Intensity Therapeutics(INTS) - 2025 Q1 - Quarterly Results

Corporate Update The company advanced its breast cancer trial, paused its sarcoma study due to funding, and raised capital via a public offering - The company is prioritizing funding for the INVINCIBLE-4 study (presurgical breast cancer) over the INVINCIBLE-3 study (sarcoma) due to cash constraints[6][8] - Completed a public offering in April 2025, raising aggregate gross proceeds of $2.35 million, with net proceeds of approximately $1.9 million[7] INVINCIBLE-4 Study (Triple-Negative Breast Cancer) - A Phase 2 study analyzing INT230-6 before standard of care (SOC) treatment in patients with early-stage, operable triple-negative breast cancer (TNBC)[3] - The study is actively recruiting patients in Switzerland and is expected to enroll a total of 54 patients across Switzerland and France[2][3] - In April 2025, the European Medicines Agency authorized the initiation of the study in France in collaboration with Unicancer[4] INVINCIBLE-3 Study (Soft Tissue Sarcoma) - A Phase 3 study testing INT230-6 as a monotherapy compared to SOC drugs for second and third-line treatment of certain soft tissue sarcoma subtypes[5] - In March 2025, the company paused new site activations and patient enrollments for this study due to funding constraints[6] - The company will continue to treat all 23 patients already enrolled in the study during the pause[6][8] First Quarter 2025 Financial Results The company reported a reduced net loss of $3.3 million for Q1 2025, driven by lower R&D and G&A expenses Key Financial Metrics | Financial Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expenses | $2.2 million | $2.8 million | | General and administrative expenses | $1.2 million | $1.9 million | | Net loss | $3.3 million | $4.6 million | | Loss per share | $(0.22) | $(0.34) | | Cash and cash equivalents (as of quarter end) | $0.9 million | N/A | - The decrease in R&D expenses was driven by a $0.2 million decline in contract manufacturing costs and a $0.4 million reduction in stock-based compensation[9] - G&A expenses decreased due to cost savings from new administrative systems and a $0.3 million reduction in stock-based compensation[10] Financial Statements Unaudited Statements of Operations and Balance Sheets detail the company's financial performance and position as of March 31, 2025 Statements of Operations | | Three Months Ended March 31, | | :--- | :--- | :--- | | (in thousands, except per share amounts) | 2025 | 2024 | | Operating expenses: | | | | Research and development | $2,189 | $2,815 | | General and administrative | $1,205 | $1,928 | | Total operating expenses | $3,394 | $4,743 | | Loss from operations | $(3,394) | $(4,743) | | Interest income | $15 | $140 | | Other income, net | $32 | $— | | Net loss | $(3,347) | $(4,603) | | Loss per share, basic and diluted | $(0.22) | $(0.34) | | Weighted average number of shares | 15,173,196 | 13,709,487 | Balance Sheets | | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | (in thousands) | | | | Assets | | | | Cash and cash equivalents | $929 | $2,590 | | Total current assets | $1,651 | $3,363 | | Total assets | $3,065 | $4,783 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $2,629 | $1,755 | | Total liabilities | $2,731 | $1,865 | | Total stockholders' equity | $334 | $2,918 | | Total liabilities and stockholders' equity | $3,065 | $4,783 | About INT230-6 and Intensity Therapeutics INT230-6 is an investigational intratumoral drug designed to kill tumors locally and stimulate a systemic immune response - INT230-6 is composed of two anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO)[13] - The drug is designed to kill tumors locally while causing a release of neoantigens that leads to a systemic anti-tumor immune response[13] - The company has initiated a Phase 3 trial in soft tissue sarcoma and a Phase 2 trial in presurgical triple-negative breast cancer[14]