Core Insights - Moderna, Inc. announced data on two investigational influenza candidates to be presented at IDWeek 2025, highlighting advancements in mRNA-based vaccine technology [1] Group 1: Presentation Details - The Late-Breaking Oral Presentation 229 will focus on mRNA-1010, an mRNA-based influenza vaccine [1] - Data indicates that mRNA-1010 is safe and efficacious in adults aged 50 years [1] - The relative vaccine efficacy (rVE) of mRNA-1010 is compared to a licensed standard dose (SD) influenza vaccine [1]

Core Viewpoint - Moderna's stock has been declining in 2025 despite receiving new vaccine approval and upcoming clinical readouts, indicating ongoing financial challenges for the company [1]. Company Summary - In January, a sell rating was issued for Moderna, anticipating continued cash burn with minimal positive outcomes [1]. Industry Context - The article highlights the focus on trading biotech stocks around significant events such as trial results and regulatory approvals, emphasizing the volatility and risks associated with the biotech sector [1].

Core Insights - The company is excited to share new data on asset 4359, which is becoming a late-stage asset similar to INT [1] - The presentation includes discussions on melanoma and the data related to 4359, featuring experts in the field [1] Pipeline Overview - The company utilizes mRNA technology in various innovative ways, including personalized therapies through the Intismeran autogene program [2] - Off-the-shelf therapies are being developed, referred to as cancer antigen therapies (CATs), along with a T-cell engager program [2] - The company is also advancing in vivo cell therapy programs, which are expected to enhance cell therapy applications [2] Efficacy Potential - The company believes that its programs hold the promise of potential efficacy across a wide range of indications and different therapeutic areas [3]

Summary of Conference Call on Oncology Pipeline Company and Industry Overview - The conference call primarily discusses **Moderna's** oncology pipeline, focusing on their **Individualized Neoantigen Therapy (INT)** and **mRNA-4359** programs, which target melanoma and other cancers. The discussion includes insights from experts in the field of oncology, particularly regarding melanoma treatment advancements. Key Points and Arguments Pipeline Development - Moderna's pipeline has significantly expanded over the past few years, now including various cancer therapies such as **Individualized Neoantigen Therapy (INT)**, **cancer antigen therapies (CATs)**, and **T-cell engagers** [1][2][3] - The INT program is currently evaluating efficacy across multiple cancer types, including melanoma, lung cancer, renal cell carcinoma, and bladder cancer [3][4] Individualized Neoantigen Therapy (INT) - The INT program is unique in its approach, utilizing patient-specific tumor data to create personalized therapies. This involves sequencing tumor DNA and identifying unique mutations to predict immunogenic responses [4][5] - Recent data from a randomized phase II trial (P201) showed a **49% reduction in the risk of recurrence or death** and a **62% reduction in distant metastasis or death** for patients receiving INT combined with pembrolizumab compared to pembrolizumab alone [6][7] - The safety profile of INT was favorable, with no increase in immune-related adverse events compared to standard treatments [6][7] mRNA-4359 Program - mRNA-4359 targets both **PD-L1** and **IDO**, aiming to enhance T-cell responses against tumors. The mechanism is designed to address immune evasion and activate T-cells against cancer cells [21][24] - Preliminary data from an ongoing phase I-II trial indicated an **overall response rate of 24%** in heavily pretreated patients with refractory melanoma, which is notable given the patient population's history of resistance to prior therapies [32][33] - The safety profile of mRNA-4359 showed manageable adverse events, primarily mild symptoms such as injection site pain and fatigue, with no significant increase in high-grade immune-related adverse events [30][31][76] Melanoma Treatment Landscape - The discussion highlighted the evolving landscape of melanoma treatments, including the introduction of immune checkpoint inhibitors and combination therapies. Despite advancements, a significant unmet need remains for patients who do not respond to existing therapies [9][10][12] - The efficacy of combination therapies, such as anti-PD-1 and anti-CTLA-4, has been shown to be superior to single-agent therapies, but many patients still experience disease progression [11][12][15] Future Directions - Moderna plans to expand its clinical trials for mRNA-4359 to include combinations with other therapies, such as ipilimumab and nivolumab, and to explore its efficacy in non-small cell lung cancer [38] - The company is also investigating the potential of T-cell engagers and cell therapy enhancing programs, aiming to improve treatment outcomes for various cancers [39][40][41] Additional Important Insights - The conference emphasized the importance of biomarkers in identifying patients who may benefit from specific therapies, particularly in the context of precision medicine [33][34] - Ongoing translational research aims to better understand the mechanisms of action and patient responses to therapies, which is crucial for future drug development [51][52][53] This summary encapsulates the key discussions and findings from the conference call, highlighting Moderna's innovative approaches in oncology and the promising data emerging from their clinical trials.

