On November 3, 2022 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, reported financial results for the third quarter ended September 30, 2022 (Press release, Theseus Pharmaceuticals, NOV 3, 2022, View Source [SID1234622996]).
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"This quarter brought progress throughout our growing pipeline of novel kinase inhibitors with strong execution across our programs," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "We opened all sites in the Phase 1 portion of the Phase 1/2 trial of THE-630, a next-generation KIT inhibitor, in GIST patients and remain on track to share initial data from dose escalation in the second quarter of 2023. At EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper), we shared compelling preclinical data, characterizing THE-349 as a significantly differentiated fourth-generation EGFR inhibitor candidate: a single molecule with potent activity against all major classes of EGFR activating and resistance mutations, meaningful selectivity over wild-type EGFR, and activity in the central nervous system. We look forward to evaluating THE-349 in the clinic and anticipate submitting an IND application for this candidate in the second half of next 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 with gastrointestinal stromal tumors (GIST) that have 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. Phase 1 site activation was completed in the third quarter of 2022 and the study continues to enroll patients in the dose-escalation portion of the trial.
●Initial safety and pharmacokinetic data, as well as initial analysis of circulating tumor DNA, from the dose-escalation portion of the clinical trial are expected to be presented at a scientific conference in the second quarter of 2023.
●Additional data from the Phase 1 portion of the clinical trial is expected to be presented in the fourth quarter of 2023.
THE-349: a fourth-generation epidermal growth factor receptor (EGFR) inhibitor with potent activity against single-, double-, and triple-mutant EGFR variants, including T790M and C797X, found in the tumors of patients with EGFR-mutant non-small cell lung cancer (NSCLC) who have developed resistance to first- or later-line osimertinib.
●During the third quarter, Theseus nominated THE-349 as the development candidate for its fourth-generation EGFR inhibitor program, targeting the treatment of EGFR-driven NSCLC.
● In a poster presentation at the 2022 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, Theseus shared preclinical data characterizing THE-349, demonstrating it can potently inhibit all major classes of EGFR activating and resistance mutations observed in a post-first- or later-line osimertinib setting consisting of single-, double-, and triple-EGFR mutant variants, including T790M and C797X, with kinome and wild-type selectivity and central nervous system activity.
● Theseus expects to submit an Investigational New Drug (IND) application for THE-349 to the U.S. Food and Drug Administration in the second half of 2023.
R&D Portfolio: Theseus’ discovery platform incorporates its structure-guided drug design and predictive resistance assay (PRA) to develop selective, next-generation, pan-variant inhibitor molecules targeting all major cancer-causing and treatment-resistance mutations of tyrosine kinase targets.
●In addition to its lead programs, Theseus continues to advance its preclinical discovery pipeline and has selectively prioritized additional small molecule research programs with established targets of unmet medical need. Theseus expects to prioritize a new kinase target program by the end of 2022.
Business Highlights:
●In October 2022, Theseus announced the appointment of Steven Stein, M.D., to its Board of Directors. Dr. Stein brings over 15 years of oncology expertise to the Board, including an extensive track record of bringing effective medicines through development. He currently serves as Executive Vice President, Chief Medical Officer of the global biopharmaceutical company, Incyte.
Third Quarter Financial Results:
Cash Position: As of September 30, 2022, Theseus had cash, cash equivalents and short-term and long-term investments of $221.0 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 $11.4 million for the third quarter of 2022, as compared to $5.0 million for the same period in 2021. This increase was primarily due to $4.3 million of increased employee-related costs, and $1.7 million of increased expenses for clinical and preclinical studies as Theseus advanced THE-630 and THE-349 in clinical and preclinical studies, respectively, as well as increased expense for its discovery programs.
G&A Expenses: General and administrative expenses were $4.5 million for the third quarter of 2022, as compared to $2.4 million for the same period in 2021. This increase was primarily due to $1.2 million of increased employee-related costs, as well as $1.0 million of increased professional fees.
Net Loss: Net loss was $14.7 million for the third quarter of 2022, as compared to a net loss of $7.4 million for the same period in 2021.