SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 8, 2022
ANNOVIS BIO, INC.
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction
1055 Westlakes Drive, Suite 300
Berwyn, PA 19312
(Address of Principal Executive Offices, and Zip Code)
Registrant’s Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report)
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $0.0001 per share||ANVS||New York Stock Exchange|
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|¨||Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
|Item 2.02||Results of Operations and Financial Condition.|
On August 8, 2022, Annovis Bio, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2022 and providing a corporate update. A copy of the press release is furnished herewith as Exhibit 99.1.
The information furnished in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
|Item 9.01||Financial Statements and Exhibits.|
|99.1||Press Release, dated August 8, 2022.|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|ANNOVIS BIO, INC.|
|Date: August 8, 2022||By:||/s/ Jeffrey McGroarty|
|Name: Jeffrey McGroarty|
|Title: Chief Financial Officer|
Annovis Bio Announces Second Quarter 2022 Results and Provides Corporate Update
Berwyn, Pennsylvania—August 8, 2022 - Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing neurodegenerative diseases, today announced second quarter financial results for the quarter ended June 30, 2022, and reviewed recent accomplishments.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, commented: “Because of buntanetap’s unique mode of action, it has the potential to act on a variety of neurodegenerative disorders. As a result, in the second quarter, we have taken significant steps to expand our intellectual property portfolio as it relates to buntanetap. Importantly, the FDA has approved our Phase 3 clinical trial design in early PD patients. This approval affirms the Company's path to securing approval for buntanetap to treat neurodegenerative diseases, including Parkinson's and Alzheimer's diseases, with longer treatment regimens.”
Recent Highlights and New Developments
|·||Receipt of positive FDA Notice for Buntanetap Phase 3 clinical trial in Parkinson’s Disease: The Company received notice from the FDA that the Phase 3 clinical study in early Parkinson's patients may proceed. The FDA accepted the final protocol and the clinical development plan, approved the use of the Company's new large-scale batch of good manufacturing practice material, and found the chronic toxicology in rats and dogs safe and adequate to support long-term human studies lasting decades compared to the previous restriction of one month.|
|·||Submission of an international patent application to cover the treatment of neurological injuries caused by infections: The Company announced the submission of an international patent application under the Patent Cooperation Treaty for its drug platform buntanetap. The patent claims a method of inhibiting, preventing, or treating neurological injuries due to viral, bacterial, fungal, protozoan, or parasitic infections in humans.|
|·||Cooperative Research and Development Agreement with the National Institute on Aging: The Company announced a Cooperative Research and Development Agreement (CRADA) with the National Institute on Aging (NIA), a part of the National Institutes of Health. Under this CRADA, NIA and Annovis are collaborating to develop pharmacodynamic biomarkers for buntanetap, focusing on isolating brain-derived extracellular vesicles (EV) containing potential biomarkers of neuronal function and viability.|
Financial Results for the Second quarter of 2022
Cash, cash equivalents, and marketable securities were $36.0 million as of June 30, 2022. Research and development expenses for the quarter ended June 30, 2022, were $6.8 million, compared to $1.8 million for the same period in 2021. The increase was primarily the result of an increase of $2.4 million in clinical expenses as the Company incurred costs related to its upcoming Phase 3 study in early PD patients, an increase of $1.8 million for the cost of materials and an increase of $0.7 million in stock-based compensation expense. General and administrative expenses for the quarter ended June 30, 2022, were $1.9 million, compared to $0.7 million for the same period in 2021. The increase was primarily the result of an increase of $1.2 million in stock-based compensation expense.
For the quarter ended June 30, 2022, Annovis reported a net loss of $8.7 million, compared to a net loss of $2.5 million for the same period in 2021.
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, including Alzheimer's in Down Syndrome (AD-DS). We believe that we are the only company developing a drug for AD, PD, and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. Annovis conducted two Phase 2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study buntanetap showed improvements in cognition and memory in AD as well as body and brain 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.
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 buntanetap 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, 2021, 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.
and Investor Contact:
Russo Partners, LLC