On August 10, 2023 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 highlights and highlighted financial results for the second quarter ended June 30, 2023 (Press release, Theseus Pharmaceuticals, AUG 10, 2023, View Source [SID1234634219]).
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"We are excited to be advancing our pipeline, including lead candidate THE-349, a potential best-in-class fourth generation EGFR inhibitor, and continue to expect an IND submission for THE-349 in EGFR-mutant NSCLC in the fourth quarter of this year. Additionally, we look forward to nominating development candidates from our BCR-ABL and next-generation KIT programs in the first half of next year," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "While we are disappointed by the outcome of the THE-630 program in GIST patients, we believe the update announced today supports the exploration of THE-630 in mast cell-driven diseases, which we anticipate pursuing internally or through a partnership."
Pipeline Highlights and Upcoming Expected Milestones:
THE-349 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) product candidate with 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 that 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.
•IND-enabling toxicology studies have been completed, and Theseus remains on track to submit an Investigational New Drug Application (IND) for THE-349 in the fourth quarter of 2023, and commence its clinical program as soon as possible thereafter, subject to clearance of the IND by the U.S. Food and Drug Administration.
BCR-ABL Program: Theseus is aiming 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).
•Theseus plans to pursue 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.
•Preclinically, Theseus lead molecules have shown 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 in the first half of 2024.
Next-Generation KIT Program: Theseus is aiming to develop a potent and selective pan-variant TKI candidate targeting all major activating and resistance KIT mutations for treatment of early-line gastrointestinal stromal tumors (GIST).
•Theseus has maintained an extensive medicinal chemistry effort to target KIT, which has led to the discovery of a series of chemically distinct, highly selective, pan-variant KIT inhibitors for the treatment of early-line GIST.
•Theseus plans to nominate a development candidate from this series in the first half of 2024.
THE-630: In July, Theseus discontinued enrollment in its phase 1/2 study of THE-630 in patients with GIST. Theseus subsequently analyzed trial data to inform the feasibility of developing low dose THE-630 for KIT-associated mast cell-driven inflammatory indications.
•Theseus measured levels of serum tryptase, a biomarker for mast cell activation, in GIST patients treated with once-daily oral THE-630 in the phase 1 dose escalation trial at doses of 4 mg to 18 mg.
•Dose-dependent and sustained reductions in serum tryptase observed at all doses, including reductions below detection limit of the assay in some patients, seen at first timepoint (day 8).
•Theseus is evaluating next steps for potential plans to explore doses of 9 mg and below in clinical studies in patients with mast cell-driven diseases, such as chronic urticaria. The safety profile at these doses was generally favorable in GIST patients.
Second Quarter Financial Results:
Cash Position: As of June 30, 2023, Theseus had cash, cash equivalents, and marketable securities of $234.2 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 2026 based on its current operating plan.
R&D Expenses: Research and development expenses were $12.9 million for the second quarter of 2023, as compared to $7.3 million for the same period in 2022. This increase was primarily due to a $2.1 million increase in expense for preclinical studies and drug manufacturing to support THE-349 IND enabling studies, a $1.2 million increase in development expense related to discovery programs, as well as a $1.6 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 second quarter of 2023, consistent with the expense for the same period in 2022.
Net Loss: Net loss was $14.8 million for the second quarter of 2023, as compared to a net loss of $11.6 million for the same period in 2022.