-- THE-630 initial dose escalation data to be
presented at investor event on May 25,
2023, with additional dose escalation data expected in Q4
2023 --
-- 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 by early 2024
--
-- $243.6
million of cash, cash equivalents, and marketable securities
as of March 31, 2023, with runway
projected into Q3 2025 --
CAMBRIDGE, Mass., May 11, 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 first quarter ended March 31, 2023.
"We look forward to continued clinical execution and important
pipeline advancements in the months ahead, most notably with two
anticipated clinical readouts from our lead program, THE-630, in
advanced GIST," said Tim Clackson,
Ph.D., President and Chief
Executive Officer of Theseus. "We maintain a strong financial
position as we continue to progress our pipeline, with an
anticipated IND submission for THE-349 in the fourth quarter of
this year as well as advancement of our BCR-ABL and discovery
programs."
Recent Pipeline Highlights and Upcoming Expected
Milestones:
THE-630 is a pan-variant tyrosine kinase inhibitor
(TKI) of the receptor tyrosine kinase KIT, designed for patients
with gastrointestinal stromal tumors (GIST) that have developed
resistance to earlier lines of therapy.
- As of March 31, 2023, Theseus is
enrolling patients in cohort 7 of its ongoing phase 1/2 dose
escalation and expansion clinical trial evaluating THE-630 in
patients with advanced GIST.
- Theseus submitted its initial dose escalation results to the
2023 American Society of Clinical Oncology (ASCO) Annual Meeting,
taking place June 2-6, in
Chicago, Illinois, and the
abstract was selected for online publication. Theseus plans to
present data with an updated cutoff date during a virtual investor
event on May 25, 2023, at
5:30pm ET, after the public release
of the abstract. The initial dose escalation data will include
preliminary safety, pharmacokinetic (PK), and clinical activity
data through cohort 6, as well as an analysis of circulating tumor
DNA (ctDNA) through cohort 5.
- Theseus plans to present follow-up data at a scientific
conference in the fourth quarter of 2023, which is expected to
include data from additional dose escalation cohorts, including
cohort 8, where Theseus expects to have reached the target systemic
exposure for pan-variant KIT activity.
THE-349 is a fourth-generation (4G) epidermal growth
factor receptor (EGFR) TKI development candidate, which has
demonstrated 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 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.
- Theseus expects to submit an Investigational New Drug
Application (IND) for THE-349 to the U.S. Food and Drug
Administration (FDA) in the fourth quarter of 2023 and to initiate
the first-in-human trial as soon as possible thereafter, subject to
clearance of the IND by the FDA.
BCR-ABL Program: Theseus aims 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).
- Preclinically, Theseus lead molecules have been observed to
show 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 by early 2024, with the goal of pursuing 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.
Business Highlights:
- In May 2023, Theseus announced
the appointment of Franklin
Vairinhos, Ph.D., as Vice President, Regulatory Affairs. Dr.
Vairinhos has more than 30 years of experience in Regulatory
Affairs, predominantly in developing regulatory strategies for
oncology therapies.
First Quarter Financial Results:
Cash Position: As of March
31, 2023, Theseus had cash, cash equivalents, and marketable
securities of $243.6 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 the third quarter of
2025 based on its current operating plan.
R&D Expenses: Research and development expenses
were $12.4 million for the first
quarter of 2023, as compared to $6.5
million for the same period in 2022. This increase was
primarily due to a $2.7 million
increase in expense for preclinical studies and drug manufacturing
to support THE-349 IND enabling studies, a $1.4 million increase in development expense
related to discovery programs, as well as a $1.5 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
first quarter of 2023, as compared to $4.0
million for the same period in 2022. This increase was
primarily due to an increase in stock-based compensation expense
and employee-related costs.
Net Loss: Net loss was $14.6
million for the first quarter of 2023, as compared to a net
loss of $10.5 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' 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 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), and
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). 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," "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: Theseus' strategy, future
operations, prospects and plans, including statements regarding its
cash runway; the structure and timing of its preclinical studies
and clinical trials, expected milestones, and objectives of
management; the timing for the presentation of preliminary data for
THE-630 and significance of such results; Theseus' plans regarding
the phase 1/2 dose escalation and expansion clinical trial for
THE-630, including timing for enrollment of patients in such trial;
the significance of results of preclinical studies of THE-349,
including the ability of THE-349 to potentially inhibit EGFR
variants and the outlook of the EGFR inhibitor program;
expectations regarding the submission of an IND for THE-349; and
Theseus' plans with respect to its third development program
target, BCR-ABL, including the intention to nominate a development
candidate for such program by early 2024.
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 and uncertainties related to the
potential IND application for THE-349; risks related to market
volatility and global economic conditions, including disruptions in
the banking industry; 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.
Media Contact
Christen
Baglaneas
Director, Corporate Communications & Investor Relations
Theseus Pharmaceuticals
857-706-4993
christen.baglaneas@theseusrx.com
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)
|
|
|
|
THREE MONTHS ENDED
MARCH 31,
|
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
$
12,401
|
|
$
6,548
|
General and
administrative
|
|
4,654
|
|
4,031
|
Total operating
expenses
|
|
17,055
|
|
10,579
|
Loss from
operations
|
|
(17,055)
|
|
(10,579)
|
Other income,
net
|
|
2,469
|
|
82
|
Net loss
|
|
$
(14,586)
|
|
$
(10,497)
|
Weighted-average common
stock outstanding—basic and diluted
|
|
42,371,206
|
|
38,247,970
|
Net loss per share
attributable to common stockholders—basic and diluted
|
|
$
(0.34)
|
|
$
(0.27)
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
Net loss
|
|
$
(14,586)
|
|
$
(10,497)
|
Other comprehensive
loss:
|
|
|
|
|
Unrealized gain (loss)
on marketable securities
|
|
227
|
|
(129)
|
Total comprehensive
loss
|
|
$
(14,359)
|
|
$
(10,626)
|
Theseus Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheets (in thousands)
|
|
|
MARCH 31,
2023
|
|
DECEMBER 31,
2022
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
109,698
|
|
$
94,605
|
Short-term marketable
securities
|
126,936
|
|
103,374
|
Long-term marketable
securities
|
6,979
|
|
13,817
|
Other assets
|
12,007
|
|
10,651
|
Total
assets
|
$
255,620
|
|
$
222,447
|
Liabilities and
Stockholders' Equity
|
|
|
|
Liabilities
|
$
10,132
|
|
$
14,832
|
Stockholders'
equity
|
245,488
|
|
207,615
|
Total liabilities and
stockholders' equity
|
$
255,620
|
|
$
222,447
|
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SOURCE Theseus Pharmaceuticals