Date: May 08, 2014 Author: Dan Miner Source: bizjournals (
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Cleveland BioLabs Inc. executives are again telling investors that the fate of their most advanced drug, Entolimod, depends on a pending meeting with the U.S. Food and Drug Administration.
BioLabs received a crushing blow this year when the Biomedical Advanced Research and Development Authority terminated negotiations regarding Entolimod, which has shown promise in treating the effects of radiation and certain types of cancer.
Its stock subsequently dropped below $1, promoting a letter from NASDAQ Stock Exchange giving the company 180 days to raise it back above $1 or be delisted. Shares are currently selling at 59 cents.
Entolimod's new hope is "emergency use pre-authorization" by the U.S. Food and Drug Administration. In a conference call today with investors, company CEO Yakov Kogan said a meeting with the FDA has been scheduled for July.
"If appropriate, we plan to file a pre-EUA submission later this year," Kogan said.
Entolimod does have another glimmer of hope: BioLabs signed a $4.6 million contract with the Ministry of Industry and Trade of the Russian Federation to support assessment of the drug's effect on colorectal cancer. That grant required matching funds from Cleveland BioLabs.
As BioLabs has struggled to find a partner to finish the development of Entolimod, its executives have expressed confidence recently about its other pipeline of candidates. Kogan said a recent completed trial of its lead oncology drug candidate, Curaxin, was completed and an interim report will be released in the third quarter.
As of March 31, BioLabs had $13.7 million in cash. It reported a net loss of $1.9 million in the first quarter, compared to an $8.9 million loss in the same time period last year. The company attributed the improved results to a $5.5 million improvement in the fair market value of certain outstanding warrants, along with $3.4 million in savings from a narrowed focus on development activities, lower development costs for Entolimod and other cost-saving measures.
Dan Miner is Business First's enterprise reporter. He also covers education and public companies.
