Celsion (CLSN)

It has been a long time coming, but Celsion should be taking the big step forward within the next couple weeks. I have been screaming from the rooftop for weeks now that if you want a position, you need to fish or cut bait pretty quickly.

Presently around $2.30, by the end of June I am forecasting a price in the $5s or $6s. As soon as they complete enrollment in the HEAT trial, several cool things occur.

First, and most importantly, HEAT then gets a "shot on goal" - an interim calculation of how the trial is going. While interim looks typically are very low likelihood of showing statistical significance (and thereby stopping the trial while they apply for approval) from various simulations I believe we may have as high as 25-30% chance of such happening! But even if this does not occur, the final calculation will then be 8-12 months away - locked into a for-real timeline for final results. Funds and institutions tend to shy away from companies depending on interim calcs, but with a less-than-one-year deadline they would be more willing to invest.

Secondly, once HEAT is enrolled, they will immediately start enrollment in the next trial. Combined with the joint venture with Royal Phillips (HIFU guided Thermodox) they will then have three trials up and running in 2011.

Companies with a trial under an SPA, in a huge, unmet medical need like later stage liver cancer, nearing an interim calc should be trading around a $150M to 450M market cap. With Celsion currently listed as around $33M market cap, we'll be looking at a 3x to 10x increase in the few months leading up to full enrollment in HEAT.

Finally, once Japan's PMDA (FDA-equivalent) agrees to allow enrollment to restart in Japan, a couple more events occur. (enrollment was halted at a pre-agreed 18 patients for an extensive safety review - which is not yet complete)
Obviously, having Japan involved in enrollment again gets us to enrollment of 600 more quickly.
Forgotten by some is the fact that our Japanese partner Yakult pays us $2M at this milestone.

While holding through the interim calculation certainly gives the chance for a 20 bagger or more, an investmnet now, holding only into the near-certain runup into the summer should repay us with a double or more.

Regards,
Trond