Core Insights - Medicenna Therapeutics is advancing its clinical programs, particularly focusing on MDNA11 and MDNA113, with promising data indicating their potential as best-in-class therapies for cancer treatment [2][3] MDNA11 Developments - In monotherapy expansion cohorts (n=21), the overall response rate (ORR) was 50% for patients treated with MDNA11 in the 2L/3L setting and 42% when MDNA11 was the next treatment post-ICI failure, indicating its best-in-class potential [5][10] - Among all efficacy-evaluable monotherapy patients (n=55) across 18 different cancers, the ORR was 19% for MDNA11 as a 2L/3L treatment and 24% when used post-ICI failure [10] - The ABILITY-1 Phase 1/2 trial has enrolled over 110 safety-evaluable patients, establishing a biologically effective dose range (BEDR) of 60-120 g/kg without dose-limiting toxicities [4][5] MDNA113 Insights - MDNA113, a bifunctional anti-PD1-IL2 superkine, has shown a favorable safety profile in non-human primates at doses up to 30 mg/kg, supporting its potential for human trials [9][16] - The IND submission and initiation of the first-in-human trial for MDNA113 are expected in H2 2026 [9][17] NEO-CYT Study - The NEO-CYT study, in collaboration with Fondazione Melanoma Onlus, will evaluate MDNA11 in front-line therapy for resectable advanced cutaneous melanoma, with patient enrollment planned for H1 2026 and interim data expected in H2 2026 [8][17] Strategic Priorities for 2026 - Medicenna aims to maximize the potential of MDNA11 in earlier-line and neoadjuvant settings, advance MDNA113 as a targeted bifunctional therapy, and progress bizaxofusp through partnerships for recurrent GBM and other brain cancers [14][17] - Key milestones include completing patient enrollment in the ABILITY-1 study, reporting updated clinical data, and securing FDA guidance for registrational trials [17][18]

Core Viewpoint - Medicenna Therapeutics is presenting new clinical data from the ABILITY-1 study evaluating MDNA11, highlighting the company's ongoing commitment to advancing its clinical programs [2]. Group 1: Company Overview - Dr. Fahar Merchant serves as the Founder, Chairman, President, and CEO of Medicenna Therapeutics, leading the company in its clinical research efforts [2]. - The webinar is part of an initiative to share significant developments in the company's research and clinical trials [2]. Group 2: Clinical Study Insights - The ABILITY-1 study focuses on evaluating the efficacy and safety of MDNA11, which is a key component of Medicenna's therapeutic pipeline [2]. - The presentation includes forward-looking statements regarding the potential outcomes of the clinical study, emphasizing the company's expectations and plans for MDNA11 [2][3].

Company Presentation & KOL Webinar MDNA11 Clinical Data Update 10 December 2025 ESMO-IO Congress 2025 Disclaimer Certain statements in this presentation may constitute "forward-looking statements" under applicable securities laws. These forward-looking statements include, but are not limited to, information about possible or assumed future results of the Medicenna Therapeutics Corp's (the "Company" or "Medicenna") business, clinical trials, drug development, financial condition, results of operations, liqui ...

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83% for patients treated with MDNA11 after progression on immune checkpoint inhibitors [1] - Combination therapy with KEYTRUDA shows an ORR of 50% and a DCR of 75% in MSS endometrial cancer, while MSS TMB-H tumors show an ORR of 25% and a DCR of 88% [1] Clinical Data - In monotherapy cohorts, ORR is 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients with disease control in monotherapy cohorts had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Safety Profile - MDNA11 shows a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient, resolving typically within 48 hours [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg in monotherapy or in combination with KEYTRUDA [4] Recommended Dose - The preliminary recommended dose for expansion for both monotherapy and combination arms is established at 90 µg/kg Q2W, with a biological effective dose range set at 60 to 120 µg/kg [5] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3]

