CRANBURY, N.J., Feb. 9, 2017 /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,
2016.
Recent Highlights
- Rekynda (bremelanotide) - Under development for
Hypoactive Sexual Desire Disorder (HSDD):
- Exclusive North American license agreement with AMAG
Pharmaceuticals, Inc. to develop and commercialize Rekynda.
- Received $60 million initial
payment under license agreement with AMAG.
- 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.
- Financial Transactions:
- December 2016, Palatin closed on
an underwritten public offering of units with gross proceeds of
$16.5 million, with net proceeds,
after deducting offering expenses, of approximately $15.4 million. Palatin issued:
- 25,384,616 shares of common stock and five year Series J
warrants to purchase 12,692,310 shares of common stock at an
exercise price of $0.80 per
share
"We are confident that AMAG's commercial capabilities and
expertise will drive a successful approval and launch of Rekynda in
early 2019," said Carl Spana, Ph.D.,
chief executive officer of Palatin Technologies. "We are excited to
now be able to devote significant resources and attention to our
other development programs, which address diseases such as heart
failure and inflammatory bowel diseases using targeted,
receptor-specific peptides which we developed."
Second Quarter Fiscal 2017 Financial Results
Palatin reported a net loss of $(10.0)
million, or $(0.06) per basic
and diluted share, for the quarter ended December 31, 2016, compared to a net loss of
$(13.2) million, or $(0.08) per basic and diluted share, for the same
period in 2015.
The difference between the three months ended December 31, 2016 and 2015 was primarily
attributable to the completion of the Phase 3 clinical trials of
our Rekynda program for HSDD.
Revenue
There were no revenues recorded in the quarters ended
December 31, 2016 and 2015.
Operating Expenses
Total operating expenses for the quarter ended December 31, 2016 were $9.4 million compared to $12.6 million for the comparable quarter of
2015. The decrease in operating expenses for the quarter
ended December 31, 2016 was primarily
attributable to the completion of the Phase 3 clinical trials of
our Rekynda program for HSDD
Other Income/Expense
Total other income (expense), net, was $(0.6) million for the quarters ended
December 31, 2016 and 2015 consisting
primarily of interest expense related to venture debt.
Cash Position
Palatin's cash, cash equivalents and investments were
$13.5 million, before giving effect
to the receipt of $60 million from
AMAG, as of December 31, 2016,
compared to cash and cash equivalents $9.4
million at June 30,
2016. Current liabilities were $19.6
million as of December 31,
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 at least the fiscal
year ending June 30, 2018.
Palatin Drug Discovery Programs
In the conference call and webcast, management will discuss
anticipated next steps in Palatin's portfolio of drug development
programs. These include Palatin's melanocortin receptor-1
agonist peptides for treatment of inflammatory and dermatologic
disease indications, natriuretic peptide receptor-A agonist
compounds for treatment of cardiovascular and pulmonary
indications, and melanocortin receptor-4 agonist compounds for
treatment of obesity and diabetes.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on
February 9, 2017 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 1-800-500-0311 (U.S./Canada) or 1-719-457-2641 (international),
conference ID 9389688. 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
webcast replay will be available approximately one hour after the
completion of the call. To access the telephone replay, dial
1-888-203-1112 (U.S./Canada) or
1-719-457-0820 (international), passcode 9389688. The webcast
and telephone replay will be available through February 16, 2017.
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,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
License
revenue
|
$
-
|
|
$
-
|
|
$
-
|
|
$
-
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
Research and
development
|
8,134,575
|
|
11,272,307
|
|
19,360,659
|
|
21,870,021
|
General and
administrative
|
1,306,300
|
|
1,356,117
|
|
2,515,646
|
|
2,556,054
|
Total operating
expenses
|
9,440,875
|
|
12,628,424
|
|
21,876,305
|
|
24,426,075
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(9,440,875)
|
|
(12,628,424)
|
|
(21,876,305)
|
|
(24,426,075)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
|
|
Interest
income
|
5,991
|
|
8,234
|
|
12,636
|
|
23,974
|
Interest
expense
|
(594,535)
|
|
(629,494)
|
|
(1,218,520)
|
|
(1,257,502)
|
Total other income
(expense), net
|
(588,544)
|
|
(621,260)
|
|
(1,205,884)
|
|
(1,233,528)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(10,029,419)
|
|
$
(13,249,684)
|
|
$
(23,082,189)
|
|
$
(25,659,603)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.06)
|
|
$
(0.08)
|
|
$
(0.13)
|
|
$
(0.16)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
177,798,511
|
|
156,358,586
|
|
171,823,390
|
|
156,268,094
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
December 31,
2016
|
|
June 30,
2016
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
12,114,581
|
|
$
8,002,668
|
Available-for-sale
investments
|
1,375,959
|
|
1,380,556
|
Prepaid expenses and
other current assets
|
838,260
|
|
1,313,841
|
Total current
assets
|
14,328,800
|
|
10,697,065
|
|
|
|
|
Property and
equipment, net
|
82,540
|
|
97,801
|
Other
assets
|
56,916
|
|
63,213
|
Total
assets
|
$
14,468,256
|
|
$
10,858,079
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIENCY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
4,706,014
|
|
$
713,890
|
Accrued
expenses
|
7,446,825
|
|
7,767,733
|
Notes payable, net of
discount and debt issuance costs
|
7,427,445
|
|
5,374,951
|
Capital lease
obligations
|
28,214
|
|
27,424
|
Total current
liabilities
|
19,608,498
|
|
13,883,998
|
|
|
|
|
Notes payable, net of
discount and debt issuance costs
|
10,210,275
|
|
14,106,594
|
Capital lease
obligations
|
-
|
|
14,324
|
Other non-current
liabilities
|
607,488
|
|
439,130
|
Total
liabilities
|
30,426,261
|
|
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 December 31, 2016 and
June 30, 2016
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 133,423,837 shares as of December 31, 2016 and
68,568,055 shares as of June 30, 2016, respectively
|
1,334,238
|
|
685,680
|
Additional paid-in
capital
|
349,204,164
|
|
325,142,509
|
Accumulated other
comprehensive loss
|
(2,006)
|
|
(1,944)
|
Accumulated
deficit
|
(366,494,441)
|
|
(343,412,252)
|
Total stockholders'
deficiency
|
(15,958,005)
|
|
(17,585,967)
|
Total liabilities and
stockholders' deficiency
|
$
14,468,256
|
|
$
10,858,079
|
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visit:http://www.prnewswire.com/news-releases/palatin-technologies-inc-reports-second-quarter-fiscal-year-2017-results-teleconference-and-webcast-to-be-held-on-february-9-2017-300404755.html
SOURCE Palatin Technologies, Inc.