UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-K

For

the fiscal year ended December 31, 2024

For

the transition period from ____________ to ____________

Commission

file number 001-36457

PROVECTUS

BIOPHARMACEUTICALS, INC.

(Exact

name of registrant as specified in its charter)

800

S Gay St, Suite 1610, Knoxville, TN37929

(Address

of principal executive offices) (Zip Code)

866-594-5999

(Registrant’s

telephone number, including area code)

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

None N/A N/A

Securities

registered pursuant to Section 12(g) of the Act:

Common

Stock, par value $0.001 per share

(Title

of class)

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. ☐ Yes ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). ☒ Yes ☐ No

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”

“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). ☐ Yes ☒ No

The

aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which

the common equity was last sold as of June 30, 2024 was $51,633,218 (computed on the basis of $0.126 per share).

The

number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of March 25, 2025 was 420,279,879.

DOCUMENTS

INCORPORATED BY REFERENCE

The

information required by Part III is incorporated by reference to portions of the definitive proxy statement to be filed within 120 days

after December 31, 2024, pursuant to Regulation 14A under the Securities Exchange Act of 1934 in connection with the 2025 annual meeting

of stockholders.

TABLE

OF CONTENTS

PART I

ITEM 1. BUSINESS 2

ITEM 1A. RISK FACTORS 12

ITEM 1B. UNRESOLVED STAFF COMMENTS 20

ITEM 1C. CYBERSECURITY 20

ITEM 2. PROPERTIES 20

ITEM 3. LEGAL PROCEEDINGS 20

ITEM 4. MINE SAFETY DISCLOSURES 20

PART II

ITEM 6. [RESERVED] 21

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 28

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 29

ITEM 9A. CONTROLS AND PROCEDURES 30

ITEM 9B. OTHER INFORMATION 30

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 30

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 31

ITEM 11. EXECUTIVE COMPENSATION 31

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 31

PART IV

ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES 32

SIGNATURES 35

CAUTIONARY

NOTE REGARDING FORWARD LOOKING STATEMENTS

This

Annual Report on Form 10-K contains “forward-looking statements” as defined under U.S. federal securities laws. These statements

reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations. These statements also express management’s

current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,”

“believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,”

“plan,” “predict,” “project,” “should,” “strategy,” “will,” and

other similar terms. While we believe that the expectations reflected in our forward-looking statements are reasonable, we can give no

assurance that such expectations will prove correct. Forward-looking statements are subject to risks and uncertainties that could cause

our actual results to differ materially from the future results, performance, or achievements expressed in or implied by any forward-looking

statement we make. Some of the relevant risks and uncertainties that could cause our actual performance to differ materially from the

forward-looking statements contained in this report are discussed below under the heading “Risk Factors” and elsewhere in

this Annual Report on Form 10-K. We caution investors that these discussions of important risks and uncertainties are not exclusive,

and our business may be subject to other risks and uncertainties which are not detailed there. Investors are cautioned not to place undue

reliance on our forward-looking statements. We make forward-looking statements as of the date on which this Annual Report on Form 10-K

is filed with the U.S. Securities and Exchange Commission (the “SEC”), and we assume no obligation to update the forward-looking

statements after the date hereof whether as a result of new information or events, changed circumstances, or otherwise, except as required

by law.

Risks

and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements:

PART

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 and may target

disease in a bifunctional multi-modal manner. Direct contact by RBS with disease may lead to cell death or repair by one or more targeting

mechanisms, depending on the disease being treated and the concentration of RBS being utilized in the formulation. 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 and are delivered by different routes of administration specific to each disease area, including:

Intellectual

Property

U.S.

Patents

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 2024, we received five patent awards from the USPTO:

U.S. Patent No. Title Issue Date Expiration Date

2024, four patent applications were also published on the USPTO’s website:

● Halogenated Xanthenes as Vaccine Adjuvants (18/581,095),

● Composition and Method for Treating Hematologic Cancers (17/890,659).

International

Patents

2024, the Company received patent awards and allowances for eight of our patent families:

● “Halogenated xanthenes as vaccine adjuvants” in Japan.

Clinical

Development and Drug Discovery

Clinical

Development Programs

Proof-of-Concept

Programs

Early

Drug Discovery Programs

Computer

Modeling Programs

Business

Strategy

The

Company is planning to initiate new intratumoral PV-10 monotherapy and combination therapy clinical trials in mPDAC and pre-operative

penile SCC 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 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.

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.

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.

Chemical

Analytical Comparison

2022, the Company began work 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 preliminary results of these analyses indicate 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.

2024

Activity

February, the Company engaged IR Labs, Inc. (“irlabs”) to develop a comprehensive investor relations and corporate communications

program for the Company. irlabs was acquired in July 2024 by shareholder engagement and advisory company Alliance Advisors LLC and is

now known as Alliance Advisors Investor Relations.

