|BioMed Momentum Index: Pause that Refreshes or More Pain to Come?|
|Wednesday, 28 October 2009 20:01|
Below is a 10-stock BioMed Momentum Index that I have created along with related financial data from Google Finance as of 10/28/09, including the stock price, 52-week change, average daily trading volume, and market cap. I have screened for small and micro-cap stocks with market caps of approximately $500 million (M) or lower with stock price increases of at least 50% in the past year and average trading volume of at least 1M shares per day.
1.) Antigenics (NASDAQ: AGEN) ($1.07) +60%, 2.5M shares / day, $95M
AGEN is a cancer immunotherapy (Oncophage) and vaccine adjuvant (QS-21) company which reported updated Phase 2 data for Oncophage in the treatment of recurrent, high-grade glioma earlier this week. Data reported in the first 20 patients treated with Oncophage show a median survival of 10.1 months. While survival data continues to accrue on all patients in the study, to date six patients (30%) have survived at or beyond 12 months. AGEN expects a decision on its European marketing application by late 2009 for Oncophage and on 10/21/09 AGEN announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMEA has verbally informed the Company at an oral meeting to anticipate a negative opinion on the application.
2.) BioCryst Pharma (NASDAQ: BCRX) ($9.18) +509%, 2.6M shares / day, $353M
On 10/23/09, BioCryst Pharma announced that the FDA issued an emergency use authorization (EUA) for the investigational anti-viral drug intravenous (IV) peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Shares of BCRX initially surged earlier this week, but have since come back down to earth given the restrictions placed around the use of the drug, which must be requested through the CDC.
3.) BioElectronics Corp. (OTC: BIEL.PK) ($0.07) +504%, 19.4M shares / day, $62M
BIEL is the ‘Tylenol Trade' of the year which has gained momentum and surged in part from a FDA Panel recommendation earlier this year to limit the availability and over-the-counter (OTC) doses of acetaminophen (Tylenol), which is found in a wide variety of OTC pain formulations, sleep aids, and cough / cold products. BIEL offers products based on pulsed electromagnetic therapy as a drug-free alternative for pain and inflammation.
4.) CEL-SCI Corp. (AMEX: CVM) ($1.08) +260%, 15.6M shares / day, $162M
On 10/26/09, CEL-SCI announced that it has received over $10 million over the past 60 days through the exercise of warrants by investors to purchase the Company's common stock. These additional funds increased the gross proceeds raised in the last 60 days to approximately $30 million. CEL-SCI plans to use the additional proceeds towards its pivotal Phase 3 clinical trial with its cancer drug Multikine and to accelerate the development of its LEAPS compound for the treatment of H1N1 hospitalized patients. CVM is developing lead product Multikine for a global Phase 3 trial in advanced primary head and neck cancer, and is also developing a treatment for hospitalized H1N1 patients using its L.E.A.P.S. technology platform once validation of its manufacturing facility in Maryland is completed.
5.) Cell Therapeutics (NASDAQ: CTIC) ($0.92) +197%, 21.75M shares / day, $515M
CTIC was my turnaround pick in February while trading at 8 cents and subsequently surged to over 2 bucks per share before settling back under a buck recently. The Company has since withdrawn its application in Europe for a non-inferiority indication in non-small cell lung cancer (NSCLC) for Opaxio and received a standard review by the FDA for pixantrone in the US while the share count has ballooned to over 500 million so the story has changed drastically given a market cap that remains north of $500 million - although the Company has succeeded at keeping the lights on with a pending FDA decision due in April 2010.
6.) Genta Inc. (OTC: GETA.OB) ($0.65) +65%, 4M shares / day, $87M
Genta Inc. will host a conference call and live audio webcast to review top-line results of its AGENDA Phase 3 trial of Genasense (oblimersen sodium) Injection in patients with advanced melanoma on 10/29/09 at 8am ET. On 7/14/09, Genta announced the publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test.
The Phase 3 AGENDA study has specified low-normal LDH as an enrollment criterion and the co-primary endpoints in this trial include progression-free survival (PFS) and overall survival (OS). This is an example of conducting another pivotal Phase 3 trial based on data mining to identify a subset of patients who benefitted from a treatment in a previous study that failed to reach its primary, pre-defined endpoint(s).
7.) Geron Corp. (NASDAQ: GERN) ($5.75) +73%, 1.25M shares / day, $524M
In late August, embryonic stem cell developer Geron provided additional comments on the recent clinical hold on its Spinal Cord Injury IND for GRNOPC1 due to safety issues involving the formation of cysts in animals from preclinical studies. The Company has submitted the data to the FDA and is in discussions with the Agency to answer its questions and proceed with the clinical trial.
8.) Hemispherx Biopharma (AMEX: HEB) ($1.53) +325%, 3.4M shares / day, $193M
The Ampligen saga continues . . . the latest information provided by CEO Dr. William Carter [click here for the 9-October interview at BioMedReports.com] indicates that animal toxicology studies conducted by Lovelace Respiratory Research Institute in NM in support of the Ampligen NDA and at the request of the FDA are currently undergoing auditing and expected to be completed by late 2009 to early 2010 in addition to other preclinical toxicology reports that are expected to be completed during 4Q09.
9.) Imaging3, Inc. (OTC: IMGG.OB) ($0.61) +1,120%, 4.8M shares / day, $161M
Imaging 3 is currently awaiting a decision by the FDA for marketing clearance of their DViS (Dominion Volumetric Imaging Scanner), which is a patented technology that produces high-quality 3D images in real time by utilizing photo-fluoroscopy. The Company will conduct a conference call at 1pm ET on 29-October to provide an update on the company's progress with the FDA to date.
10.) Nutra Pharma Corp. (OTC: NPHC.OB) ($0.50) +1,884%, 1.4M shares / day, $109M
The Company is another similar trade to BioElectronics as a Tylenol alternative which recently launched Cobroxin (derived from Asian Cobra Venom) in both oral spray and topical gel formulations in addition to other compounds in development.
With recent trading in the small / micro-cap biomed space suggesting at least a pause in the major bull run that has occurred over the past year, I will be tracking these 10 stocks as a proxy for the biomed momentum trade. Given the exponential gains in many of the stocks included in this index, I am bearish on the outlook for this index over the near-term with longer term results dependent on pending regulatory and clinical data catalysts for the companies. While I would not suggest shorting any of these 10 stocks due to the low stock prices and highly volatile trading patters; the valuation / outlook appears murky at best for the group as a whole.
Disclosure: No Positions