Peregrine Pharmaceuticals Reports Third Quarter Fiscal Year 2014
Financial Results and Recent Developments
Bavituximab SUNRISE Pivotal Phase III Trial in Second-Line
Non-Small Cell Lung Cancer Initiated and Patient Dosing Underway;
Company Receives Fast Track Designation of Bavituximab in
Second-Line NSCLC; Company Strengthens Balance Sheet With $79.7
Million in Cash as of February 28, 2014 as It Continues to Execute
on Its Business Strategy
TUSTIN, CA--(Marketwired - Mar 7, 2014) - Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), a
biopharmaceutical company focused on the development of
first-in-class monoclonal antibodies for the treatment and
diagnosis of cancer, today announced financial results for the
third quarter of fiscal year (FY) 2014 ended January 31, 2014 and
provided an update on its advancing clinical pipeline and other
corporate developments.
"We reached a significant milestone this quarter with the
initiation of the bavituximab Phase III SUNRISE trial in
second-line non-small cell lung cancer while also receiving fast
track designation for the same indication," said Steven W. King,
president and chief executive officer of Peregrine. "We are also
making great strides in advancing new immunotherapy combinations
into the clinic with bavituximab, representing novel immunotherapy
combinations. We are close to initiating the first of these
studies in evaluating bavituximab in combination with ipilimumab in
advanced melanoma patients. We expect that this trial will be the
first of many immunotherapy combinations that will allow us to
explore the potential of bavituximab to improve the activity of
other immunotherapies. Our scientists and collaborators will be
presenting at several upcoming scientific conferences and we look
forward to sharing additional data supporting this effort."
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
- Opened to enrollment and actively dosing patients in 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 is
evaluating 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 are being randomized into 1 of 2
treatment arms. All patients are receiving 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 is
overall survival. For additional information about the SUNRISE
trial visit www.sunrisetrial.com or ClinicalTrials.gov using
Identifier NCT01999673.
- During the quarter, the company received Fast Track Designation
from the U.S. Food and Drug Administration (FDA) for bavituximab in
the potential treatment of second-line NSCLC. The Fast Track
programs of the FDA are designed to facilitate the development and
expedite the review of new drugs that are intended to treat serious
or life-threatening conditions and that demonstrate the potential
to address unmet medical needs.
Clinical Data that Supports New Bavituximab Oncology
Indications:
- The company is evaluating the best way to build on data from a
Phase I clinical study that evaluated bavituximab in combination
with paclitaxel in 13 patients with HER2-negative metastatic breast
cancer including approximately half of the patients that were
"triple negative". The encouraging interim data in patients
that received the combination was presented at the 2013 American
Society of Clinical Oncology (ASCO) Annual Meeting showed 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 from the study is anticipated in
2014.
Exploring Additional Bavituximab Indications through
Investigator-Sponsored Trials (IST):
- A Phase I/II IST evaluating bavituximab in combination with
sorafenib in up to 48 patients with advanced hepatocellular
carcinoma (liver cancer). A presentation of this trial will be made
by Adam Yopp, M.D., Assistant Professor of Surgery at the
University of Texas Southwestern Medical Center, Dallas, Texas as
an oral presentation at the 2014 Society of Surgical Oncology
Cancer Symposium on March 13, 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
- Peregrine is exploring the potential to combine bavituximab
with other immunotherapies such as those targeting the PD-1 and
CTLA-4 pathways and has initiated multiple proof-of-concept studies
that could support new immunotherapy combination trials. In
advance of this, multiple proof-of-concept preclinical studies are
now underway with data anticipated throughout 2014.
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
The company recently closed an underwritten public offering of
775,000 shares of its 10.50% Series E Convertible Preferred Stock
(the "Series E Preferred Stock") at an offering price of $25.00 per
share. As a result, Peregrine received gross proceeds of
$19,375,000 before deducting underwriting discounts and
commissions. The company intends to use the proceeds from the
offering for general corporate purposes. The shares are listed on
the NASDAQ Capital Market and trade under the symbol "PPHMP".
FINANCIAL RESULTS
"We recently completed an innovative and less dilutive financing
with the closing of the Series E Preferred Stock transaction. This
transaction further strengthened our balance sheet with close to
$80 million in cash and cash equivalents as of February 28, 2014,"
said Paul Lytle, chief financial officer of Peregrine.
"Additionally, we also generated over $3.9 million in non-dilutive
contract manufacturing revenue this quarter and we are on track to
be on the higher end of our previously stated guidance for the
entire FY 2014 of $18 and $22 million."
Total revenues for the third quarter of FY 2014 were $3,885,000,
compared to $7,039,000 for the same quarter of the prior fiscal
year. This decrease was primarily attributable to lower
contract manufacturing revenue generated by Peregrine's
biomanufacturing subsidiary Avid Bioservices, which generated
contract manufacturing revenue of $3,885,000 for the third quarter
of FY 2014, compared to $6,961,000 for the same quarter of the
prior fiscal year. The decrease in contract manufacturing
revenue was primarily due to the timing of services provided to
Avid's third-party customers.
Total costs and expenses in the third quarter of FY 2014 were
$13,628,000, compared to $12,200,000 in the third quarter of FY
2013. This increase was attributable to current quarter
increases in research and development expenses and selling, general
and administrative expenses, which were offset by the current
quarter decrease in cost of contract manufacturing associated with
lower revenues in the current quarter. The increase in
research and development expenses for the third quarter FY 2014
compared to the third quarter of FY 2013 was primarily attributable
to expenses associated with preparing for the initiation of 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 third quarter FY 2014
compared to the third quarter of FY 2013 was primarily attributable
to increases in payroll and related expenses, share-based
compensation expense (non-cash) and corporate legal fees.
