- Phase 3 Pivotal Study of PL9643 in Patients with Dry Eye
Disease Ongoing
-
- Patient Enrollment on Track
- Topline Results Currently Expected Mid-Calendar Year
2023
- Phase 2 Clinical Study of Oral PL8177 in Patients with
Ulcerative Colitis Commenced
-
- First Patient Dosed
- Planned Interim Analysis Targeted for First Half Calendar
Year 2023
- Topline Results Currently Expected Second
Half Calendar Year 2023
- Phase 2 Clinical Study of Bremelanotide in Patients with
Diabetic Kidney Disease
-
- Complete Enrollment Targeted for Third Quarter Calendar Year
2023
- Topline Results Currently Expected First
Quarter Calendar Year 2024
- Vyleesi® - Net Product Revenue Increased 18% and
Prescriptions Dispensed Increased 12% Over the
Prior Quarter
- Closed on a $10.0 Million
Registered Direct Offering
- Received $4.7 Million of
Non-Dilutive Funding Through NJ Economic Development
Program
- Teleconference and Webcast to be held on February 15, 2023, at 11:00 AM ET
CRANBURY, N.J., Feb. 15,
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 second quarter ended December
31, 2022.
"We continue to execute on our strategy that the melanocortin
system is an important mechanism for the resolution of inflammation
and promotion of tissue repair," said Carl
Spana, Ph.D., President and CEO of Palatin. "We currently
have three active melanocortin-based clinical programs: our
MELODY-1 Phase 3 dry eye disease trial, a Phase 2 ulcerative
colitis trial, and a Phase 2 diabetic kidney disease trial, all
with data readouts throughout the next five calendar quarters."
Dr. Spana further commented, "We are pleased with Vyleesi's
continued quarter over quarter increases across all value metrics,
notably net product sales increased 18% and prescriptions dispensed
increased 12% over the prior quarter. We are excited that net
product revenue of approximately $1
million for the quarter ended December 31, 2022, exceeded Vyleesi operating
expenses."
Business Highlights and Recent Updates
- Anti-Inflammatory / Autoimmune Programs
-
- PL9643 melanocortin agonist for the treatment of dry eye
disease (DED)
-
- Patient enrollment on track.
- Topline data readout currently expected mid-calendar
year 2023.
- 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):
-
- First patient dosed in a Phase 2 oral formulation study of
PL8177 in patients with UC in the fourth quarter calendar year
2022.
- Interim assessment is currently expected to occur in the first
half of calendar year 2023.
- Topline data readout is currently expected
in the second half of calendar
year 2023.
- 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 initiated in the Phase 2 study in the first quarter
of calendar year 2023.
- Complete enrollment targeted for third quarter calendar year
2023.
- Topline results currently expected first quarter 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 second quarter ended December 31, 2022:
-
- Gross product sales were $2.6
million, an increase of 14% over the prior quarter, and an
increase of 238% over the comparable quarter last year.
- Net product revenue of $1 million
increased 18% over the prior quarter and increased 1,323% over the
comparable quarter last year.
- Total prescriptions dispensed increased 12% over the prior
quarter and increased 134% over the comparable quarter last
year.
- Refill rates, commercial insurance reimbursement, and net
revenue per prescription dispensed increased over the prior quarter
and comparable quarter last year.
- Patients and healthcare providers can learn more about HSDD and
Vyleesi
at www.vyleesi.com and www.vyleesipro.com.
- Other:
-
- The Company participated in the State
of New Jersey's Technology Business Tax Certificate Transfer
Program sponsored by The New Jersey Economic Development Authority.
The Program enables approved biotechnology companies with unused
Net Operating Losses ("NOLs") and unused research and development
credits ("R&D credits") to sell these tax benefits to
unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Company received
final approval in December 2022 for
the sale of NOLs and R&D credits that resulted in the receipt
of $4,674,999 in January 2023. As a result, the Company recorded
an income tax benefit for the three and six months ended
December 31, 2022, and a
corresponding receivable as of December 31,
2022.
