News Day: May 17, 2024

New investor presentation; Society of Interventional Radiology; Eyecare NewCo; Ferrari race car driver; Dog Cancers NewCo

May 18, 2024

New Provectus investor presentation

We updated our investor presentation, which is available on Provectus’s website here, based on direction and feedback from irlabs, the Company’s strategic communications partner.

PV-10 & Society of Interventional Radiology

Provectus’s cancer immunotherapy agent PV-10 and metastatic uveal melanoma data from a single-site Phase 1 clinical trial (NCT00986661) at MD Anderson Cancer Center (led by Dr. Sapna Patel) were highlighted at the annual scientific meeting of the Society of Interventional Radiology (SIR), held March 23-27, 2024 in Salt Lake City, Utah. Dr. Patel’s speaker session was titled “Locoregional interventions combined with checkpoint inhibition from an oncologist's perspective.” A Provectus website link to her presentation is here. PV-10 is highlighted on slide nos. 5-9.

Formerly of MD Anderson, this summer Dr. Patel will become the William Robinson Endowed Chair and Professor in Cancer Research at the University of Colorado Cancer Center (Anschutz Medical Campus).

Slide number 9 highlighted two sets of survival curves for patients with uveal melanoma (UM) metastatic to the liver (mUM). The curves are for mUM patients with M1a-staged disease with or without extra-hepatic metastases (i.e., an earlier stage than M1b or M1c, patients with which were also treated in this mUM clinical trial):

Monotherapy PV-10, with a median overall survival (mOS) of 10.4 months,
Combination therapy ipiliumab + nivolumab (IN) (data of M1a patients in Pelster et al. 2021), with an mOS of 12.8 months, and
Combination therapy PV-10 + IN, with an mOS of 50.0 months.

Ophthalmology: Rose bengal photodynamic antimicrobial therapy

On May 14, 2024, Provectus announced that clinical and non-clinical data on rose bengal photodynamic antimicrobial therapy (RB PDAT) from eight abstracts – six from Bascom Palmer Eye Institute (BPEI) and two from clinical sites in Brazil and Mexico – were presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), which was held May 5-9 in Seattle, Washington.

RB PDAT has now been used to treat infectious keratitis patients in four countries:

the U.S. (at BPEI itself),
India (at the two largest eye care centers in the country, LV Prasad Eye Institute Aravind Eye Care System,
Brazil (at Universidade Federal de São Paulo; data presented at ARVO), and
Mexico (at Instituto de Oftalmología FAP; data presented at ARVO).

We understand that the data readout from the international Phase 3 randomized controlled trial (RCT) for acanthamoeba and fungal keratitis (NCT05110001), which wrapped up enrollment approximately four months ahead of schedule, is planned for the fourth quarter of 2024. From the record history of this study on ClinicalTrials.gov, the trial’s recruitment status was Recruiting in January 2023 and Active, not recruiting in May 2024 (i.e., apparently 16 months to recruit 330 patients).

Brad Evans: Former PV-10 patient and Ferrari race car driver

As we wrote in Provectus’s April 6, 2024 Substack titled “Stage IV Melanoma: ‘…the company that saved my life,’” Brad Evans, a melanoma survivor who participated in a PV-10 combination therapy clinical trial (NCT02557321), is racing in the Ferrari 488 Challenge Evo series. His first two races at the Circuit of the Americas in Austin, Texas were 8^th and 11^th place finishes. You can watch the first of these races here.

His next race location (including practice sessions and time trials) is at WeatherTech Raceway Laguna Seca on May 18 and 19 in Monterrey, California.

A Potential New Spinout Company: “Dog Cancers NewCo”

As you know, Provectus entered into an exclusive worldwide license agreement with the University of Miami (University) in April 2024 for its intellectual property related to RB PDAT for treating bacterial, fungal, and parasitic (acanthamoeba) eye infections. The Company and University plan to form a start-up biotechnology company (e.g., “Eyecare NewCo”), potentially in the third quarter of 2024, aimed at commercializing BPEI’s PDAT light source medical device in combination with a drug formulation of Provectus’s proprietary pharmaceutical-grade rose bengal active pharmaceutical ingredient (RB API). The Company would contribute the RB PDAT license to and have an exclusive RB API supply arrangement with Eyecare NewCo. We are working with irlabs to develop a name, logo, branding, a website, and an investor slide deck, and addressing outside legal counsel representation for Eyecare NewCo.

We were approached by folks, who include the former chief medical officer of a publicly traded clinical-stage biopharmaceutical company (cancer and other diseases in people) that was acquired by a Top 5 (by market capitalization) commercial-stage pharmaceutical company in a multi-billion dollar transaction, to potentially consider forming a start-up biotechnology company focused on injectable canine cancers (e.g., “Dog Cancers NewCo”).

Like with Eyecare NewCo, Provectus could have an exclusive RB API supply arrangement with Dog Cancers NewCo. Due diligence on both sides under the Company’s non-disclosure agreement is ongoing.

As you know, Provectus initiated a sponsored research program in June 2023 with the University of Tennessee College of Veterinary Medicine (UTCVM) to assess the safety and preliminary efficacy of intralesional injection of a formulation of Provectus’s RB API for canine soft tissue sarcomas. This preclinical and clinical veterinary study is being undertaken as part of the State of Tennessee’s funding to develop animal health drug products in partnership with state universities that have agriculture and veterinary medicine programs and the Company (May 2021).

Soft tissue sarcomas are common malignant neoplasms in dogs that are locally invasive and have a high prevalence of recurrence after surgical excision. These tumors are often located on the extremities, where complete surgical excision is challenging because minimal soft tissues hinder the ability to gain adequate tumor margins while maintaining the ability to close the surgical wound. Adjuvant chemotherapeutic protocols do not improve either time to recurrence or overall survival with incompletely excised soft tissue sarcomas. Radical measures, such as limb amputation, are often required to ensure complete excision for limb sarcomas and this option is frequently unpalatable to patient owners. Therefore, intralesional injection resulting in tumor ablation may be an ideal treatment modality for soft tissue sarcomas.

Provectus’s go-to-market strategy

Eyecare NewCo and Dog Cancers NewCo are examples of one aspect of Provectus’s go-to-market strategy. The Company presently is the only source of effectively pure, regulatorily viable, commercially differentiated RB API.

The information provided in this Provectus Substack Post 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. Such statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 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 Provectus’s drug agents and/or their 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 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 Provectus Substack Post are made as of the date hereof or as of the date specifically specified herein, and the Company undertakes no obligation to update or revise any forward-looking statements, whether because 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’ Annual Report on Form 10-K for the period ended December 31, 2023 and on Form 10-Q for the period ended March 31, 2024.

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