Release Date: May 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Dare Bioscience Inc (DARE, Financial) announced a $22 million non-dilutive strategic royalty financing, enhancing their capital to advance Phase 3 investigational products.
- The company has received significant grant funding, including a total of approximately $1.8 million in recent months to support various product developments.
- Dare Bioscience Inc (DARE) has a robust pipeline with products like Sildenafil Cream and Ovaprene, targeting large, untapped markets with no current FDA-approved treatments.
- XACIATO, a product from Dare Bioscience Inc (DARE)'s portfolio, has been successfully commercialized and is gaining traction in the U.S. market.
- The company has demonstrated proof-of-concept for innovative drug delivery platforms, potentially transforming treatment for chronic conditions beyond women's health.
Negative Points
- Dare Bioscience Inc (DARE) reported a comprehensive loss of approximately $6.8 million for the first quarter of 2024.
- R&D expenses, although lower than the previous year, still constitute a significant part of the company's expenditures, impacting their financial stability.
- The company ended the first quarter with $3.6 million in cash and cash equivalents, which raises concerns about their financial runway without additional funding.
- There are uncertainties and dependencies on FDA feedback and approvals for advancing their key products like Sildenafil Cream into Phase 3 trials.
- The need for additional capital to initiate and complete the Sildenafil Cream Phase 3 study, estimated at around $15 million, poses a financial challenge.
Q & A Highlights
Q: Can you walk us through the steps needed to initiate the Phase 3 trial for Sildenafil Cream?
A: Sabrina Martucci Johnson, President & CEO of Dare Bioscience, explained that the company is awaiting FDA feedback to align on the final Phase 3 design and endpoints. Concurrently, they are preparing by selecting CROs, finalizing study budgets, and ensuring clinical supplies are ready. This proactive approach aims to expedite the trial's initiation once FDA feedback is received.
Q: When can we expect initial data or the final readout for the Ovaprene trial?
A: Sabrina Martucci Johnson noted that the Ovaprene trial is a 12-month study and recruitment began at the end of the previous year. While it's too early for specific timelines, the company is pleased with the response to their advertising campaign and plans to provide updates on study completion and recruitment progress throughout the year.
Q: How does your current funding align with your operational plans, especially considering the cash runway and spending levels?
A: Sabrina Martucci Johnson addressed financial strategies, highlighting the impact of the $22 million from the XOMA financing. This funding, along with reduced R&D expenses, positions the company to reach significant milestones, particularly with the Ovaprene trial. However, she clarified that initiating the Sildenafil Cream Phase 3 trial would require careful financial planning, as the estimated cost is around $15 million.
Q: What feedback are you awaiting from the FDA regarding the Sildenafil Cream trial?
A: The CEO elaborated that while the indication, patient population, and trial duration have been agreed upon with the FDA, the company awaits feedback on safety data requirements and endpoint hierarchy. This includes discussions on primary and secondary endpoints based on Phase 2b study results, which demonstrated improvements in arousal, orgasm, and desire.
Q: What does the clinical program for the DARE-LARC1 technology look like, and how does it compare to similar products?
A: Sabrina Martucci Johnson described the clinical pathway for DARE-LARC1, which will likely mirror hormone-releasing implants like Nexplanon in terms of contraceptive effectiveness studies. Additionally, the unique pause and resume dosing feature of DARE-LARC1 will be evaluated, potentially starting in Phase 1 trials.
Q: Can you provide an update on the potential for interim data from the Ovaprene trial?
A: The CEO mentioned that the company is monitoring enrollment closely, which will guide the timing of interim data availability. While final data is not expected this year, Dare Bioscience anticipates providing meaningful updates and refining timelines as more information becomes available.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
