-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, B1j3dxnkRN8+fOc70Eug6vWm+3eGMeeCwA69ifa0NmURPrFn43q0im+w2d8HJwDB RzK12RIRGGV1xr8tSQg/ag== 0001104659-05-008037.txt : 20050224 0001104659-05-008037.hdr.sgml : 20050224 20050224060629 ACCESSION NUMBER: 0001104659-05-008037 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20050224 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050224 DATE AS OF CHANGE: 20050224 FILER: COMPANY DATA: COMPANY CONFORMED NAME: LIPID SCIENCES INC/ CENTRAL INDEX KEY: 0000071478 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 430433090 STATE OF INCORPORATION: AZ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-00497 FILM NUMBER: 05635717 BUSINESS ADDRESS: STREET 1: 7068 KOLL CENTER PARKWAY STREET 2: SUITE 401 CITY: PLEASANTON STATE: CA ZIP: 94566 BUSINESS PHONE: 925-249-4000 MAIL ADDRESS: STREET 1: 7068 KOLL CENTER PARKWAY STREET 2: SUITE 401 CITY: PLEASANTON STATE: CA ZIP: 94566 FORMER COMPANY: FORMER CONFORMED NAME: NZ CORP DATE OF NAME CHANGE: 20000810 FORMER COMPANY: FORMER CONFORMED NAME: NEW MEXICO & ARIZONA LAND CO DATE OF NAME CHANGE: 19920703 8-K 1 a05-4109_18k.htm 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):  February 24, 2005

 

LIPID SCIENCES, INC.
(Exact name of registrant as specified in its charter)

 

Delaware

 

0-497

 

43-0433090

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(I.R.S Employer Identification No.)

 

 

 

7068 Koll Center Parkway, Suite 401, Pleasanton, California

 

94566

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:  (925) 249-4000

 

(Former name or former address, if changed since last report.)  N/A

 

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):

 

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

o

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 February 24, 2005, Lipid Sciences, Inc. issued a press release entitled “Lipid Sciences, Inc. Presents at Roth Capital Partners 17th Annual Growth Stock Conference.”  A copy of the press release is furnished as Exhibit 99.1 to this report.

The information in this report, including the exhibit hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section.  In addition, the information in this report shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporating language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(c) Exhibits

99.1         Press release entitled “Lipid Sciences, Inc. Presents at Roth Capital Partners 17th Annual Growth Stock Conference,” dated February 24, 2005.

 

 

2



 

SIGNATURE

 

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.

 

 

 

 

Lipid Sciences, Inc.

 

 

 

 

 

 

 

 

Date:

February 24, 2005

 

 

By:

/s/ Sandra Gardiner

 

 

 

 

Name:

Sandra Gardiner

 

 

 

Title:

Chief Financial Officer

 

 

3



 

EXHIBIT INDEX

 

Exhibit

 

Description

 

 

 

99.1

 

Press release entitled “Lipid Sciences, Inc. Presents at Roth Capital Partners 17th Annual Growth Stock Conference,” dated February 24, 2005.

 

 

4


EX-99.1 2 a05-4109_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:

February 24, 2005

 

LIPID SCIENCES, INC.  PRESENTS AT ROTH CAPITAL PARTNERS 17th ANNUAL
GROWTH STOCK CONFERENCE

 

Data Acquisition Phase of the HDL Therapy Non-Human Primate Study Complete

 

Pre-IDE Meeting with FDA Scheduled for End of March

 

PLEASANTON, Calif., February 24, 2005 – Lipid Sciences, Inc. (Nasdaq:LIPD), in a presentation made at the Roth Capital Partners 17th Annual Growth Company Conference on February 23, 2005 at 2:30 p.m. Pacific Time, announced that two significant corporate milestones had been met: the final data acquisition phase of its HDL Therapy non-human primate study has been completed, and a pre-IDE meeting with the FDA has been scheduled for the end of March.  In his presentation, Dr. S. Lewis Meyer, President and CEO of Lipid Sciences, also included an outline of additional corporate milestones as well as a detailed discussion of the Company’s HDL Therapy and Viral Immunotherapy platforms.  To listen to this presentation, log-on to the Investor Relations portion of the Lipid Sciences’ website at www.lipidsciences.com where the audio, as well as the visuals, will be archived.

