Medicenna Therapeutics Reports Fiscal Year 2025 Financial Results and Operational Highlights
Medicenna Therapeutics (OTCQX: MDNAF) reported its fiscal year 2025 financial results and operational highlights, showcasing significant progress in its clinical programs. The company's lead drug MDNA11 demonstrated compelling anti-tumor activity with response rates of 30-50% in high-dose patients, including three cancer patients remaining tumor-free. Notably, a pancreatic cancer patient has maintained remission for 18 months without additional treatment.
The company reported a net loss of $11.8 million ($0.15 per share) for FY2025, compared to $25.5 million in FY2024. With $24.8 million in cash, Medicenna has runway into mid-2026. Operating costs increased to $20.4 million, primarily due to expanded clinical trial activities. The company plans to complete MDNA11 Phase 1/2 enrollment and report topline data from both monotherapy and combination arms with KEYTRUDA by year-end.
Medicenna Therapeutics (OTCQX: MDNAF) ha comunicato i risultati finanziari e i principali traguardi operativi per l'anno fiscale 2025, evidenziando progressi significativi nei suoi programmi clinici. Il farmaco principale dell'azienda, MDNA11, ha mostrato un'attività antitumorale convincente con tassi di risposta del 30-50% nei pazienti ad alte dosi, inclusi tre pazienti oncologici che sono rimasti privi di tumore. In particolare, un paziente con cancro al pancreas ha mantenuto la remissione per 18 mesi senza trattamenti aggiuntivi.
L'azienda ha riportato una perdita netta di 11,8 milioni di dollari (0,15 dollari per azione) per l'anno fiscale 2025, rispetto ai 25,5 milioni di dollari del 2024. Con 24,8 milioni di dollari in liquidità, Medicenna dispone di risorse finanziarie sufficienti fino a metà 2026. I costi operativi sono aumentati a 20,4 milioni di dollari, principalmente a causa dell'espansione delle attività di sperimentazione clinica. L'azienda prevede di completare l'arruolamento per la fase 1/2 di MDNA11 e di comunicare i dati principali sia per la monoterapia che per il braccio in combinazione con KEYTRUDA entro la fine dell'anno.
Medicenna Therapeutics (OTCQX: MDNAF) informó sus resultados financieros y aspectos operativos del año fiscal 2025, mostrando un progreso significativo en sus programas clínicos. El medicamento principal de la compañía, MDNA11, demostró una actividad antitumoral convincente con tasas de respuesta del 30-50% en pacientes con dosis altas, incluyendo tres pacientes con cáncer que permanecen libres de tumor. Destaca un paciente con cáncer de páncreas que ha mantenido la remisión durante 18 meses sin tratamiento adicional.
La compañía reportó una pérdida neta de 11,8 millones de dólares (0,15 dólares por acción) para el año fiscal 2025, en comparación con 25,5 millones en 2024. Con 24,8 millones de dólares en efectivo, Medicenna tiene recursos financieros hasta mediados de 2026. Los costos operativos aumentaron a 20,4 millones de dólares, principalmente debido a la expansión de las actividades de ensayos clínicos. La empresa planea completar la inscripción de la fase 1/2 de MDNA11 y reportar datos principales tanto de la monoterapia como del brazo combinado con KEYTRUDA para fin de año.
Medicenna Therapeutics (OTCQX: MDNAF)는 2025 회계연도 재무 결과 및 운영 하이라이트를 발표하며 임상 프로그램에서 상당한 진전을 보였습니다. 회사의 주력 약물 MDNA11은 고용량 환자에서 30-50%의 반응률을 보이며 강력한 항종양 효과를 입증했으며, 세 명의 암 환자는 종양이 없는 상태를 유지하고 있습니다. 특히 췌장암 환자는 추가 치료 없이 18개월간 관해 상태를 유지하고 있습니다.
회사는 2025 회계연도에 1,180만 달러의 순손실(주당 0.15달러)을 보고했으며, 이는 2024년의 2,550만 달러에 비해 감소한 수치입니다. 2,480만 달러의 현금을 보유한 Medicenna는 2026년 중반까지 자금 운용이 가능합니다. 운영 비용은 주로 임상 시험 활동 확대에 따라 2,040만 달러로 증가했습니다. 회사는 연말까지 MDNA11 1/2상 등록을 완료하고 단독 요법 및 KEYTRUDA 병용 요법의 주요 데이터 발표를 계획하고 있습니다.
