Full Press Release Details
Palatin Technologies, Inc. Reports First Fiscal Quarter 2019
Results and Provides Corporate Update
Teleconference and Webcast to be held on November 13,
CRANBURY, NJ November 13, 2018 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 first fiscal quarter ended September 30,
Recent Highlights and Program Updates
Female Sexual Dysfunction / Vyleesi
the trade name for bremelanotide - Under development for Hypoactive
Sexual Desire Disorder ( HSDD ):
(U.S. Food and Drug Administration) set the PDUFA (Prescription
Drug User Fee Act) action goal date of March 23, 2019 for
completion of the review of the New Drug Application (NDA) for
8-K filing today regarding the FDA's review of the NDA
submission for Vyleesi and the request for additional
Pharmaceuticals is the exclusive licensee for North
is in discussions with potential collaboration partners for certain
regions outside of the licensed territories of North America, China
Anti-Inflammatory / Autoimmune Programs
Melanocortin 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
positive pharmacokinetics and pharmacodynamic results with no
reported safety or tolerability concerns from a first-in-human
Phase 1 safety study of subcutaneous dosing of PL-8177 in single
and multiple ascending doses.
from a separate clinical study investigating an oral formulation of
PL-8177 is currently expected by the end of calendar year
is under internal evaluation for orphan designations.
for ocular indications:
IND enabling activities commenced.
is under internal evaluation for orphan designations.
Natriuretic Peptide Program
Phase 2a, open label study in heart failure patients with preserved
ejection fraction, targeted to commence in the first half of
Preclinical studies evaluating potential use in fibrotic disease
Genetic Obesity Program
selective peptide and oral small molecule agonists: Commenced
preclinical IND activities.
is under internal evaluation for orphan designations.
debt from $7.2 million at June 30, 2018 to $5.3 million at
First Quarter Fiscal 2019 Financial Results
For the first fiscal quarter ended September 30, 2018, the Company
reported a net loss of $(5.7) million, or $(0.03) per basic and
diluted share, compared to net income of $10.6 million, or $0.05
per basic and diluted share, in the same period in 2017. The
difference was primarily attributable to the recognition of $26.9
million in license and contract revenue during the 2017 period
pursuant to our license agreements with AMAG and Fosun and
secondarily attributable to the decrease in research and
development expenses pursuant to the completion of our Vyleesi
Phase 3 clinical trial program.
The Company recognized $34,505 of revenue for the first fiscal
quarter ended September 30, 2018, compared to $21.9 million in
license and contract revenue related to our license agreement with
AMAG and $5.0 million in license revenue related to the license
agreement with Fosun for the quarter ended September 30,
Total operating expenses were $5.7 million for the first fiscal
quarter ended September 30, 2018, compared to $15.7 million in the
same period 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 expense, net was $53,288 for the first fiscal quarter
ended September 30, 2018 compared to $0.4 million for the same
period of 2017. Total other expense, net for both periods consisted
primarily of interest expense related to the Company's
venture debt offset by investment income.
to the license agreement with Fosun, $500,000 was withheld in
accordance with tax withholding requirements in China and was
recorded as an expense during the fiscal year ended June 30, 2018.
For the quarter ended September 30, 2017, Palatin incurred $225,255
in income tax expense utilizing an estimated effective annual
income tax rate applied to income for the quarter and the remaining
balance of $274,745 was included in prepaid expenses and other
current assets at September 30, 2017. Any potential credit to be
received by Palatin on its United States tax returns is currently
offset by Palatin's valuation allowance.
There was no income tax expense recorded in the quarter ended
At September 30, 2018, the Company had cash, cash equivalents, and
accounts receivable aggregating $32.7, compared to cash and cash
equivalents and accounts receivable of $38.0 million at June 30,
2018. Current liabilities were $8.5 million as of September 30,
2018, compared to $10.8 million as of June 30, 2018.
The Company believes that existing capital resources will be
sufficient to fund its planned operations through at least the 2019
Palatin Drug Discovery Programs
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 1 and
receptor-1/5 agonist peptides for treatment of anti-inflammatory
and autoimmune indications, receptor-4 peptide and small molecule
agonists for the treatment of genetic obesity indications and
natriuretic peptide receptor agonist compounds for treatment of
cardiovascular and pulmonary indications.