Annovis Bio Inc (ANVS)

[dinogreeves]

"This month, the FDA issued guidance on developing drug treatments for early Alzheimer's disease, a must-read for all $ANVS investors. The FDA emphasizes significant clinical improvement as the key outcome. If trials show clinical improvement backed by biomarker data, companies may seek traditional approval. If only biomarkers show improvement and clinical benefits need more time to manifest, accelerated approval might be pursued, contingent on further trials. This aligns with $ANVS's strategy of prioritizing clinical improvement as the primary endpoint in its PD and AD trials. I'm optimistic about the potential for approval based on upcoming PD and/or AD trial outcomes. While longer trials are anticipated, impressive results could pave the way for submitting approval applications almost immediately post-trial. The company has stated that they will meet with the FDA shortly after the trials are read out. It will be very interesting to see if they're given the ok to apply..."

[dinogreeves]

Looks like maybe some small news tomorrow, damn on Good Friday, really? C'mon now.

[dinogreeves]

Next week it's April, two datas should be released AD and PD, if they blow it out of the park with news, straight to a billion market cap, hero or zero. They also have 250 million shelf offering, if the data is great one institution could gobble those up.

[dinogreeves]

Odds are 30% data it will be a success, 70% chance a failure. If they blow out of the park with the data on AD and PD, this will run easy to billion market cap.

[dinogreeves]

Monk, very volatile especially with this one low floater, this one is either a hero or a zero after the data.

[Monksdream]

Parkinson and Alzheimer drug discovery companies are volatile
It’s come up off the mat

[dinogreeves]

"Subject to Certain Exceptions". Something is about to happen with this one next month. Good luck everyone.

[Here Today]

I also believe with only 11 million shares outstanding, of which 26% is held by insiders and 12 % held by institutions, this could see an epic run with great results.
Just my opinion. Good luck

[Here Today]

If CT results are stellar, I’m thinking we could see a run like what happened with Viking Therapeutics recently in my opinion.

[Here Today]

I just saw the announcement that they will be providing TopLine data in April. So progress has been made and let’s see what happens now! Good luck and hopefully this truly can help those in need of this drug for their ailment.

[x man]

maybe a short squeeze....20% of float is short.

[Here Today]

Hmmm. Has good news about the CT results been leaked???

[McMagyar]

A bettter question is
Those that showed plasma levels
HOW did THEY respond?

Kazillion $ question..


I bet they rocked it

[McMagyar]

Think brokerage overreacted to plasma issue..

[murocman]

Yeah, uncertainty and doubt about the Parkinson’s data readout is spooking more and more people each day that there isn’t a readout or a schedule for a read out.

It gives the impression the company is stalling trying to make “lemonade out of lemons”

This is self inflicted by the company to some degree as if they would have just said Q1 2024 for data, they would not have created some of this disappointment and doubt.

Also, the very late change to the endpoint on the PD trial is disconcerting as well.

Am hopeful for good data but just watching at this point. Too much risk for me for a bad readout. Been burned before.

Murocman

[Here Today]

Anyone else get that feeling like it’s slow unloading happening before the CT results readout??

[McMagyar]

This is the exact situation you look for as a BioPharm investor
A trusted leadership
A drug that has shown and proved save and effective through two Clinicals and five years of testing..
A glitch in timing that makes stock cheaper and adds on short pukes..

You have to worry about failure..

But .. what’s your fit tell you about their drug? Does it or doesn’t it?

If you think it does.. then this is your time

[dinogreeves]

This is on the cusp of running big on news.

[McMagyar]

I think the shorts would have used this opportunity regardless of what Maria did. Her actions have had no impact on valuationimpact. Rules should be changed for shorting stocks especially BioPharm. It’s disgusting.
Capital is raised to save lives and the shorts steal their wealth and it’s damned blood money when thy do it to BioPharm..

