It's the moments that really matter. Small slices of time change the future for the better or for the worse. That's true for individuals and for companies. For oncology drug company Celsion (NASDAQ:CLSN), 2013 looks to be a year where certain snapshots in time loom larger than perhaps ever before. Here are the company's top three make-or-break moments that will come over the next several months.
1. The moment that HEAT results are given
Nothing is as important for Celsion as the release of findings from the phase 3 HEAT study for ThermoDox. That moment of truth will arrive soon. Celsion expects to reveal the results from the study before the end of January.
More than 700 patients with liver cancer participated in the HEAT study. During the study, a group of patients were treated with radio frequency ablation, or RFA. Another group of patients were treated with Celsion's ThermoDox combined with RFA. ThermoDox is a delivery mechanism that allows a drug (in this case, doxorubicin) to be injected in an encapsulated form to a targeted area with cancer. The heat generated from RFA releases the drug in high concentrations to kill the cancerous cells.
Let's look at two scenarios for this crucial moment. One scenario is that the HEAT study's primary endpoint of progression-free survival isn't met. If this occurs, Celsion shares will implode. Another scenario is that the results are very positive, with greatly improved progression-free survival and overall survival rates for patients taking ThermoDox. If that happens, Celsion shares go into orbit. We would perhaps be looking at doubling of the stock. This moment is really that important.
2. The moment a partner for ThermoDox is revealed
Our second critical moment for Celsion will only take place if the HEAT study results are positive. Let's assume that's the case.
With great phase 3 results in hand, it won't take long for Celsion to knock on the Food and Drug Administration's door wanting approval. The company already obtained fast-track designation for ThermoDox, so that should help expedite matters. Celsion will move forward quickly on seeking approval in Europe and China as well.
The company has indicated that it will try to find one or more partners to commercialize ThermoDox outside the U.S. and perhaps for within the U.S. Actually, Celsion already announced a partnership way back in 2008 with Yakult Honsha -- but only for Japan.
When the moment of announcing a partnership arrives, it will be more important than might be obvious at face value. Celsion will be putting much of its fate in the hands of another company (or companies).
Who will the partner be? We can only speculate at this point, but you can bet that Celsion will look for one or more companies with strong oncology sales forces. As for the partner, my guess is that it will be a company with a strong motivation to generate new revenue.
There are several companies that fit those criteria. Celsion Senior VP Jeff Church actually mentioned two of them in passing during the company's most recent earnings conference call: Eli Lilly (NYSE:LLY) and Pfizer (NYSE:PFE).
Granted, Church's reference was only about those companies' relationships with the Chinese company that has been lined up to manufacture ThermoDox. However, both Lilly and Pfizer continue to deal with the loss of patent protection for major products and have ample motivation to partner with a smaller company like Celsion.
Both companies also have solid oncology sales teams. Lilly markets Alimta for nonsquamous non-small-cell lung cancer and malignant pleural mesothelioma, and Erbitux for colorectal cancer. Pfizer's oncology drugs include Sutent for renal, gastrointestinal, and pancreatic cancer, Aromasin for breast cancer, and Xalkori for non-small-cell lung cancer. A liver cancer treatment like ThermoDox could fit well into Lilly's and Pfizer's lineup.
3. The moment Celsion announces how it will raise more cash
The third big moment for Celsion in 2013 will be when it announces plans for raising more cash. The company isn't in bad shape at all for now, with nearly $23 million in cash and equivalents at the end of September. However, if it goes forward with taking ThermoDox to market in the U.S. on its own, more will be needed.
It seems quite likely that the company will decide to issue a secondary offering. Celsion currently only has 35 million shares outstanding. That's relatively low compared to some similar-sized biotechs. Regardless, though, more shares means dilution of existing shares.
The company could opt to generate a big portion of needed cash through issuing convertible bonds, which would please current shareholders. Of course, securing funds through a partnership deal would avoid dilution as well. Raising cash is make-or-break for Celsion, but how it does so really isn't for the company -- although it could be for some investors.
These three moments will be huge for Celsion and its shareholders. I think, though, that they just might be momentous for others.
I don't own shares in Celsion currently, but I'm rooting for its success. ThermoDox ultimately has the potential to be used with multiple drugs treating several types of cancer. As someone with family members who have died from cancer and a good friend fighting cancer now, I hope Celsion has some really good moments this year.