Provectus Biopharmaceuticals, Inc. (NYSEMKT:PVCT)
Q2 2014 Earnings Conference Call
August 7, 2014 4:00 pm ET
Michael J. Porter - IR, Porter, LeVay & Rose, Inc
Peter R. Culpepper - CFO and COO
Eric Wachter - CTO
Welcome to the Provectus Biopharmaceuticals first quarter conference call. At this time, all participants are in a listen only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Michael J. Porter, President of LeVay & Rose. Thank you, Mr. Porter. You may begin.
Michael J. Porter
Thank you, Adam, and good afternoon, ladies and gentlemen. On the call today are Peter Culpepper, who is COO and CFO, and Dr. Eric Wachter, the CTO of Provectus.
Before we start the conference call, please note that some of the information appearing today during our discussion will consist of forward-looking statements as defined under the federal securities law. These statements reflect management's current knowledge, assumptions, belief, estimates and expectations and express management's current views of future performance, results and trends. Actual results could differ materially from such forward-looking statements.
For more information, please refer to the risk factors discussed in Provectus' 10-K for 2013, the Form 10-Q for the second quarter of 2014, and Provectus' other filings with the Securities and Exchange Commission. Provectus assumes no obligation to update any forward-looking statements or information which speaks to their respective dates. No claims with respect to PV-10 are intended regarding safety or efficacy in the context of the forward-looking statements contained in these statements.
I'd like now to turn the call over to Peter Culpepper, CFO and COO. Good afternoon, Pete.
Peter R. Culpepper
Thank you, Mike, and welcome everyone. Today's conference call is part of our continued policy of clear communication with our shareholders. We will hold regular conference call's time to coincide with the filing of our 10-Q or 10-K, as the case may be, to allow for greater interaction between the Company and its shareholders. We believe that this will help avoid unsubstantiated gossip from damaging our financial interest and create a better atmosphere for investment.
For today, we'd like to address a few points that Mike and his company had encountered in managing our investor communications. In no particular order, they are, our cash position and financial capacity to complete our clinical trials, activities in China and India, the hiring of an FDA advisor, the roles of our advisory committees, the status of our Phase 3 protocol for PV-10 as a melanoma treatment, and an update on the status of our other research projects. After that, we will gladly answer questions on these or any other subjects you wish.
Our cash and cash equivalents were $18,126,036 at June 30, 2014, compared with $15,696,243 at December 31, 2013. The increase of approximately $2.4 million was due primarily to $4.35 million cash received from warrant and stock option exercises and $4.35 million net proceeds from the sale of our common stock prior to offerings in the six months ended June 30, 2014 offset by $6.3 million of operating cash expenses.
Now, wearing my hat as CFO, let me be crystal clear. We have enough money on hand this minute to see us through to the interim Phase 3 data for the melanoma study. I believe that by managing variable cash expenses due to minimal fixed cost, our cash and cash equivalents are sufficient to meet our current and planned operating needs now until 2016. We can curtail or defer certain expenditures, and we will do so. This means, we do not anticipate needing to raise additional capital to further develop PV-10 on our own to treat locally advanced cutaneous melanoma, cancers of the liver, recurrent breast cancer or pancreatic cancer and other indications.
Why do I say that? Because we plan to strategically monetize PV-10 through appropriate regional license transactions, and to license PH-10 for psoriasis and other related indications described as inflammatory dermatoses. We discussed this strategy in our filing today, the Q2 10-Q MD&A, particularly the Liquidity and Capital Resources section.
And how can we be so confident those regional licensing deals will happen? We believe our efforts to obtain regulatory clarity will be helpful to facilitate such transactions with potential partners. Additionally, the existing and forthcoming clinical and nonclinical mechanism of action data for both PV-10 and PH-10 are expected to further aid in both regulatory clarity and transactions with potential partners.
Also, management is returning $8.96 million to the Company as a result of the previously announced settlement of a shareholder derivative lawsuit, subject to a 2-for-1 credit to the executives, such that the total actual repayment by the executives may be $1.12 million per executive which would total $4.48 million.
