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.

Summary of Gossamer Bio FY Conference Call Company Overview - Gossamer Bio was founded in 2018 by Chairman and CEO Faheem Haznain, following a successful exit from Receptos, which was acquired by Celgene, now part of Bristol-Myers Squibb [4][6] - The company focuses on developing therapies for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [4][30] Key Developments and Data Readouts - Gossamer is nearing a key data readout for the PROCERRA study, a multinational Phase III registrational study involving 191 sites across 31 countries, with top-line results expected in February 2026 [6][10] - The company anticipates a 20 to 25 meter increase in six-minute walk distance as a primary endpoint for the PROCERRA study [6][16] - The PROCERRA study aims to enroll a patient population that is more representative of those who performed well in the previous Phase II Tory study, which was affected by the COVID-19 pandemic [8][10] Clinical Insights - The PROCERRA study has a patient demographic with a higher proportion of functional class III patients (approximately 70%) compared to the Tory study [9][10] - The study's design includes a focus on regions with historical efficacy, such as Latin America, which has shown better performance in similar studies [10][11] - The company has amended its protocol to allow patients on background therapy with cetatercept to enroll, but only a small number were able to do so due to adverse events associated with cetatercept [12][13] Commercial Strategy - Assuming positive trial results, Gossamer plans to position cerulutinib as a third-line treatment following standard care for PAH [19][20] - The company expects minimal payer resistance due to the rarity of the disease and the anticipated drop in treatment costs as existing therapies become generic by the time of cerulutinib's launch in 2027 [22][23] - Gossamer is building its commercial organization, with plans for a sales force of approximately 60 representatives to target major treatment centers [26][27] Market Opportunity - The economic opportunity for cerulutinib in PAH is estimated at $2.25 billion, with the potential for even greater revenue in the PHILD market due to less competition and a higher patient population [32][33] - The company has initiated a Phase III trial for PHILD, targeting a very sick patient population with high unmet medical needs [30][34] Pipeline Expansion - Gossamer has entered into a transaction to acquire an inhaled version of Vardenafil for PRN use, which could generate $500 to $750 million in the U.S. alone [39][41] - The acquisition is seen as a strategic move to enhance Gossamer's portfolio and establish long-term partnerships within the PAH community [42] Financial Position - Gossamer has sufficient cash to fund operations until May 2027, including the PROCERRA study and the PHILD trial [44]

Core Insights - Novartis received a positive opinion from the CHMP of the EMA for Scemblix (asciminib) to treat adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase across all treatment lines [1][4] Group 1: Treatment Efficacy - Scemblix showed superior major molecular response (MMR) rates compared to all tyrosine kinase inhibitors (TKIs) in the Phase III ASC4FIRST trial, achieving 67.7% MMR at week 48 versus 49.0% for investigator-selected TKIs [2][5] - At week 96, Scemblix maintained superior MMR rates of 74.1% compared to 52% for investigator-selected TKIs [7] - The treatment demonstrated fewer dose reductions and half the rate of adverse events leading to discontinuation compared to existing therapies [2][4] Group 2: Patient Impact - The availability of Scemblix is expected to provide patients with better treatment options, improving their chances of achieving key efficacy milestones while maintaining quality of life [2][3] - Approximately 50% of newly diagnosed CML patients miss treatment goals within one year, highlighting the need for more effective and tolerable treatment options [6] Group 3: Regulatory and Market Position - Scemblix is already approved in over 20 countries, including the US, Japan, and China, and is recommended by the 2025 European LeukemiaNet guidelines for newly diagnosed Ph+ CML-CP patients [3][9] - If approved by the European Commission, Scemblix will expand access to treatment for four times as many patients in Europe [6]

Core Insights - Kura Oncology has initiated the KOMET-015 Phase 1 clinical trial to evaluate ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure [1][3] - The combination of ziftomenib and imatinib has shown robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST preclinical models [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational menin inhibitor [8] - The company has received Breakthrough Therapy Designation from the FDA for ziftomenib in treating relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [7][8] Clinical Trial Details - The KOMET-015 trial is designed to assess the safety, tolerability, and preliminary antitumor activity of ziftomenib combined with imatinib in adults with GIST who have shown disease progression on imatinib [3][4] - The trial will evaluate primary objectives including safety and tolerability, and secondary endpoints such as overall response rate (ORR) and progression-free survival (PFS) [3] Market Context - Approximately 4,000 to 6,000 new cases of GIST are diagnosed annually in the U.S., with limited treatment options available for advanced cases [2][5] - Most patients develop resistance to imatinib within two years, highlighting the need for new therapeutic options [2][6] Preclinical Findings - Preclinical studies indicate that the combination of ziftomenib and imatinib exerts antitumor activity through a synthetic lethal mechanism, targeting vulnerabilities in GIST tumors [2][3] - The combination has the potential to delay or overcome resistance to imatinib in patients [2]

S-1 1 tenx_s1.htm FORM S-1 As filed with the U.S. Securities and Exchange Commission on December 1, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Tenax Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 26-2593535 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identi ...