Daré Bioscience, Inc. 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. 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. 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 device can provide dosing over months to years. No external charging or recharging required: A custom implant grade battery is designed to last for up to 20 years, depending on the application.

Upgradable platform: Device software can be updated without removal or replacement of the implant. Two-way communication: Smart technology can respond wirelessly to queries from an external communication device to provide status updates, modify dosing, and deliver other application specific information. Smartphone integration: Platform can be paired with custom mobile apps designed for each application to create a personalised experience for the user.