New Surge of Cases Emphasizes the Need for Widespread Diagnostic Solutions

NEW YORK, Nov. 16, 2020 /PRNewswire/ -- New restrictions are being implemented in several states across the country as the number of those infected with COVID-19 is once again on the rise. For instance, New York City's new restrictions went into effect on Friday night, imposing curfews on restaurants and gyms and limiting gatherings in private homes to 10 people. Additionally, New York City is preparing to move schools to an all-remote setting. Mayor Bill de Blasio told parents Friday to have a plan in place as early as Monday in the event the citywide rolling positive infection rate hits the school shutdown threshold (3%) over the weekend. As of Friday, the rate had climbed to 2.83%, the highest number since June 8th. The daily case average is its highest since May. de Blasio said on WNYC that "parents should have a plan for the rest of the month of November... Have an alternative plan beginning as early as Monday for whatever will help them get them through this month if school is not open." Todos Medical Ltd. (OTC: TOMDF), Heat Biologics, Inc. (NASDAQ: HTBX), Vaxart, Inc. (NASDAQ: VXRT), iBio, Inc. (NYSE: IBIO), Dynavax Technologies Corporation (NASDAQ: DVAX).

While biotech companies work on vaccines and possible treatments and medical device companies focus on patient monitoring, numerous others have been working on improving testing options. The high demand for tests put the diagnostics test manufacturing industry under immense pressure. And the sudden global need for accurate, high-quality testing is unlike anything it has experienced before. The Food and Drug Administration (FDA) emphasized the importance of testing capabilities back in March. And according to the FDA's announcement, it has issued the fourth diagnostic related Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath Combo Kit. FDA Commissioner Stephen M. Hahn, M.D explained that "we have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process."

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news last week that, "President & CEO Gerald Commissiong has provided a corporate update to the shareholders:

Dear Shareholder,

We would like to thank you for continued support as we execute on the vision we laid out in the first half of 2020, transitioning the Company from a cancer and Alzheimer's-focused R&D diagnostics company into a commercial organization focused on providing comprehensive solutions to address the United States' biggest challenges in testing, tracing and immune support in response to the COVID-19 pandemic. Going forward as the newly created business lines mature, each at their own pace, we are seeking to adjust expectations in light of the market's response to our progress and address some of the limiting factors to value creation.

Nasdaq Uplisting Timing

Given where the Company's common stock is currently trading, we do not believe it is realistic to uplist to Nasdaq in 2020, but rather look to achieve that milestone in the first half of 2021. We are focused on creating value for our common shareholders and, given where our common stock is currently trading, we believe it is prudent to remove the risk of a significant reverse split from market concerns until we have demonstrated several more months of growing sales and commercial execution. Given that the Company is now generating revenue that we expect to continue to grow significantly into 2021, we now believe that our common equity can significantly increase in value on the OTC Markets(TM) because we believe we are well positioned as a growing commercial organization with the upside of several attractive research & development programs with patent protected development-stage programs addressing large market opportunities. While we are disappointed the market is not currently recognizing our fundamental value, we now have a significant opportunity to begin to educate the marketplace with regards to our overall business, and specifically our COVID-19 business.

COVID-19 Testing

Todos has positioned itself as a 'one stop shop' for all things COVID testing related. We understand that there is significant confusion with regards to COVID testing, and therefore we are outlining here exactly what we offer in the different types of testing products we make available to clients:

Polymerase Chain Reaction (PCR) Testing

PCR testing is now the gold-standard in COVID-19 testing. Definitive diagnoses are almost exclusively confirmed by PCR. As such, screening and surveillance testing of any kind will ultimately lead to a confirmatory PCR test.

Equipment to create workflows capable of conducting over 20,000 PCR tests per day per lab include:

1. RNA automated extraction machines

2. RT-PCR machines (96 well and 384 well)

3. Liquid handler machines

4. Automated and semi-automated pipettes

Reagents and consumables include:

1. Extraction reagent kits

2. COVID and COVID + influenza a/b qPCR reagent kits

3. Swab and Viral Transport Medium kits

4. Robotic and manual pipette tips

5. PCR plates

6. Validation Samples

Todos has optimized a workflow with Tecan liquid handlers currently being implemented at our Wisconsin client that will allow their lab to reach at least 20,000 diagnostic tests per day; and with pooling strategies being deployed for screening purposes, this client is expected to reach capacity to conduct over 100,000 tests per day. This client is currently at a capacity of 3,500 diagnostic tests per day with standard processes, and therefore we are confident in their ability to scale given this added automation. As they scale, we expect our sales to scale with them and we will be working very closely with them to overcome any barriers they have to meeting their full potential.

