Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — IPO Roadshow (December 2021)
23 slides from Intensity Therapeutics's IPO roadshow presentation, Dec 16, 2021
Slide 1: A New Weapon in the War on Cancer
October 2021 A NEW WEAPON IN THE WAR ON CANCER Directly killing tumors to activate a patient - specific immune response Treating all stages of cancer December 2021 Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Number 333 - 260565
Slide 2: Safe Harbor and Forward-Looking Statements
2 2 SAFE HARBOR AND FORWARD - LOOKING STATEMENTS Intensity Therapeutics, Inc. (the “Company” or “we”) has filed a registration statement, including a preliminary prospectus, wit h the U.S. Securities and Exchange Commission (the “SEC”) (File No. 333 - 260565) in connection with the offering to which
Slide 3: Offering Summary
Issuer Intensity Therapeutics Symbol INTS Intended Listing Exchange NASDAQ Capital Market Offering Size $17.25 Million (includes 15% overallotment) Securities Offered 2.14 million shares of Common Stock (does not include 15% overallotment) Price Range $6 – $8 Expected Use of Proceeds • Phase 3 sarco
Slide 4: Management Team: Extensive Oncology and Drug Development Experience
4 MANAGEMENT TEAM: EXTENSIVE ONCOLOGY AND DRUG DEVELOPMENT EXPERIENCE Lewis H. Bender , MIT ChE, MS, MA, MBA • CEO, CTO, VP, BD & Manufacturing: Emisphere • CEO: Genomic testing, Interleukin Genetics • Roche, Manufacturing • Drug delivery expertise Preclinical • through Phase 3 • Public biotech comp
Slide 5: Investment Highlights
5 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,
Slide 6: Multiple Late Stage Pipeline Programs
6 PRECLINICAL PHASE 1 PHASE 2 PHASE 3 INT230 - 6 Colorectal, Bile Duct, Pancreatic Squamous cell cancers Sarcoma, Breast, Hepatic Cancers Combo with + BMS’ Yervoy® Combo with Merck’s Keytruda® (non - immunogenic “cold tumors”) Randomized Controlled INT230 - 6 TNBC* (Neoadjuvant) MULTIPLE LATE STAGE
Slide 7: Our Delivery Technology Is Based on a Proven Science
7 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 prot
Slide 8: DfuseRx Proprietary Drug Discovery Platform Product Candidate
8 DFUSERX SM PROPRIETARY DRUG DISCOVERY PLATFORM PRODUCT CANDIDATE: INT230 - 6 – CONTAINS PROVEN ANTI - CANCER AGENTS INT230 - 6: designed for intratumoral (IT) use; scaled - up, stable, reproducible INT230 - 6 vials contains the amphiphilic agent (SHAO) with 2 potent cytotoxic drugs Amphiphilic Mol
Slide 9: A Unique, Anti-Cancer Therapy That Disperses and Is Retained in Tumors
9 INT230 - 6: A UNIQUE, ANTI - CANCER THERAPY 100% WATER SOLUTION THAT DISPERSES, DIFFUSES AND IS HIGHLY RETAINED IN TUMORS – 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 tes
Slide 10: Clinical Studies as of September 30, 2021
10 CLINICAL STUDIES AS OF SEPTEMBER 30, 2021 RESULTS AS OF 9/30/2021 • METASTATIC REFRACTORY CANCERS: 95 PATIENTS TREATED • EARLY - STAGE BREAST CANCER: 20 PATIENTS TREATED Attacking the Tumors – Sparing the Patient
Slide 11: Data Shows Increased Median Overall Survival in Progressive Cancer
11 DATA SHOWS INCREASED MEDIAN OVERALL SURVIVAL IN PATIENTS WITH PROGRESSIVE CANCER FOLLOWING ALL APPROVED TREATMENTS Kaplan Meier survival estimates are as follows: Kaplan Meier estimates of INT230 - 6 monotherapy patients Survival Probability Data with cut - off of July 31, 2021 0% 20% 40% 60% 80%
