- Financing secures path to first NDA submission for buntanetap
- 6-Month symptomatic data readout anticipated Q1 2027
- Alzheimer’s disease Phase 3 trial 75% enrolled
- Parkinson's disease open-label study 28% enrolled
MALVERN, Pa., April 10, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced the closing of an underwritten public offering raising approximately $10 million in gross proceeds. Combined with existing cash on hand as well as a recent $1.5 million investment from the Board of Directors Chair, Michael Hoffman, the financing extends Annovis' cash runway through Q2 2027, fully funding the Company's operations through a key symptomatic data readout of its Phase 3 AD trial and the anticipated submission of a New Drug Application (NDA) for buntanetap to the U.S. Food and Drug Administration (FDA).
“This financing is a decisive step forward for Annovis and for patients waiting for a novel Alzheimer’s treatment,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “We now have the resources to reach our first major regulatory milestone: the 6-month data readout from our Phase 3 AD trial and the NDA submission that follows. With enrollment nearing completion, NDA preparations launched, and an ongoing open-label study in PD, Annovis is executing on all fronts.”
Proceeds from this offering will primarily support the advancement of buntanetap through the pivotal Phase 3 AD trial (NCT06709014), which is approaching full enrollment with 75% of participants already enrolled. The trial is designed to provide two important milestones: a 6-month evaluation of symptomatic improvement and an 18-month assessment of potential disease modification, each followed by its own NDA submission. Preparations for the 6-month data readout and corresponding FDA filing are already underway.
Notably, the FDA has agreed to integrate safety data from both AD and PD populations from the Company’s completed and ongoing clinical trials in the NDA for AD, enabling regulatory efficiency that is expected to support a faster and more robust submission process.
In parallel, Annovis is conducting an open-label extension (OLE) study in PD patients (NCT07284784), which has enrolled 28% of participants since its inception in February 2026. The OLE study will test buntanetap for 36 months and capture safety, efficacy, and biomarker data. The OLE study also incorporates an AI-enabled digital biomarker device, developed and provided by NeuroRPM, that monitors symptom changes in real time, providing granular insight into buntanetap's therapeutic effects and further differentiating Annovis' clinical program.
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. (NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). The Company's lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism of action. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in 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 under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.
Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
[email protected]