BioMark Diagnostics Highlights Fiscal Year 2025 Achievements and Sets Bold Strategic Milestones for 2025 - 2026
BioMark Diagnostics (OTCQB:BMKDF), a liquid biopsy test developer for early cancer detection, has reported significant achievements for fiscal year 2025 and outlined strategic goals for 2025-2026. The company successfully raised CAD $4.26 million through private placement and secured CAD $365,000 in non-dilutive grants.
Key operational highlights include advancing AI-powered diagnostic assays for multiple cancers, initiating ISO 15189:2022 certification, and preparing for CLIA certification. The company achieved an 18% reduction in liabilities while tripling current assets. BioMark has strengthened partnerships with AstraZeneca, University of Maryland, and Ohio State University.
Looking ahead, BioMark plans to double laboratory capacity in Q2 2025, complete a 6,000-patient lung cancer clinical trial in Q3 2025, launch commercial operations in Quebec, and begin U.S. diagnostic service rollout in early 2026.
BioMark Diagnostics (OTCQB:BMKDF), sviluppatore di test di biopsia liquida per la diagnosi precoce del cancro, ha riportato risultati significativi per l'anno fiscale 2025 e ha delineato obiettivi strategici per il 2025-2026. L'azienda ha raccolto con successo 4,26 milioni di dollari canadesi tramite collocamento privato e ha ottenuto 365.000 dollari canadesi in sovvenzioni non diluitive.
I principali traguardi operativi includono il progresso di test diagnostici basati su intelligenza artificiale per diversi tipi di cancro, l'avvio della certificazione ISO 15189:2022 e la preparazione per la certificazione CLIA. L'azienda ha raggiunto una riduzione del 18% delle passività triplicando al contempo le attività correnti. BioMark ha rafforzato le collaborazioni con AstraZeneca, l'Università del Maryland e l'Università dello Stato dell'Ohio.
Guardando al futuro, BioMark prevede di raddoppiare la capacità di laboratorio nel secondo trimestre 2025, completare una prova clinica su 6.000 pazienti con cancro ai polmoni nel terzo trimestre 2025, avviare le operazioni commerciali in Quebec e iniziare il lancio del servizio diagnostico negli Stati Uniti all'inizio del 2026.
BioMark Diagnostics (OTCQB:BMKDF), desarrollador de pruebas de biopsia líquida para la detección temprana del cáncer, ha informado logros significativos para el año fiscal 2025 y ha establecido objetivos estratégicos para 2025-2026. La empresa recaudó con éxito 4,26 millones de dólares canadienses mediante colocación privada y aseguró 365,000 dólares canadienses en subvenciones no dilutivas.
Los principales hitos operativos incluyen el avance de ensayos diagnósticos impulsados por IA para múltiples tipos de cáncer, el inicio de la certificación ISO 15189:2022 y la preparación para la certificación CLIA. La compañía logró una reducción del 18% en pasivos mientras triplicaba los activos corrientes. BioMark ha fortalecido sus alianzas con AstraZeneca, la Universidad de Maryland y la Universidad Estatal de Ohio.
De cara al futuro, BioMark planea duplicar la capacidad del laboratorio en el segundo trimestre de 2025, completar un ensayo clínico con 6,000 pacientes con cáncer de pulmón en el tercer trimestre de 2025, lanzar operaciones comerciales en Quebec y comenzar el despliegue del servicio diagnóstico en EE. UU. a principios de 2026.
BioMark Diagnostics (OTCQB:BMKDF)는 조기 암 진단을 위한 액체 생검 검사 개발업체로서 2025 회계연도에 중요한 성과를 보고하고 2025-2026년 전략 목표를 제시했습니다. 회사는 사모 배정을 통해 426만 캐나다 달러를 성공적으로 조달했으며, 36만 5천 캐나다 달러의 비희석 보조금을 확보했습니다.
주요 운영 성과로는 다중 암에 대한 AI 기반 진단 검사 개발 진전, ISO 15189:2022 인증 착수, CLIA 인증 준비 등이 있습니다. 회사는 부채를 18% 감축하는 동시에 유동 자산을 세 배로 늘렸습니다. BioMark는 AstraZeneca, 메릴랜드 대학교, 오하이오 주립대학교와의 협력을 강화했습니다.