Blood money

[McMagyar]

I understand why
I just don’t think it was necessary
The sa is owned by shorts
They don’t need any help

[Here Today]

She set the precedent last year when she said to shareholders that results would be had by end of January. She should not have said that which was an honest mistake many BioPharma company CEO’s make when trying to please shareholders wishes in finding out trial results. Everyone wants a date.

[McMagyar]

Like they are doing now?
She hasn’t stopped anything and has now set a precedent.

Data delays are normal

[Here Today]

It did because once January passes and if no results were issued, everyone would start saying the drug failed it’s trial and crush the PPS. This way the initial timeline that the CEO put out last year can be addressed properly. She would have been better off stating results end of quarter.

[McMagyar]

I don’t think this news warranted a press release.
Maria being too kind.

Buying opportunity? Hell yea

[McMagyar]

Agreed

[McMagyar]

Maria is a competent CeO who believes
in her drug.

Imo it will show efficacy ..

May we just end the cruelty of blind
Placebo groups since our medical technology May now determine bio chem changes?

Is that asking too much for Gods sake?

[TTsr]

Yes, do not trust SA, definitely ulterior motives…. Wrote a glowing piece on NKTR when it was $12/shr!

[grich1]

SeekingAlpha author is long SAVA and short ANVS. They are feeling some pressure today if they didn’t cover.
Note how a history teachers writes about his favorite AD stock. Anything to get clicks on SA is the name of the game.

[Reyeton]

Is ANVS worth a shot? If the trial results are good, yes, an easy 10 bagger. If results are not good, no, down to $1 to $1.5
This surely feels more like gambling than investing. Thoughts?
Here’s what seeking alpha says:
https://seekingalpha.com/article/4663894-annovis-bio-buntanetap-likely-disappoint-upcoming-ad-pd-clinical-trials#comments

[sab63090]

Excellent report! I really do like Maria's style and leadership....she effectively shoots down the approved drug, the FDA is scary to deal with without any noticeable effort to apply new options which show no harm and are EASY to treat....One pill, once a day.

I saw a report from BOA (Merrill Lynch's Health Care Group).....very positive for an exceptional year in ALZ.

[kund]

Looks like she is making stuff about multi phase 2 trial....clinical trials has just one phase 2 trial. This is what worries me about CEO pumping their stock using fake data.

[grich1]

https://www.clinicalleader.com/doc/was-fda-wrong-annovis-bio-shows-strong-data-and-no-side-effects-0001

[kund]

He was in his second Phase 2 trial and was not seeing any improvement. When that trial concluded he was able to try our treatment in a third Phase 2 trial

there was only one phase2, where she is getting this phases of phase2 trial?

[williamssc]

Yes. Topline data results are expected in January 2024.

[sab63090]

Phase III readout coming?
I think Maria said 1Qtr

[dmb2]

Awful experience, great that you survived it. I don't like the rot in our large govt systems such as our medical system, which is one that jeopardizes everyone if not conducted well, as you experienced. I hope some day we can achieve a continual improvement mindset of sound and active system monitoring over our medical system which can address high costs and insufficient care in many cases. I saw the extent companies go to reporting adverse events and side effects of marketed drugs and FDA cannot properly monitor and utilize this mountain of data, though there are significant learnings buried there. And the learnings can be applied to research of new therapies as well. Every area of medical research and practice could be advanced more intelligently and in more integrated fashion, AI may help but we do not have to wait for nor rely on that. As time goes by we see that any system that does not continue to progress and improve will start to decay, especially as size and monetary flows grow. Thx for sharing and great you survived but awful that you experienced it.

[XenaLives]

My personal experience - flouroquinolones did it.

I was given FQ antibiotics for a fungal infection (idiotic, in retrospect) I had an adverse reaction, died, was resuscitated.

Then I was told that the resulting hypoxic brain damage was psychiatric and given more drugs that I couldn't tolerate.

Bottom line - it's a system that rewards Doctors for giving toxic treatments that is the problem.

Vaccines, COVID - not going to go there but the abuse is egregious.

