CRANBURY, N.J., Nov. 12, 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 first quarter
ended September 30, 2015.
Recent Highlights
- Bremelanotide development for Female Sexual Dysfunction (FSD):
- Palatin's two Phase 3 clinical trials for the treatment of FSD
initiated in December 2014 and
January 2015 are progressing as
planned and meeting target objectives.
- Patient enrollment is over 90% complete and is expected to be
completed by the end of this calendar year.
- Top-line results are expected to be released in the third
quarter of calendar year 2016.
- The clinical trials are designed to randomize approximately
1,100 women (~550 each trial) to evaluate efficacy and safety of
subcutaneous bremelanotide in premenopausal women with hypoactive
sexual desire disorder as an on-demand, as-needed treatment. For
more information visit reconnectstudy.com.
- Financing Transactions
- July 2015, Palatin closed on
$30 million of debt and equity
financing consisting of:
- $10 million venture loan, which
includes an interest-only payment period for the first eighteen
months of a four year secured term loan.
- $20 million private placement of
Series E warrants to purchase 21,917,808 shares of common stock and
Series F warrants to purchase 2,191,781 shares of common
stock.
First Quarter Fiscal 2016 Financial Results
Palatin reported a net loss of $(12.4)
million, or $(0.08) per basic
and diluted share, for the quarter ended September 30, 2015, compared to net income of
$0.8 million, or $0.01 per basic and diluted share, for the same
period in 2014.
The difference for the three months ended September 30, 2015 and 2014 was primarily
attributable to the increase in expenses relating to the Phase 3
clinical trial program with bremelanotide for FSD in the quarter
ended September 30, 2015 and
secondarily to the revenue recognition of the upfront payment
relating to the license agreement with Gedeon Richter in the quarter ended September 30, 2014.
Revenue
There were no revenues recorded in the
quarter ended September 30, 2015.
Palatin recognized $4.9 million of
license revenue under our agreement with Gedeon Richter for the quarter ended
September 30, 2014, which consisted
entirely of the portion of the license payment that was
non-contingent and non-refundable.
Operating Expenses
Total operating expenses for
the quarter ended September 30, 2015
were $11.8 million compared to
$4.0 million for the comparable
quarter of 2014. The increase in operating expenses for the
quarter ended September 30, 2015 was
the result of an increase in costs primarily relating to the Phase
3 clinical trial program with bremelanotide for FSD.
Other Income/Expense
Total other income
(expense), net, was $(0.6) million
for the quarter ended September 30,
2015 consisting primarily of interest expense related to the
venture debt and $(0.1) million
primarily consisting of a foreign exchange transaction loss for the
quarter ended September 30, 2014.
Cash Position
Palatin's cash and cash
equivalents were $47.5 million as of
September 30, 2015, compared to cash
and cash equivalents $27.3 million at
June 30, 2015. Current
liabilities were $10.6 million as of
September 30, 2015, compared to
$7.4 million as of June 30, 2015.
Palatin believes that existing capital resources will be
adequate to fund our planned operations through the quarter ending
September 30, 2016.
CONFERENCE CALL / WEBCAST
Palatin will
host a conference call and webcast on November 12, 2015 at 11:00
a.m. Eastern Time to discuss the results of operations in
greater detail and an update on corporate developments.
Individuals interested in listening to the conference call live can
dial 1-877-876-9177 (domestic) or 1-785-424-1666 (international),
pass code 194249. 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 194249. The webcast and telephone replay will be
available through November 19,
2015.
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.
(Financial Statement Data Follows)
|
PALATIN
TECHNOLOGIES, INC.
|
|
and
Subsidiary
|
|
Consolidated
Statements of Operations
|
|
(unaudited)
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
License
revenue
|
$
-
|
|
$
4,932,315
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
Research and
development
|
10,597,714
|
|
2,923,966
|
|
|
General and
administrative
|
1,199,937
|
|
1,114,461
|
|
|
Total operating
expenses
|
11,797,651
|
|
4,038,427
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
(11,797,651)
|
|
893,888
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
Interest
income
|
15,740
|
|
3,799
|
|
|
Interest
expense
|
(628,008)
|
|
(1,730)
|
|
|
Foreign exchange
transaction loss
|
-
|
|
(101,283)
|
|
|
Total other income
(expense), net
|
(612,268)
|
|
(99,214)
|
|
|
|
|
|
|
|
|
|
|
|
|
NET (LOSS)
INCOME
|
$ (12,409,919)
|
|
$
794,674
|
|
|
|
|
|
|
|
Basic net (loss)
income per common share
|
$
(0.08)
|
|
$
0.01
|
|
|
|
|
|
|
|
Diluted net (loss)
income per common share
|
$
(0.08)
|
|
$
0.01
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic net
(loss) income per common share
|
156,357,755
|
|
106,953,898
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing diluted net
(loss) income per common share
|
156,357,755
|
|
107,946,021
|
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
|
and
Subsidiary
|
|
Consolidated
Balance Sheets
|
|
(unaudited)
|
|
|
|
|
|
September 30,
2015
|
|
June 30,
2015
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
47,523,791
|
|
$
27,299,268
|
|
Prepaid expenses and
other current assets
|
1,810,151
|
|
1,896,747
|
|
Total current
assets
|
49,333,942
|
|
29,196,015
|
|
|
|
|
|
Property and
equipment, net
|
130,199
|
|
123,158
|
|
Other
assets
|
219,983
|
|
155,279
|
|
Total
assets
|
$
49,684,124
|
|
$
29,474,452
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
3,436,844
|
|
$
1,106,484
|
|
Accrued
expenses
|
6,247,586
|
|
6,223,483
|
|
Notes payable, net of
discount
|
907,259
|
|
-
|
|
Capital lease
obligations
|
26,251
|
|
25,871
|
|
Total current
liabilities
|
10,617,940
|
|
7,355,838
|
|
|
|
|
|
Notes payable, net of
discount, net of current portion
|
18,618,459
|
|
9,781,086
|
|
Capital lease
obligations
|
35,041
|
|
41,749
|
|
Other non-current
liabilities
|
178,261
|
|
91,304
|
|
Total
liabilities
|
29,449,701
|
|
17,269,977
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares;
|
|
|
|
|
Series A Convertible;
issued and outstanding 4,030 shares as of September 30, 2015 and
4,697 shares as of June 30, 2015, respectively
|
40
|
|
47
|
|
Common stock of $0.01
par value – authorized 300,000,000 shares;
|
|
|
|
|
issued and
outstanding 68,029,352 shares as of September 30, 2015 and
57,128,433 shares as of June 30, 2015, respectively
|
680,293
|
|
571,284
|
|
Additional paid-in
capital
|
323,663,325
|
|
303,332,460
|
|
Accumulated
deficit
|
(304,109,235)
|
|
(291,699,316)
|
|
Total stockholders'
equity
|
20,234,423
|
|
12,204,475
|
|
Total liabilities and
stockholders' equity
|
$
49,684,124
|
|
$
29,474,452
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.