CRANBURY, N.J., Sept. 21, 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 fourth
quarter and fiscal year ended June
30, 2015.
Fiscal Year Ended June 30, 2015
and Recent Highlights
- Bremelanotide development for Female Sexual Dysfunction (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, respectively. Further
information on the trial protocols can be found at
clinicaltrials.gov.
- The two Phase 3 studies are progressing as planned and meeting
target objectives.
- Enrollment is greater than 50% to date and is expected to be
completed in the fourth quarter of calendar year 2015.
- Top-line data is expected to be available in the third quarter
of calendar year 2016.
- The clinical trials are designed to randomize approximately
1100 women (~550 per trial) to evaluate the efficacy and safety of
subcutaneous bremelanotide in premenopausal women with hypoactive
sexual desire disorder as an on-demand, as-needed treatment. For
further information visit reconnectstudy.com.
- Business Development
- FSD Program
- August 2014, Palatin entered into
a license agreement with Gedeon
Richter (Richter) to co-develop and commercialize
bremelanotide for FSD in the European Union, other European
countries and additional selected countries. Palatin received €7.5
million ($9.8 million) in total
upfront payments from Richter, and a milestone payment of €2.5
million ($3.1 million) upon the
initiation of its Phase 3 clinical trial program in the United States.
- September 2015, Palatin entered
into a termination agreement pursuant to which Palatin and Richter
agreed to mutually and amicably terminate the license agreement. In
connection with this termination, all rights and licenses to
co-develop and commercialize bremelanotide for FSD indications held
by Richter have terminated and reverted back to Palatin. Neither we
nor Gedeon Richter have any future
material obligations under the license agreement. There are no
payment or reimbursement obligations as a result of the license
agreement termination.
- Palatin now has the global rights to bremelanotide for FSD,
providing the Company and its business development efforts with
additional options and flexibility.
- Palatin is actively engaged in licensing and collaboration
discussions with multiple companies for both global and regional
commercial rights to bremelanotide.
- Natriuretic Peptide Program for Heart Failure (HF)
- Palatin is advancing its lead compound, PL-3994, towards a
Phase 2A multiple dose study in HF patients.
- The Company is actively engaged in licensing and collaboration
discussions with multiple companies for both global and regional
rights.
- MC1r Anti-Inflammatory Program
- Palatin is advancing its lead compound, PL-8177, towards a
Phase 1 clinical trial.
- The Company is actively engaged in licensing and collaboration
discussions with multiple companies for both global and regional
rights.
- MC4r Agonist Program for Obesity/Diabetes
- The research collaboration and license agreement dated
January 2007 with AstraZeneca (AZ)
expired because AZ ceased developing a compound covered by the
agreement. All rights and licenses that we granted to AZ were
returned to Palatin upon expiration of the agreement.
- Palatin is advancing its lead compound, PL-8905, towards a
Phase 1 clinical trial.
- The Company is actively engaged in licensing and collaboration
discussions with multiple companies for both global and regional
rights.
- Financing Transactions
- July 2015, Palatin closed on
$30 million of debt and equity
financing consisting of:
- $10 million venture loan, which
includes an interest-only payment period for the first eighteen
months of a four year secured term loan.
- $20 million private placement of
Series E warrants to purchase 21,917,808 shares of common stock and
Series F warrants to purchase 2,191,781 shares of common
stock.
- December 2014, Palatin closed on
$30 million of debt and equity
financing consisting of:
- $10 million venture loan, which
includes an interest-only payment period for the first eighteen
months of a four year secured term loan.
- $20 million private placement of
2,050,000 shares of common stock and Series warrants to purchase
24,919,325 shares of common stock.
- Intellectual Property - Palatin obtained patents during the
year:
- U.S. Patent 8,828,926 issued September
9, 2014, claiming uses of Palatin's PL-3994 natriuretic
peptide receptor product candidate for treatment of acute asthma
and chronic obstructive pulmonary disease.
- U.S. Patent 8,846,601 issued September
30, 2014, claiming melanocortin receptor 4 specific peptides
with potential utility for treatment of obesity, metabolic
syndrome, diabetes and sexual dysfunction.
- U.S. Patent 8,877,890 issued November
2014, claiming melanocortin receptor-1 cyclic peptides with
potential application in treatment of inflammatory and dermatologic
disease indications.
- U.S. Patent 8,933,194 issued January 13,
2015, claiming linear melanocortin receptor 1 specific
peptides
- In December 2014, Palatin
received $0.5 million in net proceeds
from the sale of New Jersey State net operating loss
carryforwards.
Fourth Quarter and Fiscal Year Ended 2015 Results
Palatin reported a net loss of $12.1
million, or $(0.09) per basic
and diluted share, for the quarter ended June 30, 2015, compared to a net loss of
$4.3 million, or $(0.04) per basic and diluted share, for the same
period in 2014.
The increase in net loss for the quarter ended June 30, 2015 compared to the net loss for the
quarter ended June 30, 2014 was the
result of an increase in operating expenses primarily related to
our bremelanotide for FSD Phase 3 development
program.
For the year ended June 30, 2015,
Palatin reported a net loss of $17.7
million, or $(0.15) per basic
and diluted share compared to a net loss of $13.9 million, or $(0.13) per basic and diluted share for the year
ended June 30, 2014.
The increase in net loss for the year ended June 30, 2015, compared to the net loss for the
year ended June 30, 2014 was mainly
attributable to the development costs for the initiation and
progression of the Phase 3 clinical trials of bremelanotide for
FSD.
