Form 8-K - Current report

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)

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 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
99.1						Press Release issued Ma y 9 , 2024.
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 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.

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]

Exhibit 99.1

Intensity Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

•INT230-6, Intensity’s lead drug candidate, continues to advance into late-stage clinical programs in sarcoma and breast cancer

•Cash and investments of $10.5 million expected to fund operations through the end of the first quarter of 2025

Shelton, CT, May 9, 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 first quarter 2024 financial results and provides a corporate update.

Corporate Update

•In mid-2024, the Company intends on initiating a Phase 3 open-label, randomized study, or the INVINCIBLE-3 Study, testing INT230-6 as a monotherapy compared to the standard of care (“SOC”) drugs in second and third line treatment for certain soft tissue sarcoma subtypes. We plan to enroll 333 patients with an endpoint of overall survival and have screened and qualified over 30 sites for the INVINCIBLE-3 Study. Contract negotiations to approve and activate these sites are in process. We estimate the sites could take between two to six months to complete their contracting processes.

•In mid-2024, the Company intends on initiating a Phase 2/3 program testing INT230-6 in combination with the SOC treatment (chemotherapy/immunotherapy) compared to SOC alone in women with triple negative breast cancer in presurgical (neoadjuvant) breast cancer. The endpoint for the Phase 2 portion of the study, or the INVINCIBLE-4 Study, is the change in the pathological complete response rate for the combination compared to the SOC alone. We expect to initiate the INVINCIBLE-4 Study in mid-2024, which will provide data to size a Phase 3 study. We are in the process of screening and qualifying sites for the INVINCIBLE-4 Study.

“We continue to make excellent progress towards the initiation of our INVINCIBLE-3 Study,” said Lewis H. Bender, Founder, President and CEO of Intensity Therapeutics, Inc. “In the first quarter, we were able to release our INT230-6 Phase 3 clinical supplies, successfully ship the entire batch to our main depot, and complete labeling of a portion of the vials for the United States sites. During the quarter, we completed evaluation of dozens of sites and are now in various stages of contract and budget discussions with over 30 different high-quality sarcoma centers. We continue to qualify new sarcoma specialty hospitals in the US and internationally, and top enrolling centers from our previous metastatic study have expressed interest in participating in the INVINCIBLE-3 trial.” Mr. Bender continued, “Our INVINCIBLE-4 Study also continues to make excellent progress. Sites are being recruited and we continue to work towards initiating the study in mid-2024.”

First Quarter 2024 Financial Results

Research and development expenses were $2.8 million for the three months ended March 31, 2024, compared to $0.8 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, costs for manufacturing a new batch of INT230-6 and increased expenses related to salary, benefits, and stock-based compensation.

General and administrative expenses were $1.9 million for the three months ended March 31, 2024, compared to $0.5 million for the same period in 2023. The increase was primarily due to increased expenses related to salary, benefits and stock-based compensation, higher legal, audit, and consulting fees, and higher directors and officers insurance.

Overall, net loss was $4.6 million for the three months ended March 31, 2024, compared to $1.3 million for the three months ended March 31, 2023.

As of March 31, 2024, cash, cash equivalents and marketable debt securities totaled $10.5 million, which the Company expects will be sufficient to fund operations through the end of 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 composed 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, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient's malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression that so often occurs with systemic chemotherapy.

About Intensity Therapeutics

Intensity Therapeutics is a late-stage clinical biotechnology company that applies novel engineered chemistry to turn "cold" tumors "hot" by enabling its aqueous cytotoxic-containing drug product, INT230-6, to mix and saturate the dense, high-fat pressurized environment of the tumor. 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 novel approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases. INT230-6 has completed enrollment of over 200 patients in a Phase 1/2 dose escalation trial (NCT03058289) and Phase 2 randomized control clinical trial in breast cancer (the INVINCIBLE 2 study) (NCT04781725). The Company is initiating 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 with overall survival as an endpoint. The Company is also planning a Phase 2/3 program in presurgical triple negative breast cancer testing INT230-6 in combination with standard of care compared to standard of care alone. For more information about the Company, 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 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

Intensity Therapeutics, Inc.

Condensed Statement of Operations

(in thousands, except share and per share amounts)

(Unaudited)


	Three Months Ended March 31,
		2024		2023
Operating expenses:
Research and development		$	2,815	$	774
General and administrative		1,928		480
Total operating expenses		4,743		1,254
Loss from operations		(4,743)		(1,254)

Other income (expense):
Interest income		140		—
Interest expense		—		(83)

Other income		—		1
Net loss		$	(4,603)	$	(1,336)




Loss per share, basic and diluted		$	(0.34)	$	(0.39)
Weighted average number of shares of common stock, basic and diluted		13,709,487		3,410,103

Intensity Therapeutics, Inc.

Condensed Balance Sheets

(in thousands)

(Unaudited)


	March 31, 2024		December 31, 2023

Assets
Current assets:
Cash, cash equivalents and marketable debt securities	$	10,497	$	14,776
Prepaid expenses and other current assets	672		688
Total current assets	11,169		15,464
Right-of-use asset, net	141		147
Other assets	1,098		1,684
Total assets	$	12,408	$	17,295

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,219	$	3,048
Accrued expenses	1,274		891
Lease liability, current portion	26		20
Total current liabilities	2,519		3,959
Other long-term liabilities	36		36
Lease liability, net of current portion	131		138
Total liabilities	2,686		4,133
Total stockholders’ equity	9,722		13,162
Total liabilities and stockholders’ equity	$	12,408	$	17,295

Cover	May 09, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	May 09, 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