With the weak third-quarter earnings season pretty much behind us, it’s time for
penny stock
investors to look for areas of growth. One sector that has been
outpacing the overall markets has been the biotechnology sector, up
60.6% for the year and 46.0% year-to-date.
One penny stock biotech
company that has been performing well since June and generating buzz is
Celsion Corporation (NASDAQ/CLSN). Celsion is a development-stage penny
stock whose lead product is “ThermoDox,” a heat-activated cancer
therapy that combines a common oncology drug, doxorubicin, with a
heat-activated liposome, which may help deliver and release the drug
more accurately. The drug is being studied as a treatment for liver
cancer and breast cancer.
The penny stock’s pivotal phase III
trial (the “HEAT Study”) was designated as a priority trial for liver
cancer by the National Institutes of Health and received fast track
designation from the U.S. Food and Drug Administration (FDA) and orphan
drug designation in both the U.S. and Europe. Results from this trial
are expected in January 2013.
Primary liver cancer, also known as
hepatocellular carcinoma, or HCC, is one of the most common and deadly
forms of cancer. It is estimated that up to 90% of liver cancer patients
will die within five years of diagnosis. Although the most effective
treatment for liver cancer is surgical resection of the tumor, 80% to
90% of patients are ineligible for surgery due to the progression of
their tumors. (Source: “Celsion’s lead indication is in Primary Liver
Cancer,” Celsion Corporation web site, last accessed November 26, 2012.)
ThermoDox
is also under phase II clinical trial for colorectal liver metastasis,
and phase II clinical trial for treatment of recurrent chest wall breast
cancer.
On November 12, Celsion announced its third-quarter
results and a business update. The penny stock’s third-quarter loss
improved to $6.0 million, or $0.18 per share, from a loss of $6.4
million, or $0.25 per share, in the same period last year. The penny
stock’s year-to-date net loss came in at $18.3 million, or $0.55 per
share, compared to $17.1 million, or $0.72 per share, in the same period
of 2011. (Source: “Celsion Corporation Reports Third Quarter 2012
Financial Results and Business Update,” Celsion Corporation press
release, November 12, 2012.)
Chart courtesy of www.StockCharts.com
Celsion’s
share price has been bullish since late June, on the heels of
encouraging ThermoDox updates and speculation. In September, the penny
stock broke through a three-year resistance level near $5.50, and
currently remains bullish, trading above $7.50.
Since Celsion is
in the development stage, it is not generating any revenues and won’t
unless its flagship product gets FDA approval. That said, Celsion has
$22.0 million in cash, which is more than enough to take it to January
2013, when data from the penny stock’s ThermoDox phase III study is
released.
If the data are positive, Celsion should have no issues
getting further financing. On the other hand, if the data are less than
positive, the penny stock has enough resources to continue operations
and look for additional funding.
In a November 9, 2012 update,
company President and CEO Michael H. Tardugno said, “We enter this
transformative period from a position of financial strength, having
taken ThermoDox through to pivotal data while maintaining full worldwide
rights outside of Japan, a minimal number of shares outstanding and a
strong balance sheet.” (Source: “Celsion Announces Phase III HEAT Study
of Thermodox,” Celsion Corporation press release, November 9, 2012.)
Tardugno
added, “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.”
In conjunction with the penny stock’s
third-quarter results, Tardugno noted, “With a positive outcome,
ThermoDox will become the most important 1st line therapy for patients
with non-resectable disease. The positive implications of this study,
for patients and their families, the healthcare community, our investors
and employees, cannot be overestimated.” (Source: “Celsion Corporation
Reports Third Quarter 2012 Financial Results and Business Update,”
Celsion Corporation press release, November 12, 2012.)
While the
company says it cannot comment on its phase III HEAT Study data, Celsion
President and CEO Tardungo seems quite optimistic. Investors appear
equally as hopeful—sending the stock to a three-year high. The next 60
to 90 days will be a very important period for Celsion. Newcomers can
either take a wait-and-see approach or follow closely.