Moderna: INT Vaccine Interim Data Expected This Fall, Flu Vaccine Approval Imminent

Overview

This report is based on UBS analyst dinner meeting notes with Moderna management during the American Society of Clinical Oncology (ASCO) annual conference. The report focuses on two key catalysts for Moderna: the latest clinical progress of personalized neoantigen therapy (INT) in melanoma adjuvant treatment, and the regulatory approval process for mRNA flu vaccine. UBS maintains a neutral rating on Moderna with a target price of $45, believing that while INT phase II data is encouraging and flu vaccine approval probability is increasing, key interim clinical data readouts and regulatory decisions remain the primary drivers of near-term stock performance.

Core views

Personalized cancer vaccine (INT) progressing well, data supports phase III success potential. Updated INT adjuvant therapy for melanoma phase II data presented at ASCO further validates durability of efficacy. As of year 5, recurrence-free survival (RFS) hazard ratio (HR) was 0.51, 5-year landmark RFS difference reached 23% (72% vs 49%), consistent with previous 3-year update data. Overall survival (OS) also shows positive trend, HR of 0.47, though 95% confidence interval crosses 1 (0.17–1.35). These consistently meaningful benefits support the potential for positive results in INT's current phase II-IV patient phase III adjuvant study. Phase III trial design optimized to balance risk and success rate. To improve probability of success (PoS), the phase III trial jointly designed with partner Merck (MRK) includes IIB stage patients, different from the phase II trial which included only III & IV stages. IIB stage patients are earlier stage and healthier with slower progression, helping to balance the population and mitigate rapid progression risks due to manufacturing cycle. Additionally, Keytruda has been approved for II stage (KN716) and III-IV stage (KN054), so including the same population is reasonable. Key timeline: INT interim data expected this fall. Company reiterated that phase III trial event rates meet expectations, with potential interim analysis possible in second half of 2026. UBS in-depth analysis believes that given enrollment completion in September 2024, interim data may be released in October or November (approximately 2 years post-enrollment). While phase II trial reached interim endpoint 18 months post-enrollment, phase III progresses more slowly due to inclusion of healthier IIB stage patients, making a 24-month timeframe more reasonable. UBS channel checks suggest data may be released as early as the ESMO conference in late October, and data should be positive. Flu vaccine approval approaching, commercialization ready. mRNA flu vaccine under FDA review, PDUFA date is August 5, 2026. Prior to this, VRBPAC advisory committee will discuss and vote on June 18. If result is positive, it will enhance market confidence in approval. This combination vaccine has already been approved in the EU, and the company is currently conducting price negotiations, hoping to complete by end of year to participate in 2027 season bidding. Additionally, norovirus vaccine interim data will be released this year, with efficacy evaluation targeting cases caused by specific strains included in the vaccine.

Analysis framework

UBS adopted an approach combining event-driven analysis with clinical pipeline valuation. First, by interpreting the latest clinical data (phase II long-term follow-up) presented at ASCO conference, verifying the biological efficacy and durability of INT therapy, which forms the basis for evaluating phase III success probability. Second, comparing differences in phase II versus phase III trial designs (patient staging selection), analyzing the company's strategic adjustments to improve trial success rate and their reasonableness. Third, combining enrollment timeline and disease natural history (progression speed), calculating specific time windows for key interim data readouts, providing clear timing anchors for investors. Finally, combining near-term regulatory catalysts (flu vaccine PDUFA) with medium-to-long-term pipeline value (INT, norovirus), comprehensively assessing the company's short-term stock drivers and long-term value support.

Methodology notes

• Industry/Sector Analysis Framework

  Clinical Trial Endpoints and Success Probability (PoS) Analysis

  In biopharma investing, analyzing clinical trial design (such as patient staging, sample size) and interim data (such as HR values, confidence intervals) to predict the probability of final trial success. For example, including earlier stage patients may reduce event rates but improve overall population representativeness and safety profile, thus affecting PoS.

• Event Gaming and Behavioral FinanceEvent-driven analysis

  Event-Driven Analysis

  Identifying and tracking specific events that have significant impact on company stock prices (such as FDA approval dates PDUFA, academic conference data releases ASCO/ESMO), and evaluating investment opportunities and risks based on event timelines and expected outcomes.

Asset mapping & comparison

Structured mapping from thesis to named assets (strengths, weaknesses, peers, risks).

• Moderna Inc (MRNA.US)

  Direct beneficiary entity, owns INT platform and flu vaccine pipeline

  Strengths

  Leading mRNA technology platform, good durability of INT phase II data, EU approval for flu vaccine

  Weaknesses

  Has not achieved stable profitability, single blockbuster product risk, intense competition

  Comparison

  Compared to traditional vaccine manufacturers, has faster R&D iteration capability; compared to other mRNA competitors, leads in pipeline progress

  Risks

  INT phase III failure, flu vaccine sales below expectations, regulatory approval delays

• Merck & Co. (MRK)

  INT project partner, jointly develops and responsible for phase III trial operations

  Strengths

  Strong oncology drug commercialization capability, Keytruda synergistic effect

  Weaknesses

  Dependent on external collaboration innovation

  Comparison

  Complementary to Moderna, Moderna provides technology, Merck provides clinical development and commercialization resources

  Risks

  INT project failure affecting collaboration benefits

Key data

• INT Phase II 5-Year RFS HR0.51Shows significant reduction in recurrence risk
• INT Phase II 5-Year RFS Delta23%72% vs 49%, durable efficacy
• INT Phase III Enrollment Completion TimeSeptember 2024Expected interim data approximately 2 years post-enrollment
• Flu Vaccine PDUFA DateAugust 5, 2026FDA final approval decision deadline
• VRBPAC Advisory Committee Vote DateJune 18, 2026Key consultation before flu vaccine approval
• Target Price$45.00Maintain neutral rating

Impact & implications

For Moderna, the positive trend in INT data and potential flu vaccine approval are key validations of the company's transition from COVID-19 dependence to diversified pipeline. If INT interim data is positive, it will significantly enhance market revaluation of its cancer vaccine platform value; if flu vaccine is approved smoothly and pricing agreements are reached, it will provide stable revenue sources for 2027 and beyond. However, since current stock price already reflects some expectations, and considering risks of clinical failure or regulatory delays, UBS maintains a neutral rating, recommending investors closely monitor the series of data readouts in the second half of the year.

Risks

• INT phase III clinical trial results below expectations or failure
• Flu vaccine uptake below expectations or facing intense competition
• FDA raises additional requirements for mRNA flu vaccine safety or efficacy causing approval delays
• Continued decline in COVID-19 vaccine demand
• Key management changes

What to watch

• June 18, 2026 VRBPAC vote results for mRNA flu vaccine
• August 5, 2026 FDA PDUFA decision for mRNA flu vaccine
• October-November 2026 INT phase III trial interim data readout
• October 2026 ESMO conference whether INT-related data is released
• Flu vaccine price negotiation progress and 2027 season bidding situation
• Norovirus vaccine interim data results