Provectus Biopharmaceuticals, Inc 10-K for FY2024
Provectus Biopharmaceuticals, Inc. (PVCT)
About this 10-K
Provectus Biopharmaceuticals, Inc filed this 10-K on March 28, 2025, covering the fiscal year ended December 31, 2024 (FY2024).
Headline figures
Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $617.14K
- up 10.7% from $557.71K a year earlier
- Net loss
- $4.73M
- compared with a net loss of $3.1M a year earlier
- Diluted EPS
- -$0.01
- compared with -$0.01 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the fiscal year ended
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DOCUMENTS INCORPORATED BY REFERENCE
TABLE OF CONTENTS
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:
| ● | The uncertainty of generating (i) sales from rose bengal sodium-based drug product candidates PV-10® and PH-10, PV-305, and/or any rose bengal sodium-based or other halogenated xanthene-based drug product candidates (if and when approved), (ii) licensing, milestone, royalty, and/or other payments related to these drug product candidates, and/or (iii) payments from the Company’s liquidation, dissolution, or winding up, or any sale, lease, conveyance, or other disposition of any intellectual property relating to these drug product candidates and/or rose bengal sodium- and other halogenated xanthene-based drug substances; | |
| ● | The uncertainty of raising additional capital through the proceeds of private placement transactions of debt and/or equity securities, the exercise of existing warrants and outstanding stock options, and/or public offerings of debt and/or equity securities; and | |
| ● | The disruptions from a public health crisis, such as severe acute respiratory syndrome coronavirus 2, or an economic predicament, such as tariffs, or another macro upheaval to our business that could adversely affect our operations and financial condition. |
| 1 |
PART I
| 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:
| ● | 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 infectious diseases and tissue regeneration and repair, 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 2024, we received five patent awards 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 |
In 2024, four patent applications were also published on the USPTO’s website:
| ● | Anti-bacterial effect of halogenated fluorescein against colistin-resistant gram-negative bacteria (USPTO application number 18/615,444), |
| 3 |
| ● | Halogenated Xanthenes as Vaccine Adjuvants (18/581,095), | |
| ● | In Vitro and Xenograft Anti-Tumor Activity of a Halogenated-Xanthene Against Refractory Pediatric Solid Tumors (18/642,051), and | |
| ● | Composition and Method for Treating Hematologic Cancers (17/890,659). |
International Patents
In 2024, the Company received patent awards and allowances for eight of our patent families:
| ● | “Combination of local and systemic immunomodulative therapies for enhanced treatment of cancer” in Canada, | |
| ● | “Combination of Local and Systemic Therapies for Enhanced Treatment of Dermatologic Conditions” in Europe, | |
| ● | “In vitro and xenograft anti-tumor activity of a halogenated xanthene against refractory pediatric solid tumors” in Canada (allowance), | |
| ● | “Composition and Methods for Treating Hematologic Cancers” in Japan and Australia (allowance), | |
| ● | “Novel Uses of halogenated xanthenes in oncology and virology” in China and Japan, | |
| ● | “Treatment of Solid Cancerous Tumors by Oral Administration of a Halogenated Xanthene” in Japan, | |
| ● | “Halogenated Xanthene Composition and Method for Treating Hematologic Cancers” in Japan, and | |
| ● | “Halogenated xanthenes as vaccine adjuvants” in Japan. |
Clinical Development and Drug Discovery
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 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.
The Company may pursue a secondary indication of 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. | |
| ● | 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. |
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| ● | 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. | |
| ● | 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. |
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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.
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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. |
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.
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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.
Chemical Analytical Comparison
In 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
In 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.
In 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.
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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%.
In 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.”
In 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.
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.
In October, the Company held an investor conference call accessible by Zoom Webinar.
In August, the USPTO awarded patent 12,064,507, titled “Composition and method for oral treatment of leukemia.”
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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, 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.
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.
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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.
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.
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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.
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
We 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.
We 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.
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We 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.
We 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.
We 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.
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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.
We 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.
We 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.
In 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.
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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.
In 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, the supply or quality of our clinical trial materials or other materials necessary to conduct clinical trials of our prescription drug candidates may be insufficient or inadequate, and our prescription drug candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators to suspend or terminate the trials.
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Moreover, we or the FDA may suspend our clinical trials at any time if it appears we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our submissions or the conduct of these trials. If initiation or completion of any of our clinical trials for our product candidates, are delayed for any of the above reasons or other reasons, our development costs may increase, the approval process could be delayed, any periods during which we may have the exclusive right to commercialize our prescription drug candidates may be reduced and our competitors may bring drug products to market before us. Any of these events could impair our ability to generate revenues from drug product sales and impair our ability to generate regulatory and commercialization milestones and royalties, all of which could have a material adverse effect on our business.
The results of our clinical trials may not support acceptable label claims concerning our prescription drug candidates.
Even if our clinical trials are completed as planned, we cannot be certain that their results will support acceptable label claims concerning our drug product candidates. Success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and pre-clinical testing. The clinical trial process may fail to demonstrate that our prescription drug candidates are safe for humans or effective for indicated uses.
This failure could cause us to abandon a prescription drug candidate and may delay development of other prescription drug candidates. Any delay in, or termination of, our clinical trials will delay our ability to commercialize our prescription drug candidates and generate product revenues. In addition, we anticipate that our clinical trials will involve only a small patient population. Accordingly, the results of such trials may not be indicative of future results over a larger patient population.
Physicians and patients may not accept and use our prescription drug candidates.
Even if the FDA approves our drug product candidates, physicians and patients may not accept and use them. Acceptance and use of our drug products will depend upon a number of factors including perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of our drug products, availability of reimbursement for our drug products from government or other healthcare payers, and effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.
Because we expect sales or licensure of our prescription drug candidates, if approved, to generate substantially all of our revenues if they are approved, the failure of any of these drugs to find market acceptance would harm our business and could require us to seek additional financing.
We have no sales, marketing, or distribution capabilities for our prescription drug candidates.
We currently have no sales, marketing, or distribution capabilities. Our future success depends, in part, on our ability to enter into and maintain collaborative relationships, the collaborator’s strategic interest in the prescription drug products under development and such collaborator’s ability to successfully market and sell any such drug products. There can be no assurance that we will be able to establish or maintain relationships with third party collaborators or develop in-house sales and distribution capabilities. To the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third parties, and there can be no assurance that such efforts will be successful. In addition, there can also be no assurance that we will be able to market and sell our prescription drug candidates in the U.S. or internationally.
Competition in the prescription pharmaceutical and biotechnology industries is intense.
Other pharmaceutical and biotechnology companies and research organizations currently engage in or have in the past engaged in research efforts related to treatment of cancer and dermatological conditions, which may compete with our clinical trials for patients and investigator resources, cause lower enrollment than anticipated, and could lead to the development of drug products or treatment therapies that could compete directly with our drug product candidates that we are seeking to develop and market.
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Many companies are also developing novel therapies to treat cancer and dermatological conditions and, in this regard, are our competitors. Many of the pharmaceutical companies developing and marketing these competing products have greater financial resources and expertise than we do in research and development, manufacturing, non-clinical and clinical testing, obtaining regulatory approvals, and marketing.
Smaller companies may also prove to be competitors, particularly through collaborative arrangements with larger and more established companies that may compete with our efforts to establish similar collaborative arrangements. Academic institutions, government agencies, and other public and private research organizations may also conduct research, seek patent protection, and establish collaborative arrangements for research, clinical development, and marketing of prescription drug candidates similar to ours. These companies and institutions compete with us in recruiting and retaining qualified scientific and management personnel as well as in acquiring technologies complementary to our drug development programs.
In addition to the above factors, we expect to face competition in product efficacy and safety, the timing and scope of regulatory consents, availability of resources, reimbursement coverage, price, and patent position, including potentially dominant patent positions of others.
Since our prescription drug candidates PV-10 and PH-10 have not yet been approved by the FDA or introduced to the marketplace, we cannot estimate what competition these prescription drug candidates might face when they are finally introduced, if at all. We cannot assure you that these prescription drug candidates will not face significant competition for other approved drug products, investigational drug products, and generic equivalents.
If we lose any of our key personnel, we may be unable to successfully execute our business plan.
Our business is presently managed by key Board members and employees: (i) Ed Pershing, who is CEO and chairman of the Board, (ii) Dominic Rodrigues, who is President and vice chairman of the Board, (iii) Eric Wachter, Ph.D., our CTO, and (iv) Heather Raines, CPA, our CFO.
In order to successfully execute our business plan, our management and Board must succeed in all of the following critical areas: researching diseases and possible therapies in the areas of oncology and dermatology, developing our prescription drugs candidates, marketing and selling developed prescription drug candidates, obtaining additional capital to finance research and development production, and marketing of our drug products, and managing our business as it grows.
Disruption resulting from management transition may have a detrimental impact on our ability to implement our strategy. The reduction in role and/or loss of key employees, contractors, and/or Board members could have a material adverse effect on our operations, and limit or constrain our ability to execute our business plan.
Our business and operations are subject to risks related to climate change.
The long-term effects of global climate change present risks to our business. Extreme weather or other conditions caused by climate change could adversely impact our supply chain and the operation of our business. Such conditions could also result in physical damage to our leased property, clinical trial materials, clinical sites, or the facilities of our contract manufacturers. These events could adversely affect our operations and our financial performance.
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Our business and operations are vulnerable to computer system failures, cyber-attacks, or deficiencies in our cyber-security, which could increase our expenses, divert the attention of our management and key personnel away from our business operations and adversely affect our results of operations.
Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from: computer viruses; malware; natural disasters; terrorism; war; telecommunication and electrical failures; cyber-attacks or cyber-intrusions over the Internet; attachments to emails; persons inside our organization; or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, and damage to our reputation, and the further development of our product candidates could be delayed. We could be forced to expend significant resources in response to a cyber security breach, including repairing system damage, increasing cyber security protection costs by deploying additional personnel and protection technologies, paying regulatory fines, and resolving legal claims and regulatory actions, all of which would increase our expenses, divert the attention of our management and key personnel away from our business operations and adversely affect our results of operations.
Risks Related to Our Intellectual Property (“IP”)
If we are unable to secure or enforce patent rights, trademarks, trade secrets or other IP, our business could be harmed.
We may not be successful in securing or maintaining proprietary patent protection for our prescription drug candidates and technologies we develop or license. In addition, our competitors may develop prescription drug candidates similar to ours using methods and technologies that are beyond the scope of our IP protection, which could reduce our anticipated sales. While some of our drug product candidates have proprietary patent protection, a challenge to these patents can subject us to expensive litigation. Litigation concerning patents, other forms of IP, and proprietary technology is becoming more widespread and can be protracted and expensive and can distract management and other personnel from performing product development duties.
We also rely upon trade secrets, unpatented proprietary knowledge and continuing technological innovation to develop a competitive position. We cannot assure you that others will not independently develop substantially equivalent proprietary technology and techniques or otherwise gain access to our trade secrets and technology, or that we can adequately protect our trade secrets and technology.
If we are unable to secure or enforce patent rights, trademarks, trade secrets, or other IP, our business, financial condition, results of operations and cash flows could be materially adversely affected. If we infringe on the IP of others, our business could be harmed.
We could be sued for infringing patents and other IP that purportedly cover prescription drug candidates and/or methods of using such prescription drug candidates held by persons other than us. Litigation arising from an alleged infringement could result in removal from the market, or a substantial delay in, or prevention of, the introduction of our prescription drug candidates, any of which could have a material adverse effect on our business, financial condition, results of operations, and cash flows.
If we do not update and enhance our technologies, they will become obsolete.
The pharmaceutical market is characterized by technological change, and our future success will depend on our ability to conduct successful research in our fields of expertise, discover new technologies as a result of that research, develop products based on our technologies, and commercialize those products. While we believe that our current technology is adequate for our present needs, if we fail to stay at the forefront of technological development, we will be unable to compete effectively. Our competitors may use greater resources to develop new pharmaceutical technologies and to commercialize products based on those technologies. Accordingly, our technologies may be rendered obsolete by advances in existing technologies or the development of different technologies by one or more of our current or future competitors.
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Risks Related to Our Governing Documents and Securities
Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent a change of control, even if an acquisition would be beneficial to our stockholders, which could affect our stock price adversely and prevent attempts by our stockholders to replace or remove our current management.
Our certificate of incorporation, as amended, and bylaws contain provisions that could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable. Among other things, these provisions will (i) permit our Board to issue up to 25,000,000 shares of preferred stock which can be created and issued by the Board without prior stockholder approval, with rights senior to those of the common stock, (ii) provide that all vacancies on our Board, including as a result of newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum, (iii) require that any action to be taken by our stockholders must be affected at a duly called annual or special meeting of stockholders and not be taken by written consent, (iv) provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice, (v) not provide for cumulative voting rights, and (vi) provide that special meetings of our stockholders may be called only by the Board or by such person or persons requested by a majority of the Board to call such meetings.
These and other provisions in our certificate of incorporation, as amended, and bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain control of our Board or initiate actions that are opposed by our then-current Board, including delaying or impeding a merger, tender offer, or proxy contest involving our company. Any delay or prevention of a change of control transaction or changes in our Board could cause the market price of our common stock to decline.
Our stock price is below $5.00 per share and is treated as a “penny stock,” which places restrictions on broker-dealers recommending the stock for purchase.
Our common stock is defined as “penny stock” under the Exchange Act and its rules. The SEC has adopted regulations that define “penny stock” to include common stock that has a market price of less than $5.00 per share, subject to certain exceptions. These rules include the following requirements: (i) broker-dealers must deliver, prior to the transaction, a disclosure schedule prepared by the SEC relating to the penny stock market, (ii) broker-dealers must disclose the commissions payable to the broker-dealer and its registered representative, (iii) broker-dealers must disclose current quotations for the securities, and (iv) a broker-dealer must furnish its customers with monthly statements disclosing recent price information for all penny stocks held in the customer’s account and information on the limited market in penny stocks.
Additional sales practice requirements are imposed on broker-dealers who sell penny stocks to persons other than established customers and accredited investors. For these types of transactions, the broker-dealer must make a special suitability determination for the purchaser and must have received the purchaser’s written consent to the transaction prior to sale. If our common stock remains subject to these penny stock rules these disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for our common stock. As a result, fewer broker-dealers may be willing to make a market in our stock, which could affect a shareholder’s ability to sell their shares.
Future sales by our stockholders may adversely affect our stock price and our ability to raise funds in new stock offerings.
