Financial Performance - Total revenue for the three months ended September 30, 2023, was $41,691, compared to $1,000,000 for the same period in 2022, representing a significant decrease [8]. - Total operating expenses for the three months ended September 30, 2023, were $4,723,040, down from $9,396,415 in the same period last year, indicating a reduction of approximately 50% [8]. - The net loss for the three months ended September 30, 2023, was $(4,702,501), compared to a net loss of $(8,299,096) for the same period in 2022, showing an improvement of approximately 43% [8]. - The company reported a basic loss per share of $(0.55) for the three months ended September 30, 2023, compared to $(1.09) for the same period in 2022, indicating a reduction in loss per share [8]. - The company experienced a comprehensive loss of $(4,679,566) for the three months ended September 30, 2023, compared to $(8,314,126) for the same period in 2022, reflecting an improvement [8]. - Net loss for the nine months ended September 30, 2023, was $(25,103,829), compared to $(1,452,799) for the same period in 2024 [13]. - The Company incurred a loss from operations of approximately $18.1 million for the nine months ended September 30, 2024 [26]. Research and Development - Research and development expenses for the three months ended September 30, 2023, were $2,656,772, down from $6,674,636 in the same period last year, reflecting a decrease of about 60% [8]. - The company’s primary operations focus on research and development activities to advance product candidates through clinical development and regulatory approval [16]. - The company recorded research and development expense credits of approximately $4.8 million related to the DARE-LARC1 award for the nine months ended September 30, 2024 [124]. - The company is entitled to receive up to $10.0 million in milestone-based payments for the DARE-HPV development program, contingent upon achieving specified research objectives over a 24-month period [131]. Cash and Liquidity - Cash and cash equivalents increased to $11,532,609 at the end of the period from $10,811,056 at the beginning of the period [13]. - The company’s total cash, cash equivalents, and restricted cash decreased to $11,532,609 from $14,229,424 [13]. - Unrestricted cash and cash equivalents amount to approximately $11.2 million as of September 30, 2024 [26]. - The Company has working capital of approximately $1.8 million as of September 30, 2024 [26]. - The Company prepared its financial statements on a going concern basis, raising substantial doubt about its ability to continue operations without additional capital [25]. - The Company expects to need to raise substantial additional capital to fund its operations and execute its current strategy [27]. Agreements and Milestones - The Company entered into a royalty purchase agreement with XOMA, receiving $22.0 million for future net royalty and milestone payments related to XACIATO, Ovaprene, and Sildenafil Cream [29]. - The Company is entitled to receive tiered double-digit royalties based on net sales and up to $180.0 million in tiered commercial and regulatory milestones under the license agreement with Organon [42]. - The Company has potential future payments of up to $5.25 million for development and regulatory milestones and up to $64.0 million for commercial sales milestones under the Douglas License Agreement [55]. - The Company agreed to pay former MBI stockholders up to $46.5 million contingent upon achieving specified funding and product development milestones, and up to $55.0 million based on aggregate net sales [59]. - The Company entered into an exclusive license agreement with Catalent JNP, Inc., paying a $250,000 upfront fee and a $100,000 annual maintenance fee, with potential milestone payments totaling up to $43.8 million [70]. Stock and Equity - The weighted average number of shares outstanding for the three months ended September 30, 2023, was 8,534,433, compared to 7,587,637 for the same period in 2022, indicating an increase in shares outstanding [8]. - A reverse stock split on July 1, 2024, reduced the number of outstanding shares from approximately 101.1 million to approximately 8.5 million [79]. - The Company has a total of 1,268,572 warrants outstanding as of September 30, 2024, with a weighted average exercise price of $7.49 [89]. - The Company recorded a warrant value of $2.9 million from the September 2023 offering using the Black-Scholes model [87]. Future Commitments and Obligations - The Company has a total obligation of approximately $3.5 million related to a clean room space lease, with fixed payments due quarterly [98]. - Total future minimum lease payments under the Company's operating leases as of September 30, 2024, amounted to $1.61 million [102]. - The company is responsible for providing $5.5 million in payments to NICHD for the Ovaprene Phase 3 study, with $0.5 million paid in July 2024 and $5.0 million paid in prior years [115]. Grants and Funding - The company has received approximately $29.3 million in non-dilutive funding from the Bill & Melinda Gates Foundation for the DARE-LARC1 project as of September 30, 2024 [124]. - The company received a grant of up to approximately $10.7 million to support the expansion of study sites for the Phase 3 clinical trial of Ovaprene, with an initial payment of $5.4 million due in 2024 [130].

Conference Call and Webcast Today at 4:30 p.m. ET Development Program Highlights and Anticipated Milestones Ovaprene® hormone-free monthly intravaginal contraceptive candidate – pivotal Phase 3 contraceptive efficacy study recruiting across the United States; foundation grant announced yesterday will provide funding to allow Daré to expand the number of clinical sites to accelerate the development timeline Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousa ...

Dare Bioscience, Inc. (DARE) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years ...

SAN DIEGO, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, will host a conference call and live webcast at 4:30 p.m. Eastern Time on Thursday, November 14, 2024, to review its financial results for the quarter ended September 30, 2024 and to provide a company update. The company will release its financial results after the close of market on Thursday, November 14, 2024, and prior to the conference call and webcast. To acc ...

DARE-HPV is a potential first-in-category treatment for human papillomavirus (HPV)-related cervical disease which could change the treatment paradigm for clinical HPV management. Essentially all cervical cancer cases worldwide are caused by HPV infection. SAN DIEGO, Oct. 23, 2024 (GLOBE NEWSWIRE) --  Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that it has been selected by the Advanced Research Projects Agency for Health (ARPA-H) as an  ...

SAN DIEGO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced it entered into a $15 million common stock purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor. Under the terms and conditions of the purchase agreement, Daré will have the right, from time to time and at its sole discretion, to sell up to $15 million of its stock ...

Daré Bioscience, Inc. (NASDAQ:DARE) Q2 2024 Earnings Call Transcript August 12, 2024 4:30 PM ET Company Participants MarDee Haring-Layton - CAO Sabrina Martucci Johnson - President and CEO Conference Call Participants Catherine Novack - Jones Research Douglas Tsao - H.C. Wainwright & Co. Operator Welcome to the conference call hosted by Daré Bioscience to review the company's second quarter financial results and to provide a general business update. This call is being recorded. My name is Leonardo, and I wi ...

Dare Bioscience, Inc. (DARE) came out with quarterly earnings of $1.52 per share, beating the Zacks Consensus Estimate of a loss of $0.57 per share. This compares to loss of $1.20 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 366.67%. A quarter ago, it was expected that this company would post a loss of $0.72 per share when it actually produced a loss of $0.84, delivering a surprise of -16.67%. Over the last four quarters, ...

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 June 30, 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 Incorp ...

Exhibit 99.1 Daré Bioscience Reports Second Quarter 2024 Financial Results and Provides Company Update Conference Call and Webcast Today at 4:30 p.m. ET Development Program Highlights and Anticipated 2024 Milestones ● Ovaprenehormone-free monthly intravaginal contraceptive candidate pivotal Phase 3 contraceptive efficacy study recruiting across the United States ● Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousal disorder continued operational progress t ...