What changed in this filing

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Item 1. Business

2023-03-30 compared with 2022-03-29 · 226 added, 103 removed, 119 unchanged (73% of the section changed)

Biopharmaceuticals, Inc., a Delaware corporation incorporated in 2002 (together with its subsidiaries, “Provectus”

or the “Company”), is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases, based

on a family of small molecules called halogenated xanthenes (“HXs”).

Our lead HX molecule is named rose bengal sodium (“RBS”).

prerequisite mechanistic step for these immunotherapies is direct contact between HX, such as RBS, and disease, which may lead

to disease death or repair, HX treatment-specific innate immune activation, and a disease-specific functional adaptive

immune response.

HX displays consistent mechanistic behavior across different indications of a disease and across different disease areas,

with the potential to be a multi-disease treatment platform and a universal contributor to standard of care and emerging medical treatments.

Property (“IP”)

hold a number of patents covering the technologies we have developed and are continuing to develop for the production of investigational

drugs and other technologies.

All patents material to an understanding of the Company are included in the table below:

Biopharmaceuticals, Inc., a Delaware corporation incorporated in 2002 (together with its subsidiaries, “Provectus” or

“the Company”), is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that

are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes (“HXs”).

molecule is named rose bengal sodium (“RBS”).

Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (“API”) in the drug

product candidates of our current clinical development programs and the preclinical formulations of our current drug discovery programs.

Importantly, our pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for

delivery by different routes of administration,

Company believes that RBS targets disease in a bifunctional manner.

First, direct contact may lead to cell death or repair depending

on the disease being treated and the concentration of the RBS utilized in the treatment.

Second, such contact may catalyze multivariate

immune signaling and activation, and response may follow that may manifest as stimulatory, inhibitory, or both.

Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease, such

as those trials reported on the clinical trials registry ClinicalTrials.gov.

Company believes that it is the first and only entity to date to successfully, reproducibly, and consistently make pharmaceutical-grade

RBS at a purity of nearly 100%.

Company’s small molecule HX medical science platform comprises a number of different drug product candidates and preclinical pharmaceutical-grade

RBS formulations using different concentrations and delivered by different routes of administration specific to each disease area and/or

The Company’s HX medical science platform includes:

development programs in oncology, dermatology, and ophthalmology

vivo proof-of-concept drug discovery programs in oncology, hematology, wound healing, and animal health, and

vitro drug discovery programs in infectious diseases and tissue regeneration and repair.

hold a number of patents covering the HX medical science platform that we have developed and are continuing to develop for drug product

candidates and drug formulations in different disease areas.

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:

antiperspirant and antimicrobial compositions

intracorporeal medicaments for high energy photodynamic treatment of disease

for the synthesis of rose bengal and related xanthenes

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of local and systemic immunomodulative therapies for enhanced treatment of cancer

received two patent awards from the U.S.

Patent and Trademark Office (USPTO) in 2021, U.S.

and Methods for Treating Hematologic Cancers

of Local and Systemic Therapies for Enhanced Treatment of Dermatologic Conditions

received two patent awards from the USPTO in 2022, U.S.

patent numbers 11,419,844 and 11,426,379.

Five patent applications were published on the USPTO’s website:

and Method for Treating Hematologic Cancers (USPTO application number 16/688319),

and Method for Oral Treatment of Leukemia (17/232393),

of Solid Cancerous Tumors by Oral Administration of a Halogenated Xanthene (17/214590),

Uses of Halogenated Xanthenes in Oncology and Virology (17/212723), and

Vitro and Xenograft Anti-Tumor Activity of a Halogenated-Xanthene Against Refractory Pediatric Solid Tumors (17/344418).

Three patent applications were also

published on the USPTO’s website:

of local and systemic immunomodulative therapies for enhanced treatment of cancer (USPTO application number 17/382,943),

Xanthenes as Immune Adjuvants (17/488,430), and

of Local and Systemic Therapies for Enhanced Treatment of Dermatologic Conditions (17/466,600).

International

2021, the Canadian Patent Office granted the Company’s patent application “Method of ex vivo enhancement of immune

cell activity for cancer immunotherapy with a small molecule ablative compound.

Product Pipeline

is an injectable pharmaceutical formulation of RBS and registration study-ready investigational drug product (“PV-10 DP”).

