- Patient Enrollment on Track in Phase 3 Pivotal Study of
PL9643 in Patients with Dry Eye Disease with Topline Results
Currently Expected Second Half Calendar 2022
- Vyleesi® - Gross product sales increased 67%, net product
revenue increased 200% and prescriptions dispensed increased 20%,
over the prior quarter
- Closed on a $15 Million
Private Placement of Convertible Redeemable Preferred
Stock
- Phase 2 Clinical Study of PL8177 in Patients with
Ulcerative Colitis Expected to Start Next Month with Topline
Results Currently Expected First Quarter Calendar
2023
- Teleconference and Webcast to be held on May 17, 2022 at 11:00 AM
EDT
CRANBURY, N.J., May 17, 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 and
natriuretic peptide receptor systems, today announced results for
its fiscal third quarter ended March 31,
2022.
"Patient enrollment is on track for our lead programs, a Phase 3
pivotal study of PL9643 in patients with dry eye disease with
topline results currently expected in the second half of calendar
year 2022, and a Phase 2 clinical study of PL8177 in patients with
ulcerative colitis is expected to start next month with
topline results currently expected first quarter calendar 2023,"
stated Carl Spana, Ph.D., President
and CEO of Palatin. "Regarding Vyleesi, our March 31, 2022 quarter reflected increases across
all value metrics compared to the prior quarter, including gross
product sales, net product revenue, prescriptions dispensed, refill
rates, and commercial insurance reimbursement."
Dr. Spana further commented, "Our $15
million preferred stock offering addresses several
objectives. It puts us in an excellent position to effect a reverse
split of our common stock at our annual meeting of stockholders,
which will provide the Company with flexibility to fund future
product development and retain and attract talented employees,
price our common stock at a price per share reflective of the
development stage of Palatin, increase our investor and financing
options, and assuming the holders convert to either common stock or
debt, coupled with our strong cash position of approximately
$38 million at March 31, 2022, provide us with sufficient
operating cash runway through at least calendar 2023."
Third Quarter Ended Fiscal Year
2022 Financial Highlights
- Net loss for the quarter ended March 31,
2022, was $7.6 million, or
$(0.03) per common share, compared to
a net loss of $5.7 million, or
$(0.02) per common share, for the
same period in 2021.
- As of March 31, 2022, the Company
had cash and investments of $37.7
million, compared to $47.3
million as of December 31,
2021, and $60.1 million as of
June 30, 2021, and no debt.
- Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire
Disorder (HSDD): Gross product sales increased 67%, net product
revenue increased 200% and prescriptions increased 20%, over the
prior quarter.
Business Highlights and
Updates
•
Anti-Inflammatory / Autoimmune Programs
|
|
° PL9643 melanocortin
agonist for the treatment of
dry eye disease (DED):
|
|
|
- Pivotal Phase 3
clinical study in DED patients is ongoing. Topline data readout expected in the second half of
calendar year 2022.
|
|
|
- NDA submission
is targeted for the first half of calendar year
2024.
|
|
|
- Hosted Key Opinion
Leader webinar on DED.
|
|
|
- Spotlight
Presentation at the Eyecelerator@ASCRS 2022 conference in
Washington D.C. covering the role of melanocortins in the
treatment of ocular disease and Phase 2 study results with PL9643
for DED conducted.
|
|
|
- Presented posters at
the Association for Research in Vision and Ophthalmology (ARVO)
2022 Annual Conference highlighting Palatin's ocular
research and PL9643 Phase 2 clinical data.
|
|
° PL8177 melanocortin
agonist for the treatment of
ulcerative colitis (UC):
|
|
|
- Presented the
positive effects of PL8177 at the 2022 Crohn's and Colitis
Congress on treating UC in an animal disease model,
including genomic data characterizing the
anti-inflammatory effects
of melanocortin agonists.
|
|
|
- A Phase 2 oral
formulation study of PL8177 in UC is currently scheduled to
start in the first half of calendar year
2022. Topline data readout currently expected in the
first quarter of calendar year 2023.
