CRANBURY, N.J., Feb. 12, 2019 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a specialized
biopharmaceutical company developing first-in-class medicines based
on molecules that modulate the activity of the melanocortin and
natriuretic peptide receptor systems for the treatment of diseases
with significant unmet medical need and commercial potential, today
announced results for its second quarter ended December 31, 2018.
Recent Highlights and Program Updates
Female Sexual Dysfunction / Vyleesi™
(bremelanotide)
- Vyleesi, the trade name for bremelanotide - Under development
for Hypoactive Sexual Desire Disorder ("HSDD"):
-
- The Prescription Drug User Fee Act ("PDUFA") date for
completion of FDA review of the Vyleesi New Drug Application
("NDA") was extended three months to June
23, 2019.
- The U.S. Food and Drug Administration ("FDA") requested a Phase
1 study in premenopausal volunteers assessing short term daily use
of Vyleesi. This study is ongoing and is being conducted by Palatin
and AMAG Pharmaceuticals, our exclusive licensee for North America.
-
- Study results are anticipated to be submitted to the FDA prior
to the updated PDUFA date.
- Palatin is in discussions with potential collaboration partners
for certain regions outside of the licensed territories of
North America, China and South
Korea.
Anti-Inflammatory / Autoimmune Programs
- Melanocortin receptor 1 and 1/5 ("MC1r", "MC1/5r") agonists
under development for the treatment of inflammatory and autoimmune
diseases such as dry eye, uveitis, diabetic retinopathy and
inflammatory bowel diseases:
-
- PL-8177, a selective MC1r peptide agonist:
-
- Completed subcutaneous dosing of human subjects in a Phase 1
single and multiple ascending dose clinical safety study, with no
safety or tolerability concerns noted in a press release dated
November 8, 2018.
- A separate clinical study with oral dosing in human subjects
was started during the quarter ended December 31, 2018, with data expected in the
first quarter of calendar year 2019.
- Program is under internal evaluation for orphan
designations.
- PL-8331 and PL-9643, dual MC1r and MC5r peptide agonists:
-
- Continuing with preclinical Investigational New Drug ("IND")
enabling activities.
- Program is under internal evaluation for orphan
designations.
Natriuretic Peptide Receptor ("NPR") System
Program
- We have designed and are developing potential NPR candidate
drugs that are selective for one or more different natriuretic
peptide receptors, including natriuretic peptide receptor-A
("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and
natriuretic peptide receptor C ("NPR-C"):
-
- PL-3994, an NPR-A agonist that has potential utility in
treatment of a number of cardiovascular diseases, including genetic
and orphan diseases resulting from a deficiency of endogenous
active NPR-A.
-
- Academic collaborations with several institutions ongoing.
- PL-5028, a dual NPR-A and NPR-C agonist in development for
cardiovascular diseases, including reducing cardiac hypertrophy and
fibrosis.
-
- Academic collaborations with several institutions ongoing.
Genetic Obesity Program
- Melanocortin receptor 4 ("MC4r") peptide PL-8905 and
orally-active small molecule PL-9610 under development for the
treatment of rare genetic metabolic and obesity disorders:
-
- Program is under internal evaluation for orphan
designations.
Corporate
- Decreased debt and related liabilities from $7.2 million at June 30,
2018 to $2.8 million at
December 31, 2018.
Second Quarter Fiscal 2019 Financial Results
Palatin
reported a net loss of $(5.0)
million, or $(0.02) per basic
and diluted share, for the quarter ended December 31, 2018, compared to net income of
$3.0 million, or $0.02 per basic and $0.01 per diluted share, for the same period in
2017.
The difference in financial results between the three months
ended December 31, 2018 and 2017 was
primarily attributable to the recognition of $10.6 million in license and contract revenue
during the 2017 period pursuant to our license agreement with
AMAG.
Revenue
There were no revenues recorded in the quarter
ended December 31, 2018.
For the quarter ended December 31,
2017, 100% of the revenue Palatin recognized was related to
our license agreement with AMAG.
Operating Expenses
Total operating expenses for
the quarter ended December 31, 2018
were $5.1 million compared to
$7.7 million for the comparable
quarter of 2017. The decrease in operating expenses was
mainly attributable to the completion of the Vyleesi Phase 3
clinical trial program and ancillary studies necessary to file the
NDA in HSDD in March 2018.
Other Income/Expense
Total other income, net was
$7,871 for the quarter ended
December 31, 2018 compared to total
other expenses, net $(0.3) million
for the quarter ended December 31, 2017. The difference
is related primarily to the decrease in interest expense related to
Palatin's venture debt.
Income Tax
There was no income tax expense, or
benefit, recorded in the quarter ended December 31, 2018.
Pursuant to the license agreements with Fosun and Kwangdong,
$500,000 and $82,500, respectively, was withheld in accordance
with tax withholding requirements in China and the Republic of Korea, respectively,
and was recorded as an expense during the fiscal year ended
June 30, 2018. For the quarter ended
December 31, 2017, Palatin recorded
$100,880 in income tax expense
related to those withholding amounts utilizing an estimated
effective annual income tax rate applied to income for the quarter
and the remaining balance of $256,365
was included in prepaid expenses and other current assets at
December 31, 2017. Any potential
credit to be received by Palatin on its United States tax returns is currently offset
by Palatin's valuation allowance. The $100,880 of income tax expense was offset by a
$500,000 tax benefit that Palatin
recorded in the quarter ended December 31,
2017 related to the release of a valuation allowance against
Palatin's federal alternative minimum tax credit as a result of the
Tax Cuts and Jobs Act signed in December 2017. Accordingly,
$500,000 was included in other
long-term assets at December 31,
2017.