앞으로 BioMark는 2025년 2분기에 실험실 용량을 두 배로 늘리고, 2025년 3분기에 6,000명 대상 폐암 임상시험을 완료하며, 퀘벡에서 상업 운영을 시작하고 2026년 초 미국에서 진단 서비스 롤아웃을 시작할 계획입니다.
BioMark Diagnostics (OTCQB:BMKDF), développeur de tests de biopsie liquide pour la détection précoce du cancer, a annoncé des résultats significatifs pour l'exercice 2025 et a présenté ses objectifs stratégiques pour 2025-2026. L'entreprise a levé avec succès 4,26 millions de dollars canadiens par placement privé et obtenu 365 000 dollars canadiens de subventions non dilutives.
Les principaux faits marquants opérationnels comprennent l'avancement des tests diagnostiques assistés par IA pour plusieurs cancers, le lancement de la certification ISO 15189:2022 et la préparation à la certification CLIA. La société a réalisé une réduction de 18 % de ses passifs tout en triplant ses actifs courants. BioMark a renforcé ses partenariats avec AstraZeneca, l'Université du Maryland et l'Université d'État de l'Ohio.
Pour l'avenir, BioMark prévoit de doubler la capacité de son laboratoire au deuxième trimestre 2025, de terminer un essai clinique sur 6 000 patients atteints de cancer du poumon au troisième trimestre 2025, de lancer ses opérations commerciales au Québec et de débuter le déploiement de ses services diagnostics aux États-Unis début 2026.
BioMark Diagnostics (OTCQB:BMKDF), ein Entwickler von Flüssigbiopsie-Tests zur Früherkennung von Krebs, hat bedeutende Erfolge für das Geschäftsjahr 2025 gemeldet und strategische Ziele für 2025-2026 skizziert. Das Unternehmen hat erfolgreich 4,26 Millionen kanadische Dollar durch Privatplatzierung eingeworben und 365.000 kanadische Dollar an nicht verwässernden Zuschüssen erhalten.
Zu den wichtigsten betrieblichen Höhepunkten zählen die Weiterentwicklung KI-gestützter diagnostischer Tests für verschiedene Krebsarten, der Beginn der ISO 15189:2022-Zertifizierung und die Vorbereitung auf die CLIA-Zertifizierung. Das Unternehmen erreichte eine 18%ige Reduzierung der Verbindlichkeiten bei gleichzeitiger Verdreifachung der Umlaufvermögen. BioMark hat Partnerschaften mit AstraZeneca, der University of Maryland und der Ohio State University gestärkt.
Für die Zukunft plant BioMark, die Laborkapazität im zweiten Quartal 2025 zu verdoppeln, eine klinische Studie mit 6.000 Lungenkrebspatienten im dritten Quartal 2025 abzuschließen, den kommerziellen Betrieb in Quebec aufzunehmen und Anfang 2026 den diagnostischen Service in den USA einzuführen.
- None.
- Operating in a challenging funding environment for biotechnology firms
- Still pending key certifications (ISO 15189:2022 and CLIA) required for commercial operations
- Commercial operations yet to begin, with launch planned for late 2025
Vancouver, British Columbia--(Newsfile Corp. - July 30, 2025) - BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTCQB: BMKDF) ("BioMark" or the "Company"), a leading developer of liquid biopsy tests for early cancer detection, today announced a summary of its fiscal year 2025 highlights and key milestones for 2025 - 2026. The Company's annual financial filings are available on the SEDAR+ website at www.sedarplus.ca and on the CSE website at https://thecse.com/.
In a globally challenging funding environment for biotechnology firms, BioMark demonstrated exceptional resilience. The Company successfully secured financing and strengthened investor confidence by completing a CAD
Investor confidence remained high throughout the year, with BioMark's share price maintaining stability and posting modest gains. This performance stands in contrast to the downward trend observed across much of the diagnostics and biotech sectors, highlighting the Company's strategic position and strong fundamentals.
"Our team remained focused on disciplined execution, data-driven strategy, and delivering tangible value," said Rashid Bux, BioMark's CEO. "That focus earned us the continued support of investors who recognized the significance of our milestones in a tough market."
