BST Trade Alert – June 9, 2015
Recommendation:
Buy Celldex Therapeutics $NASDAQ: CLDX up to $28.00 per share.
About the Company:
Celldex believes the best way to treat and destroy many of the worst diseases is by harnessing the power of the immune system.
They seek to leverage the power of the immune system’s response by combining therapeutic approaches to maximize the human body’s own response.
Their pipeline is comprised of therapeutic antibodies, antibody drug conjugates, immune system modulators and vaccines. Many of them are for underserved or completely un-served orphan indications.
This is a clinical stage company but they have many ongoing late stage programs and plan to become a fully-integrated commercial entity upon gaining FDA approval for one of their treatments.
The company lost $118 million over the last 12 months. But they did generate $3.7 million in revenue over the last year. They have $360 million in cash, enough to fund operations for at least 24 months.
About the Drug:
Rindopepimut is CLDX’s lead product. It’s a cancer treatment that has been given the trade name Rintega.
Rindopepimut is administered via intradermal injection and consists of the EGFRvIII-specific peptide sequence conjugated to the carrier protein Keyhole Limpet Hemocyanin (KLH).
The drug stimulates the patient’s immune system, inducing pronounced EGFRvIII-specific humoral and cellular responses. 85% of patients in clinical trials evaluating rindopepimut developed significant anti-EGFRvIII antibody titers, which increased with time during the study. The majority (67%) of these patients developed titers above 1:12,800. Such immune responses may contribute to the direct destruction of tumor cells expressing EGFRvIII.
They have completed three Phase 2 trials of rindopepimut in newly diagnosed EGFRvIII-positive glioblastoma patients with consistent results.
And they have completed the enrollment in their Phase 3 study.
In a press release earlier this year, their CEO said, “We completed enrollment in our Phase 3 study in newly diagnosed glioblastoma and reported positive interim PFS-6 and overall survival data from our Phase 2 ReACT study in patients with recurrent GBM. Most recently, based on these data, Rintega was issued Breakthrough Designation from the FDA.”
They have completed three Phase 2 trials of rindopepimut that have been completed in newly diagnosed EGFRvIII-positive glioblastoma patients with consistent results.
About the Market for This Drug:
Every year more than 14 million new cases of cancer occur. And more than 8 million people die from cancer each year.
Needless to say, cancer treatment is big business.
Glioblastoma is a rare form of cancer affecting the brain or spine. There are between 20K and 200K new cases per year in the US.
About the Potential Catalyst:
Rintega has been progressing steadily through clinical trials over the last few years.
In February, Reginga was granted Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastomabre by the FDA.
They have completed the enrollment in the Phase 3 study. The first interim analysis is expected in mid-2015.
About the Shares:
As of this writing, CLDX is trading for $25.18. The stock is up 120% from the 52-week low of $11.93. It’s currently 20% below the 52-week high of $32.82.
The stock has been trending higher since the positive phase 2 trial data in October. The stock spiked again in February following the Breakthrough Therapy Designation from the FDA.
Since then, CLDX has fallen back to support of the upward trending support. This is a great buying opportunity for this stock that’s showing clear bullish momentum and has a bullish catalyst in the next few months.
Key Facts:
Company: Celldex Therapeutics
Ticker: CLDX
Recent Price: $25.18
Market Cap: $2.59 billion
Average Daily Volume: 1.94M shares
Chart:
Category: BST Trade Alert
