UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): July 19, 2013
LA JOLLA PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
California |
0-24274 |
33-0361285 | ||
(State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
4660 La Jolla Village Drive, Suite 1070, San Diego, California 92122
(Address of Principal Executive Offices) (Zip Code)
Registrants telephone number, including area code: (858) 207-4264
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
ITEM 2.02 | Results of Operations and Financial Condition. |
On July 19, 2013, La Jolla Pharmaceutical Company (the Company) reported its results of operations for the quarter ended June 30, 2013. A copy of the release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the Report). The press release should be read in conjunction with the note regarding forward looking statements, which is included in the text of the release.
The information in this Item 2.02 and attached Exhibit 99.1 to this Report will not be treated as filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.
ITEM 9.01. | FINANCIAL STATEMENTS AND EXHIBITS. |
(d) Exhibits. The following exhibit is filed with this report on Form 8-K:
Exhibit No. |
Description | |
99.1 | Press Release dated July 19, 2013. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
LA JOLLA PHARMACEUTICAL COMPANY | ||||||||
Date: July 25, 2013 | By: | /s/ George F. Tidmarsh | ||||||
Name: | George F. Tidmarsh, M.D. Ph.D. | |||||||
Title: | President and Chief Executive Officer |
Exhibit 99.1
`
La Jolla Pharmaceutical Company Announces Second-Quarter 2013
Financial Results and Highlights Recent Corporate Progress
SAN DIEGO, CA. (MARKETWIRE-July 19, 2013) La Jolla Pharmaceutical Company (OTCBB: LJPC) (the Company or La Jolla), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today reported the financial results for the three and six months ended June 30, 2013 and highlighted recent corporate progress.
We achieved several critical objectives in the second quarter of 2013, highlighted by the rapid completion of our Phase 1 clinical study of GCS-100 in chronic kidney disease (CKD) patients. Furthermore, in the beginning of the 3rd quarter, we have started our Phase 2 clinical study of GCS-100, our IND for LJPC-501 for treatment of hepatorenal syndrome (HRS) was accepted by the FDA, and we received our second Orphan Drug Designation, a designation for LJPC-0712 for treatment of Niemann-Pick type C (NP-C) disease. All of these are very exciting milestones, said George Tidmarsh, M.D., Ph.D., La Jollas President and Chief Executive Officer. Overall, we have substantially advanced our clinical and pre-clinical pipeline programs in a rapid yet cost effective manner.
Recent Accomplishments
| Granted Orphan Drug Designation by the FDA for LJPC-6417 (April 18, 2013) |
| Filed IND for LJPC-501 in hepatorenal syndrome with FDA (June 4, 2013) |
| Achieved positive results in the Phase 1 trial with GCS-100 in CKD (June 6, 2013) |
| Received acceptance from the FDA of the IND for LJPC-501 in HRS (July 2, 2013) |
| Initiated Phase 2 clinical trial of GCS-100 for the treatment of CKD (July 8, 2013) |
| Granted Orphan Drug Designation by the FDA for LJPC-0712 in NP-C (July 17, 2013) |
Results of Operations
La Jollas comprehensive net loss attributable to common stockholders for the second quarter of 2013 was $3.7 million, or $0.14 per share, compared to a comprehensive net loss attributable to common stockholders of $7.8 million, or $0.67 per share, for the second quarter of 2012. The 2012 second quarter comprehensive net loss was highly driven by derivative liabilities due to certain derivative features in the preferred stock. Those derivative features were removed as of December 31, 2012. Comprehensive net loss attributable to common stockholders grew in the
second quarter of 2013 primarily due to the impact of the development of La Jollas pipeline including the Phase 1 and Phase 2 clinical trials of GCS-100 for CKD and preclinical costs for the development of LJPC-501. Comprehensive net loss attributable to common stockholders for the six months ended June 30, 2013 was $7.9 million, or $0.35 per share, compared to $2.5 million, or $0.36 per share, for the six months June 30, 2012.
At June 30, 2013, the Company had $1.8 million in cash, as compared to $3.4 million of cash at December 31, 2012. The Company had positive working capital at June 30, 2013, of $1.6 million, compared to negative working capital of $10.1 million at June 30, 2012. The Company believes that its current cash resources are sufficient to fund planned operations for at least the next 9 months.
About GCS-100
GCS-100 is a complex polysaccharide derived from pectin that binds to, and blocks the activity of, galectin-3, a type of galectin. Over-expression of galectin-3 has been implicated in a number of human diseases, including chronic organ failure and cancer. This makes modulation of the activity of galectin-3 an attractive target for therapy in these diseases.
