Annovis Bio Reports Third Quarter Financial Results and Provides Business Update

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Annovis Bio, Inc.
Annovis Bio, Inc.

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.