- Today, we revisit biotech concern Celsion Corporation for the first time in over a half-decade.
- The stock still trades right near the $2 level just like it did when we last took a look at this small-cap name in 2015.
- News flow in 2021 has picked up, so it's time to circle back on Celsion. A full analysis is provided in the paragraphs below.
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Today, we revisit a $2 biotech stock we last took a full look at in 2015. Despite the company's small size and lack of providing shareholder value over the years, the equity comes up occasionally over at The Biotech Forum as a Live Chat topic. Given how much time has elapsed since we last took more than a cursory glance at Celsion, we circle back on this small-cap name in the paragraphs below.
Celsion Corporation (CLSN) is still a 'Tier 4' biotech concern based just outside of Philadelphia. The company remains focused on development of directed chemotherapies, DNA-mediated immunotherapy, and RNA-based therapies for the treatment of cancer. The shares trade right at two bucks a share and sport an approximate $130 million market cap.
ThermoDox® is Celsion’s lead product candidate. This compound is a proprietary heat-activated liposomal encapsulation of doxorubicin. ThermaDox is currently being evaluated in a global phase 3 clinical trial called OPTIMA evaluating it the treatment of primary liver cancer. Here is how the company describes ThermoDox is more granularity on its website.
ThermoDox leverages 2 facets of tumor biology:(1) tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors, and (2) when heated, blood vessels in tumors become even more permeable, further increasing the accumulation of liposomes in tumors before releasing the doxorubicin. In animal models, ThermoDox has been shown to deliver 25 times more doxorubicin into tumors than does intravenous (IV) infusion alone, and 5 times more doxorubicin than standard liposomal formulations of the drug."
Celsion also has an earlier stage compound in pipeline called GEN-1. This produce candidate incorporates a DNA plasmid encoding IL-12 into a unique nanoparticle delivery system. GEN-1 immunotherapy is currently being evaluated in a phase I/II study named OVATION 2, in combination with chemotherapy, for newly diagnosed ovarian cancer patients. The primary endpoint of this study won't be announced in the fourth quarter of next year. As of last week, approximately one third of this trial's patient pool had been enrolled.
Finally, the company is also developing a next-generation vaccine targeting COVID-19, using its platform it has dubbed PLACCINE. Given scores of companies are targeting COVID-19 vaccines and treatments and Celsion's effort is in early stage development, it will not be germane at this time to our analysis around the company.
It has been a busy start to the year for Celsion. It did a significant capital raise (see section below) on January 22nd. On February 11th, management issued a letter with a pipeline update to its shareholders and also announced the formation of a Vaccine Advisory Board. Finally, last week GEN-1 garnered Fast Track designation from the FDA to treat advanced ovarian cancer.
Analyst Commentary & Balance Sheet:
Not surprisingly, the analyst commentary is mixed on Celsion's prospects. Over the past nine months or so, both Dawson James and Oppenheimer have reissued Hold ratings. The only support from the analyst community comes from JonesTrading who reiterated its Buy rating and $8.00 price target on CLSN in mid-May of last year and Brookline Capital Markets who maintained their Buy rating and $4.00 price target on the equity last week.
The company ended the third quarter of 2020 with just over $18 million in cash and marketable securities on its balance sheet after posting a just over $8 million net loss during the quarter. Late in January the company executed a secondary offer at $1.35 a share and raised gross proceeds of $35 million. The company now believes it has a cash runway of nearly three years. In addition, Celsion restructured its venture debt facility with Horizon Technology Finance and its outstanding debt obligation in half with that entity to $5 million during the third quarter.
Celsion has several pots in the fire and appears well-funded for the next few years. However, it is hard to have much, if any faith in this company given the pace of its pipeline development. It reminds a bit of the famous play 'Waiting For Godot'.
The company has been public for over 20 years and still hasn't gotten any candidate over the 'finish line'. The OPTIMA study was underway when we last looked at this name in 2015. There are no notable trial milestones that are apparent in 2021. And, given how much shareholder value Celsion has destroyed over the past two decades, I see no real reason to own the shares at this moment in time.
Bret Jensen is the Founder of and authors articles for the Biotech Forum, Busted IPO Forum, and Insiders Forum.
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