On May 11, 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 provided financial results for the first quarter ended March 31, 2023 (Press release, Theseus Pharmaceuticals, MAY 11, 2023, View Source [SID1234631539]).
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"We look forward to continued clinical execution and important pipeline advancements in the months ahead, most notably with two anticipated clinical readouts from our lead program, THE-630, in advanced GIST," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "We maintain a strong financial position as we continue to progress our pipeline, with an anticipated IND submission for THE-349 in the fourth quarter of this year as well as advancement of our BCR-ABL and discovery programs."
Recent Pipeline Highlights and Upcoming Expected Milestones:
THE-630 is a pan-variant tyrosine kinase inhibitor (TKI) of the receptor tyrosine kinase KIT, designed for patients with gastrointestinal stromal tumors (GIST) that have developed resistance to earlier lines of therapy.
•As of March 31, 2023, Theseus is enrolling patients in cohort 7 of its ongoing phase 1/2 dose escalation and expansion clinical trial evaluating THE-630 in patients with advanced GIST.
•Theseus submitted its initial dose escalation results to the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, in Chicago, Illinois, and the abstract was selected for online publication. Theseus plans to present data with an updated cutoff date during a virtual investor event on May 25, 2023, at 5:30pm ET, after the public release of the abstract. The initial dose escalation data will include preliminary safety, pharmacokinetic (PK), and clinical activity data through cohort 6, as well as an analysis of circulating tumor DNA (ctDNA) through cohort 5.
•Theseus plans to present follow-up data at a scientific conference in the fourth quarter of 2023, which is expected to include data from additional dose escalation cohorts, including cohort 8, where Theseus expects to have reached the target systemic exposure for pan-variant KIT activity.
THE-349 is a fourth-generation (4G) epidermal growth factor receptor (EGFR) TKI development candidate, which has demonstrated 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 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.
•Theseus expects to submit an Investigational New Drug Application (IND) for THE-349 to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023 and to initiate the first-in-human trial as soon as possible thereafter, subject to clearance of the IND by the FDA.
BCR-ABL Program: Theseus aims 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).
•Preclinically, Theseus lead molecules have been observed to show 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 by early 2024, with the goal of pursuing 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.
Business Highlights:
•In May 2023, Theseus announced the appointment of Franklin Vairinhos, Ph.D., as Vice President, Regulatory Affairs. Dr. Vairinhos has more than 30 years of experience in Regulatory Affairs, predominantly in developing regulatory strategies for oncology therapies.
First Quarter Financial Results:
Cash Position: As of March 31, 2023, Theseus had cash, cash equivalents, and marketable securities of $243.6 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 the third quarter of 2025 based on its current operating plan.
R&D Expenses: Research and development expenses were $12.4 million for the first quarter of 2023, as compared to $6.5 million for the same period in 2022. This increase was primarily due to a $2.7 million increase in expense for preclinical studies and drug manufacturing to support THE-349 IND enabling studies, a $1.4 million increase in development expense related to discovery programs, as well as a $1.5 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 first quarter of 2023, as compared to $4.0 million for the same period in 2022. This increase was primarily due to an increase in stock-based compensation expense and employee-related costs.
Net Loss: Net loss was $14.6 million for the first quarter of 2023, as compared to a net loss of $10.5 million for the same period in 2022.