Summary of Terns Pharmaceuticals FY Conference Call Company Overview - **Company**: Terns Pharmaceuticals (NasdaqGS:TERN) - **Event**: FY Conference Call on January 12, 2026 - **Key Speakers**: Amy Burroughs (CEO), Emil Kuriakose (CMO), Scott Harris (CDO) [1] Industry Context - **Industry**: Chronic Myeloid Leukemia (CML) treatment - **Current Market Dynamics**: - CML was previously a fatal disease until the introduction of BCR-ABL inhibitors like Gleevec (Imatinib) in 2001 - Asiminib, an allosteric inhibitor, gained a 22% market share in the front-line treatment within three quarters of its approval in November 2024 [4][5] Core Points and Arguments - **Performance in 2025**: Terns had a successful year and anticipates continued success in 2026, aiming to establish itself as a leader in CML therapy [2] - **Financial Position**: Terns has $1 billion in cash, alleviating financing concerns until commercial launch [3] - **Efficacy of Terns 701**: - Terns 701 shows unprecedented efficacy with a 75% major molecular response (MMR) rate in a highly refractory patient population [6][9] - Deep molecular response (DMR) rate of 36% at recommended doses [7] - Comparison with Asiminib indicates Terns 701 may outperform in both efficacy and safety [10][20] - **Safety Profile**: - No dose-limiting toxicities observed; majority of adverse events were low-grade [9][11] - Terns 701 does not exhibit the pancreatic toxicity (20%) or hypertension (18%) seen with Asiminib [5][6] - Administered once daily without food restrictions, enhancing patient convenience [9][26] Market Opportunities - **Potential for Terns 701**: - Positioned as a next-generation therapy with better efficacy and safety compared to existing treatments [10][25] - Anticipated to capture significant market share in the front-line treatment of CML [25][26] - **Regulatory Pathway**: - Plans to engage with the FDA for trial design and dose selection in 2026 [22][29] - A second-line plus trial is expected to be initiated, with confidence in achieving MMR as a primary endpoint [22][23] Additional Insights - **Patient Population**: - High baseline disease burden among trial participants, with 64% showing lack of efficacy to previous treatments [12][13] - Notable patient cases demonstrate Terns 701's effectiveness in individuals resistant to Asiminib [18][19] - **Future Directions**: - Terns plans to open a mutation cohort for patients with specific mutations, enhancing the understanding of Terns 701's efficacy [21] - Additional data releases and longer-term safety studies are anticipated in 2026 [26][27] Conclusion - Terns Pharmaceuticals is positioned to make significant advancements in CML treatment with Terns 701, backed by strong efficacy and safety data, a solid financial foundation, and strategic regulatory plans for 2026 [27]