About LJPC-501
LJPC-501 is a peptide agonist of the renin-angiotensin system that acts to help the kidneys balance body fluids and electrolytes. Studies have shown that LJPC-501 may improve renal function in patients with HRS.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics for chronic organ failure and cancer. GCS-100, the Companys lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. LJPC-501 is a product candidate for the treatment of hepatorenal syndrome. For more information on the Company please visit http://www.ljpc.com.
(financial tables follow)
La Jolla Pharmaceutical Company
Unaudited Condensed Statements of Comprehensive Loss
(In thousands, except per share amounts)
Three months
ended June 30, |
Six months
ended June 30, |
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2013 | 2012 | 2013 | 2012 | |||||||||||||
Expenses: |
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Research and development |
$ | 700 | $ | 336 | $ | 1,355 | $ | 370 | ||||||||
General and administrative |
2,463 | 2,877 | 6,011 | 3,514 | ||||||||||||
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Total expenses |
3,163 | 3,213 | 7,366 | 3,884 | ||||||||||||
Loss from operations |
(3,163 | ) | (3,213 | ) | (7,366 | ) | (3,884 | ) | ||||||||
Other income (expenses): |
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Adjustments to fair value of derivative liabilities |
| (4,485 | ) | | 1,469 | |||||||||||
Other income (expense), net |
1 | 1 | 2 | 2 | ||||||||||||
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Net loss |
(3,162 | ) | (7,697 | ) | (7,364 | ) | (2,413 | ) | ||||||||
Preferred stock dividends earned, net of forfeits |
(562 | ) | (76 | ) | (562 | ) | (76 | ) | ||||||||
Comprehensive net loss attributable to common stockholders |
$ | (3,742 | ) | (7,773 | ) | $ | (7,926 | ) | $ | (2,489 | ) | |||||
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Net loss per share, basic and diluted |
$ | (0.14 | ) | $ | (0.67 | ) | $ | (0.35 | ) | $ | (0.36 | ) | ||||
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Shares used in computing basic and diluted net loss per share |
27,515 | 11,603 | 22,545 | 6,886 | ||||||||||||
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La Jolla Pharmaceutical Company
Unaudited Condensed Balance Sheets
(In thousands, except share and par value amounts)
June 30, | December 31, | |||||||
2013 | 2012 | |||||||
Assets |
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Current assets: |
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Cash and cash equivalents |
$ | 1,842 | $ | 3,405 | ||||
Restricted cash |
37 | | ||||||
Prepaids and other current assets |
67 | 25 | ||||||
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Total current assets |
1,946 | 3,430 | ||||||
Equipment and furnishings, net |
37 | |||||||
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$ | 1,983 | $ | 3,430 | |||||
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Liabilities, redeemable convertible preferred stock and stockholders equity |
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Current liabilities: |
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Accounts payable |
$ | 176 | $ | 92 | ||||
Accrued expenses |
91 | 107 | ||||||
Accrued payroll and related expenses |
41 | 17 | ||||||
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Total current liabilities |
308 | 216 | ||||||
Commitments |
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Stockholders equity: |
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Common stock, $0.0001 par value; 12,000,000,000 shares authorized, 30,486,228 and 14,267,383 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively |
3 | 1 | ||||||
Series C-12 convertible preferred stock, $0.0001 par value; 11,000 shares authorized, 6,214 and 5,792 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively |
6,214 | 5,792 | ||||||
Series C-22 convertible preferred stock, $0.0001 par value; 22,000 shares authorized, 530 and 500 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively |
530 | 500 | ||||||
Series D-12 convertible preferred stock, $0.0001 par value; 5,134 shares authorized, 4,568 and 4,615 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively |
4,568 | 4,615 | ||||||
Additional paid-in capital |
445,090 | 439,672 | ||||||
Accumulated deficit |
(454,730 | ) | (447,366 | ) | ||||
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Total stockholders equity |
1,675 | 3,214 | ||||||
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$ | 1,983 | $ | 3,430 | |||||
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Forward Looking Statement Safe Harbor
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Companys filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SECs web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the development of GCS-100 and LJPC-501, the success and timing of future preclinical and clinical studies of these compounds, and potential indications for which GCS-100 and LJPC-501 may be developed. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Companys reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.
Company Contact
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264
Email: GTidmarsh@ljpc.com
and
Chester S. Zygmont, III
Director of Finance
La Jolla Pharmaceutical Company
Phone: (858) 207-4262
Email: czygmont@ljpc.com