Brian Culley
Analyst · Laidlaw
Thank you, Ioana, and good morning, everyone, and thank you for joining for today’s call. With me today is Brandi Roberts, our Chief Financial Officer; and on the phone is Ed Parsley, our Chief Medical Officer, who is actually on the road, evaluating sites for our heart failure study, but Ed will be available to answer questions at the conclusion of this call. I’ll begin with the most important item and that, of course, is the progress we have been making with our lead candidate, vepoloxamer in sickle cell disease. As you will recall, we are running a 388 patient pivotal Phase 3 study called EPIC to demonstrate that vepoloxamer can reduce the duration of vaso-occlusive crisis. We opened our first site in January of 2013 and are now actively enrolling at over 70 sites in more than 10 countries, with approximately two-thirds of those sites located in the U.S. We are pleased to report that our EPIC study is now more than 70% enrolled. This means that Mast has now enrolled more patients in an interventional sickle cell disease study than any other company and thanks to an incredible effort by our clinical operations team. I am pleased to reiterate for you today that we are on track to enroll the remaining patients in line with our guidance and report topline data from EPIC in the first quarter of 2016. An abundance of clinical and non-clinical data showing the vepoloxamer improves blood flow, which can be expected to shorten the length of crisis and reduce the amount of damage to vital organs, as well as patient demographic data we have reviewed from the EPIC study, gives us optimism for the outcome of our Phase 3 study. Thus, we have been working to enhance our EPIC data set and our new drug application with several supporting clinical studies. First, we completed and announced the positive results from the 60-patient thorough QT study, demonstrating that vepoloxamer had no adverse effect on QT interval. More recently, we initiated a repeat dose study called EPIC-E, which we plan to make available to anyone who has completed the EPIC study. In addition to expanding our existing CT database with repeat exposure, EPIC-E also will provide physicians and patients with experience using vepoloxamer in an unblinded fashion. Third, we are planning to conduct a study in special population of approximately 30 renal impaired patients to enhance dosing information in our label. These studies have a very specific purpose. Our objective with them is to deliver to the FDA a comprehensive and robust data package to help ensure vepoloxamer is approvable and utilized in the most appropriate way for each patient. Thus each of these three clinical studies and the tissue oxygenation sub-study within EPIC are intended to enhance our new drug application and provide the agency with supporting evidence above and beyond the 388 patient EPIC study to demonstrate vepoloxamer’s safety and tolerability for patients with sickle cell disease. Important to note the enormous unmet need for new therapy for sickle cell patients. Although, it qualifies as a rare disease in the United States and Europe, there are still around hundred thousand people with sickle cell disease in the U.S. and millions more worldwide. However, there is only one FDA approved treatment, hydroxyurea. But it was approved more than 17 years ago. It’s only used by about 20% on U.S. patients and it has not been shown to reduce the duration, of course, severity of the crisis once one begins. As a result, sickle cell patients hospitalized for crisis, spend an average of four to five days, suffering an indescribable pain, requiring an high doses of parental opioids and during which time the obstruction of blood flow is causing tissue and organ damage, leading to severe complications, organ failure and ultimately an early death. Mast is deeply committed to breaking these [indiscernible] therapies for sickle cell patients. Remarkably, aside from hydroxyurea none of the clinical approaches tried in the past have worked, including antisickling agents, anti-inflammatory, platelet inhibitors and oxygen-dissociation curve shifters. The extensive clinical record is clear that the first sickle cell disease is so complex, approaches which target a single pharmacological event do not work, so we and many disease experts believe a multifaceted approach if necessary to change clinical outcomes in sickle cell disease. Notably, non-clinical study have demonstrated that vepoloxamer doesn’t just improve blood flow, but also reduces hemolysis, protects against reperfusion injury and reduces adhesion among and between red, white and endothelial cells, all of which could be occur during the crisis. Mast has generated data on each of these attributes and there is no other agent in development with all of these properties. So we believe we alone have a treatment with enough pharmacological horsepower to improve outcomes for these patients. That being said, it’s worth speaking briefly to the several developments which has occurred in the sickle cell landscape since we began the EPIC study more than two years ago. In particular there was an announcement recently that the sickle cell patient had undergone first ever gene therapy treatment. We care deeply about sickle cell patient as evidence by our creation of a drug development conference, patient communication and [indiscernible] contest, our [indiscernible] were highly supportive and we welcome new entrants into this underserved indication. However, publicly available estimates for the eligible patient population for sickle cell gene therapy range from just 5% to 25%, that means at even if the technology proves to be safe, effective and durable, 75% to 95% of these patient populations still would be left without any treatment options. In contrast, we believe vepoloxamer would not suffer from those same patient eligibility limitations, because as a biophysical agent it performs regardless of genotype, disease severity or age of patient. With respect to other new compounds and clinical development, vepoloxamer remains the