Ensysce Biosciences, Inc. · NASDAQ:ENSC
Ensysce Biosciences — Investor Presentation (November 2009)
26 slides from Ensysce Biosciences's investor presentation, Nov 10, 2009
Slide 1: Ensysce Biosciences Presentation, Nov. 10, 2009
CEO www.ensysce.com Nov. 10, 2009
Slide 2: Company mission: carbon nanotube therapeutics
• To develop fullerene carbon nanotubes (FNT) for therapeuCc applicaCons – For delivery of cancer therapeuCcs – For delivery of macromolecules i.e. siRNA – For delivery of alpha emiGng material • To bring carbon nanotube therapeuCcs into clinical development
Slide 3: SWCNT delivery of siRNA for cancer treatment
• Single-‐walled Carbon Nanotube (SWCNT) delivery of siRNA for the treatment of Cancer – siRNA is a leading new potenCal therapeuCc for cancer treatment but lacks adequate delivery mechanisms – Texas has been the leader in SWCNT development and Ensysce now has a dominant IP posiCon to exploit their
Slide 4: Management team
• Dr. Bob Gower, Chairman – Founder of Ensysce – Co-‐founder with Dr. Rick Smalley of Carbon Nanotechnologies Inc. • Dr. D. Lynn Kirkpatrick, President and CEO – Professor of Chemistry/Biochemistry 1983-‐2001; – Co-‐founder & CEO of ProlX PharmaceuCcals 1999-‐2006; merged with Biomira 2006 – CSO
Slide 5: Medical consultant and scientific advisors
• Ann M. Lowe, MD, Medical Consultant – Physician at San Francisco General Hospital; Clinical Research at Genentech. – Physician &Medical Director at Becton Dickinson, Syntex and Scios Nova. – Designed and implemented Phase 1-‐111 clinical trials of small molecule/biological agents. – Interacted wi
Slide 6: Sponsored research and Nanotechnology Characterization Lab
• Sponsored Research – Rice University – University of Texas MD Anderson Cancer Center – Stanford University • Nanotechnology CharacterizaCon Lab – The NCL is a naConal resource and knowledge base to facilitate the development and translaCon of nanoscale parCcles for clinical applicaCons. • National
Slide 7: Exclusive worldwide licenses to FNT patents
• Exclusive Worldwide licenses to patents essenCal for therapeuCc applicaCons of FNT (including SWCNT) – U.S.P. 7,195,780 and foreign applicaCons “NanoparCcle Delivery System” from University of Florida Research FoundaCon – U.S.P 6,576,341 “ComposiCon” of FNT with coiling structures from Trinity Col
Slide 8: Worldwide license to broad patent portfolio
• Worldwide license to broad patent poriolio criCcal for use of FNT in therapeuCcs – Includes non–exclusive license to industry leading poriolio developed at Rice – Over 100 patents and patent applicaCons – Over 2100 claims; incl. over 400 COM
Slide 9: Rights to license patents from sponsored research
• Rights to license, exclusively and non-‐ exclusively, patents based on sponsored research at leading Texas and US InsCtutes – MDACC – Rice – Rice/Sloan Ke`ering – Stanford
Slide 10: Strategy: development and partnering
• To move SWCNT therapeuCc products through development into clinical trials • To partner with companies who require delivery technology • To partner with Pharma to aid late stage clinical development of Ensysce products
Slide 11: Ensysce collaborations and capabilities
ENSYSCE COLLABORATIONS & CAPABILITIES PHYSICAL ANALYSES MOLECULAR BIOLOGY RICE UNIVERSITY + @ STANFORD @@ IN VIVO ANALYSIS MD ANDERSON @@@ ENSYSCE @@ éce-cunica\ CLINICAL DRUG DEVELOPMENT & Ensysce
Slide 12: Benefits of nanotube delivery
• Improve solubility • Reduce toxicity to normal Cssue • Assist cell membrane penetraCon • Biologically inert structure • Large surface for chemical modificaCon • Easily penetrate cell membranes
Slide 13: SWCNT Cancer Therapeutics siRNA
SWCNT Cancer Therapeutics siRNA
Slide 14: siRNA therapeutics and alpha emitters
siRNA Therapeu.cs Alpha emi2ers HIF-‐1α (ENS-‐318) Doxorubicin AcCnium VEGF planned Taxol AstaCne WNT planned PlaCnumIV planned EGFR planned AnCbody targeted planned HER2 planned
Slide 15: SWCNT linked to paclitaxel and doxorubicin
SWCNT covalently linked to Paclitaxel SWCNT associated with Doxorubicin
Slide 16: siRNA promise and delivery challenge
• Promising novel targeted therapeuCc enCCes • Can silence cancer causing genes without toxicity to normal Cssue • Will not penetrate cell membrane easily without delivery technology and broken down in plasma • Current delivery technology have limited efficacy and toxicity issues
Slide 17: SWCNT/siRNA solubilization, cell entry and biological effects
siRNA can solubilize SWCNT SWCNT/siRNA can enter cells SWCNT/siRNA can produce biological effects in cell and in animals
Slide 18: Healthy versus tumor vasculature
Healthy vasculature is Abnormal vasculature like that found characterized by orderly in a tumor is newly formed, highly architecture and mature blood fractured and architecturally vessels (in green at right) that are disordered with fragile, immature stabilized and supported externally blood vessels
Slide 19: siRNA alone versus siRNA on SWNT
Length: 100mm siRNA alone penetrate cell membrane No Protein siRNA on SWNT penetrate cell membrane Ensysce “biosciences
Slide 20: Development pipeline: ENS-318, ENS-DOX, ENS-PTX
Agent Preclinical IND Phase I Phase II Phase III ENS-‐ 318 Renal cancer ENS-‐ 318 Ovarian cancer ENS-‐ 318 Lung cancer ENS-‐ 318 Head and neck cancer ENS-‐DOX ENS-‐PTX
Slide 21: ENS-318 preclinical development steps
• ENS-‐318 Preclinical development – Lead opCmizaCon – IND enabling toxicology studies – GMP manufacture of drug substance and product – Clinical Protocol development – IND preparaCon and submission – Phase I clinical trial iniCaCon
Slide 22: Clinical timeline and market potential
• Phase 1 clinical trial to initiate in 18 to 24 months, 12 months to complete • Phase 2 clinical trial 18 to 30 month to complete • Phase 3 clinical trial 24 to 36 months to complete • Regulatory filing 12 months • Marketing launch to commercialization in renal cancer 2019 • small indication of 50,
Slide 23: Competition
• Many companies are developing delivery technology for therapeuCcs • Biotech and pharma companies that are developing cancer therapies • siRNA companies that may target the same protein such as HIF
Slide 24: Competitive advantages
• Leading posiCon with IP related FNT composiCon and use • Leading posiCon for use of FNTs for delivery of drugs, macromolecules, radionucleides • In posiCon to partner with both pharma and biotech companies that require delivery of macromolecular therapies
Slide 25: Summary: two-fold approach
• Ensysce has two fold approach developing its own therapeuCc products and a plaiorm delivery system • Delivery of siRNA being sought by pharma for cancer and other indicaCons • Ensysce has extensive IP posiCon for use of FNT for therapeuCc applicaCons and Proof of Principal studies for the use of S
Slide 26: Contact
• www.ensysce.com • lkirkpatrick@ensysce.com
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