Sales of our common stock in the public market following any prospective offering could lower the market price of our common stock. Sales may also make it more difficult for us to sell equity securities or equity-related securities in the future at a time and price that our management deems acceptable.
It is our general policy to retain any earnings for use in our operation.
We have never declared or paid cash dividends on our common stock. We currently intend to retain all of our future earnings, if any, for use in our business and therefore do not anticipate paying any cash dividends on our common stock in the foreseeable future.
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In the event of the liquidation, winding-up or dissolution of the Company or certain mergers, corporate reorganizations or sales of our assets, holders of Series D and Series D-1 Preferred Stock will be entitled to a preference of a multiple of their investment amount, which will reduce the proceeds to be received by holders of our common stock.
In connection with the 2025, 2024, 2022, 2021, 2020 and 2017 Financings, we have issued convertible notes that converted or are convertible into shares of Series D and Series D-1 Preferred Stock. The Series D and Series D-1 Preferred Stock will have a first priority right to receive proceeds from the liquidation, winding-up or dissolution of us or certain mergers, corporate reorganizations, or sales of our assets (each, a “Company Event”). If a Company Event occurs within two (2) years of the date of issuance of the Series D and Series D-1 Preferred Stock (the “Date of Issuance”), the holders of Series D and Series D-1 Preferred Stock will receive a preference of four times (4x) their respective investment amount. If a Company Event occurs after the second (2nd) anniversary of the Date of Issuance, the holders of the Series D and Series D-1 Preferred Stock will receive a preference of six times (6x) their respective investment amount. As a result, upon the occurrence of a Company Event, the holders of Series D and Series D-1 Preferred Stock would have the right to receive proceeds from any such transaction before our common stockholders. The payment of this preference could result in our common stockholders not receiving any consideration in connection with a Company Event.
| ITEM 1B. | UNRESOLVED STAFF COMMENTS. |
None.
| ITEM 1C. | CYBERSECURITY. |
Our use of information systems for accessing, transmitting, and storing data is a vital aspect of our business operations. Information systems can be vulnerable to a range of cybersecurity threats that could potentially have a material impact on our business, results of operations, and financial condition.
Cybersecurity
is a key category within our risk management efforts, and our cybersecurity risk management is intended to assist in assessing, identifying,
and managing material risks from cybersecurity threats to the Company’s information systems. Our cybersecurity risk management
and strategy are based upon utilizing systems that are cloud-based which require multifactor authentication to access.
We also require our employees to participate in cybersecurity training and awareness programs. The Company’s employees are expected to help safeguard the Company’s information systems and to assist in the discovery and reporting of cybersecurity incidents. These programs are intended to decrease cybersecurity risks associated with human error and foster a culture of cybersecurity consciousness.
To
date,
| ITEM 2. | PROPERTIES. |
On June 18, 2022, the Company moved into 2,700 square feet of leased corporate office space in Knoxville, Tennessee through an operating lease agreement for a term of three years ending June 30, 2025. The monthly base rent ranges from $4,053 to $4,278 over the term on the lease.
| Item 3. | Legal Proceedings. |
The information required by this item is incorporated by reference from Part II, Item 8. Financial Statements and Supplementary Data, Notes to Consolidated Financial Statements, Note 17 – Commitments, Contingencies, and Litigation.
None.
| ITEM 4. | MINE SAFETY DISCLOSURES. |
Not applicable.
| 20 |
PART II
| ITEM 5. | MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. |
Market Information and Holders
Our common stock trades on the OTCQB Marketplace under the symbol “PVCT”.
As of March 25, 2025, we had 809 active stockholders of record of our common stock.
Dividend Policy
We have never declared or paid any cash dividends on our common stock. We currently plan to retain future earnings, if any, to finance the growth and development of our business and do not anticipate paying any cash dividends in the foreseeable future. We may incur indebtedness in the future which may prohibit or effectively restrict the payment of dividends, although we have no current plans to do so. Any future determination to pay cash dividends will be at the discretion of our Board of Directors. The holders of our Series D and Series D-1 Preferred Stock are entitled to receive dividends, if any, that are declared and paid to common stockholders.
Securities Authorized for Issuance under Equity Compensation Plans
Information about the securities authorized for issuance under our equity compensation plans will be set forth under the heading “Equity Compensation Plan Information” in the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, which will be filed with the SEC pursuant to Regulation 14A under the Exchange Act, incorporated by reference in Part III, Item 12 of this Annual Report on Form 10-K.
| ITEM 6. | [RESERVED]. |
Not applicable.
| ITEM 7. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. |
The following discussion is intended to assist in the understanding and assessment of significant changes and trends related to our results of operations and our financial condition together with our consolidated subsidiaries. This discussion and analysis should be read in conjunction with the accompanying consolidated financial statements and notes thereto included in the Annual Report on Form 10-K. Historical results and percentage relationships set forth in the statements of operations, including trends which might appear, are not necessarily indicative of future operations.
| 21 |
Business Strategy
The Company is selectively continuing ongoing and planning to initiate new monotherapy and combination therapy ITU PV-10 clinical trials in melanoma and liver cancer indications to generate more and/or new clinical data and appropriately utilizing clinical data from historical ITU PV-10 trials, EAPs, and/or QOL study of these oncology indications. Our goals are to pursue drug approval pathways and/or co-development relationships with commercial pharmaceutical companies for ITU PV-10 based on these indications and data.
The Company is developing a systemically administered formulation of pharmaceutical-grade RBS for the treatment of cancer. Our goals, when this work is complete, are to file an investigational new drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”), take an initial systemic drug 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 pharmaceutical-grade RBS using different concentrations 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 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 and indication 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 and utilize 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.
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 ITU 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 ITU PV-10 for the treatment of the Company’s former lead indication of locally advanced cutaneous melanoma, 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).
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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 the third quarter of 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 the fourth quarter of 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 in 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% and may contain substantial amounts of unreported 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.
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.
Chemical Analytical Comparison
In the first quarter of 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 by the end of the third quarter of 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.
| 23 |
Components of Operating Results
Grant Revenue
Grant revenue is recognized when qualifying costs are incurred and there is reasonable assurance that the conditions of the grant have been met. Cash received from grants in advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as grant revenue when qualifying costs are incurred.
Research and Development Expenses
A large component of our total operating expenses is the Company’s investment in research and development activities, including the clinical development of our product candidates. Research and development expenses represent costs incurred to conduct research and undertake clinical trials to develop our drug product candidates. These expenses consist primarily of:
| ● | costs of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations and consultants, among others; | |
| ● | salaries and related expenses for personnel, including stock-based compensation expense; | |
| ● | other outside service costs including cost of contract manufacturing; | |
| ● | the costs of supplies and reagents; and | |
| ● | occupancy and depreciation charges. |
| 24 |
We expense research and development costs as incurred.
Research and development activities are central to our business model. We expect our research and development expenses to increase in the future as we advance our existing product candidates through clinical trials and pursue their regulatory approval. Undertaking clinical development and pursuing regulatory approval are both costly and time-consuming activities. As a result of known and unknown uncertainties, we are unable to determine the duration and completion costs of our research and development activities, or if, when, and to what extent we will generate revenue from any subsequent commercialization and sale of our drug product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, stock-based compensation expense and other related costs for personnel in executive, finance, accounting, business development, legal, information technology and corporate communication functions. Other costs include facility costs not otherwise included in research and development expenses, insurance, and professional fees for legal, patent and accounting services.
Comparison of the Years Ended December 31, 2024 and 2023
Overview
Refer to tables below for year-over-year comparison of revenues and expenses.
| For the Years Ended | ||||||||||||||||
| December 31, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Grant Revenue | $ | 617,140 | $ | 557,710 | $ | 59,430 | 10.7 | % | ||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 1,999,127 | 1,749,240 | 249,887 | 14.3 | % | |||||||||||
| General and administrative | 3,150,397 | 1,709,720 | 1,440,677 | 84.3 | % | |||||||||||
| Total Operating Expenses | 5,149,524 | 3,458,960 | 1,690,564 | 48.9 | % | |||||||||||
| Total Operating Loss | (4,532,384 | ) | (2,901,250 | ) | (1,631,134 | ) | 56.2 | % | ||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit | 9,320 | 15,696 | (6,376 | ) | -40.6 | % | ||||||||||
| Interest expense | (239,073 | ) | (216,214 | ) | (22,859 | ) | 10.6 | % | ||||||||
| Total Other Income (Expense), Net | (229,753 | ) | (200,518 | ) | (29,235 | ) | 14.6 | % | ||||||||
| Net Loss | (4,762,137 | ) | (3,101,768 | ) | (1,660,369 | ) | 53.5 | % | ||||||||
| Net loss attributable to noncontrolling interest | 29,585 | - | 29,585 | 0.0 | % | |||||||||||
| Net loss attributable to common stockholders | $ | (4,732,552 | ) | $ | (3,101,768 | ) | $ | (1,630,784 | ) | -52.6 | % | |||||
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Grant Revenue
For the years ended December 31, 2024 and 2023, there was $617,140 and $557,710 respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development on the consolidated statements of operations.
Research and Development
Research and development expenses were $1,999,127 for the year ended December 31, 2024, an increase of $249,887 or 14.3% compared to $1,749,240 for the year ended December 31, 2023. The increase was due to (i) higher clinical trial costs associated with closing out open trials, (ii) slightly higher rent expense, partially offset by iii) lower depreciation expense, iv) lower insurance cost, and v) lower payroll taxes and vacation expense.
The following table summarizes our research and development expenses incurred during the years ended December 31, 2024 and 2023:
| For the Years Ended | ||||||||||||||||
| December 31, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development: | ||||||||||||||||
| Clinical trial and research expenses | $ | 1,463,422 | $ | 1,193,529 | $ | 269,893 | 22.6 | % | ||||||||
| Depreciation/amortization | 5,294 | 7,059 | (1,765 | ) | -25.0 | % | ||||||||||
| Insurance | 225,754 | 229,774 | (4,020 | ) | -1.7 | % | ||||||||||
| Payroll and taxes | 270,360 | 284,616 | (14,256 | ) | -5.0 | % | ||||||||||
| Rent and utilities | 34,297 | 34,262 | 35 | 0.1 | % | |||||||||||
| Total research and development | $ | 1,999,127 | $ | 1,749,240 | $ | 249,887 | 14.3 | % | ||||||||
General and Administrative
General and administrative expenses were $3,150,397 for the year ended December 31, 2024, an increase of $1,440,677 or 84.3% compared to $1,709,720 for the year ended December 31, 2023. The increase was due to (i) stock-based compensation for vested options granted to company executives, employee and independent board members, (ii) higher legal costs relating to patent application and general business fees, (iii) increased payroll expense due to hiring two executives, (iv) increased professional fees related to investor relations, (v) higher other general and administrative costs due to a refund received in 2023 for employee retention, and (vi) unfavorable foreign currency translation cost, partially offset by (vii) reversal of director fees for Mr. Horowitz as he waived these fees upon his resignation on March 25, 2024, and (viii) lower insurance costs.
The following table summarizes our general and administrative expenses incurred during the years ended December 31, 2024 and 2023:
For the Years Ended December 31, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| General and administrative: | ||||||||||||||||
| Depreciation | $ | 1,862 | $ | 1,862 | $ | - | 0.0 | % | ||||||||
| Directors fees | (121,250 | ) | 385,000 | (506,250 | ) | -131.5 | % | |||||||||
| Insurance | 168,644 | 179,846 | (11,202 | ) | -6.2 | % | ||||||||||
| Legal and litigation | 576,908 | 387,189 | 189,719 | 49.0 | % | |||||||||||
| Other general and administrative cost | 66,373 | 40,793 | 25,580 | 62.7 | % | |||||||||||
| Payroll and taxes | 644,479 | 250,685 | 393,794 | 157.1 | % | |||||||||||
| Professional fees | 512,500 | 469,438 | 43,062 | 9.2 | % | |||||||||||
| Rent and utilities | 19,314 | 19,134 | 180 | 0.9 | % | |||||||||||
| Stock based compensation | 1,280,776 | - | 1,280,776 | 0.0 | % | |||||||||||
| Foreign currency translation | 791 | (24,227 | ) | 25,018 | 100.0 | % | ||||||||||
| Total general and administrative | $ | 3,150,397 | $ | 1,709,720 | $ | 1,440,677 | 84.3 | % | ||||||||
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Other Income/(Expense)
Research and development tax credits in Australia were $9,320 for the year ended December 31, 2024, a decrease of $6,376 or 40.6%, compared to $15,696 for the year ended December 31, 2023. The decrease was mainly due to no active clinical trials currently in Australia.
Interest expense increased by $22,859 from $216,214 for the year ended December 31, 2023 to $239,073 for the year ended December 31, 2024. The increase was due to the issuance of new 2022 and 2024 Notes, partially offset by the impact of the conversion of the 2021 and 2022 Notes into shares of Series D-1 Preferred Stock.
The following table summarizes our Other Income/(Expenses) incurred during the years ended December 31, 2024 and 2023:
| For the Years Ended | ||||||||||||||||
| December 31, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Other Income/Expense): | ||||||||||||||||
| Research and development tax credit | $ | 9,320 | $ | 15,696 | $ | (6,376 | ) | -40.6 | % | |||||||
| Interest expense, net | (239,073 | ) | (216,214 | ) | (22,859 | ) | -10.6 | % | ||||||||
| Total Other Income/(Expense), Net | $ | (229,753 | ) | $ | (200,518 | ) | $ | (29,235 | ) | -14.6 | % | |||||
Liquidity and Going Concern
Our cash, and restricted cash were $489,726 at December 31, 2024, which includes the $182,284 of restricted cash associated with the grant received from the State of Tennessee. The consolidated financial statements and notes thereto included in this Annual Report on Form 10-K have been prepared on a basis that contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $257,422,961 as of December 31, 2024. These conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date that the consolidated financial statements included elsewhere in this Annual Report on Form 10-K are issued. Our financial statements do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to obtain additional financing as may be required to fund current operations.
Management’s plans include selling our equity securities and obtaining other financing to fund our capital requirements and on-going operations, including the 2025 Financing discussed above; however, there can be no assurance we will be successful in these efforts. Significant funds will be needed to continue and complete our ongoing and planned clinical trials.
As of December 31, 2024, cash requirements for our current liabilities include approximately $3,307,226 for accounts payable and accrued expenses (including lease liabilities) and a $206,463 note payable related to our short-term financing of our commercial insurance policies. Also, if not converted prior to maturity, convertible debt in the amount of $2,953,000 plus $172,687 of accrued interest will mature one year from the date of the notes. The 2024 Notes are only subject to repayment in the event of a change of control or event of default. The Company intends to meet these cash requirements from its current cash balance and from future financing.
