OTC: PVCT
PROVECTUS BIOPHARMACEUTICALS, INC.CIK 0000315545 · Pharmaceutical Preparations
Provectus Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus” or “the Company”), is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases. Our drug product candidates are based on bioactive, synthetic, small… About this business →
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About PROVECTUS BIOPHARMACEUTICALS, INC.
Source: Item 1 (Business) from the 10-K filed March 26, 2026. Description as filed by the company with the SEC.
ITEM
1.
BUSINESS.
General
Provectus
Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus” or “the Company”),
is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases. Our drug product candidates are
based on bioactive, synthetic, small molecule rose bengal sodium (“RBS”), which is a member of a class of molecules called
halogenated xanthenes (“HXs”).
The
Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (“API”) in all our
clinical development and non-clinical research programs. The Company is the first entity to advance RBS into clinical trials for the
treatment of disease. The Company is also the first entity, and currently the only one, to date to make pharmaceutical-grade RBS API
consistently at a purity of nearly 100%.
RBS
can be delivered by different routes of administration. RBS may concurrently display stimulatory and inhibitory effects, may target disease
in a multi-mechanistic manner, may be an electron acceptor and donor. Direct contact by RBS with disease may lead to cell death or repair
by one or more pathways, depending on the disease being treated and the amount of RBS being utilized. Multivariate innate and adaptive
immune activation, signaling, and response may follow.
The
Company’s RBS drug platform and pipeline comprise drug product candidates and non-clinical formulations that use different amounts
of RBS delivered by different routes of administration specific to each disease area, including:
Read full description ↓
●
Clinical:
Development programs in oncology (intratumoral administration), dermatology (topical), and ophthalmology (topical),
●
In
vivo: Proof-of-concept programs in oncology (oral), hematology (oral), wound healing (topical), and canine cancers (intratumoral),
●
In
vitro: Early discovery programs in immune vaccine adjuvants, infectious diseases, tissue regeneration and repair,
and proprietary, and
●
In
silico: Computer modeling of amyotrophic lateral sclerosis and other disease targets.
Intellectual
Property
U.S.
Patents
We
hold patents covering RBS and HX medical science. All patents awarded by the U.S. Patent and Trademark Office (“USPTO”) that
are material to an understanding of the Company are listed in the table below. In 2025, we received one patent award from the USPTO:
U.S.
Patent No.
Title
Issue
Date
Expiration
Date
8,530,675
Process
for the synthesis of rose bengal and related xanthenes
September
10, 2013
April
21, 2031
9,107,887
Combination
therapy for cancer
August
15, 2015
March
9, 2032
9,273,022
Process
for the synthesis of rose bengal and related xanthenes
March
1, 2016
September
17, 2030
9,422,260
Process
for the synthesis of rose bengal and related xanthenes
August
23, 2016
September
26, 2030
2
9,808,524
Combination
of local and systematic immunomodulative therapies for melanoma and liver cancer
November
7, 2017
March
9, 2032
9,839,688
Combination
of rose bengal and systemic immunomodulative therapies for enhanced treatment of cancer
December
12, 2017
March
9, 2032
10,130,658
Method
of ex vivo enhancement of immune cell activity for cancer immunotherapy with a small molecule ablative compound
November
20, 2018
December
18, 2035
10,471,144
Combination
of local rose bengal and systemic immunomodulative therapies for enhanced treatment of cancer
November
12, 2019
November
12 2034
11,058,664
In
vitro and xenograft anti-tumor activity of a halogenated xanthene against refractory pediatric solid tumors
July
13, 2021
May
15, 2039
11,071,781
Combination
of local and systemic immunomodulative therapies for enhanced treatment of cancer
July
27, 2021
March
9, 2032
11,419,844
Composition
and Methods for Treating Hematologic Cancers
August
23, 2022
December
3, 2040
11,426,379
Combination
of Local and Systemic Therapies for Enhanced Treatment of Dermatologic Conditions
August
30, 2022
November
29, 2038
11,938,182
Halogenated
xanthenes as vaccine adjuvants
March
26, 2024
March
35, 2041
11,975,106
Uses
of halogenated xanthenes in oncology and virology
May
7, 2024
July
6, 2041
11,974,980
In
vitro and xenograft anti-tumor activity of a halogenated xanthene against refractory pediatric solid tumors
May
7, 2024
October
13, 2038
12,064,507
Composition
and method for oral treatment of leukemia
August
20, 2024
August
4, 2041
12,133,840
Halogenated
xanthene composition and method for treating hematologic cancers
November
5, 2024
August
3, 2040
12,377,068
In
vitro and xenograft anti-tumor activity of a halogenated-xanthene against refractory pediatric solid tumors
August
05, 2025
May
13, 2039
In
2025, one patent application was also published on the USPTO’s website:
●
Micromolar
Halogenated Fluorescein Assists in Full Skin-Thickness Wound Healing (USPTO application number 19/198639).
