Intensity Therapeutics(US:INTS)2025-11-06 21:01Financial Performance - The company has incurred net losses of $8.6 million and $13.1 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $75.3 million as of September 30, 2025[89]. - The company has not generated any revenue from product sales or licensing and does not expect to do so in the foreseeable future[94]. - The company expects to incur significant expenses and operating losses for the next several years as it continues its research and development activities[90]. - The company has incurred significant operating losses and expects to continue incurring substantial expenses as it advances clinical development, indicating a need for additional capital[105]. - For the nine months ended September 30, 2025, the company reported a net cash used in operating activities of $6.8 million, an improvement from $12.6 million in the same period of 2024[115][116]. - The company generated $11.3 million in net cash from financing activities during the nine months ended September 30, 2025, primarily from stock issuances[119]. Funding and Capital Needs - The company may need substantial additional funding to support its operations and pursue its growth strategy, relying on equity sales, debt financing, or collaborations[92]. - The company filed a universal shelf registration statement for the sale of up to $150 million in various securities, including common stock and debt securities[108]. - The company raised approximately $2.35 million in the April 2025 Offering, with net proceeds of approximately $1.9 million after fees and expenses[111]. - The company completed the June 2025 Offering, selling 6,675,000 shares at $0.30 per share, raising approximately $1.8 million in net proceeds after expenses[112]. - In October 2025, the company entered a Securities Purchase Agreement to issue 5,000,000 shares at $0.80 per share, generating gross proceeds of $4.0 million[113]. - As of September 30, 2025, the company has issued 23,096,014 shares under the ATM Sales Agreement for net proceeds of $7.7 million[109]. - As of September 30, 2025, the company had cash and cash equivalents of approximately $7.1 million, projected to fund operations until the end of Q1 2027[114]. Clinical Studies and Development - The INVINCIBLE-2 Study demonstrated that INT230-6 achieved greater than 95% necrosis of the tumor in some patients, indicating a high order of necrosis in presurgical breast cancer tumors[85]. - The INVINCIBLE-3 Study, which aims to enroll 333 patients, has paused new site activations and patient enrollments due to funding constraints after enrolling 21 patients[86]. - The company initiated the INVINCIBLE-4 Study for localized triple-negative breast cancer, targeting to complete enrollment by the end of 2026, pending sufficient funding[87]. - The company has successfully developed Phase 3 quality analytical methods for the components of INT230-6 and manufactured multiple large-scale batches[88]. Expenses Management - Research and development expenses decreased by $0.6 million or 28% for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to lower clinical trial costs and no current year bonus accruals[100]. - General and administrative expenses decreased by $0.2 million or 17% for the three months ended September 30, 2025, compared to the same period in 2024, mainly due to reduced salaries and consulting expenses[101]. - For the nine months ended September 30, 2025, research and development expenses decreased by $3.2 million or 38% compared to the same period in 2024[102]. - General and administrative expenses for the nine months ended September 30, 2025, decreased by $1.3 million or 27% compared to the same period in 2024[102]. Other Financial Information - There were no investing activities reported for the nine months ended September 30, 2025, compared to $6.4 million in cash provided by investing activities in 2024[118]. - The company did not have any off-balance sheet arrangements as of September 30, 2025[121]. - The company has elected not to take advantage of the JOBS Act exemptions, thus adhering to the same accounting standards as other public companies[123].