CRANBURY, N.J., Feb. 17, 2021 /PRNewswire/ -- 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, today announced results for
its second quarter ended December 31,
2020.
Second Quarter Ended December 31,
2020 Financial Highlights
- Net loss for the quarter was $(10.0)
million, or $(0.04) per share,
compared to a net loss of $(5.2)
million, or $(0.02) per share
for the comparable quarter of 2019;
-
- The increase in net loss was primarily attributable to
commercial expenses related to Vyleesi and to PL9643's Phase 2
study for the treatment of dry eye disease.
- As of December 31, 2020, the
Company had $72.2 million in cash and
cash equivalents and $4.7 million in
accounts receivable, compared to $82.9
million in cash and cash equivalents and no accounts
receivable as of June 30, 2020, with
no outstanding debt.
Business Highlights and Updates
- Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi®
(bremelanotide injection)
-
- Vyleesi gross sales for the quarter ended December 31, 2020 amounted to $943,950. Vyleesi product revenue was
$(163,971), net of allowances and
accruals. Vyleesi gross sales for the period July 25 to September 30 amounted to $809,100. Vyleesi product revenue was
$(288,560), net of allowances and
accruals;
- Restructured the distribution network and procedures improving
the patient experience; expanded contact with prescribers and
healthcare providers through virtual meetings; increased insurance
reimbursement coverage; and initiated a highly selective digital
marketing and telemedicine campaign to rebuild awareness and demand
among pre-menopausal women with a geo-targeting approach.
- Anti-Inflammatory / Autoimmune Programs
-
- Announced positive results in its Phase 2 study of PL9643 for
the treatment of dry eye disease (DED);
-
- Announced statistically significant improvements in multiple
signs and symptoms in the moderate to severe patient population
after 2 weeks of dosing and at the 12-week visit.
- There were no safety signals identified and PL9643 had
excellent ocular tolerability.
- Statistical significance for the primary endpoints was not
reached in the overall enrolled population that included mild,
moderate, and severe patients, as measured at the 12-week primary
evaluation visit.
- A Phase 2/3 Clinical trial with PL9643 for the treatment of DED
is currently planned for mid-calendar year 2021;
- Filed an international patent application under the Patent
Cooperation Treaty (PCT) directed to the composition of PL9643 and
a related family of melanocortin agonist peptides; and
- A Phase 2 proof-of-concept clinical study with an oral
formulation of PL8177 in ulcerative colitis patients is targeted to
start mid-calendar year 2021, with data readout potentially in
mid-calendar year 2022.
"Working through the melanocortin system, PL9643 is a novel
approach to treating dry eye disease. The emerging profile of
PL9643, with its rapid therapeutic onset and excellent tolerability
profile, is a potentially distinct advance in dry eye therapy,"
stated Carl Spana, Ph.D., President and CEO of Palatin. "The
positive PL9643 Phase 2 study results identify the most appropriate
patient population, endpoints, and timepoints for the next study,
which is a Phase 2/3 study targeted for mid-calendar year 2021,
with data readout in the first half of calendar year 2022.
Regarding Vyleesi, our measured plan and investment is showing
positive trends and returns with a significant rise in payer
reimbursement and double-digit increases to month over month
prescription numbers continuing through January 2021."
Conference Call / Webcast
Palatin will host a conference call and audio webcast on
February 17, 2021 at 11:00 a.m. Eastern Time to discuss the quarter
ended December 31, 2020 results of
operations in greater detail and provide an update on corporate
developments. Individuals interested in listening to the conference
call live can dial 1-866-248-8441 (US/Canada) or 1-856-344-9206 (international),
conference ID 2203098. 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 2203098. The webcast and
telephone replay will be available through February 24, 2021.
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 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 market potential of
Palatin's products, clinical trial results, potential actions by
regulatory agencies including the FDA, regulatory plans,
development programs, proposed indications for product candidates,
Palatin's ability to manufacture and market Vyleesi, market
potential for product candidates, and potential adverse impacts due
to the global COVID-19 pandemic such as delays in regulatory
review, manufacturing and supply chain interruptions, adverse
effects on healthcare systems and disruption of the global economy,
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 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, Palatin's ability to establish and
maintain the capability for manufacturing, marketing and
distribution of Vyleesi, 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.
