Core Viewpoint - Moderna's experimental flu vaccine has successfully met the primary endpoint in its Phase 3 clinical trial, leading to a pre-market stock increase of over 6% [1]. Stock Performance - Moderna's stock price rose by 6.22% in pre-market trading, reaching $28.650 [1]. - The stock's previous closing price was $27.540, indicating a significant upward movement [1]. - The stock's trading volume in pre-market was approximately 28,900 shares, with a total market capitalization of $10.504 billion [1]. Financial Metrics - The stock has a price-to-earnings (P/E) ratio of loss, reflecting its current financial performance [1]. - The stock's 52-week high was $129.390, while the 52-week low was $23.150, showing substantial volatility [1]. - The average price in pre-market trading was $28.428, with a trading range of $27.680 to $29.180 [1].

Core Insights - Moderna's experimental mRNA-based flu vaccine has shown a stronger immune response compared to the currently available vaccine in late-stage trials, paving the way for further development of both the flu vaccine and a combination flu and Covid jab [1][3]. Company Developments - In May, Moderna voluntarily withdrew its application for the combination vaccine targeting Covid-19 and influenza, planning to resubmit it with efficacy data from the phase three trial of its standalone flu vaccine [2]. - The company intends to resubmit the application for the combination vaccine and seek approval for its standalone flu shot later this year, with expectations for regulatory approvals for both products next year [3]. Market Position - Moderna is currently a frontrunner against competitors Pfizer and Novavax in the race to market a combination vaccine, with the potential for significant revenue from the multi-billion-dollar markets of Covid, flu, and respiratory syncytial virus [4][5]. Efficacy Data - The phase three trial involved over 40,000 adults aged 50 and above, showing that Moderna's mRNA-1010 vaccine was 26.6% more effective than the standard competitor vaccine [5]. - The mRNA-1010 vaccine demonstrated strong efficacy against major influenza strains, with a 27.4% higher effectiveness in adults aged 65 and older compared to the standard flu vaccine [6]. Public Health Context - Moderna's CEO highlighted the importance of effective vaccines, especially given that flu-related hospitalizations reached a 15-year high during the 2024 to 2025 season, with over 600,000 hospitalizations reported [7]. Safety and Regulatory Engagement - The safety data for the mRNA-1010 vaccine aligns with previous phase three study results, indicating a consistent safety profile [8]. - Moderna is actively engaging with the FDA to clarify regulatory requirements and believes it has a clear path regarding flu vaccine approval [9].

Company Performance - Moderna's stock closed at $27.54, reflecting a +2.53% change from the previous day's closing price, outperforming the S&P 500's daily gain of 0.8% [1] - Over the past month, shares of Moderna have increased by 3.11%, while the Medical sector gained 3.12% and the S&P 500 gained 5.12% [1] Upcoming Earnings - Analysts expect Moderna to report an EPS of -$2.97, which is a 10.81% increase from the prior-year quarter [2] - The Zacks Consensus Estimate for revenue is projected at $130.15 million, down 46% from the same period last year [2] Fiscal Year Estimates - For the entire fiscal year, the Zacks Consensus Estimates predict an EPS of -$9.81 and revenue of $2.08 billion, indicating changes of -10.6% and -35.83% respectively from the previous year [3] - Recent changes to analyst estimates for Moderna suggest a favorable outlook on the company's business health and profitability [3] Industry Ranking - The Medical - Biomedical and Genetics industry, which includes Moderna, has a Zacks Industry Rank of 86, placing it in the top 35% of over 250 industries [6] - Research indicates that the top 50% rated industries outperform the bottom half by a factor of 2 to 1 [6]

Moderna (MRNA) ended the recent trading session at $25.90, demonstrating a +1.97% change from the preceding day's closing price. This change outpaced the S&P 500's 0.22% loss on the day. Elsewhere, the Dow saw an upswing of 0.08%, while the tech-heavy Nasdaq depreciated by 0.51%. Coming into today, shares of the biotechnology company had lost 4.94% in the past month. In that same time, the Medical sector gained 0%, while the S&P 500 gained 0.45%. Market participants will be closely following the financial r ...

