Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — IPO Roadshow (June 2023)
33 slides from Intensity Therapeutics's IPO roadshow presentation, Jun 23, 2023
Slide 1: A New Weapon in the War on Cancer
A New Weapon in the War on Cancer June 2023 Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Number 333 - 260565
Slide 2: Safe Harbor and Forward-Looking Statements
Safe Harbor and Forward - Looking Statements 2 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 wh
Slide 3: IPO Offering Summary
Intensity Therapeutics Issuer • Nasdaq Capital Markets / INTS Exchange / Symbol • Initial Public Offering Offering Type • 7,534,954 shares Shares Outstanding Pre - Offering: • 3,250,000 of common stock, or 3,737,500 shares of common stock if underwriters exercise their over - allotment option in ful
Slide 4: Investment Highlights
Investment Highlights • Novel Approach to Immuno - Oncology with First - in - Class Compound that causes cancer cell death leading to an immune response for indications with high unmet medical need • Multiple Late - Stage Pipeline Programs in the Clinic across metastatic and presurgical settings wit
Slide 5: Platform Validated by World Leading Partners
Platform Validated by World Leading Partners RESEARCH CLINICAL TRIAL SITES 5
Slide 6: Management Team: Extensive Oncology and Drug Development Experience
6 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 • 25 years, multiple transactions • Titan Pharmaceutics, IPO Daniel Donovan CEO
Slide 7: 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 8: 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 Presurgical Breast cancer : First accelerated approval endpoints, then full approval • INT2
Slide 9: Proprietary Discovery Platform - DFUSERx
9 Proprietary Discovery Platform - DFUSERx SM • 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 Vinblastine Sulfat
Slide 10: Our Delivery Technology Is Based on a Proven Science
10 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 paten
Slide 11: A Unique Anti-Cancer Therapy
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 Signi
Slide 12: The INVINCIBLE Study: Presurgical Breast Cancer
12 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
Slide 13: INVINCIBLE Study: Significant Cancer Necrosis with 1 or 2 Doses
13 Tumor Extent Extent of Necrosis within Tumor Phase 2 INVINCIBLE Study: INT230 - 6 Achieves Significant Cancer Necrosis with 1 or 2 Doses Patient #14: 3.9 cm invasive ductal cancer:: 2 injections May 6 May 13 May 20 Final Pathology (significant necrosis ~85%) Final Pathology (significant necrosis
Slide 14: Favorable Safety in the Presurgical BC 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 15: Necrosis Efficacy and Phase 2/3 Study Design
Study: Necrosis Efficacy and Phase 2/3 Study Design 15 Major pathological response (MPR) defined as < 10% residual cancer remaining in tumor • MPR was 6% overall in study with 14.3% in tumors >2.9 cm compared to control (0%) p=0.042 Pathological complete response (pCR) defined as 100% elimination of
Slide 16: Phase 2 Study in Metastatic Disease - Enrollment Complete
IT - 01 Phase 1 / 2 Study in Metastatic Disease – Enrollment Complete ENROLLED: 110 16 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 17: Favorable Safety: Active Agents Remain in the Tumor
Favorable Safety: Active Agents Remain in the 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) platinum At 1 hour the plasma
Slide 18: In Metastatic Disease Injected Tumors Shrink in Volume
18 In Metastatic Disease injected Tumors Shrink in Volume Over Ti 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 19: 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 20: 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
Slide 21: In Sarcoma Median Overall Survival Increases Compared to Synthetic Control
21 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 IN
Slide 22: 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 23: Conclusions
• INT230 - 6 represents a new treatment approach to solid tumors (immunological cell killing) both in the metastatic and presurgical (neoadjuvant) settings • Strong interest from: academic hospitals, major clinical oncology societies, big pharma and government • INT230 - 6 has: • induced significant
Slide 24: Multiple Upcoming Key Clinical Milestones
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) Q2 2023 Regulatory filings regarding phase 3 programs Q2 2023 Report Sarcoma Phase 2 Data Q2 2023 Report F
Slide 25: Investment Highlights
Investment Highlights • Novel Approach to Immuno - Oncology with First - in - Class Compound that causes cancer cell death leading to an immune response for indications with high unmet medical need • Multiple Late - Stage Pipeline Programs in the Clinic across metastatic and presurgical settings wit
Slide 26: Contact Investor Relations
INTENSITY THERAPEUTICS 26 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!
Slide 27: Appendix slides
Intensity Therapeutics A New Weapon In The War On Cancer Appendix slides 27
Slide 28: INVINCIBLE Study Design
28 • ≥ 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, Randomized 2:1 INT230 - 6 Saline Control Part 1: Safety and dose ranging – Completed: Study Investigator: Dr. A
Slide 29: INVINCIBLE Study: Tumor Necrosis with One Injection
PHASE 2 INVINCIBLE Study: INT230 - 6 Achieves Significant Cancer tumor necrosis Presurgically with One Injection in Multiple Types of Breast Cancer Patient #32 (PART II): 3.3 cm invasive ductal cancer: Grade 2, ER+PR+Her2 - 1 injection (13 mls 12 days preop) Gross : 100% necrosis Histology : Sheet l
Slide 30: Clinical Trial Case Study
INT230 - 6 Phase 1 / 2 Clinical trial: Case study PRIOR HISTORY: Failed 2 surgeries, radiation, chemotherapy • Two large deep tumor nodules in muscle of left arm • Failure on all prior therapy AFTER INT230 - 6: • Increase in necrosis and inflammation of tumor • No RECIST progression • Blood shows in
Slide 31: RECIST Metrics Are Inadequate to Capture Efficacy
31 Change in Longest Diameter Change in Volume (using 3 dimensions) The lack of correlation between a tumor’s diameter and volume indicates that RECIST IS unreliable for IT INT230 - 6 as a metric of efficacy Drug is absorbed and immune cells infiltrate Days % change in diameter % change in volume Da
Slide 32: INVINCIBLE Study: Immune Activation in Early Breast Cancer
32 Phase 2 INVINCIBLE Study: INT230 - 6 Achieves Immune Activation in Early Breast Cancer prior to surgery 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 separate
Slide 33: Survival Increases with Higher Dose Relative to Tumor Burden
33 All subjects (n=63) >40% TTB (n= 45) <40% TTB (n= 18) KM INT230+PEM* (n=24) 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. INT230 - 6