Form 8-K - Current report

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

  

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): November 12, 2024

 

  

ANNOVIS BIO, INC.

(Exact Name of Registrant as Specified in Charter) 

 

 

Delaware	001-39202	26-2540421
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

 

101 Lindenwood Drive, Suite 225
Malvern, PA 19355

(Address of Principal Executive Offices, and Zip Code)

 

[phone]

Registrant’s Telephone Number, Including Area Code

 

                       Not Applicable                       

(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. ¨

 

 

 

 

Item 2.02  Results of Operations and Financial Condition

 

On November 11, 2024, Annovis Bio, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2024 and providing a corporate update. A copy of the press release is furnished herewith as Exhibit 99.1.

 

Item 9.01   Financial Statements and Exhibits. 

 

The following exhibits are being furnished herewith:

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release Dated November 11, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

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: November 12, 2024	By:	/s/ Maria Maccecchini
		Name: Maria Maccecchini
		Title: President and Chief Executive Officer

 

 

 

Exhibit 99.1

 

Annovis Bio Reports Third Quarter Financial Results and Provides Business Update

 

MALVERN, Pa., Nov. 11, 2024 (GLOBE NEWSWIRE) – via IBN – Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced financial results for the third quarter ended September 30, 2024, and provided a business update.

 

"The third quarter was marked by important milestones outlining the next steps for buntanetap," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "The FDA gave us the green light to initiate confirmatory Phase 3 studies for early AD, and our team has been working hard to begin them in the coming year. We also strengthened our intellectual property portfolio by filing unique patents protecting new combinations of buntanetap with other medications for improving cognition."

 

Clinical Updates

 

·

On October 10, 2024, Annovis conducted a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), to discuss the data from its Phase 2/3 AD study and the next steps for buntanetap.

 

·

During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies: a 6-month study aimed at confirming buntanetap’s symptomatic effects and an 18-month study designed to demonstrate potential disease-modifying effects.

 

·

The FDA raised no concerns about the Company’s data on buntanetap’s safety, including liver enzymes, drug interactions, dose selection, pharmacokinetics, population pharmacokinetics, and confirmed that development can proceed using the new crystal form of buntanetap.

 

·

The 6-month symptomatic study is expected to begin in Q1 2025.

 

Cash Runway and Third Quarter 2024 Financial Results

 

·

As of November 8, 2024, Annovis had cash and cash equivalents of $13.6 million. The company has an adequate runway for all Phase 3 preparatory studies and for entering the pivotal Phase 3 AD study in Q1 2025.

 

·

During the third quarter, Annovis received $4.4 million in net cash from its April 2024 ELOC facility. As of November 8, 2024, a total of $12.7 million in net cash has been raised with the ELOC year to date. Recent ELOC proceeds will ensure that Annovis has sufficient liquidity to enter the Phase 3 AD study.

 

 

 

·

Annovis received $7.1 million in net cash from the exercises of Canaccord Warrants during the third quarter, in July.

 

·

Total operating expenses for the three months ending September 30, 2024, were $4.4 million, which included research and development expenses of $2.7 million and general and administrative expenses of $1.7 million. This compares to total operating expenses for the three months ending September 30, 2023, of $14.9 million, which included research and development expenses of $13.9 million and general and administrative expenses of $1.0 million.

 

·

Annovis reported a $0.97 basic and diluted net loss per common share for the three months ending September 30, 2024. This compares to a $1.63 basic and diluted net loss per common share for the three months ending September 30, 2023.

 

Conferences

 

·

The Company presented two scientific posters at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 29-November 1 in Madrid, Spain. The posters were focused on buntanetap’s efficacy data in early AD patients from Phase 2/3 study and the biomarker data.

 

Patents

 

·

On September 30, 2024, Annovis announced the filing of three new patents for innovative combination therapies involving its lead compound, buntanetap. These patents cover combinations of buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), or a combination of all three, creating a multifaceted approach to treating neurodegenerative diseases.

 

Team Expansion

 

·

The Company announced the addition of Matthew Peterson, Ph.D., as Senior Clinical Scientist. Dr. Peterson will be responsible for quality and rigor in the upcoming clinical trials for AD and PD, ensuring their successful completion.

 

 

 

About Annovis Bio, Inc. Headquartered in Malvern, Pennsylvania, Annovis Bio 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.

 

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.

 

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

 

Investor Contact
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: [phone]
‍[e-mail]
Investor Website

 

 

 

Cover	Nov. 12, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 12, 2024
Entity File Number	001-39202
Entity Registrant Name	ANNOVIS BIO, INC.
Entity Central Index Key	0001477845
Entity Tax Identification Number	26-2540421
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	101 Lindenwood Drive
Entity Address, Address Line Two	Suite 225
Entity Address, City or Town	Malvern
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19355
City Area Code	484
Local Phone Number	875-3192
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	ANVS
Security Exchange Name	NYSE
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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