Executive Summary

Q4 2024 delivered materially lower year-over-year net loss per share ($0.43 vs $2.24) driven by reduced R&D spend and a favorable change in warrant fair value; sequentially, EPS improved vs Q3 ($0.97) despite higher operating expenses .
EPS missed Wall Street consensus by $0.10 (actual -$0.43 vs -$0.33), with revenue expected at $0 given the company’s pre-commercial stage; estimates coverage was light (4 EPS, 5 revenue estimates) *.
Regulatory momentum was strong: FDA cleared the pivotal Phase 3 program in early AD (Oct 2024), and the Phase 3 trial launched in February 2025; symptomatic readout mid-2026 and disease-modifying readout mid-2027 target NDA filings .
Liquidity strengthened post the $21.0M offering; cash was $10.6M at year-end with runway guided into Q4 2025 and shares outstanding rising to 19.5M post offering—reducing near-term financing overhang but dilutive near term .

What Went Well and What Went Wrong

What Went Well

FDA granted clearance to proceed to a pivotal Phase 3 program in early AD, validating the Phase 2/3 signal and enabling a path to NDA filings for both symptomatic and disease-modifying effects .
Phase 3 AD trial launched in February 2025; management set clear timelines for 6-month symptomatic data (mid-2026) and 12-month disease-modifying data (mid-2027), establishing near- and medium-term catalysts .
Management tone conveyed momentum and confidence: “The last year was filled with extraordinary achievements... As we move ahead, our focus remains on generating robust data for buntanetap” — Maria Maccecchini, Ph.D., CEO .

What Went Wrong

EPS missed consensus by ~$0.10 (actual -$0.43 vs -$0.33), reflecting continued operating losses in a pre-revenue profile and limited sell-side coverage depth *.
Sequential operating expenses rose to $6.73M vs $4.39M in Q3 as programs advanced, partially offset by positive other income items (interest income $126k; warrants +$727k) .
Ongoing dilution: shares increased from 14.1M at 12/31/24 to 19.5M post-offering to fund operations, dampening per-share metrics even as cash runway improved .

Financial Results

Core P&L and Liquidity (USD Millions except per-share), oldest → newest

Metric	Q2 2024	Q3 2024	Q4 2024
Research & Development ($)	$5.80	$2.70	$5.00
General & Administrative ($)	$2.00	$1.70	$1.74
Total Operating Expenses ($)	$7.80	$4.40	$6.73
Operating Loss ($)	—	—	$(6.73)
Interest Income ($)	—	—	$0.13
Change in Fair Value of Warrants ($)	—	—	$0.73
Net Loss ($)	—	—	$(5.86)
Basic & Diluted EPS ($)	$(0.44)	$(0.97)	$(0.43)
Cash & Cash Equivalents ($)	$4.00	$12.64*	$10.55

Values with an asterisk were retrieved from S&P Global.

Notes:

Q3 cash balance shown using S&P Global fundamentals due to lack of quarter-end balance detail in press materials; Q3 press referenced $13.6M as of Nov 8, 2024 (post-quarter) indicating strengthened liquidity heading into Q1 2025 trial initiation .

Estimates vs Actuals (Q4 2024)

Metric	Consensus	Actual
EPS ($)	$(0.33)*	$(0.43)
Revenue ($)	$0.00*	— (no revenue reported)

Values with an asterisk were retrieved from S&P Global.
Coverage: 4 EPS estimates; 5 revenue estimates (consensus assumed zero given pre-commercial stage)*.

Highlights:

EPS miss: actual $(0.43) vs $(0.33) consensus → miss of $(0.10)* .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
AD Phase 3 Start	Q1 2025	“Expected to begin in Q1 2025”	“Launched in February 2025”	Initiated
AD Phase 3 Symptomatic Readout	Mid-2026	—	“6-month symptomatic data mid-2026” supporting NDA	New guidance
AD Disease-Modifying Readout	Mid-2027	—	“12-month disease-modifying data mid-2027” supporting NDA	New guidance
Cash Runway	Through Q4 2025	“Adequate runway for Phase 3 prep and entry”	“Runway into Q4 2025” (incl. $21M offering)	Extended/clarified
Shares Outstanding	Post-offering	11.7M as of 6/30/24	19.5M after offering	Increased (dilutive)

Earnings Call Themes & Trends

Note: No formal Q4 2024 earnings call transcript located. Narrative derived from sequential corporate press updates.

