Executive Summary

Q4 2024 EPS of $-0.15 beat Wall Street consensus of $-0.215 by $0.065; revenue remained at $0 as RVPH is pre-commercial. Cost discipline (lower operating expenses in Q4) contributed to the EPS beat relative to expectations.*
Key timelines slipped: full OLE dataset moved from Q1 2025 to Q2 2025, RECOVER-2 initiation shifted from Q1 2025 to mid-2025 (subject to financing), and NDA target moved from Q2 2026 to Q4 2026 .
Clinical signals remained favorable in the OLE: pooled PANSS total decreased 18.6 points over 1 year (71.6 → 53), with dose-dependent efficacy and low TRAE rates (15.2%) .
Financing actions: $18.0M gross proceeds in a December follow-on bolstered cash to $13.5M at year-end, while management noted an additional ~$50M is needed to complete NDA and extend runway .
Near-term stock catalysts include OLE full dataset in Q2 2025 and RECOVER-2 initiation mid-2025 (financing-dependent), against a backdrop of strong negative-symptom efficacy and supportive biomarker readouts .

What Went Well and What Went Wrong

What Went Well

Sustained, broad-spectrum efficacy and favorable safety in OLE: pooled PANSS total decreased 18.6 points over 1 year; positive and negative symptoms improved, with no drug-related SAEs .
Dose-dependent efficacy over 52 weeks: PANSS total score declines of -15.2, -18.6, and -20.8 at 15/30/50 mg doses, respectively .
Financing progress: completed a public follow-on offering for ~$18.0M in December 2024, strengthening liquidity ahead of registrational work .
Management tone: “Brilaroxazine has a robust data package… we are targeting a potential New Drug Application (NDA) submission… in the fourth quarter of 2026” — Laxminarayan Bhat, Ph.D., CEO .

What Went Wrong

Timelines drifted: OLE full dataset moved to Q2 2025 (from Q1 2025), RECOVER-2 initiation to mid-2025 (from Q1 2025), NDA target to Q4 2026 (from Q2 2026), adding execution/macro-financing risk .
Dependence on financing: RECOVER-2 initiation explicitly “subject to receipt of additional financing,” raising delivery risk on pivotal timelines .
Cash down vs prior year despite year-end raise: year-end cash was $13.5M vs $23.4M prior year, reflecting sustained development spend; management indicated ~$50M additional capital need to complete NDA .

Financial Results

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD)	$0*	$0*	$0*	$0*
Net Loss ($USD)	$(9,355,264)*	$(7,859,919)	$(8,365,798)	$(6,259,477)*
Diluted EPS ($USD)	$(0.3436)*	$(0.26)	$(0.25)	$(0.1634)*
Total Operating Expenses ($USD)	$9,619,346*	$8,129,643	$8,462,534	$6,284,606*
Cash and Equivalents (period-end) ($USD)	$23,367,456	$6,178,180	$5,558,817	$13,476,331

Notes:

Revenue is $0 given pre-commercial status; company statements of operations present operating expenses and loss without product revenue lines .
Asterisks (*) indicate values retrieved from S&P Global.

Estimate comparison (Q4 2024):

EPS: Actual $-0.15 vs Consensus $-0.215 (beat by $0.065).*
Revenue: Consensus $0; Actual $0.*

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
OLE full dataset (RECOVER)	Data timing	Q1 2025	Q2 2025	Lowered/Delayed
RECOVER-2 initiation (registrational)	Start timing	Q1 2025	Mid-2025; subject to financing	Lowered/Delayed; Financing-dependent
NDA submission (schizophrenia)	Filing target	Q2 2026	Q4 2026	Lowered/Delayed
Psoriasis IND (lipo-gel formulation)	Filing target	2025	Later in 2025	Maintained (timing clarified)
Financing	Capital raise	N/A	Completed $18.0M gross proceeds in Dec-2024	New event

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2024)	Trend
R&D execution (OLE enrollment/progress)	424 enrolled; progressing across geographies; aiming for ≥100 patients with 12-month safety by Q4 2024	Preliminary topline OLE data positive; long-term safety/efficacy sustained; full dataset in Q2 2025	Positive clinical momentum; timing slipped
Digital/vocal biomarkers	Planned; vocal latency highlighted in KOL event (Sep 2024)	Full OLE dataset to include vocal and blood biomarkers in Q2 2025	Increasing emphasis; broader validation
Regulatory alignment	FDA alignment on registrational program and post-approval randomized withdrawal	Registrational RECOVER-2 expected mid-2025 (financing-dependent)	Continued alignment; schedule dependent on financing
Financing/liquidity	Cash ~$6.2M (Q2); need ongoing funding	$18.0M follow-on completed; year-end cash ~$13.5M; mgmt indicates ~$50M needed to complete NDA	Improved liquidity; still funding gap
Product performance (negative symptoms)	Strong negative-symptom efficacy; vocal biomarker supports effect	Sustained efficacy in OLE across doses; pooled PANSS total ↓18.6 points	Reinforced efficacy durability

