http://www.businesswire.com/news/home/20091026006439/en
LAKE BLUFF, Ill.--(Business Wire)--
NeoPharm, Inc. (Other OTC: NEOL.PK), today announced its third quarter 2009
financial results.
For the third quarter ended September 30, 2009, NeoPharm reported a net loss of
$1.8 million, or ($0.06) per basic and diluted share, as compared to a net loss
of $2.4 million, or ($0.08) per share, for the same period last year. For the
nine months ended September 30, 2009, NeoPharm reported a net loss of $6.0
million, or ($0.21) per basic and diluted share, compared to a net loss of $6.0
million, or ($0.21) per share, for the same period last year.
Research and development expenses increased to $3.4 million for the nine months
ended September 30, 2009, from $3.3 million for the same period last year as the
Company continued to progress its current drug compounds to their next stages of
development. NeoPharm`s general and administrative expenses decreased by $1.0
million to $2.6 million for the nine months ended September 30, 2009, in
comparison to $3.6 million for the same period last year. The decrease in
general and administrative expenses is primarily attributable to reductions in
accounting, legal and other public company costs in connection with the
Company`s voluntary decision to delist and deregister its common stock in
January 2009 and opt-out of SEC reporting requirements. The decrease in general
and administrative expenses was partially offset by a decrease in the Company`s
net interest income and a decrease in gains on sales of equipment and furniture.
During the third quarter, the Company held its cash consumption to a level
consistent with the prior quarter allocating $1.8 million in cash to its
operations versus $1.9 million in the second quarter of 2009. NeoPharm
anticipates future cash consumption levels to increase in-line with the
advancement and progression of its clinical trials and preclinical development
activities. The Company has borrowed $14.4 million under the terms of a loan
agreement with UBS Bank USA and UBS Financial Services Inc. that provides
NeoPharm with a credit line (the "Credit Line"), which is secured by the
Company`s auction rate securities ("ARS"). The Company also has an agreement
with UBS whereby the Company has the right to require UBS to repurchase at par
value all of NeoPharm`s ARS at any time during the period from June 30, 2010
through July 2, 2012, with all proceeds being used to repay all borrowings from
UBS. The Company expects to exercise that right on June 30, 2010, and therefore
has classified its investment in ARS and its borrowing from UBS as a current
asset and a current liability, respectively, as of September 30, 2009. With $6.7
million in cash and cash equivalents at the end of the third quarter 2009, the
Company estimates that it has adequate resources to fund its operations into
mid-2010.
"We continue to make solid progress in our efforts to progress our drug
candidates through the development cycle, as we expect to release preliminary
findings for our Phase I LE-DT trial in the fourth quarter of 2009.
Additionally, IND filings for IL-13 for Idiopathic Pulmonary Fibrosis and
LE-rafAON Pancreatic Cancer with Gemcitabine are anticipated towards the end of
2009 and early 2010," commented Mr. Laurence Birch, President and Chief
Executive Officer of NeoPharm, Inc. "The NeoPharm team remains dedicated to
leveraging our intellectual property assets, while concurrently maximizing our
resources to drive long-term value for our current shareholders."
Drug Candidate Pipeline Update
LEP-ETU, Liposomal Encapsulated Paclitaxel
In the first quarter of 2009, the Company completed the targeted enrollment of
35 patients for the first part of its Phase II open-label, multicenter
outpatient study in India for LEP-ETU, a novel, proprietary liposomal delivery
system of paclitaxel, the active ingredient of Taxol, designed to evaluate the
anti-tumor effect and safety/tolerability of LEP-ETU in metastatic breast
cancer. Based on the encouraging results of the preliminary data in terms of
tumor response and protection from toxicities related to free Paclitaxel, the
Company submitted a request to the Directorate General of Health Services -
Office of Drugs Controller General (India) ("DCGI") in February 2009 to expand
the targeted enrollment to 70 patients with recurrent breast cancer.
In the third quarter of 2009, the Company received notification from DCGI that
its request to expand the Phase II study to an additional 35 patients had been
approved, and patient enrollment is expected to be completed by early 2010. In
June 2009, the Company engaged an independent clinical trial firm in India to
audit the results of the 35 patients enrolled in the first part of this Phase II
study. All of the patients in the first part of the study have received a dose
of 275 mg/m2 every three weeks without the detection of any significant infusion
related problems or unexpected toxicities with positive response rate.
