Exhibit 99.1
| 1440 Davey Road |
For Immediate Release
Investor Relations Contact: Edward P. Flavin (630) 739-6744 Ext. 211
Advanced Life Sciences Announces Second Quarter 2006 Results
WOODRIDGE, IL, August 9, 2006/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, 2006. The net loss available to common shareholders for the three months ended June 30, 2006 was $4.5 million or ($0.16) per share compared to $1.0 million or ($0.09) per share for the three months ended June 30, 2005. The increase in the net loss reflects increased development expenses related to cethromycin pivotal Phase III clinical trial costs.
“Advanced Life Sciences had a productive second quarter, making steady progress toward our milestones,” said Michael T. Flavin, Ph.D., Chairman and Chief Executive Officer of Advanced Life Sciences. “We are focused on enrolling patients in our pivotal Phase III clinical trials for cethromycin and are on track to have approximately 200 clinical sites enrolling patients in the Fall as planned. Our team is focused on the completion of the trials as we advance cethromycin toward an NDA in 2007.”
The Company ended the second quarter of 2006 with cash and cash equivalents totaling $39.2 million. Cash used during the second quarter was approximately $5.7 million.
Operating Expense Analysis
· Research and development expenses increased $3.2 million to $3.6 million for the three months ended June 30, 2006 from $0.4 million for the three months ended June 30, 2005. This increase was due to additional development expenses directly related to our Phase III clinical trials for cethromycin.
· Selling, general and administrative expenses increased $0.8 million to $1.3 million for the three months ended June 30, 2006 from $0.5 million for the three months ended June 30, 2005. This increase is primarily attributed to the public company costs related to director and officer insurance, director’s fees, investor relations and legal and accounting services.
Second Quarter 2006 Product Candidate Highlights
Advanced Life Sciences is developing cethromycin, a second generation once-a-day ketolide antibiotic in response to the emerging antibiotic resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has been tested in approximately 3,800 human subjects during clinical trials.
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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 address the need for antibiotics that overcome bacterial resistance, yet retain a mild safety profile.
Cethromycin Progress and Upcoming Milestones
The Company initiated approximately 51 new clinical sites, including 42 sites in Latin America and South Africa and 9 new sites in North America. A total of approximately 126 clinical sites have been initiated in these three geographies. Additionally, we made regulatory submissions in 12 European countries. We are targeting the start of patient enrollment at 70 sites for the beginning of CAP season in the European region.
In May 2006, the Company initiated cethromycin commercial manufacturing agreements with DSM and Cardinal Health.
Based upon the favorable results of our collaboration with USAMRIID, in July 2006 we initiated a pre-NDA animal study with Battelle for cethromycin as a potential treatment for inhalation anthrax.
The Company anticipates the following upcoming milestones in the clinical development of cethromycin:
· Complete cethromycin pivotal Phase III clinical trials by year end.
· Present data from prior cethromycin clinical trials at key scientific conferences including ICAAC and IDSA.
· Sponsor a cethromycin principal investigator meeting in Rome, Italy for physicians enrolling CAP patients in Europe.
· Advance discussions with prospective partners regarding a commercialization partnership for cethromycin.
Financial Guidance for the Third Quarter of 2006
The Company expects its third quarter 2006 cash requirements to range between $7.0 and $8.0 million.
Conference Call Details
Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, August 9, 2006 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 the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 800-573-4840 (domestic) or 617-224-4326 (international). The passcode for the conference call is 75880306. A replay of the conference call will be available until September 9, 2006. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 32997825.
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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 second generation once-a-day ketolide antibiotic in late-stage clinical development for the treatment of respiratory tract infections.
