Cervomed Inc. · NASDAQ:CRVO
Cervomed — Diffusion Pharmaceuticals — Investor Presentation (May 2017)
40 slides from Cervomed's investor presentation, May 22, 2017
Slide 1: Forward-Looking Statements
Forward-Looking Statements Diffusio.n Pharmaceuticals inc. This presentation contains forward-looking statements within the meaning of U.S. securities laws that are intended to be covered by the safe harbors created by those laws. These statements include, but may not be limited to, our operating an
Slide 2: Better Treatments for Cancer
Diffusio.n Pharmaceuticals Inc. Better Treatments for Cancer David Kalergis, CEO dkalergis@diffusionpharma.com May 19, 2017 www.diffusionpharma.com
Slide 3: Combating Cellular Oxygen Deprivation to Treat Unmet Medical Needs
Combating Cellular Oxygen Deprivation to _Diffusio.n Treat Unmet Medical Needs Pharmaceuticals inc. First-in-class small molecules that safely re-oxygenate oxygen deprived (hypoxic) tissue by a novel mechanism; acts alone or with other treatments Multiple opportunities in unmet medical needs across
Slide 4: Management & Board of Directors
Management & Board of Directors Diffusio.n Pharmaceuticals inc. Executive Management David Kalergis, JD/MBA -- CEO, Chair & Co- Founder Life sciences serial entrepreneur, former Principal and General Counsel! PRA International John L. Gainer, PhD -- CSO & Co-Founder Professor Emeritus University of
Slide 5: World Class Advisors
World Class Advisors Diffusio.n Pharmaceuticals inc. Diffusion Pharmaceuti Guy M. Chisolm, PhD, SAB Chair Professor, (ret.) Department of Cellular and Molecular Medicine; Vice Chair of Lemer Research Institute at Cleveland Clinic Gene H. Barnett, MD., MBA, FACS Director, Rose Ella Burkhardt Brain Tu
Slide 6: Target Markets
Diffusio.n Pharmaceuticals Inc. Target Markets Hypoxia-related conditions, with an initial focus on oncology
Slide 7: Hypoxia: Cellular Oxygen Deprivation
Hypoxia: Cellular Oxygen Deprivation Diffusio.n Pharmaceuticals inc. Insufficient oxygen supply (“hypoxia”) to the body or a region of the body causes major clinical problems in many life- threatening diseases Hypoxia is an especially critical obstacle in the treatment of cardiovascular and respirat
Slide 8: Hypoxia in Cancer
Hypoxia in Cancer Diffusio.n Pharmaceuticals inc. = Acommon feature of many solid cancers = Caused by tumors outgrowing their blood supply * Through HIF1a up-regulation, hypoxia is associated with many negative effects that lead to aggressive tumor phenotypes — Increased angiogenesis — Increased met
Slide 9: Target Markets: Size and Scope
Target Markets: Size and Scope Diffusio.n Pharmaceuticals inc. Cancers with hypoxia-related treatment-resistance: Glioblastoma Multiforme Worldwide Market $1B + 12,000 Patients in the USA 28,000 Patients worldwide Worldwide Market $3B + Worldwide Market $5B + 49,000 Patients in the USA 170,000 Patie
Slide 10: TSC Technology, Pipeline & Mechanism
Diffusion Pharmaceuticals Inc. TSC Technology, Pipeline & Mechanism
Slide 11: TSC: First-in-Class New Chemical Entity Targeting Hypoxia
TSC: First-in-Class New Chemical Entity Diffusio.n Targeting Hypoxia Pharmaceuticals inc. The Problem: Hypoxia is an TSC is one of a new class of compounds underlying cause of fatality or called Bipolar Trans Carotenoid Salts. morbidity in numerous unmet medical TSC is the most advanced of these nee
Slide 12: Brief History of TSC
Brief History of TSC Diffusio.n Pharmaceuticals inc. New Chemical Entity with Novel Mechanism of Action that Enhances Oxygen Diffusion to Hypoxic Regions in Many Disease Settings v TSC developed at University of Virginia (USA) by Professor John Gainer, Diffusion Pharma’s Co-Founder ¥ Initially devel
Slide 13: TSC's Mechanism of Action
TSC’s Mechanism of Action Diffusio.n Pharmaceuticals inc. = First modern drug compound designed to harness the “cosmotropic” effect to impart systemic therapeutic benefit — When added to an aqueous solution such as blood plasma, cause the aqueous molecules to form more hydrogen bonds with each other
Slide 14: Mechanism of Action Validated
Mechanism of Action Validated Diffusio.n Pharmaceuticals inc. Computer simulation studies demonstrate enhanced diffusion of oxygen In vitro studies demonstrate enhanced hydrogen bonding Direct oxygen measurement in tissue with PET, LICOX, TCOM Hypoxia-related animal models demonstrate improvements i
Slide 15: TSC Reduces Brain Tumor Hypoxia
TSC Reduces Brain Tumor Hypoxia Diffusio.n Allows better results with radiation and chemotherapy Pharmaceuticals ne Same tumor 45 minutes after TSC PET scan showing hypoxia levels in rat brain tumor, before and after TSC.
