UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of
Report (Date of earliest event reported) August 14, 2008
A.P.
Pharma, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-33221
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94-2875566
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(State
or other jurisdiction
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(Commission
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(I.R.S.
Employer
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of
incorporation)
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File
Number)
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Identification
No.)
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123
Saginaw Drive
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Redwood
City CA
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94063
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's
telephone number, including area code (650) 366-2626
N/A
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
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[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR
240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR
240.13e-4(c))
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INFORMATION
TO BE INCLUDED IN THE REPORT
ITEM
2.02 Results of Operations and Financial Condition
On
August 14, 2008, A.P. Pharma, Inc. (the “Company”) issued a press
release announcing its financial results for the second quarter and six
months ended June 30, 2008. The press release is attached as Exhibit
99.1.
The
information in this Current Report on Form 8-K, including the exhibit, is
furnished pursuant to Item 2.02 and shall not be deemed "filed" for the purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities under that Section. Furthermore, the
information in the Current Report on Form 8-K, including the exhibit, shall
not
be deemed to be incorporated by reference into the filings of the Company
under
the Securities Act of 1933, as amended.
ITEM
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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A.P.
Pharma, Inc.
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Date:
August 14, 2008
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/S/
Ronald J. Prentki
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Ronald
J. Prentki
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President,
Chief Executive Officer and
Director
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EXHIBIT
INDEX
News
Release
A.P.
PHARMA REPORTS RESULTS FOR THE SECOND QUARTER 2008
REDWOOD
CITY, Calif. (August 14,
2008) – A.P. Pharma, Inc. (NASDAQ: APPA), a specialty pharmaceutical
company, today reported financial results for its second quarter ended June
30,
2008.
Highlights
Operational:
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·
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Ronald
Prentki appointed President, Chief Executive Officer and
Director
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·
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APF530
(prevention of chemotherapy-induced nausea and
vomiting)
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o
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Patient
enrollment completed in Phase 3
trial
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o
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Announcement
of trial results remains targeted for late Q3
2008
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o
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NDA
submission planned for late 2008
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·
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Product
pipeline schedule adjustments
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o
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APF112
(post-surgical pain relief)
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o
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APF580
(intense pain relief)
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Financial:
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·
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Cash,
cash equivalents and marketable securities of $21.5 million as of
June 30,
2008
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·
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Sufficient
capital to complete APF530 clinical trial and initiate new clinical
programs
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“Our
programs continue to make important progress, and we look forward to reporting
the results from the Phase 3 trial for our lead candidate, APF530, later this
quarter,” said Ronald Prentki, the Company’s President and Chief Executive
Officer. “While our cash position is sufficient to complete the
APF530 trial and move forward with other programs, we also continue to evaluate
strategic partnership opportunities that may provide non-dilutive funding in
addition to development and marketing assistance.”
Results
of Operations
Our
net
loss for the second quarter was $6.1 million, or $0.20 per share, compared
with
a net loss of $1.8 million, or $0.19 per share (computed on a significantly
smaller outstanding share base), for the second quarter of 2007. In June 2007
the Company raised $37.2 million through the sale of 24.4 million shares of
common stock. Our increased net loss for the second quarter of 2008, as compared
with the same period in 2007, was principally due to a gain on the sale of
our
interest in royalties of $2.5 million in 2007, and an increase in research
and
development costs in 2008 of $1.8 million resulting from increased clinical
trial and related costs for our APF530 Phase 3 trial, increased costs associated
with our post-operative pain product and our undisclosed opiate pain product,
as
well as additional personnel and related costs to support our expanded
activities, including the planned filing of a new drug application (NDA) in
late
2008.
Contract
revenues related to the ongoing development program utilizing our proprietary
Biochronomer™ technology with a major animal healthcare company were $152,000 in
the second quarter of 2008, compared with $160,000 in the second quarter of
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 maintain
therapeutic drug levels which will provide for 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 for APF530. The
trial is a multi-center, randomized, observer-blind, actively-controlled,
double-dummy, parallel group study that compares the efficacy of APF530 with
Aloxi®. Patients were stratified in two groups, one receiving
moderately and the other receiving highly emetogenic (or vomit-inducing)
chemotherapeutic agents. In each group, the patients were 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 were
re-randomized to either of the two APF530 doses. In June 2008 the
company completed enrollment of approximately 1,400 patients in the
trial.
