8-K

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): May 14, 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)

Registrant’s 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 7.01 REGULATION FD DISCLOSURE.

On May 14, 2013, La Jolla Pharmaceutical Company (the “Company”) hosted a presentation at the MoneyShow in Las Vegas, Nevada. The presentation is available on MoneyShow.com for a limited time. If attendees were not able to join the event live on the day of the conference, an on-demand archive will be available for 90 days at http://www.moneyshow.com. A copy of the presentation from the event is attached hereto as Exhibit 99.1 and is also posted on the Company’s website at http://www.ljpc.com. Also on May 14, 2013 the company issued a press release about the presentation. A copy of the press release is attached as Exhibit 99.2 to this Form 8-K.

The information set forth under Item 7.01 and in Exhibit 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

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	Presentation used in connection with the MoneyShow May 14, 2013.
99.2	Press Release dated May 14, 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: May 16, 2013	By:	/s/ George Tidmarsh
	Name:	George Tidmarsh, M.D., Ph.D.
	Title:	President and Chief Executive Officer

-3-

EX-99.1

Pioneering Innovative Therapies to Treat

Chronic Organ Failure

George F. Tidmarsh, MD, PhD

Chief Executive Officer

May 2013

Exhibit 99.1

Forward-Looking Statements

These slides contain "forward-looking" statements within the meaning

of the Private Securities Litigation Reform Act of 1995. These

statements may be identified by the use of forward looking terminology

such as "anticipate", "believe", "continue", "could", "estimate", "expect",

"intend", "may", "might", "plan", "potential", "predict", "should" or "will"

and include statements regarding La Jolla Pharmaceutical’s product

candidates and clinical trial progress and results. These forward-

looking statements are based on our current expectations, speak only

of the date of this presentation and involve risks and uncertainties,

many of which are outside of our control, that can cause actual results

to differ materially from those in the forward-looking statements.

Potential risks and uncertainties include, but are not limited to, our

ability to complete our anticipated clinical trials, the time and expense

required to conduct such clinical trials, the ability to manufacture clinical

or commercial product, issues arising in the regulatory process and the

results

of

such

clinical

trials

(including

product

safety

issues

and

efficacy results). Further information is included in La Jolla’s periodic

reports filed with the SEC at www.sec.gov. We disclaim any duty to

update any forward-looking statements.

2

An Introduction to La Jolla (LJPC)

The Technology of La Jolla

GCS-100 and Organ Failure

GCS-100’s History in the Clinic

Phase 1/2 Clinical Trial

Patents and Financials

3

Mission

La Jolla Pharmaceutical: Reducing Human Suffering

Novel Therapies

Harnessing the Immune System

To Treat Life-Threatening Diseases

4

Corporate Highlights

Corporate Highlights

5

Technology Background

Pipeline

Experienced Management

•

George F. Tidmarsh, MD, PhD, Chief Executive Officer

Milestones

•

Near-term, cost-efficient Phase 2 clinical milestones to drive value

Stanford University MD/PhD, Associate Professor, Pediatrics and Neonatology

3 FDA approved drugs

Founder Horizon Pharma (HZNP: NASDQ:GM), Threshold Pharmaceuticals (THLD:

NASDAQ: GM)

•

Immune therapy platform targeting Galectin-3, an innate protein with a demonstrated

role in organ failure via immune regulation

•

Product candidate GCS-100: the leading, clinical stage galectin-3 antagonist

May prevent or reverse organ failure by reducing fibrosis via neutralization of galectin-3

Phase 1 and 2 clinical safety data with evidence for activity improving kidney function

Robust Product Pipeline

Robust Product Pipeline

6

An Introduction to La Jolla

The Technology of La Jolla

GCS-100 and Organ Failure

GCS-100’s History in the Clinic

Phase 1/2 Clinical Trial

Patents and Financials

7

Galectins and Galectin-3

Galectins and Galectin-3

3

8

•

Galectins are proteins that can

bind to specific sugars on other proteins

(receptors) to modulate cellular  function

and communication.

•

Galectin-3 is unique in that it can self-associate allowing it to bind to  several receptors

at once.