Moderna Oncology Event October 17, 2025 © 2025 Moderna, Inc. All rights reserved. Forward-looking statements and important disclaimers This presentation being made by Moderna, Inc., and is intended solely for investors and financial analysts, and is not for promotional use. The information discussed relates to investigational candidates that have not been approved by regulatory authorities. No conclusions about the safety or efficacy of those investigational candidates should be drawn. Content is limited to ...

CAMBRIDGE, MA / ACCESS Newswire / October 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, November 6, 2025 to report its third quarter 2025 financial results, and provide a corporate update. ...

Core Insights - Moderna's market value peaked at over $195 billion in 2021, driven by high demand for its COVID-19 vaccine, but has since diminished significantly due to reduced vaccine demand and changing market conditions [1][3] - The company's sales reached a high of nearly $18.9 billion in 2022, but have since dropped to $3.1 billion in the trailing 12 months, with an operating loss of $3.3 billion [4][6] - Moderna's focus on COVID-19 and flu combination shots, without diversifying its portfolio, has negatively impacted its business, leaving it vulnerable as COVID-19 vaccine demand wanes [3][7] Company Strategy - Moderna and Pfizer initially led the COVID-19 vaccine market, but their strategies have diverged, with Pfizer pursuing acquisitions for diversification while Moderna has concentrated on vaccine development and R&D [3] - The development of a personalized cancer vaccine, mRNA-4157, in collaboration with Merck shows promise, having demonstrated a 49% reduction in recurrence or death risk in high-risk melanoma patients compared to Keytruda alone [5] Market Position - Despite a significant decline in valuation, Moderna's market cap remains at $10.4 billion, raising concerns about future growth potential [6] - The company's inability to diversify beyond COVID-19 has resulted in insufficient revenue to cover operating expenses, leading to skepticism about its long-term viability [7]

Company Performance - Moderna's stock closed at $26.25, reflecting a -1.83% change from the previous day, underperforming the S&P 500's daily loss of 0.16% [1] - Over the past month, Moderna's stock has increased by 11.98%, outperforming the Medical sector's gain of 1.54% and the S&P 500's gain of 1.14% [1] Earnings Forecast - The upcoming earnings report for Moderna is expected to show an EPS of -$1.99, representing a significant 6733.33% decline from the same quarter last year [2] - Revenue is forecasted to be $861.08 million, indicating a 53.76% decrease compared to the same quarter of the previous year [2] - For the full year, earnings are projected at -$9.62 per share and revenue at $1.88 billion, reflecting changes of -8.46% and -41.8% respectively from the prior year [3] Analyst Revisions - Recent revisions to analyst forecasts for Moderna are crucial as they reflect short-term business trends, with upward revisions indicating analyst optimism regarding the company's profitability [4] - The Zacks Rank system, which incorporates estimate changes, has a strong track record of outperforming, with stocks rated 1 producing an average annual return of +25% since 1988 [6] Industry Context - The Medical - Biomedical and Genetics industry, part of the Medical sector, currently holds a Zacks Industry Rank of 94, placing it in the top 39% of over 250 industries [7] - Research indicates that the top 50% rated industries outperform the bottom half by a factor of 2 to 1 [7]

Core Insights - The proverb "you have to spend money to make money" emphasizes the importance of R&D spending for companies aiming to increase profitability and market presence [1] R&D Importance - R&D is essential for innovation, leading to new or improved products, processes, and services, contributing to long-term economic growth [2] - Significant advancements, such as mRNA-based vaccines, are direct results of substantial R&D investments by companies like Pfizer, BioNTech, and Moderna [2] Historical Context - The features of modern smartphones, including touchscreens and GPS, are outcomes of decades of R&D by major tech companies like IBM, Apple, and Google [3] Leadership Perspective - Amazon's CEO emphasizes that R&D spending is critical for companies, particularly those with opportunities to enhance capabilities [4] - R&D investments can provide a competitive advantage through intellectual property and innovative service delivery, positioning companies as market leaders [5] Investment Strategy - Successful growth-oriented companies often allocate 10% or more of their revenue to R&D, though the specific percentage should be based on available opportunities and associated risks [6] - Companies must evaluate their potential for growth and market advantage to determine the appropriateness of heavy R&D investment [6]

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over five years of experience in biotech consulting and has prepared detailed reports on more than 1,000 companies [1]