- On July 17, 2013, Synergy reached the halfway mark for total enrollment in its plecanatide Phase 2b clinical trial in patients with IBS-C. At present, over 726 patients have been screened, and 204 patients have been enrolled in the study. Synergy anticipates completing enrollment in the fourth quarter of 2013 and reporting top line data in the first quarter of 2014.
- On August 5, 2013, Synergy completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding Synergy’s drug plecanatide for the treatment of chronic idiopathic constipation (CIC). Agreement was reached with the FDA on design, duration, size and primary and secondary efficacy endpoints for pivotal phase 3 studies. A pivotal phase 3 program evaluating the safety and efficacy of plecanatide in CIC patients and is expected to be initiated in the fourth quarter of 2013.
Synergy had approximately 90 million common shares outstanding at June 30, 2013.About Synergy Pharmaceuticals Inc.
- Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy's lead proprietary drug candidate plecanatide is a synthetic analog of the human gastrointestinal (GI) hormone uroguanylin, and functions by activating the guanylate cyclase C receptor on epithelial cells of the GI tract. Synergy previously completed a Phase I study of plecanatide in healthy volunteers and a Phase IIa clinical trial in CIC patients. On January 2, 2013, Synergy announced positive results in a large multicenter clinical trial of plecanatide to treat CIC. Plecanatide is also being developed to treat patients with IBS-C. Synergy's second GC-C agonist SP-333 is in clinical development to treat inflammatory bowel diseases, and has completed a Phase I trial in healthy volunteers during the quarter ended June 30, 2013. On July 17, 2013, Synergy reached the halfway mark for total enrollment in its plecanatide Phase 2b clinical trial in patients with IBS-C. On August 5, 2013, Synergy completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding Synergy’s drug plecanatide for the treatment of chronic idiopathic constipation (CIC). More information is available at http://www.synergypharma.com.
|Condensed Consolidated Balance Sheets ($ in thousands)|
|June 30, 2013||December 31, 2012|
|Cash, cash equivalents and short term available for sale securities||$||92,300||$||32,502|
|Prepaid expenses and other current assets||2,349||1,547|
|Total Current Assets||94,649||34,049|
|Liabilities and Stockholders' Equity|
|Total Current Liabilities||7,969||7,315|
|Derivative financial instruments -warrants||973||5,258|
|Total Stockholders' Equity||86,290||24,832|
|Total Liabilities and Stockholders' Equity||$||95,232||$||37,405|
|Condensed Consolidated Statement of Operations|
|($ in thousands except share and per share data)(unaudited)||Three MonthsendedJune 30, 2013||Three MonthsendedJune 30, 2012||Six MonthsendedJune 30, 2013||Six MonthsendedJune 30, 2012|
|Costs and Expenses:|
|Research and development||9,055||7,626||23,399||12,964|
|General and administrative||2,803||1,919||6,081||3,650|
|Loss from Operations||(11,858||)||(9,545||)||(29,480||)||(16,614||)|
|Interest and investment income||16||48||34||86|
|Change in fair value of derivative instruments - warrants||1,803||(1,317||)||710||(1,309||)|
|Net Loss per common share, basic and diluted||$||(0.11||)||$||(0.17||)||$||(0.36||)||$||(0.31||)|
|Weighted Average Common Shares Outstanding||87,482,939||60,416,068||80,176,564||57,357,081|