Cleveland BioLabs executives said Thursday they are encouraged after meeting with federal regulators over the company’s efforts to gain the approval needed for its anti-radiation sickness drug to be stockpiled for emergency use.
Cleveland BioLabs executives met with U.S. Food and Drug Administration officials last month about the potential stockpiling of its Entolimod drug for emergency use through a process known as a pre-emergency use authorization. Company executives and investors believe that authorization is the fastest route for turning Entolimod – the most advanced of Cleveland BioLabs’ drug candidates – into a revenue producer.
“We were very pleased by the tone and direction of our discussion” with FDA officials to discuss the proper dosage and the potential for stockpiling the drug for emergency use, said Yakov Kogan, Cleveland BioLab’s chief executive officer, during a conference call Thursday.
The company began pursuing the emergency-use authorization in earnest after the U.S. Department of Defense in January refused to fund the final studies needed to allow it to be stockpiled for use in an emergency, such as a terrorist attack or a nuclear power plant accident.
The emergency authorization is important because Cleveland BioLabs continues to lose money, losing $4 million, or 8 cents per share, during the second quarter, compared with a loss of $3 million, or 7 cents per share, a year ago.
The company’s revenues were less than half of what they were a year ago, dropping to $600,000 from $1.6 million.
Cleveland BioLabs, which is burning through about $1.6 million of its cash each month, said it had $11.1 million in cash at the end of June – enough to fund its operations into the first quarter of next year.