Under the leadership of Professor Katoto, NanoViricides, as the drug sponsor of NV-387 Oral Gummies, has received regulatory approval to begin a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus and other Ebola viruses, from the local regulatory agency ACOREP in the Democratic Republic of Congo (DRC).

Professor Katoto and his team have already actively started the preparatory work including staff training, to accelerate time to first patient dosing, even without waiting for the regulatory approval. This has a given a head start to our efforts.

Additionally, the drug product for the clinical trial is already available in DRC, because of the impending Phase II clinical trial of NV-387 Oral Gummies as a Treatment for Mpox.

Therefore, it is anticipated that the first Ebola patient dosing with NV-387 oral gummies under this clinical trial can be expected to occur within a few weeks, barring impediments caused by the very ebola disease outbreak that the trial is designed to respond to.

"We now eagerly await the first dosing of Ebola patients with our NV-387 Oral Gummies drug product that is already in place in DRC," said Anil R. Diwan, PhD, President of the Company, adding, "We, our colleagues, and our partners are hoping that this orally available, unique and revolutionary broad-spectrum antiviral drug succeeds in combatting the Bundibugyo virus for which there is no known treatment or vaccine."

As the Ebola outbreak continues to expand, several limitations on travel are being instated. There are also limitations on availability of resources such as PPE and diagnostic kits, which are compounded by the travel and other restrictions. These on-ground situations have caused delays in our efforts, and we anticipate such delays to continue due to the tenuous outbreak situation.