Executive Summary

Q2 2025 revenue was $0.623M, driven by $0.500M license revenue and $0.123M TLANDO royalties; diluted EPS was ($0.41), and operating loss was ($2.40M). Royalty revenue rose year-over-year and OpEx fell versus Q2 2024 on lower G&A .
Results vs consensus: revenue beat ($0.623M vs $0.229M estimate*) on one-time license recognition, while EPS was roughly inline (actual ($0.41) vs ($0.40) estimate*). Expect models to adjust for episodic license revenue in Q2 .
Clinical execution advanced: first patient dosed in Phase 3 LPCN 1154 in PPD (outpatient, 48-hour regimen); topline expected Q2 2026; FDA feedback supports single Phase 3 for 505(b)(2) NDA submission .
Liquidity: unrestricted cash, cash equivalents and marketable securities totaled $17.9M at Q2-end, down from $21.6M at FY-end; management reiterated trial is fully funded and burn ~ $3M/quarter .
Stock reaction catalysts: Phase 3 execution milestones (DSMB safety review 4Q25), further TLANDO geographic expansion, and potential 2401 PoC initiation in 3Q25; Q2 revenue beat owed to license timing, not durable commercial traction .

What Went Well and What Went Wrong

What Went Well

Phase 3 LPCN 1154 initiated with first patient dosed; FDA feedback indicates a single Phase 3 could be sufficient for NDA, reinforcing an expedited regulatory path. “FDA voluntarily recommended us to do a single phase III study…along with dosing confirmation study…should suffice for the NDA submission.” .
Revenue composition quality improved quarter-over-quarter: recognition of $0.500M license revenue and YoY growth in TLANDO royalties ($122,849 vs $89,565), enabling better operating leverage versus Q2 2024 .
G&A discipline: Q2 G&A declined to $0.89M from $1.51M YoY, driven by lower business development, consulting, legal, Delaware franchise tax post authorized share reduction, and lower insurance premiums .

What Went Wrong

Core revenue base remains modest without recurring product sales; Q2 total revenue benefited from one-time license recognition ($0.500M), which can add volatility to quarterly prints .
R&D rose YoY to $2.14M with initiation of LPCN 2401 clinical studies and broader program costs; operating loss remained elevated at ($2.40M) .
Cash and marketable securities declined to $17.9M from $21.6M at year-end, reflecting funding of pipeline progression ahead of Phase 3 readout in Q2 2026 .

Financial Results

P&L and Operating Metrics (Quarterly)

Metric	Q2 2024	Q1 2025	Q2 2025
Total Revenues ($USD)	$89,565	$93,864	$622,849
License Revenue ($USD)	$0	$0	$500,000
Royalty Revenue ($USD)	$89,565	$93,864	$122,849
Research & Development ($USD)	$1,874,721	$1,061,571	$2,136,769
General & Administrative ($USD)	$1,507,412	$1,122,477	$890,433
Total Operating Expenses ($USD)	$3,382,133	$2,184,048	$3,027,202
Operating Income (Loss) ($USD)	($3,292,568)	($2,090,184)	($2,404,353)
Net Income (Loss) ($USD)	($3,068,634)	($1,864,873)	($2,205,716)
Diluted EPS ($USD)	($0.56)	($0.35)	($0.41)

Estimates vs Actuals (S&P Global consensus)

Metric	Q1 2025	Q2 2025
Revenue Actual ($USD)	$93,864	$622,849
Revenue Consensus Mean ($USD)	$352,000*	$229,000*
Primary EPS Actual ($USD)	($0.35)	($0.41)
Primary EPS Consensus Mean ($USD)	($0.35)*	($0.40)*

Values retrieved from S&P Global.*

Balance Sheet Highlights

Metric	Dec 31, 2024	Jun 30, 2025
Cash & Cash Equivalents ($USD)	$6,205,926	$6,043,980
Marketable Investment Securities ($USD)	$15,427,385	$11,891,702
Total Unrestricted Cash, Cash Equivalents & Marketable Securities ($USD)	$21,633,311	$17,935,682
Total Stockholders’ Equity ($USD)	$20,997,565	$17,128,420

