Executive Summary

Q2 print was operationally steady with narrowed operating loss as R&D fell 71% YoY on higher contra-R&D funding, but total revenue was negative due to a royalty true-up and the prior-year comp benefited from a one-time $20.4M royalty/milestone sale; diluted EPS was ($0.45) vs $1.52 in Q2’24 and ($0.50) in Q1’25 . The company reiterated a Q4’25 launch for DARE to PLAY Sildenafil Cream via a 503B pathway, positioning for first product revenue in Q4’25 .
Balance sheet at quarter-end showed $5.0M cash and a $(12.6)M working capital deficit; post-quarter capital actions added ~$17.6M net ATM proceeds plus a $6.0M grant installment, materially strengthening liquidity for launch and pipeline execution .
Pipeline momentum: DSMB endorsed continuation of the Ovaprene Phase 3 with no new safety concerns; interim pregnancy rate aligned with expectations, reinforcing differentiation of the hormone‑free monthly contraceptive candidate .
Street estimates: S&P Global consensus was not available for revenue or EPS this quarter; no beat/miss framing could be established (consensus unavailable). Values retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

Execution toward near-term commercialization: “on track for Q4 2025 launch through a 503B outsourcing facility” for DARE to PLAY Sildenafil Cream, with consumer awareness and HCP initiatives underway (Rosy Wellness collaboration, webinar) .
Non-dilutive/efficient funding and cost control: R&D expense fell to $1.4M (–71% YoY) driven by contra-R&D from awards and lower Ovaprene/Sildenafil manufacturing costs; G&A disciplined at $2.4M (vs $2.5M LY) .
Ovaprene Phase 3 safety milestone: DSMB review recommended continuation without modification; no serious safety concerns; interim pregnancy rate consistent with prior study expectations—supporting differentiation as potential first-in-category monthly hormone‑free contraceptive .

What Went Wrong

Top-line optics remain challenged: Q2 total revenue was negative ($21.2K) on royalty adjustments and compares unfavorably to Q2’24 which included a one-time $20.4M royalty/milestone sale, inflating last year’s earnings baseline .
Liquidity pressure intra-quarter: cash fell to $5.0M and working capital deficit widened to $(12.6)M before subsequent capital actions; funding reliance remains a risk despite post-quarter strengthening .
Regulatory and execution risks persist: Sildenafil Cream Phase 3 endpoints and PRO psychometrics remain under FDA dialogue; 503B route entails reliance on outsourcing facilities and potential FDA policy changes, as management cautioned in forward‑looking statements .

Financial Results

P&L summary (oldest → newest)

Metric	Q2 2024	Q1 2025	Q2 2025
Revenue ($)	$22,438	$25,427	$(21,172)
G&A ($)	$2,448,130	$2,309,164	$2,377,866
R&D ($)	$4,933,774	$2,297,381	$1,428,762
Total Operating Expenses ($)	$7,381,904	$4,606,545	$3,806,628
Loss from Operations ($)	$(7,359,466)	$(4,581,118)	$(3,827,800)
Sale of Royalty/Milestone Rights ($)	$20,379,376	—	—
Other Income (Expense), net ($)	$(109,254)	$202,811	$(188,683)
Net Income (Loss) ($)	$12,910,656	$(4,378,307)	$(4,016,483)
Diluted EPS ($)	$1.52	$(0.50)	$(0.45)

Notes: Margin metrics are not meaningful for a pre‑revenue biotech with negligible/negative revenue and no COGS disclosure this quarter.

Balance sheet and liquidity

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash & Cash Equivalents ($)	$15,698,174	$10,329,967	$5,035,006
Working Capital (Deficit) ($)	$(3,161,150)	$(9,365,525)	$(12,618,726)
Total Assets ($)	$22,101,131	$18,618,941	$12,979,525
Stockholders’ Equity (Deficit) ($)	$(6,012,089)	$(9,563,701)	$(12,733,260)

Subsequent events: ~$17.6M net ATM proceeds plus a $6.0M grant installment received after quarter‑end .

KPIs and operating drivers

Post-quarter grant installment: $6.0M for DARE‑LARC1; cumulative received ~$37.8M of up to ~$49M commitment .
Awareness/launch enablement: Rosy Wellness consumer campaign launched; HCP webinar held Aug 6; provider education ongoing .