3
International
Patents
In
2025, the Company received patent awards and allowances for three of our patent families:
Patent
No.
Title
Issue
Date
Expiration
Date
3100358
(Canada)
In
vitro and xenograft anti-tumor activity of a halogenated-xanthene against refractory pediatric solid tumors
August
5, 2025
May
15, 2039
3172420
(Canada)
Halogenated-xanthenes
as vaccine adjuvants
November
18, 2025
September
29, 2041
202478194
(Australia)
Composition
and method for treating hematologic cancers
July
31, 2025
November
19, 2039
201974803
(Australia)
Composition
and method for treating hematologic cancers
February
20, 2025
November
19, 2039
102849944
(Korea)
In vitro and xenograft anti-tumor activity
of a halogenated-xanthene against refractory pediatric solid tumors
August
20, 2025
May
15, 2039
Clinical
Development and Drug Discovery
The
Company’s small molecule platform, which comprises different drug candidates and non-clinical formulations made from pharmaceutical-grade
RBS using different concentrations and delivered by different routes of administration specific to each disease and/or disease indication,
includes:
Clinical
Development Programs
●
Oncology:
Intratumoral PV-10 has undergone and is undergoing multiple, monotherapy and combination
therapy, early-to-late-stage clinical trials, expanded access programs (“EAPs”)
for groups of and individual patients, and/or quality of life (“QOL”) study at
multiple clinical sites in Australia, Europe, and the U.S. for the treatments of Stage III
and IV melanoma, different types of liver cancers, and breast cancer.
PV-10
has undergone clinical monotherapy and combination therapy study of mechanisms of action and immune response for melanoma, metastatic
uveal melanoma, and metastatic neuroendocrine tumors at Moffitt Cancer Center (“Moffitt”) in Tampa, Florida, The Queen
Elizabeth Hospital in Adelaide, Australia, and MD Anderson Cancer Center in Houston, Texas.
The
Company’s co-lead indication for intratumoral PV-10 is pre-operative penile squamous cell carcinoma (“penile SCC”),
where patients would receive monotherapy PV-10 at a single-site early-stage clinical trial at Moffitt.
The
other co-lead indication for intratumoral PV-10 is FOLRINOX-refractory pancreatic ductal adenocarcinoma (“PDAC”) metastatic
to the liver (“mPDAC”), where patients would receive the combination therapy of PV-10 and systemically administered gemcitabine
and nab-paclitaxel at a single-site early-stage clinical trial at Moffitt.
●
Dermatology:
Topical PH-10, a formulation of PV-10, has undergone multiple mid-stage, monotherapy
clinical trials for the treatments of psoriasis and atopic dermatitis at different clinical
sites in the U.S.
PH-10
has undergone clinical monotherapy mechanism of action and mechanism of immune response study for psoriasis at The Rockefeller University
in New York, New York (“TRU”).
Different
PV-10 formulations have undergone non-clinical combination therapy study for psoriasis and are undergoing non-clinical monotherapy
study for skin inflammation and skin aging at TRU.
4
●
Ophthalmology:
The Company believes that clinical proof-of-concept (“POC”) of topical administration
of non-pharmaceutical grade rose bengal in combination with a light source medical device
for the treatment of infectious keratitis has been shown by clinicians and researchers at
the University of Miami’s (“UM’s”) Bascom Palmer Eye Institute (“BPEI”)
in Miami, Florida, who are now collaborating with the Company to evaluate the potential use
of our pharmaceutical-grade RBS.
