Form 7 Monthly Progress Report December 2024
Name of Listed Issuer:
Trading Symbol:
Number of Outstanding Listed Securities:
Date:
BioMark Diagnostics Inc. (the “Issuer”)
BUX
90,886,229
January 3, 2025
This Monthly Progress Report must be posted before the opening of trading on the fifth trading day of each month. This report is not intended to replace the Issuer’s obligation to separately report material information forthwith upon the information becoming known to management or to post the forms required by Exchange Policies. If material information became known and was reported during the preceding month to which this report relates, this report should refer to the material information, the news release date and the posting date on the Exchange website.
This report is intended to keep investors and the market informed of the Issuer’s ongoing business and management activities that occurred during the preceding month. Do not discuss goals or future plans unless they have crystallized to the point that they are “material information” as defined in the Policies. The discussion in this report must be factual, balanced, and non-promotional.
General Instructions
Prepare this Monthly Progress Report using the format set out below. The sequence of questions must not be altered, nor should question be omitted or left unanswered. The answers to the items must be in narrative form. State when the answer to any item is negative or not applicable to the Issuer. The title of each item must precede the answer.
The term “Issuer” includes the Issuer and any of its subsidiaries.
Terms used and not defined in this form are defined or interpreted in Policy 1 – Interpretation and General Provisions.
Report on Business
Provide a general overview and discussion of the development of the Issuer’s business and operations over the previous month. Where the Issuer was inactive disclose this fact.
The Issuer continued its business of developing and accelerating the commercialization of its proprietary, non-invasive, and accurate cancer diagnostic solutions which can help detect, monitor, and assess cancer treatment early, accurately, and cost-effectively. The Company has developed its annual roadmap, continues to hold regular management meetings regarding all aspects of the Company’s business plan, and executes action items that result from these meetings.
Management’s primary areas of focus continue to include:
Accelerating commercialization efforts of its lab-developed test (LDT) for early lung cancer detection following promising interim retrospective data presented at various oncology conferences across N. America and Europe.
These results were statistically significant and continued to generate interest from leading institutions in the US, France, Germany and South America which the company intends to pursue post-launching its assay initially in Canada following certification of its Quebec-based lab and data readout on its lung cancer clinical studies.
Complete data analytics on the large-scale early lung cancer multimodal study (5,400 patients) across 7 hospitals based in Quebec after the successful completion of plasma samples and analysis using BioMark’s metabolomics assay. Preliminary results are expected in early 2025. Additional data on prospective lung cancer screening cohort will be continued to be collected in 2025. Pending the outcome of the results the company intends to present it a major cancer symposium.
Preparation for lab certification and accreditation to initially meet international ISO 15189:2012 standard for the Canadian operation and later secure CLIA and CAP accreditation to provide lab services in the U.S. Canadian certification is expected by June 2025.
Seek deeper collaborations with several high-profile USA medical institutions and introduce the company to insurance companies (payers), regulatory experts, advocacy groups, and biopharma partners as its early lung cancer LDT commercialization efforts gather momentum. The US market is strategic due to its large addressable lung cancer screening market for at-risk populations (estimated at over 16 million annually). The market remains mostly untapped as there’s only a 5-6% penetration of image-based screening for the population at risk of developing lung cancer. In addition, the federal government is encouraging expanded accessibility for lung cancer screening initiatives and accessibility across different states, especially for rural communities that have limited resources.
Continue seeking additional funding including non-dilutive resources for its lab operations, certification of its clinical lab, U.S. expansion, business development, and clinical studies from Canadian, European, and US agencies and foundations to develop the platform for other cancers and assess response to treatment.
Provide a general overview and discussion of the activities of management.
BioMark acknowledges the current challenging economic climate, particularly for small-cap companies. Investor caution and a skilled labor shortage in bioinformatics and laboratory technicians are impacting the industry. Financing timelines are extended, making fundraising difficult especially for small cap diagnostic companies.
Management is taking measures to counteract any negative impact of external factors by implementing agile strategies with resilient operational and financial systems. The company is focusing on Artificial Intelligence (AI) and building a strong AI infrastructure through strategic collaborations. Most of its assay results will be enriched using AI and ML capabilities. Non-dilutive financing continues to be a preferred option by the company for its internal R&D programs.
On December 10, 2024, BioMark announced a groundbreaking study published in the International Journal of Molecular Sciences (IJMS) Special Edition. The study demonstrates the potential of BioMark’s blood-based assay to accurately predict estrogen receptor (ER) status in breast cancer patients. This non-invasive test, leveraging metabolomics and machine learning, holds promise to revolutionize breast cancer diagnosis and treatment.
BioMark continues its commitment to innovation by presenting new findings at the 47th San Antonio Breast Cancer Symposium (SABCS). On December 11th, 2024, Dr. Jean-François Haince, General Manager and CSO, shared data highlighting how plasma metabolomics can be applied to lobular breast cancer biomarker discovery during the poster session. These insights emphasize the power of machine learning techniques in analyzing complex metabolomic data and identifying significant biomarkers that can differentiate between different subtypes of breast cancer, specifically lobular breast cancer and ductal carcinoma.
