Bayer HealthCare AG

Studies seek to establish an early-stage blood biomarker, explore novel therapies and support the creation of a cohort of PSP and CBD patients in Argentina. NEW YORK, Sept. 28, 2023 /PRNewswire/ -- CurePSP has awarded its latest Pathway and Pipeline Grants and Urso Student Fellowships, totaling over $422,000. Recipients of the grants are: Dr. Kurt Farrell, assistant professor at the Icahn School of Medicine at Mount Sinai; Dr. Blas Couto, researcher at the Institute of Translational and Cognitive Neuroscience (INCyT) in Buenos Aires; Dr. Luana Fioriti, head of laboratory at the Mario Negri Institute for Pharmacological Research in Milan, alongside Dr. Carmela Tartaglia, associate professor at the University of Toronto and clinician at the Rossy PSP Centre; and Dr. Joseph B. Rayman, assistant professor of medical sciences at Columbia University Irving Medical Center. Recipients of the Urso Student Fellowship Grants are: Hania Qamar (mentor: Dr. Naomi Visanji), a graduate student at the University of Toronto; Hasnat Nuri (mentor: Dr. Stewart Clark), an undergraduate student at SUNY at Buffalo; and Soyeon Park (mentor: Dr. Jonathan Lin), an undergraduate student at Stanford University. The studies will make progress in identifying biomarkers, studying pathways for therapeutics and creating a new database of patients in Argentina. The latest Pathway grants will fund two projects: "Understanding the Roles of Risk Loci Implicated in Genome-Wide Association Studies of PSP" by Dr. Kurt Farrell, and "Epidemiology and Tau Biology in a Longitudinal Cohort of Argentinian Patients with PSP and CBD" by Dr. Blas Couto. Dr. Farrell's project will use data from a previous genetic analysis to identify specific genes and biological mechanisms that cause PSP. Dr. Couto will study a group of Argentinian patients with CBD and PSP to develop a research-ready biobank and database. The newest Pipeline grants will fund "Potential Therapeutic Biomarkers for Progressive Supranuclear Palsy" by Dr. Luana Fioriti and Dr. Carmela Tartaglia, and "Development of Small Molecule Inhibitors of Tau Oligomerization" by Dr. Joseph B. Rayman. Dr. Fioriti and Dr. Tartaglia are investigating a specific type of post-translational modification of tau that could lead to a novel PSP-specific early-stage blood biomarker. Dr. Rayman's work will continue the development of a small molecule that, via its interaction with TIA1 protein, could prevent the pathological oligomerization of the tau protein, therefore opening the way to new therapeutic approaches for tauopathies including PSP, CBD and Alzheimer's disease. Dr. Jennifer Brummet, associate director of scientific affairs and partnerships at CurePSP, hopes that these projects will lead to progress in high-priority research areas. "Together, these grants will help advance our understanding of the fundamental neurobiology of PSP and CBD while also investigating potential biomarkers and therapeutics," Dr. Brummet said. "There is a critical need for biomarkers to help ensure accurate diagnosis of PSP and CBD and for therapeutics to help treat or cure PSP and CBD, and these grants will help move the needle on these goals." The newest Urso Student Fellowship grants were awarded to students conducting projects that focus on the complex barriers facing research of PSP and CBD. "Progressive Supranuclear Palsy: A Disease-Specific Mouse Tauopathy Model" by Hania Qamar (mentor: Dr. Naomi Visanji) recognizes the lack of an animal model as a barrier to understanding PSP and aims to generate a mouse model that would be the closest replica of how PSP presents itself in the human brain. "Investigation of the Role of Non-cholinergic PPTg Neurons in a Model of PSP" by Hasnat Nuri (mentor: Dr. Stewart Clark) seeks to further develop a mouse model of PSP by administering the tau protein in the brain region known as the pedunculopontine tegmentum (PPTg) to investigate the effects of abnormal tau accumulating in this region. "Testing Anti-Tau Properties of Integrated Stress Response Boosters In Vivo" by Soyeon Park (mentor: Dr. Jonathan Lin) will study the effects of injecting mice with Integrated Stress Response (ISR) boosters to see if cell death and tau levels are reduced. The opportunities afforded by these grants will help foster the next generation of researchers dedicated to furthering our understanding of PSP, CBD and related diseases, while contributing essential information to the field. About CurePSP's Research Grants Pathway and Pipeline Grants provide seed funding to support innovative projects focused on the fundamental neurobiology and mechanisms of tauopathies ("Pathway"), and translational projects focusing on new therapeutics and biomarkers for tauopathies ("Pipeline"). The Urso Student Fellowship supports students conducting summer research