Intismeran autogene (mRNA-4157) - mRNA-4157 is designed to target an individual patient's unique tumor mutation [6] - mRNA-4157 is in Phase 3 study for adjuvant melanoma, which is fully enrolled [6] - mRNA-4157 is in two adjuvant Phase 3 studies for NSCLC, for those with and without prior neoadjuvant treatment [6] - mRNA-4157 is in randomized Phase 2 study for adjuvant high-risk muscle invasive bladder cancer and adjuvant renal cell carcinoma, the latter of which is fully enrolled [6] - mRNA-4157 is in randomized Phase 2 study for high-risk non-muscle invasive bladder cancer (HR NMIBC) [6] - mRNA-4157 is in Phase 1 basket study for solid tumors: Melanoma, Gastric, PDAC, NSCLC [6] Off-the-shelf cancer antigen therapies - mRNA-4359 targets immunosuppressive cells and mechanisms [10] - mRNA-4359 is in Phase 2, with additional indications planned [10, 11] - mRNA-4106 is in Phase 1 [10] - mRNA-4359 encodes for PD-L1 and IDO, targeting both immunosuppressive cells and cancer cells, and is applicable to many different cancer types [15] T-cell engagers - The company is developing two approaches with secreted T-cell engaging antibodies to target surface and intracellular proteins [19] In vivo cell therapy - mRNA-4203 (partnered with Immatics) has an IND open [28]

Core Insights - Moderna is focusing on its oncology pipeline as a key area of interest for investors moving forward [3][4]. Company Overview - The conference call is part of Barclays' 8th annual speaking science conference series, aimed at discussing scientific concepts, clinical program progress, and company strategy [1][2]. Oncology Pipeline - Rose Loughlin, EVP of Research, is presenting a comprehensive slide deck regarding Moderna's oncology pipeline, indicating its importance in the company's future development [3][5]. - The oncology space is highlighted as a significant focus for Moderna, with expectations of substantial investor interest [3].

Summary of Moderna (MRNA) Update / Briefing June 16, 2025 Company Overview - **Company**: Moderna (MRNA) - **Focus**: Oncology pipeline and commercial strategy Key Points on Oncology Pipeline 1. **Oncology as a Key Focus**: The company emphasizes the importance of oncology in its future development, with a focus on individualized therapies and cancer antigen therapies [3][4] 2. **Lead Program - Intisiran Auto Gene (INT)**: This individualized neoantigen therapy has shown a 49% reduction in the risk of recurrence or death in a Phase 2 study for adjuvant melanoma, with pivotal study data expected in 2026 [7][39] 3. **Expansion of INT**: The company is exploring INT in various cancer settings, including combinations with pembrolizumab and as a monotherapy [7][8] 4. **Off-the-Shelf Cancer Antigen Therapies**: These therapies are designed for broader patient use and are currently in development, with lead programs mRNA-4106 and mRNA-4359 targeting specific tumor antigens and training the immune system [10][11] 5. **T Cell Engagers**: The company is developing multiplexed T cell engagers that can target multiple proteins on cancer cells, enhancing the immune response [16][17] 6. **In Vivo Cell Therapies**: Moderna is pursuing innovative approaches to enhance the efficacy of cell therapies, including engineered T cells that can be modified within the patient's body [20][24] Clinical Development and Data 1. **Phase 2 and Phase 3 Studies**: The company is preparing for Phase 3 trials based on encouraging Phase 2 data, with a focus on event-driven trial designs [34][40] 2. **Control Arm Performance**: The performance of the pembrolizumab control arm in Phase 2 is reported to be in line with historical data, addressing investor concerns about patient allocation [32][36] 3. **Safety and Tolerability**: The safety profile of mRNA-4359 and INT is favorable, with low-grade adverse events and no dose-limiting toxicities reported [15][62] Market and Competitive Landscape 1. **Partnerships and Collaborations**: Moderna is closely monitoring competitive developments, including BioNTech's recent acquisition of CareVac and their oncology programs [78] 2. **Regulatory Environment**: The company is navigating a changing political landscape that affects vaccine development and approval processes, particularly in the context of COVID-19 and RSV vaccines [82][86] Financial Guidance and Market Outlook 1. **Revenue Guidance**: Moderna has provided a broad revenue guidance range of $1.5 billion to $2.5 billion for the year, considering potential declines in vaccination rates and other market factors [96] 2. **Future Approvals**: The company is optimistic about upcoming FDA approvals and the potential for expanded indications for its vaccines, particularly for high-risk populations [85][89] Additional Insights 1. **Combination Therapies**: The company is exploring combination therapies with checkpoint inhibitors and other agents, aiming to enhance overall response rates and progression-free survival (PFS) [65][66] 2. **Clinical Trial Design**: The design of clinical trials is being carefully considered, with a focus on achieving statistically significant outcomes that can support regulatory filings [50][52] This summary captures the essential points discussed during the call, highlighting Moderna's strategic focus on oncology, clinical development progress, market positioning, and financial outlook.

