Medicenna Therapeutics Reports First Quarter Fiscal 2026 Financial Results and Operational Highlights
Medicenna Therapeutics (OTCQX:MDNAF) reported its Q1 fiscal 2026 results, highlighting significant progress in its immunotherapy pipeline. The company ended Q1 with $20.5 million in cash, providing runway into mid-2026. Operating costs increased to $5.5 million, up from $4.0 million year-over-year, with net loss at $0.06 per share.
Key clinical achievements include promising MDNA11 results, with 30-50% response rates in high-dose patients and complete responses in pancreatic and melanoma cancers. The Phase 1/2 ABILITY-1 trial remains on track for top-line data in H2 2025. The company's IP portfolio expanded to 86 granted patents, strengthening its commercial potential.
R&D expenses increased to $4.2 million from $2.8 million, primarily due to ABILITY-1 Study expansion, while G&A expenses remained stable at $1.3 million.
Medicenna Therapeutics (OTCQX:MDNAF) ha riportato i risultati del primo trimestre dell'anno fiscale 2026, evidenziando importanti progressi nel suo portafoglio di immunoterapia. La società ha chiuso il trimestre con 20,5 milioni di dollari in cassa, garantendo liquidità fino a metà 2026. I costi operativi sono aumentati a 5,5 milioni di dollari, rispetto ai 4,0 milioni dell'anno precedente, con una perdita netta di 0,06 dollari per azione.
Tra i principali risultati clinici si segnalano i promettenti dati di MDNA11, con tassi di risposta del 30-50% nei pazienti ad alta dose e risposte complete nei tumori del pancreas e del melanoma. Lo studio di Fase 1/2 ABILITY-1 procede secondo i tempi previsti, con dati principali attesi nella seconda metà del 2025. Il portafoglio di proprietà intellettuale dell'azienda è cresciuto fino a 86 brevetti concessi, rafforzando il suo potenziale commerciale.
Le spese in ricerca e sviluppo sono salite a 4,2 milioni di dollari dai 2,8 milioni precedenti, principalmente a causa dell'espansione dello studio ABILITY-1, mentre le spese generali e amministrative sono rimaste stabili a 1,3 milioni di dollari.
Medicenna Therapeutics (OTCQX:MDNAF) informó sus resultados del primer trimestre del año fiscal 2026, destacando avances significativos en su cartera de inmunoterapia. La compañía cerró el trimestre con 20,5 millones de dólares en efectivo, asegurando recursos hasta mediados de 2026. Los costos operativos aumentaron a 5,5 millones de dólares, frente a 4,0 millones del año anterior, con una pérdida neta de 0,06 dólares por acción.
Los logros clínicos clave incluyen resultados prometedores de MDNA11, con tasas de respuesta del 30-50% en pacientes con dosis altas y respuestas completas en cánceres de páncreas y melanoma. El ensayo de Fase 1/2 ABILITY-1 sigue en marcha para obtener datos principales en la segunda mitad de 2025. La cartera de propiedad intelectual de la empresa se amplió a 86 patentes concedidas, fortaleciendo su potencial comercial.
Los gastos en I+D aumentaron a 4,2 millones de dólares desde 2,8 millones, principalmente debido a la expansión del estudio ABILITY-1, mientras que los gastos generales y administrativos se mantuvieron estables en 1,3 millones de dólares.
Medicenna Therapeutics (OTCQX:MDNAF)는 2026 회계연도 1분기 실적을 발표하며 면역치료제 파이프라인에서 의미 있는 진전을 보였다고 밝혔습니다. 회사는 1분기 말에 2,050만 달러의 현금을 보유하여 2026년 중반까지 자금 운용이 가능하다고 보고했습니다. 운영 비용은 전년 동기 대비 550만 달러로 증가했으며, 주당 순손실은 0.06달러였습니다.
