Core Viewpoint - Terns Pharmaceuticals is presenting data on TERN-701, an investigational oral allosteric BCR-ABL inhibitor for chronic myeloid leukemia (CML), highlighting its unprecedented efficacy and safety data, and potential best-in-disease profile [2]. Company Overview - Terns Pharmaceuticals is focused on developing TERN-701 for the treatment of CML, with plans to discuss key benchmarks and next steps for the drug's pivotal trial readiness [2]. Data Presentation - The company will provide a comprehensive view of the data supporting TERN-701's efficacy and safety, including details from Dr. Jabbour's ASH presentation [3].

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]

TERN-701 Efficacy and Safety - TERN-701 demonstrated a 64% Major Molecular Response (MMR) achievement rate at 24 weeks across all doses in non-T315I CP-CML patients (N=38)[20, 26] - At doses ≥320 mg QD, TERN-701 achieved a 75% MMR rate and a 36% Deep Molecular Response (DMR) rate at 24 weeks[18, 26, 75] - The majority of Treatment-Emergent Adverse Events (TEAEs) were low grade, with Grade 3 AEs less than 10%[18, 26] - No Dose Limiting Toxicities (DLTs) were observed, and the Maximum Tolerated Dose (MTD) was not identified[26, 37] - The study observed no pancreatic toxicity or clinically significant changes in blood pressure[18, 26] Patient Population and Treatment - The CARDINAL study enrolled a predominantly 3L+ refractory CML population (N=63 as of September 13, 2025)[24] - 38% of patients had prior asciminib treatment, with 75% of those discontinuing due to lack of efficacy[26, 33] - 87% of patients remained on treatment with a median treatment duration of 6.1 months[35] Competitive Landscape and Future Development - Asciminib NBRx share in 2L is 52% and in 3L+ is 53%[7] - Asciminib NBRx share of front-line is 22%[7] - TERN-701 is positioned to potentially capture new patients and switch from both Asciminib and Active Site TKIs[103] - Multiple catalysts are planned in 2026, including expanded CARDINAL data, pivotal dose selection, and alignment with regulators for pivotal studies[99, 106]

Core Insights - Terns Pharmaceuticals announced updated data from the CARDINAL trial of TERN-701, showing a 64% major molecular response (MMR) achievement by 24 weeks across all efficacy evaluable patients and a 75% MMR achievement at doses greater than 320mg QD [1][3][4] - The safety and tolerability profile of TERN-701 has been encouraging, with no dose-limiting toxicities observed and a majority of patients remaining on treatment [11][18] - The company will host an investor update call to discuss the findings further [1][16] Study Results - The CARDINAL trial has reported a cumulative MMR rate of 74% (28/38) by 24 weeks, with 100% of those achieving MMR maintaining it [7][12] - In difficult-to-treat patient subgroups, the MMR rates were 65% for those with prior lack of efficacy to the last TKI and 88% for those with prior tolerability issues [7][11] - The deep molecular response (DMR) achievement rate by 24 weeks was 29% (10/34) [11] Patient Cohorts - The study enrolled 63 patients as of the cutoff date, with a median of 3 prior TKIs and a significant portion having discontinued their last TKI due to lack of efficacy [6][11] - Among patients at doses ≥ 320mg QD, the overall MMR rate was 80% (24/30) by 24 weeks, with a DMR achievement rate of 36% [12][18] Safety Profile - 87% of patients remained on treatment as of the data cutoff, with discontinuations primarily due to disease progression or adverse events [11] - Most treatment-emergent adverse events were low grade, with common non-hematologic TEAEs including diarrhea (21%), headache (19%), and nausea (19%) [11][12] Future Development - Terns Pharmaceuticals plans to focus on pivotal clinical development for TERN-701 in chronic myeloid leukemia (CML) [4][5] - The company aims to advance TERN-701 as a potential best-in-disease therapy for both second-line and first-line CML treatments [4][19]

