-Advances Reported in All Three Clinical Programs, Including Launch of Key
Bavituximab Phase II Cancer Program-
TUSTIN, Calif., March 11 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced financial results for the third quarter of fiscal year (FY) 2008 ended January 31, 2008. The company reported a consolidated net loss of $6,154,000, or $0.03 per basic and diluted share, compared to a consolidated net loss of $5,025,000 or $0.03 per basic and diluted share for the same prior year period. The increased net loss primarily reflects increased investments in research and development as the company advanced its clinical programs for bavituximab and Cotara(R).
Total revenues for the current quarter increased to $1,675,000 compared to $363,000 for the comparable quarter last year, and were primarily generated from services provided by Avid Bioservices, the company's wholly owned contract manufacturing subsidiary.
Total costs and expenses increased to $8,077,000 in the third quarter of FY 2008 from $5,643,000 in the same prior year quarter. The increase was primarily related to the increase in the cost of contract manufacturing of $1,066,000 during the quarter resulting from higher reported revenues from external customers, in addition to the increase in research and development expenses of $1,034,000 associated with the advancement of the company's clinical and preclinical product candidates. Research and development expenses were $4,941,000 in the third quarter of FY 2008, compared to $3,907,000 in the third quarter of FY 2007 8,077,000 5,643,000 23,035,000 17,939,000
OPERATIONS (6,402,000) (5,280,000) (17,843,000) (16,471,000)
other income 259,000 267,000 851,000 955,000
other expense (11,000) (12,000) (25,000) (36,000)
NET LOSS $(6,154,000) $(5,025,000) $(17,017,000) $(15,552,000)
Diluted 226,210,617 195,299,586 219,497,601 191,067,145
BASIC AND DILUTED
LOSS PER COMMON
SHARE $(0.03) $(0.03) $(0.08) $(0.08). At January 31, 2008, the company had $20,063,000 in cash and cash equivalents compared to $16,044,000 at fiscal year end April 30, 2007.
"The past quarter was highlighted by a major milestone in our oncology program, as we dosed the first patients in a Phase II trial evaluating bavituximab in combination with chemotherapy in patients with breast cancer," said Steven W. King, president and CEO of Peregrine. "We also received regulatory approval to initiate two additional bavituximab Phase II cancer trials -- a second breast cancer study and a trial in patients with non-small cell lung cancer, a leading cause of cancer deaths worldwide. Planning for these trials is well underway and we anticipate initiating both studies next month. We also made progress in our Cotara clinical program in patients with glioblastoma multiforme (GBM), today announcing promising data from the ongoing dosimetry and Phase II trials showing that several patients are already surviving longer than the expected six-month median survival time for this patient population, with the longest surviving patient now at 15 months post-treatment. Patients who are continuing in the trials are being monitored for safety and overall survival, and we look forward to providing further updates on these trials going forward. We have also recently expanded the number of clinical sites in the Phase Il study to eight and also added a distinguished brain cancer center and experienced Cotara clinical study site -- the Barrow Neurological Institute -- to our dosimetry study in the U.S."
Mr. King added, "Our initiative to raise awareness for the bavituximab and Cotara programs in the scientific and medical communities scored gains, including an oral presentation covering the clinical experience to date in the bavituximab Phase I cancer program at Angio 2008, an oral presentation of clinical data from our Phase I bavituximab trial in hepatitis C patients at the prestigious 2007 Liver Meeting(R), a recent publication in Clinical Cancer Research highlighting bavituximab's ability to target tumor blood vessels with excellent specificity, and the acceptance last week of an abstract discussing patient data from the Cotara dosimetry trial for presentation at the 2008 ASCO Annual Meeting. We anticipate additional high profile scientific publications and presentations in the coming months while we continue making good progress in advancing our trio of Phase II bavituximab cancer trials, the two ongoing Cotara clinical trials and the trial of bavituximab in HCV patients co-infected with HIV. We look forward to a steady flow of news from these multiple activities in the coming months."
