- On August 5, 2013, Synergy announced the results of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) covering its lead guanylate cyclase-C (GC-C) agonist, plecanatide, for the treatment of chronic idiopathic constipation (CIC). At that meeting, agreement was reached with the FDA on design, duration, size and primary and secondary endpoints for the plecanatide pivotal phase 3 program, confirming safety and efficacy in CIC patients. Synergy plans to initiate the first phase 3 trial in the fourth quarter of 2013.
- On August 8, 2013, Synergy’s subsidiary, ContraVir Pharmaceuticals, Inc. filed a Form 10 registration statement with the U.S. Securities and Exchange Commission, for a planned spin-off of ContraVir to the Synergy common stock holders. ContraVir holds the rights to FV-100 , a drug being developed to treat shingles.
- On October 31, 2013, Synergy initiated a phase 2 study of SP-333, its second-generation GC-C agonist and once daily oral drug, in patients with Opioid-Induced Constipation.
Synergy had approximately 90 million common shares issued and outstanding at September 30, 2013.About Synergy Pharmaceuticals Inc. Synergy Pharmaceuticals is a biopharmaceutical company focused on the development of new drugs to treat patients with gastrointestinal (GI) diseases and disorders. Synergy is developing proprietary analogs of uroguanylin, a naturally occurring GI hormone and physiological agonist of the human GC-C receptor. Synergy’s lead GC-C agonist, plecanatide, and second-generation GC-C agonist, SP-333, mimic uroguanylin’s natural functions by activating GC-C receptors in the GI tract, promoting intestinal fluid secretion and other digestive responses. Plecanatide has been validated in a phase 2b study evaluating safety and efficacy in CIC patients and Synergy plans to initiate the pivotal phase 3 CIC program in the fourth quarter of 2013. Synergy is also developing plecanatide for irritable bowel syndrome with constipation (IBS-C) and plans to announce topline data from its ongoing phase 2b IBS-C trial in the first quarter of 2014. Synergy’s second GC-C agonist, SP-333, is in clinical development to treat opioid-induced constipation (OIC) and ulcerative colitis (UC). SP-333 has successfully completed phase 1 single and multiple ascending dose studies in healthy volunteers and is currently in a phase 2 clinical trial for OIC. More information is available at www.synergypharma.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy's Form 10-K for the year ended December 31, 2012 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
|Condensed Consolidated Balance Sheets ($ in thousands)|
|September 30, 2013||December 31, 2012|
|Cash, cash equivalents and short term availablefor sale securities||$||82,105||$||32,502|
|Prepaid expenses and other current assets||5,244||1,547|
|Total Current Assets||87,349||34,049|
|Liabilities and Stockholders' Equity|
|Total Current Liabilities||13,167||7,315|
|Derivative financial instruments -warrants||1,050||5,258|
|Total Stockholders' Equity||73,843||24,832|
|Total Liabilities and Stockholders' Equity||$||88,060||$||37,405|
|Condensed ConsolidatedStatement of Operations|
|($ in thousands except share andper share data) (unaudited)||Three Months ended September 30, 2013||Three Months ended September 30, 2012||Nine MonthsendedSeptember 30,2013||Nine Months endedSeptember 30,2012|
|Costs and Expenses:|
|Research and development||10,782||8,246||34,181||21,210|
|General and administrative||2,692||1,843||8,773||5,493|
|Loss from Operations||(13,474)||(10,089)||(42,954)||(26,703)|
|Interest and investment income||14||63||48||150|
|Change in fair value of derivativeinstruments - warrants||(77)||140||633||(1,169)|
|Net Loss per common share,basic and diluted||$||(0.15)||$||(0.15)||$||(0.51)||$||(0.46)|
|Weighted Average CommonShares Outstanding||90,182,115||65,806,178||83,548,398||60,194,004|