Provectus has developed two clinical-stage formulations of PV-10:

an intralesional (IL) administration for oncology (10% RBS) for the

treatment of cancers of the skin and cancers of the liver, and topical (“top.”) application for dermatology (0.01% RBS) for

the treatment of inflammatory dermatoses (e.g., psoriasis, atopic dermatitis, and actinic keratosis).

A third formulation is under development

for a currently proprietary disease area.

Research into new routes of RBS administration and formulations of PV-10 is ongoing, including

oral ( per os or “PO”), intranasal (“IN”), inhaled top., and/or intravenous (“IV”) for hematology,

oncology, virology, microbiology, ophthalmology, and animal health.

additional information on the disease areas in which the Company is targeting, please see Note 1 to the Company’s Consolidated

Financial Statements included in Part II, Item 8.

Financial Statements and Supplementary Data.

Lee Moffitt Cancer Center released a preprint manuscript describing how PV-10 in combination with gemcitabine may

enhance the chemotherapy’s efficacy against pancreatic tumors:

“ Intralesional injection of Rose Bengal augments the efficacy

of gemcitabine chemotherapy against pancreatic tumors .” Chemotherapy regimens that include gemcitabine are the standard of

care for the treatment of pancreatic cancer.

March, Melanoma Research published results from an investigator-led, single-center study of Australian in-transit melanoma patients who

received IL PV-10 under a Company-sponsored expanded access (“EAP;” aka compassionate use) program.

The Melanoma Research

article, entitled “Treatment of in-transit melanoma metastases using intralesional PV-10,” detailed the experience of investigators

at Melanoma Institute Australia (formerly the Sydney Melanoma Unit) in Sydney, Australia who treated 48 patients from 2008 to 2016.

State of Tennessee, as part of its fiscal year 2021-2022 budget, directed funding in the amount of $2.5 million to the Company to

develop animal health drug products through partnerships with state universities that have agriculture and veterinary medicine programs

and the Company.

from the Company’s Phase 1 clinical trial of PV-10 for the treatment of neuroendocrine tumors (“NET”) metastatic to

the liver (“mNET”) refractory to somatostatin analogs (“SSAs”) and peptide receptor radionuclide therapy (“PRRT”)

(NCT02693067) was presented at the American Society of Clinical Oncology (“ASCO”) 2021 Annual Meeting, held June 4-8 online:

“Phase I study of autolytic immunotherapy of metastatic neuroendocrine tumors using intralesional rose bengal disodium.”

from the Company’s research on oral delivery of PV-10 for the treatment of adult solid tumors were published as an abstract as

part of ASCO 2021 “ Pre-clinical evaluation of PV-10 for in vitro anti-tumor activity in refractory and high-risk

adult solid tumors .”

from an ongoing clinical trial of PV-10 for the treatment of mNET refractory to SSAs and PRRT (NCT02693067) was presented at the European

Society for Medical Oncology (“ESMO”) Congress, held online from September 16-21:

“ Phase I study of hepatic intralesional

rose bengal disodium (PV10), an autolytic immunotherapy, in metastatic neuroendocrine neoplasms .”

from the Company’s ongoing Phase 1b clinical trial of PV-10 in combination with Keytruda® (pembrolizumab) for the treatment

of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade (“CB”) (NCT02557321:

first expansion

cohort) was presented at the SMR 2021 Virtual Congress (the Society for Melanoma Research annual meeting), held online from October 28-31:

“ PV-10 and anti-PD-1 in cutaneous melanoma refractory to checkpoint blockade .”

from a meta-analysis of the Company’s Phase 2 and 3 clinical trials (NCT00521053 and NCT02288897, respectively) and EAP (NCT01260779)

of single-agent PV-10 for the treatment of Stage III cutaneous melanoma was presented at the SMR 2021 Virtual Congress:

“ Lesion-Level

Response to Single-Agent PV-10 in Stage III Cutaneous Melanoma .”

2022, the Japanese Patent Office granted two of the Company’s patent applications, “ In Vitro And Xenograft Anti-Tumor

Activity Of A Halogenated-Xanthene Against Refractory Pediatric Solid Tumors” and “Combination of Local and Systemic Therapies

for Enhanced Treatment of Dermatologic Conditions.”

Development and Drug Discovery

Company’s small molecule HX medical science platform includes:

Development Programs

Intratumoral (“ITU”) formulation PV-10 ® (“ITU 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 and different types of liver cancers.

