In the third part of this article, I wrote about three companies that have promising studies for drugs that help combat cocaine addictions and cancer.
There are another two companies that have promising studies for drugs that help combat cancer, chronic fatigue and chronic pain. So in this article, I will write about the reasons to take a speculative position in Threshold Pharmaceuticals Inc (THLD), Hemispherx Biopharma Inc (HEB) and Zogenix Inc (ZGNX).
1. Threshold Pharmaceuticals Inc
Threshold Pharmaceuticals Inc a development stage company, focuses on the discovery and development of drugs for the microenvironment of solid tumors and the bone marrows of hematologic malignancies as novel treatments for patients living with cancer. Its clinical development products include TH-302, a novel drug candidate, which is in Phase I, Phase II, and Phase III clinical trials for the severe hypoxic regions present in various solid tumors and hematologic malignancies. The company has a license and co-development agreement with Merck KGaA (MKGAY.PK) for the development and commercialization of TH-302 as well as a license agreement with Eleison Pharmaceuticals Inc to develop and marketing glufosfamide for the treatment of cancer in humans and animals.
Pipeline Portfolio
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(SOURCE)
New catalyst
On September 30, 2012, Threshold Pharmaceuticals Inc announced preliminary data from an ongoing dose-escalation Phase 1/2 clinical trial of its investigational hypoxia-targeted drug TH-302 in combination with bevacizumab in patients with recurrent glioblastoma. No dose-limiting toxicity has been reported to date in the first two dose cohorts (240 mg/m2 TH-302 plus bevacizumab and 340 mg/m2 TH-302 plus bevacizumab); dose escalation is ongoing. Preliminary results in six patients show a median time to progression (worsening of disease) of 128 days compared with a median time to progression of 89.5 days these same patients experienced while taking single-agent bevacizumab prior to study enrollment. The results were presented in a poster at the European Society for Medical Oncology (ESMO) 2012 Congress taking place September 28 - October 2, 2012, in Vienna, Austria (Abstract 435TiP).
Next catalyst
Clinical data of 406 Trial in Phase 3 multi-center, randomized, controlled clinical trial of TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma.
Fundamentals Analysis
Short interest
(SOURCE)Settlement Date Short Interest Avg Daily Share Volume Days To Cover 9/14/2012 6,647,612 1,221,777 5.440937 8/31/2012 6,553,476 1,051,319 6.233575 8/15/2012 6,693,047 757,840 8.831742
Analyst Research
(SOURCE)
Financials
The company reported the second-quarter financial results on August 5 with the following highlights:
| Revenue | $1.79MM |
| Net Income | ($16.98MM) |
| Cash | $8.30MM |
Chart Analysis
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Rsi is in a good position. The stock is in a bearish channel. The MACD marks a downward trend.
2. Hemispherx Biopharma Inc
It is a specialty pharmaceutical company, involved in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Its products include Ampligen, an experimental drug under clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Hepatitis B, human immunodeficiency virus (HIV), renal cell carcinoma, and malignant melanoma; Alferon N Injection, an injectable formulation of natural alpha interferon for the treatment of certain categories of genital warts; and Alferon LDO, an experimental low-dose oral liquid formulation of natural alpha interferon for the treatment of influenza and other emerging viral diseases. The company outsources certain components of its research, development, manufacturing, marketing, and distribution operations to third-parties.
