PVCT 8-K
Provectus Biopharmaceuticals, Inc. (PVCT)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01. Other Events.
On December 5, 2024, the Board of Directors (the “Board”) of Provectus Biopharmaceuticals, Inc. (the “Company”) approved the formation of a subsidiary of the Company to be incorporated under the laws of the State of Delaware under the name VisiRose, Inc. (“VisiRose”) and to pursue the development and commercialization of the Company’s pharmaceutical-grade active pharmaceutical ingredient (“API”) rose bengal sodium 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. A copy of VisiRose’s Press Release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the Company’s Press Release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Pursuant to the Company’s exclusive license agreement with the University of Miami (the “University”) for the development and commercialization of the University’s intellectual property related to photodynamic antimicrobial therapy in ophthalmology entered into on March 21, 2024 (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.
VisiRose shall have an initial authorized capital stock of 5,000,000 shares, consisting of 4,000,000 shares of common stock, par value $0.001 per share (the “Common Stock”) and 1,000,000 shares of preferred stock, par value $0.001 per share. Pursuant to the License Agreement, the Board approved the issuances of 95,000 shares of Class A Common Stock (the “Class A Shares”) to the Company and 5,000 Class A Shares to the University.
The Board also approved the appointment of the following individuals as the initial directors of VisiRose’s board: independent directors of the Company Webster Bailey and Jack Lacey, III, MD, chairman and chief executive officer of the Company Ed Pershing as chairman of VisiRose, and president of the Company Dominic Rodrigues. The Board also approved the following individuals as the initial officers of VisiRose: Dominic Rodrigues as Acting Chief Executive Officer of VisiRose, and Chief Financial Officer of the Company Heather Raines as Acting Chief Financial Officer of VisiRose.
On October 31, 2024, the Company entered into a non-binding seed round investment term sheet for VisiRose (the “Seed Round Term Sheet”) with non-related party investors (the “Seed Investors”), subject to final review and contract finalization by the Board. The Seed Investors shall invest in VisiRose:
| ● | $1,000,000 upon request at the lesser of a post-money valuation of $20 million or a twenty-five percent (25%) discount (the “Discount) to the valuation of a potential Series A investment round (the “Series A Round”) if its post-money valuation is less than or equal to $26.67 million, | |
| ● | $1,000,000 within thirty (30) days of a pre-investigational new drug (“IND”) application submission meeting with the U.S. Food and Drug Administration at the lesser of a post-money valuation of $25 million or at the Discount if the Series A Round’s post-money valuation is less than or equal to $33.33 million, and | |
| ● | $1,000,000 within two (2) years of their initial investment in VisiRose at the lesser of a post-money valuation of $33.33 million or at the Discount if the Series A Round’s post-money valuation is less than or equal to $44.44 million. |
On December 5, 2004, pursuant to the Seed Round Term Sheet, the Board also approved the issuance of 5,278 shares of Class B Common Stock to the Seed Investors. The Board also approved the issuance of 278 shares of Class A Shares to the University pursuant to the License Agreement, whereby the University shall receive additional shares to remain at an ownership of five percent (5%) of VisiRose until VisiRose receives a total of $2,000,000 of qualified investment.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release of VisiRose, Inc., dated December 10, 2024 | |
| 99.2 | Press Release of Provectus Biopharmaceuticals, Inc., dated December 11, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: December 11, 2024
| PROVECTUS BIOPHARMACEUTICALS, INC. | ||
| By: | /s/ Heather Raines | |
| Heather Raines | ||
| Chief Financial Officer (Principal Financial Officer) | ||
Exhibit 99.1
VisiRose Introduces Revolutionary Therapy for Severe Eye Infections
Collaboration between Bascom Palmer Eye Institute and Provectus Biopharmaceuticals
KNOXVILLE, Tenn. — December 10, 2024 — VisiRose, a clinical-stage biotechnology company, is introducing Rose Bengal Photodynamic Antimicrobial Therapy (RB PDAT), a groundbreaking, non-invasive investigational treatment for infectious keratitis and other serious eye infections developed by the University of Miami Miller School of Medicine’s Bascom Palmer Eye Institute (BPEI). VisiRose, a newly launched company of Provectus Biopharmaceuticals (OTCQB: PVCT) and the University, is focused on commercializing this innovative ocular research by combining a formulation of Provectus’s pharmaceutical-grade bioactive synthetic small molecule Rose Bengal Sodium (RBS) and BPEI’s light-based medical device to treat eye infections caused by bacteria, fungi, and parasites.
