Intensity Therapeutics Shares First Quarter 2025 Financial Results and Corporate Developments

Intensity Therapeutics: Corporate Update and Financial Report for Q1 2025

Intensity Therapeutics, Inc. (NASDAQ: INTS), a pioneering player in the realm of biotechnology, recently revealed its financial results for the first quarter of 2025, alongside crucial updates on its operations. Focusing on the advancement of novel immune-based cancer therapies, the company continues to innovate methods aimed at eradicating tumors while enhancing the body’s innate immune response against malignancies.

Corporate Update

The company is in the midst of its INVINCIBLE-4 Study, a Phase 2 randomized open-label multicenter trial that scrutinizes the efficacy and safety of its leading candidate, INT230-6. This therapy is being compared against standard care treatments in patients with operable early-stage triple-negative breast cancer (TNBC). A remarkable component of this study is the dual approach where INT230-6 is administered prior to the standard-of-care (SOC) interventions. The primary objective here is to assess the change in the rate of pathological complete response when using both therapies together.

The INVINCIBLE-4 Study is actively recruiting patients in Switzerland, with plans to enroll up to 54 individuals across Switzerland and France. Recent developments include the European Medicines Agency's approval to initiate this study in France. This milestone underscores the collaboration between Intensity and The Swiss Group for Clinical Cancer Research (SAKK), a recognized leader in cancer treatment research.

Additionally, the INVINCIBLE-3 Study is a pivotal Phase 3 trial that focuses on patients with specific soft tissue sarcoma subtypes, comparing INT230-6 as a monotherapy against existing SOC treatments. This study aims to encompass 333 patients across eight different countries and has received the green light from various health authorities including the US FDA, Health Canada, and the European Medicines Agency.

Though the enrollment process for the INVINCIBLE-3 Study faced a temporary halt due to funding limitations, the company assures that ongoing treatment for existing participants will continue, facilitated by collaboration with external research organizations. The requirement for new funding prompted the decision to prioritize resources towards the INVINCIBLE-4 Study.

In terms of financial operations, in April 2025, Intensity completed a public offering, successfully raising approximately $2.35 million, enhancing their liquidity position for advancing their clinical trials and research activities.

Financial Overview

For the period ending March 31, 2025, Intensity recorded research and development expenses of $2.2 million, a decrease compared to $2.8 million for the same timeframe in 2024. This reduction can be attributed to the ongoing patient recruitment in the INVINCIBLE-03 Study, with clinical trial expenses seeing a slight increase.

General and administrative costs also demonstrated a decline, totaling $1.2 million versus $1.9 million the prior year. This decrease reflects cost-saving measures achieved through the integration of new administrative systems. Ultimately, the company reported a net loss of $3.3 million for the first quarter of 2025, improving from a significant loss of $4.6 million in the first quarter of 2024. As of March 31, 2025, cash reserves stood at $0.9 million.

About INT230-6

At the forefront of Intensity's product pipeline is INT230-6, an innovative investigational therapy designed for direct intratumoral administration. This sophisticated formulation utilizes established anti-cancer agents such as cisplatin and vinblastine combined with a penetration enhancer, facilitating better distribution within tumors and maximizing therapeutic efficacy. Not only does INT230-6 aim to kill cancer cells locally, but it also promotes an immune response that may confer systemic anti-tumor effects without the immunosuppression seen in traditional systemic chemotherapies.

Intensity has made significant progress, having enrolled over 200 patients across multiple clinical studies with INT230-6, demonstrating promising outcomes in the fight against cancer.

Conclusion

Intensity Therapeutics is committed to pushing the boundaries of cancer treatment through innovative therapies like INT230-6. As the company navigates funding challenges and hones in on critical trial results, the potential to transform treatment paradigms and offer new hope to patients dealing with aggressive cancers remains a priority. As the landscape of oncology continues to evolve, Intensity stands at the forefront, striving to enhance patient outcomes globally.