Shares Expected to Begin Trading on Split-Adjusted Basis on July 1, 2024 The reverse stock split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company's stockholders authorized the reverse stock split at the Company's annual meeting of stockholders held on June 5, 2024. The reverse stock split will reduce the number of issued and outstanding shares of th ...

Phase 2b study demonstrated topical Sildenafil Cream, 3.6% improved outcomes among women with female sexual arousal disorder (FSAD), particularly in an exploratory subset of women with FSAD with or without concomitant decreased desire There are currently no FDA-approved therapies for FSAD SAN DIEGO, June 24, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in innovation for the health and wellbeing of women, today announced the publication in Obstetrics & Gynecology, the official publi ...

Daré Bioscience, Inc. (NASDAQ:DARE) Q1 2024 Earnings Call Transcript May 14, 2024 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and CEO MarDee Haring-Layton - Chief Accounting Officer Conference Call Participants Douglas Tsao - H.C. Wainright Kemp Dolliver - Brookline Capital Markets Catherine Novack - Jones Research Operator Welcome to the conference call hosted by Daré Bioscience to review the company's First Quarter Financial Results and to provide the General Business Update. This ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36395 DARÉ BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State or Other Jurisdiction of Incor ...

Exhibit 99.1 Daré Bioscience Reports First Quarter 2024 Financial Results and Provides Company Update *Please see below for important safety and other information. Ovaprene® Phase 3 Study Ovaprene is a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of ...

$22 million of non-dilutive capital at close provides significant capital to achieve objectives Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Daré representing 50% of the future payments otherwise payable to XOMA Transaction allows Daré to focus on advancing Phase 3 first-in-category investigational products Ovaprene®, a potential first FDA-approved hormone-free intravaginal monthly contraceptive, and Sildenafil Cream, 3.6%, a potential first FDA-appr ...

Daré Bioscience's DARE-LARC1 Platform Technology has Transformative Potential for Women's Health as well as in Treating a Broad Range of Diseases Strategic Process Underway to Explore Partnering Opportunities for Additional Indications such as with GLP-1s for Obesity and Metabolic Disorders and Other Conditions Requiring Precise, Prolonged Treatment SAN DIEGO, April 23, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced it will receive a pay ...

Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2023 Earnings Conference Call March 28, 2024 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and CEO MarDee Haring-Layton - Chief Accounting Officer Conference Call Participants Douglas Tsao - H.C. Wainright Will Hidell - Brookline Capital Markets Operator Welcome to the conference call hosted by Daré Bioscience to review the company’s Fourth Quarter Financial Results and to provide a General Business Update. This call is being recorded. My name is ...

