Core Insights - The company reported fourth quarter revenue of $0.7 billion, with a GAAP net loss of $(0.8) billion and a GAAP EPS of $(2.11) [1] - For the full year, revenue was $1.9 billion, with a GAAP net loss of $(2.8) billion and a GAAP diluted EPS of $(7.26) [1] - The company reiterated its plan to achieve up to 10% revenue growth and reduce GAAP operating expenses by 2026 [1] Regulatory and Clinical Updates - The company announced that its influenza vaccine filing has been accepted for regulatory review in the EU, Canada, and Australia; however, it received a Refusal-to-File letter from the U.S. FDA and has requested a Type A meeting to clarify the path forward [1] - The Norovirus Phase 3 trial is fully enrolled, with data readout expected in 2026 [1] - Full enrollment of the Phase 2 intismeran autogene trial in muscle invasive bladder cancer has been achieved [1] Business Developments - In 2025, the company focused on sharpening its commercial execution, launched its third product, and brought online three international manufacturing sites while advancing its mRNA pipeline [1]

Core Insights - Moderna's shares increased by 15.8% following the announcement of positive five-year follow-up data from a phase IIb study on its personalized cancer therapy for high-risk melanoma patients [1][6] Group 1: Study Overview - The KEYNOTE-942/mRNA-4157-P201 study assessed Moderna's mRNA-based individualized neoantigen therapy (intismeran autogene) in combination with Merck's PD-L1 inhibitor, Keytruda, for treating high-risk melanoma patients post-surgery [2][7] - The study showed that the combination therapy significantly improved recurrence-free survival, reducing the risk of recurrence or death by 49% compared to Keytruda alone [3][4] Group 2: Long-term Efficacy and Safety - The follow-up analysis indicated sustained and clinically meaningful improvements in recurrence-free survival, marking a significant milestone for the therapy [3][4] - The safety profile of intismeran autogene combined with Keytruda remained consistent with previous studies [5] Group 3: Future Developments - Moderna and Merck plan to present additional follow-up data at upcoming medical meetings [4][7] - Beyond melanoma, the therapy is being evaluated in pivotal phase III studies for non-small cell lung cancer and other cancer types, with a commercial launch targeted for next year [9] Group 4: Pipeline Expansion - Moderna is focusing on expanding its oncology pipeline, including the development of mRNA-4359, an investigational therapy for melanoma and metastatic non-small cell lung cancer, with data expected in 2026 [10]

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]