Intensity Therapeutics(INTS) - 2024 Q4 - Annual Results

Corporate Update In 2024, Intensity Therapeutics advanced its clinical programs by initiating two key studies: the INVINCIBLE-3 Phase 3 trial for soft tissue sarcoma and the INVINCIBLE-4 Phase 2 trial for triple-negative breast cancer. The company has successfully obtained regulatory authorizations in nine countries, engaged leading global hospitals, and is actively enrolling patients across the US, Canada, Europe, and Australia. Enrollment for INVINCIBLE-3 is expected to complete in the first half of 2026, and for INVINCIBLE-4 by the end of the first quarter of 2026 - Initiated INVINCIBLE-3, a Phase 3 study for soft tissue sarcoma, expected to enroll 333 patients across eight countries. The first patient was dosed in July 2024, with 32 sites contracted and 25 patients screened to date[4][5][9] - Initiated INVINCIBLE-4, a Phase 2 study for early-stage triple-negative breast cancer (TNBC) in collaboration with SAKK, expected to enroll approximately 54 patients. The first patient was dosed in October 2024, with eight sites activated in Switzerland[6][7][9] - CEO Lewis H. Bender highlighted that in 2024, the company finalized protocols, engaged leading hospitals worldwide, and obtained regulatory authorization to recruit patients in 9 countries[8] 2024 Year-End Financial Results For the year ended December 31, 2024, Intensity Therapeutics reported a net loss of $16.3 million, an increase from the $10.5 million loss in 2023. This was primarily driven by a significant rise in research and development expenses to $10.5 million due to the initiation of the INVINCIBLE-3 and INVINCIBLE-4 studies. General and administrative costs also increased. The company ended the year with $2.6 million in cash and cash equivalents Key Financial Metrics | Financial Metric | 2024 | 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | Research and Development Expenses | $10.5 million | $4.8 million | +$5.7 million | | General and Administrative Expenses | $6.1 million | $3.5 million | +$2.6 million | | Net Loss | $16.3 million | $10.5 million | +$5.8 million | | Cash and Cash Equivalents (at Dec 31) | $2.6 million | $14.8 million | -$12.2 million | - The increase in R&D expenses was mainly due to a $5.6 million increase for the INVINCIBLE-3 Study and a $0.5 million increase for the INVINCIBLE-4 Study[10] - The rise in G&A expenses was attributed to higher salary, benefits, stock-based compensation, legal and consulting fees, and directors and officers insurance[11] Statements of Operations The company's operating loss widened to $16.6 million in 2024 from $8.3 million in 2023, primarily due to a more than doubling of R&D expenses. The net loss attributable to common stockholders was $16.3 million, or ($1.17) per share, compared to a net loss of $11.9 million, or ($1.38) per share, in the prior year Statements of Operations (in thousands, except per share data) | (in thousands, except per share data) | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Operating Expenses | | | | Research and development | $10,496 | $4,786 | | General and administrative | $6,089 | $3,533 | | Total operating expenses | $16,585 | $8,319 | | Loss from operations | ($16,585) | ($8,319) | | Interest income | $314 | $324 | | Net loss | ($16,268) | ($10,538) | | Net loss attributable to common stockholders | ($16,268) | ($11,862) | | Loss per share, basic and diluted | ($1.17) | ($1.38) | | Weighted average number of shares | 13,906,973 | 8,616,324 | Balance Sheets As of December 31, 2024, total assets decreased significantly to $4.8 million from $17.3 million in the prior year, primarily due to a reduction in cash and cash equivalents from $14.8 million to $2.6 million. Total liabilities also decreased to $1.9 million from $4.1 million, while total stockholders' equity fell to $2.9 million from $13.2 million Balance Sheets (in thousands) | (in thousands) | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents and marketable debt securities | $2,590 | $14,776 | | Total current assets | $3,363 | $15,464 | | Total assets | $4,783 | $17,295 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $1,755 | $3,959 | | Total liabilities | $1,865 | $4,133 | | Total stockholders' equity | $2,918 | $13,162 | | Total liabilities and stockholders' equity | $4,783 | $17,295 | About INT230-6 Intensity Therapeutics is a late-stage clinical biotechnology company focused on a new approach to cancer treatment. Its lead product, INT230-6, is an investigational drug designed for direct intratumoral injection. It combines two proven anti-cancer agents (cisplatin and vinblastine) with a proprietary penetration enhancer to kill tumors locally and stimulate a systemic anti-tumor immune response. The company has completed two clinical studies with over 200 patients and is advancing into pivotal trials - INT230-6 is the lead proprietary candidate, designed for direct intratumoral injection, and was discovered using the DfuseRx℠ technology platform[13] - The drug comprises two potent anti-cancer agents, cisplatin and vinblastine, plus a penetration enhancer molecule (SHAO) to help disperse the drugs throughout the tumor[13] - INT230-6 is designed to kill tumors locally and induce a systemic anti-tumor immune response by releasing neoantigens, without the immunosuppression often seen with systemic chemotherapy[13] - The company has completed a Phase 1/2 study in metastatic cancers and a Phase 2 trial in locally advanced breast cancer, and has now initiated a Phase 3 trial in soft tissue sarcoma (INVINCIBLE-3) and a Phase 2 trial in presurgical triple-negative breast cancer (INVINCIBLE-4)[14] Forward-Looking Statements This section serves as a legal disclaimer, cautioning that statements in the press release regarding future plans, clinical trials, financial projections, and business activities are forward-looking. It warns that actual results may differ materially from these projections due to various risks and uncertainties, including clinical trial outcomes, funding needs, and regulatory approvals, as detailed in the company's SEC filings - The press release contains forward-looking statements concerning future plans, development activities, projected milestones, and financial needs[15] - These statements are subject to risks and uncertainties, such as the timing and results of clinical trials, the need for additional funding, regulatory approvals, and market acceptance of products[16] - Readers are advised not to place undue reliance on these statements, and the company does not plan to update them except as required by law[16]