Dr. Fahar Merchant reports
MEDICENNA THERAPEUTICS REPORTS THIRD QUARTER FISCAL 2026 FINANCIAL RESULTS AND PROVIDES A CORPORATE UPDATE
Medicenna Therapeutics Corp. has released financial results and corporate highlights for the fiscal quarter ended Dec. 31, 2025, as well as anticipated corporate milestones.
"We delivered strong clinical results in 2025 with our Ability-1 trial and 2026 is shaping up to be a milestone-rich year across our pipeline," said Dr. Fahar Merchant, president and chief executive officer of Medicenna. "MDNA11 continues to deliver best-in-class efficacy results in multiple solid tumours following failure of other blockbuster immunotherapies, where the needs of cancer patients remain largely unfulfilled. MDNA113, our tumour-targeted, bifunctional, conditionally activated anti-PD1-IL-2, is advancing towards IND-enabling [investigational new drug] studies and has demonstrated solid efficacy signals in preclinical models and excellent tolerability in preliminary non-human primate studies. This year, we plan to file an IND for MDNA113 and arrange an end-of-phase-1 meeting with the FDA [U.S. Food and Drug Administration] for a potential registrational trial with MDNA11. As we execute on these programs, we remain committed on advancing high-impact opportunities that have the potential to improve standards of care for patients with cancer, drive partnerships, strengthen our balance sheet and build shareholder value."
Program and business update
Highlights for the three months ended Dec. 31, 2025, along with recent developments, include:
- MDNA11: beta-enhanced, not-alpha interleukin-2 superagonist:
-
MDNA11 clinical data update:
- On Jan. 16, 2026, Medicenna updated expansion cohort data, demonstrating MDNA11's best-in-class anti-tumour activity. When administered as a 2L/3L systemic treatment or as next line following resistance to checkpoint therapy, MDNA11 achieved a monotherapy objective response rate (ORR) of 36 per cent and a disease control rate (DCR) of 86 per cent (N equal to 14), and, when combined with pembrolizumabm, ORR was 43 per cent and DCR was 72 per cent (N equal to 14).
-
Ability-1 enrolment and update:
-
Consequently, as a result of these compelling data, Medicenna is completing enrolment in the expansion portions of the Ability-1 study by enrolling patients where MDNA11 will be administered as 2/3L Tx or immediately following checkpoint resistance.
-
Tumour types currently enrolling are: MSI-H, TMB-H, cutaneous melanoma, endometrial (combination only), non-small cell lung cancer (combination only) and colorectal cancer (mono and combination in TMB-H and MSI-H cohorts). NSCLC and colorectal cancer cohorts have been added due to prior data demonstrating strong potential of IL-2 therapy in these cancers and have blockbuster market opportunities. Medicenna anticipates sharing updated clinical results from the Ability-1 study in the second half of 2026.
-
Medicenna anticipates completing enrolment of expansion cohorts in the Ability-1 study and is planning for an end-of-phase 1 meeting with the FDA, allowing for alignment regarding potential registrational trials.
-
NEO-CYT trial:
-
In collaboration with the Fondazione Melanoma Onlus, the NEO-CYT Trial is a randomized, multi-centre neoadjuvant study in high-risk, resectable Stage III melanoma, evaluating MDNA11 in combination with nivolumab, with or without ipilimumab.
-
NEO-CYT is designed to prospectively evaluate the potential of MDNA11 to enhance the efficacy of standard-of-care cancer immunotherapy in the neoadjuvant setting. Specifically, whether Medicenna's best-in-class IL-2 agonist can deepen neoadjuvant pathologic responses predictive of patient outcomes when added to established anti-PD-1 plus or minus anti-CTLA-4 regimens at a time when the tumour is still present to optimize the anti-tumour immune response.
-
Medicenna anticipates sharing interim clinical data from this study in neoadjuvant melanoma in H2 2026.
-
MDNA113: first-in-class tumour-anchored and activatable masked anti-PD-1-IL-2 Biskits:
-
MDNA113 is the company's most advanced preclinical asset encompassing both, the T-Mask
and Biskits
platforms. It is a novel first-in-class tumour targeted and activatable bifunctional anti-PD1-IL-2 superkine.
-
MDNA113 is advancing through preclinical development with plans to commence a first-in-human trial in the second half of 2026.
