2013 will likely go down to be a horrendous year for Celsion (NASDAQ:CLSN) corporation. It started the year by missing its primary endpoint in its HEAT trial for testing its drug, ThermoDox, in liver cancer patients. From there came the inevitable stock crash, a financing that, while done without warrants and at market price, was still dilutive, and a big fat (and somewhat unnecessary) reverse split to end the year. Yuck.
The company hosted its Q3 conference call on Tuesday of last week, and let investors in on what the company's future plans for ThermoDox were - as well as elaborating on the company's DIGNITY trial (for recurrent breast wall cancer) and corporate restructuring.
You can listen to the call in its entirety on Celsion's website, using the link here. The call was led by Celsion's CEO, Michael Tardugno.
The call started by talking about how big of a problem HCC remains - and that it's an extremely tough disease. Not only the HEAT study, but all others in recent past have failed to meet their primary endpoint. So, in that regard, Celsion isn't alone. It also goes to stress how monumental it could possibly be for someone to break through in this particular field.
Tardugno went on and stated that clinical data from HEAT continues to be enormous - providing many different insights and theories. He made a somewhat impressive if true claim, that Celsion knows more about liver cancer than any other company or research team on the planet. I contend that while it's impressive sounding, it's meaningless to investors unless the company can bear some kind of fruit on the efficacy front.
Tardugno pointed out that HEAT study results continue to be presented internationally as the post-hoc data continues to be reviewed.
He continued by saying that the company has continued to follow all patients to assess the value of ThermoDox going forward. The subgroup that they're focused on represented 41% of the total population in the clinical trial, which is a larger amount than I anticipated. Celsion stated that they have been focused on HCC tumors of a certain size that have been treated with RFA for over 45 minutes - a variable the company is thinking could play a significant role in ThermoDox going forward.
In the past year, the company's hypothesis has been that RFA (radio frequency ablation) to the tune of 45 minutes or more could seriously increase the efficacy of the doxorubicin when it is released from Celsion's liposomal transport vessel at the tumor site. Scientifically, I'd argue, it seems to make some simple sense.
Tardugno said that the company's hypothesis appears to "continue to strengthen" the further they go into the data.
To be very clear, any announcement of a trend has to be reviewed with caution - as most of us know - looking into data after a failed trial often produces many "trends" that don't actually have any statistical significance. I'll remind investors that this case isn't any different.
While the median O/S for this data is close at hand, Tardugno also reminded several times that there was no statistical significance behind the post-hoc analysis.
That said, Celsion stated that the "strong survival trend" continues to warrant further support.
In the vein of the company's RFA theory, Celsion talked about completing a non-clinical program to simulate RFA times - and they pointed out that it showed a "direct correlation" between increased heating time and increased amount of the drug hits the tumor. They found the same results through a 21 subject pig study.
The next step, Tardugno noted, is to show all of these findings - clinical and non-clinical - to the medical community going forward.
Celsion will go to the FDA for further study and will also try and utilize their relationship with Hisun Pharmaceuticals to get expedited trials in China. Hisun continues to be interested in the company and in the upcoming studies. Celsion anticipates initiating a new trial in first half of 2014, pending FDA approval. This is a trial that could breathe some new air not only into Celsion, but its stock.
They finished by noting that their cost reduction program has been completed. CFO Jeff Church added that spending levels have been adjusted to continue the company with a strong balance sheet. In addition, the restructuring has had no effect on the DIGNITY study, which they continue to pursue.
The company reported $45 million in cash to fund operations, through "timely and smart equity financing."
Celsion said they're going to continue working with Cantor Fitzegerald for M&A to bolster pipeline through M&A - something that they've been saying they're going to do since the beginning of the year. Celsion doesn't seem to be pursuing this with any type of urgency, in this investor's opinion. They stated their M&A review has been comprehensive, international, private and public. They are confident to find a company to acquire in the next several months.
To conclude, while I'm no longer invested in Celsion, 2014 could certainly be a year to keep an eye on them. As they are confident of a new trial starting in the "first half of 2014," the microscope will again start to tighten around Celsion as those trial results will likely decide the short-term fate of the company over the coming years.
Celsion will be happy to put 2013 in the rear view mirror, and hope for a fresh start on all accounts in 2014. Best of luck to all investors.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.