projects focused on PSP, CBD and related diseases with a goal of encouraging students at all post-secondary levels to pursue research in the field. The next deadline for Pathway and Pipeline Grant applications is October 31, 2023. The next deadline for Urso Student Fellowship Grants is January 31, 2024, and applications will open this fall. Learn more about our research grants here. Grant applications will be submitted to ProposalCentral and can be found here. About CurePSP CurePSP is the leading nonprofit organization dedicated to the awareness, care and cure for three neurodegenerative diseases: progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and multiple system atrophy (MSA). As a catalyst for new treatments and a cure, CurePSP establishes important partnerships and funds critical research internationally. Through its advocacy and support efforts, CurePSP enhances education, care delivery and quality of life for people living with PSP, CBD and MSA and their families. Science, community and hope are at the heart of CurePSP's mission and all its services. CurePSP is a registered 501(c)(3) charity within the United States (EIN: 52-1704978). For more information, please visit . Contact: Dr. Kristophe Diaz Executive Director and Chief Science Officer 646-725-1453 [email protected] SOURCE CurePSP, Inc.

Phase 2 efficacy study to be initiated in H1 2024 New data published in Nucleic Acid Therapeutics demonstrate broad distribution, as well as cell and nucleus penetration of SPL84 in lungs of animal models, overcoming hyper-concentrated mucus barriers, thus leading to specific and targeted RNA modulation JERUSALEM, Sept. 6, 2023 /PRNewswire/ -- SpliSense, a biopharmaceutical company developing transformative RNA-based therapies for pulmonary diseases including cystic fibrosis (CF), muco-obstructive diseases and idiopathic pulmonary fibrosis (IPF), today announced that it has successfully completed a first-in-human, Phase 1 clinical trial of SPL84, the Company's lead inhaled anti sense oligonucleotide (ASO) product for the treatment of patients with CF carrying the 3849+10 kilobase (Kb) C->T splicing mutation in the transmembrane conductance regulator (CFTR) gene. SPL84 was shown to be safe and well tolerated. In the Phase 1 study, 32 healthy male volunteers received a single dose of SPL84 or placebo and 4 doses were tested: 20, 40, 80, and 160 mg (active: placebo 3:1). SPL84 was shown to be safe and well tolerated, and no serious adverse events or significant related adverse events were identified. There were no significant changes from baseline in vital signs, clinical laboratory values, ECG, physical examination, or pulmonary function. Systemic exposure to SPL84 was very low and dose dependent. The first-in-human Phase 1 placebo-controlled, double–blind, randomized study evaluating the safety, tolerability, and pharmacokinetics of SPL84 was a single ascending dose study in healthy volunteers, administered via inhalation. "We are extremely excited with the safety profile of SPL84 as demonstrated in this Phase 1 study, paving the way to our Phase 2 efficacy study, that we plan to initiate in the first half of next year," said Gili Hart, PhD, Chief Executive Officer, SpliSense. "CF is one of the most common genetic diseases, leading to frequent lung infections, breathing difficulties and reduced life expectancy. Although currently available treatments managed to significantly increase life expectancy in the past few decades, they are focused on symptomatic treatments and there is still a significant unmet medical need for a CF cure. In particular CF patients carrying the 3849 +10 Kb C->T mutation have no specific approved treatment. Our lead product, SPL84, managed to completely restore CFTR activity the CF gold standard pharmacological model, and with the results announced today supporting its safety in humans, we hope to be able to deliver in the foreseeable future a life-changing treatment for CF patients." In addition, SpliSense annouced the publication of a paper titled "Delivery Characterization of SPL84 Inhaled Antisense Oligonucleotide Drug for 3849 + 10 kb C- > T Cystic Fibrosis Patients" in Nucleic Acid Therapeutics. The data demonstrate broad distribution, as well as cell and nucleus penetration of SPL84 in mouse and monkey lungs. In vivo and in vitro studies confirmed the stability of the inhaled drug in CF patient-derived mucus and in lung lysosomal extracts. The mobility of SPL8 through CF Patients hyper-concentrated mucus was also demonstrated. The results, supported by a promising preclinical pharmacological effect of full restoration of CFTR channel activity, emphasize the high potential of SPL84 as an effective drug for the treatment of CF patients. "The encouraging Phase 1 clinical trial results together with the preclinical data published in Nucleic