-----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, HAjuBiGkULmKQOWoPOHoPCpzQkULRTDQzuOp/2FoX0rDy+PMxGDYyTWa5IucDavw ozTaO99XAI01ua4ey5CkRQ== 0001104659-08-052830.txt : 20080814 0001104659-08-052830.hdr.sgml : 20080814 20080814103052 ACCESSION NUMBER: 0001104659-08-052830 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20080630 FILED AS OF DATE: 20080814 DATE AS OF CHANGE: 20080814 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: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-00497 FILM NUMBER: 081015972 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 10-Q 1 a08-18775_110q.htm 10-Q

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 


 

FORM 10-Q

 

x

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

For the Quarterly Period Ended June 30, 2008.

 

 

OR

 

 

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

For the transition period from              to              

 

Commission File Number:  0-497

 


 

Lipid Sciences, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

43-0433090

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

 

7068 Koll Center Parkway, Suite 401, Pleasanton, California 94566

(Address of principal executive offices)          (Zip Code)

 

(925) 249-4000

(Registrant’s telephone number, including area code)

 


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.   Yes x   No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See definitions of “large accelerated filer” and “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

 

Large accelerated filer ¨

 

 

Accelerated filer ¨

 

Non - Accelerated filer ¨

 

 

Smaller reporting company x

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o  No x

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class

 

Shares outstanding at July 31, 2008

Common Stock

 

 

$0.001 par value

 

37,125,348

 

 

 



Table of Contents

 

LIPID SCIENCES, INC.

 

FORM 10-Q

 

For the Period Ended June 30, 2008

 

TABLE OF CONTENTS

 

 

Page No.

 

 

PART 1 – FINANCIAL INFORMATION

 

 

 

Item 1.

Financial Statements

1

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2008 and December 31, 2007

1

 

 

 

 

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2008 and 2007, and cumulative period from Inception (May 21, 1999) to June 30, 2008

2

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2008 and 2007, and cumulative period from Inception (May 21, 1999) to June 30, 2008

3

 

 

 

 

Notes to Condensed Consolidated Financial Statements

5

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

11

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

17

 

 

 

Item 4.

Controls and Procedures

17

 

 

 

Item 4T.

Controls and Procedures

17

 

 

 

PART II – OTHER INFORMATION

18

 

 

Item 1.

Legal Proceedings

18

 

 

 

Item 1A.

Risk Factors

18

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

18

 

 

 

Item 3.

Defaults Upon Senior Securities

18

 

 

 

Item 4.

Submission of Matters to a Vote of Security Holders

18

 

 

 

Item 5.

Other Information

18

 

 

 

Item 6.

Exhibits

18

 

 

 

SIGNATURES

19

 

 

EXHIBIT INDEX

20

 



Table of Contents

 

PART I – FINANCIAL INFORMATION

 

ITEM 1.      FINANCIAL STATEMENTS

 

Lipid Sciences, Inc.
(A Development Stage Company)

Condensed Consolidated Balance Sheets (Unaudited)

(In thousands, except share amounts)

 

 

 

June 30, 2008

 

December 31, 2007

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

2,374

 

$

6,459

 

Accounts receivable

 

 

4

 

Prepaid expenses

 

311

 

508

 

Other current assets

 

5

 

25

 

Total current assets

 

2,690

 

6,996

 

Property and equipment, net

 

259

 

267

 

Long-term lease deposits

 

18

 

18

 

Total assets

 

$

2,967

 

$

7,281

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

1,924

 

$

2,317

 

Accrued related party royalties

 

500

 

250

 

Accrued compensation

 

369

 

604

 

Taxes payable

 

2

 

 

Total current liabilities

 

2,795

 

3,171

 

Deferred rent

 

16

 

17

 

Total liabilities

 

2,811

 

3,188

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

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

 

 

 

Common stock, $0.001 par value; 125,000,000 shares authorized; 37,125,348 shares issued and outstanding at both June 30, 2008 and December 31, 2007

 

37

 

37

 

Additional paid-in capital

 

91,556

 

91,269

 

Deficit accumulated in the development stage

 

(91,437

)

(87,213

)

Total stockholders’ equity

 

156

 

4,093

 

Total liabilities and stockholders’ equity

 

$

2,967

 

$

7,281

 

 

See accompanying Notes to Condensed Consolidated Financial Statements

 

1



Table of Contents

 

Lipid Sciences, Inc.

(A Development Stage Company)

Condensed Consolidated Statements of Operations (Unaudited)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

Period from
Inception
(May 21, 1999)
to June 30,

 

(In thousands, except per share amounts)

 

2008

 

2007

 

2008

 

2007

 

2008

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Collaboration agreement revenue

 

$

 

$

137

 

$

250

 

$

196

 

$

556

 

Grant revenue

 

 

 

 

 

100

 

Total revenue

 

 

137

 

250

 

196

 

656

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development(1)

 

1,256

 

2,063

 

2,894

 

3,876

 

71,968

 

Selling, general and administrative(2)

 

746

 

992

 

1,643

 

1,898

 

33,357

 

Total operating expenses

 

2,002

 

3,055

 

4,537

 

5,774

 

105,325

 

Operating loss

 

(2,002

)

(2,918

)

(4,287

)

(5,578

)

(104,669

)

Interest and other income

 

17

 

171

 

63

 

375

 

4,825

 

Loss from continuing operations

 

(1,985

)

(2,747

)

(4,224

)

(5,203

)

(99,844

)

Income tax benefit

 

 

 

 

 

8,004

 

Net loss from continuing operations

 

(1,985

)

(2,747

)

(4,224

)

(5,203

)

(91,840

)

Discontinued operations:

 

 

 

 

 

 

 

 

 

 

 

Income from discontinued operations

 

 

 

 

 

582

 

Income tax expense

 

 

 

 

 

(179

)

Income from discontinued operations - net

 

 

 

 

 

403

 

Net loss

 

$

(1,985

)

$

(2,747

)

$

(4,224

)

$

(5,203

)

$

(91,437

)

 

 

 

 

 

 

 

 

 

 

 

 

Loss per share – basic and diluted:

 

 

 

 

 

 

 

 

 

 

 

Net loss per share

 

$

(0.05

)

$

(0.07

)

$

(0.11

)

$

(0.14

)

 

 

Weighted average number of common shares outstanding – basic and diluted

 

37,125

 

37,120

 

37,125

 

37,120

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-cash option compensation expense included in operating expenses:

 

 

 

 

 

 

 

 

 

 

 


(1)Research and development

 

(2

)

103

 

88

 

181

 

 

 

(2)Selling, general and administrative

 

76

 

167

 

199

 

287

 

 

 

 

See accompanying Notes to Condensed Consolidated Financial Statements

 

2



Table of Contents

 

Lipid Sciences, Inc.