The

Company also held an investor conference call in February.

March, the USPTO allowed patent application 17/212,723, titled “Novel Uses of Halogenated Xanthenes in Oncology and Virology.”

The application covers the use of Provectus’ s pharmaceutical grade rose bengal sodium (“RBS”) drug substance for the

treatment of infectious diseases, such as coronaviruses.

The

USPTO also allowed patent application 17/344,418, titled “In Vitro and Xenograft Anti-Tumor Activity of a Halogenated-Xanthene

Against Refractory Pediatric Solid Tumors” in March. This prospective award covers the use of RBS in combination with one or more

immune checkpoint inhibitors and is a continuation of U.S. patent 11,058,664 (2021), Provectus’ s first for pediatric oncology.

The

Company’s previously allowed patent application 17/488,430 in December 2023, titled “Halogenated Xanthenes as Vaccine Adjuvants”

and covering RBS’s use as an adjuvant in vaccines to potentially make them work better, was also awarded in March as U.S. patent

11,938,182.

The

Company entered into an agreement with the University of Miami (the “University”) in March for the exclusive worldwide license

of the University’s intellectual property related to rose bengal photodynamic antimicrobial therapy (“RB-PDAT”) for

treating bacterial, fungal, and parasitic (acanthamoeba) infections of the eye. The agreement contemplated the Company forming a majority-owned

start-up company in which the University would be a minority equity shareholder, aimed at developing and commercializing the University’s

RB-PDAT medical device in combination with a formulation of RBS. Provectus would contribute the license to the new entity and have an

exclusive RBS supply arrangement with it. In December, the Company launched VisiRose, Inc. (“VisiRose”), the Company’s first Founded Entity and a new clinical-stage

biotechnology company focused on commercializing RB-PDAT for the treatment of infectious keratitis and other serious eye infections using

a formulation of PV-10, with Provectus having 95% ownership and the University having 5%.

April, data from non-clinical research by Moffitt on intratumoral PV-10 for the treatments of human papillomavirus -positive and -negative

head and neck squamous cell carcinoma were presented at the annual meeting of the American Association for Cancer Research held in San

Diego, California from April 5-10.

The

Company’s Board of Directors appointed Ed Pershing as Chief Executive Officer and Dominic Rodrigues as President in April.

Data

from non-clinical research by the University of Calgary on oral administration of PV-10 for the treatments of solid tumor cancers were

published in April in the open access journal of oncology Cancers, “Identification and In Vivo Validation of Unique Anti-Oncogenic

Mechanisms Involving Protein Kinase Signaling and Autophagy Mediated by the Investigational Agent PV-10.”

May, the USPTO allowed patent application 17/232,393, titled “Halogenated Xanthene Composition and Method for Treating Hematologic

Cancers”. The application covers the use of Provectus’s pharmaceutical grade rose bengal sodium (“RBS”) active

pharmaceutical ingredient for the single agent or combination therapy treatment of pediatric and adult leukemias.

Clinical

and non-clinical data on RB-PDAT were presented at the annual meeting of the Association for Research in Vision and Ophthalmology in

Seattle, Washington from May 5-9.

Non-clinical

data on PV-10 for the topical treatment of full-thickness cutaneous wounds were presented by the University of Texas Medical Branch at

Galveston at the annual meeting of the Society for Investigative Dermatology in Dallas, Texas from May 15-18.

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.

October, the Company held an investor conference call accessible by Zoom Webinar.

August, the USPTO awarded patent 12,064,507, titled “Composition and method for oral treatment of leukemia.”

Competition

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,

device, 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.

Supply

Chain

During

2024, we began 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.

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 the physician labeling. Phase 3 studies usually include several hundred

to several thousand people.

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

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

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.

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.

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.

ITEM 1A. RISK FACTORS.

Our

business and its future performance may be affected by various factors, the most significant of which are discussed below.

Risks

Related to Our Business

are a clinical-stage drug company, have no prescription drug products approved for commercial sale, have incurred substantial losses,

and expect to incur substantial losses and negative operating cash flow for the foreseeable future.

are a clinical-stage drug company that has no prescription drug products approved for commercial sale. We have never generated any substantial

revenues and may never achieve substantial revenues or profitability. As of December 31, 2024, we have incurred net losses of approximately

$257 million in the aggregate since inception in January 2002. We may never achieve or maintain profitability, even if we succeed in

developing and commercializing one or more of our prescription drug candidates. We also expect to continue to incur significant operating

expenditures and anticipate that our operating and capital expenses may increase substantially in the foreseeable future as we continue

to develop and seek regulatory approval for our prescription drug candidates, develop our prescription drug formulation candidates, implement

additional internal systems and infrastructure, and hire additional personnel.

