--SUNRISE Top-line Data Accepted for
Late-Breaking Oral Presentation at European Society of Medical
Oncology Congress in October 2016 --
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company committed to improving patient lives by
manufacturing high quality products for biotechnology and
pharmaceutical companies and advancing its proprietary R&D
pipeline, today announced financial results for the first quarter
of fiscal year (FY) 2017 ended July 31, 2016, and provided an
update on its contract manufacturing business, clinical pipeline
and other corporate developments.
Highlights Since April 30,
2016"Since the start of our first quarter, we have
steadily executed on our R&D and contract manufacturing
objectives. On the R&D front, we recently achieved two
important milestones beginning with the recent announcement that
the National Comprehensive Cancer Network (NCCN) has awarded grants
to three investigators to support bavituximab clinical
research. In addition, we are pleased to announce today, that
top-line data from our Phase III SUNRISE trial have been accepted
for a late-breaking oral presentation at the upcoming meeting of
the European Society of Medical Oncology (ESMO) Congress to be held
in Copenhagen in early October,” stated Steven W. King, president
and chief executive officer of Peregrine. "The presentation
at ESMO will be a great opportunity to share clinical data from the
trial in conjunction with initial results from our ongoing
biomarker analyses which are already highly encouraging. The
primary goal of the biomarker analysis is to identify a biomarker
pattern for patients that receive the most benefit from a
bavituximab-containing therapeutic regimen and we look forward to
sharing the results of the ongoing analysis with more data expected
later in the year. Our collaboration with the NCCN has been
an important part of our plans for advancing the bavituximab
clinical program in a cost effective way. The grants that
were awarded represent clinical trials with novel bavituximab
combinations in glioblastoma, head and neck cancer, and
hepatocellular carcinoma including an immunotherapy combination,
which is a major focus for advancing the program. Taken together,
these developments are setting the stage for new data throughout
the rest of 2016 and into 2017.”
Mr. King continued, "On the manufacturing front,
it remains an extraordinarily busy time. Based on the high demand
for services, we remain on track to meet our current fiscal year
revenue projections as we look to continue growing the
business. Our ultimate goal remains to reach overall
profitability within the next 21 months and Avid will be an
important driver for achieving that goal in combination with making
strategic investments in R&D while pursuing partnerships to
help advance our programs.”
Avid Bioservices Highlights"Our
biomanufacturing business was extremely busy this past quarter as
the team remained on track according to the planned production
schedule including initiating several process validation runs and
ongoing commercial manufacturing activities. Despite being on
track from a production standpoint, first quarter FY 2017 revenues
were lower than expected due to a testing backlog at a third-party
testing laboratory that delayed the shipment of manufacturing
runs. As a result of the backlog being resolved, we expect
revenue to exceed $20 million in the second quarter as we shift
revenue recognition from the first quarter to the second quarter of
fiscal year 2017. We believe this delay to be an anomaly, and
we reaffirm our revenue guidance of between $50 and $55 million for
the full fiscal year,” stated Paul Lytle, chief financial officer
of Peregrine.
- The company is projecting manufacturing revenue for the full FY
2017 of $50 - $55 million.
- Avid's current manufacturing revenue backlog is $71 million,
representing estimated future manufacturing revenue to be
recognized under committed contracts. This backlog covers
revenue to be recognized during the remainder of fiscal year 2017
and into fiscal year 2018.
- In response to demand for manufacturing services, the company
is designing a third manufacturing facility dedicated to clinical
manufacturing that is anticipated to significantly increase Avid's
manufacturing capacity. The new clinical suite is expected to
be complete and ready for clinical manufacturing activities by mid
calendar year 2017.
Clinical Development
Highlights
- SUNRISE top-line data, including initial biomarker profile
data, have been accepted for oral presentation at the European
Society of Medical Oncology (ESMO) Congress in October
2016.
- Peregrine's research collaboration with NCCN is advancing as
planned, with grants awarded to three investigators to support
research of bavituximab in combination with other therapeutics for
the following studies:
- Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic
Body Radiation Therapy (SBRT) for Unresectable Hepatitis C
Associated Hepatocellular Carcinoma
- Phase I/II Clinical Trial of Bavituximab with Radiation and
Temozolomide for Patients with Newly Diagnosed
Glioblastoma
- Phase II Study of Pembrolizumab and Bavituximab for Progressive
Recurrent/Metastatic Squamous Cell Carcinoma of the Head and
Neck
The company expects these trials to begin in early calendar year
2017.
