CRANBURY, N.J., May 9, 2019 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: 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,
2019.
Recent Highlights and Program Updates
Female Sexual Dysfunction /
Vyleesi™(bremelanotide)
- Vyleesi, the trade name for bremelanotide - Under development
for Hypoactive Sexual Desire Disorder ("HSDD"):
-
- The Prescription Drug User Fee Act ("PDUFA") date for
completion of FDA review of the Vyleesi New Drug Application
("NDA") is June 23, 2019.
- The U.S. Food and Drug Administration ("FDA") requested a Phase
1 study in premenopausal volunteers assessing short term daily use
of Vyleesi. This study, conducted by Palatin and our exclusive
licensee for North America, AMAG
Pharmaceuticals, was completed and data has been submitted to the
FDA.
- 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 Agonists under development for the treatment of
inflammatory and autoimmune diseases such as dry eye, uveitis,
diabetic retinopathy and inflammatory bowel diseases:
-
- PL-8177, a selective MC1r peptide agonist:
-
- Announced positive top line results of an oral clinical study
for ulcerative colitis and other inflammatory bowel diseases
- Phase 2 proof-of-concept clinical study with the oral
formulation in ulcerative colitis patients anticipated to commence
in the fourth quarter of calendar year 2019
- Phase 2 proof-of-concept clinical study with a systemic
formulation in non-infectious uveitis (NIU) patients anticipated to
commence in the fourth quarter of calendar year 2019
- Continuing investigation of other possible indications for
systemic administration
- Program is under internal evaluation for orphan
designations
- PL-9643, a melanocortin peptide agonist:
-
- Continuing with preclinical Investigational New Drug ("IND")
enabling activities for ocular diseases
- Program is under internal evaluation for orphan
designations
Natriuretic Peptide Receptor ("NPR") System
Program
- We have designed and are developing potential NPR candidate
drugs that are selective 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"):
-
- PL-3994, an NPR-A agonist that has potential utility in
treatment of a number of cardiovascular diseases, including genetic
and orphan diseases resulting from a deficiency of endogenous
active NPR-A
-
- Active collaborations with several institutions ongoing
- PL-5028, a dual NPR-A and NPR-C agonist in development for
cardiovascular diseases, including reducing cardiac hypertrophy and
fibrosis
-
- Active collaborations with several institutions ongoing
Genetic Obesity Program
- Melanocortin receptor 4 ("MC4r") peptide PL-8905 and
orally-active small molecule PL-9610 under investigation for the
treatment of rare genetic metabolic and obesity disorders:
-
- Program is under internal evaluation for orphan
designation
Corporate
- Decreased debt and related liabilities from $7.2 million at June 30,
2018 to $1.8 million at
March 31, 2019.
Third Quarter Fiscal 2019 Financial Results
Palatin reported a net loss of $(5.7)
million, or $(0.03) per basic
and diluted share, for the quarter ended March 31, 2019, compared to a net loss of
$(0.7) million, or $(0.00) per basic and diluted share, for the same
period in 2018.
The difference in financial results between the three months
ended March 31, 2019 and 2018 was
mainly attributable to the recognition of $9.0 million in license and contract revenue
during the 2018 period pursuant to our license agreement with
AMAG.
Revenue
There were no revenues recorded in the quarter ended
March 31, 2019.
For the quarter ended March 31,
2018, all the revenue Palatin recognized was related to our
license agreement with AMAG.
Operating Expenses
Total operating expenses for the quarter ended March 31, 2019 were $5.8
million compared to $9.5
million for the comparable quarter in 2018. 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 for Vyleesi in
March 2018.
Other Income/Expense
Total other income, net was $35,648 for the quarter ended March 31, 2019 compared to total other expense,
net of $(0.2) million for the same
period in 2018. The difference consisted primarily of
the decrease in interest expense related to Palatin's venture
debt.
Income Tax
There was no income tax expense, or benefit, recorded in the
quarter ended March 31, 2019.
Pursuant to the license agreements with our Chinese and South
Korean licensees, $500,000 and
$82,500, respectively, was withheld
in accordance with tax withholding requirements in China and the Republic of Korea, respectively,
and was recorded as an expense during the fiscal year ended
June 30, 2018. For the quarter ended
March 31, 2018, Palatin recorded an
income tax benefit of $18,746 related
to those withholding amounts utilizing an estimated effective
annual income tax rate applied to the loss for the quarter and the
remaining balance as of March 31,
2018 of $275,111 was included
in prepaid expenses and other current assets. Any potential credit
to be received by Palatin on its United
States tax returns is currently offset by Palatin's
valuation allowance.