most clinically advanced option and unlike agents with just fixed or needing 60 exposures vepoloxamer has been administered to hundreds of patient in multiple trials. We believe that vepoloxamer’s extensive development history provides safety data that no other drug candidate can match. We also currently enjoy a two and a half year head start on our closest competitor. And in some cases, our lead could be five or more years based on reasonable estimates for the unpredictable regulatory process. Meanwhile, we're in the home stretch of our Phase 2 trial. Our plan, of course, would be to use our significant lead time to establish vepoloxamer as the standard of care for a wide spectrum of sickle cell patients and then broaden its use for series of post-marketing studies, the details of which, we’ll at this time keep confidential for competitive reasons. For those who are not familiar with this patient population and what it means for commercialization, sickle cell disease offers a size of the market opportunity especially for the first drug market. In the U.S. alone, there are approximately 100,000 hospitalizations for sickle cell disease each year, with half of those occurring in just 16 metropolitan areas. Similarly, in Europe, there are approximately 40,000 patients with half of those patients residing in just two cities, Paris and London. Clearly, this is a concentrated patient population and as we get closer to the completion of enrollment in the EPIC study, we will begin sharing our commercialization plans, including our thoughts on optimal pricing and reimbursement strategies. Because we plan to obtain the first drug approval for sickle cell patients in more than 17 years, we believe that vepoloxamer will enjoy unprecedented awareness in the physician and patient communities and we nonetheless have work to do to prepare for that yet. Fortunately, we’ve got a great team working on this topic and we look forward to sharing more of our commercial plans in the coming months. We've been extremely focused on enrolling our sickle cell Phase 2 study and have produced excellent results from those efforts. But I’d like to note that we are also excited about our other clinical programs because we can potentially reach even far greater number of patients in diseases such as heart failure and stroke. In particular, we remain on track to initiate next month a Phase 2 study of vepoloxamer for the treatment of chronic heart failure. Positive results from randomized placebo controlled and repeat treatment studies of vepoloxamer in model of heart failure as well as recommendations from medical experts in the field, support our efforts to begin clinical development of vepoloxamer in chronic heart failure. If the promising results in models to date, translate the patients with heart failure that vepoloxamer may offer a way of directly improving left ventricle contracted function by restoring cardiomyocyte membrane integrity and increasing survival. Our heart failure protocol has been reviewed by the FDA and as I mentioned at the outset, we are getting sights lined up to begin this study. We plan to enroll approximately 150 patients to evaluate the safety and efficacy of a single administration of vepoloxamer compared to placebo and with all the vepoloxamer’s effect on troponin and NT-proBNP mark this a cardiac injury and wall stress respectively as well as clinical outcomes. We expect to conduct this study on an outpatient basis at medical centers both within and outside of the U.S. Importantly, we also filed patent applications claiming the use of vepoloxamer in this and other clinical studies of heart failure. And we are working on divergent strategies so as to preserve the option to partner heart failure either with or without sickle cell disease. With respect to our efforts in arterial disease, we have a very positive update to share today. Stroke represents an enormous market opportunity while ALI conversely develops a very smaller orphan disease, much smaller in fact than sickle cell disease. But as we have said for some time, we believe our clinical study in acute limb ischemia for necessary to validate the stroke program because expertise field wanted to see how vepoloxamer worked on leg clots before moving on to stroke. However a growing body of nonclinical data in stroke that we and others have generated over the last 18 months, including a study conducted by Dr. Michael Chopp of Henry Ford Hospital in which vepoloxamer significantly reduced infarct size with no effects on the incidence of hemorrhage, recently let us back to some of those same experts to assess whether vepoloxamer was now ready for a clinical campaign in stroke without data from the ALI study. We are very pleased to share that following recent meetings for some of the world leaders in the stroke field, we have decided to initiate a clinical development program in stroke. The comments we received from the experts were extremely positive. And we’ll be working with the same physicians to develop a regulatory and clinical strategy for vepoloxamer in ischemic stroke with a goal of demonstrating that vepoloxamer can improve microvascular perfusion and reduce infarct sizes in patients. Now because the ALI study was not expected to complete until the end of 2016 and its utility as a gateway to the stroke market has been superseded by this new data. We have decided to discontinue the ALI program. By doing so, we will be able to reallocate approximately $4.6 million over 2015 and 2016 to our other programs. I’ll now shift to our second asset, AIR001 program. Based on the positive hemodynamic effects observed in phase 1 and phase 2 studies of AIR001 in more than 120 healthy volunteers in patients with various form of pulmonary hypertension, we believe AIR001 maybe uniquely suited to address the serious unmet needs of patients with heart failure with preserved ejection fraction or what’s known as HFpEF. To affirm AIR001 potential in that patient population, we currently are supporting two institutional sponsored Phase 2a study of AIR001 in patients with HFpEF. We