TUSTIN, Calif., March 11 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. , 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. 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.”
Recent Highlights
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.
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.
Cotara(R) Glioblastoma Program: Peregrine continued to advance the Cotara brain cancer program.
Conference Call
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.
info@peregrineinc.com
CONTACT: Investors, 1-800-987-8256, info@peregrineinc.com, or Media,
Barbara Lindheim, +1-212-918-4650, both of GendeLLindheim BioCom Partners,
for Peregrine Pharmaceuticals, Inc.
Web site: http://www.peregrineinc.com/
