Comprehensive Diagnostics Remains a Priority As More Surges are Expected

- FinancialBuzz.com News Commentary

NEW YORK, Dec. 3, 2020 /PRNewswire/ -- When Pfizer and BioNTech SE announced earlier in November a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, it was unclear how soon the pharmaceuticals companies will get the green light to start distribution. The submission is based on a vaccine efficacy rate of 95%, and it seems the data has been convincing enough to be approved by the United Kingdom. Regulators in the U.K. granted emergency authorization to the vaccine developed by Pfizer and BioNTech, and the distribution of the first 800,000 doses is expected to start next week. The elderly and nursing home residents are to receive first priority, British Health Secretary Matt Hancock said Wednesday, according to a report by the Washington Post. U.K. Health Secretary Matt Hancock said during a press conference that "I'm confident now, with the news today, that from spring, from Easter onward, things are going to be better. And we're going to have a summer next year that everyone can enjoy." Todos Medical Ltd. (OTC: TOMDF), BioNTech SE (NASDAQ: BNTX), Chembio Diagnostics, Inc. (NASDAQ: CEMI), Dynavax Technologies Corporation (NASDAQ: DVAX), Vaxart, Inc. (NASDAQ: VXRT)

In the meantime, the number of new cases continues to surge across the United States, with experts' warnings of a strong second wave as winter comes. Dr. Anthony Fauci, the director of National Institute of Allergy and Infectious Diseases, explained in an interview with ABC's "This Week" that the level of infection in the U.S. would not "all of a sudden turn around… So clearly in the next few weeks, we're going to have the same sort of thing. And perhaps even two or three weeks down the line ... we may see a surge upon a surge." Fauci also said he planned to push the new administration for a rigorous testing program. Mass testing is crucial for governments to properly implement preventive measures throughout this pandemic. And earlier last month, the FDA finally approved the first diagnostic at-home self-test that provides rapid results. FDA Commissioner Stephen Hahn said, "This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission."

Todos Medical Ltd. (OTCQB: TOMDF) reported yesterday breaking news regarding, "$3.2 million in sales for the month of November 2020. This represents a 269% increase in monthly sales as compared with October 2020. The majority of the increase in sales occurred in the second half of November 2020 following the completion of Tecan® liquid handler automation installation at Todos' Wisconsin COVID-19 testing lab client and the receipt of purchase orders for reagents to support increased testing demand expected in response to increased travel resulting from Thanksgiving 2020 holidays. Concurrent with this announcement, the Company was cash flow positive in November 2020 for its COVID-19 testing business, and has secured $2 million in traditional receivables financing that the Company believes will significantly reduce the time between invoicing to clients and the time that cash is received.

Todos expects revenue growth for December 2020, as daily testing volumes for the majority of its COVID-19 testing clients increases sequentially on a weekly basis, and as a second potentially large COVID-19 testing client located in Brooklyn NY completes the installation of liquid handling automation technology that will allow it to achieve testing capacities of up to 20,000 PCR tests per day and begins placing reagents orders.

'Our strategy of focusing on increasing key clients' capacity by implementing automated PCR testing solutions to allow them to significantly increase the number of samples they can process daily is beginning to bear fruit,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'We are now on a clear growth trajectory and will be focused on expanding our testing offerings to existing clients with novel assays that are complementary to PCR testing. One of the key tests we expect to bring to the market is our development-stage lab-based 3CL protease diagnostic test that is being advanced to determine whether a PCR positive patient remains contagious to infecting others. We believe this assay could become quite important for labs that engage with clients who do repeat testing, and we expect the lab version of this assay to become available in the US market in the near future. We also see it as a way to persuade potential clients to switch to our traditional PCR tests as we are able to supply labs with everything they need to scale COVID-19 testing, including automation and consumables such as pipette tips.'

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

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BioNTech SE (NASDAQ: BNTX) announced yesterday together with Pfizer that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals. The distribution of the vaccine in the U.K. will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI). "Today's Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19. This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic."

Chembio Diagnostics, Inc. (NASDAQ: CEMI) reported last month that its subsidiary Chembio Diagnostics Brazil Ltda. has received regulatory approval from Agência Nacional de Vigilância Sanitária (ANVISA) to market the DPP SARS-CoV-2 Antigen test system in Brazil. The DPP SARS-CoV-2 Antigen test system is designed to detect SARS-CoV-2 antigens in only 20 minutes. The detection of specific SARS-CoV-2 viral antigens implies a current infection by the virus responsible for COVID-19 cases. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader 1 or DPP Micro Reader 2 analyzer, and a minimally invasive nasal swab. Clinical trial data demonstrates sensitivity of 96.0% at zero to six days from the onset of symptoms and specificity of 98.7% on symptomatic population as compared to PCR tests.

Dynavax Technologies Corporation (NASDAQ: DVAX) announced last month that BE has initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI). The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, along with Dynavax's advanced adjuvant CpG 1018. BE's Phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart.

Vaxart, Inc. (NASDAQ: VXRT) announced back in November additional results from its Hamster Challenge Study: Significant reduction in lung viral load of 4-5 logs in hamsters that received two oral vaccine doses, as compared to non-vaccinated animals. Potent induction of antibody response, with serum IgG antibody titers above 10,000 in hamsters that received two oral vaccine doses. Oral vaccination protected as well as intranasal vaccination against intranasal challenge with respect to key indicators: protection from weight loss, protection from increase in lung weight, viral load reduction, and induction of serum IgG antibodies, demonstrating that mucosal protection by both routes of administration was comparable. As previously announced, all hamsters that received two oral doses of Vaxart's COVID-19 vaccine candidate showed no systemic weight loss, a key indicator of protection against COVID-19 in this animal model. By contrast, the unvaccinated animals lost approximately 9% total weight. Additionally, unvaccinated hamsters had over two times (2x) the relative lung weight of orally vaccinated hamsters, a sensitive indicator of serious disease that correlates with the viral load findings.

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