Dolutegravir-based antiretroviral therapy is set to be increasingly replace ritonavir-boosted lopinavir-based regimens for the treatment of paediatric HIV. This prospective cohort study aims to compare tolerability, adverse effects, and virological outcomes between the two regimen types using a before-after design. The study is conducted in Lesotho, southern Africa, and includes children and adolescents transitioning from ritonavir-boosted lopinavir-based to dolutegravir-based antiretroviral therapy. It aims to provide detailed information on treatment tolerability and to inform paediatric treatment programmes.

Start Date11 Jul 2022

Sponsor / Collaborator

Swiss Tropical & Public Health Institute

[+4]

ChiCTR2100044217

/ RecruitingNot ApplicableIIT

A pilot study for CYP3 Ainhibitor enhance the antidepressant effects of S-ketamine

Start Date01 Sep 2020

Sponsor / Collaborator-

100 Clinical Results associated with Lopinavir

100 Translational Medicine associated with Lopinavir

100 Patents (Medical) associated with Lopinavir

6,061

Literatures (Medical) associated with Lopinavir

01 May 2026·HEART & LUNG

Mechanical ventilation patterns and outcomes in patients with right ventricular (RV) dysfunction: A cohort study

Article

Author: Barker, Anna K ; Adie, Sarah K ; Konerman, Matthew C ; Lopacinski, Aaron ; Joyce, Elizabeth ; Ketcham, Scott W ; King, Steven ; Gupta, Gagan ; Marshall, Vincent D

BACKGROUND:

Lung-protective ventilation (LPV), defined as tidal volume (TV) <8ml/kg ideal body weight and plateau pressure (Pplat) <30cmH2O, improves mortality in many populations. Although little data exists for IMV management of patients with RV failure, the American College of Cardiology (ACC) Critical Care Working Group recommends LPV and low (<3-5cmH2O) starting positive end-expiratory pressure (PEEP) in right ventricular (RV) failure.

OBJECTIVES:

Describe IMV patterns in cardiac ICU patients with RV dysfunction and compare to ACC Critical Care Working Group recommendations. Secondary was to evaluate LPV impact on two-year survival.

METHODS:

This is a single-center, retrospective study. We included patients intubated >24 h in the cardiac ICU between 2017-2022 with RV dysfunction prior to intubation, identified by echocardiography. Patients were excluded if they did not have at least one fraction of inspired oxygen ≥50 %. We collected median PEEP in initial 24 h and twice daily measurements (6am/6pm) for IMV duration or 28 days.

RESULTS:

There were 192 patients, with 4010 TVs and 2628 Pplats. When both TV and Pplat were available (2594), 2014/2594 (77.6 %) qualified as LPV. LPV was associated with decreased two-year mortality (HR 0.2, p < 0.001). Less than half (59/139, 42.4 %) had starting PEEP of ≤5cmH2O, which was not associated with two-year survival.

CONCLUSIONS:

As compared to ACC Critical Care Working group guidelines, most patients with RV dysfunction at our institution were ventilated using LPV but not low starting PEEP. LPV was associated with increased two-year survival and low starting PEEP was not associated in a positive or negative way.

01 Apr 2026·ARTIFICIAL INTELLIGENCE IN MEDICINE

Calibration-informed metrics for instance-level predictive reliability in medical AI

Article

Author: Cabitza, Federico

Conventional performance metrics in clinical decision support systems, such as accuracy or sensitivity, fail to reflect the reliability of individual predictions-an essential concern for clinicians operating in high-stakes environments. We introduce a calibration-informed framework featuring two novel metrics: the Local Predictive Value (LPV) and the Credible Predictive Value (CPV). LPV estimates the empirical reliability of a prediction by assessing the observed correctness frequency in the neighborhood of its confidence score. CPV refines this estimate using a Bayesian approach, integrating global predictive values as priors to produce a posterior distribution over correctness probabilities. LPV offers a descriptive, data-driven view of local reliability, while CPV provides a belief-adjusted estimate that mitigates overfitting to sparse local data. Applied to benchmark medical imaging datasets, these metrics yielded locally adaptive, interpretable reliability estimates. Divergences between LPV and CPV identified cases where local evidence was insufficient or misleading, highlighting how Bayesian smoothing improves stability against sparse or misleading local evidence. By combining local calibration with Bayesian inference, LPV and CPV advance the development of medical AI systems that are not only accurate but also interpretable and trustworthy at the individual case level.

01 Mar 2026·Lancet Child & Adolescent Health

Weight gain, body composition, and metabolic parameters of dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: an ancillary analysis of the ODYSSEY trial

Article

BACKGROUND:

ODYSSEY trial showed superior efficacy of dolutegravir-based antiretroviral therapy (ART) versus then-current, non-dolutegravir standard of care over 96 weeks in children and adolescents living with HIV. The aim of this ancillary analysis was to compare anthropometric and body composition outcomes, including weight, height, BMI-for-age Z score, weight-for-age and height-for-age Z scores (<14 kg), mid-upper-arm circumference (MUAC), waist circumference, hip circumference, and body fat percentage, as well as metabolic outcomes (lipids and glucose), between dolutegravir and standard of care over approximately 5 years of follow-up.

