Summary of Terns Pharmaceuticals Conference Call Company Overview - **Company**: Terns Pharmaceuticals - **Product**: Tern 701, an investigational next-generation oral allosteric BCR-ABL inhibitor for chronic myeloid leukemia (CML) treatment [2][41] Industry Context - **Disease**: Chronic Myeloid Leukemia (CML) - **Current Treatments**: First-generation and second-generation active-site tyrosine kinase inhibitors (TKIs) like Imatinib and Asciminib - **Market Need**: Significant unmet need for improved efficacy, safety, and tolerability in CML treatments, with approximately 40% of patients switching therapies within five years due to inadequate response or side effects [4][5] Key Points from the Call Efficacy and Safety Data - **Tern 701 Efficacy**: - Achieved a 75% major molecular response (MMR) and 36% deep molecular response (DMR) at 24 weeks in the recommended phase two dose range of 320 mg and above [8][31] - In a refractory patient population, 64% MMR was achieved by 24 weeks across all doses, with 75% MMR in patients at higher doses [10][22] - DMR rates are approximately two times higher than those seen with Asciminib [22][34] - **Safety Profile**: - Most treatment-emergent adverse events (AEs) were low-grade, with all grade three AEs being less than 10% [8][41] - No signs of pancreatic toxicity or significant blood pressure changes were observed, differentiating Tern 701 from Asciminib [18][41] Competitive Landscape - **Asciminib**: - First allosteric BCR-ABL inhibitor approved for CML, achieving a 22% market share in the U.S. within three quarters of launch and peak sales estimates revised to over $4 billion [5][6] - Tern 701 is positioned to potentially outperform Asciminib based on early clinical data [6][34] Clinical Trial Insights - **Cardinal Study**: - A two-part multicenter global study enrolling patients with chronic phase CML who have failed prior TKIs [12] - Enrollment has accelerated, with over 85 patients currently participating [3][41] Future Development Plans - **Next Steps**: - Plans to select a single dose for pivotal studies based on ongoing data collection and regulatory feedback [38][41] - Anticipated catalysts include expanded long-term data from the Cardinal study and potential regulatory meetings in 2026 [42][41] Market Opportunity - **Patient Population**: - Approximately 17,000 new CML patients annually in G7 nations, with a significant portion expected to switch to allosteric therapies due to better efficacy and tolerability [39][40] - **Treatment Goals**: - Focus on achieving rapid and deep molecular responses to improve long-term outcomes and quality of life for CML patients [39][52] Conclusion - Tern 701 shows promising efficacy and safety data, positioning it as a potential best-in-disease therapy for CML, with ongoing trials and future studies aimed at confirming its clinical benefits and market potential [41][42]

Kura Oncology Conference Call Summary Company Overview - **Company**: Kura Oncology - **Key Product**: Ziftomenib (also referred to as ZYPTOMENIB) - **Upcoming Milestones**: PDUFA for Ziftomenib, data updates at medical conferences, initiation of COMMOD-17 studies Core Industry Insights Ziftomenib Development and Market Position - **PDUFA Status**: Kura is optimistic about the NDA review process for Ziftomenib, receiving positive feedback from Key Opinion Leaders (KOLs) regarding its profile in relapsed/refractory settings [2][3] - **Efficacy and Safety**: The company emphasizes four pillars for Ziftomenib: efficacy, convenience, simplicity of administration, and safety [3] - **Commercial Readiness**: Kura's team is fully trained and prepared for market access and pre-approval information exchange [3] - **Combination Studies**: Data sharing is anticipated at the end of the year for the combination of Ziftomenib with venetoclax and azacitidine [3] Competitive Landscape - **Market Dynamics**: Kura expects to compete effectively against other menin inhibitors in the market, with a focus on strong efficacy and safety profiles [11][12] - **Physician Feedback**: Physicians have shown enthusiasm for Ziftomenib's once-daily oral administration and its potential for combination therapies [11][12] - **Patient Segmentation**: Initial patient starts are expected to be new patients rather than switches from existing therapies [14] Clinical Trials and Data Expectations - **Phase 3 Studies**: Kura is on track to initiate two parallel