TORONTO and HOUSTON, August 14, 2026
Medicenna Therapeutics Corp. reported its first-quarter fiscal 2027 financial results and provided a significant clinical development update covering its leading immunotherapy programs. The company continues to advance MDNA11, its IL-2 Superkine, toward completion of the Phase 1/2 ABILITY-1 study, with enrollment remaining on track for completion in Q3 2026. Medicenna plans to present updated clinical results from ABILITY-1 during an upcoming oral presentation and intends to engage with the U.S. Food and Drug Administration to explore a potential expedited registrational development pathway. The company is also continuing enrollment in the randomized Phase 1b NEO-CYT study, which is evaluating MDNA11 in combination with nivolumab with or without ipilimumab in patients with melanoma prior to surgery. The company’s pipeline progress highlights its broader strategy of developing Superkines designed to selectively stimulate immune responses against cancer while addressing difficult-to-treat solid tumors.
MDNA11 Program Advances Toward Key Clinical Milestones
A major focus of Medicenna’s clinical pipeline remains MDNA11, a long-acting IL-2 Superkine being evaluated across multiple solid tumor settings. Previously reported findings from the Phase 1/2 ABILITY-1 study demonstrated deep and durable anti-tumor activity, including response rates in the 30% to 40% range among patients treated in second- and third-line settings or following resistance to immune checkpoint inhibitors. Enrollment in the monotherapy and combination expansion cohorts remains on schedule for completion during the third quarter of 2026. Following completion, Medicenna expects to provide updated clinical findings at an upcoming medical conference and engage the FDA in an end-of-Phase 1 discussion regarding the potential development path for MDNA11. Meanwhile, the NEO-CYT Phase 1b study continues to enroll melanoma patients across multiple centers in Italy. The randomized study is assessing MDNA11 before surgery, with preliminary clinical data expected in Q4 2026. Together, these programs are intended to generate additional evidence supporting the clinical potential of MDNA11 in patients with advanced solid tumors.
Bizaxofusp and MDNA113 Expand Immunotherapy Pipeline
Medicenna is also advancing two additional next-generation immunotherapy programs, including bizaxofusp and MDNA113. Bizaxofusp, formerly known as MDNA55, is a Phase 3-ready IL-4 Empowered Superkine being developed for patients with unresectable recurrent glioblastoma, an aggressive and uniformly fatal form of brain cancer. The program has been evaluated in more than 100 patients with high-grade gliomas and has received FDA Fast Track and FDA and EMA Orphan Drug designations. Updated clinical data for bizaxofusp are expected to be presented in an oral session at an upcoming medical conference, potentially providing additional information on the program’s development prospects. At the same time, Medicenna is preparing an IND submission for MDNA113, its first-in-class targeted and conditionally activated anti-PD-1-IL-2 bifunctional Superkine. Preclinical data presented at the 2026 AACR Annual Meeting supported the potential of MDNA113 for targeted immune activation within the tumor microenvironment. The company currently plans to begin a Phase 1 clinical trial in 2027, adding another investigational candidate to its growing oncology pipeline.
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Financial Position Supports Continued Clinical Development
Medicenna ended the quarter with $5.7 million in cash and cash equivalents as of June 30, 2026, compared with $6.3 million at March 31, 2026. During the quarter, the company received $4.4 million in gross proceeds from a previously announced public offering, followed by an additional $1.3 million from the Australian R&D incentive program after quarter-end. Medicenna also has a structured financing arrangement with Sorbie that could provide additional funding, subject to customary closing conditions and required regulatory and stock exchange approvals. If completed as contemplated, the financing proceeds and existing cash are expected to support currently planned expenditures into the second quarter of 2027. Total operating costs for the quarter were $5.4 million, compared with $5.5 million during the same period in 2025, while research and development expenses were $4.3 million. The company reported a net loss of $5.1 million, or $0.06 per share. With upcoming clinical data from MDNA11 and bizaxofusp, continued NEO-CYT enrollment and preparations for MDNA113’s IND submission, Medicenna is entering a potentially data-rich period for its oncology immunotherapy pipeline
Source:Medicenna Therapeutics, press relese
