Navidea Biopharmaceuticals, Inc. · OTC:NAVBQ
Navidea Biopharmaceuticals — Investor Presentation (August 2018)
35 slides from Navidea Biopharmaceuticals's investor presentation, Aug 16, 2018
Slide 1: Precise Identification of Macrophage-Mediated Diseases
Navidea™ BIOPHARMACEUTICALS Precise Identification of Macrophage-Mediated Diseases August 2018
Slide 2: Disclaimer
Disclaimer | Navidea™ 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'
Slide 3: Our Technology
Our Technology | Navidea™ 'BIOPHARMACEUTICALS Target CD206 Activated Macrophage receptor Our proprietary activated macrophage targeting system is capable of identifying and measuring macrophage activity in-vivo Navidea is marketing its Biomarker technology for use as a novel drug development tool in
Slide 4: Macrophages and CD206 Receptors
a Macrophages and CD206 Receptors | Navidea Only Activated Macrophages express CD206 Vt Aas Environmental Exposure Hormonal Effects ates eeradeches = Other infectious agents = Variable depending on Active macrophage = Drugs/chemicals disease = Other (e.g, ultraviolet light) GE The mannose receptor,
Slide 5: The Role of Macrophages in Human Biology
The Role of Macrophages in Human Biology | Navidea™ 'BIOPHARMACEUTICALS “= Macrophages are immune system cells that respond to tissue damage or infection “= Activated macrophages are stimulated by cytokines or bacteria to respond to invading or infected cells: aa * Help clear infectious agents, repa
Slide 6: Restructuring Relationship with Macrophage Therapeutics; Spinout
Restructuring Relationship with Macrophage Therapeutics ; Sw ac Navidea™ Spinout Rationale * Current structure severely hampers the ability to finance Macrophage Tx through traditional Venture Capital structure + Mil imal overlap between Diagnostic and Therapeutic focused institutional investors + M
Slide 7: The Navidea Opportunity Post MT Spinout
The Navidea Opportunity Post MT Spinout aa Near term commercial opportunities and Macrophage valuation milestones | Navidea™ 'BIOPHARMACEUTICALS Biomarker i Y Ongoing discussion to utilize Tilmanocept in planned clinical trials Does not require additional approvals or reimbursement to generate reven
Slide 8: Our Biomarker Approach
Navidea= Our Biomarker Approach
Slide 9: Biomarker: Overview
Biomarker: Overview Navidea> Near term commercial opportunity that obviates additional regulatory clearance’ ‘BIOPHARMACEUTICALS Three Key Attributes of our Biomarker Approach ~ f ~ r Vv (1) Clear unmet need to reduce clinical trial cost burden (2) No additional regulatory requirements to generate c
Slide 10: Biomarker addresses unmet need
Biomarker addresses unmet need | Navidea> Current Clinical Landscape & Monitoring Market Opportunity BOPHARICEUTCALS 4 |mprovement in Savings for Clinical Trial Costs and Preventative Screening * Average cost per patient in clinical trials today: $36,500 Cost per Patient ¢ Avg # of Patients* * Site
Slide 11: Biomarker limits regulatory hurdles
Biomarker limits regulatory hurdles Navidea> Selling into clinical trials obviates need to obtain additional regulatory clearances’ ‘BIOPHARMACEUTICALS if Regulations permit selling Tilmanocept to Biopharmas & CROs for use in registered clinical trials * US and Europe (Japanese approval expected in
Slide 12: Biomarker revenue opportunity is robust
Biomarker revenue opportunity is robust | Navidea> Potential to integrate Tilmanocept into thousands of clinical trials BOPHARMACEUTIALS >500,000 $5,000/dose $2.5B Patients currently being recruited NAVB sales price Potential revenue for for FDA registered clinical trials in research purposes only a
Slide 13: Our Clinical Diagnostics Strategy
Navidea> Our Clinical Diagnostics Strategy
Slide 14: Navidea Product Pipeline
Navidea Product Pipeline Navidea> 'BIOPHARMACEUTICALS Preclinical/Discovery Phase Phase2 Phase 3 FDA-Approved Stage Solid Tumors Lymphatic Mapping, Sentinal Node Biopsy FDA-approved in 2014, Sold to Cardinal Rheumatoid Arthritis Ph3 meeting with FDA set for September Cardiovascular Diseases Ph2 stud
Slide 15: Our Pipeline: What's New?
