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Tag: diagnostic

  • Meridian Bioscience, Inc. (VIVO) Stock Plummeted After Failing to Meet Financial Expectations for Preliminary Q3 2021 Results

    Meridian Bioscience, Inc. (VIVO) stock prices plummeted by 22.53% some time after market trading commenced on July 13th, 2012, bringing the price per share down to USD$17.43 early on in the trading day.

    Suffering Financials

    July 13th, 2021 saw the provider of diagnostic testing solutions and life science raw materials announce preliminary revenue results for the third quarter of the fiscal year 2021. Preliminary unaudited revenue for the quarter is expected to be less than previously expected, coming in at roughly USD$63.5 million. This is largely driven by supply chain issues with the company’s LeadCare reagents that resulted in increased backorders, negatively impacting the performance of the Diagnostics segment.

    EUA Resubmission

    The company announced on June 28th, 2021 that it had resubmitted its application to the U.S Food and Drug Administration for the Emergency Use Authorization of its proprietary Covid-19 molecular diagnostic test on the Revogene platform. February 22nd 2021 had seen the company voluntarily withdraw its initial EUA application, allowing VIVO to conduct additional studies based on feedback from the FDA. The completion of the additional studies resulted in the resubmission of the EUA application on June 25th 2021.

    RT-LAMP

    Specifically designed to accelerate the development of ambient temperature stable reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) assays, the company announced the launch of the Lyo-Ready RT-LAMP Mix on June 16th 2021. The technology is designed for rapid, robust, and sensitive detection of RNA viruses.

    Scope of RT-LAMP

    RT-LAMP technology is ideal for point-of-care or portable testing, seeing as assays are performed at a single temperature, which reduces the cost and complexity of the device without the need for a thermocycler. The technology has been successfully used in the diagnosing of various infectious disease caused by RNA viruses, including, but not limited to, influenza, hepatitis C, West Nile fever, Dengue virus, and Ebola virus. The accuracy and accessibility of the simple equipment requirement makes it the perfect technology for use as a practical solution for point-of-care detection of viruses. This is particularly helpful in non-standard institutions, such as airports, rural hospitals, or from home.

    Future Outlook for VIVO

    Despite being armed with the development of RT-LAMP and the pending approval of its EUA, VIVO reported a significant dip in equity value following financial reports that did not meet previous expectations. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Check-Cap Ltd. (CHEK) Stock Plummets Following News of Registered Direct Offering

    Check-Cap Ltd. (CHEK) Stock Plummets Following News of Registered Direct Offering

    Check-Cap Ltd. (CHEK) stock prices were down by 19.5364% some time after market trading commenced on June 30th, 2021, bringing the price per share down to USD$1.2150 early on in the trading day.

    Registered Direct Offering

    The company announced on June 30th, 2021 that it had entered into various definitive agreements with institutional and accredited investors. As per the agreement, the company would put up 25,925,926 ordinary shares of the company for sale, along with warrants to purchase up to the same number of ordinary shares. The registered direct offering is seeing each ordinary share being sold in conjunction with one short-term warrant to purchase one ordinary share at a combined offering price price of USD$1.35 per ordinary share and accompanying warrant.

    Share Warrants

    The short-term warrants will have an expiry date of two and a half years following the date of issuance and will be exercisable immediately with an exercise price of USD$1.50 per ordinary share. The closing of the registered direct offering is expected to close on July 2nd, 2021, pending the satisfaction of customary closing conditions.

    Capital Generation

    CHEK forecasts generating roughly USD$35 million in gross proceeds from the offering, before the deduction of expenses related to the offering. This number does not include proceeds received from the exercising of warrants, the full exercising of which will generate additional gross proceeds of roughly USD$38.9 million before the deduction of offering-related expenses. The capital generated from the offering is planned on being allocated towards advancing the ongoing clinical development of C-Scan, including the company’s upcoming U.S pivotal study.

    Manufacturing Hickups

    Technical issues with a single source supplier resulted in delays in manufacturing, but the company continues to develop and expand its entire production process in order to meet its target manufacturing capacity. Consequently, the company forecasts delays in its clinical trials, at the forefront of which is the U.S. pivotal trial which has an updated commencement date in the first quarter of 2022. The company is continuing to scale its manufacturing up to support the upcoming clinical trials once production returns to normal.

    Future Outlook for CHEK

    Armed with an influx of capital generated from its registered direct offering, CHEK is poised to initiate clinical trials that the company hopes to see through to commercialization. Investors are keen for the company to resume normal manufacturing and allocate resources efficiently, so as to ensure maximum possible growth and increases in shareholder value.