Peregrine Pharmaceuticals Reports Fiscal Year 2006 Third Quarter Results
TUSTIN, Calif., March 13 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a biopharmaceutical company with a portfolio of innovative, clinical stage products for the treatment of viral diseases and cancer, today announced financial results for the third quarter of fiscal year 2006 ended January 31, 2006. The company reported a consolidated net loss of $3,113,000, or $0.02 per basic and diluted share, compared to $3,744,000, or $0.03 per basic and diluted share, for the same prior year period.
Total revenues for the current quarter were $1,528,000, of which $1,505,000 were attributable to Avid Bioservices, the company's wholly owned contract manufacturing subsidiary. This compares to total revenues of $1,353,000 for the comparable quarter last year. Results for the period benefited from increased revenues at Avid as it ramped up for the unit's new commercial production contract with Halozyme Therapeutics.
"Since we last reported, we have continued our progress in our key programs," said Steven W. King, president and CEO of Peregrine. "We completed planned patient enrollment in the Tarvacin™ Anti-Viral Phase I trial in Hepatitis C infected patients and presented positive top-line safety data in February, well ahead of our previous target of mid-2006. Presentation of this first human data was a major milestone for Tarvacin, our first-in-class targeted product candidate with a wholly new mechanism for addressing viral diseases and cancer. Moving forward, we are pursuing several strategies to accelerate our Tarvacin Anti-Viral and Tarvacin Anti-Cancer programs, as well as our Cotara® program in brain cancer. We are increasing our preclinical and clinical program collaborations with top researchers and institutions in target therapeutic areas and are also moving forward with plans to facilitate patient enrollment by initiating clinical trials outside the U.S., focusing initially on cancer studies for Tarvacin Anti-Cancer and Cotara."
Total costs and expenses increased $851,000 to $6,010,000 for the 2006 third quarter from $5,159,000 for the same quarter last year. This increase was primarily due to higher research and development expenses associated with the advancement of the company's clinical and preclinical product candidates combined with an increase in selling, general and administrative expenses. This was partially offset by a decrease in cost of sales associated with Avid Bioservices.
Interest and other income increased $1,316,000 during the current quarter over the prior year quarter primarily due to the recovery of a fully reserved for note receivable in the amount of $1,229,000 that was paid off in December 2005.
At January 31, 2006, the company had $15,664,000 in cash and cash equivalents, compared to $9,816,000 at fiscal year end April 30, 2005.
Update on Tarvacin™ Programs
Tarvacin Anti-Viral
Planned enrollment and dosing in the Tarvacin Anti-Viral Phase I Hepatitis C virus (HCV) trial was completed in mid-February. Positive top-line safety data from the study was presented at the "Viral Hepatitis in Drug Discovery and Development" conference in Boston on February 27th. Data from this trial should enable Peregrine to move rapidly into repeat dose studies in HCV, which the company expects to begin by mid-2006 and anticipates completing patient enrollment by calendar year-end. The company also expects to initiate and complete patient enrollment in an HCV combination therapy study by calendar year-end and is currently on track to achieve these goals. The Tarvacin Anti-Viral program is also expected to benefit from the recent addition of Dr. John G. McHutchison, a highly regarded global HCV expert, to the company's Scientific Resource Board.
Peregrine is also continuing to evaluate the potential of Tarvacin in preclinical models for the treatment of other serious viral infections including seasonal and pandemic influenza, cytomegalovirus and HIV. The company plans to initiate trials in one to two additional anti-viral indications during 2006 pending positive results from these preclinical studies.
To advance further its preclinical and clinical anti-viral programs, Peregrine is continuing to expand its collaborations with private contract laboratories, major universities and federal government agencies, including the National Institute of Allergy and Infectious Diseases and the U.S. Department of Defense (DOD).
Tarvacin Anti-Cancer
The Phase I trial of Tarvacin Anti-Cancer is now ongoing at five clinical sites. Peregrine is on track to complete patient enrollment in this trial by the end of calendar year 2006. The company is evaluating options to accelerate the program including expanding its Tarvacin Anti-Cancer studies to additional sites. Possibilities include initiating clinical research programs outside the U.S.
Early evidence of Tarvacin's potential to treat a number of major solid tumor cancers was further boosted during the quarter when Peregrine's research collaborators at the University of Texas Southwestern Medical Center at Dallas published a study in the International Journal of Oncology reporting that a mouse equivalent of the Tarvacin antibody in combination with standard chemotherapy demonstrated encouraging efficacy in both shrinking primary tumors and reducing metastatic disease in well-validated preclinical pancreatic cancer models. In January 2006, the Defense Department awarded a second grant to UT Southwestern to conduct preclinical studies of Tarvacin Anti-Cancer as a potential treatment for prostate cancer. Results from these studies are expected to help accelerate the start of additional clinical trials once the current Phase l cancer trial is successfully completed. With this new project, the total DOD commitment to Tarvacin prostate cancer research exceeds one million dollars. Altogether more than three million dollars in aggregate grant funding has been awarded to UT Southwestern researchers to study Tarvacin in anti-cancer and anti-viral applications demonstrating a growing support for this first-in-class targeted therapeutic.
Update on Cotara® Program
Peregrine is continuing its Cotara development program in patients with recurrent brain cancer through its collaboration with the New Approaches to Brain Tumor Therapy (NABTT) Consortium. The company expects to complete enrollment in the NABTT study by calendar year-end. In addition, Peregrine is actively evaluating plans to initiate a Cotara clinical study outside the U.S. to expedite clinical development.
Conference Call:
The company will host a conference call on Monday, March 13, 2006 at 11:00 a.m. ET/ 8:00 a.m. PT to discuss its third quarter results.
