Blueprint
Palatin Technologies, Inc. Reports Second Quarter
Fiscal Year 2020 Financial Results and Recent Business
Highlights
— Dry Eye Disease
Phase 2 Study to Commence Q1 2020 – Data Q4 2020
— Approximately $92
Million in Cash and Cash Equivalents at December
31, 2019
— AMAG Announced Plans to Divest
Vyleesi®
for Premenopausal Women
with Hypoactive
Sexual Desire Disorder (HSDD)
— Teleconference
and Webcast to be held on February 11, 2020
CRANBURY, NJ – February 11, 2020 – 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.
Investor Inquiries:
|
Media Inquiries:
|
Stephen T. Wills, CPA, MST
|
Paul
Arndt, MBA, LifeSci Advisors
|
CFO/COO (609) 495-2200
|
Managing
Director (646) 597-6992
|
Info@Palatin.com
|
Paul@LifeSciAdvisors.com
|
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)
3
PALATIN
TECHNOLOGIES, INC.
|
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
Six Months Ended
December 31,
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
License and
contract
|
$20,610
|
$-
|
$117,989
|
$34,505
|
|
|
|
|
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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)
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(10,503,659)
|
(10,678,989)
|
|
|
|
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OTHER INCOME
(EXPENSE)
|
|
|
|
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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)
|
$(5,042,350)
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$(9,744,576)
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$(10,724,406)
|
|
|
|
|
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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
|
|
|
|
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PALATIN TECHNOLOGIES, INC.
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Consolidated
Balance Sheets
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ASSETS
|
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Current
assets:
|
|
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Cash and cash
equivalents
|
$91,459,480
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$43,510,422
|
Accounts
receivable
|
117,989
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60,265,970
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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
|
|
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
Current
liabilities:
|
|
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Accounts
payable
|
$135,171
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$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
|
|
|
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Stockholders’
equity:
|
|
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Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares issued
and outstanding designated as follows:
|
|
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Series A
Convertible: authorized 264,000 shares: issued and outstanding
4,030 shares as of December 31, 2019 and June 30, 2019
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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
|