Form 7 Monthly Progress Report September 2023
Name of Listed Issuer:
Number of Outstanding Listed Securities:
BioMark Diagnostics Inc. (the “Issuer”)
October 1, 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 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 10th, 2022, and 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 112th Annual Meeting of the United States and Canadian Academy of Pathology (USCAP) 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 population.
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 in Q4 2023 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 approvals to provide lab services in the U.S.
Seek 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 population (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 population at risk of developing lung cancer.
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 steady rise in interest rates, financial system instability due to evolving risk, the rapid rise in AI and automation, geopolitical tensions, and labour shortages, especially in recruiting bioinformatics and laboratory technicians. 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 expanded its technical team and hired two additional staff members to support all activities related to securing lab certification and running clinical samples as it prepares the launch of its early lung cancer assay by Q4 2023. Funding to support the hiring of the personnel was provided by NRC-IRAP. The company is looking to expand its workforce in the near term to support the future scale-up of the operation.
The company has completed the recruitment of patients enrolled under the measuring response to immunotherapy for advanced-stage lung cancer trial that are being conducted at IUCPQ under Dr. P. Joubert. Results are expected by Q3/Q4 2023. This sponsored research is funded by a Foundation grant. 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 treatment which ultimately leads to better quality-of-life treatment selection for patients and overall cost savings. BioMark’s assay is intended to monitor response faster and more accurately.
BioMark collaboration with its US-based academic institution which has exceptional capabilities in AI and ML domains has yielded very promising data on its breast cancer studies that the company will present at an upcoming symposium in the United States. The data analytics and AI team successfully amplified the overall accuracy of the assay on both the sensitivity and specificity measures. The company intends to file for new patents related to this development.
Decision Letters and Presentation Instructions on BioMark’s abstract entitled “Early Detection of Breast Cancer using Targeted Plasma Metabolomic Profiling” will be announced by Mid-October. BioMark submitted an Abstract for a Poster Presentation at the upcoming 2023 San Antonio Breast Cancer Symposium (SABCS) taking place from December 5 to 9, 2023, in San Antonio, Texas. This symposium is a premier global event for breast cancer.
We submitted an application to CQDM’s Connect-Pharma presentation day: Pitch Day scheduled on Oct 19th, 2023. The organizers are seeking world-class research to develop new and effective approaches for the targeted delivery of small molecules, biologics, vaccines or nucleic acids to present to subject matter experts from leading global pharmaceutical organizations. Projects that arouse the interest of pharmaceutical companies are likely to be funded by CQDM’s Quantum Leap program.
BioMark’s innovative and patented therapeutic GBM nanoparticle-delivering platform and siRNA gene silencing target which has promising data might be a strong contender in the pitch competition. BioMark already has an assay in development to monitor response to treatment for GBM and the development of a novel therapeutic agent and delivery mechanism would be very synergistic.
BioMark’s senior management team had a preliminary meeting with a leading reimbursement organization to help understand the opportunities and challenges in securing reimbursement in the United States. This is of vital importance to the company’s US market entry strategy initially for its lung cancer diagnostic assays.
On September 26th, 2023, BioMark participated in “Eureka Investment Readiness Programme – 2023 Online session with Siemens Healthineers”.
Siemens Healthineers is a global provider of healthcare solutions and services, with activities in numerous countries around the world. It develops, manufactures, and sells a diverse range of innovative diagnostic and therapeutic products and services to healthcare providers worldwide. During this session, Siemens Healthineers presented how they currently work with startups, presented a challenge, and invited companies to apply and present their solutions.
BioMark intends to discuss with its collaborating US AI and ML group if we would like to present potential synergetic diagnostic and ML projects that could be well received by Siemens Healthineers group. The deadline for submitting a proposal and a pitch deck is October 13th, 2023.
Eureka is an international network for industrial research and development (R&D) collaboration that includes over 45 economies from Europe, Israel, South Korea, Argentina, Chile, Singapore and Canada. This unique and powerful platform has made it easier for Canadian small and medium-sized enterprises (SMEs) to accelerate their growth through access to global value chains and collaboration with international partners.
The National Research Council of Canada (NRC) is Canada’s National Office for Eureka and provides Canadian companies, researchers and academics with a first point of contact and access to the expansive global network.
On September 28th, 2023, BioMark’s subsidy BioMark Diagnostics Solution hosted an event organized by Quebec International and Québec VITAE on “The resilience of businesses in life sciences” in Quebec City. It was an inspiring event that highlighted the resilience of 3 companies active in different sectors, but still connected by omics (personalized health). Attendees had the chance to meet and visit the laboratories of Biomark Diagnostics Inc, BioTwin and Harvest Genomics, as well as to better understand the growth opportunities offered by adMare BioInnovations.
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 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 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, 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 October 1st, 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
September 30, 2023
|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