LE-DT, Liposomal Encapsulated Docetaxel
Based upon the preliminary results from its Phase I trial for LE-DT, a novel,
proprietary liposomal delivery system of docetaxel, the active ingredient of
Taxotere, for the treatment of patients with metastatic solid tumors, the
Company is planning a Phase II study of LE-DT in hormone refractory metastatic
prostate cancer patients. This open-label, Phase II study will be designed to
determine the antitumor effect as defined by the serum Prostate Specific Antigen
(PSA) levels, disease response, progression free survival, and quality of life
in patients with metastatic prostate cancer. The Company anticipates that
enrollment of 40 to 50 patients in this Phase II trial will begin at three
locations in the United States once all regulatory approvals are obtained.
NeoPharm is also developing a two-arm protocol, subject to regulatory approval,
for advanced pancreatic cancer patients to compare the clinical effectiveness of
LE-DT against 5FU or Xeloda.
The Phase I study was designed to more accurately define the maximum tolerated
dose (MTD) and is being conducted at The Lombardi Comprehensive Cancer Center at
Georgetown University and at TGen Clinical Research Services at Scottsdale
Healthcare.
LE-rafAON for Pancreatic Cancer with Gemcitabine
All preclinical studies related to the IND submission have been completed, and
the preclinical data is positive. NeoPharm is developing clinical protocols for
Phase I and II studies of pancreatic cancer with LE-rafAON in combination with
the drug gemcitabine. The Company anticipates filing an IND for LE-rafAON in
early 2010.
Cintredekin Besudotox, IL-13, for Glioblastoma Multiforme (GBM)
Patient enrollment is expected to begin in the fourth quarter of 2009 in a Phase
I clinical trial to be conducted by the National Institutes of Health ("NIH") in
connection with the Company`s Cooperative Research and Development Agreement
("CRADA") with the National Institute of Neurological Diseases and Stroke
("NINDS"), a part of the NIH, for research on a therapeutic agent for
untreatable brain diseases in humans. Under the terms of the CRADA, NINDS will
deliver IL-13, in conjunction with a surrogate marker via NINDS' patented
methodology of Convection Enhanced Delivery ("CED"), which was previously
licensed to NeoPharm. The Company will provide its proprietary drug and
technical resources to study its effects in various brain cancers in humans.
NINDS Institutional Review Board ("IRB") has approved the protocol and NeoPharm
has granted NINDS authorization to cross-reference its prior IL-13 IND for the
treatment of GBM.
Cintredekin Besudotox, IL-13, for Idiopathic Pulmonary Fibrosis (IPF)
In September 2009, NeoPharm signed a letter of intent to enter into a clinical
research agreement with Duke University, a nonprofit educational and health care
institution acting for and on behalf of its Duke Clinical Research Institute
("Duke"), regarding potential clinical trials with IL13-PE38 in patients with
idiopathic pulmonary fibrosis (IPF). The Company previously completed a two week
inhalation toxicology study in non-human primates performed by the Lovelace
Respiratory Research Institute. This study was designed to provide a detailed
safety evaluation of the product in non-human primates through nebulization and
to characterize the distribution in the lungs and other tissues and to identify
any toxicity related to any organ with IL-13 inhalation. The physio-chemical
properties of the nebulized product are extensively studied to predict its
distribution into the lungs. Based upon the initial results from this study, and
other preclinical studies, the Company anticipates filing an IND related to
IL-13 for IPF in the fourth quarter of 2009.
Previously, NeoPharm licensed IL-13 from NIH, FDA, and The University of
Michigan as a potential therapeutic agent for the treatment of pulmonary
fibrosis and asthma, and has completed extensive preclinical studies in animal
models to evaluate the control and reversal of pulmonary fibrosis with this
agent.
About NeoPharm, Inc.
NeoPharm, Inc., based in Lake Bluff, Illinois, is a publicly traded
biopharmaceutical company dedicated to the research, development and
commercialization of new and innovative cancer and other drugs for therapeutic
applications. Additional information can be obtained by visiting NeoPharm`s web
site at www.neopharm.com.
