La Jolla Pharmaceutical Company Announces Data Presentation at the American Society of Nephrology Kidney Week

Oct. 23, 2014 20:01 UTC

La Jolla Pharmaceutical Company Announces Data Presentation at the American Society of Nephrology Kidney Week

SAN DIEGO–(BUSINESS WIRE)– La Jolla Pharmaceutical Company (Nasdaq: LJPC) (“the Company” or “La Jolla”), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that an abstract of the results for the Company’s Phase 2 clinical trial of GCS-100 in chronic kidney disease (CKD) has been selected by the American Society of Nephrology’s (ASN) Program Committee for poster presentation at the Kidney Week Annual Meeting. Kidney Week will be held November 11-16, 2014 in Philadelphia, Pennsylvania.

“We are delighted that results from our Phase 2 study of GCS-100 in CKD have been selected by the ASN for presentation,” said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “More than 13,000 kidney professionals are expected to attend Kidney Week this year, and it is well established as the world’s premier nephrology meeting.”

La Jolla’s abstract, #3724 “Galectin-3 Inhibition with GCS-100 Improves eGFR in Patients with Chronic Kidney Disease, will be presented in a Poster Session titled Glomerular and Tubulointerstitial Disease: Clinical Trials and Outcomes, on Thursday, November 13, 2014 from 10:00am to 12:00pm Eastern Standard Time. The abstract is reprinted below:

Pablo E. Pergola, MD, PhD1, Geoffrey Block, MD2, Bhupinder Singh, MD3, George Fadda, MD4, Robert Cohen, DO3, William Durham, MD5, James Tumlin, MD6, George Tidmarsh, MD, PhD7, James Rolke7

1Clinical Advancement Center, San Antonio, TX

2Denver Nephrology, Denver, CO

3Southwest Kidney Institute, Tempe, AZ

4Balboa Nephrology Medical Group, La Mesa, CA

5Mountain Kidney and Hypertension Associates, Ashville, NC

6SouthEast Renal Research Institute, Chattanooga, TN

7La Jolla Pharmaceutical Company, San Diego, CA

Galectin-3 inhibition with GCS-100 Improves eGFR in Patients with Chronic Kidney Disease

INTRODUCTION:

Galectin-3 has been implicated in interstitial and glomerular fibrosis resulting in progressive loss of kidney function.

METHODS:

GCS-100, a polysaccharide inhibitor of galectin-3, was evaluated in CKD stages 3b/4 in a multicenter, randomized, placebo-controlled Phase 2 study. 121 consenting adults received placebo or GCS-100 at doses of 1.5 or 30 mg/m2 IV weekly for 8 weeks followed by a 4 week observation period. The primary endpoint was the change in eGFR from baseline to end of treatment versus placebo. Both T-test and ANCOVA were used for analyses.

RESULTS:

Demographics: 117 patients (65 Stage 4) completed treatment (mean age 65; 43 female). Baseline eGFR was 29.2 ml/min/1.73m2 ± 9.00 (SD). Diabetes and HTN were the most common etiologies of CKD.

Efficacy: In the 1.5 mg/m2 group, a change in eGFR of +1.26 ±0.77 versus placebo (-0.58±0.46) was observed (p=0.045). When restricted to diabetic etiology, for 1.5 mg/m2 the change in eGFR was 2.33 ± 1.13 versus placebo (-0.53±0.56; p=0.028). Galectin-3 and K+ were significantly reduced (p=0.07 each). Uric acid and BUN were significantly reduced vs. baseline (p=0.07, 0.08 respectively). No significant changes in eGFR, galectin-3, K+, uric acid or BUN were observed among those receiving 30 mg/m2.

Safety: Four SAEs occurred, 2 in the placebo, 2 in the 30 mg/m2 group and none at 1.5 mg/m2. None of the SAEs were drug-related.

DISCUSSION:

Short term therapy with the galectin-3 inhibitor, GCS-100 at 1.5 mg/m2, resulted in small but significant improvement in eGFR. If future, long-term studies confirm these findings, GCS-100 could be used as a disease-modifying agent to slow and potentially reverse the renal fibrosis common in CKD.

