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Key Takeaway: Palatin Technologies, Inc. Reports Second Quarter Fiscal Year 2021 Financial Results and Recent Business Positive Results from Phase 2 Clinical Study of PL9643 in Patients with Dry Eye Disease Continue to Rebuild Commercial Infrastructure and Brand Awareness for Vyleesi App

Full Press Release Details

Palatin Technologies, Inc. Reports Second Quarter
Fiscal Year 2021 Financial Results and Recent Business
Positive Results from Phase 2 Clinical Study of PL9643 in Patients
with Dry Eye Disease
Continue to Rebuild Commercial Infrastructure
and Brand Awareness for Vyleesi
Approximately $72.2 Million in Cash and Cash Equivalents
Teleconference and Webcast to be held on February 17, 2021 at 11:00
CRANBURY, NJ February 17, 2021 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 second quarter ended December 31, 2020.
Second Quarter Ended December 31, 2020 Financial
loss for the quarter was $(10.0) million, or $(0.04) per share,
compared to a net loss of $(5.2) million, or $(0.02) per share for
the comparable quarter of 2019;
increase in net loss was primarily attributable to commercial
expenses related to Vyleesi and to PL9643's Phase 2 study for
the treatment of dry eye disease.
As of December 31, 2020, the Company had $72.2
million in cash and cash equivalents and $4.7 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
Business Highlights and Updates
Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi
(bremelanotide injection)
gross sales for the quarter ended December 31, 2020 amounted to
$943,950. Vyleesi product revenue was $(163,971), net of allowances
and accruals. Vyleesi gross sales for the period July 25 to
September 30 amounted to $809,100. Vyleesi product revenue was
$(288,560), net of allowances and accruals;
the distribution network and procedures improving the patient
experience; expanded 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 a geo-targeting
Anti-Inflammatory / Autoimmune Programs
positive results in its Phase 2 study of PL9643 for the treatment
of dry eye disease (DED);
statistically significant improvements in multiple signs and
symptoms in the moderate to severe patient population after 2 weeks
of dosing and at the 12-week visit.
were no safety signals identified and PL9643 had excellent ocular
significance for the primary endpoints was not reached in the
overall enrolled population that included mild, moderate, and
severe patients, as measured at the 12-week primary evaluation
Phase 2/3 Clinical trial with PL9643 for the treatment of DED is
currently planned for mid-calendar year 2021;
an international patent application under the Patent Cooperation
Treaty (PCT) directed to the composition of PL9643 and a related
family of melanocortin agonist peptides; and
Phase 2 proof-of-concept clinical study with an oral formulation of
PL8177 in ulcerative colitis patients is targeted to start
mid-calendar year 2021, with data readout potentially in
mid-calendar year 2022.
Working through the melanocortin system, PL9643 is a novel
approach to treating dry eye disease. The emerging profile of
PL9643, with its rapid therapeutic onset and excellent tolerability
profile, is a potentially distinct advance in dry eye
therapy," stated Carl
Spana, Ph.D., President and CEO of Palatin. "The positive PL9643 Phase 2 study results identify
the most appropriate patient population, endpoints, and timepoints
for the next study, which is a Phase 2/3 study targeted for
mid-calendar year 2021, with data readout in the first half of
calendar year 2022. Regarding Vyleesi, our measured plan and
investment is showing positive trends and returns with a
significant rise in payer reimbursement and double-digit increases
to month over month prescription numbers continuing through January
Conference Call / Webcast
Palatin will host a conference call and audio webcast on February
17, 2021 at 11:00 a.m. Eastern Time to discuss the quarter ended December 31, 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 1-866-248-8441 (US/Canada) or 1-856-344-9206
(international), conference ID 2203098. 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 2203098.
The webcast and telephone replay will be available through February
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 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 market potential of
Last updated: Feb 17, 2021