-- Phase 3 AD trial: 85% of patients enrolled; full enrollment on track in
summer 2026
-- PD open-label extension (OLE) study: 40% of patients enrolled; full
enrollment on track in fourth quarter 2026
-- New Drug Application (NDA) for buntanetap as a symptomatic treatment for
AD is expected in early 2027 and as a potential disease-modifying
treatment in early 2028
MALVERN, Pa., May 15, 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 provided business updates and reported financial results for the first quarter ended March 31, 2026.
"We saw strong momentum across both our AD and PD programs in the first quarter," said Maria Maccecchini, Ph.D., President and CEO of Annovis. "Our Phase 3 AD clinical trial achieved significant enrollment growth, keeping us firmly on track to complete randomization of patients in summer 2026 and deliver first top-line results in early 2027. Simultaneously, we launched a PD OLE study and have been encouraged by the robust interest from both returning and new patients. This year is pivotal: we expect to generate substantive clinical data across both indications that will anchor our regulatory path toward an NDA submission for buntanetap."
Clinical highlights
Alzheimer's disease -- pivotal Phase 3 trial (NCT06709014)
-- Enrollment: 85% of patients enrolled.
-- Screening: On May 15, 2026, Annovis closed enrollment to new participants
after reaching a sufficient number of patients in screening to meet the
trial's enrollment goal.
-- Safety: Annovis received a positive recommendation from the Data and
Safety Monitoring Board (DSMB) regarding the drug's safety at 6 months,
supporting seamless continuation of the study.
-- Study design: The pivotal Phase 3 AD trial is recruiting early AD
patients positive for pTau217 plasma biomarker. The study is designed to
evaluate buntanetap's symptomatic effect at 6 months and its potential
disease-modifying effect at 18 months.
Parkinson's disease -- OLE study (NCT07284784)
-- Enrollment: 40% of patients enrolled.
-- Skin biomarker: The PD OLE study is implementing a biomarker test
measuring levels of phosphorylated alpha-synuclein and nerve cell fiber
density via skin biopsy.
-- Digital biomarker: Annovis entered into a partnership with NeuroRPM to
integrate an AI-powered digital biomarker, enabling continuous,
real-world assessment of motor functions in response to buntanetap.
-- Study design: The PD OLE study is designed to evaluate buntanetap's
safety and long-term efficacy over the period of 36 months in
participants from prior Annovis' trials as well as in new patients who
had deep brain stimulation $(DBS)$ surgery.
Corporate highlights
-- Publications
-- Annovis published a byline article in The Scientist, tracing the
170-year scientific history of buntanetap, from the origins of its
predecessor compound to its mechanism of action and key events
that shaped the drug's clinical development.
-- Annovis announced a peer-reviewed publication of the Phase 2/3 AD
clinical trial results in Nature NPJ Dementia, available open
access, demonstrating a dose-dependent cognitive improvement and
biomarker reductions in patients treated with buntanetap.
-- Presentations
-- Cheng Fang, Ph.D., SVP, R&D, presented two posters at the
AD/PD2026 conference, highlighting clinical data which support
buntanetap's treatment effect in PD with a particular focus on
cognition and biomarker findings as well as an update on the
ongoing pivotal Phase 3 AD trial.
-- Maria Maccecchini, Ph.D., President and CEO, presented at Fierce
Biotech Week 2026 in Boston, delivering a talk titled "The
Multi-Protein Reality of Alzheimer's Disease: What the Science Has
Known for Decades and What the Field Has Yet to Accept," making
the scientific case for targeting multiple neurotoxic proteins in
AD and presenting buntanetap's clinical evidence of cognitive and
biomarker improvements.
-- Patents
-- Annovis secured a U.S. patent, covering prevention and treatment
of neurological injuries arising from brain infections through the
administration of buntanetap or related compounds.
Upcoming milestones
-- Phase 3 AD study: Annovis expects to reach full enrollment in summer
2026. The symptomatic data readout is anticipated approximately 6 months
after the last patient is dosed. The disease-modifying data readout is
anticipated 18 months after the last patient is dosed.
-- PD OLE study: Annovis expects to complete enrollment for the PD OLE study
in the fourth quarter of 2026.
-- NDA pathway: Based on the Phase 3 AD study outcomes, Annovis plans to
engage with the FDA regarding a regulatory NDA submission for buntanetap
as a symptomatic treatment for AD in early 2027 and as a
disease-modifying treatment in early 2028.
Financial results
-- Annovis' cash and cash equivalents totaled $14.2 million as of March 31,
2026, compared to $19.5 million as of December 31, 2025. This excludes
gross proceeds from its recent $10.0 million registered direct offering
on April 10, 2026. Annovis had 28.5 million shares of common stock
outstanding as of March 31, 2026.
-- Research and development expenses for the three months ended March 31,
2026, were $16.7 million compared to $5.0 million for the three months
ended March 31, 2025.
-- General and administrative expenses for the three months ended March 31,
2026, were $1.3 million compared to $1.3 million for the three months
ended March 31, 2025.
-- Annovis reported a $0.63 basic and diluted net loss per common share for
the three months ended March 31, 2026, compared to a $0.32 basic and
diluted net loss per common share for the three months ended March 31,
2025.
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
ir@annovisbio.com
(Tables to follow)
ANNOVIS BIO, INC.
Balance Sheets
March 31,
2026 December 31,
(Unaudited) 2025
-------------- ----------------
Assets
Current assets:
Cash and cash equivalents $ 14,219,081 $ 19,532,338
Prepaid expenses and other
current assets 2,024,622 1,549,287
------------ ------------
Total assets $ 16,243,703 $ 21,081,625
============ ============
Liabilities and stockholders'
equity
Current liabilities:
Accounts payable $ 5,275,668 $ 2,590,516
Accrued expenses 7,514,977 1,044,859
------------ ------------
Total current liabilities 12,790,645 3,635,375
------------ ------------
Non-current liabilities:
Warrant liability 327,000 595,000
Total liabilities 13,117,645 4,230,375
------------ ------------
Commitments and contingencies
(Note 6)
Stockholders' equity:
Preferred stock - $0.0001 par
value, 2,000,000 shares
authorized and 0 shares issued
and outstanding -- --
Common stock - $0.0001 par
value, 70,000,000 shares
authorized, 28,537,302 and
27,199,139 shares issued and
outstanding at March 31, 2026
and December 31, 2025,
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