Research
Highlights
- Our internal efforts and collaboration with Memorial Sloan
Kettering Cancer Center continues to advance. The goal of
this pre-clinical work is to evaluate combinations of bavituximab
with other checkpoint inhibitors and immune stimulatory agents for
the purpose of developing new and increasingly effective
anti-cancer treatments. We expect initial results from our
internal work and this collaboration to be presented at multiple
conferences during the Fall of 2016.
- Peregrine in-licensed a novel exosome technology from UT
Southwestern that has potential for cancer detection and monitoring
applications. This technology aligns directly with the
company's expertise, its proprietary PS-targeting platform and the
bavituximab development program. As such, there are
opportunities to use this technology as both a complementary tool
in bavituximab's ongoing development, as well as more broadly as
the basis for novel cancer detection and monitoring tests that can
be the focus of partnering efforts.
Financial ResultsTotal revenues
for the first quarter of FY 2017 were $5,609,000, compared to
$9,671,000 for the same quarter of the prior fiscal year. The first
quarter FY 2017 decrease in revenues was primarily attributed to a
decrease in contract manufacturing revenue.
Contract manufacturing revenue from Avid's
clinical and commercial biomanufacturing services provided to its
third-party clients decreased to $5,609,000 for the first quarter
of FY 2017 compared to $9,379,000 for the first quarter of FY
2016. The first quarter decrease was primarily due to a
backlog at a third-party testing lab and unrelated to product
quality that shifted the timing of revenue recognition from the
first quarter to the second quarter of fiscal year 2017. The
company does not expect this delay to further impact revenue
projections for the fiscal year, and the company remains on track
to generate revenue in excess of $20 million in the second quarter
FY 2017.
Total costs and expenses for the first quarter
of FY 2017 were $16,691,000, compared to $23,425,000 for the first
quarter of FY 2016. This decrease for the first quarter of FY
2017 was primarily attributable to a decrease in research and
development expenses associated with the Phase III SUNRISE trial
combined with a decrease in personnel cost and manufacturing costs
related to preparing bavituximab for commercial manufacturing.
For the first quarter of FY 2017, research and
development expenses decreased 38% to $8,569,000, compared to
$13,918,000 for the first quarter of FY 2016. In addition,
cost of contract manufacturing decreased to $3,062,000 in the first
quarter of FY 2017 compared to $4,608,000 for the first quarter of
FY 2016, primarily due to lower reported revenue compared to the
same prior year period. For the first quarter of FY 2017,
selling, general and administrative expenses were $5,060,000
compared to $4,899,000 for the first quarter of FY 2016.
Peregrine's consolidated net loss attributable
to common stockholders was $12,437,000 or $0.05 per share, for the
first quarter of FY 2017, compared to a net loss attributable to
common stockholders of $15,101,000, or $0.08 per share, for the
same prior year quarter.
Peregrine reported $44,195,000 in cash and cash
equivalents as of July 31, 2016, compared to $61,412,000 at fiscal
year ended April 30, 2016.
More detailed financial information and analysis
may be found in Peregrine's Annual Report on Form 10-Q, which will
be filed with the Securities and Exchange Commission today.
Conference CallPeregrine will
host a conference call and webcast this afternoon, September 8,
2016, at 4:30 PM EDT (1:30 PM PDT).
To listen to the conference call, please dial
(877) 312-5443 or (253) 237-1126 and request the Peregrine
Pharmaceuticals conference call. To listen to the live webcast, or
access the archived webcast, please visit:
http://ir.peregrineinc.com/events.cfm.
About Peregrine Pharmaceuticals,
Inc.Peregrine Pharmaceuticals, Inc. is a biopharmaceutical
company committed to improving the lives of patients by delivering
high quality pharmaceutical products through its contract
development and manufacturing organization (CDMO) services and
through advancing and licensing its investigational immunotherapy
and related products. Peregrine's in-house CDMO services,
including cGMP manufacturing and development capabilities, are
provided through its wholly-owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and biomanufacturing
services for both Peregrine and third-party customers. The
company is also working to evaluate its lead immunotherapy
candidate, bavituximab, in combination with immune stimulating
therapies for the treatment of various cancers, and developing its
proprietary exosome technology for the detection and monitoring of
cancer. For more information, please visit
www.peregrineinc.com.