|
|
• 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
March 31, 2022:
|
|
|
- Gross product sales
increased 67% over the prior quarter, decreased 27% over the
comparable quarter in 2021.
|
|
|
- Net product revenue
increased 200% over the prior quarter, increased 144% over the
comparable quarter in 2021.
|
|
|
- Total prescriptions
dispensed increased 20% over the prior quarter, flat 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: On May 11, 2022, Palatin entered into a securities
purchase agreement with institutional investors, selling and
issuing 8,100,000 shares of Series B Convertible Redeemable
Preferred Stock ("Series B Preferred Stock") and 900,000 shares of
Series C Convertible Redeemable 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 $0.45 per share. The investors in the Series B Preferred
Stock and Series C Preferred Stock also received warrants to
purchase up to 1,666,667 shares of common stock at an exercise
price of $0.50 per share, which expire 48 months following
issuance. Total gross proceeds from the offering, before deducting
offering expenses, is $15 million.
The Company expects to call a meeting of stockholders to seek
approval of, including, but not limited to, an amendment to its
certificate of incorporation authorizing a reverse stock split.
Holders of the Series B Preferred Stock and Series C Preferred
Stock are entitled to vote only on the reverse stock split and any
adjournment of the meeting relating to the reverse stock
split.
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 quarter ended March 31,
2022 10Q filing with the United States Securities and Exchange
Commission.
|
Third Fiscal Quarter Ended
March 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 for the
quarter ended March 31, 2022,
amounted to $1.3 million, with net
product revenue of $216,097, compared
to gross product sales of $1.8
million, with net product revenue of $88,741, for the comparable quarter in 2021.
Gross product sales decreased 27% and net product revenue increased
144% over the comparable quarter in 2021.
Operating
Expenses
Total operating expenses for the quarter ended March 31, 2022, were $8.0
million, compared to $6.6
million for the comparable quarter in 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 gains of $190,719 and
$753,750, respectively, for the
quarters ended March 31, 2022 and
2021.
Cash Flows
Palatin's net cash used in operations for the quarter ended
March 31, 2022, was $9.5 million, compared to net cash used in
operations of $3.5 million for the
same period in 2021. The increase in net cash used in operations is
mainly due to a $4.3 payment received
in March 2021 related to our
Termination Agreement with AMAG Pharmaceuticals, offset by
increased operating expenses.
Net Loss
Palatin's net loss for the quarter ended March 31, 2022, was $7.6
million, or $(0.03) per basic
and diluted common share compared to a net loss of $5.7 million, or $(0.02) per basic and diluted common share, for
the same period in 2021.
The increase in net loss for the quarter ended March 31, 2022 over the quarter ended
March 31, 2021, was mainly due to the
increase in operating expenses.
Cash Position
As of March 31, 2022, Palatin's
cash and cash equivalents were $37.7
million with $0.8 million of
accounts receivable, compared to cash and cash equivalents of
$47.3 million with $0.6 million of accounts receivable as of
December 31, 2021, and $60.1 million of cash and cash equivalents 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 along with the $15 million of proceeds raised from our recent
private placement of Preferred Stock, assuming conversion to common
stock or debt, will be sufficient to fund currently anticipated
operating expenses through at least calendar year 2023.
