EX-99.1 2 a05-8958_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

FOR FURTHER INFORMATION CONTACT:
Deborah S. Lorenz
Vice President, Investor Relations and
Corporate Communications
Lipid Sciences, Inc.
925-249-4031
dlorenz@lipidsciences.com

 

FOR IMMEDIATE RELEASE:
May 9, 2005

 

LIPID SCIENCES, INC. REPORTS FINANCIAL RESULTS FOR THE FIRST QUARTER 2005

 

Data Acquisition Phase of Non-human Primate Study Complete
Latest Viral Immunotherapy Data Presented at Keystone Symposium

 

PLEASANTON, Calif., May 9, 2005 – Lipid Sciences, Inc. (Nasdaq:LIPD) today reported financial results for the first quarter ended March 31, 2005.  Lipid Sciences is a development-stage biotechnology company engaged in the research and development of products and processes intended to treat major medical indications in which lipids, or fat components, play a key role.  These medical indications include cardiovascular disease and viral infections, such as those caused by Human Immunodeficiency Virus (HIV).

 

For the first quarter of 2005, the Company reported a net loss of $2.4 million, or $0.10 per share on a basic and diluted basis.  This compares with a net loss of $2.6 million, or $0.11 per share, on a basic and diluted basis, for the same period in 2004.  Operating expenses of $2.5 million for the first quarter of 2005 declined from $2.9 million during the same period in 2004.  The decrease of 15% was due primarily to reductions in stock compensation expense, external development costs for the Company’s delipidation device, legal, and administrative expenses.

 

At March 31, 2005, the Company had $15.8 million in cash, cash equivalents, and short-term investments.  The Company anticipates that sufficient capital is available to fund its operations, including current development projects, at least through the early part of 2006.  The Board of Directors continues to consider and explore third-party inquiries and strategic alternatives and will comment when appropriate.

 

Data Acquisition Phase of Non-human Primate Study Complete

 

This study, conducted at the Wake Forest Baptist Medical Center, was designed to demonstrate the safety and effectiveness of Lipid Sciences’ HDL Therapy in treating cardiovascular disease.  The study subjects, African green monkeys, a widely-accepted model for human atherosclerosis, were evaluated with intravascular ultrasound (IVUS) to establish a baseline at the beginning of this study.  A second IVUS was conducted at the conclusion of the sequence of 12 weekly infusions of plasma that had been delipidated by Lipid Sciences’ proprietary process and device.  These infusions appear to have been well tolerated.  The complex body of IVUS data is now being analyzed by Dr. Steven Nissen, Vice Chairman of Cardiology, at the Cleveland Clinic Foundation and his colleagues.  It is anticipated that the analysis of all of the data resulting from this study will be completed by mid-2005.

 



 

Dr. S. Lewis Meyer, President and Chief Executive Officer, commented, “At the end of March, we met with representatives of the Center for Devices and Radiological Health of the FDA as scheduled.  At this meeting we discussed the steps necessary for us to proceed with the submission of an Investigational Device Exemption (IDE), covering our HDL Therapy system, in the third quarter of this year. An important component of that submission will be the data that was acquired and is now being analyzed, associated with our HDL Therapy non-human primate study conducted earlier this year.  The approval of this IDE is a critical milestone for the Company because it will set the stage for the initiation of a human clinical trial and the transition of Lipid Sciences from a pre-clinical company to a company with its proprietary delipidation system in a human clinical trial.”

 

Latest Viral Immunotherapy Data Presented at Keystone Symposium

 

The latest results of both in vivo and in vitro studies supporting our Viral Immunotherapy Platform have been presented at the Keystone Symposium – an important forum for presenting new data in the area of HIV research.

