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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 5, 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. ☒ On September 5, 2023, Intensity Therapeutics, Inc. (the “Company”) announced via press release that it will present a corporate presentation at the H.C. Wainwright 25th Annual Global Investment Conference on Monday, September 11, 2023. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K. A copy of the corporate presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K.

 

 

 

 


 

Item 7.01 Regulation FD Disclosure.

 

 

The information contained in Item 7.01 in this Current Report on Form 8-K and Exhibits 99.1 and 99.2 attached hereto are intended to be 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 the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as 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, dated September 5, 2023.
99.2   Corporate Presentation of Intensity Therapeutics, Inc., dated September 11, 2023.
104   Cover 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: September 5, 2023

 

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

 

[Signature Page to the Form 8-K]

 

 

 

 

EX-99.1 2 ea184623ex99-1_intensity.htm PRESS RELEASE, DATED SEPTEMBER 5, 2023

Exhibit 99.1

 

 

Intensity Therapeutics to Present at the H.C. Wainwright 25th Annual Global Investment Conference

 

WESTPORT, Conn., September 5, 2023 – Intensity Therapeutics, Inc. (Nasdaq: INTS), a clinical-stage 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, today announced that Lewis H. Bender, President and Chief Executive Officer, will present a company overview at the H.C. Wainwright 25th Annual Global Investment Conference on Monday, September 11, at 4:30 pm ET.

 

Mr. Bender will also host in-person and virtual one-on-one meetings during the event. Institutional investors who are registered for the conference can log into www.hcwevents.com to request a meeting with the company.

 

A live webcast of the presentation can be accessed here and will be available on the Intensity Therapeutics website at: https://ir.intensitytherapeutics.com/news-events/events-presentations. An archived replay will be available on the company’s website for approximately 90 days following the conclusion of the conference.

 

About Intensity Therapeutics

 

Intensity Therapeutics, Inc. is a clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers. Intensity leverages its DfuseRx℠ technology platform to create proprietary drug formulations that following direct injection rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Intensity’s product candidates have the potential to induce an adaptive immune response that not only attacks the injected tumor, but also non-injected tumors. The Company’s lead product candidate, INT230-6, is in development for the treatment of patients with solid tumors, such as sarcoma and breast cancer. Intensity has a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate INT230-6 with pembrolizumab. In addition, the Company has a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, ipilimumab. Intensity has also executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725). Additionally, the Company executed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s (NCI) Vaccine Branch. For more information, please visit www.intensitytherapeutics.com and follow the Company on Twitter @IntensityInc.

 

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 expected future plans, development activities, projected milestones, business activities or results. We have based these forward-looking statements on our 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 we make. These risks and uncertainties, many of which are beyond our control, include: the risk that the anticipated milestones may be delayed or not occur or be changed, as well as 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:

 

Argot Partners

Jonathan Nugent

Intensity@argotpartners.com

 

Media Contact:

 

Argot Partners

David Rosen

david.rosen@argotpartners.com

 

EX-99.2 3 ea184623ex99-2_intensity.htm CORPORATE PRESENTATION OF INTENSITY THERAPEUTICS, INC., DATED SEPTEMBER 11, 2023

Exhibit 99.2

 

 


A New Weapon in the War on Cancer September 2023 Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Number 333 - 260565 Highlights • Novel cancer treatment approach with first - in - class compound that causes cancer cell death leading to an immune response for indications with high unmet medical need • Late - stage pipeline programs in metastatic and presurgical settings with multiple near - term inflexion points • Experienced leadership team from Emisphere, Roche and Bristol Myers; CEO has public company as well as biopharma development and commercial experience • Robust IP portfolio, platform validated through multiple Industry, government and university hospital partnerships • De - risked and cost - efficient business model structured to create significant value 2 Platform Validated by World Leading Partners RESEARCH CLINICAL TRIAL SITES 3

 


 