Our Pipeline: What’s New? Detection & Monitoring of Neuroinflammatory Diseases | Navidea= 'BIOPHARMACEUTICALS + Anticipate data indicating use of Tilmanocept as a Neuroinflammation diagnostic imminently + Initial data readout expected over next several weeks * Applications in Alzheimer’s, Parkinson'
Slide 16: Sizeable addressable markets
Sizeable addressable markets Navidea> Pipeline addresses unmet preventative screening needs _ BOPHARMACEUTIALS * Rheumatoid Arthritis FDA approval will pave the way for additional FDA approved clinical Diagnostics ¢ Will pursue both diagnostic and screening pathways for Cardiovascular disease * Comm
Slide 17: Corporate Overview
Corporate Overview | Navidea™ Targeting Activated Macrophages to Detect, Monitor and Treat Disease BIOPHARMACEUTICALS ~ Building off FDA/EMA-approved diagnostic product i Leveraging FDA approved Lymphoseek® to expand to more attractive clinical =~ s diagnostic end markets ‘= Technology platform appl
Slide 18: Navidea Imaging Strategy
Navidea Imaging Strategy Image M1 or M2 Mediated Disease Dose it Same for all indications Navidea> 'BIOPHARMACEUTICALS Image it Focus the camera on area of interest 3 hourimage RA High Resolution Imaging nd bed e,ey
Slide 19: Cardiovascular Disease
Cardiovascular Disease | = | Navidea™ Potential diagnostic and screening opportunity with large addressable market 'BOPHARMACEUTICALS. ~ Detect High-risk Plaque * Fat droplets in arteries induce cytokine release * Cytokines recruit monocytes, which convert to macrophages * Activated macrophages are
Slide 20: Quantifiable Inflammation Score
Quantifiable Inflammation Score Compiled 2D/3D Imaging Navidea> 'BIOPHARMACEUTICALS Computer Generated Score of CV Images
Slide 21: Clinical Diagnostics Catalyst Calendar
Navidea= Clinical Diagnostics Catalyst Calendar
Slide 22: Clinical Diagnostics Catalyst Calendar
Clinical Diagnostics Catalyst Calendar | Navidea> 'BIOPHARMACEUTICALS GHEE RreumatciaArthrtis QI Keposisarcoma QB NASH = QI Cardiovascular Disease (__)_Neuroinflammation | Proot ofconcept |) GINS jonse Neuroinflammation Supeeee GL Completionof Tay Robust 1 |, bata expected LB post meeting Phase 1 Ne
Slide 23: Restructuring Relationship with Macrophage Therapeutics
Restructuring Relationship with Macrophage Therapeutics Pathway to Create Value for “NAVB” Navided= ‘he 2
Slide 24: Therapeutic Concept
Therapeutic Concept | Navidea> Selectively targeting Activated Macrophages BIOPHARMACEUTICALS Platform for immuno-constructs that preferentially target 206+ (and CD209+ dendritic cells) activated macrophages Mannose Moiety With One Hardwired Address - CD206 Activated Macrophages Chemotherapeutics Im
Slide 25: Preclinical Models Validate Macrophage Strategy
Preclinical Models Validate Macrophage Strategy | Navidea> Arthritis + Results report clear statistically significant ant-inflammatory activity with no apparent significant clinical signs relating to off target effects. Asthma ‘+ Results show a decrease in all three pro-inflammatory markers evaluate
Slide 26: MT 2000: Macrophage Tx Lead Candidate
MT 2000: Macrophage Tx Lead Candidate Navidea> Activated Macrophage targeted steroid ornmenserTCns MT-2000: An activated macrophage targeted steroid * Designed to inhibit inflammation caused by overactive macrophages * Converts pro-inflammatory M1 Macrophages to anti-inflammatory M2 Macrophages * Re
Slide 27: Restructuring relationship with Macrophage Therapeutics
Restructuring relationship with Macrophage Therapeutics Navidea> Recently generated pre-clinical data points to accelerated FDA pathway __/ nceEn Why Now? * Pre-clinical study just recently provided promising data in the treatment of a rare orphan Neuroinflammatory Disease + MThas selected this appr
Slide 28: Rare Pediatric Disease Voucher
Rare Pediatric Disease Voucher : ; Rare Pediatric Disease Voucher * Potential to provide both MT and Navidea with non-dilutive capital + MT plans to submit Rare Pediatric Disease Qualification package to the FDA by YE2018 + Have hired leading CRO Last 5 Rare Pediatric Disease Vouchers have sold for
Slide 29: Macrophage Tx Lead Indication
: = Macrophage x Lead Indication . Navidea™ * Lysosomal storage disease resulting in myelin damaging neuro-inflammation * Disease diagnosed at 6 months old, typically fatal by 2-3 years * MTis currently exploring the utility of MT-2000 class (anti-inflammatory) * We anticipate: * FDA Orphan Drug Des
Slide 30: Krabbe: Proof of Concept for Neuroinflammation
Krabbe: Proof of Concept for Neuroinflammation Navidea> Krabbe Disease will prove three key therapeutic traits of MT-2002 _ BIOPHARMACEUTICALS |(a) Crosses Blood Brain Barrier 7 > MT-2002 = | (2) Anti-inflammatory | s |(3) Non-enzymatic clearance of toxic metabolites Proving these attributes will op
Slide 31: Krabbe: Proof of Concept for Neuroinflammation
Krabbe: Proof of Concept for Neuroinflammation Krabbe Disease will prove three key therapeutic traits of MT2000 Neuro-Inflammation | Navidea™ 1.Goucher Disease Lipid Storage Diseases 2.Niemann-Pick Disease 3.Fabry’s Disease 30
Slide 32: Macrophage Catalyst Calendar
Macrophage Catalyst Calendar Navidea> Multiple opportunities to create value over the next 15 months Orphan indication provides accelerated regulatory pathway + Provides numerous potential valuation catalysts to create value for Macrophage Therapeutics + Value creation at Macrophage will directly tr
Slide 33: Exciting next months for Navidea and MT
Exciting next 15 months for Navideaand MT | Navidea™ 'BIOPHARMACEUTICALS Proof of Concept Neur (GD: macrophage 1x NASH: completion of Phase 1 RA: Phas chedule FDA response CV: Data evaluation & potential expected ation of Ph2 45 days RA: Phase luatio Robust ntial Pub Neuroinflammation submitted Ci d
Slide 34: End of Phase Meeting with FDA
End of Phase 2 Meeting with FDA Timeline Navidea> 'BIOPHARMACEUTICALS Timeline July 11t - Meeting Request Sent to FDA August 9** — Briefing Book Sent to FDA (Includes questions) Late September — 90 Minute Meeting with FDA Will be utilizing KOLs for the meeting with the FDA Up to 45 days post-meeting
Slide 35: Contact Details
Navidea™ BIOPHARMACEUTICALS Contact Details Jed Latkin - CEO jlatkin@navidea.com
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