Form 7 Monthly Progress Report November 1 2022
Name of Listed Issuer:
Number of Outstanding Listed Securities:
BioMark Diagnostics Inc. (the “Issuer”)
January 4, 2023
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.
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 to 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 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 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 early lung cancer lab developed test (LDT) following promising interim data presented at European Society of Medical Oncology in Paris France on Sept 10th. The data was derived on an independent large scale retrospective study with expanded control. The results were statistically significant and generated interest from leading institutions across Europe, India and S. America which the company is actively pursuing.
Preparation for lab certification and accreditation to meet both the Canadian and European ISO 15189 standard but also US based CLIA and CAP approvals to provide lab services internationally.
Engage with USA medical institutions, insurance companies (payers) regulatory experts and bio-pharma partners as it’s early lung cancer LDT commercialization efforts gather momentum. US market is strategic due to its large addressable lung cancer screening market for at risk population (Over 16 million annually)
Seek additional non-dilutive funding resources for its lab operations, certification of its clinical lab, U.S. expansion and clinical studies.
Provide a general overview and discussion of the activities of management.
Beyond the re-emergence of the new Kraken covid variant and flu worriers, businesses are currently facing strong inflationary headwinds, supply chain bottlenecks and labour shortages. Management is taking measures to counteract any negative impact of these factors after managing the Covid challenges over the past 3 years by instituting resilient operational and financial systems/processes.
On December 14, 2022, BioMark’s Quebec-based subsidiary, BioMark Diagnostic Solutions Inc (“BDS”) along with its partner TransDiag in France submitted an application to EUREKA Program for the Development and Validation of Multimodal Screening Approaches in Lung Cancer.
On December 16, 2022, BioMark’s lab equipment partners visited two important clinical sites in Brazil that had expressed strong interest for potential collaboration related to its blood based early lung cancer screening assay. Follow up meetings are expected later in January 2023.
On December 20, 2022, BioMark Diagnostics Inc. held its Annual General Meeting in Vancouver, BC at 9:00 a.m. (Vancouver Time). All the motions were passed.
On December 21, 2022, BioMark’s Quebec-based subsidiary, BioMark Diagnostic Solutions Inc (“BDS”) was approved for financial support under the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP). BDS will receive advisory services and funding of up to CAD $ 185,900 for the Development of a Quantitative Assay to Measure Drug Metabolites for Cancer Treatment.
In December 2022, BioMark commenced dialogue with a group from Germany with appropriate CE based clinical and lab accreditations along with an impressive infrastructure for potential collaboration related to lung cancer screening. The German groups has multiple operations across Europe. The parties intend to sign a Letter of Interest (LOI) by end of January after completing further due diligence.
BioMark along with a recognized oncology testing service organization based in the USA are developing a collaboration framework to apply for CPRIT – Cancer Prevention and Research Institute of Texas grant funding with a goal of accelerating better and faster access to early lung cancer diagnosis using its blood-based metabolite test. The initial focus is to build a CLIA lab in Texas where the initial samples can be analysed prior to rollout to a network of community hospitals across US.
BioMark continued to entertain discussions with various financial institutions 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 and to advance its expansion strategy in USA and internationally as well as for general corporate purposes.
CPRIT- Cancer Prevention and Research Institute of Texas
The ultimate goals of the CPRIT Prevention Program are to reduce overall cancer incidence and mortality and to improve the lives of individuals who have survived or are living with cancer. The ability to reduce cancer death rates depends in part on the application of currently available evidence-based technologies and strategies. CPRIT fosters the primary, secondary, and tertiary prevention of cancer in Texas by providing financial support for a wide variety of evidence-based risk reduction, early detection, and survivorship interventions.
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.
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.
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.
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.
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.
Describe the acquisition of new customers or loss of customers.
The Issuer continues to file trademark 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 anticipated length of lay-offs.
Report on any labour disputes and resolutions of those disputes if 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.
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.
Provide details of any loans to or by Related Persons.
Provide details of any changes in directors, officers, or committee members.
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, 2022.
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 4th, 2023
Rashid Ahmed Maula Bux______
Name of Director or Senior Officer
“Rashid Ahmed Maula Bux”____
President & CEO
Name of Issuer
BioMark Diagnostics Inc.
|For Month End
|Date of Report
130 3851 Shell Road
Richmond, BC, V6X 2W2
|Issuer Fax No.
|Issuer Telephone No.
Rashid Ahmed Bux
|Contact Telephone No.
|Contact Email Address
|Web Site Address