CRANBURY, N.J., May 13, 2015 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: 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 March 31, 2015.
Recent Highlights
- Launched reconnectstudy.com in support of our Bremelanotide
Phase 3 Program for Female Sexual Dysfunction (FSD)
- Provides FAQs on study design
- Qualification, participation, and enrollment criteria
- Bremelanotide development for FSD:
- Palatin initiated Protocols 301 and 302 of its Phase 3
reconnect study in the United
States and Canada for the
treatment of FSD in December 2014 and
January 2015. More information on the
trial protocols can be found at clinicaltrials.gov.
- Enrollment in the two Phase 3 studies is meeting target
objectives
- The clinical trials are designed to randomize approximately
1100 women (~550 each trial) to evaluate efficacy and safety of
subcutaneous bremelanotide in premenopausal women with hypoactive
sexual desire disorder as an on-demand, as-needed treatment. For
more information visit reconnectstudy.com.
"We are extremely pleased that enrollment in our two Phase 3
studies of bremelanotide for the treatment of FSD is on track and
we anticipate completing enrollment in the second half of calendar
year 2015 and reporting top-line results in mid-calendar year
2016," said Carl Spana,
President and Chief Executive Officer of Palatin. "Work is
proceeding with Gedeon Richter Plc., our co-development and
commercialization partner in Europe, to initiate a Phase
3 clinical trial later this calendar year."
Third Quarter Fiscal 2015 Financial Results
Palatin
reported a net loss of $9.2 million,
or $(0.07) per basic and diluted
share, for the quarter ended March 31,
2015, compared to a net loss of $1.5
million, or $(0.01) per basic
and diluted share, for the same period in 2014. The increase
in net loss for the quarter ended March 31,
2015 compared to the same period last fiscal year was
attributable to the increase in research and development expenses
related to our Phase 3 reconnect study with
bremelanotide for the treatment of FSD.
Revenue
There were no revenues recognized for the
quarters ended March 31, 2015 and
2014.
Operating Expenses
Total operating expenses for the
quarter ended March 31, 2015 were
$8.7 million compared to $3.4 million for the comparable quarter of
2014. The increase in operating expenses for the quarter ended
March 31, 2015 was the result of an
increase in expenses relating to our Phase 3 reconnect study
with bremelanotide for the treatment of FSD.
Cash Position
Palatin's cash and cash equivalents were
$36.7 million as of March 31, 2015, compared to cash and cash
equivalents of $12.2 million at
June 30, 2014. Current liabilities
were $5.2 million as of March 31, 2015, compared to $1.8 million, net of $1.0
million of deferred revenue, as of June 30, 2014.
Palatin believes that existing capital resources will be
adequate to fund our planned operations through the quarter ending
June 30, 2016.
Conference Call / Webcast
Palatin will host a
conference call and webcast on May 13,
2015 at 11:00 a.m. Eastern
Time to discuss the results of operations in greater detail
and provide an update on corporate developments. Individuals
interested in listening to the conference call live can dial
1-888-556-4997 (domestic) or 1-719-457-2085 (international), pass
code 6985158. The webcast and replay can be accessed by
logging on to the "Investor/Media Center-Webcasts" section of
Palatin's website at 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 (domestic) or 1-719-457-0820 (international), pass
code 6985158.
About Palatin Technologies, Inc.
Palatin
Technologies, Inc. is a biopharmaceutical company developing
targeted, receptor-specific peptide therapeutics 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.
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PALATIN
TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Statements of Operations
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(unaudited)
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Three Months Ended
March 31,
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Nine Months Ended
March 31,
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2015
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2014
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2015
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2014
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REVENUES:
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Contract
revenue
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$
-
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$
-
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$ 12,951,730
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$
-
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OPERATING
EXPENSES:
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Research and
development
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7,588,437
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2,151,225
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14,785,974
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8,230,733
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General and
administrative
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1,133,954
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1,212,513
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3,671,621
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3,236,093
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Total operating
expenses
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8,722,391
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3,363,738
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18,457,595
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11,466,826
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Loss from
operations
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(8,722,391)
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(3,363,738)
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(5,505,865)
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(11,466,826)
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OTHER (EXPENSE)
INCOME:
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Investment
income
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14,696
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4,363
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24,694
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14,613
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Interest
expense
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(311,170)
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(182)
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(344,757)
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(2,987)
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Foreign exchange
transaction loss
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(131,673)
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-
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(284,656)
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-
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Total other (expense)
income, net
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(428,147)
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4,181
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(604,719)
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11,626
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Loss before income
taxes
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(9,150,538)
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(3,359,557)
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(6,110,584)
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(11,455,200)
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Income tax
benefit
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-
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1,846,646
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531,508
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1,846,646
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NET LOSS
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$
(9,150,538)
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$ (1,512,911)
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$ (5,579,076)
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$ (9,608,554)
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Basic and
diluted net loss per common share
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$
(0.07)
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$
(0.01)
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$
(0.05)
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$
(0.09)
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Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
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134,008,239
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106,709,340
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116,632,958
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106,668,094
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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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March 31,
2015
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June 30,
2014
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ASSETS
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Current
assets:
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Cash and cash
equivalents
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$
36,729,174
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$
12,184,605
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Prepaid
expenses and other current assets
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1,971,572
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156,393
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Total current
assets
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38,700,746
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12,340,998
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Property and
equipment, net
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153,971
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160,748
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Other
assets
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173,518
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57,308
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Total
assets
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$
39,028,235
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$
12,559,054
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LIABILITIES AND
STOCKHOLDERS' EQUITY
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Current
liabilities:
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Accounts
payable
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$
2,325,778
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$
261,280
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Accrued
expenses
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2,839,406
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1,508,958
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Capital lease
obligations
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25,497
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-
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Deferred
revenue
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-
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1,000,000
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Total current
liabilities
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5,190,681
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2,770,238
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Notes payable, net of
discount
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9,757,797
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-
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Capital lease
obligations
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48,358
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-
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Other non-current
liabilities
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47,827
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-
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Total
liabilities
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15,044,663
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2,770,238
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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 4,697 shares as of March 31, 2015 and June
30, 2014, respectively
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47
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47
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Common stock of $0.01
par value – authorized 300,000,000 shares;
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issued and
outstanding 42,155,105 shares as of March 31, 2015 and 39,416,595
as of June 30, 2014, respectively
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421,551
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394,166
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Additional paid-in
capital
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303,174,803
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283,428,356
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Accumulated
deficit
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(279,612,829)
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(274,033,753)
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Total stockholders'
equity
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23,983,572
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9,788,816
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Total liabilities and
stockholders' equity
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$
39,028,235
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$
12,559,054
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SOURCE Palatin Technologies, Inc.