CEO: Bill Welch
WSA: Good day from Wall Street. This is Juan Costello, Senior Analyst with the Wall Street Analyzer. Joining us today is Bill Welch, CEO for Trovagene, Inc. The company trades on NASDAQ, ticker symbol TROV. Thanks for joining us today there, Bill.
Bill Welch: Sounds good. Thank you, Juan.
WSA: So starting off, please give us a history and overview of the company for some of our listeners that are new to your story.
Bill Welch: Trovagene is a San Diego-based biotechnology company, and we’re pursuing a pathway to transform oncology with precision cancer therapeutics. We announced in March that we’ve licensed a compound, PCM-075, which is an oral, highly-selective, investigational polo-like kinase 1, or PLK1, inhibitor. We think it has great opportunities for us overall and specifically in the acute myeloid leukemia (AML) market, which we look to bring it forward in. We licensed this compound from a company called Nerviano Medical Sciences or NMS. Nerviano is the largest oncology-focused R&D company in Italy, and one of the most highly-regarded in Europe. They’ve done a number of important collaborations and licensing agreements with companies like Genentech/Roche, Pfizer, Array Pharmaceuticals, Servier and others. And we’re excited to begin executing our strategy to integrate our circulating tumor DNA (ctDNA) technology for monitoring cancer therapeutics to develop precision medicine solutions for improved cancer care. We see this expansion of our business into precision cancer therapeutics as transformative for Trovagene, and we think it’s a great step for us and our investors.
WSA: Right. And so talk about that recent license agreement on PCM-075.
Bill Welch: PCM-075 is a polo-like kinase 1 inhibitor that basically affects cell growth. PLKs can arrest overactive cancer growth by inhibiting cell mitosis, which can lead to cell death. Among the four members of the PLK family, PLK1 is recognized to be the fundamental component for cell division to take place correctly. PLK1 is a master regulator of mitotic progression and is the only family member expressed exclusively in dividing cells, which makes PCM-075 such an attractive drug candidate. Recently a phase III study of a pan-polo kinase inhibitor demonstrated increased response rates, improvements in event-free survival, and overall survival benefits, when studied in combination with low-dose Cytarabine, in acute myeloid leukemia or AML. However, in this phase III study with a drug candidate that had gone through phase I, phase I/II and into phase III, they did see adverse toxicity events, which we believe were likely due to this drug having a very long half-life of approximately 135 hours.
PCM-075 is the only orally available PLK1 in clinical development. We believe its short half-life of 24 hours, and acceptable safety profile demonstrated in preclinical and phase I studies, including reversible hematologic toxicities, makes PCM-075 a very good potential treatment option for patients with AML.
Preclinical data with PCM-075 suggests that there is efficacy for this drug candidate in AML, as a single agent or in combination with chemotherapy agents. PLK1 is a dominant marker for various cancer types, and we think this compound — if we’re successful in AML — could have very broad opportunities beyond AML.
WSA: What are some of the key trends that you’re focusing on right now in this sector and how are you positioning the company to capitalize?
Bill Welch: As I think of the sector we’re going after, first is an indication for the treatment of acute myeloid leukemia. To put this in perspective, AML is an aggressive blood, or hematologic, cancer with about 20,000 new cases in the US and over 10,000 deaths annually. The five-year survival prognosis of about 25%. AML represents a significant unmet need and often impacts people 65 and over, for whom there is a real opportunity to bring a new treatment option to help improve patient care. Generally what doctors try to do in AML is to arrest rogue blood cells through chemotherapy, radiation and ultimately a bone marrow transplant, but many patients are not candidates for a bone marrow transplant.
We believe there is a significant opportunity for a new therapy and we think that a more targeted polo-like kinase inhibitor, along with Trovagene’s core ctDNA Precision Cancer Monitoring® (PCM) technology, could be transformational. Trovagene has a history in liquid biopsies, and what I mean by that is that with our technology we can detect tumor markers in urine and in blood at very high clinical sensitivities. In fact, we’re the only company that has ctDNA technology compatible in both urine and blood for this marketplace. We have significant intellectual property (IP), with over 120 issued patents and 60 pending patents, and we have various single gene tests for measuring EGFR, KRAS and BRAF mutations, as well as a multi-gene panel we’re developing that covers other tumor markers across a number of cancer types.
As we thought about applying our technology to enter the precision cancer therapeutics area, AML was top of our list because we are the patent holder for NPM1, which is the key founder genetic marker for leukemia. Our patent is for diagnosing and monitoring the patient’s response to therapy, and about one-third of all AML patients have the NPM1 mutation. Our goal is to develop an AML biomarker panel as we bring PCM-075 forward in clinical studies. We believe that with our highly-selective PLK1 drug candidate and a targeted diagnosis we’re well-positioned to bring PCM-075 forward.
WSA: Right. And I think you had touched on it earlier, but what are some of the factors that you feel make Trovagene unique from some of the other players in the sector?
Bill Welch: The idea of drugs working with diagnostics is not new, but the ability to pull them forward together has been challenging. Our core business is to see and identify — and we’ve shown data at very early stages when you use a therapeutic — tumors being shed and measured in urine and blood at 24, 48 hours, 1 to 2 weeks, and otherwise, as you see the drug hopefully working and the resulting changes in tumor mutation burden. We see this ahead of radiographical images, and thus we focus our core technology on high clinical sensitivity and actionable information that can make a difference in treatment decisions and patient care. It’s with this same kind of personalized diagnostic and oncology therapeutics mindset that we’re approaching the development of PCM-075 for the treatment of AML.
