-- Pivotal Phase 3 Alzheimer's disease $(AD)$ trial is fully enrolled with a total number of 850 patients, exceeding original projections. -- Parkinson's disease $(PD)$ open-label extension (OLE) study has enrolled 266 patients with full enrollment projected in Q4 2026. -- Annovis will host a corporate update webinar on Wednesday, September 2, 2026, at 4:00 pm EDT.
MALVERN, Pa., Aug. 14, 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 second quarter ended June 30, 2026.
"Our company witnessed major clinical strides during the second quarter, " said Maria Maccecchini, Ph.D., President and CEO of Annovis. "We reached an important milestone -- full enrollment of our pivotal Phase 3 study in early AD -- having recruited 850 patients. This number tells us how urgently patients and families need new options and underscores their faith in our approach to treating AD. We also plan to continue the ongoing study with an open-label extension (OLE) so AD patients can continue buntanetap treatment after finishing the trial. With topline data on track for early 2027, our team has already begun preparing for regulatory submission so that we are ready to move once the results are in hand."
Clinical highlights
Alzheimer's disease -- pivotal Phase 3 trial
-- Enrollment: The trial is fully enrolled with 850 patients, exceeding the
original target enrollment number of 760 patients.
-- Patients: The pivotal Phase 3 AD trial includes patients diagnosed with
early AD (MMSE 20-28) who are also positive for plasma pTau217 biomarker,
confirming the presence of amyloid and tau pathology in the brain.
-- Study design: The study measures cognition (ADAS-Cog13) and function
(ADCS-iADL) as co-primary endpoints, supported by volumetric MRI,
pTau217, and other biomarkers to evaluate changes in disease pathology.
The study is designed to test both symptomatic (6 months) and
disease-modifying (18 months) effects of buntanetap.
-- Timeline: The Company plans a database lock for the 6-month analysis in
Q1 2027, with the top-line symptomatic data readout anticipated in the
same quarter. The disease-modifying data readout is expected a year
later.
Alzheimer's disease -- OLE study
-- Start: The AD OLE study is expected to initiate in October 2026.
-- Aim and patients: The AD OLE study will allow patients who are currently
in the pivotal Phase 3 trial to receive buntanetap after completing their
18-month treatment period. Patients from both arms -- buntanetap and
placebo -- will be allowed to join. The initiation of the AD OLE is timed
to coincide with the first patient finishing their 18-month treatment,
ensuring seamless transition into the extension study. The AD OLE will
also be open to participants from Annovis' prior AD clinical trials.
Parkinson's disease -- OLE study
-- Enrollment: The study has so far enrolled 266 patients toward its
estimated enrollment goal of 500. It accepts participants who were in
prior Annovis' clinical trials as well as new patients who have deep
brain stimulation $(DBS)$.
-- Site activation: 26 clinical sites have been activated across the US.
-- Study design: The PD OLE study is designed to evaluate buntanetap's
safety and long-term efficacy over the period of 36 months, supported by
NeuroRPM, a real-time digital biomarker that measures core PD symptoms,
and a skin biopsy test for alpha-synuclein pathology.
Corporate highlights
-- Management: Annovis promoted Cheng Fang, Ph.D., to Chief Scientific
Officer (CSO), where she will oversee the clinical execution and
scientific advancement of buntanetap as the Company approaches key
regulatory milestones.
Upcoming milestones
-- Corporate webinar: Annovis will host a corporate update webinar on
Wednesday, September 2, 2026, at 4:00 pm EDT. To participate, please
register using the following link: Annovis Webinar - Corporate Update
-- Questions: Participants are encouraged to submit questions in advance to
ir@annovisbio.com
Financial results
-- Annovis' cash and cash equivalents totaled $18.7 million as of June 30,
2026, compared to $19.5 million as of December 31, 2025. Annovis had 42.6
million shares of common stock outstanding as of June 30, 2026.
-- Research and development expenses for the three months ended June 30,
2026, were $12.0 million compared to $5.2 million for the three months
ended June 30, 2025.
-- General and administrative expenses for the three months ended June 30,
2026, were $2.4 million compared to $1.1 million for the three months
ended June 30, 2025.
-- Annovis reported a $0.40 basic and diluted net loss per common share for
the three months ended June 30, 2026, compared to a $0.32 basic and
diluted net loss per common share for the three months ended June 30,
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. 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
ANNOVIS BIO, INC.
Balance Sheets
June 30,
2026 December 31,
(Unaudited) 2025
-------------- ----------------
Assets
Current assets:
Cash and cash equivalents $ 18,728,945 $ 19,532,338
Prepaid expenses and other
current assets 3,308,146 1,549,287
------------ ------------
Total assets $ 22,037,091 $ 21,081,625
============ ============
Liabilities and stockholders'
equity
Current liabilities:
Accounts payable $ 3,327,138 $ 2,590,516
Accrued expenses 3,031,572 1,044,859
------------ ------------
Total current liabilities 6,358,710 3,635,375
------------ ------------
Non-current liabilities:
Warrant liability 19,933,000 595,000
Total liabilities 26,291,710 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, 42,606,152 and
27,199,139 shares issued and
outstanding at June 30, 2026
and December 31, 2025,
respectively 4,260 2,719
Additional paid-in capital 191,871,978 180,552,190
Accumulated deficit (196,130,857) (163,703,659)
------------ ------------
Total stockholders' equity (4,254,619) 16,851,250
Total liabilities and
stockholders' equity $ 22,037,091 $ 21,081,625
============ ============
ANNOVIS BIO, INC.
Statements of Operations
Three Months Ended Six Months Ended
June 30, June 30,
--------------------------- ------------------------------
2026 2025 2026 2025
------------- ------------ ------------- ---------------
Operating
expenses:
Research and
development $ 12,007,300 $ 5,161,921 $ 28,727,663 $ 10,173,438
General and
Comments