Topical
formulation PV-305, a formulation of PV-10, has undergone non-clinical combination therapy study (i.e., drug and device) for diseases
and disorders of the eye, such as infectious keratitis, at BPEI.
The
Company launched a clinical-stage start-up biotechnology company named VisiRose, Inc. (“VisiRose”), a collaboration between
the Company and UM to commercialize BPEI’s ocular research using PV-305.
Proof-of-Concept
Programs
●
Oncology:
Intratumoral PV-10 has undergone non-clinical monotherapy and combination therapy study for the treatment of relapsed and refractory
pediatric solid tumor cancers at the University of Calgary’s Cumming School of Medicine in Calgary, Alberta, Canada (“UCal”).
The Company believes that the UCal researchers have achieved monotherapy in vivo POC of intratumoral administration for pediatric
solid tumor cancers.
●
Oral
(“PO”) formulations of PV-10 have undergone non-clinical monotherapy study for high-risk and refractory adult solid tumor
cancers at UCal. The Company believes that the UCal researchers and the Company have both achieved monotherapy in vivo POC
of PO administration, that the Company has achieved monotherapy in vivo POC of PO administration in both prophylactic and
therapeutic settings, and that the Company has achieved monotherapy in vivo POC of PO administration for adult solid tumors.
●
Hematology:
PO formulations of PV-10 have undergone non-clinical monotherapy study for the treatment of refractory and relapsed pediatric
and other blood cancers, including leukemias, at UCal. The Company believes that the UCal researchers have achieved in vivo
POC of PO administration for blood cancers.
●
Wound
Healing: The Company believes that monotherapy in vivo POC of topical administration
of non-pharmaceutical grade rose bengal for the treatment of this indication has been shown
by researchers at the University of Texas Medical Branch (“UTMB”) in Galveston,
Texas, who are now collaborating with the Company to use our pharmaceutical-grade RBS.
Topical
formulations of PV-10 are undergoing non-clinical monotherapy study for the healing of full-thickness cutaneous wounds at UTMB.
●
Animal
Health: PV-10 formulations have undergone non-clinical monotherapy study for the treatment of cutaneous canine cancers at the
University of Tennessee’s College of Veterinary Medicine in Knoxville, Tennessee. The Company believes that it has achieved
monotherapy POC of intratumoral administration for canine cancers.
Early
Drug Discovery Programs
●
Immune
vaccine adjuvant: Different formulations of PV-10 have undergone non-clinical study as a vaccine adjuvant to enhance T cell responses
for anti-viral and anti-cancer vaccines.
●
Infectious
Diseases: PO and intranasal (“IN”) formulations of PV-10 have undergone non-clinical monotherapy study for the treatment
of SARS-CoV-2 at UCal, another Canadian academic research center, the University of Tennessee Health Science Center (“UTHSC”)
in Memphis, Tennessee, and a U.S. contract research organization. Different formulations of PV-10 have undergone non-clinical monotherapy
and combination therapy study for the treatment of gram-positive and gram-negative bacterial infections (including multi-drug-resistant
strains) and have undergone non-clinical monotherapy study for the treatment of oral bacterial infections at UTHSC. Different formulations
of PV-10 have undergone non-clinical monotherapy study for the treatment of fungal infections at UTHSC.
5
●
Tissue
Regeneration and Repair: Different formulations of PV-10 have undergone non-clinical monotherapy study for vertebrate development,
wound healing, and tissue regrowth at the University of Nevada, Las Vegas in Las Vegas, Nevada.
●
Proprietary:
Different formulations of PV-10 are undergoing non-clinical study for proprietary diseases at an academic medical center.
Computer
Modeling Programs
●
Computer-based
molecular docking of RBS has been done and is being done for amyotrophic lateral sclerosis and other disease targets.
Business
Strategy
The
Company is planning to initiate new intratumoral PV-10 monotherapy and combination therapy clinical trials in pre-operative penile SCC
and mPDAC indications to generate new clinical data and appropriately utilize historical clinical data from intratumoral PV-10 trials,
EAPs, and/or QOL study of injectable solid tumor cancers. Our goals are to pursue drug approval pathways and/or co-development relationships
with commercial pharmaceutical companies for intratumoral PV-10 based on these and other indications.
