Todos Medical Enters into Binding Agreement to Acquire All 3CL Protease Biology-Related Assets and Intellectual Property from NLC Pharma
- Company to form majority owned subsidiary, 3CL Sciences, an entity focused on the development of variant-agnostic COVID-19 antivirals such as Tollovir that utilize the 3CL protease related IP
-Dr. Dorit Arad, pioneering biology researcher responsible for the discovery of natural 3CL protease inhibitors, to be appointed Chief Scientific Officer of 3CL Sciences
-Acquisition to include mechanism-based designed new chemical entities targeting 3CL protease and other cellular mechanisms for development of ‘next-gen’ Tollovir candidates
-Todos Medical to host conference call for the investment community on Thursday, December 2nd, 2021 at 4:30pm ET
New York, NY, and Tel Aviv, ISRAEL, Nov. 29, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has entered into a binding agreement to acquire all 3CL protease biology-related assets owned by NLC Pharma and form a majority-owned subsidiary called 3CL Sciences (“3CL Sciences”). 3CL Sciences will be focused on developing therapeutics, diagnostics and dietary supplements based on the pioneering 3CL protease (3CLpro, Main Protease, Mpro, Nsp5) biology work of Dorit Arad, PhD, who will be appointed Chief Scientific Officer of the new company. We believe this acquisition will solidify Todos Medical’s position as a key player in the development and commercialization of 3CL protease-related products. These products currently include Tollovir®, a therapeutic drug candidate for the treatment of COVID-19 and other nidovirus coronaviruses, TolloTest ™, a diagnostic testing platform to identify the presence of the 3CL protease related to SARS-CoV-2, and Tollovid® & Tollovid Daily™, 3CL protease inhibitor dietary supplements that support and maintain healthy immune function. Additionally, the acquisition gives Todos Medical access to discoveries made by Dr. Arad related to the development and commercialization of new chemical entities targeting the 3CL protease and other mechanisms critical for the treatment of COVID-19 using her ‘mechanism-based design’ approach, as well as new designs for mass-scale deployment of the TolloTest technology.
“We began the journey of building 3CL protease biology-based products with Dr. Arad in the second quarter of 2020, just as the pandemic was gaining a foothold globally, and we saw firsthand the power of the technology with initial clinical work on our proprietary diagnostic TolloTest technology,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Now more than 18 months after we began collaborating, we have made a number of key discoveries and reached a number of key development and commercial milestones that have only fortified our resolve in bringing products developed from this important biology to the masses. Pfizer’s work in the 3CL protease space has undoubtedly created greater interest in our dietary supplement product offerings in the United States and abroad. In Europe we recently announced a dietary supplements distribution license with T-Cell Protect Hellas S.A. (T-Cell Protect) for products based on our Tollovid and Tollovid Daily formulations. Our therapeutic drug candidate, Tollovir, has now advanced to the stage of an interim readout of the Phase 2 clinical data in the treatment of hospitalized COVID-19 patients. Data from our TolloTest demonstrated 100% sensitivity 1-3 days post exposure in a community-based super spreading event setting that, in our view, provided clinical proof of concept for the heightened sensitivity when compared with rapid antigen testing that was the rationale for our initial collaboration. With all these significant scientific advancements resulting from our collaboration with NLC and with the continued proliferation of COVID-19 variants across the globe, we believed now was the perfect time to solidify our relationship with Dr. Arad by officially combining forces through the creation of 3CL Sciences. As a majority owned subsidiary, 3CL Sciences will separate our critical scientific development work in COVID-19 from our other important development-stage work in cancer & Alzheimer’s diagnostics, as well as our revenue generating PCR & cPass neutralizing antibody testing services that we offer via our Provista Diagnostics CLIA/CAP lab in the United States. This structure gives us the most flexibility to attract traditional direct private investment into 3CL Sciences from major private institutional investors with the potential to maximize its future value independently to the benefit of Todos shareholders, while limiting ordinary share dilution.”
Under the terms of the agreement, Todos Medical will own 60% of 3CL Sciences, and the shareholders of NLC Pharma will own 40% upon the execution of definitive agreements (the “Closing”) to acquire all intellectual property and assets related to 3CL protease biology-related products to which NLC Pharma has rights. Todos Medical will assign its European licensing agreement T-Cell Hellas Protect S.A. to 3CL Sciences. Upon the Closing, NLC Pharma Chief Scientific Officer Dr. Dorit Arad and CEO Mr. Avraham Marilus will enter into exclusive executive employment agreements with 3CL Sciences. Todos Medical herein commits to fund 3CL Sciences with initial capital of $2.2 million. In addition NLC Pharma will receive two million dollars ($2,000,000 USD) in cash payments over 15 months, 13,333,000 Ordinary Shares of Todos Medical, and single digit net royalties on 3CL protease-biology related product sales. Todos Medical commits to funding, or assisting 3CL Sciences in obtaining funding, for an aggregate of ten million dollars ($10,000,000 USD) within 6 months of the execution of the Closing. Todos shall also commit its efforts toward facilitating a “Go Public” transaction (IPO, SPAC or reverse merger) for 3CL Sciences within 9 months of the Closing, which may also include a buyout of the unowned 40% of 3CL Sciences in shares by Todos upon mutual agreement. The transaction, which is subject to completion of satisfactory due diligence, is expected to close on December 15th, 2021, or upon another mutually agreed upon date.
