-----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, JoAUuovnBzMyNJXrbXkW8llTKeMWqJUO9QVUdUT1Omwf3GJ89qAYu9frLuq5+ipK 9RmxIeS29DKY2URef7jY6w== 0001104659-07-060515.txt : 20070809 0001104659-07-060515.hdr.sgml : 20070809 20070809081626 ACCESSION NUMBER: 0001104659-07-060515 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070808 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits 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: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51436 FILM NUMBER: 071037846 BUSINESS ADDRESS: BUSINESS PHONE: (630) 739-6744 MAIL ADDRESS: STREET 1: 1440 DAVEY ROAD CITY: WOODRIDGE STATE: IL ZIP: 60517 8-K 1 a07-21478_18k.htm 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  August 8, 2007

ADVANCED LIFE SCIENCES HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware

 

000-51436

 

30-0296543

(State or other jurisdiction

 

(Commission

 

(I.R.S. Employer

of incorporation)

 

File Number)

 

Identification No.)

 

1440 Davey Road

 

 

Woodridge, Illinois

 

60517

(Address of principal executive offices)

 

(Zip Code)

 

(630) 739-6744

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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

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

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

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 




Item 2.02.                  Results of Operations and Financial Condition.*

On August 8, 2007, Advanced Life Sciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2007.  The Company also provided financial and operational highlights for the second half of 2007.  A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01.      Financial Statements and Exhibits.

(d)         Exhibits:

99.1*     Press Release dated August 8, 2007.


*     The information furnished under Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

2




SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

 

 

 

 

 

 

 

 

 

Dated:     August 9, 2007

 

 

By:

/s/ Michael T. Flavin

 

 

 

Name:

Michael T. Flavin, Ph.D.

 

 

 

Title:

Chairman and Chief Executive Officer

 

3




Exhibit Index

Exhibit No.

 

Description

 

 

 

99.1*

 

Press Release dated August 8, 2007.

 


*       The information furnished under Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

4



EX-99.1 2 a07-21478_1ex99d1.htm EX-99.1

Exhibit 99.1

 

1440 Davey Road
Woodridge, IL 60517
(Phone) 630.739.6744
(Fax) 630.739.6754
www.advancedlifesciences.com

 

FOR IMMEDIATE RELEASE

 

Company Contact: Joe Camp 630-754-4352

AUGUST 8, 2007

 

Media Contact: Melanie Nimrodi, Financial Relations Board, 312-546-3508
Investors Contact: Kathy Price, Financial Relations Board, 213-486-6547

 

Advanced Life Sciences Announces Second Quarter 2007 Financial Results

CHICAGO, IL, August 8, 2007/PRNewswire/: — Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation, today announced its financial results for the second quarter ended June 30, 2007.

The net loss for the three months ended June 30, 2007 was $10.6 million or ($0.37) per share compared to $4.6 million or ($0.16) per share for the three months ended June 30, 2006.  The higher net loss reflects increased development expenses related to regulatory and manufacturing initiatives for cethromycin, as well as ongoing costs related to the clinical trials of the drug.

“The goal of our two pivotal Phase III clinical trials of cethromycin has been to support regulatory approval.  In late June, we announced positive results from Trial CL-06, the first of the two Phase III studies designed to assess the safety and efficacy of cethromycin for the treatment of community acquired pneumonia (CAP).  In that study, cethromycin not only achieved its primary and secondary efficacy endpoints compared to Biaxin® (clarithromycin), but it also demonstrated a favorable safety profile as expected with the incidence of adverse events not being statistically different between cethromycin and Biaxin,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences.

“We believe the strong clinical cure rates and safety profile achieved in Trial CL-06 validate our dosing strategy, as well as endorse our current regulatory and commercial partnering pathway,” continued Dr. Flavin. “To date we have enrolled more than 1,000 patients in the two studies and have surpassed our enrollment target of 500 patients for Trial CL-05, the second pivotal Phase III trial.  We eagerly anticipate the results from that study and will report the data as soon as it is compiled and confirmed by the independent CRO.  Based on the latest information we have received from our CRO, a comprehensive release of top-line data is expected to occur in the Fall.”

Dr. Flavin concluded, “An estimated 5.6 million cases of CAP occur annually in the U.S., resulting in an estimated total annual spend of $2 billion for prescribed antibiotics. With rates of penicillin and macrolide resistance currently approaching 60% and 40%, respectively, there is a critical need for new antibiotics that can overcome resistance and ultimately replace the macrolides as front-line therapies.  We believe that cethromycin, if approved, would address this growing need.  Therefore, we continue to advance it towards NDA submission.”

The company ended the second quarter of 2007 with cash totaling $13.5 million.

