Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — IPO Roadshow (September 2022)
28 slides from Intensity Therapeutics's IPO roadshow presentation, Sep 20, 2022
Slide 1: A New Weapon in the War on Cancer
October 2021 A NEW WEAPON IN THE WAR ON CANCER Products that directly kill tumors to activate a patient - specific immune response Treating all stages of cancer September 2022 Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Number 333 - 260565 Our vision : To extend patient li
Slide 2: Disclaimer 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 presentation relates. Sales of the securitie
Slide 3: Offering Summary
Issuer Intensity Therapeutics Symbol INTS Intended Listing Exchange Nasdaq Capital Market Offering Size 2,222,223 shares based on mid range price of $4.50 (does not include 15% overallotment) Securities Offered Common stock Price Range $4 to $5 per common share Expected Use of Proceeds • Phase 2/3 n
Slide 4: Investment Highlights
(INTS) INVESTMENT HIGHLIGHTS Localized Cancer Kill Leading to Immune Activation and Extended Survival • Favorable safety with efficacy; over 200 patients enrolled Multiple Phase 2 Studies ongoing; Phase 3 Registration Studies Designed – FDA alignment On Protocol • FDA Fast Track designation granted
Slide 5: Management Team: Extensive Oncology and Drug Development Experience
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 company
Slide 6: Multiple Late-Stage Pipeline Programs
Neoadjuvant Breast Cancer INT230 - 6 randomized Phase 2/3 designed INT230 - 6 PRECLINICAL PHASE 1 PHASE 2 PHASE 3 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 - immunogen
Slide 7: DfuseRx Proprietary Discovery Platform
DFUSERX SM PROPRIETARY DISCOVERY PLATFORM PRODUCT CANDIDATE: INT230 - 6 – USES PROVEN ANTI - CANCER AGENTS INT230 - 6: designed for intratumoral (IT) use; Drug is scaled - up, stable, & reproducible INT230 - 6 contains 2 proven anti - cancer drugs that are used intravenously: CISPLATIN, VINBLASTINE
Slide 8: A Unique Anti-Cancer Therapy That Diffuses Throughout Fatty Tumors
8 INT230 - 6: A UNIQUE, ANTI - CANCER THERAPY WATER SOLUTION THAT DIFFUSES THROUGHOUT FATTY 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 tested TUMOR cut in half Signi
Slide 9: INVINCIBLE Study: Significant Cancer Killing in Breast Cancers
9 Tumor Extent Extent of Necrosis wit h in T u mor PHASE 2 INVINCIBLE STUDY: INT230 - 6 ACHIEVES SIGNIFICANT CANCER KILLING WITH ONE OR TWO DOSES IN MULTIPLE TYPES OF BREAST CANCERS Patient #14: 3.9 cm invasive ductal cancer: Grade 3 (high grade): ER+PR+Her2+ 2 injections May 6 May 13 May 20 Final P
Slide 10: Delivery Technology Based on Proven Science
OUR DELIVERY TECHNOLOGY IS BASED ON A PROVEN SCIENCE USED FOR ORAL DELIVERY OF PROTEINS Technology First Developed for Oral delivery of Protein (Semaglutide); Tablet Product (Rybelsus) Intensity’s ISSUED patents claim use with therapeutic agents for intratumoral delivery Intensity has patent protect
Slide 11: Clinical Studies Enrollment
CLINICAL STUDIES ENROLLMENT: June 2022 11 • STUDY IT - 01 : Metastatic refractory cancer ( 25 types) : 110 Patients • INT 230 - 6 alone ( 63 patients) With Keytruda ( 30 patients) With Yervoy ( 17 patients) Injections into lung, liver, peritoneum, pancreas, breast, limbs, lymph nodes Dosed started w
Slide 12: INVINCIBLE Study: Presurgical Use in Early Breast Cancer
INVINCIBLE STUDY: 91 PATIENTS COMPLETED PRESURGICAL USE OF INT230 - 6 IN EARLY BREAST CANCER 12 Background : • Chemotherapy with Keytruda is used prior to surgery to try and kill all visible cancer, a pathological complete response (pCR). • Having a pCR delays disease recurrence. Yet only 63% of suc
Slide 13: Neoadjuvant Study Safety
NEOADJUVANT STUDY SAFETY INT230 - 6 HAD FAVORABLE SAFETY 13 • 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
Slide 14: INVINCIBLE Phase 2 Part 1 Immune Activation
PHASE 2 INVINCIBLE STUDY: PART 1 COMPLETED INT230 - 6 ACHIEVES IMMUNE ACTIVATION IN EARLY STAGE BC 14 Pre vs. Post treatment • In tumor: increase in abundance of CD4 naïve and B and NK T cells • In tumor microenvironment: increase in CD8 memory T, CD4 naïve and B cells • Over 200 immune cell genes a
Slide 15: INVINCIBLE Study Safety and Next Data Sets
