Form 7 Monthly Progress Report January 2024
Name of Listed Issuer:
Trading Symbol:
Number of Outstanding Listed Securities:
Date:
BioMark Diagnostics Inc. (the “Issuer”)
BUX
90,886,229
March 4th, 2024
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 questions 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 commercialization of its proprietary, non-invasive, and accurate cancer diagnostic solutions which can help detect, monitor, and assess treatment for cancer 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 throughout 2023-2024.
These results were statistically significant and continued to generate interest from leading institutions in the US, France, and South America which the company intends to pursue post-launching our assay later this fiscal year following certification of its Quebec-based lab.
Complete plasma analysis on the large-scale early lung cancer multimodal study (5000 patients) that completed patient recruitment across 7 hospitals based in Quebec. Results are expected later in May/June 2024
Preparation for lab certification and accreditation to meet initially international ISO 15189:2012 standard for the Canadian operation and later secure CLIA and CAP approval to provide lab services in the U.S.
Seek deeper collaborations with several high-profile USA medical institutions and introduce the company to insurance companies (payers), regulatory experts, and bio-pharma 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.
Continue to seek additional funding including non-dilutive resources for its lab operations, certification of its clinical lab, U.S. expansion, business development, and clinical studies from both Canadian 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.
Businesses are still facing strong inflationary headwinds with a stiff interest rate, financial system instability due to evolving risk, rapid rise in adoption of systemic AI and automation, geopolitical tensions, and skilled labor shortages, especially in recruiting bioinformatics and laboratory technicians. Challenges in financing biotechnology companies continue but the market seems to be turning around. According to HC Wainright’s weekly life sciences deal comps Feb 24, 2024, report, life sciences equity, and equity-linked deal flow is active across offering types in 2024 to date, representing the busiest start of the year in terms of volume and number of deals since 2021. Specialist healthcare investor appetite persists for data-driven stories (and deals), although opportunistic deals are getting priced in equal measure. In addition, increased consolidation activities in the biotech arena continue. Management is taking measures to counteract any negative impact of these factors by instituting agile strategies with resilient operational and financial systems/processes while also seeking to capitalize on an improved financing environment. The company is building a strong AI infrastructure necessary to leverage the power of advanced analytics in cancer diagnostics.
Advanced discussions continue with Siemens Healthineers’ senior management group following BioMark’s participation in the challenging global Eureka Investment Readiness Programme – 2023 Online session with Siemens Healthineers which was held on September 26th, 2023. More senior management and technical meetings were held in February. Official announcements regarding any collaboration will be made once the due process is completed to the satisfaction of all parties.
The second batch of clinical samples from our clinical partner institution Hospices Civils de Lyon (HCL) in France were received in late February. These samples will be analyzed in BioMark’s lab facilities based in Quebec City once technology platform validation and verification are completed.
On February 26, 2024, BioMark announced that Mrs. Theresa Peterson as a new member of BioMark’s Advisory team. Mrs. Peterson brings a unique blend of strategic thinking, financial acumen, and relationship-building skills to BioMark. She excels at identifying and capitalizing on funding opportunities, developing innovative funding strategies, and building strong relationships with government agencies, foundations, and other key stakeholders. BioMark looks forward to her professional contribution to building BioMark into a dynamic diagnostic solution provider in the US and internationally.
On February 28, 2024, BiomMark and Rubix LS, a culturally competent patient medical research organization, jointly announced a strategic partnership to develop better diagnostic tools to enhance lung cancer screening and improve breast cancer screening program, especially for women with dense breasts and Triple Negative Breast Cancer (TNBC), by focusing on reaching underserved communities. This collaboration combines the innovative strengths of both organizations to develop accessible, non-invasive, and accurate diagnostic solutions that promise to set new standards in early detection and personalized cancer treatment.
Conducted and completed quarter filing for the quarter ended December 31, 2023 – Unaudited Financial Statement and MD&A filed in SEDAR and Canadian Securities Exchange as required by regulators.
BioMark’s studies in breast cancer and lung cancer are being further refined using the latest advancements in machine learning algorithms at Harrisburg University. The team is working on various publications to demonstrate the encouraging results. The first draft of a paper on the use of AI/ML and metabolomics on breast cancer will be submitted for publication later in March /April 2024.
The management team has engaged with a new financing group based in Europe to support the company’s future capital requirements. The group has access to European Private Equity funds and family offices. Meetings were held in Feb and planned in early March. The goal is to establish a broader shareholder base, especially with strategic investors.
BioMark continued 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 applicable.
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, 2023.
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 March 4th, 2024.
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 February 29, 2024 |
Date of Report YY/MM/DD 2024/03/04 |
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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 |