Annovis Bio Inc (ANVS) ニュース

ANVS, new 52 week low

Watch Out FDA!!!! There is a new Sheriff in town and all your CROOKED DEALS with those Big Pharma's of the world trying to STOP and Destroy new Treatments and or cures before they can begin is coming to an end in my opinion!!!!

I am starting to believe that people have not realized how the confirmation of Robert F. Kennedy Jr truly means for this stock and company.... If anyone was to pay attention to his hearing and some of his pressers of how he specifically mentions Amyloid plaques are a hallmark of Alzheimer's disease and how we need more treatments addressing this issue!!!!

never mind - I see what you meant - phase 3 is starting out slow.

why do you say 2 people? Their website says this:

The study was completed with 345 patients, of which 90 were identified as having mild AD (MMSE 21-24). These 90 AD patients showed dose-dependent, statistically significant improvements from placebo in the two higher concentrations (15mg, p=0.042; 30mg, p=0.015) and all doses showed significant improvement over baseline (7.5mg, p= 0.013; 15mg p=0.001; 30mg p

We hit the bottom last 2 days.

Wow, after all this time...they (just) started phase III. And that's with only 2 people being tested.

Will be Summer until some news comes out.

Stock will be over 100$ some day

Annovis Announces First Patients Entered into Pivotal Phase 3 Study of Buntanetap for Early Alzheimer’s Disease

MALVERN, Pa., Feb. 05, 2025 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the first two patients have been entered into the pivotal Phase 3 study evaluating buntanetap in early AD.

"The launch of our highly anticipated AD study is a significant milestone in advancing buntanetap toward market approval and addressing the unmet medical need of millions of patients. Our previous trials have delivered compelling results, and we have meticulously designed a comprehensive protocol to evaluate both the symptomatic and potential disease-modifying effects of our drug candidate,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis.

The Phase 3 trial is a randomized, placebo-controlled, double-blind study designed to evaluate the safety and efficacy of a daily dose of buntanetap in patients with early AD. The treatment will last for 18 months and will consist of two parts: a 6-month assessment of symptomatic effects followed by an additional 12-month evaluation of buntanetap’s potential disease-modifying effects. This Phase 3 protocol received FDA approval following positive data from our previous Phase 2/3 trial, which demonstrated significant cognitive improvement in a subgroup of patients with early AD and showed no safety concerns.

The Company has recently completed a public offering of 5,250,000 units consisting of one share of our common stock and one warrant to purchase one share of common stock for gross proceeds of $21 million securing the estimated funding for the initial 6-month portion of the study, while the 12-month phase is expected to be supported by additional capital from the warrant exercises.

"Alzheimer’s steals so much from individuals and their families, but with drugs like buntanetap, we aim to restore quality of life and bring hope to those affected. We are grateful to the community for their continuous support and to everyone who has contributed to making this trial a reality. As we embark on this new chapter, we are optimistic that this study will help redefine the future of Alzheimer’s treatment,” adds Melissa Gaines, SVP of Clinical Operations.

The study’s primary outcomes will include the assessment of cognition using the Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog13) subscale and functional ability using the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scale.

Annovis anticipates enrolling over 750 participants across ~100 sites in the United States. The first two open sites that began recruiting include Conquest Research in Winter Park, FL and Advanced Memory Research Institute of New Jersey in Tom’s River, NJ, each managed by the dedicated teams of Malisa Agard, M.D. and Arun Singh, D.O., respectively. Detailed information about the trial is available at clinicaltrials.gov.

About Buntanetap Buntanetap is a small, orally available molecule that targets neurodegeneration by inhibiting the translation of neurotoxic aggregating proteins and thereby impeding the toxic cascade. This improves axonal transport, synaptic transmission, and reduces neuroinflammation, ultimately restoring the health of nerve cells and brain function. By normalizing these pathways, buntanetap has the potential to reverse neurodegeneration and improve quality of life for patients.

About Annovis Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

Investor AlertsInterested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

Forward-Looking StatementsThis press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact Information:Annovis Bio Inc.101 Lindenwood DriveSuite 225Malvern, PA 19355www.annovisbio.com

Investor Contact:Scott McGowanInvestorBrandNetwork (IBN)Phone: 310.299.1717www.annovisbio.com/investors-relationsIR@annovisbio.com


Source: Annovis Bio, Inc.

I went ahead and bought 40,153 shares @ $3.47ish today. Now that they've raised $21 Million, I think there is very little downside. The upcoming trial should be exciting.

FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway

MALVERN, Pa., Jan. 07, 2025 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025.

