Cymabay Therapeutics, Inc. Website: http://www.cymabay.com Details Index Membership: N/A Sector: Healthcare Industry: Biotechnology Full Time Employees: 20 Business Summary Cymabay Therapeutics, Inc. focuses on developing therapies to treat metabolic diseases. Its lead product candidate is Arhalofenate, which completed five Phase II clinical trials for the treatment of gout. The companys product candidate also includes MBX-8025, a selective agonist that is in a Phase II clinical trial in patients with mixed dyslipidemia; and MBX-2982, an oral, G-protein coupled receptor agonist to treat type II diabetes. Cymabay Therapeutics, Inc. has a development and license agreements with Janssen Pharmaceuticals, Inc. to develop and discover undisclosed metabolic disease target agonists for the treatment of T2DM and other disorders; and a license and development agreement with DiaTex, Inc. to develop and commercialize therapeutic products. The company was formerly known as Metabolex, Inc. Cymabay Therapeutics, Inc. was incorporated in 1988 and is based in Newark, California. ===================================================== Cymabay Therapeutics, Inc. (CBAY) -NasdaqCM 1.80 0.41(29.50%) 4:00PM EDT |After Hours : 1.91 0.11 (6.11%) 6:04PM EDT - Nasdaq Real Time Price Share Statistics Avg Vol (3 month)3: 215,481 Avg Vol (10 day)3: 139,600 Shares Outstanding5: 22.37M Float: 19.52M % Held by Insiders1: 5.27% % Held by Institutions1: 30.00% Shares Short (as of Mar 15, 2016)3: 265.29K Short Ratio (as of Mar 15, 2016)3: 2.80 Short % of Float (as of Mar 15, 2016)3: 1.94% Shares Short (prior month)3: 302.50K From the recent 10-Q The number of shares of common stock outstanding as of March 1, 2016, was 23,447,003. Overview CymaBay Therapeutics, Inc. is focused on developing therapies to treat metabolic diseases with high unmet medical need, including serious rare and orphan disorders. Our two key clinical development candidates are MBX-8025 and arhalofenate. We are currently developing MBX-8025 for the treatment of various orphan lipid and liver diseases. In an earlier Phase 2 clinical study conducted in patients with mixed dyslipidemia, MBX-8025 demonstrated favorable effects on cholesterol, triglycerides and markers of liver health. In March 2016, we announced data from a second Phase 2 clinical study evaluating MBX-8025 in 13 patients with homozygous familial hypercholesterolemia (HoFH). Five patients in this study experienced what we believe was a clinically meaningful maximal decrease in low density lipoprotein (LDL-C) of greater than 20% with three of them having decreases greater than 30%. However, given the variability in responses observed in this study, including a number of patients that did not experience a decrease in LDL-C, we believe additional proof-of-concept data would be warranted before determining whether or not to advance to a registration study of MBX-8025 in patients with HoFH. In November 2015, we initiated a double-blind, placebo-controlled Phase 2 study of MBX-8025 in patients with primary biliary cholangitis (PBC), formerly referred to as primary biliary cirrhosis. In this study, approximately 75 patients with PBC who have had an inadequate response to ursodiol are to be enrolled and randomized to receive either placebo or MBX-8025 (either 50 mg or 200 mg) for 12 weeks. The primary endpoint will be the change in alkaline phosphatase, and the study is expected to include patients from the U.S., as well as Canada, Germany, Poland and U.K. We expect this study to be completed by the end of 2016. We also believe that MBX-8025 could have utility in the treatment of severe hypertriglyceridemia (SHTG) and the more prevalent, but high unmet need, indication of nonalcoholic steatohepatitis (NASH). We have obtained orphan-drug designations for MBX-8025 in both HoFH and SHTG (Frederickson type I or V hyperlipoproteinemia). Arhalofenate, is being developed for the treatment of gout. Arhalofenate has been studied in five Phase 2 clinical trials in patients with gout and consistently demonstrated the ability to reduce gout flares and reduce serum uric acid (sUA). Gout flares are recurring and painful episodes of joint inflammation that are triggered by the presence of monosodium urate crystals that form as a result of elevated sUA levels. We believe the potential for arhalofenate to prevent or reduce flares while also lowering sUA could differentiate it from currently available treatments for gout and classify it as the first potential drug in what we believe could be a new class of gout therapy referred to as Urate Lowering Anti-Flare Therapy (ULAFT). Arhalofenate has established a favorable safety profile in clinical trials involving over 1,100 patients exposed to date. We have completed end of Phase 2 discussions with the FDA and intend to partner arhalofenate prior to advancing into Phase 3 development. We are an emerging growth company. Under the JOBS Act emerging growth companies can delay adopting new or revised accounting standards until such time of those standards apply to private companies. We have adopted this exemption from new or revised accounting standards, and therefore, we may not be subject to the same new or revised accounting standards as other public companies that are not “emerging growth companies.” CymaBay Pipeline Overview Our pipeline includes three clinical stage programs. Across this portfolio, a total of 23 clinical studies, including eleven Phase 2 studies, have been completed. http://www.cymabay.com/pipeline.html Showing recovery to levels prior to the bio sector take down. More confidence instilled by the CFO's direct purchase at 1.39 http://www.sec.gov/Archives/edgar/data/1042074/000117911016022848/xslF345X03/edgar.xml
