Mr. Fahar Merchant reports

MEDICENNA AND FONDAZIONE MELANOMA ONLUS COLLABORATE TO ADVANCE MDNA11 BEFORE FIRST-LINE THERAPY IN A RANDOMIZED NEOADJUVANT COMBINATION TRIAL, "NEO-CYT", IN HIGH-RISK, SURGICALLY RESECTABLE STAGE III MELANOMA

Medicenna Therapeutics Corp. has introduced NEO-CYT, a randomized, investigator-initiated neoadjuvant trial testing MDNA11, a long-acting, beta-enhanced not-alpha IL-2 superkine, in combination with nivolumab (anti-PD-1) with or without ipilimumab (anti-CTLA-4) for patients with high-risk, surgically resectable stage III cutaneous melanoma. The study is sponsored by the non-profit Melanoma Foundation (Fondazione Melanoma Onlus) at the National Cancer Institute G. Pascale Foundation. Medicenna will supply study drugs under a collaboration and supply agreement.

Fahar Merchant, chief executive officer, Medicenna Therapeutics, stated: "We are honoured to have Fondazione Melanoma Onlus sponsor the NEO-CYT trial evaluating MDNA11 as a potentially promising immunotherapy for treating patients with high-risk earlier stage melanoma. MDNA11 was designed to selectively awaken the immune system's cancer fighting immune cells without fanning the flames of suppression. We've already seen deep durable responses with MDNA11 in heavily pretreated patients with advanced metastatic cancers and profoundly compromised immune systems in the ongoing Ability-1 trial. NEO-CYT is our next chapter -- testing MDNA11 where the immune system is whole, the tumour can educate cancer fighting immune cells and pathologic response gives a fast, rigorous signal of activity within weeks. We are excited to explore this opportunity under Professor Ascierto's guidance and to redefine the role of IL-2 in early stage melanoma and further establish MDNA11's potential as a best-in-class, versatile, next-generation IL-2 therapy. We look forward to sharing updated clinical data from the ongoing Ability study with MDNA11 at the upcoming ESMO-IO congress and results from the NEO-CYT study throughout 2026."

Prof. Paolo A. Ascierto, lead principal investigator of NEO-CYT, commented: "Neoadjuvant therapy has taught us that timing of immunotherapy matters. Treating patients undergoing curative surgery while the tumour is still present can generate deeper and more durable immune responses. Advancing into the neoadjuvant setting represents a logical next step in clinical development of any promising immunotherapy by treating earlier stage, high-risk patients. Importantly, NEO-CYT is designed to evaluate combinations of MDNA11 with two major immunotherapies, nivolumab with or without ipilimumab. NEO-CYT will test whether adding a next-generation IL-2 superkine, MDNA11, to proven checkpoint combinations in resectable, high-risk melanoma can improve pathologic responses with the potential to improve curative benefit after surgery."

Neoadjuvant immunotherapy is emerging as a clinical and commercial frontier in melanoma and several other solid tumours. Pathologic response endpoints both predict long-term survival outcomes and may provide an efficient regulatory and go-forward signal for immunotherapies. NEO-CYT is designed to produce early, actionable neoadjuvant data to support clinical positioning of MDNA11 in melanoma and significantly broaden the use case for MDNA11 immunotherapy, expanding its addressable market to include the earliest line of systemic therapy for solid tumours with the potential to treat a large patient population with high-risk melanoma. By evaluating pathologic response rates at the time of surgery in a randomized setting, NEO-CYT aims to provide an early, rigorous signal of activity -- potentially accelerating the clinical development strategy for MDNA11 and expanding its commercial opportunity.

To date, MDNA11 has been studied in ABILITY-1 (NCT05086692), a continuing phase 1/2 study in advanced, treatment-refractory solid tumours as monotherapy and in combination with pembrolizumab. Early readouts have shown robust anti-tumour activity of MDNA11 both as single agent and in combination with pembrolizumab in heavily pretreated patients, including those progressed on immune checkpoint inhibition, alongside expansion of effector lymphocytes and a manageable safety profile.

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.

About MDNA11

MDNA11 is a long-acting, beta-enhanced not-alpha IL-2 superkine specifically engineered to overcome the shortcomings of aldesleukin and other next-generation IL-2 variants by preferentially activating immune effector cells (CD8+ T and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. These unique proprietary features of the IL-2 superkine have been achieved by incorporating seven specific mutations and genetically fusing it to a recombinant human albumin scaffold to improve the pharmacokinetic (PK) profile and pharmacological activity of MDNA11 due to albumin's natural propensity to accumulate in highly vascularized sites, in particular tumour and tumour draining lymph nodes. MDNA11 is currently being evaluated in the phase 1/2 Ability-1 study as both monotherapy and in combination with pembrolizumab.

About Fondazione Melanoma Onlus

Fondazione Melanoma Onlus is a non-profit organization based in Naples, Italy, that supports and promotes melanoma research, education and clinical trials. It is known for organizing international conferences like the Melanoma Bridge, which bring together clinicians and researchers to discuss advancements in melanoma treatment and its related fields. The foundation also sponsors scientific awards for outstanding achievements in melanoma research.

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 by 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 Food and Drug Administration and FDA/EMA, respectively.

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