METHODS:

In this open-label, randomised, non-inferiority trial, children (aged ≥4 weeks and <18 years), weighing 3 kg or more, starting first-line ART (ODYSSEY-A) or switching to second-line ART (ODYSSEY-B) were enrolled in 29 centres in Germany, Portugal, South Africa, Spain, Thailand, Uganda, Zimbabwe, and the UK in two cohorts (children weighing ≥14 kg and children weighing <14 kg). Treatment effects (dolutegravir vs standard of care) were estimated on randomised allocation, accounting for treatment switches (substantial in standard of care arm during extended follow-up) through censoring and inverse-probability-of-censoring-weights. Changes in continuous outcomes were compared using linear mixed models, accounting for correlated slope and baseline value. Proportions of participants with unfavourable outcomes were compared using logistic mixed models. ODYSSEY is registered with ClinicalTrials.gov, NCT02259127, EUDRACT, 2014-002632-14, and ISRCTN, ISRCTN91737921.

FINDINGS:

Between Sept 20, 2016, and Aug 26, 2019, 792 children were randomly assigned (392 to dolutegravir and 400 to standard of care). Of 707 children in the 14 kg or more cohort, 311 received first-line ART (ODYSSEY-A; 145 [92%] of 157 received efavirenz-based ART as standard of care) and 396 received second-line ART (ODYSSEY-B; 195 [98%] of 200 received boosted protease inhibitors as standard of care). Of 85 children in the less than 14 kg cohort, 72 received first-line ART (32 [74%] of 43 received lopinavir-ritonavir as first-line or second-line standard of care). Median follow-up on randomised allocation was 287 weeks (IQR 240-311) on dolutegravir-based ART and 205 weeks (168-240) on standard of care in the 14 kg or more cohort, and 220 weeks (208-232) on dolutegravir-based ART and 144 weeks (127-192) on standard of care in the less than 14 kg cohort. In the 14 kg or more cohort, 345 (49%) were female and 362 (51%) were male, 623 (88%) were Black African, median enrolment age was 12·2 years (IQR 9·1 to 14·9), weight 30·7 kg (23·4 to 43·0), and BMI-for-age Z score -0·6 (-1·4 to 0·1); 35 (5%) were overweight and six (1%) were obese. At week 240, adjusted mean differences (dolutegravir minus standard of care) were 1·0 kg for weight (95% CI -0·2 to 2·2; p=0·095) and 0·4 cm for MUAC (0·0 to 0·8; p=0·030), driven by differences in first-line participants, where higher increases were also observed in height, waist circumference, and hip circumference. Increases in BMI-for-age Z score, body fat percentage, and cross-sectional waist-to-height ratio were similar on dolutegravir-based ART and standard of care. Total cholesterol (-15·3 mg/dL [-21·0 to -9·5]; p<0·0001), triglycerides (-14·4 mg/dL [-25·2 to -3·6]; p=0·0089), and glucose (-4·4 mg/dL [-6·8 to -1·9]; p=0·0004) were lower with dolutegravir than standard of care. In the less than 14 kg cohort, 44 (52%) were female and 41 (48%) were male, 83 (98%) were Black African, median enrolment age was 1·4 years (IQR 0·6 to 2·0), weight 8·1 kg (5·4-10·0) and BMI-for-age Z score -0·8 (-1·9 to 0·2); three (4%) were overweight and none obese. Changes in weight, weight-for-age, BMI-for-age and height-for-age Z scores by 192 weeks were similar on dolutegravir and standard of care; there were small differences in MUAC (0·6 cm [-0·1 to 1·3]; p=0·070) and height (-2·5 cm [-4·5 to -0·5]; p=0·016). No significant differences in lipid biomarkers were observed; glucose decreased with standard of care but not with dolutegravir.

INTERPRETATION:

Over approximately 5 years, indices defining excessive weight gain and central adiposity were similar with dolutegravir and other anchor drugs, and lipid and glycaemia profiles with dolutegravir were reassuring, providing supporting evidence for dolutegravir-based ART as the preferred treatment in children and adolescents.

FUNDING:

Fondazione Penta ETS, ViiV Healthcare, and UK Medical Research Council.

News (Medical) associated with Lopinavir

23 Feb 2026

·www.biospace.com

Daré Bioscience Announces FDA Clearance of IND for Phase 2 Clinical Study of DARE-HPV, a Potential Treatment for Persistent High-Risk HPV Infection, the Most Common Cause of Cervical Cancer

