MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) reported third-quarter 2025 financial results and detailed a series of clinical, operational, and intellectual-property developments that the company says position its lead candidate, buntanetap, for a decisive year ahead.
CEO Maria Maccecchini described the period as “breakthrough progress on every front,” citing full activation of all clinical sites in the company’s pivotal Phase 3 Alzheimer’s disease trial, expanding biomarker evidence of drug activity, and strengthened corporate leadership.
The Phase 3 trial in early Alzheimer’s disease, which includes 84 U.S. sites, is now fully operational and enrolling steadily. Annovis said the first patients have completed the six-month treatment window, a key step toward an upcoming symptomatic readout. Screen-failure rates remain within expectations, and patient engagement has been “robust,” according to the company.
New biomarker findings announced in October from the company’s Phase 2/3 program reported substantial reductions in markers of neuroinflammation and neurodegeneration among patients treated with buntanetap versus placebo. Annovis framed these results as reinforcing the drug’s potential as a disease-modifying therapy — a claim long sought after in Alzheimer’s development.
The company also continued advancing its manufacturing and IP position. A peer-reviewed publication detailed the pharmacokinetic profile of a newly developed crystalline form of buntanetap, demonstrating improved solid-state stability while maintaining the compound’s metabolic characteristics. Annovis has transferred all patents to this new form, securing protection through 2046.
Operationally, the company added veteran executive Mark Guerin as CFO, strengthening its financial leadership as it moves toward key regulatory milestones. Annovis also presented multiple posters at the 2025 Alzheimer’s Association International Conference, covering trial progress and pharmacokinetic updates.
As of September 30, 2025, Annovis reported $15.3 million in cash and equivalents, up from $10.6 million at year-end 2024. These figures do not include $9.4 million in gross proceeds from direct offerings completed in October. Research and development expenses increased to $6.3 million from $2.7 million a year earlier, reflecting continued advancement of the Phase 3 program. General and administrative costs fell to $1.1 million from $1.7 million.
Net loss narrowed to $0.37 per share from $0.97 in the third quarter of 2024, supported by higher cash reserves and lower administrative spending.
With enrollment progressing, biomarker signals strengthening, and patent protections secured, Annovis said it is now “aligned on every element” as it heads toward pivotal data readouts and a planned future New Drug Application submission.
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