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Posted On: 03/10/2017 8:34:41 AM
Post# of 22801
$OCRX ...more news....
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 for the quarter and year ended December 31, 2016 .
“2016 was a busy year for Ocera, culminating with the timely completion of
enrollment in the fourth quarter of STOP-HE, a landmark study evaluating
intravenous OCR-002 (ornithine phenylacetate) in patients hospitalized with
acute hepatic encephalopathy (HE),” said Linda Grais , M.D., Chief Executive
Officer of Ocera. “We also advanced our oral program testing orally-administered
OCR-002 in patients with cirrhosis and developing a tablet formulation which is
poised for clinical evaluation in 2017.
“In January 2017 , we reported positive results from our Phase 1 study of
orally-administered OCR-002 in patients with chronic liver cirrhosis. The study
demonstrated robust bioavailability and promising pharmacokinetic and safety
profiles in the intended use population. In addition, we recently announced the
data from STOP-HE, including encouraging results demonstrating that OCR-002 is a
potent ammonia scavenger, that the level of HE severity directly correlates with
the level of ammonia, and that ammonia reduction correlates with clinical
improvement in HE symptoms. Recent analyses support our belief that OCR-002 can
become an important intervention in both the treatment and prevention of HE,”
added Dr. Grais.
Anticipated 2017 Activity
Initiate Phase 2a multi-dose study of oral OCR-002 in cirrhotic patients in H1 2017Meet with the Food and Drug Administration in Q3 2017 regarding STOP-HE with goal of clarifying Phase 3 development plan
Fourth Quarter and Full Year 2016 Financial Results
As of December 31 , 2016, Ocera had cash, cash equivalents and investments of $28.4 million, compared with $43.3 million at December 31, 2015 .
Net use of cash for 2016 was $22.1 million , which was consistent with Ocera’s most recent guidance of the low end of the range of $22.0 to $26.0 million . Net use of cash equals the difference of cash, cash equivalents and investments at December 31, 2016 and 2015, less cash provided by financing activities, consisting of net proceeds of $7.1 million generated by an “At-the-Market” equity program during 2016.
Net loss for the three and twelve months ended December 31, 2016 was $5.2 million and $26.9 million , respectively. Net loss for the three and twelve months ended December 31, 2015 was $7.1 million and $26.5 million , respectively. Basic and diluted net loss per share for the three and twelve months ended December 31, 2016 was $0.22 and $1.22 , respectively. Basic and diluted net loss per share for the three and twelve months ended December 31, 2015 was $0.34 and $1.32 , respectively.
Revenue for the three and twelve months ended December 31, 2016 was $512,000 and $609,000 , respectively. Revenue for the three and twelve months ended December 31, 2015 was $24,000 and $133,000 , respectively. Revenue in all periods consisted of royalty and licensing revenue generated from certain clinical-stage assets acquired in connection with the 2013 reverse merger between Ocera and Tranzyme, Inc.
Research and development (R&D) expense for the three and twelve months ended December 31, 2016 was $3.2 million and $16.1 million , respectively. R&D expense for the three and twelve months ended December 31, 2015 was $3.9 million and $16.0 million , respectively. The decrease in R&D expense for the three-month period was due primarily to a decrease in external development expenses, partially offset by personnel and related expenses.
General and administrative (G&A) expense for the three and twelve months ended December 31, 2016 was $2.2 million and $10.4 million , respectively. G&A expense for the three and twelve months ended December 31, 2015 was $2.9 million and $10.3 million , respectively. The decrease in G&A expense for the three-month period was due primarily to lower personnel and related expenses.
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 for the quarter and year ended December 31, 2016 .
“2016 was a busy year for Ocera, culminating with the timely completion of
enrollment in the fourth quarter of STOP-HE, a landmark study evaluating
intravenous OCR-002 (ornithine phenylacetate) in patients hospitalized with
acute hepatic encephalopathy (HE),” said Linda Grais , M.D., Chief Executive
Officer of Ocera. “We also advanced our oral program testing orally-administered
OCR-002 in patients with cirrhosis and developing a tablet formulation which is
poised for clinical evaluation in 2017.
“In January 2017 , we reported positive results from our Phase 1 study of
orally-administered OCR-002 in patients with chronic liver cirrhosis. The study
demonstrated robust bioavailability and promising pharmacokinetic and safety
profiles in the intended use population. In addition, we recently announced the
data from STOP-HE, including encouraging results demonstrating that OCR-002 is a
potent ammonia scavenger, that the level of HE severity directly correlates with
the level of ammonia, and that ammonia reduction correlates with clinical
improvement in HE symptoms. Recent analyses support our belief that OCR-002 can
become an important intervention in both the treatment and prevention of HE,”
added Dr. Grais.
Anticipated 2017 Activity
Initiate Phase 2a multi-dose study of oral OCR-002 in cirrhotic patients in H1 2017Meet with the Food and Drug Administration in Q3 2017 regarding STOP-HE with goal of clarifying Phase 3 development plan
Fourth Quarter and Full Year 2016 Financial Results
As of December 31 , 2016, Ocera had cash, cash equivalents and investments of $28.4 million, compared with $43.3 million at December 31, 2015 .
Net use of cash for 2016 was $22.1 million , which was consistent with Ocera’s most recent guidance of the low end of the range of $22.0 to $26.0 million . Net use of cash equals the difference of cash, cash equivalents and investments at December 31, 2016 and 2015, less cash provided by financing activities, consisting of net proceeds of $7.1 million generated by an “At-the-Market” equity program during 2016.
Net loss for the three and twelve months ended December 31, 2016 was $5.2 million and $26.9 million , respectively. Net loss for the three and twelve months ended December 31, 2015 was $7.1 million and $26.5 million , respectively. Basic and diluted net loss per share for the three and twelve months ended December 31, 2016 was $0.22 and $1.22 , respectively. Basic and diluted net loss per share for the three and twelve months ended December 31, 2015 was $0.34 and $1.32 , respectively.
Revenue for the three and twelve months ended December 31, 2016 was $512,000 and $609,000 , respectively. Revenue for the three and twelve months ended December 31, 2015 was $24,000 and $133,000 , respectively. Revenue in all periods consisted of royalty and licensing revenue generated from certain clinical-stage assets acquired in connection with the 2013 reverse merger between Ocera and Tranzyme, Inc.
Research and development (R&D) expense for the three and twelve months ended December 31, 2016 was $3.2 million and $16.1 million , respectively. R&D expense for the three and twelve months ended December 31, 2015 was $3.9 million and $16.0 million , respectively. The decrease in R&D expense for the three-month period was due primarily to a decrease in external development expenses, partially offset by personnel and related expenses.
General and administrative (G&A) expense for the three and twelve months ended December 31, 2016 was $2.2 million and $10.4 million , respectively. G&A expense for the three and twelve months ended December 31, 2015 was $2.9 million and $10.3 million , respectively. The decrease in G&A expense for the three-month period was due primarily to lower personnel and related expenses.
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