DARE-HPV development supported by $10 million ARPA-H contract; program targets major unmet need with no FDA-approved therapies SAN DIEGO, Feb. 23, 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 the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for DARE-HPV, an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, allowing initiation of a planned Phase 2 clinical study to evaluate DARE-HPV as a potential treatment for persistent high-risk human papillomavirus (HPV) infection. DARE-HPV is being developed as a non-surgical, localized, self-administered therapy designed to clear persistent high-risk HPV infection. HPV infection is the underlying cause of 99% of cervical cancer cases in the United States. There are currently no FDA-approved pharmacologic treatments for HPV infection. By targeting the virus itself rather than waiting for cellular changes to develop, DARE-HPV has the potential to redefine the treatment paradigm in cervical disease prevention. HPV is one of the most common sexually transmitted viral infections worldwide. An estimated over 11 million women in the U.S. alone acquire a new HPV infection every year. While most HPV infections resolve spontaneously, millions of women experience persistent high-risk HPV infection, the type of HPV infection that can progress to precancerous cervical lesions and, ultimately, cervical cancer if left untreated. According to the Centers for Disease Control and Prevention, high-risk HPV types are responsible for nearly all cases of cervical cancer in the United States. Today, the standard of care does not treat the virus. Instead, women with persistent high-risk HPV infection are monitored through repeated screening. Intervention typically occurs only after precancerous lesions develop, often requiring surgical procedures such as excisional or ablative treatments of cervical tissue. These procedures may increase the risk of preterm birth in future pregnancies and can pose risks to fertility – creating a significant physical and emotional burden for women. “FDA clearance to proceed to Phase 2 represents an important regulatory milestone for DARE-HPV and for women who currently have no treatment options for persistent high-risk HPV infection,” said Sabrina Johnson, President and CEO of Daré Bioscience. “For decades, women have been told to ‘watch and wait’ to see if the virus clears on its own. If it does not, the only option has been surgery once precancerous changes appear. DARE-HPV is designed to intervene earlier – targeting the virus itself before progression to cervical disease – aiming to eliminate the frequent “watchful waiting” visits to a health care provider that are costly, burdensome, and contribute to socioeconomic and racial disparities in cervical cancer.” The planned Phase 2 study is expected to evaluate the safety and antiviral activity of DARE-HPV in women with persistent high-risk HPV infection. The program, including the planned Phase 2 clinical trial, is supported by a $10 million contract funded by the Advanced Research Projects Agency for Health (ARPA-H) , part of the U.S. Department of Health and Human Services, $6.5 million of which has been received to date. Persistent high-risk HPV infection represents a substantial unmet medical need: High-risk HPV types cause virtually all cases of cervical cancer There are no FDA-approved pharmacologic treatments for high-risk HPV infection Current intervention strategies rely on surgical removal of abnormal cervical tissue Surgical procedures are associated with increased risks of preterm birth and potential impacts on fertility “This program reflects our commitment to advancing science where women have historically had limited or no therapeutic options,” Johnson added. “With ARPA-H support and FDA clearance in hand, we are positioned to advance DARE-HPV efficiently into Phase 2 and generate clinical data that could meaningfully change how persistent high-risk HPV infection is managed.” Daré Bioscience will provide additional details regarding the Phase 2 study design and anticipated timelines for study initiation, which the company is preparing for 2026, in the coming months. About Daré Bioscience Daré Bioscience 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 advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Daré 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 real, evidence-based solutions continues to lag. Daré was founded to change that. As a female-led health biotech company, Daré is accelerating the development of credible, science-based solutions that meet the high standards of clinical rigor – randomized, controlled trials; validated endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements. To learn more about Daré’s mission to deliver differentiated therapies for women and its innovation pipeline, please visit . Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré's CEO has been 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 may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website ( ), 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, products 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,” “prepare,” “seek,” “should,” “would,” “target,” “objective,” “positioned,” 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 plans and timing for initiating a Phase 2 clinical study of DARE-HPV, Daré’s expectation of receipt of additional funding under its ARPA-H award to support development, including the planned Phase 2 study, of DARE-HPV, Daré’s ability to advance DARE-HPV efficiently into Phase 2 and generate meaningful clinical data, DARE-HPV’s potential as a safe and effective treatment for clearance of high-risk HPV infection, the potential for DARE-HPV to be the first FDA-approved therapy for high-risk HPV infection, the potential for DARE-HPV to redefine the treatment paradigm in cervical disease prevention, and the potential market opportunity for DARE-HPV, if approved. 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 execute its business strategy and continue as a going concern; Daré’s ability to achieve the product development and other milestones required for it to receive additional payments under its ARPA-H award; 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, completing or conducting clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; 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 and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; the potential that a drug product candidate in Phase 2 development may never advance into or through a pivotal clinical study or obtain FDA or foreign regulatory approval; the risk that Daré’s product candidates may fail to demonstrate acceptable safety and tolerability or sufficient efficacy in clinical trials; 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, or that the duration of a study or number of study subjects must be significantly greater than anticipated; Daré’s reliance on third parties in conducting key aspects of its business, including manufacturing clinical study supplies and commercial product, conducting clinical trials and nonclinical studies, and commercializing products, and Daré’s lack of control over those third parties’ performance; difficulties or delays in establishing and sustaining relationships with third-party collaborators; 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 products and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; disputes or other developments concerning Daré’s intellectual property rights; product liability claims; governmental investigations or actions relating to Daré’s products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; changes in healthcare, pharmaceutical, consumer protection or privacy laws and regulatory policies; increased scrutiny from regulators; competitive product launches; a product’s ability to gain market acceptance; product liability claims; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; Daré’s ability to maintain compliance with Nasdaq’s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; and cybersecurity incidents or similar events that compromise Daré’s technology systems and/or significantly disrupt Daré’s business or those of third parties on which Daré relies. 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 U.S. Securities and Exchange Commission, 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.

