- The stock price of NanoViricides Inc (NYSEAMERICAN: NNVC) increased by over 10% pre-market today. This is why it happened.
The stock price of NanoViricides Inc (NYSEAMERICAN: NNVC), a global leader in nanomedicines against viruses, increased by over 10% pre-market today. Investors are responding positively to NanoViricides announcing today that it has completed the process of licensing the human Coronavirus field for drug development and commercialization from TheraCour Pharma. The company executed a license agreement for the field comprising anti-viral treatments for coronavirus-derived human infections with TheraCour Pharma, Inc. on September 8, 2021.
NanoViricides is developing oral and pediatric drugs for fighting COVID-19 designed to be effective against most variants. And the licensed field includes antiviral drugs to treat SARS-CoV-2 and its variants that cause the COVID-19 disease resulting in a global pandemic that continues to rage through the world, wave after wave, as new variants develop and take hold. There was not any upfront cash payment for the license and the compensation terms were generally consistent with prior licenses.
NanoViricides is currently working on taking its two COVID-19 lead drug candidates NV-CoV-2- and NV-CoV-2-R into human clinical trials. And the company believes that the essential preclinical work is substantially complete for taking these drugs into human evaluation.
The company believes that these broad-spectrum anti-coronavirus drugs will continue being effective even as the virus continues to mutate developing into a number of variants of concern. And antibody protection afforded by vaccines and the effectiveness of antibody drugs has continued to decline progressively as new SRAS-CoV-2 variants have emerged. The company believes that its unique anti-viral nanomachine technology overcomes these issues.
NanoViricides believes it is well-poised for delivering an out-patient oral medicine to treat COVID-19 infections. And the company has found that its anti-COVID-19 drugs exhibited strong antiviral effectiveness when given orally in animal studies.
NanoViricides also believes that its COVID-19 drugs will be suitable for use in pediatric patients and they plan to include pediatric cohorts into clinical trials at the appropriate stages. They also believe that pediatric use of these drugs is feasible based on the excellent safety profile observed in animal studies. And as the variants evolve, pediatric infections and their severity have begun to rise, causing major worldwide concerns even as the world is trying to move towards normalcy in education and child social interactions.
NanoViricides’ anti-COVID drugs are based on polymeric micelle nanomedicine technologies developed by TheraCour Pharma and its affiliate AllExcel, Inc. The inventors filed a PCT patent application that forms the basis of the company’s two lead drug candidates. The new patent application covers the new technologies, compositions, formulations, processes, manufactured products, and methods of use, among other specifics.
Under the agreement, NanoViricides obtained a worldwide, exclusive, sub-licensable, license to use, promote, offer for sale, import, export, sell and distribute antiviral drugs that treat human coronavirus infections using TheraCour’s proprietary as well as patented technology and intellectual property, including the new patent application cited above. And the discovery of ligands and polymer materials, as well as formulations, the chemistry and chemical characterization, and process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed.
These are the deal terms:
“NanoViricides will not make any upfront cash payments to TheraCour and has agreed to the following milestone payments to TheraCour: 100,000 shares of the Company’s Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”) upon the execution of the Agreement; 50,000 shares of Series A Preferred Stock after the grant of the approval of Licensee’s Investigational New Drug (IND) Application, or its equivalent; cash payments of $1,500,000 after the initiation of Phase I clinical trials or its equivalent; $2,000,000 after the completion of Phase 1 Clinical Trials or its equivalent for at least one product within twelve (12) months from the date of the acceptance of the IND; $2,500,000 no later than six (6) months after the completion of Phase 2A Clinical Trials or its equivalent for at least one product within twenty (24) months from the date of the completion of Phase 1 or its equivalent; 100,000 shares of Series A Preferred Stock after the initiation of Phase 3 clinical trials or its equivalent; and, at TheraCour’s option, $5,000,000 in cash or 500,000 shares of Series A Preferred Stock, no later than six (6) months after the completion of Phase 3 Clinical Trials or its equivalent for at least one product within thirty-six (36) months from the completion of Phase 2 Clinical Trials or its equivalent. In addition, the Company agreed to pay to TheraCour fifteen percent (15%) of net sales of licensed products and any income from sublicensed products, consistent with previous agreements. Under the Agreement, TheraCour retains the exclusive right to develop and manufacture the Licensed Products. The Agreement contemplates that the parties will enter into a separate Manufacturing and Supply Agreement for the commercial manufacture and supply of the drug products if and when NanoViricides intends to engage into commercialization of the drugs. The Agreement provides that the Manufacturing and Supply agreement would be on customary and reasonable terms, on a cost-plus basis, using a market rate based on then-current industry standards, and include customary backup manufacturing rights, as with prior agreements.
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