Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — IPO Roadshow (June 2025)
28 slides from Intensity Therapeutics's IPO roadshow presentation, Jun 11, 2025
Slide 1: A New Weapon in the War on Cancer
A New Weapon in the War on Cancer P R E S E N TAT I O N NASDAQ: INTS Q2 2025 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333-280681 June 11, 2025
Slide 2: Forward-looking statements
2 2 This presentation contains forward‐looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, such as statements wi
Slide 3: Free Writing Prospectus notice
3 3 This presentation highlights basic information about us and the proposed offering. Because it is a summary, it does not contain all of the information that you should consider before investing. We have filed a registration statement on Form S‐3 (including a base prospectus) (File No. 333‐280681)
Slide 4: Company Overview
4 • Novel solid tumor cancer treatment approach using a new delivery technology that causes cancer cell death, leading to an immune response • Over 200 patients enrolled in 2 completed clinical trials (1 metastatic & 1 presurgical) • Ongoing studies: Phase 3 in metastatic sarcoma; Phase 2 in presurg
Slide 5: Three Key INT230-6 Components
5 Three Key INT230-6 Components All are powders 1. SHAO (10 mg/mL) • A novel diffusion enhancer molecule that is soluble in both fat & water 2. CISPLATIN1 ( 0.5 mg/mL) – Commercial IV drug • Direct killing: Cause apoptotic cell death • Immune effects: Attracts and binds T-Cells 3. VINBLASTINE2 (0.1
Slide 6: INT230-6 Indications and Regulatory Designations
6 Orphan Drug (Sarcoma INT230-6 components) • Tax credits for qualified clinical trials • Exemption from user fees • Potentially seven years of marketing exclusivity (post-approval) To be initiated, pending funding INVINCIBLE-5 (to be initiated post Phase 2) INVINCIBLE-4 (randomized Phase 2 study, I
Slide 7: Solid Tumors – Why are these invaders so deadly?
7 7 Sarcoma Upper panel: Gross appearance of mesenteric leiomyosarcoma on left and liver metastasis on right. Lower panel: Each lesion bi-valved. Tumor sizes typically up to 30 cm Breast Cancer – Lumpectomy Lumpectomy is the surgical resection of a breast tumor and some surrounding tissue. Tumor siz
Slide 8: INT230-6: A Unique Anti-Cancer Therapy
8 *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 Significant drug leakage Human pancreatic cancer in mouse model Drug NOT absorbed Human pancreatic cancer in mouse model TUMOR cut
Slide 9: Phase 2 Presurgical Breast Cancer Study (INVINCIBLE-2)
9 9 Tumor Extent Extent of necrosis within the tumor after INT230-6 injections 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 ~95%) Cancer is mostly ghost cells Injection #1: Dose 7.4 cc I
Slide 10: Differential Immune Cell Composition in Treated Tumors
10 10 Changes in the immune cell composition pre- and post-treatment in INT230-6 treated tumors Each bar represents an individual patient The most significant changes are increases in the tumors of CD4 memory T-cells and NK T-cells Baseline Biopsy Surgical Resection Phase 2 Presurgical Breast Cancer
Slide 11: INT230-6 Dosing Paradigm is Personalized
11 Current Systemic Treatment Approach Dosing is set by patient’s height and weight, or fixed dosing, though body size has no correlation with survival Our Treatment Approach INT230-6 dosing is set by amount of patient’s tumor burden, dose for each tumor is set by its size Those patients with more d
Slide 12: INT230-6 for Presurgical Triple-Negative Breast Cancer
12 INT230-6 for Presurgical Triple-Negative Breast Cancer INVINCIBLE-4 Study
Slide 13: Triple-Negative Breast Cancer Is a Virulent Subtype
13 13 CU-2 Triple-Negative Breast Cancer (TNBC) Is a Virulent Subtype Associated With Early Onset and Increased Risk of Early Recurrence TNBC accounts for 15% to 20% of breast cancersa,b At diagnosis: – Majority of tumors (~70%) are histologically grade 3 and highly proliferativee – Majority dia
Slide 14: Poor Survival Prognosis in High-Risk, Early-Stage TNBC
14 14 CU-6 Poor Survival Prognosis in High-Risk, Early-Stage TNBC Having Residual Disease (no pCR) After Neoadjuvant Chemotherapy a Cortazar P, et al. Lancet. 2014;384:164-172; b Sikov WM, et al. Presented at ASCO 2019 Abstract 591. CALGB 40603b N=426 Cortazar et al. 2014a N=1157 5-year EFS: ~84% wi