Acid Therapeutics showing broad lung distribution of SPL84 support the further development of our wider pulmonary pipeline, including treatments for muco-obstructive diseases and idiopathic pulmonary fibrosis, both of which are expected to enter the clinic next year," added Dr. Hart. CF is a genetic multisystem disorder that originates from various mutations in the CFTR gene, which is responsible for the production of the CFTR protein, a chloride channel expressed in the lungs as well as in other tissues. The past decade has seen a dramatic change in CF care with the approval of new therapies (CFTR modulators). However, approved CFTR modulators do not support all patients with CF and do not offer a cure for the disease. Thus, new strategies of medication development are essential to address non-responsive CF patients, and specifically patients carrying the 3849 +10 Kb C->T splicing mutation. SpliSense utilizes short, precisely targeted proprietary RNA stretches called ASOs to correct various mutations in the CFTR mRNA. In particular, the ASO binds specifically to the mutated CFTR RNA in the targeted sequence, leading to the modulation of the mutated region in the mRNA, allowing the cell to produce fully functional CFTR proteins. The ASOs are administered directly and preferentially to the lungs via inhalation which lasts less than 10 minutes and is given weekly or every other week. The ASOs were shown to be efficiently taken up by the lung cells and drive the production of corrected CFTR mRNA and eventually fully functional CFTR proteins. About SpliSense SpliSense is a biopharmaceutical company focused on RNA-based treatments for pulmonary diseases. The Company's pioneering platform harnesses ASOs for treatment of unmet cystic fibrosis mutations and large pulmonary diseases including muco-obstructive diseases and IPF. Through its novel ASO pulmonary approach, SpliSense aims to overcome specific genetic mutations, restore or reduce protein expression and function, thus targeting the root cause of the disease. SpliSense' technology is based on the research of Prof. Batsheva Kerem, PhD, a renowned geneticist from the Hebrew University of Jerusalem, who was part of the research team that identified and cloned the CFTR gene. Investors in the Company include Orbimed, Israel Biotech Fund, Biotel Limited, Integra Holdings and the Cystic Fibrosis Foundation. For additional information, please visit our website at SpliSense.com. Company contact: Tsipi Haitovsky, Global Media Liaison; +972-52-5989-892; [email protected] SOURCE SpliSense

Conference Call and Webcast Today at 4:30 p.m. ET Second Half 2023 Anticipated Milestones (target indication(s)): XACIATO™ First Commercial Sale Ovaprene® (hormone-free monthly contraception) – Pivotal Phase 3 Contraceptive Efficacy Study – Patient Enrollment to Begin 4Q2023 Sildenafil Cream, 3.6% (female sexual arousal disorder and female sexual interest/arousal disorder) - preparations for end-of-Phase 2 meeting with FDA DARE-PDM1 (primary dysmenorrhea) – Phase 1 Clinical Study Topline Data Menopause programs: IND related activities for DARE-HRT1 (vasomotor symptoms of menopause) and DARE-VVA1 (vulvovaginal atrophy, a common condition in postmenopausal women, including those whose menopause resulted from receiving certain breast cancer treatments); Phase 3 and Phase 2 clinical study initiation plans, respectively SAN DIEGO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended June 30, 2023, and provided a company update. “We are particularly proud of the milestone we reached in June – the announcement of the topline data from our exploratory Phase 2b RESPOND study evaluating topical Sildenafil Cream, 3.6% as a treatment for female sexual arousal disorder. This study was the first at-home, Phase 2 clinical study by a pharmaceutical drug development company to address a distressing condition for women that is analogous to erectile dysfunction for men utilizing a novel topical cream formulation of sildenafil, the active ingredient in Viagra®,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The group receiving Sildenafil Cream in the RESPOND study demonstrated improvements in arousal lubrication, orgasm and sexual desire, which persisted through the end of study assessment. Based on data from the study, demonstrating improvement in multiple facets of female sexual dysfunction, and because there is no FDA-approved product for the treatment of female sexual arousal disorder or female sexual interest/arousal disorder, Sildenafil Cream has the potential to be a first-in-category product with a market opportunity comparable in size to the erectile dysfunction market.” “We also remain very enthusiastic about rest of 2023 given two highly anticipated milestones,” said Ms. Johnson. “First, we are on track to begin patient enrollment in what