RB PDAT offers a potential solution to the growing global problem of antimicrobial resistance (AMR), providing a broad-spectrum ocular therapy that may be safe, effective, and cost-efficient. The treatment has shown rapid infection resolution and improved patient outcomes in clinical trials across the U.S., India, Brazil, and Mexico.
“RB PDAT is a revolutionary, non-invasive treatment showing remarkable promise for patients with severe infectious keratitis. This innovative therapy harnesses the power of light to combat infection and offers new hope for preserving vision,” said Jean-Marie Parel, IngETS-G, Ph.D., FAIMBE, FARVO, Director and co-founder of the Ophthalmic Biophysics Center at BPEI.
Guillermo Amescua, M.D., Professor of Clinical Ophthalmology, Medical Director of the Ocular Microbiology Laboratory, and a board-certified ophthalmologist at BPEI added, “VisiRose is crucial for translating the innovation of RB PDAT from the laboratory to a widely accessible treatment, ultimately benefiting countless patients worldwide.”
“VisiRose is the bridge that connects innovation with impact. It enables us to bring the hope of RB PDAT to patients who desperately need it, transforming lives and shaping the future of eye care,” said Ed Pershing, Chairman of the Board of Directors of VisiRose and Provectus.
Dominic Rodrigues, Acting CEO of VisiRose added, “RB PDAT offers a beacon of hope for patients facing the threat of vision loss from infectious keratitis. This innovative therapy, with its targeted action and dual benefits, represents a significant advancement in eye care, paving the way for a brighter future for those struggling with this challenging condition.”
In more than 500 patients, RB PDAT has shown promising results in treating severe eye infections where traditional therapies have failed. VisiRose is poised to address a significant gap in the $60 billion global ophthalmic market, focusing on regions and populations impacted by rising AMR and the lack of access to effective treatments.
About VisiRose
VisiRose is a newly launched, clinical-stage biotechnology company of the University of Miami and Provectus Biopharmaceuticals, focused on commercializing the Miller School of Medicine’s Bascom Palmer Eye Institute and its Ophthalmic Biophysics Center’s innovative ocular research using Provectus’s bioactive synthetic small molecule Rose Bengal Sodium (RBS). For more information, please visit: https://visirose.com.
About Bascom Palmer Eye Institute
The Bascom Palmer Eye Institute, part of the University of Miami Health System, is consistently ranked #1 in ophthalmology in the U.S. by U.S. News & World Report. Known for its cutting-edge research and clinical excellence, Bascom Palmer provides world-class care across all ophthalmic subspecialties and is at the forefront of developing innovative treatments for eye diseases. With a commitment to advancing both patient care and medical research, it is recognized globally as a leader in ophthalmology. For more information, please visit: https://umiamihealth.org/en/bascom-palmer-eye-institute.
About
Provectus Biopharmaceuticals
Provectus Biopharmaceuticals (OTCQB: PVCT) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of bioactive synthetic small molecules called halogenated xanthenes. The Company’s lead molecule is named Rose Bengal Sodium. Provectus’s drug platform includes:
| ● | Clinical development programs in oncology, dermatology, and ophthalmology, | |
| ● | In vivo proof-of-concept programs in oncology, hematology, full-thickness cutaneous wound healing, and canine cancers, and | |
| ● | In vitro discovery programs in infectious diseases, tissue regeneration and repair, and several proprietary targets. |
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For more information, please visit: www.provectusbio.com.
For Media Inquiries:
VisiRose, Inc.
W: visirose.com
Contact:
VisiRose, Inc.
Dominic Rodrigues
Acting Chief Executive Officer
Exhibit 99.2
Provectus Biopharmaceuticals Launches VisiRose, Provectus’s Founded Entity for Pharmaceutical-grade Rose Bengal Sodium-based Treatments in Ophthalmology
KNOXVILLE, Tenn., December 11, 2024 (GLOBE NEWSWIRE) — Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) announced today the launch of VisiRose, Inc. (“VisiRose”), Provectus’s first Founded Entity. This new clinical-stage biotechnology company is focused on commercializing Rose Bengal Photodynamic Antimicrobial Therapy (“RB PDAT”) for the treatment of infectious keratitis and other serious eye infections using Provectus’s bioactive synthetic small molecule and active pharmaceutical ingredient (“API”) Rose Bengal Sodium (RBS). The University of Miami (the “University”) is a minority equity shareholder of VisiRose.
