CRANBURY, N.J., Nov. 13, 2018 /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 first fiscal quarter ended September 30, 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"):
‒ FDA
(U.S. Food and Drug Administration) set the PDUFA (Prescription
Drug User Fee Act) action goal date of March
23, 2019 for completion of the review of the New Drug
Application (NDA) for Vyleesi.
- See 8-K filing today regarding the FDA's review of the NDA
submission for Vyleesi and the request for additional data.
‒ AMAG
Pharmaceuticals is the exclusive licensee for North America.
‒ 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:
- Announced positive pharmacokinetics and pharmacodynamic results
with no reported safety or tolerability concerns from a
first-in-human Phase 1 safety study of subcutaneous dosing of
PL-8177 in single and multiple ascending doses.
- Data from a separate clinical study investigating an oral
formulation of PL-8177 is currently expected by the end of calendar
year 2018.
- Program is under internal evaluation for orphan
designations.
‒ PL-8331
for ocular indications:
- Preclinical IND enabling activities commenced.
- Program is under internal evaluation for orphan
designations.
Natriuretic Peptide Program
‒ PL-3994:
Phase 2a, open label study in heart failure patients with preserved
ejection fraction, targeted to commence in the first half of
2019.
‒ PL-5028:
Preclinical studies evaluating potential use in fibrotic disease
ongoing.
Genetic Obesity Program
‒ MC4r
selective peptide and oral small molecule agonists: Commenced
preclinical IND activities.
‒ Program
is under internal evaluation for orphan designations.
Corporate
‒
Decreased debt from $7.2 million at
June 30, 2018 to $5.3 million at September
30, 2018.
First Quarter Fiscal 2019 Financial Results
For the
first fiscal quarter ended September 30,
2018, the Company reported a net loss of $(5.7) million, or $(0.03) per basic and diluted share, compared to
net income of $10.6 million, or
$0.05 per basic and diluted share, in
the same period in 2017. The difference was primarily
attributable to the recognition of $26.9
million in license and contract revenue during the 2017
period pursuant to our license agreements with AMAG and Fosun and
secondarily attributable to the decrease in research and
development expenses pursuant to the completion of our Vyleesi
Phase 3 clinical trial program.
Revenue
The Company recognized $34,505 of revenue for the first fiscal quarter
ended September 30, 2018, compared to
$21.9 million in license and contract
revenue related to our license agreement with AMAG and $5.0 million in license revenue related to the
license agreement with Fosun for the quarter ended September 30, 2017.
Operating Expenses
Total operating expenses were
$5.7 million for the first fiscal
quarter ended September 30, 2018,
compared to $15.7 million in the same
period 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 expense, net was
$53,288 for the first fiscal quarter
ended September 30, 2018 compared to
$0.4 million for the same period of
2017. Total other expense, net for both periods consisted
primarily of interest expense related to the Company's venture debt
offset by investment income.
Income Tax
Pursuant to the license agreement with
Fosun, $500,000 was withheld in
accordance with tax withholding requirements in China and was recorded as an expense during
the fiscal year ended June 30, 2018.
For the quarter ended September 30,
2017, Palatin incurred $225,255 in income tax expense utilizing an
estimated effective annual income tax rate applied to income for
the quarter and the remaining balance of $274,745 was included in prepaid expenses and
other current assets at September 30,
2017. Any potential credit to be received by Palatin on its
United States tax returns is
currently offset by Palatin's valuation allowance.
There was no income tax expense recorded in the quarter ended
September 30, 2018.
Cash Position
At September 30,
2018, the Company had cash, cash equivalents, and accounts
receivable aggregating $32.7,
compared to cash and cash equivalents and accounts receivable of
$38.0 million at June 30, 2018. Current liabilities were
$8.5 million as of September 30, 2018, compared to $10.8 million as of June
30, 2018.
The Company believes that existing capital resources will be
sufficient to fund its planned operations through at least the 2019
calendar year.
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 melanocortin receptor1 and receptor-1/5 agonist
peptides for treatment of anti-inflammatory and autoimmune
indications, receptor-4 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 November 13,
2018 at 11:00 a.m. Eastern
Time to discuss the quarter ended September 30, 2018 results of operations and also
provide an update on its programs under development.
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 5988704. 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 5988704. The webcast and telephone
replay will be available through November
20, 2018.
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.
Vyleesi™ is a trademark of AMAG Pharmaceuticals, Inc. in
North America and of Palatin
Technologies, Inc. elsewhere in the world.
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
2018
|
|
2017
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
License and
contract
|
|
$
34,505
|
|
$
26,941,508
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
Research and
development
|
|
3,622,691
|
|
14,163,097
|
General and
administrative
|
|
2,040,582
|
|
1,544,575
|
Total operating
expenses
|
|
5,663,273
|
|
15,707,672
|
|
|
|
|
|
(Loss) income from
operations
|
|
(5,628,768)
|
|
11,233,836
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
Investment
income
|
|
153,583
|
|
51,726
|
Interest
expense
|
|
(206,871)
|
|
(456,677)
|
Total other expense,
net
|
|
(53,288)
|
|
(404,951)
|
|
|
|
|
|
(Loss) income before
income taxes
|
|
(5,682,056)
|
|
10,828,885
|
Income tax
expense
|
|
-
|
|
(225,255)
|
|
|
|
|
|
NET (LOSS)
INCOME
|
|
$
(5,682,056)
|
|
$
10,603,630
|
|
|
|
|
|
Basic net (loss)
income per common share
|
|
$
(0.03)
|
|
$
0.05
|
|
|
|
|
|
Diluted net (loss)
income per common share
|
|
$
(0.03)
|
|
$
0.05
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing basic net (loss)
income per common share
|
|
205,009,278
|
|
197,112,400
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing diluted net
(loss) income per common share
|
|
205,009,278
|
|
201,360,736
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
September 30,
2018
|
|
June 30,
2018
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
32,619,064
|
|
$
38,000,171
|
Accounts
receivable
|
104,189
|
|
-
|
Prepaid expenses and
other current assets
|
420,639
|
|
513,688
|
Total current
assets
|
33,143,892
|
|
38,513,859
|
|
|
|
|
Property and
equipment, net
|
149,990
|
|
164,035
|
Other
assets
|
338,916
|
|
338,916
|
Total
assets
|
$
33,632,798
|
|
$
39,016,810
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,165,151
|
|
$
2,223,693
|
Accrued
expenses
|
2,020,333
|
|
2,103,021
|
Notes payable, net of
discount
|
4,305,242
|
|
5,948,763
|
Other current
liabilities
|
969,179
|
|
487,488
|
Total current
liabilities
|
8,459,905
|
|
10,762,965
|
|
|
|
|
Notes payable, net of
discount
|
-
|
|
332,898
|
Deferred
revenue
|
-
|
|
500,000
|
Other non-current
liabilities
|
-
|
|
456,038
|
Total
liabilities
|
8,459,905
|
|
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
September 30, 2018 and June 30, 2018
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 203,032,129 shares as of September 30,
2018 and 200,554,205 shares as of June 30, 2018
|
2,030,321
|
|
2,005,542
|
Additional paid-in
capital
|
360,370,494
|
|
357,005,233
|
Accumulated
deficit
|
(337,227,962)
|
|
(332,045,906)
|
Total stockholders'
equity
|
25,172,893
|
|
26,964,909
|
Total liabilities and
stockholders' equity
|
$
33,632,798
|
|
$
39,016,810
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.