Cleveland BioLabs (CBLI): Revenues for 2011 were $9M, (versus $15M in 2010) this was a result of the difference in US biodefense revenues (contracts and grants). Opearting expenses were high at $34M versus $26MM spent in 2010. R&D expenses for the year came in at $22.8MM, up 42% from the $16.1MM spent in 2010 in the year prior. This was directly related to additional (preclinical) animal studies and manufacturing of CBLB502 as well as preparations for human clinical work. G&A expenses were $11M. CBLI ended the year with $28M in cash which is strong for a biodefense company especially since the qtrly cash burn is modest at $3.6-4.2M.
BioDefense Moving Forward: As part of todays news the company announced that last last year the company received a confirmatory letter from the FDA. The FDA did not have any objections to the development plan for CBLB502 in biodefense. Cleveland BioLabs will now respond to BARDA’s current open Broad Agency Announcement (BAA) by submitting a white paper by year end. A BARDA response should follow (90 days) followed by an invitation to submit a contract proposal.
Clinical Testing of CBLB502 in Oncology: Earlier this month the company announced that the first patient completed a series of five doses in the phase 1 trial evaluating CBLB502 in cancer patients. N=48 patients are expected to be enrolled across several arms to provide data on safety, tolerability, and PKA (dose simetry) as well as hints at efficacy.