Daré Bioscience(DARE) - 2022 Q1 - Quarterly Report

Financial Performance - Net loss for the three months ended March 31, 2022, was $8,398,670, compared to a net loss of $7,323,644 for the same period in 2021, indicating an increase in loss of about 14.7%[14] - Total operating expenses for the three months ended March 31, 2022, were $8,400,449, up from $7,693,534 in the same period of 2021, marking an increase of approximately 9.2%[14] - The company reported a loss per common share of $0.10 for the three months ended March 31, 2022, compared to a loss per common share of $0.16 for the same period in 2021[14] - For the three months ended March 31, 2022, the company incurred a net loss of approximately $8.4 million, compared to a net loss of approximately $7.3 million for the same period in 2021[32] - The company reported negative cash flow from operations of approximately $12.3 million for the three months ended March 31, 2022, an increase from negative cash flow of approximately $8.4 million in the prior year[32] Assets and Liabilities - Total current assets decreased from $55,296,016 as of December 31, 2021, to $47,817,188 as of March 31, 2022, representing a decline of approximately 13.4%[12] - Total liabilities increased from $17,052,856 as of December 31, 2021, to $18,307,672 as of March 31, 2022, reflecting a rise of approximately 7.4%[12] - Cash and cash equivalents decreased from $51,674,087 as of December 31, 2021, to $39,316,911 as of March 31, 2022, a reduction of about 23.9%[12] - The accumulated deficit increased from $110,126,902 as of December 31, 2021, to $118,525,572 as of March 31, 2022, representing a rise of about 7.8%[12] - Total stockholders' equity decreased from $38,754,321 as of December 31, 2021, to $30,878,910 as of March 31, 2022, a decline of about 20.4%[12] Shareholder Information - The weighted average number of common shares outstanding increased from 44,502,582 for the three months ended March 31, 2021, to 83,944,119 for the same period in 2022, indicating a significant increase of approximately 88.5%[14] - As of March 31, 2022, the Company had outstanding warrants for 1,374,515 shares at an exercise price of $0.96, expiring on February 15, 2023[99] - The Company has approximately 27 million authorized shares of common stock available for issuance as of the date of the report[36] Research and Development - Research and development expenses for the three months ended March 31, 2022, were $5,805,462, slightly up from $5,728,206 in the same period of 2021, reflecting an increase of approximately 1.4%[14] - The company expects significant increases in research and development expenses in 2022 compared to 2021 as it continues to develop its product candidates[34] - The Company has not generated any revenue to date and primarily focuses on research and development activities[25] Licensing and Collaboration Agreements - The Company entered into an exclusive license agreement with Organon, receiving a non-refundable upfront payment of $10.0 million and potential milestone payments up to $182.5 million[52][53][54] - The royalty payments from Organon will be tiered double-digit percentages based on net sales, continuing until the expiration of patent claims or 10 years after the first commercial sale in each country[54][55] - The license agreement with Bayer includes a $1.0 million upfront payment and potential milestone payments totaling up to $310.0 million based on sales achievements[59][61] - The Company has a strategic agreement with Hammock Pharmaceuticals, involving milestone payments up to $1.1 million for clinical and regulatory achievements[64][66] - The Company has incurred $235,000 in license fees payable to MilanaPharm, with additional milestone payments based on commercial sales[64][66] Financial Obligations and Future Funding - The Company anticipates needing to raise substantial additional capital to fund its operations and execute its current strategy[36] - The Company is committed to a total of $5.5 million in payments to NICHD for the Ovaprene Phase 3 study, with $5.0 million already paid as of March 31, 2022[111] - The Company agreed to pay up to $46.5 million in contingent consideration to former MBI stockholders based on achieving specific milestones, with $1.25 million already payable as of June 2021[112] Grants and Non-Dilutive Funding - The Company received approximately $1.9 million in non-dilutive grant funding from NICHD for Ovaprene development from 2018 to 2021[116] - A grant of $300,000 was awarded by NICHD for the development of DARE-PTB1, with potential additional funding of up to $2.0 million contingent on Phase I results[117] - The Company entered into a new grant agreement with the Foundation in June 2021 for up to $48.95 million to support DARE-LARC1 development, with an initial payment of $11.45 million received in July 2021[121] Acquisitions - The Company acquired Dare MB Inc. for $2.4 million, issuing approximately 3.0 million shares valued at $0.79 per share, to develop a long-acting reversible contraception method[86] - The Company completed the acquisition of Pear Tree Pharmaceuticals to develop a proprietary vaginal formulation of tamoxifen, with contingent payments based on clinical, regulatory, and commercial milestones[89] Clinical Studies - The Company commenced a Phase 1/2 clinical study of DARE-HRT1 in April 2022, evaluating pharmacokinetics in approximately 20 healthy, postmenopausal women[124]