-----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, NTnSAYk864pvlvMDBp35xUZIf0fRqg5LIPOe8+pfeDxyc0lj2XEfjgaR0Y80UyVm vfeyBwloJIZISXAAohBjuA== 0001104659-07-060683.txt : 20070809 0001104659-07-060683.hdr.sgml : 20070809 20070809123226 ACCESSION NUMBER: 0001104659-07-060683 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20070630 FILED AS OF DATE: 20070809 DATE AS OF CHANGE: 20070809 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Advanced Life Sciences Holdings, Inc. CENTRAL INDEX KEY: 0001322734 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 300296543 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-51436 FILM NUMBER: 071038835 BUSINESS ADDRESS: BUSINESS PHONE: (630) 739-6744 MAIL ADDRESS: STREET 1: 1440 DAVEY ROAD CITY: WOODRIDGE STATE: IL ZIP: 60517 10-Q 1 a07-19158_110q.htm 10-Q

 

 

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 AND EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended: June 30, 2007

 

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

 

Commission File No: 000-51436

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

(Exact name of registrant as specified in its charter)


DELAWARE

 

30-0296543

(State or other jurisdiction of

 

(I.R.S. Employer

incorporation or organization)

 

Identification no.)

 

1440 Davey Road
Woodridge, IL 60517
(Address, including zip code of registrants principal executive offices)

Registrant’s telephone number: (630) 739-6744


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, or a non-accelerated filer.  See definition of  “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.  (Check one):

Large accelerated filer o     Accelerated filer  o     Non-accelerated filer  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

As of August 9, 2007, the registrant had 28,294,677 shares of common stock, $0.01 par value per share, outstanding.

 

 




 

ADVANCED LIFE SCIENCES HOLDINGS, INC.
(A DEVELOPMENT STAGE ENTITY)
INDEX
Form 10-Q

 

 

 

 

PART I — FINANCIAL INFORMATION (UNAUDITED)

Item 1.

 

Condensed Consolidated Financial Statements:

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2007 and December 31, 2006

 

 

 

 

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2007 and 2006 and for the period from inception (January 1, 1999) through June 30, 2007

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity for period from inception (January 1, 1999) through June 30, 2007

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2007 and 2006 and for the period from inception (January 1, 1999) through June 30, 2007

 

 

 

 

Notes to Condensed Consolidated Financial Statements

 

 

Item 2.

 

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

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

 

Item 4.

 

Controls and Procedures

 

 

 

 

 

 

 

PART II — OTHER INFORMATION

Item 4.

 

Submission of Matters to a Vote of Security Holders

 

 

Item 6.

 

Exhibits

 

 

Signatures

 

 

Exhibit Index

 

 

 

1




 

PART I — FINANCIAL INFORMATION

Item 1.    Condensed Consolidated Financial Statements (Unaudited)

ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A Development Stage Company)

CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)

 

 

June 30,

 

December 31,

 

 

 

2007

 

2006

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

13,450,776

 

$

27,054,947

 

Prepaid insurance

 

64,956

 

380,083

 

Prepaid clinical trial expenses

 

2,266,799

 

2,364,512

 

Other prepaid expenses and deposits

 

332,020

 

273,572

 

Total current assets

 

16,114,551

 

30,073,114

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT:

 

 

 

 

 

Furniture and fixtures

 

221,417

 

250,308

 

Laboratory equipment

 

159,186

 

142,928

 

Computer software and equipment

 

236,781

 

231,022

 

Leasehold improvements

 

177,253

 

182,839

 

Total property and equipment—at cost

 

794,637

 

807,097

 

Less accumulated depreciation

 

(440,365

)

(398,486

)

Property and equipment—net

 

354,272

 

408,611

 

 

 

 

 

 

 

OTHER LONG-TERM ASSETS:

 

 

 

 

 

Deferred financing costs

 

13,251

 

26,502

 

Other assets

 

1,452

 

1,452

 

Total other long-term assets

 

14,703

 

27,954

 

TOTAL ASSETS

 

$

16,483,526

 

$

30,509,679

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

 

$

4,044,335

 

$

1,011,396

 

Accrued clinical trial expenses

 

4,793,241

 

1,410,894

 

Other accrued expenses

 

387,822

 

226,881

 

Accrued interest payable

 

12,917

 

22,756

 

Short-term lease payable

 

11,976

 

19,437

 

Short-term grant payable

 

476,708

 

476,708

 

Short-term notes payable - related party

 

2,000,000

 

2,000,000

 

Short-term notes payable - net of $5,633 debt discount

 

3,909,367

 

 

Total current liabilities

 

15,636,366

 

5,168,072

 

 

 

 

 

 

 

Long-term lease payable

 

16,583

 

20,076

 

Long-term grant payable

 

23,292

 

23,292

 

Notes payable - net of $11,266 debt discount

 

 

3,903,734

 

Total liabilities

 

15,676,241

 

9,115,174

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES:

 

 

 

 

 

Minority Interest

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Common stock, $0.01 par value—60,000,000 shares authorized;
June 30, 2007 28,294,677 issued and outstanding; December 31, 2006
28,282,677 shares issued and outstanding;

 

282,947

 

282,827

 

Additional paid-in capital

 

88,738,121

 

88,370,853

 

Deficit accumulated during the development stage

 

(88,213,783

)

(67,259,175

)

Total stockholders’ equity

 

807,285

 

21,394,505

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

16,483,526

 

$

30,509,679

 

 

See notes to unaudited condensed consolidated financial statements.

2




 

ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

 

 

 

 

 

 

 

 

 

 

Period From

 

 

 

 

 

 

 

 

 

 

 

Inception

 

 

 

 

 

 

 

 

 

 

 

(January 1, 1999)

 

 

 

Three months ended June 30,

 

Six months ended June 30,

 

Through

 

 

 

2007

 

2006

 

2007

 

2006

 

June 30, 2007

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Management fees

 

$

 

$

 

$

 

$

 

$

1,161,180

 

Grants

 

 

 

 

35,127

 

1,035,571

 

Royalty—related party

 

 

 

 

 

45,238

 

Total revenue

 

 

 

 

35,127

 

2,241,989

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

8,833,078

 

3,579,038

 

17,883,990

 

5,839,416

 

67,019,339

 

Contracted research and development—related party

 

 

 

 

 

7,980,299

 

Selling, general and administrative

 

1,810,249

 

1,338,842

 

3,358,412

 

2,488,012

 

16,450,925

 

Total expenses

 

10,643,327

 

