CRANBURY, N.J., Feb. 11, 2020 /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, whose product candidates are
targeted, receptor-specific therapeutics for the treatment of
diseases with significant unmet medical need and commercial
potential, today announced results for its second quarter ended
December 31, 2019.
"The June 2019 FDA approval of
Vyleesi® was meaningful on two fronts," said
Carl Spana, Ph.D., President and
Chief Executive Officer of Palatin. "For premenopausal women, it
provides a safe and effective, as-needed treatment option for those
with HSDD. For Palatin, we now have an enhanced cash position of
$92 million at December 31, 2019, which puts us in an excellent
position to advance our pipeline programs. We have two Phase 2
clinical studies starting in the first half of calendar year 2020:
a dry eye disease study with data expected in the fourth quarter of
calendar year 2020 and an ulcerative colitis trial with data
expected in mid-calendar year 2021."
"AMAG's planned divestiture of Vyleesi is based on
its change in strategy, and is not a result of the Vyleesi launch
performance to date," continued Spana. "As the licensor, we
maintain certain rights and will take appropriate steps to ensure
that the value of Vyleesi remains intact and continues to grow. We
will also continue to be opportunistic and flexible as the
divestiture process advances, with the objective that the ultimate
licensee of the North American rights to Vylessi is committed to
the robust commercialization of the product."
Recent Business Highlights
Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi®
(bremelanotide injection)
On January
9, 2020 AMAG Pharmaceuticals, Inc. ("AMAG") announced that,
as a result of a strategic review, it will divest Vyleesi, which it
exclusively licensed from Palatin for North America, and another female healthcare
product, Intrarosa®. AMAG stated that it has received
preliminary expressions of interest in these assets.
Under the Vyleesi license agreement, AMAG has a contractual
obligation to use commercially reasonable efforts to commercialize
Vyleesi. If AMAG materially breaches this obligation and fails to
cure such breach, Palatin could potentially have the right to
terminate the license agreement and have Vyleesi returned to
Palatin. In the event AMAG assigns its Vyleesi license, the
assignee must expressly agree to be bound by the Vyleesi license
agreement between AMAG and Palatin.
Palatin is advancing discussions on Vyleesi collaborations for
territories outside the currently licensed territories of
North America, China, and Korea, and anticipates executing
multiple agreements during calendar year 2020. Vyleesi is licensed
to Fosun Pharma in China and
Kwangdong Pharmaceuticals in South
Korea. Both companies are advancing Vyleesi through the
regulatory process in their respective territories, which includes
the conduct of certain clinical studies in those territories prior
to filing for market approval.
Vyleesi is the first as-needed treatment approved for
premenopausal women with acquired, generalized HSDD. AMAG
Pharmaceuticals, Palatin's North American licensee, launched
Vyleesi nationally in September 2019
through select specialty pharmacies with its established women's
health sales force of approximately 125 sales representatives.
While AMAG has not yet released prescription numbers for the
quarter ended December 31, 2019, AMAG
has stated publicly that the "Vyleesi launch is off to a strong
start."
Anti-Inflammatory / Autoimmune Programs
Melanocortin
agonist products are under development for the treatment of
inflammatory and autoimmune diseases such as dry eye, uveitis,
diabetic retinopathy and inflammatory bowel diseases (ulcerative
colitis).
An investigational new drug application (IND) for PL9643 in dry
eye disease was filed with the US Food and Drug Administration
(FDA) in December 2019. A Phase 2
clinical study is expected to commence in the first quarter of
calendar year 2020, with data readout anticipated in the fourth
quarter of calendar year 2020.
A Phase 2 proof-of-concept clinical study with an oral
formulation of PL8177 in ulcerative colitis patients is anticipated
to start mid-calendar year 2020, with data readout mid-calendar
year 2021.
Palatin continues its assessment and development work related to
the treatment of patients with diabetic retinopathy and
non-infectious uveitis (NIU), an indication which FDA granted
orphan drug designation, with the objective of commencing clinical
trials in calendar year 2021.
Natriuretic Peptide Receptor (NPR) System
Program
Palatin has designed and is developing potential
drug candidates that are selective agonists 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).
PL3994, an NPR-A agonist, will be evaluated in a Phase 2a
clinical study in heart failure patients with preserved ejection
fraction. The proposed study is a collaboration with two major
academic medical centers and is supported by an American Heart
Association grant. The study is anticipated to start patient
enrollment in 2020.
PL3994 has potential utility in the treatment of a number of
cardiovascular diseases, including genetic and orphan diseases
resulting from a deficiency of endogenous active NPR-A. PL5028, a
dual NPR-A and NPR-C agonist in development for cardiovascular
diseases, has potential for reducing cardiac hypertrophy and
fibrosis, among other indications.
Genetic Obesity Program
Palatin's melanocortin
receptor 4 (MC4r) peptide PL8905 and orally active small molecule
PL9610 are currently under investigation for the treatment of rare
genetic metabolic and obesity disorders. These programs are under
internal evaluation for orphan designations, potential development,
and licensing.
Second Quarter Fiscal Year 2020 Financial
Results
Revenue
For the quarter ended December 31, 2019, Palatin recognized as revenue
$20,610 in reimbursement of shared
Vyleesi costs related to our license agreement with AMAG. There
were no revenues recorded in the quarter ended December 31, 2018.
