Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — IPO Roadshow (October 2022)
21 slides from Intensity Therapeutics's IPO roadshow presentation, October 2022
Slide 1: A New Weapon in the War on Cancer
A NEW WEAPON IN THE WAR ON CANCER Directly killing tumors to activate a patient-specific immune response Treating all stages of cancer October March 2021 2022
Slide 2: Safe Harbor and Forward-Looking Statements
SAFE HARBOR AND FORWARD-LOOKING STATEMENTS Intensity Therapeutics, Inc. (the “Company” or “we”) has filed a registration statement, including a preliminary prospectus, with the U.S. Securities and Exchange Commission (the “SEC”) (File No. 333-260565) in connection with the offering to which this pre
Slide 3: Management Team: Extensive Oncology and Drug Development Experience
MANAGEMENT TEAM: EXTENSIVE ONCOLOGY AND DRUG DEVELOPMENT EXPERIENCE Chief SVP, Clinical Chief Founder, Medical Development Financial CEO Officer Officer Lewis H. Bender, MIT ChE, MS, MA, MBA Ian B. Walters, MD, MBA Syed Mahmood, MD James M. Ahlers • CEO, CTO, VP, BD & Manufacturing: Emisphere • Clin
Slide 4: Investment Highlights
INVESTMENT HIGHLIGHTS Localized Cancer Kill Leading to Immune Activation and Extended Survival • Novel drug product candidate (INT230-6) containing cytotoxic agents with a unique amphiphilic diffusion enhancing molecule • Favorable safety with efficacy; 115 patients treated through September 30, 202
Slide 5: Multiple Late Stage Pipeline Programs
MULTIPLE LATE STAGE PIPELINE PROGRAMS CLINICAL PROGRAMS ACROSS “COLD” AND “HOT” CANCERS, METASTATIC AND PRESURGICAL SETTINGS Multiple Ongoing Phase 2 Studies or Cohorts; Phase 3 Programs Designed and Discussed with FDA INT230-6 PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Advanced Soft Tissue Sarcoma INT230-
Slide 6: Our Delivery Technology Is Based on a Proven Science
OUR DELIVERY TECHNOLOGY IS BASED ON A PROVEN SCIENCE AMPHIPHILIC MOLECULES ARE SOLUBLE IN FAT AND WATER SIMULTANEOUSLY Technology First Developed for Oral Semaglutide Tablets (Rybelsus) Intensity’s ISSUED patents claim use with therapeutic agents for intratumoral delivery Intensity has patent protec
Slide 7: DfuseRx Proprietary Drug Discovery Platform; Product Candidate INT230-6
DFUSERXSM PROPRIETARY DRUG DISCOVERY PLATFORM PRODUCT CANDIDATE: INT230-6 – CONTAINS PROVEN ANTI-CANCER AGENTS INT230-6: designed for intratumoral (IT) CISPLATIN use; scaled-up, stable, reproducible • Direct killing: Binds to DNA to cause apoptotic cell death • Immune effects: Attracts and binds INT
Slide 8: INT230-6: A Unique, Anti-Cancer Therapy
INT230-6: A UNIQUE, ANTI-CANCER THERAPY 100% WATER SOLUTION THAT DISPERSES, DIFFUSES AND IS HIGHLY RETAINED IN TUMORS – DOES NOT HARM HEALTHY TISSUE Human pancreatic *Tumors contain high percentages of fat and are under high pressure cancer in mouse model Human pancreatic INT230-6 CYTOTOXICS DRUG ca
Slide 9: Clinical Studies as of September 30, 2021
CLINICAL STUDIES AS OF SEPTEMBER 30, 2021 Attacking the Tumors – Sparing the Patient RESULTS AS OF 9/30/2021 • METASTATIC REFRACTORY CANCERS: 95 PATIENTS TREATED • EARLY-STAGE BREAST CANCER: 20 PATIENTS TREATED 9
Slide 10: Data Shows Increased Median Overall Survival in Progressive Cancer
DATA SHOWS INCREASED MEDIAN OVERALL SURVIVAL IN PATIENTS WITH PROGRESSIVE CANCER FOLLOWING ALL APPROVED TREATMENTS Kaplan Meier survival estimates are as follows: All Mono, n=53 Kaplan Meier estimates of INT230-6 monotherapy patients • Subjects dosed INT230-6 alone* shows ~55% alive at 1 year • Typi
Slide 11: INT230-6 Causes Tumors to Become Highly Necrotic
