Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — Investor Presentation (September 2023)
22 slides from Intensity Therapeutics's investor presentation, Sep 5, 2023
Slide 1: A New Weapon in the War on Cancer
A New Weapon in the War on Cancer September 2023 Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Number 333 - 260565
Slide 2: Highlights
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 •
Slide 3: Platform Validated by World Leading Partners
Platform Validated by World Leading Partners RESEARCH CLINICAL TRIAL SITES 3
Slide 4: Management Team: Extensive Oncology and Drug Development Experience
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. Goldber
Slide 5: Multiple Late-Stage Pipeline Programs
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 Keyt
Slide 6: First Two Clinical Market Opportunities
• 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.
Slide 7: Proprietary Discovery Platform - DFUSERx
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 V
Slide 8: A Unique Anti-Cancer Therapy
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 Si
Slide 9: Randomized, Placebo Controlled Phase 2 Window Trial: The INVINCIBLE Study
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 • F
Slide 10: INVINCIBLE Study: Significant Cancer Necrosis with 1 or 2 Doses
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%) Fi
Slide 11: Favorable Safety in the Presurgical Breast Cancer Setting
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 with
Slide 12: Phase 2/3 Study Design Early Stage Breast Cancer
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
Slide 13: Phase 2 Study in Metastatic Disease - Enrollment Complete
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)
Slide 14: Favorable Safety: Active Agents Remain in the Tumor
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 a
Slide 15: In Metastatic Disease Injected Tumors Shrink in Volume Over Time
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
Slide 16: Immune Activation Achieved in Non-Immunogenic Cancers
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
Slide 17: Survival Increases with Higher Dose Relative to Tumor Burden
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 do
Slide 18: Sarcoma: A Deadly and Painful Cancer
Sarcoma: A Deadly and Painful Cancer 21
Slide 19: Median Overall Survival Increases Compared to a Synthetic Control
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
Slide 20: Phase 3 Trial Design in Soft Tissue Sarcoma - Monotherapy
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
Slide 21: Summary
• 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, majo
Slide 22: Intensity Therapeutics: A New Weapon in the War on Cancer
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!
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