Slide 16: TSC with Radiation Therapy Triples Survival in Animal Models
TSC with Radiation Therapy Triples Diffusio.n Survival in Animal Models Pharmaceuticals nc Rat glioblastoma cells implanted in rat brains l RT& TSC On day 10, rat brains received radiation therapy TSC increased survival from 28% to 73% Proportion Surviving 00 01 02 03 04 05 06 07 08 09 10 contro! Tu
Slide 17: TSC Enhances Temozolomide
TSC Enhances Temozolomide Diffusio.n Pharmaceuticals inc. Temozolomide (7 mg/kg) Chemotherapy of DMBA, ‘Tumors with and without TSC 1 100 = of Jhigh Dose TSC Day Tumor Volume % Change in Median = In animal models, TSC significantly enhances the effectiveness of chemotherapy with temozolomide, even i
Slide 18: Oncology Clinical Programs
Diffusio.n Pharmaceuticals Inc. Oncology Clinical Programs First Targeting Treatment Resistance in Solid Cancers Using TSC Glioblastoma Multiforme Metastatic Brain Cancer Pancreatic Cancer
Slide 19: TSC in Clinical Trials
TSC in Clinical Trials Diffusio.n Pharmaceuticals inc. About TSC Administered via bolus IV Tested in 148 human subjects in Phase 1 & 2 trials No dose-limiting side effects or serious adverse events reported CMC: Phase 3 scale-up in process FDA: Two open INDs (Cardio- Renal and Oncology) FDA Orphan D
Slide 20: Glioblastoma Market Overview
20 Glioblastoma Market Overview Diffusio.n Pharmaceuticals inc. Life-threatening cancer of glial cells in the brain with an average life expectancy post- diagnosis < 2 years Standard of care is radiation and chemotherapy (temozolomide) One of the most hypoxic cancers, causing significant resistance
Slide 21: Glioblastoma Phase 2 Clinical Trial Successfully Completed
Glioblastoma Phase 2 Clinical Trial Successfully Completed Diffusio.n Pharmaceuticals inc. = 59 newly diagnosed GBM patients enrolled at 18 cancer centers = Open label, historical control study = TSC dosed 3X/week for 6 weeks concurrent with standard radiation and chemotherapy = Patients stratified
Slide 22: Inoperable Strategy
Inoperable Strategy Diffusio.n Pharmaceuticals inc. = Focus resources on a Phase 3 trial requiring the fewest patients with highest chance of success = 380% survival increase in inoperable patients at 2 years is a strong signal, increasing chance of reproducibility = With inoperables identified as a
Slide 23: FDA Interaction and Guidance
FDA Interaction and Guidance Diffusio.n Pharmaceuticals inc. «= GBM End-of-Phase 2 meeting held at FDA headquarters = Single Phase 3 Study could serve as the basis for approval = Extensive Phase 3 trial design guidance received: - Phase 3 study of TSC as first line treatment with radiation/chemo in
Slide 24: Phase 3 GBM Pivotal Trial Design
Phase 3 GBM Pivotal Trial Design Diffusio.n (“Inoperable” Strategy) Pharmaceuticals in. TSC injected immediately prior to chemotherapy DESIGN * Randomized, placebo-controlled + Primary endpoint is overall survival; secondary endpoints are tumor status, performance, Q of L + 230 newly diagnosed inope
Slide 25: Metastatic Brain Cancer
25 Metastatic Brain Cancer Diffusio.n Pharmaceuticals inc. Life-threatening cancer that has metastasized to the brain Average life expectancy post- diagnosis of < 1 year Standard of care is radiation only One of the most hypoxic cancers, causing significant resistance to radiation treatment No appro
Slide 26: Animal Model of Brain Metastases Shows Significant Efficacy
Animal Model of Brain Metastases Shows Diffusio.n Significant Efficacy Pharmaceuticals Inc. At 30 Days | At 45 Days} At 60 Days No Treatment (% Surviving) 0% 0% 0% Radiation Only (% Surviving) 65% 40% 25%* Radiation + TSC (% Surviving) 80% 70% 70%** J Neurosurg 108:972-978, 2008, = Cancer cells impl
Slide 27: Pancreatic Cancer Market Overview
a7 Pancreatic Cancer Market Overview Diffusio.n Pharmaceuticals inc. Life-threatening cancer of the pancreas with an average life expectancy post-diagnosis < 1 year Emerging standard of care is radiation and chemotherapy One of the most hypoxic cancers, causing significant resistance to both radiati