“Particularly now with the new Omicron variant causing the SARS-CoV-2 virus to threaten the world again, and potentially decrease the effectiveness of current vaccines, we believe that our technologies will have a major and timely impact on the course of the COVID-19 pandemic,” said Dr. Dorit Arad, Chief Scientific Officer at NLC Pharma. “A mechanism based drug, that overcomes most viral mutations, is the timely solution to upcoming new variant threats, and we are excited to take the Tollovir program forward with Todos through the pending Phase 2 interim readout in hospitalized COVID-19 patients and towards registration studies and/or Emergency Use Authorization. We will also now begin to advance discovery-stage next generation small molecule compounds based on Tollovir into pre-clinical development. In parallel, we have now identified what we believe is the best design for a highly scalable deployment of our rapid TolloTest diagnostic platform as the optimal solution for global airports and mass entry points, as well as a viral infectivity monitoring tool for hospitalized COVID-19 patients. As we build up 3CL Sciences based upon the discovery of the fundamental roles of the 3CL protease in SARS-CoV-2 and the development and commercialization of natural 3CL protease inhibitors and diagnostic tests, we believe now diversifying our product portfolio with mechanism-based drug design small molecule 3CL protease inhibitors based on Tollovir will align us with traditional drug development to make 3CL Sciences more attractive for institutional investors and pharmaceutical corporate partners. In conclusion, we are very excited about the future of 3CL Sciences.”
Concurrent with this announcement, the Company intends to host a business update conference call for the investment community on Thursday, December 2nd, 2021 at 4:30pm Eastern Time. Details to log into the conference call will be made available by the Company on its website, on social media and in a subsequent press release on or before December 1st, 2021.
https://investor.todosmedical.com/news-events...cquire-all
- Company to form majority owned subsidiary, 3CL Sciences, an entity focused on the development of variant-agnostic COVID-19 antivirals such as Tollovir that utilize the 3CL protease related IP
-Dr. Dorit Arad, pioneering biology researcher responsible for the discovery of natural 3CL protease inhibitors, to be appointed Chief Scientific Officer of 3CL Sciences
-Acquisition to include mechanism-based designed new chemical entities targeting 3CL protease and other cellular mechanisms for development of ‘next-gen’ Tollovir candidates
-Todos Medical to host conference call for the investment community on Thursday, December 2nd, 2021 at 4:30pm ET
New York, NY, and Tel Aviv, ISRAEL, Nov. 29, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has entered into a binding agreement to acquire all 3CL protease biology-related assets owned by NLC Pharma and form a majority-owned subsidiary called 3CL Sciences (“3CL Sciences”). 3CL Sciences will be focused on developing therapeutics, diagnostics and dietary supplements based on the pioneering 3CL protease (3CLpro, Main Protease, Mpro, Nsp5) biology work of Dorit Arad, PhD, who will be appointed Chief Scientific Officer of the new company. We believe this acquisition will solidify Todos Medical’s position as a key player in the development and commercialization of 3CL protease-related products. These products currently include Tollovir®, a therapeutic drug candidate for the treatment of COVID-19 and other nidovirus coronaviruses, TolloTest ™, a diagnostic testing platform to identify the presence of the 3CL protease related to SARS-CoV-2, and Tollovid® & Tollovid Daily™, 3CL protease inhibitor dietary supplements that support and maintain healthy immune function. Additionally, the acquisition gives Todos Medical access to discoveries made by Dr. Arad related to the development and commercialization of new chemical entities targeting the 3CL protease and other mechanisms critical for the treatment of COVID-19 using her ‘mechanism-based design’ approach, as well as new designs for mass-scale deployment of the TolloTest technology.