The
Company is developing a systemically administered formulation of PV-10 for the treatment of cancer. Our goals, when this work is complete,
are to file and have accepted an investigational new drug application (“IND”) with the U.S. Food and Drug Administration
(“FDA”), take an initial systemic drug product candidate into an early-stage clinic trial for an initial oncology or hematology
indication, and/or pursue a co-development collaboration or out-license arrangement for this route of administration and disease area.
The
Company is developing different formulations of PV-10 and different routes of administration for other disease areas by endeavoring to
show non-clinical activity and lack of toxicity. Our goals, when each task of this work is completed, are to file and have accepted an
IND with the FDA, take an initial drug candidate into an early-stage clinic trial for an initial indication, and/or pursue a co-development
collaboration or out-license arrangement for the respective disease area and route of administration.
The
Company is endeavoring to fully elucidate the traits and characteristics of the RBS molecule using different academic medical centers
under sponsored research and testing agreements. Our goal is to gain and communicate additional knowledge of the RBS molecule’s
targeting, mechanism, signaling, immune response, and other features that are common to and/or different from each disease area under
research.
The
Company is doing rigorous chemical analytical comparisons of non-pharmaceutical grades of rose bengal from specialty chemical suppliers
against the Company’s pharmaceutical-grade RBS. Our goal is to demonstrate the proprietary nature of the Company’s pharmaceutical-grade
RBS and that our pharmaceutical-grade RBS meets the necessary uniformity and purity requirements for commercial pharmaceutical use.
RBS
API and Drug Candidate Manufacturing
Our
pharmaceutical-grade RBS resulted from:
●
The
Company’s innovation of a proprietary, patented, commercial-scale process to synthesize the RBS molecule into a viable active
pharmaceutical ingredient (“API”) for commercial pharmaceutical use,
●
The
development of unique chemistry, manufacturing, and control (“CMC”) specifications for API and drug candidate manufacturing
processes,
●
The
production and multi-year stability testing of multiple API and drug candidate lots; the comprehensive documentation of lot composition
and reproducibility, and
●
The
review and acceptance of CMC data from these lots by seven different national drug regulatory agencies for use in a prior, multi-country,
multi-center Phase 3 randomized control trial of the Company.
6
The
Company’s API and drug candidate manufacturing processes employ Quality-by-Design principles, current good manufacturing practice
(“cGMP”) regulations, and the guidelines of The International Council for Harmonization (ICH) of Technical Requirements for
Pharmaceuticals for Human Use. These processes utilize controls that eliminate the formation of historical impurities and avoid the introduction
of potentially hazardous impurities that the Company believes may have been and could be present in uncontrolled and unreported amounts
in non-pharmaceutical grades of rose bengal.
The
Company’s processes of synthesizing the RBS molecule into pharmaceutical-grade RBS and manufacturing RBS API and PV-10 drug candidate,
the processes’ CMC specifications, and the CMC data from the production of stability lots of API and drug candidate have been reviewed
by multiple national drug regulatory agencies prior to granting clinical trial authorizations for the Company to commence a historical
Phase 3 study of intratumoral PV-10 for the treatment of the Company’s former lead indication of locally advanced cutaneous melanoma
(LACM), including the U.S. FDA, Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Australia’s Therapeutic
Goods Administration (TGA) under a clinical trial notification, France’s Agence Nationale de Sécurité du Médicament
et des Produits de Santé (ANSM), Italy’s Agenzia Italiana del Farmaco (AIFA), Mexico’s Comisión Federal para
la Protección contra Riesgos Sanitarios (COFEPRIS), and Argentina’s Administración Nacional de Medicamentos, Alimentos
y Tecnología Médica (ANMAT).
RBS
Non-proprietary Name
The
RBS name for the Company’s pharmaceutical-grade API was selected by and passed the review of the World Health Organization (“WHO”)
Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations after the Company applied for a non-proprietary
name in 2020 and reached the status of recommended International Non-proprietary Names (“INN”). INN Recommended List 88,
which includes the RBS name, was published with the No. 3 issue of the WHO Drug Information, Volume 36 in 2022.
