On August 11, 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 business and pipeline highlights and reported financial results for the second quarter ended June 30, 2022 (Press release, Theseus Pharmaceuticals, AUG 11, 2022, View Source [SID1234618148]).

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"At Theseus, we are developing next-generation tyrosine kinase inhibitors (TKIs) to outsmart cancer resistance—a key challenge facing existing therapies in targeted oncology. 2022 is a critical year of execution and we have continued to make significant progress across our programs," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "Enrollment in the dose escalation portion of the Phase 1/2 trial of THE-630 in patients with advanced GIST is on track and we look forward to the expected announcement of initial clinical data in the first half of 2023. We are on track to nominate a development candidate for our EGFR inhibitor program for the treatment of non-small cell lung cancer in the third quarter of 2022 and plan to present preclinical data supporting the promising profile for this candidate in the fourth quarter of 2022. We expect to expand our pipeline with the introduction of a third TKI program later this 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 whose gastrointestinal stromal tumors (GIST), a disease that remains largely KIT-dependent following multiple lines of treatment, has 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, as the Company completes site activations and continues to enroll patients in the dose-escalation portion of the trial.
Initial data from the Phase 1 dose-escalation portion of the clinical trial are expected to be presented at a scientific conference in the second quarter of 2023.
EGFR inhibitor for non-small cell lung cancer (NSCLC): a fourth-generation, single molecule, selective EGFR inhibitor, designed to inhibit all major single-, double-, and triple-mutant EGFR variants found in the tumors of patients with EGFR-mutant NSCLC that have developed resistance to first- or later-line osimertinib treatment, including the C797S and T790M mutations, with central nervous system (CNS) activity.

Theseus expects to nominate a development candidate for this program in the third quarter of 2022 and to introduce this candidate along with a presentation of new preclinical data at a scientific conference in the fourth quarter of 2022.
Theseus expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in 2023.
At the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022, the Company presented preclinical data demonstrating that pan-variant inhibition of all major EGFR mutations consisting of single-, double-, and triple-EGFR mutants, including T790M and C797S, with selectivity over wild-type and CNS activity, can be achieved with a single molecule.
R&D Portfolio: Theseus’ discovery platform incorporates its structure-guided drug design and predictive resistance assay (PRA) to develop next-generation, pan-variant inhibitor molecules targeting all major cancer-causing and treatment-resistance mutations of tyrosine kinase targets.

The Company continues advancing its preclinical discovery pipeline and expects to introduce a new kinase target program by the end of 2022.
Business Highlights:

In May 2022, Theseus announced the appointment of Don Hayden to its Board of Directors. Mr. Hayden brings over 40 years of industry experience to the Board, including previously serving as President of Oncology and Immunology and as President of Global Pharmaceuticals at Bristol Myers-Squibb and as Chair at numerous biotech companies.
In June 2022, Theseus appointed Steve Tuller as Vice President, Quality Assurance. Mr. Tuller has 24 years of experience in the pharmaceutical and biotechnology industries. Before joining Theseus, he served as Vice President, Head of Quality Assurance at Epizyme, Inc., where he initiated the GxP Quality Assurance organization.
Second Quarter Financial Results:

Cash Position: As of June 30, 2022, Theseus had cash, cash equivalents and short-term and long-term investments of $228.6 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 $7.3 million for the second quarter of 2022, as compared to $4.5 million for the same period in 2021. This increase was primarily due to $2.0 million of increased employee-related costs, and $0.6 million of increased expenses for clinical and preclinical studies.

G&A Expenses: General and administrative expenses were $4.7 million for the second quarter of 2022, as compared to $2.3 million for the same period in 2021. This increase was primarily due to $1.6 million of increased employee-related costs, as well as $0.5 million of increased professional fees.

Net Loss: Net loss was $11.6 million for the second quarter of 2022, as compared to a net loss of $6.8 million for the same period in 2021.