80-90% prob of success

Assuming a conservative 16-month median Disease-Free Survival (DFS) for the observation group—consistent with a nationwide, unselected (MRD-agnostic) surgical PDAC population—the probability that the AMPLIFY-7P Phase 2 study will show a statistically significant improvement in the treatment arm is estimated to be 80–90%.

While the 16-month baseline represents a significantly more durable control group than the 5.0–6.4 month median seen in MRD-positive patients, the following factors derived from the sources support this high estimate:

1. The Mathematical Signal of "Fewer Events"

The study is event-driven, and in a 2:1 randomized design, the overall pace of the trial is dominated by the performance of the treatment arm.

• The Bar for Success: If the observation group is tracking toward a 16-month median DFS, it would take longer for events to accrue regardless of treatment effect.
• The Positive Delay: In November 2025, the sponsor reported that they observed fewer disease progressions and deaths than originally projected in their statistical modeling.
• Analysis: If ELI-002 7P were only marginally effective, the cumulative events from the 48-patient SOC arm and the "ineffective" portion of the treatment arm would have likely triggered the analysis by now. The delay until 1H 2026 implies that the treatment is likely pushing the median DFS in the active arm significantly beyond the 16-month mark.

2. Massive Expansion of the Effective T Cell Population

In Phase 1, the magnitude of the T cell response was the single most accurate predictor of survival. Patients exceeding a 9.17x fold-change threshold achieved an 88% reduction in the risk of relapse or death (HR 0.12, p=0.0002).

• Replication in Phase 2: Approximately 80% (72/90) of the Phase 2 patients have already achieved a T cell response above a 9.5x threshold.
• Potency Increase: The median T cell fold-change in Phase 2 is 44.3x, nearly triple the potency of the Phase 1 median (16.4x). This suggests that the "protective" immune response is not just being replicated but is significantly more robust across the Phase 2 cohort.

3. Comprehensive Immune Coverage

The Phase 2 study has achieved a 99% (89/90) mKRAS-specific T cell response rate.

• Balanced Immunity: 85% of patients induced combined CD4+ and CD8+ responses. CD4+ help is recognized as critical for licensing APCs to cross-present antigens and for the direct induction of a potent anti-tumor defense in PDAC.
• Broadening the Target: 87% of patients demonstrated antigen spreading to personalized neoantigens, with a median fold-change (10.6x) much higher than that seen in Phase 1 (3.4x). This multi-targeted immunity may limit the ability of heterogeneous PDAC tumors to escape through antigen loss.

4. Positive Validation from Independent Review

The Independent Data Monitoring Committee (IDMC) reviewed unblinded efficacy and safety data in August 2025 and provided a positive recommendation to continue the trial to final analysis without modifications. The sponsor explicitly interprets this recommendation as an indication that ELI-002 7P has already shown preliminary signals of efficacy in the unblinded dataset.

Conclusion: Even assuming a longer 16-month median DFS in the control arm, the 80–90% probability of success remains firm. The convergence of numerical superiority in immunogenicity, a validated 88% risk-reduction correlation, and the real-time slowdown in overall disease events strongly indicates that the vaccine is successfully preventing or delaying recurrence in a substantial majority of the 96 patients in the treatment arm.

Implications for the stock: This company is grossly undervalued and will re-rate significantly upward on clinical data. Shorts will get crucified.