--Peregrine and AstraZeneca to Collaborate on
Immuno-Oncology Combination Clinical Trial--
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 first quarter of fiscal year (FY) 2016
ended July 31, 2015, and provided an update on its advancing
clinical pipeline and other corporate developments.
Highlights Since April 30, 2015:
"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 Steven W. King, president and chief
executive officer of Peregrine. “In the last three months,
these achievements have compelled others to align with us as we
continue to develop bavituximab. In May, Peregrine announced
an exciting collaboration with Memorial Sloan Kettering Cancer
Center 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. Only three months later, we announced a
collaboration with AstraZeneca to clinically evaluate bavituximab
in combination with AstraZeneca's investigational anti-PD-L1 immune
checkpoint inhibitor, durvalumab (MEDI4736) in multiple solid
tumors. These collaborations with world leaders in
immuno-oncology speak to the promise of bavituximab and validate
our ever-growing enthusiasm for the investigational product.
We look forward to advancing both of these programs and completing
enrollment of our SUNRISE trial in the next few months."
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 $9,671,000, compared to $5,496,000 for the same quarter of the
prior fiscal year. The increase was primarily 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 first quarter FY 2016 were $9,379,000,
compared to $5,496,000 for the same quarter of the prior fiscal
year. Peregrine expects third-party contract manufacturing revenue
for FY 2016 to be between $30 and $35 million. In addition to
providing biomanufacturing services to its third-party clients,
Avid will continue to support the clinical and potential
commercialization of bavituximab.
Total costs and expenses in the first quarter of
FY 2016 were $23,425,000, compared to $18,667,000 in the first
quarter of FY 2015. This increase was primarily attributable to
current quarter increases in research and development expenses
associated with the SUNRISE Phase III trial and increases in the
cost of contract manufacturing associated with higher reported
revenue. For the first quarter of FY 2016, research and development
expenses were $13,918,000, compared to $10,201,000 for the first
quarter of FY 2015. For the first quarter of FY 2016, cost of
contract manufacturing was $4,608,000, compared to $3,583,000 for
the first quarter of FY 2015.
Peregrine's consolidated net loss attributable
to common stockholders was $15,101,000, or $0.08 per share, for the
first quarter of FY 2016, compared to a net loss attributable to
common stockholders of $14,157,000, or $0.08 per share, for the
same prior year quarter.
Peregrine reported $59,016,000 in cash and cash
equivalents as of July 31, 2015 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 afternoon, September 9, 2015, 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 with a pipeline of novel drug candidates
in clinical trials focused on the treatment of cancer. The
company's lead immunotherapy candidate, bavituximab, is in Phase
III development for the treatment of second-line non-small cell
lung cancer (the "SUNRISE trial") along with several
investigator-sponsored trials evaluating other treatment
combinations and additional oncology indications. 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.
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 the
company may experience delays in the enrollment of patients in the
Phase III SUNRISE trial and that the Phase III SUNRISE trial may
not achieve its anticipated enrollment timeline, the risk that the
results from the Phase III SUNRISE trial may not support a future
Biologics License Application (BLA) submission, the risk that the
company may not have or raise adequate financial resources to
complete the Phase III SUNRISE trial or its other contemplated
clinical trials, the risk that the company may experience delays in
initiating its other contemplated clinical trials, the risk that
data from pre-clinical and translational studies and early stage
clinical trials, including ISTs, may not correlate with the results
of later stage clinical trials, 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. It is important to note that 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 |
|
|
|
|
|
THREE MONTHS ENDED |
|
|
July 31, 2015 |
|
July 31, 2014 |
|
|
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 |
) |
|
|
|
|
|
PEREGRINE PHARMACEUTICALS, INC. |
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
JULY 31,2015 |
|
APRIL 30,2015 |
|
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 - $0.001
par value; authorized 5,000,000 shares; issued and outstanding –
1,574,764 and 1,574,764, respectively |
|
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.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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