pvct web presentation

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“Opening a New Front in the War  Against Cancer” Except for historical informatio n, the statements made in the presentation are forward-looking statements involving significant risks and uncertainties. These risks and uncertaintie s, including those related to the future financial position and business strategy of Provectus, are detailed in the Company’s filings with the Securities and Exchange Commission. 7327 Oak Ridge Highway Knoxville, Tennessee 37931 USA +1-866-594-5999 ex. 30 www.pvct.com Safe Harbor Statement 1

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Page 1: PVCT Web Presentation

8/3/2019 PVCT Web Presentation

http://slidepdf.com/reader/full/pvct-web-presentation 1/13

“Opening a New Front in the War  Against Cancer” 

Except for historical information, the statements made in thepresentation are forward-looking statements involving significant risksand uncertainties. These risks and uncertainties, including those relatedto the future financial position and business strategy of Provectus, aredetailed in the Company’s filings with the Securities and Exchange

Commission.

7327 Oak Ridge HighwayKnoxville, Tennessee 37931 USA

+1-866-594-5999 ex. 30www.pvct.com

Safe Harbor Statement

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Page 2: PVCT Web Presentation

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Corporate Highlights

Formed in 2002, founded by 3 scientists from ORNL, based inKnoxville, TN, OTCBB: PVCT

Focused on development of rose bengal (RB) based drugs for

treatment of cancer (PV-10) and dermatology (PH-10)

Targets rapidly growing cells, few side effects, robust efficacy,

appears to work with immune system

Clinical Progress – Valuation Inflection Point

Oncology: Melanoma Phase 3 (SPA) & TGA, Liver Phase 1, Compassionate Use

Dermatology: Licensure off completed Phase 2’s, Psoriasis Phase 2C

During the next year emphasis will be on establishing paths to

licensure, broadening applications, and business development

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Page 3: PVCT Web Presentation

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PV-10 for Oncology

Strategy: Demonstrate broad spectrum efficacy for multiple

cancer indications

PV-10: 10% RB solution, direct injection into solid tumors,

simple and effective, may stimulate immune systemresponse

Clinical Trials:

Lead: metastatic melanoma (orphan status, Phase 3 SPA,

TGA)

Background (POC):

Breast carcinoma phase 1 (completed)

Liver/mets Phase 1, expanded and compassionate use

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Page 4: PVCT Web Presentation

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Clinical Development – Melanoma

(Stage III and Stage IV)

Phase 2: Completed Study May 2010

80 subjects US/AUS (7 sites)

Possible retreat after 8, 12, 16 weeks, interim data for 20 and 40

subjects after 6 months, 12 month follow-up

ORR, PFS, imaging of visceral mets, quality of life

Final data on 40 reported at ASCO, 80 on Nov. 4 in Sydney, AUS

PV-10 is well tolerated, eliciting a robust response in a majority

of subjects

Bystander responses noted for cutaneous and visceral mets

Acceptable side effects (pain and swelling at injection sight, some

photo-sensitivity)

Phase 3 SPA under discussion with FDA

Established path to Provisional Approval with TGA 4

Page 5: PVCT Web Presentation

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Full Phase 2 Melanoma Data

CR 24%, PR 25%, SD 18%, PD 23%

Mean PFS 8.2 mon, 11.7 mon for CR+PR,

4.1 mon for SD+PD

25 of 80 subjects had stage IV melanoma

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Page 6: PVCT Web Presentation

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Clinical Development – 

Liver Tumors

Trial: Phase 1, PV-10 direct injection into one tumor, 2

groups low/high dose of 3 subjects each, follow for 28

days using CT & functional MRI

Low dose group finished: First 2 subjects with complete

tumor destruction, still following 3rd subject, minimal

side effects

Follow-up trial: Phase 2/3 for accelerated approval

currently under design

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Page 7: PVCT Web Presentation

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Day 0 – Pre-Tx Day 0 – 5 min Post-Tx

Day 7 Day 287

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4 Months3 Months

4 WeeksScreening

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Cancer Indications for PV-10

Murine Models Animal Tumors(Spontaneous)

Human Clinical Work

Hepatocellular Carcinoma Equine Sarcoids Recurrent Breast (Phase 1)

Renal Carcinoma Equine Melanoma Melanoma (Phase 3 SPA)

Melanoma Feline Sublingual

Squamous Epithelial

Liver (HCC Phase 1)

Human Gall Bladder Canine Fibrous

Histiosarcoma

Squamous Cell Carcinoma

(Compassionate Use

Program)

Human Breast Canine Bladder

Human Prostate Canine Mast Cell

Human Basal Cell

Carcinoma

Murine Breast

Human (Small Cell) Lung Murine Papilomas

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Page 10: PVCT Web Presentation

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PH-10 for Dermatology

Strategy: Demonstrate on psoriasis and atopic

dermatitis (eczema) for pharma licensure

0.001% RB topical gel (PH-10) Hydrogel for direct application to skin

Activated by ambient (green) light

Goal - final product…self treat as needed

Robust positive response comparable to competitors with virtually no

systemic uptake or substantial side effects Phase 2C psoriasis with vehicle, 2x, 5x, 10x drug then end of Phase 2

mtg with FDA

Licensure talks underway

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Provectus Pharmaceuticals: Financial

CurrentShares

Outstanding

~102 million common shares outstanding~4 million preferred

CurrentCash and USTreasuries

>$14+ million

Cash BurnRate

Cash on hand supports planned operations through 2013

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Company Focus 2011-2012

Oncology Melanoma- phase 3 SPA (FDA), TGA, mechanism study

Liver- complete phase 1, design (begin?) phase 2/3

Continue expanded and compassionate use programs

Dermatology Complete phase 2C psoriasis, end of phase 2 FDA mtg

Complete pharma licensure talks at appropriate valuation

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Craig Dees, Ph.D. – Chief Executive Officer•More than 20 years in senior positions at The Oak Ridge National Laboratoryand with numerous start-ups•Leadership in product design and development in the fields of ethicalvaccines, cosmetics, human diagnostics and OTC pharmaceuticals•Ph.D. in molecular virology from University of Wisconsin, Madison

•Infectious disease, immunology

Timothy Scott, Ph.D. – President•Served in senior management positions at Photogen Technologies, Inc.,Genase LLC, and the Oak Ridge National Laboratory•Holder of 16 U.S. patents, Scott was a co-founder, senior scientist, vicepresident and chief operating officer for Photogen Technologies• Ph.D. in chemical engineering from University of Wisconsin, Madison•Liquid/membrane transport and separations

Eric Wachter, Ph.D. – Senior Vice President•Senior positions at Photogen Technologies and the Oak RidgeNational Laboratory•A holder of over 15 U.S. patents, awards for Scientific excellence•Ph.D. in physical chemistry from University of Wisconsin, Madison•Photochemistry and spectroscopy

Peter R. Culpepper, CPA, MBA – CFO, COO•Twenty years in the financial field working in high-growth startups•Led the national operating unit of a $1 billion publicly tradedtelecommunications company•Previous employers include Neptec, Inc., Metromedia Companies, andPageNet

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