Cns Pharmaceuticals, Inc. · NASDAQ:CNSP
Cns Pharmaceuticals — IPO Roadshow (October 2019)
39 slides from Cns Pharmaceuticals's IPO roadshow presentation, Oct 10, 2019
Slide 1: Issuer Free Writing Prospectus
Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 232443 Relating to Preliminary Prospectus dated October 7, 2019
Slide 2: Disclaimer
CNS pharmaceuticals 2 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 historical fact, including state
Slide 3: Offering information and SEC statement
CNS pharmaceuticals 3 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 should consider before investing in our company . Except as otherwise
Slide 4: About us
CNS pharmaceuticals 4 • Our lead drug, Berubicin, was developed at the MD Anderson Cancer Center (MDACC) , the world’s largest cancer research facility. • Berubicin appeared to demonstrate one Durable Complete Response in a Phase 1 human clinical trial.* • We have a Collaboration Agreement with Reat
Slide 5: Offering
CNS pharmaceuticals 5 Offering. ISSUER CNS Pharmaceuticals OFFERING TYPE IPO PRICE RANGE $4 - $5 SHARES OFFERED 2,125 ,000 GROSS PROCEEDS (MIDPOINT) $ 9.6 M OVER - ALLOTMENT 15% PROPOSED LISTING / SYMBOLS Nasdaq Capital Market / “CNSP” PRE - OFFERING SHARES OUTSTANDING (PRIMARY) 13.6 Million USE OF
Slide 6: Value drivers
CNS pharmaceuticals 6 • We have received positive Pre - IND guidance from FDA. • Berubicin is poised for a Phase 2 clinical trial for treatment of Glioblastoma Multiforme (GBM). • Currently preparing IND for filing in Q2 2020. • Clinical drug supply on - hand and ready for immediate trial use per FD
Slide 7: Glioblastoma Multiforme (GBM)
CNS pharmaceuticals 7 • 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 8: Berubicin
CNS pharmaceuticals 8 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 - free 10 years after treatment with Berubicin. • Beru
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/cancer - terms/def/complete - response 6 MO. POST - TREATMENT PRE - TREATMENT A “COMPLETE RESPONS
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: FDA states CNS may plan to use its existing Berubicin supply in a Phase 2 trial
CNS pharmaceuticals 11 • 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 12: Blood Brain Barrier (BBB)
CNS pharmaceuticals 12 • 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 ca
Slide 13: Anthracyclines
CNS pharmaceuticals 13 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 - tu
Slide 14: $6M Funding & Clinical Development Partnership
CNS pharmaceuticals 14 $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 15: Planned Phase II clinical trial
CNS pharmaceuticals 15 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 16: Berubicin: novel use for a tried and true therapeutic class
CNS pharmaceuticals 16 Berubicin. NOVEL USE FOR A TRIED AND TRUE THERAPEUTIC CLASS. Berubicin was developed in a multi - step functional analytic process: • Design and synthesis of topoisomerase II inhibitors using modular approach to DNA binding agents. • Identification of agents circumventing ABC
Slide 17: Primary and refractory market opportunities
CNS pharmaceuticals 17 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 18: Proposed Development pipeline
CNS pharmaceuticals 18 Proposed Development pipeline. PRODUCT INDICATION RESEARCH PRE - CLINICAL PHASE 1 PHASE 2 (A) PHASE 2 (B) Berubicin Glioblastoma 2020 2022 Berubicin Pancreatic and Ovarian Cancers, &Lymphomas 2021 CNS - 12 CNS Cancers 2020 2021
Slide 19: Management team
CNS pharmaceuticals 19 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 20: Chief financial officer
CNS pharmaceuticals 20 Mr. Downs will begin to serve as our chief financial officer upon the closing of this offering. From March 2018 until Septemb er 2019, Mr. Downs served as vice president of finance and treasurer of Innovative Aftermarket Systems, L.P., a privately held provider of finance and