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. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences’ filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
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ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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| June 30, |
| December 31, |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
| $ | 39,167,501 |
| $ | 4,749,932 |
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Investments - available for sale |
| — |
| 10,475,000 |
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Accounts receivable - related party |
| — |
| 6,160 |
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Prepaid insurance |
| 104,895 |
| 362,241 |
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Prepaid expenses and other |
| 2,721,772 |
| 118,263 |
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Total current assets |
| 41,994,168 |
| 15,711,596 |
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PROPERTY AND EQUIPMENT: |
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Furniture and fixtures |
| 174,598 |
| 147,275 |
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Laboratory equipment |
| 142,928 |
| 142,928 |
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Computer software and equipment |
| 211,984 |
| 187,771 |
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Leasehold improvements |
| 40,646 |
| 40,646 |
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Total property and equipment—at cost |
| 570,156 |
| 518,620 |
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Less accumulated depreciation |
| (315,101) |
| (267,372) |
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Property and equipment—net |
| 255,055 |
| 251,248 |
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OTHER LONG-TERM ASSETS: |
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Deferred financing costs |
| 39,753 |
| 53,004 |
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Other assets |
| 3,654 |
| 6,062 |
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Total other long-term assets |
| 43,407 |
| 59,066 |
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TOTAL ASSETS |
| $ | 42,292,630 |
| $ | 16,021,910 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
| $ | 148,528 |
| $ | 294,816 |
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Accrued expenses |
| 1,668,986 |
| 240,761 |
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Accrued interest payable |
| 12,917 |
| 5,334 |
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Short-term lease payable |
| 19,798 |
| 1,850,229 |
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Total current liabilities |
| 1,850,229 |
| 555,025 |
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Long-term lease payable |
| 20,678 |
| 13,166 |
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Accrued interest payable - related party |
| — |
| 765,514 |
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Grant payable |
| 500,000 |
| 500,000 |
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Notes payable - net of $16,899 debt discount June 30, 2006 & $22,532 December 31, 2005 |
| 3,898,101 |
| 3,892,468 |
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Notes payable - related party |
| 2,000,000 |
| 2,000,000 |
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Total liabilities |
| 8,269,008 |
| 7,726,173 |
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STOCKHOLDERS’ EQUITY: |
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Common stock, $0.01 par value—June 30, 2006: 60,000,000 shares authorized; 28,258,899 issued and outstanding; December 31, 2005: 17,990,322 shares issued and outstanding; |
| 282,589 |
| 179,903 |
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Series A preferred stock of Advanced Life Sciences Inc., no par value— 250,000 shares authorized, issued and outstanding |
| — |
| — |
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Additional paid-in capital |
| 88,223,792 |
| 54,834,373 |
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Deficit accumulated during the development stage |
| (54,482,759 | ) | (46,718,539 | ) | ||
Total stockholders’ equity (deficit) |
| 34,023,622 |
| 16,021,910 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
| $ | 42,292,630 |
| $ | 16,021,910 |
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ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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| Period From |
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| Three months ended June 30, |
| Six months ended June 30, |
| Through |
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| 2006 |
| 2005 |
| 2006 |
| 2005 |
| June 30, 2006 |
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Revenue and income: |
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Management fees |
| $ | — |
| $ | 11,860 |
| — |
| $ | 44,379 |
| $ | 1,161,180 |
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Grant |
| — |
| — |
| 35,127 |
| — |
| 1,030,910 |
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Royalty—related party |
| — |
| — |
| — |
| — |
| 45,238 |
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Total revenue and income |
| — |
| 11,860 |
| 35,127 |
| 44,379 |
| 2,237,328 |
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Expenses: |
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Research and development |
| 3,579,038 |
| 348,148 |
| 5,839,416 |
| 685,938 |
| 37,772 |
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Contracted research and development—related party |
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| — |
| — |
| 7,980,299 |
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Selling, general and administrative |
| 1,338,842 |
| 470,828 |
| 2,488,012 |
| 838,572 |
| 10,123,130 |
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Total expenses |
| 4,917,880 |
| 818,974 |
| 8,327,428 |
| 1,504,508 |
| 55,876,081 |
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Loss from operations |
| (4,917,880 | ) | (807,114 | ) | (8,292,301 | ) | (1,460,129 | ) | (53,638,753 | ) | |||||
Other (income) expense: |
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Interest income |
| (520,100 | ) | — |
| (800,958 | ) | — |
| (1,073,174 | ) | |||||
Interest expense |
| 128,007 |
| 108,938 |
| 272,877 |
| 204,249 |
| 1,917,180 |
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Net other (income) expense |
| (392,093 | ) | 108,938 |
| (528,081 | ) | 204,249 |
| 844,006 |
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Net loss |
| (4,525,787 | ) | (916,052 | ) | (7,764,220 | ) | (1,684,378 | ) | (54,482,759 | ) | |||||
Less accumulated preferred dividends for the period |
| 43,750 |
| 43,750 |
| 87,500 |
| 87,500 |
| 1,232,292 |
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Net loss available to common shareholders |
| $ | (4,569,537 | ) | $ | (959,802 | ) | $ | (7,851,720 | ) | $ | (1,751,878 | ) | $ | (55,715,051 | ) |
Basic and diluted net loss per share available to common shareholders |
| $ | (0.16 | ) | $ | (0.09 | ) | $ | (0.32 | ) | $ | (0.16 | ) |
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Weighted average number common shares outstanding—basic and diluted |
| 28,252,354 |
| 10,826,795 |
| 24,790,486 |
| 10,780,148 |
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