Navidea Biopharmaceuticals, Inc. · OTC:NAVBQ
Navidea Biopharmaceuticals — Investor Presentation (May 2022)
18 slides from Navidea Biopharmaceuticals's investor presentation, May 2022
Slide 1: Investor Presentation May 2022
Investor Presentation May 2022
Slide 2: Disclaimer
Disclaimer Some of the statements made in this presentation represent forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this presentation, which relate to other tha
Slide 3: Precision immuno-diagnostics and therapeutics company
We are a precision immuno-diagnostics and therapeutics company commercializing a powerful and adaptable platform technology, creating a robust pipeline of products for cancer and inflammatory disorders. 3
Slide 4: Corporate Overview
Corporate Overview Adaptable Platform Technology to Target Diseases with Significant Unmet Need FDA/EMA-approved diagnostic product demonstrates the features of the proprietary platform technology, the Manocept™ Platform. The Manocept Platform enables targeted delivery of imaging agents or small mol
Slide 5: Our Diagnostics and Therapeutics Pipeline
Our Diagnostics and Therapeutics Pipeline Preclinical/Discovery Phase 1 Phase 2 Phase 3 FDA/EMEA-Approved Solid Tumors Lymphatic Mapping, Sentinel Node Biopsy Dx (Lymphoseek™) Sold to Navidea Cardinal Seeking Partner Diagnostics Rheumatoid Arthritis Dx Phase 3 Enrolling Cardiovascular Diseases Dx Pl
Slide 6: Our Core Technology
Our Core Technology Targeted Binding to Activated Macrophages • Target CD206 receptor • Macrophages are Dextran Spine (Structural Backbone) on macrophages- best- involved in a very large in-class affinity number of diseases • Flexible Manocept • FDA/EMA approved platform allows (favorable regulatory
Slide 7: Key Features of the Manocept Platform
Key Features of the Manocept™ Platform Manocept™ Key Differentiator Target Activated macrophages Significant Unmet Need in Cancer, CVD, and RA Chemistry Cell-free synthetic chemistry Scalable, low-cost production- high gross margins; Difficult to reverse engineer Backbone (BB) Made from natural carb
Slide 8: Why Focus on Rheumatoid Arthritis?
Why Focus on Rheumatoid Arthritis? Large Unmet Need to Find the Best RA Tx for the Individual Patient Hypothesis is that tilmanocept • There are many patients living with RA in the US (>1.3M by most estimates) imaging can quantify whether • Current treatments might work for a time but then typically
Slide 9: The Goals of Our Completed and Ongoing RA Studies
The Goals of Our Completed and Ongoing RA Studies Confirm Reproducibility and Evaluate Predictive Capacity of Tx Response- COMPLETED (NAV3-31 P2B) Establish Normative Database- COMPLETED (NAV3-35 P2B) Correlate with Pathology- Ongoing (NAV3-32 P2B) Establish Predictive Capacity of Tx Response- Ongoi
Slide 10: Tc99m Tilmanocept Prediction of Treatment Response
Tc99m Tilmanocept Prediction of Treatment Response Arm 3 NAV3-31 A Baseline Week 5 Week 0 Week 5 Week 12 Week 24 ACR50 Global TUV ~90% accuracy at early prediction of ACR50 response (90% at week 12 and 86% at week 24) B Baseline Week 5 Week 0 Week 5 Week 12 Week 24 ACR50 Global TUV Legend Responder
Slide 11: Our First Rheumatoid Arthritis Indications
Our First Rheumatoid Arthritis Indications Quantitative Imaging with Tc 99m Tilmanocept for candidates of Anti-TNF Therapy Early prediction of RA treatment response to a new or first time anti-TNFα therapy. Imaging shortly after initiation of a new Tx Identify RA patients with low level of localizat
Slide 12: RA Path to NDA Submission
RA Path to NDA Submission FDA discussion & review of Phase 3 meeting held September 1 Began Phase 3 NAV3-32 Phase 2b correlation of imaging to biopsy readout ongoing Not on critical path for FDA approval, supports adoption and biomarker designation, proof of MoA Aim for completion of Phase 3 by end
Slide 13: Tc-Tilmanocept Base-case Revenue Projections (U.S. and EU)
Tc-Tilmanocept Base-case Revenue Projections* (U.S. and EU) Tc-Tilmanocept may generate ~$735 M and ~$500 M in annual revenue by 2036 in the U.S. and EU, respectively Base-case U.S. and EU Projected Net Revenue ($M) $2,000 $1,800 U.S. Sales $1,600 $1,400 EU Sales $1,201 $1,214 $1,229 $1,243 $1,119 $
Slide 14: Tc-Tilmanocept Upside Revenue Projections (U.S. and EU)
Tc-Tilmanocept Upside Revenue Projections* (U.S. and EU) If Tc-Tilmanocept is incorporated into ACR/EULAR guidelines, 2036 U.S. / EU sales may approach ~$2.6 B Upside Projected Net Revenue ($M) $3,000 $2,497 $2,525 $2,555 $2,586 $2,418 $2,443 $2,469 $2,500 U.S. Sales $2,264 EU Sales $1,055 $2,000 $1
Slide 15: Therapeutics Optionality
Therapeutics Optionality Leveraging our core Manocept Platform to deliver targeted therapeutics. 15
Slide 16: Therapeutics Concept
Therapeutics Concept Platform for Therapeutics that target CD206+ (and CD209 dendritic cells) Activated Macrophages GPS Delivery Targeted Payload Mannose Moiety Immune-modulators, With One Hardwired Address - ManoceptTM Chemotherapeutics, Tc99, CD206 Activated Macrophages Backbone Other Isotopes 16
Slide 17: Therapeutics Pipeline
Therapeutics Pipeline Oncology- almost all cancers Anti-inflammatory- ARDS Flipping Tumor Associated Macrophages & Altering Activated Macrophage Function Altering the Tumor Microenvironment to Enhance & Treating the Mechanism of Disease Immunotherapies Targeted therapeutics convert M2-like (pro-tumo
Slide 18: Key Management
Key Management Michael Rosol Jeffrey Smith Erika Eves Chief Medical Officer Vice President, Operations Vice President, Finance & Administration Prior to Navidea, Dr. Rosol served as Prior to joining Navidea in 2012, Mr. Erika has served as Vice President, Finance Associate Director in the Clinical a
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