La Jolla Pharmaceutical Company to Provide Corporate Overview at the 2014 BIO International Convention

2014 BIO International Convention

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 George Tidmarsh, MD, Ph.D., President and Chief Executive Officer, will provide a corporate overview at the 2014 BIO International Convention, taking place June 23-26 in San Diego, California.

2014 BIO International Convention

Date: Thursday, June 26, 2014

Time: 11:30am Pacific Time

Location: Mission Beach Room @ The San Diego Convention Center

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
858-207-4264
GTidmarsh@ljpc.com
and
Chester S. Zygmont, III
Director of Finance
858-207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company to Provide Corporate Overview at the 9th Annual JMP Securities Healthcare Conference

JMP Securities Healthcare Conference 2014

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 George Tidmarsh, MD, Ph.D., President and Chief Executive Officer, will provide a corporate overview at the 9th Annual JMP Securities Healthcare Conference taking place June 24-25 in New York City.

The 9th Annual JMP Securities Healthcare Conference Presentation Details

Date: Wednesday, June 25, 2014
Time: 2:00pm Eastern Time
Location: The Westin New York Grand Central
Webcast:

http://wsw.com/webcast/jmp24/ljpc/

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 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
Director of Finance
858-207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company Enters into Agreement With Stanford University for New Drug Delivery Technology

June 16, 2014 08:00 AM Eastern Daylight Time

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 it has signed an option agreement with Leland Stanford Junior University (“Stanford”) that will add proprietary technology to the Company’s programs.

“We look forward to working with Stanford to develop their technology,” said George Tidmarsh, President and CEO of La Jolla. “As we continue to expand our product portfolio, we remain committed to helping patients who suffer from severe diseases for which no treatment is available.”

The option agreement with Stanford allows La Jolla to test the technology potentially adding important and diversified product opportunities to La Jolla’s pipeline. La Jolla is currently testing novel oral formulations using the technology in an animal model of Non-alcoholic Steatohepatitis (NASH). If successful, these product candidates will add to the company’s growing pipeline that includes treatments for chronic kidney disease, hepatorenal syndrome, chronic iron overload, and rare diseases.

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 for the treatment of hepatorenal syndrome. LJPC-401 (hepcidin) is in preclinical development for iron overload conditions. 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 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 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.
858-207-4264
President & Chief Executive Officer
GTidmarsh@ljpc.com
or
Chester S. Zygmont, III
858-207-4262
Director of Finance
czygmont@ljpc.com

La Jolla Pharmaceutical Company Announces Completion of Enrollment of Phase 2 Extension Study of GCS-100 in Chronic Kidney Disease

SAN DIEGO–(BUSINESS WIRE)–La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced that it has completed enrollment of GCS-100-CS-4003 (“4003 study”), its Phase 2 Extension study of GCS-100 in chronic kidney disease (“CKD”). The 4003 study was initiated to study the long-term safety and efficacy of GCS-100 in patients who completed the initial 12-week Phase 2 study (GCS-100-CS-4002). A total of 93 patients enrolled across 5 sites. Initial data from the 4003 Extension study is expected late this year.

“We have been impressed with how many patients were willing to continue participation in the extension study and how well they continue to tolerate GCS-100,” said Pablo Pergola, MD, PhD, Renal Associates PA, San Antonio, TX and Clinical Associate Professor of Medicine, University of Texas Health Science Center at San Antonio. “We look forward to seeing if patients on this ongoing trial experience similar or greater improvement in kidney function with longer term treatment.”“We are pleased to have completed enrollment and encouraged by the greater than 80% participation of eligible patients,” said George Tidmarsh, MD, PhD, Chief Executive Officer of La Jolla Pharmaceutical Company. “Chronic kidney disease affects nearly 50 million people in the United States. We believe GCS-100 can be an effective treatment option for those suffering from CKD.”

About the GCS-100 Phase 2 CKD Studies

The 4003 extension study was designed to enroll CKD patients who completed the 4002 study. Subjects were randomized in a 1:1 ratio to either treatment with 1.5 mg/m2 GCS-100 or 30 mg/m2 GCS-100. All doses of study drug will be administered intravenously once weekly for up to 8 consecutive weeks with a 4-week follow-up period and then once a month for a total of 1 year.

The primary objective of the Phase 2 Extension study is to determine the safety and tolerability of extended dosing with GCS-100. The secondary objective is to determine the efficacy as measured by eGFR of GCS-100 administered for 8-weeks relative to the effect of 8-weeks of treatment for the same patient on the GCS-100-CS-4002 study including those who were on placebo. This study also provides the opportunity to compare crossover data for individual patients from the initial Phase 2 study and this extension study.

