Published:
Lipid Sciences, Inc. Reports Results for the Third Quarter 2005
Dr. S. Lewis Meyer to Present at Rodman & Renshaw Healthcare Conference on November 8, 2005
Lipid Sciences, Inc. (NASDAQ: LIPD) today
reported financial results for the third quarter and nine months ended
September 30, 2005. Lipid Sciences is a development-stage biotechnology
company engaged in the research and development of products and processes
intended to treat major medical indications in which lipids, or fat
components, play a key role. These medical indications include
cardiovascular disease and viral infections, such as those caused by Human
Immunodeficiency Virus (HIV).
For the third quarter of 2005, the Company reported a net loss of $2.6
million, or $0.10 per share on a basic and diluted basis. This compares
with a net loss of $3.2 million, or $0.13 per share, on a basic and diluted
basis, for the same period in 2004. Operating expenses for the third
quarter of 2005 were $2.7 million representing a decrease of 15% from $3.2
million reported during the same period in 2004. Research and development
expenses, which accounted for 66% of the Company's operating expenses,
decreased 21% to $1.8 million from $2.3 million in the same period last
year. The decrease in research and development expenses was due primarily
to reductions in stock compensation expenses, and costs associated with the
Company's HDL Therapy non-human primate study, which concluded in the
second quarter of this year. This decrease was partially offset by an
increase in expenses related to the anticipated submission of the Company's
Investigational Device Exemption (IDE) application to the Food and Drug
Administration (FDA) and the anticipated initiation of a human clinical
trial of the Company's HDL Therapy platform.
For the nine months ending September 30, 2005, the Company reported a net
loss of $7.6 million, or $0.31 per share, on a basic and diluted basis.
This compares with a net loss of $9.4 million or $0.38 per share, on a
basic and diluted basis, for the same nine-month period in 2004. For the
nine months ended September 30, 2005, operating expenses decreased by 18%
to $7.9 million from $9.6 million for the same period in the previous year
for the reasons stated above. The research and development portion, which
accounted for 67% of the Company's operating expenses for the nine months
ended September 30, 2005, decreased 22% to $5.3 million from $6.7 million
for the same period last year.
As previously announced on September 30, 2005, Lipid Sciences closed a
private placement of common stock and warrants. The Company issued
2,430,198 shares of common stock at $2.98 per share for gross proceeds of
approximately $7.2 million. In addition, Additional Investment Rights
(AIRs) in the form of warrants to purchase 1,215,096 shares of common stock
at $3.73 per share, and warrants to purchase 729,057 shares of common stock
at $4.20 per share were issued as part of this transaction, with the
potential to raise an additional $4.5 million in gross proceeds for the
Company upon the exercise of the AIRs. The warrants expire on September
30, 2010 and the AIRs expire 90 days after the date a registration
statement related to the resale of these shares of common stock, warrants
and AIRs is deemed effective by the Securities and Exchange Commission.
The shares, warrants and AIRs were offered and sold only to institutional
and accredited investors.
At September 30, 2005, the Company had approximately $18.3 million in cash,
cash equivalents, and short-term investments. The Company anticipates that
sufficient capital is available to fund its operations, including current
development projects, through mid-2007. The Board of Directors continues
to consider third-party inquiries and explore strategic alternatives.
Dr. S. Lewis Meyer, President and Chief Executive Officer, commented, "The
funds from our recently closed private placement will provide important
financial flexibility and visibility as we pursue development programs
related to our three product opportunities: Our HDL Therapy selective
delipidation system, HDL mimetic peptide drugs, and our Viral Immunotherapy
process. We have successfully completed the third-party electrical and
safety performance testing of our PDS-2 selective delipidation device by
Intertek Testing Services NA Inc. This system validation is an important
component of our Investigational Device Exemption (IDE) submission to the
FDA. We are now working toward validating the disposable components of our
PDS-2 system. We anticipate that the submission of our IDE to the FDA, the
approval of the IDE submission, and the initiation of a planned human
clinical trial of our HDL Therapy platform should occur during the fourth
quarter of this year and the first quarter of next year."
He continued, "We also expect to launch the next stage of a pre-clinical
non-human primate study for our Viral Immunotherapy program by year end.
We anticipate that the results of this 18-month study will provide safety
data that could be used as the basis of a future application to the FDA for
the initiation of a human clinical trial designed for the treatment of
HIV-infected patients or for a potential offshore human study in
collaboration with a corporate partner."
