News
Release
A.P.
PHARMA REPORTS RESULTS FOR THE FIRST QUARTER 2008
APF530
PHASE 3 TRIAL CLOSE TO COMPLETION
REDWOOD
CITY, Calif. (May 15, 2008) –
A.P. Pharma, Inc. (NASDAQ: APPA), a specialty pharmaceutical company,
today reported financial results for its first quarter ended March 31,
2008.
Highlights
Operational:
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·
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APF530 (Prevention
of CINV)
|
|
o
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Patient
enrollment almost complete
|
|
o
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Announcement
of trial results targeted for Q3
2008
|
|
o
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NDA
submission planned for late 2008
|
|
·
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APF112 (Post-surgical
pain relief)
|
|
o
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Preclinical
work completed
|
|
o
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Initiation
of Phase 2b trial will be delayed into Q3 2008 due to manufacturing
issue
|
|
o
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Expect
resolution of manufacturing issue within
weeks
|
|
·
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APF580 (Intense
pain relief)
|
|
o
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IND
submission shortly
|
|
o
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Plan
initiation of Phase 1 trial in Q2
2008
|
|
·
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CEO
Succession Program
|
|
o
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Active
discussions underway with prospective
candidates
|
Financial:
|
·
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Cash,
cash equivalents and marketable securities $27.8 million as of March
31,
2008
|
|
·
|
Sufficient
capital to complete APF530 clinical trial and initiate new clinical
programs
|
Results
of Operations
Our
net
loss for the first quarter was $6.8 million, or $0.22 per share, compared with
a
$6.0 million net loss, or $0.94 per share (computed on a much smaller
outstanding share base), for the first quarter of 2007. Our increased net loss
for the first quarter of 2008, as compared to the same period in 2007, was
principally due to increased research and development costs, resulting from
increased expenditures on APF580, our undisclosed opiate product candidate
for
pain, additional personnel and related costs to support our expanded activities,
including the higher activity level of our Phase 3 trial for APF530, and to
a
lesser extent, increased expenditures on our post-operative pain
product, APF112.
Contract
revenue related to the ongoing development program utilizing our proprietary
Biochronomer™ technology with a major animal healthcare company was $133
thousand in the first quarter of 2008 and $0 for the comparable period in
2007.
About
APF530
Our
lead
product candidate using our proprietary Biochronomer technology is APF530,
which
contains granisetron, a drug approved for the prevention of chemotherapy-induced
nausea and vomiting (CINV). We selected granisetron because it is a
potent drug that blocks a specific receptor found in the gut that is responsible
for triggering CINV. Additionally, the applicable granisetron U.S.
patent expired on December 29, 2007. APF530 is designed to provide at
least five days prevention of CINV. In September 2005, we completed a
Phase 2 human clinical trial of APF530 that achieved all of its primary and
secondary endpoints. In May 2006, we initiated our pivotal Phase 3
clinical trial of AFP530. We believe that this clinical trial will lead to
regulatory approval of APF530 for the prevention of acute and delayed onset
CINV
for patients undergoing both moderately and highly emetogenic, or
vomit-inducing, chemotherapy.
Our
pivotal Phase 3 clinical trial is a multi-center, randomized, observer-blind,
actively-controlled, double-dummy, parallel group study that will compare the
efficacy of APF530 with Aloxi®. The trial will include approximately 1,350
patients, stratified in two groups, one receiving moderately and the other
receiving highly emetogenic chemotherapeutic agents. In each group, the patients
are randomized to receive in the first chemotherapy treatment cycle either
APF530 high dose (10 mg), APF530 low dose (5 mg) or the currently approved
dose
of Aloxi. In subsequent treatment cycles (up to three additional cycles), the
patients are re-randomized to either of the two APF530 doses.
About
APF112
APF112
utilizes our Biochronomer delivery technology to target post-surgical pain
relief. The product is designed to provide up to 36 hours of
localized pain relief by delivering mepivacaine directly to the surgical
site. Mepivacaine is a well-known, short-acting local anesthetic with
an excellent safety profile. APF112 is designed to prolong the
anesthetic effect of mepivacaine, thereby minimizing or eliminating the use
of
opiates.
We
have
been completing additional preclinical work in early 2008 on a revised protocol
from that which was utilized in our 2004 Phase 2 trial. The previous
Phase 2 trial indicated excellent safety and tolerability, but did not produce
a
significant difference between APF112 and the standard of care, wherein the
latter showed significantly lower pain scores than exhibited in previously
published studies. Our plans to initiate a Phase 2b clinical trial of
APF112 in the second quarter of 2008 utilizing this revised protocol have been
delayed due to a manufacturing issue encountered while producing materials
for
this trial at our contract manufacturer. We determined that some
batches of our polymer, AP135, contained an extraneous material not present
in
previous lots of AP135. We believe we have identified the source of
this extraneous substance, and expect to conclude corrective actions and
reinitiate production of APF112 trial materials in the near
future. As a result of this issue, however, initiation of the APF
Phase 2b trial will be deferred into the third quarter of 2008.
There
should be no impact of this manufacturing issue on the APF530 Phase 3 clinical
trial and its timelines, or on the plans for APF580 as mentioned
below.
