Daré Bioscience, Inc. (NASDAQ: DARE) is a biopharmaceutical company dedicated to advancing innovative products for women's health. The company has assembled a diverse portfolio of differentiated product candidates targeting unmet needs in areas such as contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. Daré's unique model and strategic collaborations position it well to accelerate innovation for women while driving value for its stakeholders.
Financial Overview
In the fiscal year 2023, Daré reported annual revenue of $2,807,885, primarily driven by license fee revenue from its exclusive global license agreement with Organon to commercialize XACIATO (clindamycin phosphate) vaginal gel 2%. However, the company incurred a net loss of $30,161,391 and had negative operating and free cash flows of $38,856,654 and $39,486,084, respectively, as it continued to invest heavily in the development of its pipeline.For the first quarter of 2024, Daré reported general and administrative expenses of approximately $2.7 million and research and development expenses of approximately $3.3 million, a 34% decrease compared to the first quarter of 2023. The company's comprehensive loss for the quarter was approximately $6.8 million. As of March 31, 2024, Daré had approximately $3.6 million in cash and cash equivalents and approximately 101 million shares of common stock outstanding.
Strengthening the Balance Sheet through Strategic Financing
To support the advancement of its pipeline, Daré recently announced a $22 million non-dilutive royalty financing transaction with XOMA. Under the agreement, Daré received the upfront $22 million in gross proceeds, and XOMA will make upside-sharing milestone payments to Daré equal to 50% of all remaining cash flows sold to XOMA. This transaction accelerates potential cash flows from the future commercial success of XACIATO and allows Daré to focus on advancing its Phase III investigational products, Ovaprene and Sildenafil Cream.In addition to the royalty financing, Daré has received approximately $29.4 million in grant funding to date under its agreement with a foundation to support the development of its investigational contraceptive DARE-LARC1. The company may receive up to a total of $49 million under this grant agreement.
Business Overview
Daré's business strategy is to in-license or acquire the rights to differentiated product candidates in women's health, advance them through mid to late-stage clinical development or regulatory approval, and establish strategic collaborations to achieve commercialization. The company's portfolio includes one FDA-approved product, XACIATO, and several product candidates in advanced clinical development, including Ovaprene, Sildenafil Cream, DARE-HRT1, DARE-VVA1, and DARE-CIN.XACIATO: Commercialization Underway
XACIATO, a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older, was approved by the FDA in December 2021. Daré has an exclusive global license agreement with Organon to commercialize XACIATO, and the product became available by prescription across the United States in the first quarter of 2024. Organon's Women's Health sales team continues to see strong acceptance from clinicians who have prescribed XACIATO for their patients, and the company expects the commercial ramp-up to build momentum throughout 2024.Sildenafil Cream, 3.6%: Advancing Towards Phase III for Female Sexual Arousal Disorder
Daré's Sildenafil Cream, 3.6% represents a significant market opportunity, as there are currently no FDA-approved treatments for any form of sexual arousal disorder in women. The company recently announced the successful completion of an end-of-Phase II meeting with the FDA, paving the way for the initiation of a Phase III clinical trial. Daré is continuing to interact with the FDA to finalize the Phase III study design, including the primary and secondary efficacy endpoints. The company expects to provide updates on the FDA's feedback and its Phase III plans later this year.Ovaprene: Pivotal Phase III Study Underway for Hormone-Free Contraception
Ovaprene, Daré's novel investigational hormone-free monthly intravaginal contraceptive, has the potential to be a disruptive product in the contraceptive category and an important option for women who cannot use or prefer not to use hormone-based birth control. In December 2023, Daré commenced patient enrollment in the pivotal Phase III clinical study of Ovaprene, which is being conducted in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH). Recruitment is currently underway at 18 sites across the United States, supported by a central advertising campaign. Daré plans to provide updates on the anticipated timing for study completion as enrollment progresses.DARE-HRT1 and DARE-VVA1: Advancing Towards Phase III for Menopausal Indications
Daré's portfolio also includes DARE-HRT1, an intravaginal ring designed to deliver both bio-identical estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms as part of menopausal hormone therapy, and DARE-VVA1, a proprietary formulation of tamoxifen for intravaginal administration being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe vulvovaginal atrophy. The company is conducting activities to support the submission of investigational new drug applications and the initiation of Phase III clinical studies for both product candidates.DARE-LARC1: Innovative Contraceptive Implant Technology
Daré's preclinical-stage DARE-LARC1 program represents an innovative contraceptive implant technology designed to deliver levonorgestrel with a woman-centered design that has the potential to be a long-acting, yet convenient and user-controlled contraceptive option. The company recently achieved a significant milestone, demonstrating technological proof-of-concept for the underlying drug delivery platform, which has transformative potential not only in women's health but also in various chronic conditions outside of women's health. Daré's development of DARE-LARC1 is supported by a grant of up to $49 million from a foundation.