About Avid BioservicesAvid
Bioservices provides a comprehensive range of process development,
high quality cGMP clinical and commercial manufacturing services
for the biotechnology and biopharmaceutical industries. With over
15 years of experience producing monoclonal antibodies and
recombinant proteins in batch, fed-batch and perfusion modes,
Avid's services include cGMP clinical and commercial product
manufacturing, purification, bulk packaging, stability testing and
regulatory strategy, submission and support. The company also
provides a variety of process development activities, including
cell line development and optimization, cell culture and feed
optimization, analytical methods development and product
characterization. For more information about Avid, please visit
www.avidbio.com.
Safe Harbor Statement:
Statements in this press release which are not purely historical,
including statements regarding Peregrine Pharmaceuticals'
intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. The forward-looking statements involve risks
and uncertainties including, but not limited to, the risk that one
or more of the NCCN grant funded investigator-initiated clinical
studies may experience initiation and/or enrollment delays, the
risk that data from one or more of the NCCN grant funded
investigator-initiated clinical studies does not support the
company’s current understanding of the potential role of
bavituximab in the treatment of various cancers or is otherwise
inconclusive, the risk that the final data from the biomarker
analysis does not generate any partnership interest, the risk that
on-going analysis of SUNRISE trial data, bio-specimen samples and
patient characteristics may not identify any subgroup that received
clinical benefit from the addition of bavituximab, the risk that
the company is unable to secure patent protection or other
intellectual property protection for the biomarker analyses, the
risk that the company may not have or raise adequate financial
resources from debt and/or equity financings and/or Avid's
manufacturing operations to fund the further development of
bavituximab, the risk that Avid's revenue growth may slow or
decline, the risk that the company does not achieve profitability
in 21 months, the risk that Avid may experience technical
difficulties in processing customer orders, including delays in
third party release testing, which could delay delivery of products
to customers, revenue recognition and receipt of payment, the risk
that one or more existing Avid customers terminates its contract
prior to completion, the risk that the new clinical manufacturing
facility will not be operational in mid-2017, or generating revenue
in 2017, due to construction or other delays or causes, the risk
that the company may not develop, or may experience delays in
developing, a commercializable and/or regulatory approvable test
derived from the licensed exosome technology, the risk that the
company experiences difficulties in developing a test that is able
to distinguish between PS-positive exosomes from blood samples of
cancer patients and PS-positive exosomes from patients with other
diseases or illnesses that express PS-positive exosomes, the risk
that the company is unable to generate partnering interest in any
cancer diagnostic test that maybe developed from the licensed
exosome technology, and the risk that the company is unable to
secure patent protection or other intellectual property protection
for the cancer test based on the licensed exosome technology.
The company's actual results could differ materially from those in
any such forward-looking statements. Factors that could cause
actual results to differ materially include, but are not limited
to, uncertainties associated with completing preclinical and
clinical trials for our technologies; the early stage of product
development; the significant costs to develop our products as all
of our products are currently in development, preclinical studies
or clinical trials; obtaining additional financing to support our
operations and the development of our products; obtaining
regulatory approval for our technologies; anticipated timing of
regulatory filings and the potential success in gaining regulatory
approval and complying with governmental regulations applicable to
our business. Our business could be affected by a number of other
factors, including the risk factors listed from time to time in our
reports filed with the Securities and Exchange Commission
including, but not limited to, our annual report on Form 10-K for
the fiscal year ended April 30, 2016 as well as any updates to
these risk factors filed from time to time in the company's other
filings with the Securities and Exchange Commission. The company
cautions investors not to place undue reliance on the
forward-looking statements contained in this press release.
Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does
not undertake to update or revise any forward-looking statements in
this press release.