(A Development Stage Company)

Condensed Consolidated Statements of Cash Flows (Unaudited)

 

 

 

Six Months Ended
June 30,

 

Period from
Inception
(May 21, 1999)
to June 30,

 

(In thousands)

 

2008

 

2007

 

2008

 

Cash flows used in operating activities:

 

 

 

 

 

 

 

Net loss from continuing operations

 

$

(4,224

)

$

(5,203

)

$

(91,840

)

Adjustments to reconcile net loss from continuing operations to net cash used in operating activities:

 

 

 

 

 

 

 

Depreciation and amortization

 

63

 

90

 

1,614

 

Loss on disposal of assets

 

 

3

 

214

 

Accretion of discount on investments

 

 

 

(891

)

Stock compensation expense for options issued to consultants, employees and advisors

 

287

 

468

 

9,156

 

Issuance of warrants to consultants

 

 

 

1,282

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

4

 

(127

)

 

Prepaid expenses and other current assets

 

217

 

90

 

(316

)

Notes receivable

 

 

 

6,569

 

Other assets

 

 

 

(19

)

Taxes payable

 

2

 

1

 

2

 

Accounts payable and other current liabilities

 

(393

)

23

 

(120

)

Accrued related party royalties

 

250

 

250

 

500

 

Accrued compensation

 

(235

)

(137

)

369

 

Deferred revenue

 

 

23

 

 

Deferred rent

 

(1

)

1

 

17

 

Net cash used in operating activities of continuing operations

 

(4,030

)

(4,518

)

(73,463

)

 

 

 

 

 

 

 

 

Cash flows used in investing activities:

 

 

 

 

 

 

 

Capital expenditures

 

(55

)

(65

)

(2,102

)

Proceeds from disposal of assets

 

 

 

17

 

Purchases of investments

 

 

 

(91,395

)

Maturities and sales of investments

 

 

 

92,286

 

Net cash used in investing activities of continuing operations

 

(55

)

(65

)

(1,194

)

 

 

 

 

 

 

 

 

Cash flows provided by financing activities:

 

 

 

 

 

 

 

Acquisition of NZ Corporation – cash acquired

 

 

 

20,666

 

Payment of acquisition costs

 

 

 

(1,863

)

Payment to repurchase stock

 

 

 

(12,513

)

Proceeds from sale of common stock, net of issuance costs

 

 

25

 

36,587

 

Proceeds from issuance of warrants

 

 

 

40

 

Net cash provided by financing activities of continuing operations

 

 

25

 

42,917

 

Net decrease in cash and cash equivalents from continuing operations

 

(4,085

)

(4,558

)

(31,740

)

 

 

 

 

 

 

 

 

Cash flows provided by discontinued operations:

 

 

 

 

 

 

 

Operating activities

 

 

 

38,185

 

Investing activities

 

 

 

10,837

 

Financing activities

 

 

 

(14,908

)

 

 

 

 

 

 

 

 

Net cash provided by discontinued operations

 

 

 

34,114

 

Cash and cash equivalents at beginning of period

 

6,459

 

16,691

 

 

Cash and cash equivalents at end of period

 

$

2,374

 

$

12,133

 

$

2,374

 

 

3



Table of Contents

 

 

 

Six Months Ended
June 30,

 

Period from
Inception
(May 21, 1999)
to June 30,

 

(In thousands)

 

2008

 

2007

 

2008

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION

 

 

 

 

 

 

 

Cash paid during the year for:

 

 

 

 

 

 

 

Interest (net of amount capitalized)

 

$

 

$

 

$

839

 

Income tax recovered

 

 

 

(1,473

)

 

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING TRANSACTIONS

 

 

 

 

 

 

 

Acquisition of NZ Corporation:

 

 

 

 

 

 

 

Current assets (other than cash)

 

$

 

$

 

$

1,040

 

Property and equipment

 

 

 

30,193

 

Commercial real estate loans

 

 

 

16,335

 

Notes and receivables

 

 

 

15,166

 

Investments in joint ventures

 

 

 

2,343

 

Current liabilities assumed

 

 

 

(1,947

)

Long-term debt assumed

 

 

 

(14,908

)

Deferred taxes associated with the acquisition

 

 

 

(7,936

)

Fair value of assets acquired (other than cash)

 

$

 

$

 

$

40,286

 

 

See accompanying Notes to Condensed Consolidated Financial Statements

 

4



Table of Contents

 

Lipid Sciences, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

NOTE 1:  ORGANIZATION AND BASIS OF PRESENTATION

 

In this Quarterly Report on Form 10-Q, unless the context otherwise requires, Lipid Sciences, Inc., a Delaware corporation, is referred to as “we,” “the Company” or “Lipid Sciences.”

 

On November 29, 2001, Lipid Sciences, Inc., a privately-held corporation, merged with and into NZ Corporation, an Arizona corporation.  Immediately after the completion of the merger, NZ Corporation changed its name to Lipid Sciences, Inc.  On June 26, 2002, Lipid Sciences changed its state of incorporation from Arizona to Delaware.  In this Quarterly Report on Form 10-Q, we refer to our former name, NZ Corporation, as “NZ,” and we refer to the merged corporation, Lipid Sciences, Inc., as “Pre-Merger Lipid.”

 

The Company is engaged in research and development of products and processes intended to treat major medical indications such as cardiovascular disease and viral infections in which lipids, or fat components, play a key role.  Our primary activities since incorporation have been conducting research and development (including pre-clinical studies); conducting a clinical trial; performing business, strategic and financial planning; and raising capital.  Accordingly, the Company is considered to be in the development stage.

 

In the course of our research and development activities, we have incurred significant operating losses and we expect these losses to continue for the foreseeable future as we continue to invest in research and development and begin to allocate significant and increasing resources to clinical testing and other activities related to seeking approval to market our products.  As of June 30, 2008, we had cash and cash equivalents equal to approximately $2.4 million.  We anticipate that existing cash and cash equivalents, in addition to any proceeds received from current or future licensing partnerships, will provide sufficient cash to fund our operations, including our current development projects, into the fourth quarter of 2008.  We have based this estimate on current assumptions that may prove to be wrong, and we could, utilize our available capital resources sooner than we currently expect.  We will need to raise additional capital.  We intend to finance our operations through existing cash on hand, proceeds received from public or private financings, any proceeds received from our current or future licensing partnerships, and research and development grants.  If adequate funds are not available to satisfy our requirements we may have to substantially reduce or eliminate certain areas of our product development activities, significantly limit our operations, modify our business strategy, or cease business operations.

 

The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries.  Intercompany accounts and transactions have been eliminated upon consolidation.

 

The accompanying interim unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”), and do not contain all of the information and footnotes required by GAAP and the SEC for annual financial statements.  The results for interim periods are not necessarily indicative of the results to be expected for the full year.  The December 31, 2007 balance sheet, as presented, was derived from the audited Consolidated Financial Statements as of December 31, 2007.  These Condensed Consolidated Financial Statements should be read in conjunction with the Company’s audited Consolidated Financial Statements and notes thereto included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2008.

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual amounts could differ from those estimates and assumptions.

 

5



Table of Contents

 

In connection with the collaborative research and license agreement entered into with Elanco Animal Health (“Elanco”), the Company may periodically record revenue resulting from various financial components described in the agreement. These components may include: reimbursable expenses incurred by us pertaining to the development of certain immunological products for animal health using our delipidation immunological technology; technology access fees which provide for exclusive license rights in a limited field of use; and milestone payments for regulatory submission by Elanco, as well as the subsequent regulatory approval, if received. In addition, the agreement provides for patent and technology royalties which are paid based on a percentage of sales revenue received by Elanco. Consistent with Emerging Issues Task Force (“EITF”) Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables,” the Company recognizes revenue as reimbursable expenses are incurred, and upon the realization of the milestones as described in the agreement. The period or periods for recognition are determined based on the ongoing obligation of the Company, if any, under the contract or Elanco’s intent to further develop the related product.

 

NOTE 2:  NET LOSS PER SHARE

 

The Company computes its net loss per share under the provisions of Statement of Financial Accounting Standards (“SFAS”) No. 128, “Earnings Per Share.”  Basic net loss per share is calculated by dividing net loss by the weighted average number of shares of common stock outstanding during the period.

