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Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) is a clinical-stage biopharmaceutical company dedicated to improving the lives of cancer patients by developing transformative targeted therapies. The company is at the forefront of outsmarting cancer resistance, focusing on pan-variant tyrosine kinase inhibitors (TKIs) that target all classes of cancer-causing and resistance mutations, thereby addressing the challenge of treatment resistance.
Core Business: Theseus is pioneering the development of best-in-class, pan-variant kinase inhibitors. Its lead candidate, THE-349, is a fourth-generation epidermal growth factor receptor (EGFR) inhibitor designed to counteract C797X-mediated resistance in non-small cell lung cancer (NSCLC) patients previously treated with osimertinib. The company is also working on a pan-variant BCR-ABL inhibitor for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL), and a next-generation, highly selective, pan-variant KIT inhibitor for early-line gastrointestinal stromal tumors (GIST).
Recent Achievements: The company recently made significant progress in its pipeline, despite discontinuing its THE-630 program for GIST due to dose-limiting toxicities observed in clinical trials. However, Theseus is exploring the potential of low-dose THE-630 for KIT-associated mast cell-driven diseases. The company successfully raised $234.2 million in cash and equivalents by June 30, 2023, to fund operations through 2026.
Strategic Developments: In December 2023, Theseus entered into a merger agreement with Concentra Biosciences, LLC, where Concentra will acquire Theseus for a price per share ranging from $3.90 to $4.05 in cash, along with contingent value rights (CVRs). This move aims to maximize shareholder value and includes strategic options such as asset sales, mergers, or other actions.
Partnerships and Products: The company's robust pipeline includes partnerships and potential internal developments targeting various cancer mutations. Theseus is set to nominate development candidates for its BCR-ABL and KIT programs in early 2024 and anticipates filing an Investigational New Drug (IND) application for THE-349 soon.
Outlook: Despite challenges, Theseus remains committed to its mission of developing therapies that outsmart cancer resistance. With a focus on pan-variant kinase inhibitors, Theseus aims to bring forth innovative treatments that offer significant clinical benefits to cancer patients globally.
Theseus Pharmaceuticals (NASDAQ: THRX) announced that initial dose escalation data from the phase 1/2 study of its drug THE-630 for advanced gastrointestinal stromal tumors (GIST) will be showcased at the 2023 ASCO Annual Meeting in Chicago from June 2-6. An online publication of the abstract was submitted on February 14, 2023, and a virtual investor event on May 25, 2023, will present updated data, including preliminary safety and clinical activity results. THE-630 is a pan-variant tyrosine kinase inhibitor designed for patients with GIST who have developed resistance to previous therapies. The study aims to assess the safety profile and determine a recommended phase 2 dose (RP2D) for GIST patients who have undergone treatment with imatinib and another TKI.
Theseus Pharmaceuticals (NASDAQ: THRX), a clinical-stage biopharmaceutical company, is set to participate in two upcoming virtual investor conferences. The events include the 22nd Annual Needham Virtual Healthcare Conference on April 20, 2023, at 8:45am ET, and the Stifel 2023 Virtual Targeted Oncology Days on April 26, 2023, at 12:00pm ET. Interested investors can access live webcasts on the company's investor relations website, which will be archived for 30 days post-conference. Theseus focuses on developing targeted therapies for cancer patients, including its lead product candidate, THE-630, designed to treat advanced gastrointestinal stromal tumors (GIST). Other projects include THE-349, aimed at non-small cell lung cancer, and a BCR-ABL inhibitor for chronic myeloid leukemia.
Theseus Pharmaceuticals (NASDAQ: THRX) announced participation in the Cantor Future of Oncology Virtual Symposium from April 3-5, 2023. The company will present on April 3 at 2:00 PM ET. Theseus focuses on developing targeted therapies for cancer patients, including pan-variant tyrosine kinase inhibitors to combat resistant cancer mutations. Their lead candidate, THE-630, targets gastrointestinal stromal tumors, while THE-349 addresses resistance in non-small cell lung cancer. Live webcasts will be accessible to registered attendees of the symposium.
Theseus Pharmaceuticals (NASDAQ: THRX) reported significant progress in its clinical pipeline for 2022. The company initiated a first-in-human study for its lead drug, THE-630, targeting advanced GIST, and nominated THE-349 for EGFR-mutant NSCLC. Additionally, it prioritizes a BCR-ABL program for CML and Ph+ ALL. The company’s cash position was $211.8 million as of December 31, 2022, funding operations into Q3 2025. However, R&D expenses rose to $35.7 million due to increased headcount and clinical studies, with a net loss of $50.6 million for the year, compared to $27.3 million in 2021.
Theseus Pharmaceuticals (NASDAQ: THRX), a clinical-stage biopharmaceutical company dedicated to cancer treatment, will virtually participate in the SVB Securities Global Biopharma Conference from February 14-16, 2023. The fireside chat is scheduled for February 16 at 10:40 AM ET. Investors can access a live webcast on their investor relations website, which will be available for 30 days post-event. Theseus focuses on developing targeted therapies for cancer, including the lead candidate THE-630 for advanced gastrointestinal stromal tumors.
Theseus Pharmaceuticals (THRX) outlined significant milestones for 2023, including ongoing Phase 1/2 trials for THE-630 targeting advanced gastrointestinal stromal tumors (GIST). Preliminary data is anticipated in Q2 and Q4 2023. An IND submission for the EGFR inhibitor THE-349 is expected in Q4 2023, alongside the introduction of a new BCR-ABL program targeting chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), with a candidate nomination expected by early 2024.
Theseus Pharmaceuticals (THRX) reported significant advancements in its clinical pipeline during Q3 2022, with all sites activated for the Phase 1 trial of THE-630 in advanced gastrointestinal stromal tumors (GIST). Preliminary data is anticipated in Q2 2023. The company presented promising preclinical data for THE-349, a fourth-generation EGFR inhibitor for NSCLC, with IND submission expected in H2 2023. Theseus holds $221 million in cash, enough to fund operations into Q4 2024, despite a rising net loss of $14.7 million for Q3 2022.
Theseus Pharmaceuticals (NASDAQ: THRX) announced preclinical results for its fourth-generation EGFR inhibitor, THE-349, at the 34th EORTC-NCI-AACR Symposium. THE-349 effectively inhibits all major classes of EGFR mutations, including C797X and T790M, showing strong anti-tumor activity and CNS penetration. The company plans to submit an Investigational New Drug (IND) application to the US FDA in the second half of 2023. The data suggest a promising treatment option for patients with EGFR-mutant non-small cell lung cancer (NSCLC) resistant to existing therapies.
Theseus Pharmaceuticals (NASDAQ: THRX) announced the appointment of Dr. Steven Stein to its Board of Directors. This strategic leadership move aims to enhance the company's development of its therapeutic programs, particularly THE-630 and THE-349, targeting advanced cancer treatments. Dr. Stein, currently Chief Medical Officer at Incyte, brings extensive oncology expertise. His track record in clinical development is expected to be invaluable as Theseus advances its precision oncology initiatives.
FAQ
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