Medicenna Therapeutics (OTCQX : MDNAF) a publié ses résultats financiers pour l'exercice 2025 ainsi que ses faits marquants opérationnels, mettant en avant des progrès significatifs dans ses programmes cliniques. Le médicament principal de la société, MDNA11, a démontré une activité antitumorale convaincante avec des taux de réponse de 30 à 50 % chez les patients à dose élevée, incluant trois patients cancéreux restant sans tumeur. Notamment, un patient atteint d'un cancer du pancréas est en rémission depuis 18 mois sans traitement supplémentaire.
La société a enregistré une perte nette de 11,8 millions de dollars (0,15 dollar par action) pour l'exercice 2025, contre 25,5 millions en 2024. Avec 24,8 millions de dollars en liquidités, Medicenna dispose de ressources financières jusqu'à la mi-2026. Les coûts d'exploitation ont augmenté à 20,4 millions de dollars, principalement en raison de l'expansion des activités des essais cliniques. La société prévoit de terminer le recrutement de la phase 1/2 de MDNA11 et de publier les données principales des bras monothérapie et en combinaison avec KEYTRUDA d'ici la fin de l'année.
Medicenna Therapeutics (OTCQX: MDNAF) meldete seine Finanzergebnisse und operative Highlights für das Geschäftsjahr 2025 und zeigte dabei erhebliche Fortschritte in seinen klinischen Programmen. Das führende Medikament des Unternehmens, MDNA11, zeigte eine überzeugende antitumorale Aktivität mit Ansprechquoten von 30-50 % bei Hochdosispatienten, darunter drei Krebspatienten, die tumorfrei geblieben sind. Besonders bemerkenswert ist ein Patient mit Bauchspeicheldrüsenkrebs, der seit 18 Monaten ohne weitere Behandlung in Remission ist.
Das Unternehmen verzeichnete für das Geschäftsjahr 2025 einen Nettoverlust von 11,8 Millionen US-Dollar (0,15 US-Dollar pro Aktie), verglichen mit 25,5 Millionen US-Dollar im Jahr 2024. Mit 24,8 Millionen US-Dollar in bar verfügt Medicenna über finanzielle Mittel bis Mitte 2026. Die Betriebskosten stiegen auf 20,4 Millionen US-Dollar, hauptsächlich aufgrund erweiterter klinischer Studienaktivitäten. Das Unternehmen plant, die Einschreibung für die Phase 1/2 von MDNA11 abzuschließen und bis Jahresende Hauptdaten sowohl aus der Monotherapie- als auch aus der Kombinationsarmstudie mit KEYTRUDA zu berichten.
- Three cancer patients achieved complete tumor resolution and remain tumor-free
- Strong response rates of 30-50% in high-dose patient cohorts
- Cash runway extended into mid-2026 with $24.8M in cash reserves
- Net loss decreased significantly from $25.5M to $11.8M year-over-year
- Potential accelerated approval pathway being evaluated for MDNA11
- Operating costs increased by 9% to $20.4M from $18.7M year-over-year
- Research and development expenses rose by 33% to $14.4M
- Still seeking partnership opportunities for phase-3 ready Bizaxofusp program
Updated cash guidance provides runway into at least mid-2026
MDNA11 Phase 1/2 clinical trial on track for data readouts in second half of the year as a single agent and in combination with KEYTRUDA® at medical conferences and a planned KOL event
MDNA11 continues to exhibit compelling deep and durable anti-tumor activity in difficult-to-treat solid tumors with best-in-class potential relative to competing IL-2 programs
Results presented at the 2025 AACR showed response rates in the 30
Three cancer patients treated with MDNA11 remain tumor free since achieving complete resolution of all target and non-target lesions
MDNA11 Phase 2b development plan to be solidified by end of calendar year, including evaluation of strategies for accelerated approval
MDNA113, the Company’s first-in-class masked and tumor-targeted PD-1 x IL-2 bi-specific, is advancing to non-human primate studies in the second half of 2025
TORONTO and HOUSTON, June 26, 2025 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer, autoimmune, and inflammatory diseases, today reported financial results and corporate highlights for the fiscal year ended March 31, 2025, as well as anticipated corporate milestones.
“We are delighted to announce that the first MDNA11 monotherapy responder, a pancreatic cancer patient who had failed multiple lines of therapy including a checkpoint inhibitor, continues to be in remission for at least 18 months without any further treatment. Complete and partial responses in nine other patients in mono- and combination arms demonstrates best-in-class potential of MDNA11 amongst competing IL-2 programs,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “We plan to complete enrollment in the Phase 1/2 ABILITY-1 trial and report top-line data from both monotherapy and combination arms before the end of this year. Encouraged by previously reported data from each of the three tumor-specific cohorts, we are eager to develop MDNA11 via expedited regulatory routes to address unmet needs for patients who do not benefit from block-buster immunotherapies. We are also excited with the progress we are making with our lead candidate from our proprietary BiSKIT platform, MDNA113, a bi-functional anti-PD1-IL2 Superkine that has built-in targeting and stealth capabilities allowing tumor localization and activation while concealing its peripheral activity. The design of MDNA113 addresses many safety issues associated with the current slate of high-profile bi-specific anti-PD1 candidates without compromising its efficacy in aggressive and immunologically “cold” tumors. We look forward to providing additional updates in the second half of 2025 at medical conferences as well as the planned KOL event.”
