MALVERN, Pa., March 16, 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 business updates and reported financial results for the fiscal year 2025.
In 2025, Annovis achieved a significant milestone in its clinical development program with the initiation of a pivotal Phase 3 clinical trial in early AD. The year was largely dedicated to the activation of clinical sites and the enrollment of participants across the United States. The Company also reported encouraging data from both its previous Alzheimer's and Parkinson's programs, demonstrating a potential disease-modifying signal for buntanetap through reductions in biomarkers of amyloid and tau pathology, neuroinflammation, and neurodegeneration. Building on this momentum, Annovis recently initiated an open-label extension (OLE) study in PD.
"The year 2025 was a landmark period for Annovis, one in which we took decisive steps toward bringing buntanetap to patients," said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. "We initiated our pivotal Phase 3 AD study and later launched an OLE PD study, both critical milestones on the path to an NDA submission. Throughout the year, we remained focused on designing, preparing, and executing these studies with the highest standards of rigor while maintaining our scientific presence through key conferences, meetings, and publications. Equally important, we also revealed new biomarker data on buntanetap from our ongoing analysis of the completed studies, reinforcing the drug's therapeutic potential."
Clinical progress
Alzheimer's disease
-- In February 2025, Annovis launched a pivotal Phase 3 study (NCT06709014)
evaluating buntanetap over a period of 18 months as both a symptomatic (6
months) and a potential disease-modifying (18 months) treatment in early
AD patients.
-- In October 2025, Annovis announced that the first participants reached
the 6-month milestone aimed at measuring the symptomatic effect of
buntanetap.
-- In October 2025, the Company also reported new biomarker data from its
Phase 2/3 AD trial, demonstrating potential disease-modifying activity of
buntanetap as measured by reductions in biomarkers of neurotoxic proteins,
neuroinflammation, and neurodegeneration.
-- In February 2026, Annovis received a positive recommendation from the
Data and Safety Monitoring Board (DSMB) regarding buntanetap's safety at
6 months, supporting the continuation of the trial without modifications.
-- As of March 2026, Annovis has enrolled 65% of the target participant
population for its pivotal Phase 3 AD clinical trial across 83 clinical
sites in the United States.
Parkinson's disease
-- In November 2025, Annovis reported novel biomarker data linking amyloid
co-pathology in PD to accelerated cognitive decline. The data also showed
that buntanetap improved cognition in these patients and reduced amyloid
and tau pathology as measured by total tau, phosphorylated tau (pTau217),
and brain-derived tau.
-- In December 2025, Annovis announced an OLE study in PD (NCT07284784),
which commenced in January 2026. The OLE study is currently enrolling
patients from the Company's previous PD trials as well as new
participants with a stable deep brain stimulation $(DBS)$ therapy, and it
is designed to evaluate the long-term safety and tolerability of
buntanetap over 36 months. The study also aims to evaluate a potential
efficacy response and collect biomarker data to measure changes in
disease pathology.
-- In January 2026, following the data demonstrating significant cognitive
improvements in cognitively impaired PD patients with amyloid pathology
after treatment with buntanetap, Annovis met with the FDA to discuss a
new study in PD dementia $(PDD)$. The Company received a positive
recommendation to proceed and is currently in discussions with the FDA to
determine the trial design and endpoints for its execution.
Buntanetap development
-- In August 2025, Annovis announced the transfer of all Company's patents
to the new crystal form of buntanetap. This new form offers improved
solid-state stability while preserving the drug's pharmacokinetic
profile. This transfer also extends the intellectual property protection
for buntanetap -- covering composition of matter, mechanism of action,
applications of buntanetap for multiple indications, and its combination
with other drugs -- until 2047.
-- As of year-end 2025, Annovis held a total of 40 granted patents and 48
patent applications. Most granted patents have received approval across
major global markets, and all patent applications have been or are being
filed worldwide.
-- In September 2025, Annovis announced a publication in a peer-reviewed
journal Biomolecules describing the new crystal form of buntanetap, its
pharmacokinetics, and comparison to the original form.
-- The new crystal form is now used in the ongoing clinical trials --
pivotal Phase 3 AD study and OLE PD study -- and will be used in any
future Company's trials.