In October 2024, the FDA granted clearance for Annovis to proceed with the pivotal Phase 3 AD studies based on its Phase 2/3 data demonstrating cognitive improvement in early-stage AD patients. The original protocol design proposed two separate trials: a 6-month symptomatic study and an 18-month disease-modifying study. Under the revised protocol, these studies are now integrated into a single 6/18-month trial, which will include a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap.

“This consolidated protocol will accelerate the development timeline while maintaining the scientific rigor necessary to advance buntanetap as a treatment for AD,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. “With this design, we can leverage the 6-month symptomatic data to potentially support a New Drug Application (NDA) filing, all while continuing the same study seamlessly to assess long-term disease-modifying outcomes. We are excited to move forward with this approach, which brings us closer to delivering a novel treatment to patients in need.”

About Annovis Bio

Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

Investor Alerts

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.annovisbio.com/email-alerts. Additionally, we invite you to explore our updated investor website, which provides comprehensive access to company news, financial reports, and other key information.

Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com

Investor Contact:
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
www.annovisbio.com/investors-relations
IR@annovisbio.com

Let's hope we're both right, Loof, in our reasons for accumulation. $30+ would be good.

This was supposed to be a great PR this morning.

All my hopes in the company has ended.

This went up 64% premarket, and 20 minutes into trading it's in the red by 8%.

The company has become a scam enterprise.

I'll have to agree with you. I watched this hit $8.76 premarket, dumping, then right back down to yesterday's close at $5.35.

HF’s must be licking their lips readying for another round of funding using every market event to further their profit.

I bought 2,000 shares of this one...even though it looks like this might drop lower with the selling.

Wow!

“ Annovis CEO Showcases Groundbreaking Advances in Neurodegenerative Disease Treatment on Today’s Marketplace”

What did the Annovis CEO “showcase” that would drive the price down?

Is the company needing to raise more money again? If so then the drop makes sense.

Long on ANVS. Been holding and accumulating for about a year. I believe this company has a game changing drug for Parkinson’s and Alzheimer’s disease. Analyst target is $30. I believe it can go. Much higher.

Jmo
Loofman

Starter $7.90

$ANVS

Is that Chart of yours showing the nice squeeze play I saw or are my eyes deceiving me?

Or is it that it has been shorted to a point and now a reverse is in effect??? What’s your chart say???

Hmmmm. Has a deal announcement been leaked?????

ANVS under $10

$$$ANVS$$$ Conf on Weds could mean MONSTER WEEK AHEAD! $$$ GLTA

Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap

MALVERN, Pa.

July 16, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future clinical trials.

In June 2024, Annovis announced the filing of a composition of matter patent for the new crystal form of buntanetap and a provisional patent for the manufacturing process of this new form. The Company conducted comprehensive bridge studies in various solvents and in animals, comparing the old semi-crystalline form with the new crystalline form of buntanetap. Additionally, Annovis developed an innovative large-scale manufacturing process for the new form. This comprehensive data was submitted to the FDA for review.

The FDA has now approved the continuation of buntanetap's development using the new crystal form. This positive response allows Annovis to conduct a comparative study between the old and new forms of buntanetap in a small, single-dose, bioavailability study in humans as part of the transition process.

Oh yeah!

$$$ANVS$$$ Glad I got mine!!! $$$

Agreed on the $20+ ANVS share price coming.

But if you want a Cancer Breakthrough treatment, take a look at RNAZ which has an extremely low OS if 6.6 million shares. They constantly get shorted same like ANVS does, but huge difference is the extremely low outstanding share count.

Hopefully we can see a cure for Parkinson’s, Alzheimer’s and cancer in short fashion. Good luck.

$ANVS look for continuation higher! 20.00+ coming.
Also loading breast cancer cure! $ICCM.
$ANVS

Isn't that the problem with almost every stock nowadays?
If it has to be,ANVS will succeed no matter the amount of shorting.
GLTY

The shorting is too strong. I'm concerned about getting back in.

$$$ANVS$$$ Looks like MONSTER RUN today!!! $$$

Schwab's short sale Stock Borrow Rate is now at 729.75%

I don't know what to think about this anymore.

.