4,917,880

 

21,242,402

 

8,327,428

 

91,450,563

 

Loss from operations

 

(10,643,327

)

(4,917,880

)

(21,242,402

)

(8,292,301

)

(89,208,574

)

 

 

 

 

 

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

 

 

 

 

 

Interest Income

 

(214,495

)

(520,100

)

(521,064

)

(800,958

)

(2,445,196

)

Interest expense

 

116,836

 

128,007

 

233,270

 

272,877

 

2,389,457

 

Gain on sale of interest in Sarawak Medichem Pharmaceuticals joint venture

 

 

 

 

 

(939,052

)

Net other income

 

(97,659

)

(392,093

)

(287,794

)

(528,081

)

(994,791

)

Net loss

 

(10,545,668

)

(4,525,787

)

(20,954,608

)

(7,764,220

)

(88,213,783

)

Less accumulated preferred dividends for the period

 

43,750

 

43,750

 

87,500

 

87,500

 

1,407,292

 

Net loss available to common shareholders

 

$

(10,589,418

)

$

(4,569,537

)

$

(21,042,108

)

$

(7,851,720

)

$

(89,621,075

)

Basic and diluted net loss per share available to common shareholders

 

$

(0.37

)

$

(0.16

)

$

(0.74

)

$

(0.32

)

 

 

Weighted average number common shares outstanding—basic and diluted

 

28,294,380

 

28,252,354

 

28,290,865

 

24,790,486

 

 

 

 

See notes to unaudited condensed consolidated financial statements.

3




 

ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR THE PERIOD FROM INCEPTION (JANUARY 1, 1999) THROUGH JUNE 30, 2007
(Unaudited)

 

 

 

 

 

 

 

 

Deficit

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

Additional

 

During the

 

 

 

 

 

Common Stock

 

Paid-in

 

Development

 

 

 

 

 

Shares

 

Amount

 

Capital

 

Stage

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

BALANCE—January 1, 1999 (inception)

 

 

$

 

$

 

$

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of stock (since inception)

 

1,588,000

 

250,000

 

 

 

 

 

250,000

 

Compensation expense related to stock options (since inception)

 

 

 

 

 

15,097

 

 

 

15,097

 

Capital contributions (since inception)

 

 

 

10,415,599

 

 

10,415,599

 

Net loss (since inception)

 

 

 

 

(13,087,375

)

(13,087,375

)

BALANCE—December 31, 2003

 

1,588,000

 

250,000

 

10,430,696

 

(13,087,375

)

(2,406,679

)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.157 per share

 

41,685

 

6,563

 

 

 

6,563

 

Compensation expense related to stock options

 

 

 

5,604

 

 

5,604

 

Exchange of shares under recapitalization

 

(1,629,685

)

(256,563

)

 

 

(256,563

)

Issuance of shares under recapitalization

 

9,482,015

 

94,820

 

161,743

 

 

256,563

 

Capital contributions

 

 

 

2,295,731

 

 

2,295,731

 

Issuance of 14,887 warrants

 

 

 

11,898

 

 

11,898

 

Issuance of common stock in exchange for licenses

 

1,122,569

 

11,226

 

8,988,774

 

 

9,000,000

 

Net loss

 

 

 

 

(27,186,918

)

(27,186,918

)

BALANCE—December 31, 2004

 

10,604,584

 

106,046

 

21,894,446

 

(40,274,293

)

(18,273,801

)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock, net of offering costs

 

6,721,814

 

67,218

 

29,210,558

 

 

29,277,776

 

Issuance of stock related to option exercises

 

63,924

 

639

 

14,240

 

 

14,879

 

Compensation expense related to stock options

 

 

 

696,204

 

 

696,204

 

Issuance of common stock in exchange for reduction of milestones payable

 

600,000

 

6,000

 

3,000,000

 

 

3,006,000

 

Modification of 14,887 warrants

 

 

 

18,925

 

 

18,925

 

Net loss

 

 

 

 

(6,444,246

)

(6,444,246

)

BALANCE—December 31, 2005

 

17,990,322

 

179,903

 

54,834,373

 

(46,718,539

)

8,295,737

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock, net of offering costs

 

10,233,464

 

102,335

 

33,266,653

 

 

33,368,988

 

Issuance of stock related to option exercises

 

58,891

 

589

 

8,656

 

 

9,245

 

Compensation expense related to stock options

 

 

 

261,171

 

 

261,171

 

Net loss

 

 

 

 

(20,540,636

)

(20,540,636

)

BALANCE—December 31, 2006

 

28,282,677

 

$

282,827

 

$

88,370,853

 

$

(67,259,175

)

$

21,394,505

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of stock related to option exercises

 

12,000

 

120

 

1,764

 

 

1,884

 

Compensation expense related to stock options

 

 

 

365,504

 

 

365,504

 

Net loss

 

 

 

 

(20,954,608

)

(20,954,608

)

BALANCE—June 30, 2007

 

28,294,677

 

$

282,947

 

$

88,738,121

 

$

(88,213,783

)

$

807,285

 

 

See notes to unaudited condensed consolidated financial statements.

4




 

ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

 

 

 

 

 

 

Inception

 

 

 

Six months ended

 

(January 1, 1999)

 

 

 

June 30,

 

Through

 

 

 

2007

 

2006

 

June 30, 2007

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

Net loss

 

$

(20,954,608

)

$

(7,764,220

)

$

(88,213,783

)

Adjustments to reconcile net loss to net cash flows used in operating activities:

 

 

 

 

 

 

 

Depreciation and amortization

 

105,088

 

47,729

 

521,107

 

Non-cash interest expense

 

18,884

 

18,884

 

81,939

 

Stock compensation expense

 

365,504

 

117,605

 

1,343,580

 

Non-cash research and development

 

 

 

24,466,667

 

Non-cash settlement of milestone payment

 

 

 

6,000

 

Gain on sale of interest in Sarawak Medichem Pharmaceuticals (SMP)

 

 

 

(939,052

)

Loss on disposal

 

1,761

 

 

13,294

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Clinical supplies

 

 

 

533,333

 

Accounts receivable, related party

 

 

6,160

 

 

Prepaid expenses

 

354,392

 

(2,346,163

)

(2,663,775

)

Other assets

 

 

2,408

 

(1,452

)

Accounts payable

 

3,028,893

 

(218,869

)

4,040,289

 

Accrued expenses

 

3,543,288

 

1,428,225

 

5,181,063

 

Licenses payable

 

 

 