Revenue Mix

Metric	Q2 2024	Q1 2025	Q2 2025
License Revenue ($USD)	$0	$0	$500,000
Royalty Revenue ($USD)	$89,565	$93,864	$122,849

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY/Q3 outlook	Not provided	Not provided	Maintained (no formal guidance)
EPS	FY/Q3 outlook	Not provided	Not provided	Maintained (no formal guidance)
R&D Expense	FY/Q3 outlook	Not provided	Not provided	Maintained (no formal guidance)
G&A Expense	FY/Q3 outlook	Not provided	Not provided	Maintained (no formal guidance)
Tax Rate	FY/Q3 outlook	Not provided	Not provided	Maintained (no formal guidance)
Dividends	FY/Q3 outlook	Not applicable	Not applicable	N/A

No formal quantitative guidance was issued in the Q2 2025 materials .

Earnings Call Themes & Trends

Note: No Q2 earnings-call transcript was available. We used the July 9, 2025 investor R&D event transcript to assess management commentary and Q&A.

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q2 2025)	Trend
LPCN 1154 (PPD) Phase 3 execution	Q1 2025: Phase 3 initiated; first patient dosing anticipated in Q2 2025 . Q3 2024: targeting NDA submission; qEEG data supportive .	First patient dosed; outpatient 48-hour regimen; FDA indicated single Phase 3 may suffice for NDA; topline Q2 2026 .	Improving execution visibility
Regulatory/Legal (FDA pathway)	FY 2024 update: FDA advised efficacy study needed for 505(b)(2) NDA; registration stability studies completed .	FDA aligned to single Phase 3 plus PK bridge data for NDA if positive .	Clarified, constructive
TLANDO commercialization/royalties	Q3 2024: expansion to GCC and South Korea .	TLANDO NDS filed in Canada; TLANDO Brazil license signed (April) .	Expanding geographies
LPCN 2401 (Obesity adjunct)	Q3 2024: positive Phase 2 data; KOL event; planning PoC design .	PoC Phase 2 targeted in 3Q 2025; elderly focus for functional endpoints .	Moving toward PoC
Liquidity/burn	FY 2024: cash/securities $21.6M at year-end .	Q2 cash/securities $17.9M; management: trial fully funded; ~$3M/quarter burn .	Adequate near-term runway
Breastfeeding safety considerations	Not emphasized previously.	KOL commentary: low relative infant dose; short course may aid adherence vs 14-day alternatives .	Broadening clinical narrative

Management Commentary

“FDA voluntarily recommended us to do a single phase III study…along with the supporting data from the dosing confirmation study…should suffice for the NDA submission.” — Anthony DelConte, Chief Medical Director .
“This trial is fully funded, and conducting and executing the trial won’t really change our historic burn rate…roughly $3 million a quarter.” — Mahesh Patel, CEO .
“LPCN 1154 met all standard bioequivalence criteria to IV brexanolone…well tolerated with no sedation or somnolence events observed.” — Ben Bruno, VP Clinical Development .
“First patient has been dosed in pivotal Phase 3…outpatient setting with no requirement for medical monitoring… topline results expected Q2 2026.” — Company release .

Q&A Highlights

Safety and tolerability: No serious/severe AEs and no excessive sedation/loss of consciousness observed to-date with oral brexanolone in PK studies; safety confirmation will occur in Phase 3 .
Prescribing dynamics: Increasing OB/GYN screening and initiation; SSRIs remain prevalent due to familiarity and cost, but short-acting neuroactive steroids fit practice logistics and may improve adherence .
DSMB: Planned safety-only review in 2H 2025; no interim efficacy readout .
Breastfeeding considerations and adherence: Shorter dosing window (48 hours) may reduce barriers compared to 14-day alternatives; low breastmilk passage emphasized .

Estimates Context

Q2 2025 revenue beat: actual $622,849 vs $229,000 consensus*, primarily due to $500,000 license revenue recognition and higher TLANDO royalties .
EPS essentially inline: actual ($0.41) vs ($0.40) consensus*; OpEx discipline (lower G&A) offset higher R&D tied to program initiations .
Forward quarters: consensus implies continued modest revenue absent additional licenses; investors should model episodic license revenue and rising R&D through Phase 3 execution* .