Now that brings us to activities in India and China. We have provided data on a confidential basis to both potential global and geographic partners for both PV-10 for oncology and PH-10 for dermatology via a secure electronic data room. We are encouraged by the number of companies doing due diligence on our technologies. For instance, we recently had a team in India meeting with potential partners and lead Indian pharmaceutical firms are continuing the research into our data, they are regular visitors to our data room. Additionally, we are having discussions on possible commercialization.
Also, we have two teams focused in China working with potential partners there and discussions on working with these Chinese businesses continue. The Chinese talks involve both melanoma and liver indications, the latter being a more widespread problem in China. We also have begun to consider co-development transactions with one or more pharmaceutical or biotech companies to combine PV-10 with immunology agents such as those referred to as checkpoint protein inhibitors. While none of these has yielded a concrete result that we can refer to you, I am comfortable mentioning these activities because I'm confident they will do so eventually, maybe potentially even this year.
At this stage, I will hand the floor to Eric Wachter, our Chief Technology Officer for a discussion of FDA related matters. Eric?
Thank you, Pete. I want to startup my remarks by emphasizing that our primary focus is on managing the FDA regulatory process. Provectus is contemplating adding to its consulting advisors a group to help us validate our efforts with the agency. This group is a full-service regulatory consulting firm that provides strategic guidance to companies like Provectus regulated by the Food and Drug Administration in developing innovative solutions to pressing public health challenges around the globe.
Under the terms of the contemplated agreement, this consultant will have several duties. They will review all the correspondence between Provectus and the FDA, they will provide an overview of potential drug regulatory pathways for PV-10, they will review and analyze the FDA's breakthrough therapy designation program to see what more can be gained from what we went through earlier this year.
This group will review and analyze our development program for PV-10, highlighting things like our proposed indication, mechanism of action, primary and secondary endpoints selected for clinical studies, pivotal study designs and available Phase 2 data. They'll analyze the current landscape for marketed and emerging products for melanoma and compare PV-10 to the current care standard for melanoma.
They will summarize their analysis of our PV-10 development program and key regulatory challenges and opportunities. In essence, they will aid us in validating the relevance of the PV-10 drug development program in all material aspects for the treatment of serious or life threatening diseases or conditions such as locally advanced cutaneous melanoma. This comprehensive third-party review will identify our strengths allowing us to build on those, and our weaknesses allowing us to address those.
We have a very unique product in PV-10 and as the inventor and chief proponent of our drug, we have developed unique expertise related to the unique challenges of establishing safety and efficacy sufficiently to support regulatory approval. This consultant relationship will allow us to see how our approach compares to standard industry practice and help us to identify those areas where we can improve our execution. We don't expect this process to drastically change our course but rather to verify that we are on the right course, and make small corrections necessary to ensure that we are successful in reaching our goals.
I think that the efforts of this advisor group dovetail very well with the function and expertise of our existing Strategic Advisory Board. As many of you know, our advisors take an active role in helping Provectus. For example, Craig Eagle, a Senior VP with Pfizer Oncology, is a co-inventor on our drug patent application with Pfizer covering certain uses of PV-10 in combination with systemic therapies. Bob Miglani, Head of Medical Advocacy and External Medical Affairs at Pfizer, has played an instrumental role in advancing our efforts to establish global and geographic partnerships for both PV-10 for oncology and PH-10 for dermatology. And Joe Chalil, Associate Director, Health Science Executives at Boehringer Ingelheim, has been very instrumental in advancing our efforts to establish key partnerships for PV-10, in particular across Asia.
Let's turn now to the status of protocol for our Phase 3 study of PV-10 for melanoma. This study will assess response to intralesional PV-10 versus that of systemic chemotherapy in patients with disease confined to cutaneous and subcutaneous sites. These patients who have failed or been ineligible for systemic immunotherapy and thus have extremely limited options, consisting principally of systemic chemotherapy, such as DTIC or temozolomide, or a clinical trial.
As we've indicated previously, the primary endpoint of the study is progression-free survival assessed using standard criteria. Secondary endpoints are complete response rate and overall survival. Progression-free survival and overall survival are standard endpoints for oncology approvals. With these assessment methods and endpoints, we're following what the FDA has suggested to document the clinical benefit to patients after intralesional injection.
Furthermore, our endpoints with complete response rate should allow us to highlight one of the key features of PV-10, and we'll measure patient reported outcomes to better characterize the relationship between complete response and symptoms of locally advanced cutaneous melanoma, such as pain and bleeding.