also expect to experience negative operating cash flow for the foreseeable future as we fund our operating losses and any future capital

expenditures. As a result, we will need to generate significant revenues in order to achieve and maintain profitability. We may not be

able to generate these revenues or achieve profitability in the future. Our failure to achieve or maintain profitability could negatively

impact the value of our common stock.

need additional capital to conduct our operations and commercialize and/or further develop our prescription drug candidates and prescription

drug formulation candidates in 2025 and beyond, and our ability to obtain the necessary funding is uncertain.

need additional capital in 2025 and beyond to continue developing and seeking to commercialize our drug product candidates. We intend

to continue with the development of our prescription drug candidates and prescription drug formulation candidates on the basis of historical,

ongoing, and prospective clinical and non-clinical study results. However, we need to raise additional capital through public or private offerings, debt financing, or other means

in order to successfully implement our business plan and develop and market our products.

Such financing may not be available on acceptable terms, or at all. As discussed in more detail below, additional equity financing

could result in significant dilution to stockholders. Further, in the event that additional funds are obtained through licensing or other

arrangements, these arrangements may require us to relinquish rights to some of our products, product candidates, and technologies that

we would otherwise seek to develop and commercialize ourselves. If sufficient capital is not available, we may be required to delay,

reduce the scope of, or eliminate one or more of our programs, any of which could have a material adverse effect on our business.

There

is substantial doubt as to our ability to continue as a going concern.

The

Company’s cash balance was $489,726 at December 31, 2024, which includes $182,284 of restricted cash resulting from a grant received

from the State of Tennessee. The Company’s working capital deficiency was $5,998,712 and $7,652,098 as of December 31, 2024 and 2023, respectively. The Company continues to incur significant operating losses and management expects that significant

on-going operating expenditures will be necessary to successfully implement our business plan and develop and market our products. These

circumstances raise substantial doubt about our ability to continue as a going concern for a period of one year from the date that the

consolidated financial statements included elsewhere in this Annual Report on Form 10-K are issued. Implementation of our plans and our

ability to continue as a going concern will depend upon our ability to develop our prescription drug candidates and prescription drug

formulation candidates, and to raise additional capital.

Management

believes that we may have access to capital resources through possible public or private equity offerings, including the 2025 Financing,

exchange offers, debt financings, corporate collaborations, or other means. If we are unable to raise sufficient capital, we will not

be able to pay our obligations as they become due.

Our

prescription drug product candidates are at early- to mid-stages of development and may never obtain U.S. or international regulatory

approvals required for us to commercialize our investigational drug product candidates.

will need approval of the FDA to commercialize our prescription drug product candidates in the U.S. and approvals from FDA-equivalent

regulatory authorities in international jurisdictions to commercialize our investigational drug product candidates there.

are continuing to pursue clinical development of our most advanced drug product candidates, PV-10 and PH-10, for use as treatments for

specific disease indications. The continued and further development of these drug product candidates will require significant additional

research, formulation and manufacturing development, and pre-clinical and extensive clinical testing prior to their regulatory approval

and commercialization. Pre-clinical and clinical studies of our drug product candidates may not demonstrate the safety and efficacy necessary

to obtain regulatory approvals. Pharmaceutical and biotechnology companies have suffered significant setbacks in advanced clinical trials,

even after experiencing promising results in earlier trials. Pharmaceutical products that appear to be promising at early stages of development

may not reach the market or be marketed successfully for a number of reasons, including a product may be found to be ineffective or have

harmful side effects during subsequent pre-clinical testing or clinical trials, a product may fail to receive necessary regulatory clearance,

a product may be too difficult to manufacture on a large scale, a product may be too expensive to manufacture or market, a product may

not achieve broad market acceptance, others may hold proprietary rights that will prevent a product from being marketed, and others may

market equivalent or superior products.

Satisfaction

of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate

and requires substantial resources for research, development, and testing. We cannot predict whether our research and clinical approaches

will result in drugs that the FDA considers safe for humans and effective for indicated uses. The FDA has substantial discretion in the

drug approval process and may require us to conduct additional nonclinical and clinical testing or to perform post-marketing studies.

The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes

in FDA policy that occur prior to or during our regulatory review. Delays in obtaining regulatory approvals may delay commercialization

of, and our ability to derive revenues from our prescription drug candidates, impose costly procedures on us, and diminish any competitive

advantages that we may otherwise enjoy.

Our

research and product development efforts may not be successfully completed and may not result in any successfully commercialized drug

products. Further, after commercial introduction of a new drug product, discovery of problems through adverse event reporting could result

in restrictions on the product, including withdrawal from the market and, in certain cases, civil or criminal penalties.

Even

if we comply with all FDA requests, we cannot be sure that we will ever obtain regulatory clearance for any of our drug product candidates.

