Could you please give us an update on the status of Mainz Biomed’s financing? What is planned to secure financing going further?

At year end, Dec 31, 2023, we reported that our cash balance amounted to 7.1 million USD. In the meantime, we have secured funding in the form of an additional 3.3 million USD financing under our 50 million USD borrowing facility. We have implemented strict financial discipline across all departments to reduce our burn, which in turn extends our runway, and we are constantly evaluating multiple financing options.

When will the quarterly results be published?

Last year, we reported quarterly financial results on a voluntary basis. As we are focusing our resources on the preparation of ReconAAsense as well as securing the necessary funding for our Company, we will report financial results on a half-year basis in 2024 in accordance with the disclosure requirements for foreign issuers listed at NASDAQ.

When will ReconAAsense start, what is the rationale for the current delays?

ReconAAsense, our FDA PMA pivotal study, is the basis for approval of our next-generation product in the US as well as its international market launch. The success of this study is of strategic importance for Mainz Biomed and, therefore, our highest priority. With planned recruitment estimated between 10,000 and 15,000 patients in 150 sites across the USA, ReconAAsense requires strong strategic and institutional commercial and financial support. The next major milestone on our mission to transforming the CRC diagnostic landscape is the beginning of enrolment.

Why does Mainz Biomed no longer seek reimbursement by public insurances for ColoAlert in Germany?

Our marketing experts are constantly evaluating our sales strategy for sustainable, long term growth of revenue for ColoAlert® and our next generation product. Mainz Biomed is currently focusing on the next-generation screening test, including the mRNA biomarkers, which according to recent very positive clinical results accurately detects both colorectal cancer and notably also advanced adenomas at a high level of sensitivity and specificity. As the next-gen test offers significant added value to policyholders and insurers, Mainz Biomed concentrates its efforts towards reimbursement as well as the inclusion into the guidelines on the new version of the screening test. We are still in close exchange with statutory health insurances in Germany regarding the reimbursement of ColoAlert® and are making steady progress. This could result in individual contracts with certain health insurance companies for our current ColoAlert® product. Given our planned market launch of our next-gen CRC screening test in Germany in 2026, that is the focus of our reimbursement efforts.

What is the status of the Mainz Biomed’s FDA Breakthrough Device application?

Following encouraging feedback from the FDA, we’ve made the strategic decision to withdraw our breakthrough device designation application to focus on expanding our clinical research program to address feedback received from the FDA. We will expand our patient dataset to include a larger average-risk patient population. We plan to submit this comprehensive data in 2025 to FDA. Exciting progress ahead for Mainz Biomed!

What is the anticipated timing of Mainz Biomed’s 2024 interim financial reporting?

Pursuant to Nasdaq and SEC rules the June 30, 2024, financials are required by December 31, 2024.  The Company plans not to wait that long, but rather file during the fourth quarter of 2024.