Intensity Therapeutics Inc（INTS）资讯与事件INTSIntensity Therapeutics Inc

Company Cash and Cash Equivalents Reach $9.5M, CEO Reveals Research Progress

As of June 30, cash and cash equivalents totaled $9.5M. During Q2, the company raised $1.7M under the ATM, for net proceeds of $1.6M. "We are pleased that the capital raised in 2025 and to date in 2026 provides the resources to reinitiate the Phase 3 INVINCIBLE-3 Study. In addition, during the 2025 pause, we evaluated and modified the protocol based on feedback from key investigators and sarcoma thought leaders. The FDA-reviewed amended protocol will first be implemented in select U.S. sites," stated CEO Lewis Bender. "In the Phase 2 INVINCIBLE-4 Study, early data show potential for an improvement in the pCR rate with a reduction in the number of grade 3 adverse events including immune-related adverse events. These preliminary findings are encouraging, and we are excited that investigators have restarted treatment in patients in Switzerland. We look forward to enrolling new patients in this study in France now that sites are being activated. Lastly, we continue to pursue potential partnerships to advance our programs, and held meetings with potential strategic partners at the BIO International Conference in late June. While early, we are pleased with the interest expressed in our science and clinical trials, and we expect to continue discussions in the second half of 2026."

Intensity Therapeutics Initiates New Patient Enrollment in INVINCIBLE-4 Study in Switzerland

Intensity Therapeutics announces that new patients have been administered INT230-6 in the INVINCIBLE-4 Study in Switzerland. The trial analyzes INT230-6 given before administration of the standard-of-care neoadjuvant immuno-chemotherapy, or SOC, and the SOC alone by using a 2-cohort design. The study evaluates the pathological complete response, or pCR, rates of the two cohorts relative to a null hypothesis, which is a pCR rate of less than or equal to 0.6. The success of each cohort in rejecting the null hypotheses will be evaluated. The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer who undergo SOC treatment and SOC alone. The primary endpoint is pCR in the primary tumor and affected lymph nodes. In the amended protocol, patients will be randomized to receive a regimen of one dose of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or to SOC alone. The INVINCIBLE-4 Study reopens following a pause in patient accrual to evaluate skin irritation issues seen in some patients. In March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a slightly lower drug-to-tumor volume ratio and a single injection of INT230-6. Prior to the pause, fourteen patients were treated, seven with the combination and received the SOC alone. Patients receiving INT230-6 prior to the SOC reported a favorable trend towards much fewer overall grade 3 or higher adverse events and immune-related adverse events compared to those patients receiving the SOC alone. The INVINCIBLE-4 Study is expected to enroll an additional 47 patients in Switzerland and France.

Company Cash and Cash Equivalents Reach $10.2 Million

Cash and cash equivalents of $10.2M as of March 31. Lewis Bender, Founder, President, and CEO, stated, "The Company made excellent progress in the first quarter. We announced early data from the INVINCIBLE-4 Study, our randomized controlled study in TNBC, showing the possibilities for INT230-6 to increase efficacy while also potentially improving safety. We are now seeking additional patients in our INVINCIBLE-4 Study in Switzerland and expect to initiate enrollment in France in the second or third quarter of 2026. Further, after a successful funding campaign in 2025 and the establishment of a $60 million ATM facility in March 2026, we have made the decision to reinitiate enrollment of our INVINCIBLE-3 Study and plan to manage our cash burn judiciously. Both of our clinical trials focus on indications with high unmet medical need."