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Dare Bioscience, Inc. (DARE)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was a transitional quarter ahead of initial product revenue in Q4: DARE reiterated December availability of DARE to PLAY Sildenafil Cream via a 503B outsourcing facility and expects first revenue recognition in Q4 2025 .
  • Operating discipline and non-dilutive funding improved the P&L: R&D fell 56% YoY on higher contra-R&D and lower Ovaprene manufacturing and personnel costs; G&A rose on professional services and commercial readiness spend .
  • Balance sheet strengthened materially during Q3, ending cash and equivalents at ~$23.1M and working capital at ~$3.8M, aided by ~$18.7M ATM proceeds and $7.3M grant receipts in the quarter .
  • Near-term stock catalysts: December 503B launch of DARE to PLAY, broadening to 50-state fulfillment in early 2026, and continued Ovaprene Phase 3 execution after a favorable DSMB review in July; additional grant installments expected support non-dilutive runway .

What Went Well and What Went Wrong

What Went Well

  • Executing dual-path commercial + FDA strategy: “We remain on track” for initial prescription fulfillment of DARE to PLAY in December via 503B, with early-2026 nationwide availability; initial Q4 revenue expected .
  • Non-dilutive funding momentum: Received $6M (Jul) and $4M (Oct) installments for DARE-LARC1 and anticipate an additional $3.6M installment in Nov 2025; Q3 grants totaled $7.3M received .
  • Ovaprene Phase 3 de-risking: DSMB recommended study continuation without modification; interim pregnancy rate consistent with expectations .

What Went Wrong

  • Minimal revenue and ongoing losses: Q3 revenue was $2.3K with net loss of $(3.56)M; EPS improved but remains negative .
  • G&A stepped up YoY to support commercialization, pressuring near-term opex: G&A rose to $2.5M vs $2.0M in Q3 2024 on professional services and commercial readiness .
  • HRT timing pushed out: DARE to RECLAIM (HRT1 via 503B) moved from late 2026 (Q2 guidance) to early 2027, albeit with a supportive regulatory backdrop per management’s Q&A commentary on FDA/menopause guidance .

Financial Results

Income statement and key balance metrics (USD)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($)$25,427 $(21,172) $2,262
General & Administrative ($)$2,309,164 $2,377,866 $2,499,242
Research & Development ($)$2,297,381 $1,428,762 $1,175,168
Total Operating Expenses ($)$4,606,545 $3,806,628 $3,674,410
Net Income (Loss) ($)$(4,378,307) $(4,016,483) $(3,562,766)
Diluted EPS ($)$(0.50) $(0.45) $(0.28)
Wtd Avg Shares (Basic/Diluted)8,759,053 8,871,155 12,755,112
Cash & Equivalents (period end) ($)$10,329,967 $5,035,006 $23,075,261
Working Capital ($)$(9,365,525) $(12,618,726) $3,787,786
Total Assets ($)$18,618,941 $12,979,525 $30,748,574
Stockholders’ Equity (Deficit) ($)$(9,563,701) $(12,733,260) $2,857,903

Year-over-Year snapshot (Q3)

MetricQ3 2024Q3 2025
Revenue ($)$41,691 $2,262
General & Administrative ($)$2,041,268 $2,499,242
Research & Development ($)$2,681,772 $1,175,168
Total Operating Expenses ($)$4,723,040 $3,674,410
Net Income (Loss) ($)$(4,702,501) $(3,562,766)
Diluted EPS ($)$(0.55) $(0.28)
Wtd Avg Shares8,534,433 12,755,112

Notes and drivers:

  • R&D down 56% YoY on contra-R&D from non-dilutive awards and lower Ovaprene manufacturing/personnel costs; offset partly by increased spend on DARE-HPV, DARE-LARC1, Sildenafil 3.6%, DARE to PLAY, and DARE-PTB1 .
  • G&A up YoY due to professional services and commercial readiness investments .
  • Cash/working capital improved significantly in Q3 on ~$18.7M net stock sales and ~$7.3M grant receipts during the quarter .

Results vs. Estimates

MetricQ3 2025 ActualS&P Global ConsensusSurprise
Revenue ($)$2,262 N/AN/A
EPS ($)$(0.28) N/AN/A

S&P Global consensus for quarterly EPS and revenue was not available at the time of analysis; as a micro-cap with limited coverage, estimates are often sparse for DARE.

Segment breakdown and KPIs

  • Segment reporting: Not applicable; DARE reports on a consolidated basis .
  • Operational KPIs and funding milestones:
    • Ovaprene Phase 3 DSMB review (July): continue without modification; interim pregnancy rate consistent with expectations .
    • Grant funding: $6M received in July; $4M in October; $3.6M installment anticipated in November 2025 .
    • Commercial readiness: 503B launch DARE to PLAY in December; 50-state fulfillment expected early 2026 .

