Full Press Release Details
Palatin Technologies, Inc. Reports Third Quarter
Fiscal Year 2019 Results;
Teleconference and Webcast to be held on May 9, 2019
CRANBURY, NJ May 9, 2019 Palatin Technologies, Inc.
(NYSE American: PTN), a biopharmaceutical company developing
targeted, receptor-specific peptide therapeutics for the treatment
of diseases with significant unmet medical need and commercial
potential, today announced results for its third quarter ended
Recent Highlights and Program Updates
Female Sexual 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 ) is June 23, 2019
U.S. Food and Drug Administration ( FDA ) requested a
Phase 1 study in premenopausal volunteers assessing short term
daily use of Vyleesi. This study, conducted by Palatin and our
exclusive licensee for North America, AMAG Pharmaceuticals, was
completed and data has been submitted to the FDA
is in discussions with potential collaboration partners for certain
regions outside of the licensed territories of North America, China
/ Autoimmune Programs
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:
positive top line results of an oral clinical study for ulcerative
colitis and other inflammatory bowel diseases
2 proof-of-concept clinical study with the oral formulation in
ulcerative colitis patients anticipated to commence in the fourth
quarter of calendar year 2019
2 proof-of-concept clinical study with a systemic formulation in
non-infectious uveitis (NIU) patients anticipated
to commence in the fourth quarter of calendar year
investigation of other possible indications for systemic
is under internal evaluation for orphan designations
a melanocortin peptide agonist:
with preclinical Investigational New Drug ( IND )
enabling activities for ocular diseases
is under internal evaluation for orphan designations
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 investigation for the treatment of
rare genetic metabolic and obesity disorders:
is under internal evaluation for orphan designation
debt and related liabilities from $7.2 million at June 30, 2018 to
$1.8 million at March 31, 2019.
Third Quarter Fiscal 2019 Financial Results
Palatin reported a net loss of $(5.7) million, or $(0.03) per basic
and diluted share, for the quarter ended March 31, 2019, compared
to a net loss of $(0.7) million, or $(0.00) per basic and diluted
share, for the same period in 2018.
The difference in financial results between the three months ended
March 31, 2019 and 2018 was mainly attributable to the recognition
of $9.0 million in license and contract revenue during the 2018
period pursuant to our license agreement with AMAG.
There were no revenues recorded in the quarter ended March 31,
For the quarter ended March 31, 2018, all the revenue Palatin
recognized was related to our license agreement with
Total operating expenses for the quarter ended March 31, 2019 were
$5.8 million compared to $9.5 million for the comparable quarter in
2018. 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 for Vyleesi in March
Other Income/Expense
Total other income, net was $35,648 for the quarter ended March 31,
2019 compared to total other expense, net of $(0.2) million for the
same period in 2018. The difference consisted primarily of the
decrease in interest expense related to Palatin's venture
was no income tax expense, or benefit, recorded in the quarter
ended March 31, 2019.
to the license agreements with our Chinese and South Korean
licensees, $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
March 31, 2018, Palatin recorded an income tax benefit of $18,746
related to those withholding amounts utilizing an estimated
effective annual income tax rate applied to the loss for the
quarter and the remaining balance as of March 31, 2018 of $275,111
was included in prepaid expenses and other current assets. Any
potential credit to be received by Palatin on its United States tax
returns is currently offset by Palatin's valuation
Palatin's cash and cash equivalents were $19.8 million as of
March 31, 2019, compared to cash and cash equivalents of $38.0