Cervomed Inc. · NASDAQ:CRVO
Cervomed — Diffusion Pharmaceuticals — Investor Presentation (January 2017)
45 slides from Cervomed's investor presentation, Jan 27, 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 lavis 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 a
Slide 2: Offering Summary
Offering Summary Diffusio.n Pharmaceuticals inc. ‘Name of Issuer Diffusion Pharmaceuticals Inc. (NasdaqCM: DFFN) Minimum / Maximum $5 million / $15 million (may be increased to $25 million upon DFFN's Offering and Maxim Group's mutual agreement) ‘Type of Security Series A Convertible Preferred Stock
Slide 3: Better Treatments for Cancer
Diffusio.n Pharmaceuticals Inc. Better Treatments for Cancer David Kalergis, CEO [email protected] January 26, 2017 ~~
Slide 4: Combating Cellular Oxygen Deprivation to Treat Unmet Medical Needs
Combating Cellular Oxygen Deprivation to _Diffusio.n Treat Unmet Medical Needs Phamaceitial Ine 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 $ bi
Slide 5: Management & Board of Directors
Management & Board of Directors Diffusio.n Pharmaceuticals inc. Executive vanagement 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 V
Slide 6: World Class Advisors
World Class Advisors Diffusio.n Pharmaceuticals inc. Diffusion Pharmaceuticals’ Scientific Advisory Board Guy M. Chisolm, PhD, SAB Chair Professor, (ret.) Department of Cellular and Molecular Medicine; Vice Chair of Leer Research Institute at Cleveland Clinic Gene H. Barnett, MD., MBA, FACS Director
Slide 7: Hypoxia-related conditions, with an initial focus on oncology
Diffusio.n Pharmaceuticals Inc. Hypoxia-related conditions, with an initial focus on oncology
Slide 8: 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 9: Hypoxia in Cancer
Hypoxia in Cancer Diffusio.n Pharmaceuticals inc. = Acommon feature of many solid cancers = Caused by tumors outgrowing their blood supply * Through HIF 1a up-regulation, hypoxia is associated with many negative effects that lead to aggressive tumor phenotypes — Increased angiogenesis — Increased me
Slide 10: Target Markets: Size and Scope
Target Markets: Size and Scope Diffusion Pharmaceuticals inc. Cancers known to have 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 170,0
Slide 11: China Opportunity
a Opportunity Diffusio.n Pharmaceuticals inc. With increasing incidence and mortality, cancer is the leading cause of death in China and is a major public health problem. 4.3 million new cancer cases in 2015 12,000 newly diagnosed invasive cancer cases per day 2.8 million cancer deaths in 2015. 7,50
Slide 12: Diffusion
Diffusion Pharmaceuticals Inc.
Slide 13: TSC: First-in-Class New Chemical Entity Targeting Hypoxia
TSC: First-in-Class New Chemical Entity Targeting Hypoxia Diffusio.n Pharmaceuticals inc. The Problem: Hypoxia is underlying cause of fatality or morbidity in numerous unmet medical needs The Solution: Oxygen diffusion enhancing compounds that selectively regulates oxygen’s pathway through the body
Slide 14: 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 15: 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 16: 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 17: TSC Reduces Brain Tumor Hypoxia
TSC Reduces Brain Tumor Hypoxia Diffusio.n Allows better results with radiation and chemotherapy Pharmaceuticl tne Same tumor 45 minutes after TSC PET scan showing hypoxia levels in rat brain tumor, before and after TSC.
Slide 18: TSC with Radiation Therapy Triples Survival in Animal Models
18 TSC with Radiation Therapy Triples Diffusio.n Survival in Animal Models Pharmaceuticals inc. Rat glioblastoma cells implanted in rat brains On day 10, rat brains received radiation therapy TSC increased survival from 28% to 73% Tumor remission seen in TSC survivors RTE TSC Bs Ze as i: b= Es 3 con
Slide 19: Oncology Clinical Programs
Diffusio.n Pharmaceuticals Inc. ncology Clinical Programs First Targeting Treatment Resistance in Solid Cancers Using TSC Glioblastoma Multiforme Pancreatic Cancer Metastatic Brain Cancer
Slide 20: TSC in Clinical Trials
TSC in Clinical Trials Diffusio.n Pharmaceuticals inc. Abo sc » Administered via bolus IV Phase 1 & 2 trials * No dose-limiting side effects or = CMC: Phase 3 scale-up in process = FDA: Two open INDs (Cardio- Renal and Oncology) = FDA Orphan Drug Designation granted in multiple indications « Tested
Slide 21: Glioblastoma Market Overview
24 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 22: Glioblastoma Phase 2 Clinical Trial
Glioblastoma Phase 2 Clinical Trial Successfully Completed Diffusio.n Pharmaceuticals inc. a cs = 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 strati
Slide 23: TSC/GBM Trial — Patient
TSC/GBM TRIAL — PATIENT 427 Cavity WHERE RING oF ‘TUMOR WAS REMAINING Removes i TUMOR = POST-OP MRI (MARCH 2013) 1 YEAR FOLLOW-UP MRI (MARCH 2014)
Slide 24: GBM End-of-Phase FDA Meeting