(11,000,000

)

Accrued interest on debt

 

(9,839

)

(757,931

)

590,980

 

Net cash flows from operating activities

 

(13,546,637

)

(9,466,172

)

(66,039,810

)

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

Purchase of property and equipment

 

(48,464

)

(45,075

)

(720,376

)

Proceeds from the sale of SMP

 

 

 

939,052

 

Proceeds from the sales of investments

 

 

14,807,158

 

31,557,158

 

Purchase of investments

 

 

(4,332,158

)

(31,557,158

)

Net cash flows from investing activities

 

(48,464

)

10,429,925

 

218,676

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

Proceeds from issuance of common stock and capital contributions

 

 

33,455,801

 

69,856,339

 

Proceeds from issuance of notes payable

 

 

3,915,000

 

12,933,691

 

Payments on notes payable

 

 

(3,915,000

)

(3,915,000

)

Proceeds from grants

 

 

 

500,000

 

Proceeds from stock options exercised

 

1,884

 

5,512

 

32,571

 

Payments on capital leases

 

(10,954

)

(7,497

)

(135,691

)

Net cash flows from financing activities

 

(9,070

)

33,453,816

 

79,271,910

 

 

 

 

 

 

 

 

 

NET (DECREASE) INCREASE IN CASH

 

(13,604,171

)

34,417,569

 

13,450,776

 

 

 

 

 

 

 

 

 

CASH—Beginning of period

 

27,054,947

 

4,749,932

 

 

CASH—End of period

 

$

13,450,776

 

$

39,167,501

 

$

13,450,776

 

 

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

 

 

 

 

 

 

 

Cash paid during the period for interest

 

$

211,594

 

$

1,025,188

 

$

1,707,817

 

 

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURE OF NONCASH TRANSACTIONS

 

 

 

 

 

 

 

Noncash investment activity:

 

 

 

 

 

 

 

Purchase of property and equipment under capital leases

 

$

 

$

20,693

 

$

164,249

 

Capital expenses included in accounts payable

 

4,046

 

14,232

 

4,046

 

Noncash financing activity:

 

 

 

 

 

 

 

Issuance of common shares for licenses

 

 

 

9,000,000

 

Issuance of common shares for reduction of milestone payment

 

 

 

3,000,000

 

Cost of proceeds

 

 

86,813

 

 

Debt discount

 

 

 

30,823

 

Deferred financing costs

 

$

 

$

 

$

30,000

 

 

See notes to unaudited condensed consolidated financial statements.

5




 

ADVANCED LIFE SCIENCES HOLDINGS, INC
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(UNAUDITED)

1.      Summary of Significant Accounting Policies

Nature of Business-Advanced Life Sciences Holdings, Inc. and its subsidiary Advanced Life Sciences, Inc. (together, the “Company”) conducts new drug research and development in the fields of infectious disease, oncology and inflammation.  Since inception, the Company has devoted substantially all of its efforts to activities such as financial planning, capital raising and product development, and has not derived significant revenues from its primary business activity.  Accordingly, the Company is in the development stage, as defined by Statement of Financial Accounting Standards (“SFAS”) No. 7, Accounting and Reporting by Development Stage Enterprises.

Basis of Presentation-The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements.  However, in the opinion of management, all adjustments, consisting only of normal recurring adjustments, unless otherwise noted herein, necessary to present fairly the results of operations, financial position and cash flows have been made.  Therefore, these condensed consolidated financial statements should be read in conjunction with the Company’s most recent audited financial statements for the year ended December 31, 2006 and notes thereto. The condensed consolidated financial statements include the accounts of the Advanced Life Sciences Holdings, Inc. and its wholly-owned subsidiary Advanced Life Sciences, Inc. (“ALS Inc.”)  All intercompany balances and transactions have been eliminated.  The results of operations for any interim period are not necessarily indicative of the results of operations expected for the full year.

The condensed consolidated financial statements have been prepared on a going concern basis, which contemplates continuity of operations and the realization of assets and liquidation of liabilities in the ordinary course of business.  However, as a result of the Company’s continued losses and current cash and financing position, such realization of assets or liquidation of liabilities, without substantial adjustments is uncertain.  Given this uncertainty, there is significant doubt as to the Company’s ability to continue as a going concern.

Business and Credit Risks- The Company is subject to risks and uncertainties common to drug discovery companies, including technological change, potential infringement on intellectual property of third parties, new product development, regulatory approval and market acceptance of its products, activities of competitors and its limited operating history.

The Company has incurred losses since its incorporation in January 1999, and, prior to its incorporation, its business activities as a segment of MediChem incurred losses.  The Company has funded its operations to date primarily from debt financings and capital contributions from its founder and Chief Executive Officer, proceeds from the initial public offering of its common stock and the subsequent sale of its common stock in a private placement.  The Company will not be generating revenues or realizing cash flows from operations in the near term, and will require additional equity or debt financing to meet working capital needs, to fund operating losses associated with research and development and to fund clinical trials.  In order to address its working capital shortfall the Company intends to raise additional capital during 2007 through the issuance of equity securities or the receipt of milestone payments which would be paid as a result of consummating a commercial partnership for cethromycin, or a combination of both.  Although management believes the Company could obtain such financing, there can be no assurances that such financing will be available in the future at terms acceptable to the Company, if at all.  To the extent the Company raises additional capital by issuing equity securities; its stockholders could experience substantial dilution.  The accompanying financial statements do not include any adjustments that might result from the outcome of these uncertainties.

6




2.      Private Placement

In March 2006, the Company completed the private placement of 10,233,464 shares of its common stock to a group of institutional investors at $3.53 per share, resulting in gross proceeds of $36.1 million.  In addition to the shares sold, the Company issued warrants to purchase 5,116,732 shares of its common stock at a price of $3.81 per share.  The warrants became exercisable upon issuance and will expire five years from the date of grant.  The warrants contain the right, at the discretion of the purchaser, to convert into common stock through a net exercise provision.  The Company has recorded the issuance of the warrants as a permanent component of equity.  In connection with the offering, the Company paid approximately $2.5 million in underwriting discounts and incurred other offering expenses of approximately $226,000. The net cash proceeds from the offering were approximately $33.4 million.

3.      Related Party Transactions

The Company’s Chief Executive Officer, Michael T. Flavin Ph.D., loaned $2.0 million to the Company in 2001 (see Note 4).  Interest expense of $78,000 and $97,000 was recorded for the six months ended June 30, 2007 and 2006, respectively, related to the note.