Non-Pharmaceutical
Grades of Rose Bengal
Commercial
Grade
Commercial
grade rose bengal can be purchased from specialty chemical suppliers in the U.S. and other parts of the world that manufacture it under
non-cGMP conditions. Commercial grade rose bengal appears to have reported purities that may vary between 80% and 95%, which we believe
may not be wholly accurate, and may contain substantial amounts of unreported related impurities and/or gross contaminants. Commercial
grade rose bengal is typically used by researchers unaffiliated with the Company for non-clinical study of the rose bengal molecule for
potential biomedical therapeutic applications. The Company provides PV-10 to researchers affiliated with the Company for their non-clinical
study of RBS for potential biomedical therapeutic applications.
We
believe that commercial grade rose bengal is still manufactured using the original historical process, or a variant thereof, developed
by the molecule’s original Swiss creator Rudolph Gnehm in 1881. Some chemical manufacturers may, however, apply purification techniques
that the Company believes still result in commercial grade rose bengal possessing questionable purity and contaminants and substantial
lot-to-lot manufacturing variability.
Diagnostic
Grade
Diagnostic
grade rose bengal describes non-approved rose bengal that is used as an ingredient in historical or current ophthalmic solutions, strips,
and devices, has been historically or is presently compounded by pharmacists for ophthalmic use, and has been or is in other non-ophthalmic
diagnostic tests such as the rose bengal test for human brucellosis.
We
presume, but have not yet confirmed, that diagnostic grade rose bengal is derived from commercial grade rose bengal that may have undergone
a form of purification under cGMP regulations and/or may have been compounded by a pharmacist, academic medical researcher, or commercial
entity under cGMP regulations. Here too, the Company believes that purification may not sufficiently improve the amounts and accuracy
of diagnostic grade rose bengal purity and lot contents and may not adequately reduce or eliminate lot-to-lot manufacturing variability.
7
Chemical
Analytical Comparison
In
2022, the Company worked with a U.S. contract development and manufacturing organization to assess rigorously and methodically three
lots of commercial grade rose bengal, one each from three different specialty chemical suppliers, and compare these non-pharmaceutical
grade materials with the Company’s pharmaceutical-grade RBS. This chemical analytical work was substantially completed in 2022.
The Company believes that the results of these analyses indicated that all three lots of commercial grade rose bengal had
rose bengal purity that was drastically different from what was represented on their respective certificates of analysis (“CofAs”),
and that one of the three lots contained gross contaminants that were not represented on its CofA.
Potential
Barriers to Entry
The
Company believes that the Company’s proprietary, patented, pharmaceutical-grade RBS possesses several competitive advantages over
non-pharmaceutical-grade rose bengal (i.e., commercial and diagnostic grades) that researchers, clinicians, and academic, business, and/or
governmental competitors have used, are using, and/or may attempt to use for potential biomedical applications. The Company believes
that non-pharmaceutical-grade rose bengal may suffer from the uncontrolled presence of substance-related impurities and/or gross contaminants,
substantial lot-to-lot manufacturing variability, inaccurately reported and/or misrepresented purity and contents, and the lack of reproducible,
consistent, and fulsome CMC specifications and documentation. The Company believes that historical and potentially hazardous impurities
and other manufacturing and handling issues facing non-pharmaceutical grade rose bengal may pose significant scientific, technological,
and economic challenges to overcome and validate for compliance with modern drug regulatory standards.
2025
Activity
In
June, the Company held its annual stockholder meeting where stockholders approved the proposals of the Board of Directors (“Board”)
to seek the authority to undertake a reverse stock split and an authorized share reduction. Meeting activities and the company update
were made accessible by Zoom Webinar.
Non-clinical
data on PV-10 for the intratumoral treatment of head and neck squamous cell carcinoma were published in Molecular Cancer Therapeutics,
titled “PV-10 triggers immunogenic cell death in head and neck squamous cell carcinoma via endoplasmic reticulum stress and apoptosis.”
In
September, the Company initiated preclinical research on oral PV-10 in bladder cancer.
