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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) reported Q3 2025 results and a corporate update on Nov 6, 2025. Key points: the company had $7.1 million cash as of Sept 30, 2025 and raised an additional $6.1 million in Q4 2025, extending cash runway to the end of Q1 2027.
Clinical: a peer‑reviewed IT‑01 manuscript reported a 75% disease control rate (48/64) and median overall survival of 11.9 months; a metastatic sarcoma subset mOS was 21.3 months. An exploratory >40% total tumor burden dosing subgroup showed mOS 18.7 vs 3.1 months (HR 0.17; P<0.0001). No dose‑limiting toxicities reported.
Program updates: INVINCIBLE‑4 dosing will be amended and enrollment expected to restart in Q1 2026; INVINCIBLE‑3 remains paused after 21 patients due to funding.
Intensity Therapeutics (Nasdaq: INTS) announced a registered direct offering of 5,000,000 shares of common stock at $0.80 per share for gross proceeds of approximately $4.0 million. The offering is expected to close on or about November 3, 2025, subject to customary closing conditions.
The company expects to use net proceeds to advance clinical trials, for working capital and general corporate purposes, and expects the cash runway to extend until the end of Q1 2027. A.G.P./Alliance Global Partners is acting as sole placement agent. The offering is being made under an effective Form S-3 registration statement declared effective July 11, 2024.
Intensity Therapeutics (Nasdaq: INTS) announced publication in eBioMedicine of phase 1/2 results for intratumoral INT230-6 in metastatic or refractory solid tumors (Online First Oct 29, 2025).
Key outcomes: disease control rate 75% (48/64), overall median survival 11.9 months, sarcoma subset mOS 21.3 months. In an exploratory analysis treating >40% total tumor burden, mOS was 18.7 months vs 3.1 months when <40% treated (HR 0.17; P<0.0001). Approximately 20% of >40% patients showed uninjected tumor shrinkage (abscopal effects). Safety: no dose‑limiting toxicities, grade 3 events in 10.9%, no grade 4/5 treatment‑related AEs. Pharmacokinetics: >95% of active agents remained in injected tumors. The company will host an author webinar on Oct 31, 2025 at 9:00 AM ET.
Intensity Therapeutics (NASDAQ:INTS) has reported an update on its INVINCIBLE-4 trial for triple-negative breast cancer treatment. The company achieved a significant milestone with a pathological complete response (pCR) in the first evaluated patient from Cohort A, where patients receive two doses of INT230-6 before standard immunochemotherapy.
While safety in Cohort A has been generally favorable and patients show significant tumor necrosis, the trial has temporarily paused new enrollment due to localized skin irritation in some patients. The company plans to evaluate the data and implement necessary modifications to the INT230-6 dosing regimen before resuming enrollment. The pause was a company decision, not a regulatory directive.
Intensity Therapeutics (Nasdaq: INTS), a late-stage clinical biotech company specializing in intratumoral cancer therapies, will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025.
CEO Lewis H. Bender will engage in a fireside chat with Dr. Swayampakula Ramakanth, Managing Director and Senior Healthcare Analyst at H.C. Wainwright. The discussion will be available on-demand for registered conference attendees starting September 5, 2025, at 7:00 AM ET.
Intensity Therapeutics (Nasdaq: INTS), a late-stage clinical biotech company, has successfully regained compliance with Nasdaq's minimum Stockholders' Equity Requirement. The company confirmed having at least $2.5 million in stockholders' equity as of June 30, 2025, following successful fundraising efforts through July 2025.
Intensity, which focuses on developing novel intratumoral cancer therapies using its proprietary non-covalent conjugation technology, received confirmation from Nasdaq's Listing Qualifications Staff on August 8, 2025. CEO Lewis H. Bender stated that the company now projects having sufficient cash to fund operations into the second half of 2026.
Intensity Therapeutics (NASDAQ:INTS) reported Q2 2025 financial results and provided updates on its clinical trials. The company successfully raised over $11.3 million since Q2 2025, extending its cash runway into H2 2026. The INVINCIBLE-4 Study, testing INT230-6 in triple-negative breast cancer, showed promising early results with high tumor necrosis achieved in 8 days.
The company's Phase 3 INVINCIBLE-3 Study for soft tissue sarcoma has temporarily paused new enrollments due to previous funding constraints, though existing patients continue treatment. Q2 financial results showed reduced losses, with net loss decreasing to $2.5 million from $5.0 million year-over-year. R&D expenses decreased to $1.5 million from $3.6 million, while G&A expenses reduced to $1.2 million from $1.5 million.
Intensity Therapeutics (Nasdaq: INTS), a late-stage clinical biotech company, has successfully raised $6.6 million in gross proceeds ($6.3 million net) through its At-the-Market (ATM) offering in July 2025. The company sold 19.9 million shares at an average price of $0.3323 per share, which was notably 10% higher than its June 2025 public offering price.
The funding extends Intensity's cash runway into the second half of 2026, supporting the advancement of its clinical trials for novel intratumoral cancer therapies. Following the ATM sales, the company's total outstanding common stock reached 46 million shares as of July 31, 2025.
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.