주요 임상 성과로는 고용량 환자에서 30-50%의 반응률과 췌장암 및 흑색종에서 완전 반응을 보인 MDNA11의 유망한 결과가 포함됩니다. 1/2상 ABILITY-1 임상시험은 2025년 하반기 주요 데이터 공개를 목표로 순조롭게 진행 중입니다. 회사의 지적 재산권 포트폴리오는 86건의 특허 등록으로 확대되어 상업적 잠재력을 강화했습니다.
연구개발 비용은 ABILITY-1 연구 확장으로 인해 주로 증가하여 420만 달러로 전년 280만 달러에서 상승했으며, 일반관리비는 130만 달러로 안정적으로 유지되었습니다.
Medicenna Therapeutics (OTCQX:MDNAF) a publié ses résultats du premier trimestre de l'exercice 2026, mettant en avant des progrès significatifs dans son portefeuille d'immunothérapies. La société a clôturé le trimestre avec 20,5 millions de dollars en liquidités, assurant une trésorerie jusqu'à la mi-2026. Les coûts opérationnels ont augmenté à 5,5 millions de dollars, contre 4,0 millions l'année précédente, avec une perte nette de 0,06 dollar par action.
Les principales avancées cliniques incluent des résultats prometteurs pour MDNA11, avec des taux de réponse de 30 à 50 % chez les patients à dose élevée et des réponses complètes dans les cancers du pancréas et du mélanome. L'essai de phase 1/2 ABILITY-1 reste sur la bonne voie pour des données principales attendues au second semestre 2025. Le portefeuille de propriété intellectuelle de la société s'est étendu à 86 brevets délivrés, renforçant son potentiel commercial.
Les dépenses de R&D ont augmenté à 4,2 millions de dollars contre 2,8 millions, principalement en raison de l'expansion de l'étude ABILITY-1, tandis que les frais généraux et administratifs sont restés stables à 1,3 million de dollars.
Medicenna Therapeutics (OTCQX:MDNAF) berichtete über seine Ergebnisse für das erste Quartal des Geschäftsjahres 2026 und hob bedeutende Fortschritte in seiner Immuntherapie-Pipeline hervor. Das Unternehmen schloss das erste Quartal mit 20,5 Millionen US-Dollar in bar ab, was eine Finanzierung bis Mitte 2026 sichert. Die Betriebskosten stiegen auf 5,5 Millionen US-Dollar im Vergleich zu 4,0 Millionen im Vorjahr, mit einem Nettoverlust von 0,06 US-Dollar pro Aktie.
Wesentliche klinische Erfolge umfassen vielversprechende Ergebnisse von MDNA11 mit 30-50 % Ansprechrate bei Hochdosis-Patienten und vollständigen Remissionen bei Bauchspeicheldrüsen- und Melanomkrebserkrankungen. Die Phase-1/2-Studie ABILITY-1 verläuft planmäßig, mit Topline-Daten, die für das zweite Halbjahr 2025 erwartet werden. Das IP-Portfolio des Unternehmens wurde auf 86 erteilte Patente erweitert, was das kommerzielle Potenzial stärkt.
Die F&E-Ausgaben stiegen hauptsächlich aufgrund der Erweiterung der ABILITY-1-Studie auf 4,2 Millionen US-Dollar von zuvor 2,8 Millionen, während die allgemeinen Verwaltungsaufwendungen mit 1,3 Millionen stabil blieben.
