European Study ColoFuture and U.S. Study eAArly DETECT report sensitivity and specificity for the detection of Colorectal Cancer and Advanced Adenoma exceeding competition
ReconAAsense designed to evaluate gold standard at home colorectal cancer screening test and is on track to commence enrollment in mid-2024
Expanded international commercialization of ColoAlert® in major European markets and Israel
BERKELEY, US – MAINZ, Germany – January 9, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a year end summary of its corporate and product development progress.
Key Commercial, Product Development and Operational Highlights Included:
- Announced groundbreaking results from ColoFuture (Europe) and eAArly DETECT (U.S.) clinical studies evaluating the potential to integrate portfolio of novel gene expression (mRNA) biomarkers into a next generation version of ColoAlert®.
- ColoFuture reported sensitivity for colorectal cancer (CRC) of 94% with specificity of 97% and advanced adenoma (AA) sensitivity of 80%.
- eAArly DETECT reported sensitivity for CRC of 97% with a specificity of 97% and a sensitivity for AA of 82%.
- Expanded international commercialization of ColoAlert®, a highly efficacious and easy-to-use DNA-based detection test for CRC being sold via Company’s unique business model of marketing products via partnerships with third-party laboratories versus the traditional methodology of operating a single facility.
- Established commercial operations in major markets including Spain, Poland, Romania, Portugal, Israel, and the UK.
- Launched corporate health program with Germany serving as initial market via integration into Country’s BGM system (“betriebliches Gesundheitsmanagement”).
- Ramped-up preparations for pivotal FDA PMA clinical trial (ReconAAsense) which remains on track to commence patient enrollment in mid-2024. Presents an opportunity to achieve gold-standard status for at home CRC screening.
“This past year was an exceptional period for the Company as we executed our international commercial strategy for flagship product ColoAlert® while advancing product development programs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The latter half of 2023 was especially exciting given the groundbreaking results from the ColoFuture and eAArly DETECT studies which reported extraordinary statistical significance for CRC lesion detection and advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease. This outstanding outcome enables optimal trial design for the ReconAAsense pivotal FDA PMA study that if successful, will now represent disruptive innovation in self-administered CRC screening, providing the opportunity to bring to market the most advanced diagnostic tool on the market. As such, we head into 2024 with a great deal of momentum as we make final preparations for ReconAAsense, with patient enrollment targeted to commence mid-year. On the commercial front we’ll continue to expand our international footprint while strengthening our presence in established markets.”
2023 Commercial Summary: Expanded international partnership network and increased presence in established markets.
Throughout 2023, Mainz Biomed executed its differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Under the standard terms of all partnerships, Mainz Biomed is providing ColoAlert® to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz Biomed’s customized polymerase chain reaction (PCR) assay kits on an on-demand basis and provides their respective network of physicians and patients with a comprehensive solution for advanced CRC detection. During the year, Mainz Biomed expanded its commercial operations in major international territories by extending its network of laboratory and distribution partners while continuing to gain traction in established markets.
During the year, Mainz Biomed launched commercial operations in Spain, Portugal, Romania, Poland, the United Kingdom, and Israel. For Spain and Portugal, the Company established a partnership with The Instituto de Microecologia, widely known for its pioneering work in intestinal health. The laboratory offers a wide range of diagnostic and analytical services and is continuously advancing its scientific and technical capabilities through ongoing internal research alongside external collaborations. The Institute deploys the most innovative diagnostic techniques by continuously auditing procedures to ensure delivery of the highest standard of quality and reliability of diagnostic results. According to the World Cancer Research Fund International, CRC is the third most common cancer worldwide and Portugal ranks seventh in total global CRC rates with 10,501 cases reported in 2020. On its website, the Institute lists CRC as the second leading cause of death from cancer in Spain and the most frequent malignant tumor, with over 41,000 new cases each year affecting 1 in 20 men and 1 in 30 women before the age of 74.
For the UK, Mainz Biomed is collaborating with Marylebone Laboratory, which recently expanded its presence in London, under the Marylebone Diagnostic Centre brand where it provides a comprehensive range of screening and diagnostic testing services. Across the UK, CRC remains a critical health concern, with approximately 43,000 diagnoses and 16,800 deaths occurring each year in the UK alone. This equates to an average of 46 lives lost every day. With a population of 67 million people, the UK, presents a substantial market for CRC screening. Specifically, within the age groups of 40 to 49 years and 50 to 75 years, there are approximately 8.4 million and 20 million individuals respectively. Additionally, there are 6.2 million individuals aged over 75. With a recommended frequency of CRC screening once every two years for patients aged 50 to 74, ColoAlert® represents a pivotal tool in the fight against this devastating disease. Considering these figures, the addressable UK market for ColoAlert® amounts to a staggering 34.6 million potential users.