 

Diluted net loss per share reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted into common stock.  The Company had securities outstanding, which could potentially dilute basic net earnings per share, but because the Company incurred a net loss for all periods presented, such securities were excluded from the computation of diluted net loss per share as their effect would have been antidilutive.  The securities excluded from diluted loss per share consist of the following:

 

 

 

At June 30,

 

 

 

2008

 

2007

 

Stock options

 

7,288,726

 

7,317,006

 

Warrants to purchase common stock

 

2,626,239

 

3,365,749

 

 

 

9,914,965

 

10,682,755

 

 

NOTE 3:  STOCK-BASED COMPENSATION

 

Effective January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based Payment,” “FAS 123(R),” which requires that we recognize compensation cost relating to share-based payment transactions in our financial statements.  We have adopted FAS 123(R) on a modified prospective basis, which requires that we recognize compensation cost relating to all new awards and to awards modified, repurchased, or cancelled in our financial statements beginning January 1, 2006.  Additionally, compensation cost for the portion of awards for which the requisite service had not been rendered and were outstanding as of January 1, 2006 will be recognized as the requisite service is rendered on or after January 1, 2006.  The pro forma disclosures previously permitted under SFAS No. 123, “Accounting for Stock-Based Compensation,” are no longer an alternative to financial statement recognition.  To calculate the excess tax benefits available for use in offsetting potential future tax shortfalls, the Company follows the alternative method discussed in Financial Accounting Standards Board (“FASB”) staff Position No. 123(R)-3, “Transition Election Related to Accounting for the Tax Effects of Share-Based Payment Awards.”

 

Stock Option Plans

 

Prior to the merger, we maintained stock-based compensation plans for our employees, consultants and Directors.  The 2000 Stock Option Plan (the “2000 Plan”), adopted by the Board of Directors in May 2000 and approved by stockholders on March 20, 2001, allows for the granting of options for up to 3,118,040 shares of common stock.  Stock options granted under the 2000 Plan may be either incentive stock options or nonstatutory stock options.  Options may be granted with exercise prices not less than the fair value of the Company’s common stock at the date of grant, as determined by the Board of Directors.  All options granted pursuant to the 2000 Plan are to have a term not greater than 10 years from the date of grant.  Options vest as determined by the Board of Directors, but generally over four years (but not less than 20% of the total number of shares granted per year).

 

6



Table of Contents

 

In October 1997, NZ’s Board of Directors approved the New Mexico and Arizona Land Company 1997 Stock Incentive Plan (the “1997 Plan”).  The 1997 Plan provides that the following types of awards may be granted under the 1997 Plan: stock appreciation rights, incentive stock options, non-qualified stock options, restricted stock awards, unrestricted stock awards, and performance share awards which entitle recipients to acquire shares upon the attainment of specified performance goals.  Under the 1997 Plan, awards may be granted with respect to a maximum of 900,000 shares of the Company’s common stock, subject to adjustment in connection with certain events such as a stock split, merger or other recapitalization of the Company.  We assumed the 1997 Plan as a result of the merger.

 

In November 2001, the Company’s Board of Directors approved the 2001 Performance Equity Plan (the “2001 Plan”).  The stockholders approved the Plan on November 29, 2001.  The 2001 Plan allows for the granting of options for up to 5,000,000 shares of common stock to employees, officers, consultants, and Directors.  The number of shares authorized automatically increased on January 1, in each of the calendar years 2002 through 2006 by 500,000 shares of common stock, which was the maximum amount allowable in each year, under the terms of the 2001 Plan.  Stock options granted under the 2001 Plan may be either incentive stock options or nonstatutory stock options.  Options may be granted with exercise prices not less than the fair value of the Company’s common stock at the date of grant, as determined by the Board of Directors.  All options granted pursuant to the 2001 Plan are to have a term not greater than 10 years from the date of grant.  Options vest as determined by the Board of Directors, generally over four years (but not less than 20% of the total number of shares granted per year).

 

All options in the 2000 Plan were adjusted to reflect the 1.55902 merger exchange ratio with the number of shares underlying each option multiplied by the ratio and the related exercise prices divided by the ratio.  All the above disclosures reflect the share and per share amounts on a post merger equivalent basis.  Additionally, all historical stock option information of Pre-Merger Lipid provided herein has been similarly restated.

 

At June 30, 2008, options to purchase an aggregate of 4,645,333 shares of common stock remain available for grant under all the plans.

 

Other Required FAS 123(R) Disclosures

 

The following table represents stock option activity for the three months ended June 30, 2008:

 

 

 

Number of
Shares

 

Weighted-
Average
Exercise
Price

 

Weighted-
Average
Remaining
Contract Life

 

Aggregate
Intrinsic
Value

 

Outstanding options at beginning of period

 

6,590,908

 

$

1.81

 

 

 

 

 

Granted

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

Forfeited

 

 

 

 

 

 

 

Expired

 

42,719

 

9.17

 

 

 

 

 

Outstanding options at end of period

 

6,548,189

 

$

1.76

 

5.47

 

 

Options vested and expected to vest at end of period

 

6,390,167

 

$

1.77

 

5.39

 

 

Exercisable options at end of period

 

5,633,620

 

$

1.86

 

4.96

 

 

 

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The following table represents stock option activity for the six months ended June 30, 2008:

 

 

 

Number of
Shares

 

Weighted-
Average
Exercise Price

 

Weighted-
Average
Remaining
Contract Life

 

Aggregate
Intrinsic
Value

 

Outstanding options at beginning of period

 

6,796,085

 

$

1.99

 

 

 

 

 

Granted

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

Forfeited

 

10,781

 

1.52

 

 

 

 

 

Expired

 

237,115

 

8.27

 

 

 

 

 

Outstanding options at end of period

 

6,548,189

 

$

1.76

 

5.47

 

 

Options expected to vest at end of period

 

6,390,167

 

$

1.77

 

5.39

 

 

Exercisable options at end of period

 

5,633,620

 

$

1.86

 

4.96

 

 

 

For the three and six month periods ending June 30, 2008, there is no Aggregate Instrinsic Value of options outstanding at the end of the period, options expected to vest at the end of the period, or options exerciseable at the end of the period, because the closing market price of our common stock on June 30, 2008 was below the average exercise price of the options considered in the respective valuations.

 

We use the Black-Scholes option pricing model to estimate the fair value of stock-based awards with the following weighted-average assumptions for the indicated periods:

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Risk-free interest rate

 

 

4.92

%

 

4.86

%

Expected life of options (in years)

 

 

3.90

 

 

4.74

 

Expected volatility

 

 

76.97

%

 

89.89

%

Expected dividend yield

 

 

 

 

 

Weighted-average grant-date fair value

 

 

$

0.75

 

 

$

0.96

 

 

No assumptions were made for the three and six month periods ended June 30, 2008 due to no stock options being granted during the respective periods.  For the three and six month periods ended June 30, 2007, the assumptions are based on multiple factors, including historical exercise patterns of employees and post-vesting employment termination behaviors.  We use historical data to estimate the options’ expected term, which represents the period of time that options granted are expected to be outstanding.  Due to the relatively low trading volume of options on our common stock, we do not use implied volatility to determine the expected volatility of our common stock.  Rather, the historical volatility that is commensurate with the expected life of the option on the date that it is measured is used as our estimate of future expected volatility.  Since we have never paid any dividends and do not anticipate paying any dividends at least through the expected life of our stock options outstanding, we use an expected dividend yield of zero when calculating the fair value of stock options.  The risk-free interest rate for periods within the contracutal life of the option is based on the U.S. Treasury yield curve in effect at the measurement date of the option.

 

FAS 123(R) requires that we estimate forfeitures, or the number of shares that are expected to be cancelled prior to vesting, at the time of grant, and adjust for actual forfeitures in subsequent periods if they differ from our original estimates.  Based on our historical experience of options that have been cancelled prior to vesting, we have assumed an annualized forfeiture rate of 12% for all new option grants.

