Dare Bioscience, Inc.

Welcome to the conference call hosted by Daray Bioscience to review the company's third quarter financial results and to provide a general business update. This call is being recorded. My name is Desiree and I will be your operator today. With us today from Daray are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Mardy Herring-Layton, Chief Accounting Officer. Ms. Herring-Layton, please proceed.

Good afternoon and welcome to the DARE Bioscience Financial Results and Business Update Call for the quarter ended September 30th, 2024. Today we will review our third quarter results and discuss developments and expectations for our pipeline and portfolio. I would like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter end of September 30, 2024, which was filed today. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, November 14, 2024. The RA undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. I will now turn it over to Sabrina.

Thank you, and thank you for joining the call today. We have a number of updates to cover, including regarding the over $20 million in non-dilutive funding that we announced in just the last 30 days. So we very much look forward to taking you through them. We believe Dari is the only publicly traded company focused solely on women's health, pharmaceutical product development broadly. across contraception, sexual health, pelvic pain, fertility, infectious disease, and menopause. And we remain dedicated to advancing disruptive products for the health and well-being of women through clinical development, regulatory review, and ultimately to market. Our commitment and focus is to improve health outcomes in the lives of women by leveraging the basic science and pharmacology that is understood about certain active pharmaceutical ingredients, and marketed products to accelerate innovative treatments that women want and need by boldly addressing existing therapeutic gaps, and we believe this is a competitive advantage. We believe we have the broadest portfolio of potentially high-impact first-in-category product candidates to improve the health and well-being of women, many of which have already demonstrated proof-of-concept And then our robust pipeline positions us well for the short, medium, and long term. Our broad portfolio allows us to integrate clinical and regulatory learnings from across our knowledge base. And this is what has allowed us to conduct eight successful clinical trials to date and hold 25 FDA interactions across six product candidates in 2023 and 2024 alone. We continue to be excited about the increased attention on the health and well-being of women, including by the Advanced Research Projects Agency for Health, or ARPA-H, as evidenced by their recent announcement related to the awardees of the ARPA-H Sprint for Women's Health and our announcement under that program of the $10 million award we were selected to receive. For DARE-HPV, which is an innovative investigational treatment for human papillomavirus or HPV-related cervical diseases. Essentially, all cervical cancer cases worldwide are caused by HPV infection. And just this week, we announced an up to $10.7 million grant from the Bill and Melinda Gates Foundation to support activities that will aid in the identification, and development of novel non-hormonal intravaginal contraceptive product candidates, and we'll also provide funding to allow DARE to expand the number of clinical sites in the ongoing oviprene pivotal study to accelerate the development timeline. We continue to execute on our mission to accelerate development of and bring to market innovative treatments that, as I mentioned earlier, women want and need, and we do this by advancing our late-stage candidates, all of which represent a first-in-category opportunity as we seek to deliver value for all of DARI's stakeholders. In addition to the continued commercialization by our collaborator organon of Daciato, clindamycin phosphate vaginal gel 2%, which is the first FDA-approved product to emerge from our portfolio and which is a treatment for bacterial vaginosis in females age 12 and older that is available by prescription nationwide, We also continued to advance our first in category Phase III development candidates with ongoing enrollment in our Phase III study of oviprene at sites across the U.S. and continued constructive interactions with the FDA focused on aligning on the Phase III program for sedentafil cream 3.6% in female sexual arousal disorder. As we've discussed before, despite its high prevalence, there are currently no FDA-approved treatments. for female sexual arousal disorder, and we look forward to advancing this program into phase three. Additionally, we are conducting activities in preparation for a phase two clinical study of DARE VVA-1 and a phase one study of DARE PTB-1, which is supported by a $2 million grant from NICHD, all of which I will cover briefly today. The progress across our portfolio, along with the $10.7 million grant announcement yesterday, and the $10 million award from ARPA-H announced in October, the $15 million equity line arrangement we established with Lincoln Park Capital Fund LLC or Lincoln Park in October, and the $22 million we secured in the non-dilutive strategic royalty financing in the second quarter put DARI on track for meaningful milestones in 2025. We have a number of updates on our development portfolio to that end that I will provide today. But before I do, I'm going to first turn it back over to our Chief Accounting Officer, Marty, to review the third quarter financial results.