New NIH award will provide approximately $908,000 in year-long support of preclinical development, with potential for an additional future-year grant of approximately $1.3 million
DARE-PTB2 is an early-stage, investigational program focused on developing a potential new therapeutic approach for the prevention of preterm birth
SAN DIEGO, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women's health between promising science and real-world solutions, today announced that it received a new notice of award from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) in the amount of approximately $908,000 to advance the Company’s DARE-PTB2 program for the prevention of preterm birth. The notice of award also includes recommended future-year support of approximately $1.3 million for completion of initial preclinical pharmacokinetic, safety, and toxicity studies.
DARE-PTB2 is an early-stage investigational program focused on developing a potential new therapeutic approach for the prevention of idiopathic preterm birth. The program aims to address a significant unmet medical need, as preterm birth remains a leading cause of infant morbidity and mortality worldwide and there are no FDA-approved therapeutic options available to reduce the risk of preterm birth.
“We are grateful for the continued support from the NIH and NICHD for the DARE-PTB2 program and for their recognition of the importance of developing new approaches to address preterm birth. This new award provides important non-dilutive funding to support the continued advancement of DARE-PTB2 and reflects our strategy of leveraging non-dilutive funding opportunities to advance innovative programs addressing significant unmet needs in women’s health,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
The DARE-PTB2 program builds on research previously supported by NICHD. In July 2023, Daré received a notice of award from NICHD of approximately $400,000 to support preclinical development of a potential new therapeutic for the prevention of idiopathic preterm birth. The funding supported proof-of-concept target validation studies conducted in collaboration with the University of South Florida.
“Continued support from the NIH enables us to advance the scientific foundation of the DARE-PTB2 program and further evaluate a potential new therapeutic approach to addressing preterm birth,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “We appreciate the NICHD’s continued commitment to this important area of research and to the development of innovative solutions for women and their babies.”
About DARE-PTB2
DARE-PTB2 is an early-stage, investigational program for the development of a therapeutic treatment to prevent idiopathic preterm birth. The program is focused on a novel therapeutic approach intended to address biological mechanisms associated with preterm birth.
Preterm birth, defined as birth before 37 weeks of pregnancy have been completed, is a significant global health challenge and is associated with substantial morbidity and mortality among infants. Preterm birth can result from a range of underlying causes, and there remains a significant need for therapeutic approaches to reduce the risk of preterm delivery.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit www.nichd.nih.gov.
The research described in this press release was supported by the NICHD of the NIH under Award Number R41HD113465, or will be supported by the NICHD of the NIH under Award Number R44HD113465. The content of this press release is solely the responsibility of Daré Bioscience and does not necessarily represent the official views of the NIH.
ABOUT DARÉ BIOSCIENCE, INC.
Daré Bioscience (NASDAQ: DARE) is a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions. Every innovation Daré Bioscience advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, sexual health to fertility, vaginal health to infectious disease, Daré Bioscience is working to close critical gaps in care using science that serves her needs. For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to proven solutions is lagging. Daré Bioscience is working to change that. Learn more at darebioscience.com.
FORWARD-LOOKING STATEMENTS
Daré Bioscience 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,” “prepare,” “aim,” “should,” “would,” “build” 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: receipt of payments under the new NIH award; the potential for an additional future-year NIH grant in support of DARE-PTB2; the extent of preclinical development work that may be completed with the support of NIH funding; plans and timing for continued development of DARE-PTB2; the potential safety and therapeutic benefits of a novel approach for the prevention of preterm birth; Daré’s ability to obtain and leverage non-dilutive funding to advance development of therapeutic candidates for women’s health; and the potential market opportunity for DARE-PTB2.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré Bioscience’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 Bioscience’s ability to demonstrate satisfactory progress with the DARE-PTB2 project to NICHD and continued compliance with the terms and conditions of the funding award; federal government actions to freeze or terminate NIH grants or significantly reduce the NIH’s budget and research funding; disruptions at the NIH or NICHD due to federal government shutdowns, other funding shortages, policy changes, leadership changes, or significant layoffs or personnel turnover; Daré Bioscience’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; potential suspension and delisting of Daré Bioscience’s common stock from the Nasdaq Capital Market; Daré Bioscience’s dependence on grants and other financial awards from governmental entities and a private foundation; Daré Bioscience’s reliance on third parties to manufacture and conduct preclinical and clinical studies of its product candidates and the risk that those third parties do not perform as expected; failure or delay in starting, conducting and completing preclinical and clinical studies and the inherent uncertainty of outcomes of such development work; Daré Bioscience’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; the risks 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 Bioscience’s interpretation of or conclusions regarding data from nonclinical and/or clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré Bioscience anticipates, or that the duration of a study or number of study subjects must be significantly greater than anticipated; the loss of, or inability to attract, key personnel; Daré Bioscience’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré Bioscience’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 Bioscience’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; disputes or other developments concerning Daré Bioscience’s intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré Bioscience’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 Bioscience’s products or product candidates or the business activities of Daré Bioscience, its commercial collaborators or other third parties on which Daré Bioscience relies; changes in healthcare, pharmaceutical, consumer protection or privacy laws and regulatory policies; increased scrutiny from regulators; global trends toward health care cost containment; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré Bioscience’s ability to raise additional capital or on Daré Bioscience’s operations, financial results and condition, and ability to achieve current plans and objectives; and cybersecurity incidents or similar events that compromise Daré Bioscience’s technology systems and/or significantly disrupt Daré Bioscience’s business or those of third parties on which it relies.
Daré Bioscience’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 Bioscience’s risks and uncertainties, you are encouraged to review its documents filed with the U.S. Securities and Exchange Commission (SEC), including Daré Bioscience’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 Bioscience 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.
Contact:
Daré Bioscience Investor Relations
innovations@darebioscience.com
Source: Daré Bioscience, Inc.
