Provectus Biopharmaceuticals, Inc. (PNK:PVCT) Q1 2024 Earnings Call Transcript

Provectus Biopharmaceuticals, Inc. (PNK:PVCT) Q1 2024 Earnings Call Transcript February 22, 2024

Provectus Biopharmaceuticals, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Thank you for standing by. This is the conference operator. Welcome to the Provectus Biopharmaceuticals First Quarter 2024 Conference Call. As a reminder, all participants are in listen-only mode and the conference is being recorded. I would now like to turn the conference over to Alyssa Barry, irLabs Investor Relations. Please go ahead.

Alyssa Barry: Thank you, operator. Good afternoon. Welcome to the first quarter 2024 conference call of Provectus Biopharmaceuticals, which is developing immunotherapy medicines for cancer and other diseases. My name is Alyssa Barry, Co-Founder and Principal of investor relations firm irLabs. I am hosting today’s call. Ed Pershing, Chairman of Provectus’ Board of Directors, and Dominic Rodrigues, Board Vice Chairman, will provide company updates and their remarks. First, Nathan Kibler, Provectus’ Outside Legal Counsel from the law firm of Baker Donelson, will read the company’s forward-looking statements.

Nathan Kibler: Thank you, Alyssa. The information provided on this conference call 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 Provectus’ drug product candidates and/or their uses under investigation have not been established. There is no guarantee that these 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, listeners should not place undue reliance on these forward-looking statements. The forward-looking statements discussed on this conference call are made as of the date hereof or as of the date specifically specified herein, and the company undertakes no obligations 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 Provectus’ filings with the U.S. Securities and Exchange Commission, including those described in Item 1A of the company’s Annual Report on Form 10-K for the period ended December 31, 2022, and Provectus’ quarterly report on Form 10-Q for the period ended September 30, 2023.

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Q&A Session

Alyssa Barry: Thank you, Nathan. Ed will now make his opening remarks.

Ed Pershing: Thank you, Alyssa. We are very pleased to have irLabs join our team as Provectus seeks to increase its investor communications and engagement and expand the company’s visibility and outreach to the investment community. Our vision, governing philosophies, and corporate goals are the foundation of why I and how I have led Provectus. These points inspire me because I believe the company is on the cusp of potentially showing the extraordinary promise in pancreatic cancer that cancer immunotherapy PV-10 and synthetic small molecule rose bengal gall sodium can truly exhibit. These points also comprise the rationale for my stepping in to lead Provectus as it teetered on the brink of collapse following the resignation of its former CEO and Co-Founder in early 2016 and termination of its former CFO in late 2016.

My leadership of Provectus draws upon almost 50 years of the work experience in several different areas of the healthcare sector and a track record of assembling and leading teams to start and build half a dozen thriving, profitable companies and successfully turning around dozens of other existing businesses and organizations. At various times, former Provectus Strategic Advisory Board members in senior position at pharma companies, principal investigators at U.S. and international academic medical centers involved in PV-10 clinical trials and expanded access programs, pharma companies search and evaluation teams, and the FDA acknowledged PV-10’s potential in the case of the FDA its drug activity. Some identified PV-10’s data paucity and data gaps, which I believe the company has since been addressing.

Turning around the biotech company, you did not create a very different business proposition than in any other area of the healthcare sector. You cannot slash and burn or start from scratch in the situation where other people created a compelling emerging drug therapy that patients and clinicians are using. As circumstances unfolded since 2017, we secured and transferred existing scientific knowledge from Provectus’ former co-founders to us and created new scientific insights. We have proactively and sometimes reactively zigged and zagged to backfill clinical datasets, tested medical and scientific hypotheses, such as the importance of potentially improving clinical outcomes of metastatic patients by targeting hepatic disease, increased PV-10’s dosing regimen, optimized clinical trial protocols, and generate new and existing clinical and preclinical datasets, and sought and validated regulatory strategy and affairs feedback and counsel.

I believe Provectus is well positioned to advance immunotherapy PV-10 and its lead indication of hepatic metastatic pancreatic cancer towards a potential defined approval pathway and successfully traverse it. I believe forthcoming preclinical datasets could clearly show the vast potential broad spectrum therapeutic applications of a synthetic small molecule of rose bengal sodium. I want to conclude my opening remarks with comments about Provectus’ business philosophy. I believe maximizing patient outcomes from drug therapies and patient access to those medicines maximize return on investment and shareholder value. According to the American Cancer Society’s 2024 statistics, the incidences of many common cancers, including six of the top 10, breast, prostate, endometrial, pancreatic, kidney, and melanoma, are increasing.

This present situation exacerbates the 2019 statistics of socioeconomic inequalities widening in the poorest American counties where cancer mortality rates were higher because of inadequate access to leading cancer treatments or treatment at all, among other factors. It is an American horror story that financial toxicity from cancer treatment directly contributes to significant patient and family stress, debt, and bankruptcy. When the time comes, I believe Provectus can potentially price its future drugs commensurate with the research and development risk that the company has taken, and produce generous gross profit margins that reflect the cost of manufacturing small molecule drugs. I believe Provectus is simple and elegant yet complex manufacturing innovation for making rose bengal sodium [indiscernible] and PV-10 and other company drugs time to peak sales, thereby potentially protecting future drug franchises longer.

Provectus’ scorecard for its future drugs will not be just how much money they generate from prescriptions, but the number of patients they successfully treat in a meaningful, durable way as the company pursues financial success. Since saving the company’s profound medical science from the ash heap of history in 2017, our strategic plan has been consistently twofold. One, secure the right cancer indication for PV-10 to achieve its first approval, choosing that right indication has been an exercise in optimizing various considerations, including clinical outcomes and data sets, treatment standards, regulatory strategies, addressable markets, appropriate partners and other factors. Two, prove that rose bengal sodium is an immunotherapeutic molecule for cancer and applicable to other diseases.

We began this at the outset of our tenure at the company by green lighting mechanisms of action and immune action research on Provectus’ immunodermatology drug PH-10, a clinical stage asset that people at the company wanted to discard. This research revealed PH-10’s potential curative properties for psoriasis, identified its multi-immune signaling possibilities that were later confirmed by research on PV-10 for cancer and deeply influenced subsequent research on rose bengal sodium as a possible multi-disease, broad spectrum immunotherapeutic. I believe this two-fold business strategy for Provectus is firmly grounded in science, economics and fundamental shareholder value creation. Provectus has collaborated with medical researchers in the U.S., Canada and elsewhere to reproducibly and repeatedly show that PV-10’s mechanisms are cancer and tumor type agnostic, multifaceted, immune system engaged, comprehensive, integrated and consistent.

Further, the company has collaborated with researchers to explore, discover and show that these therapeutic mechanisms and more are consistent in other disease areas beyond cancer. This work has been and continues to be done as a part of our efforts to maximize the potential value of the company’s medical science platform for Provectus shareholders. On today’s call, Dominic will explain that while we believe PV-10’s clinical data is compelling. Regulatory bodies and pharma companies require randomized, controlled trial data as a minimum hurdle to garner regulatory recognition or partnership. The feedback we have sought along this journey has been important input to our decision making. Our areas of focus for 2024 are keenly related to trying to further improve the company’s market capitalization.