anticipate reporting preliminary data from the first of those studies in the fall of 2015. That trial is enrolling approximately 30 subjects in a randomized double-blind placebo controlled study to evaluate the effects of AIR001 on resting and exercise hemodynamics in patients with HFpEF. And in results from this Phase 2a study, we expect to make a decision with respect to conducting a Phase 2b proof-of-concept study of AIR001 in HFpEF patients either on our own or with the partner. Before I turn the call over to Brandi to update you on our financials, I want to make a few comments about our business, financing strategies and share costs. We’ve realized we have a special opportunity here. And so far as we own nearly 100% of the vepoloxamer worldwide commercial rights and because the patient population sickle cell disease is so concentrated, it is attractive for us to commercialize ourselves and we are positioning this business with commercialization in mind. In parallel, we will evaluate licensing and partnership opportunities. But even if we decide to license rights to vepoloxamer, a sound commercialization plan will be an asset at those negotiated tables. So therefore to prepare for commercialization, we are now spending more on NDA preparation for commercial strategy and readiness and other activity that make the asset more valuable. Even with substantial savings from the conclusion of the ALI study, we still need to consider how best to finance this company. We believe a mix of several strategies provides diversification, flexibility and puts our shareholders in the best possible position. Thus, we employ and approach, which includes traditionally equity financings, an ATM vehicle and as we discussed in our most recent 10-Q, our debt facility. It clearly isn’t attractive to raise capital at these low prices, but we believe our debt instruments is a preferable solution for our investors at this time. We thoroughly evaluated debt providers and they are pleased to have entered into a partnership with Hercules Technology Growth Capital, a recognized leader in growth capital financing. I want to ensure that everyone understands that this facility is baked at not convertible debt that does not require us to maintain certain cash minimum on our balance sheet. We view Hercules as a long-term partnership and this deal has been setup opportunistically with no obligation for us to take any money above the $5 million we received this week. However, Hercules did provide the option on the additional $10 million of debt if certain conditions are met. As I explained, we value financial flexibility, so any divisions on drawing additional money will be made in the future as events unfold and more data and information is generated. Meanwhile, we believe establishing this relationship with Hercules is preferable to additional equity issuances and we appreciate Hercules showing confidence in Mast’s long-term business strategy. Next, I want to make a comment about our ATM. The ATM also gives us additional financial flexibility because we can choose when and how or whether to utilize it at all and it allows us to push traditional more dilutive financings into the future or minimize their size until our share price might be higher. The ATM also offers a company superior cost of capital in terms of both dilution and fees. Currently, there is approximately $12.5 million available under the ATM program. However, our current shelf S-3 is expiring and we intend to reset our ATM, when our new S-3 registration statement goes effective later this month. I want to point out that the company sold approximately $15 million of stock last year at an average price of $0.74 with no warrants, terms superior to our last financing. In contrast to 2014, our share price has been lower this year and consequently, we almost sold about $2 million in stock in the first six months of this year. This significant reduction in ATM use should tell you a lot about what we think about our current share price. Again, we are planning to success and want to ensure we have several options available for us to choose from in terms of financing the company. Our combination of debt, additional equity, the ATM and critically evaluating our expenses provides us with that flexibility. Now finally, with respect to share price, Mast by far has the most clinically advanced new drug in the sickle cell space. We have more human drug exposures and safety information than anyone else. We’ve also produced a long and consistent line of positive data since acquiring vepoloxamer in 2011 and yet, we are being severely undervalued by the marketplace. Consequently, we are taking steps to try and reverse that situation. I have already spoken about using simple debt instead of equity and reducing the use of our ATM but those are supply considerations. We also need to focus on the demand side of buyers because there are so many newly public companies where investors fall and a lot of attention is being given to early stage sickle cell companies in particular. We want to ensure our story is known and appreciated by a wider audience of investors. Consequently, on September 3rd, we will be presenting at Fourth Annual Sickle Cell Drug Development Conference and on October 7th, we plan to host our first-ever Mast R&D event. Botsh of these events will be held in New York City and every investor and analyst in our database will be invited to attend. We also will webcast our R&D event on October for those investors who cannot attend in person. At the end of day, we believe the best way to reward our shareholders for their patience is to complete the EPIC study as quickly as we can and with the highest quality data possible, so there is no longer any uncertainty about vepoloxamer’s critical value. In the meantime, increasing awareness of Mast, announcing data from the AIR001 study and continued success with EPIC enrollment are several things we plan to deliver to you. With that, I’ll turn the call over to Brandy, to go through our financials and discuss our partnership with Hercules in greater detail.