Intensity Therapeutics Provides Comprehensive Update and Q3 2025 Financial Results

Intensity Therapeutics Provides Corporate Update and Q3 2025 Financial Results

On November 6, 2025, Intensity Therapeutics, Inc. announced its financial performance for the third quarter of 2025, alongside a significant corporate update regarding their clinical trials. The company, focused on innovative intratumoral cancer therapies using its proprietary non-covalent conjugation technology, reported a cash balance of $7.1 million, which is projected to sustain their operations until the end of the first quarter of 2027.

Corporate Update Highlights

Within the update, Intensity highlighted plans to amend the dosing protocol in their ongoing INVINCIBLE-4 Study. This Phase 2 study, which looks at the effectiveness and safety of the INT230-6 treatment in patients with early-stage operable triple-negative breast cancer, initially faced a pause in new patient enrollments due to localized skin irritation experienced by some patients. The protocol amendment aims to optimize dosing so that patient enrollment can be restarted in the first quarter of 2026, with a goal to complete enrollment by late 2026.

The company is committed to enhancing patient safety while ensuring the success of the study, which will continue to focus on the primary endpoint: the change in pathological complete response rate in patients receiving the combined treatment of INT230-6 and standard of care (SOC) compared to SOC alone.

In addition to this, Intensity provided an update on the INVINCIBLE-3 Study—a pivotal Phase 3 trial assessing INT230-6 as a monotherapy against SOC for specific soft tissue sarcoma subtypes. Despite pausing new site activations and patient enrollment due to funding issues, the company is continuing to treat enrolled patients and is actively seeking to resume recruitment once sufficient funding is secured.

IT-01 Study Achievements

Recently, the company celebrated the publication of the IT-01 clinical study manuscript in eBioMedicine, a journal under the Lancet Discovery Science umbrella. This comprehensive evaluation demonstrated promising data for the INT230-6 treatment in advanced solid tumors, reporting a disease control rate of 75% in heavily pretreated patients, along with a median overall survival of 11.9 months. Notably, patients with metastatic sarcomas treated with INT230-6 recorded a median overall survival of 21.3 months.

One striking aspect of the findings was the significant improvement in outcomes for patients who received a higher total dose of INT230-6. For those treating over 40% of their total tumor burden, the disease control rate soared to 83.3%. Furthermore, approximately 20% of these patients demonstrated abscopal effects, where uninjected tumors also showed signs of regression.

Financial Performance

For the three months ended September 30, 2025, the company reported research and development expenses of $1.6 million, lower than the previous year due to decreased costs from the INVINCIBLE-3 Study. The total net loss stood at $2.7 million, showcasing an improvement compared to a net loss of $3.5 million in the same quarter of 2024. General and administrative expenses also decreased, indicating a strategic approach towards reducing overall costs.

Amidst financial endeavors, Intensity successfully raised a total of $13.6 million in gross proceeds since the start of Q3 2025, including various direct offerings. This robust fundraising strategy has significantly bolstered the company's cash reserves, enabling them to pursue their business strategy without requiring immediate additional funding.

Looking Ahead

Intensity Therapeutics is excited about the upcoming phase of its clinical trials, particularly with the INVINCIBLE-4 study, as they aim to restart enrollment in the first quarter of 2026. The company elaborated on their commitment to research and patient safety as a core component of their strategy. The leadership at Intensity, including Founder Lewis H. Bender, expressed optimism about the future trajectory of their clinical trials and the potential of INT230-6 as a transformative treatment option for various cancers.

For additional information regarding their findings, corporate updates, or partnerships, interested parties can visit Intensity Therapeutics' official website.