Peregrine Pharmaceuticals Reports Financial Results for First Quarter of Fiscal Year 2016 and Recent Developments
--Peregrine and AstraZeneca to Collaborate on Immuno-Oncology Combination Clinical Trial--
--Phase III SUNRISE Clinical Trial on Track to Complete Patient Enrollment by Calendar Year-End 2015--
--Avid Bioservices Reports
Highlights Since
"Over the years, Peregrine's foundational science and positive clinical results have consistently pointed to bavituximab's potential as a high-value, next-generation anti-cancer agent," said
Clinical Development Highlights
- Peregrine and AstraZeneca entered into a cancer immunotherapy clinical trial collaboration to evaluate bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid
tumors. Peregrine is working closely with AstraZeneca to finalize the trial design.
- Phase III SUNRISE clinical trial in non-small cell lung cancer (NSCLC) continues to enroll patients and remains on track to complete patient enrollment by end of calendar year 2015.
- Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II trial to evaluate the combination of bavituximab and Opdivo® (nivolumab), an anti-PD-1 antibody, in previously treated, metastatic NSCLC. This trial is expected to be initiated by the end of calendar year 2015.
- Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is expected to be
initiated by the end of calendar year 2015.
Supportive Research Highlights
- Peregrine and
Memorial Sloan Kettering Cancer Center entered into a research agreement to explore the potential of Peregrine's proprietary PS-targeting antibody platform. The goal of the research is to identify effective treatments combining bavituximab with other checkpoint inhibitors or immune stimulating agents. - 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 estimated survival curves that plateau.
- Data from preclinical studies presented at the 2015 ASCO annual meeting demonstrated the ability of the company's PS-targeting antibodies to significantly increase the prevalence of tumor infiltrating CD8+ T-cells and immune-activating cytokines, while decreasing tumor-promoting macrophages and myeloid cells. These findings highlight the ability of the antibodies to enhance the anti-tumor effects of both chemotherapy and immune checkpoint inhibitors.
Avid Bioservices Highlights
- Avid's new manufacturing
suite is fully constructed and the first internal pilot run is currently underway to verify all systems and equipment are properly functioning. Company plans to announce the launch of the new facility in the near term, allowing us to meet our internal manufacturing timelines as well as those of our third-party clients.
- Contract manufacturing committed backlog reached
$42 million from existing customers covering services to be completed in FY 2016 and into FY 2017.
Corporate Highlights
- The European Patent Office (EPO) granted Patent Number 2,269,656, licensed to Peregrine titled "Selected Antibodies Binding to Aminophospholipids and their Use in Treatment, Such as Cancer." The patent covers bavituximab as a composition of matter and for use in therapy, such as for treating cancer including in combination with radiotherapy or chemotherapy, e.g., with docetaxel. This important patent expands upon the company's intellectual property portfolio, which now numbers more than 140 worldwide issued patents and pending applications for the bavituximab oncology program.
Financial Results
Total revenues for the first quarter of FY 2016 were
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the first quarter FY 2016 were
Total costs and expenses in the first 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 | ||||||||
| THREE MONTHS ENDED | ||||||||
| Unaudited | Unaudited | |||||||
| REVENUES: | ||||||||
| Contract manufacturing revenue | $ | 9,379,000 | $ | 5,496,000 | ||||
| License revenue | 292,000 | - | ||||||
| Total revenues | 9,671,000 | 5,496,000 | ||||||
| COSTS AND EXPENSES: | ||||||||
| Cost of contract manufacturing | 4,608,000 | 3,583,000 | ||||||
| Research and development | 13,918,000 | 10,201,000 | ||||||
| Selling, general and administrative | 4,899,000 | 4,883,000 | ||||||
| Total costs and expenses | 23,425,000 | 18,667,000 | ||||||
| LOSS FROM OPERATIONS | (13,754,000 | ) | (13,171,000 | ) | ||||
| Interest and other income | 31,000 | 42,000 | ||||||
| NET LOSS | $ | (13,723,000 | ) | $ | (13,129,000 | ) | ||
| COMPREHENSIVE LOSS | $ | (13,723,000 | ) | $ | (13,129,000 | ) | ||
| Series E preferred stock accumulated dividends | (1,378,000 | ) | (1,028,000 | ) | ||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (15,101,000 | ) | $ | (14,157,000 | ) | ||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING | ||||||||
| Basic and diluted | 197,317,374 | 179,118,255 | ||||||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.08 | ) | $ | (0.08 | ) | ||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
2015 |
2015 | ||||||
| Unaudited | |||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 59,016,000 | $ | 68,001,000 | |||
| Trade and other receivables, net | 1,805,000 | 3,813,000 | |||||
| Inventories | 10,457,000 | 7,354,000 | |||||
| Prepaid expenses and other current assets, net | 1,052,000 | 1,355,000 | |||||
| Total current assets | 72,330,000 | 80,523,000 | |||||
| Property and equipment, net | 18,395,000 | 15,124,000 | |||||
| Other assets | 1,307,000 | 1,817,000 | |||||
| TOTAL ASSETS | $ | 92,032,000 | $ | 97,464,000 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 9,840,000 | $ | 10,385,000 | |||
| Accrued clinical trial and related fees | 4,106,000 | 3,910,000 | |||||
| Accrued payroll and related costs | 3,094,000 | 4,606,000 | |||||
| Deferred revenue | 8,291,000 | 6,630,000 | |||||
| Customer deposits | 9,599,000 | 11,363,000 | |||||
| Other current liabilities | 620,000 | 437,000 | |||||
| Total current liabilities | 35,550,000 | 37,331,000 | |||||
| Deferred rent, less current portion | 1,036,000 | 1,098,000 | |||||
| Commitments and contingencies | |||||||
| STOCKHOLDERS' EQUITY: | |||||||
| Preferred stock - | 2,000 | 2,000 | |||||
| Common stock-$0.001 par value; authorized 325,000,000 shares; issued and outstanding - 200,983,948 and 193,346,627, respectively | 201,000 | 193,000 | |||||
| Additional paid-in capital | 522,590,000 | 512,464,000 | |||||
| Accumulated deficit | (467,347,000 | ) | (453,624,000 | ) | |||
| Total stockholders' equity | 55,446,000 | 59,035,000 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 92,032,000 | $ | 97,464,000 | |||
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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