bioAffinity Technologies(BIAF) - 2025 Q1 - Quarterly Results

Executive Summary & Business Update Company Overview bioAffinity Technologies, Inc. is a biotechnology company focused on developing accurate, noninvasive tests for early-stage lung cancer and other lung diseases, with its primary product being CyPath Lung - bioAffinity Technologies, Inc. is a biotechnology company focused on noninvasive tests for early-stage lung cancer and other lung diseases, as well as broad-spectrum cancer treatments[2][13] - The company's first product, CyPath Lung, is a noninvasive test for early-stage lung cancer, marketed as a Laboratory Developed Test (LDT) by its subsidiary, Precision Pathology Laboratory Services[13] Key Highlights & Management Commentary The company reported strong momentum in Q1 2025, driven by significant year-over-year growth in CyPathLung sales and strategic actions to streamline operations and reduce costs, while also expanding its commercial footprint and intellectual property Operational & Strategic Achievements Key operational achievements include a substantial increase in CyPathLung sales, successful beta launch results, significant cost reduction initiatives, and advancements in intellectual property and processing efficiency CyPathLung Sales Growth (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 | YoY Change | | :--------------- | :------ | :--------- | | CyPathLung Sales | N/A | +276% | - Strategic actions implemented in March 2025, including streamlining operations, reducing labor costs, and discontinuing suboptimal pathology services, are expected to reduce annual costs by approximately $3.8 million[5][6] - The company received acceptance of a new patent application from the Australian Patent Office, enhancing international IP protection and global commercialization potential for CyPathLung[6] - Subsequent to the first quarter, improvements to CyPath Lung processing increased data acquisition throughput by 50% and reduced unit cost by over 25%[6][7] Management Outlook CEO Maria Zannes emphasized the growing demand for CyPathLung, the successful execution of the company's strategy focusing on high-value services and operational efficiency, and a commitment to expanding access and developing new diagnostics - CEO Maria Zannes highlighted strong momentum in Q1 2025, attributing it to growing demand for CyPathLung and successful execution of a strategy focused on high-value services and operational efficiency[4] - The company is committed to expanding access to CyPath Lung for patients at risk of lung cancer and advancing new diagnostics for diseases like COPD and asthma[8] Financial Performance First Quarter 2025 Financial Results Overview bioAffinity Technologies reported $1.9 million in revenue for Q1 2025, a decrease from the prior year, alongside an increase in operating expenses and a higher net loss. The company's cash position decreased, though subsequent financing activities raised additional capital Q1 2025 vs Q1 2024 Financial Summary | Metric | Q1 2025 | Q1 2024 | YoY Change | | :------------------------------------ | :------------- | :------------- | :--------- | | Net Revenue | $1.9 million | $2.4 million | -20.8% | | Operating Expenses | $4.5 million | $4.4 million | +2.3% | | Net Loss | $(2.7) million | $(2.0) million | +35.0% | | Net Loss Per Share (basic & diluted) | $(0.16) | $(0.20) | -20.0% | | Cash and Cash Equivalents (as of period end) | $0.4 million (Mar 31, 2025) | $1.1 million (Dec 31, 2024) | -63.6% | - Subsequent to the end of 2024, bioAffinity Technologies raised gross proceeds of $1.4 million through warrant exercises in February 2025 and $3.3 million in a public offering in May 2025[12] Condensed Consolidated Balance Sheets As of March 31, 2025, the company's total assets decreased to $5.5 million from $6.5 million at December 31, 2024, primarily driven by a reduction in cash and cash equivalents. Total liabilities increased, while total stockholders' equity decreased significantly Selected Balance Sheet Items (March 31, 2025 vs. December 31, 2024) | Item | March 31, 2025 | December 31, 2024 | | :------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $444,706 | $1,105,291 | | Total current assets | $1,863,782 | $2,695,098 | | Total assets | $5,547,283 | $6,513,667 | | Total current liabilities | $3,415,409 | $3,104,905 | | Total liabilities | $4,107,879 | $3,911,631 | | Total stockholders' equity| $1,439,404 | $2,602,036 | Unaudited Condensed Consolidated Statements of Operations For Q1 2025, net revenue was $1.85 million, a decrease from Q1 2024. Operating expenses totaled $4.48 million, with direct costs decreasing due to strategic actions, while clinical development and selling, general and administrative expenses increased, leading to a net loss of $2.66 million Q1 2025 vs Q1 2024 Operating Expenses Breakdown | Expense Category | Q1 2025 | Q1 2024 | YoY Change | | :-------------------------------- | :----------- | :----------- | :--------- | | Direct costs and expenses | $1,367,860 | $1,573,441 | -13.0% | | Research and development | $367,386 | $393,639 | -6.7% | | Clinical development | $138,353 | $48,960 | +182.6% | | Selling, general and administrative | $2,452,549 | $2,185,944 | +12.2% | | Depreciation and amortization | $154,588 | $149,637 | +3.3% | - Direct costs and expenses decreased 13% year-over-year, primarily due to targeted strategic actions implemented in March 2025[10] - Selling, general and administrative expenses increased, mainly driven by higher employee compensation related to administrative and sales functions to scale the commercialization of CyPath Lung[11] Additional Information Forward-Looking Statements This section provides a standard disclaimer regarding forward-looking statements, highlighting that future results may differ materially due to various risks and uncertainties - The press release contains forward-looking statements, which are based on current estimates and assumptions and are subject to various risks and uncertainties that could cause actual results to differ materially from current expectations[14] Contacts Contact information for media and investor relations is provided for inquiries related to bioAffinity Technologies - Contact information for bioAffinity Technologies' Director of Communications (Julie Anne Overton) and Investor Relations (Dave Gentry of RedChip Companies Inc.) is provided[15]