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]

Daré Bioscience, Inc. (NASDAQ:DARE) Q1 2023 Earnings Conference Call May 11, 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 Kumar Raja – ROTH Capital Kemp Dolliver – Brookline Capital Markets Doug Tsao – H.C. Wainwright Operator Welcome to the conference call hosted by Daré Bioscience to review the Company’s ...

Financial Performance - Net loss for the three months ended March 31, 2023, was $8.04 million, compared to a net loss of $8.40 million for the same period in 2022, indicating a reduction in loss of about 4.3%[17] - The company reported a comprehensive loss of $8.06 million for the three months ended March 31, 2023, compared to a comprehensive loss of $8.41 million for the same period in 2022, a decrease of about 4.2%[17] - For the three months ended March 31, 2023, the company reported a net loss of approximately $8.0 million, compared to a net loss of $8.4 million for the same period in 2022, representing a 4.3% improvement in net loss year-over-year[33] Assets and Liabilities - Total current assets decreased from $43.04 million as of December 31, 2022, to $29.51 million as of March 31, 2023, representing a decline of approximately 31.2%[16] - Total assets decreased from $43.83 million as of December 31, 2022, to $30.37 million as of March 31, 2023, a reduction of about 30.7%[16] - Total liabilities decreased from $32.71 million as of December 31, 2022, to $25.40 million as of March 31, 2023, reflecting a decrease of approximately 22.3%[16] Cash Flow - Cash and cash equivalents decreased from $34.67 million as of December 31, 2022, to $19.83 million as of March 31, 2023, a decline of about 42.7%[16] - The net cash used in operating activities for the three months ended March 31, 2023, was approximately $16.1 million, an increase of 30.4% compared to $12.3 million for the same period in 2022[33] - The company reported a net change in cash and cash equivalents of approximately $(14.8) million for the three months ended March 31, 2023[33] - As of March 31, 2023, the company had cash and cash equivalents of approximately $19.8 million, down from $39.3 million at the end of the previous year, indicating a decrease of 49.7%[33] Operating Expenses - Operating expenses for the three months ended March 31, 2023, were $8.38 million, slightly down from $8.40 million in the same period of 2022, showing a decrease of approximately 0.2%[17] - General and administrative expenses increased from $2.57 million in Q1 2022 to $3.34 million in Q1 2023, an increase of approximately 29.8%[17] - Research and development expenses decreased from $5.81 million in Q1 2022 to $5.02 million in Q1 2023, a reduction of about 13.6%[17] Revenue Generation - The company recognized $10.0 million in license fee revenue from its agreement for XACIATO, which was the only revenue recognized as of March 31, 2023[44] - The company has not recognized any collaboration revenues as of March 31, 2023, indicating limited revenue generation from partnerships[43] Capital Needs and Future Outlook - The company expects to continue incurring negative cash flows from operations for the foreseeable future, necessitating substantial additional capital to fund operations and execute its strategy[34] - The company will need to raise substantial additional capital to continue its operations and may face significant operational adjustments if capital is not available[35] Stock and Equity - The weighted average number of shares outstanding increased from 83.94 million in Q1 2022 to 85.52 million in Q1 2023, an increase of approximately 1.9%[17] - The Company entered into a sales agreement to sell up to $50.0 million of common stock through an ATM equity offering program, with no shares sold during the three months ended March 31, 2023[85][86] - As of March 31, 2023, the Company had 9,110,219 stock options outstanding with a weighted average exercise price of $1.48[97] Milestone Payments and Agreements - The Company is entitled to receive up to $310.0 million in milestone payments related to the commercial sales of Ovaprene, along with tiered royalties starting in the low double digits based on annual net sales[49] - An exclusive license agreement with Organon resulted in a $10.0 million non-refundable payment, with potential milestone payments totaling up to $182.5 million and tiered double-digit royalties based on net sales[52][53] - The Company has potential future payments of up to $6.25 million for development and regulatory milestones and up to $45.0 million for commercial sales milestones under the Hennepin License Agreement[64] - The acquisition of Dare MB Inc. included contingent payments of up to $46.5 million for specified milestones and up to $55.0 million based on aggregate net sales of products[66] - The Company has paid $1.25 million in milestone payments related to the MBI acquisition, with a portion paid in shares of common stock[67] - The Pear Tree acquisition includes potential payments of up to $15.5 million for clinical development milestones and up to $47.0 million for commercial milestones, along with tiered royalties based on net sales[72] Grant Funding and Non-Dilutive Funding - The Company received a grant of $585,000 from the Bill & Melinda Gates Foundation for the development of DARE-LBT, with a deferred grant funding liability of approximately $552,000 recorded as of March 31, 2023[117][118] - Cumulative total of approximately $23.9 million in non-dilutive funding received under the DARE-LARC1 agreement, with a deferred grant funding liability of approximately $15.3 million as of March 31, 2023[120] Lease Obligations - The Company reported operating lease right of use assets of approximately $368,000 as of March 31, 2023[104] - Total operating lease costs for Q1 2023 were approximately $139,000, down from $169,000 in Q1 2022, representing a decrease of about 17.8%[105] - Cash paid for operating lease liabilities was approximately $105,000 in Q1 2023, compared to $123,000 in Q1 2022, indicating a decrease of approximately 14.6%[106] - Future minimum lease payments under operating leases total $410,000, with $317,000 due in the remainder of 2023 and $93,000 in 2024[106]