To listen to a live broadcast of the call over the Internet, please visit: http://www.peregrineinc.com. The broadcast will be archived on Peregrine's website for approximately 30 days.
To listen to the live teleconference by telephone, please dial 1-800-860-2442. A telephonic replay of the conference call will also be available through March 20, 2006, by calling 1-877-344-7529 and entering 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 viral diseases. The company is pursuing three separate clinical trials in cancer and anti-viral indications with its lead product candidates Tarvacin™ and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and biomanufacturing 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 following: that safety and efficacy studies in the Phase I clinical cancer study may not correlate to safety and efficacy data from the preclinical animal models, the timing of enrolling all patients in any clinical trial, that preclinical binding studies of Tarvacin™ against various enveloped viruses may prove to be ineffective during clinical testing, the timing for initiating any new studies and the completion of such studies within our stated goals, and increased manufacturing activity at Avid Bioservices, Inc. due to the signing of new contracts and the profitability of such contracts. 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 and the outcomes of preclinical and clinical trials for our technologies; slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of antibody products in patients, the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials and no revenue has been generated from commercial product sales; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; complying with governmental regulations applicable to our business; consummating collaborative arrangements with corporate partners for product development; and achieving milestones under collaborative arrangements with corporate partners. Our business could be affected by all of the foregoing and 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, 2005. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake, to update or revise any forward-looking statements in this press release.
PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED NINE MONTHS ENDED January 31, January 31, January 31, January 31, 2006 2005 2006 2005 Unaudited Unaudited Unaudited Unaudited
REVENUES: Contract manufacturing revenue $1,505,000 $1,334,000 $2,227,000 $3,983,000 License revenue 23,000 19,000 65,000 57,000 Total revenues 1,528,000 1,353,000 2,292,000 4,040,000
COSTS AND EXPENSES: Cost of contract manufacturing 1,088,000 1,273,000 1,820,000 3,265,000 Research and development 3,294,000 2,548,000 9,330,000 8,122,000 Selling, general and administrative 1,628,000 1,338,000 4,715,00 3,642,000 Total costs and expenses 6,010,000 5,159,000 15,865,000 15,029,000
LOSS FROM OPERATIONS (4,482,000) (3,806,000) (13,573,000) (10,989,000)
OTHER INCOME (EXPENSE): Interest and other income 1,381,000 65,000 1,585,000 197,000 Interest and other expense (12,000) (3,000) (35,000) (3,000)
NET LOSS $(3,113,000) $(3,744,000)$(12,023,000) $(10,795,000)
WEIGHTED AVERAGE SHARES OUTSTANDING: Basic and Diluted 171,355,523 145,175,059 165,772,373 142,677,820
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.02) $ (0.03) $ (0.07) $ (0.08)
PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31, APRIL 30, 2006 2005 Unaudited
ASSETS
CURRENT ASSETS: Cash and cash equivalents $15,664,000 $ 9,816,000 Trade and other receivables, net of allowance for doubtful accounts of nil (January) and $69,000 (April) 681,000 486,000 Inventories 1,060,000 627,000 Prepaid expenses and other current assets 867,000 1,197,000
Total current assets 18,272,000 12,126,000
PROPERTY: Leasehold improvements 503,000 494,000 Laboratory equipment 3,365,000 3,029,000 Furniture, fixtures and office equipment 666,000 647,000
4,534,000 4,170,000 Less accumulated depreciation and amortization (2,710,000) (2,532,000)
Property, net 1,824,000 1,638,000
OTHER ASSETS: Note receivable, net of allowance of nil (January) and $1,512,000 (April) - - Other 680,000 481,000
Total other assets 680,000 481,000
TOTAL ASSETS $20,776,000 $14,245,000
PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (continued)
JANUARY 31, APRIL 30, 2006 2005 Unaudited LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES: Accounts payable $ 1,493,000 $ 1,325,000 Accrued clinical trial site fees 211,000 8,000 Accrued legal and accounting fees 174,000 549,000 Accrued royalties and license fees 158,000 149,000 Accrued payroll and related costs 617,000 806,000 Notes payable, current portion 363,000 234,000 Capital lease obligation, current portion 15,000 - Other current liabilities 267,000 563,000 Deferred revenue 612,000 517,000
Total current liabilities 3,910,000 4,151,000
NOTES PAYABLE, less current portion 457,000 434,000 CAPITAL LEASE OBLIGATION, less current portion 50,000 - DEFERRED LICENSE REVENUE 25,000 50,000 COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY: Preferred stock-$.001 par value; authorized 5,000,000 shares; non-voting; nil shares outstanding - - Common stock-$.001 par value; authorized 250,000,000 shares; outstanding - 174,109,349 (January); 152,983,460 (April) 174,000 153,000 Additional paid-in capital 198,305,000 180,011,000 Deferred stock compensation (319,000) (751,000) Accumulated deficit (181,826,000) (169,803,000)
Total stockholders' equity 16,334,000 9,610,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 20,776,000 $ 14,245,000
Investors Media Brod & Schaffer Barbara Lindheim (800) 987-8256 GendeLLindheim BioCom Partners ir@peregrineinc.com (212) 918-4650
SOURCE Peregrine Pharmaceuticals, Inc.
CONTACT: Investors - Brod & Schaffer, 1-800-987-8256,
ir@peregrineinc.com; Media - Barbara Lindheim of GendeLLindheim BioCom
Partners for Peregrine Pharmaceuticals, Inc., +1-212-918-4650
Web site: http://www.peregrineinc.com
http://www.avidbio.com