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Daré Bioscience Announces Grant Funding Installment to Support Further Development of Novel Contraceptive Technology DARE-LARC1

Daré Bioscience's DARE-LARC1 Platform Technology has Transformative Potential for Women's Health as well as in Treating a Broad Range of Diseases Strategic Process Underway to Explore Partnering Opportunities for Additional Indications such as with GLP-1s for Obesity and Metabolic Disorders and Other Conditions Requiring Precise, Prolonged Treatment SAN DIEGO, April 23, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced it will receive a payment of $1 million as the latest installment under a grant agreement to advance the development of Daré's investigational contraceptive DARE-LARC1 through nonclinical proof of principle studies and other IND-enabling work to allow for the submission of an Investigational New Drug (IND) Application with the FDA, approval of which will be required to commence testing in humans. Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1. To date, Daré has received payments totaling approximately $28.3 million. Additional payments are conditioned on the program meeting specified development and reporting milestones. "The DARE-LARC1 product candidate is one of a number of novel contraceptive technologies being developed by Daré," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "We believe that DARE-LARC1 has the potential to address important and unique needs not currently being addressed by commercially available options, and has the potential to become a new and unique birth control option, potentially leading to a meaningful expansion of the already recognized 18 contraceptive categories." DARE-LARC1 is a potential new category of long-acting, reversible contraceptive (LARC). If successfully developed and approved, DARE-LARC1 could provide women with unparalleled control over the management of their fertility to better meet specific individual family planning goals and objectives. As with other types of LARC products, investigational DARE-LARC1 is intended to provide effective contraception for an extended period without requiring day-to-day effort. Unlike current LARC products, DARE-LARC1's innovative features include precision dosing, extended device duration and wireless control. DARE-LARC1 utilizes levonorgestrel, which is the active pharmaceutical ingredient in a number of FDA-approved birth control methods. Earlier this year Daré announced that it achieved technological proof of concept for DARE-LARC1 and the underlying innovative drug delivery platform designed to store and precisely deliver therapeutic doses over months or years through a single device. That milestone reflects the drug delivery platform's potential to address the treatment burden for various conditions where treatment requires frequent dosing or regular injections. The technology behind this drug delivery platform was originally developed at the Massachusetts Institute of Technology by renowned researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D. and was previously validated in a first-in-human study in osteoporosis patients using an earlier prototype. Daré has since made significant technological enhancements to the design and integration of custom electronics, hardware, and software to achieve drug delivery targets while incorporating user feedback to optimize form and function. Daré's progress has resulted in a highly versatile platform technology with potential to address meaningful unmet needs in reproductive health as well as other therapeutic areas including diabetes, obesity, and other conditions requiring precise and prolonged treatment. To support development opportunities outside of the reproductive health category, including diabetes, obesity, and other conditions requiring precise and prolonged treatment, Daré is exploring strategic discussions with potential industry partners. Key features of the implant technology include: Precision dosing: Unique design allows for precise dose timing and amount using individually addressable drug micro-reservoirs. Extended duration and dosing interval control: The ability to house up to hundreds of individual doses means a single ...