DELAWARE | 001-35119 | 63-1192270 | ||
(State or other jurisdiction | (Commission File Number) | (I.R.S. Employer | ||
of | Identification No.) | |||
incorporation) |
525 University Avenue, Suite 610 | ||
Palo Alto, CA | 94301 | |
(Address of principal executive offices) | (Zip Code) |
Exhibit No. | Description | |
99.1 | Press Release of Ocera Therapeutics, Inc. dated November 13, 2014, regarding financial results and other information, furnished hereto. | |
November 13, 2014 | Ocera Therapeutics, Inc. | ||
By: | /s/ Linda S. Grais, M.D. | ||
Name: Linda S. Grais, M.D. | |||
Title: President and Chief Executive Officer |
• | Ocera continued to enroll patients at U.S. sites and began activating sites in Europe in its “STOP-HE” Phase 2b study of OCR-002, or ornithine phenlyacetate. STOP-HE is a placebo-controlled, double-blind trial evaluating the efficacy, safety and pharmacokinetics of intravenously-administered OCR-002 in reducing the severity of hepatic encephalopathy symptoms in hospitalized patients with liver cirrhosis and an acute episode of hepatic encephalopathy. Ocera expects to complete enrollment in mid-2015. This expectation is based on a projection of enrollment in Europe that is comparable to what has been experienced in the U.S. to date. |
• | Enrollment was completed in a Phase 2a investigator-sponsored study in Spain evaluating the effect of OCR-002 on ammonia levels in patients with cirrhosis and upper gastrointestinal bleeding. |
• | Ocera raised $25.2 million in gross proceeds in a public offering of 4.2 million shares of its common stock at $6.00 per share. Ocera intends to use these proceeds to continue clinical development of OCR-002 and for working capital and other general corporate purposes. |
• | Ocera appointed Rajiv Patni, M.D. as chief development officer and appointed Steven James to the Board of Directors as lead independent director. |
• | As of September 30, 2014, Ocera had cash, cash equivalents and investments of $55.6 million. |
• | Net loss for the three and nine months ended September 30, 2014 was $6.6 million and $17.9 million, respectively. Net loss for the three and nine months ended September 30, 2013 was $7.4 million and $10.2 million, respectively. Basic and diluted net loss per share for the three and nine months ended September 30, 2014 was $0.34 and $1.07, respectively. Basic and diluted net loss per share for the three and nine months ended September 30, 2013 was $0.77 and $2.77, respectively. |
• | Revenue for three and nine months ended September 30, 2014 was $0.2 million and $0.3 million, respectively. Revenue for each of the three and nine months ended September 30, 2013 was $33,000. Revenue in all periods consisted of royalty revenue generated from a license agreement acquired in the merger with Tranzyme in July 2013. In addition, the revenue in the 2014 periods consisted of license revenue generated from an asset acquired |
• | Research and development (R&D) expense for three months ended September 30, 2014 was $4.2 million, compared to $1.4 million for the same period in 2013. R&D expense for the nine months ended September 30, 2014 was $11.5 million, compared to $1.8 million for the same period in 2013. The increase in R&D expense for both periods was due primarily to costs associated with Ocera’s clinical development of OCR-002, as well as increases in personnel-related and stock-based compensation expense. |
• | General and administrative (G&A) expense for three months ended September 30, 2014 was $2.7 million, compared to $3.0 million for the same period in 2013. G&A expense for the nine months ended September 30, 2014 was $7.8 million, compared to $5.2 million for the same period in 2013. The decrease in G&A expense for the three month period was due primarily to a decrease in personnel-related costs associated with severance payments issued in the third quarter of 2013, partially offset by an increase in stock-based compensation expense. The increase in G&A expense for the nine-month period was due primarily to an increase in stock-based compensation expense and legal and accounting fees. |
Three-Months Ended September 30, | Nine-Months Ended September 30, | ||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||
Revenue: | |||||||||||||||
Licensing revenue | $ | 200 | $ | — | $ | 200 | $ | — | |||||||
Royalty revenue | 33 | 33 | 111 | 33 | |||||||||||
Total revenue | 233 | 33 | 311 | 33 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 4,189 | 1,351 | 11,481 | 1,785 | |||||||||||
General and administrative | 2,682 | 2,990 | 7,836 | 5,213 | |||||||||||
Amortization of intangibles | 41 | 172 | 123 | 172 | |||||||||||
Impairment of intangibles | — | 1,576 | — | 1,576 | |||||||||||
Total operating expenses | 6,912 | 6,089 | 19,440 | 8,746 | |||||||||||
Loss from operations | (6,679 | ) | (6,056 | ) | (19,129 | ) | (8,713 | ) | |||||||
Net interest income (expense) | 18 | (12 | ) | 43 | (185 | ) | |||||||||
Change in fair value of warrant liability | — | 3 | — | 15 | |||||||||||
Net loss from continuing operations | (6,661 | ) | (6,065 | ) | (19,086 | ) | (8,883 | ) | |||||||
Net income from discontinued operations | 58 | (1,337 | ) | 1,195 | (1,337 | ) | |||||||||
Net loss | $ | (6,603 | ) | $ | (7,402 | ) | $ | (17,891 | ) | $ | (10,220 | ) | |||
Net loss per share from continuing operations- basic and diluted | $ | (0.34 | ) | $ | (0.63 | ) | $ | (1.14 | ) | $ | (2.41 | ) | |||
Net income (loss) per share from discontinued operations- basic and diluted | — | (0.14) | 0.07 | (0.36) | |||||||||||
Net loss per share-basic and diluted | $ | (0.34 | ) | $ | (0.77 | ) | $ | (1.07 | ) | $ | (2.77 | ) | |||
Shares used to compute net loss per share-basic and diluted | 19,330,888 | 9,669,320 | 16,778,047 | 3,683,156 |
September 30, | December 31, | ||||||
2014 | 2013 | ||||||
Cash, cash equivalents and investments | $ | 55,630 | $ | 47,213 | |||
Working capital | 53,423 | 42,605 | |||||
Total assets | 57,687 | 51,820 | |||||
Accumulated deficit | (99,377 | ) | (81,486 | ) | |||
Total stockholders' equity | $ | 54,715 | $ | 45,132 |