Financial Data and Key Metrics Changes - The comprehensive loss for 2022 was approximately $31.1 million, with cash and cash equivalents at approximately $34.7 million at year-end [64] - The company received approximately $24.1 million in non-dilutive funding during the year, including a $10 million license fee from Organon [64][63] - General and administrative expenses were approximately $11.2 million, while research and development expenses were approximately $30 million [79] Business Line Data and Key Metrics Changes - The company has secured its second commercial collaboration for XACIATO with Organon and received FDA acceptance for the pivotal study of Ovaprene [6][41] - Enrollment was completed for the Sildenafil Cream Phase IIb study, with positive results from two Phase I/II studies for DARE-VVA1 and DARE-HRT1 [6][24] Market Data and Key Metrics Changes - Women's health products represent 27% of blockbuster products generating over $500 million in annual sales, contributing 35% of revenue from all blockbuster products [7] - The global market for dysmenorrhea treatment is estimated to be valued at $13 billion in 2022, expected to increase to $28 billion by 2029 [52] Company Strategy and Development Direction - The company focuses solely on women's health, with 12 independent development stage candidates, claiming to have the deepest pipeline in this area [13] - The strategy includes prioritizing candidates that address meaningful market opportunities and have the potential to be first-in-category products [15] - The company aims to leverage collaborations with established commercial partners like Organon and Bayer to enhance market access and commercialization efforts [56][61] Management's Comments on Operating Environment and Future Outlook - Management believes that investment in women's health is efficient and impactful, addressing significant unmet needs in the market [5][14] - The company anticipates achieving additional commercialization, clinical, and regulatory milestones in 2023, with several key programs progressing [34] Other Important Information - The company is focused on developing differentiated first-line or first-in-category products, allowing flexibility in commercialization strategies [56] - The FDA's 505(b)(2) pathway will be utilized for obtaining marketing approvals for several products, including DARE-HRT1 and DARE-VVA1 [26][51] Q&A Session Summary Question: Can you discuss the components going into the arousal sensation domains and what would be considered a clinically meaningful improvement? - The study includes various exploratory endpoints to assess clinically meaningful improvements, with a focus on patient-reported outcomes [69][101] Question: How is the commercialization strategy for Sildenafil Cream being developed? - The company evaluates each product individually, considering the best approach for development and commercialization based on the product's needs and market conditions [86][91] Question: How do the doses being tested for DARE-PDM1 compare with systemically dosed versions? - The study is designed to understand the localized effects of diclofenac, with a focus on achieving effective concentrations in the targeted tissue [95][107]

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, 2022 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 DARÉ BIOSCIENCE, INC. (Exa ...

Dare Bioscience, Inc. (NASDAQ:DARE) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Sabrina Johnson - President and Chief Executive Officer Lisa Walters-Hoffert - Chief Financial Officer John Fair - Chief Strategy Officer Conference Call Participants Kumaraguru Raja - ROTH Capital Operator Welcome to the conference call hosted by Dare Bioscience to review the company's financial results for the quarter ended September 30, 2022 and to provide a 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 September 30, 2022 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 ...

Dare Bioscience, Inc. (NASDAQ:DARE) Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Sabrina Johnson - President, CEO, Secretary & Director John A. Fair - Chief Strategy Officer Lisa Walters-Hoffert - CFO Conference Call Participants Operator Good . My name is Joanne, and I will be your conference operator today. At this time, I would like to welcome everyone to the Dare Bioscience, Inc. Q2 2022 Conference Call. [Operator Instructions]. Ms. Johnson, you may begin your conferen ...