 

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Total compensation cost for share-based payment arrangements recognized in income for the three and six month periods ended June 30, 2008 and 2007 is presented in the following table:

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

(In thousands)

 

2008

 

2007

 

2008

 

2007

 

Employee related compensation cost

 

$

109

 

$

217

 

$

293

 

$

383

 

Non-employee related compensation cost

 

(35

)

53

 

(6

)

85

 

Total compensation cost recognized in income

 

$

74

 

$

270

 

$

287

 

$

468

 

 

The total compensation cost related to non-vested awards not yet recognized as of June 30, 2008 was approximately $606,000 and the weighted average expected remaining recognition period as of June 30, 2008 was approximately 1.3 years.

 

We did not receive any gross proceeds as no stock options were exercised in the six month period ending June 30, 2008.  We did not recognize any tax benefit related to these share-based arrangements as we are in a loss position and have a full valuation allowance against our tax benefits.

 

NOTE 4:  RECENTLY ISSUED ACCOUNTING STANDARDS

 

In March 2008 the FASB issued SFAS No. 161, “Disclosures About Derivative Instruments and Hedging Activities – an amendment of FASB Statement No. 133.”  This statement is intended to enhance current disclosure framework in Statement 133, “Accounting for Derivative Instruments and Hedging Activities.”  This statement changes the disclosure requirements for derivative instruments and hedging activities, and requires that objectives for using derivative instruments be disclosed in terms of underlying risk and accounting designation.  We believe that the adoption of this statement will not have a material impact on our financial position, results of operations, or cash flows.

 

In May 2008 the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted Accounting Principles.”  This statement is intended to identify the sources of accounting principles and the framework for selecting the principles to be used in the preparation of financial statements of non-governmental entities that are presented in conformity with generally accepted accounting principles.  We believe that the adoption of this statement will not have a material impact on our financial position, results of operations, or cash flows.

 

NOTE 5:  RELATED PARTY TRANSACTIONS

 

In December 1999, we entered into an Intellectual Property License Agreement to obtain the exclusive worldwide rights to certain patents, trademarks, and technology with Aruba International Pty. Ltd., an Australian company controlled by Bill E. Cham, Ph.D., a founding stockholder of Pre-Merger Lipid and one of our former Directors.  As consideration for the license, we issued Aruba 4,677,060 shares of our common stock valued at $250,000.  Under this agreement, we are obligated to pay Aruba a continuing royalty on revenue in future years, subject to a minimum annual royalty amount of $500,000 and 10% of any External Research Funding initiated by Dr. Cham and received by us to further this technology, as defined in the agreement.  In November 2004, all rights, title, interest and obligations covered under the Intellectual Property License Agreement were assigned to Aruba International B.V., a Netherlands company controlled by Dr. Cham.  We have expensed to research and development approximately $125,000 in both three month periods ended June 30, 2008 and 2007 related to this agreement.  Accrued related party royalties under this agreement were $500,000 and $250,000 at June 30, 2008 and December 31, 2007, respectively.

 

On May 16, 2005 we entered into a consulting agreement with H. Bryan Brewer, Jr., M.D., a Director of the Company, and Washington Cardiovascular Associates, LLC (“WCA”), an entity co-owned by Dr. Brewer and his spouse, Silvia Santamarina-Fojo, Ph.D., pursuant to which WCA provides the services of Dr. Brewer as the Company’s Chief Scientific Director.  Dr. Brewer was also appointed Vice Chairman of the Company’s Board of Directors on May 16, 2005, and serves as Chairman of the Company’s Scientific Advisory Board.  The consulting agreement was for an initial three-year term.  On July 31, 2007 the consulting agreement was amended to extend the term of the consulting agreement until May 16, 2011.  Upon expiration, the agreement automatically renews for an additional

 

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three-year term unless the Company or WCA provides at least 30 days notice of intent not to renew. In consideration for Dr. Brewer’s services as Chief Scientific Director we are required to pay WCA annual fees of $395,000.  For both six month periods ended June 30, 2008, approximately $198,000 was charged to selling, general and administrative expense for fees related to the consulting agreement.  In addition to the annual fee, we granted Dr. Brewer an option award of 100,000 shares of our common stock to vest in three equal annual installments on the first, second and third anniversaries of the consulting agreement.  Dr. Brewer’s 100,000 option share award was re-priced in December 2007 as a result of the Company’s election to re-price certain stock options that had been previously granted to employees, Directors, and consultants of the Company.  The options were re-priced to the fair market value of our stock as of market closing on December 3, 2007, $0.89 per share.  The other terms of the options, including the vesting schedules, remained unchanged.  For the three month period ended June 30, 2008, approximately $5,000 was recorded as non-cash compensation income related to the stock option awarded to Dr. Brewer under the consulting agreement.  For the six month period ended June 30, 2008, approximately $11,000 was recorded as non-cash compensation expense related to the stock option awarded to Dr. Brewer under the consulting agreement.  For the three and six month periods ended June 30, 2007, approximately $5,000 and $14,000, respectively, was recorded as non-cash compensation expense related to the stock option awarded to Dr. Brewer pursuant to his consulting agreement.

 

On November 13, 2007, the Company entered into a consulting agreement with Dr. Santamarina-Fojo and WCA, an entity co-owned by Dr. Brewer and Dr. Santamarina-Fojo, pursuant to which WCA provides the services of Dr. Santamarina-Fojo as co-investigator responsible for the execution of all aspects of the mouse atherosclerosis study using the Company’s HDL Mimetic Peptide technology.  In consideration for Dr. Santamarina-Fojo’s services, the Company pays WCA fees of $150.00 per hour, plus reimbursement of expenses incurred in the performance of the contract.  In connection with this effort, on December 13, 2007, the Company issued to Dr. Santamarina-Fojo a non-qualified stock option to purchase 50,000 shares of common stock at an exercise price of $0.78 per share, with immediate vesting upon grant.  For the three month period ended March 31, 2008, no fees were charged to research and development expense.  For the six month period ended June 30, 2008, approximately $1,000 was charged to research and development expense for fees related to the consulting agreement.

 

NOTE 6:  INCOME TAX

 

The Company’s effective tax rate was zero for the three and six month periods ended June 30, 2008 and 2007.  The effective tax rate was calculated using an estimate of our expected annual pretax income.

 

A valuation allowance is provided when it is more likely than not that some portion of the deferred tax asset will not be realized.  The Company has established a valuation allowance against its net operating loss carryforward and credits due to uncertainty of realizing future benefits.

 

NOTE 7:  SUBSEQUENT EVENTS

 

On August 6, 2008, the Company engaged Rodman & Renshaw, LLC (“Rodman”) as its financial advisor to explore a broad range of strategic options to maximize shareholder value. The range of options to be explored includes corporate partnerships and joint ventures as well as a merger or sale of the Company or its assets. Rodman will also continue discussions the Company is having with potential partners and acquirers. The engagement agreement is for a period of three months. After such period, the agreement shall continue until terminated by either party, but no longer than February 6, 2009, unless further extended by mutual written agreement of the parties. Under the agreement, Rodman received payments of cash and shares of the Company’s stock totaling $200,000 at the time of execution and will receive additional cash and stock payments if and when a transaction is entered into based on a percentage of the aggregate total transaction value.