 

The in vivo study was designed to demonstrate whether there was a measurable response to delipidated Simian Immunodeficiency Virus (SIV) in severely SIV-infected monkeys.  SIV is a widely-accepted primate model for viral diseases like HIV.  This preliminary study demonstrated that the autologous SIV virus, delipidated by Lipid Sciences’ proprietary delipidation process, was efficiently recognized by the animals’ immune systems and has resulted in a measurable improvement in the conventional indicators of overall health in these study animals.  These results included a viral load reduction of 90+%, weight gain, and extended post-infection survival.  The ability to use small amounts of a patient’s autologous circulating viral antigen to generate a virus-specific immune response could potentially lead to the control of viral replication and provide a unique approach to the development of an effective treatment for chronic HIV infection.

 

By mid-2005 the Company plans to launch a pre-clinical safety and effectiveness study in a statistically significant group of SIV-infected non-human primates.  The purpose of this study will be to gather sufficient information to begin to dialogue with the Food and Drug Administration about a human clinical trial for the treatment of HIV-infected patients.

 

The in vitro experiments demonstrated that Lipid Sciences’ proprietary delipidation process removed the majority of all lipids from the virus.  This lipid removal was confirmed by electrospray ionization mass spectrometry.  The delipidated viruses appear to represent a promising approach to the development of a therapy to treat HIV-infected patients.

 

The posters containing this data have been added to the Company’s website, www.lipidsciences.com, under the Abstracts and Publications heading.

 

Annual Meeting of Stockholders

 

The 2005 Annual Meeting of Stockholders of Lipid Sciences, Inc. will be held at the Company’s executive offices in Pleasanton, California on Thursday, June 9, 2005, at 8:00 a.m. Pacific Daylight Time.  An Annual Report, Proxy Statement, and Proxy Card were mailed on April 28, 2005 to stockholders of record as of April 12, 2005.

 

Lipid Sciences, Inc. is a development-stage biotechnology company engaged in the research and development of products and processes intended to treat major medical indications, in which lipids, or fat components, play a key role.  The Company’s technologies are based on a unique patented process, known as delipidation, which selectively and rapidly removes lipids, such as cholesterol, from targeted lipoproteins or viruses circulating in blood plasma without disrupting the non-targeted plasma proteins’ function.  The Company’s HDL Therapy Platform is aimed at developing treatments for the reversal of atherosclerosis, a systemic disease of the blood vessels caused by the build-up of cholesterol-filled plaques in the vascular system and, most critically, in the coronary arteries.  If left untreated, these plaques are highly vulnerable to rupture and to blood clot formation, which can result in a fatal myocardial infarction (heart attack).  Regression of such plaques may have a major impact on reducing the risk of acute coronary events.  The Company’s Viral Immunotherapy Platform is focused on the removal of the lipid coatings from lipid-enveloped viruses and other lipid-containing infectious agents by application of Lipid Sciences’ delipidation technology.  The Company believes that removing the virus’ protective lipid coating exposes otherwise hidden viral proteins, to

 



 

stimulate the body’s immune system to effectively fight the disease.  Conditions that could potentially be impacted by this technology include HIV, Hepatitis B and Hepatitis C, West Nile, SARS and influenza.

 

Forward-Looking Statements:  This release contains forward-looking statements concerning plans, objectives, goals, strategies, study results, anticipations, expectations, future events or performance as well as all other statements that are not statements of historical fact.  The forward-looking statements contained in this release reflect our current beliefs and expectations on the date of this release.  Actual results, performance or outcomes may differ materially from what is expressed in the forward-looking statements.  Readers are referred to the documents filed by us with the SEC, specifically the most recent reports on Form 10-K and Form 10-Q which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.  In addition to those risk factors, other factors that could cause actual results to differ materially include the following:  Our inability to obtain adequate funds; our technology not proving to be safe or effective; our inability to obtain regulatory approval for our technology, which is only in the clinical development stage; delay or failure to complete clinical studies; our dependence on our license agreement with Aruba International B.V.; our reliance on collaborations with strategic partners and consultants; competition in our industry, including the development of new products by others that may provide alternative or better therapies; failure to secure and enforce our intellectual property rights; risks associated with use of biological and hazardous materials;  and our dependence on key personnel.

