Release Date: November 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) secured over $20 million in non-dilutive funding in the last 30 days, including a $10.7 million grant from the Bill and Melinda Gates Foundation.
- The company has a broad portfolio focused on women's health, with ongoing advancements in contraception, sexual health, pelvic pain, fertility, infectious disease, and menopause.
- Dare Bioscience Inc (DARE) is progressing with its first FDA-approved product, Clindamycin phosphate vaginal gel, for bacterial vaginosis, with increasing prescription rates.
- The company is advancing its late-stage candidates, including Ovaprene, a hormone-free contraceptive, and Sildenafil Cream for female sexual arousal disorder, with ongoing FDA interactions.
- Dare Bioscience Inc (DARE) has established a $15 million equity line arrangement with Lincoln Park Capital Fund LLC, enhancing its financial flexibility.
Negative Points
- General and administrative expenses increased by 24% compared to Q3 2023, indicating higher operational costs.
- The company's comprehensive loss for the third quarter was approximately $4.7 million, reflecting ongoing financial challenges.
- R&D expenses decreased by 60% compared to Q3 2023, which may indicate reduced investment in research and development activities.
- The company faces uncertainties related to FDA approval processes for its late-stage candidates, which could impact timelines and outcomes.
- Dare Bioscience Inc (DARE) needs to secure additional funding to fully support its clinical trials, particularly for the Sildenafil Cream program.
Q & A Highlights
Q: Congrats on the progress, especially on accelerating enrollment in the Ovaprene study. Are we still expecting an interim look by the end of Q2 2025, and what should we expect from this interim readout? Just safety, or can we learn about efficacy too?
A: Yes, the interim look is an important milestone. The study is open-label, meaning everyone receives the active product, which allows us to monitor safety continuously. The specifics of what will be reviewed and disclosed are still being discussed with our commercialization collaborator, Bayer, and the data safety monitoring board. The contraceptive rates tend to improve over time, so we need to consider how to handle any interim data.
Q: Can you share more about what you mean by operational progress towards phase three for Sildenafil Cream, and what is still outstanding with the FDA?
A: Our discussions with the FDA have focused on defining appropriate endpoints for the phase three program, as this is a first-in-category product. We are working to ensure alignment on expectations for efficacy and safety. Operationally, we are preparing by identifying CROs, sites, and ensuring drug supply, so we are ready to proceed once we have alignment with the FDA.
Q: Regarding the Ovaprene trial and potential interim analysis, what specific actions might follow from this analysis?
A: The DSMB is primarily monitoring safety, and the interim analysis will be conducted when we have enough patients and cycles to review. The timing is significant because contraceptive studies typically require a minimum of six months of data. We are considering how to handle the data review and any potential disclosures, especially given the known improvements in contraceptive rates over time.
Q: With the additional funding for the Ovaprene study, how many additional sites do you plan to add?
A: We currently have 20 sites under the NIH's clinical trial network, with recruitment focused on about half of them. The additional funding will allow us to add a handful of new sites, which can significantly impact enrollment given the efficiency of the sites we've selected based on past performance.
Q: For Sildenafil Cream, once you have FDA alignment and funding, how soon could you initiate the trial?
A: After aligning with the FDA on the final protocol, traditional study startup activities like site contracts and IRB approvals will take a couple of months. If funding is secured, starting the trial early next year is possible.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
