Daré Bioscience Announces Grant to Support Biotherapeutic Product Development
- None.
- None.
Receiving a grant from a renowned entity like the Bill & Melinda Gates Foundation is a significant endorsement for Daré Bioscience. This funding is earmarked for the development of bacteria-based live biotherapeutic products, a niche yet growing segment within the biotechnology industry. Live biotherapeutics represent a promising frontier in medicine, particularly in addressing unique health challenges faced by women and newborns.
From an industry perspective, this grant not only bolsters Daré's financial position but also reinforces its strategic focus on women's health. The support for the global bacterial biologic supply chain analysis indicates a proactive approach towards ensuring the scalability and accessibility of these biotherapeutics. Identifying suitable Contract Manufacturing Organizations (CMOs) is crucial, as it impacts the speed to market and cost-effectiveness of new therapies.
The collaboration with the Gates Foundation may also enhance investor confidence in Daré's capabilities and commitment to bringing innovative treatments to market. While the immediate financial impact of the grant is modest relative to the overall cost of drug development, the strategic implications for long-term growth and positioning within the women's health sector are substantial.
The development of live biotherapeutic products, especially for vaginal health, is an area of medical research with significant unmet needs. The grant from the Gates Foundation, which follows a previous grant for a related hydrogel formulation, highlights the foundation's commitment to advancing women's health technologies. The focus on bacteria-based biotherapeutics is particularly relevant as it taps into the growing understanding of the human microbiome and its impact on health.
For stakeholders, the potential benefits of these products include targeted, non-antibiotic treatments that could prevent or treat infections and other conditions without contributing to antibiotic resistance. The emphasis on data gathering and analysis of the supply chain underscores the importance of robust, scalable production processes that can meet clinical and commercial demands.
However, the path from development to market for biotherapeutics is fraught with challenges, including regulatory hurdles and the need for extensive clinical trials to demonstrate safety and efficacy. The grant may help mitigate some of these risks by providing resources to navigate the complexities of manufacturing and supply chain logistics.
The financial infusion from the Gates Foundation grant represents more than just capital—it's a strategic investment that could leverage Daré Bioscience's position in the market. The grant's size, $750,000, while not transformative, does provide a runway extension for specific R&D activities without diluting shareholder value. This is crucial for a biotech firm where cash burn rates are high and the time to profitability is often extended.
Investors should note the incremental nature of funding, with Daré having received a previous grant, which suggests a vote of confidence in the company's direction and management. This could be a positive signal for the stock, as it implies a level of due diligence and endorsement by a reputable philanthropic organization.
Long-term, the strategic benefits include potential partnerships and the strengthening of Daré's pipeline. The focus on manufacturing capabilities could streamline the path to commercialization, which is a significant value driver in biotech. However, investors must remain cognizant of the inherent risks in drug development and the fact that grants do not guarantee product success.
Grant funds support activities that will aid the ultimate development of bacteria-based biotherapeutic products designed to benefit women and newborns
SAN DIEGO, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it has received a grant from the Bill & Melinda Gates Foundation (the foundation) of
The additional grant is intended to cover the costs of Daré personnel to gather and analyze data on the global bacterial biologic supply chain to help the foundation identify potential Contract Manufacturing Organization (CMO) partners for manufacturing clinical and commercial supplies of bacteria-based biotherapeutic products.
“Daré was selected to conduct this landscape review given our proven ability to find, audit and recommend global manufacturers capable of commercial scale therapeutic production, as we have done for XACIATOTM (clindamycin phosphate) vaginal gel
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, vaginal health, reproductive health, menopause, sexual health and fertility.
Daré’s first FDA-approved product, 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,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “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 impact of the activities funded by the grant, including the potential for such activities to lead to the development of safe and effective bacteria-based biotherapeutic products designed to benefit women and newborns. 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 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:
Media and Investors on behalf of Daré Bioscience, Inc:
Camilla White / Simona Kormanikova
Dentons Global Advisors
DareBioscience@dentonsglobaladvisors.com / 1.212.466.6450
Source: Daré Bioscience, Inc.
FAQ
What grant did Daré Bioscience receive and from whom?
What is the purpose of the grant received by Daré Bioscience?
Who will benefit from the activities funded by the grant?