Bavituximab Anti-Cancer Program: The company launched the Phase II
cancer clinical program for bavituximab during the quarter and achieved a
number of other clinical and preclinical advancements.
-- Initiated patient dosing in a Phase II combination therapy trial of
bavituximab and docetaxel in patients with advanced breast cancer
within 14 days of study initiation.
-- Received regulatory approval to begin two additional Phase II
bavituximab combination therapy trials -- one in combination with
carboplatin and paclitaxel in patients with advanced breast cancer and
another in combination with carboplatin plus paclitaxel in patients
with non-small cell lung cancer (NSCLC). Both trials are preparing to
begin enrolling patients shortly.
-- A bavituximab cancer investigator presented data at a leading
scientific meeting on anti-angiogenic agents -- the 10th Annual
International Symposium on Anti-Angiogenic Agents (Angio 2008) --
highlighting the positive clinical experience to date with
-- A preclinical study published in Clinical Cancer Research confirmed
bavituximab's ability to target tumor blood vessels with excellent
specificity. The high degree of selective targeting seen in the study
provides additional evidence of bavituximab's therapeutic potential.
Bavituximab Anti-Viral Program: During the third quarter, the company
continued to advance its bavituximab HCV program and presented positive
data at a key liver disease meeting.
-- Added The Johns Hopkins Hospital and a private clinic in Orange
County, California as additional clinical study sites for the HCV/HIV
-- Presented final results from the Phase I multiple dose HCV trial at
the prestigious Annual Meeting of the American Association for the
Study of Liver Disease that showed bavituximab was well tolerated and
demonstrated encouraging signs of anti-viral activity.
Cotara(R) Glioblastoma Program: Peregrine continued to advance the
Cotara brain cancer program.
-- Added additional study sites and continued patient dosing and
follow-up in the Cotara Phase II study in patients with glioblastoma
multiforme, the most deadly form of brain cancer. Eight sites are now
open for patient enrollment.
-- Added an additional site, the Barrow Neurological Institute (BNI) in
Phoenix, Arizona, to the ongoing Cotara dosimetry and dose
confirmation clinical study. BNI also participated in a previous
Cotara Phase II clinical trial.
-- Announced positive results from the first cohort of patients treated
in the Cotara dosimetry trial and from the initial patients treated in
the Cotara Phase II trial. Cotara appeared safe and well tolerated
with no dose-limiting adverse events, with continuing patients being
monitored for overall survival. Several patients in these studies
have lived longer than the six-month expected median survival time for
this patient population.
Other Preclinical Programs:
-- Preclinical data presented at the 5th Annual International
Anti-Angiogenesis Conference confirmed that Peregrine's fully human,
selective anti-VEGF antibody R84 was as effective as Avastin(R) in
inhibiting tumor growth in a model of human breast cancer. Selective
anti-VEGF agents may have potential advantages over non-selective
-- Wholly owned manufacturing subsidiary Avid Bioservices signed an
agreement with ARIUS Research to produce clinical supplies of their
lead cancer stem cell anti-CD44 antibody.
-- Avid continued to demonstrate strong revenue performance during the
third quarter of fiscal year 2008.
The company will host a conference call today, March 11, 2008 at 11:30 a.m. EDT/8:30 a.m. PDT to discuss its third quarter FY 2008 financial results.
To listen to a live broadcast of the call over the Internet or to review the archived call, please visit: http://www.peregrineinc.com. The webcast will be archived on Peregrine's website for approximately 30 days.