Part I [Business](index=5&type=section&id=ITEM%201.%20Business) Daré Bioscience is a biopharmaceutical company focused on women's health, advancing a pipeline of product candidates through clinical development and strategic commercial partnerships - The company's business model is to in-license or acquire promising women's health product candidates, develop them through mid- to late-stage clinical trials, and then partner with larger companies for commercialization[20](index=20&type=chunk) - **XACIATO™**, the company's first FDA-approved product for bacterial vaginosis, was launched in the U.S. in Q4 2023 by commercial partner Organon[21](index=21&type=chunk) - The company's advanced clinical pipeline targets key areas in women's health: Ovaprene® for contraception (pivotal Phase 3), Sildenafil Cream for female sexual arousal disorder (Phase 3 preparation), and DARE-HRT1 for menopause symptoms (Phase 3 preparation)[24](index=24&type=chunk) - Daré actively seeks non-dilutive funding and has received significant grants to support development, including up to approximately **$49.0 million** for the DARE-LARC1 program[28](index=28&type=chunk)[89](index=89&type=chunk) [Our Pipeline: Clinical-Stage Programs](index=9&type=section&id=Our%20Pipeline%3A%20Clinical-Stage%20Programs) The company's diverse clinical-stage pipeline is led by Ovaprene®, Sildenafil Cream, and DARE-HRT1, which are advancing toward or are in late-stage development Advanced Clinical Pipeline Status | Product Candidate | Indication | Development Status | | :--- | :--- | :--- | | **Ovaprene®** | Monthly Contraception (Hormone-free) | Pivotal Phase 3 study commenced Q4 2023 | | **Sildenafil Cream, 3.6%** | Female Sexual Arousal Disorder (FSAD) | End-of-Phase 2 meeting with FDA completed; preparing for Phase 3 | | **DARE-HRT1** | Menopause Symptoms (Hormone Therapy) | Phase 1/2 study completed; preparing for Phase 3 | | **DARE-VVA1** | Painful Intercourse (VVA) | IND cleared; preparing for Phase 2 study | | **DARE-CIN** | HPV / Cervical Dysplasia | Phase 1 and proof-of-concept studies completed | - The pivotal Phase 3 study for Ovaprene® commenced in December 2023, aiming to enroll approximately 250 participants to complete 13 menstrual cycles of use[41](index=41&type=chunk)[42](index=42&type=chunk) - Following the Phase 2b RESPOND study, Daré held a successful end-of-Phase 2 meeting with the FDA in January 2024, aligning on key elements for the Sildenafil Cream Phase 3 program[53](index=53&type=chunk)[54](index=54&type=chunk) [Strategic Agreements and Financing](index=20&type=section&id=Strategic%20Agreements%20and%20Financing) The company has secured key commercialization and financing agreements, including partnerships with Organon and Bayer and a royalty interest financing deal - The exclusive worldwide license agreement with Organon for XACIATO provides for tiered double-digit royalties on net sales and up to **$180.0 million** in potential milestone payments[100](index=100&type=chunk) - The license agreement with Bayer for U.S. commercialization of Ovaprene gives Bayer the option to pay Daré **$20.0 million** to make the license effective, with potential for up to **$310.0 million** in sales-based milestones[103](index=103&type=chunk)[104](index=104&type=chunk) - In December 2023, Daré entered into a royalty interest financing agreement, receiving an initial **$5.0 million** with the option for up to **$7.0 million** more[157](index=157&type=chunk)[158](index=158&type=chunk) [Intellectual Property](index=28&type=section&id=Intellectual%20Property) The company protects its product portfolio through a combination of in-licensed and owned patents, trade secrets, and trademarks across key global jurisdictions - XACIATO is protected by three licensed U.S. patents, with expirations in **December 2028** and **September 2036**[165](index=165&type=chunk) - Ovaprene is covered by nine granted U.S. patents and seven granted foreign patents, with pending applications that could extend protection to **2035**[166](index=166&type=chunk)[167](index=167&type=chunk) - Sildenafil Cream is protected by 10 U.S. patents and 13 foreign patents, with U.S. patents having terms expiring in **June 2029**[168](index=168&type=chunk) [Government Regulation](index=31&type=section&id=Government%20Regulation) The company's operations are subject to extensive regulation by the FDA and other authorities, utilizing pathways like 505(b)(2) to streamline development - The company's products are subject to rigorous premarket review and post-marketing oversight by the FDA and other government bodies[186](index=186&type=chunk)[188](index=188&type=chunk) - Daré plans to utilize the FDA's **505(b)(2) pathway** for many of its product candidates, which allows reliance on prior findings of safety and efficacy for an approved product[204](index=204&type=chunk) - Combination products like Ovaprene (drug-device) are subject to complex regulatory processes with the FDA's Office of Combination Products[238](index=238&type=chunk)[240](index=240&type=chunk) [Risk Factors](index=55&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant financial risks regarding its going concern status, alongside clinical development, third-party reliance, and commercialization uncertainties - The company requires substantial additional capital to continue operations and has a history of losses, raising **substantial doubt about its ability to continue as a going concern**[324](index=324&type=chunk) - Clinical development is inherently uncertain, and failure to successfully complete trials and obtain regulatory approval for key product candidates like Ovaprene and Sildenafil Cream would materially harm the business[320](index=320&type=chunk)[352](index=352&type=chunk) - The company is **heavily reliant on third parties**, including Organon for XACIATO commercialization revenue and single-source contract manufacturers for product supply[320](index=320&type=chunk)[405](index=405&type=chunk) - On July 19, 2023, the company was notified by Nasdaq of non-compliance with the **minimum $1.00 bid price requirement**, with an exception until July 15, 2024, to regain compliance[578](index=578&type=chunk)[579](index=579&type=chunk) [Unresolved Staff Comments](index=107&type=section&id=ITEM%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[602](index=602&type=chunk) [Cybersecurity](index=107&type=section&id=ITEM%201C.