NanoViricides reports Q3 EPS (10c) vs. (23c) last year

The company said, “During the current quarter, we have diligently continued our progress towards initiating a Phase II human safety and effectiveness clinical trial for the evaluation of NV-387 as a treatment of Monkeypox in the Democratic Republic of Congo. The local regulatory agency, ACOREP, has already approved this Phase II clinical trial, subject to completion of certain requirements. Africa continues to suffer from the Monkeypox epidemic, which has resulted in the Africa CDC declaring in August 2024 a “Public Health Emergency of Continental Security”, a status that continues because this epidemic has continued to expand across national boundaries. This Mpox epidemic is driven by the more morbid and more virulent versions, Clade 1a and 1b, as compared to the 2022 outbreak that was driven by the less virulent Clade 2. The latter has become endemic in the USA and the Western World, but remains limited to sexual transmission primarily in the men-having-sex-with-men population. The case fatality rate of Clade 1 has been between 9% to 1.5%, whereas that of Clade 2 is less than 0.3%. Our objective is to bring the data from the clinical trials external to the USA and utilize it for further regulatory advancement of NV-387 against various indications under the US FDA. NV-387 has certain orphan disease as well as bioterrorism related indications. Therefore, we first plan to file the appropriate Orphan Drug Designations for NV-387 as a treatment for MPOx, Smallpox, and also for Measles. The ODD if approved provides several benefits that would accelerate the NV-387 program towards regulatory licensure. These include frequent FDA meetings and rapid decision-making. Additionally, the economic benefits include certain tax credits for R&D costs, waiver of certain PDUFA fees, and a seven year exclusivity for marketing the drug for the licensed indication.”