05/12/2022 | Press release | Archived content
THE-630 Phase 1/2 clinical trial actively enrolling patients with advanced gastrointestinal stromal tumors (GIST); initial data expected in 1H 2023
On track to nominate development candidate for fourth-generation epidermal growth factor receptor (EGFR) program targeting non-small cell lung cancer (NSCLC) in Q3 2022; IND expected in 2023
$237.0 millionin cash, cash equivalents, and investments as of March 31, 2022, expected to fund operations into the second half of 2024
CAMBRIDGE, Mass., May 12, 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 first quarter ended March 31, 2022.
"We are pleased by the progress achieved in the first quarter of 2022 as we continue to make strides in advancing our pipeline of novel pan-variant targeted therapies. Notably, we began the year by enrolling patients in our first clinical trial of THE-630 in advanced GIST, and more recently presented encouraging preclinical data on our EGFR program at AACR that support our approach of pan-variant inhibition in a single molecule," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "Over the next 12 months we have a robust set of milestones, including the nomination of a development candidate for our EGFR program and the expansion of our pipeline with a third TKI program. We look forward to seeing these developments over the remainder of 2022, and to sharing initial clinical data from THE-630 in the first half of 2023."
Recent Business Highlights and Upcoming Milestones:
First Quarter Financial Results:
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, 2021filed with the SEC on March 10, 2022and Theseus' Form 10-Q for the quarter ended March 31, 2022expected to be filed with the SEC in the second 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
[email protected]
Investor Contacts
Christen Baglaneas
Theseus Pharmaceuticals
857-706-4993
[email protected]
Josh Rappaport
Stern Investor Relations
212-362-1200
[email protected]
Theseus Pharmaceuticals, Inc. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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(in thousands, except share and per share data) |
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|
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|
|
Three Months Ended March 31, |
||||
|
|
2022 |
|
2021 |
||
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
6,548 |
|
$ |
3,825 |
General and administrative |
|
|
4,031 |
|
|
664 |
Total operating expenses |
|
|
10,579 |
|
|
4,489 |
Loss from operations |
|
|
(10,579) |
|
|
(4,489) |
Other income, net |
|
|
82 |
|
|
16 |
Net loss |
|
$ |
(10,497) |
|
$ |
(4,473) |
Net loss per share attributable to common |
|
$ |
(0.27) |
|
$ |
(4.90) |
Weighted-average common stock outstanding-basic |
|
|
38,247,970 |
|
|
912,222 |
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
Net loss |
|
$ |
(10,497) |
|
$ |
(4,473) |
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized loss on investments |
|
|
(129) |
|
|
- |
Total comprehensive loss |
|
$ |
(10,626) |
|
$ |
(4,473) |
|
|
|
|
|
|
|
Theseus Pharmaceuticals, Inc. |
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Condensed Consolidated Balance Sheets |
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(in thousands) |
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|
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|
|
Three Months |
|
Year Ended |
||
March 31, |
|
December 31, |
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|
|
2022 |
|
2021 |
||
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
146,281 |
|
$ |
244,662 |
Short-term investments |
|
|
85,757 |
|
|
- |
Long-term investments |
|
|
4,945 |
|
|
- |
Other assets |
|
|
10,522 |
|
|
6,267 |
Total assets |
|
|
247,505 |
|
|
250,929 |
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Liabilities |
|
|
9,653 |
|
|
4,495 |
Stockholders' equity |
|
|
237,852 |
|
|
246,434 |
Total liabilities and stockholders' equity |
|
$ |
247,505 |
|
$ |
250,929 |
|
|
|
|
|
|
|
SOURCE Theseus Pharmaceuticals