Celsion Corporation (NASDAQ:CLSN) Is A Big Winner For Us

We have looked at Celsion Corporation (NASDAQ:CLSN) a couple of times in the past, with the most recent coverage coming back at the start of June 2017.At the time, Celsion went for around $2.60 a share on the back of the company having just completed a reverse split. We suggested that it is a stock that's well with keeping an eye on throughout 2017 based on some then just-released clinical trial data and the potential for future iterations of the same program hitting press in line with the early findings.Turns out we were right.Celsion dipped to around $1.50 a share during the months subsequent to our initial analysis but, this week, spiked to current prices at $6.75. From our initial highlight price, that's a 159% appreciation. Anybody that waited until last week to get in is now sitting on a 350% run.So what is driving the action and what is next?The company just presented translational data from a phase 1B study of its ovarian cancer asset, called GEN-1, at the AACR Special Conference on Ovarian Cancer. It is this translational data that is driving the gains we have seen over the last few days. Interestingly, however, most of the recently presented data was already available and some of it goes back as far as June, when we last took a look at the company. The difference now is that the data is, as described above, translational, which essentially means the numbers have been crunched to identify a real world impact as opposed to laboratory setting implications. CLSN Daily ChartAnyway, for anybody wanting to take a look at the data in detail, it's available here. We aren't going to go into it too deeply right now but suffice to say the numbers suggest that GEN-1 can have a real impact in the target population of ovarian cancer patients; a group that has an incredibly poor prognosis on diagnosis (as they are late stage).The idea with this trial now is to submit a protocol for a phase 2 study that will build on the efficacy data already presented. As far as catalysts are concerned, and as relates to this program, initiation of said trial (subsequent to the FDA approving the protocol) is what we are on the lookout for.With that said, however, the real driver for Celsion medium-term is rooted in an ongoing phase 3 program investigating the company's lead development asset, a heat-sensitive liposomal formulation of doxorubicin called ThermoDox, for the treatment of newly diagnosed primary liver cancer patients. There are over 850,000 new diagnoses of primary liver cancer annually and it is the world's largest unmet need in oncology. ThermoDox has shown incredible promise during mid-stage trials and the company is now working to enroll a total of 550 patients as part of said phase 3 (called Optima) in an attempt to build on this promising base of data.In a recent conference call, management outlined expectations that enrollment should complete mid-2018, meaning we should see some initial efficacy data hit press within, and we are quoting here, 5 to 6 quarters.We got a DMC recommendation from Celsion recently that pointed to a unanimous decision to continue the trial based on a 50% enrollment point (275 patients), which suggests that there should be no unexpected safety concerns between now and completion.While the ovarian cancer trial is driving near term appreciation, therefore, and while it will likely continue to do so as the program moves into phase 2, it's the Optima trial that we are really looking at longer term as driving revaluation for Celsion.A recent $5 million registered direct offering extended runway to end 2017, meaning we may see a raise in early 2018 to cover the costs of completing the phase 3 program. With no debt on the books, however, and an array of near-term catalysts, any such raise isn't going to be overly important in the grand scheme of things if the numbers hit press as positive.Check out our previous coverage of this one here. We will be updating our subscribers as soon as we know more. For the latest updates on CLSN, sign up below!Image courtesy of eLife - the journal via FlickrDisclosure: We have no position in CLSN and have not been compensated for this article.