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| 8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Technologies, Inc. Reports First Fiscal Quarter 2019
Results and Provides Corporate Update
Teleconference and Webcast to be held on November 13,
2018
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,
2018.
Recent Highlights and Program Updates
Female Sexual Dysfunction / Vyleesi™
(bremelanotide)
●
Vyleesi,
the trade name for bremelanotide - Under development for Hypoactive
Sexual Desire Disorder (“HSDD”):
¯
FDA
(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
Vyleesi.
o
See
8-K filing today regarding the FDA’s review of the NDA
submission for Vyleesi and the request for additional
data.
¯
AMAG
Pharmaceuticals is the exclusive licensee for North
America.
¯
Palatin
is in discussions with potential collaboration partners for certain
regions outside of the licensed territories of North America, China
and South Korea.
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
diseases:
o
Announced
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.
o
Data
from a separate clinical study investigating an oral formulation of
PL-8177 is currently expected by the end of calendar year
2018.
o
Program
is under internal evaluation for orphan designations.
1
¯
PL-8331
for ocular indications:
o
Preclinical
IND enabling activities commenced.
o
Program
is under internal evaluation for orphan designations.
Natriuretic Peptide Program
¯
PL-3994:
Phase 2a, open label study in heart failure patients with preserved
ejection fraction, targeted to commence in the first half of
2019.
¯
PL-5028:
Preclinical studies evaluating potential use in fibrotic disease
ongoing.
Genetic Obesity Program
¯
MC4r
selective peptide and oral small molecule agonists: Commenced
preclinical IND activities.
¯
Program
is under internal evaluation for orphan designations.
Corporate
¯
Decreased
debt from $7.2 million at June 30, 2018 to $5.3 million at
September 30, 2018.
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.
Revenue
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,
2017.
Operating Expenses
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
HSDD in March 2018.
2
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.
Income Tax
Pursuant
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
September 30, 2018.
Cash Position
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
calendar year.
Palatin Drug Discovery Programs
In 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 receptor1 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.
Conference Call / Webcast
Palatin will host a conference call and webcast on November 13,
2018 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2018 results of
operations and also provide an update on its programs under
development. Individuals interested in listening to the conference
call live can dial 1-877-260-1479 (US/Canada) or 1-334-323-0522
(international), conference ID 5988704. The 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 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 5988704. The webcast and telephone replay
will be available through November 20, 2018.
3
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, results of
clinical trials, regulatory actions by the FDA 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.
|
Investor
Inquiries:
|
Media Inquiries:
|
|
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Stephen T. Wills, CPA,
MST
|
Paul Arndt, MBA,
LifeSci Advisors
|
|
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CFO/COO (609) 495-2200
|
Managing
Director (646) 597-6992
|
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Info@Palatin.com
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Paul@LifeSciAdvisors.com
|
|
Vyleesi™ is a trademark of AMAG Pharmaceuticals, Inc. in
North America and of Palatin Technologies, Inc. elsewhere in the
world.
(Financial Statement Data Follows)
4
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PALATIN
TECHNOLOGIES, INC.
|
||
|
and
Subsidiary
|
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|
Consolidated
Statements of Operations
|
||
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(unaudited)
|
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|
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Three Months Ended
September 30,
|
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|
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2018
|
2017
|
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|
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REVENUES:
|
|
|
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License and
contract
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$34,505
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$26,941,508
|
|
|
|
|
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OPERATING
EXPENSES:
|
|
|
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Research and
development
|
3,622,691
|
14,163,097
|
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General and
administrative
|
2,040,582
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1,544,575
|
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Total operating
expenses
|
5,663,273
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15,707,672
|
|
|
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(Loss) income from
operations
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(5,628,768)
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11,233,836
|
|
|
|
|
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OTHER INCOME
(EXPENSE):
|
|
|
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Investment
income
|
153,583
|
51,726
|
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Interest
expense
|
(206,871)
|
(456,677)
|
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Total other
expense, net
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(53,288)
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(404,951)
|
|
|
|
|
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(Loss) income
before income taxes
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(5,682,056)
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10,828,885
|
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Income tax
expense
|
-
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(225,255)
|
|
|
|
|
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NET (LOSS)
INCOME
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$(5,682,056)
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$10,603,630
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|
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Basic net (loss)
income per common share
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$(0.03)
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$0.05
|
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|
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Diluted net (loss)
income per common share
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$(0.03)
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$0.05
|
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Weighted average
number of common shares outstanding used in computing basic net
(loss) income per common share
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205,009,278
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197,112,400
|
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|
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Weighted average
number of common shares outstanding used in computing diluted net
(loss) income per common share
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205,009,278
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201,360,736
|
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5
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PALATIN TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Balance Sheets
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(unaudited)
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September
30,
2018
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June
30,
2018
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ASSETS
|
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Current
assets:
|
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Cash and cash
equivalents
|
$32,619,064
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$38,000,171
|
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Accounts
receivable
|
104,189
|
-
|
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Prepaid expenses
and other current assets
|
420,639
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513,688
|
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Total current
assets
|
33,143,892
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38,513,859
|
|
|
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Property and
equipment, net
|
149,990
|
164,035
|
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Other
assets
|
338,916
|
338,916
|
|
Total
assets
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$33,632,798
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$39,016,810
|
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
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Current
liabilities:
|
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Accounts
payable
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$1,165,151
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$2,223,693
|
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Accrued
expenses
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2,020,333
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2,103,021
|
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Notes payable, net
of discount
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4,305,242
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5,948,763
|
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Other current
liabilities
|
969,179
|
487,488
|
|
Total current
liabilities
|
8,459,905
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10,762,965
|
|
|
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Notes payable, net
of discount
|
-
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332,898
|
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Deferred
revenue
|
-
|
500,000
|
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Other non-current
liabilities
|
-
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456,038
|
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Total
liabilities
|
8,459,905
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12,051,901
|
|
|
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Stockholders’
equity:
|
|
|
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Preferred stock of
$0.01 par value – authorized 10,000,000 shares:
|
|
|
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Series A
Convertible: issued and outstanding 4,030 shares as of September
30, 2018 and June 30, 2018
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40
|
40
|
|
Common stock of
$0.01 par value – authorized 300,000,000 shares:
|
|
|
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issued and
outstanding 203,032,129 shares as of September 30, 2018 and
200,554,205 shares as of June 30, 2018
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2,030,321
|
2,005,542
|
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Additional paid-in
capital
|
360,370,494
|
357,005,233
|
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Accumulated
deficit
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(337,227,962)
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(332,045,906)
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Total
stockholders’ equity
|
25,172,893
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26,964,909
|
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Total liabilities
and stockholders’ equity
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$33,632,798
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$39,016,810
|
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6