 

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ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This Form 10-Q contains forward-looking statements concerning plans, objectives, goals, strategies, future events or performance as well as all other statements which are not statements of historical fact.  These statements contain words such as, but not limited to, “believes,” “anticipates,” “expects,” “estimates,” “projects,” “will,” “may” and “might.”  The forward-looking statements contained in this Form 10-Q reflect our current beliefs and expectations on the date of this Form 10-Q.  Actual results, performance or outcomes may differ materially from what is expressed in the forward-looking statements.  We have discussed the important factors, which we believe could cause actual results, performance or outcomes to differ materially from what is expressed in the forward-looking statements, in “Item 1A. Risk Factors” in our Annual Report on Form 10-K, filed with the SEC on March 28, 2008.  We are not obligated to publicly announce any revisions to these forward-looking statements to reflect a change in facts or circumstances.  You should read the discussion below in conjunction with Part I, Item 1, “Financial Statements,” of this Form 10-Q and Part II, Items 7, 7A and 8, “Management’s Discussion and Analysis of Financial Condition and Results of Operation,” “Quantitative and Qualitative Disclosures About Market Risk” and “Financial Statements and Supplementary Data,” respectively, of our Annual Report on Form 10-K for the year ended December 31, 2007.

 

Overview

 

We are a development-stage biotechnology company engaged in research and development of products and processes intended to treat major medical indications such as cardiovascular disease and viral infections in which lipids, or fat components, play a key role.  Our primary activities since incorporation have been: conducting research and development (including pre-clinical studies); conducting a clinical trial; performing business, strategic and financial planning; and raising capital.  Accordingly, the Company is considered to be in the development stage.

 

In the course of our research and development activities, we have incurred significant operating losses and we expect these losses to continue for the foreseeable future as we continue to invest in research and development and allocate significant and increasing resources to clinical testing and other activities related to seeking approval to market our products.

 

We intend to finance our operations through existing cash on hand, proceeds received from public or private financings, any proceeds received from our current or future licensing partnerships, and research and development grants.  We anticipate that existing cash and cash equivalents, in addition to any proceeds received from our current or future licensing partnerships, will provide sufficient cash to fund our operations, including our current development projects, into the fourth quarter of 2008.  In the longer term, we expect to additionally finance our operations through revenues from product sales and licenses.  We will need to raise additional capital to fund the continued development of our technology, to meet our license and contractual obligations, and to fulfill our financial requirements.  If adequate funds are not available to satisfy our requirements we may have to substantially reduce or eliminate certain areas of our product development activities, significantly limit our operations, modify our business strategy, or cease business operations.

 

In November 2006, we entered into a collaborative research and license agreement with Elanco Animal Health, a division of Eli Lilly and Company, to develop one or more immunological products for animal health applications beginning with a vaccine directed against certain lipid-enveloped organisms.  Under the agreement, the Company granted to Elanco a worldwide exclusive license to research, develop, manufacture, and sell certain immunological products for animal health, which will be developed using its delipidation immunological technology.  Pursuant to the terms of the agreement, Elanco will pay for all the associated research and development expenses for each targeted product.  In exchange for the license, subject to completion of Elanco’s due diligence and sales of products meeting various thresholds, we may receive technology access fees, milestone payments and royalties.  Elanco has exercised its option for the first vaccine indication developed by us.  As a result, we received a technology access fee from Elanco and may receive payments in the future including milestone payments and royalties from product sales.

 

In January 2008, the Company demonstrated a positive therapeutic effect with the Company’s proprietary delipidated autologous virus vaccine in Simian Immunodeficiency Virus (“SIV”)-infected non-human primates. Primates infected with SIV are a widely-accepted model for Human Immunodeficiency Virus (“HIV”).  The 22-month

 

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study, conducted at the Yerkes National Primate Research Center at Emory University in Atlanta, included six animals in the treatment arm and six placebo animals.  Vaccination with autologous SIV, delipidated by our proprietary process, led to an average 11.5 times viral load reduction in the treated animals.  All six animals in the treatment arm of the study responded with an average drop in viral load in excess of 90%.  While the study was not powered for statistical significance, it revealed a trend of p=0.16, indicating the benefit of autologous delipidated viral vaccination in lowering viral loads in chronically-infected animals.  We are currently incorporating this data in our efforts to secure external grant funding for the development of an HIV vaccine.

 

In March 2008, we released the results of the intravascular ultrasound data analysis from our ‘first in man’ clinical trial initiated in June 2006.  The clinical trial, entitled “A Randomized Single-Blind, Placebo-Controlled Study to Evaluate the Safety of the Lipid Sciences’ PDS-2 in Subjects with Prior Acute Coronary Syndrome,” consisted of 28 patients (14 treatment patients and 14 placebo patients), and was conducted at the Washington Hospital Center in Washington, D.C.  Dr. Ron Waksman, Associate Director, Division of Cardiology at the Washington Hospital Center, was the principal investigator for the trial.  The intravascular ultrasound (“IVUS”) analysis was conducted at the Cardiovascular Research Institute, MedStar Research Institute, under the direction of Dr. Neil J. Weissman, Director of the Cardiac Ultrasound and Ultrasound Core Laboratories.  The clinical trial subjects were between the ages of 18 and 85 with angiographic evidence of Coronary Artery Disease in the target artery, as defined by at least one lesion with an occlusion between 20-50%.  Each potential participant underwent an initial screening, which included a blood panel and IVUS assessment to determine eligibility for enrollment and randomization into the study.  The trial consisted of a total of seven weekly delipidation/re-infusion procedures.  The treatment subjects received infusions of their own plasma that had been delipidated by the PDS-2 system; the control subjects received infusions of their own untreated plasma that had not been delipidated.  The study duration for each participant was approximately ten weeks.  The data revealed a strong trend of regression of coronary atherosclerosis as measured by IVUS in the group of patients treated by the Company’s proprietary HDL Selective Delipidation technology.  These measurements showed that the average total atheroma volume in the target coronary arteries decreased by 12.18 mm3 in the treatment group versus a 2.80 mm3 increase in the placebo group.  The effect on the average of the 10mm most diseased arterial segments was a 6.24 mm3 decrease for the treated group as compared to a 1.73 mm3 decrease in the placebo group.  While the results of this trial were not statistically significant due to the small number of patients enrolled in the trial, they were, nevertheless, an indication of the potential of this therapy to reverse coronary artery disease.  The patients in the trial tolerated the process very well, and the 93% patient retention rate demonstrated feasibility of this therapy in a clinical setting.  We will continue to analyze data from the clinical trial utilizing our PDS-2 device and prepare a final study report, as well as seek clarity from the Food and Drug Administration (“FDA”) on the design of a future pivotal trial leading to a Pre-Market Approval (“PMA”) application and subsequent approval for commercialization.  During the past 90 days, the U.S. Patent and Trademark Office issued to the Company three patents, each entitled, “Methods and Apparatus for Creating Particle Derivatives of HDL with Reduced Lipid Content.”  These patents extend the depth of coverage surrounding the Company’s HDL Therapy platform, and in particular, the proprietary Selective Delipidation process.  The Company’s patent portfolio is a critical component of its strategic plan to maximize shareholder value through the pursuit of a corporate partner related to our HDL Selective Delipidation therapy.  The Company has begun to aggressively pursue a business development campaign regarding the potential licensing or acquisition of this promising medical technology.

