Chronicle Journal: Finance

Diagnostic Capabilities Remain of Utmost Importance as Cases Surge Worldwide

NEW YORK, Nov. 25, 2020 /PRNewswire/ -- As of earlier this week, the U.S. has reported more than 12.4 million cases and over 257,600 deaths, according to Johns Hopkins University data. Dr. Anthony Fauci, the National Institute of Allergy and Infectious Diseases, has also warned of "two to three thousand deaths a day times a couple of months, and you're approaching a really stunning number of deaths," USA Today reported. Overall, the global situation is quite concerning, as global totals have reached 59.3 million cases and 1.3 million deaths. According to Communications Officer World Health Organization (WHO), the pandemic has led to a dramatic loss of human life worldwide and presents an unprecedented challenge to public health, food systems and the world of work. The economic and social disruption caused by the pandemic is similarly devastating, with tens of millions of people at risk of falling into extreme poverty, while the number of undernourished people, currently estimated at nearly 690 Million, could increase by up to 132 Million by the end of the year. Todos Medical Ltd. (OTC: TOMDF), CytoDyn Inc. (OTC: CYDY), Aytu BioScience, Inc. (NASDAQ: AYTU), Novavax, Inc. (NASDAQ: NVAX), iBio, Inc. (NYSE: IBIO)

Additionally, it is still unclear just how soon the vaccine candidates from Pfizer and Moderna will be ready to be distributed to the public, considering the logistical challenges associated with it. Whatever the case, continuous testing on a mass scale remains a crucial component in the fight against the pandemic. Testing is also necessary for businesses to bring back customers and some have started to offer various testing options. For example, according to a report by Recode, airlines including United, American Airlines, and Hawaiian Airlines are offering options for COVID-19 testing to passengers traveling to the state of Hawaii. These will include at-home testsdrive-through testing, and in-person tests at the airport. With a negative result in hand, travelers will be exempt from the state's two-week quarantine requirements for new arrivals. 

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news yesterday that, "it has completed the installation of Tecan® laboratory automated equipment at its Wisconsin laboratory client, bringing the client's total capacity to 12,000 COVID-19 PCR tests per day. The installation and scripting of new Tecan EVO200 and Tecan Fluent 780 systems, in combination with the use of Todos' proprietary ANDis 350 automated RNA extraction systems, allow the lab to process 12,000 PCR COVID-19 tests per day. The Company will continue to work with the client to further optimize the workflow to increase capacity to 18,000 tests per day in the weeks ahead, and add additional automated liquid handling, extraction and qPCR instrumentation as required to further support the client's growth. Provided that the client can continue to increase demand from its main client, the State of Wisconsin, the lab expects demand for Todos' testing reagents and consumables to increase to 50,000 COVID-19 PCR tests per day in the next 6 weeks.

Concurrent with this announcement, the Company announced that it has secured a proprietary supply chain for the most in-demand lab consumable products required to conduct PCR testing. This supply chain allows Todos to source over 2,000,000 manual and robotic pipette tips per week for its clients, as well as PCR plates, providing a key competitive advantage to its clients over other labs. An international shortage of lab consumables has emerged as the key rate limiting steps for laboratories to increase their PCR testing capacity worldwide.

'We are excited to have completed this installation process of the Tecan instruments in such a way that we can now replicate this process for several of our clients who are looking to further increase their capacity,' said Gerald Commissiong, President & CEO of Todos Medical. 'Now that we have also secured access to sufficient lab consumables to allow our clients to grow unimpeded as compared with their competition, we are becoming laser focused on supporting the further scaling up of our client's operations within the lab to meet the surging demand for COVID-19 PCR testing in the state of Wisconsin. Additionally, we have delivered a similar set of equipment, including Tecan liquid handlers, ANDis automated extraction and PCR machines to one of our clients in Brooklyn that will allow it to reach similar COVID-19 testing capacities as our Wisconsin client, and we are working with them to implement the workflow in their lab. We expect revenues from our Wisconsin client to increase in the weeks ahead and expect that revenue from our client in Brooklyn to come online in December. We are very excited with the progress we are making in our base PCR lab testing business.'

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com "    

For our latest "Buzz on the Street" Show featuring Todos Medical Ltd. recent corporate news, please head over to: https://www.youtube.com/watch?v=HhBfw-F0BXY

CytoDyn Inc. (OTCQB: CYDY) announced on August 25th the Company has reached the requisite number of enrolled patients in its Phase 3 trial for COVID-19 patients with severe-to-critical symptoms to perform an interim analysis following the 28-day phase of the trial.  Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, "We are very thankful for the many clinicians and their staff who have worked tirelessly to advance enrollment this quickly and for their care of these seriously ill patients. We are eager to perform an interim analysis of the data and remain optimistic the interim results will be consistent with those experienced by patients who received leronlimab through multiple EINDs (over 60) previously authorized by the FDA. And, in the event we are successful, we are well positioned with our distribution partner to accelerate distribution of leronlimab to patients throughout the U.S."

Aytu BioScience, Inc. (NASDAQ: AYTU) announced on September 8th, that the Company has signed an agreement to distribute the Pinnacle CovID RAD Rapid Antigen Detection Test worldwide. The rapid antigen test, which delivers results in fifteen minutes, tests for the presence of the SARS-CoV-2 virus antigen via a nasopharyngeal sample and can be conducted without the use of laboratory equipment.  Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We continue to find ways to help in the COVID-19 fight. This high-performing antigen test - that directly detects the presence of the COVID-19 virus antigen - requires no laboratory equipment and enables medical professionals to deploy large-scale testing in a rapid and simple-to-use format. Antigen testing has become a primary screening tool as we seek to decentralize testing and speed up turnaround times."

Novavax, Inc. (NASDAQ: NVAX) announced on November 4th, the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the Company's COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community.  "This arrangement with the Australian Government reflects the importance of the ongoing clinical development of NVX-CoV2373, and will ensure that the citizens of Australia will have access to its supply," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are pleased with the progress of our ongoing Phase 3 clinical trial in the UK, and are pressing forward to deliver efficacy data for NVX-CoV2373, with interim data in this event-driven trial expected as soon as early first quarter 2021."

iBio, Inc. (NYSE: IBIO) announced on September 9th, that it has selected IBIO-201, its LicKM™-ubunit vaccine, as its leading candidate for the prevention of SARS-CoV-2 infection.  "Our decision to evaluate IBIO-200 and IBIO-201 in tandem, and in combination with multiple adjuvants, proved beneficial given the results observed with IBIO-201 in preclinical studies," said Tom Isett, Chairman & CEO of iBio. "While IBIO-201 produced significantly higher anti-spike neutralizing antibody titers than IBIO-200, we are still encouraged by the potential of IBIO-200."

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