Peregrine Pharmaceuticals Provides Corporate Update Highlighting Latest Developments for Contract Manufacturing and Drug Deve...
02 June 2016 - 10:05PM
- Contract Manufacturing Revenue Hits All-Time
High of $44 Million for Fiscal Year Ended April 2016; Fiscal Year
2017 Contract Manufacturing Revenue Projected Between $50-55
Million; Continued Growth Expected to Lead to Future Sustainable
Profitability in 24 Months -
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
company focused on continued revenue growth from its contract
manufacturing business and developing its novel immuno-oncology
products, today provided a corporate update highlighting the
company’s operational strategies and latest developments. The
company’s contract manufacturing subsidiary, Avid Bioservices,
continues to experience significant organic growth, generating $44
million in revenue for fiscal year (FY) 2016 compared to $26.7
million in contract manufacturing revenue in FY 2015. Peregrine
expects to continue to have double digit contract manufacturing
revenue growth, and for FY 2017, the company is providing revenue
guidance of $50-55 million for Avid, due in part to the revenue
backlog of $56 million under committed contracts from existing
clients. Peregrine expects this trend, driven by increasing client
demand and several ongoing expansion initiatives, to lead to future
sustainable profitability for the company in 24 months.
“The past several months have been a busy and
productive time at Peregrine as we work to optimally position the
company for future success with both our contract manufacturing and
drug development businesses. We are very pleased that Avid
exceeded its revenue projections for fiscal year 2016 and excited
for what we expect will be continued growth for that business,”
said Steven W. King, president and chief executive officer of
Peregrine. “At the same time, we continue to work to advance
our phosphatidylserine (PS)-targeting platform. In order to
move toward overall profitability while continuing to generate
valuable clinical data, we will focus our future development
efforts on small, early stage clinical trials evaluating
combinations of bavituximab and immuno-oncology (I-O) agents.
This strategy will be supported through our current and future
collaborations, which we believe will efficiently generate the
clinical data required to identify and pursue the most valuable
opportunities for bavituximab.”
Contracting Manufacturing Highlights:
- Avid Bioservices exceeded its full FY 2016 revenue target of
$40 million, generating $44 million in contract manufacturing
revenue.
- The company today announced full FY 2017 revenue guidance for
Avid Bioservices of $50-55 million.
- Avid currently has a revenue backlog of $56 million under
committed contracts from existing clients.
- The recently commissioned second manufacturing facility has
completed its initial process validation runs and is ramping up to
conduct multiple new process validation runs for three current
clients. Process validation is a critical element in
preparing a facility to launch commercial manufacturing
activities. As such, this milestone moves Peregrine a key
step closer to realizing revenue from commercial production from
this new manufacturing suite.
- Based on significant client demand, Peregrine is in the process
of designing a third manufacturing facility focused on clinical
manufacturing. This suite will significantly increase the
company’s manufacturing capacity, with the potential to generate up
to $30 million in additional revenue annually. The company
has secured a 25,000 square foot location in close proximity to its
current campus and expects the new clinical suite to be complete
and ready for clinical manufacturing activities by the first half
of calendar 2017.
- In continued efforts to evolve into a fully integrated
manufacturing business capable of efficiently meeting all of its
clients’ needs, Peregrine is in the process of exploring additional
service expansion opportunities.
Drug Development Highlights:
- The company will pursue a clinical development strategy focused
on conducting small, early stage studies of bavituximab in
combination with I-O agents. These trials may be conducted as
part of ongoing collaborations with AstraZeneca and the National
Comprehensive Cancer Network (NCCN). The goal of these trials
will be to generate compelling data capable of driving partnering
interest. As part of this new strategy, the company has
discontinued plans to initiate further Phase II and Phase III
trials.
- The company continues to evaluate data from the SUNRISE trial
in order to collect information that can best inform the ongoing
clinical development of bavituximab. As part of these
efforts, Peregrine is working closely with AstraZeneca to identify
the optimal strategy for the companies’ clinical development
collaboration focused on combining bavituximab with AstraZeneca’s
PD-L1 inhibitor, durvalumab. It is expected that the initial
trial in the collaboration will be a Phase I study evaluating the
treatment combination in a range of solid tumors. The
expected timing of initiation of any trial will be determined by
the continued collection of data from the SUNRISE trial and
finalization of the trial design.
- Peregrine’s research collaboration with the NCCN, a
not-for-profit alliance of 27 of the world’s leading cancer
centers, is underway. The NCCN is currently accepting
proposals from its member institutions and their affiliate
community hospitals to conduct clinical trials combining
bavituximab with I-O agents for the treatment of a range of
cancers. It is expected that between two and five different
clinical studies will be conducted as part of this collaboration,
potentially providing Peregrine with a wealth of valuable human
data to steer future development of bavituximab. While
specific timing has not been established, it is expected that the
first studies will be initiated in late calendar year 2016 or early
2017.
- Peregrine’s ongoing preclinical research collaboration with
Memorial Sloan Kettering Cancer Center (MSKCC) continues to
progress as planned. Researchers at MSKCC are evaluating novel
combinations of bavituximab and other relevant I-O therapeutic
approaches including checkpoint inhibitors, adoptive T-cell therapy
and oncogenic virus, in multiple preclinical cancer models.
Initial data from these studies is expected to be presented at
scientific conferences later in calendar year 2016.
Financial Strength Supporting Ongoing
Activities
- Peregrine remains in a strong financial position to continue to
execute against its operational strategies for its contract
manufacturing and drug developments businesses. As of April
30, 2016, the company had $61 million in cash and cash
equivalents.
About Bavituximab: A Targeted
Investigational ImmunotherapyBavituximab is an
investigational chimeric monoclonal antibody that targets
phosphatidylserine (PS). Signals from PS inhibit the ability of
immune cells to recognize and fight tumors. Bavituximab is believed
to override PS mediated immunosuppressive signaling by blocking the
engagement of PS with its receptors as well as by sending an
alternate immune activating signal. PS targeting antibodies
have been shown to shift the functions of immune cells in tumors,
resulting in multiple signs of immune activation and anti-tumor
immune responses.
About Peregrine Pharmaceuticals,
Inc.Peregrine Pharmaceuticals, Inc. is a company focused
on continued revenue growth from its contract manufacturing
business and developing its novel immuno-oncology products.
The company is working to evaluate its lead immunotherapy
candidate, bavituximab, in combination with a range of novel
immuno-oncology (I-O) agents for the treatment of various
cancers. Peregrine’s in-house cGMP manufacturing 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. For more information, please visit
www.peregrineinc.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 data
from future immuno-oncology trials are not consistent with the
company’s translational and preclinical data, the risk that one or
more of the company’s immuno-oncology collaborators
terminates its collaboration, the risk that the results from the
company’s contemplated immuno-oncology trials does not support
further development of bavituximab, the submission of a Biologics
License Application or drive partnership interest, 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 ongoing profitability in 24 months, the
risk that Avid may experience technical difficulties in processing
customer orders which could delay delivery of products to customers
and receipt of payment, and the risk that one or more existing Avid
customers terminates its contract prior to completion. 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, 2015 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.
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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