EXHIBIT 99.1
Investor Inquiries
Hawk Associates, Inc.
Frank Hawkins and Ken AuYeung
(800) 987-8256
info@hawkassociates.com | Media Inquiries
Rachel Martin
Edelman
(323) 202-1031/(323) 893-1047
Rachel.Martin@edelman.com |
FOR IMMEDIATE RELEASE
PEREGRINE PHARMACEUTICALS ANNOUNCES THIRD QUARTER FINANCIAL RESULTS
Tustin, CA — March 14, 2005 – Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a biopharmaceutical company with a broad portfolio of products under development, today announced financial results for the third quarter ended January 31, 2005. The company reported a net loss of $3,744,000 or $0.03 per share, basic and diluted, for the quarter ended January 31, 2005. This compares to a net loss of $4,137,000 or $0.03 per share, basic and diluted, for the same period last year. The company’s net loss for the third quarter of fiscal year 2005 resulted primarily from the continued advancement of its technologies under development for treatment of cancer, viruses, and other diseases, including the clinical advancement of Tarvacin™ and Cotara®.
Total revenues for the current quarter increased $1,124,000 to $1,353,000 compared to revenues of $229,000 for the comparable quarter last year. The total revenue figure was boosted by an increase in contract manufacturing revenue generated by Avid Bioservices, Inc., the company’s wholly-owned subsidiary, engaged in providing contract manufacturing and development services of biologics.
At January 31, 2005, the company had $10,439,000 in cash and cash equivalents, compared to $14,884,000 at fiscal year end April 30, 2004.
Highlights of Third Quarter of Fiscal Year 2005
| | • | Tarvacin™ protocol received FDA approval to commence phase I study for treatment of advanced cancer |
| | — Company expects to initiate patient enrollment in the near term |
| | • | Pre-clinical data showing that a Tarvacin™ equivalent plus radiation therapy reduced tumor growth by up to 98% was presented at a Vascular Targeting Agent conference in Cambridge, MA |
| | • | National Cancer Institute approved Cotara® brain cancer protocol between Peregrine and New Approaches to Brain Tumor Therapy (NABTT) Consortium |
| | — Peregrine and NABTT are currently in the process of initiating the multi-center study at participating institutions |
| | • | Peregrine gained access to Merck KGaA’s Protein Expression Technology |
| | — Technology will be employed to advance Peregrine’s Vasopermeation Enhancement Agent (VEA) technology toward clinical trials |
| | • | Peregrine and Affitech AS expanded their collaboration to develop up to six new fully human antibodies |
| | — The expanded collaboration will potentially expand the company’s product pipeline for the production of up to an additionalsix human antibodies |
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a broad portfolio of products under development directed towards the treatment of cancer, viruses, and other diseases through a series of proprietary platform technologies. Our oncology programs entering the clinic or in pre-clinical development are primarily focused on the areas of anti-angiogenesis and vascular targeting. These are agents that affect blood vessels and blood flow in cancer may have application in other disease types including certain cardiovascular and ocular diseases. Our agents in development for oncology applications fall under several different proprietary platforms, including Anti-Phospholipid Therapy (APT), Vascular Targeting Agents (VTAs), Anti-Angiogenesis and Vasopermeation Enhancement Agents (VEAs). In addition to our oncology programs, we are also investigating certain agents that fall under our APT technology platform for the treatment of viral diseases. This viral therapy approach is based on the fact that enveloped viruses and virally infected cells have phospholipids exposed on their surface and thus can be targeted using our APT agents.
Peregrine Pharmaceuticals recently received approval from the FDA for its Tarvacin™ Phase I study for the treatment of advanced cancer. Tarvacin™, a novel anti-cancer agent, is part of Peregrine’s Anti-Phospholipid Therapy (APT) platform, which binds directly to tumor blood vessels to inhibit tumor growth and development. The company plans on initiating the approved Phase I study in the near term.
Peregrine Pharmaceutical’s most clinically advanced therapeutic program is known as Tumor Necrosis Therapy (TNT) and targets dead or dying tumor cells that are common to the majority of different tumor types. The company is developing a radioactive TNT agent that it has trademarked Cotara® for the treatment of cancer. The company is working with New Approaches to Brain Tumor Therapy (NABTT) Consortium to initiate the first part of Peregrine’s U.S. Food and Drug Administration (FDA)-approved product registration trial using Cotara® to treat patients with brain cancer. Peregrine has also completed enrollment in a Phase I Cotara® clinical trial for the treatment of colorectal carcinoma at Stanford University Medical Center and is working closely with scientific advisors to design Phase II studies using Cotara® for other solid tumor indications. In addition, a TNT-based agent similar to Cotara® was developed under a licensing agreement in China and has received marketing approval for the treatment of advanced lung cancer.
