5 Pharmaceutical Companies With Phase III Clinical Study Catalysts During The Next 4-18 Months
August 23, 2012 | includes:
CTIC,
ECYT,
EXEL,
INCY,
THLD
Pharmaceutical companies with a set Phase III data release date very often have a run-up leading into the release date. I usually try to buy the stocks three to nine months before the catalyst date to make profit from the run-up. I screened for companies that have a Phase III data release date set during the next 4-18 months. Here is a look at 5 companies that I found.
2.
Cell Therapeutics (CTIC) is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.
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Upcoming Phase III catalysts
James A. Bianco, Principal Founder, Chief Executive Officer, President and Executive Director commented on the conference call
on August 1:
So let me just touch briefly on OPAXIO and brostallicin before we open for questions. We previously mentioned that the GOG has informed us that they have modified the statistical analysis plan to take an earlier look at the survival data of OPAXIO in their trial of monthly maintenance, OPAXIO for 12 months in patients with advanced ovarian cancer who achieved a complete remission after front-line therapy. We believe the first interim analysis will take place in January 2013. In addition with over 900 patients enrolled to date, we anticipate that they should complete the target enrollment of 1,100 patients late next year.
OPAXIO (paclitaxel poliglumex, CT-2103; formerly known as XYOTAX) is the company's biologically enhanced chemotherapeutic that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. CTI and the Gynecologic Oncology Group (GOG) are presently evaluating OPAXIO as monthly maintenance in a phase III clinical trial in ovarian cancer patients who have achieved a complete response following standard first-line chemotherapy. The trial includes a third paclitaxel arm to determine safety.
The company's complete pipeline is as follows:
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Financials
The company reported the
second-quarter financial results on August 1 with the following highlights:
Net loss$58.6 millionCash$14.8 millionThis cash amount was before the receipt of $15 million in gross proceeds received from the sale of CTI's Series 15-2 convertible preferred stock and warrants in July 2012 as part of a $35 million financing. CTI completed the first closing of $20 million of Series 15-1 convertible preferred stock and warrants in May 2012.
My analysis
The stock has seen steady
insider selling since May 2011. I am not expecting the first interim analysis of OPAXIO, that will take place in January 2013, will move the stock above $1.