Palatin Technologies Inc 8-K, filed Sep 28, 2020
Palatin Technologies Inc (PTN)
8-K
2020-09-28
For: 2020-09-28
View Original
Added on
April 06, 2026
About this 8-K
Palatin Technologies Inc filed this 8-K on September 28, 2020.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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): September 28, 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
September 28, 2020, we issued a press release including results for
our fourth quarter and fiscal year ended June 30, 2020 and
announcing a teleconference and webcast to be held September 28,
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
September 28, 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:
September 28, 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
September 28, 2020
Exhibit 99.1
Palatin Technologies, Inc. Announces Fourth Quarter
and
Fiscal Year 2020 Financial Results and Provides a Business
Update
●
$82.9 Million in Cash and Cash Equivalents at June 30,
2020
● Mutual Termination of License Agreement with AMAG
Pharmaceuticals for Vyleesi® in July 2020 Resulted in Palatin
Receiving $12 Million from AMAG Plus $4.3 Million Due March 31,
2021
●
Phase 2 Study Data of PL9643 for the Treatment of Dry Eye Disease
Expected in Fourth Calendar Quarter of
2020
●
Teleconference and Webcast to be held on September 28,
2020
CRANBURY, NJ – September 28, 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 financial
results for its fourth quarter and fiscal year ended June 30,
2020.
Fourth Quarter and Fiscal Year 2020 Financial
Highlights
●
Net loss for the
fourth quarter ended June 30, 2020 was $(7.3) million, or $(0.03)
per basic and diluted share, compared to net income of $52.2
million, or $0.25 per basic and $0.23 per diluted share for the
comparable quarter of 2019;
●
Net loss for the
year ended June 30, 2020 was $(22.4) million, or $(0.10) per basic
and diluted share, compared to net income of $35.8 million, or
$0.17 per basic and $0.16 per diluted share for the year ended June
30, 2019;
●
As of June 30,
2020, the Company had $82.9 million in cash and cash equivalents,
compared to $43.5 million as of June 30, 2019, and no
debt.
Recent Business Highlights and Updates
●
In July 2020
mutually terminated the January 2017 license agreement granting
AMAG Pharmaceuticals ("AMAG") exclusive North American rights to
market Vyleesi® (bremelanotide), 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;
●
Completed
enrollment of a Phase 2 clinical study with PL9643 for the
treatment of dry eye disease (DED). Final patient and topline data
readout is targeted for the fourth calendar quarter of
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.
-More-
"We are pleased to have completed enrollment last month in our
PL9643 Phase 2 clinical study in subjects with dry eye disease.
Data readout is targeted for
the fourth calendar quarter of 2020. We believe that, if approved, PL9643’s
potentially quick onset to efficacy and favorable tolerability and
safety profile may provide a treatment option to the millions of
individuals suffering from DED,” stated Carl Spana,
Ph.D., President and CEO of Palatin.
“We
believe that Vyleesi is an important treatment for the millions of
premenopausal women suffering from HSDD. Our goal with the Vyleesi
program is to demonstrate value in the marketplace by increasing
patient demand and access. Our objective is to re-license the U.S.
rights to a committed women’s healthcare company. Having
taken steps to ensure no disruption for patient access to Vyleesi,
we are working to expand awareness of the condition and treatment
in a highly-targeted and informed manner, enhance and stream-line
patient access, and increase insurance
coverage.”
Dr.
Spana further commented, “Our strong cash position of $83
million at June 30, 2020 and no debt, coupled with the $12 million
received in July 2020 from AMAG, plus an additional $4.3 million
due from AMAG March 31, 2021, provides us the financial resources
to significantly advance our Anti-Inflammatory and Autoimmune
programs, and make complimentary targeted investments to our
Vyleesi program.”
“The
entire Palatin team thanks healthcare workers across the nation for
their selfless efforts in the treatment and care of COVID-19
patients. I would also like to thank all of our employees for their
dedication and commitment to ensure the advancement of our
development programs and clinical trial patient support,”
continued Spana. “Although Palatin has experienced
limited adverse impact on operations from the pandemic, we are
cognizant there may be further disruptions to business activity
based on a resurgence of the virus and have taken steps to be as
prepared as possible for this potential
outcome.”
Programs Overview
Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi®
(bremelanotide injection)
In July 2020, Palatin announced the mutual termination of its
License Agreement with AMAG for Vyleesi. Under the terms of 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 will transfer all
information, data, and assets related exclusively to Vyleesi,
including, but not limited to, existing inventory. AMAG will
provide certain transitional services to Palatin for a period of
time to ensure continued patient access to Vyleesi and regulatory
compliance during the transition back to Palatin. Palatin will
reimburse AMAG for the agreed upon costs of the transition
services.
Palatin is exploring its options pertaining to enhancing the
commercialization of Vyleesi, including but not limited to,
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.
In the interim, 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 have the ability to connect with a
healthcare provider through telemedicine. Patients and healthcare
providers can learn more about HSDD and Vyleesi at
www.vyleesi.com.
-More-
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 was completed in
August 2020. Data readout is targeted for the fourth calendar
quarter 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 IND
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
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 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. The study is now anticipated to start patient enrollment in
the fourth calendar quarter of 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.
-More-
Fourth Quarter and Fiscal Year 2020 Financial Results
Revenue
Palatin recognized no revenues for the quarter ended June 30, 2020
and $117,989 in license and contract revenue for the year ended
June 30, 2020 related to our license agreement with
AMAG.
