Peregrine Pharmaceuticals Reports First Quarter Fiscal Year 2015 Financial Results and Recent Developments
"We continued to advance the bavituximab clinical program on multiple fronts with the major focus on executing the SUNRISE Phase III trial which is progressing well with the initiation of new global clinical sites bringing the total participating sites to over 130. In addition, our collaborator at UT Southwestern recently completed enrollment in an important liver cancer study opening the door for data from this study as well as other bavituximab clinical trials to be presented over the coming months," said
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
The company continues to actively open trial sites worldwide and enroll patients in the SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) Phase III Trial. SUNRISE is a Phase III, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-small cell lung cancer (NSCLC). The trial is evaluating bavituximab plus the standard chemotherapy 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 are being randomized into 1 of 2 treatment arms. All patients are receiving 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 or toxicity. The primary endpoint of the trial is overall survival. As of today, over 130 sites worldwide have been initiated in this pivotal trial.
For additional information about the SUNRISE trial please visit www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673.
Clinical Data that Supports New Bavituximab Oncology Indications:
The company is currently evaluating opportunities to advance the clinical development of bavituximab in breast cancer. Final data from a Phase I investigator-sponsored trial (IST) that evaluated bavituximab in combination with paclitaxel in 13 patients with HER2-negative metastatic breast cancer are anticipated to be published in a manuscript in the near future.
Exploring Additional Bavituximab Indications through Investigator-Sponsored Trials (IST):
A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer) has completed enrollment of the Phase II portion and data from this trial are expected to be presented at an upcoming conference.
"The Phase II portion of this trial has completed enrollment with a number of patients currently on treatment, the longest of whom has been on treatment for 18 months," said
A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC has completed enrollment with interim data accepted for presentation at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology to be held
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 is open for patient enrollment.
A Phase Ib IST evaluating bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®) in up to 24 patients with advanced melanoma is open for patient enrollment.
BAVITUXIMAB IMMUNO-ONCOLOGY DEVELOPMENT PROGRAM
This program continues to explore the potential of combining bavituximab with other immunotherapies, experimental immuno-oncology drugs including checkpoint inhibitors, as well as vaccines. Recently, data presented at ImVacS, The Annual Immunotherapies and Vaccine Summit shows that the combination of a PS-targeting antibody equivalent to bavituximab administered with an anti-PD-1 antibody displays statistically significant tumor growth suppression while also demonstrating a significant increase in tumor-fighting T-cells into the tumor microenvironment compared to anti-PD-1 antibody treatment alone in an immune competent animal model of breast cancer.
Data from the company's immuno-oncology program, as well as clinical translational data aimed at assessing and measuring changes in immune response pre- and post-treatment from the liver cancer IST will be the subject of presentations at the 29th Annual Meeting of the
PS-TARGETING MOLECULAR IMAGING PROGRAM
The company is exploring the potential of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. This is an open-label, single-center trial with a primary goal of estimating radiation dosimetry in critical and non-critical organs and secondary objectives of tumor imaging and safety.
AVID BIOSERVICES
"Avid Bioservices started the fiscal year on a strong note generating
FINANCIAL RESULTS
Total revenues for the first quarter of FY 2015 were
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the first quarter FY 2015 were
Total costs and expenses in the first quarter of FY 2015 were
Peregrine's consolidated net loss attributable to common stockholders was
Peregrine reported
More detailed financial information and analysis may be found in Peregrine's Quarterly 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
Yervoy is a registered trademark of Bristol-Meyers Squibb.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||
THREE MONTHS ENDED | ||||||||||
Unaudited | Unaudited | |||||||||
REVENUES: | ||||||||||
Contract manufacturing revenue | $ | 5,496,000 | $ | 4,581,000 | ||||||
License revenue | - | 107,000 | ||||||||
Total revenues | 5,496,000 | 4,688,000 | ||||||||
COSTS AND EXPENSES: | ||||||||||
Cost of contract manufacturing | 3,583,000 | 2,670,000 | ||||||||
Research and development | 10,201,000 | 5,304,000 | ||||||||
Selling, general and administrative | 4,883,000 | 4,334,000 | ||||||||
Total costs and expenses | 18,667,000 | 12,308,000 | ||||||||
LOSS FROM OPERATIONS | (13,171,000 | ) | (7,620,000 | ) | ||||||
OTHER INCOME (EXPENSE): | ||||||||||
Interest and other income | 42,000 | 21,000 | ||||||||
Interest and other expense | - | (1,000 | ) | |||||||
NET LOSS | $ | (13,129,000 | ) | $ | (7,600,000 | ) | ||||
COMPREHENSIVE LOSS | $ | (13,129,000 | ) | $ | (7,600,000 | ) | ||||
Series E preferred stock accumulated dividends | (1,028,000 | ) | - | |||||||
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (14,157,000 | ) | $ | (7,600,000 | ) | ||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING | ||||||||||
Basic and diluted | 179,118,255 | 149,393,630 | ||||||||
BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.08 | ) | $ | (0.05 | ) | ||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
2014 |
2014 |
||||||||
Unaudited | |||||||||
ASSETS | |||||||||
CURRENT ASSETS: | |||||||||
Cash and cash equivalents | $ | 73,256,000 | $ | 77,490,000 | |||||
Trade and other receivables, net | 1,391,000 | 1,332,000 | |||||||
Inventories | 5,998,000 | 5,530,000 | |||||||
Prepaid expenses and other current assets, net | 883,000 | 1,419,000 | |||||||
Total current assets | 81,528,000 | 85,771,000 | |||||||
Property and equipment, net | 3,647,000 | 2,447,000 | |||||||
Other assets | 2,432,000 | 2,327,000 | |||||||
TOTAL ASSETS | $ | 87,607,000 | $ | 90,545,000 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
CURRENT LIABILITIES: | |||||||||
Accounts payable | $ | 5,080,000 | $ | 2,434,000 | |||||
Accrued clinical trial and related fees | 1,887,000 | 4,433,000 | |||||||
Accrued payroll and related costs | 2,654,000 | 3,837,000 | |||||||
Deferred revenue, current portion | 4,670,000 | 5,241,000 | |||||||
Customer deposits | 6,226,000 | 5,760,000 | |||||||
Other current liabilities | 606,000 | 502,000 | |||||||
Total current liabilities | 21,123,000 | 22,207,000 | |||||||
Deferred revenue, less current portion | - | 292,000 | |||||||
Other long-term liabilities | 892,000 | 347,000 | |||||||
Commitments and contingencies | |||||||||
STOCKHOLDERS' EQUITY: | |||||||||
Preferred stock-$0.001 par value; authorized 5,000,000 shares; issued and outstanding 1,175,000 and 775,000, respectively | 1,000 |
1,000 |
|||||||
Common stock-$0.001 par value; authorized 325,000,000 shares; issued and outstanding - 179,216,032 and 178,871,164, respectively | 179,000 |
179,000 |
|||||||
Additional paid-in capital | 481,807,000 | 470,785,000 | |||||||
Accumulated deficit | (416,395,000 | ) | (403,266,000 | ) | |||||
Total stockholders' equity | 65,592,000 | 67,699,000 | |||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 87,607,000 | $ | 90,545,000 | |||||
Contact:
(800) 987-8256
info@peregrineinc.com
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