IND submission for THE-349 in EGFR-mutant
NSCLC expected in Q4 2023
Development candidate nomination for BCR-ABL
program in CML and Ph+ ALL expected in H1 2024
Nomination of highly selective pan-variant KIT
inhibitor candidate for GIST expected in H1 2024
Announces plans to explore the development of
low dose THE-630 in mast cell-driven inflammatory indications based
on dose-dependent reductions in serum tryptase levels in patients
in GIST study
$234.2 million of cash, cash equivalents,
and marketable securities as of June 30,
2023
CAMBRIDGE, Mass., Aug. 10,
2023 /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 second quarter
ended June 30, 2023.
"We are excited to be advancing our pipeline, including lead
candidate THE-349, a potential best-in-class fourth generation EGFR
inhibitor, and continue to expect an IND submission for THE-349 in
EGFR-mutant NSCLC in the fourth quarter of this year. Additionally,
we look forward to nominating development candidates from our
BCR-ABL and next-generation KIT programs in the first half of next
year," said Tim Clackson, Ph.D.,
President and Chief Executive
Officer of Theseus. "While we are disappointed by the outcome of
the THE-630 program in GIST patients, we believe the update
announced today supports the exploration of THE-630 in mast
cell-driven diseases, which we anticipate pursuing internally or
through a partnership."
Pipeline Highlights and Upcoming Expected Milestones:
THE-349 is a fourth-generation epidermal growth
factor receptor (EGFR) tyrosine kinase inhibitor (TKI) product
candidate with activity against single-, double-, and triple-mutant
EGFR variants, including T790M and C797X, found in EGFR-mutant
non-small cell lung cancer (NSCLC) that has developed resistance to
first- or later-line osimertinib.
- Preclinical data demonstrate that THE-349 can potently inhibit
all major classes of EGFR activating and resistance mutations
observed in a post-first- or later-line osimertinib setting,
possesses kinome and wild-type EGFR selectivity, and has central
nervous system (CNS) activity.
- IND-enabling toxicology studies have been completed, and
Theseus remains on track to submit an Investigational New Drug
Application (IND) for THE-349 in the fourth quarter of 2023, and
commence its clinical program as soon as possible thereafter,
subject to clearance of the IND by the U.S. Food and Drug
Administration.
BCR-ABL Program: Theseus is aiming to develop a
potent and selective, next-generation, pan-variant BCR-ABL TKI
candidate that optimizes the balance of safety and efficacy for
patients with relapsed/refractory chronic myelogenous leukemia
(CML) and patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute
lymphoblastic leukemia (ALL).
- Theseus plans to pursue clinical development in patients with
CML who have been previously treated with a second-generation TKI
or have the T315I mutation, and in newly diagnosed patients with
Ph+ ALL.
- Preclinically, Theseus lead molecules have shown a high degree
of potency against BCR-ABL and clinically relevant resistance
mutations, such as the T315I gatekeeper mutation, and substantial
kinome selectivity.
- Theseus expects to nominate a development candidate for this
program in the first half of 2024.
Next-Generation KIT Program: Theseus is aiming
to develop a potent and selective pan-variant TKI candidate
targeting all major activating and resistance KIT mutations for
treatment of early-line gastrointestinal stromal tumors (GIST).
- Theseus has maintained an extensive medicinal chemistry effort
to target KIT, which has led to the discovery of a series of
chemically distinct, highly selective, pan-variant KIT inhibitors
for the treatment of early-line GIST.
- Theseus plans to nominate a development candidate from this
series in the first half of 2024.
THE-630: In July, Theseus discontinued enrollment in its
phase 1/2 study of THE-630 in patients with GIST. Theseus
subsequently analyzed trial data to inform the feasibility of
developing low dose THE-630 for KIT-associated mast cell-driven
inflammatory indications.
- Theseus measured levels of serum tryptase, a biomarker for mast
cell activation, in GIST patients treated with once-daily oral
THE-630 in the phase 1 dose escalation trial at doses of 4 mg to 18
mg.
- Dose-dependent and sustained reductions in serum tryptase
observed at all doses, including reductions below detection limit
of the assay in some patients, seen at first timepoint (day
8).
- Theseus is evaluating next steps for potential plans to explore
doses of 9 mg and below in clinical studies in patients with mast
cell-driven diseases, such as chronic urticaria. The safety profile
at these doses was generally favorable in GIST patients.
Second Quarter Financial Results:
Cash Position: As of June 30,
2023, Theseus had cash, cash equivalents, and marketable
securities of $234.2 million, as
compared to $211.8 million as of
December 31, 2022. Theseus expects
its current cash, cash equivalents, and marketable securities to
fund operations and capital expenditures into 2026 based on its
current operating plan.
