This interview is from July 2015. The author was portrayed by the Cabal as being a paid promoter (part of the photo printing scam) and for faking his credentials as a Dr. They ignored the science and everything else as we have come to know. The reason that they are no longer out in force as previously, is that their arguments no longer hold water. Dr. Missling is executing exactly as he has been telling everyone willing to listen, which all of us long-term holders are. I did not edit the patent stuff since it is good to reaffirm everyone that there are no patent issues. Good look back and how the plan continues to evolve.
Kanak Kanti De - Let me see if I understand the science correctly. Is the primary function of Anavex 2-73 to correctly fold back misfolded protein? By stimulating the sigma-1r chaperone? Is there anything else that it does?
Christopher Missling - Correct, however, additionally targeting Sigma-1 receptor and muscarinic receptors, which ANAVEX 2-73 does, is believed to increase cellular plasticity and reduce oxidative stress, inflammation, abeta generation and tau hyperphosphorylation (Note: Please see the publications section on Anavex's website and the following publication for protein misfolding.)
KKD - And adding Aricept to it - that is to reduce the plaque that's already been built up by existing misfolded protein, correct?
CM - Reducing the abeta plaque is also a function of sigma-1 R. Adding Aricept (donepezil) is believed to increase acetylcholine, a messenger for memory and hence work synergistically with ANAVEX 2-73.
KKD - So, A2-73 may work in early stages of the disease, when plaque buildup isn't considerable, but needs a plaque reducing agent in more advanced stages?
CM- Possibly, however, preclinically ANAVEX 2-73 might be sufficient to also reduce abeta by itself. Hence, could be applicable both in MCI and mild-to-moderate Alzheimer's disease. The current Phase 2a is in mild-to-moderate Alzheimer's disease.
KKD - However, since there's no biomarker to properly identify onset of Alzheimer's disease, A2-73 as a monotherapy doesn't work right now, and you need donepezil?
CM - That answer will come from this current Phase 2a. However, preclinical evidence shows ANAVEX 2-73 works very well alone and might have a further boost in combination with donepezil.
KKD - Is this a new formulation, or cannot you simply combine dosages of A2-73 and donepezil?
CM - The outcome of the Phase 2a will determine what the best "ratio" might be if data confirms preclinical findings of synergy with donepezil. Anavex could develop a proprietary new formulation or a standard combination depending on the findings of Phase 2a.
KKD - You are running only the A2-73 trial now according to clinicaltrials.gov, although your press release mentioned both A2-73 and PLUS. Which is correct?
CM - ANAVEX 2-73 is the investigational drug in the trial. ANAVEX PLUS is the potential "combination" drug in case the trial confirms the strong synergy with donepezil and Anavex could develop a proprietary new formulation or a standard combination with donepezil, called ANAVEX PLUS.
KKD - Without donepezil in the mix, can you run a meaningful trial with A2-73 alone? Or do you plan to combine donepezil at some point when the dispute is settled and the patent is granted?
CM - Phase 2a will answer the impact of ANAVEX 2-73 alone. There is no patent dispute.
KKD - That brings me to the patent question - what is its status?
CM - All patents are irrevocably owned by Anavex.
KKD - What were the terms of your original agreement with Dr Alexandre Vamvakides?
CM - 2007 Original Agreement, between Assignor (Vamvakides) and Assignee (Anavex) regarding ANAVEX 2-73 was amended in late 2012 in order to clarify language regarding IP ownership for Anavex of all IP. Also to be noted is that potential royalty to A Vamvakides is 6% is on net income - not net sales.
KKD - What is the importance of Dr Steffen Thomas in this patent dispute?
CM - There is no patent dispute. Dr Steffen Thomas joining the company likely confirms that there are no IP concerns. Since Dr Steffen reviewed all IP files before joining.
KKD - Does it relate to a claimed foreign priority by Dr Vamvakides, and do you think that claim has merit?
CM - Don't understand what this claim is in reference to.
KKD - So, until you get the patent assigned to you, you cannot begin the Anavex Plus trial, correct?
CM - No. All patents are irrevocably assigned or owned by Anavex.