We're working with several leading CROs with specialized expertise in the assessment of patient reported outcomes to show that our planned assessments are rock-solid. This is an important but complex topic and the experience of these expert groups is allowing us to put into place the final missing pieces of our protocol.
We've indicated previously that we plan to commence the study this year and this work is allowing us to put the finishing touches on the protocol before it undergoes final review in the next few weeks by key melanoma investigators and consultants in clinical operations and regulatory affairs.
So to summarize so far, we are finalizing the process of combining our expertise gained from years of clinical testing of PV-10, inputs from meetings with our scientific advisors, investigators and advocates in the field, and design input from multiple CROs having specialized expertise in key areas such as assessment of patient reported outcomes, radiologic and clinical image management, bio-statistics, clinical data management, and so on, to ensure that we have a robust protocol that can address the needs of licensure.
We are also adopting, to the extent possible, important design elements from successful pivotal trials of other drugs recently approved in melanoma and other cancers that address issues pertinent to pivotal testing in PV-10. These include details on scheduling of response assessments, handling of issues pertinent to our comparative drugs, and the collection and interpretation of patient reported outcome.
While the study design process is being wrapped up, I'd like to note that our prior guidance on design of the study remains unchanged, with approximately 210 patients needed for the study and 2 to 1 randomization. We use a dosings team based on our current expanded access protocol which was updated about a month ago incorporating all that we've learned since we began our melanoma program.
To hit the ground running, we expect to start enrolling patients at our existing PV-10 sites in the United States and Australia, which are currently enrolling melanoma patients into our expanded access protocol. And then add additional sites in these two countries while we expand traditional sites in other parts of the world.
Our initial focus on the United States and Australia will allow us to leverage almost a decade of clinical experience working with leading investigators in these countries, and that together represent a very substantial fraction of the global population of melanoma patients.
As we finalize preparation for launching the study, we expect to add a few additional standards to our expanded access program allowing us to establish the local operational, contractual and regulatory framework for rapid transition of these centers to participation in the Phase 3 study. We're also adding a number of closely held consultants and CRAs or clinical research associates who will play important roles in management of this trial as well as our other ongoing and future studies.
As is standard in our industry for Phase 3, routine management of study operations and data collection and analysis will be handled by a full-service international CRO with expertise in clinical operations and integrated data management. This key member of our team, a quarterback as it were, will coordinate the global efforts of the study team, including that of our investigators as well as independent review committees analyzing study data, and an independent clinical trial data monitoring committee or DMC that will periodically review the accumulating data to ensure that our study provides patients with maximum possible safety while protecting the scientific validity and integrity of the data we gather.
These preparations and the fact that we're closely following precedent of recent successful pivotal trials in melanoma and other cancers as well as the advice with the agency in the fundamental design of our study, are intended to ensure to the full extent possible that we have a successful trial.
As Pete mentioned earlier, we're also looking beyond single-agent therapy with PV-10 to address the needs of patients with more extensive disease, particularly those with visceral tumors that are not injectable. One attractive and complementary approach may be to combine PV-10 with a systemic immunotherapy, such as an immune checkpoint protein inhibitor. Immune checkpoint protein inhibitors, such as anti-CTLA4, anti-PD-1, and anti-PD-L1 agents, are an important advance in the treatment of melanoma and other cancers, another subject of intense development in our industry.
However, while these drugs represent an important step forward, like any drug they are not perfect and they might be improved. As was clearly presented by the medical oncology community earlier this summer at ASCO, using an agent like PV-10 to prime the immune system could be synergistic in combination with such a systemic agent.
Our patent application on this strategy was published in 2012 and we've been vigorous by pursuing this approach since. The nonclinical research we first presented at the Society for Immunotherapy of Cancer Annual Meeting in 2012, together with ongoing translational clinical research on PV-10's mechanism of action that we were sponsoring at Moffitt Cancer Center and our own Phase 2 data, provide a rationale for combination testing of PV-10.
This development track, separate from the Phase 3 study I discussed earlier, could represent a path forward for patients with significant disease burden not amenable to intralesional injection, and is a possible candidate for co-development with one or more pharmaceutical or biotech companies.
