Core Insights - Moderna, Inc. will host its Investor Event - Analyst Day on November 20, 2025, at 9:00 a.m. ET [1] Company Information - The event is aimed at providing insights and updates to investors regarding the company's strategies and future directions [1]

Core Insights - Moderna has decided to discontinue the development of its experimental vaccine aimed at preventing cytomegalovirus, which is a common cause of birth defects, due to its failure to meet the primary endpoint in a late-stage trial [1] Company Summary - The decision to halt the vaccine development reflects challenges in achieving clinical trial objectives, which may impact the company's pipeline and future research directions [1] - This move indicates a strategic shift for Moderna as it reallocates resources towards more promising projects within its portfolio [1] Industry Context - The discontinuation of the cytomegalovirus vaccine development highlights the difficulties faced by biopharmaceutical companies in bringing new vaccines to market, particularly for diseases that are less prioritized compared to more prevalent health issues [1] - The outcome may influence investor sentiment and market dynamics within the vaccine development sector, as companies navigate the complexities of clinical trials and regulatory approvals [1]

Core Insights - The company has decided to discontinue the development of mRNA-1647, an investigational cytomegalovirus (CMV) vaccine [1] - The ongoing Phase 2 trial for mRNA-1647 in bone marrow transplant patients will continue [1] - The company does not expect any impact on its 2025 financial guidance or its goal of achieving breakeven by 2028 [1] Trial Results - The Phase 3 pivotal trial for mRNA-1647 did not meet its primary efficacy endpoint, which was to prevent CMV infection in seronegative female participants aged 16-40 [1]

Market Overview - The CNN Money Fear and Greed index showed a slight increase in fear, with a current reading of 30.3 compared to the previous 29.1, indicating continued market anxiety [5] - U.S. stocks experienced a positive session, with the Dow Jones gaining approximately 516 points to close at 46,706.58, while the S&P 500 rose by 1.07% to 6,735.13, and the Nasdaq Composite surged by 1.37% to 22,990.54 [3] Company Performance - Moderna Inc. was the top gainer in the S&P 500, with shares jumping around 5% following the announcement of new data on investigational flu vaccines to be presented at IDWeek 2025 [2] - Cleveland-Cliffs Inc. saw a significant increase in its stock price, rising more than 21% after reporting its third-quarter 2025 results [2] Sector Performance - Most sectors within the S&P 500 closed positively, with communication services, materials, and industrials recording the largest gains, while utilities and consumer staples stocks closed lower [3] Upcoming Earnings - Investors are anticipating earnings results from major companies including Coca-Cola Co., General Motors Co., and Netflix Inc. [4]

Core Insights - CytomX Therapeutics has appointed Rachael Lester as Senior Vice President and Chief Business Officer to enhance its strategic long-term value creation and partnering strategy [1][2] - The company is well-positioned to advance its clinical assets, particularly CX-2051 and CX-801, which target high unmet medical needs in cancer treatment [2][4] Company Overview - CytomX Therapeutics is a clinical-stage biopharmaceutical company focused on developing conditionally activated, masked biologics aimed at localized tumor treatment [4] - The company's PROBODY therapeutic platform enables the creation of safer and more effective cancer therapies, with a pipeline that includes antibody-drug conjugates, T-cell engagers, and immune modulators [4] Leadership Experience - Rachael Lester brings over 20 years of experience in corporate strategy and business development within the biopharmaceutical industry [3] - Prior to joining CytomX, she held significant roles at Replicate Bioscience and Harpoon Therapeutics, where she was instrumental in securing financing and establishing major partnerships [3] Clinical Pipeline - CytomX's lead clinical assets include CX-2051, a masked ADC targeting EpCAM, and CX-801, a masked interferon alpha-2b PROBODY cytokine, both of which have broad potential across various cancer types [4] - CX-2051 is designed to treat multiple EpCAM-expressing epithelial cancers, including colorectal cancer, while CX-801 has applications in both immuno-oncology sensitive and insensitive tumors [4] Strategic Collaborations - The company has established strategic partnerships with leading oncology firms such as Amgen, Astellas, Bristol Myers Squibb, Regeneron, and Moderna to enhance its research and development efforts [4]

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 ...