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 March 10, 2017, furnished hereto. |
March 10, 2017 | Ocera Therapeutics, Inc. | ||
By: | /s/ Linda S. Grais, M.D. | ||
Name: Linda S. Grais, M.D. | |||
Title: President and Chief Executive Officer |
• | 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 |
• | 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 |
• | 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. |
Ocera Therapeutics, Inc. | |||||||||||||||
Condensed Consolidated Statement of Operations | |||||||||||||||
(Unaudited) | |||||||||||||||
(In thousands, except per share data) | |||||||||||||||
Three Months Ended December 31, | Twelve Months Ended 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 | 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 | |||||||||||
6-E7)(XY(YKXP_9'U:72_CK
MH";L+?QW5LX]0T+.!_WT@->U2HU)82<*JVU5SXO%XRA3S:E7PLTU/25GWTU_
M!_(^FOV^O^0+X-_Z^;S_ - CKYB_9O\ A4_QB\;0:5K;N_AS0$-U>R\O+
MN=C7@O[1?PFE^+GP[FT?3-JZQI\@N[$LAR/:OG"__ &$_AI/,7T_6M5M$/\!>
M&4#Z$Q@U[57%86O[U5-2\CXS#99FF!7L\-*,X=$^GY?F=QK/[8WP-TN-FM-3
MN=4<=$MK27)_&41K^M?+OCO]JOXC_%RX/@7X2:-/IRZAF,F(^;?RH>#AE^6%
M<=6!) _B%>^Z+^P_\)-/E675;O4M5VG.R29(D/U$2*W_ (]7TUX0\ >"_ -D
M;#P=H]OI43?>,*8=\?WW.7;_ ($367M\)2UIQ