Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and serious viral infections, today announced financial results for the third quarter of fiscal year (FY) 2010 ended January 31, 2010. The company also provided an update on its clinical programs and corporate developments.
"During the quarter, we made important progress in advancing our Phase II clinical development programs to reach significant milestones over the coming year," said Steven W. King, president and CEO of Peregrine. "We completed patient treatment in our three Phase II cancer clinical trials with our lead product candidate bavituximab and are planning to report additional data in the first half of this year. We also expanded our ongoing Phase II Cotara® brain cancer clinical trial into the U.S. and began treating additional patients with this novel therapeutic approach. By mid-year, we expect to begin enrolling patients in two new bavituximab Phase II clinical trials in front-line and refractory non-small cell lung cancer as our lead indications. By executing our clinical trials and expanding Avid's commercial business and new initiatives, we believe we have multiple opportunities to reach our product commercialization goals."
Total revenues for the third quarter of FY 2010 increased 45% to $9,877,000, compared to $6,826,000 for the same quarter of the prior fiscal year. This was attributable to an increase in government contract revenue for services provided under Peregrine's contract with the U.S. Defense Threat Reduction Agency for the Transformational Medical Technologies Initiative (TMTI). Avid Bioservices, the company's wholly owned cGMP manufacturing subsidiary, provided the majority of the services under the government contract during the quarter. Contract manufacturing revenue provided to third party customers of Avid was $2,945,000 for the third quarter of FY 2010, compared to $5,778,000 for the comparable prior year quarter, a decrease of 49%. This decrease was attributable to a shift in Avid's source of revenue from third party clients to the TMTI government contract.
For the first nine months of FY 2010, total revenues increased 129% to $23,523,000, compared to $10,284,000 for the same period of the prior fiscal year. For the first nine months of FY 2010, contract manufacturing revenue provided to third-party clients increased 30% to $10,323,000, compared to $7,954,000 for the same period of the prior fiscal year.
Total costs and expenses in the third quarter of FY 2010 were $11,194,000, compared to $10,060,000 in the third quarter of FY 2009, an increase of 11% primarily due to higher research and development expenses to advance Peregrine's clinical programs for bavituximab and Cotara combined with increased costs incurred to advance the company's anti-viral research efforts under its government contract. For the first nine months of FY 2010, total costs and expenses were $29,567,000, compared to $23,228,000 for the same period of the prior fiscal year, an increase of 27%.
Research and development expenses were $7,322,000 for the third quarter of FY 2010, compared to $4,465,000 for the third quarter of FY 2009, an increase of 64%. For the nine months of FY 2010, research and development expenses were $17,528,000, compared to $12,834,000 for the same period of the prior fiscal year, an increase of 37%.
Peregrine's consolidated net loss decreased 54% to $1,538,000, or $0.03 per share, in the third quarter of FY 2010, compared to a net loss of $3,332,000, or $0.07 per share, for the same quarter of the prior year. For the first nine months of FY 2010, net loss was $6,753,000, or $0.14 per share, a 48% decrease from the net loss of $12,915,000, or $0.29 per share, for the same period of the prior fiscal year.
At January 31, 2010, the company had $16,837,000 in cash and cash equivalents, compared to $13,599,000 at October 31, 2009 and $10,018,000 at fiscal year-end April 30, 2009.
"As we invest in our clinical programs, we continue to achieve solid financial and operational performance," commented Paul J. Lytle, Peregrine's chief financial officer. "Our record revenues, decreased net loss and increased cash position this quarter are consistent with our strategy of managing our financial resources to support the development of our clinical-stage products as we move toward potential commercialization."
Clinical Program Highlights
Bavituximab Oncology Program
Peregrine has completed the combination treatment period in its three Phase II bavituximab clinical trials for breast cancer and non-small cell lung cancer (NSCLC) and expects to report additional data in the first half of 2010. In addition, the company will present final data from a Phase I clinical trial of bavituximab in solid tumors at the American Association for Cancer Research (AACR) Annual Meeting, held April 17 – 21, 2010. For more information on this meeting, please visit www.aacr.org. In mid-year 2010, Peregrine plans to initiate two new Phase II clinical trials for bavituximab in NSCLC.
Bavituximab Anti-Viral Program
In the first half of 2010, Peregrine expects to report additional preclinical data from its ongoing bavituximab anti-viral program.
Cotara Brain Cancer Program
Peregrine has expanded its Phase II Cotara brain cancer program into the U.S. and has initiated treatment in additional patients. The company expects to complete enrollment in a 40-patient Phase II trial during 2010. Recently reported data from the Cotara program include:
- Publication of long-term follow up data from a prior trial showing 7 of 28 (25%) of patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer, survived more than one year after treatment. Five years after treatment, 3 of 28 (10.7%) have survived, including 2 patients who have survived more than 9 years. These data compare favorably to the 5-year survival rate of 3.4% reported by the U.S. Brain Tumor Registry. These data were published in the journal Current Cancer Therapy Review by investigators at the Huntsman Cancer Institute at the University of Utah Medical Center and researchers at Peregrine.
Avid is presenting additional data on its manufacturing successes achieved with its disposable, versus traditional, 1000 liter (1000L) bioreactor systems at the Thermo Scientific BioProduction Optimization Workshop on March 16, 2010 in San Francisco. The company's presentation will include cell culture performance from the completion of 1000 liter manufacturing production runs of bavituximab and other antibody projects, highlighting the comparability between Avid's 1000L single-use bioreactor system and traditional 1000L stainless steel bioreactor systems.
Peregrine recently announced that Marvin R. Garovoy, M.D. has joined the company as head of clinical science. With extensive industry experience, Dr. Garovoy will be responsible for establishing and supervising an Investigator-Sponsored Trials (IST) program, assisting with clinical trial design, and expanding scientific outreach.
Peregrine will present at the ROTH 22nd Annual OC Growth Stock Conference on Wednesday, March 17, 2010 at 12:30 pm PDT. For more information about this conference, please visit:>
A live and archived webcast of the company's presentation will be available on the Investors section of Peregrine's website at https://avidbio.com/.
SOURCE Peregrine Pharmaceuticals, Inc.