BERWYN, Pa., May 11, 2023 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company addressing neurodegenerative diseases, announced first quarter financial results for the period ended March 31, 2023, and reviewed recent accomplishments.

First Quarter 2023 Highlights and New Developments

Clinical Updates
At a recent R&D webcast on April 20, 2023, the Company:

• Reviewed its ongoing clinical programs in AD and PD.
  
  
• Discussed preliminary plans to develop buntanetap with the FDA for all stages of diseases, both short- and long-term.
  
  
• Provided updates to its then current enrollment levels for each trial:
  
  
  • AD Phase 2/3 study: 27 sites had been activated and 38 patients had been screened as of April 20; 13 patients had been randomized to receive either one of three doses of buntanetap or placebo.
  • PD Phase 3 study: Over 540 patients had been screened and 385+ patients were on the drug as of April 20. Due to U.S clinical sites opening earlier than EU sites, there were approximately four times more U.S. patients enrolled in the study versus EU patients. To accommodate the strong enrollment trends in the U.S. excess supplies of buntanetap were shipped from the EU to the U.S.   
    
    
• PD Updates
  
  
  • Explained the results from the pre-planned blinded interim analysis of the ongoing Phase 3 study for early PD, announced on March 31, 2023. The analysis was based on 132 patients from all cohorts collectively for which baseline and two-month data was available. The results enabled the Company to move forward with the previously established protocol and original patient enrollment estimates for the trial.  
    
    
  • Announced on February 8, 2023, the approval by the EU to start clinical trials in five EU countries for the ongoing Phase 3 study of buntanetap for the treatment of early PD. Annovis is actively recruiting for the ongoing Phase 3 study, with approximately 53 clinical trial sites open and currently enrolling in the U.S. The approval adds approximately 49 additional sites in the EU for the Company's ongoing study.

Patents

• Announced on February 1, 2023, the filing of a provisional patent application that extends the breadth of its platform from neurodegenerative to neuropsychiatric indications to cover the administration of buntanetap and its analogues for the treatment of mental illnesses.
  
  
• Announced on April 27, 2023, the issuance of U.S. Patent 11,596,621 B2 by the United States Patent and Trademark Office titled, “Prevention or Treatment of Disease States Due to Metal Dis-homeostasis Via Administration of Posiphen [buntanetap] to Healthy or Sick Humans.” The patent is expected to confer protection for use of buntanetap and its related analogue molecules for the prevention and treatment of various neurodegenerative diseases associated with metal dis-homeostasis out to early 2040.

Financial Results (for the quarter ending March 31, 2023)

• Cash and cash equivalents were $16.8 million. Research and development expenses for the quarter were $7.8 million, compared to $2.1 million for the same period in 2022. The increase was primarily the result of an increase of $5.6 million in clinical expenses, as the Company incurred costs related to its Phase 3 study in early Parkinson’s Disease (PD) patients and its Phase 2/3 Alzheimer's Disease (AD) study, partially offset by a decrease of $0.4 million in stock-based compensation expense.
  
  
• General and administrative expenses for the first quarter were $2.2 million, compared to $3.1 million for the same period in 2022. The decrease was primarily the result of a decrease of $1.5 million in stock-based compensation expense, partially offset by an increase in professional fees of $0.6 million.
  
  
• Annovis reported a net loss of $9.7 million for the quarter, compared to a net loss of $5.2 million for the same period in 2022.

Raised Approximately $8.7 million 

The Company announced on April 11, 2023, that it had raised aggregate gross proceeds of approximately $8.7 million between its now-terminated at–the-market (ATM) program and a private placement to individual members of its Board of Directors and management. The additional capital will fund the company's two ongoing studies (Phase 3 in early PD and Phase 2/3 in moderate AD) through completion and otherwise fund operations into the first quarter of 2024.

Staff News

• New appointments will strengthen the Company’s senior leadership team: The Company announced on January 6, 2023, the appointment of Michael Christie, Ph.D. as Vice President of Process Chemistry, and David Prohaska as Vice President of Toxicology and Pharmacology. Dr. Christie has over 40 years of experience in the pharmaceutical industry and formally served as the Senior Director of Chemical Process and R&D for Teva Pharmaceuticals.
  
  Prohaska brings 25 years of experience in all aspects of preclinical drug development and has a long track record of successful FDA submissions with multiple drug approvals. He joined Annovis from Aravive Biologics where he served as the Director of Preclinical Development and Clinical Operations Support.

• Presented at the AD/PD™ 2023 International Conference on Alzheimer's and Parkinson's Diseases (April 1, 2023): The Company presented data combining and comparing old data in mice and new data in humans to show that mouse and rat data are predictive of human outcomes. In the presentation, titled "Do Mouse Data Lie? For Buntanetap They Totally Predict Human Outcome", data from the AD mice, Down Syndrome mice, PD mice, two Phase 1/2 double-blind, placebo-controlled human AD studies and one Phase 2 PD study were compared to show the consistency on buntanetap's mechanism of action, the reversal of the toxic cascade, and the resulting efficacy in AD and PD mice and humans.
  
  
• Message from Dr. Maria

As highlighted during our R&D webinar, Annovis continues to make significant  progress in our ongoing Alzheimer’s and Parkinson’s clinical programs. 
Enrollment in the Phase 3 Parkinson’s study remains exceptionally strong and reflects our team’s excellent operational execution and the growing interest in the therapeutic potential of our lead pipeline candidate, buntanetap. 

Given our continued execution and the growing momentum in these two programs, we were able to strengthen our balance sheet with both new and existing investors, including several members from our Board of Directors. Thus far, 2023 is proving to be a momentous year for our Company, and with additional data readouts anticipated later this year, we remain on track for delivering what we hope will be positive news for our clinical programs. 

We remain steadfast in our mission to develop truly groundbreaking therapies for both AD and PD patients. 

–Maria L. Maccecchini, Ph.D., Annovis Founder, President, and CEO 

About Buntanetap

Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), which mode of action leads to a lower level of neurotoxic proteins and consequently less toxicity in the brain. In a Phase 1/2 clinical trial in AD and PD patients, buntanetap was shown to be well-tolerated and its pharmacokinetics were found to be in line with levels measured earlier in humans, meeting both the primary and secondary endpoints. Additionally, exploratory endpoints were also met, as treatment with buntanetap resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients. Presently buntanetap is being studied in a Phase 3 study in early PD patients and in a Phase 2/3 study in mild to moderate AD patients.

About Annovis Bio, Inc.

Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and other chronic neurodegenerative diseases. We believe that we are the only company developing a drug for AD and PD that is designed to inhibit more than one neurotoxic protein and has a mechanism of action designed to restore axonal and synaptic activity. By improving brain function, the company’s goal is to treat memory loss and dementia associated with AD as well as body and brain function associated with PD. Annovis conducted two Phase 1/2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study buntanetap showed improvements in cognition in AD as well as movement and function in PD patients. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.

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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding 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. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Investor Contacts:

Chris Calabrese
+1 (917) 680-5608
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LifeSci Advisors, LLC

Kevin Gardner
+1 (617) 283-2856
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LifeSci Advisors, LLC