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83%, indicating the potential of MDNA11 in earlier lines of treatment [1] - Combination treatment with KEYTRUDA shows promising results, with an ORR of 50% and a DCR of 75% in MSS endometrial cancer [1][9] Clinical Data - In monotherapy expansion cohorts, ORRs are 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients treated with MDNA11 as the next treatment after immune checkpoint inhibitors had an ORR of 42% [8] - In MSS endometrial cancers, the ORR was 50% with a DCR of 75%, while TMB-H tumors showed an ORR of 25% and a DCR of 88% [9] Safety Profile - MDNA11 exhibits a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg, and Grade 3-4 events were mainly laboratory abnormalities without clinical sequelae [4] Overall Survival - In monotherapy cohorts, patients with disease control had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3] - The NEO-CYT trial provides external validation of MDNA11's approach, suggesting its potential as a de-risked drug candidate for earlier stage cancer patients [3]

Core Insights - Medicenna Therapeutics Corp. is hosting a live webinar on December 10, 2025, at 08:30 AM Eastern Time to discuss updated clinical data from the ABILITY-1 Phase 1/2 Study evaluating MDNA11 [1][2] Company Overview - Medicenna is a clinical-stage immunotherapy company focused on developing Superkines for cancer and autoimmune diseases, with a particular emphasis on long-acting IL-2 Superkine, MDNA11, which has superior affinity toward CD122 and preferentially stimulates cancer-killing T cells and NK cells [5] - The company is also developing MDNA113, a bispecific targeting PD-1 and IL-2 for solid tumors, utilizing proprietary BiSKITs™ and T-MASK™ platforms [5] - Bizaxofusp, an IL-4 Empowered Superkine, has been studied in five clinical trials with over 130 patients and has received FastTrack and Orphan Drug status from the FDA and EMA [5] Webinar Details - The webinar will feature presentations from Medicenna's executive and scientific advisory team, including Dr. Fahar Merchant, Dr. Arash Yavari, and Dr. André Mansinho, along with commentary from key opinion leaders and a live Q&A session [4][9]

Core Insights - Medicenna Therapeutics is advancing its clinical programs, particularly focusing on MDNA11 and MDNA113, with significant updates expected at the ESMO Immuno-Oncology Congress in December 2025 [1][5][2] MDNA11: IL-2 Superkine Program - The updated clinical data from the Phase 1/2 ABILITY-1 Study for MDNA11 will be presented, showcasing its potential as a leading IL-2 therapy [5] - A new clinical trial, NEO-CYT, will evaluate MDNA11 in combination with checkpoint inhibitors for high-risk melanoma patients prior to surgery [1][5] - The primary endpoint of the NEO-CYT trial is Major Pathologic Response (MPR), which is predictive of long-term survival outcomes [5] MDNA113: First-in-Class Anti-PD-1-IL-2 Bispecific Superkine - MDNA113 is being evaluated in non-human primate studies, with plans for a first-in-human clinical trial to start in 2026 [1][12] - The bispecific therapy is designed to enhance safety and efficacy through proprietary technologies [12] - Preclinical data presented at AACR 2025 supports its development potential in cancers affecting over 2 million patients annually [5][12] Intellectual Property Update - Six new patents have been issued or allowed across multiple jurisdictions, protecting various superkine assets, including the anti-PD1 x IL-2 program [1][7] Financial Overview - As of September 30, 2025, the company reported cash and cash equivalents of $15.7 million, providing a runway into at least mid-2026 [8] - Total operating costs for the quarter were $5.5 million, consistent with the previous year, with a noted increase in R&D expenses to $4.1 million due to expanded clinical activities [9][11] - The net loss for the quarter was $4.9 million, compared to a loss of $4.2 million in the same period last year [10]

Core Insights - The NEO-CYT trial is a randomized, multi-centre study evaluating MDNA11 as a neoadjuvant immunotherapy for early-stage melanoma patients, sponsored by Fondazione Melanoma Onlus and led by Professor Paolo A. Ascierto [1][2] - MDNA11 is believed to significantly reduce the risk of cancer recurrence post-surgery, based on positive results from the ABILITY-1 study [1][2] - The trial will assess MDNA11 in combination with nivolumab and possibly ipilimumab, focusing on Major Pathologic Response (MPR) as a primary endpoint, which is indicative of long-term survival [1][2] Company Overview - Medicenna Therapeutics is a clinical-stage immunotherapy company developing Superkines for cancer treatment, with MDNA11 being a long-acting IL-2 Superkine designed to activate immune effector cells while minimizing immunosuppressive effects [6][8] - The company has a cash runway expected to last until at least mid-2026, ensuring continued operations and development of its clinical programs [1] Clinical Development - The NEO-CYT trial aims to provide early, actionable data on the efficacy of MDNA11 in enhancing standard cancer immunotherapy, potentially expanding its market to include high-risk melanoma patients [2][5] - The trial is positioned to evaluate the combination of MDNA11 with established checkpoint inhibitors, which may improve pathologic responses and curative benefits post-surgery [2][5] Research and Collaboration - The Fondazione Melanoma Onlus, a non-profit organization, is sponsoring the NEO-CYT trial, emphasizing the collaborative effort in advancing melanoma research and treatment [7] - The trial is expected to generate significant clinical data that could redefine the role of IL-2 in early-stage melanoma treatment [2][3]