•

Galectin-3 is normally present at low concentration, but is up-regulated in organ failure

and cancer.

GCS-100: The Leading Galectin-3 Antagonist

GCS-100: The Leading Galectin-3 Antagonist

•

GCS-100 is a well-characterized, complex sugar derived from

pectin

•

GCS-100 binds to and neutralizes galectin-3. Binding activity

is localized to the galactose

containing side-branches

•

Patented manufacturing process required for biologic activity;

unmodified pectin has reduced biologic activity

9

GCS-100

An Introduction to La Jolla

The Technology of La Jolla

GCS-100 and Organ Failure

GCS-100’s History in the Clinic

Phase 1/2 Clinical Trial

Patents and Financials

10

Galectin-3 and Organ Failure

Galectin-3 and Organ Failure

Kidney, Heart, Liver

Kidney, Heart, Liver

•

Mice lacking galectin-3 develop significantly less kidney fibrosis and

failure

after

damage

compared

to

normal

mice

1,2

•

Mice lacking galectin-3 develop significantly less liver fibrosis when

exposed

to

toxin

•

Galectin-3 serum assay is FDA approved to identify patients at risk for

death

due

to

heart

failure

4

•

Serum galectin-3 levels identify patients with end-stage renal disease

who

are

at

highest

risk

for

death

5

•

Higher galectin-3 levels in normal individuals is associated with reduced

survival

6

11

1

The American Journal of Pathology, 2008, Vol. 172, No. 2: 288-298.

2

Transplantation International, 2008, Vol. 21, No. 10: 999-1007.

3

Proceedings

of

the

National

Academy

of

Sciences,

2006,

Vol.

103,

No.

13:

5060-5065.

4

Annals of Medicine, 2011, 43: 60–68.

5

Galectin-3 and Outcomes in Patients with End-Stage Renal Disease: Data from the German Diabetes and Dialysis Study, presented by Rudolf de Boer, MD, PhD, Associate

Professor of Cardiology at the University of Groningen, the Netherlands; American Heart Association Scientific Presentation,

November 2011

6

Journal of Internal Medicine, 2012, 272; 55-64. 

3

Galectin-3 in the General Population

Galectin-3 in the General Population

12

Galectin-3 in the General Population

Galectin-3 in the General Population

•

High galectin-3 is independently associated with lower

survival in the general population

13

Journal of Internal Medicine, 2012, 272; 55-64. 

Galectin-3: Promotes Organ Failure

Galectin-3: Promotes Organ Failure

via Scar Formation

via Scar Formation

•

Mice genetically altered to lack

galectin-3 produce much less

scar tissue in the kidney after

injury.

Normal (wild-type, WT) mice or

galectin-3 knockout mice were

either left alone (-) or surgically

injured by obstructing the outflow

of urine from the kidney (UUO).

The amount of collagen and

procollagen

produced is a

measure of scar formation. As

indicated, galectin-3 knockout

mice produced much less

scaring.   

14

The American Journal of Pathology, 2008; Vol. 172, No. 2: 288-298.

Chronic Kidney Disease Market

Chronic Kidney Disease Market

•

49 million Americans

suffer with CKD

1

•

$7.1 billion spent on

CKD therapeutics in

2010

2

•

Market growth of 6.4%

CAGR over the next 5

years

2

15

1

The United States Renal Data System, 2012 Annual Data Report

2

$7.1

$11.7

$7.0

$8.0

$9.0

$10.0

$11.0

$12.0

Chronic Kidney Disease (CKD) Therapeutics - Pipeline Assessment and Market Forecasts to 2018, Globaldata, September 2011

Liver Disease Market

Liver Disease Market

16

1

The National Institute of Diabetes and Digestive and Kidney Diseases

2

Liver

Disease

Treatments:

The

Global

Market,

January

1,

2012

BCC

Research

•

17.5 million

Americans suffer

with CLD

•

$12.4 billion spent on

CLD therapeutics in

2010

•

CLD market growth

of 3.3% CAGR

expected until 2017

1

2

2

GCS-100 is Effective in Liver Fibrosis:

