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“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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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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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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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
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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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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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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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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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