ITU PV-10 has undergone

and is undergoing clinical monotherapy and combination therapy mechanism of action and mechanism of immune response study for melanoma,

metastatic uveal melanoma, and metastatic neuroendocrine tumors at and/or with Moffitt Cancer Center in Tampa, Florida, The Queen

Elizabeth Hospital in Adelaide, Australia, and MD Anderson Cancer Center in Houston, Texas.

Topical (“TOP”) formulation PH-10 ® (“TOP PH-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.

TOP 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”).

formulations have undergone preclinical combination therapy study for psoriasis and are undergoing preclinical monotherapy study

for skin inflammation at TRU.

Ophthalmology:

The Company believes that clinical monotherapy proof-of-concept (“POC”) of

TOP administration of non-pharmaceutical grade rose bengal 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

PV-305 is undergoing preclinical monotherapy study for diseases and disorders of the eye, such as infectious keratitis at BPEI.

Vivo Proof-of-Concept Drug Discovery Programs

ITU PV-10 has undergone preclinical 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 ITU administration.

(“PO”) formulations are undergoing preclinical monotherapy study for high-risk and refractory adult solid tumor cancers

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 prophylactic and therapeutic settings, and that

the Company has achieved monotherapy in vivo POC of intravenous (“IV”) administration.

PO formulations are undergoing preclinical 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.

Different formulations are undergoing preclinical monotherapy study for the healing of full-thickness cutaneous wounds.

The Company believes that monotherapy in vivo POC of TOP 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.

Different formulations are undergoing preclinical 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 in canines of ITU administration.

Vitro Drug Discovery Programs

PO and intranasal (“IN”) formulations have undergone and are undergoing preclinical 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.

formulations have undergone preclinical monotherapy and combination therapy study for the treatment of gram-positive and gram-negative

bacterial infections (including multi-drug resistant strains) and are undergoing preclinical monotherapy study for the treatment

of oral bacterial infections at UTHSC.

formulations are undergoing preclinical monotherapy study for the treatment of fungal infections at UTHSC.

Regeneration and Repair :

Different formulations are undergoing preclinical monotherapy study for vertebrate development, wound

healing, and tissue regrowth at the University of Nevada, Las Vegas (“UNLV”) in Las Vegas, Nevada.

January, preclinical research on a formulation of the Company’s pharmaceutical-grade rose bengal against Gram-positive bacteria

was published in Molecules, an open-access journal of chemistry by UTHSC:

“ Antibacterial Activity of Pharmaceutical-Grade Rose

An Application of a Synthetic Dye in Antibacterial Therapies .”

USPTO published the Company’s patent application entitled “Halogenated Xanthenes as Vaccine Adjuvants” (publication

17/488,430) that contained, among other things, in vitro data that showed PV-10 was able to significantly increase numbers

of interferon gamma-producing CD8 cells (compared to controls) for peptides representing various antigenic regions of the Hepatitis B

virus (“HBV”) core protein (HBcAg).

These peptides were selected for their capability to raise CD4 and CD8 T cells against

March, data from an ongoing clinical trial of PV-10 for the treatment of neuroendocrine tumors metastatic to the liver refractory to

somatostatin analogs and peptide receptor radionuclide therapy (NCT02693067) were presented as an oral presentation at the annual conference

of the European Neuroendocrine Tumor Society (ENETS), held from March 10-11, 2022 in a hybrid setting of Barcelona, Spain and online:

“A phase 1 study of percutaneous autolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastases.”

Company successfully developed and manufactured a second HX.

The molecular name of the newly synthesized HX is 4,5,6,7-tetrabromo-3′,6′-dihydroxy-2′,4′,5′,7′-tetraiodo-3H-spiro[isobenz-

ofuran-1,9′-xanthen]-3-one.

April, preclinical research on systemic administration of PV-10 for the treatment of high-risk and refractory adult solid tumor cancers

is being presented at the annual meeting of the American Association for Cancer Research (AACR), held April 8-13, 2022 in New Orleans,

“ Identification and In Vivo Validation of Unique Anti-Oncogenic Properties and Mechanisms Involving Protein

Kinase Signaling and Autophagy Mediated by the Investigational New Agent PV-10 .”

Narendran, MD, PhD was added to the Company’s Scientific Advisory Board.