Forward Looking Statements - This press release contains "forward-looking
statements" within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. The Company has tried to
identify such forward-looking statements by use of such words as "expects,"
"intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and
"estimates," and other similar expressions, but these words are not the
exclusive means of identifying such statements. Such statements include, but are
not limited to, any statements relating to the Company`s strategic review of
projects and operations, the Company's drug development programs, the
initiation, progress and outcomes of clinical trials of the Company's drug
product candidates, projections regarding cash used in operations, financial
projections, and any other statements that are not historical facts. Such
statements involve risks and uncertainties, including, but not limited to, those
risks and uncertainties relating to difficulties or delays in financing,
development, testing, regulatory approval, production, and marketing of the
Company's drug compounds including, but not limited to, the Company's ability to
fund and pursue additional testing of Cintredekin Besudotox and its NeoLipid
drug product candidates, uncertainty regarding the outcomes of ongoing or
potential clinical studies, the Company's financial guidance and projection,
including but not limited to, the fact that the Company`s financial statements
have not been subjected to a review by the Company`s independent registered
accounting firm in accordance with Statement of Auditing Standards No. 100, the
Company's ability to evaluate the strategic alternatives available to the
Company and to cut back on its funding of certain of its development projects in
order to conserve its cash resources, the ability of the Company to procure
additional future sources of financing, unexpected adverse side effects or
inadequate therapeutic efficacy of the Company's drug compounds, including, but
not limited to, Cintredekin Besudotox and its NeoLipid drug product candidates,
that could slow or prevent products coming to market, uncertainty regarding the
Company's ability to market its drug products, including, but not limited
toCintredekin Besudotox and its NeoLipid drug product candidates, the
uncertainty of patent protection for the Company's intellectual property or
trade secrets, and other risks of the type previously detailed in filings the
Company formerly made with the Securities and Exchange Commission ("SEC"). Such
statements are based on management's current expectations, but actual results
may differ materially due to various factors, including those risks and
uncertainties mentioned or referred to in this press release.At the Company`s
request, the Company`s obligation to file reports with the SEC was suspended
effective February 12, 2009.For the foregoing reasons, you should not rely on
these forward-looking statements or on previously filed SEC reports as a
prediction of actual future results.
NEOPHARM, INC.
Condensed Consolidated Statements of Operations
Three and Nine Months Ended September 30, 2009 and 2008
Three Months Ended Nine Months Ended
(unaudited) (unaudited)
September 30, September 30, September 30, September 30,
2009 2008 2009 2008
Total revenue $ - $ - $ - $ -
Expenses:
Research and development 997,000 1,454,000 3,439,000 3,291,000
Selling, general, and administrative 738,000 1,056,000 2,606,000 3,572,000
Facility consolidation costs - - - (64,000 )
Gain on sale of equipment and furniture - (41,000 ) (21,000 ) (350,000 )
Total Expenses 1,735,000 2,469,000 6,024,000 6,449,000
Loss from operations (1,735,000 ) (2,469,000 ) (6,024,000 ) (6,449,000 )
Net Interest income (expense) (30,000 ) 58,000 65,000 453,000
Net loss $ (1,765,000 ) $ (2,411,000 ) $ (5,959,000 ) $ (5,996,000 )
Net loss per share - basic and diluted $ (0.06 ) $ (0.08 ) $ (0.21 ) $ (0.21 )
Weighted average shares outstanding - basic and diluted 28,498,814 28,492,954 28,498,814 28,490,910
Selected Balance Sheet data
September 30, December 31,
2009 2008
(unaudited) (audited)
Cash and cash equivalents 6,740,000 7,298,000
Auction rate securities (current) 12,750,000 -
Put option on auction rate securities (non-current) 1,600,000 -
Total current assets 21,407,000 7,636,000
Auction rate securities (non-current) - 12,321,000
Put option on auction rate securities (non-current) - 2,379,000
Total assets 22,329,000 23,353,000
Short-term debt 14,406,000 -
Total current liabilities 17,385,000 3,542,000
Long-term liabilities 44,000 9,259,000
Accumulated deficit (286,411,000 ) (280,452,000 )
Total stockholders' equity 4,900,000 10,552,000
The interim financial information presented above has not been subjected to a review
by the Company`s independent registered public accounting firm.
NeoPharm, Inc.
Laurence P. Birch, 847-887-0800
President & CEO
lbirch@neopharm.com
Copyright Business Wire 2009