we believe will be the single pivotal Phase 3 study for Daré’s late-stage portfolio candidate, Ovaprene, an investigational, hormone-free, monthly intravaginal contraceptive designed to be an easy-to-use monthly option with effectiveness approaching hormonal methods and whose U.S. commercial rights are under a license agreement with Bayer. Second, we are looking forward to the U.S. commercial launch of XACIATO™ by our global collaboration partner, Organon. Finally, later this year we expect to announce the topline findings from our DARE-PDM1 Phase 1 trial, a multi-center, randomized, placebo-controlled, double-blind, 3-arm parallel group study of approximately 36 healthy, premenopausal women with primary dysmenorrhea, also referred to as menstrual cramps and pain. Prevalence rates of dysmenorrhea vary but range from 50% to 90%. Recent market research suggests that the global market for dysmenorrhea treatment was valued at $13 billion in 2022 and is expected to increase to $28.5 billion by 2029¹.” 1H-2023 In Review and 2H-2023 Anticipated Developments Period Portfolio Asset Development/Outcome 1Q-2023 DARE-HRT1 Announced positive topline pharmacokinetic (PK) data from Phase 1/2 clinical study DARE-PDM1 Commenced Phase 1 clinical study 2Q-2023 Sildenafil Cream, 3.6% Announced positive topline results of exploratory Phase 2b RESPOND clinical study 2H-2023 (expected) XACIATO™ First commercial sale Ovaprene® Initiation of enrollment in pivotal contraceptive study conducted with NICHD Sildenafil Cream, 3.6% Preparation for end-of-Phase 2 meeting with FDA DARE-PDM1 Announcement of topline results of Phase 1 clinical study DARE-VVA1 IND preparation and other activities to allow initiation of Phase 2 clinical study DARE-HRT1 IND preparation and other activities to allow initiation of Phase 3 clinical study Daré Portfolio Summary One FDA approved product, XACIATO™ 13 development programs across 9 distinct indications 3 products in, or nearing, Phase 3 clinical development Key XACIATO, Sildenafil Cream, and Ovaprene milestones anticipated during 2H-2023 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. Please click here for full prescribing information. 3Q-2022: $10.0 million cash payment received under commercial license agreement with Organon 2H-2023: $1.0 million cash received, and $1.8 million milestone anticipated upon 1st commercial sale Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 23 million women in the U.S.2 The condition results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge. In addition to being the most common type of vaginal infection in women of reproductive age and having bothersome symptoms, bacterial vaginosis has been associated with certain increased health risks, including pre-term labor and infertility. 2, 3 Ovaprene® A novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. 4Q-2022: Investigator meeting held (with NICHD) for the pivotal Phase 3 clinical study 4Q-2023: Anticipated initiation of subject enrollment in the pivotal Phase 3 clinical study, a single arm, open-label contraceptive efficacy study over 12-months of use (13 menstrual cycles) The pivotal Phase 3 clinical study will be conducted under a Cooperative Research and Development Agreement with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. 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 and/or female sexual interest/arousal disorder. 2Q-2023: Initiated Phase 1 thermography study with expected completion in 2023 2Q-2023: Announced positive topline data from exploratory Phase 2b RESPOND clinical study Activities related to psychometric analyses to further refine the measures and resulting endpoints from the Phase 2b RESPOND study for use in a Phase 3 pivotal clinical study and preparations for data review in an end-of-Phase 2 meeting with the FDA are underway. DARE-HRT1 A unique, investigational intravaginal ring designed to deliver bio-identical estradiol and progesterone continuously over a 28-day period for the treatment of moderate to severe vasomotor symptoms, as part of menopausal hormone therapy. 4Q-2022: Positive topline efficacy data reported from Phase 1/2 clinical study 1Q-2023: Positive topline PK data reported from Phase 1/2 clinical study, and plans to progress to a single Phase 3 study announced 2H-2023: Activities underway to support an Investigational New Drug application (IND) submission and Phase 3 clinical study initiation DARE-VVA1 A proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvovaginal atrophy in women without the use of hormones. 