CRANBURY, N.J., May 17, 2021 /PRNewswire/ -- Palatin (NYSE
American: PTN), a biopharmaceutical company developing
first-in-class medicines based on molecules that modulate the
activity of the melanocortin peptide receptor system, today
announced results for its third fiscal quarter ended March 31, 2021.
"I am excited with Palatin's evolution and development
advancements utilizing our proprietary melanocortin agonists to
treat patients with inflammatory and autoimmune conditions,"
stated Carl Spana, Ph.D., President and CEO of
Palatin. "We are hosting a KOL webinar on May 21st to introduce our growing
portfolio of melanocortin agonists to treat the harmful effects of
inflammation in the eye. On the clinical front, we are targeting to
commence a Phase 3 trial of PL9643 in patients with dry eye disease
in the second half of calendar year 2021. The emerging profile of
PL9643, with its rapid therapeutic onset and excellent tolerability
profile, is a potentially distinct advantage over commercially
available dry eye therapies. In addition, we are targeting to
commence a Phase 2 study with an oral formulation of PL8177 in
ulcerative colitis patients in the second half of calendar year
2021."
"I am also pleased with the progress we have made with the
Vyleesi program," continued Spana. "Our quarter ended
March 31, 2021 reflected significant
increases in gross sales, net sales, prescriptions, and insurance
coverage over the prior quarter."
Business Highlights and Updates
- Anti-Inflammatory / Autoimmune Programs
-
- PL9643 for the treatment of dry eye disease (DED):
-
- Announced positive results from its Phase 2 clinical study
reflecting 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. There were no safety
signals identified and PL9643 had excellent ocular
tolerability.
- A Phase 3 clinical trial is currently planned for the second
half of calendar year 2021, with data readout potentially in the
first half of calendar year 2022.
- Presented two presentations of the Company's melanocortin
platform, including Phase 2 clinical trial results for PL9643 in
dry eye disease and preclinical data in retinal disease, at the
Association for Research in Vision and Ophthalmology (ARVO) 2021
Annual Meeting, held virtually May 1-7,
2021.
- PL8177 for the treatment of ulcerative colitis:
-
- A Phase 2 proof-of-concept clinical study with an oral
formulation of PL8177 in ulcerative colitis patients is targeted to
start second half of calendar year 2021, with data readout
potentially in mid-calendar year 2022.
- Key Opinion Leader webinar planned for May 21, 2021 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:
-
- Introduces the Company's growing portfolio of melanocortin
agonists to treat the harmful effects of inflammation in the
eye.
- Vyleesi® (bremelanotide injection) / Hypoactive Sexual
Desire Disorder (HSDD)
-
- Quarter ended March 31, 2021
gross product sales increased 89%, net revenue increased 154%, and
prescriptions increased 24%, over the prior quarter ended
December 31, 2020.
- Geo-targeted marketing efforts expected to drive healthcare
provider and consumer engagement. The current digital campaign
applications reach thousands of healthcare providers and millions
of premenopausal women monthly and has resulted in increased
website and telemedicine traffic and conversions.
- The Company continues to focus on expanding access and
reimbursement coverage. The Company estimates that it has achieved
approximately 75% of commercially insured lives and approximately
50% of commercial formulary coverage, including two of the three
major pharmacy benefit managers and numerous regional plans.
- Prescription increases and expanding access and reimbursement
coverage have resulted in more favorable gross-to-net adjustments
and positive quarterly net product revenue for the first time.
- Palatin has filed an election to extend the patent term of U.S.
patent 6,794,489 to June 26, 2025.
This Vyleesi patent has claims to the bremelanotide composition of
matter as well as methods for stimulating sexual response.
Third Quarter 2021 Results
Total net revenues,
consisting of net product revenues of Vyleesi, were $88,741. There was no revenue reported for the
third quarter of 2020.
- Vyleesi gross sales amounted to $1,780,020, with net product revenue of
$88,741, net of allowances and
accruals, compared to gross sales for the prior quarter ended
December 31, 2020 of $943,950, with net product revenue of
$(163,971), net of allowances and
accruals.
Total operating expenses were $6.6
million, compared to $5.7
million for the same period in 2020. The increase was mainly
due to commercial expenses related to Vyleesi.
Palatin's net loss was $(5.7)
million, or $(0.02) per share,
compared to a net loss of $(5.4)
million, or $(0.02) per share,
for the comparable quarter of 2020.
As of March 31, 2021, the Company
had $68.6 million in cash and cash
equivalents and $1.9 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 debt.
