- SUNRISE Phase III Lung Cancer Trial On Track to
Complete Enrollment by Calendar Year-End -
- Encouraging and Consistent Data from
Immuno-Oncology Development Program Continue to Support
Bavituximab's Immunostimulatory Mechanism -
- Avid Bioservices Increases Revenue Guidance to
Between $23 and $25 Million for Full Fiscal Year 2015 Based on
Strong Demand for Services –
Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), a
biopharmaceutical company focused on advancing bavituximab, a novel
immuno-oncology agent in Phase III development, today announced
financial results for the third quarter of fiscal year (FY) 2015
ended January 31, 2015. The company also provided an update on its
advancing clinical pipeline and reviewed other corporate
developments.
"This is an exciting time for the company on many fronts. Our
lead clinical program, bavituximab is in a unique position as a
Phase III immuno-oncology agent that has shown great potential in
combination with both current standard cancer treatments, such as
chemotherapy, as well as emerging immuno-oncology agents such as
those targeting PD-1 and PD-L1. We have continued to advance the
bavituximab Phase III SUNRISE trial and are on track to complete
enrollment in the study by year-end," said Steven W. King,
president and chief executive officer of Peregrine. "Aside from
completing enrollment in the SUNRISE trial, our clinical focus is
to enter into new clinical collaborations to further explore the
combination potential of bavituximab with anti-PD-1 and PD-L1 in
multiple tumor indications and we expect these activities to be
quite visible over the coming months as the planning that is
underway now, comes to fruition. These efforts, on top of
completing the Avid capacity expansion and continued revenue
growth, point to many important milestones throughout remainder of
2015."
The company's mission is to develop a brand new class of
immunotherapies focused on the clinical advancement of our lead
drug candidate bavituximab which targets the immunosuppressive PS
signaling pathway. Bavituximab has the potential to be an effective
part of treatment regimens in many different tumor types and has
recently shown promise in combination with other immuno-oncology
compounds in multiple preclinical models of cancer. Over the past
quarter, the company has made important progress in bringing this
novel immunotherapy closer to the market led by the SUNRISE Phase
III clinical trial.
The company continues to enroll patients in the SUNRISE
(Stimulating ImmUne
RespoNse thRough
BavItuximab in a PhaSE III Lung
Cancer Study) trial. SUNRISE is a Phase III, randomized,
double-blind, placebo-controlled clinical trial designed to
evaluate the safety, tolerability and efficacy of bavituximab as a
second-line treatment in patients with non-squamous, non-small cell
lung cancer (NSCLC). The trial is evaluating bavituximab plus the
standard chemotherapy docetaxel versus docetaxel plus placebo in
approximately 600 patients at clinical sites worldwide. Patients
with Stage IIIb/IV non-squamous NSCLC who have progressed after
standard front-line treatment are eligible for enrollment. The
primary endpoint of the trial is overall survival. The company
anticipates completing patient enrollment in the SUNRISE trial by
the end of calendar year 2015. For additional information about the
SUNRISE trial, please visit www.sunrisetrial.com or
ClinicalTrials.gov using the Identifier NCT01999673.
The company's commitment to exploring the full clinical
potential of bavituximab in combination with chemotherapies or
other immuno-oncology agents is being executed through a series of
Investigator-Sponsored Trials (IST) in multiple solid tumor
indications. The following represents anticipated upcoming data
from ongoing or completed clinical studies as well as the status of
trials that can yield data in the future:
Final data from a Phase I IST that evaluated bavituximab in
combination with paclitaxel in patients with HER2-negative
metastatic breast cancer has been accepted for publication in the
peer-reviewed journal Cancer Medicine and will be published online
in the coming weeks. The company is currently evaluating
opportunities to advance the clinical development of bavituximab in
breast cancer.