The Company’s line of credit is secured by substantially all of the Company’s assets, except that the collateral specifically excludes any rights that the Company has as a result of its license agreement with Abbott Laboratories for cethromycin, and is further secured by 2.5 million shares of the Company’s stock held by ALS Ventures, LLC (see Note 4), which is beneficially owned by the Company’s Chief Executive Officer.

The Company leases facilities from the BioStart Property Group, LLC. (“BioStart”), a wholly-owned subsidiary of Flavin Ventures, which is owned by the Company’s Chief Executive Officer.  Lease payments totaled approximately $119,000 and $132,000 for the six months ended June 30, 2007 and 2006, respectively.

4.               Debt Obligations

In September 2001, the Company incurred indebtedness under a $2.0 million promissory note with the Chief Executive Officer of the Company, which bears interest at 7.75%.  Accrued but unpaid interest is added to the outstanding principal annually.  Principal plus accrued interest is due in a lump sum on December 31, 2007.  In May 2006, the Company’s Board of Directors authorized the payment of accumulated interest on the loan with the Chief Executive Officer, totaling $837,000. The authorization also provides for monthly payments of accumulated interest until the loan matures on December 31, 2007.  As of June 30, 2007 and December 31, 2006, the Company had $2.0 million outstanding under the note.

The Company has a $4.0 million line of credit with a financial institution.  Interest under the line is payable monthly at a fixed interest rate of 6.75% per annum, and outstanding principal and interest are payable on January 1, 2008.  The line of credit is secured by substantially all of the Company’s assets, except that the collateral specifically excludes any rights that the Company has a result of its license agreement with Abbott Laboratories for cethromycin.  The line of credit is further secured by 2.5 million shares of the Company’s common stock held by ALS Ventures, LLC.  As of June 30, 2007 and December 31, 2006, the Company had $3.9 million outstanding under the note.  In connection with the line of credit, the financial institution received a warrant entitling it to purchase 14,887 shares of the Company’s common stock at an exercise price of $5.00 per share, subject to certain adjustments.  The warrant is immediately exercisable and will terminate, if not exercised, on December 21, 2009. The warrant was valued, using the Black-Scholes option pricing model, at $27,000. The amount was recorded as a discount to the related debt and is being amortized to interest expense over the term of the debt.

7




5.      Commitments

Vendor Contracts- The Company administers its cethromycin development program largely under contracts with third parties.  To date, contracts totaling $41.0 million have been executed related to the cethromycin program, which includes anthrax related studies.  The remaining balance of $16.7 million is expected to be paid in 2007.  In addition, to date the Company has executed $423,000 in contracts related to the ALS-357 program, of which the majority of the remaining balance of $266,000 is expected to be paid in 2007.

Grant Payable- In April 2005, the Company was awarded a $500,000 grant from the State of Illinois to fund expansion of its corporate headquarters in Woodridge, Illinois.  Under the terms of the grant, the Company is to utilize the funds for construction costs associated with expanding its corporate headquarters and create 100 full-time jobs at the same location between January 31, 2005 and December 31, 2007 (“grant period”).  During the second quarter of 2007 the period in which construction costs could be expended was extended six months to December 31, 2007 and the period that the Company has to create 100 full time jobs was extended 3.5 years to December 31, 2010.  Funds that are not expended in a manner consistent with the grant award are to be repaid at the end of the grant period.  In addition, if the Company does not create the specified number of full-time jobs, it is required to repay the grant proceeds on a pro-rata basis of actual jobs created compared to the total defined in the grant.  As of June 30, 2007 the Company classified approximately $477,000 of the grant proceeds as a short term liability based upon the actual costs of the facility expansion incurred and the number of jobs created during the grant period.  The remaining $23,000 has been classified as a long-term liability as the Company must maintain the positions created during the grant period through January 31, 2010.  If the Company does not maintain the positions created until January 31, 2010, it will owe the State of Illinois grant proceeds equal to a pro-rata share of the positions that were retained as compared to the total created during the grant period.

6.      Minority Interest

The Series A preferred stock (“Series A Preferred Stock”) of the Company’s  subsidiary, ALS, Inc., is held by deCODE Genetics (“deCODE”) as a result of ALS Inc.’s spin-off from MediChem Life Sciences in January 1999, and MediChem’s subsequent acquisition by deCODE Genetics in March 2002. deCODE provides analytical services to the Company on an as needed basis.

As of June 30, 2007, ALS Inc. had 250,000 shares of Series A Cumulative Preferred Stock authorized, issued and outstanding to deCODE. The Series A Preferred Stock is nonvoting except as to certain matters including the issuance of any class of stock ranking prior to the shares of Series A Preferred Stock, or the merger or consolidation of ALS Inc. if such merger would adversely affect the powers, preferences or rights of the Series A Preferred Stock. The Series A Preferred stockholder is entitled to receive dividends payable in cash at the rate of 7.0% per annum per share on the amount of liquidation preference of the shares.  Dividends are only payable when, as and if declared by our board of directors.

7.      Stock Option Grants

For the six months ended June 30, 2007 and 2006, the Company granted stock options to purchase up to 724,300 and 233,500 shares of common stock, respectively, to certain employees and scientific advisory board members and directors. The exercise price of the options was the fair market price of the Company’s common stock on the date of grant.  The Company recognized compensation expense totaling approximately $366,000 and $118,000 for the six months ended June 30, 2007 and 2006, respectively, in accordance with SFAS No. 123 (R), Share based Payment.

8.     Net Loss Per Share

Basic loss per share is computed by dividing net loss by the number of weighted average common shares outstanding during the reporting period.  Diluted loss per share is calculated to give effect to all potentially dilutive common shares that were outstanding during the reporting period.  The computation of diluted shares outstanding for the periods ended June 30, 2007 and 2006 excludes incremental shares of 6,988,180 and 6,265,536, related to employee stock options and warrants.  These shares are excluded due to their anti-dilutive effect as a result of the Company’s losses for the periods ended June 30, 2007 and 2006.

8




9.      Income Taxes

In 2006, the Financial Accounting Standards Board issued Interpretation No. 48 Accounting for Uncertainty in Income Taxes (“FIN 48”).  FIN 48 requires reporting of taxes based on tax positions which meet a more likely than not standard and which are measured at their more likely than not settlement.  Differences between financial and tax reporting which do not meet this threshold are required to be recorded as unrecognized tax benefits.  FIN 48 also provides guidance on the presentation of tax matters and the recognition of potential IRS interest and penalties.

