Cabaletta Bio(CABA) - 2025 Q3 - Quarterly Report

Financial Performance - Net loss for the nine months ended September 30, 2025, was $125,937,000, compared to a net loss of $83,278,000 for the same period in 2024, representing a 51.2% increase in losses[17] - The company reported a net loss per share of $0.44 for the three months ended September 30, 2025, compared to $0.62 for the same period in 2024[17] - For the three months ended September 30, 2025, the Company reported a net loss of $44.866 million, compared to a net loss of $30.629 million for the same period in 2024, reflecting a 46.4% increase in losses[72] - The net loss for the three months ended September 30, 2025, was $44.9 million, compared to a net loss of $30.6 million for the same period in 2024, reflecting an increase of $14.2 million[176] - Net loss for the nine months ended September 30, 2025, was $125.9 million, compared to a net loss of $83.3 million in 2024, reflecting a 51.1% increase in losses[188] Cash and Liquidity - Cash and cash equivalents decreased to $60,206,000 as of September 30, 2025, from $163,962,000 as of December 31, 2024[15] - Cash, cash equivalents, and investments totaled $159.931 million as of September 30, 2025, indicating a decrease in liquidity compared to previous periods[32] - As of September 30, 2025, the company had $159.9 million in cash, cash equivalents, and investments, expected to fund operations into the second half of 2026[187] - Cash used in operating activities was $95.7 million for the nine months ended September 30, 2025, compared to $65.1 million in 2024, indicating a 46.9% increase in cash outflow[198] - Cash provided by financing activities was $92.0 million for the nine months ended September 30, 2025, significantly higher than $7.3 million in 2024[201] Research and Development - Research and development expenses for the three months ended September 30, 2025, were $39,824,000, up 51.5% from $26,290,000 in the same period of 2024[17] - Research and development expenses increased to $106.5 million for the nine months ended September 30, 2025, up from $71.7 million in 2024, representing a 48.6% increase[182] - The company expects to continue incurring operating losses for the foreseeable future as it advances its research and development activities[30] - The company has significant reliance on third parties for research and development activities, which may impact its operational capabilities[31] Liabilities and Equity - Total liabilities increased to $50,293,000 as of September 30, 2025, compared to $32,711,000 on December 31, 2024[15] - The total stockholders' equity as of September 30, 2025, was $139,466,000, down from $152,335,000 as of December 31, 2024[15] - The accumulated deficit as of September 30, 2025, was $475,038,000, up from $349,101,000 as of December 31, 2024[15] - The company has substantial doubt about its ability to continue as a going concern, as its current cash and investments may not be sufficient to fund operations for at least the next twelve months[32] Clinical Trials and Agreements - The FDA granted clearance for the company's rese-cel IND applications for multiple autoimmune diseases, including systemic lupus erythematosus and idiopathic inflammatory myopathies, between March 2023 and January 2025[113] - The RESET-Myositis Phase 1/2 clinical trial is actively enrolling patients, targeting approximately 80,000 patients in the U.S. and 85,000 in Europe, with an estimated 20%-25% of the prevalent population potentially eligible for treatment[114] - The company entered into an Exclusive License Agreement with IASO Biotherapeutics, with potential total consideration of up to $162,000, including milestone payments and royalties[56] - The License and Supply Agreement with Oxford Biomedica includes regulatory and sales milestones in the low tens of millions and royalties in the low single digits on net sales of products incorporating Oxford technology[59] Stock and Compensation - The Company recorded total stock-based compensation of $5.815 million for the three months ended September 30, 2025, compared to $5.250 million for the same period in 2024[99] - The weighted average grant-date fair value of stock options granted during the nine months ended September 30, 2025, was $1.46, down from $15.61 in 2024[93] - The Company has a total of 13,618,173 stock options outstanding as of September 30, 2025, with a weighted average exercise price of $8.75[92] Market and Operational Risks - The company has not experienced any changes in its internal control over financial reporting that would materially affect its financial reporting processes[213] - The company is exposed to market risks primarily related to interest rate sensitivities, which could affect future investment income if interest rates decline[210] - The company continues to focus on attracting and retaining skilled personnel, which may increase operational costs due to inflation[211]