Celsion HEATing up

Please excuse the title - I promise that is the last time I'll use that atrocious pun.

I spoke to Jeff Church from Celsion Friday morning. Mr Church was the CFO until last Tuesday, when he was promoted to Senior Vice President, Strategy and Investor Relations. I've copied some notes of that chat at the end. Much is not exactly "new" information, but this is the first I've seen of the specific number of patients needed to be considered "registrational" for various Asian countries. My thanks to Mr. Church for taking the time to speak with me!

Please understand that these are MY words, even the text in quotes are my recollection of his words as I took extremely abbreviated notes as we were talking.

Last week the DMC also did a review of the 535 patients already randomized in the HEAT trial and unanimously recommended the trial continue. This gives extra credence to the notion that the upcoming interim look will have no problem at all with a futility analysis. It's interesting to note that this look was not even "supposed" to happen - they had expected enrollment to be completed by now!

A report called "Biorunup" was released on Thursday that calculated a fair market share price of $5.67 to $7.16 at the interim look. I take pride in saying all the way last winter that I expected $5-7 right before the interim look. I still think that is a pretty fair assumption - although I expect several spikes that may take up to $9 or more for brief periods.

Here's to a good-to-great interim look. I am still holding an obscene amount of Celsion in my real money accounts, as well as my Port24 holdings at around 20% and a similar weighting in my Marketocracy mutual fund. I will begin slimming the holdings at around $5.

Regards,
Trond
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Celsion notes 7/15/2011
Telephone chat w/ Jeff Church

Congrats on promotion.

Can only speak to cash as have publicly released - $2M at eoQ1, raised $18M since. Should have “enough” through calendar year but will need more before filing. [guidance was for ~$1.3M/mo, so should have used 5.2M through eom July = 14.8M at this point]

Addressed payables from Q1 filing as liabilities, have some room to do payments, should not be regarded as immediately gone from cash. Most are CRO payments. These will not go away after enrollment completes, as when patients progress and are followed for OS, still make payments. But they’ll “be over the hump of the bell curve”.

I suggested a direct stock purchase program, helps existing shareholders get new shares first as well as gives company a steady, though small, source of capital that remains under their control. Pretty much dismissed this.

600 enrolled by end of July, “maybe a week into Aug.” 190 PFS events “maybe another week”.
Reiterated interim results by end of September.

Japan needs 60 to be “registrational” – how many in other Asian countries? China = 200 (both control and drug arm), Korea 90, Taiwan 90. China “almost there”.

CRLM trial, timing? Been “lots of planning”, takes some time, his view is most important piece is getting sign off by the review. They have that. Expects trial to start “in Q3”.

NDA has three modules: preclinical, manufacturing, clinical trials. They can use Dox safety and equivalency data for preclinical. Manufacturing will take huge amount of work, registrational batches for drug and stability, facility inspection, etc.

Interim enough for approval, “Possible, not a lot of probability”.

HIFU trial – excited for different heating modalities, get to hard to treat areas. [imagine trying RFA inside a bone!]