Maybe some have noticed the large 3 spikes up which stopped suddenly...Dec 2023, May of this year & July of this year...each high was progressively lower....the difference this time is the way the selloffs occurred....1st one was right away and continued for some days, the 2nd one was like a brick dropping from 5 stories up to a crash bottom...this one (so far) has not been as sharp or massive bust; it's early so I would think the trading might hold above the 200 day sma (9.34)...I'm watching, but certainly think Maria does her best to communicate with shareholders and has the boldness to file with the FDA and present her case for approval at this time!

https://bigcharts.marketwatch.com/advchart/frames/frames.asp?show=&insttype=&symb=anvs&x=0&y=0&time=8&startdate=1%2F4%2F1999&enddate=4%2F12%2F2018&freq=1&compidx=aaaaa%3A0&comptemptext=&comp=none&ma=1&maval=55550&uf=8&lf=2&lf2=8&lf3=4&type=4&style=350&size=4&timeFrameToggle=false&compareToToggle=false&indicatorsToggle=false&chartStyleToggle=false&state=11

Constant shorting here is amazing. It’s like the Wild Wild West OTC in here the way they short it dramatically only to score and then see the huge rises again.

Good for you you Xena!
Guess he is human after all
Didn’t think the head Dr Fauci
was Valdemort, Bad Trump.

Trumps not God, he didn’t believe
the EVIL that so many have chosen.

Don’t blame Trump, blame those that choose evil over humanity

Interesting comment, but as far as Trump is concerned --- the COVID scam started during his term and he did nothing to stop it.

I have no faith in him either.

Anavex doesn’t and won’t do anything for severe AD..
Not enough S1r cells to activate
Annovis IMO clears the channels for improvement but doesn’t necessarily stop
Why Dementia started..

I think they would make a great COMBO

Start with Annovis to Clear the Webs
and then engage anavex as a constant web sweeper..

But alas, everyone knows more than me.
Everyone is so much smarter than little old me.. I saw this 5 years ago and reached ou t to anavex but Chris didn’t have the time to talk to Maria.. so there you go..


Two safe drugs that AD patients should have already had.. surprised they don’t give both to Dementia Joe!

I don’t plan on meeding either anymore
with my X39 button feom LifeWave.com.
And until Trump destroys the beast that our FDA, FBI, NHS DOJ FBI have become
none of this really matters..

It’s all kabuki theater

So checking out Seeking Alpha today....

[Three things to note here:

The "dose-dependent and statistically significant improvements in cognition in the overall enrolled PD population" (n=523) is an inverse one, i.e., 10mg improved more than 20mg.
This inverse "dose-dependent" improvement in cognition occurs in the overall enrolled patients (n=523), but is reversed in the "Mild Dementia MMSE 20-26" subgroup, where the 10mg group has no statistically significant improvement.
MMSE improvement data is the only data reported from the entire enrolled patients (n=523) in the PR./quote]

https://seekingalpha.com/article/4702593-annovis-bio-a-close-look-at-their-parkinsons-trial-data

I've been following Anavex for years, and I believe their approach is better,




Anavex Life Sciences Reports New Mechanism of Action Data Related to ANAVEX Compounds Targeting Sigma-1 Receptor
?

?

Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, announced today the presentation of new mechanism of action data related to ANAVEX compounds targeting the sigma-1 receptor at the AD/PDTM 2017 Meeting.



Hall H et al presented preclinical data indicating that during pathological conditions, ANAVEX 3-71 demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes. In neurodegenerative diseases like Alzheimer’s and Parkinson’s disease, synaptogenesis is believed to be impaired.



Goguadze N et al presented preclinical data indicating that in addition to reducing oxidative stress, ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41 also demonstrated protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions. The mitochondrial enzyme complex IV is directly involved in the synthesis of ATP, which provides energy within cells for metabolism. It is believed that energy production impairment and mitochondrial dysfunction play a role in the pathogenesis of neurodegenerative disorders and neurodevelopmental diseases.



“These new results provide converging evidence on mechanism of action as well as possible disease-modifying properties potentially by restoring homeostasis by means of the sigma-1 receptor agonists in our pipeline. This data also provides a foundation for our ongoing translational research efforts,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.



Both data sets described that Aß1-42 (amyloid beta) significantly impairs biological function in the respective animal models and the observed regain of function confirmed the protective potential of ANAVEX sigma-1 receptor agonists against amyloid beta -induced toxicity. The former presentation further reported that although that the transgenic McGill rats had a very late stage of Alzheimer’s disease-like pathology (13 months of age), treatment with ANAVEX 3-71 fully reversed cognitive deficits, reduced amyloid pathology and also significantly reduced inflammation. Furthermore, the sustained recovery in cognition and pathophysiology observed following a month-long washout phase in advanced pathology (19 months of age) strongly suggests true disease-modifying properties of ANAVEX 3-71.




AI agrees with me -

query:
does clearing amyloid plaque stop alzheimer's disease

Search Labs | AI Overview
Learn more
…
No, clearing amyloid plaque alone is not likely to stop Alzheimer's disease. While amyloid plaque buildup is a hallmark of Alzheimer's disease, researchers believe that other factors also contribute to its progression, such as tau protein tangles, immune function, and vascular health. In fact, some research suggests that 25% of people with a clinical diagnosis of Alzheimer's disease have little to no amyloid in their brains.