GCS-100 is Effective in Liver Fibrosis:

Stelic NASH Model

Stelic NASH Model

17

1

Boehringer Ingelhiem GmbH & Co. KG

2

Galectin Therapeutics

Effect of GCS-100 in liver fibrosis was studied by an

independent, contract research group

The 61

st

annual meeting of the American Association for the Study of Liver Diseases

(AASLD 2011), “The Dipeptidyl Peptidase-4 Inhibitor Linagliptin is an Effective

Therapeutic

for

Metabolic

Liver

Disease

in

Several

Rodent

Models

of

Non-Alcoholic

Fatty

Liver

Disease

(NAFLD)

and

Non-Alcoholic

Steatohepatitis

(NASH)”

1

European

Association

for

the

Study

of

the

Liver

(EASL)

Special

Conference

–

Liver

Transplantation 2011, “Improvement of steatosis, inflammation, and fibrosis in a mouse

model

of

steatohepatitis

following

treatment

with

galectin

inhibitor”

2

EASL The International Liver Congress

TM

2001 –

46

th

Annual Meeting of the European

Association for the Study of the Liver, “Novel FXR agonists with potent lipid lowering,

insulin sensitizing, anti-inflammatory and anti-fibrotisation effects in mouse models of

metabolic syndrome and NASH”

The 84

th

Annual Meeting of the Japanese Pharmacological Society, “Effects of telmisartan

against novel non-alcoholic steatohepatitis model in mice”

Stelic NASH Model

Stelic NASH Model

18

Treatment

Control

GCS-100 1 mg/kg

GCS-100 25 mg/kg

Endpoints

Pathology

Serum Chemistry

NAFLD Score

Fibrosis

GCS-100 Treatment Reduced Liver Fibrosis

GCS-100 Treatment Reduced Liver Fibrosis

19

Each circle represents

data from one mouse.

GCS-100 Treatment Reduced Liver Fibrosis

GCS-100 Treatment Reduced Liver Fibrosis

20

GCS-100 Improved Gross Pathology

GCS-100 Improved Gross Pathology

21

Vehicle

GCS-100

GCS-100 Effect of NASH: Summary

GCS-100 Effect of NASH: Summary

•

Significant reduction in fibrosis as measured by Sirius Red

staining

•

Significant reduction in NAFLD score

•

Significant reduction in plasma ALT

•

No change in:

Body weight

Serum glucose

Liver weight

Liver hydroxyproline

Collagen mRNA

22

An Introduction to La Jolla

The Technology of La Jolla

GCS-100 and Organ Failure

GCS-100’s History in the Clinic

Phase 1/2 Clinical Trial

Patents and Financials

23

GCS-100 Clinical Summary

GCS-100 Clinical Summary

•

179 patients dosed in 10 Phase 1 and Phase 2 clinical trials

•

Pharmacokinetic parameters established

Single-

and

multiple-dose

administration

of

30-160

mg/m

Effective half-life in blood of 36 hours

•

Evidence of positive effect on renal function

24

2

Source of Patients in Retrospective Analysis

Source of Patients in Retrospective Analysis

25

Study No.

