Form 7 Monthly Progress Report April 2024

biomark-progress-report

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

April 5th, 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

  1. 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.

  2. The term “Issuer” includes the Issuer and any of its subsidiaries.

  3. Terms used and not defined in this form are defined or interpreted in Policy 1 – Interpretation and General Provisions.

Report on Business

  1. 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.

  • 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. 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.

  1. 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 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 March 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 necessary to leverage the power of advanced analytics in cancer diagnostics.

  • Advanced discussions continue with Siemens Healthineers’ senior management group. BioMark joined their IHI partner meeting held on March 27 that involved a selected group of 10 leading European institutions and other SMEs. The group will be working on completing a major proposal that will be submitted under the Europe Horizon program. Details will be shared when an official announcement is made, and as specific proposal milestones are completed and submitted to the agency in charge of the application.

  • The Company received a second batch of lung cancer samples from our European partner institution Hospices Civils de Lyon (HCL) in France. These sample are from a prospective screening program and will be analyzed in BioMark’s lab facilities in Quebec City by the end of April/early May. Data will be shared with the group from HCL. Data from a second-time point will also be shipped later to BioMark to prospectively analyze the data to assess the disease status or progression.

  • Advanced discussions continued between BioMark and AstraZeneca’s team to map out a roadmap for several high-impact projects that could lead to deeper and more expansive collaboration between the 2 parties.

  • BioMark and Rubix team banded together to submit a Solution Summary to the APRA-H Sprint for Women’s Health Program in the USA. The program seeks unconventional approaches and innovative new avenues to push high-impact biomedical research forward to improve women’s health outcomes. The submission process includes a Solution Summary followed by a Pitch session. The first application has been submitted with a topic focused on preserving ovarian health past reproductive age. The group is working on 2 additional submissions. One is related to early lung cancer detection for at-risk women representing underserved communities and the other is on assessing response to treatment for women with TNBC (Triple negative breast cancer an aggressive breast cancer subtype that is common in African American women) using BioMark’s SSAT legacy assay. The total grant (non-dilutive can range between $3 million for early discovery to $10 million for ready-to-launch projects.)

  • 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 peer-reviewed publication later by the end of April 2024.

  • BioMark Diagnostic Solutions Inc. based in Quebec is preparing to secure lab certification status within 4-6 months. Pre-audit meetings with audit offers for the lab certification were held throughout the month of March.

  • Biomark and Dr. Don Miller are expecting to receive positive notification of their Research Manitoba and Mitacs grant applications entitled: “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.” The total value of the grant is over$250K and will be used to generate a first proof-of-concept in animal model.

  • 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, 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.

The ARPA-H Sprint for Women’s Health aims to address critical unmet challenges in women’s health across all demographics, geographies, and socioeconomic statuses, championing transformative innovations and tackling health conditions that uniquely or disproportionately affect women from every walk of life.

Through the sprint, ARPA-H aims to galvanize the innovator, investor, researcher, and patient advocate communities to proactively address women’s health challenges, raise awareness, and spur innovation with two significant funding opportunity tracks, up to a total of $100 million.

These funding opportunity tracks aim to foster transformative research and development efforts: one for early-stage research, or “Spark” solutions, and the other for later-stage development, or “Launchpad” solutions.

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. Describe the acquisition of new customers or loss of customers.

Not applicable.

  1. Describe any new developments or effects on intangible products such as brand names, circulation lists, copyrights, franchises, licenses, patents, software, subscription lists and trademarks.

On March 26, 2024, the Company was informed that the patent application named “METHOD FOR ASSAYING THE ACTIVITY OF SPERMIDINE/SPERMINE N1-ACETYLTRANSFERASE” has been allowed by the USPTO. The application will be officially granted after completing certain formalities.

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.

  1. Report on any employee hiring, terminations or lay-offs with details of the anticipated length of lay-offs.

Not applicable.

  1. Report on any labour disputes and resolutions of those disputes if applicable.

Not applicable.

  1. 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.

  1. Provide details of any indebtedness incurred or repaid by the Issuer together with the terms of such indebtedness.

Not applicable.

  1. Provide details of any securities issued and options or warrants granted.

Not applicable.

  1. Provide details of any loans to or by Related Persons.

Not applicable.

  1. Provide details of any changes in directors, officers, or committee members.

Not applicable.

  1. 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:

  1. 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.

  2. As of the date hereof there where is no material information concerning the Issuer which has not been publicly disclosed.

  3. 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).

  4. All of the information in this Form 7 Monthly Progress Report is true.

Dated April 5th, 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

March 4, 2024
Date of Report
YY/MM/DD

2024/04/05
Issuer Address

130 3851 Shell Road
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
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BioMark Diagnostics Inc.
CSE: BUX
OTC: BMKDF
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