4 Management Team: Extensive Oncology and Drug Development Experience Veteran Operators with Public Company and IPO Experience • Drug delivery expertise Preclinical through Phase 3 • Public biotech company CEO experience Daniel Donovan CEO Rare Life Emer Leahy, Ph.D. CEO Psychogenics Mark A. Goldberg, MD Former President & COO of PAREXEL Lewis H. Bender CEO Intensity Lewis H. Bender, MIT ChE, MS, MA, MBA Founder, CEO John Wesolowski, MBA, CPA Chief Financial Officer, Principal Accounting Officer and Controller Brian Schwartz, MD Clinical Development CE O , CT O , V P, B D & Manufacturing Manufacturing CEO James M. Ahlers Executive Vice President – Corporate Finance • 25 years, multiple transactions • Titan Pharmaceutics, IPO BOARD OF DIRECTORS KEY MANAGEMENT Ian Walters Medical Advisor Steve Innaimo Project Management Rebecca Drain, Doranne Frano Regulatory & Quality Rita Cooney PH.D.

 


Analytical Chemistry Karen Du Clinical Operations Joseph Bernadino, George Klein Manufacturing Advanced Soft Tissue Sarcoma INT230 - 6 randomized Phase 3 Protocol drafted, CRO engaged PHASE 3 PHASE 2 PHASE 1 PRECLINICAL INT230 - 6 Colorectal, Bile Duct, Pancreatic Squamous cell cancers (on - going) Sarcoma, Breast, Hepatic Cancers (on - going) Combo with + BMS’ Yervoy® Combo with Merck’s Keytruda® (non - immunogenic “cold tumors”) Multiple Late - Stage Pipeline Programs Clinical Programs Across Metastatic and Presurgical Settings Phase 2 Studies finishing; Phase 3 Programs Designed, Discussed with FDA and in process of initiating The INVICIBLE Study: INT230 - 6 pre - surgical local or regional disease Early - Stage Breast Cancer on - going CLI N IC AL P ha se 3 st ar t p o te n t ia l H 124 Phase 2/3 start potential H124 #R and om iz ed C o n t r o ll e d : data expected Q4 2023 #Final Data expected 2023 #Final Data expected 2023 *Phase 2/3 study per fast track #E nr o ll m e n t c om pl e t ed *TNBC is triple negative breast cancer R and om iz ed C o n t r o ll ed I N T 230 - 6 T N BC* ( Met a st a ti c) Neoadjuvant Breast Cancer INT230 - 6 randomized Phase 2/3 designed 5 • Phase 3 programs - important market opportunities: Metastatic sarcoma : • 157,000 patients in US; • 12,000 new cases per year (6,000 deaths); (US) • Estimated annual revenue per patient based on phase 2 use Breast Cancer • ~287,850 new cases of invasive breast cancer diagnosed in women in the U.S. during 2022 • About 1 in 8 U.S. women (about 13%) will develop invasive breast cancer over the course of her lifetime Presurgical breast cancer : • INT230 - 6 with Standard of Care (SOC) chemotherapy: 30,000 patients US • w/out chemotherapy: 60,000 Large tumor cases; (US) INT230 - 6 vs. no treatment (current SOC) 6 First Two Clinical Market Opportunities

 


 


7 Proprietary Discovery Platform - DFUSERx SM Created INT230 - • Designed for intratumoral (IT) use in the fatty environment of a tumor; Drug is 100% water - based, scaled - up, stable, & reproducible • Product Candidate : INT230 - 6 – Uses two proven, commercial anti - cancer agents Cisplatin and Vinblastine Sulfate; both drugs kill cancer directly And via different mechanisms cause anti - cancer immune activation • Novel diffusion enhancer (SHAO) SHAO • Enables the drugs to become soluble in fat and water • Disperses throughout the tumor and diffuse into cancer cells 10 INT230 - 6: A Unique Anti - Cancer Therapy A Water Solution That Kills Fatty or Stromal Tumors and Does Not Harm Healthy Tissue *Tumors contain high percentages of fat and are under high pressure CYTOTOXICS DRUG + dye in water Little to no drug dispersion in all tumors tested TUMOR cut in half Significant drug leakage Drug NOT absorbed Human pancreatic cancer in mouse model TUMOR cut in half Significant dispersion in all tumors tested No leakage INT230 - 6: Fully absorbed INT230 - 6 + dye in water Dose is set by a tumor’s volume or diameter T UMO R T UMO R Published

