What changed in this filing

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Item 1. Business

2026-03-26 compared with 2025-03-28 · 68 added, 103 removed, 318 unchanged (35% of the section changed)

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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.

RBS may concurrently display stimulatory and inhibitory effects, may target disease

in a multi-mechanistic manner, may be an electron acceptor and donor.

Direct contact by RBS with disease may lead to cell death or repair

by one or more pathways, depending on the disease being treated and the amount of RBS being utilized.

Multivariate innate and adaptive

immune activation, signaling, and response may follow.

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:

of RBS delivered by different routes of administration specific to each disease area, including:

Development programs in oncology (intratumoral administration), dermatology (topical), and ophthalmology (topical),

Proof-of-concept programs in oncology (oral), hematology (oral), wound healing (topical), and canine cancers (intratumoral),

Early discovery programs in infectious diseases and tissue regeneration and repair, and

Early discovery programs in immune vaccine adjuvants, infectious diseases, tissue regeneration and repair,

and proprietary, and

Computer modeling of amyotrophic lateral sclerosis and other disease targets.

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are material to an understanding of the Company are listed in the table below.

In 2024, we received five patent awards from the USPTO:

In 2025, we received one patent award from the USPTO:

for the synthesis of rose bengal and related xanthenes

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xanthene composition and method for treating hematologic cancers

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),

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

Vitro and Xenograft Anti-Tumor Activity of a Halogenated-Xanthene Against Refractory Pediatric Solid Tumors (18/642,051), and

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

vitro and xenograft anti-tumor activity of a halogenated-xanthene against refractory pediatric solid tumors

2025, one patent application was also published on the USPTO’s website:

Halogenated Fluorescein Assists in Full Skin-Thickness Wound Healing (USPTO application number 19/198639).

International

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

of local and systemic immunomodulative therapies for enhanced treatment of cancer” in Canada,

of Local and Systemic Therapies for Enhanced Treatment of Dermatologic Conditions” in Europe,

vitro and xenograft anti-tumor activity of a halogenated xanthene against refractory pediatric solid tumors” in Canada (allowance),

and Methods for Treating Hematologic Cancers” in Japan and Australia (allowance),

Uses of halogenated xanthenes in oncology and virology” in China and Japan,

of Solid Cancerous Tumors by Oral Administration of a Halogenated Xanthene” in Japan,

Xanthene Composition and Method for Treating Hematologic Cancers” in Japan, and

xanthenes as vaccine adjuvants” in Japan.

2025, the Company received patent awards and allowances for three of our patent families:

vitro and xenograft anti-tumor activity of a halogenated-xanthene against refractory pediatric solid tumors

Halogenated-xanthenes

as vaccine adjuvants

and method for treating hematologic cancers

In vitro and xenograft anti-tumor activity

of a halogenated-xanthene against refractory pediatric solid tumors

Development and Drug Discovery

Company’s small molecule platform, which comprises different drug candidates and non-clinical formulations made from pharmaceutical-grade

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

Development Programs

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.

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.

has undergone clinical monotherapy and combination therapy study of mechanisms of action and immune response for melanoma, metastatic

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

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

Company’s co-lead indication for intratumoral PV-10 is pre-operative penile squamous cell carcinoma (“penile SCC”),

where patients would receive monotherapy PV-10 at a single-site early-stage clinical trial at Moffitt.

other co-lead indication for intratumoral PV-10 is FOLRINOX-refractory pancreatic ductal adenocarcinoma (“PDAC”) metastatic

to the liver (“mPDAC”), where patients would receive the combination therapy of PV-10 and systemically administered gemcitabine

and nab-paclitaxel at a single-site early-stage clinical trial at Moffitt.

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.

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.

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.

has undergone clinical monotherapy mechanism of action and mechanism of immune response study for psoriasis at The Rockefeller University

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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.

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.

formulation PV-305, a formulation of PV-10, has undergone non-clinical combination therapy study (i.e., drug and device) for diseases

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POC of PO administration for blood cancers.

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.

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.

formulations of PV-10 are undergoing non-clinical monotherapy study for the healing of full-thickness cutaneous wounds at UTMB.

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molecular docking of RBS has been done and is being done for amyotrophic lateral sclerosis and other disease targets.

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,

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

and mPDAC indications to generate new clinical data and appropriately utilize historical clinical data from intratumoral PV-10 trials,

EAPs, and/or QOL study of injectable solid tumor cancers.

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Analytical Comparison

2022, the Company began work with a U.S.

2022, the Company worked with a U.S.

contract development and manufacturing organization to assess rigorously and methodically three

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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

The Company believes that the results of these analyses indicated that all three lots of commercial grade rose bengal had

rose bengal purity that was drastically different from what was represented on their respective certificates of analysis (“CofAs”),

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and economic challenges to overcome and validate for compliance with modern drug regulatory standards.

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.

Company also held an investor conference call in February.

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

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

treatment of infectious diseases, such as coronaviruses.

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.

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.

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

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

treating bacterial, fungal, and parasitic (acanthamoeba) infections of the eye.

The agreement contemplated the Company forming a majority-owned

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

RB-PDAT medical device in combination with a formulation of RBS.

Provectus would contribute the license to the new entity and have an

exclusive RBS supply arrangement with it.

In December, the Company launched VisiRose, Inc.

(“VisiRose”), the Company’s first Founded Entity and a new clinical-stage

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

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

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

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

Diego, California from April 5-10.

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

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

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

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

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

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.

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.

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

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

June, the Company held its annual stockholder meeting where stockholders approved the proposals of the Board of Directors (“Board”)

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were made accessible by Zoom Webinar.

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

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

data on PV-10 for the intratumoral treatment of head and neck squamous cell carcinoma were published in Molecular Cancer Therapeutics ,

titled “PV-10 triggers immunogenic cell death in head and neck squamous cell carcinoma via endoplasmic reticulum stress and apoptosis.”

September, the Company initiated preclinical research on oral PV-10 in bladder cancer.

December, non-clinical data on PV-10 for the activation of the body’s natural STING (stimulator of interferon genes) immune pathway

were published in Human Vaccines & Immunotherapeutics , titled “PV-10 as New Adjuvant Enhances Immune Responses in Hepatitis

B Vaccination Through STING Pathway.”

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

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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,

devices, or other competitors may develop products that accomplish similar functions to our technologies in ways that may be less expensive,

receive faster regulatory approval, or receive greater market acceptance than our products.

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and may be further along in their respective product cycles.

2024, we began manufacturing new clinical supplies of PV-10 and PV-305.

2025, we continued manufacturing new clinical supplies of PV-10 and PV-305.

Regulation of Therapeutic Products

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Phase 3 studies also provide an adequate basis for extrapolating the results

to the general population and transmitting that information in the physician labeling.

to the general population and transmitting that information in physician labeling.

Phase 3 studies usually include several hundred

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The website is http://www.sec.gov .

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

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.

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).

information and observations that the Company posts through these social media channels may be deemed material.

investors should monitor these social media channels in addition to following the Company’s press releases, SEC filings, and

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.

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

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

What changed 10-K

Item 1. Business