Dare Bioscience, Inc. Q1 FY2026 earnings call

Corporate Identity & Strategy

• DARE is a 10-year-old pure-play women's health product company focused exclusively on developing clinically studied, differentiated products for conditions uniquely impacting women, covering contraception, menopause, sexual health, fertility, vaginal health, and HPV. It is not a telehealth subscription or care navigation platform; telehealth is only used as an access infrastructure to deliver products to patients.
• Core strategy is a dual path approach: commercialize proprietary formulations via 503B compounding while pursuing FDA approval, and launch select branded over-the-counter consumer health products, to bring products to market efficiently while generating real-world data to support future regulatory submissions.
• Capital allocation strategy leverages non-dilutive grant funding to advance multiple pipeline programs simultaneously, minimizing shareholder dilution. The company has a broad portfolio of pipeline assets rather than a single product bet.

Commercial Product Updates

• Dare to Play (first-in-class GMP-manufactured topical sildenafil arousal cream for women, available via 503B compounding): Pre-fulfillment prescribing has been live across all 50 U.S. states since February 2026, with strong enthusiastic clinician response observed at the 2026 ACOG annual conference. Partner Bravado (503B registered outsourcing facility) is targeting national dispensing commencement in summer 2026 as it completes required state licensing and fulfillment preparations. The company is simultaneously advancing the product toward a 505(b)(2) NDA for FDA approval.
• Dare to Restore FloraSync LF5 (first over-the-counter vaginal probiotic suppository): Seeding campaigns to build clinician awareness and drive initial consumer trial began in May 2026, with full commercial launch and the company's first ever direct product revenue expected in June 2026. The product has published peer-reviewed clinical data and is expected to complement prescription 503B offerings.

Pipeline Development Highlights

• Oviprene (hormone-free monthly intravaginal contraceptive candidate): The company recently announced a second consecutive positive interim review from the independent DSMB, which recommended the Phase III trial continue without modification. Interim data from 340 subjects (nearly 1,800 cycles of exposure) shows a 9% pregnancy rate consistent with expectations, improved tolerability (12% discontinuation for vaginal odor, a 5% decrease from the 2025 interim review), no new adverse event signals, and 50%+ of participants reported they would likely use the product if approved. The company plans to engage the FDA to discuss whether fewer than 250 subjects completing 13 cycles is sufficient to evaluate safety based on interim data. Full enrollment to reach the 2,500 cycle exposure target is expected in 2026, with primary endpoint analysis planned for 2027. There are currently no FDA-approved hormone-free monthly intravaginal contraceptives.
• Dare to Reclaim (monthly intravaginal ring for bioidentical hormone therapy, targeting the $2.5-$4.5 billion compounded hormone therapy market): 503B prescription fulfillment is targeted for 2027, with parallel activities ongoing to support NDA filing and a pivotal Phase III trial per the dual path strategy.
• DARE HPV: A pharmacologic treatment for high-risk HPV infection (a $0 billion addressable market with no existing approved drug therapies, 6 million new U.S. cases annually) is funded by ARPA-H, and Phase II trial initiation is planned for May 2026 following IND clearance in February 2026.
• Earlier-stage programs (DARE-LARC1, CASIA-S, DARE-NHC, DARE-PTB1) are fully or partially funded by non-dilutive grants and continue to advance.

DARE Bioscience is a pure-play women's health product company with two primary segments: pipeline R&D and pre-commercial/early commercial consumer/prescription products. For Q1 2026:

• Selling, General & Administrative (SG&A) expenses: $2.2 million, down from $2.3 million in Q1 2025, driven by lower personnel costs offset by higher commercial readiness expenses for upcoming product launches and stock-based compensation.
• Reported Research & Development (R&D) expenses: $0.7 million, down from $2.3 million in Q1 2025. Non-dilutive grant funding is recorded as contra-R&D expense, which offset $3.5 million of R&D costs in Q1 2026 (up from $3.1 million in Q1 2025), meaning total actual R&D investment is significantly higher than the reported net expense line.
• As of March 31, 2026, the company held $18.5 million in cash and cash equivalents, with working capital of approximately $0.5 million. No product revenue was recorded in Q1 2026, as the first commercial product launches are scheduled for Q2/Q3 2026.

• Product revenue timelines: First direct revenue from FloraSync LF5 (over-the-counter probiotic) is expected in June 2026; first revenue from Dare to Play is expected in Q3 2026; first revenue from Dare to Reclaim is targeted for 2027.
• Dare to Play national dispensing via Bravado is targeted to commence in summer 2026.
• Oviprene Phase III trial is expected to complete enrollment sufficient to reach the 2,500 cycle exposure target in 2026, putting primary endpoint analysis within reach in 2027.
• DARE HPV Phase II clinical study is expected to initiate in May 2026.
• Dare to Reclaim 503B commercial availability is maintained at a 2027 target, with ongoing NDA preparatory work.

• Actual clinical and commercial results could differ materially from forward-looking expectations due to known and unknown risks and uncertainties, as outlined in the company's SEC filings.
• 503B outsourcing facilities require state-by-state registration, and some states delay approval until they review operational data from other states, which can delay full national access.
• The company currently has less than 12 months of general operating capital from existing cash holdings (not accounting for projected product revenue, future grant disbursements, or new financing), so it will need to raise additional capital to fund ongoing operations and launches.
• Oviprene is a first-in-category product, and final safety and efficacy results may differ from positive interim data, and FDA feedback on the proposed modified trial endpoint could change development timelines.
• Commercial launch of new products may not meet demand or clinician adoption expectations, even with positive early feedback.

Q: How could the dynamic of reaching 2,500 cycles of exposure before 250 subjects complete 13 cycles impact Oviprene's readout timing? Is it a minor or major delay? / A: The interim safety data shows no change in adverse event signals or types with prolonged use, which is promising for Oviprene as a first-in-category product. This dynamic can impact the timing of the 2027 readout, but no specific estimate of the delay can be provided right now. The company plans to engage the FDA to discuss the interim findings and get their input on trial requirements, which will clarify the timeline.

Q: What factors have delayed the national fulfillment launch of Dare to Play? / A: Delays stem from two core requirements: Bravado (the 503B outsourcing facility) must complete GMP manufacturing readiness to ensure consistent quality supply to meet commercial demand, and they must complete required state-by-state registration, which most 503B facilities do not hold nationally. Bravado currently has ~28 state registrations complete, and some states require data from other states' operations before approving access. The company prioritizes launching correctly rather than quickly to ensure quality and broad access.

Q: What is the current status of DARE's cash runway? / A: DARE's cash is split between allocated funding for grant-specified programs and unallocated cash for general operating activities. Excluding projected future product revenue and future grant disbursements, current cash holdings provide less than 12 months of general operating capital, so the company will need to raise additional funding. The cash runway covers at least a couple of quarters of operations at current spending levels.