THE-630 Phase 1/2 clinical trial enrolling
patients; initial data expected in Q2 2023
Nomination of development candidate for
fourth-generation epidermal growth factor receptor (EGFR) inhibitor
program expected in Q3 2022; IND expected in 2023
$228.6 million
in cash, cash equivalents, and investments as of June 30, 2022; expected to fund operations into
the fourth quarter of 2024
CAMBRIDGE, Mass., Aug. 11, 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 and pipeline highlights and reported financial
results for the second quarter ended June
30, 2022.
"At Theseus, we are developing next-generation tyrosine kinase
inhibitors (TKIs) to outsmart cancer resistance—a key challenge
facing existing therapies in targeted oncology. 2022 is a critical
year of execution and we have continued to make significant
progress across our programs," said Tim
Clackson, Ph.D., President and Chief Executive Officer of
Theseus. "Enrollment in the dose escalation portion of the Phase
1/2 trial of THE-630 in patients with advanced GIST is on track and
we look forward to the expected announcement of initial clinical
data in the first half of 2023. We are on track to nominate a
development candidate for our EGFR inhibitor program for the
treatment of non-small cell lung cancer in the third quarter of
2022 and plan to present preclinical data supporting the promising
profile for this candidate in the fourth quarter of 2022. We expect
to expand our pipeline with the introduction of a third TKI program
later this year."
Recent Pipeline Highlights and Upcoming Expected
Milestones:
THE-630: a single molecule, pan-variant
inhibitor of the receptor tyrosine kinase KIT. Designed for
patients whose gastrointestinal stromal tumors (GIST), a disease
that remains largely KIT-dependent following multiple lines of
treatment, has developed resistance to earlier lines of
therapy.
- A Phase 1/2 dose-escalation and expansion clinical trial
evaluating THE-630 in patients with advanced GIST is ongoing, as
the Company completes site activations and continues to enroll
patients in the dose-escalation portion of the trial.
- Initial data from the Phase 1 dose-escalation portion of the
clinical trial are expected to be presented at a scientific
conference in the second quarter of 2023.
EGFR inhibitor for non-small cell lung cancer
(NSCLC): a fourth-generation, single molecule, selective
EGFR inhibitor, designed to inhibit all major single-, double-, and
triple-mutant EGFR variants found in the tumors of patients with
EGFR-mutant NSCLC that have developed resistance to first- or
later-line osimertinib treatment, including the C797S and T790M
mutations, with central nervous system (CNS) activity.
- Theseus expects to nominate a development candidate for this
program in the third quarter of 2022 and to introduce this
candidate along with a presentation of new preclinical data at a
scientific conference in the fourth quarter of 2022.
- Theseus expects to submit an Investigational New Drug (IND)
application to the U.S. Food and Drug Administration in 2023.
- At the 2022 American Association for Cancer Research (AACR)
Annual Meeting in April 2022, the
Company presented preclinical data demonstrating that pan-variant
inhibition of all major EGFR mutations consisting of single-,
double-, and triple-EGFR mutants, including T790M and C797S, with
selectivity over wild-type and CNS activity, can be achieved with a
single molecule.
R&D Portfolio: Theseus' discovery platform
incorporates its structure-guided drug design and predictive
resistance assay (PRA) to develop next-generation, pan-variant
inhibitor molecules targeting all major cancer-causing and
treatment-resistance mutations of tyrosine kinase targets.
- The Company continues advancing its preclinical discovery
pipeline and expects to introduce a new kinase target program by
the end of 2022.
Business Highlights:
- In May 2022, Theseus announced
the appointment of Don Hayden to its
Board of Directors. Mr. Hayden brings over 40 years of industry
experience to the Board, including previously serving as President
of Oncology and Immunology and as President of Global
Pharmaceuticals at Bristol Myers-Squibb and as Chair at numerous
biotech companies.