Phase 2IND

13 May 2025

·ir.darebioscience.com

Daré Bioscience Reports First Quarter 2025 Financial Results and Provides Company Update

Creates commercial opportunity in the estimated up to $4.5 billion compounded hormone therapy market, enabling women to access an evidence-based solution Four on-market products will accelerate revenue generation and provide path to profitability Daré expects to start recording revenue in the 4th quarter of this year Conference call today at 4:30 p.m. ET to discuss the further expanded business strategy to commercialize multiple solutions in 2025 and 2026 2025 and 2026 Milestones Sildenafil Cream, 3.6% an investigational topical formulation of sildenafil being developed to treat female sexual arousal disorder, targeting availability via prescription as a Section 503B compounded drug this year DARE-HRT1 an investigational monthly intravaginal hormone therapy being developed to treat the vasomotor symptoms of menopause, targeting availability via prescription as a Section 503B compounded drug next year Vaginal probiotics, designed to restore a healthy vaginal microbiome, targeting availability as branded consumer health products this year Ovaprene®, a novel, investigational hormone-free monthly intravaginal contraceptive; enrollment ongoing in pivotal Phase 3 contraceptive efficacy study; data safety monitoring board interim assessment scheduled for July 2025 SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today reported financial results for the quarter ended March 31, 2025 and provided a company update. “The first quarter of 2025 has been marked by distractions and disruptions for the overall healthcare and biotech sector. I am proud that Daré is uniquely positioned to cut through the noise and deliver value to all of our stakeholders – women, healthcare providers, and investors. Today, biopharmaceutical companies with relatively low risk assets, a competitive advantage and a path toward near-term revenue are positioned to oﬀer upside. We believe that is Daré today,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Women's health is ripe for returns because it has been underfunded and fragmented – and with our recently announced expanded business strategy, we believe we are uniquely positioned to deliver value and returns to all of our stakeholders, with a business model that is nimble, allowing us to rapidly commercialize multiple products via multiple channels. We are no longer only seeking FDA approval; we are leveraging a dual path strategy where we commercialize via 503B compounding while continuing to seek FDA approval. We are also taking steps toward launching certain solutions as branded consumer health products that do not require a prescription.” “To our knowledge, we are the only publicly traded company focused solely on developing therapeutic products for a broad range of conditions affecting women – contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. And, to our knowledge, we are the only publicly traded company leveraging all available paths to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care – as an FDA-approved treatment, as a compounded product, as a consumer health product that does not require a prescription – available via telehealth, online, or via an in-person visit with her healthcare provider. Our portfolio is compelling and over the next months we look forward to providing updates regarding strategic partnerships and collaborations to facilitate access to Daré on-market brands for women across multiple channels,” said Ms. Johnson. Therapeutic Development Pipeline Highlights Ovaprene®, a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. Pivotal Phase 3 contraceptive efficacy study ongoing across the United States; an up to $10.7 million foundation non-dilutive grant announced in November 2024 supported addition of 5 new investigator sites in the first quarter of 2025. Review of interim data by the study's data safety monitoring board, an independent group of experts which evaluates the safety and integrity of the study, scheduled for July 2025. The primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles, or the estimated Pearl Index for Ovaprene. Secondary objectives are to assess Ovaprene's 13-cycle use cumulative pregnancy rate, safety, acceptability, product fit/ease of use, and assessments of vaginal health. If successful, Daré expects the study to support the submission of a premarket approval application for Ovaprene to the FDA, as well as regulatory filings in Europe and other countries worldwide, to allow for marketing approvals of Ovaprene. Sildenafil Cream, 3.6%, a proprietary, investigational cream formulation of sildenafil, the active ingredient in an oral erectile dysfunction drug for men, for topical on-demand administration to treat female sexual arousal disorder (FSAD). Continued interactions with the FDA regarding planned Phase 3 study; Phase 3 study design, development, and collaboration strategy updates expected throughout 2025. Daré is targeting submission of additional information requested by the FDA, along with the protocol and statistical analysis plan for the Phase 3 study, to the FDA by the end of the second quarter of 2025. DARE-HPV, a proprietary, investigational fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases. Conducting activities necessary to enable submission of an IND application to the FDA for a Phase 2, randomized, placebo-controlled, double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women. Supported with up to $10 million milestone-based non-dilutive award announced October 2024. Financial Highlights for the Quarter ended March 31, 2025 Cash position: at March 31, 2025, cash and cash equivalents of approximately $10.3 million, and working