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 | |
La Jolla Pharmaceutical Company | ||
Date: | October 27, 2017 | /s/ Dennis M. Mulroy |
Dennis M. Mulroy | ||
Chief Financial Officer |
• | In August 2017, La Jolla announced that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application (NDA) for the investigational drug LJPC‑501, La Jolla’s propriety formulation of synthetic human angiotensin II, for the treatment of hypotension in adult patients with distributive or vasodilatory shock (dangerously low blood pressure with adequate cardiac function) who remain hypotensive despite fluid and vasopressor therapy (catecholamines and/or vasopressin). The review classification for the application is Priority, and the user fee goal date under the Prescription Drug User Fee Act (PDUFA) is February 28, 2018. In its letter to the Company, the FDA stated that it does not currently plan to hold an advisory committee meeting to discuss this application. The NDA for LJPC-501 is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study of LJPC-501 in patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy, which were published by The New England Journal of Medicine in May 2017. |
• | In September 2017, an analysis from ATHOS-3 entitled, “Baseline angiotensin levels and ACE effects in patients with vasodilatory shock treated with angiotensin II,” was presented during the 30th European Society of Intensive Care Medicine Annual Congress. The pre-specified analysis showed that a relatively low angiotensin II state (as measured by the ratio of angiotensin I to angiotensin II) predicted increased mortality in patients with vasodilatory shock, suggesting that a low angiotensin II state is a negative prognostic indicator of outcomes. Furthermore, the analysis showed a statistically significant treatment effect of LJPC-501 compared to placebo on mortality in these patients with a relatively low angiotensin II state (relative risk reduction of 36%; HR=0.64; 95% CI: 0.41-1.00; p=0.047). |
• | In September 2017, La Jolla announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued favorable Scientific Advice regarding the EU regulatory pathway for LJPC‑501 for the treatment of hypotension in adult patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. Based on this Advice, La Jolla intends to submit a Marketing Authorization Application (MAA) for LJPC-501 in the third quarter of 2018. |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Revenue | |||||||||||||||
Contract revenue - related party | $ | — | $ | 44 | $ | — | $ | 531 | |||||||
Total revenue | — | 44 | — | 531 | |||||||||||
Expenses | |||||||||||||||
Research and development | 19,093 | 16,992 | 57,666 | 42,111 | |||||||||||
General and administrative | 7,390 | 4,349 | 18,915 | 11,868 | |||||||||||
Total expenses | 26,483 | 21,341 | 76,581 | 53,979 | |||||||||||
Loss from operations | (26,483 | ) | (21,297 | ) | (76,581 | ) | (53,448 | ) | |||||||
Other income, net | 195 | 46 | 324 | 150 | |||||||||||
Net loss | $ | (26,288 | ) | $ | (21,251 | ) | $ | (76,257 | ) | $ | (53,298 | ) | |||
Basic and diluted net loss per share | $ | (1.19 | ) | $ | (1.23 | ) | $ | (3.65 | ) | $ | (3.10 | ) | |||
Weighted-average common shares outstanding - basic and diluted | 22,125 | 17,211 | 20,900 | 17,211 |
September 30, 2017 | December 31, 2016 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 120,840 | $ | 65,726 | |||
Restricted cash | 911 | 200 | |||||
Prepaid expenses and other current assets | 1,772 | 1,505 | |||||
Total current assets | 123,523 | 67,431 | |||||
Property and equipment, net | 6,534 | 3,145 | |||||
Other assets | — | 219 | |||||
Total assets | $ | 130,057 | $ | 70,795 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 6,239 | $ | 6,652 | |||
Accrued clinical and other expenses | 795 | 1,029 | |||||
Accrued payroll and related expenses | 3,228 | 2,077 | |||||
Total current liabilities | 10,262 | 9,758 | |||||
Shareholders’ equity: | |||||||
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 22,145,243 and 18,261,557 shares issued and outstanding at September 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 September 30, 2017 and December 31, 2016, and liquidation preference of $3,906 at September 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 September 30, 2017 and December 31, 2016, and liquidation preference of $2,737 at September 30, 2017 and December 31, 2016 | 2,737 | 2,737 | |||||
Additional paid-in capital | 796,118 | 661,103 | |||||
Accumulated deficit | (682,968 | ) | (606,711 | ) | |||
Total shareholders’ equity | 119,795 | 61,037 | |||||
Total liabilities and shareholders’ equity | $ | 130,057 | $ | 70,795 |