Conference Call / Webcast
Palatin will host a
conference call and audio webcast on May 17,
2021 at 11:00 a.m. Eastern
Time to discuss the quarter ended March 31, 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
1-866-248-8441 (US/Canada) or
1-856-344-9206 (international), conference ID 6765353 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 6765353. The webcast and telephone replay
will be available through May 24,
2021.
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.
Vyleesi® is a registered trademark of Palatin.
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PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
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|
Three Months Ended
March 31,
|
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Nine Months Ended
March 31,
|
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2021
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2020
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2021
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2020
|
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|
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|
REVENUES
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Product revenue,
net
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$
88,741
|
|
$
-
|
|
$
(363,790)
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|
$
-
|
License and
contract
|
-
|
|
-
|
|
-
|
|
117,989
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|
88,741
|
|
-
|
|
(363,790)
|
|
117,989
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|
|
|
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|
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OPERATING
EXPENSES
|
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|
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Cost of products
sold
|
55,440
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|
-
|
|
110,040
|
|
-
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Research and
development
|
2,509,490
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|
3,641,250
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|
9,444,759
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|
10,026,363
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Selling, general and
administrative
|
4,010,055
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|
2,072,032
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11,386,574
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6,308,567
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Gain on license
termination agreement
|
-
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|
-
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(1,623,795)
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-
|
Total operating
expenses
|
6,574,985
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|
5,713,282
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|
19,317,578
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|
16,334,930
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|
|
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|
Loss from
operations
|
(6,486,244)
|
|
(5,713,282)
|
|
(19,681,368)
|
|
(16,216,941)
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|
OTHER INCOME
(EXPENSE)
|
|
|
|
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Investment
income
|
2,834
|
|
331,285
|
|
19,769
|
|
1,101,921
|
Foreign currency
gain
|
753,750
|
|
-
|
|
8,748
|
|
-
|
Interest
expense
|
-
|
|
(278)
|
|
(9,360)
|
|
(11,831)
|
Total other income
(expense), net
|
756,584
|
|
331,007
|
|
19,157
|
|
1,090,090
|
NET LOSS
|
$
(5,729,660)
|
|
$
(5,382,275)
|
|
$(19,662,211)
|
|
$
(15,126,851)
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Basic and
diluted net loss per common share
|
$
(0.02)
|
|
$
(0.02)
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|
$
(0.08)
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|
$
(0.06)
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|
|
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|
|
Weighted average
number of common shares outstanding used
in computing basic and diluted net loss per common
share
|
236,832,283
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|
235,322,087
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|
236,525,514
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|
234,449,813
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PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
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March 31,
2021
|
|
June 30,
2020
|
ASSETS
|
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|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
68,641,312
|
|
$
82,852,270
|
Accounts
receivable
|
1,869,120
|
|
-
|
Inventories
|
6,114,718
|
|
-
|
Prepaid expenses and
other current assets
|
2,760,242
|
|
738,216
|
Total current
assets
|
79,385,392
|
|
83,590,486
|
|
|
|
|
Property and
equipment, net
|
107,376
|
|
140,216
|
Right-of-use
assets
|
1,322,326
|
|
1,266,132
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Other
assets
|
56,916
|
|
56,916
|
Total
assets
|
$
80,872,010
|
|
$
85,053,750
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LIABILITIES AND
STOCKHOLDERS' EQUITY
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Current
liabilities:
|
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Accounts
payable
|
$
864,012
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$
715,672
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Accrued
expenses
|
5,197,759
|
|
2,899,097
|
Short-term operating
lease liabilities
|
347,070
|
|
312,784
|
Other current
liabilities
|
3,628,000
|
|
-
|
Total current
liabilities
|
10,036,841
|
|
3,927,553
|
|
|
|
|
Long-term operating
lease liabilities
|
986,175
|
|
953,348
|
Other long-term
liabilities
|
6,972,832
|
|
-
|
Total
liabilities
|
17,995,848
|
|
4,880,901
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares
issued and outstanding designated as follows:
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|
Series A Convertible:
authorized 264,000 shares: issued and outstanding
4,030 shares as of March 31, 2021 and June 30, 2020
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and
outstanding 230,049,691 shares as of March 31, 2021 and
229,258,400 shares as of June 30, 2020
|
2,300,497
|
|
2,292,584
|
Additional paid-in
capital
|
398,436,738
|
|
396,079,127
|
Accumulated
deficit
|
(337,861,113)
|
|
(318,198,902)
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Total stockholders'
equity
|
62,876,162
|
|
80,172,849
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Total liabilities and
stockholders' equity
|
$
80,872,010
|
|
$
85,053,750
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SOURCE Palatin Technologies, Inc.