Form 7 Monthly Progress Report May 2023
Name of Listed Issuer:
Number of Outstanding Listed Securities:
BioMark Diagnostics Inc. (the “Issuer”)
June 2, 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 European Society of Medical Oncology in Paris France on Sept 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.
These 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 ISO 15189:2012 standard for the Canadian operation but also CLIA and CAP approvals to provide lab services in U.S.is ongoing.
Engage with several high-profile 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). 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 non-dilutive funding 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, supply chain bottlenecks and labour shortages especially in bioinformatics and laboratory technician. Management is taking measures to counteract any negative impact of these factors by instituting agile strategies with resilient operational and financial systems/processes.
On May 3rd, 2023, BioMark announced that its abstract has been accepted for presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from June 2nd. to 6th. 2023, in Chicago, Illinois. The abstract entitled “Large Scale Retrospective Validation of Plasma Metabolite Panel for Early-Stage Lung Cancer Risk Assessment”, will be featured during a poster session on June 3, 2023, from 8:00 – 11:00 a.m. CT at the McCormick Place in Chicago.
BioMark signed an NDA with a Brazilian based laboratory on May 16, 2023. This will set the stage to explore further collaboration and commercialization options related to its early lung cancer molecular diagnostic for the domestic Brazilian and other S. American markets which the party has a leading market presence. The Canadian Trade Commissioner in Brazil continues to provide important country specific information to facilitate a deeper market understanding of the Brazilian market and key health imperatives under the newly elected government. More updates to follow as advancements are made.
BioMark and AstraZeneca team were invited to present data at the Lord/SynergiQc scientific offsite retreat meeting in Quebec held from May 9-10th. by IUCPQ. The group discussed progress on the current 4000 lung cancer trial along with other developments.
BioMark’s Quebec based subsidiary, BioMark Diagnostic Solutions Inc (“BDS”), submitted the IP Commercialisation Grant application to the City of Quebec. The grant is to advance commercialisation of patented technologies owned by BioMark. The grant is up to amount of $250,000.00, and it will be split between 2023 and 2024 budget. The city committee will be evaluating the proposal during the month of June. Outcome will be announced accordingly.
BioMark’s along with its clinical collaborators at Mt. Sinai, Drs. Hirsch, Rolfo and Zulueta are working on several important funding applications linked to government institutions looking at emerging and disruptive diagnostic technologies that can offer affordable and accessible options to underserved and under resourced communities geared to increase lung cancer screening across the US. These efforts are also being strongly supported under Biden’s Moonshot cancer program. Biden’ Moonshot program which has 5 Key priority areas: close the screening gap, understand and address environmental exposure, decrease the impact of preventable cancers, bring cutting-edge research through the pipeline to patients and communities, and support patients and caregivers.
BioMark and its research partners at IUCPQ have submitted a funding proposal to AstraZeneca under its “Matters to Millions” initiative to support novel approaches and technologies that enable access to lung screening to remote and underserved communities. The proposal was presented to the international group at the end of May. The outcome will be announced accordingly.
On May 31st, 2023, BioMark announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,656,229, which was filed as a provisional on June 26, 2015, and titled Method of Detecting Lung Cancer. The issued patent belongs to a larger family of patents on the Company’s biomarker panel for detecting lung cancer, and complements similar patents already approved in Japan and Canada and pending in Europe, and China.
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.
On May 31st, 2023, BioMark announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,656,229, which was filed as a provisional on June 26, 2015, and titled Method of Detecting Lung Cancer.
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 June 2nd, 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
May 31, 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