Guidance Changes

Metric/Item	Period	Previous Guidance	Current Guidance	Change
DARE to PLAY Sildenafil Cream – launch/first revenue	Q4 2025	“Start recording revenue in the 4th quarter of this year” (Q1’25)	“On track for Q4 2025 launch via 503B; positioned for product revenue beginning in Q4 2025”	Maintained (timing reiterated)
Vaginal Probiotics (consumer)	Late 2025	“Targeting availability as branded consumer health products this year (2025)”	“Availability targeted to follow DARE to PLAY availability”	Sequencing clarified (post‑DARE to PLAY)
DARE‑HRT1 (503B compounded)	Late 2026	“Targeting availability… next year (2026)”	“Targeted for late 2026”	Timing refined (late 2026)
Sildenafil Cream, 3.6% (FDA path)	2025 program updates	Submit protocol/SAP by end of Q2’25 (target)	FDA discussions ongoing re endpoint assessment; Phase 3 endpoints under dialogue	Execution ongoing; regulatory dialogue continues
Ovaprene Phase 3	2025	DSMB interim in July 2025 (planned)	DSMB recommended continuation; no serious safety concerns	Progressing per plan

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
Dual-path (503B + 505(b)(2)) strategy	Initiated; plan to bring Sildenafil Cream via 503B in Q4’25 while pursuing FDA approval; explore similar path for other assets	Reiterated dual-path; Q4’25 availability “on track”; continued FDA dialogue on endpoints/PROs	Steady execution
Near-term revenue initiation	“Expect to start recording revenue in Q4’25”	“Positioned for product revenue beginning in Q4 2025”	Maintained
Ovaprene Phase 3 status	Enrollment complexities; NIH/NICHD site pauses due to federal actions; DSMB safety review planned mid‑’25	DSMB recommended continuation; interim pregnancy rate in line with expectations; no new safety issues	Positive safety signal; execution continues
Non-dilutive funding/OpEx discipline	Emphasis on grants; R&D cadence tied to study activity; only active clinical study: Ovaprene	R&D down 71% YoY on contra‑R&D; $6M LARC1 grant installment in July	Strengthened
Go-to-market partnerships	Plan for telehealth, online, HCP education; multiple partners per product and platform	Consumer education with Rosy launched; more HCP/partner updates to follow	Advancing
Regulatory/legal	FDA PRO psychometrics request for Sildenafil; careful claim boundaries pre‑approval	FDA endpoint discussions ongoing; forward-looking risk disclosures reiterated	Ongoing

Management Commentary

“Daré is rapidly transitioning its business model by executing on a dual-path strategy designed to unlock both near-term revenue and long-term value” — Sabrina Martucci Johnson, President & CEO .
“We remain on track to support the commercial availability of DARE to PLAY Sildenafil Cream through a 503B outsourcing facility in the fourth quarter of this year” .
On Ovaprene: “DSMB… recommended the study continue as planned… interim pregnancy rate… consistent with our expectations” .
On funding and launch readiness: “After quarter-end, we received approximately $17.6 million in net proceeds… and a $6.0 million grant installment payment… significantly strengthens the company’s balance sheet” .

Q&A Highlights

The company did not hold a Q&A session on the Q2 call due to technical difficulties .
Prior-quarter calls emphasized 503B commercialization mechanics, FDA PRO/endpoint work for Phase 3, partner strategy across telehealth/online channels, and Ovaprene execution amid NIH site dynamics .

Estimates Context

Wall Street consensus (S&P Global) for quarterly revenue and EPS was unavailable for Q2 and forward periods; as a result, no beat/miss analysis versus Street can be provided this quarter. Values retrieved from S&P Global.

Key Takeaways for Investors

Launch catalyst confirmed: Q4’25 503B launch for DARE to PLAY Sildenafil Cream is intact; initial product revenue expected in Q4’25, making execution on tech transfer, supply, and partner channels the near-term stock driver .
Liquidity bridge improved post-quarter (~$23.6M gross inflows combining ATM net and grant), supporting launch and pipeline milestones into 2026; monitor cash burn as G&A and commercialization activities step up .
Ovaprene de-risking increment: DSMB continuation and aligned interim pregnancy rate keep the first-in-category contraceptive thesis on track; potential Bayer commercialization option ($20M) remains a medium-term upside lever if the pivotal succeeds .
Operating model pivot: Material YoY R&D reduction from contra‑R&D highlights the strategy to leverage non-dilutive funds while advancing programs; expect OpEx mix shift toward commercial enablement through 2H’25 .
Regulatory path remains a swing factor: Ongoing FDA endpoint/PRO dialogue for FSAD Phase 3 underscores that long-term value creation from an approved label is separate from 503B revenue and will require robust clinical validation .
Commercial strategy hedged via partnerships: Telehealth, online channels, and HCP education (e.g., Rosy Wellness) should accelerate early adoption in a self-pay environment pre-approval; pricing/access strategy will be important to enable transition to a future labeled product .
Risk monitor: Dependence on 503B outsourcing facilities and potential FDA policy shifts, access/awareness lift necessary in a cash-pay launch, and continued need for external capital remain key considerations (as disclosed in forward-looking statements) .

Appendix: Additional Relevant Press Releases in Q2 2025

July 11: $6M grant installment for DARE‑LARC1; total received ~$37.8M of up to ~$49M .
July 14: Positive Ovaprene Phase 3 interim DSMB outcome and supportive interim pregnancy rate; most common AE-related discontinuation was vaginal odor (17%) with overall tolerability favorable .
July 29: Rosy Wellness collaboration launches initial consumer education phase for DARE to PLAY .

Dare Bioscience, Inc. (DARE)·Q2 2025 Earnings Summary