Cash Position
Palatin's cash and cash equivalents were $19.8 million as of March
31, 2019, compared to cash and cash equivalents of
$38.0 million at June 30, 2018. Current liabilities were
$4.9 million as of March 31, 2019, compared to $10.8 million as of June
30, 2018.
Palatin believes that existing capital resources will be
sufficient to fund our planned operations through at least
May 31, 2020.
CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on May 9, 2019 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 1-800-667-5617 (domestic) or 1-334-323-0509 (international),
conference ID 7024541. 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 (domestic) or 1-719-457-0820 (international),
passcode 7024541. The webcast and telephone replay will be
available through May 16, 2019.
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 obtain regulatory approvals,
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.
(Financial Statement Data Follows)
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
Nine Months Ended
March 31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
License and
contract
|
|
$
-
|
|
$
8,962,709
|
|
$
34,505
|
|
$
46,516,370
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
3,943,982
|
|
7,068,849
|
|
10,528,329
|
|
27,277,830
|
General and
administrative
|
|
1,818,796
|
|
2,411,302
|
|
5,947,943
|
|
5,581,066
|
Total operating
expenses
|
|
5,762,778
|
|
9,480,151
|
|
16,476,272
|
|
32,858,896
|
|
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
|
(5,762,778)
|
|
(517,442)
|
|
(16,441,767)
|
|
13,657,474
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE):
|
|
|
|
|
|
|
|
|
Investment
income
|
|
107,460
|
|
86,496
|
|
361,212
|
|
219,578
|
Interest
expense
|
|
(71,812)
|
|
(326,983)
|
|
(370,981)
|
|
(1,175,023)
|
Total other income
(expense), net
|
|
35,648
|
|
(240,487)
|
|
(9,769)
|
|
(955,445)
|
|
|
|
|
|
|
|
|
|
(Loss) income before
income taxes
|
|
(5,727,130)
|
|
(757,929)
|
|
(16,451,536)
|
|
12,702,029
|
Income tax
benefit
|
|
-
|
|
18,746
|
|
-
|
|
192,611
|
|
|
|
|
|
|
|
|
|
NET (LOSS)
INCOME
|
|
$
(5,727,130)
|
|
$
(739,183)
|
|
$
(16,451,536)
|
|
$
12,894,640
|
|
|
|
|
|
|
|
|
|
Basic net (loss)
income per common share
|
|
$
(0.03)
|
|
$
(0.00)
|
|
$
(0.08)
|
|
$
0.07
|
|
|
|
|
|
|
|
|
|
Diluted net (loss)
income per common share
|
|
$
(0.03)
|
|
$
(0.00)
|
|
$
(0.08)
|
|
$
0.06
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic net
(loss) income per common share
|
|
207,016,304
|
|
197,485,758
|
|
206,148,695
|
|
197,277,286
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing diluted net
(loss) income per common share
|
|
207,016,304
|
|
197,485,758
|
|
206,148,695
|
|
202,712,963
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
March 31,
2019
|
|
June 30,
2018
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
19,813,349
|
|
$
38,000,171
|
Prepaid expenses and
other current assets
|
697,178
|
|
513,688
|
Total current
assets
|
20,510,527
|
|
38,513,859
|
|
|
|
|
Property and
equipment, net
|
156,648
|
|
164,035
|
Other
assets
|
338,916
|
|
338,916
|
Total
assets
|
$
21,006,091
|
|
$
39,016,810
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
474,773
|
|
$
2,223,693
|
Accrued
expenses
|
2,640,208
|
|
2,103,021
|
Notes payable, net of
discount
|
1,328,973
|
|
5,948,763
|
Other current
liabilities
|
495,169
|
|
487,488
|
Total current
liabilities
|
4,939,123
|
|
10,762,965
|
|
|
|
|
Notes payable, net of
discount
|
-
|
|
332,898
|
Deferred
revenue
|
-
|
|
500,000
|
Other non-current
liabilities
|
-
|
|
456,038
|
Total
liabilities
|
4,939,123
|
|
12,051,901
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares:
|
|
|
|
Series A Convertible:
issued and outstanding 4,030 shares as of March 31, 2019 and June
30, 2018
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 203,063,429 shares as of March 31, 2019 and 200,554,205
shares as of June 30, 2018
|
2,030,634
|
|
2,005,542
|
Additional paid-in
capital
|
362,033,736
|
|
357,005,233
|
Accumulated
deficit
|
(347,997,442)
|
|
(332,045,906)
|
Total stockholders'
equity
|
16,066,968
|
|
26,964,909
|
Total liabilities and
stockholders' equity
|
$
21,006,091
|
|
$
39,016,810
|
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SOURCE Palatin Technologies, Inc.