Failure to obtain FDA approval of any of our prescription drug candidates will severely undermine our business by reducing our number

of saleable drug products and, therefore, corresponding revenues.

international jurisdictions, we must receive approval from the appropriate regulatory authorities before we can commercialize our prescription

drug candidates. International regulatory approval processes generally include all of the risks associated with the FDA approval procedures

described above.

Before

obtaining regulatory approval for the sale of our drug product candidates, including PV-10 and PH-10, we must conduct additional clinical

trials to demonstrate the safety and efficacy of our drug product candidates. Clinical testing is expensive, difficult to design and

implement, can take many years to complete and is uncertain as to timing and outcome. Competition in clinical development has made it

difficult to enroll patients at an acceptable rate in some of our clinical trials. Advances in medical technology could make our prescription

drug candidates obsolete prior to completion of clinical testing. A failure of one or more of our clinical trials may occur at any stage

of testing. The outcome of pre-clinical testing and early clinical trials may not be predictive of the success of later clinical trials,

and interim results of a clinical trial do not necessarily predict final results. Moreover, pre-clinical and clinical data are often

susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily

in pre-clinical studies and clinical trials have nonetheless failed to obtain marketing approval for their products. Product candidates

in later stages of clinical trials may fail to show the desired safety and efficacy characteristics despite having progressed satisfactorily

through pre-clinical studies and initial clinical testing. A number of companies in the pharmaceutical and biotechnology industries,

including those with greater resources and experience, have suffered significant setbacks in Phase 3 clinical development, even after

seeing promising results in earlier clinical trials.

Our

research and development expenses may increase in connection with expanding clinical trials of our product candidates in existing indications

and undertaking clinical trials of our product candidates in new indications. Because successful development of our drug product candidates

is uncertain, we are unable to estimate the actual funds required to complete research and development and commercialize our products

under development.

Negative

or inconclusive results of our future clinical trials of PV-10 and PH-10, or any other clinical trial we conduct, could cause the FDA

to require that we repeat or conduct additional clinical studies. Despite the results reported in earlier clinical trials for PV-10 and

PH-10, we do not know whether any clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory

approval to market our product candidates. If later stage clinical trials do not produce favorable results, our ability to obtain regulatory

approval for our product candidates may be adversely impacted.

Delays

in clinical trials are common and have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability

to obtain regulatory approval.

Our

planned or ongoing clinical trials may not begin on time, have an effective design, enroll a sufficient number of subjects, or be completed

on schedule, if at all. Events which may result in delays or unsuccessful completion of clinical trials, including our future clinical

trials, include inability to raise funding, initiate or continue a trial, delays in obtaining regulatory approval to commence a trial,

delays in reaching agreement with the FDA or other regulatory authorities on final trial design, imposition of a clinical hold following

an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities, delays in reaching agreement

on acceptable terms with prospective contract research organizations and clinical trial sites, delays in obtaining required institutional

review board approval at each site, delays in recruiting suitable patients to participate in a trial, delays in having subjects complete

participation in a trial or return for post-treatment follow-up, delays caused by subjects dropping out of a trial, delays caused by

clinical sites dropping out of a trial, time required to add new clinical sites or to obtain regulatory approval and open sites in geographic

regions beyond the sites initially planned, and delays by our contract manufacturers to produce and deliver sufficient supply of clinical

trial materials.

addition, we may experience a number of unforeseen events during clinical trials for our prescription drug candidates, including PV-10

and PH-10, that could delay or prevent the commencement and/or completion of our clinical trials, including regulators or institutional

review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial

site, the clinical study protocol may require one or more amendments delaying study completion, clinical trials of our product candidates

may produce negative or inconclusive results, and we may decide, or regulators may require us to conduct additional clinical trials or

abandon product development programs, the number of subjects required for clinical trials of our product candidates may be larger than

we anticipate, subjects may drop out of these clinical trials at a higher rate than we anticipate and enrollment in these clinical trials

may be significantly slower than we anticipated requiring us to expand the geographic scope of enrollment of patients, clinical investigators

or study subjects may fail to comply with clinical study protocols, trial conduct and data analysis errors may occur, including, but

not limited to, data entry and/or processing errors, our third-party contractors may fail to comply with regulatory requirements or meet

their contractual obligations to us in a timely manner, or at all, we might have to suspend or terminate clinical trials of our prescription

drug candidates for various reasons, including a finding that the subjects are being exposed to unacceptable health risks, regulators

or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including

noncompliance with regulatory requirements, the cost of clinical trials of our prescription drug candidates may be greater than we anticipate,

PVCT US Equity

PVCT · 10-K · period ended 2024-12-31

ITEM 1. BUSINESS.

ITEM 1A. RISK FACTORS.

PVCT US Equity☆

PVCT · 10-K · period ended 2024-12-31

ITEM 1. BUSINESS.

ITEM 1A. RISK FACTORS.

PVCT US Equity