Summary of Tango Therapeutics Conference Call Company Overview - **Company**: Tango Therapeutics (NasdaqGM:TNGX) - **New CEO**: Malte Peters, who has been a board member since 2018 and emphasizes continuity in strategy following the transition from former CEO Barbara. Key Priorities and Strategic Focus - **Regulatory Approval**: The primary focus is to achieve regulatory approval for vopimetostat, either as a monotherapy or in combination with RAS inhibitors [4][5]. - **Clinical Development**: Transitioning Tango into a late-phase drug development company is a key priority, with a pivotal trial protocol developed for second-line pancreatic cancer [4][6]. Clinical Trials and Data - **Pivotal Trial for Pancreatic Cancer**: A pivotal trial protocol for second-line pancreatic cancer has been developed, with positive feedback from the FDA regarding trial design and statistical analysis [6][11]. - **Combination Trials**: A combination trial of vopimetostat with RevMed's RAS inhibitors (daraxonrasib and zoldonrasib) has been initiated, showing early signs of clinical activity [6][16]. - **Monotherapy Study**: A 300-patient study is planned, focusing on progression-free survival (PFS) and overall survival [9][12]. - **Promising Data**: Previous monotherapy data indicated a 25% overall response rate (ORR) and approximately 7 months PFS in pancreatic cancer [12]. Market and Competitive Landscape - **Global Trial Design**: The study will be conducted globally, including the USA, Europe, and Asia Pacific, to enhance patient recruitment [11]. - **Chemo-Free Regimen**: There is significant interest in developing a chemotherapy-free regimen for pancreatic cancer, which could greatly benefit patients [37][41]. - **Comparison with Competitors**: Tango is pursuing a different strategy than competitors like BMS, focusing on non-chemotherapy combinations due to scientific and financial considerations [40][41]. Future Directions and Opportunities - **Expansion into Other Tumor Types**: The company is exploring opportunities in other tumor types with MTAP deletions, showing promising signals in head and neck cancer [45][46]. - **TNG456 Development**: The TNG456 clinical trial is in dose escalation, with plans to explore its potential in glioblastoma and non-small cell lung cancer [42][43]. - **Combination with Abemaciclib**: There are plans to pursue a combination with abemaciclib based on preclinical data suggesting potential benefits [49]. Upcoming Updates - **Data Releases**: Updates on pancreatic cancer monotherapy data, combination data with Revolution Medicines, and TNG456 dose escalation data are expected later this year [51][56]. Conclusion - **Exciting Year Ahead**: The company anticipates a year filled with significant developments and data releases, positioning itself for potential breakthroughs in cancer treatment [56].

Core Viewpoint - The FDA's refusal to review Moderna's application for its new mRNA flu vaccine has left the company's president in shock, citing confusion over the agency's decision regarding trial adequacy and control measures [1][6][7]. Group 1: FDA's Decision - The FDA stated that Moderna's application lacked an "adequate and well-controlled" trial, specifically not comparing the new vaccine to the best-available standard of care at the time of the study [2][9]. - The FDA indicated that the trial should have used a high-dose flu vaccine as a comparator, particularly for individuals over 65, as these are considered more effective for older adults [10][11]. - The FDA's letter did not express concerns about the safety or efficacy of the vaccine, but emphasized that the trial design did not meet their guidelines [6][9]. Group 2: Moderna's Response - Moderna's president expressed surprise and confusion over the FDA's decision, noting that the company had previously discussed trial designs with regulators and received written confirmation that their approach was acceptable [5][9]. - The company reportedly invested over a billion dollars in the clinical trial, which involved more than 40,000 participants and reached the pivotal Phase 3 stage [5][14]. - Moderna warned that the FDA's decision could deter future investments in new medicines and cures, suggesting a significant impact on innovation in the pharmaceutical industry [6]. Group 3: Implications and Reactions - The Health and Human Services spokesperson criticized Moderna for not following FDA guidance, stating that the trial exposed older participants to increased risks by using a substandard control [11][12]. - The recent policy changes under Health and Human Services Secretary Robert F. Kennedy, Jr. have led to the termination of nearly $500 million in federal funding for mRNA vaccine development, affecting multiple companies including Moderna [12][13]. - The decision has drawn criticism from health officials, who argue that it undermines the potential of mRNA vaccines in pandemic preparedness [13].

Top-line Results for the Phase 2 VALIANT Trial in Severe Asthma February 11, 2026 © 2026 Upstream Bio, Inc. No Image Disclaimer This presentation contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "continue," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," ...