Palatin Technologies® and Vyleesi® are registered trademarks of
Palatin Technologies, Inc.
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Six Months Ended
December 31,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
(163,971)
|
|
$
-
|
|
$
(452,531)
|
|
$
-
|
|
License and
contract
|
-
|
|
20,610
|
|
-
|
|
117,989
|
|
|
(163,971)
|
|
20,610
|
|
(452,531)
|
|
117,989
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
Cost of products sold
|
29,400
|
|
-
|
|
54,600
|
|
-
|
|
Research and
development
|
4,011,418
|
|
3,257,624
|
|
6,935,269
|
|
6,385,113
|
|
Selling, general and
administrative
|
5,044,913
|
|
2,404,093
|
|
7,376,519
|
|
4,236,535
|
|
Gain on license
termination agreement
|
-
|
|
-
|
|
(1,623,795)
|
|
-
|
|
Total operating
expenses
|
9,085,731
|
|
5,661,717
|
|
12,742,593
|
|
10,621,648
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(9,249,702)
|
|
(5,641,107)
|
|
(13,195,124)
|
|
(10,503,659)
|
|
|
|
|
|
|
|
|
|
|
OTHER (EXPENSE)
INCOME
|
|
|
|
|
|
|
|
|
Investment
income
|
4,800
|
|
399,982
|
|
16,935
|
|
770,636
|
|
Foreign currency
loss
|
(745,002)
|
|
-
|
|
(745,002)
|
|
-
|
|
Interest
expense
|
(1,871)
|
|
(2,502)
|
|
(9,360)
|
|
(11,553)
|
|
Total other (expense)
income, net
|
(742,073)
|
|
397,480
|
|
(737,427)
|
|
759,083
|
|
NET LOSS
|
$
(9,991,775)
|
|
$
(5,243,627)
|
|
$
(13,932,551)
|
|
$
(9,744,576)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.04)
|
|
$
(0.02)
|
|
$
(0.06)
|
|
$
(0.04)
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
236,405,065
|
|
234,923,592
|
|
236,375,463
|
|
234,018,417
|
|
|
|
|
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
December 31,
2020
|
|
June 30,
2020
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
72,156,110
|
|
$
82,852,270
|
Accounts
receivable
|
4,746,623
|
|
-
|
Inventories
|
6,031,088
|
|
-
|
Prepaid expenses and
other current assets
|
2,556,911
|
|
738,216
|
Total current
assets
|
85,490,732
|
|
83,590,486
|
|
|
|
|
Property and
equipment, net
|
116,362
|
|
140,216
|
Right-of-use
assets
|
1,113,685
|
|
1,266,132
|
Other
assets
|
56,916
|
|
56,916
|
Total
assets
|
$
86,777,695
|
|
$
85,053,750
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,174,493
|
|
$
715,672
|
Accrued
expenses
|
4,799,561
|
|
2,899,097
|
Short-term operating
lease liabilities
|
265,339
|
|
312,784
|
Other current
liabilities
|
1,010,250
|
|
-
|
Total current
liabilities
|
7,249,643
|
|
3,927,553
|
|
|
|
|
Long-term operating
lease liabilities
|
855,626
|
|
953,348
|
Other long-term
liabilities
|
10,837,300
|
|
-
|
Total
liabilities
|
18,942,569
|
|
4,880,901
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares issued and
outstanding designated as follows:
|
|
|
|
Series A Convertible:
authorized 264,000 shares: issued and outstanding 4,030 shares as
of December 31, 2020 and June 30, 2020
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 230,034,307 shares as of December 31, 2020 and
229,258,400 shares as of June 30, 2020
|
2,300,343
|
|
2,292,584
|
Additional paid-in
capital
|
397,666,196
|
|
396,079,127
|
Accumulated
deficit
|
(332,131,453)
|
|
(318,198,902)
|
Total stockholders'
equity
|
67,835,126
|
|
80,172,849
|
Total liabilities and
stockholders' equity
|
$
86,777,695
|
|
$
85,053,750
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.