aibioIntensity Therapeutics reports Q1 2026 results and enrollment plans
Tickers INTS
Cash and cash equivalents were $10.2 million at March 31, 2026. The company plans to resume enrollment in INVINCIBLE-3 at a limited number of U.S. sites by the third quarter of 2026.
Key facts
- Company
- Intensity Therapeutics, Inc. (NASDAQ: INTS)
- News type
- Company Updates
- Primary source
- Intensity Therapeutics, Inc. 8-K (2026-05-07)
Intensity Therapeutics, Inc. (Nasdaq: INTS) reported first quarter 2026 financial results and a corporate update on May 7, 2026. Cash and cash equivalents totaled $10.2 million as of March 31, 2026. The company said it plans to resume enrollment in its Phase 3 INVINCIBLE-3 study at a limited number of U.S. sites by the third quarter of 2026, and that it expects to initiate enrollment in France for INVINCIBLE-4 in the second or third quarter of 2026.
INVINCIBLE-4 early data
In March 2026 the company reported preliminary INVINCIBLE-4 observations. Five of seven patients, or 71.4%, who received INT230-6 before standard of care, known as Cohort A, achieved a pathological complete response. Two of six patients, or 33%, in the standard of care arm alone, known as Cohort B, achieved one, with one patient still to be evaluated. The company also reported 44% fewer grade 3 or higher adverse events in Cohort A compared with Cohort B.
The company said that a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee, and that full approval to resume enrollment was granted on March 26, 2026. It expects to present more detailed results for the seven Cohort A patients at a future oncology conference.
INVINCIBLE-3 status
INVINCIBLE-3 is a Phase 3 open-label, randomized study of INT230-6 as monotherapy compared with standard-of-care drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes. In March 2025 the company paused new site activations and patient enrollment due to funding constraints, after the trial had enrolled 21 patients. The company has continued to treat enrolled patients and maintain the database at significantly reduced ongoing costs. In April 2026 it decided to resume enrollment at a limited number of U.S. sites, and it has prioritized full enrollment and site activations once sufficient incremental funding is obtained.
Bender, the company's founder, president and chief executive officer, said in the release that "we have made the decision to reinitiate enrollment of our INVINCIBLE-3 Study." He also said the company would manage its cash burn judiciously, pointing to the successful funding campaign in 2025 and a $60 million at-the-market facility established in March 2026.
First quarter financial results
Research and development expenses were $1.2 million for the three months ended March 31, 2026, compared with $2.2 million for the same period in 2025. The decrease was primarily due to lower INVINCIBLE-3 study costs. Lower headcount-related costs were entirely offset by an estimated bonus accrual, which was not present in the 2025 quarter. General and administrative expenses were $1.3 million, compared with $1.2 million. The increase was due to the bonus accrual, partly offset by lower stock-based compensation and one-time expenses tied to the reverse stock split in February 2026. The net loss was $2.4 million for the first quarter of 2026, compared with $3.3 million for the same period in 2025.
Background on the lead candidate
Intensity Therapeutics, Inc. is a late-stage clinical biotechnology company focused on localized cancer reduction and anti-cancer immune activation. Its approach involves direct injection into tumors of a product created from its DfuseRx discovery platform. Its lead product candidate, INT230-6, is primarily comprised of cisplatin, vinblastine sulfate and an amphiphilic molecule called SHAO.
The risks ahead
The INVINCIBLE-4 observations are preliminary and open-label. They rest on seven patients in one arm and six evaluated in the other, with one still to be assessed, and the release reports no p-values or confidence intervals. Five of seven against two of six cannot be called a proven difference, and the company itself describes the sample as small.
INVINCIBLE-3 has been paused since March 2025 for funding reasons, with 21 patients enrolled, and the company says full enrollment and site activation depend on sufficient incremental funding. Cash and cash equivalents were $10.2 million at March 31, 2026, against cash from operations of negative $9.2 million and a net loss of $11.6 million for 2025. The $60 million at-the-market facility means further share sales and dilution for holders. The company plans to resume INVINCIBLE-3 enrollment by the third quarter and start INVINCIBLE-4 enrollment in France in the second or third quarter.