In
December, non-clinical data on PV-10 for the activation of the body’s natural STING (stimulator of interferon genes) immune pathway
were published in Human Vaccines & Immunotherapeutics, titled “PV-10 as New Adjuvant Enhances Immune Responses in Hepatitis
B Vaccination Through STING Pathway.”
Competition
In
general, the pharmaceutical and biotechnology industries are competitive, characterized by steady and sometimes disruptive advances in
products and technology. A number of companies have developed and continue to develop products that address the areas we have targeted.
Some of these companies are pharmaceutical companies and biotechnology companies that are international in scope and very large in size,
while others are small companies that have been successful in one or more areas we are targeting. Existing or future pharmaceutical,
devices, or other competitors may develop products that accomplish similar functions to our technologies in ways that may be less expensive,
receive faster regulatory approval, or receive greater market acceptance than our products. Many of our competitors have been in existence
longer than we have, have greater capital resources, broader internal structure for research, development, manufacturing, and marketing,
and may be further along in their respective product cycles.
8
Supply
Chain
During
2025, we continued manufacturing new clinical supplies of PV-10 and PV-305.
Federal
Regulation of Therapeutic Products
All
the prescription drug candidates that we currently contemplate developing will require approval by the U.S. Food and Drug Administration
(“FDA”) prior to sales within the U.S. and by comparable international governmental healthcare regulatory agencies prior
to sale outside the U.S. The FDA and comparable international agencies impose substantial requirements on the manufacturing and marketing
of pharmaceutical products. These agencies and other entities regulate, among other things, research and development activities and the
testing, manufacturing, quality control, safety and effectiveness claims, labeling, storage, record keeping, approval, advertising, and
promotion of our prescription drug candidates. While we attempt to minimize and avoid significant regulatory bars when formulating our
products, some degree of regulation from these regulatory agencies is unavoidable.
The
regulatory process required by the FDA, through which our prescription drug candidates must successfully pass before they may be marketed
in the U.S., generally involves pre-clinical laboratory and animal testing, submission of an application that must become effective before
clinical trials may begin, adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for
its intended indication, and FDA approval to market a given product for a given indication after the appropriate application has been
filed. For pharmaceutical products, pre-clinical tests include laboratory evaluation of the product, its chemistry, formulation, and
stability, as well as in vitro and animal studies to assess the potential safety and efficacy of the product. We will require
sponsored work to be conducted in compliance with pertinent local and international regulatory requirements, including those providing
for Institutional Review Board approval, national governing agency approval, and patient informed consent, using protocols consistent
with ethical principles stated in the Declaration of Helsinki and other internationally recognized standards and delineated by The International
Conference on Harmonisation (“ICH”) Good Clinical Practice standards.
If
the FDA is satisfied with the results and data from pre-clinical tests, it will authorize human clinical trials. Human clinical trials
traditionally are conducted in three sequential phases which may overlap. Each of the three phases involves testing and study of specific
aspects of the effects of the investigational product on human subjects, including testing for safety, dosage tolerance, side effects,
absorption, metabolism, distribution, excretion, and clinical efficacy.
Phase
1 clinical trials include the initial introduction of an investigational new drug into humans, or via a new route of administration or
new organ system if previously investigated in humans. These studies are closely monitored and may be conducted in patients but may also
be conducted in healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacologic actions of the drug
in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. While the FDA
can cause us to end clinical trials at any phase due to safety concerns, Phase 1 clinical trials are primarily concerned with safety
issues. We also attempt to obtain sufficient information about the drug candidate’s pharmacokinetics and pharmacological effects
during Phase 1 clinical trials to permit the design of scientifically valid, Phase 2 studies.
Phase
1 studies also evaluate drug metabolism, structure-activity relationships, and the mechanism of action in humans. These studies also
determine which investigational drugs are used as research tools to explore biological phenomena or disease processes. The total number
of subjects included in Phase 1 studies varies with the drug but is generally in the range of 10 to 80.
Phase
2 clinical trials include early controlled clinical studies conducted to obtain preliminary data on the effectiveness of the drug for
a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common
short-term side effects and risks associated with the drug. Phase 2 studies are often randomized controlled studies that are closely
monitored and conducted in a relatively small number of patients, usually involving up to several hundred people.