-MORE-




Operating Expense Analysis

·                  Research and development expenses were $8.8 million for the three months ended June 30, 2007 compared to $3.6 million for the three months ended June 30, 2006.  This increase was the result of additional development expenses associated with the Phase III clinical trials and NDA-related expenses for cethromycin.

·                  Selling, general and administrative expenses were $1.8 million in the second quarter of 2007 compared to $1.3 million for the same period in 2006.   This increase was due primarily to the development of medical education programs, higher compensation costs for existing personnel and increased costs associated with Sarbanes-Oxley compliance.

Second Quarter Achievements

·                  Released positive data from Trial CL-06, the first of two pivotal Phase III clinical trials for the use of cethromycin in CAP, which met primary and secondary endpoints as guided by the FDA;

·                  Progressed negotiations with multiple prospective partners regarding the commercial development of cethromycin as a treatment for CAP;

·                  Released positive data from non-human primate study for inhalation anthrax indication, which demonstrated that cethromycin was 100% protective against a lethal dose of inhaled anthrax as compared to the standard of care, Cipro® (ciprofloxacin), which demonstrated 90% protection;

·                  Completed API manufacturing and initiated stability testing to satisfy FDA’s CMC requirements for the upcoming cethromycin NDA submission;

·                  Advanced development of ALS-357 with clinical materials manufactured and placed on stability for the melanoma program; and

·                  Formed National Advisory Board for Cethromycin consisting of 10 thought leaders in the area of respiratory tract infections and antibiotic therapies.

Business Outlook for the Second Half 2007

·                  Release data from Trial CL-05, the second of two pivotal Phase III clinical trials for the use of cethromycin in CAP;

·                  Advance negotiations with potential commercial partners for cethromycin;

·                  Present 11 posters on cethromycin at The American Society for Microbiology’s 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago – September 17 - 20 and the 45th Annual Meeting of the Infectious Disease Society of America (IDSA) in San Diego – October 4 – 7;

·                  Host satellite symposium on current treatment options for drug-resistant CAP at the ICAAC Conference;

·                  Conduct further NDA submission activities and pre-launch medical education programs relating to cethromycin as a treatment for CAP;

·                  Finalize and initiate clinical sites for the Phase I/II study of ALS-357 as a treatment for melanoma;

·                  Expand collaborations with the National Institute of Allergy and Infectious Diseases (NIAID) and The U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) to explore cethromycin’s activity against high-priority bioterror agents for its use as a broad spectrum countermeasure; and

·                  Establish and convene additional meetings with the National Advisory Board for Cethromycin.




Financial Guidance for the Second Half of 2007

Advanced Life Sciences expects its third quarter 2007 cash requirements to fall in the range of $ 6.5 million and $ 7.5 million leaving a cash balance of $6.0 to $7.0 million as of September 30, 2007.  We believe that this cash balance will be sufficient to allow us to progress through the period in which we report comprehensive top-line data from our Phase III cethromycin program in the Fall.  To fund ongoing operations, the Company intends to raise additional capital in the fourth quarter of 2007 through a commercial partnership and/or the sale of equity, if available at terms acceptable to us, which cannot be assured.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Thursday, August 9, 2007 to discuss the company’s second quarter financial results.

The conference call will be webcast simultaneously over the Internet.  Please visit the Investor Relations section of Advanced Life Sciences’ corporate website www.advancedlifesciences.com.  Alternatively, callers may participate in the conference call by dialing 888-873-4896 (domestic) or 617-213-8850 (international).  The passcode for the conference call is 16007877.  A telephone replay of the call will also be available for 48 hours.  Callers may access the telephone replay by dialing (domestic) 888-286-8010 or 617-801-6888 (international), passcode 88970844.

About Advanced Life Sciences

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation.  The company’s lead candidate, cethromycin, is a novel once-a-day antibiotic in late-stage clinical development for the treatment of respiratory tract infections.

About Cethromycin

Advanced Life Sciences is developing cethromycin, a novel once-a-day antibiotic in response to the emerging bacterial resistance observed in the treatment of community acquired pneumonia (CAP).  Cethromycin has been tested in approximately 5,000 human subjects during clinical trials.

The company is currently conducting pivotal Phase III clinical trials of cethromycin for the treatment of mild-to-moderate CAP.  Advanced Life Sciences believes that cethromycin, if approved, would build upon the growing market opportunity in the antibiotic marketplace and address the critical need for antibiotics that overcome bacterial resistance.

Forward-Looking Statements

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Except for historical information, the statements made in this press release are forward-looking statements about Advanced Life Sciences Holdings, Inc., including statements regarding the clinical trials and regulatory pathway of cethromycin.  Forward-looking statements represent our management’s judgment regarding future events and are accurate at the time they are made.  The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise.




Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain  regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, capital requirements, and our ability to access capital through partnerships, stock offerings and future revenues; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers.  These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.

###




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.




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.



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