Daré Bioscience Receives $2.5M Grant for DARE-LARC1 Contraceptive Development

Daré Bioscience, Inc. (NASDAQ: DARE), a pioneering company in women's health, announced the receipt of a $2.5 million payment under a grant agreement to advance the development of its investigational contraceptive, DARE-LARC1. This grant is intended to support nonclinical proof of principle studies and other work needed to submit an IND (Investigational New Drug) application to the FDA, a crucial step before human testing can begin. The total potential funding under this grant is approximately $49 million, with Daré having already received about $31.8 million. Further payments are contingent on achieving specific progress milestones.

Sabrina Martucci Johnson, President and CEO of Daré Bioscience, emphasized that this milestone validates the ongoing significance of developing DARE-LARC1. She highlighted its potential not only in reproductive health but also in treating conditions like diabetes and obesity that require precise, prolonged treatment. Daré's innovative technologies, such as the DARE-LARC1, continue to receive substantial non-dilutive funding, underpinning their importance and potential impact.

DARE-LARC1 represents a new class of long-acting, reversible contraceptives (LARC). If successfully developed and approved, this product could offer women superior control over their fertility, aligning with their family planning needs. Unlike existing LARC methods, DARE-LARC1 features precision dosing, extended device duration, and wireless control. It uses levonorgestrel, an active ingredient in several FDA-approved contraceptives.

Earlier this year, Daré achieved technological proof of concept for DARE-LARC1 and its innovative drug delivery platform, designed to store and deliver therapeutic doses over extended periods through a single device. This milestone underscores the platform's potential to alleviate the burden of frequent dosing or regular injections for various conditions. The technology was originally developed at MIT by researchers Robert Langer, Ph.D., and Michael J. Cima, Ph.D., and had been validated in a first-in-human study with osteoporosis patients. Daré has since enhanced the design, integrating custom electronics, hardware, and software to meet drug delivery targets while incorporating user feedback to optimize the device.

Daré's progress has resulted in a versatile platform technology with potential applications beyond reproductive health, including diabetes and obesity management. The company is currently exploring strategic partnerships to support these opportunities.

Key features of the DARE-LARC1 implant technology include:

- Precision dosing: Enables precise timing and amount of doses using drug micro-reservoirs.
- Extended duration: One device can provide doses over months to years.
- No need for external recharging: The implant contains a battery designed to last up to 20 years.
- Upgradable platform: Device software can be updated without removing the implant.
- Two-way communication: The device can wirelessly respond to external queries, provide updates, and modify dosing.
- Smartphone integration: Custom mobile apps can personalize the user experience.

Daré Bioscience is dedicated to advancing innovative products for women's health. Their mission is to develop and market a diverse portfolio of therapies that prioritize women's health, expanding treatment options and improving outcomes in areas such as contraception, sexual health, pelvic pain, fertility, infectious diseases, and menopause. Their first FDA-approved product is XACIATO™ (clindamycin phosphate) vaginal gel 2%, used to treat bacterial vaginosis, under a global license agreement with Organon.

Daré's portfolio includes several promising candidates in clinical development, such as Ovaprene®, a hormone-free monthly contraceptive licensed to Bayer; Sildenafil Cream, 3.6%, a new formulation to treat female sexual arousal disorder; and DARE-HRT1, an intravaginal ring for menopausal hormone therapy. The company continues to seek opportunities to deliver differentiated therapies for women.

In recognition of its contributions to innovation and advocacy in women's health, Daré Bioscience and its leadership have received various honors. In 2023, its CEO was named one of Fierce Pharma’s Most Influential People in Biopharma. Additionally, Daré was recognized as the top small company in the San Diego Business Journal’s 2023 Best Places to Work Awards.

Daré Bioscience remains committed to using various channels, including its website, SEC filings, press releases, and social media, to share important company updates and material information with investors and the public.