整理 | GLP1减重宝典内容团队 Terns Pharmaceuticals, Inc.（纳斯达克：TERN），一家临床阶段的生物制药公司，专注于开发用于治疗严重疾病的小分子药物，包括 肿瘤学和肥胖症，近日公布了其TERN-601临床二期试验的顶线结果。这是一种口服GLP-1受体激动剂（GLP-1RA），每日一次，用 于治疗肥胖症的潜力。 关键试验结果： 体重减轻： 在使用超过500毫克剂量的参与者中，最大安慰剂调整体重减轻为4.6%。在超过500毫克的剂量下观察到了统计学显著的体重减轻。 剂量和体重减轻： TERN-601 250毫克：-1.8%安慰剂调整 TERN-601 500毫克慢速递增：-3.6%安慰剂调整 TERN-601 750毫克：-3.0%安慰剂调整 安慰剂：无显著体重减轻 p值：500毫克和750毫克剂量的p值低于0.01，显示出统计学显著性。 安全性概况： 不良事件：12%的参与者因不良事件（AEs）停止治疗，主要为胃肠道（GI）问题，其中恶心最为常见。 胃肠道不良事件：这些通常为轻度或中度，包括恶心（56%）、呕吐（26.9%）、便秘（11.9%）和腹泻（9.7%）。胃肠道不良事件与 ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

Core Insights - Terns Pharmaceuticals Inc. announced topline results from its FALCON Phase 2 trial of TERN-601, an oral GLP-1 receptor agonist aimed at treating obesity in adults without diabetes [1][2]. Weight Loss Results - At a 250 mg dose, the placebo-adjusted weight loss was 1.8%, which was not statistically significant (p=0.056) [3]. - At a 500 mg slow titration, weight loss was approximately 3.6%, and at a 500 mg dose, it was around 4.6% [3]. - Weight loss at a 750 mg dose was about 3% [3]. Safety and Tolerability - Among the 134 participants who received TERN-601, 11.9% discontinued treatment and 8.2% had dose modifications due to adverse events (AEs), primarily gastrointestinal [4]. - The most common gastrointestinal AEs included nausea (56%), vomiting (26.9%), constipation (11.9%), and diarrhea (9.7%), with a dose-related occurrence [4]. - Liver function tests (LFTs) remained stable during the treatment period, although three participants experienced grade 3 LFT elevations, with two cases consistent with drug-induced liver injury (DILI) [5][6]. Market Reaction - Following the announcement, Terns Pharmaceuticals shares fell by 3.33%, trading at $7.85 [6].

Terns Pharmaceuticals said on Tuesday it will stop developing its experimental obesity drug after a mid-stage trial showed modest weight loss and raised safety concerns. ...

Results show maximum placebo-adjusted weight loss of 4.6% with 12% treatment discontinuation due to adverse events Asymptomatic, reversible grade 3 liver enzyme elevations occurred in three participants during post-treatment follow-up period, two of which were deemed drug related Company will not advance TERN-601 or invest in other metabolic assets Reiterates focus on TERN-701, a potential best-in-class allosteric BCR-ABL inhibitor, for chronic myeloid leukemia with clinical data this quarter FOSTER CITY, C ...

Company Overview - Terns Pharmaceuticals is a small-cap, clinical-stage biotech company focused on developing therapies for metabolic dysfunction and obesity-related conditions, with key candidates including TERN-601 and TERN-501 [3][4][6] - TERN-601 is an oral GLP-1 candidate currently in mid-stage studies, with a 12-week phase 2 clinical trial initiated for weight loss, expecting data in the fourth quarter [3][6] Pipeline and Development - Terns Pharmaceuticals is also developing TERN-501 for metabolic dysfunction-associated steatohepatitis and as a potential combination therapy to enhance GLP-1 medicines [1] - TERN-701 is another candidate in a phase 1 study for cancer therapy, with data readout anticipated in the fourth quarter [1] Market Context - The anti-obesity market is rapidly growing, attracting significant attention from both large and small pharmaceutical companies, with the potential for substantial financial returns [5] - Oral medications like TERN-601 could address patient preferences and lower manufacturing costs compared to subcutaneous injections, which may enhance market competitiveness [2][3] Competitive Landscape - Terns Pharmaceuticals faces competition from other biotech firms developing oral GLP-1 medicines, making it crucial to deliver strong results for TERN-601 to impress the market [2][6] - The success of Terns Pharmaceuticals is heavily reliant on the progress of TERN-601, with potential stock volatility if mid-stage studies do not yield positive results [6]

Group 1 - The presentation features Kelly McCarthy from the Morgan Stanley Healthcare team, alongside Terns Pharma's CEO Amy Burroughs and Chief Development Officer Scott Harris [1] - The conference aims to provide insights and updates on the healthcare sector, highlighting the collaboration between Morgan Stanley and Terns Pharma [1]