KKD - There is speculation that the dispute can be settled against added compensation to Dr Vamvakides. Is that correct?
CM - There is no patent dispute. Dr Vamvakides is required according to amended 2012 license agreement if requested by Anavex to comply with signing IP related paperwork. If Dr Vamvakides decides not to comply with the request, it does not change the course of the filing.
KKD - So, based on all that, how much of a hurdle would you say the patent dispute is to your progression towards market?
CM - There is no patent dispute. There is no hurdle.
KKD - Anavex began life as Thrifty Printing, a digital to photo print business targeting corner stores that didn't work out. In 2007, when Dr Vamvakides joined Anavex, he was the only one with real medical expertise. How far would you say the company has come since then? What sort of medical and related business expertise do you have today?
CM - Anavex has now a team of big pharma and biotech experts, doubled the number of Scientific Advisors which is mostly Medical Doctors, raised a company's record amount of $10M in one funding transaction, advanced after that quickly into Phase 2a, licensed additional promising compounds into the company. Anavex is significantly more advanced that in 2007.
KKD - Are you looking at licensing deals and/or outright acquisition by anybody? What are the prospects of that?
CM - Anavex will do what is best for shareholder value.
KKD - By how much do you expect the cash burn rate to increase once Anavex Plus trial begins and you reach advanced stages?
CM - Phase 2a already started and will be finished by year end 2015. All within budget of monthly burn rate of $300k-$500k per month.
KKD - Are you looking for an uplisting to Nasdaq in the near future?
CM - Yes. That is very likely.
KKD - Give our readers 5 reasons investors would be interested in AVXL.
Alzheimer's disease is a significant unmet need since no cure has been found yet.
ANAVEX 2-73 and pipeline targets novel mechanism of action further "upstream" of the Alzheimer's disease pathology by targeting Sigma-1 receptor and muscarinic receptors, which is believed to increase cellular plasticity and reduce oxidative stress, inflammation, abeta generation and tau hyperphosphorylation. All these effects are believed to be relevant to reduce Alzheimer's disease pathology.
Safety profile of ANAVEX 2-73 is clean based on Phase 1 and interim Phase 2a data.
Anavex management team and Scientific Advisory Board, consisting of Alzheimer's disease experts like Jeff Cummings, Paul Aisen, Norm Relkin.
Valuation still very attractive compare to AXON.
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Follow up questions:
KKD - Question about patents
I heard from some sources that Dr Vamvakides has not signed an assignment document for the '352 patent. So I checked that at USPTO. The assignment document is only signed by Tangui Maurice. It has not been signed by Dr Vamvakides.
Secondly, this is ongoing for a year, because your last two 10-Ks mention it.
Third, Dr Vamvakides filed a patent very similar to the '352 patent.
Fourth, you added a patent lawyer to your team.
All this gives some credence to the source that there may be a patent issue.
Q: Are you having an issue for Dr Vamvakides to sign the patent assignment document? What are the implications of this, if any?
CM - All patent applications are owned by Anavex, independently of who filed them (Dr Vamvakidis or Anavex). Dr Vamvakides is required according to license agreement to comply with signing IP related paperwork. Sometimes this process can be delayed, but has no implications. If a signatory cannot be provided, e.g. if a signer cannot be reached, the patent application continues - just an additional form is required. Hence, it does not change the course of the filing. Anavex is confident of its intellectual property rights in the cited patent applications.
KKD - Your PR from yesterday mentions Anavex 2-73 as the investigational drug. However, in the same release, you mention that most of the 12 patients have taken donepezil.
Now, were they given donepezil as part of the trial, or were they taking donepezil therapeutically?
Q: Either way, did the trial measure Anavex 2-73 alone, or Anavex 2-73 PLUS donepezil?
Can you clarify that? This follows from question 6 from before.
CM - The trial measures both: ANAVEX 2-73 effect alone and ANAVEX 2-73 on top of donepezil. Patients are also allowed with being on donepezil (before they started the trial). We will break this down when full data of the trial will be disclosed. For the interim 12 patients, this breakdown has not been looked at yet.