Cash Position
Palatin's cash, and cash equivalents
were $24.7 million as of December 31, 2018, compared to cash and cash
equivalents of $38.0 million at
June 30, 2018. Current
liabilities were $4.5 million as of
December 31, 2018, compared to
$10.8 million as of June 30, 2018.
Palatin believes that existing capital resources will be
sufficient to fund our planned operations through at least
March 31, 2020.
Palatin Drug Discovery Programs
In the conference
call and webcast, management will update and discuss next steps in
Palatin's portfolio of drug development programs. These include
Palatin's MC1r and MC1/5r agonist peptides for treatment of
anti-inflammatory and autoimmune indications, MC4r peptide and
small molecule agonists for the treatment of genetic obesity
indications and natriuretic peptide receptor agonist compounds for
treatment of cardiovascular and pulmonary indications.
Conference Call / Webcast
Palatin will host a
conference call and webcast on February 12,
2019 at 11:00 a.m. Eastern
Time to discuss the quarter ended December 31, 2018 results of operations in
greater detail and provide an update on corporate
developments. Individuals interested in listening to the
conference call live can dial 1-877-260-1479 (US/Canada) or 1-334-323-0522 (international),
conference ID 4414047. 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 (US/Canada) or
1-719-457-0820 (international), passcode 4414047. The webcast
and telephone replay will be available through February 19, 2019.
About Palatin Technologies, Inc.
Palatin
Technologies, Inc. is a specialized biopharmaceutical company
developing first-in-class medicines based on molecules that
modulate the activity of the melanocortin and natriuretic peptide
receptor systems, with targeted, receptor-specific product
candidates 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
December 31,
|
|
Six Months Ended
December 31,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
License and
contract
|
|
$
-
|
|
$
10,612,153
|
|
$
34,505
|
|
$
37,553,661
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
2,961,656
|
|
6,045,884
|
|
6,584,347
|
|
20,208,981
|
General and
administrative
|
|
2,088,565
|
|
1,625,189
|
|
4,129,147
|
|
3,169,764
|
Total operating
expenses
|
|
5,050,221
|
|
7,671,073
|
|
10,713,494
|
|
23,378,745
|
|
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
|
(5,050,221)
|
|
2,941,080
|
|
(10,678,989)
|
|
14,174,916
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
|
|
|
Investment
income
|
|
100,169
|
|
81,356
|
|
253,752
|
|
133,082
|
Interest
expense
|
|
(92,298)
|
|
(391,363)
|
|
(299,169)
|
|
(848,040)
|
Total other income
(expense), net
|
|
7,871
|
|
(310,007)
|
|
(45,417)
|
|
(714,958)
|
|
|
|
|
|
|
|
|
|
(Loss) income before
income taxes
|
|
(5,042,350)
|
|
2,631,073
|
|
(10,724,406)
|
|
13,459,958
|
Income tax
benefit
|
|
-
|
|
399,120
|
|
-
|
|
173,865
|
|
|
|
|
|
|
|
|
|
NET (LOSS)
INCOME
|
|
$
(5,042,350)
|
|
$
3,030,193
|
|
$
(10,724,406)
|
|
$
13,633,823
|
|
|
|
|
|
|
|
|
|
Basic net (loss)
income per common share
|
|
$
(0.02)
|
|
$
0.02
|
|
$
(0.05)
|
|
$
0.07
|
|
|
|
|
|
|
|
|
|
Diluted net (loss)
income per common share
|
|
$
(0.02)
|
|
$
0.01
|
|
$
(0.05)
|
|
$
0.07
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in
computing basic net (loss)
income per common
share
|
|
206,487,984
|
|
197,238,056
|
|
205,724,321
|
|
197,175,316
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in
computing diluted net
(loss) income per
common share
|
|
206,487,984
|
|
202,711,616
|
|
205,724,321
|
|
200,430,824
|
|
|
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
December 31,
2018
|
|
June 30,
2018
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
24,658,024
|
|
$
38,000,171
|
Prepaid expenses and
other current assets
|
535,147
|
|
513,688
|
Total current
assets
|
25,193,171
|
|
38,513,859
|
|
|
|
|
Property and
equipment, net
|
136,153
|
|
164,035
|
Other
assets
|
338,916
|
|
338,916
|
Total
assets
|
$
25,668,240
|
|
$
39,016,810
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
619,900
|
|
$
2,223,693
|
Accrued
expenses
|
1,101,045
|
|
2,103,021
|
Notes payable, net of
discount
|
2,321,123
|
|
5,948,763
|
Other current
liabilities
|
486,474
|
|
487,488
|
Total current
liabilities
|
4,528,542
|
|
10,762,965
|
|
|
|
|
Notes payable, net of
discount
|
-
|
|
332,898
|
Deferred
revenue
|
-
|
|
500,000
|
Other non-current
liabilities
|
-
|
|
456,038
|
Total
liabilities
|
4,528,542
|
|
12,051,901
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
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, 2018 and
June 30, 2018
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 203,063,429 shares as of December 31, 2018
and 200,554,205
shares as of June 30, 2018
|
2,030,634
|
|
2,005,542
|
Additional paid-in
capital
|
361,379,336
|
|
357,005,233
|
Accumulated
deficit
|
(342,270,312)
|
|
(332,045,906)
|
Total stockholders'
equity
|
21,139,698
|
|
26,964,909
|
Total liabilities and
stockholders' equity
|
$
25,668,240
|
|
$
39,016,810
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.