--Company Focused on Advancing Its Bavituximab
Immuno-Oncology Program Through Its Pharmaceutical, Academic and
Clinical Collaborations--
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company focused on developing therapeutics to
stimulate the body's immune system to fight cancer, today announced
financial results for the third quarter of fiscal year (FY) 2016
ended January 31, 2016, and provided an update on its advancing
clinical pipeline and other corporate developments.
Highlights Since October 31, 2015
“Earlier this week, we announced the
commissioning of our new commercial biomanufacturing facility,
which gives us significant revenue growth potential over the short
term. This represented a key corporate milestone and we are
continuing to evaluate a number of additional opportunities to
further expand this important, revenue-generating business,” stated
Steven W. King, president and chief executive officer of
Peregrine. “On the drug development side, we unfortunately
experienced a recent setback with the early discontinuation of our
SUNRISE Phase III study evaluating the combination of bavituximab
and chemotherapy. While we continue to collect patient
follow-up data in the SUNRISE study and work to better understand
the final trial outcome, we have made the decision to put a hold on
our other chemotherapy combination trials so that we can make an
informed decision on how to potentially proceed.”
Mr. King continued, “In the meantime, we remain
enthusiastic about the potential of combining bavituximab with
other immuno-oncology (“I-O”) agents based on a significant amount
of translational and preclinical data demonstrating that
bavituximab has the potential to enhance the activity of checkpoint
inhibitors. These I-O combinations are based on completely
different mechanistic synergies than the chemotherapy combinations
and the interest in pursuing this development pathway remains
high. We are in the process of engaging all of our
collaborators to formulate a comprehensive clinical strategy for
exploring the potential of bavituximab with immune checkpoint
inhibitors, such as PD-L1 and PD-1 inhibitors. The overall
goal of these efforts is to generate important clinical data that
will guide the program toward the specific patient populations that
can realize the biggest benefit from these I-O combination
treatments.”
Clinical Development
Highlights
- Peregrine is working closely with its collaborators and key
opinion leaders (“KOLs”) to transition the company’s clinical
program to focus on bavituximab combinations with I-O agents.
Peregrine’s partners and advisors, including AstraZeneca, Memorial
Sloan Kettering Cancer Center, the National Comprehensive Cancer
Network® (NCCN®) and the University of Texas, Southwestern, are
leaders in the field of immuno-oncology, and their collective
guidance will play an important role in the program.
Activities in this area include:
- Peregrine and AstraZeneca are currently evaluating the trial
designs for the two previously announced clinical trials combining
bavituximab with AstraZeneca’s PD-L1 inhibitor, durvalumab. In
light of the recent development in the SUNRISE trial, the companies
are currently working together to identify the optimal path forward
for demonstrating potential mechanistic synergies between
bavituximab and durvalumab in different patient populations. The
expected timing of initiation of any trial will be determined upon
finalization of its trial design.
- Peregrine entered into a new research collaboration with the
NCCN to expand upon the company's clinical development program of
bavituximab in combination with immuno-oncology agents for the
treatment of a range of tumors. NCCN is a not-for-profit
alliance of 26 of the world's leading cancer centers dedicated to
improving the quality, effectiveness, and efficiency of cancer
care. Peregrine will fund multiple investigator-initiated
clinical and correlative studies with bavituximab in multiple
cancers at NCCN Member Institutions and their affiliate community
hospitals through a $2 million research grant to NCCN's Oncology
Research Program (ORP). NCCN will be responsible for
oversight and monitoring of the clinical studies through the
research grant.
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.
Avid Bioservices Highlights
“The Avid business grew 20% in fiscal year 2015
to $26.7 million in revenue, and is expected to top $40 million in
revenue for the current fiscal year ending April 30, 2016,” stated
Paul Lytle, chief financial officer of Peregrine. “Our new
state-of-the-art, 40,000 square foot commercial biomanufacturing
facility, which was recently formally commissioned, is outfitted
with cutting-edge, single-use equipment to accommodate a fully
disposable biomanufacturing process for late Phase III clinical and
commercial production of biologics. Demand for this new
production capacity is high and we already have manufacturing
commitments for products to be delivered in fiscal year 2017.
With demand expected to grow, we are actively considering options
for potentially adding more production capacity to support
additional growth of this business.”
- Avid’s new state-of-the-art commercial biomanufacturing suite
has been formally commissioned. The new facility will double
the company’s prior manufacturing capacity, supporting up to an
additional $40 million in revenue each year.
