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].

Core Insights - Terns Pharmaceuticals has decided to halt the development of its experimental obesity drug due to modest weight loss results and safety concerns raised during a mid-stage trial [1] Company Summary - The decision to stop the drug development was influenced by the trial outcomes, which indicated only modest weight loss [1] - Safety concerns were a significant factor in the decision-making process, suggesting potential risks associated with the drug [1] Industry Summary - The halt in development reflects ongoing challenges in the obesity drug market, where efficacy and safety are critical for success [1] - This incident may impact investor confidence in similar obesity treatments under development by other companies in the industry [1]

Core Insights - Terns Pharmaceuticals announced the topline results from its Phase 2 trial of TERN-601, a novel oral GLP-1 receptor agonist for obesity, which showed a maximum placebo-adjusted weight loss of 4.6% but did not meet the high threshold for safety, tolerability, and efficacy required for further development [1][2][3] - The company will not advance TERN-601 or invest in other metabolic assets, instead focusing on TERN-701, a potential best-in-class allosteric BCR-ABL inhibitor for chronic myeloid leukemia, with new clinical data expected this quarter [1][2] Phase 2 Trial Results - The Phase 2 trial demonstrated statistically significant weight loss at doses greater than 500 mg, with the following placebo-adjusted weight loss results: - 250 mg: -1.8% - 500 mg slow titration: -3.6% - 500 mg: -4.6% - 750 mg: -3.0% - p-values for these results were significant, particularly for the 500 mg dose [3][4] - The trial included 134 participants, with 11.9% discontinuing treatment and 8.2% modifying doses due to adverse events, primarily gastrointestinal [4][9] Safety and Tolerability - The most common adverse events were gastrointestinal, with nausea reported in 56% of participants and vomiting in 26.9% [4][9] - No severe gastrointestinal adverse events were reported, and liver function tests remained stable during the treatment period, although three participants experienced grade 3 liver enzyme elevations post-treatment, with two deemed drug-related [9][10] Participant Demographics - The trial participants were predominantly female (78-79%), with a mean age range of 47-53 years, and mean weight and BMI ranges of 99-102 kg and 36-37 kg/m², respectively [5][10] Company Focus - Following the trial results, the company reiterated its commitment to advancing the TERN-701 program for chronic myeloid leukemia, with new data from the Phase 1 CARDINAL trial expected to be announced this quarter [2][8]

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].

Group 1: Core Insights - Goldman Sachs' latest report focuses on "2Q25 EPS updates," analyzing biotech companies such as Amylyx (AMLX.US), CG Oncology (CGON.US), GPCR (GPCR.US), and Ideaya Biosciences (IDYA.US), concluding that operational data largely meets expectations with minor adjustments to target prices due to cash flow or clinical milestones [1] Group 2: Amylyx (AMLX.US) - In Q2, Amylyx reported operating expenses of approximately $43 million, slightly above market consensus of $41 million and Goldman Sachs' estimate of $40 million, primarily due to higher R&D costs of $27 million compared to the expected range of $22 million to $25 million [2] - The management reiterated the timeline for the Phase III clinical trial for post-bariatric hypoglycemia (PBH), aiming for enrollment completion in 2025, data readout in the first half of 2026, and potential market entry in 2027, with an estimated patient population of around 160,000 [2] - Goldman Sachs maintains a "Buy" rating with a target price of $10 [2] Group 3: CG Oncology (CGON.US) - CG Oncology's BOND-003 Phase III trial data showed a complete response rate of 75.5% for its bladder cancer gene therapy, with 12-month and 24-month sustained response rates of 50.7% and 42.3%, respectively [3] - The company has $661 million in cash, sufficient to support operations until mid-2028, and Goldman Sachs maintains a "Buy" rating with minor model adjustments [3] Group 4: GPCR (GPCR.US) - GPCR's Q2 R&D expenses were approximately $54 million, significantly higher than market expectations of $36 million and Goldman Sachs' estimate of $44 million, attributed to workforce expansion and increased trial costs [4] - The company has $787 million in cash, expected to last until 2027, and plans to read out Phase 2b ACCESS data in 2025 [4] Group 5: Ideaya Biosciences (IDYA.US) - Ideaya reported Q2 R&D expenses of about $74 million, slightly above market expectations of $71 million and Goldman Sachs' estimate of $68 million, with cash reserves of $992 million projected to last until 2029 [5] - The core pipeline includes darovasertib in combination with crizotinib for HLA-A2 negative metastatic uveal melanoma, with Phase 2/3 results expected by year-end [5] Group 6: Terns Pharmaceuticals (TERN.US) and RNA (RNA.US) - Terns Pharmaceuticals plans to release preliminary data for its leukemia drug TERN-701 and obesity drug TERN-601 in Q4 2025, with cash reserves of $315 million sufficient until 2028 [6] - RNA has signed a manufacturing agreement with Lonza to ensure product supply stability from 2026 to 2028, with BLA submissions expected for its treatments by the end of 2025 and mid-2026 [6] Group 7: AI in Biotech - Goldman Sachs emphasizes the core role of biotechnology R&D, highlighting collaborations with institutions like OpenAI to drive innovation, while also focusing on the pricing potential of rare disease drugs and opportunities for indication expansion [7] Group 8: Overall Industry Outlook - The biotech sector is expected to see over 15 key clinical data readouts from late 2025 to early 2026, with a focus on companies like AMLX, CGON, and RNA for their potential breakthroughs [8] - Despite some companies facing increased short-term losses due to R&D spending, pipeline progress remains in line with expectations, and cash flow is generally secure [8]

Core Insights - Terns Pharmaceuticals reported progress in its clinical programs for chronic myeloid leukemia (CML) and obesity, while maintaining a strong cash position [1][3][12] Financial Performance - GAAP net loss per share was $(0.26), better than the expected $(0.29) and improved from $(0.31) in Q2 2024, reflecting a 16.1% year-over-year improvement [2][7] - Total revenue remained at $0.0, consistent with Q2 2024 [2] - Research and development expenses increased by 10.9% to $20.4 million compared to $18.4 million in Q2 2024 [2][7] - General and administrative expenses decreased slightly to $7.0 million from $7.2 million in Q2 2024 [2][7] - The net loss for the quarter was $24.1 million, widening from $22.7 million in the prior year [2][7] Clinical Development - TERN-701, a kinase inhibitor for CML, is in the dose expansion phase of the Phase 1 CARDINAL trial, with positive interim results indicating meaningful molecular responses and a favorable safety profile [5][9] - TERN-601, an oral GLP-1 receptor agonist for obesity, completed enrollment for its Phase 2 FALCON trial, with results expected in early Q4 2025 [6][10] Strategic Focus - The company has shifted its strategy to prioritize oncology, particularly CML, while seeking external partnerships for its metabolic disease assets [4][10] - Terns plans to host an educational session in September 2025 to discuss CML unmet needs and TERN-701's positioning [9] Partnerships and Intellectual Property - Terns maintains an exclusive licensing agreement with Hansoh for TERN-701 development in China, which includes milestone payments and royalties [8] - TERN-701 has Orphan Drug status in the U.S., providing seven-year market exclusivity upon approval [8] Outlook - The company has $315.4 million in cash and equivalents, projected to fund operations into 2028, allowing for continued clinical development without immediate capital needs [12] - Key clinical readouts for TERN-701 and TERN-601 are anticipated by the end of 2025, which will be critical for future partnerships and commercialization [13]