Peregrine Announces Second Quarter Financial Results
Friday December 10, 2:53 pm ET
It appears the FDA has responded to PPHM's response regarding the protocol and MOA questions. It's now down to submitting the final revised protocol. I don't think the company would resubmit until they were 100% positive the FDA would be satisfied, good news IMO, since they state it would happen in the near term, I also don't feel the FDA will wait thirty days to render a decision
TUSTIN, Calif., Dec. 10 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News) today announced financial results for the second quarter ended October 31, 2004. The company reported a net loss of $3,638,000 or $0.03 per share, basic and diluted, for the quarter ended October 31, 2004. This compares to a net loss of $2,915,000 or $0.02 per share, basic and diluted, for the same period last year. The increase in the net loss for the second quarter of fiscal year 2005 was primarily due to an increase in research and development expenses of $1,029,000 associated with the planned Phase I clinical trial using Tarvacin(TM) and several other second-generation antibodies in development under the company's Anti- Phospholipid Therapy program for the possible treatment of cancer, viruses and other diseases.
Total revenues for the current quarter amounted to $2,183,000, an increase of 154%, compared to revenues of $858,000 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 of biologics to support Phase I through Phase III clinical trials.
"We are pleased with our current quarter revenues and we expect to continue generating contract manufacturing revenues as our increased manufacturing capacity comes online and additional ongoing projects are completed," said Steven King, Peregrine's president and CEO. "We achieved several important milestones this quarter as we advanced the development of potentially important therapeutics for cancer and viral diseases. The most important product development milestones achieved this quarter were submitting the Investigational New Drug (IND) application for Tarvacin, entering into a collaboration with the New Approaches to Brain Tumor Therapy (NABTT) consortium to initiate the Cotara® product registration trial, and completing enrollment in the Cotara Phase I colorectal cancer clinical trial at Stanford University Medical Center. These were significant steps forward as we continue to develop an exciting product pipeline."
As of the quarter ended October 31, 2004, the company had $10,325,000 in cash and cash equivalents, compared to $14,884,000 at fiscal year end April 30, 2004.
Highlights of Second Quarter of Fiscal Year 2005
Submitted Investigational New Drug (IND) application to the FDA for Tarvacin
Company continues discussions with FDA regarding IND filing and plans to submit a revised clinical protocol in the near term
Entered into collaboration with New Approaches to Brain Tumor Therapy (NABTT) Consortium to initiate the first part of the product registration trial for patients with recurrent glioblastoma multiforme, a deadly form of brain cancer
Patient enrollment to begin following final approval of the protocol by the National Cancer Institute
Completed patient enrollment for the Cotara Phase I clinical study for the treatment of colorectal cancer
Company is working closely with scientific advisors to design Phase II clinical studies using Cotara for other solid tumor indications
Completed humanization of the 3G4 antibody, the parent antibody of Tarvacin, with AERES Biomedical Ltd.
The humanized antibody is being developed as a future generation antibody for the possible treatment of cancer, viruses and other diseases
Increased manufacturing capacity at Avid Bioservices through the addition of a 1,000-liter bioreactor
Bioreactor to be operational in early calendar year 2005
AI