4Q-2022: Positive topline safety, tolerability, PK and pharmacodynamics data reported from Phase 1/2 clinical study 2H-2023: Activities underway to support IND submission and Phase 2 clinical study initiation Financial Highlights for the Quarter ended June 30, 2023 Cash and cash equivalents: $13.3 million at June 30, 2023. General and administrative expenses: $2.9 million in 2Q-2023 as compared to $2.8 million in 2Q-2022, with the current quarter’s increase primarily attributable to increases in personnel costs, professional services expense, and stock-based compensation expense, partially offset by decreases in general corporate overhead expenses. Research and development expenses: $6.0 million in 2Q-2023 as compared to $6.8 million in 2Q-2022, with the current quarter’s decrease primarily attributable to decreases in expenses related to our Sildenafil Cream Phase 2b RESPOND clinical study, and clinical trial and manufacturing and regulatory activities for Ovaprene, partially offset by increases in costs related to development activities for our Phase 1 and Phase 1-ready programs. 1 , accessed 5 August 2023 2 and , accessed 5 August 2023 3 , accessed 5 August 2023 Conference Call Daré will host a conference call and live webcast today at 4:30 p.m. Eastern Time to review financial results for the quarter ended June 30, 2023 and to provide a company update. To access the conference call via phone, dial (800) 715-9871 (U.S.) or (646) 307-1963 (international). The conference ID number for the call is 8451277. To listen to the event and view the presentation slides via live webcast, join from the Investors section of the Company's website at under “Presentations, Events & Webcasts.” Callers will be able to access the presentation slides at the same location on the Company’s website. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast and presentation slides will be archived under “Presentations, Events & Webcasts" in the Investors section of the Company's website at and available for replay until August 24, 2023. 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, 2% is 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. 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 to treat female sexual arousal disorder (FSAD) and/or female sexual interest/arousal disorder (FSIAD) utilizing the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit . Daré may announce material information about its finances, product 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, 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 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 expectations regarding the commercial launch of XACIATO in the U.S., including the timing of the first commercial sale of XACIATO, plans and expectations with respect to Daré’s product candidates, including anticipated timing for commencement and conduct of clinical trials and announcement of topline results, the potential for FDA approval of a product candidate based on a single pivotal clinical study, the expectation that a product candidate could be a first-in-category product, and the potential market size and opportunity for a product candidate, 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, risk 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 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 the COVID-19 pandemic, macroeconomic conditions and geopolitical events on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré’s ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business to fulfill their contractual obligations to Daré; 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; cyber attacks, security breaches 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: Investors on behalf of Daré Bioscience, Inc.: Lee Roth / Julia Weilman Burns McClellan lroth@burnsmc.com / jweilman@burnsmc.com 646.930.4406 / 646.732.4443 OR Media on behalf of Daré Bioscience, Inc.: Jake Robison Evoke Canale jake.robison@evokegroup.com 619.849.5383 Source: Daré Bioscience, Inc. Daré Bioscience, Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) Three months ended June 30, 2023 2022 Revenue License fee revenue $ - $ 10,000,000 Total revenue - 10,000,000 Operating expenses General and administrative 2,920,672 2,792,894 Research and development 6,043,684 6,797,784 License fee expense 25,000 25,000 Total operating expenses 8,989,356 9,615,678 Income (loss) from operations (8,989,356 ) 384,322 Other income 227,124 29,676 Net income (loss) $ (8,762,232 ) $ 413,998 Foreign currency translation adjustments $ (31,151 ) $ (135,869 ) Comprehensive income (loss) $ (8,793,383 ) $ 278,129 Income (loss) per common share: Basic $ (0.10 ) $ 0.00 Diluted $ (0.10 ) $ 0.00 Weighted average number of shares outstanding: Basic 86,403,117 84,682,765 Diluted 86,403,117 85,369,424 Daré Bioscience, Inc. and Subsidiaries Condensed Consolidated Balance Sheets Data June 30, 2023 December 31, 2022 (unaudited) Cash and cash equivalents $ 13,329,101 $ 34,669,605 Working capital $ (2,457,536 ) $ 11,414,826 Total assets $ 23,209,954 $ 43,826,383 Total stockholders' equity (deficit) $ (2,719,402 ) $ 11,112,110