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The net loss allocable to common shareholders for the three months ended June 30, 2009 was $2.6 million or ($0.06) per share compared to a net loss allocable to common shareholders of $3.4 million or ($0.09) per share for the three months ended June 30, 2008. The decrease in the net loss is due to decreased costs involved in the clinical development of the Company's lead compound, Restanza(TM) (cethromycin).
The Company ended the second quarter of 2009 with cash and cash equivalents totaling $1.0 million. Cash used during the quarter was approximately $2.9 million.
"Advanced Life Sciences today is focused on continuing to pursue approval for Restanza in community acquired pneumonia or CAP and complying with the recommendations by the FDA concerning next steps that can lead to a registration pathway," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "Based on the agency's recent communication with the Company, we anticipate that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. We intend to work closely with the agency to design and establish a protocol under a Special Protocol Assessment. We are working on these clinical plans with Wyeth, our development and commercialization partner in the Asia Pacific region, and will also continue to pursue additional collaborations. At the same time, we are also continuing to advance Restanza as a biodefense agent against anthrax, plague and tularemia in our collaborative work with the U.S. government which is fully funding our bioterror countermeasure development program."
Operating Expense Analysis
-- Research and development expenses were $1.3 million for the three months
ended June 30, 2009 compared to $1.7 million for the three months ended
June 30, 2008.
-- Selling, general and administrative expenses totaled $1.7 million,
approximately the same amount as the second quarter of last year.
Business Outlook for 2009
-- Work with the FDA and Wyeth to develop a new clinical protocol to
further demonstrate Restanza's efficacy in CAP;
-- Pursue a meeting with the FDA relative to establishing a Special
Protocol Assessment for development of Restanza in CAP;
-- Advance negotiations with prospective U.S. and E.U. partners for the
development and commercialization of Restanza;
-- Under the Department of Defense (DOD) contract, continue studies and
report data emerging from Restanza non-human primate studies in plague
and tularemia.
Financial Outlook
To fund ongoing operations in 2009, the Company intends to raise additional capital through commercial partnerships and/or the sale of equity.
Conference Call Details
Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Tuesday, August 11, 2009 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 888.680.0860 (domestic) or 617.213.4852 (international). The passcode for the conference call is 88622532. A replay of the conference call will be available until August 18, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 69105186. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at https://www.theconferencingservice.com/prereg/key.process?key=P8EHLRVGT. Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.
About Restanza
Restanza has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Restanza has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.
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 respiratory diseases. The Company's lead candidate, cethromycin, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at www.advancedlifesciences.com.
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. Forward-looking statements represent our management's judgment regarding future events. 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, the adequacy of our clinical results, the timing and terms of any commercial partnership, 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, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; 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)
June 30, December 31,
CONSOLIDATED BALANCE SHEETS 2009 2008
-----------------------------------------------------------------------
(Unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 998,912 $1,527,108
Grant receivable 586,820 63,444
Prepaid insurance 47,932 227,313
Other prepaid expenses and deposits 35,281 143,808
------------- -------------
Total current assets 1,668,945 1,961,673
------------- -------------
PROPERTY AND EQUIPMENT:
Furniture and fixtures 244,072 244,072
Laboratory equipment - 159,186
Computer software and equipment 258,786 258,786
Leasehold improvements 505,804 505,804
