Provectus Biopharmaceuticals, Inc. · OTC:PVCT
Provectus Biopharmaceuticals — Investor Presentation (February 2021)
23 slides from Provectus Biopharmaceuticals's investor presentation, February 2021
Slide 1: Developing Small Molecule Immunotherapy Medicines
Developing Small Molecule Immunotherapy Medicines February 2021 10025 Investment Drive, Suite 250, Knoxville, Tennessee, USA 37932 | provectusbio.com | © 2021, Provectus Biopharmaceuticals, Inc.
Slide 2: Forward-Looking Statements
Forward-Looking Statements The information in this presentation may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus Biopharmaceuticals, Inc. and its affiliates (Provectus or the Company), which are based on the opinions a
Slide 3: Provectus Biopharmaceuticals (Provectus)
Provectus Biopharmaceuticals (Provectus) • A clinical-stage biotechnology company developing immunotherapy medicines for different diseases • Our aims: To maximize the curative impact of these medicines; to achieve immunity from treated disease Ticker: PVCT • Reproducible science based on small mole
Slide 4: A Validated Multi-Disease Treatment Platform
A Validated Multi-Disease Treatment Platform o RBD is an innovative physical chemistry science ● Broad-spectrum prophylactic and therapeutic medical applications Rose bengal disodium o Prerequisite mechanistic step – direct contact between RBD and disease; leads to: ● Immunogenic disease death Estab
Slide 5: New Science & Business Leadership
New Science & Business Leadership o New leadership secured board control in 2017 Leadership ● A compelling new vision of accessible and affordable, safe, broad-spectrum, small molecule • Ed Pershing, Board Chairman immunotherapy medicines • Dominic Rodrigues, Board Vice Chairman2 ► Pivoted and enhan
Slide 6: RBD-HX Science Platform
RBD-HX Science Platform 6 © 2021, Provectus Biopharmaceuticals, Inc.
Slide 7: Rose Bengal Disodium
Rose Bengal Disodium Provectus’ Proprietary API o A small molecule and active pharmaceutical ingredient (API) ● Stable and environmentally-adaptive Time-dependent ● Nominal formula: 4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein activity disodium4 Route of o Highly-pure, pharmaceutical-grade r
Slide 8: PV-10 (RBD)
PV-10 (RBD) Provectus’ Broad-Spectrum Drug Product o PV-10 is a systemically-active injectable pharmaceutical formulation of RBD PO Hematology • in vitro ✓ • in vivo ongoing ● Registration study-ready investigational drug product (PV-10 DP) IL Oncology ~450 patients ● Multiple lots of PV-10 DP have
Slide 9: Provectus' Drug Discovery and Development Strategy
Provectus’ Drug Discovery and Development Strategy o Our science platform has demonstrated PV-10’s ► innovative, multi-faceted, single-agent strengths Expand ● Systemic activity ✓ • • New disease areas and indications Explore ● Treatment-specific innate immune activation • • Prophylactic and/or • •
Slide 10: The RBD Effect
The RBD Effect Direct Contact Between RBD and Disease Direct contact between Immunogenic disease death RBD treatment-specific Disease-specific functional RBD and disease (or disease normalization) innate immune activation adaptive immune response • OncologyP,C • OncologyP,C • OncologyP,C • OncologyC
Slide 11: PV-10 Immunotherapy
PV-10 Immunotherapy The RBD Effect in IL Oncology o Injection of PV-10 into tumor tissue ● Rapid accumulation of PV-10 in tumor lysosomes destabilizes them, and triggers lysosomal disruption, which leads to immunogenic cell death (ICD) ● This process can occur within hours of tumor injection o ICD c
Slide 12: Cancer Cell Autolytic Death via RBD
