Daré Bioscience(DARE) - 2025 Q1 - Quarterly Results

Daré Bioscience First Quarter 2025 Update Expanded Business Strategy and 2025/2026 Milestones The company is pursuing a dual commercialization strategy to accelerate revenue generation starting in Q4 2025 - The company is implementing a dual-path strategy, commercializing products via 503B compounding for near-term revenue while simultaneously seeking full FDA approval[3] - Daré expects to begin recording revenue in the fourth quarter of 2025[2] - Key commercialization targets include Sildenafil Cream and vaginal probiotics in 2025, followed by DARE-HRT1 in 2026[1][2] - The company is targeting the compounded hormone therapy market, which is estimated to be up to $4.5 billion[1] Therapeutic Development Pipeline Highlights The company is advancing its clinical pipeline, with a key data review for Ovaprene® scheduled for July 2025 - Ovaprene®: Enrollment is ongoing in the pivotal Phase 3 contraceptive efficacy study, with a data safety monitoring board scheduled to review interim data in July 2025[2][5][9] - Sildenafil Cream, 3.6%: The company continues interactions with the FDA regarding the planned Phase 3 study and expects to submit the protocol by the end of Q2 2025[6][9] - DARE-HPV: Daré is preparing to submit an IND application for a Phase 2 clinical study for the clearance of high-risk HPV, supported by a non-dilutive award of up to $10 million[7][9] First Quarter 2025 Financial Results The company reported a reduced net loss and ended the quarter with $10.3 million in cash and cash equivalents Financial Highlights Summary Daré demonstrated fiscal discipline by significantly reducing operating expenses compared to the prior-year period Key Financial Position & Expense Changes (Q1 2025 vs Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $10.3 million | N/A | - | | Research and development expenses | $2.3 million | $3.4 million | -31% | | General and administrative expenses | $2.3 million | $2.7 million | -15% | Consolidated Statements of Operations The net loss for Q1 2025 improved to $4.4 million, down from a $6.8 million loss in Q1 2024 Consolidated Statements of Operations (Three Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Total revenue | $25,427 | $9,302 | | Total operating expenses | $4,606,545 | $6,031,775 | | Loss from operations | ($4,581,118) | ($6,022,473) | | Net loss | ($4,378,307) | ($6,755,356) | | Loss per common share | ($0.50) | ($0.81) | Condensed Consolidated Balance Sheet Data The balance sheet showed $10.3 million in cash and a working capital deficit of $9.4 million as of March 31, 2025 Condensed Consolidated Balance Sheet Data | Metric | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,329,967 | $15,698,174 | | Working capital deficit | ($9,365,525) | ($3,161,150) | | Total assets | $18,618,941 | $22,101,131 | | Total stockholders' deficit | ($9,563,701) | ($6,012,089) | Company Information and Forward-Looking Statements This section outlines Daré's business focus, investor call details, and significant risks and uncertainties - A conference call to discuss the financial results and company update was scheduled for May 13, 2025, at 4:30 p.m. Eastern Time[11] - Daré Bioscience is a biopharmaceutical company focused on advancing innovative products for women's health in areas like contraception, sexual health, and menopause[13][14] - The report contains extensive forward-looking statements concerning go-to-market strategies, product timelines, and clinical development, which are subject to significant risks[17]