Pipeline Portfolio
Indication | Product Candidate | Status |
CFS/ME | Ampligen® | Phase 3 Completed (USA) |
HIV | Ampligen® | Phase 2b Ongoing |
HIV | Ampligen® | Phase 3 Preparation (CHINA) |
| Avian Flu | Ampligen® | Preclinical Studies (USA, Japan and Canada) |
Hepatitis C | Alferon N Injection® | Phase 3 Preparation |
| Multiple Sclerosis | Alferon N Injection® | Phase 2 Preparation |
West Nile Virus | Alferon N Injection® | Phase 2/3 Preparation - Investigator Sponsored |
| Antiviral Indications | Alferon LDO® | Phase I/II Ongoing (USA & Hong Kong) |
HIV | Alferon LDO® | Phase 2 Preparation (Africa) |
| Avian Flu | Alferon N Injection® / Alferon LDO® | Preclinical Studies (USA and Canada) |
Various | Oragens™ | Preclinical Studies |
(SOURCE)
New Catalyst
On September 24, 2012, Hemispherx Biopharma Inc announced that the U.S. Food and Drug Administration ("FDA") has tentatively scheduled an Advisory Committee ("AC") meeting to discuss the Ampligen(R) New Drug Application for Chronic Fatigue Syndrome ("CFS") which is currently under review by the FDA. The date of the AC review has been tentatively set for December 20, 2012. As previously announced, the Prescription Drug User Fee Act ("PDUFA") review goals for the FDA to complete its review on February 2, 2013.
Next Catalyst
Meeting to discuss the Ampligen New Drug Application for Chronic Fatigue Syndrome for December 20, 2012.
Fundamentals Analysis
Short interest
| Settlement Date | Short Interest | Avg Daily Share Volume | Days To Cover |
|---|---|---|---|
| 9/14/2012 | 3,042,867 | 3,312,768 | 1.000000 |
| 8/31/2012 | 2,955,405 | 2,001,075 | 1.476909 |
| 8/15/2012 | 2,993,441 | 564,992 | 5.298201 |
Analyst Research
(SOURCE)
Financials
The company reported the second-quarter financial results on August 8 with the following highlights:
| Revenue | $49k |
| Net Income | ($2.78MM) |
| Cash | $2.17MM |
Chart Analysis
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Rsi is in a good position. The MACD marks a downward trend. The stock is in a bullish channel.
3. Zogenix Inc
It is a pharmaceutical company, involved in the development and commercialization of products for the treatment of central nervous system disorders and pain. Its commercial product includes Sumavel DosePro (sumatriptan injection), a delivery system that offers needle-free subcutaneous administration of sumatriptan for the acute treatment of migraine and cluster headache. The company's lead product candidate, Zohydro, is a single-entity extended-release hydrocodone, which has completed Phase III clinical trials for the treatment of moderate to severe chronic pain requiring around-the-clock opioid therapy. It is also developing Relday, an injectable formulation of risperidone to treat the symptoms of schizophrenia and bipolar disorder in adults as well as in thirteen-years-old teenagers and older. Zogenix, Inc. markets and sells its Sumavel DosePro through field sales force primarily to neurologists and other prescribers of migraine medications, including headache clinics and headache specialists in the United States.
Pipeline Portfolio
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(SOURCE)
New Catalyst
On September 27, 2012 Zogenix announced availability of new resources for migraine sufferers at SUMAVELDosePro.com to support national pain awareness month.
Fundamentals Analysis
Short interest
(SOURCE)Settlement Date Short Interest Avg Daily Share Volume Days To Cover 9/14/2012 3,340,363 579,238 5.766823 8/31/2012 3,285,615 190,201 17.274436 8/15/2012 3,234,955 245,407 13.182000
Analyst Research
(SOURCE)
Financials
The company reported the second-quarter financial results on August 8 with the following highlights:
| Revenue | $8.03MM |
| Net Income | ($17.16MM) |
| Cash | $21.97MM |
Chart Analysis
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The MACD marks an upward trend. RSI is in a good position. The stock is in a bullish channel.
*Chart data sourced from stockcharts, all other data sourced from Nasdaq.com and yahoo.com as well as the web of the previously mentioned company.
Additional disclosure: Investors buy and/or sell at their own risk. I declare that I may day-trade any stock at any time mentioned in this article. For me "long" is until I sell and few tell you that. I do not "short" stocks and few tell you that too. I also get paid one penny per view from SA and other than being published by SA and my own private stock account, I have zero connection to Wall Street and few tell you that too.
