Cns Pharmaceuticals, Inc. · NASDAQ:CNSP
Cns Pharmaceuticals — Investor Presentation (January 2020)
22 slides from Cns Pharmaceuticals's investor presentation, Jan 13, 2020
Slide 1: WWW.CNSPHARMA.COM 2100 West Loop South Suite Houston, TX 77027 (800) 946 - 9185
Nasdaq: CNSP WWW.CNSPHARMA.COM 2100 West Loop South Suite 900 Houston, TX 77027 (800) 946 - 9185
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 • Our lead drug, Berubicin, was developed at the MD Anderson Cancer Center (MDACC) , the world’s largest cancer research facility. • Berubicin is an Organ Targeted Therapeutic that appeared to demonstrate one Durable Complete Response in a Phase 1 human clinical trial.* • We ha
Slide 4: Berubicin value drivers
CNS pharmaceuticals 4 • We have received positive Pre - IND guidance from FDA for our lead compound. • Clinical drug supply on - hand and ready for use per FDA guidance. • Currently preparing IND for filing in Q2 2020. • CNS plans to initiate a Phase 2 clinical trial of Berubicin for treatment of Gl
Slide 5: Glioblastoma Multiforme (GBM)
CNS pharmaceuticals 5 • Glioblastoma Multiforme (GBM) is one of the most aggressive and common primary brain cancer in adults. It is highly invasive, malignant, and virtually incurable. • Nearly 15,000 new GBM patients are diagnosed each year in the US (National Cancer Institute 2015). • With optima
Slide 6: Anthracyclines
CNS pharmaceuticals 6 BERUBICIN IS THE FIRST ANTHRACYCLINE TO CROSS THE BBB IN ADULTS AND REACH TUMOR CELLS IN BRAIN CANCER PATIENTS. • Anthracyclines are among the most effective anti - cancer treatments ever developed. • According to academic literature, Anthracyclines have demonstrated anti - tum
Slide 7: Blood Brain Barrier (BBB)
CNS pharmaceuticals 7 • The Blood Brain Barrier (BBB) is a layer of specialized endothelial cells providing the brain active and passive defense against disease - causing pathogens and toxins. • The same features of the BBB that protect the brain also prevent the vast majority of potential brain can
Slide 8: Berubicin
CNS pharmaceuticals 8 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 clinical
Slide 9: A complete response in Berubicin Phase 1 clinical trial
CNS pharmaceuticals 9 A complete response in Berubicin Phase 1 clinical trial. * This does not always mean the cancer is cured. Also called a complete remission: www.cancer.gov/publications/dictionaries/c anc er - terms/def/complete - response 6 MO. POST - TREATMENT PRE - TREATMENT A “COMPLETE RESPO
Slide 10: A complete response in Berubicin Phase 1 clinical trial
CNS pharmaceuticals 10 A complete response in Berubicin Phase 1 clinical trial. A “COMPLETE RESPONSE” TO TREATMENT MEANS NO SIGNS OF CANCER ARE VISIBLE ON MRI.* A complete response in Berubicin Phase 1 clinical trial. * This does not always mean the cancer is cured. Also called a complete remission:
Slide 11: Planned Phase II clinical trial
CNS pharmaceuticals 11 Planned Phase II clinical trial. # SITES Up to 6 (10 patients/site/year) # PATIENTS 60 (up to 80 dependent upon screen failures) TIMEFRAME 6 months startup, 2 years (1 year recruitment, 1 year follow - up): 2.5 years COST/PATIENT* $70,000 ($5 - $8 MM) OTHER COSTS $4MM ($3 - $5
Slide 12: FDA states CNS may use its existing Berubicin supply in Phase 2 trial
CNS pharmaceuticals 12 • CNS obtained a quantity of Berubicin from Reata (“Batch 1”) sufficient to conduct a majority of the planned 60 - patient Phase 2 Clinical Trial. • On May 1, 2019 FDA notified CNS that “ its planned use of lyophilized drug product [”following reprocessing by recrystallization
Slide 13: $6M Funding & Clinical Development Partnership
CNS pharmaceuticals 13 $6M Funding & Clinical Development Partnership. CNS ENTERED INTO A FUNDING AND DEVELOPMENT PARTNERSHIP WITH WPD PHARMACEUTICALS, A POLISH COMPANY AFFILIATED WITH OUR FOUNDER (“WPD”). • The Company granted WPD a sub - license to Berubicin for certain Eastern European territorie
Slide 14: Primary and refractory market opportunities
CNS pharmaceuticals 14 Primary and 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 2nd line drug treatment for these patients. • In the remaining
Slide 15: Potential additional treatment populations
CNS pharmaceuticals 15 Potential additional treatment populations. INDICATION SPECIFIC PATIENT POPULATION ESTIMATED SIZE 1 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 5
Slide 16: WP1244
CNS pharmaceuticals 16 WP1244 AN ENTIRELY NOVEL CLASS OF DNA BINDING AGENT POTENTIAL THERAPEUTICS.
Slide 17: Proposed Development pipeline
CNS pharmaceuticals 17 Proposed Development pipeline. PRODUCT INDICATION RESEARCH PRE - CLINICAL PHASE 1 PHASE 2 (start) PHASE 2 (complete) Berubicin Glioblastoma 2020 2022 Berubicin Pancreatic and Ovarian Cancers, &Lymphomas 2021 WP1244 CNS tumors 2020
Slide 18: For years Mr. Climaco has served in leadership roles in a variety of healthcare
CNS pharmaceuticals 18 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 19: Dr. Waldemar Priebe, PhD, Chairman of the Scientific Advisory Board, is a world -
CNS pharmaceuticals 19 Dr. Waldemar Priebe, PhD, Chairman of the Scientific Advisory Board, is a world - renowned medicinal chemist and entrepreneur. Dr. Priebe is a Professor of Medicinal Chemistry in the Section of Immunobiology and Drug Carriers in the Department of Bioimmunotherapy at MD Anderso
Slide 20: Board of directors
CNS pharmaceuticals 20 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 21: Investment highlights
CNS pharmaceuticals 21 Investment highlights. • Unique small cap investment opportunity initially focusing on the treatment of Glioblastoma Multiforme (GBM). THERE IS CURRENTLY NO CURATIVE TREATMENT FOR GBM. • Our lead drug candidate, Berubicin, was developed at MD Anderson Cancer Center and has dem
Slide 22: 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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