Annovis Bio Inc (ANVS)

[benderostap4]

2023 Anticipated Milestones, please?

[McMagyar]

The quality of the annovis treatment will be the Gold Ring..
I see annovis as a once or twice treatment over a period of years.. followedby daily consumption of Blarcamesine..

[dinogreeves]

I am fully and undeniably confident with their science, I have here long enough to know, this company will set the standard for Alzheimers and Parkinsons Disease, don't be fooled by the low volume, the shares are in very tight hand, including the insiders. Their communication sucks donkey balls, but their science will be proven and this stock will trade in the billions, 1-2 years. Furthermore, this stock is not to make a living of off day trading, this is something you hold for billions in market cap, once the science is proven.

[dinogreeves]

This is going to run to triple dollars by end of the year at the maximum Easter next year. Here is why: Buntanetap is the only drug to attack multiple proteins simultaneously. This is paramount huge, not just huge. Watch what happens by fall this year.

[dinogreeves]

Should be trading in the high teens before the conference. This stock and the market makers specifically do not like traders, trade with caution. Just a word of caution. If you plan on taking a big chunk, the trade will go against you immediately, just slowly accumulate. This stock is hands down triple dollar stock end of this year.

[dinogreeves]

This is thing is real beauty.

[dinogreeves]

They withdrew ATM. Very nice.

[dinogreeves]

Too much overreaction, swing and day traders killed it.

[sab63090]

Took my lumps on this....my bad & overstayed this.....ouch

[McMagyar]

May someone post links to presentations?
Please thx

[dinogreeves]

What? Link? nah, just a hunch?

[McMagyar]

Send me a link please

[dinogreeves]

Go read it. You want to hear it from me? OK!!! It was freaking great.

[McMagyar]

What was in presentations?

[dinogreeves]

Expecting some news this week, after that the floor would be between 18-22.

[dinogreeves]

That is all that matters bud.

[sab63090]

yes, very familiar with ATM's....note that she went to a powerhouse

[dinogreeves]

I don't if you realized that shelf offering is not for immediate future, my thinking after the AD data is released sometime in the fall, that is not immediate secondary public offering, I expect news sometime next week, they will start selling on the upside to the tune of 2-3 million shares to add to the OS, which is still minor bump, still very small share structure compared to its peers, I am not concerned one bit. These guys have the science, but very poor with investor communication, this is not the first fumble, during the communications with the mass audience, whether it is deliberate or no, I don't know, but they are very poor communicating and getting their message across, but the science could be worth billion in the future, 2026 is going to be year for ANVS. Good luck

[sab63090]

Needed to have a backstop....needed that no doubt, also saw that Maria exercised options @ 14 cents that expired in 2027....pretty open with shareholders....any feedback from April Fool's Day presentation? I caught the momentum turn pretty well, but overstayed, also saw and mentioned the overbought position, but failed to act...my bad.

[dinogreeves]

Shelf offering was presented after market from time to time sale of securities. This stock is going to get another pop.

[sab63090]

Doc328,

Thanks for your input...actually this is exactly where I bought in. & I even mentioned that it was overbought, too...back to go for me!

I think we'll see if the CEO can succeed or fail here; my idea is that she is a good person & has spent good money last year ($500,000 @25) and has her eye on the target with shareholder respect with that....she certainly has a problem now if this presentation is a flop.

Also, noticed that she has a boatload of options, too....with very low strikes.

[Xunefox]

That was known 2 days ago that the report was on Saturday? Or sorry the conference ended on Saturfay

[Doc328]

The 8k reports

Annovis Bio, Inc. (NYSE: ANVS) (the “Company”) has received the interim analysis for sample size re-estimation for its Phase 3 clinical trial for the treatment of early Parkinson’s Disease (“PD”). This trial, which was initiated in August 2022, is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of Buntanetap in patients with early PD.

