- Phase 3 Pivotal Study of PL9643 in Patients with Dry Eye
Disease Ongoing Positive Interim Analysis – DMC Recommended Study
Sample Size of 350 Patients Topline Results Currently Expected
Second Quarter Calendar 2023
- Vyleesi® - Gross product sales increased 79%, net product
revenue increased 257% and prescriptions dispensed increased 49%,
over the prior quarter
- Closed on a $15 Million
Private Placement of Redeemable Convertible Preferred
Stock
- Patient Recruitment Initiated in a Phase 2 Clinical Study of
Oral PL8177 in Patients with Ulcerative Colitis with an Interim
Analysis and Topline Results Currently Expected First Half Calendar
2023
- Teleconference and Webcast to be held on September 22, 2022, at 11:00 AM EDT
CRANBURY, N.J., Sept. 22,
2022 /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, 2022.
"We are excited to have two novel melanocortin receptor peptides
with differentiating product profiles progressing in clinical
trials - a Phase 3 pivotal study of PL9643 in patients with dry eye
disease, and a Phase 2 clinical study of oral PL8177 in patients
with ulcerative colitis," stated Carl
Spana, Ph.D., President and CEO of Palatin. "Topline results
from the Phase 3 study of PL9643 is currently expected in the
second quarter calendar of 2023, and the interim analysis and
topline results from the Phase 2 study of PL8177 currently expected
in the first half of 2023."
Dr. Spana further commented, "Vyleesi sales continue to grow,
with our June 30, 2022, quarter
showing significant increases across all value metrics, including
gross product sales, net product revenue, prescriptions dispensed,
refill rates, and commercial insurance reimbursement, compared to
the prior quarter and comparable quarter last year."
Financial Highlights for the
Fourth Quarter Ended June 30,
2022
- Net loss for the quarter ended June 30,
2022, was $12.8 million, or
$(1.34) per common share, compared to
a net loss of $13.9 million, or
$(1.47) per common share, for the
same period in 2021.
- As of June 30, 2022, the Company
had cash and cash equivalents of $29.9
million, compared to $37.7
million as of March 31, 2022
and $60.1 million as of June 30, 2021.
- Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire
Disorder (HSDD): Gross product sales increased 79%, net product
revenue increased 257% and prescriptions dispensed increased 49%,
over the prior quarter.
Business Highlights and Recent
Updates
- Anti-Inflammatory / Autoimmune Programs
-
- PL9643 melanocortin agonist for the treatment of dry eye
disease (DED)
-
- Positive interim analysis in ongoing Pivotal Phase 3 clinical
study in patients with DED.
-
- The independent data monitoring committee (DMC) performed their
assessment on the first 120 patients to complete the study and
based on their recommendation, Palatin plans to enroll up to an
additional 230 patients in the study for a final sample size of 350
patients.
- No safety concerns were identified by the DMC.
- Topline data readout expected in the second quarter of
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):
-
- Initiated patient recruitment in a Phase 2 oral formulation
study of PL8177 in patients with UC.
- Interim assessment is currently expected to occur in the first
quarter of calendar year 2023.
- Topline data readout is currently expected in the second
quarter of calendar year 2023.
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov/ via the
identifier NCT05466890.
- 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, 2022:
-
- Gross product sales increased 79% over the prior quarter,
increased 91% over the comparable quarter in 2021.
- Net product revenue increased 257% over the prior quarter,
increased 857% over the comparable quarter in 2021.
- Total prescriptions dispensed increased 49% over the prior
quarter, increased 54% compared to the comparable quarter in
2021.
- Refill rates, commercial insurance reimbursement, and net
revenue per prescription dispensed, increased over the prior
quarter and comparable quarter in 2021.
- Patients and healthcare providers can learn more about HSDD
and Vyleesi at www.vyleesi.com
and www.vyleesipro.com
- Other:
-
- Redeemable Convertible Preferred Stock: On May 11, 2022, Palatin entered into a securities
purchase agreement with institutional investors, selling and
issuing 8,100,000 shares of Series B Redeemable Convertible
Preferred Stock ("Series B Preferred Stock") and 900,000 shares of
Series C Redeemable Convertible Preferred Stock ("Series C
Preferred Stock"). Each share of Series B Preferred Stock and
Series C Preferred Stock had a purchase price of $1.67 and is convertible into Palatin common
stock at an initial conversion price of $11.25 per share. The investors in the Series B
Preferred Stock and Series C Preferred Stock also received warrants
to purchase up to 66,666 shares of common stock at an exercise
price of $12.50 per share, which expire 48 months following
issuance. Total gross proceeds from the offering, before deducting
offering expenses, is $15.0 million
which was deposited in, and is being held in, an escrow account as
of June 30, 2022, pending the
investors' election to redeem the shares for cash or in notes, or
convert the shares to common stock. The escrowed proceeds have been
presented as a deduction to Series B and C Redeemable Convertible
Preferred Stock on the Company's consolidated balance sheet at
June 30, 2022.
