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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): 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
99.1
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.
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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]
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Exhibit 99.1
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Intensity Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

First patient dosed in randomized, Phase 2 study in presurgical triple negative breast cancer


Shelton, Conn., November 13, 2024 – Intensity Therapeutics, Inc. (“Intensity” or “the Company”) (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces third quarter 2024 financial results and provides a corporate update.


Corporate Update

INVINCIBLE-3 Study: a Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. The primary endpoint in the INVINCIBLE-3 Study is overall survival.

•July 2024: the first patients were dosed in the U.S. in the INVINCIBLE-3 Study.
•July 2024: authorization received from Health Canada to initiate the INVINCIBLE-3 Study in Canada.
•September 2024: authorization received from The European Medicines Agency to initiate the INVINCIBLE-3 Study in Europe.
•October 2024: authorization received from Australia's Therapeutic Goods Administration to initiate INVINCIBLE-3 Study in Australia.

INVINCIBLE-4 Study: a Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care (“SOC”) treatment in patients with early-stage, operable triple-negative breast cancer (“TNBC”) and SOC alone. The primary endpoint is the pathological complete response (“pCR”) rate in the primary tumor and affected lymph nodes. The INVINCIBLE-4 Study is expected to enroll approximately 54 patients in Switzerland and France.

•September 2024: authorization from the Swiss Medic and the Swiss Ethics Commission to initiate the INVINCIBLE-4 Study.
•October 2024: first patient dosed in the INVINCIBLE-4 Study.

“This has been an excellent quarter of regulatory success in multiple countries. We received the regulatory authorizations needed to initiate sites in eight countries for our Phase 3 global sarcoma study and our Phase 2 breast cancer study in Switzerland,” said Lewis H. Bender, Intensity Founder, President, and CEO. “Our efforts now turn to site activation and patient recruitment. We remain committed to exploring our new treatment that causes immunological cell death in severe diseases such as soft tissue sarcoma and triple-negative breast cancer. We are excited that our drug will be tested in multiple countries on three continents. INT230-6’s ability to debulk tumors and activate an immune response is now in late-stage testing for two indications. We expect that the results from these ongoing studies could potentially demonstrate a meaningful clinical benefit for patients with high unmet need in both the metastatic and local disease settings.”

Third Quarter 2024 Financial Results

Research and development expenses were $2.2 million for the three months ended September 30, 2024, compared to $1.4 million for the same period in 2023. The increase was primarily due to preliminary work related to the INVINCIBLE-3 Study, and to a lesser extent, increased expenses related to salary, benefits, and stock-based compensation.

General and administrative expenses were $1.4 million for the three months ended September 30, 2024, compared to $1.1 million for the same period in 2023. The increase was primarily due to increased expenses related to salary, benefits and stock-based compensation, and higher directors and officers insurance.

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Overall, net loss was $3.5 million for the three months ended September 30, 2024, compared to a net loss of $2.3 million for the three months ended September 30, 2023.

As of September 30, 2024, cash and cash equivalents totaled $2.8 million, which the Company expects will be sufficient to fund operations into the first quarter in 2025.

About INT230-6
INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy.
About Intensity Therapeutics
Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6; a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the “INVINCIBLE-2 Study”) (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the “INVINCIBLE-3 Study”) (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com.

Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company’s research to generate and advance additional product candidates; the implementation of the Company’s business model, strategic plans for the Company’s business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company’s system; the Company’s competitive position; the Company’s intellectual property position; developments and projections relating to the Company’s competitors and its industry; the Company’s ability to maintain and establish collaborations or
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obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company’s SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

Investor Relations Contact:
Justin Kulik
justin@coreir.com
(558) 230-6401

Media Contact:
Jules Abraham
CORE IR
julesa@coreir.com
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Intensity Therapeutics, Inc.
Condensed Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Operating expenses:
Research and development$2,151 $1,352 $8,529 $2,985 
General and administrative1,419 1,139 4,853 1,982 
Total operating expenses3,570 2,491 13,382 4,967 
Loss from operations(3,570)(2,491)(13,382)(4,967)
Other income (expense):
Interest income48 148 286 148 
Interest expense— — — (305)
Loss on debt extinguishment— — — (2,262)
Other income (expense)9 14 9 20 
Net loss $(3,513)$(2,329)$(13,087)$(7,366)
Preferred stock deemed dividend— — — (1,324)
Net loss attributable to common stockholders$(3,513)$(2,329)$(13,087)$(8,690)
Loss per share, basic and diluted$(0.25)$(0.17)$(0.95)$(1.26)
Weighted average number of shares of common stock, basic and diluted13,804,651 13,660,627 13,742,325 6,899,984 
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Intensity Therapeutics, Inc.
Condensed Balance Sheets
(in thousands)

September 30, 2024December 31, 2023
(Unaudited)*
Assets
Current assets:
Cash, cash equivalents and marketable debt securities$2,782 $14,776 
Prepaid expenses and other current assets1,005 688 
Total current assets3,787 15,464 
Right-of-use asset, net128 147 
Other assets1,298 1,684 
Total assets$5,213 $17,295 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable$540 $3,048 
Accrued expenses1,749 891 
Lease liability, current portion28 20 
Total current liabilities2,317 3,959 
Other long-term liabilities— 36 
Lease liability, net of current portion117 138 
Total liabilities2,434 4,133 
Total stockholders’ equity2,779 13,162 
Total liabilities and stockholders’ equity$5,213 $17,295 
*Derived from audited financial statements
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v3.24.3
Cover
Nov. 13, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 13, 2024
Entity Registrant Name Intensity Therapeutics, Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 001-41109
Entity Tax Identification Number 46-1488089
Entity Address, Address Line One 1 Enterprise Drive,
Entity Address, Address Line Two Suite 430
Entity Address, City or Town Shelton,
Entity Address, State or Province CT
Entity Address, Postal Zip Code 06484-4779
City Area Code (203)
Local Phone Number 221-7381
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.0001 par value per share
Trading Symbol INTS
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Entity Central Index Key 0001567264
Amendment Flag false
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