Access to Capital
Management plans to access 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 through the 2025 Financing or otherwise, we will not be able to pay our obligations as they become due.
| 27 |
The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, we cannot assure you that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing our prescription drug candidates. Moreover, even if we are successful in improving our current cash flow position, we nonetheless plan to seek additional funds to meet our current and long-term requirements in 2025 and beyond. We anticipate that these funds will otherwise come from the proceeds of private placement transactions, including the 2025 Financing, exercise of outstanding stock options, or public offerings of debt or equity securities. While we believe that we have a reasonable basis for our expectation that we will be able to raise additional funds, we cannot assure you that we will be able to complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders.
During the years ended December 31, 2024 and 2023, our sources and uses of cash were as follows:
Net Cash Used in Operating Activities
We experienced negative cash flows from operating activities for the years ended December 31, 2024 and 2023 in the amounts of $3,284,091 and $2,571,978, respectively. The net cash used in operating activities for the year ended December 31, 2024 was primarily due to cash used to fund a net loss of $4,762,137, adjusted for non-cash items in the aggregate amount of $1,335,335, plus $156,942 of cash generated from changes in the levels of operating assets and liabilities. The net cash used in operating activities for the year ended December 31, 2023 was primarily due to cash used to fund a net loss of $3,101,768, adjusted for non-cash expenses in the aggregate amount of $56,868, plus $472,922 of cash generated from changes in the levels of operating assets and liabilities.
Net Cash Provided by Financing Activities
Net cash provided by financing activities during the years ended December 31, 2024 and 2023 was $2,733,158 and $2,191,555, respectively. During the year ended December 31, 2024, we received $2,853,000 proceeds from the issuance of convertible notes payable, $300,000 from the issuance of common stock of our majority-owned subsidiary, VisiRose, and offset by $100,000 repayment of a 2021 convertible note payable and $305,135 for repayment of the short-term note payable. During the year ended December 31, 2023, we received $2,475,000 proceeds from the issuance of convertible notes payable and paid $283,445 for the repayment of the short-term note payable.
Critical Accounting Estimates
We prepare our consolidated financial statements in accordance with U.S. GAAP, which require our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.
We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are items within our financial statements that require estimation but are not deemed critical, as defined above.
| ITEM 7A. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. |
Not applicable.
| 28 |
| ITEM 8. | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. |
INDEX TO FINANCIAL STATEMENTS
| 29 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors of
Provectus Biopharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Provectus Biopharmaceuticals, Inc. (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ deficit, and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, based on our audits, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
Explanatory Paragraph – Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has a significant working capital deficit, has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/
Marcum LLP
We have served as the Company’s auditor since 2016.
March 27, 2025
| F-1 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
| December 31, | December 31, | ||||||||
| 2024 | 2023 | ||||||||
| Assets | |||||||||
| Current Assets: | |||||||||
| Cash | $ | $ | |||||||
| Restricted cash | |||||||||
Short-term receivables | |||||||||
| Prepaid expenses and other current assets | |||||||||
| Total Current Assets | |||||||||
| Equipment and furnishings, less accumulated depreciation of $ | |||||||||
| Operating lease right-of-use asset | |||||||||
| Total Assets | $ | $ | |||||||
| Liabilities and Stockholders’ Deficit | |||||||||
| Current Liabilities: | |||||||||
| Accounts payable | $ | $ | |||||||
| Unearned grant revenue | |||||||||
| Other accrued expenses | |||||||||
| Accrued interest | |||||||||
| Accrued interest - related parties | |||||||||
| Accrued interest | |||||||||
| Notes payable | |||||||||
| Convertible notes payable | |||||||||
| Convertible notes payable - related parties | |||||||||
| Convertible notes payable | |||||||||
| Operating lease liability, current portion | |||||||||
| Total Current Liabilities | |||||||||
| Operating lease liability, non-current portion | |||||||||
| Total Liabilities | |||||||||
| Commitments, contingencies, and litigations (Note 17) | |||||||||
| Stockholders’ Deficit: | |||||||||
Preferred stock; par value $ per share; shares authorized; | |||||||||
|
Series D Convertible Preferred Stock; and shares designated at December 31, 2024 and 2023, respectively; and shares issued and outstanding at December 31, 2024 and 2023, respectively; aggregate liquidation preference of $ | |||||||||
| Series D-1 Convertible Preferred Stock; and shares designated at December
31, 2024 and 2023, respectively; and shares issued and outstanding at December 31, 2024 and 2023, respectively; aggregate liquidation preference of $ | |||||||||
| Preferred stock, value | |||||||||
| Common stock; par value $ per share; shares authorized; and shares issued and outstanding at December 31, 2024 and 2023 | |||||||||
| Additional paid-in capital | |||||||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | |||||
| Accumulated deficit | ( | ) | ( | ) | |||||
| Total stockholders’ deficit attributable to Provectus Biopharmaceuticals, Inc. stockholders | ( | ) | ( | ) | |||||
| Non-controlling interest | ( | ) | |||||||
| Total Stockholders’ Deficit | ( | ) | ( | ) | |||||
| Total Liabilities and Stockholders’ Deficit | $ | $ | |||||||
See accompanying notes to consolidated financial statements.
| F-2 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| 2024 | 2023 | |||||||
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Grant Revenue | $ | $ | ||||||
| Operating Expenses: | ||||||||
| Research and development | ||||||||
| General and administrative | ||||||||
| Total Operating Expenses | ||||||||
| Total Operating Loss | ( | ) | ( | ) | ||||
| Other Income/(Expense): | ||||||||
| Research and development tax credit | ||||||||
| Interest expense | ( | ) | ( | ) | ||||
| Total Other Income (Expense), Net | ( | ) | ( | ) | ||||
| Net Loss | ( | ) | ( | ) | ||||
| Less: Net loss attributable to noncontrolling interest | ||||||||
| Net loss attributable to Provectus Biopharmaceuticals, Inc. stockholders | $ | ( | ) | $ | ( | ) | ||
| Basic and Diluted Loss Per Common Share | $ | ) | $ | ) | ||||
| Weighted Average Number of Common | ||||||||
| Shares Outstanding - Basic and Diluted | ||||||||
See accompanying notes to consolidated financial statements.
| F-3 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
| 2024 | 2023 | |||||||
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Net Loss | $ | ( | ) | $ | ( | ) | ||
| Other Comprehensive (Loss): | ||||||||
| Foreign currency translation adjustments | ( | ) | ( | ) | ||||
| Comprehensive loss | ( | ) | ( | ) | ||||
| Comprehensive loss attributed to non-controlling interest | ( | ) | ||||||
| Comprehensive loss attributed to controlling interests | $ | ( | ) | $ | ( | ) | ||
See accompanying notes to consolidated financial statements.
| F-4 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
| Preferred Stock | Preferred Stock | Additional | Accumulated Other | |||||||||||||||||||||||||||||||||||||||||
| Series D | Series D-1 | Common Stock | Paid-In | Comprehensive | Accumulated | Noncontrolling | ||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Loss | Deficit | Interest | Total | ||||||||||||||||||||||||||||||||||
| Balance at January 1, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||
| Stock-based compensation: | ||||||||||||||||||||||||||||||||||||||||||||
| Common stock | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Conversion of 2021 Notes to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Conversion of 2022 Notes to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||||||||||
| Balance | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||
| Forfeited shares of Series D Preferred Stock | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred Stock | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock of majority-owned subsidiary | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation: | ||||||||||||||||||||||||||||||||||||||||||||
| Options | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Conversion of accrued directors’ fees to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Conversion of 2022 Notes to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Conversion of Series D-1 Preferred Stock to Common Stock | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||
| $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||
See accompanying notes to consolidated financial statements.
| F-5 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Non-cash operating lease expense | ||||||||
| Depreciation | ||||||||
| Changes in operating assets and liabilities | ||||||||
| Short term receivables | ( | ) | ||||||
| Prepaid expenses and other current assets | ||||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Unearned grant revenue | ( | ) | ( | ) | ||||
| Other accrued expenses | ||||||||
| Operating lease liability | ( | ) | ( | ) | ||||
| Accrued interest | ||||||||
| Net Cash Used In Operating Activities | ( | ) | ( | ) | ||||
| Cash Flows From Financing Activities: | ||||||||
| Proceeds from issuance of convertible notes payable | ||||||||
| Proceeds from issuance of convertible notes payable - related party | ||||||||
| Proceeds from issuance of common stock of majority-owned subsidiary | ||||||||
| Repayment of short-term note payable | ( | ) | ( | ) | ||||
| Repayment of 2021 convertible note payable - related party | ( | ) | ||||||
| Net Cash Provided By Financing Activities | ||||||||
| Effect of exchange rates on cash and restricted cash | ( | ) | ( | ) | ||||
| Net Decrease In Cash and Restricted Cash | ( | ) | ( | ) | ||||
| Cash and Restricted Cash, Beginning of Period | ||||||||
| Cash and Restricted Cash, End of Period | $ | $ | ||||||
| Cash and restricted cash consisted of the following: | ||||||||
| Cash | $ | $ | ||||||
| Restricted cash | ||||||||
| $ | $ | |||||||
| Supplemental Disclosures of Cash Flow Information: | ||||||||
| Cash paid during the year for: | ||||||||
| Interest | $ | $ | ||||||
| Income taxes | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Conversion of 2021 Notes and related accrued interest to Series D-1 Preferred Stock | $ | $ | ||||||
| Conversion of 2022 Notes and related accrued interest to Series D-1 Preferred Stock | $ | $ | ||||||
| Conversion of accrued directors’ fees to Series D-1 Preferred Stock | $ | $ | ||||||
| Conversion of Series D-1 Preferred Stock to common stock | $ | 683 | - | |||||
| Forfeited shares of Series D Preferred Stock | $ | ( | ) | |||||
| Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred Stock | $ | |||||||
| Issuance of common stock of majority-owned subsidiary | ||||||||
| Purchase of insurance policies financed by short-term note payable | $ | ( | ) | $ | ( | ) | ||
See accompanying notes to consolidated financial statements.
| F-6 |
PROVECTUS BIOPHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Business Organization and Nature of Operations
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 based on a class of bioactive synthetic small molecule halogenated xanthenes (“HXs”). Our lead HX molecule is named rose bengal sodium (“RBS”).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (“API”) in the drug candidates of our current clinical development programs and the formulations of our current non-clinical in vivo proof-of-concept and in vitro early 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.
The Company believes that RBS targets disease in a bifunctional multi-modal manner. Direct contact by RBS with disease may lead to cell death or repair, depending on the disease being treated and the concentration of RBS being utilized in the therapeutic formulation, by one or more targeting mechanisms. Multivariate innate and adaptive immune activation, signaling, and response may follow that may manifest as stimulatory, inhibitory, or both.
The 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 at ClinicalTrials.gov. The Company believes that it is the first and only entity to date to make pharmaceutical-grade RBS successfully, reproducibly, and consistently at a purity of nearly 100%.
The Company’s small molecule platform comprises several different drug candidates and non-clinical targets using different concentrations delivered by different routes of administration specific to each disease area and/or disease indication, including:
| ● | 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), and | |
| ● | In vitro: Early discovery programs in infectious diseases and tissue regeneration and repair. |
Risks and Uncertainties
The Company’s activities are subject to significant risks and uncertainties, including failing to successfully develop and license or commercialize the Company’s prescription drug candidates.
2. Liquidity and Going Concern
To date, the Company has not generated any revenues or profits from planned principal operations.
The
Company’s aggregate cash and restricted cash balance was $
| F-7 |
Future
cash requirements for our current liabilities include approximately $
These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued.
The Company plans to access capital resources through possible public or private equity offerings, including additional convertible debt issuance pursuant to the 2025 Financing (see Note 5 and Note 10), exchange offers, debt financings, corporate collaborations, or other means. In addition, the Company continues to explore opportunities to strategically monetize its lead drug candidates, PV-10 and PH-10, through potential co-development and licensing transactions, although there can be no assurance that the Company will be successful with such plans. The Company has historically been able to raise capital through equity offerings, although there can be no assurance that it will continue to be successful in the future. If the Company is unable to raise sufficient capital, it will not be able to pay its obligations as they become due.
Under ASC Subtopic 205-40, Presentation of Financial Statements—Going Concern (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet future financial obligations as they become due within one year after the date that these financial statements are issued. The accompanying consolidated financial statements have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustment that might become necessary should the Company be unable to continue as a going concern.
These factors raise substantial doubt about the Company’s our ability to continue as a going concern. Management’s plans to mitigate the factors which raise substantial doubt include (1) raising funds from the proceeds of private placement transactions, the exercise of outstanding stock options, or public offerings of debt or equity securities, and (2) monetizing the Company’s lead drug candidates. While the Company believes that it has a reasonable basis for its expectation that it will be able to raise additional funds, the Company cannot provide assurance that such financing will be available when needed or on acceptable terms, or that it will be able to complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders.
The consolidated financial statements do not include any adjustments relating to the recoverability and classification of liabilities that may be necessary should the Company be unable to continue as a going concern.
3. Significant Accounting Policies
Basis of Presentation
The consolidated financial statements include the consolidated results of Provectus, its wholly owned subsidiaries, and its newly created majority-owned subsidiary, VisiRose (see Note 16). The interests of non-controlling shareholders in VisiRose are presented as net income attributable to noncontrolling interest in the Consolidated Statements of Operations and as noncontrolling interest in the Consolidated Balance Sheets. Intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s significant estimates and assumptions include the recoverability and useful lives of long-lived assets, stock-based compensation, accrued liabilities and the valuation allowance related to the Company’s deferred tax assets.
Restricted Cash
Restricted
cash consists of a grant award received from the State of Tennessee. Restricted cash available as of December 31, 2024 is $
Cash Concentrations
Cash
and restricted cash are maintained at financial institutions and, at times, balances may exceed federally insured limits of $
Equipment and Furnishings, net
Equipment and furnishings are stated at cost less accumulated depreciation. Depreciation of equipment is provided for using the straight-line method over the estimated useful lives of the assets. Computers and office equipment are being depreciated over five years; furniture and fixtures are being depreciated over ten years. Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Maintenance and repairs are charged to operations as incurred. The Company capitalizes cost attributable to the betterment of property and equipment when such betterment extends the useful life of the assets.
