CRANBURY, N.J., Nov. 15, 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 first fiscal quarter ended
September 30, 2021.
"I am excited with the significant advancement of our
melanocortin agonist programs and their differentiating product
profiles, which include the expected initiation of a Phase 3
pivotal study of PL9643 in patients with dry eye disease next
month, and a Phase 2 clinical trial of PL8177 for ulcerative
colitis in the first half of calendar year 2022," stated
Carl Spana, Ph.D., President and CEO
of Palatin.
"Regarding Vyleesi, our measured plan is showing positive trends
for our targeted value metrics with net revenue up 98% and net
revenue per prescription up 45% over the prior quarter ended
June 30, 2021," concluded Dr.
Spana.
Recent Highlights and Upcoming Events
- Anti-Inflammatory / Autoimmune Programs
-
- PL9643 melanocortin agonist for the treatment of dry eye
disease (DED):
-
- Palatin remains on track to initiate its pivotal Phase 3
clinical program in DED patients in December
2021, with data readout expected in the second half of
calendar year 2022.
- Presented Phase 2 clinical trial results for PL9643 in DED at
the American Society of Cataract and Refractive Surgery (ASCRS)
Annual Meeting.
- Presented Phase 2 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.
- PL8177 melanocortin agonist for the treatment of ulcerative
colitis:
-
- A Phase 2 oral formulation study of PL8177 in ulcerative
colitis is currently scheduled to start in the first half of
calendar year 2022, with data readout expected in the second half
of calendar year 2022.
- Conducted a Featured Speaker presentation on Vyleesi and two
poster presentations of PL9643 and PL8177 at the TIDES USA hybrid conference.
- Hosted a Key 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
in the eye.
- Presented the protective effects of PL8331 and PL9654 in mouse
models of retinopathy, at the 2021 Annual Meeting of the American
Society of Retina Specialists (ASRS). Awarded "Top Ten Poster"
Designation.
- Research and Development Infrastructure: Strengthened
R&D department with key appointments who have demonstrated a
high-level of expertise in their fields to support the advancement
of our development programs.
- Vyleesi® (bremelanotide injection) / Hypoactive
Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is
to demonstrate product value in the marketplace with an objective
of re-licensing the U.S. rights to a committed women's healthcare
company.
-
- For the quarter ended September 30,
2021:
-
- Gross product sales increased 18%, net revenue increased 98%,
net revenue per prescription dispensed increased 45%, despite a 13%
decrease in total prescriptions dispensed, over the prior quarter
ended June 30, 2021.
- Market access, reimbursement coverage, and refill rates
increased over the prior quarter ended June
30, 2021.
- Patients and healthcare providers can learn more about HSDD and
Vyleesi at www.vyleesi.com and www.vyleesipro.com
First Quarter Ended Fiscal Year 2022 Financial
Results
Revenue
Total net revenues consist of gross product sales of Vyleesi,
net of allowances and accruals.
Vyleesi gross product sales for the quarter ended September 30, 2021, amounted to $1.4 million, with net product revenue of
$159,482, compared to gross product
sales for the period July 25 (the
date Palatin regained North American rights to Vyleesi) to
September 30, 2020, of $809,100, with negative net product revenue of
$(288,560).
Operating Expenses
Total operating expenses for the quarter ended September 30, 2021, were $7.4 million, compared to $3.7 million for the comparable quarter of
2020.
The increase in operating expenses was primarily due to the gain
of $1.6 million (which reduced
expenses) recorded during the quarter ended September 30, 2020, as a result of the Vyleesi
Termination Agreement with AMAG Pharmaceuticals, and secondarily to
increased commercial expenses related to Vyleesi.
Cash Flows
Palatin's net cash used in operations for the quarter ended
September 30, 2021, was $6.4 million, compared to net cash provided by
operations of $3.8 million for the
same period in 2020. The difference is due to the cash received in
excess of the gain on termination of the Vyleesi agreement with
AMAG.
Net Loss
Palatin's net loss for the quarter ended September 30, 2021, was $7.1 million, or $0.03 per basic and diluted common share compared
to a net loss of $3.9 million or
$0.02 per basic and diluted common
share for the same period in 2020.
The difference between the quarter ended September 30, 2021, and the quarter ended
September 30, 2020, was primarily due
to the gain of $1.6 million recorded
during the quarter ended September 30,
2020, as a result of the Vyleesi Termination Agreement with
AMAG Pharmaceuticals and secondarily to increased commercial
expenses related to Vyleesi.
Cash Position
As of September 30, 2021,
Palatin's cash and cash equivalents were $53.4 million with $0.9
million of accounts receivable, compared to cash and cash
equivalents of $60.1 million with
$1.6 million of accounts receivable,
as of June 30, 2021.
