Update: Provectus's Bascom Palmer Eye Institute's RBS-PDAT license option discussions are ongoing
Ophthalmic Biophysics Center's photodynamic antimicrobial therapy (PDAT) medical device in combination with Provectus's pharmaceutical grade rose bengal sodium (RBS)
Under Note 11. License Transactions of “Notes to Condensed Consolidated Financial Statements” of Provectus’s Form 10-Q for the period ending March 31, 2023, filed on May 11th, Provectus wrote:
On February 16, 2022, and later amended on May 11, 2022, the Company entered into an option agreement with the University of Miami (“UM”) for an exclusive worldwide license of intellectual property (“IP”) developed by the Ophthalmic Biophysics Center (“OBC”) of Bascom Palmer Eye Institute (“BPEI”) that included the use of OBC’s ophthalmic photodynamic antimicrobial therapy (“PDAT”) medical device in combination with formulations of the Company’s pharmaceutical-grade RBS for the treatment of bacterial, fungal, and viral infections of the eye. The Company completed the arrangements of this collaboration during the third quarter of 2022, whereby the Company (i) paid $5,000 for the option to obtain an exclusive worldwide, royalty-bearing license that expires on May 31, 2023, (ii) agreed to pay up to $10,000 of new UM patent expenses for this IP during the period of the option, (iii) agreed to pay up to $25,000 of past UM patent expenses for this IP, and (iv) entered into a sponsored research agreement with UM on September 16, 2022 to study the combination of OBC’s PDAT and TOP PV-305, a formulation of the Company’s pharmaceutical-grade RBS, for the treatment of infectious keratitis. If the Company elects to exercise the option, UM and the Company have six months to negotiate a license agreement. If UM and the Company are unable to reach an agreement, UM may offer its patent rights to any third party. As of March 31, 2023, the Company has not elected to exercise the options.
Principles of Collaboration
Provectus believes that a potentially substantial, long-term, medical scientific, technologic, and financial opportunity exists for a mutually-beneficial collaboration between UM and Provectus on RBS-PDAT, given:
BPEI’s longstanding number one ranking, experience, and domestic and international reputation as the preeminent medical institution treating eye-related conditions,
OBC’s long history of and experience in developing numerous research innovations that have advanced the management of ophthalmic conditions,
Provectus’ effectively sole-sourced pharmaceutical-grade RBS drug substance, and
Provectus’s desire and intent to seek approval for and commercialize OBC’s PDAT using Provectus’ RBS drug substance (RBS-PDAT) for global access and affordability.
Proposed RBS-PDAT Development Program
In support of these ongoing discussions, we previously provided UM’s Office of Technology Transfer (OTT), at its request, with an initial, preliminary, and draft development plan for Provectus to potentially commercialize RBS PDAT. The framework of the proposed development program comprised, but was not limited to:
Potential development activities to be undertaken,
Potential germane drug/device regulatory steps and contemplated approvals,
Proposed go-to-market approach,
Potential competitors, and
Proposed corporate structure and funding.
Update
Our discussions with OTT about the above mentioned license have continued past the original license option expiration date of May 31st. There currently isn’t a new milestone expiration date. Rather, discussions are ongoing, and UM and Provectus may eventually agree to a license deal or they won’t.
Where to Find Available Information
Investors and others should note that Provectus Biopharmaceuticals, Inc. (the Company) uses, and will continue to use, press releases distributed by GlobeNewswire®, filings with the Securities and Exchange Commission (SEC), and the Company's website (provectusbio.com) to disclose material financial and operational information to the Company's shareholders, prospective investors, the media, and others interested in the Company. The Company also intends to use 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 Twitter 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.
Forward-Looking Statements
The information in Provectus’s Substack post may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management 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 “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “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 Provectus’s Substack 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 SEC, including those described in Item 1A of:
the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and
Provectus’ Quarterly Report on Form 10-Q for the period ended March 31, 2023.