About the American Society of Nephrology and Kidney Week

The American Society of Nephrology (ASN) leads the fight against kidney disease by educating health professionals, sharing new knowledge, advancing research and advocating the highest quality care for patients. Kidney Week is the world’s premier nephrology meeting, providing participants exciting and challenging opportunities to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative discussions with leading experts in the field.

About GCS-100

GCS-100 is a complex polysaccharide derived from pectin that binds to, and blocks the activity of, galectin-3. Over-expression of galectin-3 has been implicated in a number of human diseases, including chronic organ failure and cancer. La Jolla is developing GCS-100 for the treatment of chronic kidney disease (CKD). The Company recently completed a multicenter, randomized, placebo-controlled, Phase 2 study in CKD patients in which treatment with GCS-100 resulted in a statistically significant improvement in estimated glomerular filtration rate (eGFR) compared to placebo.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has four product candidates in development. LJPC-501 is a proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension (CRH) and hepatorenal syndrome (HRS). GCS-100 is a first-in-class inhibitor of galectin-3 for the potential treatment of chronic kidney disease (CKD). LJPC-1010 is a more potent and purified derivative of GCS-100 that can be delivered orally for the potential treatment of nonalcoholic steatohepatitis (NASH). LJPC-401 is a novel formulation of the natural peptide hepcidin for the potential treatment of iron overload. For more information on La Jolla, please visit http://www.ljpc.com.

Forward-Looking Statement Safe Harbor

This document and the abstract referred to herein contain “forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to our expectations regarding future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, any one of 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 Company’s filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC’s web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the future development of LJPC-501 for the treatment of CRH and HRS, GCS-100 for the treatment of CKD, LJPC-1010 for the treatment of NASH, and LJPC-401 for the treatment of iron overload and the success of future development activities for these and other drug development programs sponsored by the Company; and potential indications for which these drug candidates 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 Company’s reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
(858) 207-4264
GTidmarsh@ljpc.com
or
Chester S. Zygmont, III
Senior Director of Finance
(858) 207-4262
czygmont@ljpc.com

View this news release online at:

http://www.businesswire.com/news/home/20141023006448/en

La Jolla Pharmaceutical Company to Provide Corporate Overview at the Rodman & Renshaw 16th Annual Global Investment Conference

September 08, 2014 08:00 AM Eastern Daylight Time

Rodman & Renshaw Global Investment Conference 2014

SAN DIEGO–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the “Company” or “La Jolla”), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer, will provide a corporate overview at the Rodman & Renshaw 16th Annual Global Investment Conference taking place September 8-10 in New York City.

Rodman & Renshaw 16th Annual Global Investment Conference Presentation Details

Date: Wednesday, September 10, 2014

Time: 11:40 am Eastern Time

Location: Holmes I Salon @ New York Palace Hotel

Webcast: LJPC Webcast Link

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. LJPC-501, La Jolla’s lead product candidate, is a proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension and hepatorenal syndrome. GCS-100, La Jolla’s second product candidate, is a first-in-class inhibitor of galectin-3 for the potential treatment of chronic kidney disease. LJPC-1010, La Jolla’s third product candidate, is a more potent and purified derivative of GCS-100 that can be delivered orally for the potential treatment of nonalcoholic steatohepatitis. LJPC-401, La Jolla’s fourth product candidate, is a natural peptide for the potential treatment of iron overload. For more information on La Jolla, please visit http://www.ljpc.com.

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
(858) 207-4264
GTidmarsh@ljpc.com
and
Chester S. Zygmont, III
Senior Director of Finance
(858) 207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company Announces First Patient Enrolled in Clinical Trial of LJPC-501 in Hepatorenal Syndrome

SAN DIEGO–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (NASDAQ: LJPC), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the first patient has been enrolled in the Phase 1/2 clinical trial of LJPC-501 for the treatment of type 1 and type 2 hepatorenal syndrome (HRS). HRS is a life-threatening form of progressive renal failure in patients with liver cirrhosis or fulminant liver failure.

“We are very grateful to the investigator, the patient and the patient’s family,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “We believe that LJPC-501, which helps the kidneys balance body fluids and electrolytes, may improve kidney function in patients with HRS. For many patients with HRS, reduced kidney function is the major debilitating aspect of their illness.”