------------- -------------
Total property and equipment-at cost 1,008,662 1,167,848
Less accumulated depreciation (677,543) (760,329)
------------- -------------
Property and equipment-net 331,119 407,519
------------- -------------
OTHER ASSETS:
Commercial launch materials 2,760,936 -
Deferred offering and financing costs 20,348 450,861
Other long-term assets 25,006 -
------------- -------------
Total other assets 2,806,290 450,861
TOTAL ASSETS $4,806,354 $2,820,053
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable $4,387,982 $1,379,941
Accrued clinical trial and NDA expenses 112,514 458,260
Accrued payroll 451,243 506,537
Other accrued expenses 611,095 352,466
Accrued interest payable 136,256 72,572
Short-term lease payable 8,131 8,468
Short-term notes payable - related party 2,000,000 -
------------- -------------
Total current liabilities 7,707,221 2,778,244
Long-term lease payable 621 4,350
Long-term grant payable 500,000 500,000
Long-term notes payable - related party - 2,000,000
Line of credit 10,000,000 9,915,000
------------- -------------
Total liabilities 18,207,842 15,197,594
------------- -------------
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY (DEFICIT):
Common stock, $0.01 par value-120,000,000
shares authorized; 50,698,926 issued and
outstanding at June 30, 2009; 40,810,932
shares issued and outstanding at
December 31, 2008 506,989 408,109
Additional paid-in capital 113,331,011 109,601,807
Deficit accumulated during the
development stage (127,239,488) (122,387,457)
Noncontrolling interest in subsidiary - -
------------- -------------
Total equity (deficit) (13,401,488) (12,377,541)
------------- -------------
TOTAL LIABILITIES AND EQUITY (DEFICIT) $4,806,354 $2,820,053
============= =============
ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
-------------------------------------------------------------------------
Period From
Inception
(January 1,
Three months Six months 1999)
ended ended Through
June 30, June 30, June 30,
2009 2008 2009 2008 2009
----------- ----------- ----------- ----------- -------------
Revenue:
Management
fees $- $- $- $- $1,161,180
Grants 706,814 - 1,118,299 - 2,394,700
Royalty-
related
party - - - - 45,238
-------- ----------- ----------- ----------- -------------
Total
reve-
nue 706,814 - 1,118,299 - 3,601,118
-------- ----------- ----------- ----------- -------------
Expenses:
Research
and
develop-
ment 1,309,050 1,690,088 2,243,819 3,558,141 92,824,220
Contr-
acted
research
and
development-
related
party - - - - 7,980,299
Selling,
general
and
admin-
istra-
tive 1,690,505 1,682,604 3,199,458 3,408,972 30,248,095
--------- ----------- ----------- ----------- -------------
Total
expe-
nses 2,999,555 3,372,692 5,443,277 6,967,113 131,052,614
--------- ----------- ----------- ----------- -------------
Loss from
opera-
tions (2,292,741) (3,372,692) (4,324,978) (6,967,113) (127,451,496)
Net other
(income)
expense:
Interest
income (1,739) (76,444) (3,471) (233,086) (2,952,333)
Interest
expense 258,211 102,664 510,929 207,019 3,659,782
Other
(income)
expense,
net 19,595 - 19,595 - 19,595
Gain on
sale of
interest
in
Sarawak
Medichem
Pharmace-
uticals
joint
venture - - - - (939,052)
------- ----------- ----------- ----------- -------------
Net other
(income)
expense 276,067 26,220 527,053 (26,067) (212,008)
----------- ----------- ----------- ----------- -------------
Net loss (2,568,808) (3,398,912) (4,852,031) (6,941,046) (127,239,488)
----------- ----------- ----------- ----------- -------------
Less net
loss
attributable
to the
noncon-
trolling
interest in
subsidiary - - - - -
------- ----------- ----------- ----------- -------------
Net loss
Attributable
to Advanced
Life
Sciences
Holdings,
Inc. (2,568,808) (3,398,912) (4,852,031) (6,941,046) (127,239,488)
----------- ----------- ----------- ----------- -------------
Less
accumulated
preferred
stock
dividends
of
subsidiary
for the
period 43,750 43,750 87,500 87,500 1,757,292
----------- ----------- ----------- ----------- -------------
Net loss
Available
to
common
share-
hold-
ers $(2,612,558) $(3,442,662) $(4,939,531) $(7,028,546) $(128,996,780)
=========== =========== =========== =========== =============
Net loss
per share
available
to common
share-
holders
- basic
and
diluted $(0.06) $(0.09) $(0.11) $(0.18)
=========== =========== =========== ===========
Weighted
average
shares
outstand-
ing
- basic
and
diluted 47,077,869 38,502,987 44,443,387 38,502,987
SOURCE Advanced Life Sciences Holdings, Inc.
http://www.advancedlifesciences.com
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