MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) more than doubled second-quarter research spending as its pivotal Phase 3 Alzheimer’s disease trial reached full enrollment at 850 patients, positioning the biotechnology company for its first efficacy readout in early 2027.
Research and development expenses rose to $12 million for the three months ended June 30 from $5.2 million a year earlier, according to Annovis. General and administrative expenses increased to $2.4 million from $1.1 million.
The company recorded a basic and diluted net loss of 40 cents per common share, widening from 32 cents in the second quarter of 2025.
Annovis ended June with $18.7 million in cash and cash equivalents, down from $19.5 million at the end of 2025. The clinical-stage company had 42.6 million common shares outstanding as of June 30.
The increased spending comes as Annovis advances buntanetap, its investigational oral treatment for neurodegenerative diseases, through late-stage development in Alzheimer’s disease and a long-term extension study in Parkinson’s disease.
Its pivotal Phase 3 Alzheimer’s trial enrolled 850 patients, exceeding the original target of 760. Participants have early Alzheimer’s disease, defined by Mini-Mental State Examination scores of 20 to 28, and are positive for the plasma pTau217 biomarker associated with amyloid and tau pathology.
The study is evaluating cognition using ADAS-Cog13 and function using ADCS-iADL as co-primary endpoints. Volumetric MRI, pTau217 and other biomarkers are being used to assess changes in disease pathology.
Annovis designed the trial to evaluate buntanetap’s symptomatic effects after six months and potential disease-modifying effects after 18 months.
The company expects to lock the database for the six-month analysis during the first quarter of 2027 and release topline symptomatic results in the same quarter. The 18-month disease-modification readout is expected about a year later.
“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,” Chief Executive Officer Maria Maccecchini stated.
Annovis also plans to begin an open-label extension of the Alzheimer’s program in October. Participants completing the 18-month Phase 3 treatment period will be eligible to receive buntanetap regardless of whether they originally received the drug or placebo.
Participants from earlier Annovis Alzheimer’s trials will also be eligible for the extension study.
In Parkinson’s disease, Annovis has enrolled 266 patients toward an estimated 500-patient target in its open-label extension study, with full enrollment projected for the fourth quarter of 2026.
The company has activated 26 U.S. clinical sites for the study, which accepts participants from earlier Annovis trials as well as new patients who have undergone deep brain stimulation.
The Parkinson’s study will evaluate buntanetap’s safety and long-term efficacy for as long as 36 months. It incorporates NeuroRPM, a digital biomarker used to measure Parkinson’s symptoms, along with skin biopsies assessing alpha-synuclein pathology.
Annovis also promoted Cheng Fang to chief scientific officer, placing her in charge of clinical execution and scientific development of buntanetap as the company approaches potential regulatory milestones.
The company plans to hold a corporate update webinar Sept. 2 at 4 p.m. EDT. Participants may submit questions in advance to ir@annovisbio.com.
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