capital deficit of approximately $9.4 million. General and administrative expenses: $2.3 million in 1Q-2025 as compared to $2.7 million in 1Q-2024, with the current quarter’s decrease primarily attributable to decreases in stock-based compensation expense, professional services expense and personnel costs. Research and development expenses: $2.3 million in 1Q-2025 as compared to $3.4 million in 1Q-2024, a 31% decrease compared to Q1-2024. The current quarter’s decrease is primarily attributable to decreases in manufacturing costs related to Ovaprene, costs related to development activities for Sildenafil Cream, and costs related to development activities for preclinical stage programs. We encourage investors to review the more detailed discussion of our financial statements, our financial condition, liquidity, capital resources, and risk factors in our quarterly report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC today. Conference Call Daré will host a conference call and live webcast today, May 13, 2025, at 4:30 p.m. Eastern Time to review financial results for the quarter ended March 31, 2025 and to provide a company update. To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free). The conference ID number for the call is 3461324. The live webcast can be accessed under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under the same section of the company's website and available for replay until May 27, 2025. About Daré Bioscience Daré Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Daré believes that innovation does not have to start from scratch. The company’s goal is to bring to market as soon as practicable innovative evidence-based solutions that address decades of unmet needs in women’s health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential products Daré identifies, in many cases, already have clinical proof of concept or existing safety data for the active ingredient that the company leverages. This provides optionality and flexibility, in many cases, in how Daré seeks to bring solutions to market in ways designed to optimize access for women in a fiscally responsible manner. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in an oral erectile dysfunction drug for men, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré’s full portfolio of women’s health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré's CEO has been 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 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,” “on track,” 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 Daré’s go-to-market strategies; Daré’s plans and timing for making its proprietary formulations available by prescription in the U.S. as compounded drugs via Section 503B of Federal Food, Drug, and Cosmetic Act (FDCA) and for launching branded consumer health products; the market opportunity for those products and their ability to gain market acceptance; expected timing of revenue from sales and that such sales will provide a path to profitability for Daré; plans and expectations with respect to Daré’s product candidates, including clinical development plans, trial design, timelines, costs, milestones, targeted indications, clinical trials and results, regulatory strategy, and U.S. Food and Drug Administration (FDA) communications, submissions and review of applications; the clinical potential of and market opportunities for Daré’s product candidates; potential strategic partnerships and third-party collaborations; expectations regarding existing collaborations; and the amount and timing of Daré’s receipt of funds under grant agreements. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women’s health that is not being met by existing FDA-approved products. 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 execute its business strategy and continue as a going concern; the risk of delisting of Daré’s common stock from Nasdaq; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; Daré’s ability to enter into and maintain third-party collaborations to facilitate access to the solutions Daré intends to bring to market as compounded drugs or consumer health products and Daré’s reliance on those third parties; the performance of Section 503B-registered outsourcing facilities and other third parties on which Daré will rely to execute its expanded business strategy; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound the drug substances in the proprietary formulations Daré intends to bring or brings to market; the degree of market demand and acceptance for the products Daré brings to market; Daré’s reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future products, if any; the risk that the current regulatory pathway known as the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; Daré’s ability to achieve the product development and other milestones required for it to receive payments under its subaward and grant agreements; the potential for termination of the subaward and grant agreements before Daré receives additional payments; the limits on Daré’s ability to sell stock under its equity line arrangement at times it may desire to raise additional capital; 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 and the inherent uncertainty of outcomes of clinical trials; 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 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 and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; 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 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, pricing and reimbursement from third-party payors; 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 products 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. Source: Daré Bioscience, Inc.

