Daré Bioscience targets Q4 2025 launch for DARE to PLAY Sildenafil cream while advancing dual-path strategy

Earnings Call Insights: Daré Bioscience (DARE) Q2 2025

MANAGEMENT VIEW

* Sabrina Martucci Johnson, CEO, stated that "Daré is at an inflection point. The second quarter of 2025 reflects the continued acceleration of our dual-path strategy as we focus on closing the gap in women's health between promising science and real solutions, generating near-term commercial revenue while advancing long-term innovation in women's health." She confirmed the company remains on track to support the commercial availability of DARE to PLAY Sildenafil cream through a 503B outsourcing facility in the fourth quarter of 2025, describing this as a "major milestone not just for Daré, but for the field of women's sexual health."
* Johnson highlighted the launch of a direct-to-patient awareness campaign for DARE to PLAY Sildenafil cream in partnership with Rosy Wellness, as well as a provider-oriented webinar in August featuring key opinion leaders. She described the product as "positioned to be the first meaningful prescription innovation in this category" and a "near-term revenue driver."
* She reported that the independent Data and Safety Monitoring Board for the Ovaprene Phase III study recommended the trial continue as planned, with interim pregnancy rates consistent with expectations and no new safety concerns. If Bayer exercises its option, Daré could receive a $20 million payment and up to $310 million in milestone payments plus double-digit tiered royalties.
* Johnson announced progress with DARE-HRT1, targeting availability via a 503B outsourcing facility in late 2026, and the upcoming launch of two nonprescription vaginal probiotics as part of a consumer health expansion.
* She discussed grant-funded programs including DARE-HPV and DARE-LARC1, with the latter receiving a $6 million grant installment in the quarter.
* Chief Accounting Officer MarDee J. Haring-Layton stated, "We ended the quarter with approximately $5 million in cash and cash equivalents, and working capital deficit of approximately $12.6 million. After quarter end, we received approximately $17.6 million in net proceeds from sales of our common stock and a $6 million grant payment. This additional capital significantly strengthens our balance sheet, enhancing our ability to execute on our dual-path strategy."

OUTLOOK

* Johnson reiterated the targeted Q4 2025 launch for DARE to PLAY Sildenafil cream through a 503B outsourcing facility. She stated, "We remain on track to support a fourth quarter 2025 launch." DARE-HRT1 is targeted for availability via a 503B facility in late 2026. The introduction of two nonprescription vaginal probiotics is anticipated following the DARE to PLAY launch later in 2025. No changes to these timelines were mentioned compared to the previous quarter.

FINANCIAL RESULTS

* The company reported approximately $5 million in cash and cash equivalents and a working capital deficit of about $12.6 million as of June 30, 2025. After quarter end, Daré received $17.6 million in net proceeds from common stock sales and a $6 million grant payment.
* G&A expenses were $2.4 million, down from $2.5 million in Q2 2024, primarily due to decreased personnel costs and stock-based compensation, partially offset by higher professional services expenses.
* R&D expenses were $1.4 million, representing a 71% decrease versus Q2 2024, mainly due to increased contra R&D expenses from nondilutive funding and decreased manufacturing and development costs for Ovaprene and Sildenafil cream, partially offset by higher costs for DARE-HPV and DARE-LARC1.

Q&A

* NOT_APPLICABLE. The company stated, "Due to technical difficulties, we will not be able to hold the Q&A session today." No analyst questions or answers were included in the current quarter transcript.

SENTIMENT ANALYSIS

* Analyst sentiment cannot be assessed for this quarter due to the absence of a Q&A session.
* Management’s tone in prepared remarks was confident and forward-looking, emphasizing the strength of the dual-path strategy and the company’s ability to bring products to market efficiently. Johnson underscored the "exciting potential" and highlighted "significant interest and unmet need" in the women’s health segment.
* Compared to the previous quarter, management maintained a similarly optimistic and proactive tone, though the lack of analyst questions removed any opportunity for challenge or defensive responses this quarter.

QUARTER-OVER-QUARTER COMPARISON

* Both quarters emphasized the dual-path strategy and upcoming product launches, specifically DARE to PLAY Sildenafil cream and DARE-HRT1. The Q2 2025 call provided explicit confirmation of the Q4 2025 launch timeline for DARE to PLAY and a late 2026 target for DARE-HRT1, consistent with previous guidance.
* The Ovaprene Phase III study update in Q2 2025 included DSMB feedback that the trial should continue as planned, while Q1 2025 anticipated this review but had not yet reported outcomes.
* The company reported an improvement in cash resources following stock sales and grant funding in Q2 2025 compared to Q1 2025.
* No analyst questions this quarter meant less scrutiny and no new themes from the investment community, whereas Q1 included multiple questions around product partnerships, manufacturing, and regulatory milestones.
* Management sentiment remained positive and focused on execution, with no shift in guidance language or strategic priorities.

RISKS AND CONCERNS

* The company highlighted a working capital deficit of approximately $12.6 million as of June 30, 2025.
* Johnson noted the need for FDA discussions to define acceptable endpoints for a future registration path for DARE to PLAY Sildenafil cream, and continued reliance on grant funding and partnerships to advance the pipeline.
* There was reference to the market’s historical under-recognition of women’s sexual health needs and the risk of clinical evaluation lagging behind demand.
* Management encouraged investors to review risk factors in the recently filed Form 10-Q.

FINAL TAKEAWAY

Daré Bioscience reiterated its commitment to bringing innovative women’s health products to market with a dual-path strategy, targeting the commercial launch of DARE to PLAY Sildenafil cream in Q4 2025 and advancing multiple additional assets, including DARE-HRT1 and nonprescription probiotics. The company strengthened its financial position with recent stock sales and grant funding, and reported major progress in its clinical pipeline, including a positive DSMB review for Ovaprene Phase III. The absence of a Q&A session in this quarter limited analyst interaction, but management maintained a confident and execution-focused tone, emphasizing the potential for near-term revenue and long-term growth in women’s health.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/dare/earnings/transcripts]

MORE ON DARE BIOSCIENCE

* Daré Bioscience, Inc. (DARE) Q2 2025 Earnings Call Transcript [https://seekingalpha.com/article/4813864-dare-bioscience-inc-dare-q2-2025-earnings-call-transcript]
* Dare Bioscience GAAP EPS of -$0.45 beats by $0.13 [https://seekingalpha.com/news/4485653-dare-bioscience-gaap-eps-of-0_45-beats-by-0_13]
* Seeking Alpha’s Quant Rating on Dare Bioscience [https://seekingalpha.com/symbol/DARE/ratings/quant-ratings]
* Historical earnings data for Dare Bioscience [https://seekingalpha.com/symbol/DARE/earnings]
* Financial information for Dare Bioscience [https://seekingalpha.com/symbol/DARE/income-statement]