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Posted On: 03/10/2017 8:38:42 AM
Post# of 23063
$OCRX,
Ocera Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
2 hours 37 minutes ago - DJNF
Ocera Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 10, 2017 (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 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 2017
-- Meet 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.
Financial Guidance
Ocera anticipates it will have sufficient cash to fund operations into the second quarter of 2018 based on its current operating plan and re-prioritization of certain development activities.
About Ocera
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.
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 patients with hepatic encephalopathy, the timing of our planned meeting with the FDA, our ability to identify a development path forward for OCR-002, whether any future studies of OCR-002 we may conduct will demonstrate similar results to our Phase 2b study, the timing of our planned Phase 2a study of the oral formulation of OCR-002 in cirrhotic patients, the timing and nature of our future clinical development plans, 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 the risk that we may need to conduct one or more additional studies in light of the fact our Phase 2b trial did not meet its clinical endpoints, including related cost and timing issues associated with future studies, if any, our ability to raise sufficient capital or consummate other strategic transactions to enable the continued development of OCR-002 and 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, 2015 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.
Susan Sharpe
Ocera Therapeutics, Inc.
contact@ocerainc.com
919-328-1109
Ocera
Therapeutics,
Inc.
Condensed
Consolidated
Statement of
Operations
(Unaudited)
(In thousands,
except per share
data)
Three Months Ended Twelve Months Ended
December 31, December 31,
2016 2015 2016 2015
Revenues:
Royalty and
licensing
revenues $ 512 $ 24 $ 609 $ 133
Operating
expenses:
Research and
development 3,186 3,927 16,125 15,977
General and
administrative 2,222 2,861 10,364 10,321
Amortization of
intangibles - 48 - 171
Total operating
expenses 5,408 6,836 26,489 26,469
Loss from
operations (4,896) (6,812) (25,880) (26,336)
Net interest
income
(expense) (257) (272) (1,015) (413)
Net loss from
continuing
operations (5,153) (7,084) (26,895) (26,749)
Net income from
discontinued
operations - 8 - 227
Net loss $ (5,153) $ (7,076) $ (26,895) $ (26,522)
Net loss per
share from
continuing
operations,
basic and
diluted $ (0.22) $ (0.34) $ (1.22) $ (1.33)
Net income per
share from
discontinued
operations,
basic and
diluted - - - 0.01
Net loss per
share, basic and
diluted $ (0.22) $ (0.34) $ (1.22) $ (1.32)
Shares used to
compute net loss
per share, basic
and diluted 23,223,569 20,556,822 21,957,917 20,067,660
Ocera
Therapeutics,
Inc.
Condensed
Consolidated
Balance Sheets
(Unaudited)
(In thousands)
December 31, December 31,
2016 2015
Cash, cash
equivalents and
marketable
securities $ 28,360 $ 43,336
Working capital,
excluding notes
payable 24,890 40,188
Total assets 29,639 44,737
Notes payable 9,703 9,508
Accumulated
deficit (158,328) (131,433)
Total
stockholders'
equity $ 15,737 $ 31,394
(MORE TO FOLLOW) Dow Jones Newswires
March 10, 2017 06:00 ET (11:00 GMT)
Ocera Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
2 hours 37 minutes ago - DJNF
Ocera Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 10, 2017 (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 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 2017
-- Meet 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.
Financial Guidance
Ocera anticipates it will have sufficient cash to fund operations into the second quarter of 2018 based on its current operating plan and re-prioritization of certain development activities.
About Ocera
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.
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 patients with hepatic encephalopathy, the timing of our planned meeting with the FDA, our ability to identify a development path forward for OCR-002, whether any future studies of OCR-002 we may conduct will demonstrate similar results to our Phase 2b study, the timing of our planned Phase 2a study of the oral formulation of OCR-002 in cirrhotic patients, the timing and nature of our future clinical development plans, 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 the risk that we may need to conduct one or more additional studies in light of the fact our Phase 2b trial did not meet its clinical endpoints, including related cost and timing issues associated with future studies, if any, our ability to raise sufficient capital or consummate other strategic transactions to enable the continued development of OCR-002 and 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, 2015 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.
Susan Sharpe
Ocera Therapeutics, Inc.
contact@ocerainc.com
919-328-1109
Ocera
Therapeutics,
Inc.
Condensed
Consolidated
Statement of
Operations
(Unaudited)
(In thousands,
except per share
data)
Three Months Ended Twelve Months Ended
December 31, December 31,
2016 2015 2016 2015
Revenues:
Royalty and
licensing
revenues $ 512 $ 24 $ 609 $ 133
Operating
expenses:
Research and
development 3,186 3,927 16,125 15,977
General and
administrative 2,222 2,861 10,364 10,321
Amortization of
intangibles - 48 - 171
Total operating
expenses 5,408 6,836 26,489 26,469
Loss from
operations (4,896) (6,812) (25,880) (26,336)
Net interest
income
(expense) (257) (272) (1,015) (413)
Net loss from
continuing
operations (5,153) (7,084) (26,895) (26,749)
Net income from
discontinued
operations - 8 - 227
Net loss $ (5,153) $ (7,076) $ (26,895) $ (26,522)
Net loss per
share from
continuing
operations,
basic and
diluted $ (0.22) $ (0.34) $ (1.22) $ (1.33)
Net income per
share from
discontinued
operations,
basic and
diluted - - - 0.01
Net loss per
share, basic and
diluted $ (0.22) $ (0.34) $ (1.22) $ (1.32)
Shares used to
compute net loss
per share, basic
and diluted 23,223,569 20,556,822 21,957,917 20,067,660
Ocera
Therapeutics,
Inc.
Condensed
Consolidated
Balance Sheets
(Unaudited)
(In thousands)
December 31, December 31,
2016 2015
Cash, cash
equivalents and
marketable
securities $ 28,360 $ 43,336
Working capital,
excluding notes
payable 24,890 40,188
Total assets 29,639 44,737
Notes payable 9,703 9,508
Accumulated
deficit (158,328) (131,433)
Total
stockholders'
equity $ 15,737 $ 31,394
(MORE TO FOLLOW) Dow Jones Newswires
March 10, 2017 06:00 ET (11:00 GMT)
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I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
