Form 7 Monthly Progress Report April 2024
Name of Listed Issuer:
Trading Symbol:
Number of Outstanding Listed Securities:
Date:
BioMark Diagnostics Inc. (the “Issuer”)
BUX
90,886,229
May 3rd, 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 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 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.
Realize plasma analysis on the large-scale early lung cancer multimodal study (5000 patients) across 7 hospitals based in Quebec which recently completed enrollment of patients. Early 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. Certification is expected later in Q2.
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 and accessibility across different states especially for rural and communities that have limited resources.
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, 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.
Businesses are still facing strong inflationary headwinds with a stiff and sticky high-interest rate, rapid 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 April 29, 2024, report, life sciences equity and equity-linked deal flow was robust across offering types in Q1, 2024. Specialist healthcare investor appetite persists for data-driven stories (and deals), although opportunistic deals are dominating 2024 equity issuance. There are early signs of a return of generalist investor interest in life sciences equities. Q1,24 rivaled Q1,21 in terms of volume raised. 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 through strategic collaboration to leverage the computing power of advanced analytics in cancer diagnostics. Most of its assay results will be enriched using AI and ML capabilities.
On April 9, 2024, BioMark announced the Company has received non-dilutive research funding from a competitive grant to advance the development of a cancer treatment for Glioblastoma. Led by Dr. Donald Miller of the University of Manitoba, Faculty of Health Sciences, the project titled “Examination of lipid nanoparticle loaded hydrogels for localized silencing of spermidine/spermine acetyl transferase-1 (SAT1) expression in tumor and enhanced radiation and chemotherapy response” has secured over $290,000 in funding over two years, including support from Research Manitoba IPoC Grant and Mitacs Accelerate research programs.
Two abstracts related to Glioblastoma research led by Drs. Donald Miller and Dr. Ted Lakowski group have been submitted for presentation at the 14th biennial Globalisation of Pharmaceutics Education Network (GPEN) to be held at the University of Copenhagen taking place from the 14th-17th of July 2024. The abstracts are titled: a). Evaluation of Hydrogel Formulations for Local, Sustained Delivery of Spermidine/spermine N1-acetyltransferase Small Interfering RNA Loaded Lipid Nanoparticles to Glioblastoma Tumor Cells and b). Examination and identification of potential drug biomarker candidates for glioblastoma
Advanced discussions continue with Siemens Healthineers’ senior management group. BioMark is actively involved in bi-weekly consortium meetings that involves a select group of 10 leading European institutions and other SMEs. The group is working on completing work packages for the Innovative Health Initiative (IHI) “Breathe” proposal that will be submitted under the Europe Horizon program. The proposal due date is slated for the end of May 2024 and BioMark’s management is currently heavily focused on completing the business, technical, and scientific application requirements. Program highlights and results of the application will be shared when an official announcement is made later in July 2024.
On April 18, 2024, BioMark announced that the Company amended the terms of 5,062,000 non-broker warrants (the “Warrants”) issued to a private placement financing that closed on May 4th, 2022. The warrants will be extended its term by two years such that the warrants will be exercisable until May 4th, 2026, at the same exercise price per share of C$0.45. All other terms of the warrants will remain unchanged. In addition, the Company granted 4,625,000 stock options to key employees, the management team, scientific advisors, and consultants. Each Option grants the holder the right to purchase one Common Share at a purchase price of $0.45 per Common Share for three years from the date of issuance. All terms and conditions of these options will be in accordance with the terms of the Company’s Stock Option Plan (2022).
BioMark and AstraZeneca’s North American early cancer detection team are scheduled to meet on May 1, 2024, in Toronto to update the group on its progress related to the early lung cancer clinical trials and further discuss potential collaboration initiatives specifically focused on North America (US and Canada) with a key emphasis on lung cancer and respiratory disease.
BioMark, AstraZeneca Global, and Canada Group will be attending the presentation for the LORD/SynergiQc scientific retreat to be held from May 7th to May 9th in Quebec City. This meeting will discuss some highlights on the completion of the 5000-patient multimodal early lung cancer clinical trial.
BioMark’s studies in breast and lung cancers are being further refined using the latest advancements in advanced statistical analysis and machine learning algorithms at Harrisburg University. The team is working on various publications to demonstrate the encouraging results. The team is finalizing the paper on the use of AI/ML and metabolomics on breast cancer that will be submitted in a special edition peer-reviewed publication by May 10, 2024.
BioMark Diagnostic Solutions Inc. based in Quebec has retained LOK North America to conduct an internal audit of its Quality Management System for its lab certification under ISO 15189:2022 international standards. There was no major non-conformance that were identified, and the final accreditation audit will take place within the second half of 2024.
Dr. Rolfo from the Icahn School of Medicine at Mount Sinai, New York City, with his team including, Dr. Fred R. Hirsch, Dr. Diego de Miguel Perez, and the Incidental Lung Nodule program at Mount Sinai Morningside Hospital along with BioMark are jointly filing an NIH R01 PAR 21-166 grant application for up to $1.5 million funding with a focus lung cancer nodule management using metabolomics and radiomics.
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 planned in early April. 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, favorable 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.
On April 18, 2024, the Company amended the terms of 5,062,000 non-broker warrants (the “Warrants”) issued to a private placement financing that closed on May 4th, 2022. The warrants will be extended its term by two years such that the warrants will be exercisable until May 4th, 2026, at the same exercise price per share of C$0.45. All other terms of the warrants will remain unchanged.
In addition, the Company granted 4,625,000 stock options to key employees, management team, scientific advisors, and consultants. Each Option grants the holder the right to purchase one Common Share at a purchase price of $0.45 per Common Share for three years from the date of issuance. All terms and conditions of these options will be in accordance with the terms of the Company’s Stock Option Plan (2022).
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 May 3rd, 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 April 3-, 2024 |
Date of Report YY/MM/DD 2024/05/03 |
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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 |