Our wholly-owned subsidiary, Avid Bioservices, Inc., (http://www.avidbio.com) is engaged in providing contract manufacturing services and development of biologics for biopharmaceutical and biotechnology companies, including Peregrine.
Copies of Peregrine Pharmaceuticals press releases, SEC filings, current price quotes and other valuable information for investors may be found athttp://www.peregrineinc.com.
| | Statements in this press release which are not purely historical including statements regarding Peregrine Pharmaceutical’sintentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-lookingstatements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risksand uncertainties including, but not limited to,initiating patient enrollment in the Tarvacin™ study in the near term, initiatingthe multi-center study with NABTT at participating institutions, employing technology to advance Peregrine’s VasopermeationEnhancement Agent (VEA) technology toward clinical trials, continuing to receive assistance from scientists on our ScientificResource Board in the evaluation of potential ways to use Anti-Phospholipid Therapy (APT) agents clinically to treat viral diseasesand to moving our 2C3 program toward clinical studies, and increasing manufacturing activity at Avid Bioservices, Inc. due to thesigning of a new contract. It is important to note that the company’s actual results could differ materially from those in any suchforward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to,uncertainties associated with completing pre-clinical and clinical trials for our technologies; the significant costs to develop ourproducts as all of our products are currently in development, pre-clinical studies or clinical trials and no revenue has beengenerated from commercial product sales; obtaining additional financing to support our operations and the development of ourproducts; 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 collaborativearrangements with corporate partners. Our business could be affected by all of the foregoing and a number of other factors, includingthe risk factors listed from time to time in the Company’s SEC reports including, but not limited to, the annual report on Form 10-Kfor the year ended April 30, 2004, and the quarterly report on Form 10-Q for the quarter ended January 31, 2005. PeregrinePharmaceuticals, Inc. disclaims any obligation, and does not undertake, to update or revise any forward-looking statements in thispress release. |
Condensed Consolidated Statements of Operations and Balance Sheets to follow.
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| THREE MONTHS ENDED
| | NINE MONTHS ENDED
| |
| January 31,
2005
| | January 31,
2004
| | January 31,
2005
| | January 31,
2004
| |
| Unaudited | | Unaudited | | Unaudited | | Unaudited | |
| REVENUES: | | | | | | | | | | | | | | |
| Contract manufacturing revenue | | | $ | 1,334,000 | | $ | 211,000 | | $ | 3,983,000 | | $ | 1,403,000 | |
| License revenue | | | | 19,000 | | | 18,000 | | | 57,000 | | | 56,000 | |
|
| |
| |
| |
| |
| Total revenues | | | | 1,353,000 | | | 229,000 | | | 4,040,000 | | | 1,459,000 | |
| |
| COST AND EXPENSES: | | |
| Cost of contract manufacturing | | | | 1,273,000 | | | 223,000 | | | 3,265,000 | | | 1,207,000 | |
| Research and development | | | | 2,548,000 | | | 2,723,000 | | | 8,122,000 | | | 6,570,000 | |
| Selling, general and administrative | | | | 1,338,000 | | | 1,096,000 | | | 3,642,000 | | | 3,224,000 | |
|
| |
| |
| |
| |
| Total cost and expenses | | | | 5,159,000 | | | 4,042,000 | | | 15,029,000 | | | 11,001,000 | |
|
| |
| |
| |
| |
| |
| LOSS FROM OPERATIONS | | | | (3,806,000 | ) | | (3,813,000 | ) | | (10,989,000 | ) | | (9,542,000 | ) |
|
| |
| |
| |
| |
| |
| OTHER INCOME (EXPENSE): | | |
| Interest and other income | | | | 65,000 | | | 70,000 | | | 197,000 | | | 219,000 | |