FQ toxicity is probably a function of genetics.... but they don't test for it. So Ancestry.com will reflect a genetic pattern but it's actually a toxic drug that causes it.

"Research" like this makes me want to scream...

Multidrug resistance seen in bacteria today is one of the global threats as recognized by WHO. Misuse, overuse, and poor hygiene or infection control practices have all contributed to this rising problem [37]. Hence, repurposing clinically approved antibiotics for the treatment of other diseases would be economical and spare the redundancy of antibiotics. Some of the antibiotics, such as rifampicin, minocycline, benzylpenicillin, doxycycline, and bleomycin have shown anti-amyloidogenic activity, with rifampicin reaching clinical trials. This has prompted us to study another antibiotic for its anti-amyloidogenic behavior [[38], [39], [40], [41], [42], [43], [44]].

Levofloxacin is a fluoroquinolone (Fig. 1) with bactericidal activity against Gram-positive and Gram-negative bacteria including Mycobacterium tuberculosis. Emergence of levofloxacin-resistant strains of bacterium have been reported [[45], [46], [47]]. Levofloxacin has a favorable cerebrospinal fluid penetration and expected blood brain barrier penetrability [48].

Because of these properties, we investigated the possibility that levofloxacin could be effective in interfering with the amyloid formation by human lysozyme. We first investigated the possible mechanism of action of levofloxacin in this regard by detailed biophysical in vitro studies and computational analyses involving molecular dynamic simulations and docking, and further extended those studies by testing the effects of levofloxacin on the cytotoxicity of lysozyme aggregates using human red blood cells.

https://www.sciencedirect.com/science/article/abs/pii/S000398612100326X

[dmb2]

Neuro-degenerative diseases are like using Ancestry.com, the further you go back the complexity is geometric. Each stage causes the next successive stage so you could say each stage is causative of the next stage. Ultimately these diseases may be deeply understood as to what causes the first stage of degeneration but there may be simple answers in some cases like old age, yet more complex answers in others like genetic disposition and/or other related triggers. I suspect we are still decades away from connecting all the dots, and even when we do, the approach to managing the disease may not be to address the first stage but to address a stage which we can affect more efficiently.
This is a complex space with so much work to do, with advances coming mostly through the set of small companies with good researchers who continue to progress. The ANVS approach is another fascinating one in a space desperately in need of solid progress toward effective treatment, even if not yet addressing the initial root cause stage.

Jan readout will determine if this approach is progress or not, I am bullish as I am with other small companies advancing this field, like all people I have seen people affected by these terrible diseases. My observation is this company has a well done body of research behind its approach though as with all small companies the depth is limited, especially the clinical data, with only the 54 patient PD data providing data strength. But all is aligned from compound design to clinical data so hopefully real progress will be made.

GLTA

[McMagyar]

Treden
This drug will work

Just depends on how many hoops
how many years
How many bbbbbillions of research dollars
BP and The Dementia Industry will make them spend before they are allowed to start helping people..

[Here Today]

Who knows. All depends on what the current Phase 3 trial results show and then what else they have in the wings that Big Pharma’s are after. Anything to do with positive Alzheimer’s or Parkinson drugs is a huge money market.

[ttubular]

What could they be bought out for? At one time it was trading over 130

[Here Today]

Sprinkle in a little bit of a short squeeze and you have todays action.

[Here Today]

Buyout potential along with Expected good Phase 3 results??? At current share structure and with good to great Phase 3 results, sky is the limit for share price in my opinion.

[sukus]

Up 43% now.

[DJPele]

I believe anticipation of PH3 results

[XenaLives]

Your comment implies that proteins are causative....

What if the real issue is the process that creates these proteins?

[sukus]

Up 16%. What is cooking?

[tredenwater2]

I really pray this drug works and offers a great amount of symptomatic relief. The latest stock climb is due to the fact that hf’s bought warrants in the $6 range and now they are pushing this stock onto others so they can unload for a quick profit. Its nothing more than a game and she is holding her own in the dance.

