Provectus Biopharmaceuticals Announces Seed Financing for VisiRose, Provectus’s Spinoff Company for Rose Bengal-Based Eye Drugs

Rhea-AI Summary

Provectus Biopharmaceuticals (OTCQB: PVCT) announced a $3 million seed financing round for its spinoff company, VisiRose. VisiRose is a clinical-stage biotechnology company focused on developing Rose Bengal Photodynamic Antimicrobial Therapy (RB-PDAT) for treating infectious keratitis and other eye infections. RB-PDAT uses Provectus's bioactive synthetic small molecule, Rose Bengal Sodium (RBS), combined with a light-based medical device from the Ophthalmic Biophysics Center at Bascom Palmer Eye Institute.

The financing will support several key initiatives: preparing for a pre-IND submission meeting with the FDA for RB-PDAT, submitting an IND application for the investigational eye drug PV-305, manufacturing an initial clinical supply of PV-305, and applying for Small Business Innovative Research grant funding. Dominic Rodrigues, Vice Chairman of Provectus and Acting CEO of VisiRose, expressed optimism about advancing VisiRose's ophthalmology drug pipeline.

VisiRose's website is accessible at: visirose.com

Positive

• $3 million seed financing round secured.
• Development of novel ocular therapeutics using Rose Bengal Sodium.
• RB-PDAT targets infectious keratitis and other eye infections, including multidrug-resistant organisms.
• Support for key regulatory steps, including pre-IND and IND applications.
• Initial clinical supply manufacturing for PV-305.

Negative

• None.

KNOXVILLE, Tenn., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced a $3 million seed financing round for VisiRose, Inc. (“VisiRose”), Provectus’s Founded Entity that is developing novel ocular therapeutics.

VisiRose is a newly launched, privately held, clinical-stage biotechnology company focused on initially commercializing Rose Bengal Photodynamic Antimicrobial Therapy (“RB-PDAT”) for the treatment of infectious keratitis and other eye infections using Provectus’s bioactive synthetic small molecule and active pharmaceutical ingredient (“API”) Rose Bengal Sodium (“RBS”).

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 of Miami’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.

VisiRose’s seed financing round supports several key ongoing initiatives:

• Preparing for and completing a pre-investigational new drug (“IND”) submission meeting with the U.S. Food and Drug Administration (“FDA”) for RB-PDAT for infectious keratitis,
  
• Preparing and submitting an IND application for investigational eye drug PV-305, and working towards the IND’s acceptance by the FDA,
  
• Manufacturing an initial clinical supply of PV-305 for VisiRose to initiate clinical trials and undertake expanded access post-IND acceptance, and
  
• Applying for Small Business Innovative Research grant funding to support VisiRose’s clinical development of RB-PDAT for infectious keratitis and to undertake more novel research with BPEI.
  

Dominic Rodrigues, Vice Chairman of the Board of Directors and President of Provectus, who also serves as Acting Chief Executive Officer of VisiRose, said, “We are pleased that VisiRose completed this first financing round to support the advancement of its ophthalmology drug pipeline. The funding enables VisiRose to advance its lead drug candidate PV-305 through critical initial regulatory steps, ultimately moving VisiRose and Provectus closer to providing patients with innovative therapies for corneal diseases and other serious ocular conditions.”

VisiRose’s website is accessible here: https://visirose.com/.

About VisiRose

VisiRose is a newly launched, privately held, 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 23^rd time and 21^st 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
hraines@pvct.com
(866) 594-5999

VisiRose, Inc.
Dominic Rodrigues
Acting Chief Executive Officer
rodrigues@visirose.com
(866) 216-7333

Investor Relations & Media
Alliance Advisors Investor Relations
Ira M. Gostin
igostin@allianceadvisors.com
(775) 391-0213

FAQ

What is the significance of the $3 million seed financing for PVCT?

The $3 million seed financing supports VisiRose in advancing its ophthalmology drug pipeline, including critical initial regulatory steps and clinical supply manufacturing.

What is RB-PDAT and how does it relate to PVCT?

RB-PDAT is a non-invasive investigational treatment for eye infections developed by VisiRose, a spinoff of Provectus. It uses Provectus's Rose Bengal Sodium and a light-based medical device.

What are the key initiatives supported by VisiRose's seed financing?

The financing supports pre-IND and IND submissions to the FDA, manufacturing clinical supplies of PV-305, and applying for grant funding to further develop RB-PDAT.

How does VisiRose's RB-PDAT treatment work?

RB-PDAT combines Provectus's Rose Bengal Sodium with a light-based medical device to treat eye infections caused by bacteria, fungi, and parasites, including multidrug-resistant organisms.

What is the role of Dominic Rodrigues in VisiRose?

Dominic Rodrigues is the Vice Chairman of Provectus and serves as the Acting Chief Executive Officer of VisiRose.

Where can I find more information about VisiRose?

More information about VisiRose can be found on their website: visirose.com.