Operating Expenses
Total operating expenses for the
quarter ended December 31, 2019 were
$5.7 million compared to $5.1 million for the comparable quarter of 2018.
The increase in operating expenses was mainly due to the final
payment of $625,000 made in
connection with the mutually agreed upon termination of our
engagement agreement on Vyleesi with Greenhill & Co.
Other Income/Expense, net
Total other income was
$397,480 for the quarter ended
December 31, 2019 compared to total
other income $7,871 for the quarter
ended December 31, 2018. The
difference is related primarily to the increase in investment
income.
Net Loss
Palatin reported a net loss of $(5.2) million, or $(0.02) per basic and diluted share, for the
quarter ended December 31, 2019,
compared to a net loss of $(5.0)
million, or $(0.02) per basic
and diluted share, for the same period in 2018.
The difference in financial results between the three months
ended December 31, 2019 and 2018 was
attributable to the increase in operating expenses of $0.6 million offset by the increase of
$0.4 million in other income.
Cash Position
Palatin's cash, cash equivalents, and
accounts receivable total $91.6
million as of December 31,
2019, compared to cash, cash equivalents, and accounts
receivable of $103.8 million at
June 30, 2019. Current liabilities
were $1.4 million as of December 31, 2019, compared to $4.2 million as of June
30, 2019.
Conference Call / Webcast
Palatin will host a
conference call and audio webcast on February 11, 2020 at 11:00
a.m. Eastern Time to discuss the results of operations for
the quarter ended December 31, 2019
in greater detail and provide an update on corporate developments.
Individuals interested in listening to the conference call live can
dial 1-800-353-6461 (US/Canada) or
1-334-323-0501 (international), conference ID 7551093. 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 audio 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 7551093. The webcast and telephone replay
will be available through February 18,
2020.
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,
AMAG's plans to divest Vyleesi, Palatin's ongoing relationship with
AMAG and ability to protect its rights as the Vyleesi licensor, 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, transfer of marketing and sale of
Vyleesi in North America to
another pharmaceutical company, sales of Vyleesi in the United States and elsewhere in the world,
results of clinical trials, regulatory actions by the FDA and other
regulatory 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 registered trademark of AMAG Pharmaceuticals, Inc.
in North America and of Palatin
Technologies, Inc. elsewhere in the world.
(Financial Statement Data Follows)
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Six Months Ended
December 31,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
License and
contract
|
$
20,610
|
|
$
-
|
|
$
117,989
|
|
$
34,505
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Research and
development
|
3,257,624
|
|
2,961,656
|
|
6,385,113
|
|
6,584,347
|
General and
administrative
|
2,404,093
|
|
2,088,565
|
|
4,236,535
|
|
4,129,147
|
Total operating
expenses
|
5,661,717
|
|
5,050,221
|
|
10,621,648
|
|
10,713,494
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(5,641,107)
|
|
(5,050,221)
|
|
(10,503,659)
|
|
(10,678,989)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
|
|
Investment
income
|
399,982
|
|
100,169
|
|
770,636
|
|
253,752
|
Interest
expense
|
(2,502)
|
|
(92,298)
|
|
(11,553)
|
|
(299,169)
|
Total other income
(expense), net
|
397,480
|
|
7,871
|
|
759,083
|
|
(45,417)
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(5,243,627)
|
|
$
(5,042,350)
|
|
$
(9,744,576)
|
|
$
(10,724,406)
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per common share
|
$
(0.02)
|
|
$
(0.02)
|
|
$
(0.04)
|
|
$
(0.05)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing basic and diluted net
loss per common share
|
234,923,592
|
|
206,487,984
|
|
234,018,417
|
|
205,724,321
|
|
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
December 31,
2019
|
|
June 30,
2019
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
91,459,480
|
|
$
43,510,422
|
Accounts
receivable
|
117,989
|
|
60,265,970
|
Prepaid expenses and
other current assets
|
656,599
|
|
637,289
|
Total current
assets
|
92,234,068
|
|
104,413,681
|
|
|
|
|
Property and
equipment, net
|
167,913
|
|
141,539
|
Right-of-use
assets
|
173,666
|
|
-
|
Other
assets
|
179,916
|
|
179,916
|
Total
assets
|
$
92,755,563
|
|
$
104,735,136
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
135,171
|
|
$
504,787
|
Accrued
expenses
|
1,079,591
|
|
2,848,692
|
Notes payable, net of
discount
|
-
|
|
332,896
|
Other current
liabilities
|
160,178
|
|
499,517
|
Total current
liabilities
|
1,374,940
|
|
4,185,892
|
|
|
|
|
Other
liabilities
|
13,488
|
|
-
|
Total
liabilities
|
1,388,428
|
|
4,185,892
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares
issued and outstanding designated as follows:
|
|
|
|
Series A Convertible:
authorized 264,000 shares: issued and outstanding
4,030 shares as of December 31, 2019 and June 30, 2019
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 229,174,754 shares as of December 31, 2019 and
226,815,363 shares as of June 30, 2019
|
2,291,748
|
|
2,268,154
|
Additional paid-in
capital
|
394,592,802
|
|
394,053,929
|
Accumulated
deficit
|
(305,517,455)
|
|
(295,772,879)
|
Total stockholders'
equity
|
91,367,135
|
|
100,549,244
|
Total liabilities and
stockholders' equity
|
$
92,755,563
|
|
$
104,735,136
|
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SOURCE Palatin Technologies, Inc.