JanOne has successfully completed its initial engineering batch of JAN101. The JAN101 formulation is a patented sodium nitrite proprietary compound that demonstrated success in Phase 1 and Phase 2a trials for improving blood flow and vascular function, necessary in the treatment of Peripheral Artery Disease (PAD) and potentially for Covid-19 vascular complications that is believed to be the cause of severe vital organ and tissue damage.

"We are very fortunate to have had the foresight to initiate the manufacturing process this past February. Should we gain FDA approval for our Covid-19 study, we will be in a position to start patient trials immediately and still remain on track for our planned PAD Phase 2b trials to begin in early 2021," Dr. Tony Giordano, JanOne's chief scientific officer said.

The company expects to submit the investigational new drug (IND) for the treatment of Covid-19 vascular complications in the coming weeks and continues to advance plans to scale-up production of JAN101. The company has secured a partner for bottling and labeling, GMP batch production, including placebo batches. The company expects to deliver 250,000 doses within 30 days after start of manufacturing and have GMP batches of more than 20 million doses ready next year.