The provisions of FIN 48 became effective on January 1, 2007, and had no effect on the Company’s financial position, cash flows or results of operations upon adoption as the Company does not have any unrecognized tax benefits.  The Company also evaluated its tax positions as of June 30, 2007 and reached the same conclusion.

The Company classifies penalty and interest expense related to income tax liabilities as an income tax expense. There are no interest and penalties recognized in the statement of operations or accrued on the balance sheet.

The Company files tax returns in the US, and in the state of Illinois.  The tax years 2003 through 2006 remain open to examination by the major taxing jurisdictions to which the Company is subject.

10.   Recent Accounting Pronouncements

In March 2007, the Emerging Issues Task Force (“EITF”) issued a tentative conclusion on EITF 07-03, “Accounting for Advance Payments for Goods or Services to Be Used in Future Research and Development” and the FASB ratified the tentative conclusion.  EITF 07-03 addresses the diversity which exists with respect to the accounting for the non-refundable portion of a payment made by a research and development entity for future research and development activities. Under this conclusion, an entity would defer and capitalize non-refundable advance payments made for research and development activities until the related goods are delivered or the related services are performed. EITF 07-03 is effective for interim or annual reporting periods in fiscal years beginning after December 15, 2007. The Company does not expect the adoption of EITF 07-03 to have a material impact on its consolidated financial statements.

 

9




 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion of our financial condition and results of operations in conjunction with our condensed consolidated financial statements and the related notes included elsewhere in this quarterly report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements.

Overview

We are a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs in the areas of infectious disease, oncology and inflammation.  Using our internal discovery capabilities and our network of pharmaceutical and academic partners, we have assembled a promising pipeline of clinical and preclinical product candidates.  Our most advanced product candidate, cethromycin, is a second generation ketolide antibiotic in Phase III clinical development for the treatment of respiratory tract infections.  We also have product candidates in earlier stages of development for the treatment of indications including inflammation-related tissue damage and malignant melanoma.

None of our product candidates have been approved by the United States Food and Drug Administration (“FDA”) or any comparable foreign agencies, and we have not generated any significant revenues to date.  Our ability to generate revenues in the future will depend on our ability to meet development or regulatory milestones under any license agreements that trigger payments to us, to enter into new license agreements for other products or territories and to receive regulatory approvals for, and successfully commercialize, our product candidates either directly or through commercial partners.

Since our inception we have incurred net losses each year.  Our net loss for the six months ended June 30, 2007 was $21.0 million.  As of June 30, 2007, we had an accumulated deficit of $88.2 million.  Our operations to date have been funded principally through proceeds from our initial public offering (“IPO”) in August 2005, our private placement in March 2006, debt and capital contributions made by our Chief Executive Officer and borrowings under our bank line of credit.  We currently do not have sufficient cash or other funding available to complete our anticipated business activities during 2007.  As a result, there is significant doubt about our ability to continue as a going concern.

In December 2005, we initiated two Phase III clinical trials for cethromycin which compare cethromycin with standard of care therapies for community acquired pneumonia (CAP) in the United States, Canada, Europe, South America and South Africa.  Each trial seeks to demonstrate statistical non-inferiority to a comparator using a 95% confidence interval.  Clinical cure rate serves as the primary endpoint in each trial with bacteriological eradication serving as the secondary endpoint.

During the second quarter of 2007 we completed the first of two pivotal phase III clinical trials.  In the trial, cethromycin achieved non-inferiority in its primary endpoint of per protocol clinical cure rate compared to Biaxin ® (clarithromycin) in CAP.  Cethromycin was evaluated using a 300 mg once-daily dosing regimen compared to 250 mg twice-daily dosing for Biaxin ® , both over a seven-day course of therapy.  No drug-related serious adverse events were observed in any study subject.  Liver function tests and electrocardiogram monitoring demonstrated no significant differences between subjects receiving cethromycin and subjects receiving Biaxin ® , consistent with the hepatic and cardiac side effect profile reported in cethromycin’s previous clinical trials.  We expect to have initial data from the second trial by the end of the third quarter of 2007.  This timeline depends on our contract research organization’s ability to collect, compile and report data from this study.

Cethromycin has also been demonstrated to have significant in vitro activity against over 30 anthrax (Bacillus anthracis) strains.  During the second quarter of 2007, we concluded a study testing cethromycin’s efficacy in treating inhalation anthrax post-exposure for prophylaxis in non-human primates.  Results from this study demonstrated that a thirty (30) day course of oral cethromycin at a 16 mg/kg of once-daily dosing (equivalent 300 mg) was 100% protective against a lethal dose of inhaled B. anthracis Ames strain spores.

Clinical testing for our product candidates has been delayed from our initial plans, resulting in increased development costs.  As a result, we will need to raise capital to fund operating activities during 2007 and beyond.  Such a capital raise could be achieved by the sale of additional common stock, the receipt of milestone payments which would be paid to us as a result of entering into a commercial partnership for cethromycin, or a combination of both.

10




 

Even if our pivotal Phase III clinical trials of cethromycin are successfully completed, we do not expect to receive FDA approval for commercialization until 2009 at the earliest.  As of June 30, 2007, we estimate that our cethromycin development program will require an additional $50.5 million in research and development expenses which includes $40.0 million in additional milestones to Abbott, $7.1 million to complete the cethromycin clinical trials, $2.4 million for the preparation of the cethromycin NDA and other commercialization-related costs.  We expect to incur expenses up to $1.0 million to complete our non-human primate studies to determine cethromycin’s efficacy for the prophylactic treatment of inhalation anthrax.  Our $10.0 million and $30.0 million Abbott milestone payments are triggered upon submitting an NDA and receiving FDA approval, respectively.  Development timelines and related costs are difficult to estimate and may vary significantly from our current estimates.

If cethromycin is approved for marketing by the FDA, we plan to sell cethromycin using a commercial partner to access the primary care physician market and to build and utilize a focused internal sales force that will market directly to early adopters such as, but not limited to, pulmonary medicine and infectious disease physicians.

Results of Operations

Three months ended June 30, 2007 compared to three months ended June 30, 2006

Revenue.   The Company had no revenue for the three months periods ended June 30, 2007 and 2006.