PEREGRINE PHARMACEUTICALS,
INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS (UNAUDITED)
|
|
THREE MONTHS ENDEDJULY
31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
REVENUES: |
|
|
|
|
Contract manufacturing
revenue |
|
$ |
5,609,000 |
|
|
$ |
9,379,000 |
|
License revenue |
|
|
— |
|
|
|
292,000 |
|
Total revenues |
|
|
5,609,000 |
|
|
|
9,671,000 |
|
|
|
|
|
|
COSTS AND
EXPENSES: |
|
|
|
|
Cost of contract
manufacturing |
|
|
3,062,000 |
|
|
|
4,608,000 |
|
Research and
development |
|
|
8,569,000 |
|
|
|
13,918,000 |
|
Selling, general and
administrative |
|
|
5,060,000 |
|
|
|
4,899,000 |
|
Total costs and
expenses |
|
|
16,691,000 |
|
|
|
23,425,000 |
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
|
(11,082,000 |
) |
|
|
(13,754,000 |
) |
|
|
|
|
|
Interest and other
income |
|
|
25,000 |
|
|
|
31,000 |
|
|
|
|
|
|
NET
LOSS |
|
$ |
(11,057,000 |
) |
|
$ |
(13,723,000 |
) |
|
|
|
|
|
Comprehensive
loss |
|
$ |
(11,057,000 |
) |
|
$ |
(13,723,000 |
) |
|
|
|
|
|
Series E preferred stock
accumulated dividends |
|
|
(1,380,000 |
) |
|
|
(1,378,000 |
) |
|
|
|
|
|
NET LOSS
ATTRIBUTABLE TO COMMON STOCKHOLDERS |
|
$ |
(12,437,000 |
) |
|
$ |
(15,101,000 |
) |
|
|
|
|
|
WEIGHTED AVERAGE
COMMON SHARES OUTSTANDING |
|
|
|
|
Basic and diluted |
|
|
239,595,089 |
|
|
|
197,317,374 |
|
|
|
|
|
|
BASIC AND DILUTED
LOSS PER COMMON SHARE |
|
$ |
(0.05 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
PEREGRINE PHARMACEUTICALS,
INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|
JULY 31,2016 |
|
APRIL 30,2016 |
|
Unaudited |
|
|
ASSETS |
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash
equivalents |
$ |
44,195,000 |
|
|
$ |
61,412,000 |
|
Trade and other
receivables |
|
7,537,000 |
|
|
|
2,859,000 |
|
Inventories |
|
25,274,000 |
|
|
|
16,186,000 |
|
Prepaid expenses and other
current assets |
|
1,235,000 |
|
|
|
1,351,000 |
|
Total current assets |
|
78,241,000 |
|
|
|
81,808,000 |
|
Property and equipment,
net |
|
24,261,000 |
|
|
|
24,302,000 |
|
Restricted cash |
|
600,000 |
|
|
|
600,000 |
|
Other assets |
|
2,502,000 |
|
|
|
2,333,000 |
|
TOTAL ASSETS |
$ |
105,604,000 |
|
|
$ |
109,043,000 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable |
$ |
9,095,000 |
|
|
$ |
8,429,000 |
|
Accrued clinical trial and
related fees |
|
6,577,000 |
|
|
|
7,594,000 |
|
Accrued payroll and
related costs |
|
3,653,000 |
|
|
|
5,821,000 |
|
Deferred revenue |
|
21,531,000 |
|
|
|
10,030,000 |
|
Customer deposits |
|
21,731,000 |
|
|
|
24,212,000 |
|
Other current
liabilities |
|
669,000 |
|
|
|
1,488,000 |
|
Total current liabilities |
|
63,256,000 |
|
|
|
57,574,000 |
|
|
|
|
|
Deferred rent, less
current portion |
|
1,414,000 |
|
|
|
1,395,000 |
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY: |
|
|
|
Preferred stock - $0.001
par value; authorized 5,000,000 shares; 1,577,440 and 1,577,440
issued and outstanding at July 31, 2016 and April 30, 2016,
respectively |
|
2,000 |
|
|
|
2,000 |
|
Common stock - $0.001 par
value; authorized 500,000,000 shares; 241,456,721 and 236,930,485
issued and outstanding at July 31, 2016 and April 30, 2016,
respectively |
|
241,000 |
|
|
|
237,000 |
|
Additional paid-in
capital |
|
561,024,000 |
|
|
|
559,111,000 |
|
Accumulated deficit |
|
(520,333,000 |
) |
|
|
(509,276,000 |
) |
Total stockholders’ equity |
|
40,934,000 |
|
|
|
50,074,000 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY |
$ |
105,604,000 |
|
|
$ |
109,043,000 |
|
Contacts:
Jay Carlson
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
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