I believe ongoing communications with you is my responsibility; therefore, I wanted to take this opportunity to review our accomplishments over the past year and provide some insight on what we expect to come in the new year.
Berwyn, Pennsylvania--(Newsfile Corp. - December 20, 2021) - Annovis Bio, Inc. (NYSE American: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company addressing neurodegenerative diseases, today released the following letter to stockholders from its Chief Executive Officer, Dr. Maria Maccecchini.
Dear Fellow Stockholder,
I believe ongoing communications with you is my responsibility; therefore, I wanted to take this opportunity to review our accomplishments over the past year and provide some insight on what we expect to come in the new year.
It’s been nearly two years since we went public, an essential step in advancing clinical trials to demonstrate the efficacy of our drug in Alzheimer’s and Parkinson’s patients. In 2021 we leveraged the momentum, thanks also to the successful completion of the phase 2 studies, and raised $50 million. Now, the company is in a comfortable position with adequate funding to conduct two phase 3 clinical studies and move toward our ultimate goal: to see our drug in the hands of patients in need.
The GOOD
ANVS401, our oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), is currently being developed for Alzheimer’s Disease (AD), Alzheimer’s Disease in Down Syndrome (AD-DS), and Parkinson’s Disease (PD). In our Phase 2a trial, ANVS401 was shown to be well-tolerated and safe, and its pharmacokinetics was found to be in line with levels measured earlier in humans. In particular, the data showed that ANVS401 treatment resulted in statistically significant improvement in motor function in PD patients and statistically significant cognition improvement in AD patients.
As we expected, our Phase 2a trial demonstrated that treatment with ANVS401 reversed the toxic cascade leading to nerve cell death: reduced neurotoxic proteins, improved axonal integrity and synaptic functions, and decreased inflammation resulted in healthier nerve cells and improved cognition and function as shown in two neurodegenerative diseases.
The DETOUR
Running clinical trials during a global pandemic was a feat unto itself. Clinical trials worldwide slowed down or were completely halted due to hospitals and clinics being overwhelmed with COVID-19 cases. The team was able to pivot and through a combination of new protocols to enhance safety and accessibility and an increase in the number of smaller clinical sites, we completed the studies smoothly and on time.
Over the summer our stock price increased and then decreased dramatically. Due to the enormous need for a disease-modifying treatment, a failure rate of 99.6% in clinical trials, and data that can be easily questioned and misinterpreted, we witnessed an extremely volatile market segment. We are pleased that the two class action lawsuits filed against Annovis were voluntarily dismissed. This allows us to focus on our clinical execution.
The WAY FORWARD
To gear up for the next steps in the clinical development of ANVS401 we have added two high-quality professionals to complement our Board of Directors and Management team. In April 2021, we welcomed Reid S. McCarthy to our Board of Directors, and in May 2021, we welcomed Cheng Fang, Ph.D., as our new Vice President of Research.
We are now actively seeking experienced individuals to join our team to prepare for the imminent next step in the clinical testing of ANVS401.
Further, the successful validation of our approach in two diseases with the Phase 2 trials allows us to move forward in our development of ANVS401. We expect to have guidance from the U.S. Food and Drug Administration (FDA) in Q1 of 2022 on the initiation of two phase 3 clinical trials for AD and two phase 3 clinical trials for PD. We look forward on updating you as we move ahead with the FDA.
Additionally, I thought it was important to point out that we never wavered on our beliefs regarding ANVS401’s efficacy and on our dedication to develop it through all necessary testing to market.
Additional VALIDATION
In December 2021, our studies on the mechanism of action were published in the peer-reviewed journal Pharmaceutics. The publication supports and solidifies ANSV401’s ability to reduce the translation of several neurotoxic proteins. This work validates its mode of action and confirms it as a promising drug candidate for the treatment of numerous neurodegenerative diseases.
During 2021, Annovis obtained three more patent families in the U.S., in Japan, and in Europe.
Finally, in November 2021, we announced that the New York Stock Exchange had approved the transfer of the listing of our common stock from the NYSE American. I would like to reiterate the importance of this financial milestone for our collective interest. We are now better positioned to improve stock liquidity and attract a broader pool of investors. We believe this will enhance the value of our company.
Closer to our GOAL
I’d like to close by reminding you our goal is to ultimately benefit patients and build stockholder value by developing a solution that does not merely provide symptomatic relief but addresses the unmet clinical need for disease modifying therapies to improve the lives of patients. As the Management team and our Board continue to share a vested interest in the Company, we believe our goals are directly aligned with the stockholders of the Company.
We look forward to working hard for our collective benefit and executing on the strategy that we have communicated with you. Thank you again for your support.
Sincerely,
Maria Maccecchini, Ph.D.
Founder, President and Chief Executive Office, Annovis Bio, Inc.
Forward-Looking Statements
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words, and include, without limitation, statements regarding the timing, effectiveness, and anticipated results of ANVS401 clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.
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Media and Investor Contact:
Nic Johnson
Russo Partners, LLC
(303) 482-6405
nic.johnson@russopartnersllc.com
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