Data from a Phase II IST that evaluated bavituximab in
combination with sorafenib in patients with advanced hepatocellular
carcinoma (HCC), or liver cancer, presented at the 2015
Gastrointestinal Cancers Symposium Data show that the combination
of bavituximab and sorafenib is associated with an improved time to
progression (TTP) of 6.7 months, a disease specific survival (DSS)
of 8.7 months, a disease control rate (DCR) of 58% (22 out of 38
patients) and a 4-month progression-free survival (PFS) of 62%. Two
patients (5%) achieved a partial response according to Response
Evaluation Criteria In Solid Tumors (RECIST). The secondary
endpoint of median overall survival (OS) was 6.2 months. The
combination of bavituximab and sorafenib was well-tolerated in
patients with advanced HCC with no indications of autoimmune
adverse events that have been seen with other checkpoint
immunotherapies. During the quarter, translational data from six
patients from this trial were presented at the Society for
Immunotherapy of Cancer's (SITC) 29th Annual Meeting and Associated
Programs. These data, to assess and measure changes in immune
response pre- and post-treatment, show the ability of bavituximab
to positively regulate an increase in tumor fighting immune cells
(particularly CD8 T cells) following one cycle of treatment, thus
further confirming in patients what has been shown for PS-targeting
antibodies in multiple preclinical cancer models. This trial is
also the subject of an oral presentation at the Society of Surgical
Oncology's (SSO) 68th Annual Cancer Symposium to be held March
25-28, 2015 in Houston, Texas.
A Phase I IST evaluating bavituximab in combination with
capecitabine and radiation therapy in up to 18 patients with Stage
II or III rectal adenocarcinoma is open for patient enrollment.
A Phase Ib IST evaluating bavituximab in combination with
Bristol-Myers Squibb's ipilimumab (Yervoy®) in up to 24 patients
with advanced melanoma is open for patient enrollment.
As part of the company's mission to discover the full potential
of its immunotherapy bavituximab in clinical disease applications,
the company is advancing studies through its Immuno-Oncology
Development Program. This program is designed to explore the
potential of combining bavituximab with other immunotherapies,
experimental immuno-oncology drugs including checkpoint inhibitors,
as well as vaccines.
During the quarter, data presented at the 2014 San Antonio
Breast Cancer Symposium (SABCS) show that the monotherapy
preclinical equivalent to bavituximab demonstrated statistically
significant tumor growth inhibition in breast tumor models when
compared to a control antibody. Data further show that this
monotherapy yielded statistically significant increases in the
percentage of tumor fighting T-lymphocytes and decreases in tumor
inflammatory myeloid-derived suppressor cells (MDSC), all key
indicators of immune activation.
Data presented recently at the Keystone Tumor Immunology meeting
show that the PS-targeting antibody equivalent to bavituximab
combined with an anti-PD-1 antibody displayed statistically
significant improvement in tumor fighting immune cells, activation
signals and cytokines in a model of melanoma compared to anti-PD-1
alone. Moreover, cells that suppress the immune system from
recognizing tumors, such as MDSCs, were reduced by more than 40% in
the combination with the PS-targeting antibody versus anti-PD-1
alone.
Peregrine announced today the acceptance of three posters at the
American Association for Cancer Research's (AACR) Annual Meeting to
be held April 18-22, 2015 in Philadelphia, Pennsylvania. These
posters include preclinical data from the company's Immuno-Oncology
Development Program of PS-targeting agents in combination with
immune checkpoint inhibitors in breast cancer and melanoma, as well
as translational research conducted with tumor tissue from lung
cancer patients.
The company is also exploring other applications for the
PS-targeting platform outside of cancer therapy. These activities
include:
PS-TARGETING MOLECULAR IMAGING PROGRAM
The company is exploring the potential of its experimental
PS-targeting molecular imaging candidate, 124I-PGN650, in patients
with various solid tumor types. This is an open-label,
single-center trial with a primary goal of estimating radiation
dosimetry in critical and non-critical organs and secondary
objectives of tumor imaging and safety.