The Phase 3 trial is designed to enroll 450 early PD patients, which are separated into three cohorts of 150 patients. Patients are randomly assigned to receive either 10 or 20 mg of Buntanetap or placebo once per day. The trial’s primary endpoints will be evaluated after patients have been treated for six months using the following measures: the MDS-Unified PD Rating Scale (MDS-UPDRS) Part II and III, which is a 42-item rating scale designed to assess PD-related disability and impairment, and evaluates activities of daily living and motor function; and safety and tolerability, which is assessed using physical examinations, vital signs, clinical laboratory test results, electrocardiogram findings, adverse events leading to study discontinuation, drug related adverse events, severity of adverse events and adverse events.

The Company has received the results of the pre-planned interim analysis conducted by a data analytics provider based on 132 patients from all cohorts collectively for which baseline and two-month data was available. As the interim analysis was conducted at two months of the six-month endpoint and only on 132 patients, it may not be indicative of the results at six months for the full patient population because as the trial progresses, clinical outcomes may materially change as patient enrollment continues and more patient data become available, or different conclusions or considerations may qualify such results once additional data have been received and fully evaluated. Based on the results of the interim analysis, the Company intends to proceed with the trial as planned in accordance with the previously established protocol. The Company remains blinded to the Phase 3 trial and does not have safety or efficacy data from the trial. A separate safety interim analysis is in process and the Company expects that interim analysis to be released in the second quarter of 2023.

With non-adaptive studies, the vast majority of time, DSMB reviews are followed by a recommendation to continue the study as planned. It would be surprising to stop a study in a neurodegenerative disease for either profound success or complete failure (treated would have to be worse than placebo). So there is no surprise. The SP reaction today may be due to a realization that the company has insufficient cash to complete the study as planned (not a reduced n) and still have enough cash to fund continuing operations and fund a reserve. They need a larger cushion of cash in this environment of higher rates and cautious investors. It would be unwise to allow cash to get too low and I suspect they will need to raise funds by the end of the year. Coupled with what is certain, now, to be a nonevent presentation, the price is going to be range bound. In retropspect, its easy to say that they should have raised more cash May-July 2021. I hold no current position, just an observation.

[eur06]

Very courageous as usual!
ANVS

[dinogreeves]

Huge over reaction today, I went in with this drop with head in first, double and triple my size. Saturday is the day. Either I lose big or I win huge on Monday and next week.

[sab63090]

450 enrollment should be enough, right?....1/3 in each enrollment (150)
noticed on 8K that 2month data so far
stock dropping from overbought condition
need to watch this more for today may or may not reflect the DSMB reasons
appreciate your comments

[sokol]

Stocktwits reports this morning that both ANVS presentations have been rescheduled for tomorrow, Saturday?

[MZlu]

Reasons why PD data is delayed

Someone on Stocktwits called Annovis's IR and learned that:
- the Data and Safety Monitring Board (DSMB) was the responsible of the delay
- the IR person said DSMB is pondering whether or not Annovis should continue enrolling more patients for its ph3 PD trial

Two possibilities:
A- Data was horrible and the DSMB thinks it is better to stop here and saving patients' time.
B- Data was so good that the DSMB thinks current patient population is enough to demonstrate statistical significant efficacy, which will expedite the approval process.

Arguments supporting outcome B include:
- Positive and correlated feedback from ph2 PD patients with their being in the treatment arm.
- Noticeable improvement in PD symptoms (Maria mentioned writing speed).
- Enthusiam from the patient community in enrolling into the trial (Maria mentioned some centers had to stop recruiting because they reached their quotas).

On the valuation side:
- Company like Cerevel (CERE) has an enterprise value (EV) of $3.1B.
- CERE essentially has one phase 3 asset in PD and a three others in phase 2.
- Their lead drug candidate is just a better version of levodopa.

A quick and dirty valuation math gives us around $800M of value for this asset (simple division but in reality more as it is more advanced than the rest of the pipeline). Annovis's EV is only around $150M. If (when?) market recognizes buntanetap's potential, share price may reach $100+... on PD alone. Because if improvement is shown in PD, it is a confirmation of Maria's hypothesis for AD as well.

Thank you for those who took the time to read this and good luck.

