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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.

1. Threshold Pharmaceuticals (NASDAQ:THLD) is a biotechnology company focused on the discovery and development of drugs targeting tumor hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of some hematologic malignancies. This approach offers broad potential to treat a variety of cancers. By selectively targeting tumor cells, Threshold is building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs.

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Upcoming Phase III study catalysts

The company will provide an update in the first half of 2013 on the interim progression free survival futility analysis for the TH-302 Phase III "406 trial". The 406 Trial is a Phase 3, multi-center, randomized, open-label study is designed to evaluate the efficacy and safety of TH-302 plus doxorubicin as compared with doxorubicin.

Financials

The company reported the second-quarter financial results on August 2 with the following highlights:

Revenue$1.8 million
Net income$17.0 million
Cash$66.5 million

The company believes its cash, cash equivalents and marketable securities to be sufficient to fund the company's projected operating requirements for at least the next twelve months based upon current operating plans, milestone payment forecasts and spending assumptions.

Upcoming (other) milestones

The company currently anticipates the following key clinical milestones for TH-302:

  • Report overall survival results and updated top-line efficacy analysis from the "404 trial" in the second half of 2012
  • Report interim results by year end 2012 from the "408 trial" and the "410 trial"
  • Provide an update in the first half of 2013 on the interim progression free survival futility analysis for the "406 trial"

TH-302 is a hypoxia-targeted drug candidate that was designed to be activated under extreme hypoxic conditions, a hallmark of many cancer indications. Areas of low oxygen levels (hypoxia) within tissues are common in many solid tumors due to insufficient blood vessel growth. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be extremely hypoxic.

My analysis

The stock has a $9.75 price target from the Point and Figure chart. The stock has seen some insider selling this year. I believe $10 level is achievable after positive Phase III interim results in the first half of 2013. If the data is negative we will most likely dip below $5.

2. Cell Therapeutics (NASDAQ: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 million
Cash$14.8 million

This 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.

3. Incyte Corporation (NASDAQ:INCY) is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs for oncology and inflammation.

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Upcoming Phase III study catalysts

Two clinical trials, in partnership with Novartis (NYSE:NVS), are underway to evaluate ruxolitinib in patients with advanced polycythemia vera (PV) with results expected to be part of a supplemental new drug application (SNDA) submission in 2014.

  • A global Phase III trial (known as the RESPONSE trial) evaluating ruxolitinib versus best available therapy in patients with advanced polycythemia vera who are resistant to or intolerant of hydroxyurea continues to enroll patients and is targeted to complete recruitment in the second half of 2012. Results from the RESPONSE trial are expected in the second half of 2013.
  • A randomized Phase III trial (known as the RELIEF trial) comparing disease-related symptoms in patients with polycythemia vera treated with ruxolitinib versus those treated with hydroxyurea is now enrolling patients. This trial is designed to support potential labeling claims on symptomatic benefit.

Polycythemia vera (PV) is a blood cancer characterized by the overproduction of red blood cells which increases blood viscosity and leads to elevated thromboembolic risk. Increased levels of white blood cells and platelets are also common. In advanced disease, patients frequently exhibit spleen enlargement and debilitating symptoms, including pruritus, night sweats, fatigue and muscle and bone pain.

Financials

The company reported the second-quarter financial results on August 2 with the following highligts:

Revenue$86.5 million
Net income$4.0 million
Cash$261.8 million

Upcoming (other) milestones

According to a presentation dated August 15:

My analysis

The stock has seen some insider selling in the May - July 2012 time frame. The stock could test $30 level after positive results from the RESPONSE trial in the second half of 2013.

4. Endocyte (NASDAQ:ECYT) is a biopharmaceutical company developing targeted therapies for the treatment of cancer and inflammatory diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging diagnostics for personalized targeted therapies. The company's SMDCs actively target receptors that are over-expressed on diseased cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently, and over longer periods of time than would be possible with the untargeted drug alone. The companion imaging diagnostics are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment.

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Upcoming Phase III study catalysts

Top-line data expected from the Phase 3 PROCEED trial in the first half of 2014.

Vintafolide (EC145) delivers a very potent vinca chemotherapy directly to cancer cells by targeting the folate receptor expressed on cancer cells, but not on most normal cells. Approximately 80-90 percent of ovarian and lung cancers express the receptor, as do many other types of cancer.

Endocyte and Merck (NYSE:MRK) entered into a partnership for vintafolide in April 2012. Under this partnership Endocyte granted Merck an exclusive license to develop, manufacture and commercialize vintafolide. Endocyte will be responsible for the majority of funding and completion of the PROCEED trial, with Merck responsible for all other development activities and costs.

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Financials

The company reported the second-quarter financial results on August 2 with the following highlights:

Net loss$10.5 million
Cash$211.5 million

Upcoming (other) milestones

  • File EU conditional marketing authorization applications in fourth quarter 2012
  • Anticipated access to new supply of DOXIL from Janssen Products, LP by year end 2012
  • Data from human study of prostate-specific membrane antigen diagnostic imaging agent (EC0652) by year end 2012
  • Initiation of clinical trial of folate targeted tubulysin therapeutic in first half of 2013
  • Top-line data expected from the Phase 3 PROCEED trial and Phase 2b TARGET trial in the first half of 2014

My analysis

The stock has a $18.25 price target from the Point and Figure chart. The stock has seen some insider selling in May - August 2012 time frame. The stock could reach the $18 target price after positive Phase 3 PROCEED trial results in the first half of 2014. If the trial data is negative, the stock would likely drop below $5.

5. Exelixis (NASDAQ:EXEL) is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its proprietary resources and development efforts exclusively on cabozantinib (formerly known as XL184), its most advanced product candidate, in order to maximize the therapeutic and commercial potential of this compound. Exelixis believes cabozantinib has the potential to be a high-quality, broadly-active, differentiated pharmaceutical product that can make a meaningful difference in the lives of patients. Exelixis has also established a portfolio of other novel compounds that it believes have the potential to address serious unmet medical needs, many of which are being advanced by partners as part of collaborations.

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Upcoming Phase III study catalysts

Exelixis announced on May 30 the initiation of COMET-1, a Phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint for COMET-1 is overall survival in mCRPC patients who have had disease progression after treatment with docetaxel and abiraterone acetate and/or MDV3100. Exelixis expects data from COMET-1 to be available in the first half of 2014.

Financials

The company reported the second-quarter financial results on August 2 with the following highlights:

Revenue$7.8 million
Net loss$36.5 million
Cash$294.8 million

On August 9 Exelixis announced the pricing of its concurrent underwritten public offering of 30 million shares of newly issued common stock at a price to the public of $4.25 per share and $250 million aggregate principal amount of its 4.25% convertible senior subordinated notes due 2019. Exelixis anticipates that its aggregate net proceeds from the concurrent offerings will be $361.9 million.

Upcoming (other) milestones

Exelixis announced on July 30 that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). The FDA also granted priority review designation to the NDA for cabozantinib. The Prescription Drug User Fee Act (PDUFA) action date is November 29, 2012.

My analysis

The first major catalyst for the stock is the November 29 PDUFA date for cabozantinib as a treatment for MTC. I believe the stock would most likely best $8 level if the drug is approved. If the company receives a CRL, the stock would most likely drop below $3.

Source: 5 Pharmaceutical Companies With Phase III Clinical Study Catalysts During The Next 4-18 Months