INVINCIBLE STUDY SAFETY AND NEXT DATA SETS 15 PART II (ongoing) increased INT230 - 6 loading • INT230 - 6 treatment compared to saline sham injection (% necrosis, effect on Ki67) • Evaluate other immunomodulatory (T - cell repertoire) and biologic effects Design of Phase 3 Program: INT230 - 6 + Stan
Slide 16: Data Presented at ASCO 2022
DATA PRESENTED AT ASCO 2022 Results in Metastatic Cancers: INT230 - 6 Monotherapy or with immunotherapy 16
Slide 17: Metastatic Study: Favorable Safety, Agents Remain in Tumor
METASTATIC STUDY: IT - 01 FAVORABLE SAFETY: ACTIVE AGENTS REMAIN IN TUMOR INT230 - 6 >95% of the active agents remain in the tumor relative to IV dosing at 1 to 6 hours Retention is independent of cancer type, location or size Cisplatin levels are not measured - only (non - toxic) platinum metal is
Slide 18: Safety Data as of April 1, 2022
SAFETY OF INT230 - 6 ALONE DATA AS OF APRIL 1, 2022 Treatment - Related Adverse Events for INT230 - 6 of Study IT - 01, n (%), – All Treated Population (>4 events) 18
Slide 19: RECIST Measures Do Not Capture Efficacy Benefit
Change in Longest Diameter 19 Change in Volume (using 3 dimensions) RECIST metrics use longest diameter (LD) INT230 - 6 is highly absorbed by tumors There is potential for immune infiltration There is a lack of correlation between diameter and volume in many subjects Often diameter increases or chan
Slide 20: Injected Tumors Shrink Over Time in Metastatic Disease
3/08/2022 Scan at 6 months 9/22/2021 Pre dose scan IN METASTATIC DISEASE INJECTED TUMORS SHRINK OVER TIME SHRINKAGE OF UNINJECTED TUMORS OBSERVED A scan of a monotherapy sarcoma tumor highlights tumor regression. Longest diameter declines 15%, whereas 2nd longest diameter declines 42% Using WHO Crit
Slide 21: Immune Activation in Non-Immunogenic Cancers
21 Post 2 doses Day 28 Pre dose Day 0 Liposarcoma cancer IMMUNE ACTIVIATON ACHIEVED IN NON - IMMUNOGENIC CANC After 2 doses of INT230 - 6 alone there is an anti - cancer immune cell influx into the tumor Ovarian cancer Day 0 Day 28 cancer
Slide 22: Survival Increased Relative to Historical Data
22 All subjects (n=63) >40% TTB (n= 45) <40% TTB (n= 18) KM INT230+PEM* (n=24) KM INT230 - 6 alone mOS not yet reached with 143 days of median follow up Monotherapy: 19 different cancers An exploratory analysis of dose relative to a subject’s incoming total tumor burden (TTB) was performed. Data as
Slide 23: Overall Survival Increased in Sarcoma
23 Kaplan Meier estimates sarcoma patients Historical sarcoma phase 1/2 control (Subbiah) Ipi Combination data Control ( S ubbiah data) INT230 - 6 all INT2306 >40% TTB INT230 - 6 + IPI mOS , CI 205 days 649 (146, 715 (649, 1219) Not reached 1219) median follow - up: 297 days Dose relative to incomin
Slide 24: Phase 3 Trial Design in Soft Tissue Sarcoma
24 1 0 0% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 0 5 10 15 Dacarbazine Trabectedin E r i b u li n( L i p o) INT 230 - 6 modeled from P 2 data Standard of care drug references: Trabectedin: Cancer. 2019 Aug 1;125(15):2610 - 2620 Eribulin: Lancet. 2016 Apr 16;387(10028):1629 - 37 Pazopanib: Lancet. 20
Slide 25: Platform Validated by World Leading Partnerships
25 PLATFORM VALIDATED BY WORLD LEADING PARTNERSHIPS RESEARCH CLINICAL TRIAL SITES
Slide 26: Multiple Upcoming Milestones
26 MULTIPLE UPCOMING MILESTONES MILESTONES EXPECTED TIMING Report Phase 2 INVINCIBLE Study data (Part 1) Q2 2022 Report interim IT - 01 data on combination with Keytruda Q2 2022 Report interim IT - 01 data on combination with Yervoy Q2 2022 Report INVINCIBLE immune data (Part2) Q4 2022 Report Sarcom
Slide 27: Conclusions and First Market Opportunities
• INT230 - 6 has induced up to 95% necrosis in large tumors following a single IT dose with immune activation in non - immunogenic cancer types: potential for presurgical use • INT230 - 6 has shown favorable safety and promising efficacy of increased survival alone or combined with immunotherapies i
Slide 28: Thank You and Contact
INTENSITY THERAPEUTICS 28 A NEW WEAPON IN THE WAR ON CANCER Contact Investor Relations Contact : Rx Communications Group Michael Miller (917) - 633 - 6086 mmiller@rxir.com Thank you!
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