Medicenna Reports Third Quarter Fiscal 2025 Financial and Operational Results and Provides Anticipated Milestones
Medicenna Therapeutics (OTCQX: MDNAF) reported its Q3 FY2025 financial results and operational updates. Key highlights include a 78% disease control rate in the MDNA11-KEYTRUDA combination arm and a 30% objective response rate in the monotherapy dose expansion cohort. The company maintained a strong financial position with $30 million in cash, expected to fund operations through mid-2026.
The ABILITY-1 trial showed promising results, including one complete response in a 70-year-old patient with advanced anal cancer and one partial response in a colorectal cancer patient. R&D expenses increased to $3.4 million from $3.0 million year-over-year, while G&A expenses slightly decreased to $1.7 million. The company reported a quarterly net loss of $5.2 million ($0.07 per share).
Medicenna Therapeutics (OTCQX: MDNAF) ha riportato i risultati finanziari e gli aggiornamenti operativi del terzo trimestre dell'esercizio 2025. I punti salienti includono un tasso di controllo della malattia del 78% nel braccio di combinazione MDNA11-KEYTRUDA e un tasso di risposta obiettivo del 30% nel coorte di espansione della monoterapia. L'azienda ha mantenuto una solida posizione finanziaria con 30 milioni di dollari in contante, previsti per finanziare le operazioni fino a metà 2026.
Il trial ABILITY-1 ha mostrato risultati promettenti, inclusa una risposta completa in un paziente di 70 anni con cancro anale avanzato e una risposta parziale in un paziente con cancro colorettale. Le spese per R&S sono aumentate a 3,4 milioni di dollari rispetto ai 3,0 milioni dell'anno precedente, mentre le spese generali e amministrative sono leggermente diminuite a 1,7 milioni di dollari. L'azienda ha riportato una perdita netta trimestrale di 5,2 milioni di dollari (0,07 dollari per azione).
Medicenna Therapeutics (OTCQX: MDNAF) reportó sus resultados financieros y actualizaciones operativas del tercer trimestre del año fiscal 2025. Los aspectos más destacados incluyen una tasa de control de la enfermedad del 78% en el brazo de combinación MDNA11-KEYTRUDA y una tasa de respuesta objetiva del 30% en la cohorte de expansión de monoterapia. La empresa mantuvo una sólida posición financiera con 30 millones de dólares en efectivo, que se espera financien las operaciones hasta mediados de 2026.
El ensayo ABILITY-1 mostró resultados prometedores, incluyendo una respuesta completa en un paciente de 70 años con cáncer anal avanzado y una respuesta parcial en un paciente con cáncer colorrectal. Los gastos de I+D aumentaron a 3,4 millones de dólares desde 3,0 millones interanual, mientras que los gastos generales y administrativos disminuyeron ligeramente a 1,7 millones de dólares. La empresa reportó una pérdida neta trimestral de 5,2 millones de dólares (0,07 dólares por acción).
메디센나 테라퓨틱스 (OTCQX: MDNAF)는 2025 회계연도 3분기 재무 결과 및 운영 업데이트를 보고했습니다. 주요 하이라이트로는 MDNA11-KEYTRUDA 조합 요법에서 78%의 질병 조절률과 단독 요법 용량 확장 집단에서 30%의 객관적 반응률이 포함됩니다. 이 회사는 3천만 달러의 현금을 보유하고 있어 2026년 중반까지 운영 자금을 지원할 것으로 예상됩니다.
ABILITY-1 시험은 70세의 진행성 항문암 환자에서 완전 반응 1건과 대장암 환자에서 부분 반응 1건을 포함한 유망한 결과를 보여주었습니다. 연구개발(R&D) 비용은 전년 대비 340만 달러로 증가했으며, 일반 및 관리 비용은 170만 달러로 약간 감소했습니다. 이 회사는 분기 순손실 520만 달러 (주당 0.07달러)를 보고했습니다.
Medicenna Therapeutics (OTCQX: MDNAF) a publié ses résultats financiers et ses mises à jour opérationnelles pour le troisième trimestre de l'exercice 2025. Les points clés incluent un taux de contrôle de la maladie de 78% dans le bras de combinaison MDNA11-KEYTRUDA et un taux de réponse objective de 30% dans la cohorte d'expansion de monothérapie. L'entreprise a maintenu une solide position financière avec 30 millions de dollars en espèces, prévus pour financer les opérations jusqu'à mi-2026.
L'essai ABILITY-1 a montré des résultats prometteurs, y compris une réponse complète chez un patient de 70 ans atteint d'un cancer anal avancé et une réponse partielle chez un patient atteint d'un cancer colorectal. Les dépenses de R&D ont augmenté à 3,4 millions de dollars contre 3,0 millions de dollars l'année précédente, tandis que les dépenses générales et administratives ont légèrement diminué à 1,7 million de dollars. L'entreprise a déclaré une perte nette trimestrielle de 5,2 millions de dollars (0,07 dollar par action).
Medicenna Therapeutics (OTCQX: MDNAF) hat seine finanziellen Ergebnisse und operativen Updates für das dritte Quartal des Geschäftsjahres 2025 veröffentlicht. Zu den wichtigsten Highlights gehören eine Krankheitskontrollrate von 78% in der MDNA11-KEYTRUDA-Kombinationsgruppe und eine objektive Ansprechrate von 30% in der Monotherapie-Expansionskohorte. Das Unternehmen hat eine starke finanzielle Position mit 30 Millionen Dollar in bar beibehalten, die voraussichtlich die Operationen bis Mitte 2026 finanzieren werden.