[sab63090]

Hello, Maria... good luck on today's presentation & tomorrow, too


MARIA L. MACCECCHINI, Ph.D.
Founder, President, CEO and Executive Board Member

Dr. Maccecchini founded Annovis in May 2008 to develop better therapeutics for Alzheimer’s, Parkinson’s and other neurodegenerative diseases. Was partner and director of two angel groups, Robin Hood Ventures and MidAtlantic Angel Group; Founder and CEO of Symphony Pharmaceuticals/Annovis a biotech company that sold in 2001 to Transgenomic; General Manager of Bachem Bioscience, the US subsidiary of Bachem AG, Switzerland and Head Molecular Biology Mallinckrodt; Dr. Maccecchini did one postdoc at Caltech and one at the Roche Institute of Immunology, her PhD in biochemistry is from the Biocenter of Basel with a two-year visiting fellowship at The Rockefeller University.

[sab63090]

Details on the Company's two presentations are provided below.

AD/PD™ 2023
Abstract Number: 3080
Title: Phase 3 Clinical Studies in Alzheimer's and Parkinson's Disease; Interim Analysis of the Parkinson's Clinical Study
Date: Thursday, March 30, 2023
Presenter: Cheng Fang, Ph.D.

https://tinyurl.com/583mexd6

Abstract Number: 3114
Title: Do Mouse Data Lie? For Buntanetap They Totally Predict Human Outcome
Date: Friday, March 31, 2023
Presenter: Maria Maccecchini, Ph.D

[dinogreeves]

Data presentation coming out tomorrow.

[dinogreeves]

ANVS is the next to go parabolic.

[sab63090]

This trading base is very large, so it might just offer some news pretty soon.

The target I have is substantially higher, assuming a push above the September 2022 high.

I'm long and expecting it!.........but certainly have my share of errors....

I like the CEO, Maria Maccecchini very much and she is a shareholder owning stock!

[McMagyar]

Our govt may send billions to Ukraine
For fascist oligarch one world era to share and connive upon( blood money) while Americans die of terrible CNS disease which Blarcamesine could prevent..

Won’t go into the pure idiocy of giving healthy babies and pregnant women dangerous myocarditis creating experimental medicine while denying dying death sentenced dementia sufferers
safe experimental medicines like Blarcamesine , biovie, cassava, annovis, while they complete trials.

It’s the insanity of the bureau of the demented oligarchy of
Good Health

[McMagyar]

A long way to go

[McMagyar]

https://irpages2.eqs.com/websites/annovis/English/431010/us-press-release.html?airportNewsID=34982805-7465-4ec1-93e4-46751a70b467

I don’t know how this doesn’t connect to company news?

[McMagyar]

Thought the snow would melt today so we could play gold tomorrow.
Made tee times
Called my friends

But although it’s 50 degrees
The ground is so cold from arctic blast
That all my plans for tomorrow which seemed reasonable based upon
temperature are for naught.

Didn’t try to lie, didn’t plan on not being able to play..but I will be working upon other aspects of life fulfillment until the snow melts..


The best laid plans of mice and men..


And that happened without people making money if I dont play golf tomorrow..

Thank God no one actively to destroy my financial value..other than democrats

[McMagyar]

Do we have news?

[sokol]

“Every day thousands of patients die from aging-associated non-communicable diseases (AA-NCDs) that might have otherwise been given new treatments that current regulatory systems have no framework to allow them to try. AA-NCDs have been recognized by the United Nations as a “threat
to global development.” and a mandate has been set to improve the consequences of such diseases. Helping patients get access to new drugs is an imperative of the BCM.” Go to the site. Read about it. Sign the petition if you are so inclined. Best Choice Medicine makes sense for patients suffering from aging associated diseases such as AD. By the time a patient is diagnosed, the disease has done irreparable damage, and there is a short window of opportunity to stop the progression of the disease - especially for older patients. Why not allow establish a framework to allow these patients access to new drugs that may help them? Several drugs seem to candidates to help elderly patients with neurological disorders. These patients do not have the time to wait years for a promising drug to be approved according to the current regulatory systems.
https://www.bestchoicemedicine.com/

[McMagyar]

Congrats Maria!!!!

[dinogreeves]

I did, early this morning, I trade based on momentum and logic, mostly logic and logic tells me, I shouldn't follow the herd, I know ANSV is going to multiple billions early next year.

