CRANBURY, N.J., Sept. 20, 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 financial results for its
fourth quarter and fiscal year ended June
30, 2016.
Significant Highlights
- Bremelanotide - Under development for Hypoactive Sexual
Desire Disorder (HSDD):
- Palatin's two Phase 3 clinical trials for the treatment of HSDD
randomized a total of approximately 1,250 women to evaluate
efficacy and safety of subcutaneous bremelanotide in premenopausal
women with HSDD as an on-demand, as-needed treatment.
- Patient enrollment was completed in the fourth quarter of
calendar year 2015.
- Last patient visits for the efficacy portion of the trials were
completed in the third quarter of calendar year 2016.
- Topline results are projected to be released early fourth
quarter calendar year 2016.
- Issued a key U.S. Patent on May 31,
2016 for methods of treating female sexual dysfunction using
the dose and formulation utilized in the Phase 3 trials. The patent
expires no earlier than November
2033.
- 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
- July 2015, Palatin closed on a
debt and equity financing with gross proceeds of $30 million, with net proceeds, after deducting
offering expenses, of $29.7 million,
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, and Series G warrants to
purchase 549,450 shares of common stock at an exercise price of
$0.91 per share
- $20 million private placement of
Series E warrants to purchase 21,917,808 shares of common stock at
an exercise price of $0.01 per share
and Series F warrants to purchase 2,191,781 shares of common stock
at an exercise price of $0.91 per
share
- Intellectual Property:
- Issue Notification for U.S. Patent to issue October 4, 2016, with composition of matter
claims for a broad group of melanocortin peptides.
- U.S. Patent issued September 20,
2016 with composition of matter claims for a broad family of
melanocortin receptor-1 peptides with potential application in
inflammatory disease-related and autoimmune indications.
Fourth Quarter and Fiscal Year Ended 2016 Financial
Results
Palatin reported a net loss of $(13.4) million, or $(0.09) per basic and diluted share, for the
quarter ended June 30, 2016, compared
to a net loss of $(12.1) million, or
$(0.09) per basic and diluted share,
for the same period in 2015. The difference between the three
months ended June 30, 2016 and 2015
was primarily attributable to the increase in expenses relating to
the Phase 3 clinical trial and development program with
bremelanotide for HSDD in the quarter ended June 30, 2016.
For the year ended June 30, 2016,
Palatin reported a net loss of $(51.7)
million, or $(0.33) per basic
and diluted share compared to a net loss of $(17.7) million, or $(0.15) per basic and diluted share for the year
ended June 30, 2015. The
increase in net loss for the year ended June
30, 2016, compared to the net loss for the year ended
June 30, 2015 was primarily
attributable to the increase in development costs for the
progression of the Phase 3 clinical trials and development of
bremelanotide for HSDD and secondarily related to the license and
contract revenue recognized in the year ended June 30, 2015.
Revenue
There were no revenues recorded in the quarter
or year ended June 30, 2016 or in the
quarter ended June 30, 2015.
For the year ended June 30, 2015,
Palatin recognized $12.9 million of
license and contract revenue under the agreement with Gedeon Richter.
Operating Expenses
Operating expenses for the quarter
ended June 30, 2016 were $12.7 million, compared to $11.8 million for the comparable quarter of
2015. For the year ended June 30,
2016, Palatin incurred $49.3
million of operating expenses, compared to $30.2 million for the year ended June 30, 2015. The increase in operating
expenses for the quarter and the year ended June 30, 2016 was the result of an increase in
expenses primarily relating to the Phase 3 clinical trial and
development program with bremelanotide for HSDD.
Other Income/Expense
Total other income (expense),
net, was $(0.6) million for the
quarter ended June 30, 2016, compared
to $(0.3) million for the quarter
ended June 30, 2015. For the
year ended June 30, 2016, total other
income (expense), net, was $(2.5)
million, compared to $(0.9)
million for the year ended June
30, 2015. Total other income (expense) for both fiscal
years ended June 30, 2016 and
June 30, 2015 primarily consists of
interest expense related to the venture debt. The increase in
total other income (expense), net, for the year ended June 30, 2016 is due to the additional
July 2015 venture debt.
Cash Position
Palatin's cash, cash equivalents and
investments were $9.4 million as of
June 30, 2016, compared to cash and
cash equivalents of $27.3 million at
June 30, 2015. Current
liabilities were $14.0 million as of
June 30, 2016, compared to
$7.4 million as of June 30, 2015.
