Attached files
| file | filename |
|---|---|
| 8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Technologies, Inc. Reports Second Quarter
Fiscal Year 2021 Financial Results and Recent Business
Highlights
●
Positive Results from Phase 2 Clinical Study of PL9643 in Patients
with Dry Eye Disease
●
Continue to Rebuild Commercial Infrastructure
and Brand Awareness for Vyleesi®
●
Approximately $72.2 Million in Cash and Cash Equivalents
at
December 31, 2020
●
Teleconference and Webcast to be held on February 17, 2021 at 11:00
AM ET
CRANBURY, NJ – February 17, 2021 – 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.
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.
-More-
Exhibit 99.1
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.
|
Investor Inquiries:
|
Media Inquiries:
|
|
Stephen T. Wills, CPA, MST
|
Paul Arndt, MBA,
LifeSci Advisors
|
|
CFO/COO (609) 495-2200
|
Managing
Director (646) 597-6992
|
|
Info@Palatin.com
|
Paul@LifeSciAdvisors.com
|
Palatin Technologies® and Vyleesi® are registered
trademarks of Palatin Technologies, Inc.
###
(Financial Statement Data Follows)
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
|