“We began the journey of building 3CL protease biology-based products with Dr. Arad in the second quarter of 2020, just as the pandemic was gaining a foothold globally, and we saw firsthand the power of the technology with initial clinical work on our proprietary diagnostic TolloTest technology,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Now more than 18 months after we began collaborating, we have made a number of key discoveries and reached a number of key development and commercial milestones that have only fortified our resolve in bringing products developed from this important biology to the masses. Pfizer’s work in the 3CL protease space has undoubtedly created greater interest in our dietary supplement product offerings in the United States and abroad. In Europe we recently announced a dietary supplements distribution license with T-Cell Protect Hellas S.A. (T-Cell Protect) for products based on our Tollovid and Tollovid Daily formulations. Our therapeutic drug candidate, Tollovir, has now advanced to the stage of an interim readout of the Phase 2 clinical data in the treatment of hospitalized COVID-19 patients. Data from our TolloTest demonstrated 100% sensitivity 1-3 days post exposure in a community-based super spreading event setting that, in our view, provided clinical proof of concept for the heightened sensitivity when compared with rapid antigen testing that was the rationale for our initial collaboration. With all these significant scientific advancements resulting from our collaboration with NLC and with the continued proliferation of COVID-19 variants across the globe, we believed now was the perfect time to solidify our relationship with Dr. Arad by officially combining forces through the creation of 3CL Sciences. As a majority owned subsidiary, 3CL Sciences will separate our critical scientific development work in COVID-19 from our other important development-stage work in cancer & Alzheimer’s diagnostics, as well as our revenue generating PCR & cPass neutralizing antibody testing services that we offer via our Provista Diagnostics CLIA/CAP lab in the United States. This structure gives us the most flexibility to attract traditional direct private investment into 3CL Sciences from major private institutional investors with the potential to maximize its future value independently to the benefit of Todos shareholders, while limiting ordinary share dilution.”
Under the terms of the agreement, Todos Medical will own 60% of 3CL Sciences, and the shareholders of NLC Pharma will own 40% upon the execution of definitive agreements (the “Closing”) to acquire all intellectual property and assets related to 3CL protease biology-related products to which NLC Pharma has rights. Todos Medical will assign its European licensing agreement T-Cell Hellas Protect S.A. to 3CL Sciences. Upon the Closing, NLC Pharma Chief Scientific Officer Dr. Dorit Arad and CEO Mr. Avraham Marilus will enter into exclusive executive employment agreements with 3CL Sciences. Todos Medical herein commits to fund 3CL Sciences with initial capital of $2.2 million. In addition NLC Pharma will receive two million dollars ($2,000,000 USD) in cash payments over 15 months, 13,333,000 Ordinary Shares of Todos Medical, and single digit net royalties on 3CL protease-biology related product sales. Todos Medical commits to funding, or assisting 3CL Sciences in obtaining funding, for an aggregate of ten million dollars ($10,000,000 USD) within 6 months of the execution of the Closing. Todos shall also commit its efforts toward facilitating a “Go Public” transaction (IPO, SPAC or reverse merger) for 3CL Sciences within 9 months of the Closing, which may also include a buyout of the unowned 40% of 3CL Sciences in shares by Todos upon mutual agreement. The transaction, which is subject to completion of satisfactory due diligence, is expected to close on December 15th, 2021, or upon another mutually agreed upon date.
“Particularly now with the new Omicron variant causing the SARS-CoV-2 virus to threaten the world again, and potentially decrease the effectiveness of current vaccines, we believe that our technologies will have a major and timely impact on the course of the COVID-19 pandemic,” said Dr. Dorit Arad, Chief Scientific Officer at NLC Pharma. “A mechanism based drug, that overcomes most viral mutations, is the timely solution to upcoming new variant threats, and we are excited to take the Tollovir program forward with Todos through the pending Phase 2 interim readout in hospitalized COVID-19 patients and towards registration studies and/or Emergency Use Authorization. We will also now begin to advance discovery-stage next generation small molecule compounds based on Tollovir into pre-clinical development. In parallel, we have now identified what we believe is the best design for a highly scalable deployment of our rapid TolloTest diagnostic platform as the optimal solution for global airports and mass entry points, as well as a viral infectivity monitoring tool for hospitalized COVID-19 patients. As we build up 3CL Sciences based upon the discovery of the fundamental roles of the 3CL protease in SARS-CoV-2 and the development and commercialization of natural 3CL protease inhibitors and diagnostic tests, we believe now diversifying our product portfolio with mechanism-based drug design small molecule 3CL protease inhibitors based on Tollovir will align us with traditional drug development to make 3CL Sciences more attractive for institutional investors and pharmaceutical corporate partners. In conclusion, we are very excited about the future of 3CL Sciences.”
Concurrent with this announcement, the Company intends to host a business update conference call for the investment community on Thursday, December 2nd, 2021 at 4:30pm Eastern Time. Details to log into the conference call will be made available by the Company on its website, on social media and in a subsequent press release on or before December 1st, 2021.
https://investor.todosmedical.com/news-events...cquire-all
