Cns Pharmaceuticals, Inc. · NASDAQ:CNSP
Cns Pharmaceuticals — IPO Roadshow (July 2019)
37 slides from Cns Pharmaceuticals's IPO roadshow presentation, Jul 16, 2019
Slide 1: Issuer Free Writing Prospectus
1 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 232443 Relating to Preliminary Prospectus dated July 16, 2019
Slide 2: Disclaimer
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Disclaimer This presentation incorporates information from a prospectus filed with the SEC for the offering to which this communication relates and contains forward - looking statements . All statements contained herein other than statements of hist
Slide 3: Statement about Free Writing Prospectus
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Statement about Free Writing Prospectus This presentation highlights basic information about us and the offering . Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you
Slide 4: The Offering
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED The Offering Issuer CNS Pharmaceuticals, Inc. Offering Type IPO Price Range $4.00 - $5.00 Shares Offered 2,125,000 Gross Proceeds (midpoint) $9.56 Million Over - allotment 15% Proposed Listing / Symbols Nasdaq Capital Market / “CNSP” Pre - Offering
Slide 5: About Us
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED About Us CNS is a biotechnology company developing novel anticancer drug candidates for the treatment of primary and metastatic brain and central nervous system tumors ● Our lead drug candidate, Berubicin, was developed at the MD Anderson Cancer Cen
Slide 6: Value Drivers
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Value Drivers x We have receiv ed Pre - IND guidance from FDA that our proposed Phase 2 clinical trial plan is reasonable. x Berubicin is poised for Phase 2 clinical trial for treatment of Glioblastoma Multiforme (GBM) ● Currently preparing IND for
Slide 7: Glioblastoma Multiforme (GBM)
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Glioblastoma Multiforme (GBM) There are NO approved curative treatment options for GBM. ● Glioblastoma Multiforme (GBM) is one of the most aggressive and common primary brain cancer in adults. It is highly invasive, malignant, and virtually incurabl
Slide 8: CNS Lead Drug Candidate: Berubicin
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED CNS Lead Drug Candidate: Berubicin ● Berubicin is a novel drug candidate for the treatment of GBM ● 44% of GBM patients enrolled in Phase 1 trial showed a clinically significant response to Berubicin ● One GBM patient from Phase 1 remains cancer - f
Slide 9: A Complete Response in Berubicin Phase 1 Clinical Trial
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED A Complete Response in Berubicin Phase 1 Clinical Trial A “complete response” to treatment means NO SIGNS OF CANCER are visible on MRI*. *This does not always mean the cancer is cured. Also called a complete remission: https://www.cancer.gov/publica
Slide 10: A Complete Response in Berubicin Phase 1 Clinical Trial
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Pre - Treatment 6 Months Post Treatment A Complete Response in Berubicin Phase 1 Clinical Trial A “complete response” to treatment means NO SIGNS OF CANCER are visible on MRI*. *This does not always mean the cancer is cured. Also called a complete r
Slide 11: FDA states CNS may use existing Berubicin supply in Phase 2
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED FDA states CNS may plan to use its existing Berubicin supply in a Phase 2 trial ✓ CNS obtained approximately 110g of Berubicin from Reata, a quantity sufficient to conduct the planned 60 - patient Phase 2 Clinical Trial. ✓ Manufacturing anthracyclin
Slide 12: $6M Funding & Clinical Development Partnership
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED $6M Funding & Clinical Development Partnership CNS entered into a funding and development partnership with WPD Pharmaceuticals, a Polish company affiliated with our founder. ● The Company granted WPD a sub - license to Berubicin for certain Eastern
Slide 13: Blood Brain Barrier
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Blood Brain Barrier ● 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. ● T he same features of the BBB that protect the brain als
Slide 14: Anthracyclines
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Anthracyclines Based on limited clinical data, Berubicin is the first anthracycline that appears to cross the BBB in adults and reach tumor cells in brain cancer patients. ● As a class of drugs, Anthracyclines are among the most effective anti - can
Slide 15: Berubicin
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Berubicin The treatment of GBM with Berubicin is a n ovel use for Anthracyclines, a tried and true drug class. Berubicin was developed to be an Organ Targeted Therapeutic in a multi - step functional analytic process: 1. Design and synthesis of topo
Slide 16: Planned Phase II Clinical Trial
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED 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
Slide 17: Primary and Refractory Market Opportunities
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Primary and Refractory Market Opportunities With no other curative options available, we believe Berubicin may have the potential to become standard of care for GBM and other brain cancers. ● Nearly all of the 40% of patients genetically predisposed
Slide 18: Projected Development Pipeline
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Projected Development Pipeline Indication Research Pre - Clinical Product Glioblastoma 1 Berubicin Pancreatic and Ovarian Cancers, and Lymphomas 2 Berubicin CNS Cancers 3 CNS - 12 Phase 1 2021 Phase 2 (a) 2020 Phase 2 (b) 2022 2020
Slide 19: Management
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Management John M. Climaco, Esq. President & CEO of CNS Pharmaceuticals, Inc. For 16 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
Slide 20: Board of Directors
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Board of Directors Jeff Keyes Chief Financial Officer of Custopharm, Inc. Mr. Jeff Keyes joined our board on June 25, 2018. Mr. Keyes is currently the Chief Financial Officer of Custopharm, Inc., a p riv ate equity backed developer of generic steril
Slide 21: Scientific Advisors
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Scientific Advisors Dr. Waldemar Priebe, PhD Chairman of the Scientific Advisory Board Dr. Waldemar Priebe, PhD, Chairman of the Scientific Advisory Board, is a world renowned medicinal chemist and entrepreneur. Dr. Priebe is a Professor of Medicina
Slide 22: Use of Proceeds
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Use of Proceeds • Commencement of Phase 2 trial for Berubicin; • Other research and development; and • Working capital.