AVID BIOSERVICES
Avid Bioservices, Inc. is the contract manufacturing subsidiary
of Peregrine. Avid provides high quality clinical and commercial
manufacturing services under cGMP for the biotechnology and
biopharmaceutical industries. As announced in December, Avid is in
the process of expanding its manufacturing capacity with a new
state-of-the-art facility. Activities supporting this expansion
continue and the company remains on track to commence manufacturing
in the new facility during mid-2015.
"Our Avid business had another strong quarter further supporting
our decision announced in December to expand our manufacturing
capacity to meet the growing needs of our manufacturing business as
well as the anticipated commercial launch of bavituximab," said
Paul Lytle, chief financial officer of Peregrine. "Our current
backlog for manufacturing services has increased to $29 million and
we are increasing our revenue guidance from between $19 to $23
million to between $23 and $25 million for the full fiscal year
2015."
FINANCIAL RESULTS
Contract manufacturing revenue from Avid's clinical and
commercial biomanufacturing services provided to its third-party
customers for the third quarter FY 2015 were $5,677,000, compared
to $3,885,000 for the same quarter of the prior fiscal year. In
addition to providing biomanufacturing services to its third-party
customers, Avid will continue to support the potential
commercialization of bavituximab.
Total costs and expenses in the third quarter of FY 2015 were
$18,699,000, compared to $13,628,000 in the third quarter of FY
2014. This increase was primarily attributable to the current
quarter increases in research and development expenses associated
with the SUNRISE Phase III trial and cost of contract manufacturing
associated with higher contract manufacturing revenue, which were
offset by the current quarter decrease in selling, general and
administrative expenses. For the third quarter FY 2015,
research and development expenses were $11,261,000, compared to
$6,649,000 for the third quarter of FY 2014. For the third quarter
of FY 2015, cost of contract manufacturing was $3,113,000, compared
to $2,416,000 for the third quarter of FY 2014. For the third
quarter of FY 2015, selling, general and administrative expenses
were $4,325,000 compared to $4,563,000 for the third quarter of FY
2014.
Peregrine's consolidated net loss attributable to common
stockholders was $14,027,000, or $0.08 per share, for the third
quarter of FY 2015, compared to a net loss attributable to common
stockholders of $9,724,000, or $0.06 per share, for the same
quarter of the prior year.
Peregrine reported $55,238,000 in cash and cash equivalents as
of January 31, 2015 compared to $77,490,000 at fiscal year ended
April 30, 2014.
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, March 12, 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 for the
treatment and diagnosis of cancer. The company's lead immunotherapy
candidate, bavituximab is in Phase III development for the
treatment of second-line non-small lung cancer (the "SUNRISE
trial") along with several investigator-sponsored trials evaluating
other treatment combinations and additional oncology indications.
The company is also advancing a molecular imaging agent,
124I-PGN650, in an exploratory clinical trial for the imaging of
multiple solid tumor types. 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. Additional information about Peregrine can be found at
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 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 additional clinical trials,
such as a breast cancer trial, the risk that data from pre-clinical
studies and early stage clinical trials, including ISTs, may not
correlate with the results of later stage clinical trials, the risk
that data from the company's Immuno-Oncology Development Program
and/or translational studies may not correlate to the results of
future 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, 2014 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.
Yervoy is a registered trademark of Bristol-Myers Squibb.