Peregrine's consolidated net loss was $9,724,000, or $0.06 per
share, for the third quarter of FY 2014, compared to a net loss of
$4,914,000, or $0.04 per share, for the same quarter of the prior
year.
Peregrine reported cash and cash equivalents of $63,177,000 at
its quarter ended January 31, 2014 and $79,673,000 at February 28,
2014, including net proceeds from the Series E Preferred Stock
transaction, compared to $44,443,000 at its previous quarter ended
October 31, 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 morning, March 7, 2014, at 11:00 AM ET (8:00 AM
PT).
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 March 14, 2014 by
calling (855) 859-2056, or
(404) 537-3406 and
using passcode 4248303.
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 is developing
multiple clinical programs in cancer with its lead immunotherapy
candidate bavituximab while seeking a partner to further advance
its novel brain cancer agent Cotara®. 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 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 January 31, |
|
|
Nine Months Ended January 31, |
|
|
2014 |
|
|
2013 |
|
|
2014 |
|
|
2013 |
|
|
Unaudited |
|
|
Unaudited |
|
|
Unaudited |
|
|
Unaudited |
|
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract manufacturing revenue |
$ |
3,885,000 |
|
|
$ |
6,961,000 |
|
|
$ |
15,820,000 |
|
|
$ |
17,157,000 |
|
License revenue |
|
- |
|
|
|
78,000 |
|
|
|
107,000 |
|
|
|
272,000 |
|
|
Total
revenues |
|
3,885,000 |
|
|
|
7,039,000 |
|
|
|
15,927,000 |
|
|
|
17,429,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of contract manufacturing |
|
2,416,000 |
|
|
|
3,651,000 |
|
|
|
9,281,000 |
|
|
|
9,378,000 |
|
Research and development |
|
6,649,000 |
|
|
|
5,437,000 |
|
|
|
18,910,000 |
|
|
|
18,471,000 |
|
Selling, general and administrative |
|
4,563,000 |
|
|
|
3,112,000 |
|
|
|
12,913,000 |
|
|
|
9,469,000 |
|
|
Total
costs and expenses |
|
13,628,000 |
|
|
|
12,200,000 |
|
|
|
41,104,000 |
|
|
|
37,318,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
(9,743,000 |
) |
|
|
(5,161,000 |
) |
|
|
(25,177,000 |
) |
|
|
(19,889,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
23,000 |
|
|
|
255,000 |
|
|
|
68,000 |
|
|
|
307,000 |
|
Interest and other expense |
|
(4,000 |
) |
|
|
(8,000 |
) |
|
|
(5,000 |
) |
|
|
(53,000 |
) |
Loss on early extinguishment of debt |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,696,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
$ |
(9,724,000 |
) |
|
$ |
(4,914,000 |
) |
|
$ |
(25,114,000 |
) |
|
$ |
(21,331,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
$ |
(9,724,000 |
) |
|
$ |
(4,914,000 |
) |
|
$ |
(25,114,000 |
) |
|
$ |
(21,331,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and Diluted |
|
163,223,767 |
|
|
|
131,489,994 |
|
|
|
156,521,874 |
|
|
|
114,726,569 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
$ |
(0.06 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.19 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PEREGRINE PHARMACEUTICALS, INC. |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
|
|
JANUARY 31, 2014 |
|
|
APRIL 30, 2013 |
|
|
Unaudited |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
63,177,000 |
|
|
$ |
35,204,000 |
|
Trade and other receivables, net |
|
2,782,000 |
|
|
|
1,662,000 |
|
Inventories |
|
5,224,000 |
|
|
|
4,339,000 |
|
Prepaid expenses and other current assets, net |
|
1,050,000 |
|
|
|
709,000 |
|
|
Total
current assets |
|
72,233,000 |
|
|
|
41,914,000 |
|
Property and equipment, net |
|
2,514,000 |
|
|
|
2,678,000 |
|
Other assets |
|
1,738,000 |
|
|
|
466,000 |
|
TOTAL ASSETS |
$ |
76,485,000 |
|
|
$ |
45,058,000 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,879,000 |
|
|
$ |
2,821,000 |
|
Accrued clinical trial and related fees |
|
1,358,000 |
|
|
|
930,000 |
|
Accrued payroll and related costs |
|
3,309,000 |
|
|
|
3,582,000 |
|
Deferred revenue, current portion |
|
4,329,000 |
|
|
|
4,171,000 |
|
Customer deposits |
|
8,646,000 |
|
|
|
8,059,000 |
|
Other current liabilities |
|
1,228,000 |
|
|
|
998,000 |
|
|
Total
current liabilities |
|
20,749,000 |
|
|
|
20,561,000 |
|
Deferred revenue, less current portion |
|
292,000 |
|
|
|
292,000 |
|
Other long-term liabilities |
|
373,000 |
|
|
|
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 - 176,453,261 and 143,768,946,
respectively |
|
176,000 |
|
|
|
143,000 |
|
Additional paid-in capital |
|
447,913,000 |
|
|
|
391,521,000 |
|
Accumulated deficit |
|
(393,018,000 |
) |
|
|
(367,904,000 |
) |
|
Total
stockholders' equity |
|
55,071,000 |
|
|
|
23,760,000 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
76,485,000 |
|
|
$ |
45,058,000 |
|
|
|
|
|
|
|
|
|
Contact: Christopher Keenan or Jay Carlson Peregrine
Pharmaceuticals (800) 987-8256
info@peregrineinc.com
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