Management Commentary

“Our late stage brilaroxazine program has consistently shown… robust broad-spectrum efficacy across all major symptom domains of schizophrenia and a well-tolerated safety profile… We… expect to report the full data set from the RECOVER OLE study… in the second quarter of 2025… targeting a potential NDA submission… in the fourth quarter of 2026.” — Laxminarayan Bhat, Ph.D., CEO .
“Initiation of registrational Phase 3 RECOVER-2… expected in mid-2025, subject to receipt of additional financing” .
“Positive topline data… presented… at SIRS… Completed a public follow-on offering… ~$18.0M” .

Q&A Highlights

Trial operations: ~90–95% of RECOVER-1 sites will be re-engaged for RECOVER-2; protocol largely identical, with 30 mg replacing 15 mg as the low dose — supporting confidence in replication .
Mechanistic differentiation: Emphasis on balanced dopamine/serotonin modulation vs muscarinic approaches; consistent negative-symptom efficacy across Phase 2/3 and biomarker support .
Financing strategy: December raise of $18M; management estimates an additional ~$50M needed to complete NDA and maintain runway .
Biomarkers: Vocal biomarker enrichment showed larger treatment effects in high negative-symptom subgroups; OLE full dataset expected to include vocal/blood biomarkers .

Estimates Context

Q4 2024 EPS actual $-0.15 vs consensus $-0.215 (beat) and 6 estimates; revenue consensus $0 with 6 estimates.*
Estimates may adjust modestly for 2025 on operating expense cadence and timing of RECOVER-2 initiation; financing dependency could introduce variability in quarterly opex run-rate.

Note: Values marked with an asterisk (*) were retrieved from S&P Global.

KPIs (Clinical Efficacy and Safety — OLE)

KPI	Value	Source
PANSS Total change (15 mg)	-15.2 points (baseline → 52 weeks)
PANSS Total change (30 mg)	-18.6 points (baseline → 52 weeks)
PANSS Total change (50 mg)	-20.8 points (baseline → 52 weeks)
PANSS Total pooled (N=113)	-18.6 points (71.6 → 53), p ≤ 0.0001
PANSS Positive symptoms	-5.2 points, p ≤ 0.0001
PANSS Negative symptoms	-4.5 points, p ≤ 0.0001
Discontinuation rate	35% (consent withdrawal 22%, lost to follow-up 7%, TRAE 1.6%)
TRAE incidence	15.2% (mostly mild/moderate); common: weight ↑ 3.2%, insomnia 1.8%, somnolence 1.6%
Drug-related SAEs	None observed over 1 year

Additional Financial Detail (Quarterly)

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
R&D Expense ($USD)	N/A	$5,584,347	$6,858,285	N/A*
G&A Expense ($USD)	N/A	$2,545,296	$1,604,249	N/A*
Year-end cash (2024)	—	—	—	$13,476,331

Note: Year-level 2024 R&D $22,907,368 and G&A $7,891,521; net loss $29,918,802 ($0.90/share) .

Key Takeaways for Investors

The quarter delivered an EPS beat versus consensus, driven by lower operating expenses and no revenue; the absence of commercial revenue keeps valuation tied to clinical and regulatory milestones.*
Strong and durable efficacy/safety signals in OLE, especially on negative symptoms, underpin differentiation and support maintenance-of-effect post-approval strategy .
Timeline slippage across OLE readout, RECOVER-2 initiation, and NDA target increases execution sensitivity; watch for financing updates to de-risk schedules .
Liquidity improved with the December raise but management’s ~$50M additional capital need remains a gating factor for RECOVER-2 and NDA .
Near-term catalysts: Full OLE dataset (Q2 2025), RECOVER-2 start (mid-2025); positive data and on-time starts are likely stock movers .
Biomarker strategy (vocal/blood) could strengthen regulatory narrative and payer/physician adoption if consistency is shown in OLE and RECOVER-2 .
Medium-term thesis: If RECOVER-2 replicates efficacy and negative-symptom benefit with favorable tolerability, RVPH could position brilaroxazine competitively vs recent entrants, pending timely execution and adequate financing .

Disclosures on Source Documents and Availability

Q4 2024 press release and accompanying 8-K furnished the year-end financials and business highlights .
Prior two quarters’ results and program updates are from Q3 and Q2 2024 press releases and 8-Ks .
No Q4 2024 earnings call transcript was found; analysis incorporates management commentary from the Oppenheimer conference transcript (Feb 12, 2025) .
Estimates and certain quarterly metrics marked with an asterisk (*) were retrieved from S&P Global.

REVIVA PHARMACEUTICALS HOLDINGS, INC. (RVPH)·Q4 2024 Earnings Summary