Executive Summary

Annovis reported Q2 2025 net loss per share of $0.32, better than Wall Street consensus by ~$0.08 (actual -$0.32 vs. consensus -$0.40*) and an improvement vs. Q2 2024 (-$0.44) .
Clinical execution advanced: 76 U.S. sites secured (46 actively enrolling), 38 patients dosed, and nearly 200 patients in screening with ~50% screen failure rate, underscoring momentum in the pivotal Phase 3 AD program .
Balance sheet remained adequate for near-term operations: cash was $17.1M at 6/30/2025 (down from $22.2M at 3/31/2025; up from $10.6M at 12/31/2024); the company previously guided cash runway into Q4 2025 post offering .
Key catalysts: Phase 3 AD enrollment updates and AAIC data flow; IP strengthened via full transfer of all patent families to the new crystal form of buntanetap (coverage extends to 2046); NYSE accepted plan to regain listing compliance—monitor plan execution and enrollment pace as stock drivers .

What Went Well and What Went Wrong

What Went Well

Accelerating pivotal AD trial execution: “76 secured clinical sites… 46 currently enrolling… 38 patients already receiving buntanetap or placebo and nearly 200 more in screening,” providing tangible proof points on trial momentum .
IP defensibility improved: all patent families transferred to crystal buntanetap, providing comprehensive global coverage for both original and new forms with protection through 2046 .
Operating discipline: R&D ($5.2M) and G&A ($1.1M) declined y/y, and EPS loss narrowed to $0.32 from $0.44 y/y, reflecting lower OpEx and higher interest income .

What Went Wrong

Cash declined sequentially ($22.2M → $17.1M) as clinical spend continued; while still adequate near term, liquidity remains a watch item until additional financing or partnerships materialize .
Ongoing listing standard pressure: NYSE accepted the company’s plan to regain compliance; execution against the plan and market cap recovery are critical .
Still pre-revenue and loss-making ($6.22M net loss in Q2), with inherent biotech development risks and timeline to pivotal readouts (symptomatic mid-2026; disease-modifying mid-2027) .

Financial Results

Income Statement and EPS (oldest → newest)

Metric	Q2 2024	Q1 2025	Q2 2025
Revenue ($USD Millions)	$0.00	$0.00	$0.00
R&D Expense ($USD Millions)	$5.79	$5.01	$5.16
G&A Expense ($USD Millions)	$1.98	$1.27	$1.11
Total Operating Expenses ($USD Millions)	$7.76	$6.28	$6.27
Operating Loss ($USD Millions)	$(7.76)	$(6.28)	$(6.27)
Net Loss ($USD Millions)	$(5.02)	$(5.54)	$(6.22)
EPS (Basic & Diluted)	$(0.44)	$(0.32)	$(0.32)

Notes: Statements of operations do not present revenue lines, consistent with pre-revenue status .

Cash and Shares

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash & Cash Equivalents ($USD Millions)	$10.55	$22.24	$17.13
Shares Outstanding (Millions)	14.14	19.49	19.49

Results vs S&P Global Consensus (oldest → newest)

Metric	Q1 2025 Actual	Q1 2025 Consensus*	Q2 2025 Actual	Q2 2025 Consensus*
EPS (USD)	$(0.32)	$(0.377)*	$(0.32)	$(0.403)*
Revenue (USD)	$0	$0*	$0	$0*

Values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
AD Phase 3 symptomatic readout timing	Program	Mid-2026 targeted	Reaffirmed; enrollment accelerating (sites/patients disclosed)	Maintained (timeline); operational progress updated
AD Phase 3 disease-modifying readout timing	Program	Mid-2027 targeted	Reaffirmed directional timeline	Maintained
Cash runway	FY 2025	“Into Q4 2025” post-$21M offering	No update provided in Q2 release	Maintained/Not updated
Enrollment footprint	Q1 → Q2 2025	Trial launched; sites activating (no counts)	76 sites secured; 46 enrolling	Raised (operational)
Patients dosed / in screening	Q1 → Q2 2025	Not disclosed	38 dosed; ~200 in screening; ~50% screen failure	New disclosure

No revenue, margin, or EPS financial guidance was provided in company communications reviewed .

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available in our source set; themes are drawn from the company’s Q4 2024, Q1 2025, and Q2 2025 press releases.