%20Cybersecurity) Cybersecurity risk is managed through an enterprise program overseen by the audit committee, and no material threats have been identified to date - Cybersecurity risk is managed through an enterprise risk management program overseen by the audit committee, which receives periodic updates from management and an external IT consultant[603](index=603&type=chunk)[608](index=608&type=chunk) - The company utilizes multiple security layers, conducts annual cybersecurity assessments, and maintains an incident response plan to safeguard information assets and operational integrity[604](index=604&type=chunk)[605](index=605&type=chunk) - The company does not believe there are any risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[606](index=606&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=109&type=section&id=ITEM%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Capital Market under "DARE," and it has never paid cash dividends, retaining earnings for growth - The company's common stock is listed on the Nasdaq Capital Market under the trading symbol **'DARE'**[614](index=614&type=chunk) - The company has **never declared or paid cash dividends** and does not plan to in the foreseeable future[616](index=616&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=109&type=section&id=ITEM%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $30.2 million in 2023 with decreased revenue and R&D expenses, and requires additional capital to fund operations Consolidated Results of Operations (2023 vs. 2022) | | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $2,807,885 | $10,000,000 | $(7,192,115) | (72)% | | **R&D Expenses** | $21,538,074 | $30,042,217 | $(8,504,143) | (28)% | | **G&A Expenses** | $12,109,691 | $11,243,271 | $866,420 | 8% | | **Loss from Operations** | $(30,939,880) | $(31,385,488) | $445,608 | 1% | | **Net Loss** | $(30,161,391) | $(30,947,738) | $786,347 | (3)% | - The company will need to raise additional capital to fund its operating needs into the third quarter of 2024, which raises **substantial doubt about its ability to continue as a going concern**[674](index=674&type=chunk)[678](index=678&type=chunk) - Revenue in 2023 of **$2.8 million** was primarily from a $1.8 million milestone payment and a $1.0 million license fee amendment from Organon, down from **$10.0 million** in 2022[664](index=664&type=chunk) - R&D expenses decreased by **$8.5 million** in 2023, mainly due to a **$6.4 million** reduction in development costs for Sildenafil Cream[666](index=666&type=chunk) [Controls and Procedures](index=120&type=section&id=ITEM%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of year-end 2023 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2023[695](index=695&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2023, based on the COSO 2013 framework[699](index=699&type=chunk) - **No changes** in internal control over financial reporting occurred during the fourth quarter of 2023 that have materially affected, or are reasonably likely to materially affect, these controls[701](index=701&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=122&type=section&id=ITEM%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Required information regarding directors, officers, and corporate governance is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[706](index=706&type=chunk) [Executive Compensation](index=122&type=section&id=ITEM%2011.%20Executive%20Compensation) Required information concerning executive compensation is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[707](index=707&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=122&type=section&id=ITEM%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Required information concerning security ownership is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[708](index=708&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=122&type=section&id=ITEM%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Required information concerning related party transactions and director independence is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[709](index=709&type=chunk) [Principal Accountant Fees and Services](index=122&type=section&id=ITEM%2014.%20Principal%20Accountant%20Fees%20and%20Services) Required information concerning principal accountant fees and services is incorporated by reference from the company's 2024 proxy statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[710](index=710&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=123&type=section&id=ITEM%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed with the Form 10-K, including key commercial and financing agreements - This section contains the index to the Consolidated Financial Statements, which begin on page F-1[713](index=713&type=chunk) - A list of exhibits is provided, including key commercial agreements with Organon and Bayer, and the recent Royalty Interest Financing Agreement[715](index=715&type=chunk)[717](index=717&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=131&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report provides a clean opinion on the financial statements but includes a paragraph highlighting substantial doubt about the company's going concern status - The auditor's report contains a **"going concern" paragraph**, citing recurring losses, negative cash flow, and dependence on additional financing, which raise substantial doubt about the company's ability to continue operations[730](index=730&type=chunk) - The auditor's opinion states that the financial statements for the year ended December 31, 2023, are **fairly presented** in conformity with U.S. GAAP[729](index=729&type=chunk) [Consolidated Financial Statements](index=134&type=section&id=Consolidated%20Financial%20Statements) The company's financial position weakened in 2023, with cash decreasing to $10.5 million, total assets declining, and a shift to a stockholders' deficit of $5.0 million Key Balance Sheet Data (as of Dec 31) | | 2023 | 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,476,056 | $34,669,605 | | Total Assets | $21,282,215 | $43,826,383 | | Total Liabilities | $26,329,855 | $32,714,273 | | Total stockholders' equity (deficit) | $(5,047,640) | $11,112,110 | Key Cash Flow Data (Year Ended Dec 31) | | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,856,654) | $(18,088,429) | | Net cash provided by financing activities | $15,637,120 | $1,343,354 | | Net decrease in cash | $(23,858,549) | $(17,004,482) | [Notes to Consolidated Financial Statements](index=138&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail the going concern uncertainty, terms of strategic agreements, equity financing activities, and significant non-dilutive grant funding - Note 2 (Going Concern): The financial statements were prepared on a going concern basis, but management notes that the company's history of losses and need for additional capital raise **substantial doubt** about this assumption[765](index=765&type=chunk)[768](index=768&type=chunk) - Note 11 (Sale of Future Royalties): In December 2023, the company received **$5.0 million** from the sale of an interest in future XACIATO royalties, which was recorded as a liability[890](index=890&type=chunk)[892](index=892&type=chunk)[898](index=898&type=chunk) - Note 13 (Grant Awards): The company has received significant non-dilutive funding from the Bill & Melinda Gates Foundation for its DARE-LARC1 program, with a cumulative total of **$28.4 million** received as of December 31, 2023[916](index=916&type=chunk)[917](index=917&type=chunk)[918](index=918&type=chunk) - Note 8 (Stockholders' Equity): In 2023, the company raised approximately **$7.0 million (net)** from a registered direct offering of stock and warrants in September, and approximately **$2.3 million (net)** from its ATM sales agreement[860](index=860&type=chunk)[861](index=861&type=chunk)