 

The financial information contained in this release should be read in conjunction with the consolidated financial statements and notes thereto included in our most recent reports on Form 10-K and Form 10-Q.  Copies are available through the SEC’s Electronic Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov.  Lipid Sciences assumes no obligation to update the forward-looking statements included in this document.

 

Press releases for Lipid Sciences, Inc. are available on our website: www.lipidsciences.com.  If you would like to receive our press releases via email, please contact: info@lipidsciences.com.

 



 

Lipid Sciences, Inc.

(A Development Stage Company)

Condensed Consolidated Balance Sheet (Unaudited)
(In thousands, except share amounts)

 

 

 

March 31, 2005

 

December 31, 2004

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

3,901

 

$

4,640

 

Short-term investments

 

11,922

 

12,414

 

Prepaid expenses

 

256

 

313

 

Restricted cash

 

106

 

105

 

Other current assets

 

8

 

11

 

Assets held for sale

 

 

1,167

 

Total current assets

 

16,193

 

18,650

 

Property and equipment

 

385

 

436

 

Total assets

 

$

16,578

 

$

19,086

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

1,064

 

$

863

 

Accrued related party royalties

 

375

 

750

 

Accrued compensation

 

551

 

542

 

Income taxes payable

 

4

 

 

Other current liabilities

 

17

 

20

 

Total current liabilities

 

2,011

 

2,175

 

Total liabilities

 

2,011

 

2,175

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized and issuable; no shares outstanding

 

 

 

 

 

 

 

 

 

Common stock, $0.001 par value; 75,000,000 shares authorized; 24,912,263 and 24,912,263 shares issued and outstanding at March 31, 2005 and December 31, 2004, respectively

 

25

 

25

 

 

 

 

 

 

 

Additional paid-in capital

 

69,994

 

69,953

 

Deficit accumulated in the development stage

 

(55,452

)

(53,067

)

Total stockholders’ equity

 

14,567

 

16,911

 

Total liabilities and stockholders’ equity

 

$

16,578

 

$

19,086

 

 



 

Lipid Sciences, Inc.
(A Development Stage Company)
Condensed Consolidated Statements of
Operations
(Unaudited)

 

 

 

Three Months Ended
March 31,

 

Period from
Inception (May
21, 1999) to
March 31,

 

(In thousands, except per share amounts)

 

2005

 

2004

 

2005

 

 

 

 

 

 

 

 

 

Grant Revenue

 

$

 

$

 

$

32

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

1,624

 

1,828

 

46,702

 

Selling, general and administrative

 

848

 

1,066

 

20,404

 

Total operating expenses

 

2,472

 

2,894

 

67,106

 

Operating loss

 

(2,472

)

(2,894

)

(67,074

)

Interest and other income

 

87

 

188

 

3,215

 

Loss from continuing operations

 

(2,385

)

(2,706

)

(63,859

)

Income tax benefit

 

 

 

8,004

 

Net loss from continuing operations

 

(2,385

)

(2,706

)

(55,855

)

Discontinued operations:

 

 

 

 

 

 

 

Income from discontinued operations

 

 

62

 

582

 

Income tax expense

 

 

 

(179

)

Income from discontinued operations - net

 

 

62

 

403

 

 

 

 

 

 

 

 

 

Net loss

 

$

(2,385

)

$

(2,644

)

$

(55,452

)

 

 

 

 

 

 

 

 

Loss per share – basic and diluted:

 

 

 

 

 

 

 

Net loss per share continuing operations

 

$

(0.10

)

$

(0.11

)

 

 

Income per share discontinued operations

 

$

 

$

 

 

 

Net loss per share

 

$

(0.10

)

$

(0.11

)

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares outstanding – basic and diluted

 

24,912

 

24,437