- Enrollment in Phase 3 PL9643 MELODY-1 Study in
Dry Eye Disease (DED) is Complete with 570 Patients Enrolled
- Topline Data Expected Late 4Q Calendar Year 2023
- Interim Analysis of Initial 120 Patients Showed
- Statistical Separation for Clinical Efficacy Across Multiple
Signs and Symptoms of Dry Eye
- Excellent Patient Safety and
Tolerability Product Profile
- Phase 2 Clinical Study of Oral PL8177 in Patients with
Ulcerative Colitis
- Interim Analysis Targeted for 1Q Calendar Year 2024
- Topline Results Currently Expected First Half
Calendar Year 2024
- Vyleesi®
- Net Product Revenue Increased 47% Over the Prior
Quarter
- Prescriptions Dispensed Increased 16% Over the Prior
Quarter
- 6 Consecutive Quarters of Double-Digit Growth
- Teleconference and Webcast to be held on September 28, 2023, at 11:00 AM ET
CRANBURY, N.J., Sept. 28,
2023 /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 receptor system,
today announced financial results for its fiscal
fourth quarter and fiscal year ended June
30, 2023.
"On the development front, our Phase 3 PL9643 clinical study is
fully enrolled, and we are excited that the comprehensive interim
analysis of the data for the Lead-In population of the initial 120
patients demonstrated statistically significant positive effects on
multiple endpoints for both signs and symptoms, with an excellent
patient safety and tolerability," said Carl
Spana, Ph.D., President and CEO of Palatin. "On the
commercial front, we are pleased with Vyleesi's quarter over
quarter double-digit increases across all value metrics, notably
net product revenue increased 47% and prescriptions dispensed
increased 16% over the prior quarter. We are excited that Vyleesi
quarterly net product revenue continues to exceed Vyleesi quarterly
operating expenses."
Fourth Quarter Fiscal Year Ended 2023 Business
Highlights and Recent Updates
- Anti-Inflammatory / Autoimmune Programs
- PL9643 melanocortin agonist for the treatment of dry eye
disease (DED)
- Pivotal Phase 3 MELODY-1 clinical study patient enrollment
completed.
- Topline data is currently expected late fourth quarter of
calendar year 2023.
- Final data is currently expected first quarter of calendar year
2024.
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov/ via the
identifier NCT04268069.
- PL8177 oral melanocortin agonist for the treatment of
ulcerative colitis (UC):
- Interim assessment is currently expected in the first quarter
of calendar year 2024.
- Topline data is currently expected in the first half of
calendar year 2024.
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov/ via the
identifier NCT05466890.
- Bremelanotide BREAKOUT study (BMT 701) in patients with
diabetic kidney disease:
- Enrollment is ongoing and currently expected to be completed in
the second half of calendar year 2023.
- Topline results are currently expected in the first half
calendar year 2024.
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov/ via the
identifier NCT05709444.
- Vyleesi® (bremelanotide injection) / Hypoactive
Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is
to demonstrate commercial product value in the marketplace with an
objective of re-licensing the U.S. rights to a committed women's
healthcare company.
- For the fiscal fourth quarter ended June
30, 2023:
- Gross product sales of $4.1
million increased 20% over the prior quarter and increased
78% over the comparable quarter last year.
- Net product revenue of $1.8
million increased 47% over the prior quarter and increased
128% over the comparable quarter last year.
- Total prescriptions dispensed increased 16% over the prior
quarter and increased 92% over the comparable quarter last
year.
- Refill rates, commercial insurance reimbursement, and net
revenue per prescription dispensed continued with positive and
impactful results and trends, versus the prior quarter and
comparable quarter last year.
- Fosun Pharma, Palatin's licensee of Vyleesi in China, reported its first sale in the
Hainan Province of China.
- Kwangdong Pharmaceuticals, Palatin's licensee of Vyleesi in
South Korea, completed enrollment
in its Phase 3 clinical trial evaluating the efficacy and safety of
Vyleesi in premenopausal women with HSDD.
- Data from this trial is currently anticipated by calendar year
end with a potential regulatory submission in the first half of
calendar 2024.
- Palatin entered a strategic partnership with UpScriptHealth, a
leading direct-to-consumer telemedicine company providing
telemedicine services to pharmaceutical and medical technology
companies.
- Patients and healthcare providers can learn more
about HSDD and Vyleesi at www.vyleesi.com and
www.vyleesipro.com.
- Other:
- Palatin initiated a clinical development program evaluating
bremelanotide, a melanocortin receptor 4 (MCR4) agonist,
co-formulated with a PDE5 inhibitor (PDE5i), for the treatment of
erectile dysfunction (ED) in patients that do not respond to PDE5i
monotherapy. A Phase 2 clinical study in PDE5i non-responder ED
patients is currently expected to commence late fourth quarter
calendar year 2023.
Fourth Quarter and Fiscal Year Ended June 30, 2023 Financial Results
Revenue
Total revenue consists of gross product sales of Vyleesi, net of
expenses, allowances and accruals, and license and contract
revenue.
