Novellus Therapeutics, an engineered cellular medicines company, announced today that it has licensed its induced mesenchymal stem cells (iMSCs) on a worldwide basis to NoveCite, Inc., a newly formed subsidiary of Citius Pharmaceuticals, Inc., a speciality pharmaceutical company focused on developing and commercializing critical care drug products. NoveCite will develop and commercialize Novellus's iMSCs to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ("ARDS") associated with COVID-19. Novellus is a 25% equity holder in NoveCite. Novellus received a $5 million upfront payment and is eligible to receive up to $51 million in development milestone payments, as well as low double-digit royalties.

iMSCs are a next-generation cell therapy product created from induced pluripotent stem cells (iPSCs) with the following advantages:

Created using a patented non-immunogenic mRNA cell reprogramming process.

Derived from a single donor and produced from a clonal, perpetual master cell bank.

Streamlined manufacturing process enables near-unlimited supply.

Superior immunomodulatory protein secretion compared to donor-derived MSCs.

"Novellus's iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of their high potency as demonstrated in our pre-clinical studies, as well as our ability to cost-effectively provide high doses and repeat doses," said Myron Holubiak, CEO of Citius.

"We are excited to be developing iMSCs because of their promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19," said Matt Angel, Chief Science Officer of Novellus. He continued, "Our iMSCs have multimodal immunomodulatory mechanisms of action that make them promising for the treatment of acute respiratory diseases."