[MonstaGains]

Just check it out, insiders own over 70% of the float

[dinogreeves]

I am not going anywhere, have been loading this for months now. PXMD can run and do whatever it wants, this one has a legit run in it to triple dollars.

[MonstaGains]

PXMD running like NERV SC-13 filing

[dinogreeves]

Forget AVX*L and SNP*X, best of the best breed here. Nothing like ANV*S. Triple dollars coming here if you are patient.

[dinogreeves]

The best of the best breed out there when it comes to Alzheimers and Parkinson's disease, nothing out there like this biotech. Will be in triple dollars when that data hits the wires.

[McMagyar]

Awesome sauce

[p_c]

7:36 am ET September 8, 2022
Annovis Bio, Inc. (NYSE:ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company addressing neurodegenerative diseases, today released the following letter to stockholders from its Chief Executive Officer Dr. Maria Maccecchini.

Dear Fellow Stockholder,

Over the years we have been talking about the potential of buntanetap to treat more than Alzheimer's disease. In cell models, animal models and human clinical studies, we have seen that buntanetap works in numerous acute and chronic neurodegenerative conditions. I would like to take this opportunity to explain how one drug can be so broadly applicable.

Buntenatap works by inhibiting specific neurotoxic proteins such as amyloid precursor protein (APP), Tau, alpha-synuclein (aSYN), TAR DNA binding protein 43 (TDP-43), huntingtin (HTT) and prion protein. These proteins have normal functions but in their neurotoxic aggregating form, they impair axonal transport, slow synaptic transmission, cause inflammation, and ultimately, kill nerve cells, resulting in the loss of affected function in various neurodegenerative conditions.

The overexpression and aggregation of these proteins is caused by elevated levels of iron in the nerve cell. The mRNAs of neurotoxic aggregating proteins contain an iron response element (IRE) which binds to an iron regulatory protein called IRP1. At normal iron levels, translation occurs at appropriate physiological levels. When iron flows into the cell, the mRNAs are released and translated at higher rates by the ribosome. When massive iron flows in, the mRNAs remain unbound for as long as the iron is high and the proteins for these neurotoxic aggregating proteins are overexpressed. In this high iron situation, buntanetap binds to the atypical IRE-IRP1 complex and prevents the mRNA from being released and, therefore, from being translated and overexpressed.

Buntanetap is able to inhibit the translation of multiple neurotoxic proteins through this mechanism of action, and as a result has the potential to treat numerous acute and chronic neurodegenerative conditions that share this pathway. In mouse or rat models of Alzheimer's, Parkinson's, stroke, frontotemporal dementia, traumatic brain injury, glaucoma, and Down Syndrome, buntanetap has been shown to normalize the levels of these neurotoxic proteins and to restore function.

Most importantly, this has been demonstrated in human clinical trials. In our recent Phase 2 clinical trial in Alzheimer's disease and Parkinson's disease, treatment with buntanetap resulted in reduction of aggregating proteins and statistically significant improvement in motor function in Parkinson's disease patients and cognition in Alzheimer's disease patients.

FUNCTION

TEST

SUBJECT

ANIMALS



Memory, learning

Mazes

AD mice, DS mice, stroke mice, TBI rats

Movement

Colonic motility, grip strength

PD mice, tau mice

Vision

Sight

Glaucoma rats

Infections

Cell death

P. Gingivalis mice, Covid mice

HUMANS



Cognition, memory, learning

ADAScog11

Early AD patients

Attention, thinking speed

WAIS coding

Early AD patients

Movement, coordination

MDS-UPDRS

Early PD patients

Movement speed

WAIS coding

Early PD patients



Table 1: Summary of all animal and human study data.

We look forward to unlocking the full potential of buntanetap and addressing unmet needs across a range of acute and chronic neurological conditions.

Maria L. Maccecchini, Ph.D.,
Founder, President, CEO and Executive Board Member

[dinogreeves]

Data coming hot by end of this year, will send this into to the stratosphere, the only cure for Alzheimers.

[20stockman20]

Looking for a good day tomorrow $$$$$