INTENSITY THERAPEUTICS, INC. FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2024
Intensity Therapeutics, Inc. filed its annual report for the fiscal year ended December 31, 2024. The company reported a net loss of $14.3 million, or $0.94 per share, compared to a net loss of $12.1 million, or $0.83 per share, in the prior year. Revenue was $0.4 million, primarily from research and development grants. The company had cash and cash equivalents of $12.3 million as of December 31, 2024, and a working capital deficit of $14.1 million. The aggregate market value of the company’s common equity held by non-affiliates was $45.3 million as of June 30, 2024. As of March 12, 2025, the company had 15,180,945 shares of common stock outstanding.
Overview
Intensity Therapeutics, Inc. is a late-stage clinical biotechnology company focused on developing a new approach to treating solid tumors. The company’s lead product candidate, INT230-6, is a novel formulation that combines proven anti-cancer drugs with amphiphilic molecules to enable the drugs to better penetrate and disperse through the tumor microenvironment.
Financial Performance
- Intensity Therapeutics has not generated any revenue from product sales to date, as it is still in the clinical development stage.
- The company incurred net losses of $16.3 million and $10.5 million in 2024 and 2023, respectively, as it continues to invest in research and development for its product candidates.
- Research and development expenses increased by $5.7 million (119%) in 2024, primarily due to increased costs for the INVINCIBLE-3 and INVINCIBLE-4 clinical studies.
- General and administrative expenses increased by $2.6 million (72%) in 2024, mainly due to higher costs associated with being a public company.
- As of December 31, 2024, Intensity Therapeutics had approximately $2.6 million in cash and cash equivalents, which the company projects will be sufficient to fund operations through the end of the first quarter of 2025.
Strengths and Weaknesses
Strengths:
- Unique drug delivery platform that aims to overcome challenges with intratumoral drug delivery
- Promising clinical data for lead product candidate INT230-6, showing high levels of tumor necrosis and immune activation
- Established partnerships with major pharmaceutical companies for combination studies
Weaknesses:
- Significant operating losses and need for additional funding to continue clinical development and operations
- Reliance on third-party contract research and manufacturing organizations
- Limited revenue generation as a pre-commercial stage company
Outlook
Intensity Therapeutics is focused on advancing its lead product candidate INT230-6 through late-stage clinical trials for various solid tumor indications. The company has several ongoing and planned studies, including:
- INVINCIBLE-3 Study: Evaluating INT230-6 as a monotherapy in second- and third-line soft tissue sarcoma
- INVINCIBLE-4 Study: Evaluating INT230-6 in combination with standard of care in localized triple-negative breast cancer
If these studies are successful, Intensity Therapeutics plans to seek regulatory approvals for INT230-6. However, the company will need to secure additional funding to complete the clinical development and commercialization of its product candidates.
Overall, Intensity Therapeutics is making progress with its novel approach to treating solid tumors, but faces the typical challenges of a pre-revenue, clinical-stage biotechnology company in terms of funding its operations and advancing its pipeline.
