Ocera Therapeutics, Inc.
Mar 11, 2015

Ocera Reports Fourth Quarter and Full Year 2014 Financial Results

Conference Call Today at 4:30 p.m. ET

PALO ALTO, Calif., March 11, 2015 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced updates to its clinical development programs and reported financial results and other business highlights for the quarter and year ended December 31, 2014.

"2014 was a transformational year for Ocera," said Linda Grais, M.D., chief executive officer of Ocera. "We completed a $25 million gross financing, strengthened our management team and Board of Directors, initiated enrollment in our "STOP-HE" Phase 2b trial of OCR-002 in patients with acute hepatic encephalopathy, a rare, progressive and episodic disorder that can be life-threatening to those affected, and advanced development of our oral formulation of OCR-002 to allow us to initiate a Phase 1 clinical trial later this year.

"We are nearing full capacity in our STOP-HE study with 94 sites activated across North America and Europe. We believe that we are on-track to complete enrollment by approximately the end of 2015, assuming that enrollment outside of the U.S. progresses at a rate that is comparable to enrollment in the U.S. We will update this projection after a planned interim analysis, which we now expect will occur by the end of the first quarter of 2015. With $51.2 million in capital at the end of 2014, we are well positioned to fund our operations through a number of significant milestones anticipated in 2015, bringing us closer to achieving our mission of helping people with acute and chronic orphan liver diseases, for whom treatment options are limited."

Recent Highlights

Anticipated 2015 Milestones

Ocera expects to achieve several clinical milestones in 2015, including:

Ocera Fourth Quarter and Full Year 2014 Financial Results

On July 15, 2013, Ocera Therapeutics, Inc., a private company (Private Ocera), consummated a reverse merger with Tranzyme, Inc. (Tranzyme). The resulting public entity became Ocera Therapeutics, Inc. (Ocera). As Private Ocera was the accounting acquirer, Ocera's financial statements with respect to periods prior to the closing of the merger reflect only the financial statements of Private Ocera.

Upon the restructuring of Tranzyme Pharma Inc., the Canadian subsidiary of Tranzyme prior to the merger, and disposal of related assets, the operations and cash flows of this component were eliminated from ongoing operations of Ocera. As a result, Ocera has classified the results of operations of Tranzyme Pharma Inc., related restructuring costs, assets and liabilities as discontinued operations.

Financial Guidance

Ocera expects net use of cash for 2015 to be between $28.0 million and $32.0 million. Ocera expects that it will have sufficient cash to fund operations to late 2016 based on its current operating plan.

Conference Call

Ocera will host a conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) today to discuss its financial results and provide an update on its business. To access the conference call via the Internet, go to http://ir.ocerainc.com/. To access the live conference call via phone, dial 877-317-6789. International callers may access the live call by dialing 412-317-6789. The reference name to enter the call is "Ocera Therapeutics, Inc.".

The replay of the conference call may be accessed later today after 8:00 p.m. Eastern Time (5:00 p.m. Pacific Time) via the Internet, at http://ir.ocerainc.com/, or via phone at 877-344-7529 for domestic callers, or 412-317-0088 for international callers. The replay will be available for approximately 90 days. The reference number to enter the replay of the call is 10061684.

About Ocera

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate). OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy in patients with acute liver failure and acute-on-chronic liver disease. For additional information, please see www.ocerainc.com.

Forward-Looking Statements

This press release contains "forward-looking" statements, including, without limitation, all statements related to the OCR-002 clinical development program, including but not limited to the potential benefits of OCR-002 to help people with acute and chronic orphan liver diseases, expected timing of the completion of enrollment of its "STOP-HE" study, the expected timing of release of clinical data and other developmental milestones, as well as cash projections. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believe," "expected," "hope," "plan," "potential," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera's current expectations. Forward-looking statements involve risks and uncertainties and Ocera's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including those risks and uncertainties discussed under the heading "Risk Factors" in Ocera's Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.

Ocera Therapeutics, Inc.        
Condensed Consolidated Statement of Operations        
(Unaudited)        
(In thousands, except per share data)        
     
 Three-Months EndedYear-Ended
 December 31, 2014December 31, 2013December 31, 2014December 31, 2013
Revenue:        
Licensing revenue  $ --  $ --  $ 200  $ --
Royalty revenue  30  52  141  85
Total revenue  30  52  341  85
Operating expenses:        
Research and development  3,464  1,764  14,945  3,549
General and administrative  2,074  3,287  9,910  8,500
Amortization of intangibles  41  123  164  295
Impairment of intangibles  --  1,494  --  3,070
Total operating expenses  5,579  6,668  25,019  15,414
Loss from operations  (5,549)  (6,616)  (24,678)  (15,329)
Net interest income (expense)  11  10  54  (175)
Change in fair value of warrant liability  --  --  --  15
Net loss from continuing operations  (5,538)  (6,606)  (24,624)  (15,489)
Net income (loss) from discontinued operations  4  (688)  1,199  (2,025)
Net loss  $ (5,534)  $ (7,294)  $ (23,425)  $ (17,514)
         
Net loss per share from continuing operations-basic and diluted  $ (0.28)  $ (0.48)  $ (1.41)  $ (2.52)
Net income (loss) per share from discontinued operations-basic and diluted  --  (0.06)  0.07  (0.33)
Net loss per share-basic and diluted  $ (0.28)  $ (0.54)  $ (1.34)  $ (2.85)
Shares used to compute net loss per share-basic and diluted 19,742,245  13,632,204 17,525,187 6,145,731
         
         
Ocera Therapeutics, Inc.        
Condensed Consolidated Balance Sheets        
(Unaudited)        
(In thousands)        
         
 December 31,December 31,    
 20142013    
         
Cash, cash equivalents and investments  $ 51,167  $ 47,213    
Working capital  45,364  42,605    
Total assets  53,052  51,820    
Accumulated deficit  (104,911)  (81,486)    
Total stockholders' equity  $ 50,145  $ 45,132    
CONTACT: Susan Sharpe

         Ocera Therapeutics, Inc.

         Contact@ocerainc.com

         919-328-1109