Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — IPO Roadshow (April 2022)
23 slides from Intensity Therapeutics's IPO roadshow presentation, Apr 20, 2022
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 April 2022 Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration Number 333 - 260565 Novel, Highly Tumor Diffusive Cytotoxic Drug Pro
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
Issuer Intensity Therapeutics Symbol INTS Intended Listing Exchange Nasdaq Capital Market Offering Size $17.25 Million (includes 15% overallotment) Securities Offered Units comprised of one share of common stock and one warrant to purchase one share of common stock Price Range TBD Expected Use of Pr
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 compan
Slide 5: Localized Cancer Kill Leading to Immune Activation and Extended Survival
Localized Cancer Kill Leading to Immune Activation and Extended Survival • Novel product candidate (INT230 - 6) containing cytotoxic agents with a diffusion enhancing molecule • Favorable safety with efficacy; 168 patients treated through March 31, 2022, • No maximum tolerated dose; adverse events a
Slide 6: Multiple Late-Stage Pipeline Programs
6 INT230 - 6 PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Colorectal, Bile Duct, Pancreatic Squamous cell cancers Sarcoma, Breast, Hepatic Cancers Combo with + BMS’ Yervoy® Combo with Merck’s Keytruda® (non - immunogenic “cold tumors”) Controlled INT230 - 6 TNBC* (Neoadjuvant) MULTIPLE LATE - STAGE PIPELINE
Slide 7: DfuseRx Proprietary Discovery Platform
7 DFUSERX SM PROPRIETARY DISCOVERY PLATFORM PRODUCT CANDIDATE: INT230 - 6 – USES 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 Molecule SHA
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: Our Delivery Technology Is Based on a Proven Science
OUR DELIVERY TECHNOLOGY IS BASED ON A PROVEN SCIENCE Technology First Developed for Oral Semaglutide Tablets (Rybelsus) Intensity’s ISSUED patents claim use with therapeutic agents for intratumoral delivery Intensity has patent protection in 37 countries EMISPHERE WAS ACQUIRED BY NOVO NORDISK FOR $1
Slide 10: Clinical Studies Enrollment: March 31, 2022
11 CLINICAL STUDIES ENROLLMENT: MARCH 31, 2022 • STUDY IT - 01 : Metastatic refractory cancer (25 types): 107 Patients (+ 2 repeats) INT230 - 6 alone (61 patients) With Keytruda (30 patients) With Yervoy (16 patients) Average tumor burden ~200 cc at enrollment First patient max dose 5 mL 1x per 28 d
Slide 11: Favorable Safety: Active Drugs Stay in Tumor
C ON F I D E N 1 T 3 I A L 13 FAVORABLE SAFETY: ACTIVE DRUGS STAY IN TUMOR: LOW GRADE ADVERSE EVENTS IV VIN ~6.5 mg Dose - dependent blood levels of vinblastine across all INT230 - 6 doses ranging from 2 to 118 mL, independent of cancer type, tumor position or size SHAO has no toxicity and is G ener
Slide 12: Data Shows Extended Median Overall Survival
*INT230 - 6 alone subjects with reported total tumor burdens >2 cc and <700 cc. 14 0% 25% 50% 75% 100% 0 100 200 300 400 500 Survival Probability Days All, n=56 Dosed <40% TTB, n=14 Dosed >40% TTB, n=42 Censored <40% (N=14) DATA SHOWS EXTENDED MEDIAN OVERALL SURVIVAL PATIENTS HAVING TRIED ALL APPROV
Slide 13: Causes Tumors to Become Necrotic
15 INT230 - 6 CAUSES TUMORS TO BECOME NECROTIC CASE STUDY PATIENT: Has 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 to 100% of his tumor volu
Slide 14: INVINCIBLE Study: Necrosis of Early, Invasive Breast Cancer
16 PHASE 2 INVINCIBLE STUDY: NECROSIS OF EARLY, INVASIVE BREAST CANCER (WHOLE TUMOR RESECTIONS) DOSE DEPENDENT DIFFUSION ACHIEVES SIGNIFICANT CANCER KILLING Patient #14: 3.9 cm invasive ductal cancer: Grade 3 (high grade): ER+PR+Her2+ 2 injections May 6 May 13 May 20 Final Pathology (significant nec
Slide 15: Immune Activation Observed in Multiple Cancer Types
17 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 16: Potential Treatment of Soft Tissue Sarcoma
18 POTENTIAL TREATMENT OF SOFT TISSUE SARCOMA (STS) HIGH UNMET MEDICAL NEED – SIGNIFICANT MARKET POTENTIAL 26 metastatic sarcoma subjects treated as of December 31, 2021 • Soft tissue sarcomas cancer is from fat, muscle, nerves • US: 12,000 new cases per year; more than 157,000 total cases • Toxic,
Slide 17: Extends Survival Compared to Historical Phase 1/2 Results in Advanced Sarcomas
19 • Matched Risk Control phase 1/2 pop. 28% (From Subbiah dataset) • INT230 - 6 mono phase 1 / 2(n=15) 52% • INT230 - 6 mono >40% of TTB (n=11) 77% • IO combo (n=11) (>90% Yervoy IPI) 90% (data still very early) * INT2306 alone was without retreatment or optimized tumor loading IT INT230 - 6 EXTEND
Slide 18: Decreased Tumor Volume Seen Post-Treatment Despite Increase in Diameter
20 DECREASED TUMOR VOLUME SEEN POST - TREATMENT DESPITE INCREASE IN RECIST/iRECIST MAY NOT BE A GOOD METRIC FOR EFFICACY USING OUR TECHNOLOGY: TUMOR DIAMETERS INCREASE WHILE VOLUME DECREASES Each color represents a different sarcoma’ patient’s injected tumor The left panel is each tumor’s change in
Slide 19: Phase 3 Trial Design in Soft Tissue Sarcoma
21 PHASE 3 TRIAL DESIGN FOR INT230 - 6 IN SOFT TISSUE SARCOMA (S S) 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 20: Platform Validated by World Leading Partnerships
22 PLATFORM VALIDATED BY WORLD LEADING PARTNERSHIPS RESEARCH CLINICAL TRIAL SITES
Slide 21: Multiple Upcoming Milestones
23 MULTIPLE UPCOMING MILESTONES Next 24 months MILESTONES TIMING Multiple data presentations made in Q4 2021; SITC (2) (immunotherapy), CTOS (sarcoma Oral Podium) SABCS (breast cancer) Reported safety and efficacy data of monotherapy and both I/O combinations Q4 2021 Report Phase 2 INVINCIBLE Study
Slide 22: INTS Investment Summary
24 INTS INVESTMENT SUMMARY A unique and new cancer killing, treatment approach Experienced Oncology Drug Development Management Team Novel Technology to Kill Cancer and Activate the Immune System; Extended Patient Survival Favorable safety; 168 patients as of 03/31/2022 On - going Phase 2 Studies; P
Slide 23: Intensity Therapeutics: Contact
25 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!