Phase 3 studies in Q4 [4] - **Combination Therapy Data**: The company aims to improve upon existing combination therapies' outcomes without increasing toxicity [28] - **Enrollment Strategy**: Kura's trial design allows for easier patient enrollment, which is expected to enhance participation rates [30][31] Financial Position - **Cash Reserves**: Kura reported $630.7 million in cash, with expectations of substantial milestone payments to maintain a strong financial position [6] Additional Opportunities Menin Inhibitors in Other Indications - **GIST and Diabetes**: Kura is exploring the use of menin inhibitors in GIST and has nominated a next-gen menin inhibitor for diabetes [45] - **Long-term Vision**: The company aims to lead the discovery and development of menin inhibitors across various oncology applications [45] Future Priorities - **Strategic Goals**: Key priorities include the approval and launch of Ziftomenib, additional combination data, and the start of the COMMOD-17 study [46] Important but Overlooked Aspects - **Collaboration with Kyowa Kirin**: Kura has a strong partnership with Kyowa Kirin for co-development and co-promotion, with Kura leading commercialization efforts in the US [25][26] - **Focus on Safety and Efficacy**: The emphasis on maintaining a favorable safety profile while improving efficacy in combination therapies is crucial for Kura's strategy [28][40] This summary encapsulates the key points discussed during the conference call, highlighting Kura Oncology's strategic direction, product development, and market positioning.

Summary of Kura Oncology Conference Call Company Overview - **Company**: Kura Oncology - **Event**: Jefferies Global Healthcare Conference 2025 - **Key Participants**: CEO Troy, Commercial Officer Brian, CMO Molly Industry Focus - **Industry**: Oncology, specifically Acute Myeloid Leukemia (AML) and Menin inhibitors Key Highlights from the Call 1. **Positive Trial Results**: Kura Oncology reported two positive trials indicating that their mechanism works in AML, suggesting that their drugs are likely approvable [4][10] 2. **Clinical Data**: - Phase 2 trial showed a 23% complete response (CR) rate and a median overall survival of 16.4 months for responders, compared to typical survival of 3 months in relapsed refractory leukemia [5] - Zifdomenib demonstrated consistent activity regardless of prior treatments or therapy lines [6] 3. **Safety Profile**: - No myelosuppression differentiation syndrome was reported, and QT prolongation was not clinically meaningful [7][8] - Once-daily oral dosing was highlighted as a convenience factor for patients and physicians [8][15] 4. **Regulatory Milestones**: - Kura has a PDUFA date set for November 30, indicating a priority review status [10][12] - The company is preparing for a significant data presentation at EHA on June 12 [9] 5. **Market Opportunity**: - Approximately 20,000 AML patients are diagnosed annually, with an estimated 10,000 potentially eligible for Menin inhibitors [52] - The potential market size for Kura's product in AML is estimated between $5 billion to $10 billion, with Kura aiming to capture around $3 billion [53] 6. **Combination Therapies**: - Kura is exploring combination therapies, including a study combining Zifdomenib with Imatinib for GIST, which could enhance treatment durability [56][59] - The company is also investigating combinations in breast cancer and other solid tumors [60][61] 7. **Pipeline and Funding**: - Kura has $703 million in cash and is eligible for an additional $375 million in near-term milestones, ensuring funding through the AML program [67] - The company is focused on advancing its pipeline, including FTI programs and diabetes treatments [67] Additional Insights - **Physician Feedback**: Physicians are excited about the introduction of Menin inhibitors, indicating a competitive landscape but also a growing acceptance of new therapies [21][22] - **Regulatory Environment**: Kura does not anticipate changes in FDA perspectives that would affect their accelerated approval pathway [33][36] - **Operational Efficiency**: Kura is combining two phase three trials under a single protocol to streamline operations and enhance patient eligibility [39][40] This summary encapsulates the critical points discussed during the conference call, highlighting Kura Oncology's advancements, market potential, and strategic direction in the oncology space.