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Annovis Bio, Inc. (ANVS)·Q1 2025 Earnings Summary

Executive Summary

  • Annovis initiated its pivotal Phase 3 Alzheimer’s trial in early AD and entered first patients on Feb 5, 2025; Q1 focused on site activation and enrollment progress . Cash and equivalents rose to $22.2M at March 31, 2025, aided by a $21M February equity offering, strengthening near-term funding for the 6‑month portion of the study .
  • Q1 2025 EPS was -$0.32 vs S&P Global consensus of -$0.38*, a beat driven by lower R&D versus prior year and modest warrant fair value gains; no product revenue was reported . Revenue consensus was $0.0*, in line with the company’s development-stage status.
  • YoY, operating expenses declined (R&D $5.0M vs $6.5M), but net loss widened (-$5.5M vs -$1.1M) due to a much smaller non-cash warrant fair value gain than in Q1 2024 ($0.6M vs $6.7M) .
  • Risk watch: On Mar 26 the NYSE notified ANVS it was below market cap/equity listing standards; management will submit and execute a remediation plan; symbol tagged “.BC” until compliance regained .

Values retrieved from S&P Global.*

What Went Well and What Went Wrong

What Went Well

  • Phase 3 AD program execution: First patients entered in February; trial designed for a 6‑month symptomatic readout and 18‑month disease‑modifying follow‑up within a single protocol (target ~760 participants) .
  • Strengthened liquidity: Closed a $21M offering (5.25M shares and 5.25M warrants) to fund the 6‑month Phase 3 portion; cash increased to $22.2M at 3/31/25 from $10.6M at 12/31/24 .
  • Cost control momentum: R&D down to $5.0M from $6.5M YoY; G&A flat YoY at $1.3M, reflecting disciplined spend into Phase 3 .
    • “We are advancing as planned with our pivotal Phase 3 Alzheimer’s study, making steady progress every day.” — Melissa Gaines, SVP Clinical Operations .
    • “Our mission remains clear: to deliver a potentially life‑changing treatment to patients as soon as possible.” — Maria Maccecchini, Ph.D., CEO .

What Went Wrong

  • Net loss widened YoY (-$5.5M vs -$1.1M) despite lower OpEx, primarily because the non‑cash warrant fair value gain was much smaller ($0.6M in Q1’25 vs $6.7M in Q1’24) .
  • Continued dependence on external capital: Company noted the 12‑month Phase 3 portion is expected to require additional funding (anticipated from warrant exercises), underscoring financing risk .
  • Listing compliance risk: NYSE notified the company it is below Section 802.01B criteria (30‑day avg market cap ~$37.9M and equity $9.3M as of 12/31/24); plan under review; symbol carries “.BC” designation .

Financial Results

P&L and EPS

MetricQ1 2024Q4 2024Q1 2025
Revenue ($USD)$0.00 (no revenue reported) $0.00 (no revenue reported) $0.00 (no revenue reported)
R&D Expense ($USD)$6.51M $5.00M $5.01M
G&A Expense ($USD)$1.29M $1.74M $1.27M
Total Operating Expenses ($USD)$7.81M $6.73M $6.28M
Operating Loss ($USD)-$7.81M -$6.73M -$6.28M
Other Income, net ($USD)$6.74M $0.87M $0.75M
Net Loss ($USD)-$1.07M -$5.86M -$5.54M
EPS (Basic)-$0.10 -$0.43 -$0.32
EPS (Diluted)-$0.72 -$0.43 -$0.32
MarginsN/A (no revenue) N/A (no revenue) N/A (no revenue)

Balance Sheet / Shares

MetricQ1 2024Q4 2024Q1 2025
Cash & Cash Equivalents ($USD)$10.55M (as of 3/31/24) $10.55M (as of 12/31/24) $22.24M (as of 3/31/25)
Shares Outstanding (Common)N/A14.14M (12/31/24) 19.49M (3/31/25)

Consensus vs Actual (Q1 2025)

MetricConsensusActual
EPS (Primary)-$0.38*-$0.32
Revenue ($USD)$0.0*$0.00

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 3 AD symptomatic data timing6‑month readoutMid‑2026 anticipated (as of Q4 2024) Mid‑2026 reiterated (single 6/18‑month protocol accepted Jan 7) Maintained
Phase 3 AD disease‑modifying data timing18‑month readoutMid‑2027 anticipated (as of Q4 2024) Mid‑2027 reiterated Maintained
Cash runwayFY 2025Into Q4 2025 incl. Feb $21M financing (as of Q4 PR) Not updated in Q1 PR; cash increased to $22.2M at 3/31/25 Maintained/implicit
Financial guidance (rev/margins/OpEx)FY 2025None providedNone providedMaintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available in our source set.

