Todos Medical Partner NLC Pharma Assigns IP for Tollovir™, Tollovid™, and TolloTest™ into JV 3CL Pharma

Rhea-AI Summary

Todos Medical (OTCQB: TOMDF) announced plans for a crowdfunding campaign to support Emergency Use Authorization (EUA) filing for its COVID-19 therapeutic, Tollovir, targeting hospitalized patients. Additionally, the funds will aid in the clinical development of Tollovid and TolloTest for Long COVID. The company has finalized an agreement with NLC Pharma, granting joint venture 3CL Pharma ownership of relevant intellectual property, which includes patent applications for Tollovir and related products. A national marketing campaign for Tollovid sales is also in the works.

Positive

• Successful completion of agreement with NLC Pharma for IP ownership.
• Valuation of 3CL Pharma at $1.9 billion based on Tollovir program.
• Crowdfunding to diversify funding sources for strategic initiatives.

Negative

• Funding for EUA submission may indicate potential cash flow issues.
• Risks associated with regulatory approval processes for Tollovir.

• 3CL Pharma preparing crowdfunding to fund Tollovir EUA filing in hospitalized COVID patients and Tollovir, Tollovid and TolloTest clinical development for Long COVID
  
• Funding also to be used to support US national marketing campaign for Tollovid sales

New York, NY, and Tel Aviv, ISRAEL, Sept. 12, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that it signed an amendment to its agreement with its 3CL protease biology theranostics partner NLC Pharma, Ltd. As a consequence, NLC Pharma has assigned ownership of all relevant intellectual property to majority-owned joint venture 3CL Pharma Ltd. The assignment includes the patent applications for dual mechanism (3CL protease inhibitor and CCR5 antagonist) Phase 2 therapeutic drug candidate Tollovir™, commercial-stage 3CL protease inhibitor immune support supplement Tollovid™, and 3CL protease biomarker test TolloTest™ for SARS-CoV-2 infectivity monitoring and PASC/Long COVID viral persistence assessment (“The IP”). 3CL Pharma Ltd. is now preparing to launch a crowdfunding campaign to fund the necessary requirements for an Emergency Use Authorization (EUA) submission to the US FDA for Tollovir in the treatment of hospitalized (severe/critical) COVID-19 patients, the clinical development of Tollovir, Tollovid and TolloTest in Long COVID, as well as a national marketing campaign for Tollovid to support US sales. Todos is targeting a crowdfunding launch ahead of October 6th, 2022 in alignment with the FDA’s Adcom meeting for Veru, Inc.’s sabizabulin which is another COVID-19 drug seeking approval in the hospitalized setting.

“We are extremely pleased to have completed this key milestone in our joint venture with NLC Pharma allowing us to finalize preparations for the 3CL Pharma crowdfunding campaign that we have been planning for several months,” said Gerald E. Commissiong, President & CEO of Todos Medical and Interim-CEO of 3CL Pharma. “Todos has been funding the incredible work of Dr. Arad who has been leading a team from both Todos and NLC working together to achieve key milestones for Tollovir, Tollovid and TolloTest. With The IP now formally in 3CL Pharma, we can now open up the opportunity to directly invest into that entity that recently received a $1.9 billion dollar valuation from a third-party IP firm primarily based upon the value of the Tollovir therapeutic program. Additionally, this empowers investors with a vehicle that can capture the essence of a pure play opportunity in 3CL protease inhibition. The 3CL protease market is dominated by Pfizer’s COVID-19 drug which is expected to do $22 billion this year. All-natural 3CL protease inhibitors like Tollovid offer consumers an all-natural versus chemical option and the ability to have 3CL protease inhibition sitting in their medicine cabinet today.  Given that Tollovid is a commercial product with an extremely loyal customer base, we believe we are uniquely positioned to drive crowdfunding interest that will allow us to fund all of 3CL Pharma’s strategic initiatives. The timing of our initiatives aligns with another potential approval of a COVID-19 therapeutic in the hospitalized setting. Until death is taken off the table people will be asking what’s next, and we believe Tollovir will be the next therapeutic in the hospitalized setting.”

“We are proud of the lifesaving products that we have developed and very much appreciate the efforts of Todos Medical’s team contribution to bring us to where we are today, and consistently pushing us forward,” said Dr. Dorit Arad, Founder and Chief Technology Officer at NLC Pharma and 3CL Pharma. “Assigning the IP to 3CL Pharma is a crucial step to enable building the appropriate corporate infrastructure to raise funds for the 3CL. We believe that funding will accelerate the introduction of our products reaching patients at scale so that we can have a significant impact for COVID and Long COVID patients.”

