Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — IPO Roadshow (January 2023)
27 slides from Intensity Therapeutics's IPO roadshow presentation, Jan 13, 2023
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 January 2023 Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Number 333 - 260565 Our vision : To extend patient life
Slide 2: Intensity Therapeutics, Inc. (the “Company” or “we”) has filed a registration statement, including a
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
3 Issuer Intensity Therapeutics Symbol INTS Intended Listing Exchange Nasdaq Capital Market Offering Size 1,777,778 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
Slide 4: Investment Highlights
4 (INTS) INVESTMENT HIGHLIGHTS Localized Cancer Kill Leading to Immune Activation and Extended Survival • Favorable safety with efficacy; over 200 patients enrolled Phase 2 Studies Finishing; Phase 3 Registration Studies Designed – FDA alignment On Protocol • FDA Fast Track designation granted for T
Slide 5: Platform Validated by World Leading Partners
5 PLATFORM VALIDATED BY WORLD LEADING PARTNERS RESEARCH CLINICAL TRIAL SITES
Slide 6: Management Team: Extensive Oncology and Drug Development Experience
6 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 compan
Slide 7: Multiple Late-Stage Pipeline Programs
7 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 - immunog
Slide 8: DfuseRx Proprietary Discovery Platform
8 DFUSERX SM PROPRIETARY DISCOVERY PLATFORM PRODUCT CANDIDATE: INT230 - 6 – USES PROVEN ANTI - CANCER AGENTS Designed for intratumoral (IT) use; Drug is scaled - up, stable, & reproducible Product contains 2 proven anti - cancer drugs that are used IV: CISPLATIN, VINBLASTINE Both drugs kill cancer d
Slide 9: A Unique Anti-Cancer Therapy That Diffuses Throughout Fatty Tumors
9 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 10: Phase 2 INVINCIBLE Study: Significant Cancer Killing With One Injection
10 Tumor Extent Extent of Necrosis wit h in T u mor PHASE 2 INVINCIBLE STUDY: INT230 - 6 ACHIEVES SIGNIFICANT CANCER KILLING WITH ONE INJECTION IN MULTIPLE TYPES OF BREAST CANCERS Final Pathology (significant necrosis ~95%) cancer is mostly ghost cells Patient #20: 4.4 cm invasive lobular cancer: 1
Slide 11: 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 12: Clinical Studies Enrollment
12 CLINICAL STUDIES ENROLLMENT: June 2022 • STUDY IT - 01 : Metastatic refractory cancer (25 types): 110 Patients INT230 - 6 alone (63 patients) With Keytruda (30 patients) With Yervoy (17 patients) Injections into lung, liver, peritoneum, pancreas, breast, limbs, lymph nodes Dosed started with 5 mL
Slide 13: INVINCIBLE Study Design
13 • ≥ 18 years • Female patients with newly diagnosed invasive BC • Treatment naïve, awaiting surgery. • Tumor ≥ 1.5 cm • Bloom Richardson grade ≥2 • Invasive ductal or lobular carcinoma, R a ndo mized 2:1 INT230 - 6 Sa li n e Con t r ol Part 1: Safety and dose ranging - Completed Open - label 2:1
Slide 14: Neoadjuvant Study Safety
14 NEOADJUVANT STUDY SAFETY INT230 - 6 HAD FAVORABLE SAFETY • 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 15: INVINCIBLE Study Part 1 Achieves Immune Activation in Early Stage BC
15 PHASE 2 INVINCIBLE STUDY: PART 1 INT230 - 6 ACHIEVES IMMUNE ACTIVATION IN EARLY STAGE BC Relative abundance levels of immune cells present in the tumor compared to current standard of care (no treatment controls) Each bar demonstrates the immune cell abundance in a patient separated by BC subtype
Slide 16: INVINCIBLE Study Safety, Efficacy and Next Data Sets
16 INVINCIBLE STUDY SAFETY, EFFICACY AND NEXT DATA SETS PART 2 (ongoing analysis): INT230 - 6 treatment compared to saline sham injection Major pathological response (MPR) defined as < 10% residual cancer in tumor MPR was 6% overall in study with ~14.3% in tumors >2.9 cm compared to control (0%) p=0
Slide 17: Data Presented at ASCO 2022: Results in Metastatic Cancers
17 DATA PRESENTED AT ASCO 2022 Results in Metastatic Cancers: INT230 - 6 Monotherapy or with immunotherapy
Slide 18: Metastatic Study: Favorable Safety, Active Agents Remain in Tumor
18 METASTATIC STUDY: IT - 01 FAVORABLE SAFETY: ACTIVE AGENTS REMAIN IN TUMOR 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 Plasma cisplatin levels cannot be measured - only (non - toxic) plati
Slide 19: Survival Increased Relative to Historical Data
20 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 20: Injected Tumors Shrink Over Time in Metastatic Disease
21 IN METASTATIC DISEASE INJECTED TUMORS SHRINK OVER TIME SHRINKAGE OF UNINJECTED TUMORS 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 Cri
Slide 21: Immune Activation Achieved in Non-Immunogenic Cancers
22 Post 2 doses Day 28 Pre dose Day 0 Liposarcoma cancer IMMUNE ACTIVIATON ACHIEVED IN NON - IMMUNOGENIC CANCERS 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: Use of RECIST in Sarcoma May Not Capture Efficacy
Change in Longest Diameter Change in Volume (using 3 dimensions) The lack of correlation between diameter and volume indicates that RECIST may be unreliable for IT INT230 - 6 as a metric of efficacy Days % change in diameter % change in volume Days Changes in a tumor longest diameter over time and t
Slide 23: Overall Survival Increased Compared to Historical Result in Sarcoma
24 1 0 .9 0 .8 0 .7 0 .6 0 .5 0 .4 Survival Probability INT230 - 6 dosed >40% TTB, n=11 Control, n=56 INT230 - 6, n=15 INT230 - 6 + IPI, n=14 Censored 0.3 Historical sarcoma phase 0.2 1/2 control (Subbiah data*) 0.1 0 0 100 200 300 400 500 600 700 Days Kaplan Meier estimates sarcoma Ipi Combination
Slide 24: Phase 3 Trial Design in Soft Tissue Sarcoma
25 Two interim looks at 50% and 75% of events: test for futility and endpoint Must have had doxorubicin HR: 0.65 Overall survival: 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 S) EXPECTED TO OFFER SURVIVAL IMPROVE
Slide 25: Conclusions and First Market Opportunities
26 • INT230 - 6 has induced significant necrosis in large tumors following a single dose • Immune activation observed of non - immunogenic cancer types: potential for presurgical use • Favorable safety and promising increased survival efficacy • INT230 - 6 represents a new approach to cancer treatme
Slide 26: Multiple Upcoming Key Clinical Milestones
27 MULTIPLE UPCOMING KEY CLINICAL MILESTONES MILESTONES EXPECTED TIMING Report Phase 2 INVINCIBLE Study data (Part 1) Q4 2022 Report Phase 2 INVINCIBLE Study Systemic Immune Response Data (Part 2) Q1 2023 Regulatory filings regarding phase 3 programs Q1/2 2023 Report Sarcoma Phase 2 Data Q2 2023 Rep
Slide 27: Intensity Therapeutics: Contact Investor Relations
28 INTENSITY THERAPEUTICS 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!