Synergy Pharmaceuticals Inc. (Nasdaq: SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, today reported its financial results and business update for the third quarter ended September 30, 2013.
- 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's cash, cash equivalents and available-for-sale securities balance as of September 30, 2013 was $82.1 million, as compared to $32.5 million on December 31, 2012. During the nine months ended September 30, 2013, net cash provided by financing activities was $89.2 million resulting from its controlled equity sales of its common stock and underwritten public offering, as compared to $48.2 million during the nine months ended September 30, 2012. Net cash used in operating activities during the nine months ended September 30, 2013 and 2012 was $38.7 million and $23.1 million, respectively. Net loss for the nine months ended September 30, 2013 was $42.3 million or $0.51 per share, as compared to a net loss of $27.5 million, or $0.46 per share, for the nine months ended September 30, 2012.Net loss for the quarter ended September 30, 2013 was $13.5 million or $0.15 per share, as compared to a net loss of $9.9 million, or $0.15 per share, for the quarter ended September 30, 2012. During the quarter ended September 30, 2013, non-cash expense items, principally the change in fair value of derivative instruments and stock based compensation expense, totaled $1 million, or $0.01 per share, whereas such items in the three months ended September 30, 2012 totaled $0.4 million, or $0.01 per share.