Tuesday, August 9, 2011

Celsion Q2 conference call


I'm most disappointed that they again missed their guidance on the interim calc - most recently in July, they said they'd have results from the interim by the end of Sept. According to the 10Q (pg 20), they now expect the 190th event "in Q3" and the interim results "in Q4". With 6-8 weeks necessary for that calc, that means the results could be anywhere from 10/1 to 11/25. I thus sold my Oct calls today, perhaps a bit hasty but Jan is now the safest. Still expect a runup, just pushed back again by a month or so.

Everything else looked okay, CRLM trial being initiated, EMA guidance for trial approval by eoy, Japan will start a separate trial from HEAT so as to take different standard of care issues into account - Yakult still responsible for 100% of that new trial costs. RCW Phase 2 trial (Dignity study) will be extended to other indications than just RCW cancer in order to speed enrollment, but that kills the registrational ability.

Please note that pushing out the 190 event was blamed on the slower than expected enrollment, but there is some reason for optimism about how well Thermodox is doing. The trial was based on assuming the placebo (RFA only) would lead to a median PFS of about 12 months and Tdox extending that by 33%. It appears to me that both arms are doing better than assumed, but Tdox by at least the same proportion. I still intend on selling 1/2 to 2/3 on the runup, but I'm getting a bit more excited about interim success.

Regards,
Trond

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