Significant events, news, and commentary covering select smaller cap BioPharma companies from Monday and today:
Antares Pharma (ATRS) announced this morning positive results from an Actual Human Use (AHU) study for VIBEX Methotrexate (MTX). The clinical trial was conducted as a multi-center, open-label, single-arm, in-clinic study to evaluate the actual human use of methotrexate administered via the VIBEX Medi-Jet in adult patients with rheumatoid arthritis (RA).
The results of this study show that self-administration of MTX using the VIBEX Medi-Jet is safe and well tolerated. Following standardized training by site personnel and review of written instructions, all 101 patients performed the self-administration successfully.
Results of the Ease of Use Questionnaire indicated that 98% of patients found the VIBEX Medi-Jet easy to use and 100% of patients found the instructions and training to be clear and easy to follow. Patients were also asked to report site administration pain at the end of the treatment period. Administration site pain was measured using a 100 mm Visual Analog Scale (VAS) and showed that patients experienced minimal or no pain with a mean value of 3.6 mm on a scale of 100 mm. Importantly, no patients experienced treatment-emergent serious adverse events related to the drug.
The company expects to file an NDA for VIBEX MTX in February of 2013, but I expect the NDA filing to be as early as December of this year, based on the company's prior history of under-promising and over-delivering. This news coupled along with a possible faster than expected NDA filing here could propel the stock to test its 52 week high of $5.58 in the next few weeks.
Antares stock is currently trading around $4.49 $0.28 (6.52%).
Aeterna Zentaris (AEZS) announced this morning that the European Patent Office ("EPO") has granted a patent for the use of the ghrelin agonist, AEZS-130, related to methods and kits for use in relation to the diagnosis of growth hormone deficiency ("GHD") in a human or animal subject.
The patent could be a key element to ensure the protection of AEZS-130 for the diagnosis of GHD.
AEZS-130 is a novel synthetic small molecule, acting as a ghrelin agonist, that is orally active and stimulates the secretion of growth hormone (GH). Based on results of Phase 1 studies, AEZS-130 has potential applications for the treatment of cachexia, a condition frequently associated with severe chronic diseases such as cancer, chronic obstructive pulmonary disease and AIDS. In addition to the therapeutic application, a Phase 3 trial with AEZS-130 as a diagnostic test for growth hormone deficiencies in adults has been completed.
AEZS has been rallying lately, coming off a trading range in August that saw the stock price in the $0.40's range. This news is positive for AEZS, and the company can certainly use positive news after the stock fell hard in April of this year when its cancer drug perifosine, which was partnered with Keryx Biopharma (KERX) failed to show any real improvement in patients with advanced colorectal cancer -- both companies' stocks plummeted 65%.
I believe AEZS might be back on the road to see a stock price in the $1.50 range soon as anonymous sources tell me financing could be on the horizon at a price higher than $1.50. AEZS is currently trading around $0.8065 $0.0266 (3.41%).
Genetic Technologies Ltd. (GENE)
GENE announced today that BREVAGen™ has been cleared for sale into the State of Florida following the grant of a permit to the company's Australian-based laboratory by the Clinical Laboratory Unit of the Florida Agency for Healthcare Administration
The news follows the approval of the drug for California in July. Florida and California, combined, represent between 15% and 20% of breast cancer incidence in the United States.
BREVAGen™ is a first-in-class predictive risk test for sporadic breast cancer. By combining a woman's individual clinical risk factors (Gail score) with specific genetic markers, BREVAGen can assist physicians in developing personalized breast cancer risk management plans. As a non-invasive, oral swab test, BREVAGen is very easy to use in the clinic setting.
|Total Cash (mrq):||9.33M|
|Total Cash Per Share (mrq):||0.60|
|Total Debt (mrq):||18.57K|
|Total Debt/Equity (mrq):||0.12|
|Current Ratio (mrq):||5.15|
|Book Value Per Share (mrq):||0.96|
|Cash Flow Statement|
|Operating Cash Flow (TTM):||-8.03M|
While the news today for GENE is very positive, I would caution investors that possible financing/dilution might be on the horizon here for the company -- as we can see from above, the company is burning about $2.5M a quarter and has about $9.3M in cash.
GENE stock is currently trading around $4.12 $0.77 (22.99%).
Peregrine issued a press release saying not to trust the Phase 2 clinical trial results for its lead drug candidate, bavituximab. I warned listeners of my show last week that the sudden positive data results announced by the company on September 7th was not to be trusted.
Even more troubling to me is the fact the company announced that it has secured a $30 million term loan from Oxford Finance, which was the lead lender, MidCap Financial, and Silicon Valley Bank - Only one week prior to the announcement of the preliminary positive data, which as mentioned above, the company now says should not be trusted.
Under the loan facility, the company received initial funding of $15 million and has an option to receive an additional $15 million.
My question here is did the company know of the bad results prior to this financing? Was the data possibly doctored -- on purpose?
I expect multiple lawsuits here to address the questions here and ultimately find the truth in this matter -- whatever that might be. The company lost more than 80% of its value on Monday, closing at $1.16 after a prior closing price of $5.39 in its prior trading session. PPHM stock is currently trading around $1.36 $0.20 (17.24%).
Disclosure: I am long ATRS.
Additional disclosure: Disclaimer: This article is intended for informational and entertainment use only, and should not be construed as professional investment advice. They are my opinions only. Trading stocks is risky -- always be sure to know and understand your risk tolerance. You can incur substantial financial losses in any trade or investment. Always do your own due diligence before buying and selling any stock, and/or consult with a licensed financial adviser.