Slide 21: Board of directors
CNS pharmaceuticals 21 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 22: Scientific Advisory Board
CNS pharmaceuticals 22 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 23: Use of proceeds
CNS pharmaceuticals 23 Use of proceeds. COMMENCEMENT OF PHASE 2 TRIAL FOR BERUBICIN OTHER RESEARCH & DEVELOPMENT WORKING CAPITAL
Slide 24: Capitalization
CNS pharmaceuticals 24 Capitalization. SHARES OUTSTANDING 13,587,004 WARRANTS * 3,837,881 SHARES UNDERLYING CONVERTIBLE DEBT ** 200,000 OPTIONS *** 1,564,500 SHARES ISSUABLE TO SAFE SECURITY HOLDERS **** 169,611 FULLY DILUTED 19,358,996 INSIDER OWNERSHIP 66.5% * Weighted average exercise price of $3
Slide 25: Investment highlights
CNS pharmaceuticals 25 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 26: Scientific Appendix
SCIENTIFIC APPENDIX. CNS PHARMACEUTICALS
Slide 27: Berubicin features
CNS pharmaceuticals 27 • High central nervous system uptake. • Broader spectrum of anti - tumor activity. • High activity against different forms of multidrug resistance. • Potent inducer of apoptosis in tumors cells. • Low cytotoxicity and apoptotic potential in normal cells. • Consistent activity
Slide 28: Potential targets for drug design
CNS pharmaceuticals 28 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 an integral part of the blood - br
Slide 29: Guiding hypothesis in the development of Berubicin
CNS pharmaceuticals 29 Guiding hypothesis in the development of Berubicin. • NTopoisomerase II inhibitors that; • Circumvent P - gp and MRP1 mediated efflux; • Will cross the blood - brain barrier; and • Potently kill glioblastoma cells.
Slide 30: Functional domains of DNR & DOX important for DNA binding
CNS pharmaceuticals 30 Functional domains of DNR & DOX important for DNA binding.
Slide 31: Modular approach to DNA binding agents
CNS pharmaceuticals 31 Modular approach to DNA binding agents. Three base - pair - binding module Minor groove binding block Intercalating block Library of TOPO II poisons crossing BBB Libraries of intercalating blocks Libraries of minor groove binding blocks
Slide 32: MTD near current dose - toxicities
CNS pharmaceuticals 32 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 107 No Grade 2 / Grade 2 Grade 2 Decreased /
Slide 33: Patient examples in Phase I trial of Berubicin (WP744)
CNS pharmaceuticals 33 Patient examples in Phase I trial of Berubicin (WP744). PATIENT 119 ACHIEVES PARTIAL RESPONSE AFTER 2 CYCLES OF WP744 AT A DOSE OF 7.5 MG/M2/DAY X 3. • 52 Year - old female. • Diagnosed with AO December 2000. • 81% reduction in lesion. • Previous treatments include resection,
Slide 34: Significant anti-tumor activity following one cycle at 9.6 dose - patient 110
CNS pharmaceuticals 34 Significant anti - tumor activity following one cycle at 9.6 dose - patient 110. JUNE 25 JULY 5
Slide 35: Significant anti-tumor activity following one cycle at 9.6 dose - patient 110
CNS pharmaceuticals 35 Significant anti - tumor activity following one cycle at 9.6 dose - patient 110. JUNE 25 JULY 5
Slide 36: Partial response at 2.4 - patient 103
CNS pharmaceuticals 36 Partial response at 2.4 - patient 103. DEC 28: BASELINE FEB 20 (3wk): POST - CYCLE 2 MAR 16: POST - CYCLE 3
Slide 37: Potential treatment populations
CNS pharmaceuticals 37 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 Cell Lung Cancer 56,500 Anthr
Slide 38: Toxicity profile and Phase 1 summary
CNS pharmaceuticals 38 The toxicity profile of Berubicin is consistent with that of other anthracyclines with myelosuppression (lymphopenia, leukope nia , and neutropenia) emerging as the DLT. The MTD of Berubicin dosed for the first three days of a 21 - day cycle has been determined as 7.5 mg/m2. B
Slide 39: CNS Pharmaceuticals contact details
WWW.CNSPHARMA.COM 2100 West Loop South Suite 900 Houston, TX 77027 (800) 946 - 9185