Phase
3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of
the drug has been obtained in Phase 2 and are intended to gather definitive information about effectiveness and safety that is needed
to evaluate the overall benefit-risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results
to the general population and transmitting that information in physician labeling. Phase 3 studies usually include several hundred
to several thousand people.
9
We
have established a core clinical development team and have been working with external and FDA-experienced consultants to assist us in
developing product-specific development and approval strategies, preparing the required submittals, guiding us through the regulatory
process, and providing input into the design and site selection of human clinical studies.
The
testing and approval process requires substantial time, effort, and financial resources, and we may not obtain FDA approval on a timely
basis, if at all. Success in non-clinical or early-stage clinical trials does not assure success in later-stage clinical trials. The
FDA or research institutions conducting the trials may suspend clinical trials or may not permit trials to advance from one phase to
another at any time for various reasons, including a finding that the subjects or patients are being exposed to an unacceptable health
risk. Once issued, the FDA may withdraw a prescription drug approval if we do not comply with pertinent regulatory requirements and standards
or if problems are identified after the product reaches the market. If the FDA grants approval of a prescription drug candidate, the
approval may impose limitations, including limits on the indicated uses for which we may market a drug product. In addition, the FDA
may require additional testing and surveillance programs to monitor the safety and/or effectiveness of approved drug products that have
been commercialized, and the agency has the power to prevent or limit further marketing of a product based on the results of these post-marketing
programs. Further, later discovery of previously unknown problems with a drug product may result in restrictions on the product, including
withdrawal from the market.
Marketing
our prescription drug candidates abroad will require similar regulatory approvals by equivalent national authorities and is subject to
similar risks. To expedite development, we may pursue some or all of our initial clinical testing and approval activities outside the
U.S., and in particular in those countries where our prescription drug candidates may have substantial medical and commercial relevance.
In some such cases, any resulting drug products may be brought to the U.S. after substantial offshore experience is gained. Accordingly,
we intend to pursue any such development in a manner consistent with U.S. and ICH standards so that the resultant development data is
maximally applicable for potential global approval.
Additional
Regulation
We
are subject to various federal, state, and local laws and regulations relating to the protection of the environment, human health, and
safety in the U.S. and in other jurisdictions in which we operate. If we violate these laws and regulations, we could be fined, criminally
charged, or otherwise sanctioned by regulators. Environmental laws and regulations are complex, change frequently and have become more
stringent over time. We believe that our operations currently comply in all material respects with applicable environmental laws and
regulations.
Human
Capital Resources
We
have six full-time employees who currently serve as CEO, CFO, CTO, president, senior scientist, and controller. We also engage an independent
contractor, who currently serves as an information technology manager.
We
believe the Company’s success depends on its ability to attract, develop, and retain key personnel. The skills, experience, and
industry knowledge of key members of our Board of Directors, employees, and contractors significantly benefit our operations and performance.
The Company’s Board of Directors and management oversee various employee and contractor initiatives.
Available
Information
Our
website is located at www.provectusbio.com. We make available free of charge through this website our annual reports on Form 10-K,
quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed with or furnished to the SEC pursuant
to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as soon as reasonably
practicable after they are electronically filed with or furnished to the SEC. Reference to our website does not constitute incorporation
by reference of the information contained on the site and should not be considered part of this document.
10
The
SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file
electronically with the SEC as we do. The website is http://www.sec.gov.
The
Company also intends to use press releases, the Company’s website and certain social media accounts as a means of disclosing
information and observations about the Company and its business, and for complying with the Company’s disclosure obligations
under Regulation FD: the Provectus Substack account (provectus.substack.com), the @ProvectusBio X account
(twitter.com/provectusbio), and the Company’s LinkedIn account (linkedin.com/company/provectus-biopharmaceuticals). The
information and observations that the Company posts through these social media channels may be deemed material. Accordingly,
investors should monitor these social media channels in addition to following the Company’s press releases, SEC filings, and
website. The social media channels that the Company intends to use as a means of disclosing the information described above may be
updated from time to time.
The
contents of the websites provided above are not intended to be incorporated by reference into this Annual Report on Form 10-K or in any
other report or document we file with the SEC. Further, our references to the URLs for these websites are intended to be inactive textual
references only.