Presentation at the Rodman & Renshaw Techvest 7th Annual Healthcare
Conference: Dr. S. Lewis Meyer, President and Chief Executive Officer of
Lipid Sciences, Inc. will make a presentation at this Annual Healthcare
Conference in New York on Tuesday, November 8, 2005, at 11:15 a.m. (Eastern
Time). He will outline the progress of the Company's HDL Therapy and Viral
Immunotherapy platforms. To listen to the webcast at the time of the
presentation, please log-on to
www.rodmanandrenshaw.com/rodman.asp?link=Conferences7/ConferenceWebcasters&
bgcolor=wht. Afterwards, the webcast and the accompanying slides will be
archived at www.lipidsciences.com in the Investor Relations section of the
Company website.
SIV-Infected Non-Human Primate Study Completed: Statistical significance
was reached both in the long-term survival of these animals as compared to
a retrospective, SIV-infected, non-immunized control group (p=0.0067), as
well as a viral load reduction of approximately 90% (p=0.04) that was
maintained for the nine months' duration of the study follow-up period.
The Company is now moving forward with an 18-month, placebo-controlled
study of 28 animals to demonstrate both survival and viral load reduction.
The Company anticipates that the results of this expanded study will
provide safety data that could be used in a future application to the Food
and Drug Administration to allow for the initiation of a human clinical
trial designed for the treatment of HIV-infected patients, or for a
potential offshore human study in collaboration with a corporate partner.
Launch of Expanded HDL Therapy Platform in Collaboration with Washington
Hospital Center: As part of a strategic plan to broaden the scope of the
HDL Therapy platform, the Company will embark on a new development program
in the field of HDL mimetic peptides under the leadership of Dr. H. Bryan
Brewer, Jr., Lipid Sciences' Vice-Chairman and Chief Scientific Director,
and in collaboration with the Washington Hospital Center and the
Cardiovascular Research Institute of the MedStar Research Institute in
Washington, D.C. The HDL mimetic peptide program is a logical outgrowth of
Lipid Sciences expertise in, and focus on, HDL as a critical element in
cardiovascular disease therapy and an opportunity to address a significant
unmet market need -- in line with the Company's strategy to address
clinically all aspects of the Acute Coronary Syndrome patient. HDL mimetic
peptides can be efficiently and economically synthesized in quantities
sufficient for pre-clinical and clinical research and can be scaled for
low-cost commercial production as a drug.
Lipid Sciences, Inc. is a development-stage biotechnology company engaged
in the research and development of products and processes intended to treat
major medical indications, in which lipids, or fat components, play a key
role. The Company's HDL Therapy platform (selective HDL delipidation and
HDL mimetic peptides) is aimed at developing treatments for the reversal of
atherosclerosis, a systemic disease of the blood vessels caused by the
build-up of cholesterol-filled plaques in the vascular system and, most
critically, in the coronary arteries. Regression of such plaques may have a
major impact on reducing the risk of acute coronary events. The Company's
Viral Immunotherapy platform is focused on the removal of the lipid
coatings from lipid-enveloped viruses and other lipid-containing infectious
agents by application of Lipid Sciences' proprietary delipidation
technology. The Company believes that removing the virus' protective lipid
coating exposes otherwise hidden viral proteins, to stimulate the body's
immune system to effectively fight the disease. Conditions that could
potentially be impacted by this technology include HIV, Hepatitis B and
Hepatitis C, West Nile, SARS and influenza.
Forward-Looking Statements: This release contains forward-looking
statements concerning plans, objectives, goals, strategies, study results,
anticipations, expectations, future events or performance as well as all
other statements that are not statements of historical fact. The
forward-looking statements contained in this release reflect our current
beliefs and expectations on the date of this release. Actual results,
performance or outcomes may differ materially from what is expressed in the
forward-looking statements. Readers are referred to the documents filed by
us with the SEC, specifically the most recent reports on Form 10-K and Form
10-Q which identify important risk factors that could cause actual results
to differ from those contained in the forward-looking statements. In
addition to those risk factors, other factors that could cause actual
results to differ materially include the following: Our inability to
obtain adequate funds; our technology not proving to be safe or effective;
our inability to obtain regulatory approval for our technology, which is
only in the clinical development stage; delay or failure to complete
clinical studies; our dependence on our license agreement with Aruba
International B.V.; our reliance on collaborations with strategic partners
and consultants; competition in our industry, including the development of
new products by others that may provide alternative or better therapies;
failure to secure and enforce our intellectual property rights; risks
associated with use of biological and hazardous materials; and our
dependence on key personnel.