The clinical trial is an open-label, multi-center study of LJPC-501 in patients with type 1 and/or type 2 HRS.

The trial is designed to enroll up to 15 patients with type 1 or type 2 HRS. The primary endpoint is safety and tolerability. Secondary endpoints include determining the maximum tolerated dose and the effects of LJPC-501 on serum creatinine through 5 days of treatment. Patients will receive LJPC-501 at titrated doses, with a starting range from 1 to 100 ng/kg/min, by continuous infusion on days 1 through 5. Dose titrations will occur every 4 hours until a mean arterial pressure of 110 mmHg is reached, maximum urine output is achieved or a dose of 100 ng/kg/min is achieved. Dosing will then continue at such maximum dose through day 5.

About Hepatorenal Syndrome

Hepatorenal syndrome (HRS) is a life-threatening form of progressive renal failure in patients with liver cirrhosis. In these patients, the diseased liver secretes vasodilator substances (e.g., nitric oxide and prostaglandins) into the bloodstream that cause under-filling of blood vessels. This low blood pressure state causes a reduction in blood flow to the kidneys. As a means to restore systemic blood pressure, the kidneys induce both sodium and water retention, which contribute to ascites, a major complication associated with HRS.

About LJPC-501

LJPC-501, a proprietary formulation of angiotensin II, is a peptide agonist of the renin-angiotensin system that acts to stabilize blood pressure. La Jolla is developing LJPC-501 for the treatment of catecholamine-resistant hypotension (CRH), which is an acute, life-threatening condition in which blood pressure drops to dangerously low levels and is poorly responsive to current treatments. LJPC-501 has been shown to raise blood pressure in a randomized, placebo-controlled clinical trial in CRH, as well as animal models of hypotension. La Jolla plans to initiate a Phase 3 registration program with LJPC-501 in the treatment of CRH as the result of a recent meeting with the U.S. Food and Drug Administration (FDA) at which agreement was reached that blood pressure could serve as an appropriate primary endpoint for approval. Due to the estimated size of the patient population in the United States for this indication, La Jolla has filed an application for Orphan Drug status for LJPC-501. Studies have shown that LJPC-501 may also improve renal function in patients with hepatorenal syndrome (HRS).

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. LJPC-501, La Jolla’s lead product candidate, is a proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension and hepatorenal syndrome. GCS-100, La Jolla’s second product candidate, is a first-in-class inhibitor of galectin-3 for the potential treatment of chronic kidney disease. LJPC-1010, La Jolla’s third product candidate, is a more potent and purified derivative of GCS-100 that can be delivered orally for the potential treatment of nonalcoholic steatohepatitis. LJPC-401, La Jolla’s fourth product candidate, is a natural peptide for the potential treatment of iron overload. For more information on La Jolla, please visit http://www.ljpc.com.

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 Company’s filings with the U.S. Securities and Exchange Commission (“SEC”), all of which are available free of charge on the SEC’s web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the timing for the commencement of clinical studies and the anticipated timing for completion of such studies; the success of future development activities for LJPC-501, GCS-100, LJPC-1010 and LJPC-401; estimated market sizes and the ability to successfully receive Orphan Drug designation for LJPC-501; and potential indications for which LJPC-501, GCS-100, LJPC-1010 and LJPC-401 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 Company’s reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
(858) 207-4264
GTidmarsh@ljpc.com
or
Chester S. Zygmont, III
Senior Director of Finance
(858) 207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company Announces Second Quarter and Year-to-Date 2014 Financial Results

SAN DIEGO–(BUSINESS WIRE)– La Jolla Pharmaceutical Company (NASDAQ: LJPC), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today reported second quarter and year-to-date 2014 financial results and highlighted recent corporate progress.

