September 21, 2017
Dear Provectus Shareholders,
Thank you for your continued support of the Company.
As you know, on April 3, 2017, a group of shareholders – Ed Pershing, Dominic Rodrigues, and Bruce Horowitz (collectively, the “PRH Group” ) – closed a definitive financing with Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”).
As fellow shareholders, we are committed to maximizing stockholder value through continuing to develop Provectus’ investigational drugs for the treatment of solid tumor cancers in adults as well as pediatric cancers (i.e., intralesional PV-10), and inflammatory dermatoses for dermatology in both adults and children (i.e., topical PH-10). The Company’s mission is to deliver these and other advanced, economical, healthcare solutions around the world and, in so doing, address unmet medical needs in disease areas affecting tens of millions of patients and their caregivers.
Provectus is innovating a different approach to treating cancer by leading the development of small molecule oncolytic immunotherapy. Delivered by intralesional injection (i.e., injection into a cancerous tumor), PV-10 first acts locally, causing oncolytic destruction of injected tumors. The local immunogenic cell death then has the potential to engage the adaptive immune system for a systemic, or global, effect. By harnessing the immune system in this way, PV-10 may enable patients to achieve immunity to their cancer. PH-10, delivered topically to affected skin, shares similar mechanistic themes.
At the beginning of 2017, these exciting technologies resided within a company at a crossroads and desperately in need of change.
The PRH Group listened to our fellow shareholders and specifically conditioned the definitive financing on a change of control of the Board of Directors (the “Board”) as well as the appointment of new operational management. We accomplished both goals. Mr. Rodrigues was named Chairman of the Board. Mr. Pershing was added as a Board observer and named Chairman of Provectus’ renewed Strategic Advisory Board. Mr. Horowitz was named a member of the Board, and also appointed as the Company’s chief operations consultant to manage company operations with input and assistance from Mr. Rodrigues. The PRH Group is both mindful and very appreciative of the confidence shareholders expressed through your overwhelming support of our slate of Board directors at the Company’s annual meeting of stockholders held on May 30th.
The PRH Group determined it was in the best interest of shareholders to utilize a tranche-based financing program as an efficient and less dilutive method of providing the financial resources necessary to achieve success. The PRH Group and other investors currently have committed to invest approximately $7.85 million into the Company, $5.85 million of which has been invested to date. We continue to discuss potential commitments to the definitive financing vehicle in order to secure additional operating capital as and when needed to execute our business plan.
The PRH Group has integrated itself into every facet of this business, enabling the Provectus team to achieve significant efficiencies in a very short time since Mr. Horowitz’s operational appointment. Having been in control for only three months (ending June 30th), the Company’s general & administrative expenses and net cash used for operating activities decreased 64% and 42% quarter-over-quarter, respectively, and decreased 70% and 52% year-over-year, respectively. Furthermore, monies directed to research & development increased 28% quarter-over-quarter and 19% year-over-year. We continue to proactively manage the Company’s cash position and evaluate Provectus’ portfolio of biotechnology assets.
From the moment we assumed control of the Company, the Provectus team undertook a laser-like focus to resolve the “legacy” issues discovered by the PRH Group, including but not limited to:
The PRH Group intends to continue to maintain a lean staff because Provectus’ operational team has shown the ability to manage outsourced and contracted clinical trial, regulatory affairs, and supply chain activities. It is important that shareholders know Provectus has a dedicated team of experienced, knowledgeable, competent, and hardworking professionals who manage the Company’s various clinical development programs. They quickly grasped PRH Group’s business culture of accountability, and renewed their pursuit of excellence. Despite the difficulties this Company experienced in 2016, Provectus continued to make good progress with each and every clinical program.
The PRH Group has spent the last approximately five months restructuring this entire organization. The Provectus team has worked diligently to develop a more efficient operational foundation. We continue to implement the Company’s intended strategic and tactical framework as well as execute Provectus’ clinical development plans. The team is actively engaged with core contractor relationships integral to the success of the Company’s clinical operations. We have re-engaged clinicians and medical researchers as well as key opinion leaders familiar with PV-10 and PH-10 and who themselves have exhibited a culture of excellence. Together, we are working towards executing Provectus’ existing programs, and pursuing new opportunities for the Company’s small molecule therapeutic technology platform.