 

We have developed a synthetic form of HDL that mimics key functions of naturally-occurring human HDL.  Our lead HDL Mimetic Peptide compound, LSI-518P, and several back-up compounds have been identified and validated with an extensive battery of in vitro assays.  The lead compound was selected as a result of screenings at multiple external research sites.  In these in vitro tests, the selected mimetic peptide candidates effluxed cholesterol via the ABCA1 transporter metabolic pathway–known to be optimal for removing cholesterol from arterial plaque via the reverse cholesterol transport mechanism–at a rate similar to naturally-occurring HDL.  Having identified a lead compound, we then initiated a study designed to demonstrate its effectiveness in reducing the progression of atherosclerosis, as well as, an additional study to demonstrate its anti-inflammatory properties.  The study results demonstrated the ability to reduce the progression of atherosclerosis by 20% after four weeks of treatment (p=0.106), and by 32% (p=0.01) after eight weeks of treatment, when compared to a placebo group in a well-accepted, Apo E knockout mouse model for atherosclerosis.  This placebo-controlled study was conducted at MedStar Research Institute in Washington D.C., and the data analyzed at an independent laboratory.  Because the initial design goals of the HDL Mimetic Peptide development program have now been met, we will move to validate other key cardio-protective characteristics of LSI-518P and begin conducting a comprehensive series of toxicology studies in the next phase of the LSI-518P development program.  Additional analysis indicates that LSI-518P exhibits anti-inflammatory properties as shown by statistically significant reduction in expression of endothelial cell adhesion molecules, VCAM-1 (p< 0.02) and ICAM-1 (p < 0.01), on human coronary artery cells comparable to that of ApoA-I.

 

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Table of Contents

 

On April 22, 2008, the U.S. Patent and Trademark Office issued to the Company a patent, “A Method of Treating Cancer cells to Create a Modified Cancer Cell that Provokes an Immunogenic Response,” which covers the ability of the Company’s delipidation process to modify cancer cells and create a cancer cell antigen – demonstrating the potential of this novel process to develop a range of cancer vaccines.

 

Results of Continuing Operations – Three Months Ended June 30, 2008 and 2007

 

Revenue.  The Company did not recognize any revenue during the three month period ending June 30, 2008, compared with $137,000 of collaboration agreement revenue in the same three month period ending June 30, 2007.  This revenue is related to our collaborative research agreement entered into with Elanco in November 2006.

 

We have had no product revenues since our Inception (May 21, 1999).  Future product revenues will depend on our ability to develop and commercialize our HDL Therapy and Viral Immunotherapy platforms.

 

Research and Development Expenses.  Research and development expenses include applied and scientific research, regulatory and business development expenses, and comprise approximately 63% of operating expenses in the three months ended June 30, 2008.  Research and development expenses decreased approximately $807,000, or 39%, to $1,256,000 in the second quarter of 2008 from $2,063,000 for the same period in 2007.  This decrease was primarily related to the conclusion of the clinical trial using our HDL Selective Delipidation technology conducted at the Washington Hospital Center in Washington, D.C., and the completion of the 22-month study of SIV-infected non-human primates, conducted at the Yerkes National Primate Research Center at Emory University in Atlanta, using our Viral Immunotherapy platform.  Partially offsetting these decreases were increased costs associated with the Company’s HDL Mimetic Peptide program.

 

While we allocate and track resources when required pursuant to the terms of development arrangements, our research team typically works on different platforms concurrently, and our equipment and intellectual property resources often are deployed over a range of products with a view to maximize the benefit of our investment.  Accordingly, we have not, and do not intend to, separately track the costs for each of our research projects on a product-by-product basis.  For the three months ended June 30, 2008, we estimate that the majority of our research and development expense was associated with our two primary platforms, HDL Therapy and Viral Immunotherapy.

 

Selling, General and Administrative Expenses.  General and administrative expenses include costs associated with our business operations, inclusive of management, legal, finance, and accounting expenses.  General and administrative expenses decreased approximately $246,000, or 25%, from $992,000 in the three months ended June 30, 2007 to $746,000 during the same three month period in 2008.  This decrease was primarily attributed to decreased employee related expenses, stock option compensation expense, and consulting expenses.

 

Interest and Other Income.  Interest and other income for the three months ended June 30, 2008 decreased approximately $154,000, or 90% to $17,000, compared with $171,000 for the same period in 2007.  This decrease was primarily due to a lower cash balances and interest rate yields in the second quarter of 2008 as compared with the same period in 2007.

 

Results of Continuing Operations – Six Months Ended June 30, 2008 and 2007

 

Revenue.  We recognized $250,000 in collaboration agreement revenue in the six months ended June 30, 2008, compared with $196,000 of collaboration agreement revenue during the same period ending June 30, 2007.  This revenue relates to our collaborative research agreement entered into with Elanco in November 2006.

 

We have had no product revenues since our Inception (May 21, 1999).  Future product revenues will depend on our ability to develop and commercialize our HDL Therapy and Viral Immunotherapy platforms.

 

Research and Development Expenses.  Research and development expenses include applied and scientific research, regulatory and business development expenses.  In the six months ended June 30, 2008, research and development expenses decreased approximately $982,000 or 25% to $2,894,000, compared with $3,876,000 in the same six month period in 2007.  This decrease was primarily related to the conclusion of the clinical trial using our HDL Selective Delipidation technology conducted at the Washington Hospital Center in Washington, D.C., and the

 

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Table of Contents

 

completion of the 22-month study of SIV-infected non-human primates, conducted at the Yerkes National Primate Research Center at Emory University in Atlanta, using our Viral Immunotherapy platform.  Partially offsetting these decreases were increased costs associated with the Company’s HDL Mimetic Peptide development program.

 

While we allocate and track resources when required pursuant to the terms of development arrangements, our research team typically works on different platforms concurrently, and our equipment and intellectual property resources often are deployed over a range of products with a view to maximize the benefit of our investment.  Accordingly, we have not, and do not intend to, separately track the costs for each of our research projects on a product-by-product basis.  For the six months ended June 30, 2008, we estimate that the majority of our research and development expense was associated with our two primary platforms, HDL Therapy and Viral Immunotherapy.

 

Selling, General and Administrative Expenses.  General and administrative expenses include costs associated with our business operations, inclusive of management, legal and finance, and accounting expenses.  General and administrative expenses decreased approximately $255,000, or 13%, to $1,643,000 in the six months ended June 30, 2008 from $1,898,000 in the same period in 2007.  This decrease was primarily related to a decrease in employee-related expenses, stock compensation expense and legal expenses.

 

Interest and Other Income.  Interest and other income for the six months ended June 30, 2008 decreased approximately $312,000 or 83%, to $63,000 from $375,000 for the same period in 2007.  The decrease was primarily the result of lower cash balances and reduced interest rate yields during the six months ended June 30, 2008, as compared to the same period during 2007.

 

Liquidity and Capital Resources

 

Net cash used in operating activities was approximately $4,030,000 and $4,518,000 for the six months ended June 30, 2008 and June 30, 2007, respectively, resulting primarily from operating losses incurred as adjusted for non-cash compensation charges and partially offset by the payment or accrual of prepaid expenses and accounts payable.

 

Net cash used by investing activities of approximately $55,000 and $65,000 for the six months ended June 30, 2008 and 2007, respectively, was the result of capital equipment purchases.

 

No cash was provided by, or used in, financing activities during the six months ended June 30, 2008.  During the six months ended June 30, 2007, approximately $25,000 was provided by financing activities and was attributable primarily to an adjustment to offering costs related to the December 2006 private placement of our common stock, and to the exercise of employee stock options.

 

Our principal uses of funds are expected to be the payment of operating expenses and continued research and development funding to support our HDL Therapy platform, the majority of which will strengthen our HDL Mimetic Peptide program.  We will seek to further develop our HDL Mimetic Peptide program, including additional pre-clinical data and toxicology studies, to support an Investigational New Drug (“IND”) filing and the initiation of Phase I clinical trials.  The expected use of funds related to our HDL Selected Delipidation technology include costs associated with the data analysis and final study report from the clinical trial utilizing our PDS-2 device, as well as obtaining clarity from the FDA on the design of a future pivotal trial leading to a PMA application and subsequent approval for commercialization.  Our primary strategy for our Viral Immunotherapy technology is to pursue external grant funding for the further development both of preventive and therapeutic vaccines, and to continue to expand our collaborative research and license agreement with Elanco to develop immunological products in the field of animal health.

