Peregrine Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2013 Financial Results and Recent Developments
"The combination of preclinical data supporting bavituximab's immunotherapeutic mechanism of action presented at AACR, compelling second-line NSCLC data presented at ASCO and reaching the recent agreement with the
Data from a series of preclinical studies exploring the mechanism of action for phosphatidylserine (PS)-targeting antibodies, such as bavituximab, were presented at the Annual Meeting of the
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
- Reached agreement with the
U.S. Food and Drug Administration (FDA) on a Phase III registration trial design of bavituximab in second-line non-small cell lung cancer (NSCLC). - Recently announced final results from its 121 patient Phase IIb randomized, double-blind, placebo-controlled trial of bavituximab in second-line NSCLC at the 2013
American Society of Clinical Oncology (ASCO) Annual Meeting.- Promising 60% improvement in median overall survival (OS) in the 3mg/kg bavituximab plus docetaxel arm compared to the control arm and bavituximab was well-tolerated with no significant differences in adverse events between the trial arms.
- Subgroup analyses of OS by key patient characteristics including age, gender, ECOG status, ethnicity and prior treatment favored the bavituximab 3 mg/kg arm.
- Planning for the initiation of a pivotal Phase III trial by calendar year-end.
Other Oncology Indications:
The company is exploring the potential of bavituximab through a number of other company-sponsored and investigator-sponsored trials (IST) including:
- A Phase II randomized, open-label, clinical trial evaluating bavituximab plus gemcitabine in 70 patients with previously untreated, advanced Stage IV pancreatic cancer. Data presented at the 2013 ASCO Annual Meeting showed a more than a doubling of overall response rate (ORR) in the bavituximab-containing arm, a positive safety profile and a modest improvement in median OS. As enrollment included patients with poor prognosis including advanced metastatic disease with significant liver involvement and poor performance status associated with rapid disease progression, a subgroup analysis was conducted. Results from this subgroup analysis showed that the effect of bavituximab plus gemcitabine was more pronounced in patients with ECOG ≤ 1 and those without hepatic metastases. While the final data combined with the results from subgroup analyses warrant future
consideration, given the fast progression of pancreatic cancer and the need for longer treatment periods associated with immunotherapies such as bavituximab, there are no plans to initiate a follow-on trial in pancreatic cancer at this time.
- A Phase II randomized, open-label clinical trial evaluating bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel (C/P) alone in up to 86 patients with previously untreated Stage IIIb or Stage IV NSCLC. Data recently announced, with less than 60% of survival events reached, that while the bavituximab-containing treatment arm demonstrated a median OS of over 14 months, there was not a meaningful enough difference in survival between the two arms of the trial to support another study using this combination and timing of therapy. An independent study with another immunotherapy agent showed that when C/P are given together with an immunotherapy, as was done in this bavituximab trial, the results were similar to the control arm however when C/P are administered in advance of the immunotherapy much more favorable results are achieved. We are currently evaluating
options for moving bavituximab forward in front-line NSCLC. Full results from this trial will be presented at a future scientific meeting or through publication.
- A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer. Interim data on 13 evaluable patients were presented at the 2013 ASCO Annual Meeting showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria. All patients have been enrolled in this trial.
- 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.
