Executive Summary

Q1 2025 showed modest royalty revenue ($25.4K) and materially lower operating spend, with G&A down 14% YoY and R&D down 31% YoY; net loss improved to $(4.38)M and EPS to $(0.50) from $(0.81) in Q1 2024 .
Management unveiled an expanded dual-path commercialization strategy: launch four “on-market” solutions in 2025–2026 via 503B compounding and consumer channels, with Dare expecting to start recording revenue in Q4 2025; Phase 3 protocol for Sildenafil Cream targeted for submission by end of Q2 2025; Ovaprene DSMB safety review slated for July 2025 .
Liquidity tightened: cash fell to $10.3M (from $15.7M at 12/31/24) and working capital deficit widened to $(9.37)M; balance sheet underscores urgency for non-dilutive funding and near‑term revenue execution .
Management positioned women’s health as a differentiated upside category and emphasized telehealth/online distribution partnerships; key stock catalysts: 503B launch preparations, multiple partnership announcements, Ovaprene DSMB review in July, and FDA feedback on Phase 3 Sildenafil Cream .

What Went Well and What Went Wrong

What Went Well

Operating discipline: G&A fell to $2.31M (−14% YoY) and R&D to $2.30M (−31% YoY), improving operating loss to $(4.58)M and narrowing net loss to $(4.38)M .
Strategic expansion: “Four on-market products” plan to accelerate revenue with 503B compounding for Sildenafil Cream in 2025, DARE‑HRT1 in 2026, and probiotics as consumer products in 2025; “We expect to start recording revenue in the fourth quarter of this year” .
Pipeline momentum: Ovaprene Phase 3 ongoing with DSMB review scheduled for July; Sildenafil Cream Phase 3 protocol/statistical plan targeted for end of Q2; incremental federal/NIAID support for DARE‑HPV increased program resourcing .

Quote: “We’re leveraging a dual path strategy where we commercialize via 503B compounding while continuing to seek FDA approval… Four on‑market products will accelerate revenue generation and provide a path to profitability” .

What Went Wrong

Liquidity pressure: Cash declined to $10.33M and working capital deficit widened to $(9.37)M by 3/31/25, increasing near-term funding risk absent revenue ramp or additional financing .
Revenue still de minimis: Total revenue was $25.4K (royalties), limiting scale benefits; other income aided bottom line, but core monetization remains ahead of plan .
External headwinds: Prior commentary flagged first‑quarter disruptions and federal funding uncertainty impacting Ovaprene NICHD activities; emphasizes sensitivity to macro/government dynamics for development timelines .

Financial Results

Metric	Q1 2024	Q3 2024	Q1 2025
Total Revenue ($USD)	$9,302	$41,691	$25,427
G&A Expense ($USD)	$2,670,581	$2,041,268	$2,309,164
R&D Expense ($USD)	$3,353,520	$2,656,772	$2,297,381
Total Operating Expenses ($USD)	$6,031,775	$4,723,040	$4,606,545
Loss from Operations ($USD)	$(6,022,473)	$(4,681,349)	$(4,581,118)
Other Income (Expense) ($USD)	$(732,883)	$(21,152)	$202,811
Net Loss ($USD)	$(6,755,356)	$(4,702,501)	$(4,378,307)
EPS (Basic & Diluted, $)	$(0.81)	$(0.55)	$(0.50)
Weighted Avg Shares	8,376,189	8,534,433	8,759,053

Note: Q4 2024 quarterly breakdown was not disclosed; FY 2024 details provided below .

KPIs and balance sheet trend:

Metric	Sep 30, 2024	Dec 31, 2024	Mar 31, 2025
Cash & Equivalents ($USD)	$11,232,609	$15,698,174	$10,329,967
Working Capital (Deficit) ($USD)	$1,790,546	$(3,161,150)	$(9,365,525)
Total Assets ($USD)	$18,058,801	$22,101,131	$18,618,941
Stockholders’ Deficit ($USD)	$(1,484,483)	$(6,012,089)	$(9,563,701)

FY 2024 (context):

Metric	FY 2023	FY 2024
Total Revenue ($USD)	$2,807,885	$9,784
G&A Expense ($USD)	$12,109,691	$9,156,061
R&D Expense ($USD)	$21,538,074	$14,205,208
Net Loss ($USD)	$(30,161,391)	$(4,053,299)
EPS (Basic & Diluted, $)	$(4.15)	$(0.48)
Cash & Equivalents ($USD)	$10,476,056	$15,698,174

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Start of revenue recognition	Q4 2025	“Start recording revenue and cash flow in the 4th quarter of this year” (Mar 31 PR)	“Expect to start recording revenue in the 4th quarter of this year” (May 13 PR/8‑K/call)	Maintained
Sildenafil Cream (503B) availability	2025	Target availability via one 503B outsourcing facility in Q4 2025	Target availability via prescription as a Section 503B compounded drug this year	Maintained/affirmed
DARE‑HRT1 (503B) availability	2026	Not specified previously	Target availability via prescription as Section 503B compounded drug next year	New
Vaginal probiotics (consumer)	2025	Not specified previously	Target availability as branded consumer health products this year	New
Sildenafil Cream Phase 3 protocol/SAP	Q2 2025	Plans to submit in 2Q 2025 pending further FDA recommendations	Target submission by end of Q2 2025	Clarified timing
Ovaprene DSMB review	Mid‑2025	Interim assessment expected ~end Q2 2025	DSMB safety review scheduled for July 2025	Date specified
DARE‑HPV funding	2024–2026	Up to $10M ARPA‑H award	Supplemental NIAID grant up to $2M (Notice of Award), bringing potential non‑dilutive support to ~$12M	Strengthened funding

