Anavex: Paving the Way in Precision Medicine
*Authored by MayoMobile under SOTC Analytics; not an official company product*
Anavex (Nasdaq: AVXL) stands to defy clinical atmospherics and bring precision medicine into a new era, and we're here to watch their story unfold.
What we've done
This publication took over 130-hours to complete and reveals in-depth disease modification attributes enabled by the brilliance of Sigma-1 receptor activation. SOTC Analytics will continue future updates in the Update Compendium section.
AVXL is nearing completion in multiple pivotal trials in neurodegenerative and neurodevelopmental diseases.
Blarcamesine, an S1R & M1-M4 muscarinic agonist is capable of rescuing cellular homeostasis throughout the body, from the CNS to the heart.
Reductions in neuroinflammation, expression of neurotransmitters, protein clearing, restorative autophagy, and mRNA transcription, likely prompt cascading beneficial effects.
I outline a possible prioritization for future indications. Assessed indications were: Alzheimer's Disease, Parkinson's Disease Dementia, Parkinson's Disease, Rett Syndrome, Angelman Syndrome, Infantile Spasms, Fragile X, holistic Autism Spectrum Disorders, Frontotemporal Dementia, Depression, Cancer, Cerebral Palsy, Retinal Disorders, Sexual Dysfunction, General Aging, ALS, Multiple Sclerosis, Heart Disease, Batten Disease, and Insomnia/Sleep issues.
Anavex Life Sciences Corporation (AVXL) is expecting late-stage Rett Syndrome and Alzheimer’s disease clinical data in 2022 for their lead drug candidate Blarcamesine (Anavex 2-73). Blarcamesine is potentially the most promising remedy for holistic neurodegenerative and neurodevelopmental diseases in development, thanks to its wide-sweeping mechanism of action (MOA) revolving around Sigma-1 receptor (S1R) & muscarinic agonist properties. Considering a 5-year cash runway of ~$151m, no expectation for near-term dilution, and short-term pivotal trial outcomes, the current $1.05B (~$13.60 per share) market cap is significantly undervalued and should currently surpass $2B (~$25 per share), as other biotech companies - such as Annovis Bio Inc. (ANVS) and Cassava Sciences Inc. (SAVA) - with worse clinical outcomes or lesser statistical power, and earlier-stage trials, have achieved. While ANVS and SAVA have their unique merits, AVXL deviates with exceptional room for growth beyond Alzheimer's, an extensive pipeline in large unmet needs, a slew of orphan disorders, an immaculate safety profile, and an entire platform of other early-stage drugs like Anavex 3-71, Anavex 1-41, and Anavex-1066 which provide long-term growth potential.
Wide-Sweeping Therapeutic Potential
Indication Priority Methodology
A weighted point-based evaluation matrix was then devised to mathematically prioritize therapeutic benefit to individualistic disorders. Please see below for end-results of this analysis; overarching analytic display (graphic 1), therapeutic benefit % congruent with individual disorders (graphic 2), and % of disorders therapeutic benefits are congruent with (graphic 3). One of the end-goals of this analysis was to determine whether or not Anavex made a good decision prioritizing Rett Syndrome over Angelman Syndrome in clinical trials, and whether off-label prescription for Angelman Syndrome patients would be warranted/valid considering all analyzed facets. To not tease the reader, the answer was yes, and yes.
In graphic 2, we see that Anavex has done exceptionally well in prioritizing their clinical trials with high likelihood of success. Alzheimer’s disease, Parkinson’s disease dementia, Fragile X, insomnia/sleep issues, and Rett Syndrome all have over 90% congruency with therapeutic effects known to be produced by Blarcamesine. This data indicates a very high synergistic relationship between Blarcamesine’s MOA and individual disorders. Even super rare disorders like Angelman Syndrome and Batten Disease see modest congruency.
As a concise summation for investors, this medical intelligence displays the importance of regulating dysfunctional receptors. Because Blarcamesine’s primary MOA is restoring autophagy through chromatin remodeling, S1R expression, and neuroinflammation reduction, the drug allows the body to partially rescue all of these ailments – which largely interoperate with each other. With the rescue of a singular neurotransmitter (i.e. serotonin) a chain of positive cascading effects will follow, thus the wide-reaching effect of S1R protection. Here we see that Autophagic Homeostasis/Protein Clearing (100% congruent), Neuroinflammation Reduction (95%), ATP Production (93%), 5-HT (93%) BDNF (92%), Glutamate & Myelin Regulation (92%), and D1/D2 Expression (90%) are all synergistically linked to the majority of the disorders analyzed – and would likely make significant symptomatic or pathological changes to the disorder.
Extensive Marketability with Favorable Trial Diversity
Excitedly, Blarcamesine trials are being ran in a geographically diverse population to include the United States, Canada, Australia, Spain, Germany, and the UK. Being a leader in precision medicine, wide geographic diversity allows for a vigorous genomic analysis while simultaneously opening approval opportunities to many regulatory approvals including the U.S. FDA, the Australian TGA, and the European EMA conglomerate. Intriguingly, UK trial inclusion will now also allow separate regulatory approval, as the EMA is expected to eventually split with a new post-BREXIT UK (graphic 4).
Alzheimer's Disease Market Applicability
United States Alzheimer's Market Size Conclusion
Unknowns & Assumptions
Most of the analysis within this article is contingent upon the drugs MOA working as intended and as described by the company/peer-reviewed journals. Deviation from this hypothesis would likely change market size, chances of approval, and indication swath. In addition, it is important to note potential partnership and marketing costs which would devalue the best case share price presented above. It is also possible the company ultimately fails its current clinical trials, or fails to maintain its coffers - although unlikely considering its multi-year runway. While it is technically feasible for Anavex to be surpassed in clinical development by a competitor, this seems unlikely as there are few companies running like-trials, and most are not as far in development. Finally, while the author regulated as many variables and biases as possible during the indication prioritization analysis, the author is an expert is aerospace and does not have a formal background in biotechnology - please view this analysis with a level of speculation and set expectation.
Exceedingly Bullish on Long-term & Short-term Company Growth
With the extraordinary reward presented with Anavex’ s potential clinical success, a long position in Anavex appears to be exceptionally warranted. All trials to date have had overwhelming efficacy with many transformative catalysts coming within the next 12 months. This meta-analysis lends credence to Anavex breaking the mold in precision medicine and potentially surpassing even the largest of existing biopharmaceutical companies in market capitalization (exceeding $100B) over the long-term. In the short-term, Anavex represents an extremely undervalued prospect with an absolute minimal fair value around $25 per share. 2022 will play host to at least 2 pivotal moments for Anavex; their Alzheimer's 2b/3 data readout mid-to-late year, and the conclusion of their Rett Syndrome trial suite - also mid-year. As other biotech developing S1R agonists continue expanding, it is increasingly likely S1R platforms will become a healthcare staple. Furthermore, it is my strong belief that Blarcamesine’s address of sweeping dysfunction presents the drug as the best catch-all medicine in development today.
Complete Analytic Production
I encourage investors, enthusiasts, and patients to see my complete analysis (PDF) and download for ease of viewing.