Long-Lived Assets
The Company reviews the carrying values of its long-lived assets for possible impairment whenever an event or change in circumstances indicates that the carrying amount of the assets may not be recoverable. Any long-lived assets held for disposal are reported at the lower of their carrying amounts or fair value less cost to sell. Management has determined there to be no impairment of its long-lived assets during the years ended December 31, 2024 and 2023.
| F-8 |
Short-term Receivables
Management estimates expected credit losses immediately based on existing economic conditions in addition to current and future economic conditions and events. Receivables are considered past due if full payment is not received by the contractual date. Past due amounts are generally written off against the reserve for uncollectibility only after all collection attempts have been exhausted. As of December 31, 2024 and 2023, there was no allowance for uncollectible amounts.
Grant Revenue
Grant revenue is recognized when qualifying costs are incurred and there is reasonable assurance that the conditions of the grant have been met. Cash received from grants in advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as grant revenue when qualifying costs are incurred.
Research and Development
Research and development costs are charged to expense when incurred. An allocation of payroll expenses to research and development is made based on a percentage estimate of time spent. The research and development costs include the following: payroll, consulting and contract labor, lab supplies and pharmaceutical preparations, insurance, rent and utilities, and depreciation and amortization.
Patent Costs
The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the accompanying statements of operations.
Leases
The Company leases properties under operating leases. The Company recognizes a liability to make lease payments, the “lease liability”, and an asset representing the right to use the underlying asset during the lease term, the “right-of-use asset” upon the commencement of a lease. The lease liability is measured at the present value of the remaining lease payments, discounted at the Company’s incremental borrowing rate. The right-of-use asset is measured at the amount of the lease liability adjusted for the remaining balance of any lease incentives received, any cumulative prepaid or accrued rent if the lease payments are uneven throughout the lease term, any unamortized initial direct costs, and any impairment of the right-of-use-asset. Operating lease expense consists of a single lease cost calculated so that the remaining cost of the lease is allocated over the remaining lease term on a straight-line basis, variable lease payments not included in the lease liability, and any impairment of the right-of-use asset.
Income Taxes
The Company accounts for income taxes under the liability method in accordance with Accounting Standards Codification (“ASC”) 740 “Income Taxes”. Under this method, deferred income tax assets and liabilities are determined based on differences between financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established if it is more likely than not that all, or some portion, of deferred income tax assets will not be realized. The Company has recorded a full valuation allowance to reduce its net deferred income tax assets to zero. In the event the Company were to determine that it would be able to realize some or all its deferred income tax assets in the future, an adjustment to the deferred income tax asset would increase income in the period such determination was made.
The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination. Any recognized income tax positions would be measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement would be reflected in the period in which the change in judgment occurs. The Company would recognize any corresponding interest and penalties associated with its income tax positions in income tax expense. There were no income taxes, interest or penalties incurred in 2024 or 2023.
Convertible Instruments
The Company evaluates its convertible instruments to determine if those contracts or embedded components of those contracts qualify as derivative financial instruments to be separately accounted for in accordance with ASC Topic 815: Derivatives and Hedging. The accounting treatment of derivative financial instruments requires that the Company record qualifying embedded conversion options and any related freestanding instruments at their fair values as of the inception date of the agreement and at fair value as of each subsequent balance sheet date. Any change in fair value is recorded as non-operating, non-cash income or expense for each reporting period at each balance sheet date. The Company reassesses the classification of its derivative instruments at each balance sheet date. If the classification changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification. Embedded conversion options classified as derivative liabilities and any related equity classified freestanding instruments are recorded as a discount to the host instrument.
| F-9 |
Preferred Stock
The Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as equity.
Basic loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during the period. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive:
| 2024 | 2023 | |||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Warrants | ||||||||
| Options | ||||||||
| Convertible preferred stock | ||||||||
| 2021 unsecured convertible notes and accrued interest | ||||||||
| 2022 unsecured convertible notes and accrued interest | ||||||||
| 2024 unsecured convertible notes and accrued interest | ||||||||
| Total potentially dilutive shares | ||||||||
Fair Value of Financial Instruments
The Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. The Company determines the estimated fair value of amounts presented in these consolidated financial statements using available market information and appropriate methodologies. However, considerable judgment is required in interpreting market data to develop the estimates of fair value. The estimates presented in the financial statements are not necessarily indicative of the amounts that could be realized in a current exchange between buyer and seller. The use of different market assumptions and/or estimation methodologies may have a material effect on the estimated fair value amounts. These fair value estimates were based upon pertinent information available as of December 31, 2024 and 2023. The carrying amounts of the Company’s financial assets and liabilities, such as cash, restricted cash, receivables, other current assets, accounts payable, unearned grant income, and accrued expenses approximate fair value due to the short-term nature of these instruments.
The carrying amounts of our credit obligations approximate fair value because the effective yields on these obligations, which include contractual interest rates are comparable to rates of returns for instruments of similar credit risk.
ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
| Level 1 | Inputs use quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. | |
| Level 2 | Inputs use directly or indirectly observable inputs. These inputs include quoted prices for similar assets and liabilities in active markets as well as other inputs such as interest rates and yield curves that are observable at commonly quoted intervals. | |
| Level 3 | Inputs are unobservable inputs, including inputs that are available in situations where there is little, if any, market activity for the related asset or liability. |
| F-10 |
In instances where inputs used to measure fair value fall into different levels in the above fair value hierarchy, fair value measurements in their entirety are categorized based on the lowest level input that is significant to the valuation. The Company’s assessment of the significance of particular inputs to these fair value measurements requires judgment and considers factors specific to each asset or liability.
Both observable and unobservable inputs may be used to determine the fair value of positions that are classified within the Level 3 category. As a result, the unrealized gains and losses for assets within the Level 3 category may include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in historical company data) inputs. Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable.
Foreign Currency Translation
The
Company’s reporting currency is the United States Dollar. The functional currencies of the Company’s operating subsidiaries
are their local currencies (United States Dollar and Australian Dollar). Australian Dollar denominated assets and liabilities of $
The Company engages in foreign currency denominated transactions with its Australian subsidiary. At the date that the transaction is recognized, each asset, liability, revenue, expense, gain, or loss arising from the transaction is measured and recorded in the functional currency of the recording entity using the exchange rate in effect at that date. At each balance sheet date, recorded monetary balances denominated in a currency other than the functional currency are adjusted using the exchange rate at the balance sheet date, with gains or losses recorded in other income or other expense.
The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and then is recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. The Company computes the fair value of equity-classified options granted using the Black-Scholes option pricing model. Option valuation models require the input of highly subjective assumptions including the expected volatility factor of the market price of the Company’s common stock which is determined by reviewing its historical public market closing prices.
Segment
The Company has one operating and reporting segment (clinical stage biotechnology), namely, the development of immunotherapy medicines. The accounting policies of the segment are the same as those described in the summary of significant accounting policies. The chief operating decision maker (“CODM”), who is the Company’s chief executive officer, utilizes the Company’s financial information on an aggregate, consolidated basis for purposes of making operating decisions, allocating resources and assessing financial performance, as well as for making strategic operations decisions and managing the organization. The CODM is not regularly provided with disaggregated expense information, other than the expense information included in the consolidated statements of operations and comprehensive loss. The measure of segment assets is reported on the balance sheet as total assets.
| F-11 |
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in this update address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for the Company for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-09.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures. ASU 2024-03 is intended to improve disclosures about a public business entity’s expenses and provide more detailed information to investors about the types of expenses in commonly presented expense captions. The amendments in this ASU will be applied retrospectively and are effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of implementing this guidance.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” These amendments require a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. Public entities with a single reporting segment are required to provide both the new disclosures and all of the existing disclosures required under ASC 280. The amendments in ASU2023-07 require, among other things, disclosure of significant segment expenses that are regularly provided to an entity’s chief operating decision maker (“CODM”) and a description of other segment items (the difference between segment revenue less the segment expenses disclosed under the significant expense principle and each reported measure of segment profit or loss) by reportable segment, as well as disclosure of the title and position of the CODM, and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. Annual disclosures are required for fiscal years beginning after December 15, 2023 and interim periods are required for periods within fiscal years beginning after December 15, 2024. The Company has adopted this guidance on December 31, 2024, which did not have an impact on its financial position, results of operations, or cash flows, although it did result in expanded reportable segment disclosures,
4. Other Accrued Expenses
The following table summarizes the other accrued expenses at December 31, 2024 and 2023:
Schedule of Other Accrued Expenses
| 2024 | 2023 | |||||||
| For the Years Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Accrued payroll and taxes | $ | $ | ||||||
| Accrued vacation | ||||||||
| Accrued directors’ fees | ||||||||
| Accrued other expenses | ||||||||
| Total other accrued expenses | $ | $ | ||||||
5. Convertible Notes Payable
The following summarizes convertible note activity during the years ended December 31, 2024 and 2023:
Schedule of Convertible Notes Payable
| Non-Related Party | Related Party | Non-Related Party | Related Party | Non-Related Party | Related Party | Non-Related Party | Related Party | |||||||||||||||||||||||||
| 2021 Financing | 2022 Financing | 2024 Financing | Total | |||||||||||||||||||||||||||||
| Non-Related Party | Related Party | Non-Related Party | Related Party | Non-Related Party | Related Party | Non-Related Party | Related Party | |||||||||||||||||||||||||
| Balance as of January 1, 2023 | $ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
| Notes issued | ||||||||||||||||||||||||||||||||
| Principal converted | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||
| Balance as of December 31, 2023 | ||||||||||||||||||||||||||||||||
| Notes issued | ||||||||||||||||||||||||||||||||
| Principal repaid | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Principal converted | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||
| Balance as of December 31, 2024 | $ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
As
of December 31, 2024 and December 31, 2023, accrued interest on the convertible notes was $
| F-12 |
Related party investors in the Company’s convertible notes consist of an officer and an officer/director of the Company.
2021 Financing
The 2021 Financing is in the form of unsecured convertible notes (individually, a “2021 Note” and collectively, the “2021 Notes”). Pursuant to the 2021 Term Sheet, the 2021 Notes will either be paid back, convert into shares of the Company’s Series D-1 Preferred Stock, or convert into Company equity securities and/or debt instruments of certain future financings on or before twelve months after the issue date of a 2021 Note, subject to certain exceptions.
In addition to customary provisions, the 2021 Notes contain the following provisions:
| (i) | The
2021 Notes bear interest at the rate of eight percent ( | |
| (ii) | In the event there is a change of control of the Board, the term of the 2021 Notes will be accelerated and all amounts due under the 2021 Notes may be immediately due and payable at the investors’ option; | |
| (iii) | The outstanding principal amount and interest payment under the 2021 Notes may be paid back at maturity at the investors’ option; | |
| (iv) | The outstanding principal amount and interest payable under the 2021 Notes are convertible at the holders’ option into shares of Series D-1 Preferred Stock at a price per share equal to $. The Series D-1 Preferred Stock is convertible into ten () shares of common stock; and | |
| (v) | In
the event the Company conducts a qualified equity or debt financing and the Company receives gross proceeds in the aggregate amount
of $ |
The embedded conversion options associated with the 2021 Notes do not require bifurcation and treatment as a derivative liability.
On September 20, 2022, the Board approved the closure of the 2021 Financing.
During the year ended December 31, 2024, the Company repaid $
During
the year ended December 31, 2023, principal and interest in the aggregate amount of $
For
the years ended December 31, 2024 and 2023, the Company recorded interest expense of $
2022 Financing
Pursuant to the 2022 Term Sheet, the 2022 Notes (defined below) will convert into shares of the Company’s Series D-1 Preferred Stock twelve months after the issue date of a 2022 Note, subject to certain exceptions.
| F-13 |
The 2022 Financing is in the form of unsecured convertible promissory notes (individually, a “2022 Note” and collectively, the “2022 Notes”). In addition to customary provisions, the 2022 Notes will contain the following provisions:
| (i) | The
2022 Notes bear interest at the rate of eight percent ( | |
| (ii) | In the event there is a change of control of the Board, the term of the 2022 Notes will be accelerated and all amounts due under the 2022 Notes may be immediately due and payable at the 2022 Note Investors’ option; | |
| (iii) | The outstanding principal amount and interest payable under the 2022 Notes is convertible at the holders’ option into shares of Series D-1 Preferred Stock at a price per share equal to $. The Series D-1 Preferred Stock is convertible into ten () shares of common stock; and | |
| (iv) | The outstanding principal amount and interest payable under the 2022 Notes will be automatically convertible into shares of the Company’s Series D-1 Preferred Stock twelve (12) months after the issue date of a 2022 Note. |
The embedded conversion options associated with the 2022 Notes do not require bifurcation and treatment as a derivative liability.
On July 11, 2024, the Board approved the closure of the 2022 Financing.
During
the year ended December 31, 2024, principal and interest in the aggregate amount of $
As of December 31, 2024, principal and interest in the amount of $
2024 Financing
On
July 11, 2024, the Board approved a Financing Term Sheet (the “2024 Term Sheet”), which set forth the terms under which the
Company will use its best efforts to arrange for financing of a maximum of $
The 2024 Financing is in the form of unsecured convertible promissory notes (individually, a “2024 Note” and collectively, the “2024 Notes”). In addition to customary provisions, the 2024 Notes contain the following provisions:
| (i) | The
2024 Notes bear interest at the rate of eight percent ( | |
| (ii) | In the event there is a change of control of the Board, the term of the 2024 Notes will be accelerated and all amounts due under the 2024 Notes may be immediately due and payable at the option of the holder; | |
| (iii) | The outstanding principal amount and interest payable under the 2024 Notes is convertible at the holder’s option into shares of Series D-1 Preferred Stock at a price per share equal to $. The Series D-1 Preferred Stock is convertible into ten () shares of common stock; and | |
| (iv) | The outstanding principal amount and interest payable under the 2024 Notes will be automatically convertible into shares of the Company’s Series D-1 Preferred Stock twelve (12) months after the issue date of a 2024 Note. |
The embedded conversion options associated with the 2024 Notes do not require bifurcation and treatment as a derivative liability.
As
of December 31, 2024, principal and interest in the amount of $
On January 15, 2025, the Board approved the closure of the 2024 Financing.
6. Notes Payable
The
Company obtained short-term financing from First Insurance Funding in 2024 for our commercial insurance policies. As of December 31,
2024, the balance of the note payable was $
| F-14 |
7. Related Party Transactions
During
the years ended December 31, 2024 and 2023, the Company incurred consulting fees of $
Director
fees for Mr. Horowitz for the years ended December 31, 2024 and 2023 were $
On
March 25, 2024, the Board retained Dominic Rodrigues as the Company’s interim chief operations consultant pursuant to an
Independent Contractor Agreement entered into with Mr. Rodrigues. In this role, Mr. Rodrigues will serve as the Company’s
principal executive officer and will be paid $
See Note 5 for details of other related party transactions.
