Matt Foehr
Analyst · H.C. Wainwright. Your line is open
Thanks John. I'll start today with a review of a couple of recent developments for selected partner programs. And then I'll discuss progress with our technology platforms in general, recent and upcoming publications and presentations and progress on some of our internal R&D activities. Starting with partner programs, just a few weeks ago Sage Therapeutics announced that they submitted a new drug application to the FDA for intravenous brexanolone in the treatment of postpartum depression or PPD. IV brexanolone utilizes our Captisol Technology in its formulation. Brexanolone received breakthrough therapy designation in 2016, which underscores a significant unmet need that exists in PPD, as breakthrough therapy designation is intended to offer a potentially expedited development path for promising drug candidates intended to treat serious conditions. As background, PPD generally involves a range of symptoms from feelings of fear and hopelessness, to crippling isolation and a general sense of not being whole. It’s estimated that PPD affects more than 400,000 women in the U.S. each year. And without proper screening more than half of those cases may go undiagnosed. There are no approved therapies for PPD. And there’s clear on that medical need for treatment. SAGE's recent NDA submission is supported by data from their Hummingbird program, which is a clinical program that included three multicenter, randomized, double-blind, placebo-controlled trials, each designed to evaluate the safety and effectiveness of Brexanolone in women with moderate or severe PPD. Last week SAGE also reported on progress achieved in launch readiness preparations in anticipation of a potential first half of 2019 launch, including their strategy to deliver a family-centric support model with work towards the development of a national network intended to support home infusion of IV Brexanolone. Our relationship with SAGE started back in 2011 with a Captisol platform license agreement. And we continue to be very impressed with the work that the team at Sage is doing. I’d also like to highlight that in early April our partners at Retrophin initiated a pivotal Phase III clinical trial of sparsentan for the treatment of focal segmental glomerulosclerosis or FSGS, which is a rare kidney disorder that often leads to end stage renal disease. FSGS is also a disease with no approved pharmacologic treatments available. The trial, which is called the DUPLEX Study is a global, pivotal Phase III trial evaluating the long-term nephroprotective potential of sparsentan for the treatment of FSGS. Retrophin is highlighted that DUPLEX study builds upon the promising results from the Phase II DUET study of sparsentan and positions a program for potential Subpart H accelerated approval with the inclusion of an interim endpoint assessing modified partial remission of proteinuria. Top line data from a 36-week interim efficacy end point analysis are expected in the second half of 2020. Retrophin also announced last week that they obtained FDA and EME feedback on a pathway to NDA and MAA filings for sparsentan in IgA nephropathy, which is an added potential indication for the drug. Retrophin reported that they now expect to initiate registration enabling Phase III trial for sparsentan in IgA nephropathy in the fourth quarter of this year. I’ll also mention briefly that our partners at Sermonix are making good progress toward a Phase II trial of oral lasofoxifene in metastatic breast cancer. Data in emerging literature from thought leading groups suggest that a more potent and bio available compound to block estrogen receptor signaling may play a key role in the future management of ER positive metastatic breast cancer, particularly in the presence of ESR1 estrogen receptor gene mutations. We look forward to the continuation of the progress of the team at Sermonix is making and to the initiation of their Phase II trial. So now to our OmniAb antibody discovery technology platform, our team is coming off a very successful PEGS meeting in Boston last week. PEGS is one of the industry's preeminent, global, antibody related events focused on accelerating bio therapeutic protein drug discovery and development. Our partners presented data illustrating that our OmniAb of transgenic animals continue to produce highly diversified fully human antibody repertoires that are optimized in vivo for manufacturability, therapeutic efficacy and reduced immunogenicity. And I note also that our single license OmniAB offering continues to be the industry only platform with three species and multiple genetic backgrounds to address even the most challenging biologic targets. That’s part of why we consider OmniAb to clearly be a best-in-class technology, given that it’s a transgenic animal platform with the most partners and that we are seeing a growing number of OmniAb derived drug candidates moving to the clinic. There are now five OmniAn derived antibodies in clinical development and we expect others to be entering the clinic in the coming months. I note also that we now expect partners that clinical data for two OmniAb derived antibodies before the end of 2018. We hosted the third OmniAb Partner Summit prior to the start of the PEGS meeting in Boston and we had over 60 attendees from current and prospective partners with some presenting their data and experiences with our platform. There continues to be growing interest in our Omni Chicken technology both from existing partners who have now expanded licenses to include Chicken and also from new potential partners. I note that a peer reviewed paper by Ligand scientists describing the Omni Chicken was published recently in the journal MAbs and that article has increased visibility for the use of Omni Chicken. We're also continuing to invest in the OmniAb platform as we work on next generation animals with different genetic characteristics to meet a variety of future partner needs. From a deal perspective we've announced OmniAb license agreement with venBio Partners, Ferring Pharmaceuticals and Glenmark Pharmaceuticals and we expect we will continue to add new OmiAb partners this year. The venBio agreement is unique in that it serves as an umbrella agreement for the full OmniAb platform for venBio portfolio companies. Switching now to Captisol, we also continue to enter new research agreements and expand existing relationships around our Captisol technology illustrating the partners see the value of the global validation of Captisol for enabling successful products. Our Captisol drug master files and growing safety database are significant value drivers for our technology with our Type IV and Type V DMFs in the U.S. our Canadian Drug Master File, and our Japanese file. And I note that we are also now planning to establish a Drug Master File in China later this year as well. Visibility for Ligand technologies, as well as Ligand partner programs continues at a recent upcoming scientific and medical conferences, as well. Noting first a couple of recent presentations on our liver-targeting prodrug or LTP technology, with data from Nucorion Pharmaceuticals that was presented at EASL for Nucorion’s NCO-1010 program for Hepatitis B. Their data showed that LTP enablement achieved seven to 15-fold higher drug concentrations in the liver which is the target organ, compared with an equivalent dose of a non-LTP parent compound. Also our scientists from Ligand presented last week at the National Lipid Association's 2018 Scientific Sessions meeting, showing that the LTP technology significantly improves liver targeting of the statin drug rosuvastatin and maybe an effective strategy to increase the therapeutic index of statins and potentially reduce statin intolerance. The annual ASCO meeting is approaching in a few weeks and we've noted a number of presentations related to Ligand partner programs. These include oral presentations for Kyprolis Phase III ARROW study presentation of Lilly’s Captisol-enabled prexasertib Phase Ib data in advanced cancer; Merrimack’s Seribantumab data in solid tumors; MEI’s ME-344 data in breast cancer and J-Pharma presenting on captisol-enabled JPH-203 in advanced solid tumors among others. So I'll conclude now with a brief remark about some of our continuing internal R&D. John discussed our recent partnership with Roivant for our GRA program, which is now known as RVT-1502. That program was a significant focus of our R&D efforts over the last few years and that R&D effort translated into a new and exciting partnership for us. Our internal R&D is now primarily focused on our Captisol-enabled iohexol program, which is the next-generation contrast agent for diagnostic imaging. We recently initiated key pre-clinical experiments for CE iohexol and we believe those studies may add significant value and help define our precise clinical strategy. We intend to discuss our clinical plans with the FDA in the coming months prior to filing of our IND into the initiation of clinical trials. We're excited about this program and look forward to updating you as we continue to make progress. With that I'll turn the call over to Matt Korenberg to discuss the financials.