Broad Diagnostic Measures Remain Crucial as Vaccinations Near

FinancialBuzz.com News Commentary

LONDON, Dec. 7, 2020 /PRNewswire/ -- As of late last week, the U.S. has reported more than 14.3 million cases and over 278,400 deaths, according to Johns Hopkins University data. Overall, the global situation is quite concerning, as global totals have reached 65.7 million cases and 1.5 million deaths. However, there is encouraging news on vaccines from Pfizer and Moderna. Earlier last month, Pfizer and BioNTech SE announced that they will submit a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate. Additionally, Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the Phase 3 study of mRNA-1273, its vaccine candidate against the virus, has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. Then, last week, Pfizer and BioNTech SE reported that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. had granted a temporary authorization for emergency use for their mRNA vaccine (BNT162b2). Todos Medical Ltd. (OTC: TOMDF), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Pfizer Inc. (NYSE: PFE), Abbott Laboratories (NYSE: ABT), Johnson & Johnson (NYSE: JNJ)

Despite the encouraging news, it is still unclear what the implementation process for the vaccine will be, and how quickly it will be available to the general public. However, an update from New York City may provide some clarifications. Last week, Gov. Andrew Cuomo said that the state would receive its first set of the Pfizer vaccine — 170,000 doses — on Dec. 15th, pending federal approval. In addition, according to a report by the New York Times, New York City anticipates receiving around 480,000 doses by the beginning of January, a spokesman for Mayor Bill de Blasio said on Wednesday. In the long run, consistent testing remains a major tool in the fight against the virus, as knowing the number of infected helps local and federal institutions to make more informed decisions regarding implementation of further restrictions. 

Todos Medical Ltd. (OTCQB: TOMDF) reported last week 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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Sorrento Therapeutics, Inc. (NASDAQ: SRNE) announced last month that its wholly-owned subsidiary, SmartPharm Therapeutics, Inc., had been awarded a contract from the Defense Advanced Research Projects Agency (DARPA) co-funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop a rapid countermeasure to COVID-19. The contract would provide SmartPharm up to USD $34 million for development through Phase 2 clinical studies of a gene-encoded antibody ("Gene MAb") that could enable rapid protection from and/or treatment of SARS-CoV-2 infection and COVID-19. Sorrento will seek further funding in support of the COVID Gene MAb program toward EUA (emergency use authorization) approval and large-scale manufacturing pending successful clinical studies.

Pfizer Inc. (NYSE: PFE) announced last week 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).

Abbott Laboratories (NYSE: ABT) announced on October 12th that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT® and Alinity™ platforms. IgM antibody testing can play an important role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection. "Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery," said Robert B. Ford, President and Chief Executive Officer, Abbott. "Antibody tests will continue to play an important role to better understand the virus, the prevalence of COVID-19 in an area and where a patient may be in their recovery."

Johnson & Johnson (NYSE: JNJ) announced recently the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen's investigational COVID-19 vaccine candidate. Under the amendment, Janssen will commit approximately USD 604 Million and BARDA will commit approximately USD 454 Million to support the ongoing Phase 3 ENSEMBLE trial evaluating Janssen's investigational COVID-19 vaccine candidate as a single-dose in up to 60,000 volunteers worldwide. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "We greatly value the ongoing confidence and support of our investigational COVID-19 vaccine candidate development program. Combined with our own significant investment, this agreement has enabled our vital research and development and underscores the importance of public-private partnerships to tackle the worldwide COVID-19 pandemic."

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