 

As of June 30, 2008, we had cash and cash equivalents equal to approximately $2,374,000.  We anticipate that these assets will provide sufficient cash to fund our operations, including our current development projects, into the fourth quarter of 2008.  We will need to raise additional capital to fund the continued development of our technology, to meet our license and contractual obligations, and to meet our financial requirements.  We intend to finance our operations through existing cash on hand, proceeds received from public or private financings, any proceeds received from our current or future licensing partnerships, and research and development grants.  In the longer term, we expect to additionally finance our operations through revenues from product sales and licenses. However, there can be no assurance that funds secured from any of these efforts, if obtained, will be sufficient to meet the Company’s future cash requirements.  If adequate funds are not available to satisfy our requirements we may have to substantially reduce or eliminate certain areas of our product development activities, significantly limit our operations, modify our business strategy, or cease business operations.

 

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Table of Contents

 

Contractual Obligations

 

Future estimated contractual obligations are:

 

(In thousands)

 

2008

 

2009

 

2010

 

2011

 

2012

 

Total

 

Operating Leases

 

$

217

 

$

223

 

$

56

 

$

 

$

 

$

496

 

Royalty Payments*

 

500

 

500

 

500

 

500

 

500

 

2,500

 

Total

 

$

717

 

$

723

 

$

556

 

$

500

 

$

500

 

$

2,996

 

 


*We have agreed to pay annual royalties in the amount of $500,000 to Aruba International B.V. in exchange for the exclusive worldwide rights to certain patents, trademarks, and technology.  Under certain circumstances, additional payments related to this agreement could be required in the future.  The amounts presented in the above table reflect the minimum annual royalty amount payable through the next five years.

 

Off-Balance Sheet Arrangements

 

As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities of financial partnerships, such as entities often referred to as structured finance or Special Purpose Entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

 

Critical Accounting Policies

 

The SEC has indicated that a “critical accounting policy” is one which is both important to the portrayal of the Company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.  We consider the accounting policies described below to be our most critical accounting policies because they are impacted significantly by estimates we make.  We base our estimates on past experience and on various other assumptions our management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets and liabilities that are not readily apparent from other sources.  Actual results will differ, and may differ materially from these estimates under different assumptions or conditions.  Additionally, changes in accounting estimates could occur in the future from period to period.  Our management has discussed the development and selection of our most critical financial estimates with the Audit Committee of our Board of Directors.  Our most critical accounting policies are:

 

Revenue Recognition

 

In connection with the collaborative research and license agreement entered into with Elanco Animal Health, the Company may periodically record revenue resulting from various financial components described in the agreement.  These components may include: reimbursable expenses incurred by us pertaining to the development of certain immunological products for animal health using our delipidation immunological technology; technology access fees which provide for exclusive license rights in a limited field of use; and milestone payments for regulatory submission by Elanco, as well as the subsequent regulatory approval, if received.  In addition, the agreement provides for patent and technology royalties which are paid based on a percentage of sales revenue received by Elanco.  Consistent with EITF Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables,” the Company recognizes revenue as reimbursable expenses are incurred, and upon the realization of the milestones as described in the agreement.  The period or periods for recognition are determined based on the ongoing obligation of the Company, if any, under the contract or Elanco’s intent to further develop the related product.

 

Stock-Based Compensation

 

The Company accounts for all stock options in accordance with the provisions of FAS 123(R), which requires that we recognize compensation cost relating to share-based payment transactions in our financial statements.  The Company accounts for stock-based awards to non-employees in accordance with FAS 123(R) and EITF Issue No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.”  Significant judgment is required on the part of management in determining the

 

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proper assumptions to use in the computation of the amounts to be recorded pursuant to the provisions of FAS 123(R).  We estimate the fair value of each option granted to an employee on the date of grant using the Black-Scholes option valuation model.  The assumptions used in the Black-Scholes option valuation model include the risk free interest rate, expected life, expected volatility, expected forfeitures and dividend yield of the option.  Management bases its assumptions on historical data where available.  However, these assumptions consist of estimates of future market conditions, which are inherently uncertain, and therefore are subject to management’s judgment.

 

Prior to the adoption of FAS 123(R) in the first quarter of 2006, the Company accounted for stock-based awards to employees using the intrinsic value method in accordance with Accounting Principles Board (“APB”) No. 25, “Accounting for Stock Issued to Employees,” as interpreted by FASB Interpretation No. 44, “Accounting for Transactions Involving Stock Compensation—an Interpretation of APB No. 25.”  The Company accounted for stock based awards to non-employees in accordance with SFAS No. 123, “Accounting for Stock-Based Compensation” and EITF Issue No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.”

 

The impact of the adoption of FAS 123(R) is more fully described in Note 3 of the Condensed Consolidated Financial Statements.

 

Income Taxes

 

The Company follows SFAS No. 109, “Accounting for Income Taxes.”  Under the asset and liability method of SFAS No. 109, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities resulting from a change in tax rates is recognized in income in the period that includes the enactment date.  Deferred tax assets are reduced, if necessary, by a valuation allowance if the corresponding future tax benefits are not expected to be realized.

 

In June 2006, the FASB issued FASB Interpretation No. (“FIN”) 48, “Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109.”  FIN 48 clarifies the accounting for uncertainty in income taxes by creating a framework for how companies should recognize, measure, present, and disclose in their financial statements uncertain tax positions that they have taken or expect to take in a tax return.  This interpretation is effective for fiscal years beginning after December 15, 2006.  We adopted FIN 48 on January 1, 2007.  Since its adoption we have not recorded any adjustments as a result of our adoption of the new interpretation.

 

The above listing is not intended to be a comprehensive list of all of our accounting policies.  In many cases, the accounting treatment of a particular transaction is specifically dictated by generally accepted accounting principles, with no need for management’s judgment in their application.  There are also areas in which management’s judgment in selecting any available alternative would not produce a materially different result.  Our significant accounting policies are more fully described in our audited Consolidated Financial Statements and notes thereto for the year ended December 31, 2007, which appear in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2008.

 

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ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our exposure to market risk associated with changes in interest rates relates to our investment portfolio.  We maintain an investment portfolio consisting typically of government issued securities, although at June 30, 2008, we did not have any investments on our balance sheet.  When we carry an investment balance, these investments are classified as held-to-maturity and are accounted for at their amortized cost, as per Statement of Financial Accounting Standards No. 115, “Accounting for Certain Investments in Debt and Equity Securities.”

 

Every quarter we evaluate our investment portfolio and follow the guidance of FASB Staff Position No. 115-1, “The Meaning of Other-Than-Temporary Impairment and its Application to Certain Investments,” to determine if any of our investments are impaired.  We have not booked any impairment charges during 2008 and have concluded that an impairment analysis was not necessary.  Since we held no investments at June 30, 2008, a sensitivity analysis of a 10% change in market interest rates was not performed.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

(a)                Evaluation of Disclosure Controls and Procedures.  Our President and Chief Executive Officer and our Chief Financial Officer have performed an evaluation, required pursuant to Rule 13a-15(b) or 15d-15(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q (the “Evaluation Date”).  Based on such evaluation, such officers have concluded that, as of the Evaluation Date, our disclosure controls and procedures are effective in alerting them, on a timely basis, to material information relating to the Company (including its consolidated subsidiaries) required to be included in our periodic filings under the Exchange Act.