- Strong clinical efficacy with 30-50% response rates in high-dose patients
- Complete cancer resolution in pancreatic and melanoma patients lasting 18 and 6 months respectively
- Cash runway extended into mid-2026 with $20.5M in cash
- IP portfolio strengthened with 5 new patents, totaling 86 granted patents
- On track for key ABILITY-1 trial data readouts in H2 2025
- Operating costs increased 37.5% to $5.5M year-over-year
- Net loss increased to $4.9M ($0.06/share) from $3.6M ($0.05/share)
- R&D expenses rose significantly to $4.2M from $2.8M
- Foreign exchange loss increased by $1.0M
Updated cash guidance provides runway into at least the middle of calendar 2026
Company remains encouraged by MDNA11 clinical results presented to-date, demonstrating best-in-class potential of our IL-2 superkine by exceeding ORR benchmarks demonstrated with other competing therapies in similar checkpoint resistant tumor types
A patient with pancreatic cancer and a melanoma cancer patient remain cancer free for 18 and 6 months, respectively, after achieving complete resolution of their target and non-target lessions without any additional treatment following MDNA11 monotherapy
Company remains on track to complete enrollment in the Phase 1/2 ABILITY-1 monotherapy and combination arms and provide top-line clinical data readouts in calendar H2 2025
Partnering efforts for bizaxofusp, Medicenna’s phase-3 ready recurrent glioblastoma program, and IND-enabling studies for its conditionally activated bi-specific anti-PD-1 x IL-2 superkine program continue to advance
Recently granted patents in major markets solidify portfolio IP position across the entire platform
TORONTO and HOUSTON, Aug. 01, 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 quarter ended June 30, 2025, as well as anticipated corporate milestones.
“We enter the second half of 2025 encouraged by positive clinical data from the Phase 1/2 ABILITY-1 trial, and remain on track to complete enrollment and report top-line data from both the monotherapy and combination arms before year-end,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “We are motivated by previously reported data, from each of the three tumor-specific cohorts, to pursue expedited regulatory pathways for MDNA11 in order to address critical unmet needs in patients who do not respond to blockbuster immunotherapies. In parallel, we are making strong progress with MDNA113, our lead candidate from the proprietary BiSKIT platform. This bi-functional anti-PD1-IL2 Superkine is engineered with integrated targeting and stealth capabilities, enabling tumor-specific activation while minimizing peripheral effects. We look forward to sharing further clinical updates at conferences and scientific events later this year.”
PROGRAM AND BUSINESS UPDATE:
Highlights for the three months ended June 30, 2025, along with recent developments, include:
MDNA11: IL-2 Superkine Program
- MDNA11 continues to deliver strong signals of durable efficacy, including complete, long-lasting responses in hard-to-treat cancers and 30–
50% response rates in high-dose patients across multiple tumor types, supporting its best-in-class potential. - Clinical and strategic momentum is progressing well, with active enrollment in the Phase 1/2 ABILITY-1 trial and key data readouts are expected in H2 2025.
MDNA113: First-in-Class Anti-PD-1-IL-2 Bispecific Superkine
- Promising preclinical data for MDNA113 was presented at AACR 2025, highlighting its tumor-targeted design and strong anti-tumor activity in IL-13Rα2–positive tumor models, supporting development potential in cancers affecting over 2 million patients annually.
- MDNA113 is a first-in-class targeted and conditionally activated bispecific anti-PD1-IL2 Superkine demonstrating highly differentiated safety and efficacy profile as we advance IND enabling studies with this asset.
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
Medicenna was recently granted an additional five patents, four from the US Patent and Trademark Office (USPTO) and one from the European Patent Office (EPO), covering the Company’s IL-2 and IL-4 Superkine platforms. These patents strengthen Medicenna’s intellectual property (IP) position across major markets and further support the Company’s lead clinical and preclinical programs.
In total, the Company’s global IP portfolio now stands at 86 granted or allowed patents, reinforcing long-term commercial potential for its proprietary IL-2 and IL-4 assets across key jurisdictions.
Quarterly Financial Results
Medicenna exited the quarter ended June 30, 2025, with cash and cash equivalents of
For the three months ended June 30, 2025, the Company reported total operating costs of
Net loss for the quarter ended June 30, 2025, was
R&D expenses of
Medicenna’s financial statements for the quarter ended June 30, 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 X and LinkedIn.
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), the Company's expected cash runway, upcoming development and regulatory milestones, and intellectual property protection. 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:
Shushu Feng
Investor Relations, Medicenna Therapeutics
ir@medicenna.com
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