Revenue
For the year ended June 30, 2015,
Palatin recognized $12.9 million of
license and contract revenue under the agreement with Gedeon Richter. There were no revenues recorded
in the quarter ended June 30, 2015 or
in the year ended June 30, 2014.
Operating Expenses
Operating expenses for the quarter ended June 30, 2015 were $11.8
million, compared to $4.3
million for the comparable quarter of 2014. For the year
ended June 30, 2015, Palatin incurred
$30.2 million of operating expenses,
compared to $15.8 million for the
year ended June 30, 2014.
The increase in operating expenses for the year and quarter
ended June 30, 2015 was primarily the
result of higher period costs related to Phase 3 clinical trial
program costs for bremelanotide for the treatment of FSD.
Cash Position
Palatin's cash and cash equivalents were $27.3 million as of June
30, 2015 compared to cash and cash equivalents of
$12.2 million at June 30, 2014. Current liabilities were
$7.4 million as of June 30, 2015, compared to $1.8 million, net of $1.0
million of deferred income, as of June 30, 2014.
Palatin believes that its existing capital resources, together
with approximately $29.7 million
received from the July 2015
financings will be adequate to fund planned operations through the
quarter ending September 30,
2016. Assuming the Phase 3 clinical trials of bremeloanotide
for FSD are successful, as to which there can be no assurance, the
Company will need additional funding to complete submission of
required regulatory applications to the FDA for bremelanotide for
FSD.
CONFERENCE CALL / WEBCAST
Palatin will host a
conference call and webcast on September 21,
2015 at 11:00 a.m. Eastern
time to discuss the results of operations and an update on
corporate developments in greater detail. Individuals
interested in listening to the conference call live can dial
1-888-505-4369 (domestic) or 1-719-325-2393 (international), pass
code 989803. The webcast and replay can be accessed by
logging on to the "Investor/Media Center-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 (domestic) or 1-719-457-0820
(international), pass code 989803. The webcast and telephone
replay will be available through September
28, 2015.
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, business development and licensing 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, entering into marketing and
distribution agreements, 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.
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
Year Ended June
30,
|
|
|
2015
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
License and
contract
|
$
12,951,730
|
|
$
-
|
|
$
10,361
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
Research and
development
|
24,560,233
|
|
10,826,921
|
|
10,528,691
|
|
General and
administrative
|
5,677,654
|
|
4,960,731
|
|
5,066,830
|
|
Total operating
expenses
|
30,237,887
|
|
15,787,652
|
|
15,595,521
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(17,286,157)
|
|
(15,787,652)
|
|
(15,585,160)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
|
Investment
income
|
35,439
|
|
18,923
|
|
42,734
|
|
Interest
expense
|
(661,697)
|
|
(6,211)
|
|
(8,411)
|
|
Foreign exchange
transaction loss
|
(284,656)
|
|
-
|
|
-
|
|
Increase in fair
value of warrants
|
-
|
|
-
|
|
(7,069,165)
|
|
Gain on disposition
of supplies and equipment
|
-
|
|
-
|
|
4,620
|
|
Total other income
(expense), net
|
(910,914)
|
|
12,712
|
|
(7,030,222)
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
(18,197,071)
|
|
(15,774,940)
|
|
(22,615,382)
|
|
Income tax
benefit
|
531,508
|
|
1,846,646
|
|
1,753,208
|
|
|
|
|
|
|
|
|
NET LOSS
|
$ (17,665,563)
|
|
$ (13,928,294)
|
|
$ (20,862,174)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.15)
|
|
$
(0.13)
|
|
$
(0.21)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
121,014,506
|
|
106,679,476
|
|
97,618,714
|
|
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
|
|
|
|
|
June 30,
2015
|
|
June 30,
2014
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 27,299,268
|
|
$ 12,184,605
|
Prepaid
expenses and other current assets
|
1,896,747
|
|
156,393
|
Total current assets
|
29,196,015
|
|
12,340,998
|
|
|
|
|
Property and
equipment, net
|
123,158
|
|
160,748
|
Other
assets
|
155,279
|
|
57,308
|
Total assets
|
$ 29,474,452
|
|
$ 12,559,054
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,106,484
|
|
$
261,280
|
Accrued
expenses
|
6,223,483
|
|
1,508,958
|
Capital lease
obligations
|
25,871
|
|
-
|
Unearned
revenue
|
-
|
|
1,000,000
|
Total current liabilities
|
7,355,838
|
|
2,770,238
|
|
|
|
|
Notes payable, net of
discount
|
9,781,086
|
|
-
|
Capital lease
obligations
|
41,749
|
|
-
|
Other non-current
liabilities
|
91,304
|
|
-
|
Total liabilities
|
17,269,977
|
|
2,770,238
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred
stock of $0.01 par value – authorized 10,000,000 shares;
|
|
|
|
Series A Convertible; issued and outstanding 4,697 shares as of
June 30, 2015 and 2014,
respectively
|
47
|
|
47
|
Common
stock of $0.01 par value – authorized 300,000,000
shares;
|
|
|
|
issued and outstanding
57,128,433 shares as of June 30, 2015 and
39,416,595 as of June 30, 2014,
respectively
|
571,284
|
|
394,166
|
Additional paid-in
capital
|
303,332,460
|
|
283,428,356
|
Accumulated
deficit
|
(291,699,316)
|
|
(274,033,753)
|
Total stockholders' equity
|
12,204,475
|
|
9,788,816
|
Total liabilities and stockholders' equity
|
$ 29,474,452
|
|
$ 12,559,054
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.