Provectus Biopharmaceuticals Initiates Preclinical Study of Oral PV-10 in Bladder Cancer

KNOXVILLE, Tenn., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced the start of a preclinical study of its lead investigational drug PV-10 in an orthotopic bladder cancer model. Results are expected in the first quarter of 2026. PV-10 is formulated from the Company’s pharmaceutical-grade rose bengal sodium active pharmaceutical ingredient.

Conducted by Translational Drug Development, LLC (TD2), the study will evaluate PV-10’s performance across different treatment arms, including oral and intravesical monotherapy and combination with an anti-PD-1 checkpoint inhibitor. The study is designed to generate translational data that would inform future clinical development of PV-10 for bladder cancer and support broader immuno-oncology applications of oral PV-10 for solid tumor cancers.

Alan Bryce, MD, Interim President and Chief Clinical Officer, City of Hope Cancer Center Phoenix said, “Our goal is to be able to translate successful mouse model data into the foundation for a corresponding clinical trial of PV-10 in bladder cancer, with the key being to have an evidence basis for dose and route of administration determinations.”

Dominic Rodrigues, President and Vice Chair of the Board of Directors of Provectus, said “Successful results from this preclinical research will allow us to expand PV-10’s investigational new drug application for site-specific and systemic administration. We believe oral PV-10 has the potential to be a game-changing treatment across solid tumor and hematologic cancers.”

About Provectus

Provectus Biopharmaceuticals, Inc. is a clinical-stage biotechnology company developing a pipeline of immunotherapy medicines based on rose bengal sodium, a first-in-class synthetic small molecule from the halogenated xanthene family. The Company’s clinical programs span oncology, dermatology, and ophthalmology, with additional proof-of-concept programs in hematology, wound healing, infectious diseases, and tissue repair.

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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 Securities and Exchange Commission (SEC), including those described in Item 1A of:

• The Company’s Annual Report on , and
• Provectus’s Quarterly Report on .

Contacts:

Provectus Biopharmaceuticals, Inc.

Heather Raines, CPA

Chief Financial Officer

(866) 594-5999

Investor Relations & Media

Susan Xu



(778) 323-0959