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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Exhibit No. | Description | |
99.1 | Earnings Press Release dated March 16, 2015. |
LA JOLLA PHARMACEUTICAL COMPANY | |||
Date: | March 18, 2015 | By: | /s/ George F. Tidmarsh |
Name: | George F. Tidmarsh, M.D., Ph.D. | ||
Title: | President and Chief Executive Officer |
• | In February 2015, La Jolla reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for its planned Phase 3 clinical trial of LJPC-501, La Jolla’s propriety formulation of angiotensin II, for the treatment of catecholamine-resistant hypotension (CRH), in which the agreed-upon primary efficacy endpoint will be increase in blood pressure. |
• | In December 2014, La Jolla entered into an exclusive worldwide license agreement with the George Washington University for intellectual property rights covering the use of angiotensin II (LJPC-501) for the therapeutic treatment of patients with hypotension and shock. |
• | In November 2014, La Jolla presented positive results from its randomized, placebo-controlled, Phase 2 clinical trial of GCS-100, La Jolla’s first-in-class galectin-3 inhibitor, in advanced chronic kidney disease (CKD) patients, in which GCS-100 met its primary efficacy endpoint of a statistically significant improvement in kidney function, at the American Society of Nephrology’s Kidney Week Annual Meeting. |
• | In October 2014, La Jolla presented positive data from a preclinical study of LJPC-501 for the treatment of CRH. |
• | In the first quarter of 2015, La Jolla plans to initiate a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial of LJPC-501 in CRH, in accordance with its recently obtained SPA. |
• | In the first quarter of 2015, La Jolla plans to initiate a multicenter, randomized, double-blind, placebo-controlled, Phase 2b clinical trial of GCS-100 in diabetic patients with Stage 3b or 4 CKD. |
• | In the second quarter of 2015, La Jolla plans to file an Investigational New Drug Application (IND) with the FDA and initiate a Phase 1 clinical trial of LJPC-1010, La Jolla’s second-generation galectin-3 inhibitor. |
• | In the second half of 2015, La Jolla plans to file an IND with the FDA and initiate a Phase 1 clinical trial of LJPC-401, La Jolla’s novel formulation of hepcidin. |
Three Months Ended December 31, (unaudited) | Year Ended December 31, | ||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||
Expenses: | |||||||||||||||
Research and development | $ | 3,726 | $ | 2,059 | $ | 9,944 | $ | 4,362 | |||||||
General and administrative | 3,137 | 4,339 | 11,396 | 13,579 | |||||||||||
Total expenses | 6,863 | 6,398 | 21,340 | 17,941 | |||||||||||
Loss from operations | (6,863 | ) | (6,398 | ) | (21,340 | ) | (17,941 | ) | |||||||
Other income, net | 14 | 1 | 27 | 6 | |||||||||||
Net loss and comprehensive loss | (6,849 | ) | (6,397 | ) | (21,313 | ) | (17,935 | ) | |||||||
Convertible preferred stock dividends earned | — | — | — | (801 | ) | ||||||||||
Net loss attributable to common shareholders | $ | (6,849 | ) | $ | (6,397 | ) | $ | (21,313 | ) | $ | (18,736 | ) | |||
Basic and diluted net loss per share | $ | (0.45 | ) | $ | (1.45 | ) | $ | (2.00 | ) | $ | (12.16 | ) | |||
Shares used in computing basic and diluted net loss per share | 15,226 | 4,397 | 10,667 | 1,540 |
December 31, | |||||||
2014 | 2013 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 48,555 | $ | 8,629 | |||
Restricted cash | 37 | 37 | |||||
Prepaid clinical expenses | 1,528 | — | |||||
Prepaid expenses and other current assets | 137 | 43 | |||||
Total current assets | 50,257 | 8,709 | |||||
Property and equipment, net | 279 | 38 | |||||
Total assets | $ | 50,536 | $ | 8,747 | |||
Liabilities and shareholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 730 | $ | 834 | |||
Accrued expenses | 926 | 187 | |||||
Accrued payroll and related expenses | 424 | 73 | |||||
Total current liabilities | 2,080 | 1,094 | |||||
Commitments and contingencies | |||||||
Shareholders’ equity: | |||||||
Common stock, $0.0001 par value; 100,000,000 and 12,000,000,000 shares authorized, 15,225,980 and 4,404,407 shares issued and outstanding at December 31, 2014 and 2013, respectively | 2 | 4 | |||||
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,917 and 7,016 shares issued and outstanding at December 31, 2014 and 2013, respectively, and a liquidation preference of $3,917 | 3,917 | 7,016 | |||||
Series F Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized, 2,798 and 3,250 shares issued and outstanding at December 31, 2014 and 2013, respectively, and a liquidation preference of $2,798 | 2,798 | 3,250 | |||||
Additional paid-in capital | 528,353 | 462,684 | |||||
Accumulated deficit | (486,614 | ) | (465,301 | ) | |||
Total shareholders’ equity | 48,456 | 7,653 | |||||
Total liabilities and shareholders' equity | $ | 50,536 | $ | 8,747 |