CRANBURY, N.J., May 16, 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 third quarter
ended March 31, 2017.
Quarter and 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.
- Closed an exclusive North American license agreement with AMAG
Pharmaceuticals to develop and commercialize bremelanotide in
February 2017.
- Received $60 million upfront
payment
- Working closely with AMAG on completing the tasks and
activities necessary to file a New Drug Application (NDA) with the
Food and Drug Administration (FDA).
- Target NDA filing with the FDA for the first quarter of
calendar year 2018.
- A Notice of Allowance was issued by the U.S. Patent and
Trademark Office (USPTO) on a patent for methods of treating female
sexual dysfunction and HSDD with bremelanotide. Once issued the
patent will have a term to November
2033.
"Meeting our Phase 3 co-primary endpoints with bremelanotide and
licensing the North American rights to AMAG were truly
transformational for Palatin," said Stephen
T. Wills, chief operating officer and chief financial
officer of Palatin Technologies. "In addition to advancing the
activities required to file an NDA with the FDA, we are progressing
with discussions and negotiations with potential partners for other
regions around the globe for bremelanotide. We are also excited to
now be able to devote resources and attention to our other
development programs, which address indications such as heart
failure, ophthalmic disorders and inflammatory bowel diseases using
targeted, receptor-specific peptides which we developed."
Third Quarter Fiscal 2017 Financial Results
Palatin reported a net loss of $(3.6)
million, or $(0.02) per basic
and diluted share, for the quarter ended March 31, 2017, compared to a net loss of
$(12.7) million, or $(0.08) per basic and diluted share, for the same
period in 2016.
The difference between the three months ended March 31, 2017 and 2016 was primarily
attributable to the recognition of $10.8
million in contract revenue pursuant to our license
agreement with AMAG.
Revenue
For the quarter ended March 31,
2017, Palatin recognized $10.8
million in contract revenue related to our license agreement
with AMAG. There were no revenues recorded in the quarter ended
March 31, 2016.
Operating Expenses
Total operating expenses for the quarter ended March 31, 2017 were $13.8
million compared to $12.1
million for the comparable quarter of 2016. The
increase in operating expenses was predominately attributable to
professional services incurred related to closing our license
agreement with AMAG.
Other Income/Expense
Total other income (expense), net, was $(0.6) million for the quarters ended
March 31, 2017 and 2016 consisting
mainly of interest expense related to venture debt.
Cash Position
Palatin's cash, cash equivalents and investments were
$55.4 million as of March 31, 2017, compared to cash, cash
equivalents and investments of $9.4
million at June 30,
2016. Current liabilities were $17.4
million, net of deferred revenue of $53.8 million, as of March
31, 2017, compared to $13.9
million as of June 30,
2016.
Palatin believes that with the proceeds from our license
agreement with AMAG, capital resources will be adequate to fund our
planned operations through calendar year 2018.
Palatin Drug Discovery Programs
In the conference call and webcast, management will discuss next
steps in Palatin's portfolio of drug development programs.
These include Palatin's melanocortin receptor1 and receptor-5
agonist peptides for treatment of inflammatory and dermatologic
disease indications, natriuretic peptide receptorA 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
May 16, 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 1-888-523-1227 (U.S./Canada) or 1-719-457-2656 (international),
conference ID 3692572. 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 3692572. The webcast
and telephone replay will be available through May 23, 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
March 31,
|
|
Nine Months Ended
March 31,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
Contract
revenue
|
$10,823,748
|
|
$
-
|
|
$
10,823,748
|
|
$
-
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
Research and
development
|
9,062,316
|
|
10,676,342
|
|
28,422,975
|
|
32,546,363
|
General and
administrative
|
4,773,696
|
|
1,409,406
|
|
7,289,342
|
|
3,965,460
|
Total operating
expenses
|
13,836,012
|
|
12,085,748
|
|
35,712,317
|
|
36,511,823
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(3,012,264)
|
|
(12,085,748)
|
|
(24,888,569)
|
|
(36,511,823)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
|
|
Interest
income
|
6,304
|
|
15,062
|
|
18,940
|
|
39,036
|
Interest
expense
|
(558,702)
|
|
(625,832)
|
|
(1,777,222)
|
|
(1,883,334)
|
Total other income
(expense), net
|
(552,398)
|
|
(610,770)
|
|
(1,758,282)
|
|
(1,844,298)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(3,564,662)
|
|
$(12,696,518)
|
|
$(26,646,851)
|
|
$(38,356,121)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.02)
|
|
$
(0.08)
|
|
$
(0.15)
|
|
$
(0.25)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing basic and
diluted net loss per common share
|
196,580,519
|
|
156,368,617
|
|
179,841,133
|
|
156,301,259
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
March 31,
2017
|
|
June 30,
2016
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
54,505,215
|
|
$
8,002,668
|
Available-for-sale
investments
|
924,790
|
|
1,380,556
|
Accounts
receivable
|
4,657,577
|
|
-
|
Prepaid expenses and
other current assets
|
1,064,112
|
|
1,313,841
|
Total current
assets
|
61,151,694
|
|
10,697,065
|
|
|
|
|
Property and
equipment, net
|
74,910
|
|
97,801
|
Other
assets
|
56,916
|
|
63,213
|
Total
assets
|
$
61,283,520
|
|
$
10,858,079
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIENCY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,243,144
|
|
$
713,890
|
Accrued
expenses
|
8,316,692
|
|
7,767,733
|
Notes payable, net of
discount and debt issuance costs
|
7,792,639
|
|
5,374,951
|
Capital lease
obligations
|
21,331
|
|
27,424
|
Deferred
revenue
|
53,833,828
|
|
-
|
Total current
liabilities
|
71,207,634
|
|
13,883,998
|
|
|
|
|
Notes payable, net of
discount and debt issuance costs
|
8,250,004
|
|
14,106,594
|
Capital lease
obligations
|
-
|
|
14,324
|
Other non-current
liabilities
|
684,831
|
|
439,130
|
Total
liabilities
|
80,142,469
|
|
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 March
31, 2017 and June 30, 2016
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and outstanding
144,893,690 shares as of March 31, 2017
and 68,568,055 shares as of June 30, 2016, respectively
|
1,448,937
|
|
685,680
|
Additional paid-in
capital
|
349,752,596
|
|
325,142,509
|
Accumulated other
comprehensive loss
|
(1,419)
|
|
(1,944)
|
Accumulated
deficit
|
(370,059,103)
|
|
(343,412,252)
|
Total stockholders'
deficiency
|
(18,858,949)
|
|
(17,585,967)
|
Total liabilities and
stockholders' deficiency
|
$
61,283,520
|
|
$
10,858,079
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/palatin-technologies-inc-reports-third-quarter-fiscal-year-2017-results-teleconference-and-webcast-to-be-held-on-may-16-2017-300458056.html
SOURCE Palatin Technologies, Inc.