CAMBRIDGE, Mass., Nov. 15, 2021 /PRNewswire/ -- Theseus
Pharmaceuticals, Inc. (NASDAQ: THRX), a biopharmaceutical company
focused on improving the lives of cancer patients through the
discovery, development and commercialization of transformative
targeted therapies, today announced business and program highlights
and reported financial results for the third quarter ended
September 30, 2021.
"At Theseus, we are leveraging our deep expertise in the
development of targeted therapies to address the problem of drug
resistance mutations in cancer," said Tim
Clackson, Ph.D., President and Chief Executive Officer of
Theseus Pharmaceuticals. "The third quarter marked two significant
milestones for Theseus: our entrance into the public markets and
the start of our transition into a clinical-stage company. The
recent IND clearance for our lead candidate, THE-630, a pan-variant
KIT inhibitor with the potential to address unmet need in patients
with previously treated gastrointestinal stromal tumors (GIST), and
the completion of our successful IPO position Theseus well to
advance both the Phase 1/2 clinical trial of THE-630 and our
pipeline of novel pan-variant inhibitors specifically designed to
overcome the full range of drug resistance mutations."
Third Quarter Highlights and Upcoming Milestones:
- Received FDA clearance of an investigational new drug (IND)
application to evaluate THE-630 in patients with GIST. Theseus
plans to initiate a Phase 1/2 dose escalation and expansion
clinical trial of THE-630, its lead development program, in
patients with previously treated advanced GIST between late fourth
quarter 2021 and mid-first quarter 2022. 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.
- Completed $178.8 million
upsized initial public offering. In October 2021, Theseus sold 11,172,190 shares of
common stock at a price to the pubic of $16.00 per share. The gross proceeds from the
offering were approximately $178.8
million, before deducting underwriting discounts and
commissions and other estimated offering expenses.
- Leadership strengthened through appointments to senior
scientific team. Theseus recently appointed Nachu Narasimhan,
Ph.D., as Senior Vice President, Drug Metabolism and Preclinical
Safety, and Len Rozamus as Senior
Vice President, Technical Operations. Together, their deep
experience in targeted oncology research and development will help
to further advance Theseus' pipeline.
-
- Dr. Narasimhan brings over 30 years of experience in drug
metabolism and bioanalytical disciplines and over 10 years'
experience in preclinical safety and clinical pharmacology. Dr.
Narasimhan was most recently Vice President of Drug Metabolism and
Clinical Pharmacology at Verastem Oncology. Previously, he
contributed to the development and approval of several drugs while
working at Merck, ARIAD Pharmaceuticals, and
Bristol-Myers-Squibb.
- Mr. Rozamus brings over 30 years of experience in
pharmaceutical discovery and development, from pre-clinical
programs through commercial products. Most recently, Mr. Rozamus
served as Founder and President of Rozamus and Associates, Inc.
Previously, his work while Senior Director of Manufacturing
Operations at ARIAD Pharmaceuticals contributed to the approval of
three oncology drugs.
- Advanced fourth-generation epidermal growth factor receptor
(EGFR) program towards development candidate nomination in the
first half of 2022, and thereafter initiate IND-enabling
studies. For its second development program, 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 non-small cell lung cancer
(NSCLC) that have developed resistance to osimertinib, including
the C797S mutation.
- One or more additional kinase targets expected to be
nominated by the end of 2022.
Third Quarter Financial Results:
- As of September 30, 2021, Theseus
had cash and cash equivalents of $90.4
million, which does not include net proceeds from its IPO,
which was completed in October
2021.
-
- Theseus expects its cash and cash equivalents, including
proceeds from the IPO, to fund operations and capital expenditures
into the second half of 2024.
- Research & Development expenses for the third quarter of
2021 were $5.0 million.
- General & Administrative expenses for the third quarter of
2021 were $2.4 million.
- Net Loss for the third quarter 2021 was $7.4 million, or $5.16 per share.
About Theseus Pharmaceuticals, Inc.
Theseus is a
biopharmaceutical company focused on improving the lives of cancer
patients through the discovery, development and commercialization
of transformative targeted therapies. Theseus is developing
next-generation tyrosine kinase inhibitors (TKIs): "pan-variant"
targeted therapies that address all major drug resistance
mutations. 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
clinical trial, expected milestones, market opportunity and sizing
and objectives of management, including in relation to THE-630 and
the planned Phase 1/2 does escalation and expansion clinical trial
and its EGFR 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. 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.
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
Statements of Operations and Comprehensive Loss
(in thousands, except
share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED
SEPTEMBER 30,
|
|
NINE MONTHS ENDED
SEPTEMBER 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
4,996
|
|
$
|
1,275
|
|
$
|
13,306
|
|
$
|
3,470
|
General and
administrative
|
|
2,378
|
|
|
154
|
|
|
5,371
|
|
|
478
|
Total operating
expenses
|
|
7,374
|
|
|
1,429
|
|
|
18,677
|
|
|
3,948
|
Loss from
operations
|
|
(7,374)
|
|
|
(1,429)
|
|
|
(18,677)
|
|
|
(3,948)
|
Other income
(expense), net
|
|
2
|
|
|
—
|
|
|
25
|
|
|
(5,159)
|
Net loss
|
$
|
(7,372)
|
|
$
|
(1,429)
|
|
$
|
(18,652)
|
|
$
|
(9,107)
|
Net loss per share
attributable to common stockholders—basic and diluted
|
$
|
(5.16)
|
|
$
|
(2.12)
|
|
$
|
(18.69)
|
|
$
|
(18.11)
|
Weighted-average
common stock outstanding—basic and diluted
|
|
1,428,054
|
|
|
672,911
|
|
|
997,949
|
|
|
502,804
|
Theseus
Pharmaceuticals, Inc.
|
|
Condensed Balance
Sheets
(in thousands, except
share and per share data)
(Unaudited)
|
|
|
|
NINE MONTHS
ENDED
|
|
YEAR ENDED
|
|
|
SEPTEMBER 30,
|
|
DECEMBER 31,
|
|
|
2021
|
|
2020
|
Assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
90,404
|
|
$
|
8,457
|
Other
assets
|
|
|
7,215
|
|
|
157
|
Total
assets
|
|
$
|
97,619
|
|
$
|
8,614
|
Liabilities,
Redeemable Convertible Preferred Stock and Stockholders'
Deficit
|
|
|
|
|
|
|
Liabilities
|
|
|
6,583
|
|
|
1,595
|
Redeemable
convertible preferred stock
|
|
|
141,181
|
|
|
41,289
|
Stockholders'
deficit
|
|
|
(50,145)
|
|
|
(34,270)
|
Total liabilities,
redeemable convertible preferred stock and stockholders'
deficit
|
|
$
|
97,619
|
|
$
|
8,614
|
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SOURCE Theseus Pharmaceuticals