CRANBURY, NJ – November 13, 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, 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.
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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.
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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 June30, 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 November13, 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 November20, 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.
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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.