Research and development expense.   Research and development expenses increased $5.2 million to $8.8 million for the three months ended June 30, 2007 compared to $3.6 million for the three months ended June 30, 2006.  Of the total increase in research and development expenses of $5.2 million, $3.7 million of this increase consists of the costs to conduct our phase III clinical trials of our lead compound cethromycin, $1.2 million relates to the compilation of the cethromycin NDA, $200,000 was incurred in our anthrax and ALS-357 development programs and $100,000 was incurred for general research and development expenses, including personnel costs.  We estimate that the expense to complete the trials including the expense to compile and submit the NDA is $50.5 million.  Of the $50.5 million, $10.5 million of development costs will be recognized over the remainder of this year and milestones of $10.0 million and $30.0 million will be recognized in 2008 and 2009, respectively.

General and administrative expense.   General and administrative expense increased $471,000 to $1.8 million for the three months ended June 30, 2007 as compared to the three months ended June 30, 2006.  Approximately $251,000 of the total increase was attributable to higher compensation costs of existing personnel as well as compensation for new employees in the legal and accounting functions that will manage the Company’s Sarbanes-Oxley compliance program.  General corporate expenses increased $109,000.  Marketing expense related to the branding of cethromycin compound increased $65,000.  Expenses related to our facilities increased $46,000 resulting from the expansion of our corporate offices to accommodate additional personnel which occurred during the fourth quarter of 2006.

11




 

Interest income.   Interest income decreased $306,000 to $214,000 for the three months ended June 30, 2007.  Interest income is derived through the investment of our IPO and private placement proceeds in money market funds, until they are used in operations.  The decrease in interest income reflects lower cash balances this quarter versus the same quarter the prior year.

 Interest expense.   Interest expense decreased $11,000 to $117,000 for the three months ended June 30, 2007.  In May of 2006 we restructured our line of credit from a variable rate based on Prime to a fixed rate of 6.75%.  As a result, the effective rate of interest on our line of credit decreased 1.8% which decreased our interest expense for the three months ended June 30, 2007 as compared to the three months ended June 30, 2006, by $11,000.

Six months ended June 30, 2007 compared to six months ended June 30, 2006

Revenue.   The Company had no revenue for the six months ended June 30, 2007 compared to $35,000 for the six months ended June 30, 2006.  Revenue in 2006 resulted from a phase I grant that was awarded in the third quarter of 2005.

Research and development expense.   Research and development expenses increased $12.0 million to $17.9 million for the six months ended June 30, 2007 compared to $5.9 million for the six months ended June 30, 2006.  Of the total increase in research and development expenses of $12.0 million, $7.7 million of this increase consists of the costs to conduct or phase III clinical trials of our lead compound cethromycin, $3.0 million relates to the compilation of the cethromycin NDA, $1.1 million was incurred in our anthrax and ALS-357 development programs and $200,000 was incurred for general research and development expenses, including personnel costs.

General and administrative expense.   General and administrative expense increased $870,000 to $3.4 million for the six months ended June 30, 2007 as compared to the six months ended June 30, 2006.   Approximately $581,000 of the total increase was attributable to higher compensation costs of existing personnel as well as compensation for new employees in the legal and accounting functions that will manage the Company’s Sarbanes-Oxley compliance program.  Marketing expense related to the branding of cethromycin increased $101,000.  Expenses related to our facilities increased $92,000 resulting from the expansion of our corporate offices to accommodate additional personnel which occurred during the fourth quarter of 2006.  General corporate expenses increased $96,000.

 Interest income.   Interest income decreased $280,000 to $521,000 for the six months ended June 30, 2007 due to lower cash balances in the current year.

Interest expense.   Interest expense decreased $40,000 to $233,000 for the six months ended June 30, 2007.  In May of 2006 we restructured our line of credit from a variable rate based on Prime to a fixed rate of 6.75%.  As a result, the effective rate of interest on our line of credit decreased 1.8% which decreased our interest expense for the first half of 2007 as compared to the first half of 2006, by $40,000.

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Liquidity and Capital Resources

We have devoted substantially all of our cash resources to research and development and general and administrative expenses.  To date, we have not generated any revenues from the sale of products, and we do not expect to generate any such revenues for a number of years, if at all.  As a result, we have incurred an accumulated deficit of $88.2 million as of June 30, 2007 and we expect to incur significant operating losses for the foreseeable future.    Cash and cash equivalents was $13.5 million as of June 30, 2007.  Since our inception in 1999 to August 2005, we financed our operations primarily through debt and capital contributions from our founder and controlling stockholder and borrowings under our bank line of credit.  In August 2005 we completed our initial public offering in which we raised $28.7 million, net of underwriters discount and offering costs.  In March 2006 we completed a private placement in which we raised $33.4 million, net of underwriters discount and offering costs.  Our working capital as of June 30, 2007 amounted to $478,000.

In September 2001, our Chief Executive Officer made a $2.0 million loan to us.  The loan accrues interest at the rate of 7.75%, compounded annually, and is due and payable on December 31, 2007.  The balance of the loan and accrued interest was $2.0 million as of June 30, 2007.

We have a $4.0 million line of credit with a local financial institution.  As of June 30, 2007, the line of credit had an outstanding balance of $3.9 million bearing interest of 6.75% per annum.  Interest is payable monthly, and the line of credit matures on January 1, 2008.  The line of credit is secured by substantially all the assets of the Company, excluding any rights that we have under of our license agreement with Abbott Laboratories for cethromycin.  The line of credit is also secured by 2.5 million shares of our common stock held by Flavin Ventures, LLC. (see Note 4 to the unaudited condensed consolidated financial statements).

During the six months ended June 30, 2007, cash used in operating activities totaled $13.5 million.  Approximately $10.5 million was used for the development of cethromycin, $837,000 for Anthrax trials, $269,000 for research activities related to our proprietary portfolio of compounds and $2.0 million for general operations net of $568,000 in interest income.