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. Recently, data were presented from imaging studies demonstrating that the chemotherapeutic drug docetaxel, a commonly prescribed second-line treatment for patients with advanced NSCLC, increases the exposure of bavituximab's target molecule, PS, on tumor blood vessel cells and tumor cells. Results also showed that PS exposure in tumors is correlated with tumor burden and response to docetaxel treatment, supporting exposed PS as a promising biomarker of cancer and response to therapy. In the
FINANCIAL RESULTS
"This quarter capped off a record year for our wholly-owned manufacturing subsidiary, Avid Bioservices, which generated over
Total revenues for the fourth quarter of FY 2013 were
Contract manufacturing revenues from Avid's clinical and commercial biomanufacturing services provided to its third-party clients increased 44% to
Total costs and expenses in the fourth quarter of FY 2013 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-K, 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
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||||
Three Months Ended |
Twelve Months Ended |
||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Unaudited | Unaudited | ||||||||||||||||
REVENUES: | |||||||||||||||||
Contract manufacturing revenue | $ | 4,176,000 | $ | 1,987,000 | $ | 21,333,000 | $ | 14,783,000 | |||||||||
License revenue | 78,000 | 78,000 | 350,000 | 450,000 | |||||||||||||
Total revenues | 4,254,000 | 2,065,000 | 21,683,000 | 15,233,000 | |||||||||||||
COSTS AND EXPENSES: | |||||||||||||||||
Cost of contract manufacturing | 3,217,000 | 934,000 | 12,595,000 | 10,153,000 | |||||||||||||
Research and development | 5,835,000 | 8,930,000 | 24,306,000 | 35,688,000 | |||||||||||||
Selling, general and administrative | 3,665,000 | 3,091,000 | 13,134,000 | 11,462,000 | |||||||||||||
Total costs and expenses | 12,717,000 | 12,955,000 | 50,035,000 | 57,303,000 | |||||||||||||
LOSS FROM OPERATIONS | (8,463,000 | ) | (10,890,000 | ) | (28,352,000 | ) | (42,070,000 | ) | |||||||||
OTHER INCOME (EXPENSE): | |||||||||||||||||
Interest and other income | 15,000 | 10,000 | 322,000 | 41,000 | |||||||||||||
Interest and other expense | (1,000 | ) | (2,000 | ) | (54,000 | ) | (90,000 | ) | |||||||||
Loss on early extinguishment of debt | - | - | (1,696,000 | ) | - | ||||||||||||
NET LOSS | $ | (8,449,000 | ) | $ | (10,882,000 | ) | $ | (29,780,000 | ) | $ | (42,119,000 | ) | |||||
COMPREHENSIVE LOSS | $ | (8,449,000 | ) | $ | (10,882,000 | ) | $ | (29,780,000 | ) | $ | (42,119,000 | ) | |||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | |||||||||||||||||
Basic and Diluted | 137,872,343 | 99,303,678 | 120,370,333 | 83,572,761 | |||||||||||||
BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.06 | ) | $ | (0.10 | ) | $ | (0.25 | ) | $ | (0.50 | ) | |||||
CONSOLIDATED BALANCE SHEETS | |||||||||
AS OF |
|||||||||
2013 | 2012 | ||||||||
ASSETS | |||||||||
CURRENT ASSETS: | |||||||||
Cash and cash equivalents | $ | 35,204,000 | $ | 18,033,000 | |||||
Trade and other receivables, net | 1,662,000 | 2,353,000 | |||||||
Inventories | 4,339,000 | 3,611,000 | |||||||
Prepaid expenses and other current assets, net | 709,000 | 795,000 | |||||||
Total current assets | 41,914,000 | 24,792,000 | |||||||
PROPERTY: | |||||||||
Leasehold improvements | 1,383,000 | 1,383,000 | |||||||
Laboratory equipment | 5,441,000 | 4,967,000 | |||||||
Furniture, fixtures, office equipment and software | 2,627,000 | 2,287,000 | |||||||
9,451,000 | 8,637,000 | ||||||||
Less accumulated depreciation and amortization | (6,773,000 | ) | (5,737,000 | ) | |||||
Property, net | 2,678,000 | 2,900,000 | |||||||
Other assets | 466,000 | 570,000 | |||||||
TOTAL ASSETS | $ | 45,058,000 | $ | 28,262,000 | |||||
CONSOLIDATED BALANCE SHEETS | |||||||||
AS OF |
|||||||||
2013 | 2012 | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
CURRENT LIABILITIES: | |||||||||
Accounts payable | $ | 2,821,000 | $ | 3,492,000 | |||||
Accrued clinical trial and related fees | 930,000 | 2,111,000 | |||||||
Accrued payroll and related costs | 3,582,000 | 2,468,000 | |||||||
Deferred revenue, current portion | 4,171,000 | 3,651,000 | |||||||
Customer deposits | 8,059,000 | 4,865,000 | |||||||
Other current liabilities | 998,000 | 1,052,000 | |||||||
Total current liabilities | 20,561,000 | 17,639,000 | |||||||
Deferred revenue, less current portion | 292,000 | 361,000 | |||||||
Other long-term liabilities | 445,000 | 779,000 | |||||||
Commitments and contingencies | |||||||||
STOCKHOLDERS' EQUITY: | |||||||||
Preferred stock - |
- | - | |||||||
Common stock - |
143,000 | 101,000 | |||||||
Additional paid-in-capital | 391,521,000 | 347,506,000 | |||||||
Accumulated deficit | (367,904,000 | ) | (338,124,000 | ) | |||||
Total stockholders' equity | 23,760,000 | 9,483,000 | |||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 45,058,000 | $ | 28,262,000 | |||||
Contact:
(800) 987-8256
info@peregrineinc.com
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