Recent Corporate Highlights

  • On July 28, 2014, La Jolla closed an underwritten public offering of approximately 5.4 million shares of common stock, which includes a portion of the overallotment option, at a public offering price of $10.50 per share. The Company received total net proceeds of approximately $53.1 million.
  • On July 15, 2014, La Jolla announced positive data from a preclinical study of LJPC-1010, its oral galectin-3 inhibitor, in the treatment of nonalcoholic steatohepatitis (NASH).
  • On July 8, 2014, La Jolla announced that it plans to initiate a Phase 3 registration program with LJPC-501 in the treatment of catecholamine-resistant hypotension (CRH).
  • On June 27, 2014, La Jolla joined the Russell Microcap Index, as a result of the annual Russell Index Reconstitution.
  • On June 4, 2014, La Jolla announced the completion of enrollment of its Phase 2 extension trial of GCS-100 in Chronic Kidney Disease (CKD).

“We have had a very exciting year so far, highlighted by the announcement of our plans for our LJPC-501 Phase 3 registration program, the positive top-line results from our Phase 2 clinical trial of GCS-100 in severe CKD and the close of our recent financing,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “During the second half of 2014, we plan to move our new LJPC-501 CRH Phase 3 program forward, continue the progress of our GCS-100 CKD program and advance our other new programs.”

Results of Operations

At June 30, 2014, La Jolla had $3.9 million in cash, as compared to $8.6 million in cash at December 31, 2013. As of August 1, 2014, La Jolla had approximately $56.6 million in cash, which includes the net proceeds of the public offering of common stock, which closed on July 28, 2014.

La Jolla’s comprehensive net loss attributable to common shareholders for the three and six months ended June 30, 2014 was $4.3 million and $9.4 million, or $0.63 per share and $1.16 per share, respectively, compared to a comprehensive net loss attributable to common shareholders of $3.7 million and $7.9 million, or $6.77 per share and $17.57 per share, respectively, for the same periods in 2013.

The increase in comprehensive net loss attributable to common shareholders was primarily due to increases in research and development expenses related to the GCS-100 Phase 2 program in the treatment of CKD, as well as preclinical work on LJPC-1010 and LJPC-401.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. LJPC-501, La Jolla’s lead product candidate, is a proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension and hepatorenal syndrome. GCS-100, La Jolla’s second product candidate, is a first-in-class inhibitor of galectin-3 for the potential treatment of chronic kidney disease. LJPC-1010, La Jolla’s third product candidate, is a more potent and purified derivative of GCS-100 that can be delivered orally for the potential treatment of nonalcoholic steatohepatitis. LJPC-401, La Jolla’s fourth product candidate, is a natural peptide for the potential treatment of iron overload. For more information on La Jolla, please visit http://www.ljpc.com.

About LJPC-501

LJPC-501, a proprietary formulation of angiotensin II, is a peptide agonist of the renin-angiotensin system that acts to stabilize blood pressure. La Jolla is developing LJPC-501 for the treatment of catecholamine-resistant hypotension (CRH), which is an acute, life-threatening condition in which blood pressure drops to dangerously low levels and is poorly responsive to current treatments. LJPC-501 has been shown to raise blood pressure in a randomized, placebo-controlled clinical trial in CRH, as well as animal models of hypotension. La Jolla plans to initiate a Phase 3 registration program with LJPC-501 in the treatment of CRH as the result of a recent meeting with the U.S. Food and Drug Administration (FDA) at which agreement was reached that blood pressure could serve as an appropriate primary endpoint for approval. Due to the estimated size of the patient population in the United States for this indication, La Jolla has filed an application for Orphan Drug status for LJPC-501. Studies have shown that LJPC-501 may also improve renal function in patients with hepatorenal syndrome (HRS).

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. La Jolla is developing GCS-100 for the treatment of chronic kidney disease (CKD). In March of 2014, La Jolla announced positive top-line results from its randomized, placebo-controlled Phase 2 clinical trial of GCS-100 in severe CKD, in which the predefined primary efficacy endpoint was met. La Jolla completed enrollment for a Phase 2 extension clinical trial of GCS-100 in patients with severe CKD in June of 2014 and plans to initiate a Phase 2b clinical trial in late 2014.

About LJPC-1010

LJPC-1010 is a more potent and purified derivative of GCS-100 that can be delivered orally. The Company is developing LJPC-1010 for the treatment of nonalcoholic steatohepatitis (NASH). NASH is the more serious form of nonalcoholic fatty liver disease, or NAFLD, which can lead to liver failure. In July of 2014, La Jolla announced positive preclinical data of LJPC-1010 in NASH. La Jolla plans to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) and initiate a Phase 1 clinical trial of LJPC-1010 in NASH in early 2015.