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2024 and Q4 2024)	Current Period (Q1 2025)	Trend
Dual‑path 503B + FDA strategy	Discussed as emerging strategy; targeting Sildenafil 503B availability; evaluating other formulations; revenue goal in Q4 2025	Expanded to four on‑market products (Sildenafil, HRT1, probiotics) and consumer channels; reiterated Q4 revenue start	Intensifying execution
Partnerships & distribution	Preparing partnerships; equity line for funding; Organon/Bayer collaborations	Multiple partnerships per product; telehealth, online retailers, and prescription fulfillment platforms emphasized	Broadening
Manufacturing & provider education	Operational readiness for Phase 3; site and CRO prep	503B GMP ramp driving Q4 timing; provider education at ACOG; medical society engagement	Operational build‑out
Ovaprene Phase 3	Recruitment pacing; grant to add sites; interim look targeted mid‑2025	DSMB review July 2025; ongoing enrollment; pause at NICHD noted previously	On track for DSMB
Sildenafil Phase 3 endpoints/PRO	Aligning with FDA on endpoints; 2 Phase 3 studies anticipated	FDA requested PRO psychometrics info; protocol/SAP submission targeted by end Q2	Regulatory clarifications
R&D spending trajectory	Guidance for lower 2024 R&D vs 2023; grants to offset costs	R&D down 31% YoY; trend to continue until new studies start	Cost discipline maintained
Macro/regulatory effects	Admin actions/funding freeze impacted NICHD recruitment	Q1 prepared remarks focused on execution; prior risk factors reiterated in filings	Ongoing watch

Management Commentary

“We expect to start recording revenue in the fourth quarter of this year.” — Sabrina Johnson (CEO), prepared remarks .
“We’re leveraging a dual path strategy where we commercialize via 503B compounding while continuing to seek FDA approval.” — Sabrina Johnson (CEO) .
“Four on‑market products will accelerate revenue generation and provide a path to profitability.” — Q1 press release .
“Targeting submission of additional information requested by the FDA, along with the protocol and statistical analysis plan for the Phase 3 study, by the end of the second quarter of 2025.” — Q1 PR/update and call .
“Review of interim data by the study’s data safety monitoring board… scheduled for July 2025.” — Q1 PR/8‑K .

Q&A Highlights

Partnerships: Expect several partnerships per product and across platforms to maximize access via telehealth and online distribution .
503B manufacturing timeline: GMP scale‑up at the outsourcing facility, partnership build‑out, and provider education drive Q4 availability for Sildenafil Cream .
Industry feedback: Traditional pharma responded positively to the creative dual‑path approach to accelerate access while continuing FDA approval efforts .
FDA requests: April request on PRO psychometrics; company targeting submission of further info plus protocol/SAP by end of Q2 2025 .
Ovaprene DSMB: Focused on safety/integrity; no statistical analysis of Pearl Index and no sample size changes at the interim .
Spend outlook: R&D lower given limited active studies (primarily Ovaprene, largely grant‑funded); trend to persist until new studies commence .
Cost to enable 503B: ~$1M for Sildenafil Cream start‑up/tech transfer to 503B; HRT1 expected in similar single‑digit millions range .

Estimates Context

S&P Global consensus for Q1 2025 EPS and revenue was unavailable; no published quarterly consensus to assess beat/miss.
Implication: With no Street anchors, focus shifts to execution milestones (503B readiness, partnerships, DSMB review, protocol submission) and liquidity runway.

Metric	Q1 2025
Primary EPS Consensus Mean	N/A*
Revenue Consensus Mean ($USD)	N/A*

*Values retrieved from S&P Global.

Key Takeaways for Investors

Near‑term catalysts: Phase 3 protocol/SAP submission for Sildenafil Cream by end Q2 2025; Ovaprene DSMB safety review in July; multiple partnership announcements across telehealth/retail; 503B launch preparation for Q4 revenue start .
Liquidity watch: Cash fell to $10.3M with working capital deficit of $(9.37)M; timely non‑dilutive funding and early commercialization execution are critical to sustain operations into 2026 .
Strategy differentiation: Dual‑path (503B + FDA) plus consumer probiotics expands addressable channels and may accelerate cash generation while preserving regulatory value creation .
Development risk: FDA endpoint alignment and PRO psychometrics for Sildenafil Cream, and Ovaprene Phase 3 outcomes remain pivotal value inflection points; DSMB is safety‑focused (no efficacy read) .
Execution priorities: 503B tech transfer/manufacturing, provider education (e.g., ACOG presence), and telehealth integration will drive launch quality and uptake .
Grant tailwinds: ARPA‑H (up to $10M) plus NIAID (up to $2M) bolster DARE‑HPV non‑clinical and clinical advancement, diversifying pipeline momentum .
Risk overlay: Company‑disclosed risks include going concern/capital needs, Nasdaq listing risk, reliance on third parties/outsourcing facilities, and regulatory pathway uncertainty—keep position sizing disciplined until revenue visibility improves .

Dare Bioscience, Inc. (DARE)·Q1 2025 Earnings Summary