Cns Pharmaceuticals, Inc. · NASDAQ:CNSP
Cns Pharmaceuticals — Investor Presentation (March 2020)
23 slides from Cns Pharmaceuticals's investor presentation, Mar 10, 2020
Slide 1: CNS Pharmaceuticals
www.cnspharma.com 2100 West Loop South, Suite 900 Houston, TX 77027 (800) 946 - 9185 Nasdaq: CNSP
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 candidate, Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center. • Berubicin is an Organ Targeted Therapeutic that appeared to demonstrate one durable Complete Response in a Phase
Slide 4: Investment Highlights
CNS pharmaceuticals 4 Investment Highlights. • Focusing on unmet need as glioblastoma multiforme (GBM) is an aggressive and incurable form of brain cancer - Orphan drug designation opportunity - Upside in additional cancer types • Lead drug candidate developed Dr. Priebe, Professor of Medicinal Chem
Slide 5: Product Development Pipeline
CNS pharmaceuticals 5 Product Development Pipeline. PRODUCT INDICATION RESEARCH PRECLINICAL PHASE 1 PHASE 2 (start) PHASE 2 (complete) Berubicin GBM (U.S., adults) 2020 2022 Berubicin GBM (Poland, 1 trial in adults + 1 trial in children) 2020 2022 Berubicin Pancreatic & ovarian cancers and lymphomas
Slide 6: Berubicin Value Drivers
CNS pharmaceuticals 6 • We have received positive pre - IND guidance from the FDA. • Our clinical drug supply is on - hand and ready for use, per FDA guidance. • We are preparing an IND for filing in Q2 2020. • We plan to initiate a U.S. Phase 2 clinical trial of Berubicin for the treatment of GBM i
Slide 7: About Glioblastoma Multiforme
CNS pharmaceuticals 7 • 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 8: About Anthracyclines
CNS pharmaceuticals 8 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 9: About Berubicin
CNS pharmaceuticals 9 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 cl
Slide 10: Berubicin Phase 1 Clinical Trial
CNS pharmaceuticals 10 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 PRE - TREATMENT A COMPLETE RESPONSE TO BERUBICIN MEANS NO
Slide 11: Berubicin Phase 1 Clinical Trial
CNS pharmaceuticals 11 * 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 12: Planned U.S. Phase 2 Clinical Trial
CNS pharmaceuticals 12 Planned U.S. Phase 2 Clinical Trial. # SITES Up to 6 (10 patients/site/year) # PATIENTS 60 (up to 80 dependent upon screen failures) TIMEFRAME 6 months startup + 1 year recruitment + 1 year follow - up = 2.5 years COST/PATIENT* $70,000 ($5 - $8 million) OTHER COSTS $4 million
Slide 13: Berubicin Supply Ready for U.S. Phase 2 Trial
CNS pharmaceuticals 13 • 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 14: Funding & Clinical Development Partnership
CNS pharmaceuticals 14 Funding & Clinical Development Partnership. CNS ENTERED INTO A $6 MILLION FUNDING AND DEVELOPMENT PARTNERSHIP WITH WPD PHARMACEUTICALS, A POLISH COMPANY AFFILIATED OUR FOUNDER. • The Company granted WPD a sub - license to Berubicin for certain Eastern European territories. • I
Slide 15: Primary & Refractory Market Opportunities
CNS pharmaceuticals 15 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 16: Additional Patient Populations
CNS pharmaceuticals 16 Additional Patient Populations. INDICATION 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 56,500 Anthracycline s
Slide 17: Pipeline: WP1244
CNS pharmaceuticals 17 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 18: Key Catalysts in 2020
CNS pharmaceuticals 18 Key Catalysts in 2020. • Manufacture of clinical trial Berubicin and release 1Q20 • Submit Orphan Drug filing April 2020 • Submit IND for Berubicin 2Q20 • Initiate Phase 2 trial for Berubicin for GBM 3Q20 • Initiate WP1244 preclinical studies 4Q20 • WPD initiates clinical tria
Slide 19: Financial Profile
CNS pharmaceuticals 19 Financial Profile. CNS Pharmaceuticals, Inc. (Nasdaq: CNSP) Cash and Cash Equivalents as of Sept. 30, 2019 • $0.9 million Initial Public Offering Nov. 13, 2019 • $9.8 million in gross proceeds Shares outstanding as of Dec. 20, 2019 • 16.5 million Options and Warrants outstandi
Slide 20: For years Mr. Climaco has served in leadership roles in a variety of healthcare
CNS pharmaceuticals 20 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 21: Founder, Chairman of the Scientific Advisory Board
CNS pharmaceuticals 21 Dr. Waldemar Priebe, Ph.D., 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 The Univ
Slide 22: Board of Directors
CNS pharmaceuticals 22 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 23: CNS Pharmaceuticals contact details
www.cnspharma.com 2100 West Loop South, Suite 900 Houston, TX 77027 (800) 946 - 9185 Nasdaq: CNS
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