Cns Pharmaceuticals, Inc. · NASDAQ:CNSP
Cns Pharmaceuticals — Investor Presentation (February 2021)
26 slides from Cns Pharmaceuticals's investor presentation, Feb 25, 2021
Slide 1: CNS Pharmaceuticals Investor Presentation February 2021
www.cnspharma.com 2100 West Loop South, Suite 900 Houston, TX 77027 (800) 946 - 9185 Nasdaq: CNSP FEBRUARY 2021
Slide 2: Disclaimer
CNS pharmaceuticals 2 Disclaimer. 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 fin
Slide 3: About Us
CNS pharmaceuticals 3 A bout Us . CNS IS DEVELOPING NOVEL ANTI - CANCER DRUG CANDIDATES FOR THE TREATMENT OF PRIMARY AND METASTATIC BRAIN CENTRAL NERVOUS SYSTEM CANCERS. * A “complete response” to treatment means no signs of cancer are visible on MRI. This does not always mean the cancer is cur ed.
Slide 4: Investment Highlights
CNS pharmaceuticals 4 Investment Highlights. • Focusing on unmet need as glioblastoma multiforme (GBM) is the most common and aggressive form of brain cancer - IND approved on December 16, 2020 - Orphan drug designation for malignant gliomas received in June 2020 - Upside in additional cancer types
Slide 5: Product Development Pipeline
CNS pharmaceuticals 5 PRODUCT SPONSOR INDICATION RESEARCH PRECLINICAL PHASE 1 PHASE 2 Berubicin CNS GBM (U.S., adults) Q1 2021 Berubicin WPD GBM (Poland, adults) Q2 2021 Berubicin WPD GBM (Poland, pediatric) 2H 2021 Berubicin CNS CNS Lymphoma, Metastatic Lung & Breast 2021 - 2022 WP1244 CNS CNS tumo
Slide 6: About Glioblastoma Multiforme
CNS pharmaceuticals 6 • GBM is one of the most aggressive and common primary brain cancers in adults; it is highly invasive, malignant and virtually incurable. • Nearly 15,000 new GBM patients are diagnosed each year in the U.S. (National Cancer Institute 2015). • With optimal therapy (surgical rese
Slide 7: About Anthracyclines
CNS pharmaceuticals 7 BERUBICIN IS THE FIRST ANTHRACYCLINE TO CROSS THE BLOOD - BRAIN BARRIER IN ADULTS AND REACH TUMOR CELLS IN PATIENTS WITH BRAIN CANCER. • Anthracyclines are among the most effective anti - cancer treatments ever developed. • According to academic literature, anthracyclines have
Slide 8: About Berubicin
CNS pharmaceuticals 8 About Berubicin. • Berubicin is a novel anthracycline drug candidate for the treatment of GBM. • Berubicin is an Organ Targeted Therapeutic designed to concentrate in the brain and specifically in tumor tissue therein. • 44% of GBM patients enrolled in Phase 1 trial showed a “s
Slide 9: Berubicin Phase 1 Clinical Trial
CNS pharmaceuticals 9 Berubicin Phase 1 Clinical Trial. * This does not always mean the cancer is cured. Also called a complete remission: www.cancer.gov/publications/dictionaries/cancer - terms/def/complete - response 6 MO. POST - TREATMENT A COMPLETE RESPONSE TO BERUBICIN MEANS NO SIGNS OF CANCER
Slide 10: Berubicin Phase 1 Clinical Trial
CNS pharmaceuticals 10 * This does not always mean the cancer is cured. Also called a complete remission: www.cancer.gov/publications/dictionaries/cancer - terms/def/complete - response PRE - TREATMENT 6 MO. POST - TREATMENT Berubicin Phase 1 Clinical Trial. A COMPLETE RESPONSE TO BERUBICIN MEANS NO
Slide 11: Funding & Clinical Development Partnership
CNS pharmaceuticals 11 Funding & Clinical Development Partnership. CNS TO RECEIVE THE BENEFIT OF $6 MILLION OF FUNDING FROM DEVELOPMENT PARTNERSHIP WITH WPD PHARMACEUTICALS, A POLISH COMPANY AFFILIATED OUR FOUNDER. • The Company granted WPD a sub - license to Berubicin for certain Eastern European t
Slide 12: Berubicin Clinical Drug Supply for U.S. Phase 2 Trial
CNS pharmaceuticals 12 • CNS has implemented a dual - track drug product manufacturing strategy and engaged U.S. - based Pharmaceutics International, Inc. (" Pii ") and Italy - based BSP Pharmaceuticals S.p.A. ("BSP") for the production of Berubicin. • By engaging two separate manufacturers on two s
Slide 13: Overview of Phase 2 Clinical Trial of Berubicin
CNS pharmaceuticals 13 Overview of Phase 2 Clinical Trial of Berubicin. • The CNS Phase 2 trial of Berubicin in adults is designed to be: • Adaptive : a trial design that allows for modifications to aspects of the design based on accumulating data from trial subjects • Randomized : randomly assigns
Slide 14: Berubicin Phase 2 Trial Design
