CRANBURY, N.J., Feb. 13, 2015 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential, today announced results for its second
quarter ended December 31,
2014.
"We achieved a significant clinical and corporate milestone by
advancing bremelanotide for the treatment of female sexual
dysfunction into the phase 3 pivotal stage in the U.S. Both trials
of the phase 3 reconnect study are active and enrolling
patients," said Carl Spana, Ph.D.,
President and CEO of Palatin. "We currently project
completing enrollment in the second half of calendar year 2015 and
reporting topline results in mid-calendar year 2016."
Recent Highlights
- Bremelanotide development for Female Sexual Dysfunction (FSD):
- December 2014 and January 2015, Palatin initiated Protocols 301 and
302 of its phase 3 clinical trial reconnect study in
the United States for the
treatment of female sexual dysfunction (FSD).
- Each pivotal trial of the reconnect study is a
multicenter (~80 sites), randomized, placebo controlled,
parallel-group, eight month trial with an open-label extension
phase. The clinical trials are designed to randomize approximately
1100 women (~550 each trial) in North
America to evaluate the efficacy and safety of subcutaneous
bremelanotide in premenopausal women with hypoactive sexual desire
disorder (HSDD) as an on-demand, as-needed treatment. More
information on the trial protocol, including trial design and
inclusion/exclusion criteria, can be found at
http://clinicaltrials.gov.
- The start of the reconnect study in the U.S. triggered a
development milestone payment of €2.5 million (approximately
$3 million) from Gedeon Richter Plc,
which was recognized as revenue in the quarter ended December 31, 2014.
- In November 2014 Palatin obtained
U.S. Patent 8,877,890 for melanocortin receptor-1 cyclic peptides
with potential application in treatment of inflammatory and
dermatologic disease indications.
- In December 2014, Palatin
received $0.5 million in net proceeds
from the sale of New Jersey state
net operating loss carryforwards, which resulted in the recognition
of $0.5 million in tax benefits for
the quarter ended December 31,
2014.
- In December 2014, Palatin closed
on debt and equity financing consisting of:
- $10.0 million venture loan, which
includes an interest-only payment period for the first eighteen
months, is a four year senior secured term loan that bears interest
at a floating coupon rate of one-month LIBOR (floor of 0.50%) plus
8.50%. The lenders also received immediately exercisable Series D
warrants to purchase 666,666 shares of Palatin's common stock at an
exercise price of $0.75 per share
which expire on the fifth anniversary of the date of issuance.
- A private placement of 2,050,000 shares of its common stock and
Series C warrants to purchase 24,949,325 shares of its common
stock. Two accredited investment funds invested $10 million each. The funds paid $0.75 for each share of common stock and
$0.74 for each Series C warrant,
resulting in gross proceeds to Palatin of $20 million, with net proceeds, after deducting
estimated offering expenses, of approximately $18.6 million. The Series C warrants are
exercisable at an exercise price of $0.01 per share immediately upon issuance and
expire on the tenth anniversary of the date of issuance.
Second Quarter Fiscal 2015 Financial Results
Palatin
reported net income of $2.8 million,
or $0.03 per basic and diluted share,
for the quarter ended December 31,
2014, compared to a net loss of $3.6
million, or $(0.03) per basic
and diluted share, for the same period in
2013.
The increase in net income for the quarter ended December 31, 2014 compared to the same period
last fiscal year was mainly attributable to the recognition of
approximately $8.0 million in
contract revenue pursuant to our agreement with Gedeon Richter.
Revenue
For the quarter ended December 31, 2014, Palatin recognized the
remaining $4.9 million of license
revenue (previously deferred) under our agreement with Gedeon Richter plus approximately $3.1 million from a development milestone upon
the start of the reconnect study in the U.S. There
were no revenues recorded in the quarter ended December 31, 2013.
Operating Expenses
Total operating expenses for the
quarter ended December 31, 2014 were
$5.7 million compared to $3.6 million for the comparable quarter of
2013. The increase in operating expenses for the quarter
ended December 31, 2014 was the
result of an increase in costs primarily relating to phase 3
clinical trial program costs for bremelanotide for the treatment of
FSD.
Cash Position
Palatin's cash and cash equivalents were
$42.7 million, with accounts
receivable of approximately $3.0
million as of December 31,
2014, compared to cash and cash equivalents $12.2 million at June 30,
2014. Current liabilities were $5.1 million as of December 31, 2014, compared to $1.8 million, net of $1.0
million of deferred revenue, as of June 30, 2014.
Palatin believes that existing capital resources will be
adequate to fund our planned operations through the quarter ending
March 31, 2016.
CONFERENCE CALL / WEBCAST
Palatin will host a
conference call and webcast on February 13,
2015 at 11:00 a.m. Eastern
Time to discuss the results of operations in greater detail
and provide an update on corporate developments. Individuals
interested in listening to the conference call live can dial
1-888-510-1765 (domestic) or 1-719-457-2689 (international), pass
code 9168599. The webcast and replay can be accessed by
logging on to the "Investor/Media Center-Webcasts" section of
Palatin's website at http://www.palatin.com. A telephone and
webcast replay will be available approximately one hour after the
completion of the call. To access the telephone replay, dial
1-888-203-1112 (domestic) or 1-719-457-0820 (international), pass
code 9168599.
About Palatin Technologies, Inc.