In Poland, Mainz Biomed partnered with testDNA Sp. z o. o. Sp. K (“testDNA”), one of the country’s leading DNA-based testing services. Its laboratory, headquartered in Katowice, Poland, boasts an expansive network of over 300 collection points throughout the country. Poland is a particularly important market as the need for alternative CRC screening options is underscored by data from the World Cancer Research Fund International which ranked Poland 7th (seventh) in the world for the highest mortality rate. With over 21 million people aged over 40, the market opportunity for ColoAlert® is significant, especially as there has been a low level of national participation in CRC screening which traditionally has been colonoscopies.
In Romania, Mainz Biomed secured a partnership with Bioclinica a leading supplier of healthcare products in Romania, with over 25 years of experience in medical diagnostics. Through its 15 associated laboratories and 146 collection points, Bioclinica provides state-of-the-art diagnostics to the Romanian population. According to United Nations, Department of Economic and Social Affairs population statistics, ColoAlert® screening has the potential to benefit over 6 million individuals aged between 50 and 74 years in Romania where the CRC incidence rates are among the highest in Europe.
Mainz Biomed entered the Israeli market via a partnership with Fugene Genetics (FG). Founded in 2008, FG is a renowned genetic testing service provider offering a wide range of advanced genetic testing services to private clients, health organizations, hospitals, and genetic institutes throughout the country. Israel has one of the highest screening compliance rates in the world with over one million people being screened each year. It is expected that over 3.5 million adults could benefit from the availability of ColoAlert® in Israel.
A major commercial objective for 2023 was to fortify the Company’s presence in Germany, its flagship international market. To this end, Mainz Biomed expanded its footprint with additional laboratory partnership, increasing awareness of ColoAlert® in the Country’s private health insurance segment, and by launching a corporate health program via integration into the Country’s BGM system (“betriebliches Gesundheitsmanagement”), an established health initiative providing services to employees at 48 of the 50 largest companies in the country.
Key German partnership highlights included the establishing a partnership with Dr Staber & Kollegen GmbH (Labor Staber), which for more than 35 years, has been providing physicians and hospitals with medical laboratory services at nine locations across Germany.
During the year, integrating ColoAlert® into Germany’s private health insurance reimbursement segment was an important initiative and a significant highlight of this effort was partnering with Ärztliches Labor Dr. Buhlmann, a respected player in PCR-based analysis. Approximately 10.5% of Germany’s population, or roughly 8.7 million individuals, are covered by private health insurance (PHI), as estimated by the Association of Substitute Health Insurance Funds (vdek) in 2022. A substantial portion of these PHI beneficiaries fall within the critical 50-74 age range, the target demographic for CRC screening in Germany so clearly, this is an important addressable market.
Mainz Biomed’s launch of a corporate health program in Germany was the final piece to the German specific commercial strategy for ColoAlert®. The Company’s integration into the Country’s BGM (“betriebliches Gesundheitsmanagement”) corporate health network provided access to a €1 billion annual market. The BGM provides healthcare services to employees ranging from gym memberships to diabetes management to counseling, all to better their health. Mainz Biomed’s integration into these BGM programs included the launch of an online portal through which employees can register to be sent the ColoAlert test. Once the sample is received and processed, confidential test results are sent back to the employee through the portal, along with an explanation of the results. If an employee has approved for their physician to also be notified, then the doctor can follow up with the patient accordingly. Mainz Biomed provides education for both the employee and physician regarding the ColoAlert® results and CRC, as well as recommendations for next steps.
2023 Product Development Summary: Achieved major milestone by reporting groundbreaking ColoFuture and eAArly DETECT study results which positioned U.S. pivotal clinical trial (ReconAAsense) to evaluate a gold standard self-administered CRC screening test. ReconAAsense on track to commence patient enrollment mid-2024.