Narendran is a professor in the departments of Pediatrics,

Oncology, and Biochemistry & Molecular Biology at UCal, and holds the Kids Cancer Care Foundation Endowed Chair in Clinical and Translational

Research in pediatric oncology.

USPTO allowed US patent application 16/688,319 (Patent No.

11,419,844), “Composition and Method for Treating Hematologic Cancers,” covering the

use of PV-10 for the treatment of hematologic diseases.

In vivo data of mice with acute lymphoblastic leukemia receiving oral

PV-10 showed increased survival compared to controls.

This allowed patent application was the first patent awarded to the Company in

hematology from the USPTO.

May, the USPTO allowed US patent application 17/466,600 (Patent No.

11,426,379), “Combination of local and systemic therapies for enhanced treatment of

dermatologic conditions,” covering the use of topical PH-10 in combination with one or more systemic therapies for the treatment

of various inflammatory dermatoses, such as psoriasis and atopic dermatitis, and various epithelial diseases.

This allowed patent application

was the first patent awarded to the Company in dermatology from the USPTO.

June, updated data from the Company’s initial expansion cohort of patients with uveal melanoma metastatic to the liver in its cancers-of-the-liver

Phase 1 trial of PV-10 (NCT00986661) were presented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, held June

3-7 in Chicago, Illinois and online:

“ Metabolic complete responses (mCR) in metastatic uveal melanoma (mUM) patients treated

with image-guided injection (IGI) of PV-10 .”

Company’s 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.

data from the Company’s initial expansion cohort of patients with uveal melanoma metastatic to the liver in its cancers-of-the-liver

Phase 1 trial of PV-10 (NCT00986661) were part of two oral presentations at the 20 th Congress of the International Society

of Ocular Oncology (ISOO), held June 17-21, 2022 in Leiden, The Netherlands:

“ A phase 1 study of percutaneous autolytic rose

bengal disodium for metastatic uveal melanoma patients with hepatic metastases ” and “ Metabolic complete responses

(mCR) in metastatic uveal melanoma (mUM) patients treated with image-guided injection of PV-10 .”

July, the Company initiated a new sponsored research program with Kelly Tseng, PhD, Associate Professor of Pathology and Lab Medicine,

School of Life Sciences at UNLV to characterize the effects of the Company’s pharmaceutical-grade RBS on vertebrate tissue regeneration

The Tseng Lab at UNLV will assess the effects of RBS on animal development and tissue repair using the African clawed frog

( Xenopus laevis ), an established vertebrate model organism, and in vivo assays to evaluate key biological processes:

embryo development,

wound healing, and tissue regeneration.

August, the Company expanded its sponsored research program with Dr.

Narendran at UCal to investigate systemic administration of Provectus’

pharmaceutical-grade rose bengal for the treatment of pediatric leukemia.

The Company’s innovatively-assembled and proprietary

rose bengal is the lead member of a class of small molecules called halogenated xanthenes.

As part of this new sponsored research, the

Narendran team plans to identify clinically-feasible drug combinations and synthetic lethality that have synergistic activity with Provectus’

rose bengal, evaluate systemic drug administration routes for maximal tolerability, evaluate the modulation of WNK1 (lysine deficient

protein kinase 1) and other related pathways induced by the Company’s rose bengal, and complete demonstration of STING (stimulator

of interferon genes) dimerization in leukemia cells.

Company expanded its sponsored research program with Michio Kurosu, PhD, Professor, Department of Pharmaceutical Sciences at the College

of Pharmacy of UTHSC to investigate the Company’s pharmaceutical-grade RBS for the treatment of anti-fungal and anti-oral bacterial

As part of this new sponsored research, the Kurosu team plans to evaluate the in vitro activity of Provectus’ rose

bengal against different fungal strains and to conduct susceptibility tests against fungal and bacterial mouth microbes.

September, the Company entered into an option agreement with UM for an exclusive worldwide license of intellectual property developed

by the Ophthalmic Biophysics Center (“OBC”) of BPEI, which is part of the UM Health System, for the use of OBC’s photodynamic

antimicrobial therapy (PDAT) medical device in combination with Provectus’ proprietary pharmaceutical-grade rose bengal for the

treatment of bacterial, fungal, and viral infections of the eye.

The Company also initiated a sponsored research program with OBC to

investigate the Company’s pharmaceutical-grade RBS for the treatment of infectious keratitis.

