CRANBURY, N.J., Nov. 13, 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, 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 first quarter ended
September 30, 2019.
Quarter End and Recent Highlights
Hypoactive Sexual Desire Disorder / Vyleesi™
(bremelanotide injection)
Vyleesi is the first as needed
treatment for premenopausal women with acquired, generalized
HSDD.
AMAG Pharmaceuticals, Palatin's North American licensee,
launched Vyleesi nationally in September with its established
women's health sales force of approximately 125 sales
representatives. In the four weeks since the national launch, more
than 1,300 healthcare providers have prescribed Vyleesi, which has
resulted in more than 3,000 prescriptions received by AMAG's
specialty pharmacy partners.
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). We announced
positive results of a micro-dose study of radiolabeled PL8177, a
selective melanocortin receptor 1 ("MC1r") peptide agonist, using
an oral, delayed-release, polymer formulation. The study met all
primary and secondary endpoints. PL8177 has potential application
in treatment of ulcerative colitis and other inflammatory bowel
diseases. The FDA has granted orphan drug designation for PL8177
for the treatment of non-infectious intermediate, posterior, pan
and chronic anterior uveitis. Non-infectious uveitis (NIU) is a
group of inflammatory diseases that produces swelling and destroys
eye tissue and can result in vision loss. A Phase 2
proof-of-concept clinical study with a systemic formulation in NIU
patients is anticipated to commence in the first quarter of
calendar year 2020. A Phase 2 proof-of-concept clinical study with
an oral formulation in ulcerative colitis patients is anticipated
to commence in the second quarter of calendar year 2020.
An IND application for PL9643, a melanocortin peptide agonist,
and commencement of a Phase 2 clinical study in dry eye disease,
are currently anticipated in the first quarter of calendar year
2020.
Natriuretic Peptide Receptor ("NPR") System
Program
The Company has designed and is developing
potential drug candidates that are selective agonist 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"). Active
collaborations with several institutions are ongoing for PL3994, an
NPR-A agonist that 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,
and PL5028, a dual NPR-A and NPR-C agonist in development for
cardiovascular diseases, including reducing cardiac hypertrophy and
fibrosis. A Phase 2A clinical trial evaluating PL3994 in heart
failure patients with preserved left ventricular ejection fraction
will begin enrollment in the latter half of calendar year 2019.
This trial is supported by a grant from the American Heart
Association.
Genetic Obesity Program
The Company'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 designation and
potential development.
Corporate
Cash, cash equivalents and accounts
receivable balances at September 30,
2019 total $96.8 million.
Debt and related liabilities were fully paid off in July 2019.
In September 2019, the Company's
Board of Directors approved a plan to offer to purchase and
terminate certain outstanding common stock purchase warrants
through privately negotiated transactions. The purchase and
termination program has no time limit and may be suspended for
periods or discontinued at any time.
To date, the Company entered into several warrant termination
agreements to repurchase and cancel previously issued
warrants. The Company repurchased and cancelled in the
aggregate 6.5 million warrants at an aggregate buyback price of
$2.5 million.
First Quarter Fiscal 2020 Financial Results
Palatin
reported a net loss of $(4.5)
million, or $(0.02) per basic
and diluted share, for the quarter ended September 30, 2019, compared to a net loss of
$(5.7) million, or $(0.03) per basic and diluted share, for the same
period in 2018.
The difference in financial results between the three months
ended September 30, 2019 and 2018 was
due to reductions in operating and interest expenses combined with
increases in reported license and contract revenue and investment
income.
Revenue
For the quarter ended September 30, 2019, Palatin recognized as revenue
$97,379 in reimbursement of shared
Vyleesi costs compared to $34,505 for
the quarter ended September 30,
2018.
Operating Expenses
Total operating expenses for
the quarter ended September 30, 2019
were $5.0 million compared to
$5.7 million for the comparable
quarter of 2018. The decrease in operating expenses was mainly
attributable to decreases in salaries and other employee related
expenses.