Palatin
Technologies, Inc. is a biopharmaceutical company developing
targeted, receptor-specific peptide therapeutics for the treatment
of diseases with significant unmet medical need and commercial
potential. Palatin's strategy is to develop products and then form
marketing collaborations with industry leaders in order to maximize
their commercial potential. For additional information
regarding Palatin, please visit Palatin's website at
www.Palatin.com.
Forward-looking Statements
Statements in this press
release that are not historical facts, including statements about
future expectations of Palatin Technologies, Inc., such as
statements about clinical trial results, potential actions by
regulatory agencies including the FDA, regulatory plans,
development programs, proposed indications for product candidates
and market potential for product candidates, are "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and as
that term is defined in the Private Securities Litigation Reform
Act of 1995. Palatin intends that such forward-looking statements
be subject to the safe harbors created thereby. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that could cause Palatin's actual
results to be materially different from its historical results or
from any results expressed or implied by such forward-looking
statements. Palatin's actual results may differ materially from
those discussed in the forward-looking statements for reasons
including, but not limited to, results of clinical trials,
regulatory actions by the FDA and the need for regulatory
approvals, Palatin's ability to fund development of its technology
and establish and successfully complete clinical trials, the length
of time and cost required to complete clinical trials and submit
applications for regulatory approvals, products developed by
competing pharmaceutical, biopharmaceutical and biotechnology
companies, commercial acceptance of Palatin's products, and other
factors discussed in Palatin's periodic filings with the Securities
and Exchange Commission. Palatin is not responsible for updating
for events that occur after the date of this press release.
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Six Months Ended
December 31,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
Contract
revenue
|
$
8,019,415
|
|
$
-
|
|
$ 12,951,730
|
|
$
-
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
Research and
development
|
4,273,571
|
|
2,630,368
|
|
7,197,537
|
|
6,079,508
|
General and
administrative
|
1,423,206
|
|
980,070
|
|
2,537,667
|
|
2,023,580
|
Total operating
expenses
|
5,696,777
|
|
3,610,438
|
|
9,735,204
|
|
8,103,088
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
2,322,638
|
|
(3,610,438)
|
|
3,216,526
|
|
(8,103,088)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
|
|
Investment
income
|
6,199
|
|
4,931
|
|
9,998
|
|
10,250
|
Interest
expense
|
(31,857)
|
|
(954)
|
|
(33,587)
|
|
(2,805)
|
Foreign exchange
transaction loss
|
(51,700)
|
|
-
|
|
(152,983)
|
|
-
|
Total other (expense)
income, net
|
(77,358)
|
|
3,977
|
|
(176,572)
|
|
7,445
|
|
|
|
|
|
|
|
|
Income (loss) before
income taxes
|
2,245,280
|
|
(3,606,461)
|
|
3,039,954
|
|
(8,095,643)
|
Income tax
benefit
|
531,508
|
|
-
|
|
531,508
|
|
-
|
|
|
|
|
|
|
|
|
NET INCOME
(LOSS)
|
$
2,776,788
|
|
$ (3,606,461)
|
|
$
3,571,462
|
|
$ (8,095,643)
|
|
|
|
|
|
|
|
|
Basic net income
(loss) per common share
|
$
0.03
|
|
$
(0.03)
|
|
$
0.03
|
|
$
(0.08)
|
|
|
|
|
|
|
|
|
Diluted net income
(loss) per common share
|
$
0.03
|
|
$
(0.03)
|
|
$
0.03
|
|
$
(0.08)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic net
income (loss) per common share
|
109,314,460
|
|
106,668,186
|
|
108,134,179
|
|
106,638,953
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing diluted net
income (loss) per common share
|
109,815,718
|
|
106,668,186
|
|
108,888,313
|
|
106,638,953
|
|
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
December 31,
2014
|
|
June 30,
2014
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
42,694,472
|
|
$
12,184,605
|
Accounts
receivable
|
3,035,400
|
|
-
|
Prepaid expenses and
other current assets
|
1,484,703
|
|
156,393
|
Total current
assets
|
47,214,575
|
|
12,340,998
|
|
|
|
|
Property and
equipment, net
|
185,563
|
|
160,748
|
Other
assets
|
190,835
|
|
57,308
|
Total assets
|
$
47,590,973
|
|
$
12,559,054
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,914,038
|
|
$
261,280
|
Accrued
expenses
|
3,183,027
|
|
1,508,958
|
Capital lease
obligations
|
25,128
|
|
-
|
Deferred
revenue
|
-
|
|
1,000,000
|
Total current
liabilities
|
5,122,193
|
|
2,770,238
|
|
|
|
|
Notes payable, net of
discount
|
9,734,509
|
|
-
|
Capital lease
obligations
|
54,872
|
|
-
|
Other non-current
libilities
|
4,348
|
|
-
|
Total
liabilities
|
14,915,922
|
|
2,770,238
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares;
|
|
|
|
Series A Convertible;
issued and outstanding 4,697 shares as of December 31, 2014 and
June 30, 2014, respectively
|
47
|
|
47
|
Common stock of $0.01
par value – authorized 300,000,000 shares;
|
|
|
|
issued and outstanding
41,540,161 shares as of December 31, 2014 and 39,416,595 as of June
30, 2014, respectively
|
415,401
|
|
394,166
|
Additional paid-in
capital
|
302,721,894
|
|
283,428,356
|
Accumulated
deficit
|
(270,462,291)
|
|
(274,033,753)
|
Total stockholders'
equity
|
32,675,051
|
|
9,788,816
|
Total liabilities and
stockholders' equity
|
$
47,590,973
|
|
$
12,559,054
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.