A Reasoned Case For Celsion's ThermoDox
December 10, 2012 BY:
James Stocklasar Thomas Jr
I think it's common knowledge that any therapy that promotes progression free recurrence is a global billion dollar plus market opportunity. As others have pointed out, with ThermoDox targeting multiple medical indications, the long-term market opportunity is a billion dollar multiple. Seeing how Celsion has already extended the ThermoDox footprint into the European and Asia markets along with the rest of the world including the United States, I hesitate to imagine how high on phase III success the company's share price could rise as events unfold. Therefore, priced in the $7's/share and taking every risk into account, I conclude based on my three-prong study that Celsion is a VERY STRONG BUY.
Added a comment to SA, but generally a good overview. My comment copied below:
A little history on the trial enrollment. Long term longs were more than slightly put off by management's predictions from 2009 through 2011.
The enrollment was delayed enormously throughout the trial. A little-appreciated fact is that at ClinicalTrials.gov, you can look at the historical changes that the company has made over time. I misremember the exact dates but enrollment was initially expected to complete by 2009/10. It kept getting pushed back, as can be seen from the wording of various PRs through that time period.
It was not all management's fault: China had sFDA personnel issues (like the head being executed for treason!) and Japan's enrollment (planned for 60, halted at 18). It was after completing full enrollment at 600 (one of the two interim triggers) that they decided to continue enrolling to 700, both to allow enough patients in China for a full application there, AND to get to the 380th event more quickly.
It was at that point, in the middle of 2011, that IMO mgmt started underpromising and overdelivering as they have through the present time. Also, mgmt has stated numerous times that they get unblinded updates of the gross number of events.
So while your point that the TRIAL is well designed is correct, IMO, it is not quite correct to say "... It's remarkable that Celsion targeted the completion of the primary end-point that precisely, but that only speaks well of the trial design."
Other quick hits:
Please note that HEAT is only in HCC, while the ph1 data included small numbers of both HCC (8) and MLC (14).
Both HEAT trial arms undergo RFA, which is SOC for this indication, for this size tumor. So do not make the mistake of thinking it is simply Thermodox "vs. a placebo." RFA does burn away the tumor and is effective as far as it goes.
Japan had enrollment halted by the DMC in late 2010. They saw some safety issues (which are attributable to SOC differences particular to Japan).
The expansion of indications you mention should also include alternate heating methodologies. They are starting to look at HIFU (high frequency ultrasound) instead of RFA also, with a partnership with Phillips. Trials will be underway in London shortly, I misremember the exact timing but a recent PR should spell it out.
Disclaimer - I am long this stock. This is presented for educational and informational purposes only, and should not be construed as personalized legal, tax, investment, or financial advice. Stocks may lose value and this is not recommendation to buy or sell this particular issue.
SHORT downward pressure is getting increasingly nervous this afternoon. Betting against Thermodox just isn't intelligent.
The real money follows the logic. The logic is: Thermodox looks great!
Another POP in the share price is IMMINENT.
Sentiment: Strong Buy