Die ABILITY-1-Studie zeigte vielversprechende Ergebnisse, darunter eine vollständige Remission bei einem 70-jährigen Patienten mit fortgeschrittenem Analkrebs und eine partielle Remission bei einem Patienten mit Kolorektalkrebs. Die F&E-Ausgaben stiegen auf 3,4 Millionen Dollar von 3,0 Millionen Dollar im Vorjahr, während die allgemeinen und Verwaltungskosten leicht auf 1,7 Millionen Dollar sanken. Das Unternehmen meldete einen vierteljährlichen Nettoverlust von 5,2 Millionen Dollar (0,07 Dollar pro Aktie).
- 78% disease control rate in MDNA11-KEYTRUDA combination trial
- 30% objective response rate in monotherapy dose expansion cohort
- $30 million cash position funding operations through mid-2026
- $3.8 million proceeds from warrant exercises
- Net loss increased to $5.2 million from $5.0 million year-over-year
- R&D expenses increased by $0.4 million compared to previous year
- Disease control rate (DCR) of
- MDNA11 continued to demonstrate deep and durable single agent activity, with a
- Anticipated H1/2025 milestones related to the ABILITY-1 trial includes completion of enrolment in MDNA11 monotherapy dose expansion arm and MDNA11 + KEYTRUDA® combination dose escalation arm and initiation of combination dose expansion arm
- MDNA113 advancing towards IND-enabling studies as a first-in-class, targeted and conditionally activated bispecific anti-PD1-IL2 immunotherapy
- Ended quarter unchanged relative to previous quarter with
TORONTO and HOUSTON, Feb. 13, 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, today announced its FY Q3 2025 financial results and provided its 2025 strategic outlook with anticipated milestones.
“We are thrilled about the year ahead as we build on the significant progress we achieved last year,” said Dr. Fahar Merchant, President and CEO of Medicenna. “Our excitement is driven by the impressive response rates seen in the ABILITY-1 trial, particularly in the monotherapy arm where 5 patients responded to MDNA11 out of 20 patients with heavily pre-treated advanced solid tumors, including one complete response, despite all of them having failed prior checkpoint inhibitor therapies. Additionally, we are encouraged by early results from the combination dose-escalation arm, where two confirmed objective responses including a complete response have been observed in patients with treatment refractory tumors with historically low response rates to immune checkpoint inhibition. We look forward to presenting PK/PD data from the ABILITY-1 trial at the AACR-Immuno-Oncology Conference later this month and updated efficacy data at other medical conferences in Q2.”
Dr. Merchant added, “Equally motivating is the strong financial support we received from RA Capital last year, which validates and reinforces confidence in our innovative approach and positions us well to execute on a robust clinical development program for MDNA11 to support its use across a range of tumor types. As we approach critical value inflecting milestones in the ABILITY-1 trial, we remain committed to advancing our programs and our mission to deliver life-changing therapies for patients with cancer.”
CLINICAL PROGRESS DURING FY Q3 2025
- Provided clinical update to the ABILITY-1 study and announced the first complete responder in MDNA11 in combination with KEYTRUDA® (pembrolizumab) in dose escalation arm at an oral presentation at the Immunotherapy Bridge conference. A 70-year-old patient with advanced chemo-refractory anal cancer achieved a complete response in 8 weeks when treated with MDNA11 in combination with KEYTRUDA®. A partial response was seen in a chemo-refractory patient with microsatellite-stable colorectal cancer in the combination escalation arm. Five patients showed stable disease, delivering a
78% disease control rate. - Presented data from the ongoing Phase 1/2 ABILITY-1 study at the 39th Annual Meeting of the Society for Immunotherapy of Cancer, demonstrating positive single-agent activity of MDNA11 from the dose expansion cohorts and an encouraging safety profile and early anti-tumor activity in combination with KEYTRUDA®. MDNA11 continued to demonstrate promising deep and durable single agent activity, with a
30% (3 of 10) objective response rate (“ORR”) in the monotherapy dose expansion cohort (in checkpoint-resistant patients).
ANTICIPATED MILESTONES FOR 2025
| MILESTONE | ANTICIPATED CALENDAR DATE |
| MDNA11 – a long-acting superkine with best-in-class potential for solid tumors ( | |
| Feb. 2025 |
| mid 2025 |
| Q2 2025 |
| mid 2025 |
| Q2 2025 |
| Preclinical programs | |
| H2/2025 |
| H2/2025 |
FINANCIAL RESULTS
As at December 31, 2024, the Company reported cash and equivalents of
For the three months ended December 31, 2024, the Company reported total operating costs of
R&D expenses of
G&A expenses of
For the three months ended December 31, 2024, the Company reported a net loss of
Medicenna’s financial statements for the three and nine months ended December 31, 2024, and the related management’s discussion and analysis (MD&A) will be available on SEDAR+ at 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. MDNA11 is being evaluated in the Phase 1/2 ABILITY-1 Study (NCT05086692) as monotherapy and in combination with pembrolizumab. 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 medicenna.com, and follow us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain 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 treatment potential and safety profile of MDNA11 (both as monotherapy and in combination with pembrolizumab) and MDNA113, expected future milestones, cash runway, strategic outlook and the timing and/or release of any additional clinical updates. 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. Forward-looking statements are based on a number of assumptions believed by the Company to be reasonable at the date of this news release. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such statements will prove to be accurate. These statements are subject to certain risks and uncertainties and may be based on assumptions that could cause actual results and future events to differ materially from those anticipated or implied 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 or implied in forward-looking statements. 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.
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Investor and Company Contact
Christina Cameron
Investor Relations
ir@medicenna.com
(647) 953-0673
FAQ
What are the key efficacy results from MDNAF's ABILITY-1 trial in Q3 2025?
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What was MDNAF's net loss per share in Q3 2025?
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