Navidea Biopharmaceuticals, Inc. · OTC:NAVBQ
Navidea Biopharmaceuticals — Investor Presentation (August 2020)
36 slides from Navidea Biopharmaceuticals's investor presentation, Aug 10, 2020
Slide 1: Investor Presentation August 2020
Navidea> BIOPHARMACEUTICALS Investor Presentation August 2020 Navidea Biopharmaceuticals, Inc. 2020 All Rights Reserved
Slide 2: Disclaimer
Disclaimer The private securities litigation reform act of 1995 (the act) provides a safe harbor for forward-looking statements made by or on behalf of the company. Statements in this presentation, which relate to other than strictly historical facts, such as statements about the Company's plans and
Slide 3: Precision immuno-diagnostics and therapeutics company
We are a precision immuno-diagnostics and therapeutics company focused on solving the many problems presented by inflammatory conditions We are leveraging our platform technology to create a robust pipeline of immuno-diagnostics and immuno-therapeutics Navidea> 'IOPHARMACEUTICALS
Slide 4: Corporate Overview
Corporate Overview A precision immuno-diagnostics company focused on inflammatory diseases 1. Building off FDA/EMA-approved diagnostic prod! mphoseek: netum Te 99m timanocept nection 2. Non-invasive imaging targeting CD206 receptors on Activated Macrophages 3. Initial focus on personalized Rheumatoi
Slide 5: Our Diagnostic and Therapeutics Pipeline
Our Diagnostic and Therapeutics Pipeline = = | Solid T hati jing, Sentinal Node Biopsy Dx (tymphozeck™ old Tumors, Lymphatic Monpine, Comins cde Bote U tea ad SoldtoCardinal _Navidea Seeking Partner Rheumatoid Arthritis Dx a cinding MOU Signed with Jubilant Cardiovascular Diseases Dx Planning Phase
Slide 6: Our Core Tilmanocept Technology
Our Core Tilmanocept Technology Targeted Binding to Activated Macrophages Structural Backbo D206 Targeting Moiety Best-in-class CD206 affinity allows sensitive detection of all types of activated macrophages in vivo Radio Label Disease agnostic provides robust pipeline beyond RA FDA/EMA approved (fa
Slide 7: The Tilmanocept Difference (Diagnostics)
The Tilmanocept Difference (Diagnostics) Manocept™ Key Differentiator Target ‘Activated Macrophages Highly: specifictarget correlated to active inflammatory response Able to penetrate circulating and deep Molecular Weight ~2-20kilo-daltons tissue macrophages while maintaining industry leading specif
Slide 8: Why Focus on Rheumatoid Arthritis?
Why Focus on Rheumatoid Arthritis? Patients in the US $39 billion drag to 20-50% of patients RA is the 2nd are living with RA the US Economy respond adequately largest drug to any RA treatment category globally Navidea Biopharmaceuticals, Inc. 8
Slide 9: Why are Current Dx & Treatment Paradigms Failing?