Directors’
fees incurred during the year ended December 31, 2024 and 2023, were $
8. Short-term Receivables
Short-term
receivables at December 31, 2024 and 2023, include the Australian VAT tax credit and $
9. Prepaid Expenses and Other Current Assets
The following table summarizes the pre-paid expenses and other current assets at December 31, 2024 and 2023:
Schedule of Prepaid Expenses And Other Current Assets
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Deferred tax asset | $ | $ | ||||||
| Deposits | ||||||||
| Prepaid insurance | ||||||||
| Prepaid rent | ||||||||
| Prepaid subscriptions | ||||||||
| Prepaid other | ||||||||
| Other current assets | ||||||||
| Total Prepaid Expenses and Other Current Assets | $ | $ | ||||||
Other current assets at December 31, 2024 include a refund due from the University of Tennessee College of Veterinary Medicine upon termination of contract.
10. Stockholders’ Deficit
Authorized Capital
As of December 31, 2024, the Company was authorized to issue shares of common stock, $par value, and shares of preferred stock, $par value. The holders of the Company’s common stock are entitled to one vote per share. The preferred stock is designated as follows: shares to Series D Convertible Preferred Stock (the “Series D Preferred Stock”), and shares of Series D-1 Convertible Preferred Stock (the “Series D-1 Preferred Stock”) and shares undesignated.
Series D and Series D-1 Preferred Stock
The rights, preferences and privileges of the Series D Preferred Stock and Series D-1 Preferred Stock (collectively, the “D-Series Preferred Stock”) are set forth in their respective Certificates of Designation.
| F-15 |
Rank
The Series D Preferred Stock and the Series D-1 Preferred Stock rank pari passu with each other. The D-Series Preferred Stock rank senior to the Common Stock and any other class or series of the Company’s capital stock, the terms of which do not provide that shares of such class rank senior to, or pari passu with, the D-Series Preferred as to dividends and distributions upon a change of control transaction, or the liquidation, winding-up and dissolution of the Company.
Dividends
The D-Series Preferred Stock does not have any dividend preference but are entitled to receive, on a pari passu basis, dividends, if any, that are declared and paid on the common stock and any other class of the Company’s capital stock that ranks junior or on par to the D-Series Preferred Stock.
Liquidation Preference
Upon the occurrence of the liquidation, winding-up or dissolution of the Company or certain mergers, corporate reorganizations, or sales of the Company’s assets (each, a “Company Event”), holders of D-Series Preferred Stock will be entitled to receive a liquidation preference before any distributions are made to holders of any other class or series of the Company’s capital stock junior to the D-Series Preferred Stock. If a Company Event occurs within two years of June 20, 2021 (the “Date of Issuance”), the holders of D-Series Preferred Stock will receive, for each share of D-Series Preferred Stock, an amount in cash equal to the Original Issue Price (as defined in the respective Certificates of Designation) multiplied by four. If a Company Event occurs from and after the second anniversary of the Date of Issuance, the holders of D-Series Preferred Stock will receive, for each share of D-Series Preferred Stock, an amount in cash equal to the Original Issue Price multiplied by six. The Original Issue Price for the Series D Preferred Stock is $, and the Original Issue Price for the Series D-1 Preferred Stock is $.
Voting Rights
Holders
of shares of D-Series Preferred Stock will vote together with the holders of common stock as a single class. Each share of Series D Preferred
Stock carries the right to one vote per share.
The Company is not permitted to amend, alter or repeal its Certificate of Incorporation or bylaws in a manner adverse to the relative rights, preferences, qualifications, limitations or restrictions of the D-Series Preferred Stock without the affirmative vote of a majority of the votes entitled to be cast by holders of outstanding shares of D-Series Preferred Stock, voting together as a single class with each share of D-Series Convertible Preferred Stock having a number of votes equal to the number of shares of common stock then issuable upon conversion of such share of D-Series Preferred Stock.
Conversion
The Series D Preferred Stock is convertible at the option of the holders thereof into shares of common stock based on a one-for-one conversion ratio. The Series D-1 Preferred Stock is convertible at the option of the holders thereof into shares of common stock based on a one-for-ten conversion ratio. The conversion ratio of the D-Series Preferred Stock is subject to adjustment for stock splits and combinations, recapitalizations, reclassifications, reorganizations, mergers, and consolidations. The D-Series Preferred Stock will automatically convert into shares of common stock upon the fifth anniversary of the date of issuance.
Preferred Stock Issuances
During
the year ended December 31, 2024, the Company issued shares of Series D-1 Preferred Stock in satisfaction of accrued directors’
fees in the amount of $
During the year ended December 31, 2024, the Company issued shares of Series D-1 Preferred Stock in exchange of shares of Series D Preferred Stock.
During the year ended December 31, 2024, principal
and interest in the aggregate amount of $
During the year ended December 31, 2023, principal
and interest in the aggregate amount of $
| F-16 |
Common Stock Issuances
During the year ended December 31, 2024, the Company issued shares of common stock upon the conversion of shares of Series D-1 Preferred Stock.
During
the year ended December 31, 2023, the Company issued an aggregate of shares of immediately vested restricted common stock with
a grant date fair value of $
The 2017 Amendment and Restatement of the Provectus Biopharmaceuticals, Inc. 2014 Equity Compensation Plan (the “2017 Equity Compensation Plan”) provides for the issuance of up to shares of common stock pursuant to stock options for the benefit of eligible employees and directors of the Company. Options granted under the 2017 Equity Compensation Plan are either “incentive stock options” within the meaning of Section 422 of the Internal Revenue Code or options which are not incentive stock options. Vested stock options are exercisable over a period determined by the Board of Directors (through its Compensation Committee), but generally no longer than years after the date they are granted. The 2017 Equity Compensation Plan, as amended, expired on April 25, 2023.
2024 Equity Compensation Plan
At the shareholder meeting held on June 20, 2024, the proposal for the new 2024 Equity Compensation Plan was approved. The approval gives the Company the authority to grant Options and award Restricted Stock under the 2024 Equity Compensation Plan for up to shares of our common stock. As of December 31, 2024, there were shares available for issuance under the 2024 Equity Compensation Plan.
Stock Options
Schedule of Option Activity
| Weighted Average | Weighted Average Remaining | Aggregate Intrinsic | ||||||||||||||
| Shares | Exercise Price | Life in Years | Value | |||||||||||||
| Outstanding and exercisable at January 1, 2023 | $ | $ | ||||||||||||||
| Forfeited | ( | ) | ||||||||||||||
| Outstanding and exercisable at December 31, 2023 | $ | $ | ||||||||||||||
| Granted | ||||||||||||||||
| Forfeited | ( | ) | ||||||||||||||
| Options outstanding at December 31, 2024 | ||||||||||||||||
| Options exercisable at December 31, 2024 | $ | $ | ||||||||||||||
On December 2, 2024, the Company granted five and ten-year options for the purchase of shares of the Company’s common stock exercisable at $ per share, as follows:
| ● | Ten-year options for the purchase of shares of the Company’s common stock, with an aggregate grant date value of $ were granted to certain directors of the Company. The options were fully vested upon grant. | |
| ● | Ten-year options for the purchase of shares of the Company’s common stock, with an aggregate grant date value of $ were granted to certain Company executives. One-third of the options were fully vested upon grant; the remaining two-thirds vested on each of the next two anniversaries of the date of grant. | |
| ● | Five-year options for the purchase of shares of the Company’s common stock, with an aggregate grant date value of $ were granted to an employee of the Company. One-third of the options were fully vested upon grant; the remaining two-thirds vested on each of the next two anniversaries of the date of grant. |
| F-17 |
Schedule of Grant Date Value of Stock Option using Black Sholes Valuation Model
| Risk free interest rate | - % | |
| Expected term (years) | – | |
| Expected volatility | % - % | |
| Expected dividends | % |
Option forfeitures are accounted for at the time of occurrence. The expected term used is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of employee option grants. The Company utilizes an expected volatility figure based on the historical volatility of its common stock over a period of time equivalent to the expected term of the instrument being valued. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued.
During the year ended December 31, 2024, the Company recognized stock-based compensation expense of $. As of December 31, 2024, there was $ of unrecognized stock-based compensation related to the above stock options, which will be recognized over the weighted average remaining vesting period of years.
As of December 31, 2024, the intrinsic value of outstanding and exercisable options was $.
Schedule of Stock Options Outstanding
| Options Outstanding | Options Exercisable | |||||||||||||
| Outstanding | Weighted Average | Exercisable | ||||||||||||
| Number of | Remaining Life | Number of | ||||||||||||
| Exercise Price | Options | In Years | Options | |||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
Warrants
There were no warrants granted during the years ended December 31, 2024 and 2023.
The following table summarizes warrant activity during the years ended December 31, 2024 and 2023:
Schedule of Warrant Activity
| Number of Warrants | Weighted Average Exercise Price | Weighted Average Remaining Life in Years | ||||||||||
| Outstanding and exercisable at January 1, 2023 | $ | |||||||||||
| Forfeited | ( | ) | ||||||||||
| Outstanding and exercisable at December 31, 2023 | $ | |||||||||||
| Forfeited | ( | ) | ||||||||||
| Outstanding and exercisable at December 31, 2024 | $ | |||||||||||
| F-18 |
Holders of the outstanding warrants are not entitled to vote and the exercise prices of such warrants are subject to customary anti-dilution provisions.
12. Income Taxes
The domestic and foreign components of loss before income taxes from operations for the years ended December 31, 2024 and 2023 are as follows:
Schedule of Domestic and Foreign Loss Before Income Taxes
| 2024 | 2023 | |||||||
| Year ended December 31 | ||||||||
| 2024 | 2023 | |||||||
| Components of Pre-Tax Income (Loss): | ||||||||
| Domestic | $ | ( | ) | $ | ( | ) | ||
| Foreign | ( | ) | ||||||
| Net Pre-Tax Loss | $ | ( | ) | $ | ( | ) | ||
The income tax provision (benefit) consists of the following:
Schedule of Income Tax Provision (Benefit)
| Year ended December 31 | ||||||||
| 2024 | 2023 | |||||||
| Federal: | ||||||||
| Current | $ | $ | ||||||
| Deferred | ||||||||
| State and local: | ||||||||
| Current | ||||||||
| Deferred | ||||||||
| Foreign | ||||||||
| Current | ||||||||
| Deferred | ||||||||
| Change in valuation allowance | ( | ) | ( | ) | ||||
| Income tax provision (benefit) | $ | $ | ||||||
The reconciliations between the statutory federal income tax rate and the Company’s effective tax rate are as follows:
Schedule of Statutory Federal Income Tax Rate and Effective Tax Rate
| 2024 | 2023 | |||||||
| Years ended December 31 | ||||||||
| 2024 | 2023 | |||||||
| Tax benefit at federal statutory rate | ( | )% | ( | )% | ||||
| State income taxes, net of federal benefit | ( | )% | ( | )% | ||||
| Permanent differences | ( | )% | ( | )% | ||||
| Change in valuation allowance | % | % | ||||||
| Prior year true-up | % | ( | )% | |||||
| Expiration of federal & state net operating loss carryforwards | % | % | ||||||
| Expiration of warrants and options | % | % | ||||||
| Issuance of options | % | % | ||||||
| Miscellaneous | ( | )% | ( | )% | ||||
| Effective income tax rate | % | % | ||||||
| F-19 |
The components of the Company’s deferred income taxes are summarized below:
Schedule of Components of Deferred Income Taxes
| 2024 | 2023 | |||||||
| December 31 | ||||||||
| 2024 | 2023 | |||||||
| Deferred Tax Assets: | ||||||||
| Net operating loss carryforwards | $ | $ | ||||||
| Research and development credit carryovers | ||||||||
| Stock-based compensation | ||||||||
| Intangible assets | ||||||||
| Capitalized R&D expenditures | ||||||||
| Contribution carryovers | ||||||||
| Accrued liabilities | ||||||||
| Gross deferred tax assets | ||||||||
| Deferred Tax Liabilities: | ||||||||
| Intangible assets | ( | ) | ( | ) | ||||
| Prepaid expenses | ( | ) | ( | ) | ||||
| Other | ||||||||
| Gross deferred tax liabilities | ( | ) | ( | ) | ||||
| Valuation allowance | ( | ) | ( | ) | ||||
| Deferred tax asset, net of valuation allowance | $ | $ | ||||||
| Change in valuation allowance | $ | $ | ||||||
A valuation allowance against deferred tax assets is required if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets may not be realized. The Company is in the early stages of development and realization of the deferred tax assets is not considered more likely than not. As a result, the Company has recorded a full valuation allowance for the net deferred tax asset. A portion of the valuation allowance relates to Research and Development credit carryovers. There has been no formal Research and Development studies performed related to the amounts calculated for these credits. While management believes the amounts taken as credits are accurate, it is possible a future adjustment would be necessary to reduce the value of the of these credit carryovers.
Since
inception of the Company on January 17, 2002, the Company has generated federal, state, and Australian tax net operating losses of approximately
$
Schedule of Net Operating Loss
| Year | Year of | |||||||
| Generated | Expiration | Amount | ||||||
| 2005 | $ | |||||||
| 2006 | ||||||||
| 2007 | ||||||||
| 2008 | ||||||||
| 2009 | ||||||||
| 2010 | ||||||||
| 2011 | ||||||||
| 2012 | ||||||||
| 2013 | ||||||||
| 2014 | ||||||||
| 2015 | ||||||||
| 2016 | ||||||||
| 2017 | ||||||||
| 2018 | N/A | |||||||
| 2019 | N/A | |||||||
| 2020 | N/A | |||||||
| 2021 | N/A | |||||||
| 2022 | N/A | |||||||
| 2023 | N/A | |||||||
| 2024 | N/A | |||||||
| Total NOLS | $ | |||||||
| F-20 |
State
NOLS totaling $
| Year | Year of | |||||||
| Generated | Expiration | Amount | ||||||
| 2009 | $ | |||||||
| 2010 | ||||||||
| 2011 | ||||||||
| 2012 | ||||||||
| 2013 | ||||||||
| 2014 | ||||||||
| 2015 | ||||||||
| 2016 | ||||||||
| 2017 | ||||||||
| 2018 | ||||||||
| 2019 | ||||||||
| 2020 | ||||||||
| 2021 | ||||||||
| 2022 | ||||||||
| 2023 | ||||||||
| 2024 | ||||||||
| Total NOLS | $ | |||||||
Australia
NOLS totaling $
| Year Generated | Year of Expiration | Amount | ||||||
| 2017 | N/A | $ | ||||||
| 2018 | N/A | |||||||
| 2019 | N/A | |||||||
| 2020 | N/A | |||||||
| 2021 | N/A | |||||||
| 2022 | N/A | |||||||
| 2023 | N/A | |||||||
| 2024 | N/A | ( | ) | |||||
| Total NOLS | $ | |||||||
The Company has determined that there are no uncertain tax positions as of December 31, 2024 or 2023.
| F-21 |
We
file income tax returns in the U.S., Tennessee, and Australia. As of December 31, 2024,
To date, the Company’s operations conducted by its Australian subsidiary consist primarily of research and development activities. As of December 31, 2024, there were no accumulated earnings and profits in the Company’s foreign subsidiary. At current tax rates, no additional federal income taxes (net of available tax attributes) would be payable if such earnings were to be repatriated.