This release should be read in conjunction with the consolidated financial
statements and notes thereto included in our most recent reports on Form
10-K and Form 10-Q. Copies are available through the SEC's Electronic
Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov. Lipid
Sciences assumes no obligation to update the forward-looking statements
included in this document.
Press releases for Lipid Sciences, Inc. are available on our website:
www.lipidsciences.com. If you would like to receive our press releases via
email, please contact: info@lipidsciences.com.
Lipid Sciences, Inc.
(A Development Stage Company)
Condensed Consolidated Statements of Operations (Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
(In thousands, except
per share amounts) 2005 2004 2005 2004
------- ------- ------- -------
Grant Revenue $ -- $ -- $ 1 $ --
Operating expenses:
Research and development 1,787 2,262 5,282 6,744
Selling, general and
administrative 908 927 2,617 2,848
------- ------- ------- -------
Total operating expenses 2,695 3,189 7,899 9,592
------- ------- ------- -------
Operating loss (2,695) (3,189) (7,898) (9,592)
Interest and other income 101 71 290 283
------- ------- ------- -------
Loss from continuing operations (2,594) (3,118) (7,608) (9,309)
Income tax benefit -- 2 -- 2
------- ------- ------- -------
Net loss from continuing
operations (2,594) (3,116) (7,608) (9,307)
------- ------- ------- -------
Discontinued operations:
Income/(loss) from
discontinued operations -- (107) -- (121)
Income tax expense -- -- -- --
------- ------- ------- -------
Income/(loss) from discontinued
operations - net -- (107) -- (121)
------- ------- ------- -------
Net loss $(2,594) $(3,223) $(7,608) $(9,428)
======= ======= ======= =======
Loss per share - basic
and diluted:
Net loss per share continuing
operations $ (0.10) $ (0.13) $ (0.31) $ (0.38)
Net loss per share discontinued
operations $ 0.00 $ 0.00 $ 0.00 $ 0.00
Net loss per share $ (0.10) $ (0.13) $ (0.31) $ (0.38)
Weighted average number of
common shares outstanding -
basic and diluted 24,925 24,679 24,919 24,592
Period from Inception
(May 21, 1999) to
(In thousands, except per share amounts) September 30, 2005
----------
Grant Revenue $ 33
Operating expenses:
Research and development 50,361
Selling, general and administrative 22,172
----------
Total operating expenses 72,533
----------
Operating loss (72,500)
Interest and other income 3,418
----------
Loss from continuing operations (69,082)
Income tax benefit 8,004
----------
Net loss from continuing operations (61,078)
----------
Discontinued operations:
Income/(loss) from discontinued operations 582
Income tax expense (179)
----------
Income/(loss) from discontinued operations - net 403
----------
Net loss $ (60,675)
==========
Loss per share - basic and diluted:
Net loss per share continuing operations
Net loss per share discontinued operations
Net loss per share
Weighted average number of common shares
outstanding - basic and diluted
Lipid Sciences, Inc.
(A Development Stage Company)
Condensed Consolidated Balance Sheet
(Unaudited) September December
(In thousands, except share amounts) 30, 2005 31, 2004
-------- --------
ASSETS
Current assets:
Cash and cash equivalents $ 11,354 $ 4,640
Short-term investments 6,925 12,414
Prepaid expenses 135 313
Restricted cash -- 105
Other current assets 11 11
Assets held for sale -- 1,167
-------- --------
Total current assets 18,425 18,650
Property and equipment 428 436
Long-term lease deposits 19 --
-------- --------
Total assets $ 18,872 $ 19,086
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued
liabilities $ 2,344 $ 863
Accrued related party royalties 125 750
Accrued compensation 362 542
Income taxes payable -- --
Other current liabilities 7 20
-------- --------
Total current liabilities 2,838 2,175
Deferred rent 6 --
-------- --------
Total liabilities 2,844 2,175
-------- --------
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.001 par value;
10,000,000 shares authorized and
issuable; no shares outstanding -- --
Common stock, $0.001 par value;
75,000,000 shares authorized;
27,359,267 and 24,912,263 shares
issued and outstanding at September
30, 2005 and December 31, 2004,
respectively 27 25
Additional paid-in capital 76,676 69,953
Deficit accumulated in the
development stage (60,675) (53,067)
-------- --------
Total stockholders' equity 16,028 16,911
-------- --------
Total liabilities and stockholders'
equity $ 18,872 $ 19,086
======== ========
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