The 4002 study was a blinded, multi-center, randomized clinical trial that enrolled 121 subjects, at least 18 years of age, with Stage 3b or 4 CKD across 6 sites. In this study, subjects were randomly assigned 1:1:1 to treatment with placebo, 1.5 mg/m2 GCS-100 or 30 mg/m2 GCS-100. Patients received the assigned treatment weekly for eight weeks followed by a four-week follow-up period. According to the pre-defined protocol and statistical analysis plan, the primary endpoint was reached if the change in eGFR from baseline to the end of treatment in either GCS-100 dose group compared to placebo had a significance of less than 10% (p value of <0.10). The t-test was the primary statistical test used for comparison between groups unless a significant covariate was found and then the ANCOVA test was employed.

In March 2014 the Company announced that the trial met its primary efficacy endpoint of a statistically significant improvement in kidney function. Specifically, a dose of 1.5 mg/m2 led to a statistically significant (p=0.045) increase in estimated glomerular filtration rate (eGFR) compared to placebo between baseline and end of treatment. Key secondary endpoints were also met, and the effect on circulating galectin-3 levels was consistent with the effect on eGFR. For the 1.5 mg/m2 dose, there was a statistically significant (p=0.067) reduction in circulating levels of galectin-3, while there was no significant difference at the 30 mg/m2 dose level. GCS-100 was well-tolerated. Out of 121 patients enrolled, 117 completed treatment, including all 41 patients treated at the 1.5 mg/m2 dose. There were no serious adverse events (SAEs) in the 1.5 mg/m2 dose group compared to two in the placebo group and two in the 30 mg/m2 group. All SAEs were deemed by the investigators as not drug-related.

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 for the treatment of hepatorenal syndrome. 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 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 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 to Provide Corporate Overview at the Jefferies 2014 Global Healthcare Conference

Jefferies 2014 Global Healthcare Conference

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 George Tidmarsh, MD, Ph.D., President and Chief Executive Officer, will provide a corporate overview at the Jefferies 2014 Global Healthcare Conference taking place June 2-5 in New York City.

Jefferies 2014 Global Healthcare Conference Presentation Details

Date: Thursday, June 5, 2014
Time: 11:30am Eastern Time
Location: Grand Hyatt Hotel in New York City
Webcast:

http://wsw.com/webcast/jeff82/ljpc

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
(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 First-Quarter 2014 Financial Results

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 announces first-quarter 2014 financial results and highlights recent corporate progress.

Results of Operations

At March 31, 2014, the Company had $5.9 million in cash, as compared to $8.6 million in cash at December 31, 2013. At March 31, 2014 the Company had positive working capital of $5.2 million, compared to positive working capital of $7.5 million at December 31, 2013.

La Jolla’s comprehensive net loss attributable to common stockholders for the first quarter of 2014 was $5.1 million, or $0.93 per share, compared to a comprehensive net loss attributable to common stockholders of $4.3 million, or $12.26 per share, for the first quarter of 2013. Per share numbers for the first quarter of 2013 reflect the 1- for-50 reverse stock split of La Jolla’s common stock, which became effective on January 14, 2014.

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 LJPC-401 (Hepcidin)

LJPC-401 is also known as hepcidin. The use of hepcidin will be evaluated as a treatment for disorders of iron overload including hemolytic anemia. We licensed intellectual property covering the composition of hepcidin from INSERM in February 2014.

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.

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. 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
March 31,
2014 2013
Expenses:
Research and development $ 1,996 $ 655
General and administrative 3,134 3,548
Total expenses 5,130 4,203
Loss from operations (5,130 ) (4,203 )
Other income:
Other income, net 2 1
Net loss and comprehensive loss (5,128 ) (4,202 )
Preferred stock dividends earned (93 )
Net loss attributable to common stockholders $ (5,128 ) $ (4,295 )
Net loss per share basic and diluted $ (0.93 ) $ (12.26 )
Shares used in computing basic and diluted net loss per share 5,535 350
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Balance Sheets
(in thousands, except share and par value amounts)
March 31,
2014
December 31,
2013
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 5,885 $ 8,629
Restricted cash 37 37
Prepaids 156 43
Total current assets 6,078 8,709
Equipment and furnishings, net 51 38
Total assets $ 6,129 $ 8,747
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 562 $ 834
Accrued expenses 262 187
Accrued payroll and related expenses 82 73
Total current liabilities 906 1,094
Commitments
Stockholders’ equity:
Common stock, $ 0.0001 par value; 12,000,000,000 shares authorized, 7,257,033 and 4,404,407 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively 4 4
Series C-12 Convertible Preferred Stock, $ 0.0001 par value; 11,000 shares authorized, 5,393 and 7,016 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively 5,393 7,016
Series F Convertible Preferred Stock, $ 0.0001 par value; 10,000 shares authorized, 3,066 and 3,250 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively 3,066 3,250
Additional paid-in capital 467,189 462,684
Accumulated deficit (470,429 ) (465,301 )
Total stockholders’ equity 5,223 7,653
Total liabilities and stockholders’ equity $ 6,129