So to reiterate, we expect to commence the Phase 3 melanoma study by the end of the year, including filing the protocol with the agency and starting patient enrollment at sites already using PV-10 under our expanded access protocol.
Moving from melanoma, I want to discuss what we're doing with PV-10 in other cancers, along with development with PH-10 for skin conditions. We recently expanded our exploratory Phase 1 study of cancers of the liver to three centers, St. Luke's University Health Network in Bethlehem, Pennsylvania and The Southeastern Center for Digestive Disorders & Pancreatic Cancer in Tampa, Florida in addition to Sharp Memorial Hospital in San Diego, California. And we're evaluating addition of several additional centers to further advance this study.
We've been working with our investigators to report results from long-term follow-up of our initial patients at one or more conferences and in the literature in coming months, and we're assessing strategies to accelerate transition to Phase 2 testing in a randomized controlled trail, either alone or in combination with systemic therapy. Any combination studies in the liver are likely to follow similar development strategies to those outlined earlier for melanoma and rely on much of the same foundational science.
The current Phase 1 study, initially intended only to establish safety of percutaneous injection of PV-10 into liver tumors, that is injection on the tumor through the skin, is providing valuable safety and efficacy data crucial for planning such Phase 2 development. This trial is open to patients with hepatocellular carcinoma or other cancers that are metastasized with liver who have at least one tumor that has either originated in or spread to the liver.
All patients receive the same treatment. An interventional radiologist injects PV-10 percutaneously into a single liver tumor. Patients with multiple injectable tumors may later receive further PV-10 to their other tumors. In addition to comprehensive Phase 3 monitoring, we are assessing both the short and long-term effects on injected lesions and any effects on uninjected lesions in the patient's liver. We have received numerous inquiries about this study from researchers as well as patients and their doctors, and refer these to our investigators through the contact information available on the clinicaltrials.gov Web-site.
As we continue to learn more about the effects of PV-10 on both HCC and other metastatic cancers, the data on non-HCC tumors may shape plans for future indications. And as Pete mentioned at the start of the call, given the well-known public health crisis posed by HCC in parts of Asia, what we're learning in this study may have direct bearing on potential partnerships in China.
During our studies in melanoma, hepatocellular carcinoma, and other cancers, metastatic liver and breast carcinoma, well over 240 patients have received PV-10 since we started clinical work with our first patients in Australia. Over 200 of these are melanoma patients, representing the 100 patients who participated in our Phase 1 and Phase 2 melanoma trials and over 100 melanoma patients who've been enrolled under our expanded access protocol since then. These numbers are based on our 2013 Annual Report to the agency and we will update these totals later in the year as we prepare our 2014 Annual Report.
While we're encouraged by the sustained enrolment of patients by our investigators, I'll note that this demand illustrates the need for new options for cancer patients. We expect to greatly increase these numbers in the coming months as we continue to build our case in support of initial approval of PV-10 and in support of extending approval to additional indications.
And finally, just a quick update on PH-10, our lead investigational drug candidate for dermatology. So far, over 220 patients have participated in Phase 1 and Phase 2 trials of PH-10. We anticipate posting results from these studies on the clinicaltrials.gov Web-site in the coming months and are encouraged by what we've observed to-date.
Following the model we have successfully used in oncology, we have designed translational clinical study to better understand the possible immunologic mechanism of PH-10 in the skin. This mechanism of action study will focus on the suspected cellular and structural changes in psoriatic plaque upon treatment with PH-10. We have observed structural changes since our first trial of PH-10 in psoriasis and clinical observations from subsequent studies point to a possible immunologic response to PH-10.
Looking at concordance of clinical changes with any changes observed inside the skin should provide insight into this apparent response. We have designed the study with numeral input from several leading experts on the immunology of psoriasis. We have completed nonclinical validation of the concept to show with PH-10, which is pink in color, does not interfere with the immunologic testing of skin samples from study participants, and reviewed our previous psoriasis studies as a template for the operational aspects of this study.
We expect to conduct the majority of the clinical work at major academic centers in the United States to ensure the integrity of the results to be generated. The knowledge we expect to gain from this study should enable us to design bench trials in psoriasis, eczema and other inflammatory dermatoses and potentially differentiate the product among a range of options for these conditions.
