Caladrius Biosciences Inc (NASDAQ:CLBS) received ODD (Orphan Drug Designation) for its CLBS12, CD34+ cell therapy product from the US FDA to treat thromboangiitis obliterans, aka Buerger’s disease.
Currently, there are no approved treatments for this disease in the US. CEO of Caladrius, David J. Mazzo, said the company is excited to receive ODD for its CLBS12 from the FDA to cure Buerger’s disease. It paves the way for the company to reverse the US’s disease with its innovative drug formulation.
David further said the company achieved a positive CLI-free endpoint for its HONEDRA, which is undergoing open-label study in Japan to treat Buerger’s disease and CLI.
Shows a positive outcome
Around 60% of the patients in the open-label study of CLBS12 to treat Buerger’s disease have demonstrated positive outcomes. The ODD allows Caladrius to engage with FDA to expedite registration in the US.
David further said achieving ODD for its CLBS12 is one step closer to realizing its target of satisfying the unmet medical requirements for worldwide patients with Buerger’s disease.
Eligible for fee waivers and tax credits
FDA offers ODD for biologics or drugs to cure rare disorders or diseases that affect less than 200,000 in the US. Caladrius now qualifies for tax credits, fee waivers, and qualified clinical trials. It is also eligible for 7 years of market exclusivity subject to market approval from the US FDA.
Virtual Conference
Caladrius will conduct a virtual conference on March 9 and 10, 2021, at H.C. WGLS (Wainwright Global Life Sciences).
Closes RDO of $65 million
Caladrius announced the previously announced sale of 24.906 million of its common stock/ warrants to institutional investors. The company raised a capital of $65 million through a registered direct offering. The company hired H.C. Wainwright & Co as an exclusive agent to issue the common shares to institutional investors.
Caladrius will use the proceeds for general corporate and working capital purposes like advancing CD34+ technology-based clinical trials.
David said the company continued its development programs despite the impact of coronavirus in Q4 2020. The company ended the previous year with a sound strategic and strong financial position.
Caladrius holds cash equivalents and cash of $34.6 million as of December 31, 2020.