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
R&D execution (AD)	FDA cleared pivotal AD; trial launched early 2025; symptomatic mid-2026, disease-modifying mid-2027	76 sites secured; 46 enrolling; 38 dosed; ~200 screening; ~50% screen failure	Improving execution; enrollment scaling
Regulatory/IP	Expanded patent portfolio; scientific presence at CTAD, DLB workshop	Completed transfer of all patent families to crystal form; global coverage to 2046	Stronger IP moat
Financing/Listing	Cash runway into Q4 2025 post-offering	NYSE accepted plan to regain compliance (18-month period)	Compliance plan in place; monitor execution
External visibility	Conferences/webcasts (Oppenheimer; AD/PD; shareholder webcast)	AAIC 2025 with four posters; June Phase 3 update webcast	Increased scientific engagement
Parkinson’s program	Phase 3 PD completed with promising results	Management reiterates advancing PD program	Ongoing, secondary to AD focus

Management Commentary

“Our efforts were centered on driving enrollment for the pivotal Phase 3 trial in early AD… 76 secured clinical sites… over 400 patients screened… we reached other notable milestones, including… completing the transfer of all patent families to crystal buntanetap.” — Maria Maccecchini, Ph.D., President & CEO .
“With full IP protection now in place for both forms of buntanetap, we are well-positioned to continue its development and fully explore its therapeutic potential… opens doors to possible pipeline expansions and broader clinical applications.” — Maria Maccecchini, Ph.D., President & CEO .
“We look forward to providing continued updates on the current trial and other initiatives we have planned for this year.” — Melissa Gaines, SVP, Clinical Operations (Q1 update) .

Q&A Highlights

No public Q2 2025 earnings call transcript was available in our document set; therefore, no Q&A details or guidance clarifications could be extracted from a call transcript. Company communications for the quarter consisted of press releases and corporate updates .

Estimates Context

EPS beat: Q2 2025 EPS of $(0.32) vs. S&P Global consensus of $(0.403), a ~$0.08 beat; Q1 2025 also beat $(0.32) vs. $(0.377)*. Actuals from company filings, estimates from S&P Global .
Revenue: Pre-revenue profile consistent with consensus at $0 for Q1 and Q2 2025*.
Implications: With no revenue and net losses ongoing, estimate revisions hinge on OpEx cadence and enrollment milestones. Faster enrollment can de-risk timelines and modestly lower per-patient overhead assumptions, but financing path and listing compliance can influence cost-of-capital assumptions in models .

Values retrieved from S&P Global.

KPIs and Operational Metrics

KPI	Q1 2025	Q2 2025
AD Phase 3 sites secured	Not disclosed; trial launched and sites activating	76 secured
Active enrolling sites	Not disclosed	46 enrolling
Patients dosed	Not disclosed	38 dosed
Patients in screening	Not disclosed	~200 in screening
Screen failure rate	Not disclosed	~50%

Additional Relevant Disclosures (Q2 2025 window)

AAIC 2025 participation with four posters (trial design; dual 6/18-month paradigm; PK characterization of semi-crystalline vs. crystalline buntanetap) .
NYSE acceptance of plan to regain listing compliance; 18-month plan period from March 26, 2025 notice .
Patent portfolio: completed transfer to crystal buntanetap; global coverage to 2046 .

Key Takeaways for Investors

Execution momentum: Enrollment metrics (sites, dosing, screening) point to tangible progress that can de-risk the mid-2026 symptomatic readout path if sustained .
IP moat improved: Completed patent transfers to the crystal form with protection through 2046 strengthens long-term option value and partnering discussions .
Financials stable but watched: Sequential cash draw from $22.2M to $17.1M reflects steady OpEx; prior guidance pointed to runway into Q4 2025—monitor financing/BD catalysts .
Listing overhang: NYSE accepted the remediation plan; continued compliance milestones are important for investor confidence and liquidity .
EPS beats despite pre-revenue status: Q2 and Q1 2025 both beat S&P Global consensus on EPS*, aided by disciplined OpEx and interest income; estimate paths remain mostly a function of OpEx and trial cadence .
Near-term catalysts: enrollment updates, AAIC visibility, and any regulatory/BD updates could move sentiment and the stock .
Risk posture: Binary clinical readouts (symptomatic mid-2026; disease-modifying mid-2027) and financing needs dominate risk/reward—position sizing should reflect clinical and capital market risks .

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Sources:

Q2 2025 8-K and press release, including financial statements and clinical updates
Q1 2025 8-K and press release
Q4/FY 2024 8-K and press release
NYSE plan acceptance press release
Patent transfer press release
AAIC 2025 posters press release

Estimates: Values retrieved from S&P Global.*

Annovis Bio, Inc. (ANVS)·Q2 2025 Earnings Summary