Peregrine Pharmaceuticals Reports Second Quarter Fiscal Year 2014
Financial Results and Recent Developments
SUNRISE Pivotal Phase III Lung Cancer Trial on Track for
Initiation by Calendar Year-End; Company Strengthens Focus in
Immunotherapy With Strategic Appointments to Scientific Advisory
Board; Avid Continues Solid Performance With Revenue Topping $7M in
Current Quarter
TUSTIN, CA--(Marketwired - Dec 10, 2013) - Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM), a biopharmaceutical company
developing first-in-class monoclonal antibodies focused on the
treatment and diagnosis of cancer, today announced financial
results for the second quarter of fiscal year (FY) 2014 ended
October 31, 2013 and provided an update on its advancing clinical
pipeline and other corporate developments.
"We made important clinical and regulatory progress this quarter
towards the initiation of our SUNRISE global Phase III trial in
second-line non-small cell lung cancer, allowing for patient
enrollment to commence by year-end," said Steven W. King, president
and chief executive officer of Peregrine. "In parallel with
these activities, we made tremendous strides in raising the
awareness of bavituximab's novel immunotherapy mechanism of
action. At the 15th World Conference on Lung Cancer,
immunology researchers discussed bavituximab's key role in blocking
an immunosuppressive upstream checkpoint that allows cancer to
evade immune detection while also highlighting potential synergies
between bavituximab and downstream immune checkpoint inhibitors
like anti-PD-1 and anti-CTLA-4 antibodies. In addition, at the
Society for Immunotherapy of Cancer Annual Meeting, we presented
encouraging preclinical data that showed that bavituximab plus an
anti-CTLA-4 antibody showed superior tumor suppression in a mouse
melanoma model. As a result of these and other data, we
anticipate initiating a Phase I clinical trial in combination with
an approved immunotherapy in patients with advanced melanoma in the
coming months. Another important development this quarter was
the expansion of our scientific advisory board with four new key
experts in immunotherapy who will be instrumental in assisting us
with our continued development efforts."
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
- Finalizing operational activities surrounding the SUNRISE Phase
III Trial (Stimulating ImmUne RespoNse thRough BavItuximab in a
PhaSE III Lung Cancer Study).
- SUNRISE is a Phase III, global, randomized, double-blind,
placebo-controlled clinical trial designed to evaluate the safety,
tolerability and efficacy of bavituximab in patients with
second-line non-small cell lung cancer (NSCLC). The trial will
evaluate bavituximab plus 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. Patients will be randomized into 1 of 2
treatment arms. All patients will receive up to six 21-day
cycles of docetaxel at 75 milligrams per meter squared plus weekly
infusions of either bavituximab (3mg/kg) or placebo until
progression or toxicity. The primary endpoint of the trial will be
overall survival. The trial is anticipated to be open to
enrollment by the end of the calendar year. For additional
information about the SUNRISE trial visit ClinicalTrials.gov using
Identifier NCT01999673.
Other Oncology Indications:
The company is exploring the potential of bavituximab through a
number of investigator-sponsored trials (IST) including:
- A Phase I IST evaluating bavituximab in combination with
paclitaxel in up to 14 patients with HER2-negative metastatic
breast cancer. Encouraging interim data on 13 evaluable patients
receiving the combination was presented at the 2013 American
Society of Clinical Oncology (ASCO) Annual Meeting showing that 85%
of patients achieved an objective tumor response, including 15% of
patients achieving a complete response measured in accordance with
RECIST criteria. Final data is anticipated in 2014.
- A Phase I/II IST evaluating bavituximab in combination with
sorafenib in up to 48 patients with advanced hepatocellular
carcinoma (liver cancer). Interim data has been accepted for
oral presentation at an upcoming scientific conference in the first
quarter of 2014.
- A Phase Ib IST evaluating bavituximab in combination with
carboplatin and pemetrexed in up to 25 patients with previously
untreated Stage IV NSCLC.
- 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.
BAVITUXIMAB IMMUNOTHERAPY DEVELOPMENT PROGRAM
Data from preclinical studies showing that tumor growth
inhibition of a PS-targeting antibody equivalent to bavituximab and
an anti-CTLA-4 combination therapy in a mouse melanoma model was
superior to either antibody alone were recently presented at
Society for Immunotherapy of Cancer (SITC) Annual Meeting.
