, 2021 and Theseus' Form
10-K for the year ended December 31,
2021 expected to be filed with the SEC in the first 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 Contact
Christen
Baglaneas
Theseus Pharmaceuticals
857-706-4993
christen.baglaneas@theseusrx.com
Theseus
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(in thousands, except
share and per share data)
|
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December 31,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
5,022
|
|
$
|
2,488
|
|
$
|
18,328
|
|
$
|
5,958
|
General and
administrative
|
|
|
3,637
|
|
|
400
|
|
|
9,008
|
|
|
878
|
Total operating
expenses
|
|
|
8,659
|
|
|
2,888
|
|
|
27,336
|
|
|
6,836
|
Loss from
operations
|
|
|
(8,659)
|
|
|
(2,888)
|
|
|
(27,336)
|
|
|
(6,836)
|
Other income
(expense), net
|
|
|
3
|
|
|
(2)
|
|
|
28
|
|
|
(5,161)
|
Net loss
|
|
$
|
(8,656)
|
|
$
|
(2,890)
|
|
$
|
(27,308)
|
|
$
|
(11,997)
|
Net loss per share
attributable to common
stockholders—basic and diluted
|
|
$
|
(0.24)
|
|
$
|
(3.78)
|
|
$
|
(2.84)
|
|
$
|
(21.10)
|
Weighted-average
common stock outstanding—basic
and diluted
|
|
|
35,877,802
|
|
|
763,746
|
|
|
9,631,818
|
|
|
568,467
|
Theseus
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
December 31,
|
|
|
2021
|
|
2020
|
Assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
244,662
|
|
$
|
8,457
|
Other
assets
|
|
|
6,267
|
|
|
157
|
Total
assets
|
|
|
250,929
|
|
|
8,614
|
Liabilities,
Redeemable Convertible Preferred Stock and Stockholders' Equity
(Deficit)
|
|
|
|
|
|
|
Liabilities
|
|
|
4,495
|
|
|
1,595
|
Redeemable
convertible preferred stock
|
|
|
-
|
|
|
41,289
|
Stockholders' equity
(deficit)
|
|
|
246,434
|
|
|
(34,270)
|
Total liabilities,
redeemable convertible preferred stock and stockholders' equity
(deficit)
|
|
$
|
250,929
|
|
$
|
8,614
|
|
|
|
|
|
|
|
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SOURCE Theseus Pharmaceuticals