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 chemotherapy. The Company anticipates clinical
trial results will be announced in the third quarter and that an NDA will be
filed with the FDA by the end of 2008.
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.
In
2004
we completed a Phase 2 clinical study with APF112 which indicated excellent
safety and tolerability, but did not produce a significant difference between
APF112 and the standard of care. We believe the reason for the lack
of differentiation was that the control group showed significantly lower pain
scores than those exhibited in previously published studies. In 2008
we have completed additional preclinical work and our plan is to initiate a
Phase 2b clinical trial of APF112, in 4Q 2008, which will incorporate certain
modifications in dosing and tighter control of rescue medications.
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 an opiate rather than a local anesthetic. APF580 may have utility
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 are completing our
preparation of the Investigational New Drug Application (IND) for APF580, which
we plan to submit in 3Q 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
58503776. 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:
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Company
Contacts:
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Lippert/Heilshorn
& Associates
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Ronald
Prentki
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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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Results
of Operations Highlights
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(in
thousands, except per share data)
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(Unaudited)
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Three
Months Ended
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Six
Months Ended
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June
30,
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June
30,
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June
30,
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June
30,
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|||||||||||||
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2008
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2007
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2008
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2007
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Contract
Revenues
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$ | 152 | $ | 160 | $ | 284 | $ | 160 | ||||||||
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Operating
Expenses:
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Research
& Development
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5,538 | 3,763 | 11,678 | 8,749 | ||||||||||||
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General
& Administrative
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863 | 872 | 1,943 | 1,991 | ||||||||||||
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Total
Operating Expenses
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6,401 | 4,635 | 13,621 | 10,740 | ||||||||||||
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Operating
Loss
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(6,249 | ) | (4,475 | ) | (13,337 | ) | (10,580 | ) | ||||||||
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Interest
Income, Net
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155 | 156 | 436 | 304 | ||||||||||||
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Gain
on Sale of Interest in Royalties
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— | 2,500 | — | 2,500 | ||||||||||||
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Other
Income , Net
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4 | 3 | 7 | 3 | ||||||||||||
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Loss
from Continuing Operations
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(6,090 | ) | (1,816 | ) | (12,894 | ) | (7,773 | ) | ||||||||
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Income
(Loss) from Discontinued Operations
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(40 | ) | 40 | (80 | ) | 32 | ||||||||||
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Loss
before Income Taxes
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(6,130 | ) | (1,776 | ) | (12,974 | ) | (7,741 | ) | ||||||||
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Provision
for Income Taxes
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— | — | — | (36 | ) | |||||||||||
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Net
Loss
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$ | (6,130 | ) | $ | (1,776 | ) | $ | (12,974 | ) | $ | (7,777 | ) | ||||
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Basic
and Diluted Net Loss Per Common Share:
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Loss
from Continuing Operations
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$ | (0.20 | ) | $ | (0.19 | ) | $ | (0.42 | ) | $ | (0.98 | ) | ||||
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Net
Loss
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$ | (0.20 | ) | $ | (0.19 | ) | $ | (0.42 | ) | $ | (0.98 | ) | ||||
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Shares
Used in Calculating Net Loss Per Share
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30,800 | 9,591 | 30,786 | 7,961 | ||||||||||||
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AP
PHARMA, INC.
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Balance
Sheet Highlights
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(in
thousands)
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||||||||
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June
30, 2008
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December
31, 2007
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(Unaudited)
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(1)
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Assets
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Cash,
Cash Equivalents and Marketable Securities
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$ | 21,520 | $ | 35,062 | ||||
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Accounts
Receivable, Net
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152 | 152 | ||||||
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Other
Current Assets
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489 | 582 | ||||||
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Total
Current Assets
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22,161 | 35,796 | ||||||
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Property
and Equipment, Net
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1,163 | 1,079 | ||||||
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Other
Non-Current Assets
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103 | 75 | ||||||
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Total
Assets
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$ | 23,427 | $ | 36,950 | ||||
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Liabilities
and Stockholders' Equity
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||||||||
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Total
Liabilities
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6,246 | 7,476 | ||||||
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Stockholders'
Equity
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17,181 | 29,474 | ||||||
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Total
Liabilities and Stockholders' Equity
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$ | 23,427 | $ | 36,950 | ||||
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(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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