Slide 15: Phase 2 Neoadjuvant TNBC Study (INVINCIBLE-4) Design
15 Enrollment Criteria (n = 54) • Tumors ≥ 1.5 cm, but no cT4d (less likely to have a pCR with KN522 • Female or Male ≥18Y • Any N stage (N0/N+ randomized) • M0; ECOG 0-1 • No anticoagulation • No bilateral BC • No contraindication to Keynote-522 Therapy Standard of Care (24 Weeks) Neoadjuvant Thera
Slide 16: INVINCIBLE-4 TNBC Study Imaging
16 Phase 2 INVINCIBLE-4 TNBC Study (IT-04) After 8 Days: live cancer has decreased significantly (as seen by lower contrast uptake) Tumor become necrotic – edges less active
Slide 17: INT230-6 in Metastatic Cancers
17 INT230-6 in Metastatic Cancers
Slide 18: Favorable Safety as Active Agents Remain in the Tumor
18 *Two patients were in both the INT230-6 alone and INT230-6 + Keytruda cohorts IT-01 Study 110* patients, 20 cancer types; 64 patients on INT230-6 alone, 30 on INT230-6+Keytruda and 18 of INT230-6 + Yervoy >95% of the active agents remain in the tumor relative to the drugs given IV The drug retent
Slide 19: Phase 1/2 Refractory or Metastatic Cancer Study (IT-01)
19 Phase 1/2 Refractory or Metastatic Cancer Study (IT-01) Live cancer decreases significantly over time (as seen by lower contrast uptake) 6.15 cm 14.4 cm 3.18 cm 12.28 cm Sarcoma subject: 2 tumors at baseline: 21Mar 2018 FU3: 30Oct2018 Tumor become necrotic and cystic: volume increases then declin
Slide 20: Abscopal Responses in Uninjected Tumors
20 Abscopal effects may be underestimated; • No tumors under 1 cm in diameter were recorded, and • Many tumors above 1 cm were untracked per RECIST target guidelines Abscopal Responses - Maximum reduction in Longest Diameter of Uninjected Tumors 13 Tumors from 10 Subjects (Study IT-01)
Slide 21: Refractory or Metastatic Sarcoma Median Overall Survival
21 Kaplan Meier estimates Median OS improved with more drug administered relative to the patient’s total tumor burden (TTB) > 40% (n=11) All patients (n=15) < 40% (n=4) Refractory or Metastatic Sarcoma Subpopulation Study (IT-01) Median Overall Survival (mOS): 21.3 Month All Patients; mOS not yet re
Slide 22: Overall Survival of Sarcoma Patients is Poor After First Therapy Fails
22 22 Overall Survival (OS) of Sarcoma Patients is Poor After First Therapy fails Second and Third line Treatments – Trabectedin, Pazopanib and Eribulin Pe rc en t a liv e Months 93% of patients are deceased in less than three years* * Standard of care drug references: Trabectedin: Cancer. 2019 Aug
Slide 23: INVINCIBLE-3 Phase 3 Sarcoma Study Design
23 Interims Looks At 20%, 40% and 60% of events (deaths) Final Data Readout At 80% of events (deaths) Enrollment Criteria • Subtypes: unresectable or metastatic • Liposarcoma • Undifferentiated pleomorphic sarcoma • Leiomyosarcoma • ≥ 18 years • ECOG PS ≤ 2 • 2L/3L • Measurable disease by RECIST 1.1
Slide 24: Anticipated Key Milestones
24 2025 2026 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Phase 3 Advanced Soft Tissue Sarcoma INVINCIBLE-3 Study Phase 2 Neoadjuvant TNBC INVINCIBLE-4 Study – Phase 2 INVINCIBLE-5 Study – Phase 3: Post-Phase 2 Phase 2 Presurgical Breast Cancer INVINCIBLE-2 Study – Completed Phase 1/2 Refractory or Metastatic Cancer IT-
Slide 25: Financial Highlights and Capitalization Table
25 Pro Forma March 31, 2025*(All Figures in Thousands) Cash and Cash Equivalents 2,829 Total Assets 4,965 Total Debt - Total Liabilities 2,731 Total Stockholder’s Equity 2,234 Balance Sheet June 5, 2025 Shares Outstanding 18,398,202 Options (WAEP $4.10) 4,040,801 Warrants (WAEP: $1.70) 8,308,229 Ful
Slide 26: Key Management and Board of Directors
26 Lewis H. Bender, MIT ChE, MS, MA, MBA • Drug delivery expertise Preclinical through Phase 3 • Public biotech company CEO experience • Public CFO, 30 years, • Extensive M&A and financing transactions John Wesolowski, MBA, CPA Lewis H. Bender Founder and CEO Daniel Donovan CEO, rareLifeSolutions, I
Slide 27: Company Highlights
27 Unmet need Poor survival prognosis in target indications using standard of care Diffusion-based MOA Utilizes a novel diffusion enhancer molecule that is soluble in both fat & water Two Ongoing Trials Phase 2 in presurgical breast cancer, Phase 3 in metastatic sarcoma Favorable Safety No grade 4 o
Slide 28: Thank you!
28 INTENSITY THERAPEUTICS A NEW WEAPON IN THE WAR ON CANCER Thank you!