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
DARE to PLAY (503B) initial prescription fulfillmentQ4 2025“On track for Q4 2025 launch” (Q2 PR) December 2025 (via 503B) Maintained; timing specified
DARE to PLAY 50-state fulfillmentEarly 2026Not specifiedEarly 2026 New detail
DARE to RESTORE (vaginal probiotics)2026Availability targeted to follow DARE to PLAY Targeted for Q1 2026 Timeline specified/advanced
DARE to RECLAIM (HRT1 via 503B)2026–2027Late 2026 (Q2 PR) Early 2027 Later
Initial revenue recognitionQ4 2025“Start recording revenue in Q4 2025” (Q1 PR) “Initial revenue recognition in Q4 this year” Reaffirmed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1–Q2 2025)Current Period (Q3 2025)Trend
Dual-path (503B + FDA) strategyExpanded strategy outlined; target launches via 503B and consumer channels Executing: DARE to PLAY December; 50-state early 2026 Strengthening execution
DARE to PLAY commercializationQ4 2025 launch targeted; Rosy Wellness DTC phase initiated December via 503B; Medvantx portal/logistics; national scale-up and partnerships after 50-state coverage Building infrastructure
Ovaprene Phase 3DSMB review scheduled July (Q1) ; DSMB continued study (Q2) Reiterated DSMB continuation and interim data consistency On plan
Non-dilutive fundingARPA-H/NIH support described ; $6M July installment noted (Q2) $4M Oct installment; $3.6M Nov installment anticipated Strengthening
HRT (DARE to RECLAIM/HRT1)503B and FDA paths; timelines evolving Early 2027 via 503B; FDA path continues; supportive external HRT policy signals discussed Timeline extended; backdrop improving
Go-to-market channels/partnersRosy Wellness (Q2) Medvantx for fulfillment/telehealth; broader partnerships post-50 states; digital marketing ramp Expanding

Management Commentary

  • “We remain on track for our 503B outsourcing facility partner to begin fulfilling prescriptions in select states in December… and… in all 50 states in early 2026.”
  • “We therefore believe that DARE to PLAY Sildenafil Cream is poised to be the first meaningful prescription innovation in this category… a near-term revenue driver.”
  • On Ovaprene: “DSMB… recommended that the trial continue as planned… interim pregnancy rate… consistent with our expectations.”
  • On funding: “During the third quarter, we received approximately $18.7 million in net proceeds from sales of our common stock and a total of $7.3 million in grant payments.”
  • CEO tone: “We believe the coming weeks will represent a historic moment for Daré and for women seeking new options.”

Q&A Highlights

  • Menopause HRT policy shift: Management “thrilled” with FDA’s recent change; reiterated dual-path for DARE to RECLAIM with early 2027 503B timing and a single Phase 3 for FDA pathway previously aligned; expects improved provider receptivity .
  • R&D prioritization and runway: Focus on near-term commercial launches (DARE to PLAY, DARE to RESTORE), and grant-backed programs (Ovaprene, DARE-HPV, DARE-LARC1, DARE-NHC); prioritizing programs with clear regulatory roadmaps and market opportunities .
  • Commercial awareness and access: Clinician engagement via medical meetings and webinars; Medvantx portal for prescriptions and telehealth; broader partnerships to follow once nationwide availability achieved; digital marketing to ramp into new year .
  • ATM capacity: “Baby shelf” restrictions currently limit ATM utilization .

Estimates Context

  • Wall Street (S&P Global) consensus for Q3 2025 revenue and EPS was not available; no consensus-based beat/miss assessment can be made at this time. Given limited small-cap coverage, estimate visibility is currently low.

Key Takeaways for Investors

  • December launch of DARE to PLAY via 503B, with Q4 revenue recognition, is the central near-term catalyst; nationwide availability in early 2026 should broaden demand capture .
  • Operating leverage from non-dilutive funding is tangible: R&D down 56% YoY while key clinical and preclinical programs advance; this lowers cash burn ahead of initial revenue .
  • Balance sheet inflected in Q3 on capital raised and grants, supporting commercial rollout and pipeline execution; working capital turned positive .
  • Ovaprene remains a potential medium-term value driver with favorable interim DSMB review and a Bayer option post-Phase 3 (including potential $20M payment and tiered double-digit royalties, subject to a minority interest) .
  • HRT timing slipped to early 2027 for 503B availability, but management sees a more supportive regulatory and clinical discourse that could enhance market receptivity upon launch .
  • Execution risks include: 503B/state licensing and partner performance, speed of clinician/patient uptake, and limited estimate coverage; continued non-dilutive funding mitigates R&D spend and runway risk .
  • Near-term trading setup: December availability confirmation and early ordering cadence for DARE to PLAY, plus additional grant receipts, are likely stock-moving updates; watch for 50-state coverage milestones and subsequent partnership announcements .

Appendix: Additional Q3 2025 Company Communications

  • Q3 2025 results press release: commercial readiness webinar (Nov 17) and December DARE to PLAY availability via 503B .
  • 8-K Item 2.02 and EX-99.1 include full Q3 financial statements and operating commentary .
  • Gates Foundation contract up to ~$300K for global contraceptive landscape review announced Nov 3, 2025 .