INTENSITY THERAPEUTICS INC Stock Price, News & Analysis

Intensity Therapeutics (NASDAQ: INTS), a late-stage biotech company developing novel intratumoral cancer therapies, has announced a proposed public offering of common stock. ThinkEquity will serve as the sole book-running manager. The proceeds will fund patient enrollment and data readout for the INVINCIBLE-4 Study, support existing patients in the INVINCIBLE-3 Study, and provide working capital. The offering will be made through a shelf registration statement on Form S-3. Intensity's lead drug, INT230-6, has shown promising results in clinical trials, demonstrating ability to kill tumors and elicit immune responses within days of injection. The company has completed two clinical studies with over 200 patients and is currently conducting Phase 3 trials in soft tissue sarcoma and Phase 2 studies in triple-negative breast cancer.

Intensity Therapeutics (NASDAQ: INTS) reported promising initial results from its Phase 2 INVINCIBLE-4 study of INT230-6 in early-stage triple-negative breast cancer (TNBC). The first patients receiving INT230-6 showed high levels of tumor necrosis within 8 days, before starting standard-of-care (SOC) treatment. The randomized study compares two doses of INT230-6 followed by SOC immunochemotherapy versus SOC alone, with pathological complete response (pCR) as the primary endpoint. The trial, currently recruiting in Switzerland and France, aims to enroll 54 patients. The SOC regimen includes pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel. Early results show promising tumor necrosis and inflammation after INT230-6 treatment, which could be significant as TNBC patients with pCR have better survival outcomes, while currently about 40% of patients fail to achieve pCR.

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) reported Q1 2025 financial results and corporate updates. The company's net loss decreased to $3.3M from $4.6M in Q1 2024, with R&D expenses at $2.2M and G&A expenses at $1.2M. Cash position stood at $0.9M as of March 31, 2025. Due to funding constraints, INTS paused new site activations and enrollments for its Phase 3 INVINCIBLE-3 sarcoma study after enrolling 23 patients. The company raised $2.35M through a public offering in April 2025, with net proceeds of $1.9M. The Phase 2 INVINCIBLE-4 study for triple-negative breast cancer continues in Switzerland, with EMA authorization to expand into France. The study aims to enroll 54 patients to evaluate INT230-6 in combination with standard of care treatment.

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.