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 second quarter ended June 30, 2013. Synergy is developing plecanatide for the treatment of chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome (IBS-C).
- 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's cash, cash equivalents and available-for-sale securities balance as of June 30, 2013 was $92.3 million, as compared to $32.5 million on December 31, 2012. During the six months ended June 30, 2013, net cash provided by financing activities was $89.2 million resulting from its controlled equity sales of its common stock and registered direct offering, as compared to $48.4 million during the six months ended June 30, 2012. Net cash used in operating activities during the six months ended June 30, 2013 and 2012 was $28.6 million and $13.8 million, respectively. Net loss for the six months ended June 30, 2013 was $28.7 million or $0.36 per share, as compared to a net loss of $17.6 million, or $0.31 per share, for the six months ended June 30, 2012.Net loss for the quarter ended June 30, 2013 was $10 million or $0.11 per share, as compared to a net loss of $10.6 million, or $0.17 per share, for the quarter ended June 30, 2012. During the quarter ended June 30, 2013, non-cash expense items, principally the change in fair value of derivative instruments and stock based compensation expense, totaled a net gain of $0.9 million, or a net gain of $0.01 per share, whereas such items in the three months ended June 30, 2012 totaled a net loss of $1.7 million, or a net loss of $0.03 per share.