(By Balaseshan) Celsion Corp. (NASDAQ: CLSN) shares were downgraded to "Sell" from "Hold" by Brean Capital due to share runup prior to binary event and trial concerns. The brokerage cut its price target of the oncology drug development company to $1 from $7.
Analyst Jonathan Aschoff downgraded rating due to robust share price strength prior to a highly binary event in 1Q-2013 that, in his view, will define whether or not the company remains viable thereafter.
Recent share price strength places the valuation at a level where the analyst expects more downside from negative results than sustainable upside from positive results.
Aschoff questions the sustainability of a positive valuation inflection upon the potential showing of a progression free survival (PFS) benefit due to the need to show at least a clinically meaningful overall survival (OS) benefit thereafter appears more difficult than benefiting PFS, given the introduction of any additional therapy between progression and death.
The analyst said the clinically meaningful overall survival (OS) benefit was needed after only a single administration of one active therapy (RFA) versus two active therapies (RFA and ThermoDox).
Despite the HEAT trial's SPA, meeting the PFS primary endpoint is not a shoe-in for approval without at the very least a strong numerical OS advantage for those treated with ThermoDox, the analyst noted.
The brokerage widened its 2013 loss per share estimate to $0.88 from $0.46, while maintaining its 2012 loss estimate of $0.72.
CLSN is trading down 7.41% at $7.50 on Thursday.