Design

Treated Population

Treatments

# Patients with

eGFR <60

PR-CS008

Phase 2

24 CLL

160 mg/m

2

days 1-5

8

GLY-101-01

Phase 1

24 subjects various solid

tumors

30-200 mg/m

2

days 1-5

4

GCS-100-01-001

Phase 1

12 subjects various solid

tumors

30-80 mg/m

2

x2/week

2

GBC-590-II-001

Phase 2

20 subjects pancreatic cancer

20 mg/m

2

x2/week

2

GBC-590-II-002

Phase 2

23 subjects advanced CRC

20 mg/m

2

x2/week

3

C96-002-01

Phase 1

22 various solid tumors

1.9-20 mg/m

2

x2/week

5

C96-001-01

Phase 1

13 various solid tumors

1.9-13 mg/m

2

x2/week

1

Totals

138

25

Low Dose GCS-100 Increases Renal

Low Dose GCS-100 Increases Renal

Function

Function

26

17 patients treated with low dose GCS-100

GCS-100

GCS-100 Clinical Summary

GCS-100 Clinical Summary

•

Well tolerated and tolerable side effects based on 179 patients

treated to date

Principle side effects: mild rash, joint pain, muscle pain

•

Dosing exposure up to 1000 mg/m  per week

•

Evidence for improving kidney function

27

2

An Introduction to La Jolla

The Technology of La Jolla

GCS-100 and Organ Failure

GCS-100’s History in the Clinic

Phase 1/2 Clinical Trial

Patents and Financials

28

Clinical Trial Rational

Clinical Trial Rational

•

Galectin-3 is increased and the level correlates to overall

survival in end-stage renal disease patients

•

Galectin-3 knockout mice develop less kidney scar after injury

•

Retrospective analysis shows low dose GCS-100 improves

renal function in patients

•

Kidney disease patients have a high mortality rate and

biomarkers correlate with survival

•

Patients with chronic kidney disease have no existing

therapeutic options to reverse their disease

29

CKD Phase 1/2 Trial

CKD Phase 1/2 Trial

Phase 1 Portion Complete

Phase 1 Portion Complete

30

Part A

Day

-21

Day

-8

Day

0

Day

7

Screening

Visit 1

Screening

Visit 2

Each cohort n=3 patients

(up to 6 cohorts)

GCS-100

1.5-20 mg/m²

IV

D –

-21,-8

Data collected on:

Blood gal-3, Cytokine, Serum

chemistry, Quantitative urine

analysis, and eGFR rate

Data Collection Point

Dosing Point

Day

14

D –

7,14

D –

0,2,5

Evaluation for

dose escalation

Key

Proposed Phase 2a CKD Trial

Proposed Phase 2a CKD Trial

31

Day

0

Day

7

Day

49

Day

56

D –

0,7

GCS-100

PBO, 1.5 & 20 mg/m²

IV

Data collected on:

Blood gal-3, Cytokine, Serum

chemistry, Quantitative urine

analysis, and eGFR rate

Data Collection Point

Dosing Point

Key

Day

14

Day

28

Day

35

Day

21

D –

14,21

D –

28,35

D –

42,49

D –

56

Screening

Visits 1 & 2

n=36 1.5 mg/m

2

/min

n=36 20 mg/m

2

/min

n=36 Placebo

N=108 Randomized

Day

42

Expanded Phase 2/Phase 2a

GCS-100 in CKD Status

GCS-100 in CKD Status

•

Phase 1 Complete

4 leading sites in the US

Enrolled 29 patients in 3 months

•

Accelerated path to Phase 2 Data

Randomized, 3 arm study proposed

–

Endpoints:

-

Change in renal function compared to placebo

Protocol currently under review at FDA

32

An Introduction to La Jolla

The Technology of La Jolla

GCS-100 and Organ Failure

GCS-100’s History in the Clinic

Phase 1/2 Clinical Trial

Patents and Financials

33

Title

Status

Expiration

Modified Pectins, Compositions and

Methods Related Thereto

Issued

US 8,128,966

2028

Modified Pectins, Compositions and

Methods Related Thereto

Issued

US 8,187,642

2025

Modified Pectins, Compositions and

Methods Related Thereto

Pending

US 13/588,932

2025

Modified Pectins, Compositions and

Methods Related Thereto

Issued

US 13/588/877

2025

Modified Pectins, Compositions and

Methods Related Thereto

Pending

US 13/400,007

2025

Compositions and Uses of Galectin

Antagonists

Pending

US 11/803,150

2027

Intellectual Property Position

Intellectual Property Position

34

Assets

Assets

35

March

31, 2013

December

31, 2012

Assets

Cash and Cash equivalents

2,700

3,405

Restricted cash

37

–

Prepaids and other current

assets

76

25

Total current assets

2,813

3,430

Total Assets

2,813

3,430

Liabilities, Shareholders’

Liabilities, Shareholders’

Equity

Equity

36

March 31,

2013

December 31,

2012

Current Liabilities:

Accounts payable

69

92

Accrued expenses

176

107

Accrued payroll and related expenses

26

17

Total current liabilities

271

216

Stockholders’

equity:

Common stock

2

1

Preferred stock

10,888

10,907

Additional paid-in capital

443,221

439,672

Accumulated deficit

(451,569)

(447,366)

Total stockholders’

equity (deficit)

2,542

3,214

Total liabilities, preferred stock, and stockholders equity

2,813

3,430

Stock Information

Stock Information

Stock Price

$0.08

Shares Outstanding

30,486,228

Market Cap

$2,438,898

Price Range

(52 Week)

$0.04 –

$0.14

Avg. Volume

215,857

37

33.3% Gain in stock price since 12/31/12

& up 100% gain on intra day trading

$0.050

$0.070

$0.090

54.0%

Outstanding Common Stock

Public Float

Non-Affiliates

Directors, Officers & Management

Robust Product Pipeline

Robust Product Pipeline

38

Corporate Highlights

Corporate Highlights

Technology Background

Pipeline

May prevent or reverse organ failure by reducing fibrosis via

neutralization of galectin-3

Phase 1 and 2 clinical safety data with evidence for activity improving

kidney function

Management

Experienced and driven

Milestones

Near-term, cost-efficient Phase 2 clinical milestones to drive value

39

•

Immune therapy platform targeting Galectin-3, an innate protein with a

demonstrated role in organ failure via immune regulation

•

Product candidate GCS-100: the leading, clinical stage galectin-3 antagonist

Thank You

EX-99.2

Exhibit 99.2

La Jolla Pharmaceutical Company Presents Corporate Update at The MoneyShow

SAN DIEGO, CALIFORNIA – (MARKETWIRE – May 14, 2013) – La Jolla Pharmaceutical Company (OTCBB: LJPC) (“La Jolla” and “Company”), a leader in the development of therapeutics targeting galectin proteins, announced that George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer presented today at the MoneyShow, Caesars Palace in Las Vegas Nevada. The presentation was available to attendees and via live webcast at MoneyShow.com. As part of the presentation, Dr. Tidmarsh presented detailed data on GCS-100 and its positive effect on eGFR in previous clinical studies. Also, new information about the focus and direction of La Jolla for 2013 was presented. A video of the webcasted presentation is available on MoneyShow.com. This information can also be found on the Company’s website and Form 8-K filed with the SEC. La Jolla expects to release further data from the recently completed Phase 1 clinical trial in the coming weeks.

“Our retrospective analysis of renal function data from previous GCS-100 clinical trials provides solid support for our current program using GCS-100 for the treatment of Chronic Kidney Disease. This analysis shows that many patients who started treatment with reduced renal function experienced a significant improvement on GCS-100 treatment,” said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “While not all patients showed an improvement, many of those that did experienced a major improvement. We hope that this effect is confirmed in our upcoming Phase 2 trial.”

About Chronic Kidney Disease

Chronic kidney disease (“CKD”) currently affects 14% of Americans or approximately 49 million people. The United States Renal Data System, 2012 Annual Data Report, states that in 2010, costs for CKD reached $41 billion for Medicare alone. Overall per person per year costs for CKD were estimated at $22,323 for Medicare patients of age 65 and older and $13,395 for patients of age 50-64. Patients with CKD may progress to end-stage renal disease (“ESRD”). According to the National Institute of Diabetes and Digestive and Kidney Diseases as of 2008, there were 547,982 individuals in the US under treatment for ESRD and 88,630 deaths per year from ESRD.

About GCS-100

GCS-100 is a complex polysaccharide that has the ability to bind to and block the effects of galectin-3. Galectin-3 is a soluble protein, over-expression of which has been implicated in a number of human diseases including cancer and chronic organ failure. The unique ability of GCS-100 to bind and sequester galectin-3 makes it an ideal candidate to prevent and treat diseases in which galectin-3 plays an important role.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company dedicated to the development of medical treatments that significantly improve outcomes in patients with life-threatening diseases. 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. 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 from time to time 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 this compound, 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.

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