Group 1 - The presentation focuses on Moderna's oncology portfolio, which has not been a primary focus in the company's narrative over the past 5 to 10 years [2] - The session will include a presentation followed by a Q&A segment, encouraging audience participation through the Pigeonhole app for questions [3] - Courtney Breen from Sanford C. Bernstein & Co. is leading the discussion, highlighting the importance of understanding the context of Moderna's oncology business [1][2] Group 2 - Rose Loughlin from Moderna is expected to provide insights during the presentation, indicating a collaborative effort to enhance understanding of the company's oncology initiatives [3]

Summary of the Conference Call Company and Industry - **Company**: Moderna - **Industry**: Oncology and mRNA-based therapeutics Key Points and Arguments 1. **Oncology Portfolio Overview**: Moderna is advancing a diverse oncology portfolio utilizing multiple therapeutic approaches and platform technologies to address various cancer types and stages [5][27] 2. **Individualized Neoantigen Therapy (INT)**: INT is a personalized therapy that identifies patient-specific neoantigens from tumor samples, showing promising results in combination with Keytruda, reducing recurrence risk by 49% and distant metastasis risk by 62% [6][7] 3. **Phase Three Study**: A phase three study in adjuvant melanoma combining INT with Keytruda has completed enrollment, with data expected in 2026 [9] 4. **Expansion of INT Development**: INT is being tested across multiple tumor types, including non-small cell lung cancer and bladder cancer, with various combinations [10] 5. **Off-the-Shelf Cancer Antigen Therapies**: Moderna is developing off-the-shelf therapies like mRNA-4359, which targets shared antigens in cancer cells, aiming for broader applicability across different cancer types [11][12] 6. **T Cell Engagers**: The company is developing T cell engagers that guide immune responses towards cancer cells, addressing tumor heterogeneity and immune dysfunction in advanced cancers [18][19] 7. **Cell Therapy Enhancers**: Moderna is exploring in vivo cell therapies to enhance the efficacy of existing CAR-T therapies, potentially improving outcomes in solid tumors [25][26] 8. **Partnerships**: Moderna has a 50/50 partnership with Merck for INT and collaborates with Immatics for T cell receptor development, leveraging external expertise to enhance their capabilities [60][61] 9. **Future Catalysts**: Key upcoming data releases include the five-year follow-up for INT in 2026 and additional data from ongoing studies in various cancer types [39][40] 10. **Competitive Landscape**: Moderna is monitoring competitors like BioNTech and IO Biotech, assessing their data to inform and de-risk its own development strategies [51][52] Other Important Content 1. **Safety and Tolerability**: The safety profiles of INT and other therapies are encouraging, with low-grade adverse events reported [7][14] 2. **Translational Data Importance**: Translational data from early studies will guide future development and inform the potential clinical benefits of therapies [64] 3. **Diverse Therapeutic Approaches**: Moderna's strategy involves a toolkit approach, tailoring therapies based on cancer stage and patient needs, from preventive to advanced settings [30][31] 4. **Market Opportunities**: The company sees potential in both solid and liquid tumors, with a focus on enhancing immune responses in challenging environments [36][44] 5. **Long-term Vision**: Moderna aims to significantly impact patient lives through its diverse oncology portfolio, leveraging its mRNA platform technology [67]

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mRNA-4157/V940 in combination with KEYTRUDA - At ~3 years of follow-up, the recurrence-free survival rate of mRNA-4157/V940 in combination with KEYTRUDA was 74.8%, compared to 55.6% for KEYTRUDA alone[12] - At a median planned follow-up of 34.9 months, mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 49%[14] - At ~3 years of follow-up, mRNA-4157/V940 in combination with KEYTRUDA demonstrated a 62% reduction in the risk of developing distant metastasis or death compared to KEYTRUDA alone[17] Safety and Tolerability of mRNA-4157/V940 - In the adjuvant melanoma trial, any treatment-related adverse event occurred in 100% of patients (n=104) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 25% of patients[18] - Serious adverse events occurred in 14.4% of patients (n=15) receiving mRNA-4157 (V940) + pembrolizumab[18] - Immune-related adverse events occurred in 37.5% of patients (n=39) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 10.6% of patients[18] - 94.2% of patients (n=98) experienced mRNA-4157 (V940)-related adverse events, with 33.7% Grade 1, 49% Grade 2, and 11.5% Grade 3[18] Development Programs - The Phase 3 study for adjuvant melanoma with mRNA-4157/V940 is fully enrolled[21, 22] - mRNA-4359 is ongoing in Phase 1/2 study; now enrolling Phase 2 with additional indications planned[27] - mRNA-2808 is in Phase 1 development[41] - mRNA-4203: IND open, in combination with Immatics' IMA203[49]