Conference Call /
Webcast
Palatin will host a conference call and audio webcast on
May 17, 2022 at 11:00 a.m. Eastern Time to discuss the quarter
ended March 31, 2022 results of
operations in greater detail and provide an update on corporate
developments. Individuals interested in listening to the conference
call live can dial 1-800-304-0389 (US/Canada) or 1-313-209-5140 (International),
conference ID 1376619. 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 1376619. The webcast and telephone replay
will be available through May 24,
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 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 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
March 31,
|
|
Nine Months Ended
March 31,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
216,097
|
|
$
88,741
|
|
$
447,719
|
|
$
(363,790)
|
|
License and
contract
|
-
|
|
-
|
|
250,000
|
|
-
|
|
Total
revenues
|
216,097
|
|
88,741
|
|
697,719
|
|
(363,790)
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
Cost of
products sold
|
46,908
|
|
55,440
|
|
130,012
|
|
110,040
|
|
Research and
development
|
4,980,074
|
|
2,509,490
|
|
13,891,235
|
|
9,444,759
|
|
Selling, general and
administrative
|
3,009,528
|
|
4,010,055
|
|
10,163,830
|
|
11,386,574
|
|
Gain on license
termination agreement
|
-
|
|
-
|
|
-
|
|
(1,623,795)
|
|
Total operating
expenses
|
8,036,510
|
|
6,574,985
|
|
24,185,077
|
|
19,317,578
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(7,820,413)
|
|
(6,486,244)
|
|
(23,487,358)
|
|
(19,681,368)
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
|
|
|
Investment
income
|
1,127
|
|
2,834
|
|
4,100
|
|
19,769
|
|
Foreign currency
gain
|
190,719
|
|
753,750
|
|
64,000
|
|
8,748
|
|
Interest
expense
|
(3,019)
|
|
-
|
|
(11,423)
|
|
(9,360)
|
|
Total other income,
net
|
188,827
|
|
756,584
|
|
56,677
|
|
19,157
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(7,631,586)
|
|
$
(5,729,660)
|
|
$
(23,430,681)
|
|
$
(19,662,211)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.03)
|
|
$
(0.02)
|
|
$
(0.10)
|
|
$
(0.08)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares outstanding used in computing basic and diluted
net loss per common share
|
238,805,370
|
|
236,832,283
|
|
238,444,206
|
|
236,525,514
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated Balance
Sheets
|
(unaudited)
|
|
|
|
|
|
March 31,
2022
|
|
June 30,
2021
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
37,719,531
|
|
$ 60,104,919
|
Accounts
receivable
|
790,005
|
|
1,580,443
|
Inventories
|
1,031,988
|
|
1,162,000
|
Prepaid expenses and
other current assets
|
2,704,886
|
|
3,059,679
|
Total current
assets
|
42,246,410
|
|
65,907,041
|
|
|
|
|
Property and equipment,
net
|
544,622
|
|
94,817
|
Right-of-use assets -
operating leases
|
968,957
|
|
1,237,813
|
Other assets
|
56,916
|
|
56,916
|
Total assets
|
$
43,816,905
|
|
$ 67,296,587
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
2,402,739
|
|
$
640,650
|
Accrued
expenses
|
3,175,414
|
|
5,797,378
|
Short-term operating
lease liabilities
|
367,478
|
|
351,853
|
Short-term finance
lease liabilities
|
99,602
|
|
-
|
Other current
liabilities
|
5,931,414
|
|
3,721,907
|
Total current
liabilities
|
11,976,647
|
|
10,511,788
|
|
|
|
|
Long-term operating
lease liabilities
|
621,660
|
|
900,520
|
Long-term finance lease
liabilities
|
178,139
|
|
-
|
Other long-term
liabilities
|
2,955,000
|
|
6,232,907
|
Total
liabilities
|
15,731,446
|
|
17,645,215
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares; issued and
outstanding designated as follows:
|
|
|
|
Series A Convertible:
authorized 264,000 shares: issued and outstanding 4,030 shares as
of March 31, 2022 and June 30, 2021
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and outstanding
231,773,670 shares as of March 31, 2022 and 230,049,691 shares as
of June 30, 2021
|
2,317,737
|
|
2,300,497
|
Additional paid-in
capital
|
400,993,760
|
|
399,146,232
|
Accumulated
deficit
|
(375,226,078)
|
|
(351,795,397)
|
Total stockholders'
equity
|
28,085,459
|
|
49,651,372
|
Total liabilities and
stockholders' equity
|
$
43,816,905
|
|
$ 67,296,587
|
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SOURCE Palatin Technologies, Inc.