To listen to the conference call via telephone, please call the following number approximately 10 minutes prior to the scheduled start time and request to join the Peregrine Pharmaceuticals call: 1 (800) 860-2442. A telephonic replay of the conference call will be available starting approximately one hour after the conclusion of the call through March 18, 2008 by calling (877) 344-7529, passcode 382933#.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding Peregrine
Pharmaceuticals' intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future are forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995. The forward-looking statements involve risks and uncertainties
including, but not limited to the risk that the company may experience
delays in clinical trial patient enrollment, the risk that future clinical
trial results may not correlate with the results of prior clinical trials
and preclinical studies, the risk that Avid's revenue growth may slow or
decline, the risk that future protocol submissions may not be approved, the
risk that the company may not be able to monetize any of its assets, the
risk that the company will not regain compliance with the Nasdaq Stock
Market minimum bid price requirement by July 21, 2008, and the risk that
the company will not have additional high profile scientific publications
and presentations. It is important to note that the company's actual
results could differ materially from those in any such forward-looking
statements. Factors that could cause actual results to differ materially
include, but are not limited to, uncertainties associated with completing
preclinical and clinical trials for our technologies; the early stage of
product development; the significant costs to develop our products as all
of our products are currently in development, preclinical studies or
clinical trials; obtaining additional financing to support our operations
and the development of our products; obtaining regulatory approval for our
technologies; anticipated timing of regulatory filings and the potential
success in gaining regulatory approval and complying with governmental
regulations applicable to our business. Our business could be affected by a
number of other factors, including the risk factors listed from time to
time in the Company's SEC reports including, but not limited to, the annual
report on Form 10-K for the year ended April 30, 2007 and the quarterly
report on Form 10-Q for the third fiscal quarter ended January 31, 2008.
The company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. Peregrine
Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to
update or revise any forward-looking statements in this press release.
GendeLLindheim BioCom Partners
email@example.com Barbara Lindheim
(800) 987-8256 (212) 918-4650
-financial tables to follow-
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31, APRIL 30,
Cash and cash equivalents $20,063,000 $16,044,000
Trade and other receivables 1,316,000 750,000
Inventories, net 2,394,000 1,916,000
Prepaid expenses and other current assets 1,140,000 1,188,000
Total current assets 24,913,000 19,898,000
Leasehold improvements 669,000 646,000
Laboratory equipment 3,756,000 3,533,000
Furniture, fixtures and office equipment 913,000 873,000
Less accumulated depreciation and
amortization (3,537,000) (3,212,000)
Property, net 1,801,000 1,840,000
Other assets 1,527,000 1,259,000
TOTAL ASSETS $28,241,000 $22,997,000
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (continued)
JANUARY 31, APRIL 30,
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $2,387,000 $1,683,000
Accrued clinical trial site fees 244,000 228,000
Accrued legal and accounting fees 390,000 392,000
Accrued royalties and license fees 124,000 337,000
Accrued payroll and related costs 858,000 874,000
Notes payable, current portion - 379,000
Capital lease obligation, current portion 17,000 17,000
Deferred revenue 1,434,000 1,060,000
Other current liabilities 1,239,000 885,000
Total current liabilities 6,693,000 5,855,000
Notes payable, less current portion - 119,000
Capital lease obligation, less current portion 17,000 30,000
Deferred license revenue - 4,000
Commitments and contingencies
Preferred stock-$.001 par value;
authorized 5,000,000 shares; non-voting;
nil shares outstanding - -
Common stock-$.001 par value; authorized
325,000,000 shares; outstanding -
226,210,617 and 196,112,201, respectively 226,000 196,000
Additional paid-in capital 245,982,000 224,453,000
Accumulated deficit (224,677,000) (207,660,000)
Total stockholders' equity 21,531,000 16,989,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $28,241,000 $22,997,000
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED NINE MONTHS ENDED
January 31, January 31, January 31 January 31,
2008 2007 2008 2007
Unaudited Unaudited Unaudited Unaudited
revenue $1,662,000 $347,000 $5,146,000 $1,381,000
License revenue 13,000 16,000 46,000 87,000
Total revenues 1,675,000 363,000 5,192,000 1,468,000
COSTS AND EXPENSES:
Cost of contract
manufacturing 1,289,000 223,000 3,872,000 1,247,000
development 4,941,000 3,907,000 13,665,000 11,868,000
and administrative 1,847,000 1,513,000 5,498,000 4,824,000
|SOURCE Peregrine Pharmaceuticals, Inc.|
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