Topic	Q2 2024 (Previous Mentions)	Q3 2024 (Previous Mentions)	Q4 2024 (Current Period)	Trend
Regulatory milestones (FDA)	New crystal form cleared to continue Phase 3 development	FDA End-of-Phase 2 meeting successful; clearance to proceed to Phase 3 in early AD	Execution of Phase 3 launch; timelines set for readouts	Positive acceleration
Clinical data (AD/PD)	AD Phase 2/3 and PD Phase 3 showed cognition and motor improvements	Continued emphasis on AD subgroup efficacy and biomarker narrative	Reinforcement of AD/PD signals; Phase 3 aim to confirm symptomatic and disease-modifying effects	Strengthening
Funding/liquidity	ELOC and warrants strengthened cash; $12.1M as of 8/14	$13.6M cash as of 11/8; adequate runway for Phase 3 start	$21M offering completed; cash $10.6M at YE; runway guided to Q4 2025	Improved runway, dilution
IP/patents	New composition of matter patent; manufacturing provisional patent	Three new combo therapy patents filed	Continued portfolio build; scientific conference presence	Ongoing build
Manufacturing/formulation	Transition to new crystal form approved	FDA confirmed development can proceed with new crystal form	Crystal form embedded in Phase 3 program	Stable/validated

Management Commentary

“The last year was filled with extraordinary achievements for our company, and we are pleased with our continued momentum into 2025… our focus remains on generating robust data for buntanetap and advancing its path to the patients who need it most.” — Maria Maccecchini, Ph.D., CEO .
“The FDA gave us the green light to initiate confirmatory Phase 3 studies for early AD, and our team has been working hard to begin them in the coming year.” — Maria Maccecchini, Ph.D. .
“We've completed pivotal Phase 2/3 Alzheimer's and Phase 3 Parkinson's studies, both of which revealed very encouraging data for buntanetap.” — Maria Maccecchini, Ph.D. .

Q&A Highlights

No Q4 2024 earnings call transcript available in our document catalog; Annovis scheduled a live investor webcast on Dec 11, 2024 with Q&A, indicating strong inbound interest and willingness to engage on trial design, timelines, and funding strategy .
Guidance clarifications primarily came through press materials, including Phase 3 initiation and readout timing .

Estimates Context

EPS: Actual -$0.43 vs consensus -$0.33 → miss of $(0.10); low estimate count (n=4) underscores limited coverage typical for pre-commercial biotech*.
Revenue: Consensus $0.00 with n=5; company reported no revenue in press materials, consistent with pre-commercial status*.
Values retrieved from S&P Global. Actual EPS from company financials .

Key Takeaways for Investors

Phase 3 AD program now de-risked on regulatory pathway with clear timelines to two potential NDAs (symptomatic mid-2026; disease-modifying mid-2027) — key medium-term value inflection points .
Near-term trading catalyst is the enrollment/execution pace in the Phase 3 AD trial launched Feb 2025; watch trial site activation and any interim operational updates .
Liquidity improved with YE cash of $10.6M and $21M offering; runway guided into Q4 2025 mitigates near-term financing risk but increases share count to 19.5M post offering .
Q4 EPS miss versus consensus reflects pre-revenue status and operating intensity; sequential EPS improvement vs Q3 indicates beneficial non-operational items (warrant fair value, interest) alongside expense control .
Continued IP expansion and adoption of the new crystal form support manufacturing robustness and potential differentiation at scale .
Maintain focus on regulatory news flow (protocol amendments, site activation) and any biomarker updates that further validate disease-modifying potential — likely to drive narrative and multiple expansion .

Annovis Bio, Inc. (ANVS)·Q4 2024 Earnings Summary