 


 


Patients Enrolled: 91 – Complete INT230 - 6 R andomized to either no treatment or saline injection • Site: Ottawa Hospital • Investigator: Dr. Angel Arnaout • Objectives : Cause sufficient tumor necrosis prior to surgery to activate the immune system and determine INT230 - 6 safety presurgically • Final Goal: Reduce the risk of disease recurrence Our clinical results have been selected for Spotlight Oral Podium Presentation at: The San Antonio Breast Cancer Symposium (SABCS) annual meeting December 2022: 11 Design: Randomized, Placebo Controlled Phase 2 Window Trial In Presurgical Breast Cancer (BC): The INVINCIBLE Study 1 0 2 T u m o r Ex t e n t E x t e n t o f Necrosis wit h in T u m o r Phase 2 INVINCIBLE Study: INT230 - 6 Achieves Significant Cancer Necrosis with 1 or 2 Doses P a ti e n t #14 : 3.9 cm invasive ductal cancer:: 2 injections M a y 6 M a y 1 3 M a y 20 Final Pathology (significant necrosis ~85%) Final Pathology (significant necrosis ~95%) cancer is mostly ghost cells Tumor death is dependent on total dose given per treatment and observed in multiple types of breast cancers In j e c t ion #1: Dose 7.4 cc Injection #2: Dose 14.

 


8 c c S u rg e r y P a ti e n t #20 : 4.4 cm invasive lobular cancer: 1 injection M a y 2 7 J un e 16 Dose 21.

 


3 c c S u r g e r y T u mo r po s t su rg e r y T u mo r po s t su rg e r y INT230 - 6 had Favorable Safety in the Presurgical BC Setting • No surgery was delayed or cancelled • No surgical procedure was altered • No cosmetic differences noted • Mean wait time to surgery: 24 days (range 14 - 34 days) – normal timeframe • 89% of adverse events were grade 1; all resolved within 7 days • Patient interest in the drug and acceptability was high; accrual was rapid Pre vs. Post treatment • In tumor: increase in abundance of CD4+, CD8+, naïve T, B and NK T cells • In tumor microenvironment: increase in CD8 T, CD4 T, naïve and B cells • Over 200 immune cell genes activated 13 Phase 2/3 Study Design Early Stage Breast Cancer 14 Design of Phase 3 Program in the larger sized tumors INT230 - 6 + Standard of care (SOC is chemo/pembro) in TNBC and/or HER2+ versus SOC • Accelerated approval using Pathological Complete Response (pCR) rates; • Data 4 months post enrollment • Full approval show slower rate of recurrence of the cancer (EFS); • Data 3 years post enrollment

 


 


IT - 01 Phase 1 / 2 Study in Metastatic Disease – Enrollment Complete ENROLLED: 110 15 Patients whose disease had progress after treatment with all approved therapies for their cancer, over 25 types of solid tumor types: Database now locked INT230 - 6 alone (64 patients) With Keytruda (30 patients) (includes 2 who finished monotherapy) With Yervoy (18 patients) • Injections up to 6 in a session into lung, liver, peritoneum, pancreas, breast, limbs, lymph, skin, muscles • Dosed started with 5 mL once per month. Current dose 175 mL every two weeks. Intensity’s results have been selected for Discussant Oral Podium Presentations at: ASCO (2) S I TC • The Annual American Society of Clinical Oncology: • The Annual Society for the Immunotherapy of Cancer: • The Annual Connective Tissue Society (sarcoma): CTOS (2) Attacking the Tumors – Sparing the Patient Favorable Safety: Active Agents Remain in the Tumor 17 INT230 - 6 >95% of the active agents remain in the tumor relative to the drugs given IV The retention is independent of the cancer type, location or size Most common drug related adverse events are mild or moderate injection site pain, fatigue and brief nausea ~90 are low grade; No grade 4 or grade 5 related adverse events.

