Intensity Therapeutics (NASDAQ: INTS) reports pCR, pauses INVINCIBLE-4 Cohort A

Rhea-AI Filing Summary

Intensity Therapeutics reported an update on its INVINCIBLE-4 study involving its drug candidate INT230-6. The company observed a pathological complete response in the first patient evaluated in Cohort A, where patients receive two doses of INT230-6 eight days apart followed by standard immunochemotherapy. The company stated that, to date, the safety profile in Cohort A looks favorable, although some patients experienced localized skin irritation near the tumor site. Because of these local skin effects, new patient enrollment in Cohort A has been paused while the team evaluates the collected data and implements any necessary protocol adjustments before reopening enrollment.

Insights

Biotech clinical-trial analyst

Early efficacy signal is offset by a temporary enrollment pause to assess local safety effects.

Intensity Therapeutics disclosed that its INVINCIBLE-4 study of INT230-6 produced a pathological complete response in the first patient evaluated in Cohort A. Cohort A patients receive two doses of INT230-6 eight days apart, followed by standard-of-care immunochemotherapy. The company also stated that the overall safety profile in this cohort looks favorable so far.

However, some patients in Cohort A experienced localized skin irritation near the tumor site. In response, the company has paused new patient enrollment to review the data and implement any needed adjustments before resuming enrollment. This step keeps the trial within a controlled safety framework but introduces timing uncertainty until the evaluation and protocol refinements are completed.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 10, 2025

Intensity Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-41109

46-1488089

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

1 Enterprise Drive, Suite 430 Shelton, CT						06484-4779
(Address of Principal Executive Offices)						(Zip Code)

(203) 221-7381

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

o			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class:

Trading Symbol(s):

Name of Exchange on Which Registered:

Common Stock, $0.0001 par value per share

INTS

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01. Other Events.

On September 10, 2025, Intensity Therapeutics, Inc. (the “Company”) announced an update on it’s INVINCIBLE-4 study. The update reported that a pathological complete response (“pCR”) was observed in the first patient evaluated in Cohort A, where each patient received two doses of INT230-6 eight days apart, followed by the standard of care immunochemotherapy, and that to date, the safety profile looks favorable in Cohort A. However, some patients in Cohort A experienced localized skin irritation near the tumor site and therefore, new patient enrollment has been paused to evaluate the data collected and to implement necessary adjustments prior to reopening patient enrollment.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: September 10, 2025

			Intensity Therapeutics, Inc.
			By:			/s/ Lewis H. Bender
						Name:			Lewis H. Bender
						Title:			Chief Executive Officer

FAQ

What did Intensity Therapeutics (INTS) report in this 8-K filing?

Intensity Therapeutics reported an update on its INVINCIBLE-4 study of INT230-6. The company observed a pathological complete response in the first evaluated patient in Cohort A and commented that the safety profile for this cohort looks favorable to date.

What is Cohort A in Intensity Therapeutics' INVINCIBLE-4 study?

In Cohort A of the INVINCIBLE-4 study, each patient received two doses of INT230-6 eight days apart, followed by standard-of-care immunochemotherapy. The 8-K update focuses specifically on safety and response observations from this cohort.

What safety issues were observed in Intensity Therapeutics' INVINCIBLE-4 Cohort A?

The company noted that some patients in Cohort A experienced localized skin irritation near the tumor site. Despite describing the overall safety profile as favorable so far, this local irritation triggered a pause in new patient enrollment while the data are evaluated.

Why was new patient enrollment paused in the INVINCIBLE-4 study?

New patient enrollment in Cohort A was paused because some patients experienced localized skin irritation near the tumor site. Intensity Therapeutics is using this pause to evaluate the collected data and implement necessary adjustments before reopening enrollment.

Does Intensity Therapeutics plan to restart enrollment in INVINCIBLE-4?

The company stated that enrollment has been paused to review data and make necessary adjustments prior to reopening patient enrollment, indicating its intention to resume enrollment once that review and any protocol changes are completed.

What is the main efficacy signal reported for INT230-6 in this filing?

The key efficacy signal disclosed is that a pathological complete response was observed in the first patient evaluated in Cohort A of INVINCIBLE-4 after receiving INT230-6 followed by standard immunochemotherapy.