Earnings summaries and quarterly performance for INTENSITY THERAPEUTICS.
Executive leadership at INTENSITY THERAPEUTICS.
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Recent press releases and 8-K filings for INTS.
Intensity Therapeutics Highlights 2025 Milestones and Outlines 2026 Strategic Priorities
INTS
New Projects/Investments
Guidance Update
- Clinical Trial Progress and Pauses: Intensity Therapeutics reported a pathological complete response in the first patient of its INVINCIBLE-4 Phase 2 breast cancer study in September 2025, with early favorable safety data, but temporarily paused enrollment for protocol modification. The INVINCIBLE-3 Phase 3 sarcoma study was paused in March 2025 due to funding constraints, with reinitiation planned for 2026 upon securing sufficient capital.
- Clinical Validation: The company achieved peer-reviewed publication in October 2025 for its Phase 1/2 study in eBioMedicine, highlighting a 75% disease control rate and median overall survival of 11.9 months in advanced solid tumors, and 21.3 months in a sarcoma subset.
- Financial Runway and Funding Strategy: Intensity Therapeutics strengthened its balance sheet by raising over $20 million in gross proceeds during 2025, extending its operating runway into the second quarter of 2027. The company plans to opportunistically raise additional capital in 2026 to advance its clinical programs, including reinitiating INVINCIBLE-3 and potentially starting a new Phase 3 breast cancer study.
Jan 13, 2026, 12:47 PM
Intensity Therapeutics Reports Favorable Safety Data and Outlines Phase 3 Design for INT230-6 in TNBC
INTS
New Projects/Investments
- Intensity Therapeutics, Inc. (INTS) will present two posters at the San Antonio Breast Cancer Symposium on December 11-12, 2025, detailing early observations from its INVINCIBLE-4 study and a potential Phase 3 clinical study design for INT230-6 in Triple Negative Breast Cancer (TNBC).
- Early observations from the INVINCIBLE-4 Phase 2 clinical trial indicate favorable safety for INT230-6 combined with standard of care (SOC), showing 50% fewer grade 3 or higher Adverse Events (9 events) compared to SOC alone (20 events) in the respective 7-patient cohorts through November 10th.
- The INVINCIBLE-4 study protocol is being modified to administer a single dose of INT230-6 at lower volumes due to observed skin and adipose tissue necrosis with two doses, with plans to restart patient enrollment.
- A potential Phase 3 clinical study design for INT230-6 in TNBC aims to include a treatment arm combining INT230-6 with SOC without the cardiotoxic anthracycline doxorubicin, utilizing pathological complete response (pCR) as a potential FDA accelerated approval endpoint.
Dec 11, 2025, 12:47 PM
Intensity Therapeutics Granted Nasdaq Bid Price Compliance Extension
INTS
Delisting/Listing Issues
- Intensity Therapeutics, Inc. (INTS) has been granted a 180-calendar day extension by Nasdaq to regain compliance with the minimum $1.00 bid price requirement.
- The new deadline for the company to achieve a closing bid price of at least $1.00 per share for ten consecutive business days is June 1, 2026.
- The company intends to monitor its stock price and will consider a reverse stock split, if necessary, to maintain its Nasdaq listing.
- This extension has no immediate effect on the listing or trading of INTS shares.
Dec 5, 2025, 12:33 PM
Intensity Therapeutics increases at-the-market offering capacity
INTS
- On December 4, 2025, Intensity Therapeutics, Inc. increased the capacity of its existing "at-the-market" (ATM) offering program to $30 million.
- This expansion is intended to enhance the Company's financial flexibility, providing an efficient mechanism to access capital.
- The Company is not obligated to issue any shares under the program, and any utilization will be at its discretion based on prevailing market conditions and strategic priorities.
Dec 4, 2025, 12:02 PM
Intensity Therapeutics, Inc. Reports Q3 2025 Financial Results and Provides Clinical Trial Updates
INTS
Earnings
Guidance Update
New Projects/Investments
- Intensity Therapeutics, Inc. reported a net loss of $2.7 million for the third quarter of 2025, compared to a $3.5 million net loss for the same period in 2024, and held $7.1 million in cash and cash equivalents as of September 30, 2025.
- The company raised an incremental $6.1 million in October 2025, extending its cash runway until the end of the first quarter of 2027.
- Patient enrollment in the INVINCIBLE-4 Study was paused in September 2025 to revise the dosing regimen due to localized skin irritation, with reinitiation anticipated in the first quarter of 2026.
- The INVINCIBLE-3 Study remains paused for new site activations and patient enrollments since March 2025 due to funding constraints, while the IT-01 Study manuscript was published on October 29, 2025, detailing a 75% disease control rate and 11.9 months median overall survival for INT230-6 in advanced solid tumors.