- As of February 1, 2016, Avid Bioservices had a revenue backlog
in excess of $58 million under committed contracts from existing
clients, covering services to be completed in the fourth quarter of
FY 2016 and into FY 2017.
Financial Results
Total revenues for the third quarter of FY 2016
were $6,709,000, compared to $5,677,000 for the same quarter of the
prior fiscal year. The increase was attributed to an increase in
contract manufacturing revenue generated from Avid Bioservices.
Contract manufacturing revenue from Avid's
clinical and commercial biomanufacturing services provided to its
third-party clients for the third quarter FY 2016 were $6,672,000,
compared to $5,677,000 for the same quarter of the prior fiscal
year. Peregrine expects third-party contract manufacturing revenue
for the entire fiscal year to exceed $40 million. In addition
to providing biomanufacturing services to its third-party clients,
Avid will continue to support the clinical manufacturing of
bavituximab.
Total costs and expenses in the third quarter of
FY 2016 were $23,576,000, compared to $18,699,000 in the third
quarter of FY 2015. This increase was primarily attributable to
current quarter increases in research and development expenses
associated with the increase in manufacturing costs associated with
bavituximab, the planned Phase II immuno-oncology combination trial
of bavituximab and durvalumab in NSCLC, the Phase II chemotherapy
combination trial in breast cancer that was initiated in December
2015 and recently placed on hold, and an increase in the cost of
contract manufacturing associated with higher reported revenue. For
the third quarter of FY 2016, research and development expenses
were $15,156,000, compared to $11,261,000 for the third quarter of
FY 2015. For the third quarter of FY 2016, cost of contract
manufacturing was $3,896,000, compared to $3,113,000 for the third
quarter of FY 2015. Selling, general and administrative
expenses were $4,524,000 for the third quarter of FY 2016 compared
to the $4,325,000 for the third quarter of FY 2015.
Peregrine's consolidated net loss attributable
to common stockholders was $18,227,000, or $0.08 per share, for the
third quarter of FY 2016, compared to a net loss attributable to
common stockholders of $14,027,000, or $0.08 per share, for the
same prior year quarter.
Peregrine reported $67,470,000 in cash and cash
equivalents as of January 31, 2016 compared to $68,001,000 at
fiscal year ended April 30, 2015.
More detailed financial information and analysis
may be found in Peregrine's Quarterly Report on Form 10-Q, which
will be filed with the Securities and Exchange Commission
today.
Conference Call
Peregrine will host a conference call and
webcast this morning, March 9, 2016, at 11:30 AM ET (8:30 AM
PT).
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 developing therapeutics to stimulate the body's immune
system to fight cancer. The company is focused on evaluating
its lead immunotherapy candidate, bavituximab, in combination with
a range of novel immuno-oncology (I-O) agents for the treatment of
various cancers.
In addition to its drug development programs,
Peregrine also has in-house cGMP manufacturing capabilities 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.
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 data
from future immune-oncology trials are not consistent with the
company’s translational and preclinical data demonstrating that
bavituximab has the potential to enhance the efficacy of checkpoint
inhibitors, the risk that one or more of the company’s
immune-oncology collaborators terminates its collaboration,
the risk that the results from the company’s contemplated
immune-oncology trials does not support further development of
bavituximab or the submission of a Biologics License Application,
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 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.