| Interest and other expense | | | | (3,000 | ) | | (394,000 | ) | | (3,000 | ) | | (1,840,000 | ) |
|
| |
| |
| |
| |
| NET LOSS | | | $ | (3,744,000 | ) | $ | (4,137,000 | ) | $ | (10,795,000 | ) | $ | (11,163,000 | ) |
|
| |
| |
| |
| |
| |
WEIGHTED AVERAGE
SHARES OUTSTANDING: | | |
| Basic and Diluted | | | | 145,175,059 | | | 137,835,689 | | | 142,677,820 | | | 132,147,463 | |
|
| |
| |
| |
| |
| |
BASIC AND DILUTED LOSS PER
COMMON SHARE | | | $ | (0.03 | ) | $ | (0.03 | ) | $ | (0.08 | ) | $ | (0.08 | ) |
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| |
| |
| |
| |
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| JANUARY 31,
2005
| | APRIL 30,
2004
| |
| Unaudited | | (1) | |
| ASSETS | | | | | | | | |
| |
| CURRENT ASSETS: | | |
| Cash and cash equivalents | | | $ | 10,439,000 | | $ | 14,884,000 | |
| Trade and other receivables, net of allowance for doubtful accounts | | |
| of $68,000 (January) and $64,000 (April) | | | | 514,000 | | | 1,520,000 | |
| Inventories | | | | 1,545,000 | | | 1,240,000 | |
| Prepaid expenses and other current assets | | | | 777,000 | | | 240,000 | |
|
| |
| |
| Total current assets | | | | 13,275,000 | | | 17,884,000 | |
| |
| PROPERTY: | | |
| Leasehold improvements | | | | 494,000 | | | 389,000 | |
| Laboratory equipment | | | | 2,530,000 | | | 2,211,000 | |
| Furniture, fixtures and computer equipment | | | | 640,000 | | | 646,000 | |
|
| |
| |
| | | | | 3,664,000 | | | 3,246,000 | |
| Less accumulated depreciation and amortization | | | | (2,442,000 | ) | | (2,373,000 | ) |
|
| |
| |
| Property, net | | | | 1,222,000 | | | 873,000 | |
| |
| OTHER ASSETS: | | |
| Note receivable, net of allowance of $1,530,000 (January) | | |
| and $1,581,000 (April) | | | | - | | | - | |
| Other | | | | 830,000 | | | 380,000 | |
|
| |
| |
| Total other assets | | | | 830,000 | | | 380,000 | |
|
| |
| |
| |
| TOTAL ASSETS | | | $ | 15,327,000 | | $ | 19,137,000 | |
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| |
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (continued)
| JANUARY 31,
2005
| | APRIL 30,
2004
| |
| Unaudited | | (1) | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | |
| |
| CURRENT LIABILITIES: | | |
| Accounts payable | | | $ | 1,372,000 | | $ | 1,331,000 | |
| Accrued legal and accounting fees | | | | 502,000 | | | 407,000 | |
| Accrued royalties and license fees | | | | 161,000 | | | 149,000 | |
| Accrued payroll and related costs | | | | 566,000 | | | 503,000 | |
| Notes payable, current portion | | | | 230,000 | | | - | |
| Other current liabilities | | | | 539,000 | | | 339,000 | |
| Deferred revenue | | | | 1,028,000 | | | 1,524,000 | |
|
| |
| |
| Total current liabilities | | | | 4,398,000 | | | 4,253,000 | |
| |
| NOTES PAYABLE | | | | 494,000 | | | - | |
| DEFERRED LICENSE REVENUE | | | | 69,000 | | | 125,000 | |
| COMMITMENTS AND CONTINGENCIES | | |
| |
| STOCKHOLDERS’ EQUITY: | | |
Common stock-$.001 par value; authorized 200,000,000 shares;
outstanding - 149,431,262 (January); 141,268,182 (April) | | | | 149,000 | | | 141,000 | |
| Additional paid-in capital | | | | 175,621,000 | | | 168,969,000 | |
| Deferred stock compensation | | | | (258,000 | ) | | - | |
| Accumulated deficit | | | | (165,146,000 | ) | | (154,351,000 | ) |
|
| |
| |
| Total stockholders’ equity | | | | 10,366,000 | | | 14,759,000 | |
|
| |
| |
| |
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | | $ | 15,327,000 | | $ | 19,137,000 | |
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| |
| (1) | Derived from the April 30, 2004 audited financial statements. For further information, refer to the financial statements and footnotes thereto included in the Company’s annual report on Form 10-K for the year ended April 30, 2004, as filed with the Securities and Exchange Commission on July 14, 2004. |