Well, that covers the material that we wanted to discuss so far, Mike. So I think it's time for questions.
Michael J. Porter
Thanks, Eric. Before we turn the call over to the operator, I've had a number of calls today about one question everybody would like to know, and that is, why is it taking so long to start the official Phase 3 trial?
Okay, Mike. As I outlined in my earlier comments, we're working to address both long-term and recent guidance from the agency, and particularly the recent guidance provided via our interactions with the agency since December concerning the relevance of symptom assessment in our patient population, those patients with locally advanced cutaneous melanoma. We're working with leading partners in this area to finalize this aspect of our study design and expect to send our protocol out for review by our team of CROs, regulatory consultants and investigators in coming weeks.
We have a significant advantage that when this process is complete, we can access existing relationships with our investigators to accelerate progress. We also have clinical drug supply at hand and a distribution system that has been tested to ensure that PV-10 is available when the first patients are enrolled.
Michael J. Porter
Thank you, Eric. Operator, we're ready for questions.
(Operator Instructions) Our next question comes from the line of [Max Azenheimer] (ph), who is a private investor. Please proceed with your question.
Are you there, Max?
Thank you. Our next question comes from the line of [Bruce Benzel] (ph) who is a private investor.
My question about Phase 3 trials, first off, Eric, can you be more specific about the lessons learned in Phase 2, are we going to dose patients differently than earlier, can you talk about that a little bit?
Sure, Bruce. So we've progressed from Phase 1 to Phase 2 and now on the threshold of starting Phase 3, we have progressively dosed patients more aggressively based on what we've learned from those prior studies. For example, in Phase I we treated patients once, a single course of injection. In Phase 2, we waited eight weeks before we re-treated patients. In recent past in our expanded access program, we waited four weeks between possible injections and we've recently amended that to now treatment every two weeks. We'll apply those learning experiences certainly in the Phase 3 study.
Do you see then, two remaining questions, do you see a potential for better results in Phase 3, and second, exactly what be FDA's role with the protocol be, will you simply file the protocol with the FDA or do they have some other, some advanced roll in that?
I can't really speculate on what effect size we anticipate seeing in Phase 3. Classically, there is a phenomena of effect size compression and the effect of the drug is smaller progressing from Phase 1 to Phase 2 and then again from Phase 2 to Phase 3. We've seen the opposite so far going from Phase 1 to Phase 2. I don't know if that is necessarily going to be a continuing trend, but it certainly is directionally favorable. We will be using fully conforming RECIST assessments in the Phase 3 study versus modified RECIST assessment. So, really it's not directly comparable.
Having said, we do expect to see a very high rate of complete response consistent with the patients in the Phase 3 study where we treated all in existing disease, we'll be treating all existing disease in our Phase 3 patients and so we can use that group from Phase 2 as a model.
In terms of the agency's requirements, we are required to file the protocol with the agency prior to commencing the study. I can't comment on any further activities we might have with the agency in that regard.
The next question comes from the line of [Bill Hamming] (ph). Please proceed with your question.
I don't know if you just sort of answered this and I missed it, but is there a certain timeframe once you actually submit the process or the plan, the trial design, to the FDA, is there then a certain amount of time before it starts, is it a definitive amount of time, do they have 60 days, 30 days, or is it an automatic, once you're in, once you've supplied it, if you don't get a 'no', you can go forward?
There's a 30 day wait that's required when you submit a Phase 1 study, particularly the first Phase 1 study for an indication. Subsequent studies with progressive phases, there is no mandatory wait prior to commencing the study. That being said, the agency has the option to comment or take other action on a protocol at any time after it has been submitted. So, in terms of commencing a Phase 3 study, the requirement is that we submit the protocol prior to commencement of the study.
Okay. So then, you would submit it and then you would give places like [indiscernible] the green light to go forward?
That's correct. They would have to pursue IRB approval. That does not have to occur after submission to the agency. You simply have to have the IRB approval and submission to the agency in place prior to starting enrolment.
Okay, great. Thank you.
Our next question comes from the line of [Bruce Benzel] (ph) who is a private investor. Please proceed with your question.
I guess I'm in here for two questions then. There has been confusion, this is a Peter question, there's been confusion in terms of cash flow, whether to include the $4.48 million portion of the settlement or the $8.96 million. In terms of somebody projecting out cash flows, which is a more relevant and which is a better estimate of the impact on cash?
