Form 7 Monthly Progress Report January 2024
Name of Listed Issuer:
Number of Outstanding Listed Securities:
BioMark Diagnostics Inc. (the “Issuer”)
February 3, 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.
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 data presented at various oncology conferences across N. America and Europe. That includes the European Society of Medical Oncology in Paris France on September 10, 2022, and the United States and Canadian Academy of Pathology (USCAP) annual conference in New Orleans, United States, on March 10th. 2023. The ESMO data was derived from an independent large scale retrospective study for early lung cancer with expanded control. In a poster presentation at the USCAP meeting in New Orleans, LA held in March 2023, BioMark’s research team were able to detect neuroendocrine tumors (NETs) from plasma samples using its innovative liquid biopsy technology. The study included a total of 120 plasma samples from patients with biopsy-confirmed NET and 227 control patients and is one of the largest ever reported. Abstract and poster were presented during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting that took place in Chicago, Illinois. The poster entitled “Large retrospective validation study of metabolomic biomarkers for resectable lung cancer detection and risk assessment”. The poster was presented by senior author, Dr Andrew Maksymiuk. The objectives of the study were to validate whether BioMark’s panel of metabolomic biomarkers improved early lung cancer detection in over 800 plasma samples from patients that underwent lung cancer resection, and to better understand the potential role and intersection between lung cancer and other lung diseases as it relates to screening for at-risk populations.
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.
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 the 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 there seems to be a renewed interest in specific pockets of the biopharma sector. There are increased consolidation activities, especially in the pharmaceutical arena. Management is taking measures to counteract any negative impact of these factors by instituting agile strategies with resilient operational and financial systems/processes. The company is building a strong AI infrastructure necessary to leverage the power of advanced analytics. Several AI papers are planned to be published throughout this fiscal year.
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. The deeper dive into understanding BioMark’s technology platform is ongoing after signing a mutually accepted 2-way NDA. More senior management meetings are scheduled in Feb and March of 2024.
The company has completed the recruitment of patients enrolled under its measuring response to immunotherapy for the advanced-stage lung cancer trial that is being conducted at IUCPQ with Dr. P. Joubert as the principal investigator. Full results are expected by April following a faster than anticipated sample shipment than reported in the previous progress report (Dec 2023). This is sponsored research which was funded by a grant from the hospital Foundation. Sample analysis will be conducted at BioMark’s lab in Quebec. A positive outcome of the studies will further demonstrate BioMark’s diagnostic assay in differentiating patients who respond vs non-responders faster to immunotherapy, chemo, and radiotherapy treatment. The ultimate goals include improving quality-of-life treatment selection for patients and overall cost savings. BioMark’s assay is intended to monitor response faster and more accurately.
The large multimodal early lung cancer patient recruitment conducted at IUCPQ under Dr. Joubert has been concluded by the end of December 2023. Over 50% (> 2500 samples) have been analyzed at BioMark’s Quebec-based labs. Additional samples are expected in March and April. Full data readout is still expected by the end of Q1 2024 at a specific venue where all the strategic partners are expected to meet.
BioMark and AstraZeneca’s team are mapping a roadmap for several high-impact projects that could lead to a deeper and more expansive collaboration between the 2 parties.
On January 26th, 2024, Research Manitoba selected an application made by Dr. Miller under its Innovation Proof-of-Concept (IPoC) Grants program. Full details on the total funding that would also include additional funding from Mitacs will be announced shortly.
On January 31, 2024, BioMark Chief Scientific Officer Jean-François Haince, has been invited to present the Company during the “Connect-Bio: Personalized Medicine” Networking event organized by CQDM and Axelys. More than 150 people showed up to listen to interesting presentations on personalized medicine and then exchange ideas with each other during a cocktail reception which continued into the evening. The event was most stimulating, creating pleasant exchanges and effective networking between the participants.
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 is being reviewed by the group that also includes clinicians.
The management team 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 held in January were promising and interest is high as progress is being made on multiple fronts.
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.
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 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.
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, 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 February 3rd, 2024
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
January 31, 2024
|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