Thank you

The chart shows 5 minutes, apparently some trades were voided...





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07/09/24 09:39:53 14.105 14.02 14.19 301
07/09/24 09:39:53 14.07 14.02 14.19 1,473
07/09/24 09:39:51 14.145 14.10 14.19 216
07/09/24 09:39:51 14.15 14.10 14.19 6,350
07/09/24 09:39:50 13.89 13.87 13.90 1,109
07/09/24 09:39:48 13.87 13.85 13.89 1,521
07/09/24 09:39:47 13.82 13.75 13.89 3,495
07/09/24 09:39:47 13.76 13.75 13.85 1,550
07/09/24 09:39:46 13.77 13.75 13.79 200
07/09/24 09:39:45 13.77 13.75 13.79 2,932
07/09/24 09:39:43 13.76 13.75 13.85 702
07/09/24 09:39:42 13.80 13.75 13.89 2,159
07/09/24 09:39:40 13.89 13.75 13.90 407
07/09/24 09:39:39 13.90 13.75 13.90 2,737
07/09/24 09:39:38 13.84 13.75 13.90 2,400
07/09/24 09:39:37 13.7901 13.75 13.80 329
07/09/24 09:39:36 13.81 13.75 13.90 40
07/09/24 09:39:35 13.81 13.75 13.90 332
07/09/24 09:39:35 13.80 13.75 13.90 3,335
07/09/24 09:39:33 13.7701 13.77 13.90 3,487
07/09/24 09:39:32 13.7501 13.75 13.76 266
07/09/24 09:39:30 13.7501 13.75 13.76 10
07/09/24 09:39:30 13.7501 13.75 13.76 446
07/09/24 09:39:29 13.76 13.75 13.90 1,312
07/09/24 09:39:28 13.7935 13.75 13.90 16,889


07/09/24 09:34:10 13.95 13.52 14.85 125
07/09/24 09:34:08 13.95 13.94 13.95 102
07/09/24 09:34:07 13.95 13.94 13.95 10
07/09/24 09:34:06 13.95 13.94 13.95 52
07/09/24 09:34:05 13.95 13.94 13.95 101
07/09/24 09:34:03 13.95 13.94 13.95 501
07/09/24 09:34:03 13.95 13.94 13.95 25
07/09/24 09:34:02 13.95 13.92 13.95 191
07/09/24 09:34:01 13.95 13.92 13.95 137
07/09/24 09:34:00 13.95 13.92 13.95 100
07/09/24 09:33:59 13.95 13.92 13.95 200
07/09/24 09:33:58 13.95 13.92 13.95 1,730
07/09/24 09:33:56 13.95 13.92 13.95 218
07/09/24 09:33:55 13.96 13.92 13.95 25
07/09/24 09:33:54 13.96 13.92 14.28 61
07/09/24 09:33:54 13.96 13.92 14.28 2,784
07/09/24 09:33:51 13.96 13.92 14.29 160
07/09/24 09:33:51 13.96 13.92 14.29 2,427
07/09/24 09:33:51 13.95 13.92 14.00 4,716
07/09/24 09:33:49 13.95 13.92 13.95 3,217
07/09/24 09:33:48 13.95 13.92 13.95 16,076
07/09/24 09:33:47 14.50 14.49 14.81 200
07/09/24 09:33:46 14.4901 14.49 14.81 4,481
07/09/24 09:33:45 14.64 14.49 14.80 5,105
07/09/24 09:33:44 14.66 14.52 14.81 25,949
07/09/24 09:33:42 15.15 15.09 15.24 600
07/09/24 09:33:41 15.09 15.15 15.24 109
07/09/24 09:33:41 15.09 15.09 15.24 115

Did you see what they tried to do this morning?
Got to $16.00 -- massive dump down to $13.94 -- trading halt -- now trading at $17.00
No shares available to short -- not even 100 shares.

This is looking more and more like a squeeze in the future.

Good to know!!
ANVS

Daily monster runner. Love this one! $$$

Those are shorts with "connections"....

Tried to short 1,000 shares on this. They're saying there's no more shares available to short this. But all I see today are shorts trying to bring this down.

ANVS between 1-2 billion buyout, sometime this year.

LOL -- around 3:00 EST, this hit $16.50 -- and then dropped back to $15.00 in a matter of seconds. Shorting on this stock is restricted...there's no shares available to short. I think we're about to see a squeeze on this.

Always loved this ticker. Money is in the big board stocks. Holding only a couple of OTC's. Icahn and Jones.