CRANBURY, N.J., April 30, 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 provided an update on
business operations as a result of the global COVID-19
pandemic.
The Company has taken steps to ensure the safety and well-being
of its employees and clinical trial patients to comply with
guidance from federal, state and local authorities, while working
to ensure the sustainability of its business operations as this
unprecedented situation continues to evolve.
In mid-March, the Company transitioned to a company-wide work
from home policy. Business-critical activities continue to be
subject to heightened precautions to ensure safety of employees.
The Company continues to assess its policies, business continuity
plans and employee support.
The Company continues to evaluate the impact of COVID-19 on the
healthcare system and work with contract research organizations
supporting its clinical, research, and development programs to
mitigate risk to patients and its business and community partners,
taking into account regulatory, institutional, and government
guidance and policies.
Impact of COVID-19 Pandemic Related to Ongoing Programs and
Development
Management Statement on COVID-19 Pandemic Impact on
Operations
During this pandemic, the safety of Palatin's
employees, clinical trial patients and healthcare partners has been
the Company's number one priority. Assuming partial opening of
economic activities by mid-2020, senior management believes there
will be limited impact of the pandemic on operations.
However, senior management understands there can be further
disruptions to business activity based on resurgence of the virus
and will take steps to be as prepared as possible for this
potential outcome.
Anti-Inflammatory / Autoimmune Programs
A Phase
2 clinical study with PL9643 for dry eye disease started in
January 2020, and active patients
continue treatment and monthly clinic visits. Enrollment of
additional cohorts has been delayed, but we anticipate restarting
enrollment in June 2020. Data readout
remains on track for the fourth quarter of calendar year 2020 (no
delay on anticipated data readout due to COVID-19).
A Phase 2 proof-of-concept clinical study with an oral
formulation of PL8177 in ulcerative colitis patients is now
targeted to start in the first-half of calendar year 2021, with
data readout in the first-half of calendar year 2022 (two quarter
delay due to COVID-19).
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 (no delay due to
COVID-19).
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 (one quarter delay due to COVID-19).
Hypoactive Sexual Desire Disorder ("HSDD") / Vyleesi®
(bremelanotide injection)
In January 2020 AMAG Pharmaceuticals, Inc. announced
that, as a result of a strategic review, it will divest Vyleesi,
which it exclusively licensed from Palatin for North America.
Palatin will provide an update on May 12,
2020, when it reports its financial results for the first
quarter of calendar 2020, regarding its rights under the license
agreement, the status of AMAG's divestiture process as it relates
to Palatin, and specificity around the impact of the COVID-19
pandemic on Vyleesi sales and marketing.
Palatin continues discussions on Vyleesi collaborations for
territories outside the currently licensed territories of
North America, China, and Korea, and anticipates executing
multiple agreements during the second-half of calendar year 2020
and calendar year 2021 (limited to no delay due to COVID-19).
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 second half of calendar year 2020 (one
quarter delay due to COVID-19).
Cash Position
Palatin's cash and cash equivalents of
$88.9 million as of March 31, 2020, represents cash runway of at
least two years based on projected operations.
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,
AMAG's plans to divest Vyleesi, Palatin's ongoing relationship with
AMAG and ability to protect its rights as the Vyleesi licensor,
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, 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.
Vyleesi® is a registered trademark of AMAG Pharmaceuticals, Inc.
in North America and of Palatin
Technologies, Inc. elsewhere in the world.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-provides-assessment-of-impact-of-covid-19-pandemic-on-business-operations-301049945.html
SOURCE Palatin Technologies, Inc.