California | 1-36282 | 33-0361285 |
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
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Emerging growth company o |
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Exhibit No. | Description | |
99.1 | Earnings Press Release dated July 27, 2017. |
La Jolla Pharmaceutical Company | ||
Date: | July 27, 2017 | /s/ Dennis M. Mulroy |
Dennis M. Mulroy | ||
Chief Financial Officer |
• | In February 2017, La Jolla reported positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 in patients with catecholamine resistant hypotension (CRH). The analysis of the primary efficacy endpoint, defined as the percentage of patients achieving a pre-specified target blood pressure response, was highly statistically significant: 23% of the 158 placebo-treated patients had a blood pressure response compared to 70% of the 163 LJPC-501-treated patients (p<0.00001). In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 [hazard ratio=0.78 (0.57-1.07), p=0.12] for LJPC-501-treated patients. In this critically ill patient population: 92% of placebo-treated patients compared to 87% of LJPC-501-treated patients experienced at least one adverse event, and 22% of placebo-treated patients compared to 14% of LJPC-501-treated patients discontinued treatment due to an adverse event. |
• | In May 2017, the results of ATHOS-3 were published by The New England Journal of Medicine in an article entitled “Angiotensin II for the Treatment of Vasodilatory Shock.” |
Three Months Ended June 30, | Six Months Ended June 30 | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Revenue | |||||||||||||||
Contract revenue - related party | $ | — | $ | 253 | $ | — | $ | 487 | |||||||
Total revenue | — | 253 | — | 487 | |||||||||||
Expenses | |||||||||||||||
Research and development | 20,808 | 12,404 | 38,573 | 25,119 | |||||||||||
General and administrative | 6,022 | 3,466 | 11,525 | 7,519 | |||||||||||
Total expenses | 26,830 | 15,870 | 50,098 | 32,638 | |||||||||||
Loss from operations | (26,830 | ) | (15,617 | ) | (50,098 | ) | (32,151 | ) | |||||||
Other income, net | 101 | 51 | 129 | 104 | |||||||||||
Net loss | $ | (26,729 | ) | $ | (15,566 | ) | $ | (49,969 | ) | $ | (32,047 | ) | |||
Basic and diluted net loss per share | $ | (1.21 | ) | $ | (0.90 | ) | $ | (2.46 | ) | $ | (1.86 | ) | |||
Weighted average common shares outstanding - basic and diluted | 22,123 | 17,211 | 20,277 | 17,211 |
June 30, 2017 | December 31, 2016 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 141,317 | $ | 65,726 | |||
Restricted cash | 910 | 200 | |||||
Prepaid expenses and other current assets | 1,775 | 1,505 | |||||
Total current assets | 144,002 | 67,431 | |||||
Property and equipment, net | 4,585 | 3,145 | |||||
Other assets | — | 219 | |||||
Total assets | $ | 148,587 | $ | 70,795 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,920 | $ | 6,652 | |||
Accrued clinical and other expenses | 488 | 1,029 | |||||
Accrued payroll and related expenses | 1,863 | 2,077 | |||||
Total current liabilities | 8,271 | 9,758 | |||||
Shareholders’ equity: | |||||||
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 22,123,456 and 18,261,557 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 2 | 2 | |||||
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at June 30, 2017 and December 31, 2016, and liquidation preference of $3,906 at June 30, 2017 and December 31, 2016 | 3,906 | 3,906 | |||||
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 2,737 shares issued and outstanding at June 30, 2017 and December 31, 2016, and liquidation preference of $2,737 at June 30, 2017 and December 31, 2016 | 2,737 | 2,737 | |||||
Additional paid-in capital | 790,351 | 661,103 | |||||
Accumulated deficit | (656,680 | ) | (606,711 | ) | |||
Total shareholders’ equity | 140,316 | 61,037 | |||||
Total liabilities and shareholders’ equity | $ | 148,587 | $ | 70,795 |