Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — IPO Roadshow (April 2025)
29 slides from Intensity Therapeutics's IPO roadshow presentation, Apr 23, 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 April 2025 Issuer free writing Prospectus Filed Pursuant to Rule 433 Registration No. 333-286683 April 22, 2025
Slide 2: Offering disclaimer
3 3 This presentation highlights basic information about Intensity Therapeutics, Inc. (the “Company”) and the proposed offering. Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you should consider before investing in o
Slide 3: Forward-looking statements
4 4 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 4: Company Highlights
5 • 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
6 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 Clinical Program and Designations
7 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 they so deadly?
8 8 Leiomyosarcoma 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. Tu
Slide 8: Triple-Negative Breast Cancer Is a Virulent Subtype
9 9 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 diagn
Slide 9: Poor Survival Prognosis in High-Risk, Early-Stage TNBC
10 10 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 10: Overall Survival of Sarcoma Patients is Poor
11 11 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 11: INT230-6 Delivery Technology Creates Advantages
13 Intensity’s solution • Tumor saturated with cytotoxics dies • Large quantities of antigen are released to immune cells • Tumor now favorable to T-cell influx Issues with current systemic therapies • Lack of blood vessels • Drugs are unable to reach most of the tumor • Tumors can exclude T-cells •
Slide 12: INT230-6 Dosing Paradigm is Personalized
15 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 13: INT230-6: A Unique Anti-Cancer Therapy
16 *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 14: INT230-6 for Presurgical Breast Cancer
17 INT230-6 for Presurgical Breast Cancer
Slide 15: Degree of Necrosis Is Dependent on Dose Per Injection
18 18 Tumor Extent Extent of Necrosis within Tumor 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 Injection #2: Dose 14.8 cc Su
Slide 16: Differential Immune Cell Composition in Treated Tumors
19 19 Changes in the immune cell composition pre- and post- treatment in INT230-6 treated tumors. As shown in the bar plots, which represent individual patients, the most significant changes are increases in the CD4 memory T-cells and NK T-cells Baseline Biopsy Surgical Resection Phase 2 Presurgical
Slide 17: INVINCIBLE-4 Neoadjuvant TNBC Trial Design
20 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 18: INVINCIBLE-4 TNBC Study imaging
21 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
Slide 19: INT230-6 in Metastatic Cancers
23 INT230-6 in Metastatic Cancers
Slide 20: Favorable Safety as Active Agents Remain in the Tumor
24 *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 21: Live cancer decreases significantly over time
29 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 22: Abscopal Responses in Uninjected Tumors
30 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 23: Metastatic Sarcoma Subpopulation Overall Survival
32 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 24: INVINCIBLE-3 Phase 3 Trial Design
35 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 25: Anticipated Key Milestones
38 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 26: Financial Highlights
39 Cash and Cash Equivalents(1) $2.6 million Debt(1) $ 0 Shares Outstanding(1): Common 15.1 million Options (weighted average exercise price: $6.14) 2.6 million Warrants (weighted average exercise price: $4.32) 2.0 million (1) As of December 31, 2024 Financial Highlights
Slide 27: Summary
40 • Solid cancers such as sarcoma and breast are challenging to treat due to the tumor’s physical properties • Intensity is a late-stage clinical biotech company developing a new delivery technology to overcome the barriers to cancer cell death • Intensity’s product candidate, INT230-6, can be used
Slide 28: Key Management and Board of Directors
42 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 CEO Intensity Daniel Donovan CEO Rare Life Emer Leahy, P
Slide 29: Thank you
43 INTENSITY THERAPEUTICS A NEW WEAPON IN THE WAR ON CANCER Investor Contact: Justin Kulik CORE IR IntensityIR@coreIR.com Thank you!