CRANBURY, N.J., Nov. 17, 2020 /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 first quarter ended September 30,
2020.
First Quarter Ended September 30,
2020 Financial Highlights
- Net loss for the quarter was $(3.9)
million, or $(0.02) per share,
compared to a net loss of $(4.5)
million, or $(0.02) per share
for the comparable quarter of 2019;
- Vyleesi® gross sales for the period July
25 to September 30 amounted to $809,100. Recognized $(288,560) in Vyleesi product revenue, net of
allowances and accruals;
- Recognized no contract and license revenue for the quarter,
compared to $97,379 for the
comparable quarter of 2019;
- Total operating expenses for the quarter were $3.7 million, including a $1.6 million gain on the license termination
agreement, compared to $5.0 million
for the comparable quarter of 2019;
- As of September 30, 2020, the
Company had $86.6 million in cash and
cash equivalents and $5.0 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
- In July 2020, regained exclusive
North American rights to market Vyleesi® (bremelanotide injection),
the first and only on demand treatment for premenopausal women
suffering from acquired, generalized, hypoactive sexual desire
disorder (HSDD), a condition affecting one in ten premenopausal
women;
- Vyleesi commercial activities: solidified the distribution
network and procedures, improved 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 initial
geo-targeting to top prescriber and digital locations;
- Completed enrollment of a Phase 2 clinical study with PL9643
for the treatment of dry eye disease (DED). Data readout expected
December 2020;
- A Phase 2 proof-of-concept clinical study with an oral
formulation of PL8177 in ulcerative colitis patients is targeted to
start in the first half of calendar year 2021.
"We have made significant progress and improvement on Vyleesi
commercial activities, specifically around insurance reimbursement
and expanded coverage. This put us in the proper position as we
initiated a targeted marketing digital campaign to raise condition
and treatment awareness with premenopausal
women," stated Carl Spana, Ph.D., President and CEO of
Palatin.
"Despite the challenges posed by the ongoing viral pandemic, we
are on track for data readout next month on our PL9643 Phase 2
clinical study in subjects with dry eye disease. Most people living
with dry eye disease suffer from episodic flare-ups. These flares
can be caused by a multitude of triggers and frequently are not
sufficiently addressed by current therapies."
Programs Overview
Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi®
(bremelanotide injection)
In July 2020, Palatin announced
the mutual termination of its License Agreement with AMAG
Pharmaceutical, Inc, for Vyleesi. Under the termination agreement,
Palatin regained all North American development and
commercialization rights for Vyleesi. AMAG made a $12.0 million payment to Palatin at closing and
will make a $4.3 million payment to
Palatin on March 31, 2021. Palatin
assumed all Vyleesi manufacturing agreements, and AMAG transferred
information, data, and assets related exclusively to Vyleesi,
including existing inventory. AMAG is providing certain
transitional services to Palatin for a period to ensure continued
patient access to Vyleesi and regulatory compliance during the
transition back to Palatin. Palatin is reimbursing AMAG for the
agreed upon costs of the transition services.
Palatin is exploring its options to enhance the
commercialization of Vyleesi, including discussions with potential
collaboration partners that currently market female healthcare
products. Palatin continues collaboration discussions for
territories outside the currently licensed territories of
China and Korea and anticipates
executing multiple agreements through calendar year 2021.
The Company's strategy implements an informed and highly
targeted approach to marketing, focusing on telemedicine, social
media, and digital advertising. The Company is committed to working
with payers and healthcare professionals to ensure women with HSDD
have continued and affordable access to Vyleesi. Vyleesi remains
commercially available through specialty pharmacies Avella and
BioPlus. Patients also can connect with a healthcare provider
through telemedicine. Patients and healthcare providers can learn
more about HSDD and Vyleesi at www.vyleesi.com.
Vyleesi is the first FDA-approved product for the as-needed
treatment for premenopausal women who experience distress or
interpersonal difficulty due to low sexual desire. This treatment
is available as a subcutaneous self-injection in a prefilled
disposable autoinjector pen for use in anticipation of a sexual
encounter.
Anti-Inflammatory / Autoimmune Programs
Enrollment in a Phase 2 clinical study with PL9643 for the
treatment of dry eye disease was completed in August 2020. Data readout is targeted for
December of 2020. If results from the Phase 2 study support
advancing to Phase 3, the Company will initiate a Phase 3 efficacy
study as early as mid-calendar year 2021.
A Phase 2 proof-of-concept clinical study with an oral
formulation of PL8177 in ulcerative colitis patients is targeted to
start in the first half of calendar year 2021, with data readout
potentially in the first half of calendar year 2022.
The Company continues its assessment and development work
related to the treatment of patients with diabetic retinopathy,
with an investigational new drug (IND) filing targeted for
mid-calendar year 2021.
