Sana Biotechnology(SANA) - 2025 Q2 - Quarterly Results

Business Highlights and Pipeline Update Sana reported positive clinical data for its UP421 therapy, advanced its CAR T pipeline with expected 2025 data, and secured $105 million, extending its cash runway into H2 2026 - Presented positive 6-month clinical results for its type 1 diabetes study (UP421), showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression persist, function, and evade immune detection[1][3] - The New England Journal of Medicine published positive 12-week clinical results from the UP421 study[1][3] - Received positive FDA feedback from an INTERACT meeting, increasing confidence in moving forward with the GMP master cell bank for SC451 and filing an Investigational New Drug (IND) application as early as 2026[1][2][7] - Patient enrollment is ongoing for the GLEAM trial (SC291) for autoimmune diseases and VIVID trial (SC262) for B-cell malignancies, with clinical data from both expected in 2025[1][7] - Plans to file an IND for SG299 (in vivo CAR T) for a B-cell related disease as early as 2026[1][7] Recent Capital Raise (July & August 2025) | Source | Gross Proceeds (Millions USD) | | :--- | :--- | | At-the-market (ATM) offering | $29.5 | | Public Equity Offering | $75.0 | | Total | ~$105 | Second Quarter 2025 Financial Results Sana's Q2 2025 cash was $72.7 million, operating expenses decreased, and a $44.6 million impairment led to a $93.8 million GAAP net loss GAAP Financial Results Q2 2025 GAAP R&D and G&A expenses decreased, and a $44.6 million impairment charge resulted in a $93.8 million net loss Cash Position | Date | Cash, Cash Equivalents, and Marketable Securities (Millions USD) | | :--- | :--- | | June 30, 2025 | $72.7 | | December 31, 2024 | $152.5 | Q2 2025 vs Q2 2024 Operating Expenses (GAAP, in millions) | Expense Category | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Research & Development | $29.8 | $60.9 | ($31.1) | | General & Administrative | $10.3 | $16.4 | ($6.1) | - Recorded a $44.6 million non-cash impairment of long-lived assets in Q2 2025, primarily related to manufacturing facilities, as the company will now use CDMOs for near-term needs[9] Q2 2025 vs Q2 2024 Net Loss (GAAP) | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | | :--- | :--- | :--- | | Net Loss | ($93.8) | ($50.3) | | Net Loss per Share | ($0.39) | ($0.21) | Non-GAAP Financial Measures Q2 2025 non-GAAP net loss was $38.9 million, a significant improvement, with year-to-date non-GAAP operating cash burn at $79.0 million Q2 2025 vs Q2 2024 Net Loss (Non-GAAP) | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | | :--- | :--- | :--- | | Non-GAAP Net Loss | ($38.9) | ($74.2) | | Non-GAAP Net Loss per Share | ($0.16) | ($0.32) | YTD 2025 vs YTD 2024 Operating Cash Burn (Non-GAAP) | Period | Non-GAAP Operating Cash Burn (Millions USD) | | :--- | :--- | | Six Months Ended June 30, 2025 | ($79.0) | | Six Months Ended June 30, 2024 | ($104.6) | - Non-GAAP measures are used by management to exclude highly variable non-cash items, such as changes in fair value of success payments and contingent consideration, and one-time expenses like impairment charges[19][20] Consolidated Financial Statements This section presents the unaudited Consolidated Balance Sheet and Statements of Operations for June 30, 2025, supporting reported financial results Selected Consolidated Balance Sheet Data As of June 30, 2025, total assets were $361.6 million, total liabilities $239.1 million, and stockholders' equity $122.6 million Selected Balance Sheet Data (in thousands) | Account | June 30, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $72,674 | $152,497 | | Total assets | $361,645 | $501,020 | | Total liabilities | $239,089 | $250,516 | | Total stockholders' equity | $122,556 | $250,504 | Consolidated Statements of Operations For Q2 2025, total operating expenses were $95.0 million, resulting in a net loss of $93.8 million, or $0.39 per share Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 (Thousands USD) | Six Months Ended June 30, 2025 (Thousands USD) | | :--- | :--- | :--- | | Total operating expenses | $94,975 | $145,605 | | Loss from operations | ($94,975) | ($145,605) | | Net loss | ($93,800) | ($143,189) | | Net loss per common share | ($0.39) | ($0.60) | Reconciliation of GAAP to Non-GAAP Measures This section details the reconciliation of GAAP to non-GAAP financial measures, including operating cash burn and net loss, with non-cash adjustments Reconciliation of Non-GAAP Operating Cash Burn For the six months ended June 30, 2025, non-GAAP operating cash burn was $79.0 million, after adjustments for cash changes and financing Reconciliation to Non-GAAP Operating Cash Burn (Six Months Ended June 30, 2025, in thousands) | Line Item | Amount (Thousands USD) | | :--- | :--- | | Change in cash, cash equivalents, and marketable securities | ($79,823) | | Adjustments (Financing, Capex, etc.) | $832 | | Operating cash burn – Non-GAAP | ($78,991) | Reconciliation of Non-GAAP Net Loss Q2 2025 GAAP net loss of $93.8 million was adjusted for non-cash items and a $44.6 million impairment, yielding a non-GAAP net loss of $38.9 million Reconciliation to Non-GAAP Net Loss (Three Months Ended June 30, 2025, in thousands) | Line Item | Amount (Thousands USD) | | :--- | :--- | | Net loss – GAAP | ($93,800) | | Adjustment: Change in fair value of liabilities | $10,262 | | Adjustment: Impairment of long-lived assets | $44,611 | | Net loss – Non-GAAP | ($38,927) |