CNS Pharmaceuticals, Inc. · NASDAQ:CNSP
CNS Pharmaceuticals — Investor Presentation (February 2025)
23 slides from CNS Pharmaceuticals's investor presentation, February 2025
Slide 1: NASDAQ: CNSP February 2025
NASDAQ: CNSP February 2025 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation incorporates information from materials filed with the SEC and contains forward-looking statements. All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial pos
Slide 3: Overview
Overview Lead Program: Berubicin, a Novel Anthracycline • First drug of its class to appear to cross the blood-brain barrier • A clinical trial designed to be pivotal now fully enrolled • The primary analysis of data in the 1st half of 2025 • No evidence of cardiotoxicity in hundreds of patients • D
Slide 4: A Focused and Targeted CNS Oncology Pipeline
A Focused and Targeted CNS Oncology Pipeline Program Indication Preclinical Phase 1 Phase 2 Phase 3 Highlights • Study fully enrolled Glioblastoma Berubicin Multiforme (GBM) Potentially Pivotal • Primary analysis data expected H1 2025 • Recently in-licensed Glioblastoma • Plan to engage with regulat
Slide 5: Glioblastoma Multiforme (GBM)
Glioblastoma Multiforme (GBM) Most Aggressive, Deadly and Currently Incurable Brain Cancer 12 – 18 MONTHS >50,000 $1B+ New cases in the 8 Major Global annual sales TMZ Average life expectancy1 Only approved first line Markets2 each year3 drug (off patent 12 years) The Blood Brain Barrier Limits the
Slide 6: Berubicin: First-In-Human Trial Design
Berubicin: First-In-Human Trial Design 35 Subjects with recurrent or refractory glioblastoma multiforme (GBM) or other primary brain cancers 29 were GBM, 4 AO and 2 AA DOSE PRIOR THERAPIES Intravenous berubicin over 2 hours for 3 The median number of prior therapies consecutive days (one course) eve
Slide 7: Berubicin: Results of Phase 1 Dose-Finding and PK Study
Berubicin: Results of Phase 1 Dose-Finding and PK Study Complete Response at 6-Month Post Treatment* 44% Two responses with of subjects demonstrated “stable up to 80% tumor shrinkage disease or better” Extremely well DURABLE COMPLETE tolerated with a good RESPONSE (CR) - One safety profile (no off-
Slide 8: Berubicin Primary Analysis from Trial Expected 1st Half 2025
Primary Analysis from Trial Berubicin Expected 1 Half 2025 st Fully Enrolled 45 centers in 5 countries 252 Subjects 252 patients randomized Pivotal endpoint 6-12 months Randomized: 2:1 BERUBICIN LOMUSTINE 168 subjects 84 subjects Announced Independent Data Safety 7.1 mg/m2 IV infusion for 2 hours
Slide 9: Interim Analysis and Rationale
Interim Analysis and Rationale • Independent Data Safety Monitoring Board (DSMB) • Subject matter experts (oncologists, statistician) • Independently oversaw and monitored the clinical trial • Ensured the safety of the patients and the integrity of the data collected • DSMB made informed decisions a
Slide 10: Berubicin: Next Major Milestone
Berubicin: Next Major Milestone Primary Analysis Planned H1 2025 Study Patients on treatment Meeting with FDA to discuss Potential enrollment and in survival follow-up the program based on the approval complete continue unchanged primary analysis 10
Slide 11: A Much Bigger Story beyond GBM
11 A Much Bigger Story beyond GBM EST. U.S. NEW INDICATION PATIENT POPULATION COMMENTS PATIENTS ANNUALLY Primary Brain Tumors Relapsed High Grade 15,000 Existing data in this population Gliomas $2.3B Market in 2022 High Grade Gliomas are the most common malignant brain High Grade Gliomas in Pediatri
Slide 12: Intellectual Property
Intellectual Property Orphan Drug Orphan Drug Designation New gives marketing exclusivity in US market Chemical Entity for 7-years from approval CNS is exploring potential Upcoming filing after final new patent filings covering data in the E.U. for Orphan manufacturing and other Drug Designation may
Slide 13: Commercial Planning
Commercial Planning Key Appointment of Amy Mahery to Board of Directors Commercial Strategy Under Development Focus on Hiring the Right People Medical Affairs/Medical Liaisons Product Launch/Commercialization Specialist 13
Slide 14: TPI 287
TPI 287 Late Stage, Novel Blood Brain Barrier Permeable Abeotaxane for Treatment of Brain Malignancies 14
Slide 15: TPI 287: A Novel Taxane Derivative
TPI 287: A Novel Taxane Derivative • Taxanes • A class of chemotherapy that binds to microtubules and prevents them from breaking down normally, which stops cancer cells from dividing TPI 287 • A substrate for P-glycoprotein (Pgp), which is upregulated in cells that become taxane-resistant, and is p
Slide 16: Readily Penetrates the Blood Brain Barrier in Animal Models
Readily Penetrates the Blood Brain Barrier in Animal Models 16
Slide 17: Clinical Trials with TPI 287
Clinical Trials with TPI 287 ✓ Evaluated in multiple Phase 1 Engaging with regulators to ✓ and Phase 2 studies advance into registrational study Fast Track Orphan Drug Designation ✓ ✓ Designation with 7 years market exclusivity in the U.S. 17
Slide 18: TPI 287 in Combination with Bevacizumab for Recurrent Glioblastoma
TPI 287 in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma Progression-Free Survival Overall Survival Median PFS: 5.5 mo [95% C.I. 4.1, 8.2] 6-month PFS: 40% Median OS: 13.4 mo [95% C.I. 10.9, 17.9] 12-month OS: 64% 18
Slide 19: Improved GBM Survival in Combination with Bevacizumab
Improved GBM Survival in Combination with Bevacizumab * Graphs represent aggregate data from multiple studies 19
Slide 20: Management Team
Management Team John M. Climaco, Esq PRESIDENT & CHIEF EXECUTIVE OFFICER Twenty-one years experience managing the operations, strategies and finances of public and private lifescience companies. Christopher S. Downs, CPA CHIEF FINANCIAL OFFICER Nearly 20 years of finance and investment banking exper
Slide 21: 2025 Milestones
2025 Milestones Contract with Key Berubicin Primary Pediatric Pre-Clinical Transfer of Vendors to Launch Analysis H1 2025 Studies with Berubicin TPI 287 INDs TPI 287 Study Pre-Clinical Studies Meetings with FDA to Final Protocol for TPI 287 Site with Berubicin Review Strategies for TPI 287 Study Ide
Slide 22: Investment Highlights
Investment Highlights Lead Program: Berubicin, a Novel Anthracycline • First drug of its class to appear to cross the blood-brain barrier • A clinical trial designed to be pivotal now fully enrolled • The primary analysis of data in the 1st half of 2025 • No evidence of cardiotoxicity in hundreds of
Slide 23: NASDAQ: CNSP
Investor & Media Relations: JTC Team, LLC NASDAQ: CNSP Jenene Thomas 908.824.0775 [email protected] 23
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