Business highlights
-- In 2025, Annovis' leadership participated in key scientific conferences,
including the Drug Development Summit focused on innovative PD
treatments; AD/PD 2025, where the Company delivered two presentations and
participated in a forum discussion; the Alzheimer's Association
International Conference $(AAIC)$ 2025, with four presentations; the
Reuters Event: Pharma Clinical Innovation USA 2025; the Clinical Trials
on Alzheimer's Disease (CTAD) conference, with two presentations; and the
2025 Annual Meeting of the Parkinson's Study Group.
-- Annovis also presented at major investor conferences, including the
Oppenheimer 34th Annual Healthcare Life Sciences Conference and the H.C.
Wainwright 27th Annual Global Investment Conference.
-- Additionally, the Company hosted several webinars, including corporate
update and patient webinars, where the management team provided updates
on the clinical trial progress and answered live questions from the
audience.
Management highlights
-- In 2025, Annovis expanded its core management team by appointing Mark
Guerin as CFO and Hui Liu as Director of Biostatistics.
-- Mark Guerin, CPA, CMA, CFM, Annovis' CFO, has an extensive background in
biopharma financial operations, including financial reporting,
forecasting, internal controls, IPOs, follow-on offerings, and
acquisitions and divestitures.
-- Hui Liu, Director of Biostatistics, has an extensive experience in
statistical methodology and analysis, design and reporting of all phases
of clinical trials, and interpreting complex data to support regulatory
submissions.
Financial results
-- Research and development expenses for the year ended December 31, 2025
were $25.2 million compared to $20.0 million for the year ended December
31, 2024. General and administrative expenses for the year ended December
31, 2025 were $4.5 million compared to $6.7 million for the year ended
December 31, 2024. Annovis reported a $1.40 basic and $1.40 diluted net
loss per common share for the year ended December 31, 2025 on 20.6
million weighted-average common shares outstanding, compared to a $2.02
basic and $2.31 diluted net loss per common share for the year ended
December 31, 2024 on 12.2 million weighted-average common shares
outstanding.
-- Annovis' cash and cash equivalents totaled $19.5 million as of December
31, 2025 compared to $10.6 million as of December 31, 2024. The Company
estimates that its current cash and cash equivalents, including proceeds
from its stock offerings in the fourth quarter of 2025, will enable it to
fund its operations into the third quarter of 2026. The Company had 27.2
million shares of common stock outstanding as of December 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
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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
As of December 31,
--------------------------------
2025 2024
-------------- ----------------
Assets
Current assets:
Cash and cash equivalents $ 19,532,338 $ 10,551,916
Prepaid expenses and other
current assets 1,549,287 3,373,717
------------ ------------
Total assets $ 21,081,625 $ 13,925,633
============ ============
Liabilities and stockholders'
equity (deficit)
Current liabilities:
Accounts payable $ 2,590,516 $ 2,305,974
Accrued expenses 1,044,859 1,575,013
------------ ------------
Total current liabilities 3,635,375 3,880,987
------------ ------------
Non-current liabilities:
Warrant liability 595,000 737,000
------------ ------------
Total liabilities 4,230,375 4,617,987
------------ ------------
Commitments and contingencies
Stockholders' equity (deficit) :
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 and 27,199,139 and
14,151,521 shares issued and
outstanding at December 31,
2025 and December 31, 2024,
respectively 2,719 1,414
Additional paid-in capital 180,552,190 144,155,694
Accumulated deficit (163,703,659) (134,849,462)
------------ ------------
Total stockholders' equity 16,851,250 9,307,646
Total liabilities and
stockholders' equity $ 21,081,625 $ 13,925,633
============ ============
ANNOVIS BIO, INC.
Statements of Operations
Year Ended December 31,
------------------------------
2025 2024
------------- ---------------
Operating expenses:
Research and development $ 25,215,607 $ 19,995,447
General and administrative 4,479,651 6,699,481
Total operating expenses 29,695,258 26,694,928
----------- -----------
Operating loss (29,695,258) (26,694,928)
Other income (expense):
Interest income 699,061 331,849
Other financing costs -- (1,853,189)
Change in fair value of warrants 142,000 3,625,893
----------- -----------
Total other income (expense),
net 841,061 2,104,553
----------- -----------
Net loss $(28,854,197) $(24,590,375)
=========== ===========
Net loss per share
Basic $ (1.40) $ (2.02)
=========== ===========
Diluted $ (1.40) $ (2.31)
=========== ===========
Weighted-average number of common
shares used in computing net loss
per share
Basic 20,551,997 12,182,475
=========== ===========
Diluted 20,551,997 12,235,444
=========== ===========
(END) Dow Jones Newswires
March 16, 2026 07:30 ET (11:30 GMT)
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