The Company currently anticipates filing an IND and commencing
clinical trials with PL8177 for non-infectious uveitis, for which
the FDA granted orphan drug designation, in the second half of
calendar year 2021.
Palatin is advancing its COVID-19 development plan and is
conducting all the required activities needed to file an IND and
begin clinical studies with PL8177 as a treatment in COVID-19
patients. These activities will be completed in the fourth calendar
quarter of 2020, allowing the Company to potentially file an IND
with the FDA and initiate a clinical study of PL8177 for the
treatment of COVID-19 patients early in the first calendar quarter
of 2021.
The landscape for treating and conducting clinical studies in
COVID-19 patients is rapidly evolving. This impacts the design,
risk, and ability to conduct clinical studies in COVID-19
patients. Considering the risk and uncertainty of conducting
COVID-19 clinical studies, the start of a PL8177 clinical study is
subject to receiving external funding and operational support. The
Company is in the process of applying to government programs that
provide such support.
Natriuretic Peptide Receptor (NPR) System
Program
PL3994, an NPR-A agonist, will be evaluated in a Phase 2A
clinical study in heart failure patients with preserved ejection
fraction. The proposed study is a collaboration with two major
academic medical centers and is supported by an American Heart
Association grant. Patient enrollment in the study has commenced
and the first patient was dosed in November
2020.
Genetic Obesity Program
Palatin's melanocortin receptor 4 (MC4r) peptide PL8905 and
orally active small molecule PL9610 are currently under
investigation for the treatment of rare genetic metabolic and
obesity disorders. These programs are under internal evaluation for
orphan designations, potential development, and licensing.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on
November 17, 2020 at 11:00 a.m. Eastern Time to discuss the quarter
ended September 30, 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 1-800-353-6461 (US/Canada) or 1-334-323-0501 (international),
conference ID 3383273. 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 3383273. The webcast and
telephone replay will be available through November 24, 2020.
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 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, Palatin's ongoing relationship with AMAG,
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 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, 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
September 30,
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
Product revenue,
net
|
$
(288,560)
|
|
$
-
|
|
License and
contract
|
-
|
|
97,379
|
|
|
(288,560)
|
|
97,379
|
|
OPERATING
EXPENSES
|
|
|
|
|
Cost of products sold
|
25,200
|
|
-
|
|
Research and
development
|
2,923,851
|
|
3,127,489
|
|
Selling, general and
administrative
|
2,331,606
|
|
1,832,442
|
|
Gain on license
termination agreement
|
(1,623,795)
|
|
-
|
|
Total operating
expenses
|
3,656,862
|
|
4,959,931
|
|
|
|
|
|
|
Loss from
operations
|
(3,945,422)
|
|
(4,862,552)
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
Investment
income
|
12,135
|
|
370,654
|
|
Interest
expense
|
(7,489)
|
|
(9,051)
|
|
Total other income,
net
|
4,646
|
|
361,603
|
|
NET LOSS
|
$
(3,940,776)
|
|
$
(4,500,949)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.02)
|
|
$
(0.02)
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
236,345,862
|
|
233,113,241
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
September 30,
2020
|
|
June 30,
2020
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
86,587,455
|
|
$
82,852,270
|
Accounts
receivable
|
5,044,372
|
|
-
|
Inventories
|
5,792,595
|
|
-
|
Prepaid expenses and
other current assets
|
2,360,001
|
|
738,216
|
Total current
assets
|
99,784,423
|
|
83,590,486
|
|
|
|
|
Property and
equipment, net
|
126,772
|
|
140,216
|
Right-of-use
assets
|
1,190,410
|
|
1,266,132
|
Other
assets
|
56,916
|
|
56,916
|
Total
assets
|
$
101,158,521
|
|
$
85,053,750
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
971,308
|
|
$
715,672
|
Accrued
expenses
|
3,823,682
|
|
2,899,097
|
Short-term operating
lease liabilities
|
282,275
|
|
312,784
|
Other current
liabilities
|
7,575,000
|
|
-
|
Total current
liabilities
|
12,652,265
|
|
3,927,553
|
|
|
|
|
Long-term operating
lease liabilities
|
911,775
|
|
953,348
|
Other long-term
liabilities
|
10,619,000
|
|
-
|
Total
liabilities
|
24,183,040
|
|
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 September 30, 2020 and June 30, 2020
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 229,855,417 shares as of September 30, 2020 and
229,258,400 shares as of June 30, 2020
|
2,298,554
|
|
2,292,584
|
Additional paid-in
capital
|
396,816,565
|
|
396,079,127
|
Accumulated
deficit
|
(322,139,678)
|
|
(318,198,902)
|
Total stockholders'
equity
|
76,975,481
|
|
80,172,849
|
Total liabilities and
stockholders' equity
|
$
101,158,521
|
|
$
85,053,750
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.