Matt Foehr
Analyst · Stephens. Please proceed
Thanks John. I’ll start today by reviewing recent developments for some of our partner programs and I will also provide updates on our Captisol and OmniAb platforms in related licensing activities and I’ll discuss our Phase 2 clinical trial for our Glucagon Receptor Antagonist or GRA diabetes program. We're continuing to see late-stage positive progression by growing number of our partners. Our partners at Melinta Therapeutics presented data from the Baxdela clinical program at Europe Congress of clinical microbiology and infectious diseases or ECCMID conference in late April. Baxdela has completed Phase 3 testing and it is a subject of a new drug application that is currently under review at the FDA for the treatment of patients with serious hospital treated skin infection. The presentation that ECCMID included data from the Phase 3 program and demonstrated that back stellar [ph] is comparable to [indiscernible] as treated in the en-combo therapy in the treatment of patients with acute bacterial skin and skin structure infections. Importantly, this was demonstrated not only in the global study population, but in three key sub groups, patients with diabetes, patients with renal impairment and obeahs patients. The action date for the back stellar NDA is June 19, so about five weeks from now, if approved Ligand will earn a $1.5 million payment given Captisol's use in the IV form of the drug. Melinta also recently announced the execution of a license agreement with Menarini Group for exclusive rights to commercialized back stellar in 68 countries, in EU, in Asia Pacific and other ex U.S. regions. Menarini is a global leading pharmaceutical company with over 16,000 employees worldwide and with a presence in more than 100 countries, including a direct presence in more than 70 countries. As generally remainder, Ligand has a 2.5% royalty on global net sales of back stellar IV. Additionally, our partners at Eli Lilly indicated on their recent Q1 earnings call that they continue to be excited about Prexasertib which is a small molecule inhibitor of checkpoint kinase 1 or CHK1 and to a lesser extend CHK2. Prexasertib utilizes our Captisol technology in it's formulation. Just for some foundational background CHK1 is a global regulator of the sales cycle and in addition to regulating DNA damage checkpoints, checkpoints plays essential role in normal DNA replication reserving replication stress, progressing to mitosis and cytokinesis. In addition of CHK1 in the absence of DNA damage can cause impaired DNA replication, loss of DNA damage checkpoints, pre-mature entry into mitosis with highly fragmented DNA in so dept what's called replication catastrophe. Prexasertib is being investigated by Lilly in Phase 2 clinical trials in patients with head and neck cancer as well as small cell lung cancer, and Lilly indicated on their recent earnings call that we should see more data on Prexasertib over the coming next few months along with updates from them on future development plans. Switching now to Sparsentan, our partners at Retrophin and met with the FDA in the first quarter and received agreement on a path to approval with a single Phase 3 trial that is to include an interim readout. Retrophin indicated that they expect to finalize the Phase 3 protocol with the FDA in the second half of this year and start the Phase 3 near the end of the year. Additionally, Retrophin has indicated that they are working with the Europe regulatory authority to position the Phase 3 trial for European registration as well. We look forward to further update on this high profile program and also look forward to more dialog around the asset at upcoming renal scientific meetings. Our partners at Aldeyra therapeutics recently announced the start if the start of Phase 3 clinical trial of Captisol enabled topical ocular ADX-102 for the treatment of noninfectious anterior uveitis or NAU. They started the trial following positive results from a Phase 2 trial that was announced last year. ADX-102 is a novel aldehyde trap, and is being developed for aware and potentially blinding ocular disorder that affects approximately 150,000 patients in the U.S. In contracts to cortical steroids which are often use to treat NAU ADX-102 does not appear to cause increases in intraocular pressure has increased for glaucoma and according to our partners at Aldeyra ADX-102 may represent a safer therapeutic option in the current standard of care. Phase 3 clinical trial that was recently started is expected to enroll to 100 NAU actions with active disease. Randomized equally to receive either topical ocular ADX-102 or vehicle [ph] for four weeks. Consistent with the successful Phase 2 trial, the primary endpoint will be the resolution of inflammation. Results from that Phase 3 trial are expected in the second half of 2018. As announced previously in the first quarter, Vertex announce that it licensed rights to Captisol-enabled VX-970 to Merck KGaA also known as EMD Serono. Now this program has been broadening to the clinical pipeline at Merck KGaA, it has been renamed as M66207 and we look forward to future progression and to discussing the program at next month's ASCO meeting. Switching now licensing both are Captisol and OmniAb technology is continue to bring significant value to partners and are facilitating growth and progression of our partner pipeline. We continue to see please with the progression of the OmniAb technology and the feedback we have relating to the technology from current and perspective partners. Our OmniAb team is coming up a very successful protein engineering summit or PEGS conference last week in Boston, which is one of the premiere annual globally attended events in the antibody discovery space. Dr. Christel Iffland to Ligand presented the technical details and benefits of the OmniAb platform to a full room of over 130 PEGS attendees during the oral session of the meeting. Our existing OmniAb partners are showing significant intangible progression of OmniAb antibody. One of the latest example of this is the J&J [ph] who filed an IND front OmniAb antibody in Q1 that resulted in the $1 million milestone payment to Ligand. At PEGS last week, our partners at Aptevo who formed a VA spin-off from emerging biosciences presented positive pre-clinical data for their OmniMouse derived anti-CD 1, 2, 3 antibody showing strong in vitro efficacy and [indiscernible] ranges and favorable manufacture ability properties when formatted as a [indiscernible] antibody along with an anti-CD 3 for T-cell engagement. Aptevo refer to this drug as APVO436 and we look forward to watching the progression of this new OmniAb preclinical program. We also recently completed a worldwide OmniAb platform license agreement with Bluebird Bio. Under the terms of the deal Bluebird will be able to use the OmniRat, OmniMouse and OmniFlic platforms to discover fully human mono and bispecific antibodies as well as antibody fragments targeted to CAR [ph] field. For Captisol in Q1, we entered into new Captisol license agreement with Eisai and we have standard our clinical stage relationship with Menarini for Captisol-enabled IV ganaxolone to a full commercialization and supply relationship. Merc also added an additional novel compound to their Captisol platform license agreement with us in Q1. And I’ll conclude with a brief remark about our internal pipeline specifically our Glucagon Receptor Antagonist or GRA program as known as LGD 6972. We completed enrollment into our Phase 2 trial in February and are on track to have data in September. We’ve been pleased with the conduct and progression of the trial thus far. As we initiated this trial, this Phase 2 trial in September of last year and are on track to have the data within a year from when we started the trial. We are excited about the program and believe we have what could be a first in class and/or best in class molecule for a novel mechanism of treating diabetes. I noticed the landscape in the GRA space continues to evolve, Lilly and Pfizer have attempted to develop small molecules and Glucagon also remains a target of interest in diabetes with other therapeutic approaches too, with [indiscernible] progressing in antisense and Pfizer beginning early work on a Phase 1 stage antibody targeted at the Glucagon receptor. We believe that we may have a best in class and highly differentiated small molecule compared to prior molecules that were tested clinically. We are excited to see our Phase 2 data in September and expect to talk more about the various differentiating tactical features of LGD-6972 at the right time. And with that I’ll turn the call over to Matt Korenberg to discuss the financials.