— Patient enrollment progressing in STOP-HE clinical trial of OCR-002; Company expects to complete enrollment in the fourth quarter of 2016 —
— OCR-002 is the only ammonia scavenger in development for both treatment and prevention of hepatic encephalopathy (HE) —
PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 03, 2016 (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, 2015.
“2015 was an eventful year for Ocera marked by considerable advances in our clinical development programs and notable corporate achievements,” said Linda Grais, M.D., Chief Executive Officer of Ocera. “STOP-HE, a Phase 2b clinical trial of OCR-002 in hospitalized patients with acute hepatic encephalopathy (HE) is progressing as planned, with approximately 150 patients enrolled to date. An interim analysis of this trial conducted last year suggested a promising treatment effect. We expect to complete enrollment in the fourth quarter of 2016 with top-line data to be published soon thereafter.”
“Results from our first, oral single-dose trial of three extended-release oral formulations of OCR-002 were highly encouraging with OCR-002 exhibiting robust extended-release patterns and a promising pharmacokinetic (PK) profile relative to a comparable dose of ammonia-lowering agent, glycerol phenylbutyrate (RAVICTI®),” said Stan Bukofzer, M.D., Ocera’s Chief Medical Officer. “Importantly, while RAVICTI® was found in clinical studies to be effective in lowering the incidence of hepatic encephalopathy events, it is no longer being developed in this indication and we believe that OCR-002 now stands alone as the only ammonia scavenger in development for both treatment and prevention of HE.”
Commenting on company financials, Michael Byrnes, Ocera’s Chief Financial Officer, added, “Ocera’s financial position remains strong with $43.3 million in cash, which is expected to fund our operations into the second half of 2017. Importantly, our existing cash is expected to provide sufficient funding beyond critical milestones for both our OCR-002 IV and oral programs. In addition, we further strengthened our financial position in 2015 having secured a $20 million debt facility which, if fully drawn, will extend our cash runway into late 2017.”
OCR-002 IV and Oral Formulations: OCR-002 is in development as both an intravenous formulation as a potential treatment for hospitalized patients with acute HE, and as an oral formulation to potentially provide a chronic use option to maintain remission of HE in patients with liver cirrhosis.
Recent Development Highlights
Corporate and Industry Highlights
Anticipated 2016 Milestones
Fourth Quarter and Full Year 2015 Financial Results
Ocera expects net use of cash for 2016 to be between $26 million to $30 million and expects that it will have sufficient cash to fund operations into the second half of 2017 based on its current operating plan. If Ocera receives the second $10.0 million tranche of its debt facility, which is subject to the achievement of certain financial and clinical milestones, the Company expects that it will have cash to fund its operations into late 2017.
Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate) in both intravenous and oral formulations. 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.
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 patients with hepatic encephalopathy and other indications, the timing of clinical and enrollment milestones, the timing of study data and the company’s financial 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, 2014 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.
|Ocera Therapeutics, Inc.|
|Condensed Consolidated Statement of Operations|
|(In thousands, except per share data)|
|December 31, 2015||December 31, 2014||December 31, 2015||December 31, 2014|
|Research and development||3,927||3,464||15,977||14,945|
|General and administrative||2,861||2,074||10,321||9,910|
|Amortization of intangibles||48||41||171||164|
|Total operating expenses||6,836||5,579||26,469||25,019|
|Loss from operations||(6,812||)||(5,549||)||(26,336||)||(24,678||)|
|Net interest income (expense)||(272||)||11||(413||)||54|
|Net loss from continuing operations||(7,084||)||(5,538||)||(26,749||)||(24,624||)|
|Net income from discontinued operations||8||4||227||1,199|
|Net loss per share from continuing operations-basic and diluted||$||(0.34||)||$||(0.28||)||$||(1.33||)||$||(1.41||)|
|Net income per share from discontinued operations-basic and diluted||–||–||0.01||0.07|
|Net loss per share-basic and diluted||$||(0.34||)||$||(0.28||)||$||(1.32||)||$||(1.34||)|
|Shares used to compute net loss per share-basic and diluted||20,556,822||19,742,245||20,067,660||17,525,187|
|Ocera Therapeutics, Inc.|
|Condensed Consolidated Balance Sheets|
|December 31,||December 31,|
|Cash, cash equivalents and investments||$||43,336||$||51,167|
|Notes payable – Long term||9,508||–|
|Total stockholders’ equity||$||31,394||$||50,145|