About LJPC-401

LJPC-401 is La Jolla’s formulation of hepcidin, which is an endogenous peptide hormone that controls and regulates iron metabolism. La Jolla licensed intellectual property covering the composition of hepcidin from INSERM in February of 2014. The active form of hepcidin is a 25 amino acid protein that serves as a master regulator of iron metabolism. Hepcidin synthesis in the liver is regulated by multiple signals, including iron stores, erythropoietic activity (the production of red blood cells) and inflammatory cytokines. La Jolla is currently in the preclinical development stage with LJPC-401 and expects to file an IND and commence a Phase 1 clinical trial of LJPC-401 in iron overload in 2015.

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 Company’s filings with the U.S. Securities and Exchange Commission (“SEC”), all of which are available free of charge on the SEC’s web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the timing for the commencement of clinical studies and the anticipated timing for completion of such studies; the success of future development activities for LJPC-501, GCS-100, LJPC-1010 and LJPC-401; estimated market sizes and the ability to successfully receive Orphan Drug designation for LJPC-501; and potential indications for which LJPC-501, GCS-100, LJPC-1010 and LJPC-401 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 Company’s reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.

LA JOLLA PHARMACEUTICAL COMPANY

Unaudited Condensed Statements of Operations and Comprehensive Loss

(in thousands, except per-share amounts)

Three Months Ended

June 30,

Six Months Ended

June 30,

2014

2013

2014

2013

Expenses:

Research and development

$

1,597

$

700

$

3,593

$

1,355

General and administrative

2,689

2,463

5,823

6,011

Total expenses

4,286

3,163

9,416

7,366

Loss from operations

(4,286

)

(3,163

)

(9,416

)

(7,366

)

Other income:

Other income, net

2

1

4

2

Net loss and comprehensive loss

(4,284

)

(3,162

)

(9,412

)

(7,364

)

Preferred stock dividends earned

(562

)

(562

)

Net loss attributable to common shareholders

$

(4,284

)

$

(3,724

)

$

(9,412

)

$

(7,926

)

Basic and diluted net loss per share

$

(0.63

)

$

(6.77

)

$

(1.16

)

$

(17.57

)

Shares used in computing basic and diluted net loss per share

6,836

550

8,122

451

LA JOLLA PHARMACEUTICAL COMPANY

Condensed Balance Sheets

(in thousands, except share and per-share amounts)

June 30,
2014

December 31,

2013

(Unaudited)

ASSETS:

Current assets:

Cash and cash equivalents

$

3,888

$

8,629

Restricted cash

37

37

Prepaid expenses and other current assets

148

43

Total current assets

4,073

8,709

Equipment and furnishings, net

89

38

Total assets

$

4,162

$

8,747

LIABILITIES AND SHAREHOLDERS EQUITY:

Current liabilities:

Accounts payable

$

917

$

834

Accrued expenses

58

187

Accrued payroll and related expenses

94

73

Total current liabilities

1,069

1,094

Shareholders’ equity:

Common stock, $0.0001 par value; 12,000,000,000 shares authorized, 9,838,298 and 4,404,407 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively

4

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 June 30, 2014 and December 31, 2013, respectively

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 June 30, 2014 and December 31, 2013, respectively

2,798

3,250

Additional paid-in capital

471,087

462,684

Accumulated deficit

(474,713

)

(465,301

)

Total shareholders’ equity

3,093

7,653

Total liabilities and shareholders’ equity

$

4,162

$

8,747

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
(858) 207-4264
GTidmarsh@ljpc.com
and
La Jolla Pharmaceutical Company
Chester S. Zygmont, III
Senior Director of Finance
(858) 207-4262
czygmont@ljpc.com

Source: La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company Closes Offering of Common Stock

July 28, 2014 06:29 PM Eastern Daylight Time

SAN DIEGO–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the “Company” or “La Jolla”), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced the closing of its underwritten public offering of 5,395,000 shares of common stock at a public offering price of $10.50 per share, which includes the partial exercise of the underwriters’ option to purchase up to an additional 720,000 shares of common stock. Gross offering proceeds are approximately $56.6 million, including proceeds from the partial exercise of the underwriters’ option to purchase additional shares, before deducting customary underwriting discounts and commissions and offering expenses.