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Contractual Obligations

As of June 30, 2007, the annual amounts of future minimum payments under debt obligations, interest, lease obligations and other long term liabilities consisting of research, development and license agreements including the potential product based milestones which could be due to Abbott, are as follows:

 

 

Payments Due by December 31,

 

 

 

 

 

2007

 

2008

 

2009

 

2010

 

2011

 

Total

 

Notes payable

 

$

2,000,000

 

$

3,915,000

 

$

 

$

 

$

 

$

5,915,000

 

Interest

 

224,516

 

2,842

 

1,633

 

304

 

 

229,295

 

Abbott license payments

 

 

10,000,000

 

30,000,000

 

 

 

40,000,000

 

Cethromycin development costs

 

10,690,000

 

8,000

 

 

 

 

10,698,000

 

Anthrax clinical studies

 

1,093,000

 

 

 

 

 

1,093,000

 

ALS-357 clinical supplies

 

314,000

 

12,000

 

 

 

 

326,000

 

Operating leases

 

118,940

 

160,648

 

 

 

 

279,588

 

Capital leases

 

8,482

 

7,259

 

8,468

 

4,350

 

 

28,559

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

14,448,938

 

$

14,105,749

 

$

30,010,101

 

$

4,654

 

$

 

$

58,569,442

 

 

We will owe Abbott $10.0 million if we submit an NDA for cethromycin and $30.0 million if and when the FDA approves the NDA, which we estimate will occur in 2008 and 2009, respectively.  The estimated timing of these payments has been changed since last quarter due to the ongoing completion of the cethromycin development program.  Thereafter, we would owe Abbott an additional $2.5 million upon reaching $200 million in aggregate net sales of cethromycin and $5.0 million upon reaching $400 million in aggregate net sales.  The periods in which milestone obligations become payable, if at all, are only estimates due to uncertainties associated with the completion of the clinical studies and related regulatory filings.

Our long-term commitments under operating leases shown above consist of payments made to a related party relating to our facility lease in Woodridge, Illinois, which expires in September of 2008.

In the first seven months of 2007 we executed contracts totaling $3.9 million, of which $2.4 million were executed after June 30, 2007.  Of the total contracts executed, $2.5 million related to the compilation of our cethromycin NDA and NDA directed studies and $1.4 million related to clinical trials.  We anticipate executing additional contracts totaling $2.5 million related to our clinical development of cethromycin.  Of this amount, $2.0 million represents the costs we will incur to complete the Phase III pivotal clinical trials; $400,000 related to the compilation of our cethromycin NDA and NDA directed studies; $100,000 related to our ALS-357 development program.

Remaining payments due under all existing and anticipated cethromycin development contracts, including anthrax studies, total $16.7 million and are expected to be made over the next six months.  The majority of these payments are milestone based.  The periods in which milestone obligations become payable are only estimates due to uncertainties in clinical trial completion timelines.

To fund these contracts and our existing development commitments, indebtedness and general operating expenses we need to raise additional operating capital during 2007.  We anticipate raising such capital after data from the second of our Phase III pivotal clinical trials is available.  Such a capital raise could be achieved by the sale of additional common stock, the receipt of milestone payments which would be paid to us as a result of entering into a commercial partnership for cethromycin, or a combination of both.  Based upon current market conditions and discussions with potential commercial partners, we believe sufficient funds can be raised in 2007 to continue our development of cethromycin and fund our other research and corporate expenditures through the expected approval of our cethromycin NDA.  Although we believe we can obtain sufficient financing, there can be no assurances that such financing will be available, or available at terms acceptable to us.  We currently do not have sufficient cash or other funding available to complete our anticipated business activities during 2007 and are working with certain vendors and partners to extend payment terms and take other appropriate actions to conserve cash.  As a result, there is significant doubt about our ability to continue as a going concern.

 

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Our future capital uses and requirements depend on numerous forward-looking factors. These factors include, but are not limited to, the following:

·                                          progress in our clinical development programs, as well as the magnitude of these programs;

·                                          the timing, receipt and amount of milestone and other payments, if any, from present and future collaborators;

·                                          our ability to raise additional capital through the sale of common stock or the receipt of milestone payments that would be paid to us as a result of our entering into a commercial partnership for cethromycin, or a combination of both;

·                                          our ability to establish and maintain additional collaborative arrangements;

·                                          the resources, time and costs required to successfully initiate and complete our preclinical and clinical trials, obtain regulatory approvals, protect our intellectual property and obtain and maintain licenses to third-party intellectual property;

·                                          the cost of preparing, filing, prosecuting, maintaining and enforcing patent claims; and

·                                          the timing, receipt and amount of sales and royalties, if any, from our potential products.

If, at any time, our prospects for financing our clinical development programs are limited, we may decide to reduce research and development expenses by delaying or discontinuing certain programs.

Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America.  The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and related disclosure of contingent assets and liabilities.  We review our estimates on an ongoing basis.  We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances.  Actual results may differ from these estimates under different assumptions or conditions.  While our significant accounting policies are described in more detail in the notes to our financial statements included in this annual report, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our financial statements.

In-Process Research and Development

We recognize in-process research and development in accordance with FASB Interpretation No. 4, Applicability of FASB Statement No. 2 to Business Combinations Accounted for by the Purchase Method and the AICPA Technical Practice Aid, Assets Acquired in a Business Combination to be used in Research and Development Activities:  A Focus on Software, Electronic Devices, and Pharmaceutical  Industries.  Assets to be used in research and development activities, specifically, compounds that have yet to receive new drug approval from the FDA and would have no alternative use should approval not be given, are immediately charged to income when acquired.

In December 2004, we incurred $24.5 million of in-process research and development expense as a result of entering into our exclusive license with Abbott Laboratories for cethromycin.  We determined to immediately expense the purchased in-process research and development costs because the ultimate outcome of clinical trials for cethromycin is unknown and, therefore, FDA approval is uncertain.  As part of the consideration for the cethromycin license, we issued to Abbott shares of our common stock. In order to determine the value of the common stock issued to Abbott, we relied on the arms-length nature of the transaction, precedent market data and several internal valuation models and studies.  An independent appraisal was also obtained to provide additional support for the valuation methodologies utilized.  By their nature, valuations involve judgments of management that

15




 

rely on estimates regarding the timing and amount of cash flows and discount rates that, if changed, could significantly affect the conclusions as to value.

Research and Development

Research and development expenses consist of internal research costs and fees paid for contract research in conjunction with the research and development of our proprietary product portfolio.  All such costs are expensed as incurred.  Clinical trial costs incurred by third parties are expensed as the contracted work is performed.  We estimate both the total cost and time period of the trials and the percent completed as of that accounting date.  We believe that the estimates made as of June 30, 2007 are reflective of the actual expenses incurred as of that date.

Stock-based Compensation

We account for stock-based awards to employees and non-employees using the accounting provisions of Statement of Financial Accounting Standards No. 123(R) Share-based Payments which provides for the use of the fair value based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation.  We use the Black-Scholes options-pricing model to determine the fair value of each option grant as of the date of grant for expense incurred.  The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility and expected lives of the options.  Since the Company has a limited history of stock activity, expected volatility is based on historical data from several peer public companies with similar product portfolios to us.  The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant.  The expected lives for options granted represents the period of time that options granted are expected to be outstanding and is derived from the contractual terms of the options granted.