Cancer Cell Autolytic Death via RBD Lysosomal Targeting o RBD-induced autolytic cell death (death by self-digestion) in Hepa1- 6 murine hepatocellular carcinoma (HCC) cells can be seen in this Provectus video of the process; the video of individual cells in tissue culture is provided in 30-second fr
Slide 13: PV-10 Immunotherapy & Checkpoint Blockade
PV-10 Immunotherapy & Checkpoint Blockade A Common RBD Effect in IL Oncology o PV-10 + immune checkpoint blockade (CB) combination therapy (¶) ● e.g., Keytruda® (pembrolizumab)§#, Opdivo® (nivolumab)#, Bavencio® (avelumab)#, or other approved and investigational anti-PD-(L)1 agents o The PV-10-induc
Slide 14: PV-10 Immunotherapy & Checkpoint Blockade: The Z Value
PV-10 Immunotherapy & Checkpoint Blockade: The Z Value Highlighting Synergy in Cancer Combination Therapy o The ‘Schmidt index’ (Schmidt, Semin Immunopathol 2019, Chen and Schmidt, Contemp Clin Trials 2020) quantifies the combination therapy contribution of two cancer agents with demonstrated indepe
Slide 15: Global Experience
Global Experience Reproducible Science and Clinical Trials in IL Oncology Phase 3 clinical trial authorizations (CTAs) for RBD-based investigational drug products Food and Drug Administration (FDA) (USA) Systemic Lysosomal tumor-specific Therapeutic Goods Administration (TGA) targeting immune (Austr
Slide 16: The Consistency of the RBD Effect Across Disease Areas
The Consistency of the RBD Effect Across Disease Areas Oncology Dermatology Hematology Virology Microbiology Ophthalmology Route of administration IL p.o. top. p.o. PO, IN top., p.o., IV top. Stage of work Clinical in vivo Clinical in vivo in vivo in vitro in vitro/in vivo Prerequisite step ✓ ✓ ✓ ✓
Slide 17: Current RBD Drug Pipeline
Current RBD Drug Pipeline 17 © 2021, Provectus Biopharmaceuticals, Inc.
Slide 18: Oncology
Oncology o More than 450 patients have been treated with IL PV-10 ● Melanoma and non-melanoma cancers of the skin Single-agent for early-stage disease ● Cancers of the liver o IL administration: Elucidated, reproducible cytotoxic and immunotherapeutic mechanisms of action ✓ Single-agent or CB ● Agno
Slide 19: IL Oncology: Melanoma
IL Oncology: Melanoma Patient- & Lesion-level Efficacy in Single-Agent & Combination Therapy Settings in Clinical Trials PV-10 Injected Disease Overall Patient Disease Melanoma Tumor Label PV-10 Setting # of Injected Response Durability Response Tumor Type Response # of Patients Response Lesions Cri
Slide 20: IL Oncology: Cancers of the Liver
IL Oncology: Cancers of the Liver Patient- & Lesion-level Efficacy in Single-Agent & Combination Therapy Settings in Clinical Trials PV-10 Injected Disease Patient Disease Overall Liver Cancer Tumor Label PV-10 Setting Tumor Type # of Injected Response Durability Response Response # of Patients Resp
Slide 21: Dermatology
Dermatology 12-week Combination 4-week administration ✓ administration therapy Psoriasis Clinical activity Mechanism of action in vivo safety (in vitro mechanism) ✓ ► Psoriasis Atopic dermatitis Psoriasis Atopic dermatitis Actinic keratosis (clinical) (in vitro) ► o More than 200 patients have been
Slide 22: Hematology
Hematology o RBD effect playing out ● Direct contact between RBD and leukemic disease ✓ Immune mechanism ► ● in vitro observations included disease death that is • 11 primary or (in vitro) • Relapsed pediatric disease- (cell line-) and concentration-dependent, like in relapsed pediatric acute lympho
Slide 23: Virology Microbiology Ophthalmology
Virology ► Microbiology ► Ophthalmology ► o Development strategy: Build an RBD- o Development strategy: Build an RBD- o Prospective development strategy: based platform of broad-spectrum anti- based platform of broad-spectrum Seek approval of an ophthalmic drug viral agents bacterial agents product
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