To the extent any shares of Series B Preferred Stock or Series C
Preferred Stock are converted to common shares or redeemed for
debt, the Company will use such net proceeds from this offering for
working capital and general corporate purposes. Additional
information regarding the securities described above and the terms
of the offering are included in Palatin's fiscal year ended
June 30, 2022 10-K filing with the
United States Securities and Exchange Commission.
- Reverse Stock Split: At Palatin's Annual Meeting of
Stockholders held on June 24, 2022,
the Company's stockholders approved the amendment to the Company's
Amended and Restated Certificate of Incorporation to effect a
reverse stock split of the Company's common stock. The Board of
Directors approved the implementation of a 1-for-25 reverse stock
split effective as of 5:00 p.m. Eastern
Time on August 30, 2022. The
reverse stock split reduced the number of shares of Palatin's
common stock outstanding from approximately 231,774,000 shares to
approximately 9,271,000 shares but did not change the authorized
number of shares of Common Stock, which remain at 300,000,000
shares of Common Stock. The Company's common stock continues to
trade on the NYSE American Stock Market under the symbol
"PTN."
Fourth Quarter and Fiscal Year
Ended June 30, 2022 Financial
Results
All share and per share amounts are presented on a
post-reverse-split basis, giving effect to the 1- for-25 reverse
stock split.
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 for the quarter
ended June 30, 2022, were $2.3 million,
with net product revenue of $770,738, compared
to gross product sales of $1.2 million,
with net product revenue of $80,504,
for the comparable quarter in 2021. Gross product
sales increased 91% and net product revenue
increased 857% over the comparable quarter in 2021.
Vyleesi gross product sales to pharmacy distributors for the
fiscal year ended June 30, 2022, were
$5.8 million, with net product
revenue of $1.2 million, compared to
gross product sales of $4.7 million,
with negative net product revenue of $283,286, for the fiscal year ended June 30, 2021. Gross product sales increased 23%
and net product revenue increased 530% over the fiscal year ended
June 30, 2021.
Palatin recognized $250,000 in
license and contract revenue for the fiscal year ended June 30, 2022, related
to our license agreement with Fosun, compared
to $94,689 for the quarter and fiscal year
ended June 30, 2021, related to our
license agreement with Kwangdong.
Operating
Expenses
Total operating expenses were $13.9
million for the quarters ended June
30, 2022 and 2021.
Total operating expenses for the fiscal year ended June 30, 2022, were $38.1
million, compared to $33.2
million for the fiscal year ended June 30, 2021.
The increase in operating expenses was the result of increased research
and development expenses primarily related to our ongoing
pivotal Phase 3 clinical trial of PL9643, offset by decreased
commercial expenses related to Vyleesi.
Other Income /
(Expenses)
Total other income, net, consist mainly
of unrealized foreign
currency transaction gains and losses, which
consisted of gains of $325,868 and
$389,868, respectively, for the
quarter and fiscal year ended June 30,
2022, compared to losses of $221,274 and $212,526, respectively, for the quarter and
fiscal year ended June 30, 2021.
Cash Flows
Palatin's net cash used in operations for the quarter
and fiscal year ended June 30, 2022,
was $7.7 million and $29.9
million, respectively, compared to net cash used in
operations of $8.5 million and
$22.6 million, respectively, for the
same periods in 2021. The increase in net cash used in operations
is mainly due to cash received in fiscal year ended June 30, 2021 related to our
Termination Agreement with AMAG Pharmaceuticals offset by a one-time negotiated payment of
approximately $7.0 million
in the quarter ended December
31, 2020 related to inventory purchase
commitments of Vyleesi and by increased operating expenses in
fiscal year ended June 30, 2022.
Net Loss
Palatin's net loss for the quarter
and fiscal year ended June 30, 2022,
was $12.8 million and $36.2 million, or $(1.34) and $(3.79)
per basic and diluted common share, respectively, compared to a net
loss of $13.9 million and
$33.6 million, or $(1.47) and $(3.55)
per basic and diluted common share, respectively, for the same
periods in 2021.
The decrease in net loss for the quarter
ended June 30, 2022 over the quarter
ended June 30, 2021, was mainly due to the increase
of net product revenue of Vyleesi. The increase in net loss for the
fiscal year ended June 30, 2022 over
the fiscal year ended June 30, 2021,
was mainly due to increased operating expenses offset by increased
Vyleesi total revenues.
Cash Position
As of June 30, 2022, Palatin's
cash and cash equivalents were $29.9
million with $1.8 million of
accounts receivable, compared to cash and cash equivalents of
$37.7 million with $0.8 million of accounts receivable as of
March 31, 2022, and $60.1 million of cash and cash equivalents
with $1.6 million of accounts receivable as of June 30, 2021.
