Medicenna Reports Second Quarter Fiscal 2025 Financial Results and Corporate Update
Medicenna Therapeutics reported Q2 fiscal 2025 results highlighting strong performance of MDNA11 in the ABILITY-1 study. The drug showed a 30% objective response rate in monotherapy dose expansion and demonstrated effectiveness against ICI-resistant cancers. Notable results include 66.7% response rate in MSI-H patients with pancreatic cancer. The company reported $30.4 million in cash and equivalents, with an additional $1.9 million from warrant exercises, extending runway through mid-2026. The study's combination with KEYTRUDA® showed favorable safety profile with no dose-limiting toxicities at 90 µg/kg dose.
Medicenna Therapeutics ha riportato i risultati del secondo trimestre dell'esercizio 2025, evidenziando le ottime performance di MDNA11 nello studio ABILITY-1. Il farmaco ha mostrato un 30% di tasso di risposta obiettivo nell'espansione della dose in monoterapia e ha dimostrato efficacia contro i tumori resistenti agli ICI. Tra i risultati notevoli, si segnala un 66,7% di tasso di risposta nei pazienti MSI-H con carcinoma pancreatico. L'azienda ha riportato 30,4 milioni di dollari in contante e equivalenti, con un ulteriore 1,9 milioni di dollari provenienti dall'esercizio di warrant, estendendo il periodo di liquidità fino a metà 2026. La combinazione dello studio con KEYTRUDA® ha mostrato un profilo di sicurezza favorevole senza tossicità limitanti della dose a una dose di 90 µg/kg.
Medicenna Therapeutics informó los resultados del segundo trimestre del año fiscal 2025, destacando el sólido rendimiento de MDNA11 en el estudio ABILITY-1. El medicamento mostró una tasa de respuesta objetiva del 30% en la expansión de dosis de monoterapia y demostró eficacia contra cánceres resistentes a ICI. Resultados notables incluyen una tasa de respuesta del 66,7% en pacientes MSI-H con cáncer de páncreas. La empresa reportó 30,4 millones de dólares en efectivo y equivalentes, con un adicional de 1,9 millones de dólares por ejercicio de warrants, extendiendo su liquidez hasta mediados de 2026. La combinación del estudio con KEYTRUDA® mostró un perfil de seguridad favorable sin toxicidades limitantes de dosis a una dosis de 90 µg/kg.
메디센나 테라퓨틱스는 2025 회계년도 2분기 결과를 보고하며 ABILITY-1 연구에서 MDNA11의 강력한 성과를 강조했습니다. 이 약물은 단일 요법 용량 확대에서 30%의 객관적 반응률을 보였고 ICI 저항성 암에 대한 효과를 입증했습니다. 주목할 만한 결과로는 췌장암을 앓고 있는 MSI-H 환자에서의 66.7% 반응률이 포함됩니다. 이 회사는 현금 및 현금성 자산으로 3천40만 달러를 보고했으며, 추가로 190만 달러가 워런트 행사로 발생하여 2026년 중반까지 자금을 연장했습니다. 연구의 KEYTRUDA®와의 조합은 90 µg/kg 용량에서 용량 한계 독성이 없이 우호적인 안전성 프로파일을 보였습니다.
Medicenna Therapeutics a rapporté les résultats du deuxième trimestre de l'exercice 2025, mettant en avant la forte performance de MDNA11 dans l'étude ABILITY-1. Le médicament a montré un taux de réponse objectif de 30% lors de l'expansion de dose en monothérapie et a démontré son efficacité contre les cancers résistants aux ICI. Parmi les résultats notables, on trouve un taux de réponse de 66,7% chez les patients MSI-H atteints de cancer du pancréas. L'entreprise a annoncé avoir 30,4 millions de dollars en liquidités et équivalents, avec un montant supplémentaire de 1,9 million de dollars provenant de l'exercice de bons de souscription, prolongeant ainsi sa trésorerie jusqu'à mi-2026. La combinaison de cette étude avec KEYTRUDA® a montré un profil de sécurité favorable sans toxicités limitant la dose à 90 µg/kg.