La Jolla intends to use the net proceeds from the offering for general corporate purposes, including funding its ongoing and future clinical trials, and for general and administrative expenses.

Jefferies LLC acted as sole book-runner for the offering. Chardan Capital Markets, LLC, H.C. Wainwright & Co., LLC, LifeSci Capital, LLC and Noble Financial Group, Inc. acted as co-managers for the offering.

The securities described above were offered pursuant to a shelf registration statement (File No. 333-197092), including a base prospectus, which was declared effective by the United States Securities and Exchange Commission (“SEC”) on July 11, 2014. The specific terms of the offering are described in a prospectus supplement filed with the SEC in connection with the offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering was made only by means of the prospectus supplement and accompanying prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 547-6340, e-mail: Prospectus_Department@Jefferies.com.

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
(858) 207-4264
gtidmarsh@ljpc.com
or
Chester S. Zygmont, III
Director of Finance
(858) 207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company Announces Pricing of Underwritten Offering of Common Stock

SAN DIEGO–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the “Company” or “La Jolla”), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced the pricing of an underwritten offering of 4,800,000 shares of its common stock, offered at a price of $10.50 per share. La Jolla has granted the underwriters a 30-day option to purchase up to an additional 720,000 shares of common stock. The offering is expected to close on or about July 28, 2014, subject to customary closing conditions. Jefferies LLC is acting as sole book-runner for the offering. Chardan Capital Markets, LLC, H.C. Wainwright & Co., LLC, LifeSci Capital, LLC and Noble Financial Group, Inc. are acting as co-managers for the offering.

Gross offering proceeds will be $50,400,000 before deducting underwriting discounts and commissions and estimated offering expenses payable by La Jolla. La Jolla intends to use the net proceeds from the underwritten offering for general corporate purposes, including funding its ongoing and future clinical trials, and for general and administrative expenses.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-197092), including a base prospectus, which was declared effective by the United States Securities and Exchange Commission (“SEC”) on July 11, 2014. The specific terms of the offering are described in a prospectus supplement to be filed with the SEC in connection with the offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering will be made only by means of the prospectus supplement and accompanying prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 547-6340, e-mail: Prospectus_Department@Jefferies.com.

This press release contains statements relating to the proposed offering that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties, such as the risk that the conditions to the closing of the offering will not be satisfied. All forward-looking statements are based upon information available to La Jolla on the date the statements are first published. La Jolla undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
(858) 207-4264
gtidmarsh@ljpc.com
and
La Jolla Pharmaceutical Company
Chester S. Zygmont, III
Director of Finance
(858) 207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company Announces Proposed Underwritten Offering of Common Stock

SAN DIEGO–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the “Company” or “La Jolla”), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced its intention to offer and sell shares of its common stock in an underwritten offering pursuant to its existing shelf registration statement. All of the shares in the proposed offering are to be sold by La Jolla.

Jefferies LLC is acting as sole book-runner for the offering. La Jolla intends to grant the underwriters a 30-day option to purchase additional shares of its common stock. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

La Jolla intends to use the net proceeds from the underwritten offering for general corporate purposes, funding its ongoing and future clinical trials, general and administrative expenses and potential future acquisitions and other strategic purposes.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-197092), including a base prospectus, which was declared effective by the United States Securities and Exchange Commission (“SEC”) on July 11, 2014. The specific terms of the offering are described in a prospectus supplement to be filed with the SEC in connection with the offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering will be made only by means of the prospectus supplement and accompanying prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 547-6340, e-mail: Prospectus_Department@Jefferies.com.