Core Insights - The Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire is now fully operational, licensed to supply British-made COVID-19 vaccines to the UK population [1] - This facility is a key component of Moderna's ten-year strategic partnership with the UK Government, aimed at enhancing health resilience and promoting economic growth [1] - The MITC will produce mRNA respiratory vaccines for the UK public, supporting the National Health Service (NHS) seasonal vaccination programs [1]

Group 1 - The analyst had a sell call on Moderna (MRNA) in April 2025, which was considered bold at the time due to the significant correction and perception of limited further downside [1] - The analyst has over 20 years of experience in quantitative research, financial modeling, and risk management, focusing on equity valuation, market trends, and portfolio optimization [1] - The analyst previously served as Vice President at Barclays, leading teams in model validation, stress testing, and regulatory finance, indicating a strong background in both fundamental and technical analysis [1] Group 2 - The analyst collaborates with a research partner, who is also their spouse, to co-author investment research, combining complementary strengths for high-quality insights [1] - The research approach emphasizes rigorous risk management and a long-term perspective on value creation, with a focus on macroeconomic trends, corporate earnings, and financial statement analysis [1] - The goal is to provide actionable ideas for investors aiming to outperform the market [1]

Core Insights - Moderna's updated COVID-19 vaccine formulation has shown a strong immune response in all adults aged 65 and older, as well as in individuals aged 12 to 64 with at least one underlying health condition [1] Company Summary - The company has focused on enhancing its vaccine formulation to improve immune responses among older adults and those with underlying health issues [1]

Core Insights - Moderna announced positive preliminary immunogenicity data for the 2025-2026 formula of mNEXSPIKE, targeting the LP.8.1 variant of SARS-CoV-2 [1] - The vaccine demonstrated a greater than 16-fold increase in LP.8.1-neutralizing antibodies across age groups [1] Company Summary - The ongoing Phase 4 clinical trial evaluates the safety, tolerability, and immunogenicity of the 2025-2026 formula of mNEXSPIKE [1] - The vaccine showed strong immune responses against the top circulating COVID-19 strains [1] Age Group Analysis - The data indicates a significant increase in neutralizing antibodies in individuals aged 12 to 64 with underlying conditions and all adults aged 65 and older [1]

Core Insights - Moderna, Inc. is recognized as one of the top AI-powered biotech stocks to consider for investment [1] - The company specializes in mRNA therapeutics and vaccines, with a focus on expanding its pipeline beyond COVID-19 [2] Company Overview - Moderna, Inc. is based in Cambridge and is a leader in mRNA technology, particularly known for its COVID-19 vaccine [2] - The company is diversifying its vaccine offerings to include influenza, RSV, CMV, Zika, and combination vaccines, as well as mRNA therapeutics for oncology, rare diseases, and cardiovascular conditions [2] - Moderna operates globally, with manufacturing facilities in the U.S. and Europe, and utilizes strategic alliances and technology transfers to enhance its operations [2] Market Challenges - In September 2025, Moderna's stock experienced a nearly 7% decline due to reports linking COVID-19 vaccines to approximately 25 child deaths, which raised investor concerns despite the lack of scientific consensus [3] - Policy changes, such as Florida's removal of vaccine mandates, have further complicated near-term demand forecasts for the company [3] Commitment to Safety - The company emphasizes transparency and scientific rigor, citing that over a billion doses of its vaccines have been administered globally, which supports public trust and regulatory engagement [4] Innovation and Technology - Moderna is advancing its mRNA applications beyond COVID-19, integrating AI and machine learning into its R&D pipeline to enhance mRNA design, optimize vaccine formulations, and predict immune responses [5] - This combination of scientific rigor and technological innovation positions Moderna favorably among biotech stocks that are adapting to future healthcare needs [5]

Meanwhile, an RFK Junior back vaccine panel now pushing for new restrictions on a combination shot for children, changing the current recommendations that allow children under four to receive the MMR vaccine. And this morning, uh the uh hepatitis B vaccine vote also was put off. They cited a lack of data, a vote expected later, also on COVID shot recommendations.All right, let's try and make sense of all this. Missouo healthcare sector strategist Jared Holles joins us here at Post 9. I guess from an investo ...