The future of Provectus is based on the foundation of great science and technology. We are keenly focused on advancing the first small molecule oncolytic immunotherapy in PV-10, which may provide a better therapeutic option and improved quality of life for cancer patients. PV-10 represents nearly a decade of work by the Company to optimize the synthetic process for manufacturing rose bengal and its related halogenated xanthene analogs to meet modern global requirements for pharmaceutical use.
Provectus’ dedicated team of professionals inside and outside of the Company all recognize the limitations of existing approved cancer drugs. We are all committed to the goal of providing potentially better options for a far greater number of patients battling cancer (as well as other possible diseases). As key opinion leaders and principal investigators recognize the potential for PV-10 to provide attractive treatment options for patients, the Provectus team continues to focus on enhancing patient enrollment in all of the Company’s clinical trials. We are very aware that data generated from these trials and others will be the key to unlocking value for Provectus shareholders.
All Company stakeholders are in the midst of a special opportunity that very few biotechnology companies ever approach, which is to conduct a pivotal Phase 3 trial. In our case, we have the opportunity to demonstrate that a novel therapeutic approach may potentially provide superior benefit over existing treatment options for locally advanced melanoma patients (i.e., Stage III and early Stage IV disease). As the medical community and pharmaceutical industry continue their exploration of the tumor and its microenvironment as the nexus for better cancer treatment, intralesional PV-10, the first small molecule oncolytic immunotherapy, may have arrived at an opportune time.
Provectus’ approach to drug development is centered around designing clinical studies for success based on science and medicine, rather than supporting the broadest possible label at the outset. The Company has bifurcated its overall clinical development program into two complementary and related paths based on the features of our investigational drugs and their rational applicability and relevancy to different patient populations. In cancer, for example, we believe PV-10 has important implications as a single agent for earlier stages of disease (i.e., Stage III or earlier), while combination of PV-10 with other classes of therapy or therapeutic agent is more appropriate for more advanced stages (i.e., Stage IV). Our ongoing preclinical and clinical work in melanoma, cancers of the liver, pancreatic cancer, and pediatric cancers, as well as our work in inflammatory dermatoses, follows this approach.
The opportunity to bring Provectus’ lead investigational drugs for cancer (PV-10) and dermatology (PH-10) to market, and deliver advanced healthcare solutions around the world for unmet medical needs in disease areas affecting tens of millions of patients and their caregivers are exactly why the PRH Group was drawn to the significant challenges of reorganizing, restructuring, and financing this Company. There are no shortcuts to success in biotechnology drug development. The road to regulatory approval and commercial acceptance is long and expensive, and success is never assured. Nevertheless, we are confident that our current Provectus team, together with additions over time, possesses the expertise, technical know-how, experience, and commitment to excellence needed to maximize the value of the Company for the benefit of our shareholders.
Thank you again for your continued support of Provectus.
Provectus Biopharmaceuticals, Inc.
Special Note Regarding Forward-Looking Statements: This Letter to Shareholders includes “forward-looking statements” within the meanings of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this Letter to Shareholders other than statements of historical fact, are “forward-looking statements.” For example, statements relating to our beliefs, expectations, plans, projections, forecasts, and estimates are forward-looking statements, as are statements that specified actions, conditions, or circumstances will continue or change. Forward-looking statements involve risks and uncertainties. In some cases, forward-looking statements can be identified by the inclusion of words such as "believe," "could," "expect," "plan," "anticipate," "estimate," "may," "should," "will," "continue," "intend," and similar words. Our actual results could differ materially from those projected or assumed in our forward-looking statements because forward-looking statements by their nature are subject to risks and uncertainties. Factors that could contribute to these differences include the factors described in “Risk Factors” in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers should not place undue reliance on forward-looking statements. Such statements are made as of the date hereof, and we undertake no obligation to update such statements after this date.