PTN 8-K
Palatin Technologies Inc (PTN)
8-K
2020-11-17
For: 2020-11-17
View Original
Added on
April 06, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act Of
1934
Date of
Report (Date of earliest event reported): November 17, 2020
Palatin Technologies, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-15543
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95-4078884
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(State
or other jurisdiction
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(Commission
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(IRS
employer
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of
incorporation)
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File
Number)
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identification
number)
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4B Cedar Brook Drive, Cranbury, NJ
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08512
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's
telephone number, including area code: (609) 495-2200
Not Applicable
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
[ ]
Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
[ ]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[ ]
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ]
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
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Title
of Each Class
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Trading
Symbol
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Name of
Each Exchange
on
Which Registered
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Common Stock, par value $.01 per share
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PTN
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NYSE American
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Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of
1934 (§240.12b-2 of this chapter). Emerging growth
company ☐
If an
emerging growth company, indicate by checkmark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial
Condition.
On
November 17, 2020, we issued a press release including results for
our first quarter ended September 30, 2020 and announcing a
teleconference and webcast to be held November 17, 2020 at 11:00
a.m. Eastern time, which will include a discussion on results of
operations in greater detail and an update on corporate
developments. We have attached a copy of the press release as an
exhibit to this report.
The
information in this Item 2.02 and the corresponding information in
the attached Exhibit 99.1 shall not be deemed to be
“filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that section. The information contained in this Item
2.02 and the corresponding information in the attached Exhibit 99.1
shall not be incorporated into any registration statement or other
document filed with the Securities and Exchange Commission by the
company, whether made before or after the date hereof, regardless
of any general incorporation language in such filing, except as
shall be expressly set forth by specific reference in such
filing.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits:
Press Release dated
November 17, 2020
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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PALATIN
TECHNOLOGIES, INC.
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Date:
November 17, 2020
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By:
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/s/
Stephen T. Wills
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Stephen
T. Wills, CPA, MST
Executive
Vice President, Chief Financial Officer and Chief Operating
Officer
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EXHIBIT INDEX
Press Release dated
November 17, 2020
Exhibit 99.1
Palatin Technologies, Inc. Reports First Quarter
Fiscal Year 2021 Results and Provides Business Update
●
Regained North American Rights to Vyleesi® for HSDD with
Palatin Receiving $12 Million from AMAG Plus $4.3 Million Due March
31, 2021
●
Phase 2 Clinical Results of PL9643 for the Treatment of Dry Eye
Disease on Track for December 2020
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$86.6 Million in Cash and Cash Equivalents as of September 30,
2020
●
Conference Call Today at 11:00 AM ET
CRANBURY, NJ – November 17, 2020 – 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;
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Recognized
no contract and license revenue for the quarter, compared to
$97,379 for the comparable quarter of 2019;
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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.
●
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;
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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.
-More-
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.
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Investor Inquiries:
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Media Inquiries:
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Stephen T. Wills, CPA, MST
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Paul Arndt, MBA,
LifeSci Advisors
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CFO/COO (609) 495-2200
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Managing
Director (646) 597-6992
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Palatin Technologies® and Vyleesi® are registered
trademarks of Palatin Technologies, Inc.
###
(Financial Statement Data Follows)
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PALATIN
TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Statements of Operations
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(unaudited)
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Three Months Ended
September 30,
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2020
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2019
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REVENUES
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Product revenue,
net
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$(288,560)
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$-
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License and
contract
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97,379
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(288,560)
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97,379
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OPERATING
EXPENSES
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Cost
of products sold
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25,200
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-
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Research and
development
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2,923,851
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3,127,489
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Selling, general
and administrative
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2,331,606
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1,832,442
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Gain on license
termination agreement
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(1,623,795)
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Total operating
expenses
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3,656,862
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4,959,931
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Loss from
operations
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(3,945,422)
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(4,862,552)
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OTHER INCOME
(EXPENSE)
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Investment
income
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12,135
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370,654
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Interest
expense
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(7,489)
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(9,051)
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Total other income,
net
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4,646
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361,603
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NET
LOSS
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$(3,940,776)
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$(4,500,949)
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Basic and diluted
net loss per common share
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$(0.02)
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$(0.02)
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Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
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236,345,862
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233,113,241
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PALATIN TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Balance Sheets
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(unaudited)
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September 30,
2020
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June 30,
2020
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ASSETS
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Current
assets:
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Cash and cash
equivalents
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$86,587,455
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$82,852,270
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Accounts
receivable
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5,044,372
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-
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Inventories
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5,792,595
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-
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Prepaid expenses
and other current assets
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2,360,001
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738,216
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Total current
assets
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99,784,423
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83,590,486
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Property and
equipment, net
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126,772
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140,216
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Right-of-use
assets
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1,190,410
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1,266,132
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Other
assets
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56,916
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56,916
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Total
assets
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$101,158,521
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$85,053,750
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
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Current
liabilities:
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Accounts
payable
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$971,308
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$715,672
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Accrued
expenses
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3,823,682
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2,899,097
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Short-term
operating lease liabilities
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282,275
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312,784
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Other current
liabilities
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7,575,000
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-
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Total current
liabilities
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12,652,265
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3,927,553
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Long-term operating
lease liabilities
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911,775
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953,348
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Other long-term
liabilities
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10,619,000
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-
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Total
liabilities
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24,183,040
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4,880,901
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Stockholders’
equity:
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Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares issued
and outstanding designated as follows:
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Series A
Convertible: authorized 264,000 shares: issued and outstanding
4,030 shares as of September 30, 2020 and June 30,
2020
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40
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40
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Common stock of
$0.01 par value – authorized 300,000,000 shares:
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issued and
outstanding 229,855,417 shares as of September 30, 2020 and
229,258,400 shares as of June 30, 2020
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2,298,554
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2,292,584
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Additional paid-in
capital
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396,816,565
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396,079,127
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Accumulated
deficit
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(322,139,678)
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(318,198,902)
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Total
stockholders’ equity
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76,975,481
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80,172,849
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Total liabilities
and stockholders’ equity
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$101,158,521
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$85,053,750
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