The $29.9 million of cash and cash
equivalents at June 30, 2022, does
not include the $15 Million Private
Placement of Redeemable Convertible Preferred Stock. These funds
are being held in an escrow account, pending
the investors' election
to redeem the shares for cash or in notes,
or convert the shares to common stock.
Palatin's audited financial statements for the year ended June 30, 2022, 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 22, 2022 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 1-800-458- 4121
(US/Canada) or 1-313-209-6672 (International), conference ID 8655999. 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 8655999. The webcast and
telephone replay will be available through September
29, 2022.
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 highly potent, 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
June 30,
|
|
Year Ended June
30,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
770,738
|
|
$
80,504
|
|
$ 1,218,457
|
|
$
(283,286)
|
|
License and
contract
|
-
|
|
94,689
|
|
250,000
|
|
94,689
|
|
Total
revenues
|
770,738
|
|
175,193
|
|
1,468,457
|
|
(188,597)
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
Cost of products
sold
|
87,517
|
|
37,800
|
|
217,529
|
|
147,840
|
|
Research and
development
|
7,436,199
|
|
3,481,800
|
|
21,327,434
|
|
12,926,559
|
|
Selling, general and
administrative
|
6,348,112
|
|
5,950,339
|
|
16,511,942
|
|
17,336,913
|
|
Loss on license
termination agreement
|
-
|
|
4,407,987
|
|
-
|
|
2,784,192
|
|
Total operating
expenses
|
13,871,828
|
|
13,877,926
|
|
38,056,905
|
|
33,195,504
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(13,101,090)
|
|
(13,702,733)
|
|
(36,588,448)
|
|
(33,384,101)
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
|
|
|
Investment
income
|
25,863
|
|
3,803
|
|
29,963
|
|
23,572
|
|
Foreign currency gain
(loss)
|
325,868
|
|
(221,274)
|
|
389,868
|
|
(212,526)
|
|
Interest
expense
|
(18,259)
|
|
(14,080)
|
|
(29,682)
|
|
(23,440)
|
|
Total other income
(expense), net
|
333,472
|
|
(231,551)
|
|
390,149
|
|
(212,394)
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(12,767,618)
|
|
$
(13,934,284)
|
|
$
(36,198,299)
|
|
$
(33,596,495)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(1.34)
|
|
$
(1.47)
|
|
$
(3.79)
|
|
$
(3.55)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares outstanding used in computing basic and diluted
net loss per common share
|
9,543,762
|
|
9,481,910
|
|
9,543,762
|
|
9,466,004
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated Balance
Sheets
|
(unaudited)
|
|
|
|
|
|
June 30,
2022
|
|
June 30,
2021
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 29,939,154
|
|
$ 60,104,919
|
Accounts
receivable
|
1,780,020
|
|
1,580,443
|
Inventories
|
944,471
|
|
1,162,000
|
Prepaid expenses and
other current assets
|
1,932,454
|
|
3,059,679
|
Total current
assets
|
34,596,099
|
|
65,907,041
|
|
|
|
|
Property and equipment,
net
|
539,314
|
|
94,817
|
Right-of-use assets -
operating leases
|
878,465
|
|
1,237,813
|
Other assets
|
56,916
|
|
56,916
|
Total assets
|
$ 36,070,794
|
|
$ 67,296,587
|
|
|
|
|
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS'
EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
3,157,617
|
|
$
640,650
|
Accrued
expenses
|
6,875,216
|
|
5,797,378
|
Short-term operating
lease liabilities
|
371,124
|
|
351,853
|
Short-term finance
lease liabilities
|
100,921
|
|
-
|
Other current
liabilities
|
5,754,986
|
|
3,721,907
|
Total current
liabilities
|
16,259,864
|
|
10,511,788
|
|
|
|
|
Long-term operating
lease liabilities
|
529,398
|
|
900,520
|
Long-term finance lease
liabilities
|
152,407
|
|
-
|
Other long-term
liabilities
|
2,861,250
|
|
6,232,907
|
Total
liabilities
|
19,802,919
|
|
17,645,215
|
|
|
|
|
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, 2022: issued and outstanding
4,030 shares
|
|
|
|
as of June 30, 2022 and
June 30, 2021
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and outstanding
9,270,947 shares as of June 30, 2022 and 9,201,988 shares as of
June 30, 2021
|
92,709
|
|
92,020
|
Additional paid-in
capital
|
404,168,822
|
|
401,354,709
|
Accumulated
deficit
|
(387,993,696)
|
|
(351,795,397)
|
Total stockholders'
equity
|
16,267,875
|
|
49,651,372
|
Total liabilities,
redeemable convertible preferred stock, and stockholders'
equity
|
$ 36,070,794
|
|
$ 67,296,587
|
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SOURCE Palatin Technologies, Inc.