Full Press Release Details
Palatin Technologies, Inc. Reports Second Fiscal Quarter 2019
and Provides Corporate Update
Teleconference and Webcast to be held on February 12,
CRANBURY, NJ February 12, 2019 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,
Recent Highlights and Program Updates
Dysfunction / Vyleesi (bremelanotide)
the trade name for bremelanotide - Under development for Hypoactive
Sexual Desire Disorder ( HSDD ):
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,
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
results are anticipated to be submitted to the FDA prior to the
is in discussions with potential collaboration partners for certain
regions outside of the licensed territories of North America, China
Anti-Inflammatory / Autoimmune Programs
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:
a selective MC1r peptide agonist:
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,
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.
is under internal evaluation for orphan designations.
and PL-9643, dual MC1r and MC5r peptide agonists:
with preclinical Investigational New Drug ( IND )
enabling activities.
is under internal evaluation for orphan designations.
Natriuretic Peptide Receptor ( NPR ) System
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
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
collaborations with several institutions ongoing.
a dual NPR-A and NPR-C agonist in development for cardiovascular
diseases, including reducing cardiac hypertrophy and
collaborations with several institutions ongoing.
Genetic Obesity Program
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:
is under internal evaluation for orphan designations.
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
There were no revenues recorded in the quarter ended December 31,
For the quarter ended December 31, 2017, 100% of the revenue
Palatin recognized was related to our license agreement with
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
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.
was no income tax expense, or benefit, recorded in the quarter
ended December 31, 2018.
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