Company Overview

Daré Bioscience, Inc. is a biopharmaceutical company dedicated to advancing innovative products for women's health. The company has assembled a diverse portfolio of product candidates targeting unmet needs in areas such as contraception, sexual health, pelvic pain, fertility, infectious disease, and menopause. Daré's unwavering commitment to women's wellbeing has positioned it as a trailblazer in an industry that has historically overlooked this critical segment of the population.

History and Development

Founded in 2015, Daré has rapidly emerged as a leader in the women's health space, leveraging its unique expertise to develop a robust pipeline of differentiated therapies. The company began assembling its diverse portfolio in 2017 through acquisitions, exclusive in-licenses, and other collaborations. In 2018, Daré made significant strides by acquiring Pear Tree Pharmaceuticals and obtaining the rights to develop a proprietary formulation of tamoxifen for vaginal administration, which became the DARE-VVA1 program. That same year, the company entered into license agreements with Catalent and Adare Pharmaceuticals to expand its product candidate portfolio. Daré's first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel 2%), emerged from its portfolio in 2021. In 2022, the company entered into an exclusive global license agreement with Organon to commercialize XACIATO, which was subsequently launched in 2024 for the treatment of bacterial vaginosis in females 12 years of age and older. Throughout its history, Daré has faced challenges, including a history of losses from operations, net losses, and negative cash flows from operations, requiring continuous efforts to secure additional capital through equity and debt financing, as well as non-dilutive grant funding.

Financials

Daré's financial performance has been marked by both successes and challenges. For the fiscal year ended December 31, 2023, the company reported total revenue of $2.81 million, a significant improvement from the previous year's $0.00 million. However, the company also incurred a net loss of $30.16 million, reflecting the substantial investment required to advance its diverse portfolio of product candidates. This trend has continued into 2024, with the company reporting a net loss of $4.70 million for the third quarter.

The most recent quarter's revenue was $41,691, representing a 96% decrease from the $1 million reported in the same quarter of the previous year. The company's net loss for the quarter stood at $4.70 million. As of September 30, 2024, Daré had cash and cash equivalents of $11.23 million and a working capital of $1.80 million. The company reported a net income of $1.45 million for the nine months ended September 30, 2024, which was positively impacted by $20.38 million in net proceeds from the sale of its rights to future royalty and milestone payments from XACIATO and Ovaprene.

Research and development expenses for the nine-month period were $10.89 million, while general and administrative expenses were $7.16 million. In the third quarter of 2024, R&D expenses were $2.7 million, representing a 60% decrease compared to the same quarter in 2023, aligning with the company's previous guidance that full-year 2024 R&D expenses would be lower than those in 2023.

Liquidity

Despite these financial hurdles, Daré has made remarkable strides in securing non-dilutive funding to support the development of its pipeline. In the last 30 days alone, the company has announced over $20 million in grants and awards, including a $10.7 million grant from the Bill & Melinda Gates Foundation and a $10 million award from the Advanced Research Projects Agency for Health (ARPA-H) for its DARE-HPV program. These strategic partnerships and funding sources have been instrumental in enabling Daré to advance its innovative product candidates without unduly burdening its shareholders.

The company's liquidity position is reflected in its debt-to-equity ratio of 0.08, current ratio of 1.14, and quick ratio of 1.14. Daré will need to raise substantial additional capital to continue funding its operations and executing its business strategy, as its current cash resources are not sufficient to satisfy its working capital needs and other liquidity requirements over at least the next 12 months. The company is exploring various capital raising options, including sales of equity, debt financings, collaborations, and other financing arrangements.

Product Pipeline

Daré's pipeline boasts several promising late-stage candidates, including Ovaprene, a hormone-free monthly intravaginal contraceptive, and Sildenafil Cream, 3.6%, a topical formulation of sildenafil being developed to treat female sexual arousal disorder (FSAD). The company has made significant progress in the development of these programs, with the Ovaprene pivotal Phase 3 study currently enrolling patients across the United States and constructive discussions with the FDA regarding the design of the Sildenafil Cream Phase 3 program.

For the Ovaprene pivotal Phase 3 study, Daré expects that approximately half of their target number of participants (125 women) will complete approximately six months of product use by the end of Q2 2025. The company is conducting a multi-center, single-arm, non-comparative study to evaluate Ovaprene's effectiveness, safety, and acceptability.

In addition to its late-stage candidates, Daré's portfolio includes several earlier-stage programs that address a wide range of women's health needs. These include DARE-VVA1, a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe dyspareunia, and DARE-PTB1, an intravaginal ring designed to deliver bioidentical progesterone continuously for the prevention of preterm birth.

The company's contraceptive portfolio also includes DARE-LARC1, a contraceptive implant delivering levonorgestrel, and DARE-RH1, a novel approach to non-hormonal contraception. In the menopausal health segment, Daré is developing DARE-HRT1, an intravaginal ring designed to deliver both bio-identical estradiol and progesterone. However, the company does not plan to initiate the Phase 3 study of DARE-HRT1 until it secures additional capital.

In the infectious disease space, DARE-HPV is a proprietary, fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases. Daré is conducting activities to enable the submission of an investigational new drug (IND) application to the FDA for a Phase 2 clinical study, which will be supported by funding from the ARPA-H Sprint for Women's Health initiative.

Daré's preclinical pipeline further includes DARE-LBT, a novel hydrogel formulation for vaginal delivery of live biotherapeutics; DARE-GML, an intravaginally-delivered potential multi-target antimicrobial agent; and DARE-PTB2, a novel approach for the prevention and treatment of idiopathic preterm birth.

Innovation and Collaboration

Daré's commitment to innovation extends beyond its product pipeline. The company has also been at the forefront of the growing focus on women's health, collaborating with leading organizations and agencies to drive advancements in this critical area. The recent $10 million award from ARPA-H for the development of DARE-HPV, a potential first-in-category treatment for human papillomavirus (HPV)-related cervical disease, is a testament to Daré's innovative approach and the recognition of its work by prestigious institutions.

The company expects to receive an initial payment of approximately $5.4 million under the $10.7 million grant agreement with the Bill & Melinda Gates Foundation in 2024, with additional payments contingent on achieving development and reporting milestones. Furthermore, Daré anticipates receiving up to $10 million in milestone-based payments under the $10 million ARPA-H award over an approximately 24-month period.

Market Position and Industry Trends

Daré Bioscience operates exclusively in the United States women's health pharmaceutical industry. This sector has demonstrated steady growth, with a compound annual growth rate (CAGR) of 5-7% over the past five years. The company's focus on addressing unmet needs in women's health positions it well to capitalize on this growing market.

Investment Considerations

The challenges faced by Daré, such as the need for substantial investment in research and development and the inherent risks associated with pharmaceutical development, are not unique to the company. However, Daré's unwavering dedication to women's health, its diversified portfolio, and its ability to secure non-dilutive funding have positioned it as a compelling investment opportunity for those seeking exposure to the growing women's health market.

As Daré continues to navigate the complexities of the pharmaceutical industry, investors would be wise to closely monitor the company's progress in advancing its clinical programs, securing regulatory approvals, and demonstrating the commercial potential of its product candidates. With a clear focus on addressing unmet needs and a commitment to innovation, Daré Bioscience appears poised to play a pivotal role in transforming the landscape of women's health.