Slide 23: Capitalization
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED CAPITALIZATION Shares Outstanding 13,587,004 Warrants * 3,837,881 Shares underlying convertible debt** 200,000 Vested Options *** 1,464,500 Shares issuable to SAFE Security holders**** 169,611 Fully Diluted 19,258,996 Insider ownership 66.5% * Weigh
Slide 24: Investment Highlights
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Investment Highlights x Unique small cap investment opportunity initially focusing on the treatment of Glioblastoma Multiforme (GBM) • There is currently no curative treatment for GBM x Our lead drug candidate, Berubicin, was developed at MD Anderso
Slide 25: Scientific Data Appendix
m a’ BD PHARMACEUTICALS. ) ——- x Scientiic Data Appendix
Slide 26: Berubicin
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Berubicin Berubicin appears to have the following features based on limited preclinical and clinical data ● High central nervous system uptake ● Broader spectrum of anti - tumor activity ● High activity against different forms of multidrug resistanc
Slide 27: Berubicin Potential Targets for Drug Design
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Berubicin Potential Targets for Drug Design Glioblastomas display constant up - regulation of - Topoisomerase II - MRP1, LRP and P - gp * transporters ABC - transporters are also strongly expressed by normal and neoplastic vessels and are integral p
Slide 28: Guiding Hypothesis in the Development of Berubicin
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Topoisomerase II inhibitors that circumvent P - gp and MRP1 mediated efflux will cross the blood - brain barrier and potently kill glioblastoma cells Guiding Hypothesis in the Development of Berubicin
Slide 29: Functional Domains of DNR and DOX Important for DNA Binding
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED 40% 60% Functional Domains of DNR and DOX Important for DNA Binding
Slide 30: Modular Approach to DNA Binding Agents
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Modular Approach to DNA Binding Agents Molecular “Lego” and Combinatorial Libraries Three Base - pair - binding Module Intercalating Block Minor Groove Binding Block Libraries of Intercalating Blocks Libraries of Minor Groove Binding Blocks Library
Slide 31: MTD Near Current Dose – Toxicities
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Unaudited Data MTD Near Current Dose – Toxicities After 1 Cycle at 9.6 mg/m2 Pat. i.d. DLT Leukopenia/ Neutropenia (White Blood Cells) Thrombo - cytopenia (Platelets) Anemia (Red Blood Cells/ Hemoglobin) Liver Toxicity (SGOT/SGPT) Other Toxicities 1
Slide 32: Patient Examples in Phase I Trial of Berubicin (WP744)
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Patient Examples in Phase I Trial of Berubicin (WP744) Before WP744 After 2 Cycles Patient 119 Achieves Partial Response After 2 Cycles of WP744 at a Dose of 7.5 mg/m 2 /day x 3 52 Year - old female Diagnosed with AO December 2000 Previous treatment
Slide 33: Significant Anti-Tumor Activity Following One Cycle
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Significant Anti - Tumor Activity Following One Cycle at 9.6 Dose Patient 110 June 25 July 5
Slide 34: Significant Anti-Tumor Activity Following One Cycle
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Significant Anti - Tumor Activity Following One Cycle at 9.6 Dose Patient 110 June 25 July 2
Slide 35: Partial Response at 2.4
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Partial Response at 2.4 – Patient 103 Feb 20 (3 weeks) Post - Cycle 2 Dec 28 Baseline Mar 16, Post - Cycle 3
Slide 36: Potential Treatment Populations
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED Potential 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 ce
Slide 37: Toxicity profile of Berubicin
cnspharma.com CONFIDENTIAL – NOT TO BE DISTRIBUTED The toxicity profile of berubicin is consistent with that of other anthracyclines with myelosuppression (lymphopenia, leukopenia, and neutropenia) emerging as the DLT. The MTD of WP744 dosed for the first three days of a 21 - day cycle has been dete