Medicenna Therapeutics Reports First Quarter Fiscal 2026 Financial Results and Operational Highlights

Executive Summary

• Medicenna Therapeutics reported financial results for the quarter ended June 30, 2025, reporting a net loss of $4.9 million ($0.06 per share) and ending the quarter with $20.5 million in cash, providing a runway into mid-2026.
• The company provided positive clinical updates on its lead asset MDNA11, noting complete responses in pancreatic and melanoma patients and stating that enrollment in the Phase 1/2 ABILITY-1 trial is on track for completion with top-line data expected in H2 2025.
• Progress was reported on other pipeline assets, including preclinical data for MDNA113 presented at AACR 2025, partnership efforts for bizaxofusp in recurrent glioblastoma, and the granting of five new patents, bringing the total global IP portfolio to 86.

Key Details

• Financial Results (Q2 2025):
  • Cash and cash equivalents: $20.5 million.
  • Total operating costs: $5.5 million (vs. $4.0 million in Q2 2024).
  • Net loss: $4.9 million ($0.06 per share) vs. $3.6 million ($0.05 per share) in Q2 2024.
  • R&D expenses: $4.2 million (vs. $2.8 million in Q2 2024), driven by increased clinical costs for the MDNA11 ABILITY-1 study expansion and combination arm.
  • G&A expenses: $1.3 million (consistent with Q2 2024).
  • Variance drivers: $1.3 million decrease in fair value of derivative warrant liability, $1.4 million increase in R&D, and $1.0 million increase in foreign exchange loss.
• Clinical Updates (MDNA11):
  • Demonstrated best-in-class potential with ORR exceeding benchmarks in checkpoint-resistant tumor types.
  • Specific patient outcomes: A pancreatic cancer patient remains cancer-free for 18 months; a melanoma patient remains cancer-free for 6 months, both after achieving complete resolution of target and non-target lesions via MDNA11 monotherapy.
  • Response rates of 30–50% observed in high-dose patients across multiple tumor types.
  • Phase 1/2 ABILITY-1 trial enrollment is on track to complete in H2 2025, with top-line data readouts expected before year-end.
• Pipeline & Business Development:
  • MDNA113: First-in-class anti-PD-1-IL-2 bispecific Superkine; promising preclinical data presented at AACR 2025 showing tumor-targeted design and activity in IL-13Rα2–positive models; IND-enabling studies advancing.
  • Bizaxofusp (MDNA55): Phase-3 ready IL-4 Empowered Superkine for recurrent glioblastoma (rGBM); pursuing partnership opportunities.
  • Intellectual Property: Granted five new patents (four from USPTO, one from EPO) covering IL-2 and IL-4 Superkine platforms; total global portfolio now stands at 86 granted or allowed patents.

Notable Quotes

• “We enter the second half of 2025 encouraged by positive clinical data from the Phase 1/2 ABILITY-1 trial, and remain on track to complete enrollment and report top-line data from both the monotherapy and combination arms before year-end,” said Fahar Merchant, Ph.D., President and CEO of Medicenna.
• “We are motivated by previously reported data, from each of the three tumor-specific cohorts, to pursue expedited regulatory pathways for MDNA11 in order to address critical unmet needs in patients who do not respond to blockbuster immunotherapies.”