Core Insights - Medicenna Therapeutics Corp. is set to present updated clinical data for MDNA11 at the ESMO Immuno-Oncology Congress 2025 in London from December 10-12, 2025 [1][2] - The presentation will focus on the Phase 1/2 ABILITY-1 Study, evaluating MDNA11 as a monotherapy and in combination with pembrolizumab for advanced solid tumors [2] Company Overview - Medicenna is a clinical-stage immunotherapy company specializing in the development of Superkines targeting cancer and autoimmune diseases [1][3] - The company’s lead product, MDNA11, is a long-acting IL-2 Superkine designed to preferentially stimulate cancer-killing effector T cells and NK cells [3] - Medicenna is also developing MDNA113, a bispecific targeting PD-1 and IL-2 for solid tumors, utilizing proprietary platforms BiSKITs™ and T-MASK™ [3] - Bizaxofusp, an IL-4 Empowered Superkine, has been studied in five clinical trials with over 130 patients and has received FastTrack and Orphan Drug status from the FDA and EMA [3]

Summary of Medicenna Therapeutics Conference Call Company Overview - Medicenna Therapeutics is a publicly listed company on the TSX main board and OTCQX under the symbol MDNA, focused on developing immunotherapies for late-stage diseases, particularly cancer [1][2] - The company specializes in a class of molecules known as cytokines, aiming to develop enhanced versions called Superkines [1][2] Core Points and Arguments Development and Collaborations - Medicenna licensed the Superkines platform from Stanford University in 2016 and has exclusive worldwide rights [2] - The company has a clinical collaboration with Merck, utilizing Keytruda, the world's best-selling drug, in combination with its own therapies [2][3] Clinical Trials and Data - Medicenna is preparing to provide updates on its Superkine MDNA11, with over 100 patient data points collected [3][6] - The company has received FDA agreement on a phase 3 design for its brain cancer drug, indicating significant progress in its development pipeline [3][5] - MDNA11 has shown promising results, with tumor shrinkage observed in 30% to 50% of patients who have previously failed other therapies [12][14] Market Opportunity - Keytruda, which is set to go off patent in 2028, currently generates nearly $30 billion in annual sales, highlighting a significant market opportunity for alternatives like MDNA11 [11][12] - Medicenna's valuation is approximately $60 million USD, with potential for substantial growth given the response rates observed in clinical trials compared to competitors [18][19] Competitive Landscape - The company is positioned against competitors like Replimune and Iovance, which have higher valuations despite similar response rates [19][20] - Recent multibillion-dollar transactions in the bispecific molecule space, such as the $11.2 billion deal between Takeda and Innovent, indicate a growing interest in this area [21][22] Pipeline and Future Developments - Medicenna is advancing multiple drugs, including MDNA113, a bispecific molecule combining anti-PD-1 and IL-2, with data expected soon [21][23] - The brain cancer program shows potential for significant market impact, with an estimated $4 billion opportunity across various brain cancer types [25][26] Important but Overlooked Content - The company has a strong advisory team, including leading experts in brain cancer and skin cancer, which enhances its credibility and potential for success [4] - Medicenna's approach to IL-2 therapy addresses previous challenges with safety and efficacy, aiming to provide a safer treatment option that effectively shrinks tumors [10][11][13] - The company has a cash runway into Q3 of the following year, allowing it to continue its development efforts without immediate financial pressure [26][40] Upcoming Milestones - Key data readouts are expected by the end of the year, particularly at a major cancer conference in the UK [27][40] - The company plans to meet with regulators to discuss pathways for accelerated approval based on upcoming clinical trial results [28][40]