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Mainz Biomed Provides Half Year 2024 Corporate Update

Mainz Biomed Provides Half Year 2024 Corporate Update

Mainz Biomed提供了2024年上半年公司更新。
Mainz Biomed ·  07/02 12:00

Industry Leading Clinical Data Position the Company for FDA Premarket Approval Study

以行業領先的臨床數據爲後盾,公司將啓動FDA前市場批准研究。

BERKELEY, US – MAINZ, Germany – July 2, 2024 — Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first six months ending June 30, 2024, and provided a corporate update. The Company expects to release its half year financial results in September 2024.

加州伯克利市, 美國 – 德國美因茨 – 2024年7月2日 — 分子遺傳學診斷公司 Mainz Biomed N.V. (NASDAQ: MYNZ) 今日回顧了截至2024年6月30日的頭六個月的主要成就,並公佈了公司最新的情況。該公司預計將在2024年9月發佈上半年的財務報告。

Key Highlights During First Half 2024

2024年上半年的主要亮點。

  • Mainz Biomed presented industry leading results of its pooled study at ASCO 2024; which confirmed the previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia; the results from the pooled study represents the third consecutive confirmation of the consistently good performance of Mainz Biomed's mRNA biomarkers to detect CRC and precancerous lesions
  • Mainz Biomed was awarded a Poster of Distinction at Digestive Disease Week presenting data from its eAArly DETECT study, positioning the Company for its planned FDA trial; the poster presented industry leading results: 97% sensitivity for colorectal cancer, 82% for advanced precancerous lesions; the study demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected
  • The Company participated in the 39th UDH Congress 2024, in Fellbach, Germany. One of the main focus topics for this year's event, organized by the German Complementary Medicine Association (Union Deutscher Heilpraktiker, Landesverband Baden-Württemberg), was the gut and its significance in the manifestation of diseases
  • Mainz Biomed participated and exhibited at the esteemed Gynecology Congress ('Gynäkologie und Geburtshilfe aktuell') in Stuttgart, Germany. This engagement signifies the Company's commitment to advancing colorectal cancer screening through their innovative diagnostic solution ColoAlert and highlights the pivotal role of gynecologists in the early detection of this prevalent disease
  • The Company continues to make strong progress in the development of strategic partners to assist in the Mainz Biomed's efforts to achieve pre-market approval from the FDA and in its go-to-market strategy in the U.S.
  • Mainz Biomed partnered with Trusted Health Advisors to support its U.S. go-to-market strategy for the next generation early colorectal cancer diagnostic test; Jay Wohlgemuth, former Chief Medical & Scientific Officer of Quest Diagnostics and Dr. Ray Tabibiazar, a seasoned industry executive, are leading the collaboration
  • The Company formed a strategic partnership with TomaLab, a premier biotechnology laboratory based in Milan, to launch the Company's flagship product, ColoAlert in Italy. The partnership signifies a major step forward in enhancing colorectal cancer screening and diagnostics within the Italian healthcare system as it enables the implementation of ColoAlert into Italy's robust healthcare framework, providing patients with access to a cutting-edge diagnostic solution that combines convenience with clinical excellence
  • Mainz Biomed在ASCO 2024上展示了其蒐集研究的行業領先結果;目前已經確認Mainz Biomed 的mRNA生物標誌物檢測效度令敏感性達到92%的結直腸癌和82%的晚期腺瘤,包括95.8%的高級別重度異型增生;該蒐集研究結果別之前的ColoFuture和eAArly DETECt研究結果的好性能,這是第三次證實同樣好的性能。
  • Mainz Biomed在消化疾病週上獲得了一張傑出海報,並介紹了來自其eAArly DETECt研究的相關數據,爲其計劃的FDA試驗做好準備;該海報呈現了行業領先的結果:結直腸癌敏感性達97%,早期癌前病變82%;研究表明,在晚期癌前病變患者中,可以檢測到高級別重度異型增生的100%。
  • 該公司參加了在德國菲爾巴赫舉辦的第39屆UDH大會,主要討論話題之一是關於腸道及其在疾病診斷中的重要作用。
  • Mainz Biomed參加並展出了在德國斯圖加特舉辦的著名婦科會議(“Gynäkologie und Geburtshilfe aktuell”)。這次參會表明了該公司通過其創新的診斷解決方案ColoAlert來推進結直腸癌篩查的承諾,並強調了婦科醫生在早期發現這種普遍疾病中的關鍵作用。
  • 公司在開發戰略合作伙伴方面取得了強有力的進展,以協助Mainz Biomed在美國實現前市場批准,並推行市場策略。
  • Mainz Biomed與Trusted Health Advisors合作支持其早期結直腸癌診斷下一代產品的美國市場推廣戰略;曾任 Quest Diagnostics首席醫學和科學官的 Jay Wohlgemuth和業界資深人才 Dr. Ray Tabibiazar 將共同領導此次合作。
  • 公司與米蘭優秀生物技術實驗室TomaLab達成了戰略合作伙伴關係,在意大利推廣該公司的旗艦產品ColoAlert。這次合作是提升意大利醫療體系內的結直腸癌篩選和診斷的重要一步,它將使ColoAlert能夠在意大利的健康保健框架中得到推廣,併爲患者提供結合方便性和臨床卓越性的先進診斷解決方案。

