Peregrine Pharmaceuticals Reports Financial Results for Second Quarter of Fiscal Year 2016 and Recent Developments
--Peregrine and AstraZeneca Expand Immuno-Oncology Collaboration and Plan Phase II NSCLC Trial--
--Phase III SUNRISE Clinical Trial Expected to Complete Enrollment in Coming Weeks While New Clinical Trials Are Being Initiated--
--Peregrine Closes
--Biomanufacturing Business, Avid Bioservices, Posts Strong Quarter With a 52% Increase in Revenue --
--New State-of-the-Art Production Facility Ready for Initial Phase of GMP Manufacturing--
Highlights Since
"I am pleased to report that we are nearing completion of enrollment for our Phase III SUNRISE trial with over 90% of the intended number of patients enrolled. We have also made substantial progress toward initiating several new trials including a Phase II/III breast cancer study and a Phase II NSCLC trial in combination with AstraZeneca's anti-PD-L1 antibody, durvalumab," said
"As treatment paradigms shift to incorporate new drugs, it is clear that both chemotherapy and immuno-oncology agents will continue to be critical to patient care. Taken together, we believe our SUNRISE trial, as well as the newly planned breast and lung cancer trials will allow us to maximize the potential of bavituximab in both settings," said
Clinical Development Highlights
- As of today, more than 90% of the planned number of patients have been enrolled in the Phase III SUNRISE trial, representing a sufficient number of patients required to trigger the two pre-planned interim analyses as well as the final analysis for trial unblinding. The company expects to reach the trial's estimated enrollment of 582 patients in the coming weeks.
- Peregrine and AstraZeneca
expanded their cancer immunotherapy clinical trial collaboration to evaluate bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The companies are currently planning a global Phase II study in patients with previously treated squamous or non-squamous NSCLC, as well as a Phase I/Ib trial that will evaluate the safety and efficacy of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors. The company expects the Phase II study to be initiated in early 2016 with the Phase I/Ib study beginning later in 2016.
- Peregrine continues to finalize plans for its Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is on track to be initiated by the end of calendar year 2015.
Supportive Research Highlights
- Positive results were presented at the 2015 annual meeting of the
Society for Immunotherapy of Cancer (SITC) from multiple new preclinical studies demonstrating enhanced anti-tumor activity and immune activation for combinations of a preclinical bavituximab equivalent and checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 in preclinical models of breast cancer and melanoma. Additionally, the company announced preliminary results for a new clinical test specifically designed to illustrate how bavituximab modulates immune responses in the tumor microenvironment.
- New data presented at the
International Association for the Study of Lung Cancer's (IASLC's)World Conference on Lung Cancer (WCLC) from a translational study of bavituximab demonstrated the ability of bavituximab, alone or in combination with docetaxel, to induce signs of immune activation in non-small cell lung cancer (NSCLC) patient-derived tumor samples, particularly when there was negative PD-L1 expression in the tumor sample. These data further support the potential mechanistic synergies for bavituximab with chemotherapy and checkpoint inhibitors targeting the PD-1/PD-L1 pathway.
- Summary data presented at the Combination Immunotherapy Strategies session at the 10th Annual Immunotherapy and Vaccine Summit (ImVacS), highlighted key findings from several recent bavituximab-focused studies including: the potential of bavituximab to shift the tumor microenvironment from immuno-suppressive in which tumors evade immune detection to a state of immune activation in which the immune system recognizes and fights the tumor; bavituximab's potential to increase the number of activated CD8+ cells in the tumor, which stimulates PD-1 expression, potentially increasing the number of patients able to respond to PD-1 and PD-L1 targeting immunotherapies; and, results from several clinical and preclinical studies in a range of tumor types showing that bavituximab and bavituximab-like antibodies, in combination with conventional therapy, have consistently demonstrated Kaplan-Meier graphs that follow the classic immunotherapy survival plateau.
Corporate Highlights
- Peregrine closed a registered direct offering to a single institutional investor raising
$20 million dollars . The funds raised from this financing will support the ongoing Phase III SUNRISE trial, and newly planned later-stage company-sponsored trials in breast cancer and NSCLC.
Avid Bioservices Highlights
"Our contract manufacturing business continues to strengthen with a 52% current quarter increase in revenue compared to the prior year period and year-to-date growth of 61%," stated
- During the second quarter of FY 2016, Avid Bioservices achieved record-breaking revenues generating
approximately
$9.5 million dollars , a 52% increase in revenue compared to the same quarter in the prior year.
- Avid's new manufacturing facility is now ready for the initial phase of GMP manufacturing. The state-of-the-art facility will accommodate single use bioreactors (SUBs) at up to 2,000 liter scale. Upcoming production runs will support late stage clinical development as well as process validation activities in anticipation of bavituximab and other client commercial product needs. The facility has the capacity to potentially generate approximately
$40 million in new revenue annually.