$

8,747

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 Receives Patent Allowance Covering Broad Range of Modified Pectin

AN 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 United States Patent and Trademark Office (“USPTO”) has issued a notice of allowance for patent application number 13/400,007 covering methods of treating chronic inflammation using modified pectin. Specifically, the patent, which expires in 2025 without taking into account patent term extension, provides proprietary protection for methods of treating chronic inflammation by administration of modified pectin with a molecular weight of 10-250 kilodaltons prepared by tangential flow filtration purification.

“Chronic inflammation is the hallmark of many serious conditions such as chronic kidney disease (CKD), non-alcoholic steatohepatitis (NASH) and heart disease,” said George Tidmarsh, MD, PhD, President and CEO at La Jolla. “We plan to leverage our patent position to solidify our company as the leader in helping patients suffering from chronic organ diseases using therapeutics derived from modified pectin.”“Purification of modified pectin is an essential component for biological activity and safety,” said James Rolke, Senior Director of Research and Development at La Jolla and an inventor on the allowed patent application. “These newly allowed claims broaden our proprietary position for the use of modified pectin as a treatment for organ disease that results from chronic inflammation including all useful molecular weights and dosage forms such as aqueous solutions.”

The Company’s intellectual property portfolio also includes several issued patents covering various modified pectin compositions and methods for preparing biologically active modified pectins. The Company also has pending patent applications directed toward additional modified pectin compositions and methods of use. These issued and pending patents provide or will provide proprietary coverage for GCS-100 and other modified pectin materials, including all modified pectins currently in clinical development. In addition, the company has filed additional patent applications based on newly obtained clinical and preclinical data.

About Pectin and GCS-100

Pectins are high molecular weight, complex polysaccharides that can be obtained from multiple sources (e.g., citrus, apple), all of which share a common basic structure comprising a block co-polymer of 1,4-linked galacturonic acid and 1-2-linked rhamnose with side branches of either 1,4-linked β-D-galactose or 1,5-α-linked L-arabinose. In addition, some portion of the galacturonic acid backbone can be esterified or exist as the uronic acid salt.

GCS-100, the company’s lead product candidate, is a modified pectin and is covered by the newly allowed claims and several other issued patents. GCS-100 has been administered to over 200 patients at doses as high as 800 mg/m2 weekly (about 20 mg/kg) in previous clinical studies in cancer patients. In addition, La Jolla recently announced it had met the primary endpoint for a phase 2 CKD study; a statistically significant increase 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 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 for the treatment of hepatorenal syndrome. LJPC-401, the Company’s third product candidate, is a natural peptide 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. 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
Director of Finance
858-207-4262
czygmont@ljpc.com

La Jolla Pharmaceutical Company Announces Fourth-Quarter and Full-Year 2013 Financial Results and Highlights Recent Corporate Progress

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, announces fourth-quarter and full-year 2014 financial results and highlights recent corporate progress.

Recent Accomplishments“We continue to operate our business in a cost efficient manner,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “In 2013, we operated a public company, completed the Phase 1 clinical trial of GCS-100 for the treatment of chronic kidney disease (CKD), started and fully enrolled the Phase 2 clinical trial of GCS-100 in CKD and filed an investigational new drug (IND) application for LJPC-501 for the treatment of hepatorenal syndrome (HRS) all with a cash spend of $4.8 million.”

