CRANBURY, N.J., May 17, 2016 /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 third quarter
ended March 31, 2016.
Quarter Ended March 31, 2016
and 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 was completed in the fourth quarter of
calendar year 2015.
- Last patient out is expected in the third quarter of calendar
year 2016.
- Top-line results are expected to be released in the third
quarter of calendar year 2016.
- The clinical trials randomized 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.
- A Notice of Allowance was issued by the U.S. Patent and
Trademark Office on a patent for methods of treating female sexual
dysfunction using the dose and formulation in Phase 3 trials.
Third Quarter Fiscal 2016 Financial Results
Palatin
reported a net loss of $(12.7)
million, or $(0.08) per basic
and diluted share, for the quarter ended March 31, 2016, compared to a net loss of
$(9.2) million, or $(0.07) per basic and diluted share, for the same
period in 2015.
The difference between the three months ended March 31, 2016 and 2015 was primarily
attributable to the increase in expenses relating to the Phase 3
clinical trial program with bremelanotide for FSD in the quarter
ended March 31, 2016.
Revenue
There were no revenues recorded in the
quarters ended March 31, 2016 and
2015.
Operating Expenses
Total operating expenses for the
quarter ended March 31, 2016 were
$12.1 million compared to
$8.7 million for the comparable
quarter of 2015. The increase in operating expenses for the
quarter ended March 31, 2016 was the
result of an increase in expenses 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 March 31, 2016
consisting primarily of interest expense related to the venture
debt and $(0.4) million for the
quarter ended March 31, 2015
primarily consisting of interest expense related to the venture
debt and secondarily a foreign exchange transaction loss.
Cash Position
Palatin's cash, cash equivalents and
investments were $23.1 million as of
March 31, 2016, compared to cash and
cash equivalents $27.3 million at
June 30, 2015. Current
liabilities were $13.1 million as of
March 31, 2016, 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 May 17,
2016 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
1-800-524-8850 (domestic) or 1-416-204-9702 (international), pass
code 9763497. The webcast and replay can be accessed by
logging on to the "Investor/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
9763497. The webcast and telephone replay will be available
through May 24, 2016.
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
March 31,
|
|
Nine Months Ended
March 31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
License
revenue
|
$
-
|
|
$
-
|
|
$
-
|
|
$
12,951,730
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
Research and
development
|
10,676,342
|
|
7,588,437
|
|
32,546,363
|
|
14,785,974
|
General and
administrative
|
1,409,406
|
|
1,133,954
|
|
3,965,460
|
|
3,671,621
|
Total operating
expenses
|
12,085,748
|
|
8,722,391
|
|
36,511,823
|
|
18,457,595
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(12,085,748)
|
|
(8,722,391)
|
|
(36,511,823)
|
|
(5,505,865)
|
|
|
|
|
|
|
|
|
OTHER (EXPENSE)
INCOME:
|
|
|
|
|
|
|
|
Interest
income
|
15,062
|
|
14,696
|
|
39,036
|
|
24,694
|
Interest
expense
|
(625,832)
|
|
(311,170)
|
|
(1,883,334)
|
|
(344,757)
|
Foreign exchange
transaction loss
|
-
|
|
(131,673)
|
|
-
|
|
(284,656)
|
Total other income
(expense), net
|
(610,770)
|
|
(428,147)
|
|
(1,844,298)
|
|
(604,719)
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
(12,696,518)
|
|
(9,150,538)
|
|
(38,356,121)
|
|
(6,110,584)
|
Income tax
benefit
|
-
|
|
-
|
|
-
|
|
531,508
|
|
|
|
|
|
|
|
|
NET LOSS
|
(12,696,518)
|
|
(9,150,538)
|
|
(38,356,121)
|
|
(5,579,076)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.08)
|
|
$
(0.07)
|
|
$
(0.25)
|
|
$
(0.05)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
156,368,617
|
|
134,008,239
|
|
156,301,259
|
|
116,632,958
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
March 31,
2016
|
|
June 30,
2015
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
21,767,276
|
|
$
27,299,268
|
Available-for-sale
investments
|
1,382,193
|
|
-
|
Prepaid expenses and
other current assets
|
1,493,455
|
|
1,896,747
|
Total current
assets
|
24,642,924
|
|
29,196,015
|
|
|
|
|
Property and
equipment, net
|
107,632
|
|
123,158
|
Other
assets
|
164,127
|
|
155,279
|
Total
assets
|
$
24,914,683
|
|
$
29,474,452
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' (DEFICIENCY) EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,783,282
|
|
$
1,106,484
|
Accrued
expenses
|
7,802,224
|
|
6,223,483
|
Notes payable, net of
discount
|
3,475,518
|
|
-
|
Capital lease
obligations
|
27,028
|
|
25,871
|
Total current
liabilities
|
13,088,052
|
|
7,355,838
|
|
|
|
|
Notes payable, net of
discount, net of current portion
|
16,149,855
|
|
9,781,086
|
Capital lease
obligations
|
21,330
|
|
41,749
|
Other non-current
liabilities
|
352,174
|
|
91,304
|
Total
liabilities
|
29,611,411
|
|
17,269,977
|
|
|
|
|
Stockholders'
(deficiency) equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares;
|
|
|
|
Series A Convertible;
issued and outstanding 4,030 shares as of March 31, 2016 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 68,040,008 shares as of March 31, 2016 and 57,128,433
shares as of June 30, 2015, respectively
|
680,400
|
|
571,284
|
Additional paid-in
capital
|
324,680,839
|
|
303,332,460
|
Accumulated other
comprehensive loss
|
(2,570)
|
|
-
|
Accumulated
deficit
|
(330,055,437)
|
|
(291,699,316)
|
Total stockholders'
(deficiency) equity
|
(4,696,728)
|
|
12,204,475
|
Total liabilities and
stockholders' (deficiency) equity
|
$
24,914,683
|
|
$
29,474,452
|
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SOURCE Palatin Technologies, Inc.