-
Non-human primate studies are currently under way, with updated data demonstrating its potential to dramatically widen the therapeutic index and showing a favourable safety profile in non-human primates at the highest tested dose of 30 milligrams per kilogram, supporting the potential for human dosing comparable with approved anti-PD-1 therapies.
-
Bizaxofusp (formerly MDNA55): IL-4 superkine -- treatment of recurrent glioblastoma (rGBM):
-
Medicenna's phase-3-ready asset for rGBM, bizaxofusp, to date, has been tested in 118 patients with high-grade gliomas (including 112 patients with rGBM) and most recently completed a successful phase 2b (N equal to 44) trial for non-resectable rGBM where it demonstrated a doubling of median overall survival (mOS) to 13.6 months in the WHO-defined (World Health Organization) IDHwt (IDH-wildtype) high-dose population compared with the standard-of-care mOS of seven months.
- Medicenna will present updated internal and external data sets related to bizaxofusp (MDNA55) at the seventh annual Glioblastoma Development Summit to be held in Boston from Feb. 17 to Feb. 19, 2026:
-
Title:
Surmounting Barriers in Non-resectable Recurrent Glioblastoma with a Single Treatment of Bizaxofusp, an Engineered IL-4R Directed Fusion Protein;
-
Time:
Thursday, Feb. 19, 2026, at 10 a.m. Eastern Time;
-
Presenter: Dr. Merchant, president and CEO of Medicenna Therapeutics.
-
Medicenna is actively pursuing strategic partnerships to advance the program into a registrational trial and is preparing the program for commercialization and its subsequent launch in various countries where marketing authorization is granted.
Change to board of directors
Medicenna announced changes to its board of directors. Richard Sutin and Angelos Georgakis have been appointed to the board of directors of the company. Mr. Sutin's and Mr. Georgakis's appointments to the board follow the retirement of Karen Dawes, who has served on the board since 2019, most recently as chair of the compensation committee and as a member of the audit committee.
Quarterly financial results
Medicenna exited the quarter ended Dec. 31, 2025, with cash and cash equivalents of $10.6-million. Based on the company's current operating plan, these funds are expected to be sufficient to finance planned operations into the third quarter of 2026.
For the three months ended Dec. 31, 2025, the company reported total operating costs of $5.6-million, compared with $5.1-million for the three months ended Dec. 31, 2024. The increase was primarily attributable to a $500,000 increase in research and development (R&D) expenditures related to higher MDNA11 clinical trial costs in the current quarter relative to the comparable period. General and administrative (G&A) costs were consistent year over year.
Net loss for the quarter ended Dec. 31, 2025, was $4.4-million, or five cents per share, compared with a net loss of $5.2-million, or seven cents per share, for the three months ended Dec. 31, 2024. The $800,000 decrease in net loss was primarily due to a $2.9-million increase in the gain on the fair value of the derivative warrant liability, partially offset by a $1.3-million decrease in foreign exchange gain, a $500,000 increase in R&D expenses, and a $300,000 decrease in finance income.
R&D expenses were $4.1-million for the quarter ended Dec. 31, 2025, compared with $3.6-million for the same period in 2024. The increase was primarily driven by higher clinical costs associated with the expansion of the MDNA11 Ability-1 study to additional clinical sites and increased patient enrolment as well as the initiation of the NEO-CYT trial during the quarter. G&A expenses were $1.5-million for the quarter ended Dec. 31, 2025, consistent with $1.5-million for the same period in 2024, reflecting stable operating activities year over year.
Medicenna's financial statements for the three and nine months ended Dec. 31, 2025, and the related management discussion and analysis (MD&A) will be available on SEDAR+.
About Medicenna Therapeutics
Corp.
Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 superkines and first-in-class empowered superkines. Medicenna's long-acting IL-2 superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna's first-in-class targeted PD-1 x IL-2 bispecific, MDNA113, is in development for solid tumours and was designed using the company's proprietary Biskits
(bifunctional superkine immunotherapies) and T-Mask
(targeted metalloprotease activated superkine) platforms. Medicenna's IL-4 empowered superkine, bizaxofusp (formerly MDNA55), has been studied in five clinical trials enrolling over 130 patients, including a phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained fast-track and orphan drug status from the FDA and FDA/EMA (European Medicines Agency), respectively.
We seek Safe Harbor.
© 2026 Canjex Publishing Ltd. All rights reserved.