Peregrine is exploring the potential to combine bavituximab with
other immunotherapies such as PD-1 antibodies and CTLA-4 targeted
approaches and has initiated several proof-of-concept studies to
support recent mechanism data. In advance of this, multiple
proof-of-concept preclinical studies are now underway with data
anticipated over the next few months.
Peregrine anticipates the initiation of a single-center Phase Ib
IST of bavituximab plus an approved anti-CTLA-4 antibody in
patients with advanced melanoma in early calendar year 2014.
With recent scientific insights highlighting bavituximab's
immunostimulatory mechanism of action, Peregrine announced today
the following additions to its Scientific Advisory Board. The
company plans to utilize the expertise of its new advisors to help
guide the development of its novel immunotherapeutic candidate
bavituximab:
- Dimitry I. Gabrilovich, M.D., Ph.D. Dr. Gabrilovich is
currently the Christopher M. Davis Professor in Cancer Research and
Program Leader, Translational Tumor Immunology at The Wistar
Institute, Philadelphia, Pennsylvania. Prior to joining Wistar, Dr.
Gabrilovich was the Robert Rothman Endowed Chair in Cancer Research
and Head, Section of Dendritic Cell Biology at the Moffitt Cancer
Center in the Department of Immunology and a Professor of Oncologic
Sciences and Molecular Medicine at the University of South Florida.
Prior to this, Dr. Gabrilovich was a Research Fellow at the
Imperial College in London, United Kingdom and at the University of
Texas Southwestern Medical Center in Dallas, Texas. Dr. Gabrilovich
earned his M.D. from Kabardino-Balkarian State University Medical
School in Nalchik, Russia and his Ph.D. in Immunology from the
Central Institute of Epidemiology in Moscow.
- Scott J. Antonia, M.D., Ph.D. Dr. Antonia is currently the
Department Chair and Program Leader of the Thoracic Oncology
Department Associate Professor in the Department of
Interdisciplinary Oncology and Program Leader of the Immunology
Program at the H. Lee Moffitt Cancer Center and Research Institute
in Tampa, Florida. He is also a Professor of Oncology at the
University of South Florida College of Medicine in Tampa. Dr.
Antonia received his M.D. and his Ph.D. in Immunology from the
University of Connecticut Health Center in Farmington, Connecticut.
In addition, Dr. Antonia completed an internal medicine residency
at Yale University School of Medicine and pursued additional
training at Yale through a medical oncology fellowship and
post-doctoral fellowship in Immunobiology.
- David Carbone, M.D., Ph.D. Dr. Carbone is currently a Professor
of Medicine in the Division of Medical Oncology at The Ohio State
University's Ohio State's Comprehensive Cancer Center at the James
Cancer Hospital and the Solove Research Institute both in Columbus,
Ohio. Prior to joining Ohio State University, he served on the
faculty of the University of Texas Southwestern Medical Center in
Dallas, Texas and Vanderbilt University 's Thoracic and Head &
Neck Cancer Program at the Vanderbilt-Ingram Cancer Center in
Nashville, Tennessee. Dr. Carbone received his M.D. and Ph.D.
degrees in Molecular Biology and Genetics from Johns Hopkins
University in Baltimore, Maryland.
- HÃ¥kan Mellstedt, M.D., Ph.D. Dr. Mellstedt, is currently a
Professor of Oncologic Biotherapy at the Karolinska Institute and
Cancer Centre Karolinska at the Karolinska University Hospital in
Stockholm, Sweden. Prior to this, he was Professor of
Experimental Oncology at Uppsala University and head of the
Department of Experimental Oncology, Department of Oncology,
Uppsala University Hospital in Uppsala, Sweden. He was also the
Administrative Director of Cancer Center Karolinska. Dr. Mellstedt
has served as a Consultant in Internal Medicine to the Seraphimer
University Hospital in Stockholm, Sweden as a Senior Consultant to
the Department of Oncology, Karolinska University Hospital, Sweden
and as a Senior Consultant to the Sophiahemmet Hospital in
Stockholm. Dr. Mellstedt received his M.D. and his Ph.D. degrees
from the Karolinska Institute. He is Board Certified in Internal
Medicine, Hematology and Oncology.
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.
