INTENSITY THERAPEUTICS INC Stock Price, News & Analysis

Intensity Therapeutics (Nasdaq: INTS) has announced significant preclinical results for its drug candidate INT230-6 in treating Malignant Peripheral Nerve Sheath Tumors (MPNST). The study, conducted at Johns Hopkins University's Staedtke-Bai laboratory, demonstrated a 100% complete response rate in murine models after 21 days of treatment.

The research involved two groups of test subjects (n=5 each), with the INT230-6 treatment group achieving complete responses while the control group's tumors continued to grow. This marks the first time INT230-6 has been tested in neurological-specific tumors, with researchers noting that no other small molecule drug has achieved such results in their lab previously.

The company plans to conduct additional preclinical research with the Staedtke-Bai laboratory to explore INT230-6's potential in other neurological cancer models.

Intensity Therapeutics (NASDAQ: INTS) has announced the pricing of its public offering of 6,675,000 common stock shares at $0.30 per share, aiming to raise gross proceeds of $2,002,500 before deductions. The company granted underwriters a 45-day option to purchase up to 1,001,250 additional shares. The offering is expected to close on June 13, 2025. 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. ThinkEquity serves as the sole book-running manager. The offering is made through a shelf registration statement on Form S-3 filed with the SEC.

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.