Welcome to our dedicated page for INTENSITY THERAPEUTICS news (Ticker: INTS), a resource for investors and traders seeking the latest updates and insights on INTENSITY THERAPEUTICS stock.
Intensity Therapeutics, Inc. (Nasdaq: INTS) is a late-stage clinical biotechnology company focused on proprietary, immune-based intratumoral cancer therapies. News about Intensity centers on the clinical development of its lead investigational product candidate, INT230-6, corporate milestones, capital raises, and interactions with regulators and the Nasdaq Capital Market.
Company press releases frequently highlight progress in key clinical programs. These include the Phase 3 INVINCIBLE-3 study in specific soft tissue sarcoma subtypes, where INT230-6 is tested as second- or third-line monotherapy against standard-of-care drugs, and the Phase 2 INVINCIBLE-4 study in presurgical triple-negative breast cancer, which evaluates INT230-6 followed by standard-of-care immunochemotherapy versus standard of care alone with pathological complete response as the primary endpoint. Updates have covered enrollment status, dosing regimen adjustments, early safety observations, and notable findings such as a pathological complete response in the first evaluated patient in the INT230-6 cohort of INVINCIBLE-4.
News flow also includes scientific and medical communications, such as publication of the IT-01 Phase 1/2 study results in eBioMedicine, a Lancet Discovery Science journal, and presentations or posters at major oncology meetings like the San Antonio Breast Cancer Symposium. These items describe disease control rates, overall survival data, abscopal effects, immune activation, and pharmacokinetic findings for INT230-6 in advanced solid tumors.
Investors following INTS can also expect announcements on financial results, registered direct offerings, at-the-market equity sales, and updates on cash runway. Additional disclosures cover Nasdaq listing matters, including extensions to regain compliance with minimum bid price rules and stockholder votes on potential reverse stock splits. For those tracking Intensity Therapeutics, this news page provides a centralized view of clinical, scientific, financial, and regulatory developments related to the company and its intratumoral oncology pipeline.
Intensity Therapeutics (NASDAQ: INTS) announced that its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for treating metastatic soft tissue sarcomas will be presented at the ASCO 2025 Annual Meeting. The presentation will be delivered by Dr. Sant P. Chawla on May 31, 2025. INT230-6, an intratumoral therapy, has shown promising results in Phase 1/2 trials, demonstrating a 93% disease control rate and 21.3 months median overall survival in refractory metastatic sarcoma patients. The drug causes significant tumor necrosis and cyst formation with minimal adverse events. However, new enrollment for the Phase 3 study has been temporarily paused due to funding constraints, though treatment continues for currently enrolled patients.
Intensity Therapeutics (NASDAQ: INTS) has announced a collaboration with breast cancer survivor and author Christine Handy to raise awareness about early-stage breast cancer treatment options. Handy, whose book "Walk Beside Me" inspired the award-winning film "Hello Beautiful," will work with Intensity to develop educational resources about emerging therapies, including the company's investigational drug INT230-6.
The company is currently conducting the Phase 2 INVINCIBLE-4 trial for triple-negative breast cancer patients in pre-surgical settings. Additionally, Intensity will present a poster at the upcoming ASCO 2025 Annual Meeting about their Phase 3 INVINCIBLE-3 study, which evaluates INT230-6 as a monotherapy for soft tissue sarcomas.
Intensity Therapeutics (NASDAQ: INTS) and The Swiss Group for Clinical Cancer Research (SAKK) have received EMA authorization to expand their INVINCIBLE-4 Phase 2 study for INT230-6 into France. The study evaluates INT230-6 in early-stage, operable triple-negative breast cancer (TNBC) patients.
The trial, currently active in Switzerland, will randomize 54 patients to receive either two doses of INT230-6 followed by standard of care (SOC) immunochemotherapy, or SOC alone. The primary endpoint is pathological complete response in the tumor and affected lymph nodes. Initial results show promising tumor necrosis and inflammation after INT230-6 treatment. The expansion into France through Unicancer is expected to accelerate enrollment starting Q2 2025.
Intensity Therapeutics (NASDAQ: INTS) has announced a public offering priced at $0.75 per share, aiming to raise $2.35 million in gross proceeds. The offering includes 3,133,333 shares of common stock with accompanying Series B-1 and B-2 warrants.
The Series B-1 warrants have a 5-year term while Series B-2 warrants expire in 18 months, both with an exercise price of $0.85 per share. The offering, expected to close around April 28, 2025, is led by A.G.P./Alliance Global Partners with Brookline Capital Markets as co-placement agent.
The company plans to use the proceeds for patient enrollment in the INVINCIBLE-4 Study, treatment of existing patients in the INVINCIBLE-3 Study, and working capital purposes.
Intensity Therapeutics (NASDAQ: INTS) has reported its 2024 year-end financial results and provided updates on two key clinical trials. The company's INVINCIBLE-3 Phase 3 study has contracted 32 sites and screened 25 patients, testing INT230-6 as monotherapy for soft tissue sarcoma subtypes. The study aims to enroll 333 patients across eight countries.
The INVINCIBLE-4 Phase 2 study for triple-negative breast cancer has activated eight Swiss sites and treated several patients, with plans to expand to France. The company expects to complete enrollment for INVINCIBLE-3 in H1 2026 and INVINCIBLE-4 by Q1 2026.
Financial results show R&D expenses increased to $10.5M from $4.8M in 2023, while G&A expenses rose to $6.1M from $3.5M. The company reported a net loss of $16.3M for 2024, compared to $10.5M in 2023. Cash and cash equivalents stood at $2.6M as of December 31, 2024.
Intensity Therapeutics (INTS) announces that the Data Monitoring Committee (DMC) has authorized the continuation of its Phase 3 INVINCIBLE-3 sarcoma trial for INT230-6 without modifications following a periodic review of data from July to December 2024.
The INVINCIBLE-3 Study is a global open-label, randomized, controlled study comparing intratumoral INT230-6 administration to standard chemotherapy in approximately 333 adult patients with soft tissue sarcoma (STS). The trial focuses on patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma who experienced disease progression after standard therapies.
The study's primary endpoints are overall survival and safety, with an exploratory quality of life assessment. The trial has received authorizations in the U.S., Canada, Europe, and Australia, and is currently recruiting participants across these regions.