 

Data Acquisition Phase of Non-human Primate Study Complete

The data acquisition phase of Lipid Sciences’ pre-clinical non-human primate study that began in September of last year at the Wake Forest University Baptist Medical Center has now been completed.

 

This study was designed to demonstrate the safety and effectiveness of Lipid Sciences’ HDL Therapy system in a relevant human-like model.  The study subjects, African green monkeys, a widely–accepted model for human atherosclerosis, were first surveyed with intravascular ultrasound (IVUS) to determine the presence and composition of atherosclerotic plaque.  They then received a sequence of 12 weekly infusions of plasma that had been delipidated by Lipid Sciences’ proprietary process and device.  The infusions appear to have been well tolerated by the study subjects.  In addition to establishing a strong base of safety data, the effectiveness endpoint of this study will be the measurement of arterial plaque regression as determined by comparing plaque volume by IVUS at the beginning and end of the treatment cycle.   This complex body of IVUS data acquired in the study, consisting of several hundred thousand individual data points, is now being organized, collated, and edited in preparation for review by Dr. Steven E. Nissen, M.D., FACC, Vice-Chairman of Cardiology at the Cleveland Clinic Foundation and his colleagues.  Dr. Nissen has been at the forefront in the application of IVUS to diagnosis coronary artery disease.  We anticipate that the data analysis portion of this study will be completed by mid-2005.  A successful conclusion of this innovative study would potentially lead to a new therapeutic approach in the treatment of cardiovascular diseases, such as heart attacks and strokes, in the high-risk patient.

 

Pre-IDE Meeting with FDA

In January the Company forwarded a comprehensive information package to the Center for Devices and Radiological Health (CDRH) of the FDA for their review in advance of a pre-IDE (Investigational Device Exemption) meeting which is now scheduled for the end of March.  This meeting will begin the discussion of the steps necessary to proceed with the submission of an IDE—the approval of which will set the stage for the initiation of a human clinical trial.

 

- more -

 



 

Viral Immunotherapy Platform

The Company has been invited to make an oral presentation at the prestigious Keystone Conference to be held in April 2005.  In addition, our Viral Immunotherapy technology will be highlighted on two poster presentations.

 

HDL Therapy Platform Planned Milestones

                  IDE submission/approval Q3 2005

                  Human clinical trial commences Q4 2005/Q1 2006

                  CE Mark – European market clearance

                  Pivotal human clinical trial

                  Pre-market approval

                  Commercial launch

 

Viral Immunotherapy Platform Planned Milestones

                  Expanded monkey study launch Q4 2004

                  Pre-clinical monkey safety and effectiveness study – Q2/Q3 2005

 

Corporate

The Company is currently exploring outlicensing opportunities of the delipidation process for non-human health applications such as the field of animal health.

 

Lipid Sciences will report financial results for the Fourth Quarter and Year End 2004 on Thursday, March 10, 2005.

 

Lipid Sciences, Inc. is a development-stage biotechnology company engaged in the research and development of products and processes 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 removes lipids from targeted proteins.  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 envelope from certain viruses and other lipid-containing infectious agents by application of its delipidation technology.  The Company believes that removing the infectious agent’s protective lipid envelope exposes otherwise hidden viral proteins, thereby stimulating the body’s immune system to elicit an enhanced response to the infectious agent.  Conditions that could potentially be impacted by this technology include HIV, Hepatitis B and Hepatitis C, West Nile and SARS.

 

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 or attract strategic partners or to effect other transactions; 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; our reliance on collaborations with strategic partners; competition in our industry; failure to secure and enforce our intellectual property rights; risks associated with use of biological and hazardous materials; product liability claims; 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.

 


 

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