Medicenna Therapeutics Reports Second Quarter Fiscal 2026 Financial Results and Provides a Corporate Update

Executive Summary

• Updated clinical data from the Phase 1/2 ABILITY‑1 study of MDNA11 will be presented at ESMO Immuno‑Oncology Congress on 10 Dec 2025.
• The Melanoma Foundation is sponsoring a new neoadjuvant MDNA11 trial (NEO‑CYT) across up to 12 Italian cancer centres, and MDNA113 advances toward IND filing in 2026.
• Six new patents were issued or allowed covering the company’s Superkine assets; cash balance of $15.7 M provides runway into mid‑2026.

Key Details

• MDNA11 Clinical Update: Data from ABILITY‑1 (monotherapy & pembrolizumab combo) to be presented by Dr. André Mansinho at ESMO Immuno‑Oncology Congress, London, 10 Dec 2025.
• NEO‑CYT Trial: Randomized neoadjuvant study of MDNA11 + nivolumab ± ipilimumab in high‑risk resectable Stage III melanoma; primary endpoint is Major Pathologic Response (MPR). Sponsored by Fondazione Melanoma Onlus at up to 12 sites in Italy.
• MDNA113 Progress: First‑in‑class anti‑PD‑1 × IL‑2 bispecific evaluated in non‑human primates; IND‑enabling studies planned for H1 2026 and first‑in‑human trial targeted for H2 2026. Presented preclinical efficacy at AACR 2025.
• Bizaxofusp (MDNA55) Program: Company seeking partnership opportunities for its Phase‑3 ready IL‑4 Empowered Superkine targeting recurrent glioblastoma.
• Intellectual Property: Six patents issued/allowed across US, Japan, Canada, Australia covering IL‑2 superagonists, IL‑4 fusion formulations, and oncolytic virus targeting technologies.
• Financial Results (Q3 2025):
• Cash & cash equivalents: $15.7 M, sufficient to fund operations through mid‑2026.
• Operating costs: $5.5 M (flat YoY).
• Net loss: $4.9 M ($0.06 per share), up from $4.2 M ($0.05) YoY due to lower derivative warrant gain and finance income, partially offset by FX gains.
• R&D expense: $4.1 M (↑ $0.4 M) driven by expanded MDNA11 trial activities.
• G&A expense: $1.4 M (↓ $0.4 M) reflecting lower stock‑based compensation and bonus reductions.
• Guidance Update: Revised cash runway now extends to at least the middle of calendar 2026.

Notable Quotes

“We are eagerly anticipating the upcoming clinical update for MDNA11… validates our IL‑2 superkine platform and marks a significant step forward… Additionally, we are excited to advance MDNA113… These developments and strengthening of our patent portfolio underscores our commitment to pioneer innovative therapies.” – Fahar Merchant, Ph.D., President & CEO

Materiality Assessment: Material – Positive (the release contains multiple material corporate milestones—clinical data presentation, new trial initiation, IND‑enabling work, significant IP additions, and updated cash runway—that are likely to influence investor perception.)