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
|
|
THREE MONTHS ENDED
JANUARY 31, |
NINE MONTHS ENDED
JANUARY 31, |
|
2015 |
2014 |
2015 |
2014 |
|
Unaudited |
Unaudited |
Unaudited |
Unaudited |
REVENUES: |
|
|
|
|
Contract manufacturing revenue |
$ 5,677,000 |
$ 3,885,000 |
$ 17,436,000 |
$ 15,820,000 |
License revenue |
-- |
-- |
37,000 |
107,000 |
Total revenues |
5,677,000 |
3,885,000 |
17,473,000 |
15,927,000 |
|
|
|
|
|
COSTS AND EXPENSES: |
|
|
|
|
Cost of contract manufacturing |
3,113,000 |
2,416,000 |
10,835,000 |
9,281,000 |
Research and development |
11,261,000 |
6,649,000 |
31,465,000 |
18,910,000 |
Selling, general and administrative |
4,325,000 |
4,563,000 |
13,503,000 |
12,913,000 |
Total costs and
expenses |
18,699,000 |
13,628,000 |
55,803,000 |
41,104,000 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(13,022,000) |
(9,743,000) |
(38,330,000) |
(25,177,000) |
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
Interest and other income |
29,000 |
23,000 |
108,000 |
68,000 |
Interest and other expense |
(1,000) |
(4,000) |
(1,000) |
(5,000) |
|
|
|
|
|
NET LOSS |
$ (12,994,000) |
$ (9,724,000) |
$ (38,223,000) |
$ (25,114,000) |
|
|
|
|
|
COMPREHENSIVE LOSS |
$ (12,994,000) |
$ (9,724,000) |
$ (38,223,000) |
$ (25,114,000) |
Series E preferred stock accumulated
dividends |
(1,033,000) |
-- |
(2,577,000) |
-- |
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO COMMON
SHAREHOLDERS |
$ (14,027,000) |
$ (9,724,000) |
$ (40,800,000) |
$ (25,114,000) |
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING: |
|
|
|
|
Basic and Diluted |
182,519,923 |
163,223,767 |
180,562,524 |
156,521,874 |
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
$ (0.08) |
$ (0.06) |
$ (0.23) |
$ (0.16) |
|
|
|
|
|
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
JANUARY 31,
2015 |
APRIL 30,
2014 |
|
Unaudited |
|
ASSETS |
|
|
CURRENT ASSETS: |
|
|
Cash and cash equivalents |
$ 55,238,000 |
$ 77,490,000 |
Trade and other receivables, net |
6,284,000 |
1,332,000 |
Inventories |
6,148,000 |
5,530,000 |
Prepaid expenses and other current assets,
net |
934,000 |
1,419,000 |
Total current assets |
68,604,000 |
85,771,000 |
Property and equipment, net |
8,958,000 |
2,447,000 |
Other assets |
1,559,000 |
2,327,000 |
TOTAL ASSETS |
$ 79,121,000 |
$ 90,545,000 |
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
CURRENT LIABILITIES: |
|
|
Accounts payable |
$ 6,814,000 |
$ 2,434,000 |
Accrued clinical trial and related fees |
3,117,000 |
4,433,000 |
Accrued payroll and related costs |
3,716,000 |
3,837,000 |
Deferred revenue, current portion |
5,752,000 |
5,241,000 |
Customer deposits |
8,311,000 |
5,760,000 |
Other current liabilities |
490,000 |
502,000 |
Total current liabilities |
28,200,000 |
22,207,000 |
|
|
|
Deferred revenue, less current portion |
-- |
292,000 |
Other long-term liabilities |
1,127,000 |
347,000 |
Commitments and contingencies |
|
|
|
|
|
STOCKHOLDERS' EQUITY: |
|
|
Preferred stock- $0.001 par value; authorized
5,000,000 shares; issued and outstanding – 1,180,004 and 775,000,
respectively |
1,000 |
1,000 |
Common stock- $0.001 par value; authorized
325,000,000 shares; outstanding – 184,244,698 and 178,871,164,
respectively |
184,000 |
179,000 |
Additional paid-in capital |
491,098,000 |
470,785,000 |
Accumulated deficit |
(441,489,000) |
(403,266,000) |
Total stockholders' equity |
49,794,000 |
67,699,000 |
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY |
$ 79,121,000 |
$ 90,545,000 |
CONTACT: Christopher Keenan
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
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