CNS pharmaceuticals 14 Berubicin Phase 2 Trial Design. A Multicenter, Open - Label Study with a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard Fi
Slide 15: Berubicin Phase 2 Trial Design (cont'd)
CNS pharmaceuticals 15 Berubicin Phase 2 Trial Design (cont’d). Study Drugs Berubicin: Intravenously infused will be administered at a dose of 7.1 mg/m2 as free base (equivalent to 7.5 mg/m2 berubicin HCl) as a 2 - hour intravenous (IV) infusion for 3 consecutive days (q3d) followed by 18 days off s
Slide 16: Berubicin Phase 2 Trial Design (cont'd)
CNS pharmaceuticals 16 Berubicin Phase 2 Trial Design (cont’d). Objectives/Endpoints Primary Objective: Overall Survival (OS) Secondary Objective: Duration of Response ( DoR ) Objective Response Rate (ORR) Individual components of the ORR (CR/PR) Progression Free Survival at 6 Mon. (PFS6) Disease Co
Slide 17: Berubicin Value Drivers
CNS pharmaceuticals 17 • Positive pre - IND guidance from FDA on Phase 2 study design and drug supply • Clinical drug supply of Berubicin is complete via a redundant manufacturing strategy with production in the US and in Europe. • FDA approval of the IND application in Q4 2020. • Randomized and con
Slide 18: Primary & Refractory Market Opportunities
CNS pharmaceuticals 18 Primary & Refractory Market Opportunities. • Nearly all of the 40% of patients genetically predisposed to respond to temozolomide (TMZ) may become quickly become resistant; we believe Berubicin could be used as a second - line drug treatment for these patients. • In the remain
Slide 19: Additional Patient Populations
CNS pharmaceuticals 19 Additional Patient Populations. INDICATION PATIENT POPULATION ESTIMATED SIZE COMMENTS Primary Brain Tumors Relapsed High Grade Gliomas 15,000 Existing data in this population. Brain Metastases - Combination with Radiation Therapy Small Cell Lung Cancer 56,500 Anthracycline sen
Slide 20: Pipeline: WP1244
CNS pharmaceuticals 20 Pipeline: WP1244. • Licensed from The University of Texas MD Anderson Cancer Center • Developed in the Department of Experimental Therapeutics as a collaborative effort with the Neuro - Oncology Department and Pharmaceutical Development Center. • Designed using anthracycline a
Slide 21: Recent Accomplishments & Near Term Key Catalysts
CNS pharmaceuticals 21 Recent Accomplishments & Near Term Key Catalysts. x Orphan Drug Designation June 2020 x IND Approval for Berubicin Dec. 2020 • Initiate Potentially Pivotal US Phase 2 Berubicin trial for GBM 1Q 2021 • WPD initiates clinical trials in Poland Adults: Phase 2 Q2 2021 Pediatrics:
Slide 22: Financial Profile
CNS pharmaceuticals 22 Financial Profile. CNS Pharmaceuticals, Inc. (Nasdaq: CNSP) Cash and Cash Equivalents as of December 31, 2020 • $14.0 million Shares outstanding as of December 31, 2020 • 23.9 million Options and Warrants outstanding as of December 31, 2020 • 6.9 million warrants at a WAEP of
Slide 23: For years Mr. Climaco has served in leadership roles in a variety of healthcare
CNS pharmaceuticals 23 For 15 years Mr. Climaco has served in leadership roles in a variety of healthcare companies. Recently Mr. Climaco served as the Executive Vice - President of Perma - Fix Medical S.A where he managed the development of a novel method to produce Technitium - 99. Previously Mr.
Slide 24: Dr. Waldemar Priebe, Chairman of the Scientific Advisory Board
CNS pharmaceuticals 24 Dr. Waldemar Priebe, Ph.D., Chairman of the Scientific Advisory Board, is a world - renowned medicinal chemist and entrepreneur. D r. Priebe is a Professor of Medicinal Chemistry in the Section of Immunobiology and Drug Carriers in the Department of Bioimmunotherapy at The Uni
Slide 25: Board of Directors
CNS pharmaceuticals 25 board of directors Mr. Jeff Keyes joined our board on June 25, 2018. Mr. Keyes is currently the CFO of Custopharm, Inc., a private equity backed de veloper of generic sterile injectable pharmaceuticals, a role he has held since April 2018. From September 2012 to April 2018, Mr
Slide 26: www.cnspharma.com 2100 West Loop South, Suite Houston, TX 77027 (800) 946 - 9185
www.cnspharma.com 2100 West Loop South, Suite 900 Houston, TX 77027 (800) 946 - 9185 Nasdaq: CNSP
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