Full Press Release Details
Palatin Reports Fourth Quarter and Full Year
Fiscal Year 2021 Financial Results and Provides Corporate
Phase 3 Pivotal Study of PL9643 in Patients with Dry Eye Disease
Currently Expected to Start Next Quarter with Top-Line Results
Expected in the Second Half Calendar 2022
Phase 2 Clinical Study of PL8177 in Patients with Ulcerative
Colitis Currently Expected to Start Next Quarter with Top-Line
Results Expected in the Second Half Calendar 2022
$60.1 Million in Cash and Cash Equivalents at June 30, 2021
Projected Cash Runway Through Calendar 2022
Teleconference and Webcast today at 11:00 a.m. Eastern
NJ, September 29, 2021/PRNewswire/ -- Palatin Technologies, Inc.,
(NYSE American: PTN), a biopharmaceutical company developing
first-in-class medicines based on molecules that modulate the
activity of the melanocortin peptide receptor systems, today
announced results for its fourth quarter and fiscal year ended June
the past year, we worked diligently advancing our lead
investigational compound PL9643 through a successful Phase 2
clinical trial, towards a pivotal Phase 3 clinical trial for the
treatment of dry eye disease, currently one of the largest markets
in ophthalmology, stated Carl Spana, Ph.D., President
and CEO of Palatin. We believe that, if approved,
PL9643's quick onset of efficacy, favorable tolerability, and
safety profile has the potential to be a first-line therapy for the
millions of individuals suffering from DED.
Spana further commented, Our strong cash position of $60.1
million at June 30, 2021, provides us with a sufficient operating
cash runway through calendar year 2022, allowing us to advance our
novel melanocortin-based programs, including top-line data readouts
for our Phase 3 DED clinical trial and our PL8177 Phase 2 clinical
trial for ulcerative colitis in the second half of calendar year
Recent Highlights and Upcoming Events
Anti-Inflammatory / Autoimmune Programs
melanocortin agonist for the treatment of dry eye disease
completion of its End-of-Phase 2 (EOP2) meeting with the Food and
Drug Administration (FDA). The EOP2 meeting included all aspects of
PL9643's development plan, with the FDA and Palatin reaching
agreement on all key elements of a pivotal Phase 3 clinical
program, including study design, endpoints, interim assessment, and
patient population. In addition, a potential second Phase 3 study
and long-term safety study were discussed to support a New Drug
track to initiate the Phase 3 program in DED patients during the
fourth quarter of calendar year 2021, with data readout expected in
the second half of calendar year 2022.
clinical trial results for PL9643 in DED at the American Society of
Cataract and Refractive Surgery Annual Meeting.
clinical trial results for PL9643 in DED and preclinical data in
retinal disease, at the Association for Research in Vision and
Ophthalmology (ARVO) 2021 Annual Meeting.
melanocortin agonist for the treatment of ulcerative
formulation study of PL8177 in ulcerative colitis is currently
scheduled to start the fourth quarter of calendar year 2021, with
data readout expected in the second half of calendar year
speaker presentations on Vyleesi and two poster presentations of
PL9643 and PL8177 at the TIDES USA hybrid conference.
Opinion Leader webinar on melanocortin agonists for treating ocular
indications, with a primary focus on PL9643 and data from the
Company's recently completed Phase 2 clinical trial for dry
eye disease. Introduced the Company's growing portfolio of
melanocortin agonists to treat the harmful effects of inflammation
protective effects of PL8331 and PL9654 in mouse models of
retinopathy, scheduled at the 2021 Annual Meeting of the American
Society of Retina Specialists (ASRS), being held October 8-12,
Senior Leadership Additions
Appointed Michael B. Raizman, M.D. as Chief Medical
Officer; James E. Hattersley as Senior Vice President of
Business Development; and, J. Don Wang, Ph.D. as Vice
President of Product Development.
Vyleesi (bremelanotide injection) /
Hypoactive Sexual Desire Disorder (HSDD). Palatin's
goal with the Vyleesi program is to demonstrate value in the
marketplace by increasing HCP awareness, patient engagement, and
market access, with an objective of re-licensing the U.S. rights to
a committed women's healthcare company.
ended June 30, 2021:
sales increased 28%, net revenue increased 149%, and total
prescriptions increased 17%, over the quarter ended December 31,
2020 (Palatin's first full quarter of Vyleesi
sales decreased 32%, net revenue decreased 9%, and total
prescriptions decreased 5%, over the prior quarter ended March 31,
increased over the quarters ended December 31, 2020, and March 31,
reimbursement coverage increased over the quarters ended December
31, 2020, and March 31, 2021.
healthcare providers can learn more about HSDD and Vyleesi at
Fourth Quarter and Fiscal Year Ended 2021 Financial
net revenues consist of net product revenues of Vyleesi and license
and contract revenue.
gross sales for the quarter and year ended June 30, 2021, amounted
to $1.2 million and $4.7 million, respectively, with net product
revenue, net of allowances and accruals, of $80,504 and ($283,286),
respectively. Palatin recognized no product revenues for the
quarter and year ended June 30, 2020.
recognized $94,689 in the license and contract revenue for the
quarter and year ended June 30, 2021, related to our license
agreement with Kwangdong, compared to $117,989 for the year ended
June 30, 2020, related to our license agreement with AMAG
operating expenses for the quarter and year ended June 30, 2021,
were $13.9 million and $33.2 million, respectively, compared to
$7.4 million and $23.7 million, respectively, for the same periods
increase in operating expenses for 2021 was primarily due to the