Company initiated a new sponsored research program with Amina El Ayadi, PhD, Assistant Professor, Surgical Sciences Division and Jayson

Jay, PhD, Postdoctoral Research Fellow and Jeane B.

Kempner Scholar of the Burn, Trauma, and Critical Care Research Laboratory in the

Department of Surgery at UTMB to characterize the effects of Provectus’ proprietary pharmaceutical-grade RBS on full-thickness

cutaneous wounds and during the subsequent phases of wound healing.

October, the Company expanded its sponsored research program with James G.

Krueger, MD, PhD, Co-director, Center for Clinical and Translational

Martin Carter Professor in Clinical Investigation, Senior Attending Physician, and head of the Laboratory of Investigative

Dermatology at TRU to investigate the potential for PH-10 to directly alter the growth and differentiation of human keratinocytes, and

to block cytokine-mediated signaling that creates different inflammatory skin diseases and may also be important in skin neoplasms.

November, the International Nonproprietary Names (“INN”) Expert Committee of the World Health Organization (“WHO”)

selected “rose bengal sodium” (RBS) for the nonproprietary name of the Company’s API.

The RBS name was selected by

the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, reached the status of recommended INN

after a period of public consultation, and was included in INN Recommended List 88 published with the No.

3 issue of the WHO Drug Information,

Volume 36 in October 2022.

data from the Company’s ongoing, multi-cohort, Phase 1b/2 study of the combination of PV-10 and anti-PD-1 therapy Keytruda (pembrolizumab)

for the treatment of immune checkpoint blockade-naïve Stage III cutaneous melanoma (NCT01223415) were presented as a poster presentation

and an oral video communication at Melanoma Bridge 2022 in Naples, Italy and online from December 1-3, 2022:

“ Response for combination

of PV-10 autolytic immunotherapy and immune checkpoint blockade in stage III cutaneous melanoma ,”

On November 29, 2022, the Company’s Board decided to not undertake the reverse stock split and authorized share reduction, which Company stockholders

approved at the Company’s 2022 Annual Meeting of Stockholders, by the expiration date of December 31, 2022.

general, the pharmaceutical and biotechnology industries are competitive, characterized by steady and sometimes disruptive advances in

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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.

Recently, many companies across a variety of sectors

have reported disruptions, shortages, and other supply chain-related issues.

In the biopharmaceutical sector, delays and interruptions

in the supply chain have been particularly pronounced.

During 2021, we were able to effectively manage our supply of prescription

drug candidates in a manner that avoided any significant interruptions to our clinical programs.

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.

2022, many companies across a variety of sectors were still having disruptions, shortages, and other supply chain-related issues.

the biopharmaceutical sector, delays and interruptions in the supply chain have been particularly pronounced.

During 2022, we were able

to effectively manage our supply of prescription drug candidates in a manner that avoided any significant interruptions to our clinical

Regulation of Therapeutic Products

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its intended indication, and FDA approval to market a given product for a given indication after the appropriate application has been

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.

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

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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 ICH Good

Clinical Practice (“GCP”) standards.

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.

the FDA is satisfied with the results and data from pre-clinical tests, it will authorize human clinical trials.

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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.

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

Capital Resources

have four full-time employees.

We also engage independent contractors, who currently serve as COO, director of clinical operations, senior

scientist, clinical research associates, project manager, information technology manager, controller, patient advocacy manager, and database

have four full-time employees who currently serve as CFO, CTO, senior scientist, and controller.

We also engage independent contractors,

who currently serve as COO, director of clinical operations, clinical research associates, information technology manager, and patient

advocacy manager.

believe the Company’s success depends on its ability to attract, develop, and retain key personnel.

The skills, experience

and industry knowledge of key employees and contractors significantly benefit our operations and performance.

The Company’s Board

of Directors and management oversee various employee and contractor initiatives.

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.

health and safety in the workplace is one of the Company’s core values.

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In response to the pandemic, the Company has taken actions aligned with the

World Health Organization and the Centers for Disease Control and Prevention to protect its workforce so they can more safely and effectively

perform their work.

During the past two years, employees have worked remotely to ensure their safety, while continuing to perform

their duties as they would have.

WHO and the Centers for Disease Control and Prevention to protect its workforce so they can more safely and effectively perform their

During the past three years, employees have worked remotely to ensure their safety, while continuing to perform their duties as

they would have.

website is located at www.provectusbio.com .

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business