Medicenna Therapeutics Announces FY 2024 Financial Results and Highlights

Medicenna Corp. has reported notable financial outcomes and corporate achievements for the fiscal year ending March 31, 2024. The company, which is focused on developing innovative immunotherapies known as Superkines, highlighted significant progress in its programs, especially concerning its lead asset, MDNA11, and provided updates on its financial status.

One of the key advancements for Medicenna is the bolstered cash balance, which reached $37 million due to a $20 million investment by RA Capital. This financial boost extends the company's operational runway into mid-2026. MDNA11, a long-acting IL-2 Superkine, has demonstrated promising single-agent efficacy in patients with advanced cancers resistant to checkpoint inhibitors. The data presented at the Annual Meeting of the American Association for Cancer Research (AACR) revealed a 29% response rate in patients treated with MDNA11, including significant and sustained tumor regressions in pancreatic and melanoma cancer patients.

The company's ABILITY-1 study, which is investigating MDNA11, is expanding in Europe following the European Medicines Agency's approval of its Clinical Trial Application. The trial includes a combination dose escalation with pembrolizumab (KEYTRUDA). This combination treatment is currently enrolling patients at the expanded monotherapy dose, having previously cleared safety assessments at a lower dose.

Throughout the fiscal year, Medicenna reported several crucial milestones. MDNA11's clinical activity highlights include durable anti-tumor responses and acceptable safety profiles. Notably, the monotherapy demonstrated no dose-limiting toxicities, and the majority of treatment-related adverse events were mild and resolved quickly. Additionally, pharmacodynamic analyses have shown that MDNA11 induces significant immune system activation, which is crucial for sustained anti-cancer effects.

In addition to MDNA11, Medicenna is also advancing its IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), targeting recurrent glioblastoma (rGBM). The company is seeking partnerships for this Phase 3-ready asset, which has shown a substantial survival benefit in clinical trials. At the 2024 ASCO Annual Meeting, updated Phase 2b results were presented, indicating that bizaxofusp significantly improved median overall survival and reduced the risk of death in patients with rGBM.

Medicenna's preclinical pipeline also made strides, with the presentation of data on MDNA113 from its T-MASK™ platform. This candidate targets IL-13R2 expressing tumors and is designed to maximize therapeutic activity at the tumor site while minimizing systemic toxicity.

The financial results for the fiscal year reflect a net loss of $25.5 million, attributed primarily to increased operating costs and a rise in the fair value of the derivative warrant liability. Research and development expenses saw an uptick due to the expansion of the MDNA11 ABILITY-1 study and increased clinical costs. General and administrative expenses also rose, driven by higher salaries and benefits following an executive staff restructuring.

Looking forward, Medicenna anticipates presenting updated clinical data for MDNA11 and its combination with KEYTRUDA at medical conferences in the latter half of 2024. Additionally, the company is pursuing Breakthrough Therapy Designation for bizaxofusp, which could potentially streamline its path to regulatory approval.

In summary, Medicenna continues to advance its clinical programs with significant financial backing, positioning itself for further progress and potential breakthroughs in the treatment of challenging cancers.