Phase 3License out/inFinancial StatementDrug Approval

31 Mar 2025

·ir.darebioscience.com

Daré Bioscience Reports Full Year 2024 Financial Results and Provides Company Update

Enables women to access a solution that they want and need Creates an opportunity to accelerate revenue generation from this proprietary formulation Daré expects to start recording revenue and cash flow in the 4th quarter of this year Conference call today at 4:30 p.m. ET to discuss the expanded business strategy to integrate 503B compounding as part of a dual-path approach to bring select Daré proprietary formulations to market as soon as practicable SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today reported financial results for the year ended December 31, 2024 and provided a company update. “Daré exists to accelerate innovation in women’s health and our goal is to fulfill the urgent need for access to evidence-based treatment options. We are proud to announce that we are taking action to make our proprietary Sildenafil Cream formulation available via prescription this year as a compounded drug under Section 503B of the FDCA, because we believe women should not have to wait for access to our formulation when an alternative legal path via Section 503B is available while we continue to pursue FDA approval of Sildenafil Cream as a treatment for female sexual arousal disorder. Our proprietary formulation would be produced by a 503B-registered outsourcing facility partner, which is registered with the FDA, subject to FDA inspections and subject to quality standards, including compliance with cGMP regulations,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “After urging on the part of the healthcare community and hearing the demand from women, we are targeting making our proprietary Sildenafil Cream formulation available via one 503B-registered outsourcing facility partner in the fourth quarter of 2025.” “We believe the diversity of our portfolio, the progress we are making in advancing our product candidates, and the revenue opportunity from our proprietary Sildenafil Cream formulation based on our announcement today, puts Daré on track for meaningful milestones in 2025,” said Ms. Johnson. Sildenafil Cream and 503B Compounding "Healthcare providers and women are seeking a formulation of sildenafil that they can trust. Based on the study published in 2024 I am very excited about the availability of Daré’s Sildenafil Cream formulation as an ‘on demand' solution for women," stated Dr. Sheryl Kingsberg, Division Chief of Behavioral Medicine, Department of OBGYN, University Hospitals Cleveland Medical Center, Ohio, and Past President of The International Society for the Study of Women's Sexual Health, as well as co-editor of the Textbook of Female Sexual Function and Dysfunction: Diagnosis and Treatment. “I am thrilled that Daré is taking action to deliver this science-backed formulation—with product consistency from a 503B-registered outsourcing facility, complete toxicology studies, and randomized placebo-controlled studies—to the women who need it without delay." “As is the case with men, decreased genital blood flow can also compromise a woman's ability to have a pleasurable sexual experience. In January 2020 we published study findings demonstrating that Daré’s Sildenafil Cream elicits a quantifiable, rapid genital response in women within 10-15 minutes using thermography to assess genital temperature changes, a surrogate for genital blood flow,” stated Dr. Irwin Goldstein, the director of San Diego Sexual Medicine and President of The Institute for Sexual Medicine, Inc., and an expert considered a founder of the field of sexual medicine, having been involved with sexual dysfunction research since the late 1970′s and renowned for his work regarding erectile dysfunction as well as female sexual dysfunction. “It is encouraging that Daré is taking action to make this formulation available later this year for the women who need it.” “Daré is committed to a strategy that optimizes for access to solutions in a fiscally responsible manner. We plan to focus our resources on provider-to-provider education about disease state and our proprietary formulation and do not anticipate needing to invest more than $1 million to support the activities required to make our Sildenafil Cream formulation available via a partner 503B-registered outsourcing facility. We expect to start recording revenue and cash flow in the 4th quarter of this year. We are targeting the second quarter of 2025 to provide an update on the strategic partnerships to achieve these objectives,” added Ms. Johnson. “Like Sildenafil Cream, there are other proprietary formulations in the Daré portfolio that could also be provided via a prescription through the FDA’s 503B framework. We are actively evaluating a dual-path approach for some of our other proprietary formulations as part of our responsibility to women, to the healthcare community, and to our shareholders. In addition, we may also bring to market consumer health products that can be obtained without a physician’s prescription. We are also targeting the second quarter of 2025 to provide an update on timing and strategic partnerships to achieve these objectives.” 2024 Highlights and Anticipated 2025 Milestones – Therapeutic Development Pipeline Highlights Ovaprene®, a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. Pivotal Phase 3 contraceptive efficacy study ongoing across the United States; an up to $10.7 million foundation non-dilutive grant announced November 2024 supports addition of 5 new investigator sites. Currently, there are 15 active sites from within the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Contraceptive Clinical Trials Network following enrolled participants in the study. Enrollment is currently proceeding at five study sites that were initiated in 2025, funded by the grant received in 2024 to accelerate the overall study timeline. Daré anticipates that approximately 125 women, which is half of the target number of participants to complete the study, will complete approximately six months of Ovaprene use by the end of the second quarter of 2025. This is a designated check point for review of interim data by the study's data safety monitoring board, an independent group of experts which evaluates the safety and integrity of the study. The primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles, or the estimated Pearl Index for Ovaprene. Secondary objectives are to assess Ovaprene's 13-cycle use cumulative pregnancy rate, safety, acceptability, product fit/ease of use, and assessments of vaginal health. If successful, Daré expects the study to support the submission of a premarket approval application for Ovaprene to the FDA, as well as regulatory filings in Europe and other countries worldwide, to allow for marketing approvals of Ovaprene. Sildenafil Cream, 3.6%, a proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical on-demand administration to treat female sexual arousal disorder (FSAD). Continued operational progress toward a planned Phase 3 study, including constructive discussions with FDA; Phase 3 design, development, and collaboration strategy updates expected throughout 2025. In December 2024, Daré announced plans for a Phase 3 study of Sildenafil Cream reflecting FDA feedback for safety and efficacy evaluations to support the indication of treatment of FSAD in premenopausal women. Daré plans to submit the protocol and statistical analysis plan for an adequate and well-controlled Phase 3 clinical study, reflecting the FDA’s recommendations, to the FDA in the second quarter of 2025, pending review of additional forthcoming recommendations from the FDA that impact Daré’s statistical analysis plan. DARE-HPV, a proprietary, fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases. Conducting activities necessary to enable submission of an IND application to the FDA for a Phase 2, randomized, placebo-controlled, double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women. Supported with up to $10 million milestone-based non-dilutive award announced October 2024. DARE-VVA1, an investigational proprietary formulation of tamoxifen for intravaginal