Peregrine Pharmaceuticals Reports First Quarter Fiscal Year 2014 Financial Results and Recent Developments
"We continue to steadily progress the bavituximab clinical program as we prepare to initiate a global Phase III trial by year-end in second-line non-small cell lung cancer. In addition to Phase III preparations, our researchers and external collaborators have undertaken a flurry of preclinical experimentation that will help guide exciting new combinations and therapeutic areas for bavituximab. This activity was spurred on by recent data showing that bavituximab works by harnessing the body's natural immune system to fight cancer," said
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
- Continued to plan for the initiation of the SUNRISE Trial (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III
Lung Cancer Study ).- SUNRISE is a Phase III, global, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab in patients with second-line non-small cell lung cancer (NSCLC). Specifically, the trial will evaluate bavituximab plus docetaxel versus docetaxel plus placebo in approximately 600 patients at clinical sites worldwide. Patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients will be randomized into 1 of 2 treatment arms. All patients will receive up to six 21-day cycles of docetaxel at 75 milligrams per meter squared plus weekly infusions of either bavituximab (3mg/kg) or placebo until progression of toxicity. The primary endpoint of the trial will be overall survival. The company anticipates initiating the SUNRISE trial
by the end of this calendar year.
- SUNRISE is a Phase III, global, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab in patients with second-line non-small cell lung cancer (NSCLC). Specifically, the trial will evaluate bavituximab plus docetaxel versus docetaxel plus placebo in approximately 600 patients at clinical sites worldwide. Patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients will be randomized into 1 of 2 treatment arms. All patients will receive up to six 21-day cycles of docetaxel at 75 milligrams per meter squared plus weekly infusions of either bavituximab (3mg/kg) or placebo until progression of toxicity. The primary endpoint of the trial will be overall survival. The company anticipates initiating the SUNRISE trial
by the end of this calendar year.
Other Oncology Indications:
The company is exploring the potential of bavituximab through a number of investigator-sponsored trials (IST) including:
- A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer. All patients have been enrolled in this trial with interim data on 13 evaluable patients presented at the 2013
American Society of Clinical Oncology (ASCO) Annual Meeting showing that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response measured in accordance with RECIST criteria.
- A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). The Phase I portion of the trial has completed patient enrollment with enrollment in the Phase II portion of the trial ongoing.
- A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC. This trial continues to enroll and dose patients.
- A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma. This trial continues to enroll and dose patients.
BAVITUXIMAB IMMUNOTHERAPY DEVELOPMENT PROGRAM
This morning, Peregrine announced the publication of a data supporting the immune-stimulatory mechanism of action of phosphatidylserine (PS)-targeting antibodies, such as the company's lead drug candidate bavituximab in the
Peregrine is exploring the potential to combine bavituximab with other immunotherapies such as anti-CTLA-4, anti-PD-1, and anti-PD-L1 antibodies and has initiated several ongoing pre-clinical proof-of-concept studies to support an immunotherapy combination trial with bavituximab.
IMAGING PROGRAM HIGHLIGHTS
PS-Targeting Molecular Imaging Program
Peregrine continues to enroll and dose patients in an open-label, single-center trial of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. The primary goal of the trial is to estimate radiation dosimetry in critical and non-critical organs. Secondary objectives of the trial are tumor imaging and safety.
FINANCIAL RESULTS
"Our wholly-owned contract manufacturing subsidiary, Avid Bioservices, continue to perform well, generating over
Total revenues for the first quarter of FY 2014 were
Contract manufacturing revenues from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the first quarter FY 2014 were
Total costs and expenses in the first quarter of FY 2014 were
Peregrine's consolidated net loss was
Peregrine reported
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-Q, which will be filed with the
Conference Call
Peregrine will host a conference call and webcast this afternoon,
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the
To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm.
About
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||
THREE MONTHS ENDED | |||||||||
Unaudited | Unaudited | ||||||||
REVENUES: | |||||||||
Contract manufacturing revenue | $ | 4,581,000 | $ | 4,135,000 | |||||
License revenue | 107,000 | 116,000 | |||||||
Total revenues | 4,688,000 | 4,251,000 | |||||||
COSTS AND EXPENSES: | |||||||||
Cost of contract manufacturing | 2,670,000 | 2,024,000 | |||||||
Research and development | 5,304,000 | 6,981,000 | |||||||
Selling, general and administrative | 4,334,000 | 2,917,000 | |||||||
Total costs and expenses | 12,308,000 | 11,922,000 | |||||||
LOSS FROM OPERATIONS | (7,620,000 | ) | (7,671,000 | ) | |||||
OTHER INCOME (EXPENSE): | |||||||||
Interest and other income | 21,000 | 8,000 | |||||||
Interest and other expense | (1,000 | ) | (1,000 | ) | |||||
NET LOSS | $ | (7,600,000 | ) | $ | (7,664,000 | ) | |||
COMPREHENSIVE LOSS | $ | (7,600,000 | ) | $ | (7,664,000 | ) | |||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING | |||||||||
Basic and diluted | 149,393,630 | 103,283,937 | |||||||
BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.05 | ) | $ | (0.07 | ) | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
2013 |
2013 |
||||||||
Unaudited | |||||||||
ASSETS | |||||||||
CURRENT ASSETS: | |||||||||
Cash and cash equivalents | $ | 41,600,000 | $ | 35,204,000 | |||||
Trade and other receivables, net | 2,272,000 | 1,662,000 | |||||||
Inventories | 5,679,000 | 4,339,000 | |||||||
Prepaid expenses and other current assets, net | 635,000 | 709,000 | |||||||
Total current assets | 50,186,000 | 41,914,000 | |||||||
Property and equipment, net | 2,448,000 | 2,678,000 | |||||||
Other assets | 689,000 | 466,000 | |||||||
TOTAL ASSETS | $ | 53,323,000 | $ | 45,058,000 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
CURRENT LIABILITIES: | |||||||||
Accounts payable | $ | 2,160,000 | $ | 2,821,000 | |||||
Accrued clinical trial and related fees | 608,000 | 930,000 | |||||||
Accrued payroll and related costs | 3,271,000 | 3,582,000 | |||||||
Deferred revenue, current portion | 4,164,000 | 4,171,000 | |||||||
Customer deposits | 8,528,000 | 8,059,000 | |||||||
Other current liabilities | 1,335,000 | 998,000 | |||||||
Total current liabilities | 20,066,000 | 20,561,000 | |||||||
Deferred revenue, less current portion | 292,000 | 292,000 | |||||||
Other long-term liabilities | 422,000 | 445,000 | |||||||
Commitments and contingencies | |||||||||
STOCKHOLDERS' EQUITY: | |||||||||
Preferred stock-$0.001 par value; authorized 5,000,000 shares; non-voting; nil shares outstanding | - | - | |||||||
Common stock-$0.001 par value; authorized 325,000,000 shares; outstanding - 153,506,811 and 143,768,946, respectively | 153,000 |
143,000 |
|||||||
Additional paid-in capital | 407,894,000 | 391,521,000 | |||||||
Accumulated deficit | (375,504,000 | ) | (367,904,000 | ) | |||||
Total stockholders' equity | 32,543,000 | 23,760,000 | |||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 53,323,000 | $ | 45,058,000 | |||||
Contact:
(800) 987-8256
info@peregrineinc.com
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