Receptos (RCPT) Misses Q4 EPS by 13c

Receptos (NASDAQ: RCPT) reported Q4 EPS of ($1.32), $0.13 worse than the analyst estimate of ($1.19).

Development Program Updates

Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (RMS)

• After reporting positive results in the Phase 2 portion of the RADIANCE trial of ozanimod in RMS, Receptos initiated the second Phase 3 trial of ozanimod in RMS, called SUNBEAM. Similar to the RADIANCE Phase 3 trial, the SUNBEAM trial is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of ozanimod against interferon beta-1a (Avonex®) in approximately 1,200 patients with RMS. The primary objectives of the RADIANCE and SUNBEAM trials are to assess whether ozanimod is superior to Avonex® in reducing the annualized relapse rate in patients after two years of therapy and one year of therapy, respectively. Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreement with the FDA.

Ozanimod (RPC1063) in Ulcerative Colitis (UC)

• In October 2014, Receptos reported positive Phase 2 results for the induction period of the TOUCHSTONE trial of ozanimod in patients with moderately-to-severely active UC. The study met the primary efficacy endpoint and all secondary endpoints with statistical significance for patients on the 1 mg dose after 8 weeks of treatment. Safety data were consistent with the favorable profile observed in the Phase 2 trial in RMS. The 24-week maintenance portion of the trial is ongoing and is expected to be completed in 2H 2015. These induction data were reviewed in further detail on February 21, 2015 at an oral podium presentation at the annual meeting of ECCO, the European Crohn's and Colitis Organization. Receptos has also been notified that it has been granted an oral presentation during the plenary session at the Digestive Disease Week meeting in May 2015.
• Based on the positive induction period results from the TOUCHSTONE trial, the Company plans to initiate a Phase 3 program in UC and Phase 2 program in Crohn's disease (CD) in 2015.

RPC4046 in Eosinophilic Esophagitis (EoE)

• In September 2014, Receptos enrolled the first patient into the Phase 2 HEROES trial of RPC4046, Receptos' development candidate for the treatment of EoE. In addition, in February 2015 RPC4046 was granted Orphan Drug Designation for the treatment of EoE. EoE is a GI-related immunological indication with high unmet need. RPC4046 is a humanized monoclonal antibody directed against interleukin-13 (IL-13), a target which has been validated in other related allergic indications. The trial is expected to be completed in 1H 2016.

Oral GLP-1 Receptor Positive Allosteric Modulator Program

• Receptos is pursuing a research program for glucagon-like peptide-1 receptor (GLP-1R) small molecule, positive allosteric modulators (PAMs) for the treatment of Type 2 diabetes. Internally developed, orally administered lead compounds have shown single agent glucose lowering and weight loss effects in a diabetic disease model, as well as activity that is synergistic with metformin in combination studies. Receptos expects to identify a lead candidate in 2015 and expects to subsequently initiate IND-enabling studies.

For earnings history and earnings-related data on Receptos (RCPT) click here.

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