  • Positive top-line data from our Phase 2 clinical study of GCS-100 in CKD
  • Broad patent allowed covering modified pectins for the treatment of chronic inflammatory diseases such as CKD and Non-alcoholic steatohepatitis (NASH).
  • Positive preclinical data for GCS-100 in NASH
  • Initiation of Phase 2 Extension study of GCS-100 in CKD

Upcoming Milestones

  • First patient in our Phase 1/2 clinical study of LJPC-501 for the treatment of HRS
  • Full data package from Phase 2 clinical study of GCS-100 in CKD
  • Results from Phase 2 Extension study of GCS-100 in CKD
  • Phase 1/2 data for LJPC-501 in HRS
  • LJPC-401 IND

Results of Operations

All numbers reflect the 1-for-50 reverse stock split of the La Jolla’s common stock, which became effective on January 14, 2014. La Jolla’s comprehensive net loss attributable to common stockholders for the fourth quarter of 2013 was $6.4 million, or $72.74 per share (based on 87,940 shares), compared to a comprehensive net loss attributable to common stockholders of $3.6 million, or $13.08 per share (based on 275,440 shares), for the fourth quarter of 2012. Comprehensive net loss attributable to common stockholders was higher in the fourth quarter of 2013 primarily due to increased research and development expenses and the impact of stock compensation expenses. Comprehensive net loss attributable to common stockholders for fiscal year 2013 was $18.7 million, or $41.24 per share (based on 454,337 shares), compared to $8.5 million, or $41.77 per share (based on 203,924 shares), for 2012.

At December 31, 2013, the Company had $8.6 million in cash, as compared to $3.4 million of cash at December 31, 2012. At December 31, 2013, the Company had positive working capital of $7.7 million, compared to positive working capital of $3.2 million at December 31, 2012. The Company believes that its current cash resources are sufficient to fund operations through December 31, 2014.

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 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.

LA JOLLA PHARMACEUTICAL COMPANY

Unaudited Condensed Statements of Comprehensive Loss

(in thousands, except per share amounts)

(Unaudited)

Three Months Ended Twelve Months Ended
December 31, December 31,
2013 2012 2013 2012
Expenses:
Research and development $2,059 $509 $4,362 $1,353
General and administrative 4,339 2,901 13,577 9,386
Total expenses 6,398 3,410 17,939 10,739
Loss from operations (6,398 ) (3,410 ) (17,939 ) (10,739 )
Other income:
Adjustments to fair value of derivative liabilities 302 2,998
Other income, net 1 3 4 4
Net loss and comprehensive loss (6,397 ) (3,105 ) (17,935 ) (7,737 )
Preferred stock dividends earned (499 ) (801 ) (780 )
Net loss attributable to common stockholders $(6,397 ) $(3,604 ) $(18,736 ) $(8,517 )
Net loss per share basic and diluted $(72.74 ) $(13.08 ) $(41.24 ) $(41.77 )
Shares used in computing basic and diluted net loss per share 87,940 275,440 454,337 203,924
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Balance Sheets

(in thousands, except share and par value amounts)

(Unaudited)

December 31,
2013 2012
Assets
Current assets:
Cash and cash equivalents $8,629 $3,405
Restricted cash 37
Prepaids and other current assets 43 25
Total current assets 8,709 3,430
Equipment and furnishings, net 38
$8,747 $3,430
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $834 $92
Accrued expenses 187 107
Accrued payroll and related expenses 73 17
Total current liabilities 1,094 216
Commitments
Stockholders’ equity:

Common stock, $0.0001 par value; 12,000,000,000 shares authorized, 4,404,407 and 285,347 shares issued and outstanding at December 31, 2013 and 2012, respectively

4 1

Series C-12 convertible preferred stock, $0.0001 par value; 11,000 shares authorized, 7,016 and 5,792 shares issued and outstanding at December 31, 2013 and 2012, respectively and a liquidation preference of $7,016,000

7,016 5,792

Series C-22 convertible preferred stock, $0.0001 par value; zero and 22,000 shares authorized, zero and 500 shares issued and outstanding at December 31, 2013 and 2012, respectively

500

Series D-12 convertible preferred stock, $0.0001 par value; zero and 5,134 shares authorized, zero and 4,615 shares issued and outstanding at December 31, 2013 and 2012, respectively

4,615

Series F Convertible Preferred Stock, $ 0.0001 par value; 10,000 shares authorized, 3,250 and zero shares issued and outstanding at December 31, 2013 and 2012, respectively and a liquidation preference of $3,250,000

3,250
Additional paid-in capital 462,684 439,672
Accumulated deficit (465,301 ) (447,366 )
Total stockholders’ equity 7,653 3,214
$8,747 $3,430

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. 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
Director of Finance
858-207-4262
czygmont@ljpc.com