2025 Fiscal Year Highlights by Strategic Pillar
BioMark's key achievements for the fiscal year are categorized below, showcasing a period of significant progress across its core strategic pillars:
Financial Strength
Raised a total of CAD
$4.26 million through a private placement.Secured over CAD
$365,000 in non-dilutive grant funding from partners including NRC-IRAP, Mitacs, Research Manitoba, and City of Quebec.Achieved an
18% reduction in liabilities and maintained a lean monthly burnTripled current assets, a key metric for financial health, while preserving long-term capital.
Operational and Scientific Progress
Advanced a robust pipeline of AI-powered diagnostic assays for multiple cancers, including NSCLC, breast cancer, glioblastoma, and neuroendocrine tumors (NETs).
Integrated advanced technologies, including large language models (LLMs) and multitask deep learning, to enhance the predictive power and clinical utility of its assays.
Lab Certification and Commercial Readiness
Initiated the ISO 15189:2022 certification process, with completion targeted for Q4 2025.
Advanced preparations for CLIA certification, paving the way for U.S. commercialization by early 2026.
Positioned to introduce its first Lab-Developed Tests (LDTs) through a soon-to-be-accredited diagnostic facility.
Began discussions on a U.S. reimbursement strategy to support future market entry.
Publications and Thought Leadership
Published multiple high-impact studies in renowned peer-reviewed journals such as Cancers and IJMS.
Presented key clinical data at major international conferences, including the San Antonio Breast Cancer Symposium, GPEN, and USCAP.
Contributed to collaborative translational research initiatives with leading academic and industry partners in Canada and the U.S.
Strategic Collaborations
Strengthened engagements with key partners, including AstraZeneca, the University of Maryland, and Ohio State University.
Participated in several U.S. grant submissions and supported a pan-European IHI BRIDGES proposal aimed at scaling early detection diagnostics.
Initiated new relationships with U.S.-based cancer screening centers and commercial labs in Canada and other global operators.
Outlook and Key Milestones for 2025-2026
BioMark remains focused on achieving several key milestones in the coming fiscal year:
Q2 2025: Double laboratory capacity through additional equipment installation and workflow optimization initiatives. In addition, expand the lab personnel team to support higher testing volumes and the growth of its contract research organization (CRO) services.
Q3 2025: Completion and publication of BioMark's pivotal 6,000-patient lung cancer clinical trial.
Q3-Q4 2025: Launch of commercial operations for the lung cancer assay in Quebec.
Q4 2025: Finalization of ISO 15189 certification.
Early 2026: Secure CLIA certification and commence the U.S. diagnostic service rollout.
Ongoing: Continue to expand CRO services, the menu of lab-developed tests (LDTs), and the AI-integrated diagnostics portfolio.
Ongoing: Expand existing collaborations at key centers of excellence in the U.S. and Europe.
About BioMark Diagnostics Inc.
BioMark Diagnostics Inc. is a leading developer of liquid biopsy tests for the early detection of cancer that leverages the power of metabolomics and machine learning algorithms. The company's proprietary technology utilizes a simple blood draw to detect the presence of cancer-associated biomarkers, enabling earlier diagnosis and improved patient outcomes. The technology can also be used for measuring response to treatment and potentially for serial monitoring of cancer survivors. BioMark is committed to developing innovative and accessible diagnostic solutions to address unmet medical needs in oncology.
Further information about BioMark is available under its profile on the SEDAR+ website www.sedarplus.ca and the CSE website https://thecse.com/.
For further information on BioMark, please Contact:
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
Tel. 604-370-0779
Email: info@biomarkdiagnostics.com
Forward-Looking Information:
This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of BioMark. Forward-looking information is based on certain key expectations and assumptions made by the management of BioMark. Although BioMark believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because BioMark can give no assurance that they will prove to be correct. Forward-looking statements contained in this press release are made as of the date of this press release. BioMark disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events, or results or otherwise, other than as required by applicable securities laws.
The CSE has not reviewed, approved, or disapproved of the content of this press release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/260607
FAQ
What major financing did BioMark Diagnostics (BMKDF) secure in fiscal year 2025?
When will BioMark Diagnostics launch its commercial operations for lung cancer testing?
What are BioMark's key milestones for 2025-2026?
Which strategic partnerships does BioMark Diagnostics have?
What types of cancer is BioMark developing diagnostic tests for?