Nov 6, 2025, 9:04 PM
Intensity Therapeutics Reports Q3 2025 Financial Results and Provides Clinical Trial Updates
INTS
Earnings
Guidance Update
New Projects/Investments
- Intensity Therapeutics reported a net loss of $2.7 million for the third quarter of 2025 and held $7.1 million in cash and cash equivalents as of September 30, 2025.
- The company extended its cash runway until the end of the first quarter of 2027 by raising $13.6 million in gross proceeds since the beginning of the third quarter of 2025, including a $4.0 million registered direct offering in October 2025.
- Enrollment in the INVINCIBLE-4 Study was paused in September 2025 to revise the dosing regimen, with reinitiation anticipated in the first quarter of 2026; the INVINCIBLE-3 Study remains paused for new enrollments due to funding constraints.
- A manuscript for the IT-01 Study was published on October 29, 2025, highlighting that INT230-6 achieved a 75% disease control rate and 11.9 months median overall survival in heavily pretreated patients.
Nov 6, 2025, 9:02 PM
Intensity Therapeutics, Inc. Announces Pricing of $4 Million Registered Direct Offering
INTS
- Intensity Therapeutics, Inc. (INTS) announced the pricing of a registered direct offering of common stock, expecting to generate gross proceeds of approximately $4 million before deducting offering expenses.
- The company will sell 5,000,000 shares of common stock at a purchase price of $0.80 per share.
- The offering is anticipated to close on or about November 3, 2025, with net proceeds intended for the advancement of clinical trials, working capital, and general corporate purposes.
- Upon the closing of the offering, Intensity Therapeutics expects to have a cash runway until the end of the first quarter of 2027.
Oct 31, 2025, 8:54 PM
Intensity Therapeutics Discusses Positive INT230-6 Study Results and Phase 3 Funding Needs
INTS
New Projects/Investments
Guidance Update
- The IT01 study of INT230-6 in metastatic refractory solid tumor patients demonstrated a favorable safety profile with no dose-limiting toxicities and minimal systemic exposure, as 95% or greater of the drug remained within the tumor.
- The study reported a 75% disease control rate across all monotherapy patients, with a median overall survival of 12 months, which favorably compares to historical data of 4 to 7 months for systemic therapies in similar Phase 1 studies.
- Efficacy was significantly higher when 40% or greater of the total tumor burden was injected, resulting in a median overall survival of 18.7 months compared to 3 months for less than 40%. Sarcoma patients, representing a majority of the study population, showed a median survival of 21 months, with those receiving greater than 40% injection having a median survival that was not reached.
- INT230-6 also induced an intratumoral immune response and demonstrated abscopal effects, with shrinkage of uninjected tumors observed in approximately 20% of patients who had 40% or more of their tumor burden treated.
- A randomized controlled Phase 3 study for INT230-6 in three sarcoma subtypes has been approved by eight regulatory authorities, with overall survival as the primary endpoint, but requires approximately $25 million in funding to complete enrollment and interim looks.
Oct 31, 2025, 1:00 PM
Intensity Therapeutics Announces $4 Million Registered Direct Offering
INTS
New Projects/Investments
Guidance Update
- Intensity Therapeutics, Inc. (INTS) announced a registered direct offering of 5,000,000 shares of common stock at a purchase price of $0.80 per share, expecting to generate approximately $4 million in gross proceeds.
- The offering is anticipated to close on or about November 3, 2025.
- The net proceeds from the offering are intended for the advancement of clinical trials, working capital, and general corporate purposes.
- Upon the closing of the offering, the company expects to have a cash runway until the end of the first quarter of 2027.
Oct 31, 2025, 12:00 PM
Intensity Therapeutics Announces Publication of INT230-6 Clinical Results
INTS
New Projects/Investments
- Intensity Therapeutics announced on October 30, 2025, the publication of its Phase 1/2 IT-01 clinical study manuscript for INT230-6 in eBioMedicine, a Lancet Discovery Science journal.
- The study, involving heavily pretreated patients with advanced metastatic or refractory cancers, demonstrated a disease control rate of 75% (48/64 patients) and a median overall survival (mOS) of 11.9 months. For a metastatic sarcoma subset, the mOS was 21.3 months.
- In an exploratory analysis, patients receiving INT230-6 at a total dose treating greater than 40% of their total tumor burden showed a disease control rate of 83.3% (40/48) and a median overall survival of 18.7 months.
- The safety profile indicated no dose-limiting toxicities among 64 monotherapy patients, with only seven patients (10.9%) experiencing grade 3 treatment-related adverse events and no grade 4 or 5 events.
- Following these results, the company has initiated randomized controlled studies, including a Phase 3 study in sarcoma (NCT06263231) and a Phase 2 study in presurgical triple-negative breast cancer (NCT06358573).
Oct 30, 2025, 11:30 AM
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