Based on its current operating plan, Palatin believes that
existing cash and cash equivalents will be sufficient to fund
currently anticipated operating expenses through calendar year
2022.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on
November 15, 2021, at 9:30 a.m. Eastern Time to discuss the quarter
ended September 30, 2021, results of
operations in greater detail and provide an update on corporate
developments. Individuals interested in listening to the conference
call live can dial 1-877-614-0009 (US/Canada) or 1-856-344-9283 (international),
conference ID 3594800. 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 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 3594800. The webcast and telephone replay
will be available through November 22,
2021.
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ("MCr") system has effects on
inflammation, immune system responses, metabolism, food intake, and
sexual function. There are five melanocortin receptors, MC1r
through MC5r. Modulation of these receptors, through use of
receptor-specific agonists, which activate receptor function, or
receptor-specific antagonists, which block receptor function, can
have medically significant pharmacological effects.
Many tissues and immune cells located in the eye (and other
places, for example the gut and kidney) express melanocortin
receptors, empowering our opportunity to directly activate natural
pathways to resolve disease inflammation.
About Palatin
Palatin is a 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
Vyleesi and other Palatin products in development, clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates, 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, Palatin's ability to
establish and maintain the capability for manufacturing, marketing
and distribution of Vyleesi, 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.
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
2021
|
|
2020
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
Product revenue,
net
|
$
159,482
|
|
$
(288,560)
|
|
|
159,482
|
|
(288,560)
|
|
OPERATING
EXPENSES
|
|
|
|
|
Cost of products sold
|
53,933
|
|
25,200
|
|
Research and
development
|
3,484,764
|
|
2,923,851
|
|
Selling, general and
administrative
|
3,836,542
|
|
2,331,606
|
|
Gain on license
termination agreement
|
-
|
|
(1,623,795)
|
|
Total operating
expenses
|
7,375,239
|
|
3,656,862
|
|
|
|
|
|
|
Loss from
operations
|
(7,215,757)
|
|
(3,945,422)
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
Investment
income
|
1,410
|
|
12,135
|
|
Foreign currency
gain
|
107,359
|
|
-
|
|
Interest
expense
|
(5,631)
|
|
(7,489)
|
|
Total other income,
net
|
103,138
|
|
4,646
|
|
|
|
|
|
|
NET LOSS
|
$
(7,112,619)
|
|
$
(3,940,776)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.03)
|
|
$
(0.02)
|
|
Weighted average
number of common shares
outstanding used in computing basic and diluted net
loss per common share
|
238,233,063
|
|
236,345,862
|
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
September 30,
2021
|
|
June 30,
2021
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
53,421,179
|
|
$
60,104,919
|
Accounts
receivable
|
914,015
|
|
1,580,443
|
Inventories
|
1,108,067
|
|
1,162,000
|
Prepaid expenses and
other current assets
|
2,946,797
|
|
3,059,679
|
Total current
assets
|
58,390,058
|
|
65,907,041
|
|
|
|
|
Property and
equipment, net
|
140,022
|
|
94,817
|
Right-of-use
assets
|
1,146,332
|
|
1,237,813
|
Other
assets
|
56,916
|
|
56,916
|
Total
assets
|
$
59,733,328
|
|
$
67,296,587
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
762,817
|
|
$
640,650
|
Accrued
expenses
|
4,991,164
|
|
5,797,378
|
Short-term operating
lease liabilities
|
353,925
|
|
351,853
|
Other current
liabilities
|
3,679,852
|
|
3,721,907
|
Total current
liabilities
|
9,787,758
|
|
10,511,788
|
|
|
|
|
Long-term operating
lease liabilities
|
808,840
|
|
900,520
|
Other long-term
liabilities
|
6,167,603
|
|
6,232,907
|
Total
liabilities
|
16,764,201
|
|
17,645,215
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares
issued and outstanding designated as follows:
|
|
|
|
Series A Convertible:
authorized 264,000 shares: issued and outstanding
4,030 shares as of September 30, 2021 and June 30, 2021
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 231,301,673 shares as of September 30, 2021 and
230,049,691 shares as of June 30, 2021
|
2,313,017
|
|
2,300,497
|
Additional paid-in
capital
|
399,564,086
|
|
399,146,232
|
Accumulated
deficit
|
(358,908,016)
|
|
(351,795,397)
|
Total stockholders'
equity
|
42,969,127
|
|
49,651,372
|
Total liabilities and
stockholders' equity
|
$
59,733,328
|
|
$
67,296,587
|
|
|
|
|
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SOURCE Palatin Technologies, Inc.