- Contract manufacturing committed backlog reached
$49 million from existing customers covering services to be completed in FY 2016 and into FY 2017.
Financial Results
Total revenues for the second quarter of FY 2016 were
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the second quarter FY 2016 were
Total costs and expenses in the second quarter of FY 2016 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
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 (UNAUDITED) | |||||||||||||||
| (UNAUDITED) | |||||||||||||||
| THREE MONTHS ENDED | SIX MONTHS ENDED | ||||||||||||||
| 2015 | 2014 | 2015 | 2014 | ||||||||||||
| REVENUES: | |||||||||||||||
| Contract manufacturing revenue | $ | 9,523,000 | $ | 6,263,000 | $ | 18,902,000 | $ | 11,759,000 | |||||||
| License revenue | - | 37,000 | 292,000 | 37,000 | |||||||||||
| Total revenues | 9,523,000 | 6,300,000 | 19,194,000 | 11,796,000 | |||||||||||
| COSTS AND EXPENSES: | |||||||||||||||
| Cost of contract manufacturing | 4,741,000 | 4,139,000 | 9,349,000 | 7,722,000 | |||||||||||
| Research and development | 14,190,000 | 10,003,000 | 28,108,000 | 20,204,000 | |||||||||||
| Selling, general and administrative | 4,416,000 | 4,295,000 | 9,315,000 | 9,178,000 | |||||||||||
| Total costs and expenses | 23,347,000 | 18,437,000 | 46,772,000 | 37,104,000 | |||||||||||
| LOSS FROM OPERATIONS | (13,824,000 | ) | (12,137,000 | ) | (27,578,000 | ) | (25,308,000 | ) | |||||||
| Interest and other income | 626,000 | 37,000 | 657,000 | 79,000 | |||||||||||
| NET LOSS | $ | (13,198,000 | ) | $ | (12,100,000 | ) | $ | (26,921,000 | ) | $ | (25,229,000 | ) | |||
| COMPREHENSIVE LOSS | $ | (13,198,000 | ) | $ | (12,100,000 | ) | $ | (26,921,000 | ) | $ | (25,229,000 | ) | |||
| Series E preferred stock accumulated dividends | (1,380,000 | ) | (1,031,000 | ) | (2,413,000 | ) | (1,802,000 | ) | |||||||
| Net loss attributable to common stockholders | $ | (14,578,000 | ) | $ | (13,131,000 | ) | $ | (29,334,000 | ) | $ | (27,031,000 | ) | |||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | |||||||||||||||
| Basic and Diluted | 203,942,411 | 179,962,275 | 200,629,892 | 179,540,265 | |||||||||||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.07 | ) | $ | (0. 07 | ) | $ | (0.15 | ) | $ | (0.15 | ) | |||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
2015 | 2015 | ||||||
| Unaudited | |||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 72,005,000 | $ | 68,001,000 | |||
| Trade and other receivables, net | 2,904,000 | 3,813,000 | |||||
| Inventories | 12,554,000 | 7,354,000 | |||||
| Prepaid expenses and other current assets, net | 1,995,000 | 1,355,000 | |||||
| Total current assets | 89,458,000 | 80,523,000 | |||||
| Property and equipment, net | 21,764,000 | 15,124,000 | |||||
| Other assets | 1,435,000 | 1,817,000 | |||||
| TOTAL ASSETS | $ | 112,657,000 | $ | 97,464,000 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 6,901,000 | $ | 10,385,000 | |||
| Accrued clinical trial and related fees | 6,138,000 | 3,910,000 | |||||
| Accrued payroll and related costs | 4,130,000 | 4,606,000 | |||||
| Deferred revenue | 9,688,000 | 6,630,000 | |||||
| Customer deposits | 14,935,000 | 11,363,000 | |||||
| Other current liabilities | 667,000 | 437,000 | |||||
| Total current liabilities | 42,459,000 | 37,331,000 | |||||
| Deferred rent, less current portion | 972,000 | 1,098,000 | |||||
| Commitments and contingencies | |||||||
| STOCKHOLDERS' EQUITY: | |||||||
| Preferred stock - | 2,000 | 2,000 | |||||
| Common stock - | 226,000 | 193,000 | |||||
| Additional paid-in capital | 549,543,000 | 512,464,000 | |||||
| Accumulated deficit | (480,545,000 | ) | (453,624,000 | ) | |||
| Total stockholders' equity | 69,226,000 | 59,035,000 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 112,657,000 | $ | 97,464,000 | |||
Contacts:Jay Carlson Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.comStephanie Diaz (Investors)Vida Strategic Partners 415-675-7401 sdiaz@vidasp.comTim Brons (Media)Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
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