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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________ FORM 10-K ___________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 No. 001-36395 Securities registered unde ...

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]

SAN DIEGO, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the successful completion of an end-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA), supporting advancement of Sildenafil Cream, 3.6% (Sildenafil Cream) for the treatment of female sexual arousal disorder (FSAD) to a Phase ...

SAN DIEGO, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced changes in company management which includes the retirement of Chief Financial Officer, Lisa Walters-Hoffert, and the resignation of Chief Commercial Officer, John Fair. Both Ms. Walters-Hoffert and Mr. Fair have entered into plans with the Company to help ensure a seamless transition. Daré also announced an adjustment to the size of its Board of Directors to better refl ...

Daré Bioscience, Inc. (NASDAQ:DARE) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and CEO John Fair - Chief Commercial Officer Lisa Walters-Hoffert - CFO Conference Call Participants Catherine Novack - Jones Trading Doug Tsao - H.C. Wainright Operator Welcome to the conference hosted by Daré Bioscience to Review the Company's Third Quarter Financial Results and to provide a General Business Update. This call is being recorded. My name ...

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 September 30, 2023 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 I ...

DARÉ IN ITALIAN, IT MEANS "TO GIVE." IN ENGLISH, IT MEANS "TO BE BOLD." Women At Daré Bioscience, women's health is Our Sole Focus. Innovation in women's health needs to be a priority. We are working hard to identify and advance new therapies that provide additional choices and improve outcomes so that we can make a difference in the lives of women everywhere. Daré Programs Update, 08.10.2023 www.darebioscience.com 1 This presentation is for informational purposes only and is not an offer to sell or a solic ...

Daré Bioscience, Inc. (NASDAQ:DARE) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and Chief Executive Officer John Fair - Chief Commercial Officer Lisa Walters-Hoffert - Chief Financial Officer Conference Call Participants Catherine Novack - Jones Research Operator Welcome to the conference hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended June 30, 2023, and to provide a General Business Update. T ...

Financial Performance - Total revenue for Q2 2023 was $0, compared to $10 million in Q2 2022, indicating a 100% decrease year-over-year[16] - Operating expenses for Q2 2023 were $8.99 million, a slight decrease of 6.5% from $9.62 million in Q2 2022[16] - Net loss for Q2 2023 was $8.76 million, compared to a net income of $414,000 in Q2 2022, reflecting a significant decline in financial performance[16] - The company reported a comprehensive loss of $8.79 million for Q2 2023, compared to a comprehensive income of $278,000 in Q2 2022[16] - Basic loss per share for Q2 2023 was $0.10, compared to no loss per share reported in Q2 2022[16] - For the six months ended June 30, 2023, the company reported a net loss of approximately $16.8 million, compared to a net loss of $7.98 million for the same period in 2022, representing a 110% increase in losses year-over-year[23] Cash and Assets - Cash and cash equivalents decreased to $13.33 million as of June 30, 2023, down from $34.67 million at the end of 2022, representing a 61.5% decline[15] - Total assets decreased to $23.21 million as of June 30, 2023, from $43.83 million at the end of 2022, indicating a 47% reduction[15] - The company's cash and cash equivalents decreased to approximately $13.3 million as of June 30, 2023, down from $32.1 million at the end of June 2022, indicating a decline of about 59%[23] - As of June 30, 2023, the Company reported cash equivalents of $10,837,944, a decrease from $33,238,658 as of December 31, 2022[41] Liabilities and Deficits - Current liabilities increased to $24.70 million as of June 30, 2023, compared to $31.62 million at the end of 2022, showing a 21.9% decrease[15] - The accumulated deficit grew to $157.88 million as of June 30, 2023, up from $141.07 million at the end of 2022, reflecting a worsening financial position[15] - The total accumulated deficit reached approximately $157.9 million as of June 30, 2023, compared to $118.1 million at the same time in 2022, reflecting an increase of approximately 34%[34] - The company has a working capital deficit of approximately $2.5 million as of June 30, 2023, indicating liquidity challenges[34] Research and Development - Research and development expenses for the first half of 2023 were $11.06 million, down from $12.60 million in the same period of 2022, a decrease of 12.2%[16] - The company plans to continue its focus on research and development activities to advance its product candidates through clinical development and regulatory approval[27] Capital and Funding - The company expects to require substantial additional capital to fund its operations and execute its current strategy over the next 12 months[35] - The company raised $1.3 million from the exercise of common stock warrants during the six months ended June 30, 2023, compared to $120,149 in the same period of 2022, showing a significant increase in capital raised[23] Licensing and Revenue - The Company has recognized $10.0 million in license fee revenue from its license agreement for XACIATO, all of which represents the upfront payment due[45] - The Company is entitled to receive up to $310.0 million in milestone payments related to the commercial sales of Ovaprene, contingent upon achieving specified milestones[50] - The license agreement with Organon includes tiered double-digit royalties based on net sales and up to $182.5 million in milestone payments[53] - The Company has not recognized any collaboration revenues as of June 30, 2023[44] - The Company has not recognized any royalty revenue as of June 30, 2023[46] Stock and Compensation - Total stock-based compensation expense for the six months ended June 30, 2023, was $1,274,807, compared to $1,069,930 for the same period in 2022, reflecting an increase of approximately 19.1%[100] - The number of shares of common stock available for future awards under the 2022 Stock Incentive Plan was 6,718,916 as of June 30, 2023[98] - The number of shares outstanding under the stock option plans increased from 6,612,554 at December 31, 2022, to 9,470,219 at June 30, 2023, reflecting an increase of approximately 43.5%[99] Agreements and Milestones - The Company agreed to pay former MBI stockholders up to $46.5 million contingent upon achieving specified funding, product development, and regulatory milestones[65] - The Company may pay MilanaPharm up to $500,000 upon the first commercial sale of licensed products in the U.S., and $1.0 million upon achieving $50 million in cumulative worldwide net sales[68] - The Company acquired Pear Tree Pharmaceuticals for exclusive rights to develop a proprietary formulation of tamoxifen, leading to the DARE-VVA1 program[70] - The Company agreed to pay former stockholders of Pear Tree up to $15.5 million for clinical milestones and up to $47 million for commercial milestones[72] Grants and Funding - The Company received a total of approximately $23.9 million in non-dilutive funding under the DARE-LARC1 grant agreement as of June 30, 2023, with a deferred grant funding liability of approximately $13.1 million recorded[123] - The Company received a grant of approximately $385,000 from NICHD on July 28, 2023, to support preclinical development for a new therapeutic[127]