Why are Current Dx & Treatment Paradigms Failing? 1 . Measurement of treatment response relies on subjective assessments. oy Lack of biomarkers to guide treatment selection and/or monitor response 3. Development of tolerance to current therapies! (1) Sidrepoutos PL Boumpas OT Dieretia drug resistanc
Slide 10: Our Solution and Value Proposition
Our Solution and Value Proposition Quantitative Imaging of Activated Macrophages in Rheumatoid Arthritis Patients 1 . Increasing evidence of the role of activated macrophages in therapy response. 2. Selecting most appropriate treatment modality for patients based upon pathotype. 3. Convenient safe,
Slide 11: What the Experts Think
What the Experts Think (KOL Testimonials) “Tilmamocept not only provides the “If had a tool that could give me early ‘opportunity to objectively measure and information regarding how my patient follow RA disease activity in my is responding to treatment, or not patients’ joints, but it also may resp
Slide 12: Our First Rheumatoid Arthritis Indication
Our First Rheumatoid Arthritis Indication Quantitative Imaging with Tc 99m Tilmanocept for candidates of Anti-TNF Therapy Choosing an Effective Therapy: Imaging before treatment —— LABEL Early Indication of Treatment Effectiveness: Imaging shortly after initiation of a new Rx Objective Therapy Monit
Slide 13: Tilmanocept Detects and Quantifies Disease Burden
Tilmanocept Detects and Quantifies Disease Burden by Detecting Activated Macrophages Activated Macrophages ‘ Navidea Biopharmaceuticals, Inc. 13
Slide 14: Activated Macrophages are Typically Present in RA Joints
Activated Macrophages are Typically Present in RA Joints Normal Joint RA Joint
Slide 15: Tilmanocept consistently localizes in areas of macrophage driven inflammation
Tilmanocept consistently localizes in areas of macrophage driven inflammation* Healthy Control Joint RA Joint RA Patient Day 0 RA Patient Day 8 MM} Patient exhibited reproducible localization cover a 1 week period Navidea Biopharmaceuticals, Inc. 5 *Select images from NAV3-31 Trial
Slide 16: Activated Macrophages are Important in RA Joints
Activated Macrophages are Important in RA Joints EXTENDED REPORT Synovial tissue macrophages: a sensitive biomarker © Srl ela wl cles cerns eel lier cea as Slt for response to treatment in patients with rheumatoid radiographic progression in early sheumatoid arthritis pea Perr ce see montmmeniarnans
Slide 17: Our Core Tilmanocept Technology
Our Core Tilmanocept Technology Targeted Binding to Activated Macrophages Structural Backbo D206 Targeting Moiety Best-in-class CD206 affinity allows sensitive detection of all types of activated macrophages in vivo Radio Label Disease agnostic provides robust pipeline beyond RA FDA/EMA approved (fa
Slide 18: The Tilmanocept Difference (Diagnostics)
The Tilmanocept Difference (Diagnostics) Manocept™ Key Differentiator Target ‘Activated Macrophages Highly: specifictarget correlated to active inflammatory response Able to penetrate circulating and deep Molecular Weight ~2-20kilo-daltons tissue macrophages while maintaining industry leading specif
Slide 19: Tilmanocept Localization
Tilmanocept Localization Objective Diagnostic Scoring Tilmanocept localization to joints in patients with active RA These images are quantified for determination of macrophage disease activity Navidea Biopharmaceuticals, Inc. 3D SPECT/CT-Orange/green areas show high RA inflammation 2D Planar- Darker
Slide 20: Tilmanocept Localization
Tilmanocept Localization UF =p I 1. Rheumatologist 2. Radiologist Orders Imaging . Acquires Quang; "itaty, Im, '2gin, 19 4. Report informs: + The Likely Efficacy of Anti-TNF Rx + Early Indication of Effectiveness of Anti-TNF Rx 3. Images Analyzed + Monitoring Treatment Efficacy by Navidea’s Core Nav
Slide 21: US RA Market Opportunity is Large & Untapped
US RA Market Opportunity is Large & Untapped Includes: (1) Initial label, (2) Early detection of RA Potential with (3) Therapy-indiscriminate treatment Expanded Label response $>1 bn Quantitative imaging with Tc 99m Tilmanocept for candidates of anti-TNF therapy a Navidea Biopharmaceuticals, Inc.