Slide 12: Causes Tumors to Become Highly Necrotic
12 INT230 - 6 CAUSES TUMORS TO BECOME HIGHLY NECROTIC A CASE FROM OUR METASTATIC STUDY PATIENT: Multiple surgeries, radiation, chemotherapy • (Jan ’18), Two 10 cm 3 deep nodules appear in upper arm • MD’s Recommendation: Total arm and shoulder amputation Subject received 4 doses of INT230 - 6 equal
Slide 13: INVINCIBLE Study: Necrosis Achieved in Early Invasive Breast Cancer
13 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: 3.9 cm invasive ductal cancer: Grade 3 (high grade): ER+PR+Her2+ 2 injections Final Pathology (si
Slide 14: Immune Activation Observed in Multiple Cancer Types
14 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 Multiplex IHC shows: • Decreas
Slide 15: Potential Treatment of Advanced Sarcoma
15 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, muscle, nerves, (STS) and bone (osteosarcoma) • 12,000 are diagnosed per year in the U.S •
Slide 16: Decreased Tumor Volume Seen Post-Treatment Despite Increase in Diameter
16 DECREASED TUMOR VOLUME SEEN POST - TREATMENT DESPITE INCREASE IN DIAMETER -40% -30% -20% -10% 0% 10% 20% 30% 0 100 200 300 400 500 600 Percent Change in Diameter Days from First Assesment 001-010-T-2-I 002-019-T-1-M 002-019-T-2-M 002-026-T-2-M 002-030-T-1-P 004-005-T-2-M 010-001-T-1-M 010-001-T-1
Slide 17: Extends Survival Compared to Historical Phase 1/2 Results in aSTS
17 IT INT230 - 6 EXTENDS SURVIVAL COMPARED TO HISTORICAL PHASE 1/2 RESULTS ADVANCED SOFT TISSUE SARCOMAS (aSTS) – KAPLAN MEIER (KM) ESTIMATES 0% 20% 40% 60% 80% 100% 0 100 200 300 400 Survival Probability Survival Days All, n=19 All dosed >40% TTB, n=15 Mono dosed >40% TTB, n=7 INT230-6+Checkpoint I
Slide 18: Phase 3 Trial Design in Soft Tissue Sarcoma
18 PHASE 3 TRIAL DESIGN FOR INT230 - 6 IN SOFT TISSUE SARCOMA (STS) EXPECTED TO OFFER SURVIVAL IMPROVEMENT VS CURRENT 2 ND AND 3 RD LINE SOC Median OS Curve for STS standard of care drugs and projected INT230 - 6 in Phase 3 • Intent to treat (ITT) population: all STS • Size: N=331 • Enrollment: 2:1
Slide 19: Platform Validated by World Leading Partnerships
19 PLATFORM VALIDATED BY WORLD LEADING PARTNERSHIPS RESEARCH CLINICAL TRIAL SITES
Slide 20: Multiple Upcoming Milestones 2021 to 2023
20 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 S arcoma Q4 2021 San A
Slide 21: Capitalization Table Pre and Post IPO
21 CAPITALIZATION TABLE PRE AND POST IPO Security Type Pre - IPO # of Shares Post IPO 1 Common – Lewis H. Bender (Founder) 4,000,000 4,000,000 Common – Prior holder 2,820,211 2,820,211 Subtotal of Common Shares Prior holders 6,820,211 6,820,211 New Share holders - 2,142,858 Subtotal of Common Shares
Slide 22: INTS Investment Summary
22 INTS INVESTMENT SUMMARY 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 Sarcomas with FDA Alignment FDA Fast Track designati
Slide 23: Intensity Therapeutics: A New Weapon to Treat Cancer
23 INTENSITY THERAPEUTICS A NEW WEAPON TO TREAT CANCER Contact Investor Relations Contact: Rx Communications Group Michael Miller (917) - 633 - 6086 mmiller@rxir.com Thank you!
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