TopicPrevious Mentions (Q3 & Q4 2024)Current Period (Q1 2025)Trend
Regulatory path / trial designFDA EOP2 and clearance for pivotal studies; two trials (6m symptomatic, 18m disease‑modifying) planned FDA accepted consolidated single 6/18‑month protocol; trial launched and first patients entered Improving (design streamlined; execution underway)
Phase 3 enrollment / executionPreparatory work and site readiness for Q1 2025 start Site activation, enrollment commenced; target ~760 participants across ~100 U.S. sites Improving
Funding strategyELOC and warrant exercises boosted liquidity in 2H24 $21M offering closed; cash rose to $22.2M; 12‑month phase expected to need additional capital (warrants) Improving near‑term; residual medium‑term need
Competitive/macro AD landscapeLecanemab approvals shaping market; anti‑amyloid class dynamics (context) Continued context: LEQEMBI uptake, maintenance dosing approval; underscores need for alternative mechanisms like buntanetap Stable/Competitive
Listing/complianceNot highlighted in Q3 NYSE notice for below‑criteria status; remediation plan to be submitted; “.BC” marker applied Deteriorating (technical listing risk)

Management Commentary

  • “We are advancing as planned with our pivotal Phase 3 Alzheimer’s study, making steady progress every day.” — Melissa Gaines, SVP Clinical Operations .
  • “In these times of great uncertainty, we are choosing resilience and discipline... Our mission remains clear: to deliver a potentially life‑changing treatment to patients as soon as possible.” — Maria Maccecchini, Ph.D., Founder & CEO .
  • “The launch of our highly anticipated AD study is a significant milestone... designed to evaluate both the symptomatic and potential disease‑modifying effects of our drug candidate.” — Maria Maccecchini, Ph.D. (Phase 3 initiation release) .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; therefore, no Q&A themes or guidance clarifications could be assessed from a call in this period.

Estimates Context

  • Q1 2025 EPS: -$0.32 actual vs -$0.38* consensus; beat by ~$0.06. Three estimates contributed to the EPS consensus.*
  • Q1 2025 Revenue: $0.00 actual vs $0.0* consensus, in line with development-stage status.*
  • Implication: Given lower OpEx YoY and ongoing site ramp, near‑term EPS estimates may remain sensitive to trial execution pace and non‑cash warrant valuation movements rather than revenue drivers.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Clinical execution is on track: Phase 3 AD trial launched with an integrated 6/18‑month design, enabling a mid‑2026 symptomatic readout and mid‑2027 disease‑modifying readout — the primary stock catalysts over the next 18–24 months .
  • Liquidity improved: The February financing and Q1 cash balance provide runway through the 6‑month portion; watch warrant exercises and potential additional capital needs for the 12‑month phase .
  • Expense discipline continues: R&D fell 23% YoY in Q1 ($5.0M vs $6.5M), supporting a modest EPS beat versus consensus, though losses remain driven by OpEx and non‑cash items . Values retrieved from S&P Global.*
  • Technical risk: NYSE below‑criteria notice introduces listing risk; plan submission and acceptance are key; the “.BC” designation persists until compliance is regained .
  • Competitive backdrop intensifies: Anti‑amyloid therapies (e.g., LEQEMBI) continue to scale; buntanetap’s differentiated mechanism (translation inhibition of aggregating proteins) aims at symptomatic and potential disease‑modifying benefit — Phase 3 outcomes will determine positioning .
  • Watch execution KPIs: Site activation/enrollment velocity, retention, protocol adherence, and any interim operational updates from management will be critical leading indicators before the 6‑month data .
  • IP/portfolio optionality: New U.S. patent on acute brain/nerve injuries broadens potential indications, although current focus remains AD/PD .

Appendix: Additional Context (Selected Press Releases in Q1 2025)

  • FDA accepted final protocol for the pivotal Phase 3 AD study (single 6/18‑month design) — Jan 7, 2025 .
  • U.S. patent granted for buntanetap in acute brain/nerve injuries — Jan 14, 2025 .
  • $21M offering priced and closed — Feb 3–4, 2025 .
  • First patients entered Phase 3 AD study — Feb 5, 2025 .
  • NYSE below‑criteria notice — Mar 27, 2025 .

All other financial and operational data points are cited above from the company’s Q1 2025 press release and associated 8‑K exhibit , Q4 2024 press release , and Q3 2024 press release .