PropThink: Mark the Calendar; Celsion to Release ThermoDox Trial Results in January
(Thomson Reuters ONE) -
By Jake King
Oncology-focused Celsion Corp. (NASDAQ:CLSN) announced Friday morning that the
Phase III HEAT trial met its unblinding milestone, and top-line data will be
released in January of 2013, sending shares up 7% at the open. The trial
evaluates ThermoDox in combination with radiofrequency ablation (RFA) as a
treatment for liver cancer, or Hepatocellular Carcinoma (HCC). The primary
endpoint in the study is Progression Free Survival (PFS), and the study was set
to unblind for analysis once 380 progression events occurred. Management
believes the trial has done just that, to be confirmed by an independent data
monitoring committee, and plans to have data analyzed and ready for release in
January.
More important, perhaps, is guidance in this morning's press release about the
company's capital position and financing expectations. Michael H. Tardugno, CEO,
said, "Consistent with our previous guidance, we have no plans to raise
additional capital before disclosing top line data from the HEAT Study which, if
positive, will vastly expand the Company's strategic and financing options." At
June 30, Celsion had $24M in cash and marketable investments, and added $4.7M
through warrant and option exercising. The company burns roughly $5.5M
quarterly, suggesting that capital use should not be an issue in the immediate
future. The affirmation is a relief to many investors, as the companyinitiated a
$75M shelf offering in August; we speculate that the offering will be reserved
for commercialization efforts should Thermodox prove a viable cancer treatment.
Management emphasized efforts to develop ThermoDox while retaining full ex-Japan
marketing rights. There's little question that a successful product stands to
benefit from the large market for HCC treatments.
The story falls to ThermoDox's ability to meet its primary endpoint. The drug is
a heat-activated liposomal encapsulation of doxorubicin, administered
intravenously, and when combined with RFA (mild hyperthermia), results in
concentrated delivery of doxorubicin in the tumor; it's a focused payload
without the same systemic risks that accompany many cancer treatments. The drug
performed well in a Phase I study, but Bears question its ability to produce the
same results in a larger trial; oddly enough, ThermoDox moved straight from
Phase I to Phase III. The missing Phase II study can be attributed to
doxorubicin's well-established safety profile and widespread use. And the FDA
seems willing to accept the results regardless, as Celsion operates the HEAT
trial under a Special Protocol Assessment, and ThermoDox received Orphan Drug
status from the FDA. The study was also deemed a Priority Trial by the National
Institutes of Health.
Celsion's $150M market capitalization is considerably low for a company with a
late-stage oncology product. (Note Threshold Pharmaceuticals' (NASDAQ:THLD)
$236M market cap, and Ziopharm's (NASDAQ:ZIOP) $365M.) Is the market accurately
valuing the company based on clinical chances, or is this an undiscovered
opportunity? The question has plagued shareholders for years. If ThermoDox meets
its PFS endpoint in January with acceptable safety, shares could easily double
as the market adjusts for clinical success and begins looking towards potential
sales figures. CLSN recently retraced since it's $6.09 high in September and
isn't far above support at $4.25. We expect some appreciation ahead of the data
release, but trading the event takes a fair amount of risk tolerance.
See this article at PropThink.com
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Datum: 09.11.2012 - 18:13 Uhr
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News-ID 201773
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