Corbus Pharmaceuticals Holdings Inc (CRBP) Q4 2018 Earnings Conference Call Transcript

Our compounds can be designed to specifically target the ECS in certain organs, such as the liver or the brain, or alternatively, avoid certain organs, such as the brain. Unlike plant derived cannabinoids, our synthetic ones benefit from composition of matter patent protection with all the market exclusivity benefits that accompany that. Lastly, this therapeutic approach of controlling activation or inhibition of endocannabinoid receptors has broad applicability to inflammatory and fibrotic disease.

Corbus now leads in the development of first-in-class drugs targeting the endocannabinoid system. We plan to be the first to market with novel therapeutics that target inflammation and fibrosis through the regulation of the ECS. Lenabasum, a CB2 agonist, is in pivotal testing for the treatment of rare autoimmune disease, such as systemic sclerosis and dermatomyositis, and in late-stage testing for the genetic inflammatory disease cystic fibrosis, as well as, in a first-in-patient lupus study.

We believe we have the most innovative and largest pipeline of early stage drug candidates that target receptors in the endocannabinoid system. These include CRB-4001, a CB1 inverse agonist, that is being developed for NASH, and a preclinical library of over 600 rationally designed compounds. We have the largest patent portfolio protecting our compounds, targeting the endocannabinoid system for inflammation and fibrosis. And we control the global commercial rights for our compounds

To summarize, with unique drug candidates from early all the way to late stage, and strong intellectual property with patent protection and global commercial rights, we believe we are well positioned to capitalize on the large market opportunity for endocannabinoid system targeting drugs designed to treat a range of inflammatory and fibrotic diseases.

Over the past several quarters, we have achieved a number of significant corporate milestones. We now have a robust pipeline with multiple shots on goal and expanded target indications. Corbus has the exclusive worldwide rights to develop, manufacture, and market drug candidates coming from a library of more than 600 preclinical compounds that bind to the endocannabinoid system. CRB-4001 and the rest of this library are a strong foundation for our growth.

We also executed our first licensing deal to ensure lenabasum can reach patients worldwide. We licensed the commercial rights to lenabasum in systemic sclerosis and dermatomyositis in Japan to Kaken Pharmaceuticals. Kaken is an excellent partner for Corbus as we look to enter the Japanese market, which represents a significant opportunity for lenabasum with approximately 28,000 systemic sclerosis patients and 9,000 dermatomyositis patients. Importantly, the agreement calls for a $27 million upfront payment, and we are also eligible to receive up to an additional $173 million in milestones and double-digit calls after that.

We view our Kaken deal as a model to pursue similar licensing deals for commercial rights to geographies that we cannot reach ourselves, while providing near-term and future non-diluted capital to the company. Of particular focus next are South Korea and China. On January 30th, we closed on a $40 million public offering of common stock. Our current cash reserve is adequate to support the company through data in our two clinical -- key clinical studies, the pivotal study in systemic sclerosis, and the Phase 2b study in cystic fibrosis.

Another important milestone is the continued expansion of our leadership team. Recently, Craig Millian joined Corbus leadership as Corbus' first ever Chief Commercial Officer. Craig will develop and drive U.S. global marketing and commercialization strategies with an initial focus on our lead drug candidate lenabasum. Craig brings 25 years of experience building therapeutic brands and leading commercial organizations in pharmaceutical companies. We are pleased to have Craig with us on the call today, and I'd like to hand it over to him for a brief introduction.

Craig Millian -- Chief Commercial Officer

Thanks, Yuval. Let me start by saying I am thrilled to join Corbus at such an exciting time for the company. As a bit of background, I joined Corbus from EMD Serono, where I most recently served as Senior Vice President and Head of U.S. Neurology and Immunology. Prior to that, I held a number of commercial leadership roles at Vertex, Pfizer, and Sanofi. What attracted me to Corbus was, first of all, Yuval and the other talented members of the team, all of whom share an inspiring vision and a commitment to excellence. I've only been on board for a short time, but I've already witnessed the truly collaborative team-oriented environment that's been cultivated here. And it's a true source of strength for the company.

I'm also very excited about the science underpinning Corbus' work. Synthetic cannabinoid development presents a significant opportunity. As Yuval noted, this has the potential to be a truly groundbreaking therapeutic area in the coming years, and Corbus is at the forefront of developing novel synthetic cannabinoid medicines. I'm energized and excited to be joining such a talented team and I look forward to help building the commercial strategy and infrastructure as lenabasum moves toward the completion of key registrational studies in 2020.

While I'm currently head down as I get fully up to speed in my new role, I do look forward to meeting many of you in the coming months. And with that, I'd like to turn the call back over to Yuval.

Yuval Cohen -- Chief Executive Officer, Director

Thank you, Craig. Craig's appointment is an important milestone for Corbus, and we're confident that Craig's experience and leadership will drive a successful launch for lenabasum, which we expect to be in 2021.

We'd like to now provide an update on our clinical pipeline, starting with lenabasum. With that, let me turn the call over to Barbara to provide an update on our clinical pipeline. Barbara.

Barbara White -- Chief Medical Officer

Thank you, Yuval. Lenabasum, a CB2 agonist, is our lead clinical asset. Lenabasum is currently being evaluated in Phase 3 studies for systemic sclerosis and dermatomyositis, and in Phase 2 studies for cystic fibrosis and lupus. Patient enrollment and dosing in our Phase 3 RESOLVE-1 study for systemic sclerosis remain on track and we anticipate the last patients by May. We are on track for study completion in the first half of 2020, and we anticipate NDA submission at the end of 2020.

We are optimistic that lenabasum has the potential to provide clinical benefit to patients with systemic sclerosis. Our optimism is based on the mechanism of action of the drug, benefit in animal models of the disease, consistent improvement in multiple efficacy outcomes in the double blind placebo controlled Phase 2 of lenabasum in systemic sclerosis, as well as its open label extension, and evidence of improvement of inflammation and fibrosis biomarkers in skin of study subjects.

We also remind you that lenabasum has orphan drug and fast track designations for treatment of systemic sclerosis with the FDA, and orphan drug designation for treatment of systemic sclerosis with EMA. Our Phase 3 DETERMINE study is a registrational study testing safety and efficacy of lenabasum as a treatment for dermatomyositis, our second potential rare autoimmune disease indication. Corbus has received input on study design from regulatory authorities in the U.S., Europe, and Japan. This study is enrolling subjects.