Rapid Antigen Testing

Antigen testing allows for testing at lower accuracy rates than PCR, but with much faster turnaround times because the results are provided at the point of care. As such, it screens more people faster and take immediate action if a positive test leads to a suspected case of COVID-19 that needs to be confirmed by PCR. The Company has entered into several agreements with companies focused on bringing antigen tests into the marketplace. While our sales have been focused on PCR testing, we believe rapid antigen testing will become routine in the United States in the months ahead as new tests enter the marketplace and bring prices down to a level where tests can be deployed in virtually any setting. We have entered into one agreement in particular with a US-based manufacturer that expects to receive Emergency Use Authorization for their test in the near future, and we have significant plans to allow our sub-distribution network to aggressively market this test upon approval.

Rapid Antibody Testing

As schools, employers and other constituents begin to implement comprehensive COVID-19 surveillance programs, one of the key questions emerging is whether individuals have previously been infected with COVID-19. We have secured rights to the FDA Emergency Use Authorization (EUA) FaStep rapid SARS-CoV-2 antibody test and have added this to our offering to our sub-distribution partners.

Emerging COVID-19 Testing Technologies

The Company has also secured rights to several tests that are currently awaiting EUA approval from the FDA. These tests include point-of-care PCR tests that will compete with the Abbott ID Now(TM) and Cepheid point of care molecular tests. We also expect to enter into an agreement to secure distribution rights to lab-based tests to more comprehensively evaluate COVID-19 immune-status that we believe will become paramount as vaccines enter the marketplace and testing for immunity becomes more widespread in 2021..."

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Heat Biologics, Inc. (NASDAQ: HTBX) announced last week financial, clinical and operational updates for the third quarter ended September 30th, 2020. Jeff Wolf, Chief Executive Officer of Heat, commented, "We continue to make progress on both our oncology and COVID-19 vaccine programs. We presented data for HS-110 in combination with Nivolumab in our Phase 2 lung cancer trial at the 2020 American Society of Clinical Oncology Annual Meeting demonstrating a strong survival benefit in a cohort of previously treated checkpoint inhibitor naïve patients with advanced non-small cell lung cancer (NSCLC). We are actively pursuing a variety of strategies to maximize value for the program." Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company's gp96 platform is designed to activate immune responses against cancer or pathogenic antigens.

Vaxart, Inc. (NASDAQ: VXRT) a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, announced last week 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. 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.

iBio, Inc. (NYSE: IBIO) announced on September 9th, that it has selected IBIO-201, its LicKM(TM)-ubunit vaccine, as its leading candidate for the prevention of SARS-CoV-2 infection. Mr. Isett said, "We plan to conduct more focused studies on each of IBIO-200 and IBIO-201, with the goal of advancing IBIO-201 to toxicology studies ahead of planned clinical development. Meanwhile, we intend to continue preclinical development of IBIO-200 and our virus-like particle platform as a potential 'plug-and-play' vaccine development system."

Dynavax Technologies Corporation (NASDAQ: DVAX) reported ack in August a grant from the Bill & Melinda Gates Foundation of USD 3.4 Million to scale up production batch size to allow for increased capacity of Dynavax's CpG 1018 advanced adjuvant to support the global COVID-19 response. These efforts will support capacity of up to 750 million adjuvant doses annually, which can be further increased if needed. "We are honored to receive this funding from the Bill & Melinda Gates Foundation to support development of a much-needed vaccine for COVID-19. This grant facilitates scale up of production capacity to ensure the availability of CpG 1018 for collaboration partners developing adjuvanted vaccines for COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We believe adjuvants will play an important role in developing effective vaccines for COVID-19, including for those patients at greatest risk for severe disease. The ability of CpG 1018 to potentially provide an improved immune response and also reduce the amount of vaccine antigen necessary will help provide more vaccine doses to meet the global need."

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