R&D Expenses: Research and development expenses
were $12.9 million for the second
quarter of 2023, as compared to $7.3
million for the same period in 2022. This increase was
primarily due to a $2.1 million
increase in expense for preclinical studies and drug manufacturing
to support THE-349 IND enabling studies, a $1.2 million increase in development expense
related to discovery programs, as well as a $1.6 million increase in employee-related costs
driven by an increase in headcount.
G&A Expenses: General and administrative
expenses were $4.7 million for the
second quarter of 2023, consistent with the expense for the same
period in 2022.
Net Loss: Net loss was $14.8
million for the second quarter of 2023, as compared to a net
loss of $11.6 million for the same
period in 2022.
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 classes of cancer-causing and resistance mutations that lead to
clinically relevant variants in a particular protein in a given
type of cancer. Theseus is developing THE-349, a fourth-generation,
selective epidermal growth factor receptor (EGFR) inhibitor for
C797X-mediated resistance to first- or later-line osimertinib
treatment in patients with non-small cell lung cancer (NSCLC), a
pan-variant BCR-ABL inhibitor for the treatment of
relapsed/refractory chronic myeloid leukemia (CML) and newly
diagnosed Philadelphia
chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), and a
next-generation, highly selective, pan-variant KIT inhibitor for
the treatment of early-line GIST. 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," "aim," "project," "anticipate,"
"expect," "plan," "predict," "potential," "on track", "seem,"
"outlook," "continue," "intend," 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: the discontinuation of the THE–630 phase 1/2
clinical trial; Theseus' plans with respect to THE-630, including
the potential to develop low dose THE-630 for KIT-associated mast
cell-driven inflammatory indications; Theseus' plans with
respect to its BCR-ABL and next generation KIT programs, including
the intention to nominate a development candidate for such programs
in the first half of 2024; the timing for filing an IND for THE–349
and commencing a clinical program for THE-349; and Theseus'
expectations regarding its cash runway.
Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
risks, uncertainties and other factors, including, but not limited
to: uncertainties inherent in preclinical studies and clinical
trials; risks and uncertainties regarding whether results from
preclinical studies and clinical trials will be predictive of the
results of future trials; risks related to the expected timing of
submissions to regulatory authorities and timing for review by such
regulatory authorities; risks related to market volatility and
global economic conditions; and other risks, uncertainties and
other 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, 2022 and subsequent Quarterly
Reports on Form 10-Q which will be on file with the SEC and
available on the SEC's website at https://www.sec.gov/. However,
new risk factors and uncertainties may emerge from time to time
which may cause actual results to differ materially from those
anticipated or implied by the forward-looking statements in this
press release, 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.
Investor Contact
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)
(Unaudited)
|
|
|
THREE MONTHS ENDED
JUNE 30,
|
|
SIX MONTHS ENDED
JUNE 30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
12,919
|
|
$
7,344
|
|
$
25,320
|
|
$
13,892
|
General and
administrative
|
4,668
|
|
4,736
|
|
9,322
|
|
8,767
|
Total operating
expenses
|
17,587
|
|
12,080
|
|
34,642
|
|
22,659
|
Loss from
operations
|
(17,587)
|
|
(12,080)
|
|
(34,642)
|
|
(22,659)
|
Other income,
net
|
2,782
|
|
431
|
|
5,251
|
|
513
|
Net loss
|
$
(14,805)
|
|
$
(11,649)
|
|
$
(29,391)
|
|
$
(22,146)
|
Weighted-average common
stock outstanding—basic and diluted
|
43,736,275
|
|
38,415,379
|
|
43,061,113
|
|
38,332,605
|
Net loss per share
attributable to common stockholders—basic and diluted
|
$
(0.34)
|
|
$
(0.30)
|
|
$
(0.68)
|
|
$
(0.58)
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
Net loss
|
$
(14,805)
|
|
$
(11,649)
|
|
$
(29,391)
|
|
$
(22,146)
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on marketable securities
|
$
(402)
|
|
$
(203)
|
|
(175)
|
|
(332)
|
Total comprehensive
loss
|
$
(15,207)
|
|
$
(11,852)
|
|
$
(29,566)
|
|
$
(22,478)
|
Theseus
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(in
thousands)
(Unaudited)
|
|
|
JUNE 30,
2023
|
|
DECEMBER 31,
2022
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
47,465
|
|
$
94,605
|
Short-term marketable
securities
|
160,740
|
|
103,374
|
Long-term marketable
securities
|
26,027
|
|
13,817
|
Other assets
|
10,839
|
|
10,651
|
Total
assets
|
$
245,071
|
|
$
222,447
|
Liabilities and
Stockholders' Equity
|
|
|
|
Liabilities
|
$
10,988
|
|
$
14,832
|
Stockholders'
equity:
|
234,083
|
|
207,615
|
Total liabilities and
stockholders' equity
|
$
245,071
|
|
$
222,447
|
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SOURCE Theseus Pharmaceuticals