INT230-6 CAUSES TUMORS TO BECOME HIGHLY NECROTIC A CASE FROM OUR METASTATIC STUDY PATIENT: Multiple surgeries, radiation, chemotherapy Necrosis and response seen in • (Jan ’18), Two 10 cm3 deep nodules appear in upper arm several cancers • MD’s Recommendation: Total arm and shoulder amputation • Adr
Slide 12: Phase 2 INVINCIBLE Study: Necrosis Achieved in Early Invasive Breast Cancer
PHASE 2 INVINCIBLE STUDY: NECROSIS ACHIEVED IN PROLIFERATING EARLY, INVASIVE BREAST CANCER (WHOLE TUMOR RESECTIONS) DOSE DEPENDENT DIFFUSION AND HIGH PERCENTAGE OF TUMOR KILLING OBSERVED Patient #14: Patient #20: 3.9 cm invasive ductal cancer: Grade 3 (high grade): 4.4 cm invasive lobular cancer: Gr
Slide 13: Immune Activation Observed in Multiple Cancer Types at 28 Days
IMMUNE ACTIVATION OBSERVED IN MULTIPLE CANCER TYPES AT 28 DAYS MODIFICATION OF THE TUMOR MICROENVIRONMENT OBSERVED Biopsies taken on day 0 and 28 INT230-6 dosed twice: Day 0 and Day 14 • Blue color indicates live cancer, DAPI; Green & yellow indicates immune cells Pre-dose (Day 0) 28 days after firs
Slide 14: Potential Treatment of Advanced Sarcoma
POTENTIAL TREATMENT OF ADVANCED SARCOMA HIGH UNMET MEDICAL NEED – SIGNIFICANT MARKET POTENTIAL 19 metastatic sarcoma subjects treated as of July 31, 2021 • Sarcomas are cancers of soft tissues such as fat, Demographic Value muscle, nerves, (STS) and bone (osteosarcoma) Median number of prior therapi
Slide 15: Decreased Tumor Volume Seen Post-Treatment Despite Increase in Diameter
DECREASED TUMOR VOLUME SEEN POST-TREATMENT DESPITE INCREASE IN DIAMETER RECIST/iRECIST MAY NOT BE A GOOD METRIC FOR EFFICACY USING OUR TECHNOLOGY: TUMOR DIAMETER INCREASES WHILE VOLUME DECREASES Change in diameter of 6 sarcoma subjects’ injected tumors after Change in volume of 6 sarcoma subjects’ i
Slide 16: IT INT230-6 Extends Survival Compared to Historical Phase 1/2 Results
IT INT230-6 EXTENDS SURVIVAL COMPARED TO HISTORICAL PHASE 1/2 RESULTS ADVANCED SOFT TISSUE SARCOMAS (aSTS) – KAPLAN MEIER (KM) ESTIMATES Kaplan Meier estimates aSTS patients • Blue curve (n=19) all patients ~50% alive at 1 year 100% • Orange curve (n=15) all patients dosed >40% of TTB, ~60% alive at
Slide 17: Phase 3 Trial Design for INT230-6 in Soft Tissue Sarcoma
PHASE 3 TRIAL DESIGN FOR INT230-6 IN SOFT TISSUE SARCOMA (STS) EXPECTED TO OFFER SURVIVAL IMPROVEMENT VS CURRENT 2ND AND 3RD LINE SOC • Intent to treat (ITT) population: all STS Median OS Curve for STS standard of care drugs and projected INT230-6 in Phase 3 100% • Size: N=331 90% INT230-6 curve fro
Slide 18: Platform Validated by World Leading Partnerships
PLATFORM VALIDATED BY WORLD LEADING PARTNERSHIPS RESEARCH CLINICAL TRIAL SITES 18
Slide 19: Multiple Upcoming Milestones 2021 to 2023
MULTIPLE UPCOMING MILESTONES 2021 to 2023 MILESTONES TIMING Society for Immunotherapy of Cancer (SITC) 2021: Report safety and efficacy data of monotherapy and I/O combinations Q4 2021 Connective Tissue Oncology Society (CTOS 2021): Oral podium presentation of INT230-6 in Sarcoma Q4 2021 San Antonio
Slide 20: INTS Investment Summary
INTS INVESTMENT SUMMARY Experienced Oncology Drug Development Management Team Novel Technology to Kill Cancer and Activate the Immune System; Extended Patient Survival Favorable safety; 115 patients treated as of September 30, 2021 On-going Phase 2 Studies; Phase 3 Registration Study Designed in Sar
Slide 21: Intensity Therapeutics: A New Weapon to Treat Cancer
INTENSITY THERAPEUTICS Contact Investor Relations Contact: A NEW WEAPON Rx Communications Group Michael Miller TO TREAT CANCER (917)-633-6086 mmiller@rxir.com Thank you! 21