Forward-Looking Statements and Risk Factors

This Quarterly Report on Form 10-Q, including Management’s Discussion and Analysis of Financial Condition and Results of Operations, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.   Forward-looking statements often are proceeded by words such as “believes,” “expects,” “may,” “anticipates,” “plans,” “intends,” “assumes,” “will” or similar expressions.  Forward-looking statements reflect management’s current expectations, as of the date of this report, and involve certain risks and uncertainties.   Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors.   Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in our Annual Report on Form 10-K.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our exposure to market risk is currently confined to our cash and cash equivalents.  We currently do not hedge interest rate exposure. We have not used derivative financial instruments for speculation or trading purposes.  Because of the short-term maturities of our cash and cash equivalents, we do not believe that an increase in market rates would have a significant impact on their realized value.

Our most liquid assets are cash and cash equivalents.  Because of their liquidity, these assets are not directly affected by inflation.  We also believe that we have intangible assets in the value of our intellectual property.  In accordance with generally accepted accounting principles, we have not capitalized the value of this intellectual property on our balance sheet.  Due to the nature of this intellectual property, we believe that these intangible assets are not affected by inflation.  Because we intend to retain and continue to use our equipment, furniture and fixtures and leasehold improvements, we believe that the incremental inflation related to replacement costs of such items will not materially affect our operations.  However, the rate of inflation affects our expenses, such as those for employee compensation and contract services, which could increase our level of expenses and the rate at which we use our resources.

Item 4. Controls and Procedures

Our management, under the supervision and with the participation of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), has evaluated the effectiveness of our disclosure controls and procedures as defined in SEC Rules 13a-15(e) and 15d-15(e) as of the end of the period covered by this report.  Based upon that evaluation, management has concluded that our disclosure controls and procedures are effectively designed to ensure that information

16




 

we are required to disclose in reports that we file or submit under the Securities Exchange Act of 1934 is accumulated and communicated to management, including the CEO and CFO, as appropriate to allow timely decisions regarding required disclosure and is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

Changes in Internal Control

During the period covered by this report, there have been no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

17




 

PART II — OTHER INFORMATION

Item 4. Submission of Matters to a Vote of Security Holders

The following matters were submitted to a vote of security holders at the Company’s annual meeting held on May 4, 2007:

Proposal 1: Election of Directors

 

Name

 

 

 

For

 

 

 

Withheld

 

John L. Flavin

 

22,036,037

 

104,491

Richard A. Reck

 

21,957,105

 

183,423

Rosalie Sagraves

 

21,950,605

 

189,923

 

Proposal 2: Ratification of Deloitte & Touche LLP as the Company’s independent registered public accounting firm for the fiscal year ended December 31, 2007

For

 

 

 

Against

 

 

 

Abstain

 

22,038,063

 

96,708

 

5,757

 

Item 6. Exhibits

The following is a list of exhibits filed as part of this Form 10-Q:

Number

 

Description

 

 

 

31.1

 

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

 

 

 

31.2

 

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

 

 

 

32.1

 

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

 

 

 

32.2

 

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

 

18




 

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.

 

 

 

 

Advanced Life Sciences Holdings, Inc.

 

 

 

 

 

 

 

By:

 

/s/ Michael T. Flavin, Ph.D.

 

 

 

 

Michael T. Flavin, Ph.D.

 

 

 

 

Chairman of the Board, President

 

 

 

 

and Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ R. Richard Wieland II

 

 

 

 

R. Richard Wieland II

 

 

 

 

Executive Vice President and

 

 

 

 

Chief Financial Officer

 

 Dated: August 9, 2007

19




 

EXHIBIT INDEX

Number

 

Description

 

 

 

31.1

 

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

 

 

 

31.2

 

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

 

 

 

32.1

 

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

 

 

 

32.2

 

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

 

20



EX-31.1 2 a07-19158_1ex31d1.htm EX-31.1

 

EXHIBIT 31.1

CERTIFICATION

I, Michael T. Flavin, certify that:

1.                                       I have reviewed this quarterly report on Form 10-Q of Advanced Life Sciences Holdings, 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 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)) 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)                                     (Paragraph omitted pursuant to SEC Release Nos. 33-8392 and 34-49313);

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 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 the registrant’s board of directors (or persons performing the equivalent functions):

a)                                      all significant deficiencies and material weaknesses in the design or operation of internal control 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 control over financial reporting.

Date: August 9, 2007

/s/ Michael T. Flavin

 

Michael T. Flavin

 

Chief Executive Officer

 

Advanced Life Sciences Holdings, Inc.

 

 

 



EX-31.2 3 a07-19158_1ex31d2.htm EX-31.2

 

EXHIBIT 31.2

CERTIFICATION

I, R. Richard Wieland II, certify that:

1.                                       I have reviewed this quarterly report on Form 10-Q of Advanced Life Sciences Holdings, 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 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)) 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)                                     (Paragraph omitted pursuant to SEC Release Nos. 33-8392 and 34-49313);

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 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 the registrant’s board of directors (or persons performing the equivalent functions):

a)                                      all significant deficiencies and material weaknesses in the design or operation of internal control 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 control over financial reporting.

Date:  August 9, 2007

/s/ R. Richard Wieland II

 

R. Richard Wieland II

 

Chief Financial Officer

 

Advanced Life Sciences Holdings, Inc.

 

 

 



EX-32.1 4 a07-19158_1ex32d1.htm EX-32.1

 

EXHIBIT 32.1

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350

In connection with the quarterly report on Form 10-Q of Advanced Life Sciences Holdings, Inc. (the “Company”) for the fiscal quarter ending June 30, 2007 (the “Report”), I, Michael T. Flavin, Chairman and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

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

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

Date: August 9, 2007

 

 

 

 

 

/s/ Michael T. Flavin

 

Michael T. Flavin

 

Chief Executive Officer

 

Advanced Life Sciences Holdings, Inc.

 

 



EX-32.2 5 a07-19158_1ex32d2.htm EX-32.2

 

EXHIBIT 32.2

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350

In connection with the quarterly report on Form 10-Q of Advanced Life Sciences Holdings, Inc. (the “Company”) for the fiscal quarter ending June 30, 2007 (the “Report”), I, R. Richard Wieland II, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

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

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

Date:  August 9, 2007

 

 

 

 

 

/s/ R. Richard Wieland II

 

R. Richard Wieland II

 

Chief Financial Officer

 

Advanced Life Sciences Holdings, Inc

 

 



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