Vyleesi gross product sales
to pharmacy distributors, for the quarter ended
June 30, 2023, were $4.1 million,
with net product revenue of $1.8
million, compared to gross product sales of $2.3
million and net product revenue of $0.8
million for the comparable quarter last year. Gross product
sales increased 78% and net product revenue
increased 128% over the comparable quarter last
year.
Vyleesi gross product sales to pharmacy distributors for the
fiscal year ended June 30, 2023, were
$12.5 million, with net product
revenue of $4.9 million, compared to
gross product sales of $5.8 million,
with net product revenue of $1.2
million, for the fiscal year ended June 30, 2022. Gross product sales increased 114%
and net product revenue increased 298% over the fiscal year ended
June 30, 2022.
Palatin recognized $3,000 in
license and contract revenue for the fourth quarter and fiscal year
ended June 30, 2023, compared to
$250,000 for the fiscal year ended
June 30, 2022, related to our license
agreement with Fosun.
Operating Expenses
Total operating expenses were $12.6
million for the fourth quarter ended June 30, 2023, compared to $13.9 million for the comparable quarter last
year. The decrease in operating expenses
was mainly the result of the recognition of expenses
during the fiscal year ended June 30,
2022 in connection with the sale and issuance of our Series
B and C Redeemable Convertible Preferred Stock and secondarily to
lower spending on our marketing efforts of Vyleesi during fiscal
2023.
Total operating expenses for the fiscal year ended June 30, 2022, were $37.3
million, compared to $38.1
million for the fiscal year ended June 30, 2022. The decrease in operating expenses
was mainly due to the $1.0 million
gain recognized as a result of amending certain minimum purchase
commitments.
Cash Flows
Palatin's net cash used in operations for the quarter ended
June 30, 2023, was $9.6 million, compared to net cash used in
operations of $7.7 million for the
same period in 2022. The increase in net cash used in operations is
mainly due to working capital changes for the quarter ended
June 30, 2023.
Palatin's net cash used in operations for the fiscal year ended
June 30, 2023, was $28.4 million, compared to net cash used in
operations of $29.9 million, for the
same period in 2022. The decrease in net cash used in operations
was a result of a lower net loss in fiscal 2023 due to an increase
in net revenue and the sale of NOLs, offset by working capital
changes, and increased payments made related to inventory purchase
commitments.
Net Loss
Palatin's net loss for the quarter and fiscal year ended
June 30, 2023, was $10.7 million and $27.5
million, or $(0.91) and
$(2.53) per basic and diluted common
share, respectively, compared to a net loss of $12.8 million and $36.2
million, or $(1.34) and
$(3.79) per basic and diluted common
share, respectively, for the same periods in 2022.
The decrease in net loss for the quarter ended June 30, 2023 over the quarter ended June 30, 2022, was mainly due to the increase of
net product revenue of Vyleesi and a decrease in SG&A expenses
as a result of the recognition of expenses during the fiscal year
ended June 30, 2022 in connection
with the sale and issuance of our Series B and C Redeemable
Convertible Preferred Stock.
The decrease in net loss for the fiscal year ended June 30, 2023 over the fiscal year ended
June 30, 2022, was due to recognition
of an income tax benefit related to the sale of New Jersey Net
Operating Losses, increased Vyleesi total revenues, and the
recognition of a gain on purchase commitment.
Cash Position
As of June 30, 2023, Palatin's
cash, cash equivalents and marketable securities were approximately
$11.0 million plus $2.9 million of accounts receivables, compared to
cash and cash equivalents of $19.6
million with $1.7 million of
accounts receivables as of March 31,
2023, and $29.9 million with
$1.8 million of accounts receivable
as of June 30, 2022.
Based on its current operating plan, the Company believes that
existing cash, cash equivalents, marketable securities and
receivables will be sufficient to fund currently anticipated
operating expenses through calendar year 2023.
Palatin's audited
financial statements for the year ended June 30, 2023,
to be included in the Annual Report on Form 10-K
include an audit report from its independent registered public
accounting firm, KPMG LLP, that contains a going concern
explanatory paragraph.
Conference Call / Webcast
Palatin will host a conference call and audio
webcast on September 28, 2023, at 11:00
a.m. Eastern Time to discuss the results of operations in
greater detail and provide an update on corporate developments.
Individuals interested in listening to the conference call live can
dial
1-888-506-0062 (US) or 1-973-528-0011 (International), conference ID 313946.
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 1-877-481-4010 (US) or 1-919-882-2331
(International), passcode 49135. The webcast and telephone replay
will be available through October 12, 2023.
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 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 and follow Palatin on Twitter at
@PalatinTech.
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, and market potential for product candidates
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 events that occur after the date of this
press release.