From a product development standpoint, 2023 proved to be one of the most exciting periods in the Company’s history as Mainz Biomed reported groundbreaking results from its ColoFuture and eAArly DETECT studies. These clinical trials assessed the potential to integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers into its pivotal FDA PMA clinical trial (ReconAAsense) which is evaluating a next generation CRC at home screening test. The ability to integrate these biomarkers into ReconAAsense represents a potentially game-changing innovation in CRC screening as they previously demonstrated the ability to detect CRC lesions, including advanced adenomas (AA), a type of pre-cancerous polyp often attributed to this deadly disease. The ColoFuture study, a multi-center international clinical trial, reported outstanding topline results including demonstrated sensitivity for CRC of 94% with specificity of 97% and AA sensitivity of 80%. Its U.S. counterpart (eAArly DETECT) reported even more impressive top line data demonstrating sensitivity for CRC of 97% with specificity of 97% and AA sensitivity of 82%. Given this extraordinary outcome, the Company is in the process of selecting the biomarkers for inclusion into ReconAAsense, and is planning to initiate enrollment in mid-2024.
The ReconAAsense clinical trial (ClinicalTrials.gov Identifier: NCT05636085) is U.S. a pivotal clinical trial assessing Mainz Biomed’s next generation CRC test and will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization. It will include approximately 15,000 subjects from 150 sites across the U.S. The study’s primary objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA. Given the integration of Mainz Biomed’s portfolio of novel gene expression (mRNA) biomarkers into ReconAAsense, if the trial produces positive results, this next iteration of Mainz Biomed’s CRC test will be positioned as one of the most robust and accurate at home diagnostic screening solutions on the market as it will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas.
In conjunction with ColoFuture and eAArly DETECT the Company entered into a strategic partnership with Liquid Biosciences, a bio-analytics company leveraging its proprietary AI analysis technology platform (EMERGE) to serve the biopharma and diagnostics industries along with academic institutions. Since launching the EMERGE bio-analytics platform, Liquid Biosciences is widely considered to be the premier analytical partner to the life sciences industry. Its technology has been deployed in over 170 projects for Big Pharma and emerging therapeutic and diagnostic companies covering biomarker discovery, clinical trial screening and post-FDA approval services such as patient treatment selection and optimal dosing regiments. Key attributes of EMERGE that make it superior to mainstream AI and machine learning analytical solutions include its computational speed, ability to handle millions of variables and operate agnostically, without any assumptions or constraints. It was designed as a scalable, unbiased methodology to produce transparent algorithms from complex data, without any prior assumptions. This enables the identification of variables with relatively low expression, but which may be functionally important because of the non-linear interactions pervasive in complex biologic systems.
Mainz Biomed also partnered with Microba Life Sciences, a precision microbiome company leveraging a world-leading technology platform for measuring the human gut microbiome to discover and develop novel therapeutics for major diseases, for the development of PancAlert, the Company’s early stage screening test for pancreatic cancer. As part of the agreement, Microba and Mainz Biomed are conducting a pilot research project utilizing Microba’s proprietary metagenomic sequencing technology and bioinformatic tools to potentially discover novel microbiome biomarkers for pancreatic cancer detection.
2023 Operational Summary: Bolstered leadership team and strengthened financial position
During the year, Mainz Biomed continued to enhance its team with an emphasis on commercial additions given ColoAlert®’s rapid expansion in international markets. A key hire was Tarrin Khairi-Taraki as Vice President of Commercial Operations, EMEA. Mr. Khairi-Taraki’s prior experience includes serving as Regional Manager for DACH and BENELUX at Natera, one of the four global leading companies in the prenatal screening field and renowned for its non-invasive, cell-free DNA testing technology. During his tenure at Natera, Mr. Khairi-Taraki played an integral role in driving significant growth through forming crucial collaborations with laboratories, clinics, and practices as well as through enhancing the effectiveness of lab partners’ sales teams. He brings to Mainz Biomed expertise in market analysis and business development strategies which at Natera, resulted in a strong presence for the Company’s innovative Panorama Test across the DACH region and in the highly successful introduction of the test in Austria and the Netherlands.
On the financial front, Mainz Biomed executed two financial transactions. The Company entered into an agreement with investment management firm Yorkville Advisors Global LP which provides the option to access up to $50 million via a Pre-Paid Advance Arrangement and included two $5.5 million promissory notes. In addition, during the latter part of the year, Mainz Biomed executed a registered direct offering with several institutional investors to purchase $5.0 million of its ordinary shares (or pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase ordinary shares.
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ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.
About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.
About Mainz Biomed N.V.
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com.
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Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.