For the quarter and year ended June 30, 2019, Palatin recognized
$60.3 million in license and contract revenue related to our
license agreement with AMAG.
Operating Expenses
Total operating expenses for the quarter ended June 30, 2020 were
$7.4 million compared to $8.1 million for the comparable quarter of
2019. The decrease in operating expenses was due to the overall
reduction in research and development expenses and a decrease in
general and administrative expenses.
For the year ended June 30, 2020, Palatin incurred $23.7 million of
operating expenses, compared to $24.6 million for the year ended
June 30, 2019. The decrease in
operating expenses was due to the overall reduction in research and
development expenses offset by an increase in general and
administrative expenses.
Other Income/Expense, net
Total other income, net, for the quarter and year ended June 30,
2020 was $90,667 and $1.2 million, respectively.
Total other income, net, for the quarter and year ended June 30,
2019 was $38,476 and $28,707, respectively.
The difference is related primarily to the increase in investment
income and secondarily to the decrease in interest expense related
to venture debt.
Cash Position
Palatin’s cash and cash equivalents were $82.9 million with
no accounts receivable as of June 30, 2020, compared to cash and
cash equivalents of $43.5 with accounts receivable of $60.3 million
at June 30, 2019.
Management believes that its existing capital resources will be
sufficient to fund the Company’s planned operations through
at least September 30, 2021.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on September
28, 2020 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 1-800-353-6461 (US/Canada) or 1-334-323-0501
(international), conference ID 6978729. 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 6978729.
The webcast and telephone replay will be available through October
5, 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
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, transfer of
marketing and sale of Vyleesi in North America to another
pharmaceutical company, 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
Vyleesi® is a registered trademark of Palatin Technologies,
Inc.
###
(Financial Statement Data Follows)
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
(unaudited)
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Three Months Ended
June 30,
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Year Ended
June 30,
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2020
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2019
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2020
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2019
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REVENUES
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License
and contract
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$-
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$60,265,971
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$117,989
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$60,300,476
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OPERATING
EXPENSES
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Research
and development
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3,933,034
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4,328,766
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13,959,397
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14,857,095
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General
and administrative
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3,456,805
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3,751,118
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9,765,372
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9,699,061
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Total
operating expenses
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7,389,839
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8,079,884
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23,724,769
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24,556,156
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(Loss)
income from operations
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(7,389,839)
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52,186,087
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(23,606,780)
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35,744,320
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OTHER
INCOME (EXPENSE)
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Investment
income
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98,977
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85,056
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1,200,898
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446,268
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Interest
expense
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(8,310)
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(46,580)
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(20,141)
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(417,561)
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Total
other income (expense), net
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90,667
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38,476
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1,180,757
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28,707
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(Loss)
income before income taxes
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(7,299,172)
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52,224,563
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(22,426,023)
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35,773,027
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Income
tax expense
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-
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-
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-
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NET
(LOSS) INCOME
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$(7,299,172)
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$52,224,563
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$(22,426,023)
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$35,773,027
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Basic
net (loss) income per common share
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$(0.03)
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$0.25
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$(0.10)
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$0.17
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Diluted
net (loss) income per common share
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$(0.03)
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$0.23
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$(0.10)
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$0.16
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Weighted
average number of common shares outstanding used in computing basic
net (loss) income per common share
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235,394,831
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212,253,194
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234,684,776
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207,670,607
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Weighted
average number of common shares outstanding used in computing
diluted net (loss) income per common share
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235,394,831
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228,526,106
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234,684,776
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217,133,374
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###
(Financial Statement Data Follows)
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Balance Sheets
(unaudited)
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June 30,
2020
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June 30,
2019
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ASSETS
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Current
assets:
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Cash
and cash equivalents
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$82,852,270
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$43,510,422
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Accounts
receivable
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-
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60,265,970
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Prepaid
expenses and other current assets
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738,216
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637,289
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Total
current assets
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83,590,486
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104,413,681
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Property
and equipment, net
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140,216
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141,539
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Right-of-use
assets *
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1,266,132
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-
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Other
assets
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56,916
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179,916
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Total
assets
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$85,053,750
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$104,735,136
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current
liabilities:
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Accounts
payable
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$715,672
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$504,787
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Accrued
expenses
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2,899,097
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2,848,692
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Notes
payable, net of discount
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-
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332,896
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Short-term
operating lease liabilities *
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312,784
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-
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Other
current liabilities
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-
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499,517
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Total
current liabilities
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3,927,553
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4,185,892
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Long-term
operating lease liabilities *
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953,348
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-
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Total
liabilities
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4,880,901
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4,185,892
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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 June 30, 2020 and June 30, 2019
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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 229,258,400 shares as of June 30, 2020 and
226,815,363 shares as of June 30, 2019
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2,292,584
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2,268,154
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Additional
paid-in capital
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396,079,127
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394,053,929
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Accumulated
deficit
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(318,198,902)
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(295,772,879)
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Total
stockholders’ equity
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80,172,849
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100,549,244
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Total
liabilities and stockholders’ equity
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$85,053,750
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$104,735,136
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* In the first quarter of
fiscal 2020, the Company adopted Accounting Standards Update No.
2016-02, Leases. Under the new standard, lessees are required to
recognize right-of-use assets and lease liabilities on the balance
sheet for all leases. The Company adopted this standard using a
modified retrospective transition method and elected the option to
not restate comparative periods.