This press release contains statements relating to the proposed offering that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties, such as the risk that the conditions to the closing of the offering will not be satisfied. All forward-looking statements are based upon information available to La Jolla on the date the statements are first published. La Jolla undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
858-207-4264
gtidmarsh@ljpc.com
and
Chester S. Zygmont, III
Director of Finance
858-207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company Announces Planned Initiation of Phase 3 Registration Program for LJPC-501 in Resistant Hypotension

SAN DIEGO–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the “Company” or “La Jolla”), a biotechnology company developing therapeutics targeting significant unmet, life-threatening diseases, today announced that the Company plans to begin a phase 3 registration program for LJPC-501 for the treatment of catecholamine-resistant hypotension (CRH), a new indication. Initiation of this registration program is the result of a recent meeting between the Company and the U.S. Food and Drug Administration at which agreement was reached that blood pressure is an appropriate primary endpoint for approval.

“We are excited to begin a registration program in CRH,” said George F. Tidmarsh, M.D., Ph.D., President and CEO of La Jolla. “There are approximately 75,000-100,000 patients per year who suffer from CRH, and the prognosis is very poor. We are excited to advance LJPC-501 into a registration trial for this significant unmet medical need.”

Hypotension, if uncorrected, is life-threatening and occurs as the result of various underlying conditions such as blood loss due to trauma, septic shock, poor heart function or drug reactions. The first line of treatment is catecholamine infusion. Catecholamines are derived from the amino acid tyrosine and include epinephrine (adrenaline), norepinephrine (noradrenaline), and dopamine, which act as neurotransmitters that increase blood pressure. While largely effective, some patients fail to respond to adequate doses and are defined as catecholamine-resistant. Furthermore, high doses of catecholamines can lead to cardiac and other toxicities, and can contribute to the high rate of mortality in these patients. Therefore, there is a major unmet need for a new pharmacological agent that can restore blood pressure while maintaining catecholamine doses at acceptable levels.

LJPC-501 (angiotensin II) is a peptide agonist of the renin-angiotensin system that acts to stabilize blood pressure. One of the most widely prescribed classes of blood pressure medication, angiotensin converting enzyme inhibitors, inhibits the production of angiotensin II, thereby reducing blood pressure. A randomized, placebo-controlled pilot study of angiotensin II in 20 patients with catecholamine-resistant hypotension was presented at the 34th International Symposium on Intensive Care and Emergency Medicine by Dr. Lakhmir S. Chawla from George Washington University. This study demonstrated that the mean norepinephrine dose for the placebo cohort was 20.1 ± 16.8 μg/minute vs. 7.3 ± 11.9 μg/minute for the angiotensin II cohort (= 0.022). This was the pre-defined primary endpoint and a surrogate measure of blood pressure effect. Approximately 80% of patients treated with angiotensin II experienced a rise in blood pressure compared to 10-20% with placebo. The most common adverse event was hypertension, which occurred in 20% of patients receiving angiotensin II. Due to the estimated size of the patient population in the United States for this indication, the Company has filed for Orphan Drug status for angiotensin II.

Conference Call and Webcast

The Company will hold an investor conference call and webcast at 8:00 AM Eastern Time/5:00 AM Pacific Time on Wednesday, July 9, 2014. You can participate on the call by either dialing (877) 359-9508 pin: 71366477 or click here for the webcast.

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 Company’s 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, the Company’s second product candidate, is a natural peptide being developed for the treatment of hepatorenal syndrome and CRH. LJPC-401, the Company’s third product candidate, is a natural peptide being developed for the treatment of iron overload. For more information on the Company please visit http://www.ljpc.com.

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 Company’s filings with the U.S. Securities and Exchange Commission (“SEC”), all of which are available free of charge on the SEC’s web site http://www.sec.gov. These risks include, but are not limited to: risks relating to the development of GCS-100, LJPC-501 and LJPC-401; the success and timing of future preclinical and clinical studies of these compounds, and potential indications for which GCS-100, LJPC-501 and LJPC-401 may be developed; the ability of the Company to secure the necessary intellectual property rights to commercialize its product candidates, if successfully developed; and the ability to successfully obtain Orphan Drug status for LJPC-501. 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 Company’s reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
858-207-4264
GTidmarsh@ljpc.com
and
Chester S. Zygmont, III
Director of Finance
858-207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company Strengthens Board of Directors with Appointment of Robert H. Rosen

SAN DIEGO, Calif.–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the “Company” or “La Jolla”), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced the appointment of Robert H. Rosen to the Company’s Board of Directors.

