20:40:43 EST Thu 13 Nov 2025
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Medicenna Therapeutics Corp
Symbol MDNA
Shares Issued 83,409,840
Close 2025-11-13 C$ 1.37
Market Cap C$ 114,271,481
Recent Sedar Documents

Medicenna's fiscal Q2 2026 R&D expenses at $4.1M

2025-11-13 17:43 ET - News Release

Dr. Fahar Merchant reports

MEDICENNA THERAPEUTICS REPORTS SECOND 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 Sept. 30, 2025, as well as anticipated corporate milestones.

Highlights:

  • Updated MDNA11 clinical data from the Ability-1 study will be presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress on Dec. 10, 2025;
  • Fondazion Melanoma Onus will sponsor a new clinical trial (NEO-CYT) at up to 12 cancer centres in Italy to evaluate if MDNA11 in combination with leading checkpoint inhibitors, prior to surgery (neoadjuvant), can improve outcomes in patients with earlier-stage high-risk melanoma;
  • MDNA113, Medicenna's first-in-class tumour-anchored and masked anti-PD-1 x IL-2 bispecific program, is being evaluated in non-human primate studies, with plans for a first-in-human clinical trial to commence in 2026;
  • Six new patents have been issued or allowed across multiple jurisdictions (United States, Japan, Canada and Australia) protecting several superkine assets, including its wholly owned anti-PD1 x IL-2 program;
  • Updated cash guidance provides runway into at least the middle of calendar 2026.

"We are eagerly anticipating the upcoming clinical update for MDNA11 from the global phase 1/2 Ability-1 clinical trial to demonstrate its potential as a best-in-class IL-2 therapy," said Dr. Fahar Merchant, PhD, president and chief executive officer of Medicenna. "The sponsorship of the NEO-CYT trial by the Melanoma Foundation in Italy led by world-renowned principal investigators validates our IL-2 superkine platform and marks a significant step forward in exploring MDNA11's efficacy in earlier-stage melanoma patients, potentially setting new treatment benchmarks. Additionally, we are excited to advance MDNA113, our first bispecific anti-PD-1 x IL-2 in non-human primate studies to support our IND [investigational new drug] filing planned for next year. These developments and strengthening of our patent portfolio underscores our commitment to pioneer innovative therapies that address critical unmet needs in oncology."

Program and business update

Highlights for the three months ended Sept. 30, 2025, along with recent developments, include the following.

MDNA11: IL-2 superkine program:

  • MDNA11 clinical data update: Updated clinical data from the phase 1/2 Ability-1 study evaluating MDNA11, an emerging best-in-class IL-2 therapy, as a monotherapy and in combination with pembrolizumab, will be presented by Dr. Andre Mansinho, a principal investigator of the study, at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025 on Dec. 10, 2025, in London, United Kingdom.
  • NEO-CYT trial: This is a randomized neoadjuvant combination trial for MDNA11 in high-risk, surgically resectable Stage III melanoma. This trial aims to evaluate MDNA11's potential to enhance the efficacy of standard-of-care cancer immunotherapy prior to surgery in earlier-stage melanoma patients. MDNA11 will be evaluated in combination with the checkpoint inhibitors nivolumab (anti-PD1) alone or with ipilimumab (anti-CTLA4), with major pathologic response (MPR) as a primary end point, which is considered predictive of long-term survival outcomes.

MDNA113: first-in-class anti-PD-1-IL-2 bispecific superkine:

  • MDNA113 is a first-in-class targeted and conditionally activated bispecific anti-PD1-IL2 superkine demonstrating highly differentiated safety and efficacy profile, utilizing Medicenna's proprietary TMask and Biskits for tumour targeting and conditional activation to enhance therapeutic index.
  • Preclinical efficacy: MDNA113 was presented at AACR 2025, highlighting its tumour-targeted design and strong anti-tumour activity in IL-13R-alpha2-positive tumour models, supporting development potential in cancers affecting over two million patients annually.
  • Clinical potential: MDNA113 is positioned as a differentiated and potentially superior alternative to other anti-PD-1-IL-2 bispecific therapies in development, with broad applicability across various solid tumours expressing IL-13R-alpha2.
  • Development updates: MDNA113 is currently being evaluated in non-human primates, with plans to advance the program into IND-enabling studies in the first half of 2026 and preparation for a first-in-human trial in the second half of 2026.

Bizaxofusp (formerly MDNA55): empowered IL-4 superkine program

The company is currently pursuing partnership opportunities for its phase-3-ready IL-4 empowered superkine for recurrent glioblastoma (rGBM).

Intellectual property update

New patents issued:

  • U.S. patent No. 12,404,497, "Uses and Methods for Oncolytic Virus Targeting of IL-4/IL-13 and Fusions Thereof" (Medicenna owned);
  • Japanese patent No. 7,729,570, "Superagonists, Partial Agonists, and Antagonists of Interleukin-2" (in-licensed from Stanford);
  • Japanese patent No. 7,747,716, "Uses and Methods for IL-2 Superagonists, Agonists, and Fusions Thereof" (Medicenna owned);
  • Canadian patent No. 2,946,398, "Superagonists, Partial Agonists, and Antagonists of Interleukin-2" (in-licensed from Stanford).

New patents allowed:

  • Canadian patent No. 3,067,909, "Uses and Methods for IL-2 Superagonists, Agonists, and Fusions Thereof" (Medicenna owned);
  • Australian patent No. 2018347796, "IL-4 Fusion Formulations for Treatment of Central Nervous System (CNS) Tumors" (Medicenna owned).

Quarterly financial results

Medicenna exited the quarter ended Sept. 30, 2025, with cash and cash equivalents of $15.7-million. These funds are expected to provide the company with sufficient capital to execute its current planned expenditures through the middle of calendar 2026.

For the three months ended Sept. 30, 2025, the company reported total operating costs of $5.5-million compared with total operating costs of $5.5-million for the three months ended Sept. 30, 2024. Steady operating costs year over year are primarily related to a decrease in general and administrative expenses in the current period, which offsets an increase in R&D (research and development) expenditures.

Net loss for the quarter ended Sept. 30, 2025, was $4.9-million, or six cents per share, compared with a net loss of $4.2-million, or five cents per share for the three months ended Sept. 30, 2024. The $700,000 increase in net loss for the three months ended Sept. 30, 2025, compared with the three months ended Sept. 30, 2024, is due primarily to a decrease in the gain on the fair value of the derivative warrant liability of $1-million, decreased finance income of $200,00 and an increase in foreign exchange gain of $500,000.

R&D expenses of $4.1-million were incurred during the quarter ended Sept. 30, 2025, compared with $3.7-million incurred in the quarter ended Sept. 30, 2024. The increase in R&D expenses in the current period is primarily attributed to increased clinical costs related to the expansion of the MDNA11 Ability-1 study to new clinical sites and the inclusion of more patients in the study relative to the prior period. G&A (general and administrative) expenses of $1.4-million were incurred during the quarter ended Sept. 30, 2025, compared with $1.8-million during the quarter ended Sept. 30, 2024. The reduction was primarily attributable to lower stock-based compensation expense in the current period, reflecting option grants at lower share prices compared with the prior year, as well as reduced personnel costs due to an incentive bonus paid in the prior year that was not paid in the current period.

Medicenna's financial statements for the three and six months ended Sept. 30, 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 status and orphan drug status from the FDA (U.S. Food and Drug Administration) and FDA/EMA (European Medicines Agency), respectively.

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