PEREGRINE PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (UNAUDITED) |
|
|
THREE MONTHS ENDED |
NINE MONTHS ENDED |
|
JANUARY 31, |
JANUARY 31, |
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
REVENUES: |
|
|
|
|
Contract manufacturing
revenue |
$ |
6,672,000 |
|
$ |
5,677,000 |
|
$ |
25,574,000 |
|
$ |
17,436,000 |
|
License revenue |
|
37,000 |
|
|
- |
|
|
329,000 |
|
|
37,000 |
|
Total revenues |
|
6,709,000 |
|
|
5,677,000 |
|
|
25,903,000 |
|
|
17,473,000 |
|
|
|
|
|
|
COSTS AND
EXPENSES: |
|
|
|
|
Cost of contract
manufacturing |
|
3,896,000 |
|
|
3,113,000 |
|
|
13,245,000 |
|
|
10,835,000 |
|
Research and
development |
|
15,156,000 |
|
|
11,261,000 |
|
|
43,264,000 |
|
|
31,465,000 |
|
Selling, general and
administrative |
|
4,524,000 |
|
|
4,325,000 |
|
|
13,839,000 |
|
|
13,503,000 |
|
Total costs and expenses |
|
23,576,000 |
|
|
18,699,000 |
|
|
70,348,000 |
|
|
55,803,000 |
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
(16,867,000 |
) |
|
(13,022,000 |
) |
|
(44,445,000 |
) |
|
(38,330,000 |
) |
|
|
|
|
|
OTHER INCOME
(EXPENSE): |
|
|
|
|
Interest and other
income |
|
34,000 |
|
|
29,000 |
|
|
691,000 |
|
|
108,000 |
|
Interest and other
expense |
|
(14,000 |
) |
|
(1,000 |
) |
|
(14,000 |
) |
|
(1,000 |
) |
Total other income (expense),
net |
|
20,000 |
|
|
28,000 |
|
|
677,000 |
|
|
107,000 |
|
|
|
|
|
|
NET
LOSS |
$ |
(16,847,000 |
) |
$ |
(12,994,000 |
) |
$ |
(43,768,000 |
) |
$ |
(38,223,000 |
) |
|
|
|
|
|
COMPREHENSIVE
LOSS |
$ |
(16,847,000 |
) |
$ |
(12,994,000 |
) |
$ |
(43,768,000 |
) |
$ |
(38,223,000 |
) |
|
|
|
|
|
Series E preferred
stock accumulated dividends |
|
(1,380,000 |
) |
|
(1,033,000 |
) |
|
(3,448,000 |
) |
|
(2,577,000 |
) |
|
|
|
|
|
NET LOSS
ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ |
(18,227,000 |
) |
$ |
(14,027,000 |
) |
$ |
(47,216,000 |
) |
$ |
(40,800,000 |
) |
|
|
|
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING: |
|
|
|
|
Basic and Diluted |
|
227,389,225 |
|
|
182,519,923 |
|
|
209,549,670 |
|
|
180,562,524 |
|
|
|
|
|
|
BASIC AND
DILUTED LOSS PER COMMON SHARE |
$ |
(0.08 |
) |
$ |
(0.08 |
) |
$ |
(0.23 |
) |
$ |
(0.23 |
) |
|
|
|
|
|
PEREGRINE PHARMACEUTICALS, INC. |
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
JANUARY 31,2016 |
|
APRIL 30,2015 |
|
Unaudited |
|
|
ASSETS |
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash
equivalents |
$ |
67,470,000 |
|
|
$ |
68,001,000 |
|
Trade and other
receivables, net |
|
8,599,000 |
|
|
|
3,813,000 |
|
Inventories |
|
15,189,000 |
|
|
|
7,354,000 |
|
Prepaid expenses and other
current assets, net |
|
2,346,000 |
|
|
|
1,355,000 |
|
Total current assets |
|
93,604,000 |
|
|
|
80,523,000 |
|
Property and equipment,
net |
|
23,846,000 |
|
|
|
15,124,000 |
|
Other assets |
|
1,602,000 |
|
|
|
1,817,000 |
|
TOTAL ASSETS |
$ |
119,052,000 |
|
|
$ |
97,464,000 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable |
$ |
7,844,000 |
|
|
$ |
10,385,000 |
|
Accrued clinical trial and
related fees |
|
6,975,000 |
|
|
|
3,910,000 |
|
Accrued payroll and
related costs |
|
4,497,000 |
|
|
|
4,606,000 |
|
Deferred revenue |
|
15,418,000 |
|
|
|
6,630,000 |
|
Customer deposits |
|
22,433,000 |
|
|
|
11,363,000 |
|
Other current
liabilities |
|
1,047,000 |
|
|
|
437,000 |
|
Total current liabilities |
|
58,214,000 |
|
|
|
37,331,000 |
|
|
|
|
|
Deferred rent, less
current portion |
|
905,000 |
|
|
|
1,098,000 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
Preferred stock – $0.001
par value; authorized 5,000,000 shares; 1,577,440 and 1,574,764
shares issued and outstanding at January 31, 2016 and April 30,
2015, respectively |
|
2,000 |
|
|
|
2,000 |
|
Common stock – $0.001 par
value; authorized 500,000,000 shares; 232,231,242 and 193,346,627
shares issued and outstanding at January 31, 2016 and April 30,
2015, respectively |
|
232,000 |
|
|
|
193,000 |
|
Additional paid-in
capital |
|
557,091,000 |
|
|
|
512,464,000 |
|
Accumulated deficit |
|
(497,392,000 |
) |
|
|
(453,624,000 |
) |
Total stockholders’ equity |
|
59,933,000 |
|
|
|
59,035,000 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
119,052,000 |
|
|
$ |
97,464,000 |
|
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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