Palatin believes that existing capital resources, together with
approximately $8.5 million received
from the August 2016 financing, will
be adequate to fund our planned operations through the quarter
ending December 31, 2016.
Assuming the double blind efficacy portion of the Phase 3 clinical
trial of bremelanotide for HSDD is successful, as to which there
can be no assurance, we will need additional funding to complete
required ancillary studies and clinical trials, prepare and submit
regulatory filings for product approval, and establish commercial
scale manufacturing capability.
CONFERENCE CALL / WEBCAST
Palatin will host a
conference call and webcast on September 20,
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
1-888-516-2377 (domestic) or 1-719-457-2657 (international),
conference code 3301810. 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 3301810. The webcast and telephone replay will be
available through September 27,
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June
30,
|
|
2016
|
|
2015
|
|
2014
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
License and
contract
|
$
-
|
|
$
12,951,730
|
|
$
-
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
Research and
development
|
43,071,051
|
|
24,560,233
|
|
10,826,921
|
General and
administrative
|
6,179,084
|
|
5,677,654
|
|
4,960,731
|
Total operating
expenses
|
49,250,135
|
|
30,237,887
|
|
15,787,652
|
|
|
|
|
|
|
Loss from
operations
|
(49,250,135)
|
|
(17,286,157)
|
|
(15,787,652)
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
Investment
income
|
50,226
|
|
35,439
|
|
18,923
|
Interest
expense
|
(2,513,027)
|
|
(661,697)
|
|
(6,211)
|
Foreign exchange
transaction loss
|
-
|
|
(284,656)
|
|
-
|
Total other income
(expense), net
|
(2,462,801)
|
|
(910,914)
|
|
12,712
|
|
|
|
|
|
|
Loss before income
taxes
|
(51,712,936)
|
|
(18,197,071)
|
|
(15,774,940)
|
Income tax
benefit
|
-
|
|
531,508
|
|
1,846,646
|
|
|
|
|
|
|
NET LOSS
|
$
(51,712,936)
|
|
$
(17,665,563)
|
|
$
(13,928,294)
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.33)
|
|
$
(0.15)
|
|
$
(0.13)
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
156,553,534
|
|
121,014,506
|
|
106,679,476
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
|
|
|
|
|
June 30,
2016
|
|
June 30,
2015
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
8,002,668
|
|
$
27,299,268
|
Available-for-sale
investments
|
1,380,556
|
|
-
|
Prepaid expenses and
other current assets
|
1,424,282
|
|
1,896,747
|
Total current
assets
|
10,807,506
|
|
29,196,015
|
|
|
|
|
Property and
equipment, net
|
97,801
|
|
123,158
|
Other
assets
|
146,428
|
|
155,279
|
Total
assets
|
$
11,051,735
|
|
$
29,474,452
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
713,890
|
|
$
1,106,484
|
Accrued
expenses
|
7,767,733
|
|
6,223,483
|
Notes payable, net of
discount
|
5,485,392
|
|
-
|
Capital lease
obligations
|
27,424
|
|
25,871
|
Total current
liabilities
|
13,994,439
|
|
7,355,838
|
|
|
|
|
Notes payable, net of
discount
|
14,189,809
|
|
9,781,086
|
Capital lease
obligations
|
14,324
|
|
41,749
|
Other non-current
liabilities
|
439,130
|
|
91,304
|
Total
liabilities
|
28,637,702
|
|
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
June 30, 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 68,568,055 shares as of June 30, 2016 and
57,128,433 as of June 30, 2015, respectively
|
685,680
|
|
571,284
|
Additional paid-in
capital
|
325,142,509
|
|
303,332,460
|
Accumulated other
comprehensive loss
|
(1,944)
|
|
-
|
Accumulated
deficit
|
(343,412,252)
|
|
(291,699,316)
|
Total stockholders'
(deficiency) equity
|
(17,585,967)
|
|
12,204,475
|
Total liabilities and
stockholders' equity
|
$
11,051,735
|
|
$
29,474,452
|
|
|
|
|
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visit:http://www.prnewswire.com/news-releases/palatin-technologies-inc-reports-fourth-quarter-and-fiscal-year-2016-results-300330647.html
SOURCE Palatin Technologies, Inc.