INTS

EX-99.1

2 ints20260811ex99120260630p.htm

EX-99.1

Document

Exhibit 99.1

Intensity Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update

•Initiated activities to resume enrollment in a limited number of U.S. sites in the soft tissue sarcoma Phase 3 INVINCIBLE-3 Study by the third quarter of 2026

•Patient treatment restarted in the presurgical triple negative breast cancer (“TNBC”) Phase 2 INVINCIBLE-4 Study

•Cash and cash equivalents of $9.5 million as of June 30, 2026

•Increased business development activities

Conference call begins at 8:00 a.m. Eastern time today

SHELTON, Conn., August 11, 2026 – Intensity Therapeutics, Inc. (“Intensity” or “the Company”) (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces second quarter 2026 financial results and provides a business update.

Management will host a conference call and live webcast at 8:00 a.m. Eastern time today to review financial results and provide an update. The archived webcast will be available for replay shortly after the close of the call.

Conference Call Details

Date: August 11, 2026

Time: 8:00 a.m. Eastern Time

Domestic Dial-In: (866) 652-5200

International Dial-In: (412) 317-6060

Webcast URL: https://event.choruscall.com/mediaframe/webcast.html?webcastid=bZ7JyAJE

Business Update

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared with standard-of-care (“SOC”) in second- and third-line treatment of certain soft tissue sarcoma subtypes.

In April 2026, the Company initiated activities to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study using an FDA-reviewed amended protocol based on important learnings from patients previously enrolled in the study. The Company paused new site activations and patient enrollment in March 2025 due to funding constraints. At that time, the trial had enrolled 21 patients, and the Company continued to treat all patients, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its contract research organizations at significantly reduced ongoing costs. In addition, during this pause, the Company obtained important feedback and recommendations about the trial from key investigators and sarcoma thought leaders, and modifications to the protocol were made. The FDA has reviewed the amended protocol, which will be implemented for new patient enrollment. Submission of documentation necessary for restarting in the EU is in progress. Site activation and patient enrollment rates are expected to increase as sufficient funding is obtained.

INVINCIBLE-4 Study: Phase 2 open-label, randomized controlled, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before SOC in patients with early-stage, operable TNBC (Cohort A) and SOC alone (Cohort B).

In July 2026, the Company restarted patient treatment in the INVINCIBLE-4 Study and is currently targeting complete enrollment by the end of 2027. The Company paused new patient enrollment in September 2025 to revise the dosing regimen for patients receiving INT230-6 in Cohort A due to some patients experiencing localized skin irritation near the tumor site. In March 2026, a protocol amendment was approved by the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6 in Cohort A. In August 2026, the Company opened its first site in France for accrual following EU submission of the modified protocol.

Preliminary data from the first 14 patients (seven in each cohort) showed a 71% pathological complete response (“pCR”) in patients receiving INT230-6 in Cohort A and a 42% pCR in patients receiving the SOC alone (Cohort B). There was also a 44% reduction in grade 3 adverse events in Cohort A compared with Cohort B and fewer immune-related adverse events when INT230-6 was added prior to the immunochemotherapy.

Capital Raises

In March 2026, the Company established a $60 million at-the-market (“ATM”) facility. During the second quarter of 2026, the Company raised net proceeds of $1.6 million under the ATM. Subsequent to June 30, 2026, the Company has raised additional net proceeds of $1.3 million under the ATM.

“We are pleased that the capital raised in 2025 and to date in 2026 provides the resources to reinitiate the Phase 3 INVINCIBLE-3 Study. In addition, during the 2025 pause, we evaluated and modified the protocol based on feedback from key investigators and sarcoma thought leaders. The FDA-reviewed amended protocol will first be implemented in select U.S. sites,” stated Lewis H. Bender, Founder, President and CEO of Intensity. “In the Phase 2 INVINCIBLE-4 Stud

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intensity-202603050001567264FALSE00015672642026-03-052026-03-05

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): March 5, 2026 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. From time to time, Intensity Therapeutics, Inc. (the “Company”) presents and/or distributes slides and presentations to the investment community to provide updates and summaries of its business. On March 5, 2026, the Company updated the Financial Highlights Slide through December 31, 2025 (the “Slide”) of its investor presentation, which is available on the Investor Relations section of the Company’s website at https://ir.intensitytherapeutics.com. The Slide is also furnished as Exhibit 99.1 hereto and is incorporated by reference into this Item 2.02. All figures in the Slide are unaudited and preliminary and are subject to the completion of financial closing procedures, including management’s reviews. As a result, this amount may differ materially from the amount that will be reflected in the Company’s financial statements as of and for the year ended December 31, 2025. The information in this Item 2.02, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liabilities of that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Financial Highlights Slide, dated March 4, 2026

104Cover Page Interactive Data File (formatted in Inline XBRL).

1

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: March 5, 2026

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

intensity-202511060001567264FALSE00015672642025-11-062025-11-06

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): November 6, 2025 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. On November 6, 2025, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the three and nine months ended September 30, 2025. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release issued November 6, 2025.

104Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 13, 2025, the Company's Quarterly Report on Form 10-Q, filed on May 13, 2025, the Company's Quarterly Report on Form 10-Q, filed on August 7, 2025, and the Company's Quarterly Report on Form 10-Q, filed on November 6, 2025. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates. 1

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: November 6, 2025

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

intensity-202508070001567264FALSE00015672642025-08-072025-08-07

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): August 7, 2025 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. On August 7, 2025, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the three and six months ended June 30, 2025. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release issued August 7, 2025.

104Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 13, 2025, the Company's Quarterly Report on Form 10-Q, filed on May 13, 2025, and the Company's Quarterly Report on Form 10-Q, filed on August 7, 2025. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates. 1

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: August 7, 2025

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

intensity-202505130001567264FALSE00015672642025-05-132025-05-13

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): May 13, 2025 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. On May 13, 2025, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the three months ended March 31, 2025. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release issued May 13, 2025.

104Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 13, 2025, and the Company's Quarterly Report on Form 10-Q, filed on May 13, 2025. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates. 1

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: May 13, 2025

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

intensity-202503130001567264FALSE00015672642025-03-132025-03-13

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): March 13, 2025 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. On March 13, 2025, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the year ended December 31, 2024. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release issued March 13, 2025.

104Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 13, 2025. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates. 1

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: March 13, 2025

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

intensity-202411130001567264FALSE00015672642024-11-132024-11-13

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): November 13, 2024 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. On November 13, 2024, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the three and nine months ended September 30, 2024. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release issued November 13, 2024.

104Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 14, 2024. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates. 1

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: November 13, 2024

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

intensity-202408080001567264FALSE00015672642024-08-082024-08-08

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): August 8, 2024 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. On August 8, 2024, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the three and six months ended June 30, 2024. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release issued August 8, 2024.

104Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 14, 2024. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates. 1

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: August 8, 2024

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

intensity-202405090001567264FALSE00015672642024-05-092024-05-09

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): May 9, 2024 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. On May 9, 2024, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the three months ended March 31, 2024. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release issued May 9, 2024.

104Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 14, 2024. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates. 1

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: May 9, 2024

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

intensity-202403140001567264FALSE00015672642024-03-142024-03-14

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): March 14, 2024 Intensity Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-4110946-1488089 (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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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 shareINTSThe 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 2.02 Results of Operations and Financial Condition. On March 14, 2024, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the year ended December 31, 2023. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits

Exhibit No.Description 99.1Press Release issued March 14, 2024.

104Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s Annual Report on Form 10-K, filed on March 14, 2024. The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates. 1

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: March 14, 2024

Intensity Therapeutics, Inc.

By:/s/ Lewis H. Bender Name: Lewis H. Bender Title:Chief Executive Officer

[Signature Page to the Form 8-K] 2

0001567264 false

0001567264

2023-11-13 2023-11-13

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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): November 13, 2023

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):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ 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 ☒

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 2.02 Results of Operations and Financial Condition.

On November 13, 2023, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the quarter ended September 30, 2023. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.

The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release issued November 13, 2023.

104

Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING

STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” sections of the Company’s prospectus, dated June 29, 2023 and filed on June 30, 2023 pursuant to Rule 424(b) under the Securities Act relating to the Company’s Registration Statement on Form S-1 (File No. 333-260565). The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates.

1

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: November 13, 2023

Intensity Therapeutics, Inc.

By: /s/ Lewis H. Bender

Name: Lewis H. Bender

Title: Chief Executive Officer

[Signature Page to the Form 8-K]

2

0001567264 false

0001567264

2023-08-14 2023-08-14

0001567264

dei:FormerAddressMember

2023-08-14 2023-08-14

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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): August 14, 2023

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)

61 Wilton Road, 3rd Floor

Westport, CT 06880

(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):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ 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 ☒

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 2.02 Results of Operations and Financial Condition.

On August 14, 2023, Intensity Therapeutics, Inc. (the “Company”) released its financial results for the quarter ended June 30, 2023. A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.

The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release issued August 14, 2023.

104

Cover Page Interactive Data File (formatted in Inline XBRL).

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING

STATEMENTS

Comments in this Current Report on Form 8-K and in the exhibit attached hereto contain certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are based on management’s good faith expectations and beliefs concerning future developments. Actual results may differ materially from these expectations as a result of many factors. These factors include, but are not limited to, the risks and uncertainties described in the “Risk Factors” and “Cautionary Note Regarding

Forward Looking Statements” sections of the Company’s prospectus, dated June 29, 2023 and filed on June 30, 2023 pursuant

to Rule 424(b) under the Securities Act relating to the Company’s Registration Statement on Form S-1 (File No. 333-260565). The Company does not undertake any obligation to update such forward-looking statements. All market and industry data are based on Company estimates.

1

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: August 14, 2023

Intensity Therapeutics, Inc.

By: /s/ Lewis H. Bender

Name: Lewis H. Bender

Title: Chief Executive Officer

[Signature Page to the Form 8-K]

2