Arthur G. James Comprehensive Cancer Center (Ohio State University) led by Dr. Rolfo and BioMark are collaborating to submit a NIH R01 grant application that focuses on early lung cancer detection using a multi-omics approach. A dedicated team has been set to commence the submission process which is due by mid Feb 2025.
The Company successfully held its Annual General Meeting on December 27th, 2024, at 9:00 am (Vancouver Time) from its head office in Richmond, BC. All the motions were passed.
BioMark continues to entertain discussions with various financial institutions, individuals, and government agencies to secure non-dilutive funding, favourable loans, and equity investments to accelerate the commercialization of its early lung cancer liquid biopsy franchise, to advance its expansion strategy in the USA and internationally as well as for general corporate purposes.
Describe and provide details of any new products or services developed or offered. For resource companies, provide details of new drilling, exploration or production programs and acquisitions of any new properties and attach any mineral or oil and gas or other reports required under Ontario securities law.
Not applicable.
Describe and provide details of any products or services that were discontinued. For resource companies, provide details of any drilling, exploration or production programs that have been amended or abandoned.
Not applicable.
Describe any new business relationships entered into between the Issuer, the Issuer’s affiliates or third parties including contracts to supply products or services, joint venture agreements and licensing agreements, etc. State whether the relationship is with a Related Person of the Issuer and provide details of the relationship.
Not applicable.
Describe the expiry or termination of any contracts or agreements between the Issuer, the Issuer’s affiliates or third parties or cancellation of any financing arrangements that have been previously announced.
Not applicable.
Describe any acquisitions by the Issuer or dispositions of the Issuer’s assets that occurred during the preceding month. Provide details of the nature of the assets acquired or disposed of and provide details of the consideration paid or payable together with a schedule of payments if applicable, and of any valuation. State how the consideration was determined and whether the acquisition was from, or the disposition was to a Related Person of the Issuer and provide details of the relationship.
Not applicable.
Describe the acquisition of new customers or loss of customers.
Not applicable.
Describe any new developments or effects on intangible products such as brand names, circulation lists, copyrights, franchises, licenses, patents, software, subscription lists, and trademarks.
The Issuer continues to file trademarks and patents in specific jurisdictions for all its patents. Review of the filings and opinions from patent offices are being reviewed as needed.
Report on any employee hiring, terminations or lay-offs with details of the anticipated length of lay-offs.
Not applicable.
Report on any labour disputes and resolutions of those disputes if applicable.
Not applicable.
Describe and provide details of legal proceedings to which the Issuer became a party, including the name of the court or agency, the date instituted, the principal parties to the proceedings, the nature of the claim, the amount claimed, if any, if the proceedings are being contested, and the present status of the proceedings.
Not applicable.
Provide details of any indebtedness incurred or repaid by the Issuer together with the terms of such indebtedness.
Provide details of any securities issued and options or warrants granted.
Not appliable.
Provide details of any loans to or by Related Persons.
Not applicable.
Provide details of any changes in directors, officers, or committee members.
Not applicable.
Discuss any trends which are likely to impact the Issuer including trends in the Issuer’s market(s) or political/regulatory trends.
The trends and risks which are likely to impact the Issuer are discussed in the Form 51-102F1 Management’s Discussion & Analysis Annual Report for the Year Ended March 31, 2024.
Certificate Of Compliance
The undersigned hereby certifies that:
The undersigned is a director and/or senior officer of the Issuer and has been duly authorized by a resolution of the board of directors of the Issuer to sign this Certificate of Compliance.
As of the date hereof there where is no material information concerning the Issuer which has not been publicly disclosed.
The undersigned hereby certifies to the Exchange that the Issuer is in compliance with the requirements of applicable securities legislation (as such term is defined in National Instrument 14-101) and all Exchange Requirements (as defined in CNSX Policy 1).
All of the information in this Form 7 Monthly Progress Report is true.
Dated January 3rd, 2025
Rashid Ahmed Maula Bux______
Name of Director or Senior Officer
“Rashid Ahmed Maula Bux”____
Signature
President & CEO
Official Capacity
Issuer Details Name of Issuer BioMark Diagnostics Inc. |
For Month End December 31, 2024 |
Date of Report YY/MM/DD 2025/01/03 |
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Issuer Address 130 3851 Shell Road |
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City/Province/Postal Code Richmond, BC, V6X 2W2 |
Issuer Fax No. N/A |
Issuer Telephone No. (604) 370-0779 |
Contact Name Rashid Ahmed Bux |
Contact Position CEO |
Contact Telephone No. (604) 370-0779 |
Contact Email Address [email protected] |
Web Site Address www.biomarkdiagnostics.com |