- The Company announced plans to initiate a second Phase 2 study of MBX-8025 in PBC by year-end 2016. This decision was made following final analysis of data from a prior Phase 2 study in PBC and with input from the FDA.
- MBX-8025 was granted PRI ority ME dicines (PRIME) designation by the European Medicines Agency (EMA) for the treatment of PBC in patients who do not tolerate or respond to combination UDCA/obeticholic acid treatment.
- The FDA granted Orphan Drug Designation for MBX-8025 in PBC. MBX-8025 also has Orphan Drug Designation for homozygous familial hypercholesterolemia (HoFH) and hyperlipoproteinemia types I or V (Fredrickson classification). Among other benefits, the designation qualifies CymaBay for a potential seven year marketing exclusivity period upon approval for each indication, as well as exemption of FDA application fees and tax credits for qualified clinical trials.
- Two abstracts describing studies with MBX-8025 have been selected for oral presentations at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 11-15
- " A Phase 2 Proof-of-Concept Study of MBX-8025 in Patients with Primary Biliary Cholangitis (PBC) who are Inadequate Responders to Ursodeoxycholic acid (UDCA)" will be presented in a late-breaking session on November 15 by Professor David Jones, Professor of Liver Immunology, Institute of Cellular Medicine, Newcastle University in the U.K.
- " PPAR- d Agonist MBX-8025 Abolishes Lipotoxicity and Reverses NASH in Diabetic Obese Mice." will be presented on November 14 by Fahrettin Haczeyni from the Liver Research Group, the Australian National University Medical School, Canberra, Australia
- The U.S. Patent & Trademark Office (USPTO) issued two new patents providing coverage on MBX-8025 through at least 2035 for methods of treating PBC as well as for treating NAFLD and NASH.
- CymaBay has completed End-of-Phase 2 discussions with the FDA and reached agreement on all of the key elements of the planned Phase 3 program, including the co-primary endpoints of sUA responder rate and prevention of flare.
- Discussions are ongoing with potential partners with the goal of signing one or more partnership agreements that would support Phase 3 development of arhalofenate in 2017.
- Cash, cash equivalents and short-term investments as of September 30, 2016, were $23.1 million, compared to $41.5 million at December 31, 2015.
- Research and development expense for the three months ended September 30, 2016, was $3.5 million compared to $4.5 million for the prior year period.
- General and administrative expense for the three months ended September 30, 2016, was $2.1 million compared to $2.2 million for the prior year period.
- Net loss for the three months ended September 30, 2016, was $5.9 million, or ($0.25) per diluted share, compared to $5.9 million, or ($0.27) per diluted share for the prior year period.
- Research and development expense for the nine months ended September 30, 2016, was $12.1 million compared to $13.0 million for the prior year period.
- General and administrative expense for the nine months ended September 30, 2016, was $6.8 million compared to $7.1 million for the prior year period.
- Net loss for the nine months ended September 30, 2016, was $19.7 million, or ($0.84) per diluted share, compared to $9.6 million, or ($0.58) per diluted share for the prior year period. The increase in net loss for the nine months ended September 30, 2016 as compared to the prior year period was largely due to a decrease in non-cash gains of $10.9 million, from the mark-to-market valuation of the company's warrant liability.
|CymaBay Therapeutics, Inc.|
|(In thousands, except share and per share information)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||3,534||$||4,528||$||12,093||$||12,975|
|General and administrative||2,130||2,201||6,806||7,075|
|Total operating expenses||5,664||6,729||18,899||20,050|
|Loss from operations||(5,664||)||(6,729||)||(18,899||)||(20,050||)|
|Other income (expense):|
|Other income (expense), net||81||1,083||43||10,985|
|Basic net loss per common share||$||(0.25||)||$||(0.27||)||$||(0.84||)||$||(0.55||)|
|Diluted net loss per common share||$||(0.25||)||$||(0.27||)||$||(0.84||)||$||(0.58||)|
|Weighted average common shares outstanding used to calculate basic net loss per common share||23,447,003||21,674,742||23,447,003||17,368,309|
|Weighted average common shares outstanding used to calculate diluted net loss per common share||23,447,003||21,674,742||23,447,003||17,384,000|
|CymaBay Therapeutics, Inc.|
|Balance Sheet Data|
|(In thousands, except share and per share amounts)|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||23,134||$||41,480|
|Common stock and additional paid-in capital||426,221||424,424|
|Total stockholders' equity||10,212||28,115|
Contacts:Sujal ShahCymaBay Therapeutics, Inc.(510) email@example.comHans VitzthumLifeSci Advisors, LLC212-915-2568Hans@LifeSciAdvisors.com