Financial Performance - Daré Bioscience reported total revenue of approximately $2.8 million for the year ended December 31, 2023, including a $1.0 million payment in July and a $1.8 million milestone payment in October from collaborator Organon related to XACIATO[21] - Total revenue for 2023 was $2,807,885, a decrease of 72.1% compared to $10,000,000 in 2022[38] - The company recognized a net loss of approximately $30.1 million for 2023, with general and administrative expenses of approximately $12.1 million, up about 8% compared to the prior year[21] - Net loss for 2023 was $30,161,391, compared to a net loss of $30,947,738 in 2022, representing a 2.5% improvement[38] - Comprehensive loss for 2023 was $30,170,976, compared to $31,144,076 in 2022, showing a 3.1% improvement[38] - Loss per common share for 2023 was $0.35, slightly improved from $0.37 in 2022[38] - Cash and cash equivalents decreased to $10,476,056 in 2023 from $34,669,605 in 2022, a decline of 69.7%[38] - Total assets decreased to $21,282,215 in 2023 from $43,826,383 in 2022, a reduction of 51.4%[38] - Total liabilities decreased to $26,329,855 in 2023 from $32,714,273 in 2022, a decrease of 19.5%[38] - Operating expenses for 2023 were $33,747,765, down 18.5% from $41,385,488 in 2022[38] Research and Development - Research and development expenses were approximately $21.5 million in 2023, down from approximately $30.0 million in the prior year, primarily due to costs associated with clinical studies[21] - Daré commenced the Phase 3 clinical study for its hormone-free monthly intravaginal contraceptive candidate Ovaprene in December 2023, with recruitment currently underway at 17 sites across the U.S.[10] - The FDA has cleared the investigational new drug application for DARE-VVA1, a non-hormonal treatment for sexual pain, allowing Daré to plan for a Phase 2 clinical study[18] - Positive topline results were announced for DARE-PDM1, an investigational formulation of diclofenac for treating menstrual cramping pain, following a Phase 1 study[16] - Daré anticipates providing updates on the FDA feedback and Phase 3 study design for Sildenafil Cream in 2Q-2024[14] Collaborations and Milestones - The first shipment of XACIATO™ triggered a $1.8 million milestone payment from Organon, and the product is now available nationwide by prescription[7] - Daré is eligible to receive double-digit royalties based on net sales of XACIATO and up to $180 million in potential milestone payments from Organon[8] Future Outlook - The company expects a reduction in 2024 general and administrative expenses to approximately $10.0 million, despite projected accrual-based non-cash expenses[21] - The weighted average number of common shares outstanding increased to 87,303,701 in 2023 from 84,571,805 in 2022[38] Recognition - The company has been recognized for its contributions to women's health and innovation, with leadership accolades in 2022 and 2023[33]