Peter R. Culpepper
For cash forecasting purposes, I would use the $4.48 million. The settlement as we disclosed is for $8.96 million. So that's the gross amount, but it is subject to the 2-for-1 credit, given certain conditions. So conservatively, I use the $4.48 million in forecasting that presumes that we will meet the terms and then have the 2-for-1 credit. So that would be my response, Bruce.
Thank you, Peter.
Our next call comes from [Dr. Gollum] (ph) who is a private investor. Please proceed with your question.
I have two questions. One, before a licensing deal can be inked, would it be necessary to have an acceptable protocol with the FDA?
Peter R. Culpepper
This is a gray topic and we are actively discussing with potential partners in both India and China in particular when to enter into a transaction, but I think conservatively it does make sense for a protocol for both melanoma and liver that's appropriate for those respective countries to be in place prior to at least a transaction be consummated. It's possible that MoU could be signed in advance, but conservatively I think it makes sense for say you as an investor, Dr. Gollum, or any to see that protocol filed on clinicaltrials.gov and then you could make a logical assumption from there, once the Phase 3 melanoma study or the Phase 2 liver that Eric touched on has been filed, that that makes sense for potential global partner or geographic partners. Eric can comment.
As the CTO, I cover both clinical development and intellectual property portfolio of the Company and I'll point out that in those sorts of scenarios, it's almost certain any protocol that we entered into in Asia would be an international protocol because there are certain implications of a single country of protocol and intellectual property rights. So, you can expect that that would be one of the aspects of such protocol.
Okay. The second question I have, we're facing a share price below $1 and I just would like to know if you expect or are looking to take some type of action to avoid the potential delisting threat that moves over us?
Peter R. Culpepper
I'll just say we're very optimistic about our future, short-term as in this year, and I call to your attention in the MD&A and the 10-Q filed today, in the Liquidity and Capital Resources section, fourth paragraph in particular, that we believe our financial position and corporate governance are such that we will continue to meet the relevant listing requirements of New York Stock Exchange MKT, although there can be no assurance that we will continue to be listed.
So what we're doing is we're making sure that our financial position and corporate governance are appropriate to enable the share price to appreciate or to facilitate that, is exactly what we're doing with the clinical trial activities and what that means to the market and to potential transactions with partners. So, I would argue that we're doing what we need to do on all fronts to ensure that we continue to be listed.
Thank you, gentlemen. I have a lot of faith and confidence in you.
Peter R. Culpepper
Thank you. We appreciate your comment.
Our next question comes from the line of [Max Azenheimer] (ph) who is a private investor. Please proceed with your question.
I got cut off before, I don't know what happened. I was under the assumption from last conference call that Phase 1 for liver was going to be out soon. Am I wrong in that?
I don't think we indicated that the Phase 1 data would be out soon. We indicated that we were working to get that data available to the public. We have been working since the last call and since we issued the shareholder letter month after or so ago to advance that process, and I can say that we have made great progress in that but the process of preparing those sorts of materials for dissemination through either the purity of literature or through technical conferences has fairly substantial lead time. So we can't tell you right now where that is and we can't tell you exactly when that's going to happen, but I will assure you that we're moving that forward.
You think it will happen before the end of the year?
That's possible. There are a number of conferences that are in the fourth quarter that we are looking at and it depends upon whether we are able to get our data into shape in time for submission to those in advance of their deadlines.
Alright, one last quick one, when you mentioned interim results on the Phase 3, what kind of general timeframe are you looking at, sometime towards late 2015, mid 2015?
So we have previously stated that we expect that approval for the study will require approximately 18 months with an additional 12 months follow-up for the last patient. Interim assessment would be roughly at halfway point in that study. And so, it would be somewhere on the order of 15 months after commencement of the study, so sometime at the end of 2015 or early in 2016 presumably.
Thank you very much. I appreciate it.
Thank you, gentlemen. There are no further questions at this time. I would like to turn the floor back over to management for your closing comments.
Michael J. Porter
Everyone, I want to thank you all for attending our conference. We will talk to you next quarter. Have a good Labor Day weekend. Thank you very much. Goodbye now.
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