Edited Transcript of CRBP earnings conference call or presentation 12-Mar-19 12:30pm GMT

Furthermore, as a pioneer in the development of small molecules that binds the cannabinoid receptors, we believe that Corbus is uniquely positioned to become the leading source of endocannabinoid system targeting therapeutics. Stepping back, cannabinoids is a term that is attracting a lot of interest, and I'd like to briefly remind you all of how Corbus fits into this landscape. Endocannabinoids are the body's own endogenous cannabinoid signaling molecules that play a role in keeping our body healthy.

Phytocannabinoids are chemicals found in the cannabis plant, such as at THC and CBD. They are extracted from the plant and are approved as therapies for of significant medical problems, such as severe childhood epilepsy, nausea and vomiting and people undergoing chemotherapy and a loss of appetite and weight loss in people stricken with cancer. But importantly, our compounds are neither endocannabinoids or phytocannabinoids. Our compounds find the endocannabinoid system receptors in the body, but they do not exist in nature. In other words, they are artificial or synthetic cannabinoids.

There are several advantages to this strategy of rationally designing small molecules to target the endocannabinoid system, including our small molecule drug candidates can be designed for the treatment of specific diseases. Their chemical structure can be optimized to preferentially target the CB1 cannabinoid receptor or the CB2 cannabinoid receptor and to partially or fully activate or inhibit these receptors. 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 composition of matter patent protection with all of 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 diseases.

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 diseases 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-design compounds.

We have the largest patent portfolio for taking 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 drugs -- 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 royalties 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 noncapital to the company. Of particular focus next are South Korea and China. On January 30, 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 2 clinical -- key clinical studies. The pivotal study in systemic sclerosis and a phase IIb 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.

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Craig Millian, [4]

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Thank you all. 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 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 you've all 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.

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Yuval Cohen, Corbus Pharmaceuticals Holdings, Inc. - CEO & Director [5]

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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?

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Barbara White, Corbus Pharmaceuticals Holdings, Inc. - Chief Medical Officer [6]

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Thank you, Yuval. Lenabasum, a CB2 agonist, is our lead clinical asset. Lenabasum is currently being evaluated in Phase III studies for systemic sclerosis and dermatomyositis, and in Phase II studies for cystic fibrosis and lupus. Patient enrollment and dosing in our Phase III RESOLVE-1 study for systemic sclerosis remain on track, and we anticipate the last patient 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.