Slide 28: TSC Enhances Gemcitabine and Paclitaxel
TSC Enhances Gemcitabine and Paclitaxel _ Diffusio.n Pharmaceuticals inc. ; 3 3 ‘Change in DMBA Tumors 2 Days After TSC and Gemeitabine (7.5 mg/kg IV) Daye Aterinjecion TSC and 5 mgikg Paclitaxel with DMBA Tumor 300 204 8 200 & is ° In various animal models, TSC significantly enhances the standard-o
Slide 29: Other Indications
Diffusio.n Pharmaceuticals Inc. Other Indications
Slide 30: TSC: Potential Broad Applications Beyond Cancer
TSC: Potential Broad Applications Beyond _Diffusio.n Cancer Pharmaceuticals inc. Pre-clinical data supports TSC as a treatment for other hypoxia- driven conditions such as: = Stroke and myocardial infarction " Peripheral artery disease (PAD) = Neurodegenerative diseases (such as Alzheimer's or Parki
Slide 31: Stroke
Stroke Diffusio.n Pharmaceuticals inc. Stroke is restricted blood flow to the brain, caused by a clot (ischemic) or a bleed (hemorrhagic). The resulting hypoxia drives the destruction of neurons, leading to impairment and death. tPA can only be use in ischemic stroke; can be fatal in hemorrhagic, de
Slide 32: TSC Shows Safety and Efficacy in Ischemic Stroke
TSC Shows Safety and Efficacy Diffusio.n : . Pharmaceuticals Inc. in Ischemic Stroke Ischemic Stroke: Rabbits Soe ss 3 : 2 : Control gees ss 220 @TSC alone SS e2 ri} g , @tPAalone © x2 S OTSC and tPA ss5o 25 0 = 1 3 Time of drug dosing, hours after clot injection 32 SS = statistical significanos Lap
Slide 33: TSC Shows Safety and Efficacy in Hemorrhagic Stroke
33 TSC Shows Safety and Efficacy in Diffusio.n Hemorrhagic Stroke Pharmaceuticals inc. FluoroJade Positive Cells Perihematomal Neuronal Cell Death in Rat Hemorrhagic Stroke Model 412000 10000 “gs ° SS = statistical significance
Slide 34: Business Overview
34 Diffusio.n Pharmaceuticals Inc. Business Overview
Slide 35: Intellectual Property
35 Intellectual Property Diffusio.n Pharmaceuticals inc. = Issued and pending patents cover: - Composition of matter of drug product - Use of TSC for the treatment of cancer in combination with radiation and/or chemotherapy - Treatment of hypoxic conditions including stroke, heart attack, respirator
Slide 36: Upcoming Key Milestones
36 Upcoming Key Milestones Diffusio.n Pharmaceuticals inc. 230 Patient Glioblastoma Multiforme (GBM) Phase 3 2017 — Study Start-up and Begin Treating Patients 2018-2019 — Complete Enrollment 2019 — Interim Data Readout (Potential) 2020 — Complete Study Conduct Data collection, analysis and regulator
Slide 37: Financial Overview
37 Financial Overview Diffusio.n Pharmaceuticals inc. = Total capital invested to date: $88 million = Current cash on hand: $20 million = Became a public entity effective 1/8/2016 through a merger with RestorGenex Corp = Trades as Diffusion Pharmaceuticals Inc. (Ticker: NASDAQ DFFN) = Financials — S
Slide 38: Building Value & Monetizing the Asset
Building Value & Monetizing the Asset Diffusio.n Pharmaceuticals inc. Capital Markets: Institutional PIPE / Secondary Offering Pharma Partners: Possible Partnering of Earlier Assets / Upfront Capital Non-Dilutive Funding: Ability to leverage Grants / Foundations Merger & Acquisition: Strategic Sale
Slide 39: Combating Cellular Oxygen Deprivation to Treat Unmet Medical Needs
Combating Cellular Oxygen Deprivation to _Diffusio.n Treat Unmet Medical Needs Pharmaceuticals inc. « First-in-class small molecules that safely re-oxygenate oxygen deprived (hypoxic) tissue by a novel mechanism; acts alone or with other treatments = Multiple opportunities in unmet medical needs acr
Slide 40: Better Treatments for Cancer
Diffusio.n Pharmaceuticals Inc. Better Treatments for Cancer David Kalergis, CEO dkalergis@diffusionpharma.com May 19, 2017 www.diffusionpharma.com
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