RB PDAT, a groundbreaking, non-invasive investigational treatment for eye infections, is based on innovative ocular research from the Ophthalmic Biophysics Center at Bascom Palmer Eye Institute (“BPEI”) of the University’s Miller School of Medicine. RB PDAT combines a formulation of Provectus’s pharmaceutical-grade RBS API and OBC’s light-based medical device to treat eye infections caused by bacteria, fungi, and parasites, including multidrug-resistant organisms.
Dominic Rodrigues, Acting Chief Executive Officer of VisiRose, who is also President and Vice Chairman of the Board of Directors of Provectus, said, “RB PDAT represents a consequential solution for patients at risk of vision loss from infectious keratitis. We believe this innovative therapy combines precise infection-fighting capabilities with vision-preserving benefits, paving the way for a brighter future for those struggling with this challenging condition.”
Ed Pershing, Chairman of the Boards of Directors of VisiRose and Provectus added, “VisiRose exemplifies Provectus’s forward-thinking business model, bridging innovation and impact. Spinning off this clinical-stage, ophthalmology-focused entity enhances our ability to address unmet medical needs while unlocking value for our stockholders. By focusing on a high-growth area like eye care, we are both advancing RB PDAT and maximizing the intrinsic value of RBS and, ultimately, Provectus’s market position.”
A copy of VisiRose’s press release from December 10, 2024 of its launch may be found here: https://www.accesswire.com/952319/visirose-introduces-revolutionary-therapy-for-severe-eye-infections.
VisiRose’s website is accessible here: https://visirose.com/.
About VisiRose
VisiRose is a newly launched clinical-stage biotechnology company of the University of Miami and Provectus Biopharmaceuticals, focused on commercializing the Miller School of Medicine’s Bascom Palmer Eye Institute and its Ophthalmic Biophysics Center’s innovative ocular research using Provectus’s bioactive synthetic small molecule Rose Bengal Sodium (“RBS”). For more information, please visit https://visirose.com.
About Bascom Palmer Eye Institute
Bascom Palmer Eye Institute serves as the Department of Ophthalmology for the University of Miami Miller School of Medicine. The mission of BPEI is to enhance the quality of life by improving sight, preventing blindness, and advancing ophthalmic knowledge through compassionate patient care and innovative research. For 2024-2025, U.S. News & World Report (“U.S. News”) ranked BPEI as the nation’s best in ophthalmology, marking the 23rd time and 21st consecutive year that BPEI has received the No. 1 ranking since U.S. News began surveying American physicians for its annual “Best Hospitals” rankings 35 years ago.
About Provectus
Provectus Biopharmaceuticals is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of bioactive synthetic small molecules called halogenated xanthenes. The Company’s lead molecule is RBS. Provectus’s small molecule drug platform includes:
| ● | Clinical development programs in oncology, dermatology, and ophthalmology, | |
| ● | In vivo proof-of-concept programs in oncology, hematology, full-thickness cutaneous wound healing, and canine cancers, and | |
| ● | In vitro discovery programs in infectious diseases, tissue regeneration and repair, and several proprietary targets. |
Information about the Company’s clinical trials can be found at the National Institutes of Health registry, ClinicalTrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.
Forward Looking Statements
The information in this press release may include “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “aim,” “likely,” “outlook,” “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “would,” “project,” “projection,” “predict,” “potential,” “targeting,” “intend,” “can,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including those described in Item 1A of Provectus’s:
| ● | Annual Report on Form 10-K for the period ended December 31, 2023, and | |
| ● | Quarterly Report on Form 10-Q for the period ended September 30, 2024. |
Contacts:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
(866) 594-5999
VisiRose, Inc.
Dominic Rodrigues
Acting Chief Executive Officer
(866) 216-7333
Investor Relations & Media
Provectus: Alliance Advisors Investor Relations
Alyssa Barry
(833) 947-5227