"I'm extremely pleased with the progress achieved during the first half of 2024 as we execute our ambitious corporate growth strategy driven by our incredible clinical results in three studies published so far this year," commented Guido Baechler, Chief Executive Officer of Mainz Biomed "We head into the second half of 2024 with a great deal of momentum as we plan for the beginning of enrollment planning for the ReconAAsense U.S. FDA pivotal CRC study."

Mainz Biomed首席執行官Guido Baechler評論說:“非常高興看到我們在2024年上半年取得的進展,我們實現了一個雄心勃勃的企業成長策略,這歸功於我們今年迄今爲止三個研究中令人驚歎的臨床結果。我們以巨大的動力進入了2024年的下半年,計劃開始爲ReconAAsense美國FDA關鍵性CRC研究招募。”

Please visit Mainz Biomed's official website for investors at mainzbiomed.com/investors/ for more information

請訪問Mainz Biomed的官方網站mainzbiomed.com/investors/獲取更多信息。

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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.

關於結直腸癌
根據世界癌症研究基金會國際數據,結直腸癌(CRC)在全球範圍內是第三大常見癌症,2020年報告了190萬多例新病例。美國預防服務工作組建議,應每三年進行一次含大便DNA的篩查測試,如ColoAlert,起始年齡爲45歲。每年在美國進行1660萬次結直腸鏡檢查。然而,約三分之一的年齡在50-75歲之間的美國居民從未進行結腸癌篩查。這種篩查間隙爲美國提供了40億美元以上的市場機會。

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 planning to run 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.

關於梅因茨生物醫學股份有限公司
梅因茨生物醫學開發面向致命疾病的市場成熟的分子遺傳學診斷解決方案。該公司的旗艦產品是ColoAlert,是一種準確、非侵入式、易於使用的早期結直腸癌檢測診斷試驗,基於糞便樣本中分子遺傳學生物標誌物的實時聚合酶鏈反應(PCR)多重檢測。ColoAlert目前在整個歐洲市場推廣。該公司計劃進行FDA PMA臨床試驗,以獲得美國監管批准。梅因茨生物醫學產品候選人組合還包括早期胰腺癌篩查試驗PancAlert。要了解更多信息,請訪問mainzbiomed.com。

For media inquiries

媒體垂詢

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@mainzbiomed.com

如需投資者諮詢,請聯繫info@mainzbiomed.com

Forward-Looking Statements

前瞻性聲明

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 9, 2024. 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.

本新聞稿中作出的某些聲明是“前瞻性聲明”,在1995年《私人證券訴訟改革法》的“安全港”條款下。前瞻性聲明可以通過使用諸如“預計”、“相信”、“期望”、“估計”、“計劃”、“展望”和“項目”等其他類似表達方式來識別或指示未來事件或趨勢或者非歷史事項的表述。這些前瞻性聲明反映了現有信息的當前分析,並且受到各種風險和不確定性的影響。因此,在依賴前瞻性聲明時必須謹慎行事。由於已知風險和未知風險,實際結果可能與公司的預期或投影有所不同。以下因素,包括但不限於以下因素,可能導致實際結果與所描述的前瞻性聲明不同:(i)未能達到預期的發展和相關目標;(ii)適用法律或法規的變化;(iii)COVID-19大流行對公司及其現有或擬開發市場的影響;以及(IV)本文中所述的其他風險和不確定性,以及該公司在其他報告和其他公開提交給證券交易委員會(“SEC”)的文件中不時討論的風險和不確定性。有關這些和其他可能影響公司預期和投影的因素的詳細信息可在其最初提交給SEC的文件中找到,包括於2024年4月9日提交的20-F表上的年度報告。該公司的SEC備案文件可在SEC網站www.sec.gov上公開使用。我們在本新聞稿中所作出的任何前瞻性聲明,僅基於Mainz Biomed目前可用信息,且僅於發佈日作出。Mainz Biomed無需公開更新任何前瞻性聲明,無論是書面還是口頭的,這些前瞻性聲明可能會不時發生,無論是因爲新信息、未來發展趨勢還是其他原因,除非法律有要求。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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