administration being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe dyspareunia, or pain during sexual intercourse. Conducting activities in preparation for a Phase 2 clinical study of DARE-VVA1 based on FDA-cleared IND. DARE-PTB1, an investigational intravaginal ring designed to deliver bio-identical progesterone continuously for up to 14 days for the prevention of preterm birth. Conducting activities necessary to enable the IND and a Phase 1 clinical study. Supported by a $2 million grant from NICHD. A Phase 1 study would also serve to support safety and PK for this progesterone intravaginal ring to also be investigated for luteal phase support as part of an IVF regimen. Casea S, an investigational biodegradable contraceptive implant. Casea S is designed to control release of a well-characterized contraceptive, etonogestrel, for a set period of time (18-24 months) before dissolving. It is designed to provide women with a long-acting, minimally-invasive contraceptive method that will not require surgical removal by a healthcare provider, which would improve convenience and could eliminate one of the barriers to use associated with existing implanted contraceptives. Casea S is being tested in a single-center, two-part Phase 1 clinical study to evaluate the PK of etonogestrel, removability, safety, and tolerability of Casea S pellets inserted subdermally in healthy women of reproductive age (ClinicalTrials.gov ID: NCT05174884). The ongoing Phase 1 study is being conducted by FHI 360, a nonprofit organization, with support from a foundation grant. There are no development costs to Daré at this time. Casea S was recently acquired by Theramex. In February 2025, Daré entered into a co-development and licensing agreement with Theramex for the development of Casea S in the U.S. If Daré determines that the results from the Phase 1 study are positive and elects to proceed with development, Daré would be responsible for conducting a Phase 2 study in the U.S. In accordance with the agreement, the costs of such Phase 2 study would be shared by Daré and Theramex on terms to be agreed upon, taking into account the size of the opportunity for Casea S in the respective markets. DARE-LARC1, a novel, long-acting, reversible personal contraceptive implant delivering levonorgestrel with a woman-centered design that has the potential to be a long-acting, yet convenient and user-controlled contraceptive option; development supported with an up to $49 million foundation grant. DARE-LARC1’s woman-centered design seeks to offer the benefits of traditional long-acting reversible contraceptives with the added flexibility and convenience for the user to pause and resume release of levonorgestrel, depending on her desire for fertility or contraceptive protection. Under a grant agreement entered into in June 2021, Daré may receive up to approximately $49.0 million, payable over approximately five years, to advance development of the technology through nonclinical proof of principle studies to enable an IND submission. $3.5 million in grant funding received in 2024, bringing the total received to date to $31.8 million. Financial Highlights Cash position: at December 31, 2024, cash and cash equivalents of approximately $15.7 million, and working capital deficit of approximately $3.2 million. General and administrative expenses: approximately $9.2 million for 2024, which is a 24% decrease compared to the prior year due primarily to reduced commercial readiness expenses and reduced headcount. Research and development (R&D) expenses: approximately $14.2 million for 2024, which is a 34% decrease compared to the prior year. R&D expenses in 2024 primarily reflected the costs of manufacturing activities and ongoing enrollment in the Phase 3 study of Ovaprene. Currently, Daré's only active clinical study is the Phase 3 study of Ovaprene. We encourage investors to review the more detailed discussion of our financial statements, our financial condition, liquidity, capital resources, and risk factors in our annual report on Form 10-K for the year ended December 31, 2024, filed with the SEC today. Conference Call Daré will host a conference call and live webcast today, March 31, 2025, at 4:30 p.m. Eastern Time to review financial results for the year ended December 31, 2024 and to provide a company update. To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free). The conference ID number for the call is 9767621. The live webcast can be accessed under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived in the same section of the company's website and available for replay until April 14, 2025. About Daré Bioscience Daré Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. We believe that innovation does not have to start from scratch. Our goal is to bring to market as soon as practicable innovative evidence-based solutions that address decades of unmet needs in women’s health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential products we identify, in many cases, already have clinical proof of concept or existing safety data for the active ingredient that we leverage. This gives us optionality and flexibility, in many cases, in how we seek to bring solutions to market in ways designed to optimize access for women in a fiscally responsible manner. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré’s full portfolio of women’s health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré's CEO has been 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 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,” “on track,” 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 plans and expectations with respect to Daré’s product candidates, including clinical development plans, trial design, timelines, costs, milestones, targeted indications, clinical trials and results, regulatory strategy, and FDA communications, submissions and review of applications; the clinical potential of and market opportunities for Daré’s product candidates; Daré’s go-to-market strategies; Daré’s plans and timing for making its proprietary formulation of Sildenafil Cream available by prescription in the U.S. as a compounded drug via Section 503B of Federal Food, Drug, and Cosmetic Act, the anticipated amount needed to invest to support the activities required to make its proprietary formulation of Sildenafil Cream available in such manner, its market opportunity and ability to gain market acceptance, and the expected timing of revenue and cash flow from sales; the potential future development of Casea S and that funding for future studies of Casea S may be shared between Daré and Theramex; potential third-party collaborations; expectations regarding existing collaborations; the amount and timing of Daré’s receipt of funds under grant agreements. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women’s health that is not being met by existing FDA-approved products. 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; the risk of delisting of Daré’s common stock from Nasdaq; developments impacting U.S. federal government contracting and funding of research and development activities; the degree of market demand and acceptance for Daré’s proprietary formulation of Sildenafil Cream provided as a compounded drug; Daré’s reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future products, if any; the performance of Section 503B-registered outsourcing facilities on which Daré will rely; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound sildenafil citrate; the risk that the current regulatory pathway known as the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; Daré’s ability to achieve the product development and other milestones required for it to receive payments under its subaward and grant agreements; the limits on Daré’s ability to sell stock under its equity line arrangement at times it may desire to raise additional capital; 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 and the inherent uncertainty of outcomes of clinical trials; 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, pricing and reimbursement from third-party payors; 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. Source: Daré Bioscience, Inc.

