Company: INTS
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001567264-25-000103
Chunk: 24

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 1
Chunk 24
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 In 2024, the Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study"), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Also in 2024, the Company initiated a Phase 2 study (the "INVINCIBLE-4 Study") in collaboration with the Swiss Cancer Institute, formerly the Swiss Group for Clinical Cancer Research (SAKK), evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer, with pathological complete response as the endpoint. In September 2025, the Company paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in the INVINCIBLE-4 Study.

Note 2.    Liquidity and Plan of Operation

The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”), which contemplate continuation of the Company as a going concern.The Company is a research and development company and has not generated any revenue from its product candidates. The Company has experienced net losses and negative cash flows from operations each year since its inception. Through September 30, 2025, the Company has an accumulated deficit of $75.3 million. The Company’s operations have been financed primarily through the sale of equity securities and convertible notes. The Company’s net loss for the nine months ended September 30, 2025 was $8.6 million. The Company expects to incur significant expenses to complete development of its product candidates. The Company may never be able to obtain regulatory approval for the marketing of any of its product candidates in the United States or internationally and there can be no assurance that the Company will generate revenues or ever achieve profitability. The Company does not expect to receive significant product revenue in the near term. The Company, therefore, expects to continue to incur substantial losses for the foreseeable future.Cash and cash equivalents totaled $7.1 million as of September 30, 2025. Subsequent to September 30, 2025, the Company raised an additional $2.0 million in net proceeds under the ATM Sales Agreement and an additional $4.0 million in gross proceeds from the October 2025 Registered Direct Offering (see Note 13). Until such time