CORPORATE
Today Peregrine announced the addition of Mr. Stephen Worsley as
vice president of business development. Mr. Worsley joins the
Executive team bringing with him over 25 years in the biotechnology
industry with 16 of those in business development. Most recently he
was chief business officer at Centrose Pharmaceuticals. Prior to
that he held the position of vice president of business development
at Intrexon Inc., Zosano Pharma Inc., (a spin out of Johnson &
Johnson) and Raven Biotechnologies, Inc. (acquired by
MacroGenics). In addition, he was director of business
development at Abgenix (acquired by Amgen), Tripos Drug Discovery,
and OHM Technologies (acquired by Carlyle Group). Stephen received
his MBA in finance from the University of Washington and his
Bachelor of Science in international economics and finance from the
University of Utah.
FINANCIAL RESULTS
"Avid Bioservices, our contract manufacturing subsidiary, had a
strong second quarter generating over $7 million in contract
manufacturing revenue. We anticipate that with our current
commitments for services, contract manufacturing revenue for the
entire FY 2014 to be between $18 and $22 million," said Paul Lytle,
chief financial officer of Peregrine. "We have also been able to
strengthen our cash position over each of the last six quarters to
$44.4 million as of October 31, 2013 in preparation for initiating
the SUNRISE Phase III trial while we continue to pursue partnering
opportunities."
Total revenues for the second quarter of FY 2014 were
$7,354,000, compared to $6,139,000 for the same quarter of the
prior fiscal year. The increase was primarily attributed to a 21%
increase in contract manufacturing revenue generated from Avid
Bioservices associated with additional services provided to its
third-party customers.
Total costs and expenses in the second quarter of FY 2014 were
$15,168,000, compared to $13,196,000 in the second quarter of FY
2013. This increase was attributable to the current quarter
increase in the cost of contract manufacturing associated with
higher revenues in the current quarter combined with increases in
research and development expenses and selling, general and
administrative expenses. The increase in research and
development expenses for the second quarter FY 2014 compared to the
second quarter of FY 2013 was primarily attributable to expenses
associated with preparing for our Phase III SUNRISE trial combined
with an increase in share-based compensation expense
(non-cash). The increase in selling, general and
administrative expenses for the second quarter FY 2014 compared to
the second quarter of FY 2013 was primarily attributable to an
increase in share-based compensation expense (non-cash).
Peregrine's consolidated net loss was $7,790,000, or $0.05 per
share, for the second quarter of FY 2014, compared to a net loss of
$8,753,000, or $0.08 per share, for the same quarter of the prior
year.
Peregrine reported $44,443,000 in cash and cash equivalents at
October 31, 2013, compared to $35,204,000 at fiscal year ended
April 30, 2013.
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, December 10, 2013, at 4:30 PM EST (1:30 PM
PST).
To listen to the conference call, please dial (877) 312-5443 or
(253) 237-1126 and request the Peregrine Pharmaceuticals conference
call. A replay of the call will be available starting
approximately two hours after the conclusion of the call through
December 17, 2013 by calling (855) 859-2056, or (404) 537-3406 and
using passcode 17598749.
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 portfolio of innovative
monoclonal antibodies in clinical trials focused on the treatment
and diagnosis of cancer. The Company is advancing its lead
immunotherapy candidate, bavituximab, into Phase III development
for the treatment of second-line non-small cell lung cancer (the
"SUNRISE trial") while also seeking a licensing or funding partner
to further advance Cotara into Phase III development for the
treatment of brain cancer. 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 not be able to initiate
the Phase III SUNRISE trial within its anticipated 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, the risk that
the company may not find a suitable partner for the bavituximab or