Phase 1Phase 3License out/inPhase 2Financial Statement

100 Deals associated with Lopinavir

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lopinavir	J05AR10	DB01601

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	Phase 3	Argentina	Abbott Laboratories	31 Dec 2010
HIV Infections	Phase 3	United States	Bristol Myers Squibb Co.	01 Nov 2005
HIV Infections	Phase 3	Argentina	Bristol Myers Squibb Co.	01 Nov 2005
HIV Infections	Phase 3	Australia	Bristol Myers Squibb Co.	01 Nov 2005
HIV Infections	Phase 3	Austria	Bristol Myers Squibb Co.	01 Nov 2005
HIV Infections	Phase 3	Belgium	Bristol Myers Squibb Co.	01 Nov 2005
HIV Infections	Phase 3	Brazil	Bristol Myers Squibb Co.	01 Nov 2005
HIV Infections	Phase 3	Canada	Bristol Myers Squibb Co.	01 Nov 2005
HIV Infections	Phase 3	Chile	Bristol Myers Squibb Co.	01 Nov 2005
HIV Infections	Phase 3	Colombia	Bristol Myers Squibb Co.	01 Nov 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00654147 (HIV, CTgov)	Phase 2	HIV Infections	44	Lopinavir+ritonavir+Raltegravir (Raltegravir & Lopinavir/Ritonavir)	sevjstfejk(sagkccsutk) = isiobkclnv rxmsktdywv (ucmbtvqdgs, xviyhfxrvj - rembailcig) View more	-	13 Jul 2015
				tenofovir+emtricitabine+Raltegravir (Raltegravir & Emtricitabine/Tenofovir)	sevjstfejk(sagkccsutk) = oviiwajngz rxmsktdywv (ucmbtvqdgs, uxrafragwo - wbhalpkxoh) View more
NCT00424814 (Pubmed \| Clin Infect Dis)	Phase 2/3	HIV Infections	105	Lopinavir/Ritonavir Monotherapy	xjkfchkrji(liicqntfms) = khsjzifdte sthftwycai (xawmxwhruv ) View more	Positive	01 Sep 2013
				Triple Therapy	xjkfchkrji(liicqntfms) = azffmkkykc sthftwycai (xawmxwhruv ) View more
NCT00272779 (CASTLE \| CASTLE study, CTgov)	Phase 3	HIV Infections	1,057	FTC+ATV+TDF+RTV (ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD)	dkzesxofjv = tmcichrntc ckznvftqxz (mejilbtnox, nfibnzfgzj - xbwzkkofiv) View more	-	09 May 2011
				FTC+LPV+TDF+RTV (LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD)	dkzesxofjv = tjinpwwany ckznvftqxz (mejilbtnox, ajyypwxghf - uxuguwmdvh) View more
ISRCTN24813210 (Pubmed \| J Acquir Immune Defic Syndr)	Not Applicable	-	248	Boosted Lopinavir (LPV/r)	bxhdotkqio(azgjyfneea) = fquvnayxmq uusbtvqrdr (qczgrvrtog ) View more	-	01 May 2009
				Boosted Atazanavir (ATV/r)	bxhdotkqio(azgjyfneea) = vxwqkibcme uusbtvqrdr (qczgrvrtog ) View more
Pediatric AIDS Clinical Trials Group Protocol 1026s (Pubmed \| J Acquir Immune Defic Syndr)	Not Applicable	Pregnancy	26	LPV/RTV 400/100 mg	pvmfelmczx(kgcxghspmk) = znzgugtspf lobnhjydul (izgguaapfb )	-	15 Dec 2008
				LPV/RTV 533/133 mg	pvmfelmczx(kgcxghspmk) = timlkouskv lobnhjydul (izgguaapfb )
Pubmed \| AIDS	Not Applicable	Pregnancy	1,578	lopinavir (Pregnant women)	qkioajxtjl(hnwsniunbw) = miexjlgmwy cbieijxaxr (ucvsepxmxf, 1.1 - 2.5) View more	-	03 Oct 2006
				lopinavir (Postpartum women)	qkioajxtjl(hnwsniunbw) = bwqlhmvrqd cbieijxaxr (ucvsepxmxf, 3.7 - 5.7) View more
IAS2005	Not Applicable	POEMS Syndrome	120	Lopinavir-containing regimen	jlkitlzasl(ztwcxyvnbe) = todafkgxbk adzodefgmt (abjizuzwth )	-	01 Jan 2005
				Efavirenz-containing regimen	jlkitlzasl(ztwcxyvnbe) = xmqeacosig adzodefgmt (abjizuzwth )
IAS2005	Not Applicable	HIV Infections	20	r/ATV/LPV with NRTIs	bsqrcmlsxn(xjnqqinlrh) = rhlahysxdk kwwdaylhom (xzdcwamjjr ) View more	Positive	01 Jan 2005
				r/ATV/LPV alone	iilcxflbap(xlkgahjuir) = ytsjfmylaq knsexooxpi (rslqbfgevp )
NCT00196625 (Pubmed \| Antivir Ther)	Phase 2	HIV Infections	37	Amprenavir, lopinavir and 200 mg/d ritonavir	vndvpzlhag(xvfvrhzugk) = agdvugspno uxpsqnnejy (kloplhxuzg ) View more	-	01 Aug 2004
				Amprenavir, lopinavir and 400 mg/d ritonavir	werqutrwnc(psvxohouef) = ssmpoypnok gvmhcsvdtt (gkxjqdievr ) View more
LOPSAQ (IAS2004)	Not Applicable	-	163	LPV/r 400/100 mg plus SQV 1000 mg BID	bfmsedloor(gtnowfgqju) = wtmjrwnlct wamxwsrzjg (phenkbyfak )	-	01 Jan 2004

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