“We are honored to have Rob, who has a wealth of successful drug development and commercialization experience, join the board of directors of La Jolla Pharmaceutical Company,” said George Tidmarsh, Chief Executive Officer of La Jolla Pharmaceutical Company. “This will be especially important as we prepare to accelerate our drug development efforts.”

Robert H. Rosen is currently President and a Director of Heron Therapeutics, a Nasdaq-listed specialty pharmaceutical company developing products using its Biochonomer polymer-based drug delivery platform. He joined the company in October 2012 as Sr. Vice President and Chief Commercial Officer. Prior to Heron, Mr. Rosen was Managing Partner of Scotia Nordic LLC. From April 2011 to March 2012, Mr. Rosen served as Senior Vice President of Global Commercial Operations at Dendreon Corporation, a biotechnology company. Prior to Dendreon, he served as global head of oncology at Bayer HealthCare, where he was responsible for the development of the global oncology business unit for regions that included the Americas, Europe, Japan, and Asia Pacific from 2005 to 2011. During his tenure at Bayer Healthcare, he led the launch of Nexavar for the treatment of renal cell carcinoma and hepatocellular carcinoma. Nexavar’s worldwide sales in 2011 were $1.0 billion. He also led premarket activities for Stivarga for gastrointestinal stromal tumors and colon cancer and alpharadin for prostate cancer. From 2002 to 2005, Mr. Rosen was vice president of the oncology business unit at Sanofi-Synthèlabo, where he was responsible for the development of Sanofi’s U.S. oncology business and the launch of Eloxatin for colon cancer. Eloxatin U.S. sales in 2005, its third full year on the market, were $1.1 billion, ranking it among the industry’s most successful oncology drug launches. Mr. Rosen received a Bachelor of Science degree in Pharmacy from Northeastern University.

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 Company’s lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. GCS-100 currently is in Phase 2 clinical development for chronic kidney disease (CKD). LJPC-501, the Company’s second product candidate, is a natural peptide for the potential treatment of hepatorenal syndrome. LJPC-401, the Company’s third product candidate, is a natural peptide for the potential treatment of iron overload. For more information on the Company, please visithttp://www.ljpc.com.

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
Phone: (858) 207-4264
Email: GTidmarsh@ljpc.com
and
Chester S. Zygmont, III
Director of Finance
Phone: (858) 207-4262
Email: czygmont@ljpc.com

La Jolla Pharmaceutical Company Added to the Russell Microcap Index

SAN DIEGO–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the “Company” or “La Jolla”), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced that the Company was added to the Russell Microcap Index when Russell Investments reconstituted its comprehensive set of U.S. and global equity indices on June 27.

“We have been working diligently to develop novel therapies for unmet medical needs”

“We have been working diligently to develop novel therapies for unmet medical needs,” said George Tidmarsh, Chief Executive Officer of La Jolla Pharmaceutical Company. “We expect inclusion in the Russell Microcap Index will increase the liquidity of our stock and expose us to a wide range of institutions, investors, and index funds that reference them.”

The Russell Microcap Index measures the performance of the microcap segment of the U.S. equity market. Microcap stocks make up less than 3% of the U.S. equity market (by market cap) and consist of the smallest 1,000 securities in the small-cap Russell 2000 Index, plus the next 1,000 smallest eligible securities by market cap. The Russell Microcap Index is constructed to provide a comprehensive and unbiased barometer for the microcap segment trading on national exchanges. The Index is completely reconstituted annually to ensure new and growing equities are reflected and companies continue to reflect appropriate capitalization and value characteristics. You can find out more about the Russell Microcap Index by clicking here.

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 Company’s lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. GCS-100 currently is in Phase 2 clinical development for chronic kidney disease (CKD). LJPC-501, the Company’s second product candidate, is a natural peptide for the potential treatment of hepatorenal syndrome. LJPC-401, the Company’s third product candidate, is a natural peptide for the potential treatment of iron overload. For more information on the Company, please visithttp://www.ljpc.com.

Contacts

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
Phone: (858) 207-4264
Email: GTidmarsh@ljpc.com
and
Chester S. Zygmont, III
Director of Finance
Phone: (858) 207-4262
Email: czygmont@ljpc.com