13. Leases
Leases
On
June 18, 2022, the Company moved into
Total
expense for operating leases for the year ended December 31, 2024 was $
As of December 31, 2024, the Company had no leases that were classified as a financing lease. As of December 31, 2024, the Company did not have additional operating and financing leases that have not yet commenced.
A summary of the Company’s right-of-use assets and liabilities is as follows:
Schedule of Right-of-use Assets and Liabilities
| For The Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Cash paid for amounts included in the measurement of lease liabilities: | ||||||||
| Operating cash flows used in operating leases | $ | $ | ||||||
| Right-of-use assets obtained in exchange for lease obligations: | ||||||||
| Operating leases | $ | $ | ||||||
| Weighted Average Remaining Lease Term | ||||||||
| Operating leases | ||||||||
| Weighted Average Discount Rate | ||||||||
| Operating leases | % | % | ||||||
| F-22 |
Future minimum payments under the non-cancellable lease as of December 31, 2024 were as follows:
Schedule of Future Minimum Payments Under Non-cancellable Lease
| Payments during the year ended December 31, 2025 | $ | |||
| Less: amount representing imputed interest | ( | ) | ||
| Present value of lease liability | ||||
| Less: current portion | ( | ) | ||
| Lease liability, non-current portion | $ |
14. 401(K) Profit Sharing Plan
The
Company maintains a retirement plan under Section 401(k) of the Internal Revenue Code, which covers all eligible employees. All employees
with U.S. source income are eligible to participate in the plan immediately upon employment. There was
15. Grants
On
October 25, 2021, the Company received a grant award of $
16. License Transactions
On March 21, 2024, the Company entered into an exclusive worldwide license agreement (the License Agreement”) with the University of Miami (“UM”) for the license and development of the UM’s intellectual property related to photodynamic antimicrobial therapy in ophthalmology. The License Agreement grants the Company exclusive, worldwide rights to research, develop, make, use, or sell Licensed Products and/or Licensed Processes (as defined in the License Agreement) based upon patent-related rights.
As
consideration for the rights granted in the License Agreement, the Company must pay an upfront fee of $
Pursuant
to the requirements of the License Agreement, the Company created a new subsidiary “VisiRose” for the purpose of developing
and commercializing Licensed Products and Licensed Processes, assigned the License Agreement to VisiRose, and entered into an equity agreement
with respect to VisiRose’s securities. Pursuant to the equity agreement, VisiRose will be required to issue to the University %
of the total number of issued and outstanding shares of VisiRose. The University will have certain anti-dilution rights related to additional
issuances of VisiRose securities before VisiRose receives a total of $
On December 5, 2024, the Board approved the formation of a subsidiary of the Company to be incorporated under the laws of the State of Delaware under the name VisiRose and to pursue the development and commercialization of the Company’s pharmaceutical-grade API RBS for the treatments of ophthalmology diseases and disorders. The certificate of incorporation of VisiRose was filed with the secretary of state of Delaware on December 5, 2024.
Provectus
holds a majority ownership interest in its subsidiary, VisiRose, with a
The
License Agreement sets forth certain diligence milestones that include forming VisiRose, creating a Licensed Product suitable for submission
to the Food and Drug Administration (“FDA”), generating Licensed Product data suitable for required submission to the FDA,
submitting a drug-device combination application to the FDA, and receiving clearance, approval or other authorization from the FDA for
the Licensed Product portion of the drug-device combination.
Pursuant to the License Agreement, the Board approved the transfer of certain assets to VisiRose, such as the License Agreement, and the Company’s exclusive master supply agreement for API and investigational drug product, subject to final review and contract finalization by the Board. The Company and VisiRose entered into an agreement on December 20, 2024 whereby the Company assigned the License Agreement to VisiRose, which the University approved.
| F-23 |
The term of the License Agreement is the later of (i) the expiration or abandonment of all issued patents and patent applications related to patent rights under the License Agreement and/or no royalties are due, (ii) any regulatory exclusivity has expired, and (iii) 20 years from the first commercial sale of Licensed Product and/or Licensed Process. The License Agreement provides that the Company may terminate the License Agreement upon 90 days’ written notice to the University, and each party has the right to terminate the License Agreement if the other party commits a material breach of the terms of the License Agreement and such breach remains uncured for thirty days after receipt of written notice.
17. Commitments, Contingencies and Litigation
The Company may, from time to time, be involved in litigation arising in the ordinary course of business which may be expected to be covered by insurance. The Company is not aware of any pending or threatened litigation that, if resolved against the Company, would have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows.
18. Subsequent Events
The Company has evaluated events that have occurred after the balance sheet date and through the date the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed below.
2025 Financing Note
On
January 15, 2025, the Board approved a Financing Term Sheet (the “2025 Term Sheet”), which set forth the terms under which
the Company will use its best efforts to arrange for financing of a maximum of $
Pursuant to the 2025 Term Sheet, the 2025 Notes (defined below) will convert into shares of the Company’s Series D-1 Preferred Stock twelve months after the issue date of a 2025 Note.
The 2025 Financing will be in the form of unsecured convertible loans from the investors (the “2025 Note Investors”) and evidenced by convertible promissory notes (individually, a “2025 Note” and collectively, the “2025 Notes”). In addition to customary provisions, the 2025 Notes will contain the following provisions:
| (i) | The
2025 Notes will bear interest at the rate of eight percent ( | |
| (ii) | In the event there is a change of control of the Board, the term of the 2025 Notes will be accelerated and all amounts due under the 2025 Notes may be immediately due and payable at the 2025 Note Investors’ option; | |
| (iii) | The outstanding principal amount and interest payable under the 2025 Notes may be convertible at the 2025 Note Investors’ option into shares of Series D-1 Preferred Stock at a price per share equal to $. The Series D-1 Preferred Stock is convertible into ten () shares of common stock; and | |
| (iv) | The outstanding principal amount and interest payable under the 2025 Notes will be automatically convertible into shares of the Company’s Series D-1 Preferred Stock twelve (12) months after the issue date of a 2025 Note. |
Convertible Notes Payable
Subsequent
to December 31, 2024, the Company entered into 2025 Notes with a related party investor (a director of the Company) in the aggregate
principal amount of $
Preferred Stock
Subsequent
to December 31, 2024, principal and interest in the aggregate amount of $
VisiRose
Subsequent to December 31, 2024, the Company’s majority-owned subsidiary,
VisiRose, received investments totaling $
| F-24 |
| ITEM 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. |
Not applicable.
| ITEM 9A. | CONTROLS AND PROCEDURES. |
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external purposes in accordance with GAAP. Our internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures by us are being made only in accordance with authorizations of our management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the consolidated financial statements.
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of the period covered by this report based on the criteria for effective internal control described in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on the results of management’s assessment and evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2024.
Evaluation of Disclosure Controls and Procedures
Management, with the participation of our principal executive officer and principal financial officer, carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered in this report, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Inherent Limitations on Effectiveness of Controls
Even assuming the effectiveness of our controls and procedures, our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all error or all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. In general, our controls and procedures are designed to provide reasonable assurance that our control system’s objective will be met, and our principal executive officer and principal financial officer has concluded that our disclosure controls and procedures are effective at the reasonable assurance level. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of the effectiveness of controls in future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting that occurred during the fourth quarter of 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
| ITEM 9B. | OTHER INFORMATION. |
| ITEM 9C. | DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. |
Not applicable.
| 30 |
PART III
| ITEM 10. | DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE. |
The information called for by this item is incorporated herein by reference to the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, which will be filed with the SEC pursuant to Regulation 14A under the Exchange Act.
| ITEM 11. | EXECUTIVE COMPENSATION. |
The information called for by this item is incorporated herein by reference to the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, which will be filed with the SEC pursuant to Regulation 14A under the Exchange Act.
| ITEM 12. | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS. |
The information called for by this item is incorporated herein by reference to the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, which will be filed with the SEC pursuant to Regulation 14A under the Exchange Act.
| ITEM 13. | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE. |
The information called for by this item is incorporated herein by reference to the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, which will be filed with the SEC pursuant to Regulation 14A under the Exchange Act.
| ITEM 14. | PRINCIPAL ACCOUNTANT FEES AND SERVICES. |
The information called for by this item is incorporated herein by reference to the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders, which will be filed with the SEC pursuant to Regulation 14A under the Exchange Act.
| 31 |
PART IV
| ITEM 15. | EXHIBIT AND FINANCIAL STATEMENT SCHEDULES. |
Financial Statements
All financial statements are set forth under Part II, Item 8 of this report.
Financial Statement Schedules
None
Exhibits
| 32 |
| 33 |
| 31.2† | Certification of Principal Financial Officer pursuant to Rules 13a-14(a) of the Securities Exchange Act of 1934. | |
| 32†† | Certification Pursuant to 18 U.S.C. Section 1350. | |
| 101.INS† | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |
| 101.SCH† | Inline XBRL Taxonomy Extension Schema Document. | |
| 101.CAL† | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |
| 101.LAB† | Inline XBRL Taxonomy Extension Label Linkbase Document. | |
| 101.PRE† | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |
| 101.DEF† | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
| † | Filed herewith. |
| †† | Furnished herewith. |
| * | Indicates a management contract or compensatory plan or arrangement. |
| ITEM 16. | FORM 10-K SUMMARY. |
None.
| 34 |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
March 27, 2025
| PROVECTUS BIOPHARMACEUTICALS, INC. | ||
| By: | /s/ Dominic Rodrigues | |
| Dominic Rodrigues | ||
| President (principal executive officer) | ||
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
| Signature | Title | Date | ||
| /s/ Heather Raines | Chief Financial Officer | March 27, 2025 | ||
| Heather Raines, CPA | (principal financial officer and principal accounting officer) | |||
| /s/ Dominic Rodrigues | President and Director, Vice Chairman of the Board | March 27, 2025 | ||
| Dominic Rodrigues | (principal executive officer) | |||
| /s/ Webster Bailey | Director | March 27, 2025 | ||
| Webster Bailey | ||||
| /s/ John W. Lacey, III, MD | Director | March 27, 2025 | ||
| John W. Lacey, III, MD | ||||
| /s/ Ed Pershing | CEO and Director and Chairman of the Board | March 27, 2025 | ||
| Ed Pershing |
| 35 |
Exhibit 4.7
DESCRIPTION OF SECURITIES
REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT
Provectus Biopharmaceuticals, Inc. (the “Company,” “Provectus,” “we” or “our”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”): our Common Stock.
Description of Common Stock
The following description of our Common Stock is a summary and does not purport to be complete. It is subject to and qualified in its entirety by reference to our Certificate of Incorporation, as amended (the “Certificate of Incorporation”), and our Bylaws, as amended (the “Bylaws”), each of which is incorporated by reference as an exhibit to the Annual Report on Form 10-K, of which this Exhibit is a part. We encourage you to read our Certificate of Incorporation, our Bylaws, and the applicable provisions of the Delaware General Corporation Law, for additional information.
Authorized Shares of Capital Stock
Our authorized capital stock consists of 1,000,000,000 shares of common stock, $0.001 par value per share (“Common Stock”), and 25,000,000 shares of preferred stock, $0.001 par value per share (“Preferred Stock”). As of December 31, 2024, 420,279,879 shares of Common Stock were issued and outstanding. The outstanding shares of our Common Stock are duly authorized, validly issued, fully paid, and non-assessable.
Voting Rights
Holders of Common Stock are entitled to one vote per share on all matters voted on by the stockholders, including the election of directors. Our Common Stock does not have cumulative voting rights.
Dividend Rights
Subject to the rights of holders of outstanding shares of Preferred Stock, if any, the holders of Common Stock are entitled to receive dividends, if any, as may be declared from time to time by the Company’s Board of Directors (the “Board”) in its discretion out of funds legally available for the payment of dividends.
Liquidation Rights
In the event of our dissolution, liquidation or winding up, holders of our Common Stock are entitled to share ratably in any assets remaining after the satisfaction in full of the prior rights of creditors and the aggregate liquidation preference of any Preferred Stock then outstanding.
Other Rights and Preferences
Holders of our Common Stock do not have any conversion, redemption, sinking fund or pre-emptive rights.
Certain Anti-Takeover Effects
Provisions of our Certificate of Incorporation and Bylaws may delay or discourage transactions involving an actual or potential change of control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our Common Stock. Among other things, our Certificate of Incorporation and Bylaws will:
| ● | permit our Board to issue up to 25,000,000 shares of Preferred Stock, with any rights, preferences, and privileges as they may designate; | |
| ● | provide that all vacancies on our Board, including as a result of newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum; | |
| ● | require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent; | |
| ● | provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice; | |
| ● | not provide for cumulative voting rights, thereby allowing the holders of a majority of the shares of Common Stock entitled to vote in any election of directors to elect all of the directors standing for election; and | |
| ● | provide that a special meeting of our stockholders may be called only by the Board or by such person or persons requested by a majority of the Board to call such meetings. |
Preferred Stock
The rights, preferences, and privileges of the holders of our Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of Preferred Stock that we have designated and issued or may designate and issue in the future. Under our Certificate of Incorporation, we are authorized to issue up to 25,000,000 shares of Preferred Stock, from time to time in one or more series, in any manner permitted by law, as determined from time to time by our Board, and stated in the resolution or resolutions providing for the issuance of such shares adopted by our Board. Without limiting the generality of the foregoing, shares in such series shall have voting powers, full or limited, or no voting powers, and shall have such designations, preferences and relative, participating, optional, or other special rights, and qualifications, limitations, or restrictions thereof, permitted by law, as shall be stated in the resolution or resolutions providing for the issuance of such shares adopted by our Board. The number of shares of any such series so set forth in the resolution or resolutions may be increased (but not above the total number of authorized shares of Preferred Stock) or decreased (but not below the number of shares thereof then outstanding) by further resolution or resolutions adopted by the Board. As of December 31, 2024, 956,985 and 13,106,223 shares of Series D and D-1 Preferred Stock were issued and outstanding, respectively.
