Annovis Bio, Inc. (ANVS)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 was execution-heavy: the pivotal Phase 3 Alzheimer’s trial reached full activation across all 84 U.S. sites, is ~25% complete, and first patients have completed the 6‑month treatment window—key milestones ahead of the planned symptomatic readout in 2H 2026 .
• Financials were typical for a clinical-stage biotech: net loss improved year over year to $7.26M, driven by warrant fair-value effects vs. Q3 2024; EPS was -$0.37 and modestly beat Wall Street consensus of -$0.3767* (no revenue; 3 estimates) .
• Liquidity: cash was $15.29M at 9/30 (before October financings); management highlighted subsequent gross proceeds of ~$6.0M and ~$3.4M from October registered directs, and communicated an expected runway into Q3 2026; note the 10‑Q also includes a going‑concern disclosure indicating additional capital is needed within 12 months—investors should treat the runway commentary as contingent on continued financing .
• Clinical/biomarker catalysts: new Phase 2/3 AD biomarker data showed reductions in IL‑5, IL‑6, S100A12, IFN‑γ, IGF1R and decreases in NFL, supporting disease‑modifying potential claims and strengthening the narrative into CTAD and 2026 readouts .

What Went Well and What Went Wrong

What Went Well

• “Breakthrough progress on every front” with Phase 3 AD trial fully activated at 84 sites, active enrollment/treatment, and first 6‑month completions achieved, underscoring operational momentum into symptomatic readout in 2H 2026 .
• Biomarker validation: Phase 2/3 analysis showed reductions in neuroinflammation (IL‑5, IL‑6, S100A12, IFN‑γ, IGF1R) and neurodegeneration (NFL), reinforcing buntanetap’s pathway engagement and disease‑modifying thesis; “we anticipate observing an even stronger treatment response at the 18‑month analysis” .
• Team/IP strengthening: patents transferred to the new crystal form with PK published (stability preserved across species) and CFO hire adds capital markets and controls depth “at this critical juncture” .

What Went Wrong

• R&D spend stepped up with Phase 3 execution: R&D rose to $6.29M vs. $2.69M YoY; total opex up to $7.43M vs. $4.39M YoY as the AD trial moved through patient treatments .
• Liquidity disclosures are mixed: press communications reference runway into Q3 2026, but the 10‑Q reiterates going‑concern risk and insufficient capital for the next 12 months absent new financing—investors should assume further dilution is likely .
• No earnings call transcript located for Q3 2025, limiting visibility into detailed line-item commentary, guidance Q&A, and analyst challenge points in the quarter (searched, none available) [SearchDocuments, earnings-call-transcript filter, 2025-10-01 to 2025-11-30].

Financial Results

Values with asterisk retrieved from S&P Global.

Values retrieved from S&P Global.

Notes:

• No product revenue; single reportable segment focused on buntanetap for AD/PD .
• Q3 EPS beat was small and largely mechanical; underlying opex rose due to trial execution .

Guidance Changes

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was found; themes reflect press releases and 10‑Q.

Management Commentary

• CEO: “The past quarter delivered breakthrough progress on every front… [Phase 3 AD] full activation across all clinical sites… biomarker findings… powerful evidence of buntanetap’s disease‑modifying potential” .
• SVP Clinical Operations: “Our Phase 3 trial is now 25% complete… achievements keep us on schedule for our first 6‑month readout in 2026” .
• SVP R&D: “Biomarker data… confirmed target and pathway engagement after just three months… we anticipate an even stronger treatment response at the 18‑month analysis” .
• CFO: “Buntanetap has demonstrated efficacy in smaller trials and is on track to replicate that success in larger, registrational clinical studies” .

Q&A Highlights

• No Q3 2025 earnings call transcript was available; the company communicated updates via 8‑K, press releases, and the 10‑Q .
• As a result, no analyst Q&A themes, guidance clarifications, or tone analysis can be provided for the quarter.

Estimates Context

• EPS beat: ANVS reported -$0.37 vs. consensus -$0.3767 for Q3 2025; revenue expected/actual $0 given clinical-stage status (3 estimates). Expect limited estimate revisions absent material cost or timing changes; focus likely on opex trajectory and trial-timing risk. Values retrieved from S&P Global.
• Given rising R&D as the trial scales, consensus EPS for coming quarters may drift lower absent incremental financing cost changes or warrant fair‑value swings.

Key Takeaways for Investors

• Execution is the story: full Phase 3 AD site activation and ~25% trial completion de‑risk operational timelines ahead of the 2H 2026 symptomatic readout .
• Biomarker narrative strengthens disease‑modifying thesis and may catalyze partnering/interest ahead of CTAD and Phase 3 readouts .
• Liquidity requires nuance: October raises added cash, but the 10‑Q’s going‑concern disclosure signals the runway to Q3 2026 is contingent on continued access to capital; expect further dilution via ATM or registered offerings .
• Opex will stay elevated: R&D growth reflects patient treatments and bioanalytical work; monitor quarterly burn and vendor accruals for trial cost cadence .
• Governance/controls improved with CFO hire, useful for future financings and potential BD transactions as clinical milestones approach .
• Near‑term trading catalysts: CTAD biomarker presentation (Dec 2025), continued enrollment/completion updates, and any partnering/licensing signals; financing headlines remain a swing factor .
• Medium‑term thesis: binary into 2026 symptomatic readout; if positive, NDA path (short‑term efficacy) per FDA alignment could emerge, with disease‑modifying claims assessed at 18 months .