Medicenna Therapeutics berichtete über die Ergebnisse des zweiten Quartals des Geschäftsjahres 2025 und hob die starke Leistung von MDNA11 in der ABILITY-1 Studie hervor. Das Medikament zeigte eine 30%ige objektive Ansprechrate in der Dosiserweiterung der Monotherapie und bewies Wirksamkeit gegen ICI-resistente Krebserkrankungen. Zu den bemerkenswerten Ergebnissen gehört eine 66,7%ige Ansprechrate bei MSI-H-Patienten mit Bauchspeicheldrüsenkrebs. Das Unternehmen berichtete von 30,4 Millionen Dollar an liquiden Mitteln, zusätzlich 1,9 Millionen Dollar aus der Ausübung von Warrants, was die Liquidität bis Mitte 2026 verlängert. Die Kombination der Studie mit KEYTRUDA® zeigte ein günstiges Sicherheitsprofil ohne dosislimitierende Toxizität bei einer Dosis von 90 µg/kg.
- 30% objective response rate in monotherapy dose expansion cohort
- 66.7% response rate in MSI-H ICI resistant patients
- Strong cash position of $30.4M plus $1.9M from warrant exercises
- Extended cash runway through mid-2026
- Favorable safety profile in combination with KEYTRUDA®
- Net loss of $4.2M compared to $3.7M in previous year
- Increased R&D expenses to $3.7M from $3.1M year-over-year
MDNA11 continues to show best-in-class potential in the ABILITY-1 study with an objective response rate (ORR) of
Two PRs were observed among 3 microsatellite instability high (MSI-H) ICI resistant patients (ORR
First PR observed in the combination dose escalation arm of the ABILITY-1 study in a microsatellite stable (MSS) colon cancer patient not eligible for ICI therapy, indicating MDNA11’s potential to improve outcomes for cancers that do not typically respond to ICIs
Favorable safety profile in the combination dose escalation arm of the Phase 1/2 ABILITY-1 study with Merck’s (known as MSD outside of Canada and the US) KEYTRUDA® (pembrolizumab) with no dose limiting toxicities observed at the 60 and 90 µg/kg dose, Q2W with enrolment now proceeding at the 120 µg/kg dose, Q2W and Q3W
Company reported cash and cash equivalent balance of
Multiple MDNA11 milestones anticipated in Q1 and Q2 of calendar 2025
TORONTO and HOUSTON, Nov. 15, 2024 (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 reported financial results and corporate highlights for the fiscal quarter ended September 30, 2024, including updates on its on-going global Phase 1/2 ABILITY-1 study with MDNA11, a long-acting “non-alpha, enhanced beta” IL-2 Superkine.
“Achieving objective response rates with MDNA11 monotherapy that are comparable to those of block-buster immunotherapies, particularly in patients with advanced solid tumors that are resistant to immunotherapy, is a remarkable testimony to the potential of MDNA11 and our IL-2 superkine platform,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “Further evidence of our confidence in MDNA11 arises from early but encouraging signs of tumor response in the combination setting in cancers that are not approved for checkpoint inhibitors. We are also encouraged with the safety profile observed in combination with KEYTRUDA®, as we explore higher and more convenient dosing schedule of MDNA11. We look forward to sharing additional results from our programs during the next 2 quarters as well as our progress with next generation Superkines for treatment of cancer and autoimmune diseases.”
PROGRAM AND BUSINESS UPDATE:
Highlights for the three months ended September 30, 2024, along with recent developments, include:
MDNA11: IL-2 Superkine Program
On November 9th, 2024, at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), Medicenna reported positive, updated clinical results from the ongoing monotherapy expansion and combination dose escalation portions of the Phase 1/2 ABILITY-1 Study.