Cotara programs, 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, 2013 and quarterly report on Form 10-Q for the quarter ended
October 31, 2013. 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 October 31, |
|
|
Six Months Ended October 31, |
|
|
|
2013 |
|
|
2012 |
|
|
2013 |
|
|
2012 |
|
|
|
Unaudited |
|
|
Unaudited |
|
|
Unaudited |
|
|
Unaudited |
|
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract manufacturing revenue |
|
$ |
7,354,000 |
|
|
$ |
6,061,000 |
|
|
$ |
11,935,000 |
|
|
$ |
10,196,000 |
|
License revenue |
|
|
- |
|
|
|
78,000 |
|
|
|
107,000 |
|
|
|
194,000 |
|
|
Total
revenues |
|
|
7,354,000 |
|
|
|
6,139,000 |
|
|
|
12,042,000 |
|
|
|
10,390,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of contract manufacturing |
|
|
4,195,000 |
|
|
|
3,703,000 |
|
|
|
6,865,000 |
|
|
|
5,727,000 |
|
Research and development |
|
|
6,957,000 |
|
|
|
6,053,000 |
|
|
|
12,261,000 |
|
|
|
13,034,000 |
|
Selling, general and administrative |
|
|
4,016,000 |
|
|
|
3,440,000 |
|
|
|
8,350,000 |
|
|
|
6,357,000 |
|
|
Total
costs and expenses |
|
|
15,168,000 |
|
|
|
13,196,000 |
|
|
|
27,476,000 |
|
|
|
25,118,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
|
(7,814,000 |
) |
|
|
(7,057,000 |
) |
|
|
(15,434,000 |
) |
|
|
(14,728,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
|
24,000 |
|
|
|
44,000 |
|
|
|
45,000 |
|
|
|
52,000 |
|
Interest and other expense |
|
|
- |
|
|
|
(44,000 |
) |
|
|
(1,000 |
) |
|
|
(45,000 |
) |
Loss on early extinguishment of debt |
|
|
- |
|
|
|
(1,696,000 |
) |
|
|
- |
|
|
|
(1,696,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(7,790,000 |
) |
|
$ |
(8,753,000 |
) |
|
$ |
(15,390,000 |
) |
|
$ |
(16,417,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
|
$ |
(7,790,000 |
) |
|
$ |
(8,753,000 |
) |
|
$ |
(15,390,000 |
) |
|
$ |
(16,417,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and Diluted |
|
|
156,948,226 |
|
|
|
109,405,778 |
|
|
|
153,170,928 |
|
|
|
106,344,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
|
$ |
(0.05 |
) |
|
$ |
(0. 08 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0. 15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PEREGRINE
PHARMACEUTICALS, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
|
|
|
|
OCTOBER 31, 2013 |
|
|
APRIL 30, 2013 |
|
|
|
Unaudited |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
44,443,000 |
|
|
$ |
35,204,000 |
|
Trade and other receivables, net |
|
|
1,936,000 |
|
|
|
1,662,000 |
|
Inventories |
|
|
4,033,000 |
|
|
|
4,339,000 |
|
Prepaid expenses and other current assets, net |
|
|
874,000 |
|
|
|
709,000 |
|
|
Total
current assets |
|
|
51,286,000 |
|
|
|
41,914,000 |
|
Property and equipment, net |
|
|
2,315,000 |
|
|
|
2,678,000 |
|
Other assets |
|
|
1,506,000 |
|
|
|
466,000 |
|
TOTAL ASSETS |
|
$ |
55,107,000 |
|
|
$ |
45,058,000 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,371,000 |
|
|
$ |
2,821,000 |
|
Accrued clinical trial and related fees |
|
|
1,029,000 |
|
|
|
930,000 |
|
Accrued payroll and related costs |
|
|
3,152,000 |
|
|
|
3,582,000 |
|
Deferred revenue, current portion |
|
|
3,468,000 |
|
|
|
4,171,000 |
|
Customer deposits |
|
|
7,658,000 |
|
|
|
8,059,000 |
|
Other current liabilities |
|
|
1,089,000 |
|
|
|
998,000 |
|
|
Total
current liabilities |
|
|
18,767,000 |
|
|
|
20,561,000 |
|
Deferred revenue, less current portion |
|
|
292,000 |
|
|
|
292,000 |
|
Other long-term liabilities |
|
|
399,000 |
|
|
|
445,000 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY: |
|
|
|
|
|
|
|
|
Preferred stock-$0.001 par value; authorized 5,000,000
shares; non-voting; nil shares outstanding |
|
|
- |
|
|
|
- |
|
Common stock-$0.001 par value; authorized 325,000,000
shares; outstanding - 160,248,742 and 143,768,946,
respectively |
|
|
160,000 |
|
|
|
143,000 |
|
Additional paid-in capital |
|
|
418,783,000 |
|
|
|
391,521,000 |
|
Accumulated deficit |
|
|
(383,294,000 |
) |
|
|
(367,904,000 |
) |
|
Total
stockholders' equity |
|
|
35,649,000 |
|
|
|
23,760,000 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
55,107,000 |
|
|
$ |
45,058,000 |
|
|
|
|
|
|
|
|
|
|
Contact: Christopher Keenan or Jay Carlson Peregrine
Pharmaceuticals (800) 987-8256 info@peregrineinc.com
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