Harvard economist David Cutler recently revised the estimated cost of Long COVID to the US economy to be $3.7 trillion. Dr. Cutler notes on his website: “Data suggest that 22-38% of people with COVID will have at least one symptom 12 weeks after initial onset, and 12-17% will have three or more symptoms. With 80.5 million confirmed COVID cases in the United States, this implies at least 9.6 million people with three or more symptoms of long COVID. The most common symptom of long COVID is fatigue, but every organ system has been implicated.”

To learn more about the 3CL protease in SARS-CoV-2 replication, please visit www.3clpro.com. To purchase Tollovid please visit Amazon or www.MyTollovid.com.

About Tollovid™ and Tollovid Daily™

Tollovid and Tollovid Daily are oral dietary supplement products made from natural ingredients that help support and maintain healthy immune function and also have potent 3CL protease inhibition properties based upon in vitro functional assays that show strong inhibition of 3CL protease activity. Tollovid and Tollovid Daily bind to the active site of the 3CL protease. Tollovid has a 5-day dosing regimen, with 4 doses of 3 pills taken each day that provides maximum immune support. Tollovid Daily is a daily immune support product with a dosing regimen of twice daily. Preliminary data from an ongoing IRB-waived study of customers who used the products to assist with their COVID and Long COVID were recently announced.

To purchase Tollovid please visit Amazon or www.MyTollovid.com.

About Tollovir™

Tollovir is an oral 3CL protease inhibitor and anti-cytokine therapeutic candidate targeting the Nidovirus group of viruses that includes coronaviruses such as SARS-CoV-2, COVID-19, SARS-CoV-1, MERS and 229E. Tollovir is made from all natural ingredients that are qualified to ensure strong inhibition of the 3CL protease in vitro, as well as strong anti-cytokine activity. Tollovir has successfully completed a Phase 2 clinical trial in Israel for the treatment of patients hospitalized with COVID-19. Tollovir will be developed for the treatment of hospitalized COVID-19 (severe and critical), moderate COVID-19, Long COVID and, potentially, pediatric COVID-19.

About Todos Medical Ltd.

Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that examines cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally developed cancer-screening tests, TMB-1 and TMB-2 have received a CE mark in Europe. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing, Long COVID Panel analyses, and Provista's proprietary commercial-stage Videssa® breast cancer blood test. More information on Provista is available at www.provistadx.com.

Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

Todos formed the Israeli-based majority-owned joint venture 3CL Pharma, Ltd with NLC Pharma in March of 2022 to consolidate all of the intellectual property surrounding 3CL protease–based diagnostic testing and development of 3CL protease botanical and pharmaceutical inhibitors that target a fundamental reproductive mechanism of coronaviruses. 3CL Pharma, through Todos’ brand, has commercialized the 3CL protease inhibitor immune support dietary supplement Tollovid™ in the United States, is developing the dual mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollovir™, while also developing the 3CL protease diagnostic TolloTest™.

To purchase Tollovid please visit Amazon or www.MyTollovid.com. For more information, please visit https://www.todosmedical.com/.

Forward-looking Statements
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from the competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.

Todos Corporate Contact:
Daniel Hirsch CFO
Todos Medical
917-983-4229 x 104
Dan.h@todosmedical.com

Todos Press Contact:
Kyle Kappmeier
JConnelly
Vice President 973-975-7827
kkapmeier@jconnelly.com

FAQ

What is Todos Medical's crowdfunding campaign for?

The crowdfunding campaign is aimed at funding the EUA filing for Tollovir, alongside clinical development for Tollovid and TolloTest for Long COVID.

When is the crowdfunding launch for Todos Medical planned?

The crowdfunding launch is targeted ahead of October 6, 2022.

What intellectual property did Todos Medical secure through NLC Pharma?

Todos Medical secured ownership of patent applications for Tollovir, Tollovid, and TolloTest through its joint venture with NLC Pharma.

What are the planned uses for the funds raised through crowdfunding?

Funds will support EUA filing for Tollovir, clinical development for Long COVID products, and a national marketing campaign for Tollovid.

What is the current valuation of 3CL Pharma?

3CL Pharma has a valuation of $1.9 billion according to a third-party IP firm.