Program highlights for the fiscal year ended March 31, 2025, along with recent developments, include:
MDNA11: IL-2 Superkine Program
- Patient with advanced/metastatic end-stage pancreatic cancer who responded to MDNA11 treatment remains in remission for at least 18 months without any further treatment.
- Complete response also continues in patient with advanced cutaneous melanoma and patient with anal squamous cell carcinoma.
- Results presented at the AACR showed response rates in the 30
-50% range in various tumor cohorts amongst high dose patients with tumor types being enrolled in the Phase 2 portion of the clinical trial. - MDNA11 continues to exhibit compelling deep and durable anti-tumor activity in difficult-to-treat solid tumors with best-in-class potential relative to competing IL-2 programs.
Development Updates
- All expansion arms are actively enrolling in the ongoing Phase 1/2 clinical trial at the recommended dose of 90 µg/kg administered intravenously every two weeks.
- During the second half of 2025, Medicenna plans to present updated clinical results from both the monotherapy and combination arms of the clinical trial.
- Medicenna plans to solidify its Phase 2b development strategy for MDNA11 by the end of this calendar year, including strategies for evaluation of MDNA11 in patients who have previously been treated with immune checkpoint inhibitors and have tumor types with accelerated approval potential.
MDNA113: First-in-Class Anti-PD-1-IL-2 Bispecific Superkine
- At the 2025 AACR Annual Meeting, the Company presented new preclinical data on its first-in-class IL-13Rα2 targeted candidate, MDNA113, from its BiSKIT and T-MASK™ platform, which specifically delivers a masked bispecific anti-PD1-IL2 Superkine to IL-13Rα2 expressing tumors (affecting over 2 million cancer patients annually) where it is activated by cancer specific enzymes in the tumor microenvironment.
- These data demonstrated compelling anti-tumor activity in IL-13Rα2 positive tumors in mice, including signs of enhanced memory that may support durable responses.
- MDNA113’s pharmacology provides a highly differentiated and potentially superior approach to current anti-PD1-IL2 bispecifics in development.
- Medicenna is advancing it’s novel first-in-class PD-1 x IL-2 bi-specific program into non-human primate studies this calendar year.
Bizaxofusp (formerly MDNA55): Empowered IL-4 Superkine Program
The Company is currently pursuing partnership opportunities for its phase-3 ready IL-4 Superkine for recurrent glioblastoma (rGBM). Bizaxofusp, which holds both FastTrack and Orphan drug status from the FDA and FDA/EMA, respectively, is Medicenna’s Phase 3-ready asset for rGBM which has been tested in 118 patients with high grade gliomas (including 112 patients with rGBM).
Anticipated Milestones in H2 Calendar 2025:
- Additional MDNA11 monotherapy expansion results
- Topline MDNA11 combination expansion results
- Enrollment completion of the MDNA11 ABILITY-1 study
- Completion of MDNA113 non-human primate study
Annual Financial Results
Medicenna exited the fiscal year ended March 31, 2025 with cash and cash equivalents of
For the year ended March 31, 2025, the Company reported total operating costs of
Net loss for the year ended March 31, 2025, was
Research and development expenses of
General and administrative expenses of
Medicenna’s financial statements for the year ended March 31, 2025 and the related management’s discussion and analysis (MD&A) will be available on SEDAR at www.sedarplus.ca.
About Medicenna Therapeutics
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 IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 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 FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively. Medicenna’s early-stage high-affinity IL-2β biased IL-2/IL-15 Super-antagonists, from its MDNA209 platform, are being evaluated as potential therapies for autoimmune and graft-versus host diseases. Medicenna’s early-stage BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and the T-MASK™ (Targeted Metalloprotease Activated SuperKine) programs are designed to enhance the ability of Superkines to treat immunologically “cold” tumors.
For more information, please visit www.medicenna.com, and follow us on Twitter and LinkedIn.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts, such as statements on the therapeutic potential and safety profile of MDNA11, MDNA113 and MDNA55 (bizaxofusp). Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage pre-clinical or clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.
Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements.
This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release.
Investor/Media Contact:
Christina Cameron
Investor Relations, Medicenna Therapeutics
(647) 953-0673
ir@medicenna.com
FAQ
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