ORR of
- The updated results at SITC demonstrated that the ORR was
30% in the Phase 2 monotherapy dose expansion cohort (3 of 10) among ICI resistant patients with advanced and/or metastatic solid tumors. - Including patients from the dose escalation/evaluation cohort (n = 10) that meet the Phase 2 eligibility criteria, the ORR was
25% (5 of20% ), including 1 complete response (CR) and 4 partial responses (PR) and a clinical benefit rate of40% (8 of 20) including 3 patients with stable disease (SD) for at least 6 months. - Two PRs were observed among 3 microsatellite instability high (MSI-H) ICI resistant patients (ORR
66.7% ) with both responders having pancreatic ductal adenocarcinoma (PDAC) including one patient with100% tumor regression and no signs of progression of target and non-target lesions for at least 26 months. - ORR in patients with ICI resistant cutaneous melanoma was
27% (3 of 11), with one patient achieving a complete response at week 52 who remains on treatment as of week 63. - A new fourth partial response, in a cutaneous melanoma patient in the monotherapy expansion cohort, was reported at SITC. This response has since been confirmed in a subsequent scan which occurred after the data cut-off date.
MDNA11 Combination Escalation with KEYTRUDA®: Encouraging Safety Profile with No New Safety Signals and Early Signs of Anti-tumor Activity
- In the combination portion of the study with KEYTRUDA®, no dose limiting toxicities were observed at the 90 µg/kg dose level, and the next 2 cohorts have started enrollment at the higher dose of 120 µg/kg administered either once every 2 weeks or once every 3 weeks, with 400 mg KEYTRUDA® administered once every 6 weeks.
- Early pharmacodynamic analyses demonstrated robust lymphocyte expansion which was sustained with repeat dosing at both 60 µg/kg and 90 µg/kg Q2W MDNA11 in combination with 400 mg Q6W KEYTRUDA®.
- Among 5 heavily pre-treated efficacy-evaluable patients in the combination dose escalation arm, tumor control (PR or SD) was observed in 4 patients (
80% ), including a PR in a microsatellite-stable (MSS) colon cancer patient and 2 SDs in ovarian squamous cell carcinoma and triple negative breast cancer patients, tumor-types which have failed to demonstrate sufficient anti-tumor activity in response to checkpoint inhibitor therapy in previous clinical trials.
OPERATIONAL UPDATES
On November 13th, 2024, Medicenna announced that it will present pre-clinical data at the 29th Annual Meeting of the Society of Neuro-Oncology taking place in Houston, Texas from November 21 – 24, 2024, and at the 2024 San Antonio Breast Cancer Symposium (SABCS), the world’s largest breast cancer conference, taking place in San Antonio, Texas from December 10 – 13, 2024.
In Q1 and Q2 of calendar 2025, Medicenna anticipates achieving several milestones in the MDNA11 program. These include completing monotherapy expansion and combination dose-escalation enrollment, initiating the combination expansion phase of the Phase 1/2 ABILITY-1 study, and providing further clinical updates at medical conferences.
FINANCIAL RESULTS
As at September 30, 2024, the Company had a cash and cash equivalents balance of
For the three months ended September 30, 2024, the Company reported total operating costs of
R&D expenses of
G&A expenses of
For the three months ended September 30, 2024, the Company reported a net loss of
Medicenna’s financial statements for the three and six months ended September 30, 2024, and the related management’s discussion and analysis (MD&A) will be available on SEDAR+ at www.sedarplus.ca.
About Medicenna
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 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.
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 Company’s cash runway and planned expenditures, the clinical performance and potential, safety profile of MDNA11, as well as MDNA11’s treatment potential, the reporting of additional results, and anticipated corporate milestones. 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 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.
This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this news release.
Investor and Company Contact:
Christina Cameron
Investor Relations, Medicenna Therapeutics
ir@medicenna.com
(647) 953-0673
Daniel Scarr
Investor Relations & Business Development, Medicenna Therapeutics
dscarr@medicenna.com
(647) 220-4509
FAQ
What was Medicenna's (MDNAF) objective response rate in the ABILITY-1 study's monotherapy expansion cohort?
How much cash does Medicenna (MDNAF) have as of September 30, 2024?
What was Medicenna's (MDNAF) net loss for Q2 fiscal 2025?
What are the safety results of MDNA11 combination with KEYTRUDA® in the ABILITY-1 study?