- In June 2022, Theseus appointed
Steve Tuller as Vice President,
Quality Assurance. Mr. Tuller has 24 years of experience in the
pharmaceutical and biotechnology industries. Before joining
Theseus, he served as Vice President, Head of Quality Assurance at
Epizyme, Inc., where he initiated the GxP Quality Assurance
organization.
Second Quarter Financial Results:
Cash Position: As of June 30,
2022, Theseus had cash, cash equivalents and short-term and
long-term investments of $228.6
million. Theseus expects its cash, cash equivalents, and
investments to fund operations and capital expenditures into the
fourth quarter of 2024 based on its current operating plan.
R&D Expenses: Research and development expenses
were $7.3 million for the second
quarter of 2022, as compared to $4.5
million for the same period in 2021. This increase was
primarily due to $2.0 million of
increased employee-related costs, and $0.6
million of increased expenses for clinical and preclinical
studies.
G&A Expenses: General and administrative
expenses were $4.7 million for the
second quarter of 2022, as compared to $2.3
million for the same period in 2021. This increase was
primarily due to $1.6 million of
increased employee-related costs, as well as $0.5 million of increased professional fees.
Net Loss: Net loss was $11.6
million for the second quarter of 2022, as compared to a net
loss of $6.8 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 and Quarterly Report on Form
10-Q for the quarter ended March 31,
2022, which are on file with the SEC and available on the
SEC's website at https://www.sec.gov/. Additional factors may be
described in those sections of Theseus' Form 10-Q for the quarter
ended June 30, 2022, expected to be
filed with the SEC in the third 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 JUNE 30,
|
|
SIX MONTHS ENDED JUNE 30,
|
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
7,344
|
|
$
|
4,485
|
|
$
|
13,892
|
|
$
|
8,310
|
|
General and
administrative
|
|
|
4,736
|
|
|
2,329
|
|
|
8,767
|
|
|
2,993
|
|
Total operating
expenses
|
|
|
12,080
|
|
|
6,814
|
|
|
22,659
|
|
|
11,303
|
|
Loss from
operations
|
|
|
(12,080)
|
|
|
(6,814)
|
|
|
(22,659)
|
|
|
(11,303)
|
|
Other income,
net
|
|
|
431
|
|
|
7
|
|
|
513
|
|
|
23
|
|
Net loss
|
|
$
|
(11,649)
|
|
$
|
(6,807)
|
|
$
|
(22,146)
|
|
$
|
(11,280)
|
|
Net loss per share
attributable to common
stockholders—basic and
diluted
|
|
$
|
(0.30)
|
|
$
|
(6.82)
|
|
$
|
(0.58)
|
|
$
|
(11.81)
|
|
Weighted-average common
stock
outstanding—basic and
diluted
|
|
|
38,415,379
|
|
|
997,326
|
|
|
38,332,605
|
|
|
955,085
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(11,649)
|
|
$
|
(6,807)
|
|
$
|
(22,146)
|
|
$
|
(11,280)
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on
investments
|
|
|
(203)
|
|
|
—
|
|
|
(332)
|
|
|
—
|
|
Total comprehensive
loss
|
|
$
|
(11,852)
|
|
$
|
(6,807)
|
|
$
|
(22,478)
|
|
$
|
(11,280)
|
|
Theseus
Pharmaceuticals, Inc.
|
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
JUNE 30,
|
|
DECEMBER 31,
|
|
|
|
2022
|
|
2021
|
|
Assets
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
135,091
|
|
$
|
244,662
|
|
Short-term
investments
|
|
|
89,704
|
|
|
—
|
|
Long-term
investments
|
|
|
3,807
|
|
|
—
|
|
Other assets
|
|
|
9,687
|
|
|
6,267
|
|
Total
assets
|
|
$
|
238,289
|
|
$
|
250,929
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
Liabilities
|
|
$
|
9,294
|
|
$
|
4,495
|
|
Stockholders'
equity
|
|
|
228,995
|
|
|
246,434
|
|
Total liabilities and
stockholders' equity
|
|
$
|
238,289
|
|
$
|
250,929
|
|
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SOURCE Theseus Pharmaceuticals