GBM End-of-Phase 2 FDA Meeting Diffusio.n Pharmaceuticals inc. Held August 2015 at FDA headquarters. Single Phase 3 Study could serve as the basis for approval Phase 3 trial design guidance received: - Phase 3 study of TSC as first line treatment with radiation/chemo in 400 newly diagnosed primary b
Slide 25: Phase 3 GBM Pivotal Trial Design
Phase 3 GBM Pivotal Trial Design Diffusio.n Pharmaceuticals inc. TsCinjected TsC injected immediat immediately prior prior to radiation ‘to chemotherapy Randomized, placebo-controlled * Primary endpoint is overall survival; secondary endpoints are tumor status, performance, Q of L = 400 newly diagno
Slide 26: Pancreatic Cancer Market Overview
26 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 27: TSC Enhances Gemcitabine and Paclitaxel
TSC Enhances Gemcitabine and Paclitaxel Diffusio.n Pharmaceuticals inc. Chagein OMBA Ture 2 Days AterTSE and 735 ana 6 mig Pastel wth DMBATumor Ganctabne mah) a0 7g] Fao Pio ie 3 rarer oar Meas ons In various animal models, TSC significantly enhances the standard-of-care chemotherapies used in the t
Slide 28: Pancreatic Cancer Trial Design
Pancreatic Cancer Trial Design Diffusio.n Pharmaceuticals inc. Approval of First Ph. 2 protocol patient dosed | Phase 3 Study (Possible Accelerated Approval Based on | | Results) Study launch First data = Phase 2 study design in pancreatic cancer based on preclinical data and on completed Phase 2 sa
Slide 29: Metastatic Brain Cancer
29 Metastatic Brain Cancer Diffusio,n Pharmaceuticals inc. Life-threatening cancer that has metastasized to the brain Average life expectancy post- diagnosis of < 1 year 000 Patients Worldwide Standard of care is radiation only ~170,000 Patients in the US, One of the most hypoxic cancers, causing si
Slide 30: 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 31: Diffusio.n
Diffusio.n Pharmaceuticals Inc.
Slide 32: 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 Parkin
Slide 33: Stroke
33 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
Slide 34: TSC Shows Safety and Efficacy in Ischemic Stroke
TSC Shows Safety and Efficacy Diffusion in Ischemic Stroke Pharmaceuticals inc Ischemic Stroke: Rabbits foe ss 322, Con oe S253 ss m Control 220 BTSC alone S8&e2 B38 ; BtPAalone Ses DITSC and tPA SZLq Eas = 1 3 Time of drug dosing, hours after clot injection SS = statistical significance Lapchak; Br
Slide 35: TSC Shows Safety and Efficacy in Hemorrhagic Stroke
TSC Shows Safety and Efficacy in Diffusio.n Hemorrhagic Stroke Pharmaceutical nc Perihematomal Neuronal Cell Death in Rat Hemorrhagic Stroke Model 12000 10000 *ss 8000 mControl gTsc FluoroJade Positive Cells 8 3 SS = statistical significance
Slide 36: Peripheral Arterial Disease
36 Peripheral Arterial Disease Diffusio.n Pharmaceuticals inc. Reduced blood flow limits oxygen reaching leg tissue Resulting hypoxia drives cascade of symptoms; pain, limited mobility, amputation, death Very limited treatment options; TSC provides a novel approach Successful Phase 2 study enhanced
Slide 37: Business Overview
Diffusio,n Pharmaceuticals Inc. Business Overview
Slide 38: Intellectual Property
38 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 39: Upcoming Key Milestones
39 Upcoming Key Milestones Diffusio.n Pharmaceuticals inc. Company Funding — 1% Q 2017 Possible Partnering — 2017 400 Patient Glioblastoma Multiforme (GBM) Phase 3 2017 — Study Start-up and Begin Treating Patients 2018-2019 — Complete Enrollment 2019 — Interim Data Readout (Potential) 2020 — Complet
Slide 40: Financial Overview
Financial Overview Diffusio.n Pharmaceuticals inc. = Total capital invested to date: $63 million = Became a public entity effective 1/8/2016 through a merger with RestorGenex Corp = Trades as Diffusion Pharmaceuticals Inc. (Ticker: NASDAQ DFFN) = Financials — See Diffusion 10-Q for Quarter ended 9/3
Slide 41: Recent Transactions and Landscape
a Recent Transactions and Landscape *#" Diffusio.n Pharmaceuticals Inc. Company Status Value Notes Calistoga $600 Million Acquired by Gilead Pharmaceuticals Celator Phase 3ReadOut — $1.5 Billion Acquired by Jazz Clovis Oncology Phase 2/3 $2.7 Billion Mkt Cap Nasdaq: CLVS Acerta Phase 3 ‘$7 Billion A
Slide 42: Building Value & Monetizing the Asset
Building Value & Monetizing the Asset Diffusio.n Pharmaceuticals inc. Capital Mari Institutional Offering Pharma Partners: Possible Partnering of Assets / Upfront Non-Dilutive Funding: Ability to leverage Grants / Foundations Merger & Acquisition: Strategic Sale / Product Sales 42
Slide 43: Combating Cellular Oxygen Deprivation to Treat Unmet Medical Needs
Combating Cellular Oxygen Deprivation to _Diffusio.n Treat Unmet Medical Needs Phamaceitial Ine = 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 44: cour were
cour were
Slide 45: Better Treatments for Cancer
Diffusio.n Pharmaceuticals Inc. Better Treatments for Cancer David Kalergis, CEO [email protected] January 26, 2017 ~~
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