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Due Diligence Report: 73% Run Up in the Last Month Has No Resistance Ahead
CymaBay Therapeutics Inc., incorporated on October 5, 1988, is a biopharmaceutical company. The Company is focused on developing therapies to treat metabolic diseases, including serious rare and orphan disorders. Arhalofenate, the Company’s lead product candidate, is used to treat gout. The Company has completed five Phase II clinical trials of Arhalofenate in patients with gout. The Company’s second product candidate, MBX-8025, is used to treat disorder linked to deficits in lipid storage, handling and utilization, many of which result in metabolic disorders. The Company has completed five Phase I and one Phase II clinical trials of MBX-8025. The Company’s MBX-2982 is a treatment for type 2 diabetes that targets G protein-coupled receptor 119 (GPR119), a receptor that interacts with bioactive lipids known to stimulate glucose-dependent insulin secretion. MBX-2982 has completed four Phase I studies and one Phase II study.
Arhalofenate is an anti-inflammatory uricosuric drug that reduces the risk of gout flares while also lowering sUA (serum uric acid). The arhalofenate portfolio consists of approximately 135 issued patents and 87 pending patent applications relating to composition, method of use or methods of manufacture.
MBX-8025 is a selective agonist for the peroxisome proliferator-activated receptor delta (PPARd). An agonist is a substance that elicits a response by binding to a receptor. The PPARd receptor is a nuclear receptor that regulates genes involved in lipid storage, transport and metabolism (particularly fatty acid oxidation) and in insulin signaling and sensitivity. MBX-8025 is also used to treat a variety of disorders of lipid metabolism and certain diseases of the liver. The MBX-8025 portfolio consists of approximately 273 issued patents and 81 pending patent applications related to composition and method of use.
MBX-2982 is an oral, G-protein coupled receptor (GPR119) agonist being evaluated as a therapeutic agent for patients with T2DM (Type 2 diabetes), with a dual mechanism, including direct effects and indirect effects mediated by gastrointestinal hormones known as incretins on glucose-dependent insulin secretion, as well as beneficial effects on islet health. Type 2 diabetes (T2DM) is a chronic debilitating disease characterized by a progressive loss of the normal control of glucose levels in the blood and other tissues.
CymaBay Therapeutics Inc. has a current market capitalization of $69.92 with 23.45 M outstanding shares. Its daily average volume traded is 0.48 M shares.
Financial Highlights (Q4 2015):
Gross Profit: nil
Net Income: -5.98 M
Cash and Cash Equivalents: 41.48 M
Total Debt: 9.31 M
Recent News and Analysis:
The company recently provided corporate highlights and announced financial results for the quarter and year ended December 31, 2015. “We have made significant progress during the last quarter in advancing the development of our two key clinical assets,” said Harold Van Wart, President and Chief Executive Officer of CymaBay. “Earlier in March, we reported some encouraging top-line data from our pilot Phase 2 study in patients with homozygous familial hypercholesterolemia. Analysis of the data showed that MBX-8025 demonstrated the ability to lower LDL-Cholesterol in a majority of patients, despite raising PCSK9 levels. We are evaluating the feasibility of conducting a second pilot study in combination with a PCSK9 inhibitor to assess whether the reductions in LDL-C can be amplified by neutralizing PCSK9.” “Last quarter, we also initiated a 12 week, placebo-controlled, dose ranging Phase 2 study of MBX-8025 in 75 patients with primary biliary cholangitis,” said Dr. Van Wart. “We have consistently observed reductions in markers of cholestasis in clinical studies in other populations that we hope will be replicated in this study.” “For arhalofenate, our drug candidate for the treatment of gout, we have completed our End-of-Phase 2 discussions with the FDA and now have clear direction as to how to conduct a Phase 3 program that could capture the dual benefits of arhalofenate,” continued Dr. Van Wart. “Our goal is to sign one or more partnerships in order to initiate the Phase 3 program before the end of 2016.”
In March 2016, CymaBay announced results from a pilot Phase 2 clinical study that demonstrated efficacy of MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH, an autosomal genetic disease characterized by loss-of-function mutations in both alleles of the LDL receptor gene. The results showed that MBX-8025 provided a clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) for a subset of patients. A responder analysis showed that 7 subjects (or 58%) exhibited a greater than or equal to 15% decrease in LDL-C, including one patient that was LDL receptor negative. The overall mean change in LDL-C for all subjects was a decrease of 10%. Eight subjects exhibited a decrease in LDL-C with a group mean of 16%, including 3 that showed a greater than or equal to 20% decrease. Mean PCSK9 levels, associated with causing LDL-C to rise, increased significantly during treatment by a mean of 43%. CymaBay is now evaluating the feasibility of conducting a second pilot Phase 2 clinical study to further understand the potential benefits of MBX-8025 in patients with HoFH that are currently being treated with a PCSK9 inhibitor. The Food and Drug Administration (FDA) granted CymaBay orphan drug designation for MBX-8025 to treat HoFH and severe hypertriglyceridemia in 2015.
Taking a glance at where the stock might be directed in the future, on a consensus basis, the sell-side has a one year price target of $5.00 on the stock, this valuation is based on 2 number of opinions. This consensus target price comprises projections from analysts polled by First Call. In order to get a glimpse of Wall Street sentiment, we can look to brokerage analyst estimates. On a one to five ratings scale where 1 refers to a Strong Buy, 2 directs a Buy, 3 a Hold, 4 indicates a Sell and 5 a Strong Sell. CymaBay Therapeutics Inc. (NASDAQ: CBAY) currently has an average brokerage recommendation of 1.00 according to analysts. This is the average number based on the total brokerage firms taken into consideration by Zacks investment research.
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