 

(b)               Changes in Internal Controls Over Financial Reporting.  There have not been any significant changes in our internal controls over financial reporting (as such Item is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

 

Our management, including our President and Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls or our internal controls over financial reporting will prevent all error and all fraud.  A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met due to numerous factors, ranging from errors to conscious acts of an individual, or individuals acting together.  In addition, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.  Because of the inherent limitations in a cost-effective control system, misstatements due to error and/or fraud may occur and not be detected.

 

ITEM 4T.  CONTROLS AND PROCEDURES

 

Not applicable.

 

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PART II – OTHER INFORMATION

 

ITEM 1.      LEGAL PROCEEDINGS

 

We are from time to time, a party to legal proceedings.  Any legal proceeding we may be currently involved in is ordinary and routine.  Outcomes of the legal proceedings are uncertain until they are completed.  We believe that the results of any current proceedings will not have a material adverse effect on our business or financial condition or results of operations.

 

Please refer to our Annual Report on Form 10-K filed with the SEC on March 28, 2008, which discloses legal proceedings involving the Company.

 

ITEM 1A. RISK FACTORS

 

There have been no material changes to the risk factors previously disclosed in our 2007 Form 10-K, filed on March 28, 2008.

 

ITEM 2.      UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3.      DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4.      SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

On June 11, 2008, the Company held its annual meeting of stockholders.  As of April 14, 2008, the record date for the annual meeting, there were 37,125,348 shares of common stock of the Company issued and outstanding and entitled to vote at the annual meeting.  The following items were submitted to a vote of the stockholders:

 

To elect two Class III members currently serving on the Board of Directors to a three year term:

 

 

 

Votes for

 

Votes Withheld

 

Stephen E. Renneckar

 

28,167,119

 

548,980

 

Gary S. Roubin, M.D., Ph.D.

 

28,168,919

 

547,180

 

 

As a result, the following incumbent members, Stephen E. Renneckar and Gary S. Roubin, M.D., Ph.D., were elected as Directors of the Company (Class III) and will serve a term of three years, concluding at the Company’s Annual Meeting in 2011.

 

To Amend the Company’s Certificate of Incorporation to increase the number of Authorized Shares of Common Stock from 75,000 to 125,000.  The Total Authorized Shares will increase from 85,000 to 135,000.

 

 

 

Votes for

 

Votes Against

 

Votes Abstain

 

 

 

27,320,440

 

1,356,262

 

39,396

 

 

ITEM 5.      OTHER INFORMATION

 

None.

 

ITEM 6.      EXHIBITS

 

(a)          Exhibits - - See Exhibit Index, which is incorporated by reference.

 

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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 thereunto duly authorized.

 

Date: August 14, 2008

Lipid Sciences, Inc.

 

 

 

By:

/s/ Sandra Gardiner

 

Sandra Gardiner

 

Chief Financial Officer*

 


*Signing on behalf of the Registrant as a duly authorized officer and as the Principal Financial Officer of the Registrant

 

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Table of Contents

 

EXHIBIT INDEX

 

Exhibit
Number

 

Description

 

 

 

3.1

 

Certificate of Incorporation. Previously filed as Exhibit 3.1 to Registrant’s Quarterly Report on Form 10-Q filed with the Commission on August 13, 2002 and incorporated herein by reference.

 

 

 

3.2

 

Certificate of Amendment of Certificate of Incorporation

 

 

 

3.3

 

Bylaws, as amended. Previously filed as Exhibit 3.1 to Registrant’s Current Report on Form 8-K filed with the Commission on September 25, 2007 and incorporated herein by reference.

 

 

 

31.1

 

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

31.2

 

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1

 

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

20


EX-3.2 2 a08-18775_1ex3d2.htm EX-3.2

Exhibit 3.2

 

CERTIFICATE OF AMENDMENT OF

CERTIFICATE OF INCORPORATION OF

LIPID SCIENCES, INC.

a Delaware corporation

 

Lipid Sciences, Inc., a corporation duly organized and existing under the General Corporation Law of the State of Delaware (the “Corporation”), does hereby certify:

 

FIRST:  That at a meeting of the Board of Directors of the Corporation resolutions were duly adopted setting forth a proposed amendment of the Certificate of Incorporation of the Corporation, declaring said amendment to be advisable and calling a meeting of the stockholders of the Corporation for consideration thereof.  The resolution setting forth the proposed amendment is as follows:

 

RESOLVED, that the Certificate of Incorporation of the Corporation be amended by deleting the first paragraph of Article Fourth (A) thereof and inserting the following in lieu thereof:

 

“The total number of shares of all classes of capital stock which the corporation shall have authority to issue is 135,000,000 shares, comprised of 125,000,000 shares of Common Stock with a par value of $0.001 per share (the “Common Stock”) and 10,000,000 shares of Preferred Stock with a par value of $0.001 per share (the “Preferred Stock”).”

 

SECOND:  That thereafter, pursuant to resolution of its Board of Directors, an annual meeting of the stockholders of the Corporation was duly called and held upon notice in accordance with Section 222 of the General Corporation Law of the State of Delaware at which meeting the necessary number of shares as required by statute were voted in favor of the amendment.

 

THIRD:  That said amendment was duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware.

 

IN WITNESS WHEREOF, the Corporation has caused this Certificate to be executed by S. Lewis Meyer, Ph.D., its Chief Executive Officer, this 11th day of June, 2008.

 

 

 

/s/ S. Lewis Meyer

 

S. Lewis Meyer, Ph.D.

 

Chief Executive Officer

 


EX-31.1 3 a08-18775_1ex31d1.htm EX-31.1

Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT

 

I, S. Lewis Meyer, Ph.D., certify that:

 

1.                                     I have reviewed this quarterly report on Form 10-Q of Lipid Sciences, Inc.

 

2.                                     Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.

 

3.                                     Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report.

 

4.                                     The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f) for the registrant and have:

 

a.                                       Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.                                      Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c.                                       Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.                                      Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.                                     The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors:

 

a.                                       All significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.                                      Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.

 

 

Date August 14, 2008

 

 

 

 

/s/ S. Lewis Meyer, Ph.D.

 

S. Lewis Meyer, Ph.D.

 

President and Chief Executive Officer

 


EX-31.2 4 a08-18775_1ex31d2.htm EX-31.2

Exhibit 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT

 

I, Sandra Gardiner, certify that:

 

1.                                     I have reviewed this quarterly report on Form 10-Q of Lipid Sciences, Inc.

 

2.                                     Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.

 

3.                                     Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report.

 

4.                                     The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f) for the registrant and have:

 

a.                                       Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.                                      Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c.                                       Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.                                      Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.                                     The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of:

 

a.                                       All significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.                                      Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.

 

 

Date: August 14, 2008

 

 

 

 

/s/ Sandra Gardiner

 

Sandra Gardiner

 

Chief Financial Officer

 


EX-32.1 5 a08-18775_1ex32d1.htm EX-32.1

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

This certification is not to be deemed filed pursuant to the Securities Exchange Act of 1934, as amended, and does not constitute a part of the Quarterly Report of Lipid Sciences, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2008, as filed with the Securities and Exchange Commission on the date hereof (the “Report”).

 

In connection with this Report, we, S. Lewis Meyer, Ph.D., President and Chief Executive Officer of the Company and Sandra Gardiner, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)          The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)          The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

 

Date: August 14, 2008

 

 

 

 

 

/s/ S. Lewis Meyer, Ph.D.

 

S. Lewis Meyer, Ph.D.

 

President and Chief Executive Officer

 

 

 

 

 

/s/ Sandra Gardiner

 

Sandra Gardiner

 

Chief Financial Officer

 

 


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