Synergy Pharmaceuticals

NEW YORK, 2013-05-09 23:33 CEST (GLOBE NEWSWIRE) --
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 first quarter ended March 31, 2013. Synergy is
developing plecanatide for the treatment of chronic idiopathic constipation
(CIC) and constipation-predominant irritable bowel syndrome (IBS-C). 

Recent Developments

  -- On January 2, 2013, Synergy announced positive results from its large
     multicenter clinical trial of its lead investigational drug plecanatide in
     patients with CIC.
  -- On January 17, 2013, Synergy completed its merger with Callisto
     Pharmaceuticals, Inc.
  -- On March 15, 2013, Synergy announced that the full study results from its
     large multicenter CIC clinical trial would be featured in a late-breaking
     oral presentation session at Digestive Disease Week 2013 in Orlando,
     Florida on Tuesday, May 21, 2013.
  -- On April 16, 2013, Synergy closed a public offering of 16,375,000 shares of
     its common stock at a price of $5.50 per share, less underwriting discounts
     and commissions. The net proceeds to Synergy from this sale was
     approximately $84.4 million, after deducting underwriting discounts and
     commissions and other estimated offering expenses payable by Synergy.
     (Pro-forma Balance Sheets below)

Financial Update

Synergy's cash, cash equivalents and short term available for sale securities
balance as of March 31, 2013 was $21.1 million, as compared to $32.5 million on
December 31, 2012. During the three months ended March 31, 2013 net cash
provided by financing activities was $4.6 million from the controlled equity
sales of its common stock, whereas there was no such financing activity during
the three months ended March 31, 2012. Net cash used in operating activities
during the three months ended March 31, 2013 and 2012 was $15.6 million and
$6.8 million, respectively. 

Net loss for the three months ended March 31, 2013 was $18.7 million or $0.26
per share, as compared to a net loss of $7.0 million, or $0.13 per share, for
the three months ended March 31, 2012. During the three months ended March 31,
2012 non-cash expense items, principally the change in fair value of derivative
instruments and share based compensation expense, totaled $2.4 million, or
$0.03 per share, whereas such items in the three months ended March 31, 2012
totaled $.4 million, or $0.01 per share. 

Synergy had approximately 73.8 million common shares outstanding at March 31,
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 Phase II/III 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 is presently in a Phase I trial in healthy volunteers. More
information is available at http://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)                                                                
                                                                                
                                                      March 31,    December 31, 
                                                        2013           2012     
                                                    ----------------------------
                                                     (unaudited)                
Assets                                                                          
Cash, cash equivalents and short term available for      $21,116         $32,502
 sale securities                                                                
Prepaid expenses and other current assets                  1,573           1,547
                                                    ----------------------------
Total Current Assets                                      22,689          34,049
Other Assets                                                 201           3,356
                                                    ----------------------------
                                                                                
                                                    ----------------------------
Total Assets                                             $22,890         $37,405
                                                    ============================
Liabilities and Stockholders' Equity                                            
Accounts payable                                           5,978           5,255
Accrued expenses                                           3,312           2,060
                                                    ----------------------------
Total Current Liabilities                                  9,290           7,315
Derivative financial instruments – warrants                6,351           5,258
                                                    ----------------------------
Total Liabilities                                         15,641          12,573
Total Stockholders' Equity                                 7,249          24,832
                                                    ----------------------------
                                                                                
                                                    ----------------------------
Total Liabilities and Stockholders' Equity               $22,890         $37,405
                                                    ============================

                                                                                
Condensed Consolidated Statement of Operations                                  
($ in thousands except share and per share data)                                
(unaudited)                                                                     
                                          Three Months ended  Three Months ended
                                              March 31, 2013      March 31, 2012
                                                                                
                                                                                
Revenues                                                $ --                $ --
Costs and Expenses:                                                             
Research and development                              14,344               5,338
General and administrative                             3,278               1,732
                                         ---------------------------------------
Loss from Operations                                (17,622)             (7,070)
Interest and investment income                            18                  39
Change in Fair Value of Financial                    (1,093)                   8
 Instruments                                                                    
                                         ---------------------------------------
                                                                                
Net Loss                                           $(18,697)            $(7,023)
                                         =======================================
                                                                                
Net Loss per common share, basic and                 $(0.26)             $(0.13)
 diluted                                                                        
                                         =======================================
Weighted Average Common Shares                    72,789,006          54,298,079
 Outstanding                                                                    
                                         =======================================

Pro-forma Balance Sheets

The following table sets forth the pro-forma effect on the financial position
of the Company had the April 16, 2013 public offering discussed above taken
place as of March 31, 2013: 



                                                       Effect of                
                                 March 31, 2013   April 16, 2013  March 31, 2013
($000's except share amounts)       As Reported  Public Offering       Pro-forma
                                                                                
                                                                                
Cash, cash equivalents and              $21,116          $84,444        $105,560
 available for sale securities                                                  
Total Assets                             22,890           84,444         107,334
                                                                                
Common Stock                                  8                2              10
Additional paid-in-capital              134,991           84,442         219,433
(Deficit) accumulated during          (127,750)               --       (127,750)
 development stage                                                              
Total stockholder's equity                7,249           84,444          91,693
                                ------------------------------------------------
                                                                                
Total liabilities and                   $22,890          $84,444        $107,334
 stockholder's equity                                                           
                                ================================================
                                                                                
Common Shares Outstanding            73,779,680       16,375,000      90,154,680
                                ================================================




         CONTACT: Investor Contact Information:
         Danielle Spangler
         The Trout Group
         synergy@troutgroup.com
         (646) 378-2924