About
APF580
APF580
incorporates an opiate into our Biochronomer technology, and is designed to
provide analgesia lasting up to seven days by a single injection. It
is targeted for situations where the intensity and duration of pain require
use
of a presently undisclosed opiate rather than a local
anesthetic. APF580 may find use in acute and chronic pain settings,
improve patient compliance and reduce the risk of drug abuse.
Animal
studies with APF580 are currently being conducted, and data from those studies
are being supplemented with additional preclinical data from an ongoing research
and development agreement with a major animal health company, which is
evaluating APF580 for use in cats and dogs. We plan to initiate a
Phase 1 clinical trial of APF580 in the second quarter of 2008, and to initiate
a Phase 2 clinical trial in the fourth quarter of 2008.
Conference
call
Management
will host an investment-community conference call today beginning at 11:00
a.m.
Eastern time (8:00 a.m. Pacific time) to discuss the financial results, to
provide a business update and to answer questions.
To
participate in the live call by telephone, please dial (888) 803-8275 from
the
U.S. or (706) 634-1287 from outside the U.S. A telephone replay will
be available for 48 hours by dialing (800) 642-1687 from the U.S. or (706)
645-9291 from outside the U.S., and entering reservation number
47516329. The call will also be broadcast live on A.P. Pharma’s
website, www.appharma.com. A
replay will be available for 30 days.
About
A.P. Pharma
A.P.
Pharma is a specialty pharmaceutical company focused on the development of
ethical (prescription) pharmaceuticals utilizing its proprietary polymer-based
drug delivery systems. The Company's primary focus is the development and
commercialization of its bioerodible injectable and implantable systems under
the trade name Biochronomer. Initial target areas of application for the
Company's drug delivery technology include anti-nausea, pain management,
anti-inflammation and DNA/RNAI applications. For further information visit
the
Company's web site at www.appharma.com.
Forward-looking
Statements
This
news
release contains “forward-looking statements” as defined by the Private
Securities Reform Act of 1995. These forward-looking statements
involve risks and uncertainties, including uncertainties associated with timely
development, approval, launch and acceptance of new products, satisfactory
completion of clinical studies, establishment of new corporate alliances,
progress in research and development programs and other risks and uncertainties
identified in the Company’s filings with the Securities and Exchange
Commission. We caution investors that forward-looking statements
reflect our analysis only on their stated date. We do not intend to
update them except as required by law.
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Investor
Relations Contacts:
|
Company
Contacts:
|
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Lippert/Heilshorn
& Associates
|
Gregory
Turnbull
|
|
Don
Markley (dmarkley@lhai.com)
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President
and Chief Executive Officer
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(310)
691-7100
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(650)
366-2626
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(Financial
tables follow)
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A.P.
PHARMA, INC.
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Statement
of Operations Highlights
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|||
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(in
thousands, except per share data)
|
|||
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(Unaudited)
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|||
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Three
Months Ended March 31
|
|||
|
2008
|
2007
|
||
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Contract
revenue
|
$133
|
$0
|
|
|
Operating
expenses:
|
|||
|
Research
and development
|
6,140
|
4,987
|
|
|
General
and administrative
|
1,080
|
1,118
|
|
|
Total
operating expenses
|
7,220
|
6,105
|
|
|
Operating
loss
|
(7,087)
|
(6,105)
|
|
|
Interest
income, net
|
280
|
148
|
|
|
Other
income, net
|
3
|
0
|
|
|
Loss
from continuing operations
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(6,804)
|
(5,957)
|
|
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Loss
from discontinued operations
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(40)
|
(8)
|
|
|
Loss
before income taxes
|
(6,844)
|
(5,965)
|
|
|
Tax
provision
|
0
|
(36)
|
|
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Net
loss
|
$ (6,844)
|
$ (6,001)
|
|
|
Basic
and diluted net loss per common share:
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|||
|
Loss
from continuing operations
|
($0.22)
|
($0.94)
|
|
|
Net
loss
|
($0.22)
|
($0.95)
|
|
|
Shares
used to compute basic and diluted loss per
share
|
30,773
|
6,331
|
|
|
AP
PHARMA, INC.
|
|||
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Balance
Sheet Highlights
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|||
|
(in
thousands)
|
|||
|
March
31, 2008
|
December
31, 2007
|
||
|
(Unaudited)
|
(1)
|
||
|
Assets
|
|||
|
Cash,
cash equivalents and marketable securities
|
$27,834
|
$35,062
|
|
|
Accounts
receivable, net
|
133
|
152
|
|
|
Other
current assets
|
419
|
582
|
|
|
Total
current assets
|
28,386
|
35,796
|
|
|
Property
and equipment, net
|
1,212
|
1,079
|
|
|
Other
non-current assets
|
75
|
75
|
|
|
Total
assets
|
$29,673
|
$36,950
|
|
|
Liabilities
and stockholders' equity
|
|||
|
Total
liabilities
|
$6,725
|
$7,476
|
|
|
Stockholders'
equity
|
22,948
|
29,474
|
|
|
Total
liabilities and stockholders' equity
|
$29,673
|
$36,950
|
|
|
(1)
Derived from our audited financial statements for the year ended
December
31, 2007 included in the Company's 2007 Annual Report on Form 10-K
filed
with the Securities and Exchange
Commission.
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