Dare Bioscience, Inc.

Welcome to the conference call hosted by DAR-A Bayou Science to review the company's first quarter financial results and to provide the general business update. This call is being recorded. My name is Alex, and I will be your operator for today. With us today from DAR-A are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Marty Haring-Layton, Chief Accounting Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to the DARE Bioscience Financial Results and Business Update Call for the quarter ended March 31, 2024. Today, we'll review our first quarter results and discuss developments and expectations from our pipeline and portfolio. I would like to remind you that today's discussion will include forward-looking statements within the meaning of the 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 the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended March 31, 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, May 14, 2024. DARE undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. Before we begin today's update, I'd like to take a minute to remind those of you who may be newer to the DARE story of our purpose and mission. We believe DARI is the only publicly traded company focused solely on women's health, pharmaceutical product development broadly, 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 and 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. We seek to optimize these treatments for our target indications to enhance outcomes, convenience, and side effect profile, or to address a novel indication where the pharmacology is well-suited but has not been previously applied to the indication in question for women. We believe we have assembled the broadest portfolio of potential high impact first in category product candidates, many of which have already demonstrated proof of concept and that our robust pipeline positions as well for the short, medium, and long term. On our recent full year 2023 financial results and update call, we discussed the strides we made last year to advance innovative therapies for women and the key milestones anticipated for 2024. So today, in addition to the continued commercialization by our collaborator organon of Zasciato Clindamycin Phosphate Vaginal Gel 2%, the first FDA-approved product to emerge from our portfolio, and a treatment for bacterial vaginosis in female age 12 and older that's now available by prescription nationwide. On that last call, we discussed anticipated 2024 milestones. focused on our first-in-category product candidates relating to continued progress toward a Phase III clinical trial of sidenafil cream 3.6% in female sexual arousal disorder, for which there are no FDA-approved treatments, and enrollment in our Phase III study of oviprene, our potentially first-in-category hormone-free monthly intravaginal contraceptive candidates. Today, we're going to cover our first quarter 2024 accomplishments, as well as some important recent highlights, including the 22 million non-dilutive strategic royalty financing we announced a couple weeks ago. We'll also review our progress against the anticipated 2024 milestones, providing context and metrics that are important to our current and future shareholders, with a focus on those phase three candidates, oviprene and sildenafil cream. Before I do, I'm going to first turn it over to our Chief Accounting Officer, Marty, to review our first quarter financial results.

Thanks, Sabrina, and thanks, everyone, for joining us today. I would now like to summarize DARE's financial results for the quarter ended March 31, 2024, which I will refer to as the first quarter. As Sabrina mentioned, DARE's business strategy is to assemble in advance a portfolio of differentiated product candidates that address meaningful unmet needs we've identified in women's health, and then to monetize the value of our portfolio's clinical and regulatory advances over the near and long term. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development, or R&D, expenses. During the first quarter of 2024, our general and administrative expenses were approximately $2.7 million. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other R&D activities across our entire portfolio, were approximately $3.3 million for the first quarter, which is a 34% decrease compared to Q1 2023. Closeout costs related to the Phase IIb respond clinical study of sildenafil cream and other clinical studies conducted in 2023 contributed significantly to our first quarter R&D expenses, which will not be the case in future quarters. Until we commence a sildenafil cream Phase III clinical study, we expect R&D expenses for future quarters to be lower than the first quarter R&D expenses. Our comprehensive loss for the quarter was approximately $6.8 million. We ended the first quarter with approximately $3.6 million in cash and cash equivalents and had approximately 101 million shares of common stock outstanding as of May 13th. We recently announced a royalty monetization transaction with ZOMA in which DARE received $22 million in gross proceeds, and following a pre-specified total return to ZOMA, ZOMA will make upside-sharing milestone payments to DARE equal to 50% of all remaining cash flows sold to ZOMA under the transaction. This monetization of future net royalty and net milestone payments accelerates potential cash flows from the future commercial success of Zasciato and ensures that DARE and our shareholders have the opportunity to participate meaningfully in Zasciato economics as commercialization progresses. This non-dilutive financing provides significant capital to help achieve our objectives and importantly allows us to focus on advancing our phase three investigational products, Ovaprene and Sildenafil Cream, both of which represent large market first in category opportunities. The structure of this transaction also underscores the significant potential of oviprene and sildenafil cream with DARE retaining the significant majority of future economics and the ability to achieve attractive margins through retained net sales and all commercial milestones. In addition to this financing, we received total grant funding of approximately $1.8 million in January and April under our grant agreements with the foundation in support of our investigational contraceptive DARE LARP-1 and to fund activities related to bacteria-based live biotherapeutic product development. DARA may receive up to a total of approximately $49 million under our grant agreement relating to DERLARC1 to advance development of DERLARC1 through non-clinical proof-of-principle studies and other work to prepare for the submission of an investigational new drug application with the FDA, approval of which is required to begin testing in humans. To date, DARE has received approximately $29.4 million under the DARE-LARC-1 grant agreement. Together, the royalty financing and latest installment in grant funding represent our commitment to being creative, collaborative, and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value. We encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our quarterly report on Form 10-Q for the quarter ended March 31st, 2024, which we filed this afternoon, as well as in our annual report on Form 10-K for the year ended December 31st, 2023, which was filed on March 28th, 2024. I would now like to turn the call back over to Sabrina.