Core Points - Terns Pharmaceuticals is conducting an educational webinar focused on TERN-701, a next-generation oral Allosteric BCR-ABL inhibitor aimed at treating chronic myeloid leukemia (CML) [2] - The company highlights TERN-701's potential best-in-class profile and relevant benchmarks for assessing upcoming Phase I data expected next quarter [2] - The discussion will also cover the potential positioning of TERN-701 within the evolving treatment landscape for CML [2] Company Information - Amy Burroughs serves as the Chief Executive Officer of Terns Pharmaceuticals and is leading the webinar [2] - The company emphasizes the importance of reviewing SEC quarterly and annual filings for forward-looking statements and risk factors [3]

Summary of Terns Pharmaceuticals (TERN) Investor Webinar Company and Industry Overview - **Company**: Terns Pharmaceuticals - **Industry**: Pharmaceuticals, specifically focusing on treatments for Chronic Myeloid Leukemia (CML) Core Points and Arguments 1. **Introduction of TURN701**: Terns Pharmaceuticals is developing TURN701, a next-generation oral allosteric BCR ABL inhibitor for CML treatment, which is expected to have a best-in-class profile [3][4][5] 2. **Unmet Medical Need in CML**: Despite advancements with first and second-generation TKIs, approximately 40% of CML patients switch therapies within five years due to inadequate response or side effects [6][7] 3. **Market Dynamics**: Osiminib, the first allosteric BCR ABL inhibitor, has gained significant market share, achieving 15% in frontline therapy within two quarters of its launch and projected peak sales of $3 billion [7][8] 4. **Efficacy and Safety Comparison**: TURN701 aims to improve upon osiminib's efficacy, safety, and convenience, with a focus on achieving higher Major Molecular Response (MMR) rates and a better safety profile [9][10][19] 5. **Clinical Data and Study Design**: The CARDINAL Phase I study is evaluating TURN701 in patients who have failed or are intolerant to prior TKIs, with a focus on dose escalation and safety [11][12][24] 6. **Target Coverage and Selectivity**: TURN701 demonstrates higher target coverage and selectivity compared to osiminib, which may lead to better clinical outcomes [20][22][24] 7. **Regulatory Pathway**: Terns plans to initiate pivotal studies for TURN701 in both second-line and frontline settings, aiming for a broad indication across all lines of CML therapy [41][42] Important but Overlooked Content 1. **Patient Population Insights**: The majority of patients in Phase I studies have high leukemia burden and lack efficacy to their last TKI, indicating a challenging treatment landscape [28][30] 2. **Safety Profile**: Early data from TURN701 shows no dose-limiting toxicities (DLTs) up to 500 mg, contrasting with osiminib, which has reported significant adverse events [23][24][63] 3. **Market Adoption Predictions**: The anticipated shift in treatment dynamics suggests that a significant portion of newly diagnosed patients may start on allosteric TKIs, potentially changing the standard of care in CML [38][39][40] 4. **Long-term Safety Data**: There is a need for ongoing collection of long-term safety data to further differentiate TURN701 from existing therapies [24][63] This summary encapsulates the key points discussed during the Terns Pharmaceuticals investor webinar, highlighting the company's strategic focus on TURN701 and its potential impact on the treatment landscape for CML.

Core Viewpoint - Terns Pharmaceuticals is hosting an investor educational webinar on TERN-701, an investigational treatment for chronic myeloid leukemia (CML), ahead of data release expected in Q4 2025 [1][2]. Group 1: TERN-701 Overview - TERN-701 is a next-generation oral, allosteric BCR-ABL inhibitor targeting the ABL myristoyl pocket, currently evaluated for CML treatment [2][3]. - The CARDINAL Phase 1 clinical trial is assessing TERN-701's safety, tolerability, and efficacy in previously treated chronic phase CML patients [3]. Group 2: Clinical Trial Details - The dose escalation portion of the CARDINAL trial was completed in January 2025, with no dose limiting toxicities observed up to a maximum dose of 500 mg QD [3][4]. - The dose expansion phase began in April 2025, randomizing patients into two cohorts (320 mg or 500 mg QD) with up to 40 patients per arm [3]. - Efficacy and safety data from the Phase 1 trial are expected to be reported in Q4 2025, including the 6-month major molecular response achievement rate [3]. Group 3: Interim Data - Positive interim data from the dose escalation phase showed compelling molecular responses at the lowest dose in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels [4]. - The trial demonstrated an encouraging safety profile with no dose limiting toxicities or treatment discontinuations across all cohorts [4]. Group 4: Company Background - Terns Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing small-molecule product candidates for serious diseases, including oncology and obesity [5]. - The company's pipeline includes three clinical stage programs: an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, and a THR-β agonist, along with a preclinical GIPR modulator discovery effort [5].