Company Overview - Terns Pharmaceuticals is a clinical-stage biotechnology company focused on developing innovative therapies for metabolic diseases such as non-alcoholic steatohepatitis (NASH) and obesity [6][9] - The company has a pipeline of differentiated small-molecule drug candidates with advanced liver-targeted mechanisms and metabolic stability [6][9] - Terns Pharmaceuticals reported a market capitalization of $2.3 billion and a net income of ($94.4 million) for the trailing twelve months [4] Recent Developments - Commodore Capital initiated a new position in Terns Pharmaceuticals during the third quarter, acquiring 5.7 million shares valued at approximately $42.8 million, which represents 2.1% of the fund's $2 billion in reportable U.S. equity holdings [2][11] - Terns Pharmaceuticals recently reported positive early efficacy data for its lead oncology program, TERN-701, showing a 75% cumulative major molecular response rate by 24 weeks [12] - The stock price of Terns Pharmaceuticals has increased by 319% over the past year, closing at $25.79, significantly outperforming the S&P 500, which rose by 13% in the same period [3] Financial Position - As of the end of the third quarter, Terns Pharmaceuticals had $295.6 million in cash, extending its financial runway into 2028 [13] - The new stake in Terns Pharmaceuticals by Commodore Capital is outside the fund's top five holdings, indicating a strategic but cautious investment approach [3][11]

Core Insights - Terns Pharmaceuticals Inc. (NASDAQ:TERN) is experiencing significant market interest, with a price target increase from $22 to $30 by BMO Capital Markets, maintaining an Outperform rating [1][2] Company Developments - The market is underestimating the potential of Terns' drug candidate, TERN-701, for chronic myeloid leukemia (CML), supported by promising Phase 1 CARDINAL data [2] - Phase 1 results revealed a 64% molecular response rate by 24 weeks in patients with resistant or relapsed CML, surpassing current treatment options [3] - The company will present further data at the 67th Annual Meeting of the American Society of Hematology (ASH) in December [3] Executive Commentary - CEO Amy Burroughs expressed optimism about the CARDINAL trial data, highlighting TERN-701's potential as a transformative therapy for CML and its broad applicability across treatment lines [4] - The positive results led to a nearly 95% stock price increase between November 3 and 4 [4]

Summary of Terns Pharmaceuticals Conference Call Company Overview - **Company**: Terns Pharmaceuticals (NasdaqGS:TERN) - **Event**: 2025 Conference on November 17, 2025 Key Industry Insights - **Industry**: Pharmaceuticals and Biotechnology, specifically focusing on treatments for Chronic Myeloid Leukemia (CML) Core Points and Arguments 1. **Efficacy of TERN-701**: Terns reported a major molecular response rate of 64% in highly refractory CML patients during their phase one study, which is unprecedented compared to the previous best of 32% in similar studies [2][4][5] 2. **Safety Profile**: The safety profile of TERN-701 is favorable, with only one discontinuation due to an adverse event noted in the trial [2][4] 3. **Food Effect**: TERN-701 does not exhibit a food effect, allowing for dosing without regard to food intake, which is a significant advantage over competitors like asciminib [2][8] 4. **Collaboration with Hansoh**: Terns has a partnership with Hansoh in China, which has provided additional data that supports TERN-701's development, although Terns primarily relies on its own data for future trials [4][12] 5. **Comparative Analysis with Asciminib**: Terns believes that TERN-701's distinct chemical properties and binding characteristics lead to enhanced efficacy compared to asciminib, which has shown a lower response rate and higher discontinuation rates [5][8][9] 6. **Clinical Development Strategy**: Terns plans to initiate pivotal trials for TERN-701, focusing first on second-line treatments before moving to first-line studies, with the aim of running both studies in parallel [20][18] 7. **Market Opportunity**: The management team believes that the long-term market opportunity for TERN-701 extends beyond asciminib-refractory patients, emphasizing the importance of understanding patient history and disease burden [13][14] 8. **Regulatory Pathway**: Terns aims to follow a similar regulatory pathway to asciminib, targeting both second-generation treatments and imatinib in first-line studies [18][20] 9. **Financial Considerations**: The estimated direct costs for pivotal trials are under $100 million for second-line studies and under $150 million for first-line studies, indicating a more manageable financial requirement than initially anticipated [29] 10. **Future Data Expectations**: The upcoming ASH presentation is expected to provide more detailed data, including a shift table that will illustrate patient responses across different categories, which is crucial for understanding the drug's efficacy [31][32] Additional Important Insights - **Cure Potential**: The concept of treatment-free remission in CML is discussed, with TERN-701 potentially leading to faster and deeper responses that could facilitate this outcome [25][27] - **Enrollment Trends**: There has been a notable increase in enrollment rates for clinical trials, attributed to the positive reception of TERN-701's data among clinicians [33][34] - **Cash Position**: Terns has sufficient cash reserves to fund operations into 2028, allowing for strategic planning without immediate pressure to raise additional funds [40] This summary encapsulates the critical insights and strategic direction of Terns Pharmaceuticals as discussed in the conference call, highlighting the potential of TERN-701 in the competitive landscape of CML treatments.