- Registered Direct Offering: On October
31, 2022, Palatin entered into a securities purchase
agreement with an institutional investor, selling and issuing an
aggregate of (i) 1,020,000 shares of Palatin common stock,
$0.01 par value per share, (ii)
prefunded warrants (the "Pre-Funded Warrants") to purchase up to
798,182 shares of Palatin common stock, and (iii) common warrants
(the "Common Warrants") to purchase up to 1,818,182 shares of
Palatin common stock. Each share of common stock was offered with
one accompanying Common Warrant for a combined offering price of
$5.50. Each Pre-Funded Warrant was
offered with one accompanying Common Warrant for a combined
offering price of $5.4999. The
Offering was completed on November 2,
2022 with the Company receiving gross proceeds of
$10 million. The Common Warrants have
an exercise price of $5.83 per share,
are exercisable beginning six months after the date of issuance and
will expire five and one-half years from the date of issuance. The
Pre-Funded Warrants had an exercise price of $0.0001 per share and subsequent to December 31, 2022, the institutional investor
exercised all outstanding Pre-Funded Warrants to purchase 798,182
shares of Palatin's common stock.
Fiscal Second Quarter Ended December
31, 2022 Financial Results
Revenue
Total revenue consists of gross product sales of Vyleesi, net of
allowances and accruals, and license and contract revenue.
Vyleesi gross product sales to pharmacy distributors were
$2.6 million, with net product
revenue of $1,026,416, compared to
gross product sales of $0.8 million
and net product revenue of $72,140
for the comparable quarter last year. Gross product sales increased
238% and net product revenue increased 1,323% over the comparable
quarter last year.
For the quarter ended December 31,
2021, Palatin recognized $250,000 in license and contract revenue pursuant
to its license agreement with Fosun Pharma.
Operating Expenses
Total operating expenses were $6.6
million, compared to $8.8
million for the comparable quarter last year.
The decrease in operating expenses was mainly
the result of lower spending on our development
programs and the gain recognized as a result of amending certain
minimum purchase commitments.
Other Income / (Expenses)
Total other expense, net, consists mainly
of unrealized foreign
currency transaction losses of $693,231 and $234,078, respectively, for the quarters ended
December 31, 2022, and 2021.
Cash Flows
Palatin's net cash used in operations was $8.8
million, compared to net cash used in operations of $6.3 million for the same period last year. The
increase in net cash used in operations is mainly due to working
capital changes for the quarter ended December 31, 2022.
Net Loss
Palatin's net loss was $1.4 million, or
$(0.13) per basic and diluted common
share, compared to a net loss of $8.7
million, or $(0.91) per basic
and diluted common share for the comparable period last year.
The decrease in net loss over the comparable
quarter last year, was mainly due to the recognition of an income
tax benefit of $4.7 million, a
decrease in operating expenses of $2.2
million and an increase in net product revenue of
Vyleesi.
Cash Position
As of December 31, 2022, Palatin's
cash and cash equivalents were approximately $21.2 million plus $6.5
million of accounts and other receivables, compared to cash
and cash equivalents of $21.2 with
$2.0 million of accounts receivable
as of September 30, 2022, and
$29.9 million with $1.8 million of accounts receivable as of
June 30, 2022.
Based on its current operating plan, Palatin believes that
existing cash and cash equivalents and receivables will be
sufficient to fund currently anticipated operating expenses through
calendar year 2023.
Conference Call / Webcast
Palatin will host a conference call and audio
webcast on February 15, 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 928705. 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
47637. The webcast and telephone replay will be available through
March 1, 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, 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® and Vyleesi® are registered trademarks of
Palatin Technologies, Inc.