 


 


18 In Metastatic Disease injected Tumors Shrink in Volume Over Tim Shrinkage of uninjected tumors is observed A scan of a monotherapy injected sarcoma tumor highlights tumor regression Longest diameter declines 15%, whereas 2nd longest diameter declines 42% Using WHO Criteria: Partial Response Using RECIST Criteria: Stable Disease Pre - treatment: 55.65 mm x 32.48 mm September 2020 Post - treatment: 47.5 mm x 18.78 mm March 2021 Tumors may appear longer prior to shr in k in g 19 Post 2 doses Day 28 Pre dose Day 0 Liposarcoma cancer Immune Activation Achieved in Non - immunogenic Cancers After 2 doses of INT230 - 6 alone there is an increased anti - cancer immune cell influx into the tumor Ovarian cancer Day 0 Day 28 cancer

 


 


20 All subjects (n=63) >40% TTB (n= 45) <40% TTB (n= 18) INT230 - 6 alone Monotherapy: 19 different cancers An exploratory analysis of dose relative to a subject’s incoming total tumor burden (TTB) was performed. Survival Increases with Higher Dose Relative to the Patient’s Tumor Burden Increased dose relative to total tumor burden (TTB) shows prolonged survival Sarcoma: A Deadly and Painful Cancer 21

 


 


1 0 .9 0 .8 0 .7 0 .6 0 .5 0 .4 Survival Probability 0.3 Synthetic sarcoma phase 0.2 1/2 control (Subbiah data*) 0.1 0 0 100 200 300 400 500 600 700 Days INT230 - 6, n=15 INT230 - 6 dosed >40% TTB, n=11 INT230 - 6 + IPI, n=14 Control, n=56 Censored Kaplan Meier estimates sarcoma Ipi Combination data INT230 - 6 + IPI INT230 - 6 >40% TTB INT230 - 6 all S y n t h e t ic Control (Subbiah data) Not reached median follow - up: 345 days 715 (649, 1352) 649 (195, 1352) 205 days Median overall s u r v i v al, C I Uninjected tumors shrank (abscopal responses) In Sarcoma Median Overall Survival Increases with INT230 - 6 Alon or with Yervoy) Compared to a Synthetic Control Synthetic control created based on data from Subbiah, V, Scientific Reports | 6:35448 >40% TTB Monotherapy All Monotherapy 22 Must have had doxorubicin HR: 0.65 Overall survival (OS): 14.0 months Control 21.5 months INT230 - 6 Data readout at 80% of events Phase 3 Trial Design For INT230 - 6 In Soft Tissue Sarcoma (STS) INT230 - 6 - Monotherapy • INT230 - 6 q2 weeks x 5 doses • Maintenance q9 weeks x 22 months Standard of Care 23 • Pazopanib: 800 mg PO qD • Trabectedin: 1.5 mg/M 2 BSA as a 24 hour IV infusion q3 weeks • Eribulin: 1.4 mg/M 2 BSA IV on Days 1 and 8 q3 weeks 2 1 Enrollment” 12 to 15 months First look: ~12 months post Expected to Offer Survival Improvement compared to Current 2nd / 3rd Line SOC

 


 


• INT230 - 6 represents a new treatment approach to solid tumors (diffusion based immunological cell killing) for metastatic disease and presurgical (neoadjuvant) settings • Dose set by the total tumor burden – more personalized and spares the patient • Strong interest from: academic hospitals, major clinical oncology societies, big pharma and government • INT230 - 6 has: • induced significant necrosis in large tumors following a single dose • Immune activation observed of non - immunogenic cancer types • Shown favorable safety and promising increased survival efficacy 24 Summary INTENSITY THERAPEUTICS 25 A NEW WEAPON IN THE WAR ON CANCER Investor Relations Contact: Argot Partners Jonathan Nugent Intensity@argotpartners.com Media Contact: Argot Partners David Rosen david.rosen@argotpartners.com Thank you!