Series D and Series D-1 Preferred Stock
The rights, preferences and privileges of the Series D Convertible Preferred Stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (the “Series D Certificate of Designation”), a copy of which is attached as Exhibit 3.2 to this Annual Report on Form 10-K. The rights, preferences and privileges of the Series D-1 Convertible Preferred Stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of Series D-1 Convertible Preferred Stock (the “Series D-1 Certificate of Designation”), a copy of which is attached as Exhibit 3.4 to this Annual Report on Form 10-K.
The Board of Directors of the Company approved each of the Series D Certificate of Designation and Series D-1 Certificate of Designation on June 16, 2021, and each of the Series D Certificate of Designation and Series D-1 Certificate of Designation were filed with the Delaware Secretary of State on June 17, 2021. The Series D Certificate of Designation and Series D-1 Certificate of Designation are the same, other than certain key differences to account solely for the different conversion ratios for the holders of 2017 Notes who did not execute an Amendment compared to the holders of Amended 2017 Notes and the holders of 2020 Notes.
The Series D Certificate of Designation (as amended by the Certificate of Amendment, dated June 21, 2024) established and designated 957,100 shares of Series D Convertible Preferred Stock. The Series D-1 Certificate of Designation (as amended by the Certificate of Amendment, dated June 21, 2024) established and designated 23,042,900 shares of Series D-1 Convertible Preferred Stock.
The Series D Convertible Preferred Stock and the Series D-1 Convertible Preferred Stock rank pari passu with each other. The Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock rank senior to the Common Stock and any other class or series of the Company’s capital stock, the terms of which do not provide that shares of such class rank senior to, or pari passu with, the Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock as to dividends and distributions upon a change of control transaction, or the liquidation, winding-up and dissolution of the Company.
The Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock do not have any dividend preference but are entitled to receive, on a pari passu basis, dividends, if any, that are declared and paid on the Common Stock and any other class of the Company’s capital stock that ranks junior or on par to the Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock.
Upon the occurrence of the liquidation, winding-up or dissolution of the Company or certain mergers, corporate reorganizations or sales of the Company’s assets (each, a “Company Event”), holders of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock will be entitled to receive a liquidation preference before any distributions are made to holders of any other class or series of the Company’s capital stock junior to the Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock. If a Company Event occurs within two years of June 20, 2021 (the “Date of Issuance”), the holders of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock will receive for each share of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock, respectively, an amount in cash equal to the Original Issue Price (as defined in the Series D Certificate of Designation and Series D-1 Certificate of Designation, respectively) multiplied by four. If a Company Event occurs from and after the second anniversary of the Date of Issuance, the holders of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock will receive for each share of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock, respectively, an amount in cash equal to the Original Issue Price multiplied by six. The Original Issue Price for the Series D Convertible Preferred Stock is $0.2862, and the Original Issue Price for the Series D-1 Convertible Preferred Stock is $2.862.
Holders of shares of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock will vote together with the holders of Common Stock as a single class. Each share of Series D Convertible Preferred Stock carries the right to one vote per share. Each share of Series D-1 Convertible Preferred Stock carries the right to 10 votes per share.
The Company is not permitted to amend, alter or repeal its Certificate of Incorporation or Bylaws in a manner adverse to the relative rights, preferences, qualifications, limitations or restrictions of the Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock without the affirmative vote of a majority of the votes entitled to be cast by holders of outstanding shares of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock, voting together as a single class with each share of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock having a number of votes equal to the number of shares of Common Stock then issuable upon conversion of such share of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock.
The Series D Convertible Preferred Stock is convertible at the option of the holders thereof into shares of Common Stock based on a one-for-one conversion ratio. The Series D-1 Convertible Preferred Stock is convertible at the option of the holders thereof into shares of Common Stock based on a one-for-10 conversion ratio. The conversion ratio of the Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock is subject to adjustment for stock splits and combinations, recapitalizations, reclassifications, reorganizations, mergers, and consolidations. The Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock will automatically convert into shares of Common Stock upon the fifth anniversary of the Date of Issuance.
Transfer Agent and Registrar
Broadridge Financial Solutions, Inc. is the transfer agent and registrar for our Common Stock.
Listing
Our Common Stock is traded on the OTCQB Marketplace under the trading symbol “PVCT.”
Exhibit 19
Provectus BIOPharmaceuticals, Inc.
SECURITIES TRADING POLICY
The Board of Directors of Provectus Biopharmaceuticals, Inc. (the “Company”) has adopted the following Securities Trading Policy (the “Policy”) effective as of December 17, 2013.
| I. | SUMMARY |
| ● | You may not trade in Company stock when you have material information about the Company that has not been publicly released. |
| ● | You may not share material, non-public information about the Company with friends, family members or others who do not need the information as part of their work for the Company. |
| ● | Directors, executive officers and certain other Company employees are “blacked out” for certain periods from trading in Company stock prior to quarterly earnings releases. |
| ● | You may be “blacked out” from trading in Company stock if you are working on a material, non -public transaction. |
| ● | You may not engage in transactions in which you may profit from short-term speculative swings in the value of Company stock. |
| ● | The consequences of violating United States insider trading laws and the Policy can include civil penalties, criminal penalties, and jail terms. |
| II. | Background |
The Company and its employees and directors must act in a manner that does not misuse material financial or other information that has not been publicly disclosed. The United States securities laws prohibit trading in the stock of a company by a person who possesses material, non-public information. Moreover, these laws prohibit the dissemination of such information to other persons, a process commonly known as “tipping.” These laws are frequently referred to as the “insider trading laws.” The United States Securities and Exchange Commission (the “SEC”) is responsible for the enforcement of United States securities laws and will seek to enforce the laws in connection with trading in United States securities markets even if those involved are outside of the United States. If the SEC detects violations of these laws, it can seek civil penalties (fines) and, in serious cases, it can recommend to the Department of Justice to seek criminal penalties (imprisonment). Under the insider trading laws, if an employee of a company is found to have engaged in insider trading, the SEC can also seek to impose penalties on the employee’s supervisors and on the company itself.
In addition to these potential penalties, insider trading is bad business and reflects poorly on the Company and those involved. The Company’s Code of Business Conduct and Ethics prohibits trading in securities of the Company by a person who possesses material, non-public information. The Policy applies to all Company employees, not just directors and officers. The Policy does not create any rights in third parties or any new liabilities to third parties.
| 1 |
| III. | Consequences of Violations |
The consequences of insider trading violations can be staggering. For individuals who trade on material, non-public information (or provide information to others (i.e., tipping)), consequences may include:
| ● | A civil penalty of up to three times the profit gained or loss avoided; |
| ● | A criminal fine (no matter how small the actual profit from the insider trading activities) of up to $5 million; |
| ● | A jail term of up to 20 years; |
| ● | Being barred from corporate office or directorships in public companies; |
| ● | Disgorgement of any profits; and |
| ● | The entry of a temporary or permanent cease and desist order. |
For a company (as well as possibly any supervisory person) that fails to take appropriate steps to prevent illegal trading:
| ● | A civil penalty equal to the greater of $1 million or three times the profit gained or loss avoided as a result of the employee’s violation; and |
| ● | A criminal penalty of up to $25 million. |
Moreover, if you violate the Policy, you may be subject to company discipline, including termination of employment for cause. Needless to say, any of the above consequences can tarnish one’s reputation and irreparably damage a career.
| IV. | Our Policy |
Please review carefully each of our stock-trading policies described below. The Policy will be delivered to all new directors, officers, and employees at the start of their relationship with the Company, and once each year thereafter. Upon receiving a copy of the Policy or any revised versions, each director, officer, or employee must sign an acknowledgment that he or she has received a copy of the Policy and agrees to comply with the Policy’s terms.
| V. | Trading on Material, Non-Public Information is Prohibited |
If you have material, non-public information relating to the Company, you may not buy or sell securities of the Company, engage in any other action to take advantage of that information, or pass it on to others. Similarly, if you have material, non-public information about any other company (such as a customer, collaborator or supplier) that you obtained in the course of your employment with the Company, you may not buy or sell securities of the other company, engage in any other action to take advantage of that information, or pass it on to others.
Persons Covered. This section of the Policy applies to all Company personnel, including directors, officers, and employees of the Company. This section of the Policy also applies to contractors and outside advisors that come in contact with material, non-public information about the Company. In addition, if you are aware of material, non-public information when your employment or service relationship with the Company terminates, you may not trade in Company securities until that information has become public or is no longer material. Transactions that may be necessary or justifiable for independent reasons (such as your personal need to raise money for an emergency expenditure) are not exceptions from the insider trading laws, the SEC’s rules and regulations or the Company’s policies.
| 2 |
Material Information. Material information is any information that a reasonable investor would consider important in making a decision to buy, hold or sell securities. In short, any information that could reasonably be expected to affect the price of the stock is likely to be considered material. Either positive or negative information may be material. Common examples of information that will frequently be regarded as material are:
| ● | Earnings, including whether the Company will or will not meet expectations; |
| ● | Mergers, acquisitions, tender offers, joint ventures, or changes in assets; |
| ● | A significant regulatory development; |
| ● | A change in, or new, material arrangements; |
| ● | Developments regarding customers or suppliers (including the acquisition or loss of an important contract); |
| ● | Changes in senior management; |
| ● | Changes in compensation policy; |
| ● | A change in auditors or auditor notification that the Company may no longer rely on an audit report; |
| ● | Financings and other events regarding the Company’s securities (e.g., defaults on debt securities, calls of securities for redemption, repurchase plans, stock splits, public or private sales of additional securities); |
| ● | Significant litigation; and |
| ● | Bankruptcy, corporate restructuring, or receivership. |
Twenty-Twenty Hindsight. Remember, if your securities transactions become the subject of scrutiny, they will be viewed after-the-fact with the benefit of hindsight. That is to say, the SEC and others will have the benefit of knowing how the stock price was affected once the information became public. As a result, before engaging in any transaction, you should carefully consider how the SEC and others might view your transaction in hindsight. Even the appearance of an improper transaction must be avoided to preserve our reputation for adhering to the highest standards of conduct.
Transactions by Family Members. The very same restrictions that apply to you apply to your family members and others living in your home. You are expected to be responsible for the compliance of your immediate family and others living in your home. Remember that when viewed after-the-fact, it may be difficult to convince the SEC that you did not provide a family member with material, non-public information you possessed.
Tipping Information to Others. You must not pass (or “tip”) inside information to others who do not need the information as part of their work for the Company. This includes supposedly “anonymous” communications such as Internet chat rooms. The penalties mentioned above apply whether or not you derive any benefit from another’s transactions. The SEC has imposed large financial penalties on tippers even though they did not profit from their tippees’ trading.
When Information is Public. Company stockholders and the investing public should be afforded the time to receive the information and act upon it before our trading resumes. You can resume trading when at least one full trading day has elapsed after the public disclosure of the information. One full trading day following public disclosure has elapsed when, after the public disclosure, trading in Company stock has opened for trading, then closed.
| 3 |
Example. Suppose you are aware of a material development that has not been announced to the public. You are prohibited from trading in Company stock until one full trading day after release of the announcement. If the announcement is made Tuesday at 8:00 a.m. EST, before the opening of the Nasdaq Stock Market, you can begin trading again on Wednesday morning because, after the announcement, trading on the Company’s stock opened and closed on Tuesday. On the other hand, if the announcement were not made until Tuesday at 11:00 a.m., you would not be able to trade until after the open and close of trading on Wednesday, that is, on the opening of trading on Thursday, after one full trading day has elapsed.
10b5-1 Plans.
| ● | Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) was adopted by the SEC to protect persons from insider trading liability for transactions occurring under a written trading plan previously established at a time when the insider did not possess material, non-public information. To be eligible for this defense, an insider may enter into a “10b5-1 plan” for trading in company stock. If the plan meets the requirements of Rule 10b5-1, an insider may complete transactions in company stock at any time, including during blackout periods or even when the insider possesses material, non-public information. Once the plan is adopted, the insider must not exercise any influence over the amount of securities to be traded, the price at which they are to be traded or the date of the trade. |
| ● | Insiders who desire to implement a 10b5-1 plan must first obtain approval of the plan by the Company’s Chief Financial Officer, who shall serve as the Compliance Officer under the Policy. In order to be eligible for approval, the 10b5-1 plan: (i) must be established during a trading window (i.e., not during any blackout period) and at a time when there is no material, non-public information about the Company (even if the insider is unaware of such information); (ii) must be in writing; (iii) must either irrevocably set forth the future date or dates on which purchase or sale of securities are to be made, the prices at which the securities are to be purchased or sold, the broker who will be responsible for effecting the transactions (or method of transaction if not through a broker), or provide a formula or formulas for determining the price of the securities to be purchased or sold and the date or dates on which the transactions are to be completed (provided that no aspect of the formula may permit the direct or indirect exercise of any influence over the timing or terms of the purchase or sale by the insider); (iv) may not take effect until 30 days after the plan is approved by the Compliance Officer; and (v) must include a procedure for ensuring the timely filings of all required Forms 4, 5 and 144. |
| ● | The Compliance Officer will maintain a copy of all 10b5-1 plans. |
| ● | The insider must provide the Compliance Officer written notice of any termination or modification of the 10b5-1 plan (in which case the modification must be approved in writing by the Compliance Officer prior to effectiveness and may not take effect until 30 days after the modification is approved by the Compliance Officer). |
| VI. | Directors, Officers and Persons Involved in the Preparation of COMPANY Earnings are Prohibited from Trading During “Blackout Periods” |
The investing public will often view our financial results, and significant unexpected changes in those results, as material information. Thus, the Company has a policy that certain individuals may not trade in Company stock during the preparation of our quarterly and annual financial results to be publicly announced.
| 4 |
Persons Covered. This section of the Policy applies to the following persons:
| ● | Members of the Board of Directors; |
| ● | Executive Officers; |
| ● | Other Officers; |
| ● | Employees involved in the preparation of internal and external financial reports, SEC filings and disclosures to investors and the financial community; |
| ● | Anyone in possession of material, non-public information; and |
| ● | If you are one of the above identified persons, your immediate family and others living in your home, as you are expected to be responsible for the compliance of your immediate family and others living in your home. |
Period Covered. This section of the Policy applies automatically during the period beginning on the 15th day of the last month of each fiscal quarter and ending one full trading day after the release of the Company’s financial results for the quarter or fiscal year. This period is frequently referred to as a “blackout period.” However, if you receive any material information about Company financial results or any other material, non-public information prior to the 15th day of the last month of a quarter, you must still refrain from trading at that time. In addition to the standard end-of-quarter blackout periods, the Company may, from time to time, impose special blackout periods upon notice to those persons who are affected. The occurrence of any special blackout period is confidential, and you may not disclose the existence of such special blackout period to any person outside of the Company. For example, certain Company personnel may come into possession of preliminary information regarding the Company’s clinical trials before the information is made public by the Company; in such instance, the Compliance Officer may determine that trading of Company securities by certain individuals be prohibited until such information is made public.
| VII. | Prohibitions on Trading are Applicable to Our Personnel Aware of Material TransactioNS |
From time to time, you may become aware of a corporate transaction or other event that is material to the Company or another company and that has not been disclosed to the public. An acquisition of another company would be an example. Entering into a strategic alliance, license or other collaborative agreement with another company would be another example. If you are aware of transactions of this type that have not been disclosed to the public, you may not trade in Company stock or stock of the other company. Remember also that you cannot tip the information to anyone else.