Core Viewpoint - Vistagen Therapeutics, Inc. is facing a securities class action lawsuit due to alleged misleading statements regarding its clinical trial program for its lead drug candidate, with a lead plaintiff deadline set for March 16, 2026 [1][8]. Group 1: Allegations of Misleading Statements - Management allegedly created an overwhelmingly positive impression about the clinical trial program, emphasizing "notable enhancements" and "operational changes" intended to improve enrollment quality and limit variability [3]. - The company claimed that positive results from a prior Phase 3 trial, combined with operational improvements, positioned the subsequent study as a confirmatory trial with a strong likelihood of success [4]. Group 2: Omitted Risks - The complaint alleges that while promoting the trial's positive aspects, the company failed to disclose material risks inherent in the clinical trial design, specifically known issues with public speaking challenge endpoints that often show elevated placebo responses and site variability [5]. - Defendants are accused of continuing to promote the trial modifications and presenting the study as likely to succeed while concealing these known risks from investors [6].

Core Insights - OKYO Pharma Ltd is set to launch a Phase 2b/3 clinical trial for neuropathic corneal pain after a successful Type C meeting with the FDA, indicating a clear path forward for the program [1][3]. Regulatory Meeting - The Type C meeting with the FDA allowed OKYO Pharma to engage directly with the agency, addressing critical components such as primary endpoints, manufacturing, and statistical plans [3]. - The feedback from the FDA was positive, providing guidance to proceed with the clinical study without unexpected surprises [4]. Next Steps - The company plans to finalize site selection and budget, with guidance to enroll 120 subjects and clarity on the primary endpoint, allowing for protocol finalization [5]. - The goal is to initiate the first patient visit by mid-year, aiming to complete the study by year-end and target top-line results in Q1 2027 [5]. Patient Impact - The company emphasizes the significant unmet need in neuropathic corneal pain, motivated by direct feedback from patients regarding the severe impact of the condition on their quality of life [6].

Core Viewpoint - Cardiff Oncology Inc. experienced a significant decline of approximately 32% in stock price following management and trial updates, indicating investor concern over leadership changes and clinical trial focus [1][9]. Management Changes - Mani Mohindru has been appointed as interim CEO, effective immediately, following the resignation of CEO Mark Erlander and CFO James Levine [1][2]. - Brigitte Lindsay has been promoted to Chief Accounting Officer to ensure financial continuity, having been with the company for over 14 years [2]. Clinical Trial Update - Cardiff Oncology provided an update on the CRDF-004 trial, which is a Phase 2 study evaluating onvansertib in combination with standard care regimens for patients with RAS-mutated metastatic colorectal cancer [3]. - The trial showed a 72.2% confirmed objective response rate in the 30 mg dose group of onvansertib with FOLFIRI/bevacizumab, compared to 43.2% in the standard care group, approaching statistical significance (p-value = 0.051) [4]. - Progression-free survival was statistically significant for the 30 mg onvansertib plus FOLFIRI/bevacizumab group (p-value = 0.048), with median progression-free survival not yet reached in the treatment groups [5]. Future Plans - Based on the trial results, the company plans to advance the 30 mg dose of onvansertib with FOLFIRI/bevacizumab into a registrational trial for first-line patients with RAS-mutated metastatic colorectal cancer, pending FDA consultation [6]. - The focus will be narrowed to onvansertib in combination with FOLFIRI, which may reduce the total addressable market in the frontline setting to 12%-20% from a previous estimate of 40%-50% [8]. Analyst Commentary - Analysts from William Blair expressed concerns regarding the abrupt management changes and the narrowed focus on onvansertib with FOLFIRI, leading to a reduction in the probability of success from 50% to 45% [8]. - Despite the concerns, William Blair maintains an Outperform rating for the stock [9].

Core Insights - Enthorin Therapeutics, LLC is focused on circuit-modulating treatments for neurological and neurodevelopmental disorders [1] - The company announced that its licensing partner, Mirum Pharmaceuticals, initiated the BLOOM Phase 2 clinical study for MRM-3379 in Fragile X syndrome [1] - MRM-3379 is characterized as an orally available, highly brain-penetrant, selective phosphodiesterase inhibitor [1] Company Overview - Enthorin Therapeutics specializes in biotechnology with a focus on neurological and neurodevelopmental disorders [1] - Mirum Pharmaceuticals, Inc. is the licensing partner for MRM-3379 and is publicly traded on NASDAQ under the ticker MIRM [1] Clinical Development - The BLOOM Phase 2 clinical study aims to evaluate the efficacy of MRM-3379 in treating Fragile X syndrome [1] - MRM-3379 is noted for its ability to penetrate the brain effectively, which is crucial for its therapeutic application [1]