Core Insights - Terns Pharmaceuticals, Inc. is recognized as a promising small-cap stock following a Buy rating from William Blair analyst Andy Hsieh, who did not provide specific price targets [1][2]. Financial Performance - The company reported positive momentum in its fiscal third-quarter results, particularly for its CARDINAL program related to TERN-701, which is currently in Phase 1 trials for chronic myeloid leukemia [2]. - Terns Pharmaceuticals has a strong financial position with $295 million in cash, which is expected to fund operations until 2028 [3]. Product Development - The initial results from the Phase 1 CARDINAL trial indicate that TERN-701 has the potential to become a leading treatment option for chronic myeloid leukemia, potentially competing with current market leaders like Scemblix [2][3]. - Terns Pharmaceuticals is focused on developing small-molecule product candidates aimed at treating serious diseases, including cancer and obesity [4].

Core Points - Terns Pharmaceuticals, Inc. is a clinical-stage oncology company that will present at the Jefferies Global Healthcare Conference in London on November 17, 2025 [1] - The presentation will be available via a live webcast on the company's investor relations page, with a replay archived for at least 30 days [2] - Terns' lead program, TERN-701, is a selective allosteric BCR-ABL inhibitor aimed at improving treatment for chronic myeloid leukemia (CML) [3]

Clinical Trials and Drug Development - TERN-701 achieved a major molecular response (MMR) rate of 75% (24/32) by 24 weeks in the CARDINAL trial, with 100% (10/10) of patients maintaining MMR[107] - TERN-601 showed a maximum placebo-adjusted weight loss of 4.6% in the Phase 2 FALCON trial, but 12% of participants discontinued treatment due to adverse events[108] - TERN-701 received Orphan Drug Designation from the FDA for the treatment of chronic myeloid leukemia (CML) in March 2024[107] - The dose escalation portion of the CARDINAL trial was completed in January 2025 with no dose limiting toxicities observed up to 500 mg once daily[107] - TERN-800 series of GIPR modulators is being developed for obesity, with TERN-801 nominated as the first development candidate[110] - The majority (74%) of treatment-emergent adverse events (TEAEs) in the CARDINAL trial were low grade, with the most common being diarrhea (22%) and headache (18%)[107] Financial Performance - Research and development expenses for Q3 2025 were $19,917,000, an increase of $4,748,000 (31.3%) compared to Q3 2024[113] - Total operating expenses for Q3 2025 were $27,716,000, up $2,777,000 (11.1%) from $24,939,000 in Q3 2024[113] - The net loss for Q3 2025 was $24,635,000, compared to a net loss of $21,945,000 in Q3 2024, reflecting an increase of $2,690,000 (12.3%)[113] - Research and development expenses for the three months ended September 30, 2025, increased to $19.9 million from $15.2 million in 2024, a change of 31.3%[117] - For the nine months ended September 30, 2025, research and development expenses rose to $59.0 million, up from $52.1 million in 2024, reflecting a 12.6% increase[118] - Interest income for the nine months ended September 30, 2025, was $10.1 million, compared to $9.1 million in 2024, marking a 10.9% increase[123] - The company reported a net loss of approximately $72.6 million for the nine months ended September 30, 2025, compared to a net loss of $67.1 million for the same period in 2024[131] - As of September 30, 2025, the company had an accumulated deficit of approximately $494.1 million and cash, cash equivalents, and marketable securities totaling $295.6 million[131] - Net cash used in operating activities during the nine months ended September 30, 2025, was $63.1 million, compared to $55.4 million in 2024[141][142] - Net cash provided by investing activities for the nine months ended September 30, 2025, was $52.0 million, down from $81.9 million in 2024[143][144] Future Outlook - The company expects to incur significant operating losses for at least the next several years as it continues its research and development activities[129] - The company has not generated any revenue from product sales since inception and relies on funding from equity offerings and other sources[130][138] - The company anticipates needing substantial additional funding to support ongoing operations and research activities[135][137]