Cns Pharmaceuticals, Inc. · NASDAQ:CNSP
Cns Pharmaceuticals — Investor Presentation (January 2025)
23 slides from Cns Pharmaceuticals's investor presentation, Jan 3, 2025
Slide 1: January 2025
1 NASDAQ: CNSP January 2025
Slide 2: Forward Looking Statements
Forward Looking Statements 2 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
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 1 st half of 2025 • No evidence of cardiotoxicity in hundreds of patients
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 Berubicin Glioblastoma Multiforme (GBM) • Study fully enrolled • Primary analysis data expected H1 2025 TPI 287 Glioblastoma Multiforme (GBM) • Recently in - licensed • Plan to engage with
Slide 5: The Blood Brain Barrier Limits the Ability of Cancer Therapeutics to Gain Access to Brain Tumors
Glioblastoma Multiforme (GBM) The Blood Brain Barrier Limits the Ability of Cancer Therapeutics to Gain Access to Brain Tumors • Passive: Tight junctions protect the brain from harmful substances while allowing essential nutrients to pass through • Active: Efflux transporters actively pump many drug
Slide 6: Berubicin: First-In-Human Trial Design
Berubicin: First - In - Human Trial Design with recurrent or refractory glioblastoma multiforme (GBM) or other primary brain cancers 29 were GBM, 4 AO and 2 AA 35 Subjects DOSE Intravenous berubicin over 2 hours for 3 consecutive days (one course) every 21 days Doses were escalated using an accelera
Slide 7: Berubicin: Results of Phase 1 Dose-Finding and PK Study
Berubicin: Results of Phase 1 Dose - Finding and PK Study 44% of subjects demonstrated “stable disease or better” Two responses with up to 80% tumor shrinkage Extremely well tolerated with a good safety profile (no off - target toxicities) DURABLE COMPLETE RESPONSE (CR) - One subject remains cancer
Slide 8: Primary Analysis from Trial Expected 1st Half 2025
Primary Analysis from Trial Expected 1 st Half 2025 Announced Independent Data Safety Monitoring Board (DSMB) Recommendation on 12/18/23 Continuation of Clinical Trial of Berubicin Without Modification x 45 centers in 5 countries x 252 patients randomized x Pivotal endpoint 6 - 12 months Berubicin F
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 x Study enrollment complete 10 Patients on treatment and in survival follow - up continue unchanged Meeting with FDA to discuss the program based on the primary analysis Potential approval
Slide 11: A Much Bigger Story beyond GBM
A Much Bigger Story beyond GBM 11 COMMENTS EST. U.S. NEW PATIENTS ANNUALLY PATIENT POPULATION INDICATION Existing data in this population 15,000 $2.3B Market in 2022 Relapsed High Grade Gliomas Primary Brain Tumors High Grade Gliomas are the most common malignant brain tumors in children, and repres
Slide 12: Intellectual Property
Intellectual Property Orphan Drug Orphan Drug Designation gives marketing exclusivity in US market for 7 - years from approval 12 Upcoming filing after final data in the E.U. for Orphan Drug Designation may provide 10 - years of protection in Europe CNS is exploring potential new patent filings cove
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: Late Stage, Novel Blood Brain Barrier Permeable Abeotaxane
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 TPI 287 Paclitaxel • Taxanes 15 • A class of chemotherapy that binds to microtubules and prevents them from breaking down normally, which stops cancer cells from dividing • A substrate for P - glycoprotein (Pgp), which is upregulated in cells that become taxane - r
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 and Phase 2 studies Engaging with regulators to advance into registrational study Fast Track Designation Orphan Drug Designation with 7 years market exclusivity in the U.S. ض ض ض ض 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 OS: 13.4 mo [95% C.I. 10.9, 17.9] 12 - month OS: 64% Median PFS: 5.5 mo [95% C.I. 4.1, 8.2] 6 - month PFS: 40% 18
Slide 19: Improved GBM Survival in Combination with Bevacizumab
Improved GBM Survival in Combination with Bevacizumab 19 * Graphs represent aggregate data from multiple studies
Slide 20: Management Team
Management T eam Twenty - one years experience managing the operations, strategies and finances of public and private lifescience companies. PRESIDENT & CHIEF EXECUTIVE OFFICER John M. Climaco, Esq Over 35 years of drug development experience and responsible for the development of Carboplatin, one o
Slide 21: 2025 Milestones
2025 Milestones Berubicin Primary Analysis H1 2025 Pediatric Pre - Clinical Studies with Berubicin Pre - Clinical Studies with Berubicin Meetings with FDA to Review Strategies for Berubicin and TPI 287 Contract with Key Vendors to Launch TPI 287 Study Transfer of TPI 287 INDs TPI 287 Site Identifica
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 1 st half of 2025 • No evidence of cardiotoxicity in hundreds
Slide 23: Investor & Media Relations
23 NASDAQ: CNSP Investor &Media Relations: JTC Team, LLC Jenene Thomas 908.824.0775 CNSP@JTCIR.com
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