That being said I think she is getting the cart out in front of the horse a bit with all the patient “he said she said”. A few generalized comments yes but these seem a bit flashy. Why not just wait and let the data speak for itself because many ph2’s have gone on the fail ph3’s, many!

If you live by the sword, you die by the sword and make no mistake, those same HF’s she is “dancing” with will spit her out quicker and then two shakes of a dead lambs tail.

[dmb2]

The CEO is very openly bullish and since she is a lead researcher of the compound she has some credibility. In the past it has not been wise for a CEO to speak so openly about anecdotal responses but in this market place with such financial pressure by shorters there needs to be some tools or tactics for CEO's to use to support a fair valuation of their shares.
This is a fascinating compound, from its design to its MOA to its recent P2 data, though limited in volume. I place some weight on the 54 PD patients data since it is a reasonable mid size sample size to attain a starting point for stats. I don't think I have ever seen such a strong stat performance from such a small sample population, which is eye opening. The observations of rapid enrollment and low drop out rates in both trials are indicative of trial physician support and at least patient safety success.

The contradiction here is that the MOA is superbly simplistic and holistic as far as neurodegeneration is concerned but the logic of its approach gives one the initial impression that there is no way Big Pharma could have missed this approach. But BP can be blinded at times and it takes years to decades to modify their approach. This approach seems too simple, but this would not be the first such example of a simpler approach being correct since the scientific achievement is in finding how to make the simpler approach a reality. This compound's MOA helps to explain why there have been other single degenerative protein approaches which have demonstrated limited temporary success only to completely succumb in the longer term as only one degenerative protein is being controlled by the other compounds while the other degenerative proteins continue to agglomerate in the brain. This means there exists synergy between the decades long BP approaches and this one.

The alignment of all the preclinical through early to mid clinical data is consistent but in the field of neuro there are hurdles of proof in cognitive testing, which is why Parkinsons mobility is a great complement to evaluate concurrently with AD cognition. I see this as an interesting SWAG at this stage as there is compelling data but not a lot of it, otherwise the company would already be in the billions. Not many small companies, though I know of one in oncology, can offer such potential value. This compound, like the other company I reference could bring medical science revolution to the market. The benefit this company has is a shorter development timeline than the other company, more traditional trial metrics, and it has not garnered the destructive attention of large shorting entities. The timeline here now does not allow for large shorting games and the potential upside value is too significant of a risk given the low float.

All in all this is still a binary investment situation but there is a strong positive case for a potentially successful outcome in a medical field where all have failed to date, except a few very limited successes. Patenting the newly developed crystalline form of the compound for IP purposes in addition to added stability is a positive. I think, given the safety profile that will be available and the proof of the MOA post both the PD and AD trials in coming months if both trials are successful, the FDA will be receptive to an accelerated approval pathway, at least that would be logical and patient serving though it is possible there may be additional P3's in both indications required, strength of results may be the determining factor.

GLTA

[grich1]

Excerpt from 2021 article regarding Parkinson’s trial.

“I don’t want to sound cocky, but I really do not see any challenges ahead for our Phase 3 trial,” she says. “Patients are required to take one pill a day. It is a small dose with no side effects. I have also heard great feedback from patients. One Parkinson’s patient emailed me a while back. He was in his second Phase 2 trial and was not seeing any improvement. When that trial concluded he was able to try our treatment in a third Phase 2 trial. After just two weeks he contacted me to tell me that it worked. Several other patients did so as well. They reported better memory, coordination, and attention span with less shaking. We believe we will see similar results in our Phase 3 trial. We will present our data to the FDA in September and plan to start the Phase 3 trials for both Alzheimer’s and Parkinson’s this winter.”


Might be the reason CEO and Insiders are buying. A lot of drugs are in clinical for multiple indications but how often do they talk about better cognition as a side effect?? Rett, MS, trials? Several Parkinson’s patients are commenting on cognition.