Daré Bioscience Announces $2.5 Million Grant Funding Installment to Support Further Development of Novel Contraceptive Technology DARE-LARC1
Daré Bioscience received a $2.5 million grant installment for developing DARE-LARC1, a novel contraceptive technology. This payment is part of a larger $49 million grant agreement, of which $31.8 million has been received to date. DARE-LARC1 represents a potential new category of long-acting, reversible contraceptive featuring precision dosing, extended device duration, and wireless control.
The technology, originally developed at MIT, achieved technological proof of concept earlier this year. The platform uses levonorgestrel and is designed to store and deliver therapeutic doses over extended periods through a single device. Key features include precision dosing, extended duration capability, built-in battery lasting up to 20 years, wireless communication, and smartphone integration.
The company is exploring strategic partnerships for applications beyond reproductive health, including diabetes, obesity, and other conditions requiring precise, prolonged treatment.
Daré Bioscience ha ricevuto un finanziamento di 2,5 milioni di dollari per lo sviluppo di DARE-LARC1, una nuova tecnologia contraccettiva. Questo pagamento fa parte di un accordo di finanziamento più ampio di 49 milioni di dollari, di cui 31,8 milioni sono stati ricevuti fino ad oggi. DARE-LARC1 rappresenta una potenziale nuova categoria di contraccettivi a lungo termine e reversibili, caratterizzati da dosaggio preciso, durata estesa del dispositivo e controllo wireless.
La tecnologia, sviluppata originariamente al MIT, ha raggiunto la prova di concetto tecnologico all'inizio di quest'anno. La piattaforma utilizza il levonorgestrel ed è progettata per immagazzinare e fornire dosi terapeutiche nel corso del tempo attraverso un unico dispositivo. Le caratteristiche chiave includono dosaggio preciso, capacità di durata estesa, batteria incorporata che dura fino a 20 anni, comunicazione wireless e integrazione con smartphone.
L'azienda sta esplorando partnership strategiche per applicazioni oltre la salute riproduttiva, inclusi diabete, obesità e altre condizioni che richiedono trattamenti precisi e prolungati.
Daré Bioscience recibió un pago de 2.5 millones de dólares para el desarrollo de DARE-LARC1, una nueva tecnología anticonceptiva. Este pago es parte de un acuerdo de subvención más amplio de 49 millones de dólares, de los cuales se han recibido 31.8 millones hasta la fecha. DARE-LARC1 representa una nueva categoría potencial de anticonceptivos de acción prolongada y reversibles que cuenta con dosificación precisa, duración extendida del dispositivo y control inalámbrico.
La tecnología, originalmente desarrollada en el MIT, logró una prueba de concepto tecnológica a principios de este año. La plataforma utiliza levonorgestrel y está diseñada para almacenar y administrar dosis terapéuticas durante períodos prolongados a través de un único dispositivo. Las características clave incluyen dosificación precisa, capacidad de duración extendida, batería incorporada que dura hasta 20 años, comunicación inalámbrica e integración con smartphones.
La empresa está explorando asociaciones estratégicas para aplicaciones más allá de la salud reproductiva, incluyendo diabetes, obesidad y otras condiciones que requieren tratamientos precisos y prolongados.
Daré Bioscience는 새로운 피임 기술인 DARE-LARC1의 개발을 위해 250만 달러의 보조금을 받았습니다. 이 지급은 총 4,900만 달러 규모의 보조금 계약의 일환으로, 현재까지 3,180만 달러를 수령했습니다. DARE-LARC1은 정밀 투약, 장시간 사용 가능한 장치, 무선 제어 기능을 갖춘 장기 작용형 가역 피임제의 새로운 가능성을 의미합니다.
이 기술은 MIT에서 최초로 개발되었으며, 올해 초 기술 개념 증명을 달성했습니다. 이 플랫폼은 레보노르게스트렐을 사용하며 단일 장치를 통해 장기간에 걸쳐 치료용 적정 용량을 저장하고 전달하도록 설계되었습니다. 주요 기능으로는 정밀한 용량 조절, 연장된 사용 기간, 최대 20년 사용할 수 있는 내장 배터리, 무선 통신, 스마트폰 통합 등이 있습니다.
회사는 생식 건강을 넘어 당뇨병, 비만 및 정밀하고 장기간 치료가 필요한 기타 조건에 대한 응용을 위한 전략적 파트너십을 모색하고 있습니다.
Daré Bioscience a reçu une subvention de 2,5 millions de dollars pour le développement de DARE-LARC1, une nouvelle technologie contraceptive. Ce paiement fait partie d'un accord de subvention plus large de 49 millions de dollars, dont 31,8 millions ont été reçus à ce jour. DARE-LARC1 représente une nouvelle catégorie potentielle de contraceptifs à action prolongée et réversibles, dotés d'une dosage précis, d'une durée de dispositif prolongée et d'un contrôle sans fil.
