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Saturday, December 3, 2022

The Exciting Story of Anavex Life Sciences Corp.(NASDAQ:AVXL)

Anavex Life Sciences Corp.(NASDAQ:AVXL) has been moving up steadily in recent weeks after some big press from the Company including being granted Orphan Drug Designation to ANAVEX 2-73 for the treatment of infantile spasms and for the treatment of Rett syndrome by the FDA.

We have been reporting on AVXL over the past year since it moved north off its $0.15 base (pre-split) back in March of last year saying at the time ”AVXL is making an explosive move up on accelerating volume after reversing off $0.15 a share. The stock currently trades at a fraction of the $5 per share it commanded back in 2008.”

Anavex Life Sciences Corp.(NASDAQ:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases such as Alzheimer’s disease, pain and various types of cancer. According to earlier reports ”is sitting on drugs in development that could potentially turn the multi-billion dollar Alzheimer’s market upside down.”

According to fool.com ”Americans are spending $226 billion annually to treat the symptoms of Alzheimer’s disease, and other dementias, rather than the cause of this disease itself. That’s an endlessly frustrating revelation that if left unchecked, could pose a big threat to the healthcare system. According to the Alzheimer’s Association, Alzheimer’s disease could cost Americans $1.1 trillion — yes, trillion — by 2050.

So there is no cure for Alzheimer’s disease, just 4 FDA approved drugs perscribed and sold on the market to treat the symptoms, not the cause.

What makes Anavex such an exciting story is the Company is not focused on treating the symptoms of Alzheimer’s but rather is focused on the root cause which is believed to be protein misfolding. AVXL’s Anavex 2-73 can work as an agonist for the sig-1R receptor that is behind protein misfolding. What is even more exciting is the fact that the same mechanism can work in Parkinson’s and Huntington diseases.

AVXL lead drug candidates, Anavex 2-73 and Anavex PLUS, a combination of Anavex 2-73 and donepezil (Aricept®) are currently being evaluated in a Phase 2a clinical trial for Alzheimer’s disease and continue to be the major catalyst here.

In earlier preclinical studies, Anavex 2-73 showed potential to halt and/or reverse Alzheimer’s disease. Additionally, positive preclinical data reveals the potential for Anavex 2-73 as a platform drug to treat additional CNS disorders, including epilepsy.

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Anavex began life as Thrifty Printing, a digital to photo print business targeting corner stores that didn’t work out. In 2007 the Company announced it has acquired a portfolio of three patents and one patent application covering drug candidates intended to be further developed through commercialization targeting the areas of neurological diseases and cancer. The patents were assigned by Dr. Alexandre Vamvakides who became Chief Scientific Officer (CSO) of the Company.

The Anavex story really took off when Dr Christopher Missling took over as CEO; he quickly assembled a team of big pharma and biotech experts, doubled the number of Scientific Advisors which is mostly Medical Doctors and raised a company’s record amount of $10M in one funding transaction which means that AVXL is now fully funded going forward.

Last month AVXL said investigators presented positive safety and cognitive efficacy data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s disease targeting sigma-1 and muscarinic receptors, which are believed to reduce protein misfolding including reduction of beta amyloid, tau protein and inflammation at the international CTAD 2015 conference in Barcelona, Spain.

Upcoming Milestones for AVXL include PART B data updates for 12, 26, 38, 52 week timeframes of the ongoing Phase 2a Alzheimer’s trial for ANAVEX 2-73. Report pharmacokinetics and pharmacodynamics (PK/PD) data for PART A of the Phase 2a trial. Initiate double-blinded, randomized, placebo-controlled Phase 2 human trial of ANAVEX 2-73 in non-disclosed indication.

In addition to ongoing Phase 2a trial currently in PART B, start larger, double-blinded, randomized, placebo-controlled Phase 2/3 trial of ANAVEX 2-73 for Alzheimer’s disease

On June 22 AVXL announced the U.S. Food and Drug Administration’s Office of Orphan Product Development has granted Orphan Drug Designation to ANAVEX 2-73 for the treatment of infantile spasms.

“Infantile spasms marks the second Orphan Drug Designation for our ANAVEX 2-73 program, following the Orphan Drug Designation received for the treatment of Rett syndrome,” said Kristina M. Capiak, Vice President of Regulatory Affairs for Anavex.

The FDA’s Office of Orphan Products Development advances the evaluation of drugs that show promise for the safe treatment of rare diseases, defined as those affecting fewer than 200,000 people in the United States. The designation provides sponsors with development and commercial incentives, including seven years of market exclusivity in the U.S., prioritized consultation by FDA on clinical studies and certain exemptions from or reductions in regulatory fees.

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Currently moving steadily higher AVXL had $11.9 million in cash at the end of March, earlier this year the Company filed a $100-million shelf financing and entered into a purchase agreement with Lincoln Park Capital to sell an aggregate of $50 million worth of shares. The Company previously reported that it is fully funded through completion of the current Phase 2a clinical trial and that Anavex has sufficient cash for approximately two years. Recently AVXL was granted Orphan Drug Designation to ANAVEX 2-73 for the treatment of infantile spasms and for the treatment of Rett syndrome by the FDA. AVXL is one stock that has got everyone’s attention; the Company is sitting on drugs in development that could potentially turn the multi-billion dollar Alzheimer’s market upside down. And its not just Alzheimer’s, Anavex 2-73 could work for Parkinson’s and Huntington diseases as well. The science behind Anavex is compelling the implications of which could be enormous and has not changed or been the subject of the recent massive short attack. We will be updating on AVXL when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with AVXL.

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Disclosure: we hold no position in AVXL either long or short and we have not been compensated for this article.

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