Other Income/Expense
Total other income, net was
$361,603 for the quarter ended
September 30, 2019 compared to total
other expense, net of $(53,288) for
the quarter ended September 30, 2018. The difference is
primarily related to an increase in investment income and
secondarily to a decrease in interest expense.
Cash Position
Palatin's cash, cash equivalents, and
accounts receivable total $96.8
million as of September 30,
2019, compared to cash, cash equivalents and accounts
receivable of $103.8 million at
June 30, 2019. Current liabilities
were $1.9 million as of September 30, 2019, compared to $4.2 million as of June
30, 2019.
Palatin Drug Discovery and Development Programs
During
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 receptor agonist peptides for
treatment of inflammatory indications and natriuretic peptide
receptor agonist compounds for treatment of cardiovascular and
fibrotic diseases.
Conference Call / Webcast
Palatin will host a
conference call and audio webcast on November 13, 2019 at 11:00
a.m. Eastern Time to discuss the quarter ended September 30, 2019 results of operations in
greater detail and provide an update on corporate developments.
Individuals interested in listening to the conference call live can
dial 1-888-599-8686 (US/Canada) or
1-323-794-2575 (international), conference ID 1609183. 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 1609183. The webcast and telephone replay
will be available through November 20,
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, 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 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
September 30
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
License and
contract
|
$
97,379
|
|
$
34,505
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Research and
development
|
3,127,489
|
|
3,622,691
|
|
General and
administrative
|
1,832,442
|
|
2,040,582
|
|
Total operating
expenses
|
4,959,931
|
|
5,663,273
|
|
|
|
|
|
|
Loss from
operations
|
(4,862,552)
|
|
(5,628,768)
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
Investment
income
|
370,654
|
|
153,583
|
|
Interest
expense
|
(9,051)
|
|
(206,871)
|
|
Total other income
(expense), net
|
361,603
|
|
(53,288)
|
|
|
|
|
|
|
NET LOSS
|
$
(4,500,949)
|
|
$
(5,682,056)
|
|
|
|
|
|
|
Basic net loss
per common share
|
$
(0.02)
|
|
$
(0.03)
|
|
|
|
|
|
|
Diluted net loss per
common share
|
$
(0.02)
|
|
$
(0.03)
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing basic net loss per
common share
|
233,113,241
|
|
205,009,278
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing diluted net loss per
common share
|
233,113,241
|
|
205,009,278
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
September 30,
2019
|
|
June 30,
2019
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
96,698,232
|
|
$
43,510,422
|
Accounts
receivable
|
97,379
|
|
60,265,970
|
Prepaid expenses and
other current assets
|
597,853
|
|
637,289
|
Total current
assets
|
97,393,464
|
|
104,413,681
|
|
|
|
|
Property and
equipment, net
|
186,166
|
|
141,539
|
Right-of-use
assets
|
213,065
|
|
-
|
Other
assets
|
179,916
|
|
179,916
|
Total
assets
|
$
97,972,611
|
|
$
104,735,136
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
57,823
|
|
$
504,787
|
Accrued
expenses
|
1,579,460
|
|
2,848,692
|
Notes payable, net of
discount
|
-
|
|
332,896
|
Other current
liabilities
|
213,065
|
|
499,517
|
Total
liabilities
|
1,850,348
|
|
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 September 30, 2019 and June 30, 2019
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 227,697,257 shares as of September 30, 2019 and
226,815,363 shares as of June 30, 2019
|
2,276,973
|
|
2,268,154
|
Additional paid-in
capital
|
394,119,078
|
|
394,053,929
|
Accumulated
deficit
|
(300,273,828)
|
|
(295,772,879)
|
Total stockholders'
equity
|
96,122,263
|
|
100,549,244
|
Total liabilities and
stockholders' equity
|
$
97,972,611
|
|
$
104,735,136
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.