Palatin Technologies® and Vyleesi® are registered trademarks of
Palatin Technologies, I
PALATIN TECHNOLOGIES, INC.
|
and Subsidiary
|
Consolidated Statements of
Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Year Ended June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
1,758,933
|
|
$
770,738
|
|
$
4,850,678
|
|
$
1,218,457
|
|
License and
contract
|
3,000
|
|
-
|
|
3,000
|
|
250,000
|
|
Total
revenues
|
1,761,933
|
|
770,738
|
|
4,853,678
|
|
1,468,457
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
Cost of products
sold
|
104,032
|
|
87,517
|
|
418,470
|
|
217,529
|
|
Research and
development
|
7,405,681
|
|
7,436,199
|
|
22,630,577
|
|
21,327,434
|
|
Selling, general and
administrative
|
5,070,318
|
|
6,348,112
|
|
15,290,836
|
|
16,511,942
|
|
Gain on purchase
commiment
|
-
|
|
-
|
|
(1,027,322)
|
|
-
|
|
Total operating
expenses
|
12,580,031
|
|
13,871,828
|
|
37,312,561
|
|
38,056,905
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(10,818,098)
|
|
(13,101,090)
|
|
(32,458,883)
|
|
(36,588,448)
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
|
|
|
Investment
income
|
182,975
|
|
25,863
|
|
691,981
|
|
29,963
|
|
Foreign currency (loss)
gain
|
(77,850)
|
|
325,868
|
|
(429,971)
|
|
389,868
|
|
Interest
expense
|
(1,490)
|
|
(18,259)
|
|
(20,013)
|
|
(29,682)
|
|
Total other income
(expense), net
|
103,635
|
|
333,472
|
|
241,997
|
|
390,149
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
(10,714,463)
|
|
(12,767,618)
|
|
(32,216,886)
|
|
(36,198,299)
|
|
Income tax
benefit
|
-
|
|
-
|
|
4,674,999
|
|
-
|
|
NET LOSS
|
$
(10,714,463)
|
|
$
(12,767,618)
|
|
$
(27,541,887)
|
|
$
(36,198,299)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.91)
|
|
$
(1.34)
|
|
$
(2.53)
|
|
$
(3.79)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares
outstanding used in computing basic and diluted net
loss per common share
|
11,725,219
|
|
9,543,762
|
|
10,890,159
|
|
9,543,762
|
|
PALATIN TECHNOLOGIES, INC.
|
and Subsidiary
|
Consolidated Balance Sheets
|
(unaudited)
|
|
|
|
|
|
June 30, 2023
|
|
June 30, 2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
7,989,582
|
|
$ 29,939,154
|
Marketable
securities
|
2,992,890
|
|
-
|
Accounts
receivable
|
2,915,760
|
|
1,780,020
|
Inventories
|
526,000
|
|
944,471
|
Prepaid expenses and
other current assets
|
1,897,281
|
|
1,932,454
|
Total current
assets
|
16,321,513
|
|
34,596,099
|
|
|
|
|
Property and equipment,
net
|
684,910
|
|
539,314
|
Right-of-use assets -
operating leases
|
876,101
|
|
878,465
|
Other assets
|
56,916
|
|
56,916
|
Total assets
|
$ 17,939,440
|
|
$ 36,070,794
|
|
|
|
|
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK,
AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
4,303,527
|
|
$
3,157,617
|
Accrued
expenses
|
6,511,059
|
|
6,875,216
|
Short-term operating
lease liabilities
|
354,052
|
|
371,124
|
Short-term finance
lease liabilities
|
106,392
|
|
100,921
|
Other current
liabilities
|
3,856,800
|
|
5,754,986
|
Total current
liabilities
|
15,131,830
|
|
16,259,864
|
|
|
|
|
Long-term operating
lease liabilities
|
544,323
|
|
529,398
|
Long-term finance lease
liabilities
|
46,014
|
|
152,407
|
Other long-term
liabilities
|
2,083,200
|
|
2,861,250
|
Total
liabilities
|
17,805,367
|
|
19,802,919
|
|
|
|
|
Series B and Series C
Redeemable Convertible Preferred Stock of $0.01 par value:
authorized, issued, and outstanding 9,000,000 shares as of June 30,
2022, with a
liquidiation preference of $15,000,000
|
-
|
|
15,000,000
|
Escrowed
proceeds
|
-
|
|
(15,000,000)
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares (including amounts
authorized for
|
|
|
|
Series B and Series C
Redeemable Convertible Preferred Stock): shares issued and
outstanding
|
|
|
|
designated as
follows:
|
|
|
|
Series A Convertible:
authorized 4,030 shares as of June 30, 2023: issued and outstanding
4,030 shares
|
|
|
|
as of June 30, 2023 and
June 30, 2022
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and outstanding
11,656,714 shares as of June 30, 2023 and 9,270,947 shares as of
June 30, 2022
|
116,567
|
|
92,709
|
Additional paid-in
capital
|
415,553,049
|
|
404,168,822
|
Accumulated
deficit
|
(415,535,583)
|
|
(387,993,696)
|
Total stockholders'
equity
|
134,073
|
|
16,267,875
|
Total liabilities,
redeemable convertible preferred stock, and stockholders'
equity
|
$ 17,939,440
|
|
$ 36,070,794
|
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SOURCE Palatin Technologies, Inc.