CRANBURY, N.J., Nov. 15, 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 first quarter
ended September 30, 2016.
Recent Highlights
- Bremelanotide - Under development for Hypoactive Sexual
Desire Disorder (HSDD):
- November 2016 reported positive
Phase 3 clinical results - both pivotal trials met the
pre-specified co-primary efficacy endpoints of improvement in
desire and decrease in distress associated with low sexual desire,
reflecting clinical meaningfulness and statistical
significance.
- Last patient visits for the efficacy portion of the trials were
completed in the third quarter of calendar year 2016.
- New Drug Application (NDA) submission to the FDA targeted for
the second half of 2017.
- Financial Transactions:
- August 2016, Palatin closed on an
underwritten offering of units with gross proceeds of $9.25 million, with net proceeds, after deducting
offering expenses, of approximately $8.5
million. Palatin issued:
- 11,481,481 shares of common stock and ten-year prefunded Series
I warrants to purchase 2,218,045 shares of common stock at an
exercise price of $0.01 per
share
- Series H warrants to purchase 10,274,646 shares of common stock
at an exercise price of $0.70 per
share
First Quarter Fiscal 2017 Financial Results
Palatin reported a net loss of $(13.1)
million, or $(0.08) per basic
and diluted share, for the quarter ended September 30, 2016, compared to a net loss of
$(12.4) million, or $(0.08) per basic and diluted share, for the same
period in 2015.
The difference between the three months ended September 30, 2016 and 2015 was primarily
attributable to the increase in expenses relating to our
bremelanotide program for HSDD in the quarter ended September 30, 2016.
Revenue
There were no revenues recorded in the quarters ended
September 30, 2016 and 2015.
Operating Expenses
Total operating expenses for the quarter ended September 30, 2016 were $12.4 million compared to $11.8 million for the comparable quarter of
2015. The increase in operating expenses for the quarter
ended September 30, 2016 was the
result of an increase in expenses primarily relating to our
bremelanotide program for HSDD.
Other Income/Expense
Total other income (expense), net, was $(0.6) million for the quarters ended
September 30, 2016 and 2015
consisting primarily of interest expense related to venture
debt.
Cash Position
Palatin's cash, cash equivalents and investments were
$10.2 million as of September 30, 2016, compared to cash and cash
equivalents of $9.4 million at
June 30, 2016. Current
liabilities were $20.5 million as of
September 30, 2016, compared to
$13.9 million as of June 30, 2016.
Palatin believes that existing capital resources will be
adequate to fund our planned operations through the quarter ending
December 31, 2016.
CONFERENCE CALL / AUDIO WEBCAST
Palatin will host a conference call and audio webcast on
November 15, 2016 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 1-888-503-8171 (domestic) or
1-719-457-2664 (international), conference ID 9405459. The
audio 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 audio 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), passcode
9405459. The audio webcast and telephone replay will be
available through November 22,
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
September 30,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
License
revenue
|
$
-
|
|
$
-
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
Research and
development
|
11,226,084
|
|
10,597,714
|
|
General and
administrative
|
1,209,346
|
|
1,199,937
|
|
Total operating
expenses
|
12,435,430
|
|
11,797,651
|
|
|
|
|
|
|
Loss from
operations
|
(12,435,430)
|
|
(11,797,651)
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
Interest
income
|
6,645
|
|
15,740
|
|
Interest
expense
|
(623,985)
|
|
(628,008)
|
|
Total other income
(expense), net
|
(617,340)
|
|
(612,268)
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(13,052,770)
|
|
$
(12,409,919)
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.08)
|
|
$
(0.08)
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
165,848,269
|
|
156,176,618
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
September 30,
2016
|
|
June 30,
2016
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
8,867,930
|
|
$
8,002,668
|
Available-for-sale
investments
|
1,377,714
|
|
1,380,556
|
Prepaid expenses and
other current assets
|
1,007,978
|
|
1,313,841
|
Total current
assets
|
11,253,622
|
|
10,697,065
|
|
|
|
|
Property and
equipment, net
|
90,171
|
|
97,801
|
Other
assets
|
56,916
|
|
63,213
|
Total
assets
|
$
11,400,709
|
|
$
10,858,079
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIENCY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,159,427
|
|
$
713,890
|
Accrued
expenses
|
12,884,590
|
|
7,767,733
|
Notes payable, net of
discount and debt issuance costs
|
6,399,075
|
|
5,374,951
|
Capital lease
obligations
|
27,827
|
|
27,424
|
Total current
liabilities
|
20,470,919
|
|
13,883,998
|
|
|
|
|
Notes payable, net of
discount and debt issuance costs
|
12,162,471
|
|
14,106,594
|
Capital lease
obligations
|
7,214
|
|
14,324
|
Other non-current
liabilities
|
525,314
|
|
439,130
|
Total
liabilities
|
33,165,918
|
|
28,444,046
|
|
|
|
|
Stockholders'
deficiency:
|
|
|
|
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, 2016 and
June 30, 2016
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 92,806,710 shares as of September 30, 2016 and
68,568,055 shares as of June 30, 2016, respectively
|
928,067
|
|
685,680
|
Additional paid-in
capital
|
333,774,227
|
|
325,142,509
|
Accumulated other
comprehensive loss
|
(2,521)
|
|
(1,944)
|
Accumulated
deficit
|
(356,465,022)
|
|
(343,412,252)
|
Total stockholders'
deficiency
|
(21,765,209)
|
|
(17,585,967)
|
Total liabilities and
stockholders' deficiency
|
$
11,400,709
|
|
$
10,858,079
|
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SOURCE Palatin Technologies, Inc.