By a News Reporter-Staff News Editor at Clinical Trials Week -- Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal diseases and disorders, reported its financial results and business update for the first quarter ended March 31, 2014. Synergy is developing plecanatide for the treatment of both chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), plus SP-333 for opioid-induced constipation (OIC). Recent Developments On April 30, 2014, Synergy announced positive top-line results from a phase 2b dose-ranging study assessing plecanatide's safety and efficacy in 424 patients with IBS-C. The primary objective of this trial was to determine an effective, safe and well tolerated dose for plecanatide phase 3 trials with IBS-C patients. Preliminary analysis of the data indicates plecanatide 1.0, 3.0 and 9.0 mg doses demonstrated statistically significant improvement in complete spontaneous bowel movement (CSBM) frequency - the study's primary endpoint - and was safe and well tolerated at all doses. Notably, patients taking the plecanatide 3.0 mg dose consistently experienced statistically significant improvement in important secondary endpoints such as change from baseline versus placebo in worst abdominal pain and the FDA overall responder endpoint for IBS-C over the 12-week treatment. Patients in the plecanatide 3.0 mg dose group also experienced a less than 10% diarrhea rate. Once full analysis of the data is complete, Synergy plans to present complete results of the trial at an appropriate scientific conference this fall. The company intends to initiate pivotal phase 3 trials with IBS-C patients in the second half of 2014 (see also Pharmaceutical Companies).
From January 1, 2014 through February 27, 2014, Synergy sold 3,644,143 shares of common stock in the open market for gross proceeds of approximately $21.2 million, at an average selling price of $5.82 per share. This completed the Company's original $30 million of proposed sales of common stock pursuant to the June 21, 2012 Controlled Equity Offering Sales Agreement, or ATM facility, with Cantor Fitzgerald & Co.(Cantor).
On March 5, 2014, Synergy entered into Amendment No. 1 to its Controlled Equity Offering Sales Agreement with Cantor (the Amendment), pursuant to which the Company may offer and sell additional shares of its common stock, up to an additional aggregate offering price of $50.0 million. From March 5, 2014 through March 31, 2014, Synergy sold 228,249 shares of common stock, for gross proceeds of $1.4 million, at an average selling price of $6.08 per share, under the Amendment. As of May 9, 2014 Synergy had $48.6 million available unsold under this ATM facility.
"We are pleased to report that the $22.6 million raised through our ATM facility with Cantor during the quarter, at favorable per share pricing, has strengthened our balance sheet considerably, as we now prepare to successfully execute on our Phase 3 IBS-C clinical program." said Bernard Denoyer, Senior Vice President, Finance.
Synergy's cash, cash equivalents and available-for-sale securities balance as of March 31, 2014 was $70.6 million as compared to $68.1 million on December 31, 2013. During the three months ended March 31, 2014, net cash provided by financing activities was $22.0 million, as compared to $4.6 million during the three months ended March 31, 2013. Net cash used in operating activities was $19.9 million during the three months ended March 31, 2014, as compared to $15.6 million during the three months ended March 31, 2013.
Net loss for the three months ended March 31, 2014 was $16.2 million or $0.18 per share, as compared to a net loss of $18.7 million, or $0.26 per share, for the quarter ended March 31, 2013. During the three months ended March 31, 2014, non-cash expense items, principally a change in fair value of derivative instruments and stock based compensation expense, totaled approximately $1 million or $0.01 per share, whereas such items in the three months ended March 31, 2013 totaled $2.4 million, or $0.03 per share.
Keywords for this news article include: Pharmaceutical Companies, Synergy Pharmaceuticals Inc, Gastroenterology, Investment and Finance, Clinical Trials and Studies.
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