Anavex Life Sciences Corp (AVXL)

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AVXL DD- All you need to know

Anavex (AVXL)

http://www.anavex.com/

Here is some brief DD.

Fully reporting OTC.

Market Cap: Only $11 million and they are targeting indications with multi-billion potential

Outstanding Shares: 56,441,000

Insider Ownership: 24.33% (Yahoo)

Institutional Ownership: 54.39% (Figures from the Recent S1)

Auriga Global 4.99%
Auriga Investors-Montserrat 4.99%
Hudson Bay Master Fund 4.99%
DAFNA LifeScience LP 4.99%
DAFNA LifeScience Market Neutral 2.53%
DAFNA LifeScience Select L.P. 4.99%
Joann Mostovoy 4.99%
Sabby Healthcare 4.99%
Sabby Volatility Warrant Master Fund 4.99%
Sphera Global Healthcare Master Fund 9.99%
HFR HE Sphera Global Healthcare Master Trust 1.95%

Insider and institutional ownership give this stock a very small float which causes it to move quickly when she pops.

Catalysts: They are target Alzheimer’s disease and other neurological disorders. Pre-clinical results have been astounding and there is huge promise for their molecules. They are currently running a P2A study, using a combination of Anavex. Data is expected in September 2015 or Q3. Also, they have utilized an “Adaptive Trial” design which will allow them to progress into a P3 study by the end of the year.

CEO stated that in Q2 they will be filing an IND application to the FDA for an Orphan Indication. They also intend to provide an enrollment update in Q2 as well.

The CEO’s presentation at the Roth conference can be found here:

http://wsw.com/webcast/roth29/register.aspx?conf=roth29&page=avxl&url=http://wsw.com/webcast/roth29/avxl/index.aspx

Here is a summary of their pipeline. Of particular note is that their drug targets the multiple etiologies associated with Alzheimer’s disease including the Tau receptor, which the Mayo clinic just came out yesterday and said was the key driving force in Alzheimer’s.

Here is the article: http://medicalxpress.com/news/2015-03-thousands-brains-reveals-tau-driver.html

Our Pipeline

Our pipeline includes one clinical drug candidate and several compounds in different stages of pre-clinical study.
Our proprietary SIGMACEPTOR™ Discovery Platform produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, including Alzheimer’s disease. When bound by the appropriate ligands, sigma receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease.

Compounds that have been subjects of our research include the following:

ANAVEX 2-73

ANAVEX 2-73 may offer a disease-modifying approach in Alzheimer’s disease (AD) by using ligands that activate sigma-1 receptors.
In AD animal models, ANAVEX 2-73 has shown pharmacological, histological and behavioral evidence as a potential neuroprotective, anti-amnesic, anti-convulsive and anti-depressive therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate affinities to M1-4 type muscarinic receptors. In addition, ANAVEX 2-73 has shown a potential dual mechanism which may impact both amyloid and tau pathology. In a transgenic AD animal model Tg2576 ANAVEX 2-73 induced a statistically significant neuroprotective effect against the development of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers that is apparently amyloid-beta independent. It also statistically alleviated the learning and memory deficits developed over time in the animals, regardless of sex, both in terms of spatial working memory and long-term spatial reference memory.

Based on the results of pre-clinical testing, we initiated and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX 2-73 in 2011. In this Phase 1 SAD trial, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX 2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including AD.

The ANAVEX 2-73 Phase 1 SAD trial was conducted as a randomized, placebo-controlled study. Healthy male volunteers between the ages of 18 and 55 received single, ascending oral doses over the course of the trial. Study endpoints included safety and tolerability together with pharmacokinetic parameters.

Pharmacokinetics includes the absorption and distribution of a drug, the rate at which a drug enters the blood and the duration of its effect, as well as chemical changes of the substance in the body. This study was conducted in Germany in collaboration with ABX-CRO, a clinical research organization that has conducted several Alzheimer’s disease studies, and the Technical University of Dresden.

ANAVEX PLUS

ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil (Aricept®) is a potential novel combination drug for Alzheimer’s disease. Aricept® (donepezil) is now generic. ANAVEX 2-73 showed in combination with donepezil an unexpected and clear synergic effect of memory improvement by up to 80% in animal models. A patent application was filed in the US for the combination of donepezil and ANAVEX 2-73 and if granted would give patent protection at least until 2033.

In a humanized calibrated cortical network computer model the unexpected pre-clinical synergy between ANAVEX 2-73 and donepezil was confirmed and ANAVEX PLUS showed an anticipated ADAS-Cog response of 7 points at 12 weeks and 5.5 points at 26 weeks, which represents more than 2x the ADAS-Cog of donepezil alone.

ANAVEX 3-71

ANAVEX 3-71, previously named AF710B is a preclinical drug candidate with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has shown to enhance neuroprotection and cognition in Alzheimer's disease. ANAVEX 3-71 is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications. It is highly effective in very small doses against the major Alzheimer's hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions. ANAVEX 3-71 indicates extensive therapeutic advantages in Alzheimer's and other protein-aggregation-related diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.

ANAVEX 1-41

ANAVEX 1-41 is a sigma-1 agonist. Pre-clinical tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death) through the modulation of endoplasmic reticulum, mitochondrial and oxidative stress, which damages and destroys cells and is believed by some scientists to be a primary cause of AD. In addition, in animal models, ANAVEX 1-41 prevented the expression of caspase-3, an enzyme that plays a key role in apoptosis (programmed cell death) and loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. These activities involve both muscarinic and sigma-1 receptor systems through a novel mechanism of action.

They also have a very strong leadership team:

Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen.

Dr. Zografidis, the Vice President Clinical Operations of Anavex, has over 25 years of experience in the pharmaceutical and healthcare industry, including 12 years at Wyeth (now Pfizer) in clinical project management and prior to joining Anavex most recently served as clinical and pharmaceutical consultant.

Bernd Metzner, PhD, a director of Anavex, is currently Chief Financial Officer of the Doehler Group, a global producer and provider of technology-based natural ingredients for the food and beverage industry with sales activities in more than 130 countries. Previously, he was Chief Administration Officer and member of the Board of Management of Bayer Schering Pharma AG, the pharmaceutical division of $100+ billion market cap company Bayer AG.

Solid pipeline and good leadership. They are also very good at PR, which is a benefit to shareholders in that they are actively trying to spread the word about their pipeline and potential.

Here is a link to their corporate presentation:

http://www.anavex.com/files/2015-01-06_AVXL_Corporate_Presentation.pdf

Notice that on slide 24 the Market Caps of comparable companies. The LOWEST comparable it 10x’s larger than AVXL’s and they are at the same stage of development.

Now here is the kicker, the recently completed and offering, underwritten by Maxim with 66 million warrants. 33 million of those warrants are exercisable at $.30 and the other 33 million are exercisable at $.42. Also, Maxim has a price target of $7 for AVXL. Do your own DD and you see the importance of this.