Slide 22: Joint trial designs under discussion
NO - JOING < ‘Speci tol designs are under discussion aceuticals, Inc. a Biopharn
Slide 23: Encouraging interim analyses of NAV3-31
Encouraging interim analyses of NAV3-31 Overview of 3 arm phase 2B Trial for our Rheumatoid Arthritis Diagnostic Goal confirm the repeatability, reproducibility, and stability of Te 99m tilmanocept imaging and further establish the quantitative determinants of healthy joints vs. those with RA- invol
Slide 24: Encouraging interim analyses of NAV3-31
Encouraging interim analyses of NAV3-31 Interim data corroborates our hypothesis in Rheumatoid Arthritis 18 healthy controls and 12 patients with RA (Arm 1 & 2 1A1 October 2019 Data demonstrated that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammatio
Slide 25: RA Path to NDA Submission
RA Path to NDA Submission 1. FDA discussion & review of Phase 3 plan in light of IA data from NAV3-31 2. Begin Phase 3 3Q/4Q20 * runs in parallel, staggered fashion to Phase 2b 3. NAV3-32 Phase 2b correlation of imaging to biopsy readout also to begin in 3Q/4Q20 * not on critical path for FDA approv
Slide 26: RA Clinical Timeline
RA Clinical Timeline* Pre-PH3 Meeting D> with FDA 2020 @2 (@3 (a4 (202101 (a2 NAV3-33, 1a3 NDA Filing D> { NAV3-32 NAV3-31 Navidea Biopharmaceuticals, Inc. 26
Slide 27: Our Diagnostics Pipeline
Our Diagnostics Pipeline Cardiovascular Disease Kaposi Sarcoma (CVD) (KS) 92 million Americans living with Orphan Disease that is highly life Cardiovascular disease threatening in a minority of patients Ph 2 Study Ph 2 Study ongoing ‘ongoing Navidea Biopharmaceuticals, Inc. 27
Slide 28: CVD is Another Blockbuster Dx Opportunity
CVD is Another Blockbuster Dx Opportunity CVD is the leading cause of death in the US 666 1in3 = MM U.S. Adults are living with Americans Cardiovascular Disease Navidea Biopharmaceuticals, Inc.
Slide 29: Ongoing CVD Phase Trial at Mass General
Ongoing CVD Phase 2 Trial at Mass General Evaluating imaging and detection of vulnerable plaque NIH grant with + Ph 1 study completed : a ane MASSACHUSETTS + Published J Infection Diseases 16 Jan 2017 GENERAL HOSPITAL + Additional study funded to expand to IV administration Navidea Biopharmaceutical
Slide 30: Tilmanocept as CVD Detection Tools
Timanocept as CVD Detection Tools Detecting High Risk Plaque Atherosclerosis is an Activated Macrophages Macrophages tory al Mediated Disease am core Soft Plaque Activated Macrophages are ] Potential Markers of CVD Vulnerable Risk and Response to Fiwale Therapy Navidea Biopharmaceuticals, Inc. 30
Slide 31: Therapeutics Optionality
Therapeutics Optionality | # —— Navidea Biopharmaceuticals, Inc.
Slide 32: Therapeutics Concept
Therapeutics Concept Platform for Therapeutics that target CD206+ (and CD209 dendritic cells) Activated Macrophages Delivery Targeted Payload t 4 Mannose Moiety Manocept™ Backbone Immune-modulators, With One Hardwired Chemotherapeutics, Address - CD206 Activated Tc®, Other Isotopes Macrophages Navid
Slide 33: Therapeutics Pipeline
Therapeutics Pipeline 1000 CLASS (Oncology/Fibrosis) Killing TAMs & Altering the Tumor Microenvironment to Enhance Immunotherapies | | Depleting Depletes disease Through causing M2 Apoptosis Macrophages Navidea Biopharmaceuticals, Inc. 2000 CLASS (Anti-inflammatory) Altering Activated Macrophage Fun
Slide 34: Therapeutics Program Focus
Therapeutics Program Focus Aberrant macrophages are associated with several major disease states Inflammation. Aberrant activated macrophages can drive excessive inflammation and autoimmune diseases (RA, OA, Lupus, MS, Myocarditis, Uveitis CNS Improper dearance of eran compounds ae responsible for ‘
Slide 35: Key Management
Key Management Jed A. Latkin Chief Executive Officer, Chief Financial Officer and Chief Operating Officer Previously was a Portfolio Manager at Nagel Avenue Capital beginning 2010 and at ING Investment Management from 2006-2010, Morgan Stanley Investment banking (2002-2006) Previously served as CFO
Slide 36: Contact Details
Navidea BIOPHARMACEUTICALS Contact Details Jed Latkin - CEO jlatkin@navidea.com
Navidea Biopharmaceuticals — Investor Presentation (August 2020) on 6ix