Summary of China Pharma and Biotech Conference Call Industry Overview - **Sector Outlook**: The China Pharma and Biotech sector is experiencing a positive outlook with valuations returning to a more rational range compared to mid-2025. Most stocks have seen a decline of 20-30%, and major healthcare indices are below 2023 post-COVID reopening levels, providing a solid base for growth in 2026 [1][10][11]. - **Growth Drivers**: Accelerated growth and quality improvement in the sector are anticipated, driven by the unique advantages of Chinese drugmakers that support globalization and sector re-rating trends [1][10]. Key Insights on China Biopharma - **R&D Efficiency**: China's early R&D model has matured, with clinical trials costing 60-70% less than in the U.S. Preclinical research averages 1.5 years, and Phase 1 trials take less than 2 years, significantly faster than global standards [2]. - **Global Pipeline Contribution**: China's share of the global biopharma pipeline has increased to 43% in 2025, up from 38% in 2024. However, the percentage of First-in-Class (FIC) drugs remains lower than in developed markets (17% vs. 37%) [2]. - **Out-licensing Trends**: The trend of outbound deals is expected to continue, with innovative models like platform deals and co-development agreements emerging. These deals are seen as avenues for revenue maximization, although they may not impact stock prices as significantly as in 2025 [2][13]. Stock-Specific Catalysts for 2026 - **Oncology Developments**: A significant number of trials (20+) in Non-Small Cell Lung Cancer (NSCLC) are expected to report data, with key players including Kelun, Innovent, and Akeso. New modalities such as multispecific antibodies and ADCs are also anticipated to provide proof of concept data [3]. - **GLP-1 Drugs**: HRS-9531 (Hengrui) and TG103 (CSPC) have submitted New Drug Applications (NDA) in the second half of 2025, with expected approvals in late 2026 or 2027 [3]. Top Stock Picks - **Innovent**: Anticipated strong sales growth for mazdutide and updates on IBI363 trials across various indications [4]. - **Kelun**: Expected to report results from its first global Phase 3 trial and domestic sales growth of approximately 40% [4]. - **Hansoh & Hengrui**: Projected recurring license income to contribute 10-15% of revenue, with net income growth of 20-30% CAGR from 2024 to 2027 [4]. Investment Ratings - **Outperform Ratings**: Hansoh, Kelun-Biotech, Innovent, and Jiangsu Hengrui are rated as outperform [6]. - **Market-Perform Ratings**: Akeso, BeOne Medicines (BeiGene), Sino Biopharm, Zai Lab, and CSPC are rated as market-perform [6]. Financial Projections - **Stock Performance**: The report includes a detailed table of stock ratings, target prices, and financial projections for various companies, indicating significant upside potential for selected stocks [5][9]. Additional Insights - **Market Dynamics**: The sector has transitioned from exuberance to equilibrium, with a notable correction in stock prices since October 2025, following a period of rapid growth [10][11]. - **Approval Trends**: The number of innovative drug approvals by the National Medical Products Administration (NMPA) has accelerated, with 69 approvals in 2025, while the FDA remains receptive to Chinese drug candidates [33]. This summary encapsulates the key points from the conference call, highlighting the positive outlook for the China Pharma and Biotech sector, the efficiency of R&D processes, stock-specific catalysts, and investment recommendations.

Core Viewpoint - Merck has initiated a Phase 3 clinical trial named KANDLELIT-007 to evaluate calderasib (MK-1084), an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA QLEX for treating advanced or metastatic nonsquamous non-small cell lung cancer in patients with KRAS G12C mutations [1]. Group 1 - The clinical trial KANDLELIT-007 is focused on patients with KRAS G12C-mutant, advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) [1]. - The treatment being evaluated combines calderasib with KEYTRUDA QLEX, which includes pembrolizumab and berahyaluronidase alfa-pmph [1]. - This trial is randomized, indicating a structured approach to assess the efficacy and safety of the treatment combination [1].

Core Viewpoint - Tvardi Therapeutics, Inc. experienced a significant decline in stock value, dropping over 80% following disappointing preliminary data from its Phase 2 REVERT clinical trial for TTI-101 in idiopathic pulmonary fibrosis [4] Group 1: Company Overview - Tvardi Therapeutics, Inc. is publicly traded on NASDAQ under the ticker TVRD [2] - The company is currently under investigation for potential claims related to its stock performance [2] Group 2: Clinical Trial Results - The Phase 2 REVERT clinical trial aimed to evaluate the safety, pharmacokinetics, and exploratory outcomes related to lung function of TTI-101 [4] - Preliminary data indicated that the trial did not meet its goals, with changes in Forced Vital Capacity (FVC) being a key measure [4] - Patients' baseline characteristics were similar across treatment arms, except for a lower percent predicted FVC in the placebo group compared to the TTI-101 group [4]