On August 3, 2016 Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, reported financial results for the quarter ended June 30, 2016, and provided updates on its clinical development programs of OCR-002 for the treatment of hepatic encephalopathy (HE), a debilitating liver disorder and significant burden on the healthcare system (Press release, Ocera Therapeutics, AUG 3, 2016, View Source [SID:1234514257]).
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"We are pleased to report that the enrollment momentum in our STOP-HE study for acute hepatic encephalopathy continues," said Linda Grais, M.D., Chief Executive Officer of Ocera. "We now have approximately 195 patients enrolled to date and remain on track to complete our targeted full enrollment of approximately 230 patients in the fourth quarter of 2016, with top-line results of the study to be reported in the first quarter of 2017. In addition, we reported last quarter that we were preparing to conduct a two-part Phase 1 study with oral OCR-002 in cirrhotic patients, which we plan to initiate in Q3. The goals of the oral Phase 1 study are to determine safety and tolerability and define the pharmacokinetics of the oral formulation in stable cirrhotic patients. We expect to report initial findings from part one of the study, evaluating a single dose of OCR-002, by the end of 2016 and then move into part two to evaluate a multi-dose regimen of oral OCR-002 in this same patient population."
Select Second Quarter Financial Results
As of June 30, 2016, Ocera had cash, cash equivalents and investments of $35.4 million.
Net loss for the three and six months ended June 30, 2016 was $7.1 million and $14.6 million, respectively. Net loss for the three and six months ended June 30, 2015 was $6.2 million and $12.9 million, respectively. Basic and diluted net loss for the three and six months ended June 30, 2016 was $0.33 and $0.69, respectively. Basic and diluted net loss for the three and six months ended June 30, 2015 was $0.31 and $0.65, respectively.
Research and development (R&D) expense for the three months ended June 30, 2016 was $3.9 million, compared to $3.4 million for the same period in 2015. R&D expense for the six months ended June 30, 2016 was $8.7 million, compared to $7.8 million for the same period in 2015. The increase in R&D expense for both the three and six month periods was due primarily to an increase in headcount and related costs.
General and administrative (G&A) expense for three months ended June 30, 2016 was $3.0 million, compared to $2.8 million for the same period in 2015. G&A expense for the six months ended June 30, 2016 was $5.5 million, compared to $5.1 million for the same period in 2015. The increase in G&A expense for the three and six month periods was due primarily to an increase in professional service fees, while the increase in the six month period also included an increase in non-cash stock compensation expense.
Net interest expense of $250,000 and $496,000 for the three and six months ended June 30, 2016, respectively, was primarily attributable to interest and amortization associated with the debt facility which closed in July 2015.
Net cash proceeds generated from the Company’s "at the market" equity facility totaled approximately $3.0 million for the six month period ended June 30, 2016.
Financial Guidance
Ocera updates its previous guidance and expects net use of cash for 2016 to be between $22 million and $26 million, and reiterates its expectation that it will have sufficient cash to fund operations into the fourth quarter of 2017 based on its current operating plan. The decrease from the Company’s last update in expected net use of cash for 2016 at between $26 million and $30 million is due primarily to the deferral of certain external development costs for OCR-002 as well as lower than expected internal operating expenses. If Ocera receives the second $10 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 the first quarter of 2018.