Full Press Release Details
Palatin Technologies, Inc. Reports Third Quarter
Fiscal Year 2020 Financial Results and Recent Business
Dry Eye Disease Phase 2 Study Remains on Track Data
$89 Million in Cash at March 31, 2020
Teleconference and Webcast to be held on May 12, 2020
CRANBURY, NJ May 12, 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 third quarter
ended March 31, 2020.
Third Quarter Fiscal Year 2020 Financial Highlights
million, compared to $(5.7) million for the comparable quarter of
of $5.7 million, compared to $5.8 million for the comparable
$331,007, compared to $35,648 for the comparable quarter of 2019;
2020, the Company had $88.9 million in cash and cash equivalents,
compared to $91.5 million as of December 31, 2019, and no
Recent Business Highlights and Updates
multiple measures in response to the COVID-19 pandemic to safeguard
the health and well-being of employees, their families, business
partners and healthcare providers, while continuing to advance the
study with PL9643 for dry eye disease started in January 2020. Data
readout is targeted for the fourth quarter of calendar year
proof-of-concept clinical study with an oral formulation of PL8177
in ulcerative colitis patients is delayed due to the pandemic and
is now targeted to start in the first half of calendar year 2021;
that they anticipate finalizing the divestiture of Vyleesi within
the next several months.
entire Palatin team thanks healthcare workers across the nation for
their selfless efforts in the treatment and care of COVID-19
patients, and 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,
said Carl Spana Ph.D., President and CEO of
Palatin. 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.
Spana further commented, We continue to review AMAG's
process related to the divestiture of Vyleesi and their obligations
under our license agreement and are prepared to take appropriate
steps to protect our rights and Vyleesi's significant
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
is targeted for the fourth quarter of calendar year
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.
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
Hypoactive Sexual Desire Disorder ( HSDD ) /
Vyleesi (bremelanotide injection)
Due to the early commercial stage of Vyleesi and the sales and
marketing strategy of our North American licensee AMAG
Pharmaceuticals, Inc., including no charge for the first Vyleesi
prescription, AMAG has not generated positive net sales through
March 31, 2020. This has resulted in no royalties to Palatin during
is the first as-needed treatment approved for premenopausal women
with acquired, generalized HSDD. AMAG launched Vyleesi nationally
in September 2019 through select specialty pharmacies with its
established women's health sales force.
January 2020 AMAG announced that, as a result of a strategic
review, it will divest Vyleesi, which it exclusively licensed from
Palatin for North America. In May 2020 AMAG stated that it is in
negotiations regarding the divestiture of Vyleesi and will provide
an update within the next few months.
continues to closely monitor AMAG's process related to the
divestiture of Vyleesi and AMAG's obligations under the
Vyleesi license agreement. Though sales of Vyleesi have been
adversely affected by the COVID-19 pandemic, the Company believes
that AMAG's divestiture process has also adversely impacted
Vyleesi sales. Palatin is prepared to take appropriate steps to
protect its rights as the Vyleesi licensor and the significant
value of the Vyleesi program.
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
Natriuretic Peptide Receptor ( NPR ) System
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.
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