I think that we’re probably unique in the ability to pair technology with therapeutics for what we believe will be a more precise therapeutic approach and greater likelihood of success in the clinic. We’re very excited about our new venture into therapeutics and the significant opportunity this provides for Trovagene.
WSA: Certainly. And what are the main goals and milestones you’re hoping to accomplish over the course of the next six to twelve months?
Bill Welch: Our focus will be on the clinical development of PCM-075 for AML, primarily. There is an active IND in place with the FDA and a phase I study with PCM-075 has been completed, so our first goal is to transfer the existing IND to the FDA division of hematology and prepare and submit a phase II study protocol. Overall, our goal this year is to get the study protocol written, submitted, and approved so that we can prepare to initiate the trial and potentially have the first patient dosed in 2017. This study will be a dose escalation study for AML patients on PCM-075 in combination with chemotherapy agents and we plan to evaluate patient response and biomarker response in this study. Essentially, we’re following a path similar to that with volasertib, a drug candidate that was in the phase III and showed efficacy in AML. While we’re trying to capitalize on some of the things they saw, we are working with a compound that’s more selective, has a much shorter half-life – approximately 24 hours, and potentially a better response rate to help ensure a favorable program as we go forward.
We have all rights to manufacture bulk and finished goods for this compound and we already have sufficient bulk and finished product for our phase II study and for other studies. We believe that we will be able to get PCM-075 in the clinic relatively quickly to bring this product forward.
WSA: Right. And so perhaps you can talk about your background and experience and who some of the key management team is?
Bill Welch: I’ve been in healthcare for about 20 years. I’m a Chemical Engineer out of Berkeley and a Harvard MBA. I cut my teeth, so to speak, with Abbott Laboratories in Chicago and worked in the hospital products division where at that time the company’s mission statement was to be a leader in drug and drug devices. And so I think my career is paired in both therapeutics and diagnostics. I’ve managed and been responsible for three different drug programs that resulted in successfully bringing high-valued therapeutics through the FDA and to the market.
I worked in a company in San Diego that was doing B-cell tolerance in a therapeutic in orphan diseases, which was a lot of fun. I’ve worked at two different companies, one called Monogram Biosciences, where I was the Chief Operating Officer and we were doing work in HIV, HCV, and the like. And then I was the Chief Executive Officer at Sequenom where we introduced precision testing for genomics for prenatal testing. I’m a big believer in technology.
I think our technology in circulating tumor DNA is fantastic, but I do think the time for it to fully develop takes a little more maturing. Still the ability to move our technology and apply it for therapeutics and to bring it into the development of a precision therapeutic is very exciting.
Our other team members include Chief Scientific Officer Mark Erlander, who worked at Johnson & Johnson in early drug development. We’re also partnering with three key opinion leaders to form our clinical advisory board as we move forward with therapeutics: Dr. Jorges Cortes, who is the leader of the leukemia group at MD Anderson and well-regarded throughout the oncology community; Dr. Filip Janku, who is also at MD Anderson and well-known for his work doing early phase clinical studies and who has been instrumental on our diagnostic side; and Dr. David Berz, Beverly Hills Cancer Center, who was one of the first physicians to use our liquid biopsy testing in his clinical practice to assess patient response to therapy. Additionally, we will be working with Clinical Research Organizations (CROs) to develop study protocols and to help execute the studies and FDA submission.
WSA: And as far as investors and the financial community are concerned what are some of your key drivers that you wish perhaps they better understood about the company?
Bill Welch: One thing we did that was necessary so that we can bring this therapeutic forward was a restructuring of the company that allows us to save a combined $8 million this year by reducing investments in our lab services and development in our lab. We’re in this transition from precision medicine technology to precision medicine therapeutics. I would tell investors I believe that precision medicine technology is a strong technology. It works well and we’re applying our technology to developing therapeutics.
WSA: So once again joining us today is Bill Welch, CEO for Trovagene Incorporated, which trades on NASDAQ, ticker symbol TROV. Currently trading at $1.05 a share. The 52-week high is $6.67 a share, market cap is at about $35 million. And before we conclude here Bill to recap some of your key points, why do you believe investors should consider the company as a good investment opportunity today?
Bill Welch: I believe we are embarking on an exciting expansion into precision cancer therapeutics with the license of PCM-075. We believe the selectivity of this compound to PLK1, its oral availability, and its favorable 24-hour half-life with an acceptable safety profile, will be advantageous for patients with AML. We are confident that we can use our ctDNA PCM technology to create an AML biomarker panel for clinical studies that can potentially strengthen the clinical outcomes for PCM-075. We see broader opportunities for PCM-075 and other high unmet-needs in oncology markets including castration-resistant prostate cancer, triple-negative breast cancer and osteosarcoma.
We believe our ctDNA PCM technology and expertise in liquid biopsy testing provides a unique and strategic advantage to Trovagene for the development of precision cancer therapeutics and PCM-075. And we’re working to provide more information on our clinical goals for PCM-075 as we go forward, as well as timing, cost, and our planned phase II study as it becomes available. We will move along our trajectory this year and accomplish our goals. We strongly believe that we’ll achieve better parity for evaluation equilibrium in AML, and we strongly believe the market will have a clear understanding and appreciation for PCM-075 going forward. So thanks, Juan.
WSA: Well we certainly look forward to continue to track the company’s growth and report on your upcoming progress and we’d like to thank you for taking the time to join us today Bill and update our investor audience on TROV, Trovagene. It was great having you on.
Bill Welch: Yes, absolutely. Thanks, Juan. I really appreciate it.