Persons Covered. This section of the Policy applies to our directors, officers, and employees, who are aware of the transaction or event. This section of the Policy also applies to contractors and outside advisors that come in contact with material, non-public information regarding the transaction or event. The Compliance Officer may, in certain situations, send out a notice to participants in a transaction that the transaction may be material and requiring participants to refrain from trading. You should not assume, however, that if you have not received such a notice, a transaction of which you are aware is not material. The receipt of any such notice is confidential, and you may not disclose the receipt of such notice to any person other than the Compliance Officer.
Period Covered. This section of the Policy applies until the earliest to occur of (a) the first full trading day following public announcement of the transaction or event, (b) abandonment of the transaction, or (c) receipt of a notification from the Compliance Officer that trading may resume.
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| VIII. | Personnel are Prohibited from Trading in Options and Other Speculative Transactions |
Because the Company believes it is improper and inappropriate for Company personnel to engage in short-term or speculative transactions involving Company securities, it is the Company’s policy that any investing you do in Company securities be on a “buy and hold” basis. Accordingly, you may not engage in any of the following activities with respect to securities of the Company: (i) trades on a short-term basis; (ii) “short sales” (selling borrowed securities which the seller hopes can be purchased at a lower price in the future); and (iii) purchases or sales of “put” or “call” options (publicly available rights to sell or buy securities within a certain period of time at a specified price). This section of the Policy applies to all Company directors, officers, and employees.
| IX. | Directors, Executive Officers and Certain Employees Are Required to Pre-Clear Trades |
In general, most employees do not need to pre-clear their trades with the Company. The Compliance Officer’s office is available to answer any questions on the application of this section of the Policy, but ultimate responsibility for trading in securities lies with you. However, the Company requires that members of the Board of Directors, executive officers subject to reporting under Section 16(a) of the Exchange Act and any person precluded from trading in Company stock under Section VI must “preclear” all transactions in Company stock with the Compliance Officer. Under this section of the Policy, the Compliance Officer will advise such person whether the individual should refrain from trading based on information available to the Compliance Officer. The Compliance Officer may designate one or more individuals who may grant approval of a trade request in the event the Compliance Officer is unable or unavailable to perform such duty. Pre-clearance does not relieve anyone of his or her responsibility under SEC rules. Furthermore, neither the Compliance Officer nor any designee shall have liability to the person requesting pre-clearance.
The individual seeking to trade must (i) notify the Compliance Officer about the proposed trade(s) in writing at least one full business day prior to the proposed trade(s), including the amount and nature of the proposed trade(s), (ii) represent to the Compliance Officer in writing that he or she is not aware of material, non-public information about the Company and (iii) effect the trade, if at all, within 48 hours of the Compliance Officer’s approval. Trades not exercised within such 48-hour period require new approval from the Compliance Officer. If the individual possesses material, non-public information, he or she must refrain from trading, regardless of whether pre-clearance was obtained.
| X. | Securities Issued under the Company’s Plans Are Subject to the Policy |
You have the opportunity to invest in Company stock through a number of Company plans. This section provides guidance with respect to transactions under these plans.
Prohibited Transactions. If the policies contained in this document prohibit you from trading in Company stock, you may not engage in any of the following transactions during the period that the prohibition remains in effect:
| ● | Open market purchases and sales of Company stock (e.g., transactions through a broker) unless in accordance with pre-arranged written plans that comply with Rule 10b5-1 and the Policy; |
| ● | Limit orders and other pre-arranged transactions in which a trade will be executed automatically when Company stock reaches a prescribed market price, unless (i) the transaction is required to be effected within 48 hours of the order or (ii) the transaction is in accordance with a pre-arranged written plan that complies with Rule 10b5-1 and the Policy; |
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| ● | Gifts of Company stock, unless you have reason to believe that the recipient intends to sell the shares during the current blackout period; |
| ● | Switching existing balances into or out of Company stock held in a Savings/401(k) Plan; or |
| ● | Exercises of stock options in “cashless” exercise transactions (i.e., transactions where the acquired stock is immediately sold) or other exercise where all or a portion of the acquired stock is sold during a blackout period. |
Permitted Transactions. Even if you are prohibited from trading by the Policy, you may engage in any of the following transactions:
| ● | Regular and matching contributions for the purchase of Company stock in a Savings/401(k) Plan; |
| ● | Elections to change the amount of future compensation that will be contributed to purchase Company stock in a Savings/401(k) Plan (e.g., increasing the percentage of contributions allocated to a Company stock fund from 10% to 20% or terminating future contributions to the Company stock fund); |
| ● | Exercises of stock options where no Company stock is sold in the market to fund the option exercise and the acquired shares are not sold during a blackout period; and |
| ● | Transactions that comply with Rule 10b5-1 pre-arranged written plans, in accordance with the provisions of the Policy. |
Managed Accounts. If you have a managed account (where another person has been given discretion or authority to trade without your prior approval), you should advise your broker or investment advisor not to trade in Company stock at any time without your prior approval and minimize trading in securities of companies in industries similar to the Company. This restriction does not apply to investments in publicly available mutual funds.
Margin Loans. Purchases or sales of securities can result in liability whether executed in the public markets or in a private transaction. In addition, you should be aware that sales forced because you borrowed money and pledged securities as collateral for the loan are not exempt from the insider trading rules. Accordingly, you should be careful when making a margin loan in a brokerage account. Under margin arrangements, the broker may be entitled to sell your shares without your permission if the value of your securities falls below the broker’s margin requirements. The sale, even though not initiated at your request, is still a sale for your benefit and may subject you to liability under the insider trading rules if made at a time when you are aware of material, non-public information. Similar cautions apply to a bank or other loan for which you have pledged stock as collateral. Directors and executive officers subject to the reporting requirements of Section 16(a) of the Exchange Act should be particularly cautious about margin loans because sales by a lender in a margin loan situation can be difficult to manage and can easily lead to violations of the pre-clearance and notification requirements of this Policy as well as the two-business day reporting deadline under Section 16(a) of the Exchange Act and may require short-swing profit disgorgement under Section 16(b) of the Exchange Act.
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| XI. | Directors and Executive Officers Are Required to File Section 16 Reports |
The SEC’s rules under Section 16(a) of the Exchange Act impose reporting requirements on executive officers, directors and 10% stockholders. If there is any change in your ownership of Company stock at any time, other than through certain exempt Company benefit plans, you will be required to file a Form 4 with the SEC reporting the change. In virtually all cases, the Form 4 must be filed no later than the second business day following the execution date of the transaction. For transactions under Rule 10b5-1 plans or certain discretionary transactions within exempt Company benefit plans (for example, fund switching transactions), the Form 4 may not be due until the second business day following the date your broker or plan administrator notifies you of the execution date, but in no event more than five business days after the execution date.
You are also required to report certain exempt transactions to the SEC at year-end on a Form 5. The number and types of transactions eligible for Form 5 reporting are very limited. Coupled with the complexity of determining the time for filing reports in the situations described above, the need to pre-clear with the Compliance Officer all transactions that you may contemplate is essential to our ability to assist you in making the proper filings in the required time frames.
Compliance Program. Under SEC rules, the preparation and filing of Section 16(a) reports is solely your responsibility. However, because of the complexities of compliance with the Section 16(a) filing requirements and to help prevent inadvertent violations of the short-swing profit rules, the Company has determined that it is prudent to provide you with assistance in preparing and filing your reports. In this regard, the following compliance procedures have been implemented:
| ● | Designated Filing Coordinator. The Company’s Chief Financial Officer has been designated as the Company’s Filing Coordinator and can assist all executive officers and directors in preparing, reviewing, and filing all Forms 3, 4 and 5. A Form 3 initial report has been filed for all current executive officers and directors. |
| ● | Preparation and Filing. If you have any transaction or change in ownership in your Company stock or other equity securities (including derivative securities, such as stock options), please report the transaction(s) to the Filing Coordinator no later than the execution date of the transaction. This is necessary notwithstanding your receipt of pre-clearance of the transaction because the Company will not know whether or not you then proceeded to act upon such pre-clearance until you provide us with the exact dates; price(s); and other relevant information. The Filing Coordinator will contact you each January to coordinate preparation of your Form 5 (if applicable). |
| ● | Upon receipt of the details of the transaction(s) from you, the Filing Coordinator will prepare each Form 4 and Form 5 on your behalf. Due to the short two-day period in which to file the reports, the Filing Coordinator may have the Form executed on your behalf using the power of attorney that you granted to the Company for this purpose and will file the completed form with the SEC. As discussed above, the SEC must receive the Form 4 no later than the second business day following almost any transaction, and Form 5 must be received by February 14th each year, so time is of the essence. The Filing Coordinator will send you a copy of the Form 4 or Form 5 as filed with the SEC promptly following the filing. Please contact the Filing Coordinator immediately if you believe there may be any errors in the filing. If so, the Filing Coordinator will promptly amend the Form. |
Electronic Filings and Website Postings. All Forms 4 and 5 must be filed with the SEC electronically and then posted on the Company’s website. If you already have an SEC EDGAR identification number, please provide that information to the Filing Coordinator as soon as possible. Otherwise, the Filing Coordinator will obtain an identification number for you.
Forms 4 and 5 for Stock Options and Other Stock Plans. Because transactions under employee and director stock option and other stock plans can (a) raise complex Section 16(a) reporting issues; and (b) if reported incorrectly, create the appearance of short-swing profit violations, the Filing Coordinator will automatically prepare the appropriate Form on your behalf whenever you acquire shares pursuant to a Company benefit plan.
The Ultimate Responsibility Rests on You. While the Company has decided to assist executive officers and directors with Section 16 compliance, you should recognize that it will remain your legal obligation to ensure that your filings are made timely and correctly, and that you do not engage in unlawful short-swing transactions. The Company can only facilitate your compliance to the extent you provide the Company with the information required by this section of the Policy. The Company does not assume any legal responsibility in this regard. If you would like more detailed information regarding your Section 16 obligations, please contact the Filing Coordinator.
| XII. | Directors and Executive Officers Are Required to File Form 144 Reports |
Company directors and certain Company officers designated by the Board of Directors are required to file Form 144 before making an open market sale of Company securities. Form 144 notifies the SEC of your intent to sell Company securities. This form is generally prepared and filed by your broker and is in addition to the Section 16 reports filed on your behalf by the Company.
Updated as of December 17, 2013.
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ACKNOWLEDGMENT OF RECEIPT
I hereby acknowledge that I have received a copy of the Securities Trading Policy and agree to comply with its terms. I understand that violation of insider trading or tipping laws or regulations may subject me to severe civil and/or criminal penalties and that violation of the terms of the Securities Trading Policy may subject me to discipline by Provectus Biopharmaceuticals, Inc. up to and including termination for cause.
| Signed: | ||
| Name (please print): | ||
| Date: | ||
Exhibit 21
SUBSIDIARIES OF PROVECTUS BIOPHARMACEUTICALS, INC.
Subsidiary |
Jurisdiction of Incorporation | |
| VisiRose, Inc.* | Delaware | |
| Xantech Pharmaceuticals, Inc. | Tennessee | |
| Pure-ific Corporation** | Nevada | |
| Provectus Biotech, Inc. | Tennessee | |
| Provectus Devicetech, Inc. | Tennessee | |
| Provectus Imaging, Inc. | Tennessee | |
| IP Tech, Inc. | Tennessee | |
| Provectus Pharmatech, Inc. | Tennessee | |
| Provectus Biopharmaceuticals Australia PTY LTD | New South Wales, Australia | |
*Indicates a non-wholly owned subsidiary of the registrant.
**Entity status permanently revoked in the State of Nevada.
Exhibit 31.1
CERTIFICATION OF PRESIDENT
PURSUANT TO RULE 13a-14(a) UNDER
THE SECURITIES EXCHANGE ACT OF 1934
I, Dominic Rodrigues, certify that:
1. I have reviewed this Annual Report on Form 10-K for the fiscal year ended December 31, 2024 of Provectus Biopharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: March 27, 2025 | By: | /s/ Dominic Rodrigues |
| Dominic Rodrigues | ||
| President (principal executive officer) |
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO RULE 13a-14(a) UNDER
THE SECURITIES EXCHANGE ACT OF 1934
I, Heather Raines, certify that:
1. I have reviewed this Annual Report on Form 10-K for the fiscal year ended December 31, 2024 of Provectus Biopharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: March 27, 2025 | By: | /s/ Heather Raines |
| Heather Raines, CPA | ||
| Chief Financial Officer (principal financial officer) |
Exhibit 32
CERTIFICATION OF PRESIDENT AND
CHIEF FINANCIAL OFFICER PURSUANT TO RULE 13a-14(b) UNDER
THE SECURITIES EXCHANGE ACT OF 1934 AND SECTION 1350 OF
CHAPTER 63 OF TITLE 18 OF THE UNITED STATES CODE
Each of the undersigned, Dominic Rodrigues and Heather Raines, certifies, pursuant to Rule 13a-14(b) under the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code, that (1) this Annual Report on Form 10-K for the year ended December 31, 2024 of Provectus Biopharmaceuticals, Inc. (the “Company”) fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act, and (2) the information contained in this report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| This Certification is signed on March 27, 2025. | /s/ Dominic Rodrigues |
| Dominic Rodrigues | |
| President (principal executive officer) | |
| /s/ Heather Raines | |
| Heather Raines, CPA | |
| Chief Financial Officer (principal financial officer) |