Company Performance - Moderna's stock closed at $26.68, showing a decrease of -2.45% from the previous day's closing price, which was less than the S&P 500's daily loss of 1.13% [1] - Over the past month, Moderna's shares increased by 15.65%, outperforming the Medical sector's gain of 3.07% and the S&P 500's gain of 3.55% [1] Financial Projections - The upcoming earnings per share (EPS) for Moderna is projected to be -$2.97, indicating a 10.81% increase from the same quarter last year [2] - Revenue for the same quarter is estimated at $131 million, reflecting a significant decline of 45.64% compared to the equivalent quarter last year [2] - For the full year, the Zacks Consensus Estimates project an EPS of -$9.78 and revenue of $2.08 billion, representing changes of -10.26% and -35.72% from the prior year, respectively [3] Analyst Forecasts - Investors are advised to monitor any recent revisions to analyst forecasts for Moderna, as these revisions indicate the changing nature of near-term business trends [4] - Positive revisions in estimates suggest analysts' confidence in the company's performance and profit potential [4] Zacks Rank and Industry Position - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), currently places Moderna at a rank of 3 (Hold) [6] - Over the past month, the Zacks Consensus EPS estimate for Moderna has increased by 1.28% [6] - The Medical - Biomedical and Genetics industry, which includes Moderna, has a Zacks Industry Rank of 78, placing it in the top 32% of over 250 industries [7]

Core Viewpoint - The approval of Moderna's RSV vaccine for younger adults indicates a potential easing of the previous administration's resistance to mRNA vaccine technology, allowing the company to target a larger market segment [1][2]. Group 1: Regulatory Approvals - The U.S. FDA has approved Moderna's RSV vaccine for adults under 60 who are at high risk of respiratory syncytial virus (RSV) infection, expanding its market reach [1]. - This approval follows the FDA's earlier authorization of the same vaccine for individuals aged 60 and above, marking the second mRNA vaccine product for Moderna after its COVID-19 vaccine [1][2]. Group 2: Competitive Landscape - Competitors such as Pfizer and GlaxoSmithKline have also received approvals for their RSV vaccines targeting high-risk populations, with Pfizer allowed to sell to those under 60 and GlaxoSmithKline to those aged 50 to 59 [1][2]. - The global market now features three adult RSV vaccines: Moderna's mRNA-1345, Pfizer's Abrysvo™, and GlaxoSmithKline's Arexvy™, each utilizing different technological platforms and formulations [2][3]. Group 3: Vaccine Technology and Efficacy - Moderna's mRNA-1345 vaccine employs a single mRNA strand encoding the pre-F protein, encapsulated in lipid nanoparticles, which allows for rapid updates and high neutralizing antibody titers with a single injection [3]. - In contrast, Pfizer and GlaxoSmithKline utilize recombinant protein vaccines with adjuvants, which may offer better immune persistence but require more complex manufacturing processes [3].

Core Viewpoint - Moderna has faced a significant decline in stock value, approximately 80% over the past three years, due to reduced demand for its coronavirus vaccine, despite recent positive developments in its product pipeline and cost-cutting measures [1][2][10]. Group 1: Company Performance - Moderna's revenue peaked at $18.4 billion in 2022 from its coronavirus vaccine, but demand has since dropped, leading to a decline in sales [5][10]. - The company has received approval for a second product, its respiratory syncytial virus (RSV) vaccine, but initial sales have been disappointing [2][6]. - Moderna aims to achieve between $1.4 billion and $1.7 billion in GAAP operating cost reductions by 2027 [7]. Group 2: Product Pipeline and Future Goals - Moderna has a robust late-stage pipeline with goals for up to 10 product approvals in the coming years, including multiple cancer vaccines [8][9]. - Currently, there are seven cancer-vaccine candidates in phase 2 or phase 3 studies, which could provide multiple revenue streams if successful [9]. - The company continues to focus on advancing its mRNA technology across various treatment areas, including latent viruses and cancer vaccines [4][5]. Group 3: Market Challenges and Investor Sentiment - Despite positive developments, investor sentiment remains cautious due to the ongoing decline in coronavirus vaccine sales and early disappointments in the RSV market [10][12]. - Uncertainty surrounding government vaccine policies may also pose challenges for Moderna's stock performance [11]. - Long-term prospects for revenue growth remain, particularly as key product approvals approach, suggesting potential for future stock appreciation [13][14].