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Terns Pharmaceuticals (TERN) investor relations material
Terns Pharmaceuticals Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Key clinical data and efficacy
Phase I study in highly refractory CML patients showed unprecedented 64% major molecular response rate, double the previous best in similar studies.
Safety profile was favorable with only one discontinuation due to adverse events and no food effect observed, allowing flexible dosing.
TERN-701 demonstrated superior potency and target coverage compared to asciminib, including in preclinical models with BCR-ABL and Myristoyl Pocket mutations.
Data from partner Hansoh in China supported dose selection and safety insights, aiding rapid progression to pivotal trials.
Efficacy and safety data from both internal and Hansoh studies are congruent, with no contradictions observed.
Development strategy and regulatory plans
Plans to pursue both second-line plus and first-line pivotal trials, with the second-line plus study starting first and front-line study following within 6-12 months.
Dose selection for pivotal trials is ongoing, with decisions based on extended phase I data; no guidance on final dose expected before December.
Regulatory path is modeled after asciminib, targeting comparisons against second-generation TKIs and imatinib in the front line for fastest market entry.
Combination approaches are deprioritized in favor of monotherapy due to strong phase I results.
Ultimate goal includes enabling treatment-free remission (functional cure) in CML, pending long-term data.
Financial outlook and market positioning
Estimated direct costs for pivotal trials are under $100 million for second-line and under $150 million for front-line studies.
Company has cash runway into 2028 and aims to secure funding to complete pivotal trials before initiation.
Enrollment rates have increased due to compelling efficacy data, potentially accelerating timelines.
Management sees a de-risked path to market for a multi-billion dollar orphan drug, with phase I endpoints translating well to phase III.
No current plans to raise capital immediately; focus remains on trial execution and regulatory alignment.
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