La technologie, initialement développée au MIT, a atteint la preuve de concept technologique plus tôt cette année. La plateforme utilise le lévonorgestrel et est conçue pour stocker et délivrer des doses thérapeutiques sur de longues périodes via un dispositif unique. Les caractéristiques clés incluent un dosage précis, une capacité de durée prolongée, une batterie intégrée d'une durée de vie allant jusqu'à 20 ans, une communication sans fil et une intégration avec les smartphones.
L'entreprise explore des partenariats stratégiques pour des applications au-delà de la santé reproductive, y compris le diabète, l'obésité et d'autres conditions nécessitant un traitement précis et prolongé.
Daré Bioscience hat eine Finanzspritze von 2,5 Millionen Dollar für die Entwicklung von DARE-LARC1, einer neuen Verhütungstechnologie, erhalten. Diese Zahlung ist Teil eines größeren Fördervertrags über 49 Millionen Dollar, von dem bis heute 31,8 Millionen Dollar eingegangen sind. DARE-LARC1 stellt eine potenzielle neue Kategorie von Langzeit- und reversiblen Verhütungsmitteln dar, die über präzise Dosierung, lange Einsatzdauer und kabellose Steuerung verfügen.
Die Technologie, die ursprünglich am MIT entwickelt wurde, erlangte zu Beginn dieses Jahres den technologischen Nachweis des Konzepts. Die Plattform nutzt Levonorgestrel und ist darauf ausgelegt, therapeutische Dosen über längere Zeiträume durch ein einzelnes Gerät zu speichern und bereitzustellen. Zu den wichtigsten Merkmalen zählen präzise Dosierung, die Möglichkeit einer verlängerten Einsatzdauer, integrierte Batterien mit einer Lebensdauer von bis zu 20 Jahren, drahtlose Kommunikation und die Integration in Smartphones.
Das Unternehmen prüft strategische Partnerschaften für Anwendungen über die reproduktive Gesundheit hinaus, einschließlich Diabetes, Fettleibigkeit und andere Erkrankungen, die eine präzise und langfristige Behandlung erfordern.
- Received $2.5 million non-dilutive grant funding
- Total grant potential of $49 million with $31.8 million already received
- Achieved technological proof of concept for the drug delivery platform
- Platform technology has potential applications beyond contraception in lucrative markets like diabetes and obesity
- Additional grant payments are conditional on meeting specific milestones
- Product still requires FDA IND approval before human testing can begin
Insights
The
The strategic exploration of partnering opportunities for additional indications, particularly in the lucrative GLP-1/obesity market, could unlock substantial value. Given the current
DARE-LARC1's technological breakthrough in precision drug delivery represents a significant advancement in contraceptive technology. The platform's key innovations - precision dosing, extended duration and wireless control - address major limitations of current LARC options. The successful proof of concept achievement and first-in-human validation from MIT researchers adds credibility to the technology.
The platform's potential expansion into GLP-1 delivery for obesity and diabetes treatment is particularly noteworthy, as it could solve the injection burden associated with current GLP-1 medications. The ability to deliver precise doses over extended periods without frequent administration could dramatically improve treatment adherence and outcomes across multiple therapeutic areas.
The smart technology features of DARE-LARC1 set it apart in the medical device space. The integration of custom electronics, wireless communication and smartphone connectivity creates a sophisticated drug delivery ecosystem. Key technological advantages include:
- Battery life of up to 20 years without recharging
- Wireless two-way communication capabilities
- Software upgradeability without device removal
- Customizable mobile applications for different therapeutic uses
These features position the platform well for both current and future medical applications, with significant potential for technological differentiation in the market.
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, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced it received a payment of
“This latest installment continues to validate our progress and the importance of developing this technology, which can be used 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,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Like the grant that we announced earlier this month to support development of a novel non-hormonal contraceptive candidate, the DARE-LARC1 product candidate is another one of our novel contraceptive technologies that continues to be supported by non-dilutive funding.”
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 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 personalized experience for the user.
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious diseases, and menopause.
The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel
Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards.
Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.
Forward-Looking Statements
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the potential for Daré to receive additional payments under the grant agreement relating to DARE-LARC1, DARE-LARC1’s potential as a safe and effective LARC product, the potential market opportunity for DARE-LARC1, if approved, the potential of the drug delivery technology underlying DARE-LARC1 to be utilized in products for the treatment of a broad range of diseases and conditions, and the potential for Daré to enter into strategic collaborations relating to the drug delivery technology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to achieve the DARE-LARC1 pre-clinical development and other milestones required for it to receive additional payments under the grant agreement; the potential that no definitive agreements result from discussions regarding potential strategic collaborations for the drug delivery technology underlying DARE-LARC1; Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Contacts:
Daré Bioscience Investor Relations
innovations@darebioscience.com
Source: Daré Bioscience, Inc.
FAQ
How much grant funding has Daré Bioscience (DARE) received for DARE-LARC1 development?
What are the key features of DARE-LARC1 contraceptive technology?
What therapeutic areas is DARE-LARC1 targeting beyond contraception?
When did Daré Bioscience achieve technological proof of concept for DARE-LARC1?
