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Intensity Therapeutics Reports on Financial Progress and Clinical Updates for 2024

Intensity Therapeutics, Inc. has provided its financial results for the year ending December 31, 2024, alongside an important corporate update. The company, renowned for its focus on developing innovative immune-based cancer therapies, reported significant progress in its ongoing clinical trials and financial metrics.

Clinical Trials Overview

The company's pivotal trials, namely the INVINCIBLE-3 and INVINCIBLE-4 Studies, are at the forefront of its efforts to combat various forms of cancer. The INVINCIBLE-3 Study, now in Phase 3, is pivotal as it aims to evaluate the efficacy of INT230-6, a promising investigational drug, in treating certain subtypes of soft tissue sarcoma.

INVINCIBLE-3 Study

Currently, 32 sites have been contracted for the INVINCIBLE-3 Study, with 25 patients already screened. This open-label, randomized trial, which involves up to 333 patients, tests INT230-6 as a monotherapy compared to standard care options. Authenticated by multiple regulatory bodies including the FDA and Health Canada, the trial is expected to enroll participants from eight countries. The recent data presented at significant oncology meetings underscore the trial's relevance and potential impact.

INVINCIBLE-4 Study

Simultaneously, the INVINCIBLE-4 Study is a Phase 2 trial investigating the use of INT230-6 administered prior to conventional treatment in patients with early-stage triple-negative breast cancer (TNBC). Initiated in July 2024, this trial has activated eight sites in Switzerland with patient enrollment ongoing.

Lewis H. Bender, the Founder, and CEO of Intensity Therapeutics, expressed optimism during the recent disclosure, highlighting how the protocols for both studies were finalized in 2024 and how the company successfully partnered with leading hospitals globally to advance patient recruitment. The ongoing engagement from top cancer centers in the United States, Canada, Europe, and Australia has led to the promising enrollment rate of patients, which Bender noted is critical for the studies' success.

Financial Results

For the financial year ended December 31, 2024, the total research and development expenses reached $10.5 million, substantially higher than the $4.8 million recorded in 2023. This increase largely stemmed from costs associated with the INVINCIBLE-3 Study and also reflected rising salaries, benefits, and stock-based compensation. Moreover, general and administrative expenses surged to $6.1 million from $3.5 million the previous year, primarily due to increased overhead costs.

Despite these investments, the company reported a net loss of $16.3 million, compared to a net loss of $10.5 million in 2023. As of December 31, 2024, Intensity Therapeutics held cash and cash equivalents of approximately $2.6 million, indicating a strategic focus on sustaining operations while expanding clinical efforts.

About INT230-6

The lead candidate INT230-6, employing the DfuseRx℠ technology, combines cisplatin and vinblastine with a specially designed penetration enhancer aimed at improving the delivery of cancer-fighting agents directly into tumors. This strategy is designed to promote localized tumor control and stimulate an immune response without the typical system-wide suppression linked to conventional therapies.

The company is hopeful that INT230-6 will provide a functional alternative to current treatments, especially for patients with metastatic cancer. Given its innovative approach, Intensity aims to redefine cancer treatment paradigms, aiming for outcomes that not only target tumors effectively but also mobilize the immune system against malignancies.

With clinical data projected to be presented at major scientific gatherings in the near future, Intensity Therapeutics is positioning itself as a burgeoning player in the biotechnology field, working diligently to achieve milestones that will enhance patient care globally. The company's commitment to advancing its research and its focus on building crucial partnerships positions it for future growth and innovation in cancer treatment.