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Six Months Ended
December 31,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
Product revenue,
net
|
$ 1,026,416
|
|
$
72,140
|
|
$ 1,896,070
|
|
$
231,622
|
License and
contract
|
-
|
|
250,000
|
|
-
|
|
250,000
|
Total
revenues
|
1,026,416
|
|
322,140
|
|
1,896,070
|
|
481,622
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Cost of products
sold
|
98,707
|
|
29,171
|
|
185,203
|
|
83,104
|
Research and
development
|
4,367,538
|
|
5,426,397
|
|
10,394,569
|
|
8,911,161
|
Selling, general and
administrative
|
3,174,344
|
|
3,317,760
|
|
6,683,142
|
|
7,154,302
|
Gain on purchase
commitment
|
(1,027,322)
|
|
-
|
|
(1,027,322)
|
|
-
|
Total operating
expenses
|
6,613,267
|
|
8,773,328
|
|
16,235,592
|
|
16,148,567
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(5,586,851)
|
|
(8,451,188)
|
|
(14,339,522)
|
|
(15,666,945)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
|
|
Investment
income
|
186,473
|
|
1,563
|
|
274,962
|
|
2,973
|
Foreign currency
loss
|
(693,231)
|
|
(234,078)
|
|
(274,855)
|
|
(126,719)
|
Interest
expense
|
(5,487)
|
|
(2,773)
|
|
(15,089)
|
|
(8,404)
|
Total other income
(expense), net
|
(512,245)
|
|
(235,288)
|
|
(14,982)
|
|
(132,150)
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
(6,099,096)
|
|
(8,686,476)
|
|
(14,354,504)
|
|
(15,799,095)
|
Income tax
benefit
|
4,674,999
|
|
-
|
|
4,674,999
|
|
-
|
NET LOSS
|
$
(1,424,097)
|
|
$
(8,686,476)
|
|
$
(9,679,505)
|
|
$
(15,799,095)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.13)
|
|
$
(0.91)
|
|
$
(0.95)
|
|
$
(1.66)
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares
outstanding used in computing basic and diluted net
loss per common share
|
10,802,863
|
|
9,531,071
|
|
10,215,616
|
|
9,530,252
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated Balance
Sheets
|
(unaudited)
|
|
|
|
|
|
December 31,
2022
|
|
June 30,
2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
21,182,839
|
|
$
29,939,154
|
Accounts
receivable
|
1,806,990
|
|
1,780,020
|
Other
receivables
|
4,674,999
|
|
-
|
Inventories
|
759,268
|
|
944,471
|
Prepaid expenses and
other current assets
|
2,127,230
|
|
1,932,454
|
Total current
assets
|
30,551,326
|
|
34,596,099
|
|
|
|
|
Property and equipment,
net
|
674,567
|
|
539,314
|
Right-of-use assets -
operating leases
|
693,729
|
|
878,465
|
Other assets
|
56,916
|
|
56,916
|
Total assets
|
$
31,976,538
|
|
$
36,070,794
|
|
|
|
|
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
820,304
|
|
$ 3,157,617
|
Accrued
expenses
|
6,065,821
|
|
6,875,216
|
Short-term operating
lease liabilities
|
335,732
|
|
371,124
|
Short-term finance
lease liabilities
|
103,622
|
|
100,921
|
Other current
liabilities
|
4,094,600
|
|
5,754,986
|
Total current
liabilities
|
11,420,079
|
|
16,259,864
|
|
|
|
|
Long-term operating
lease liabilities
|
380,161
|
|
529,398
|
Long-term finance lease
liabilities
|
99,912
|
|
152,407
|
Other long-term
liabilities
|
3,732,800
|
|
2,861,250
|
Total
liabilities
|
15,632,952
|
|
19,802,919
|
|
|
|
|
Series B and Series C
Redeemable Convertible Preferred Stock of $0.01 par value:
authorized 9,000,000 shares, 9,000,000 shares issued and
outstanding 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 December 31, 2022: issued and
outstanding 4,030 shares
|
|
|
|
as of December 31, 2022
and June 30, 2022
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and outstanding
10,354,498 shares as of December 31, 2022 and 9,270,947 shares
as of June 30, 2022
|
103,545
|
|
92,709
|
Additional paid-in
capital
|
413,913,202
|
|
404,168,822
|
Accumulated
deficit
|
(397,673,201)
|
|
(387,993,696)
|
Total stockholders'
equity
|
16,343,586
|
|
16,267,875
|
Total liabilities,
redeemable convertible preferred stock, and stockholders'
equity
|
$
31,976,538
|
|
$
36,070,794
|
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SOURCE Palatin Technologies, Inc.