CRANBURY, N.J., Sept. 29, 2021 /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 peptide receptor systems,
today announced results for its fourth quarter and fiscal year
ended June 30, 2021.
"During the past year, we worked diligently advancing our lead
investigational compound PL9643 through a successful Phase 2
clinical trial, towards a pivotal Phase 3 clinical trial for the
treatment of dry eye disease, currently one of the largest markets
in ophthalmology," stated Carl Spana, Ph.D., President and CEO
of Palatin. "We believe that, if approved, PL9643's quick onset of
efficacy, favorable tolerability, and safety profile has the
potential to be a first-line therapy for the millions of
individuals suffering from DED."
Dr. Spana further commented, "Our strong cash position of
$60.1 million at June 30, 2021, provides us with a sufficient
operating cash runway through calendar year 2022, allowing us to
advance our novel melanocortin-based programs, including top-line
data readouts for our Phase 3 DED clinical trial and our PL8177
Phase 2 clinical trial for ulcerative colitis in the second half of
calendar year 2022."
Recent Highlights and Upcoming Events
- Anti-Inflammatory / Autoimmune Programs
-
- PL9643 melanocortin agonist for the treatment of dry eye
disease (DED):
-
- Announced the completion of its End-of-Phase 2 (EOP2) meeting
with the Food and Drug Administration (FDA). The EOP2 meeting
included all aspects of PL9643's development plan, with the FDA and
Palatin reaching agreement on all key elements of a pivotal Phase 3
clinical program, including study design, endpoints, interim
assessment, and patient population. In addition, a potential second
Phase 3 study and long-term safety study were discussed to support
a New Drug Application (NDA).
- Palatin remains on track to initiate the Phase 3 program in DED
patients during the fourth quarter of calendar year 2021, with data
readout expected in the second half of calendar year 2022.
- Presented Phase 2 clinical trial results for PL9643 in DED at
the American Society of Cataract and Refractive Surgery Annual
Meeting.
- Presented Phase 2 clinical trial results for PL9643 in DED and
preclinical data in retinal disease, at the Association for
Research in Vision and Ophthalmology (ARVO) 2021 Annual
Meeting.
- PL8177 melanocortin agonist for the treatment of ulcerative
colitis:
-
- A Phase 2 oral formulation study of PL8177 in ulcerative
colitis is currently scheduled to start the fourth quarter of
calendar year 2021, with data readout expected in the second half
of calendar year 2022.
- Two featured speaker presentations on Vyleesi and two poster
presentations of PL9643 and PL8177 at the TIDES USA hybrid conference.
- Hosted a Key Opinion Leader webinar 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. Introduced the Company's growing portfolio of
melanocortin agonists to treat the harmful effects of inflammation
in the eye.
- Presenting the protective effects of PL8331 and PL9654 in mouse
models of retinopathy, scheduled at the 2021 Annual Meeting of the
American Society of Retina Specialists (ASRS), being held
October 8-12, 2021.
- Senior Leadership Additions – Appointed Michael B. Raizman, M.D. as Chief Medical
Officer; James E. Hattersley as
Senior Vice President of Business Development; and, J. Don Wang, Ph.D. as Vice President of Product
Development.
- Vyleesi® (bremelanotide injection) / Hypoactive Sexual
Desire Disorder (HSDD). Palatin's goal with the Vyleesi program
is to demonstrate value in the marketplace by increasing HCP
awareness, patient engagement, and market access, with an objective
of re-licensing the U.S. rights to a committed women's healthcare
company.
-
- For the quarter ended June 30,
2021:
-
- Gross product sales increased 28%, net revenue increased 149%,
and total prescriptions increased 17%, over the quarter ended
December 31, 2020 (Palatin's first
full quarter of Vyleesi operations).
- Gross product sales decreased 32%, net revenue decreased 9%,
and total prescriptions decreased 5%, over the prior quarter ended
March 31, 2021.
- Refill rates increased over the quarters ended December 31, 2020, and March 31, 2021.
- Market access and reimbursement coverage increased over the
quarters ended December 31, 2020, and
March 31, 2021.
- Patients and healthcare providers can learn more about HSDD and
Vyleesi at www.vyleesi.com.
Fourth Quarter and Fiscal Year Ended 2021 Financial
Results
Revenue
Total net revenues consist of net product revenues of Vyleesi
and license and contract revenue.
Vyleesi gross sales for the quarter and year ended June 30, 2021, amounted to $1.2 million and $4.7
million, respectively, with net product revenue, net of
allowances and accruals, of $80,504
and ($283,286), respectively. Palatin
recognized no product revenues for the quarter and year ended
June 30, 2020.
Palatin recognized $94,689 in the
license and contract revenue for the quarter and year ended
June 30, 2021, related to our license
agreement with Kwangdong, compared to $117,989 for the year ended June 30, 2020, related to our license agreement
with AMAG Pharmaceuticals.
Operating Expenses
Total operating expenses for the quarter and year ended
June 30, 2021, were $13.9 million and $33.2
million, respectively, compared to $7.4 million and $23.7
million, respectively, for the same periods of
2020.
The increase in operating expenses for 2021 was primarily due to
the recognition of non-cash expenses on the Vyleesi license
termination agreement and the increase in selling, general and
administrative expenses, offset by a decrease in research and
development expenses.
Other Income/Expense, net
Total other expense, net, for the quarter and year ended
June 30, 2021, was $231,551 and $212,394, respectively, compared to total other
income, net of $90,667 and
$1.2 million, respectively, for the
same periods in 2020.
The differences are related primarily to the decrease in
investment income and secondarily to the recognition of foreign
currency losses.
Cash Flows
Palatin's net cash used in operations for the quarter and year
ended June 30, 2021, was $8.5 million and $22.6
million, respectively, compared to net cash used in
operations of $6.1 million and net
cash provided by operations of $41.3
million, respectively, for the same periods in 2020.
Net Loss
Palatin's net loss for the quarter and year ended June 30, 2021, was $13.9
million and $33.6 million, or
$0.06 and $0.14 per basic and diluted common share,
respectively, compared to a net loss of $7.3
million and $22.4 million, or
$0.03 and $0.10 per basic and diluted common share,
respectively, for the same periods in 2020.
The difference between the quarter and year ended June 30, 2021, and 2020, was primarily due to an
increase in selling, general and administrative expenses pursuant
to Palatin's reacquisition of all development and commercialization
rights to Vyleesi in North America
in July 2020, and secondarily,
related to the recognition of a non-cash loss on the Vyleesi
license termination agreement.
Cash Position
As of June 30, 2021, Palatin's
cash and cash equivalents were $60.1
million with $1.6 million of
accounts receivable, compared to cash and cash equivalents of
$82.9 million with no accounts
receivable, as of June 30, 2020.
Based on its current operating plan, Palatin believes that existing
cash and cash equivalents will be sufficient to fund currently
anticipated operating expenses through the end of calendar year
2022.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on
September 29, 2021, 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 1-800-437-2398 (US/Canada) or 1-856-344-9206 (international),
conference ID 3395813. 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 3395813. The webcast and
telephone replay will be available through October 6, 2021.
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, like 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.
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.
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Year Ended June
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
80,504
|
|
$
-
|
|
$
(283,286)
|
|
$
-
|
License and
contract
|
94,689
|
|
-
|
|
94,689
|
|
117,989
|
|
175,193
|
|
-
|
|
(188,597)
|
|
117,989
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Cost of products
sold
|
37,800
|
|
-
|
|
147,840
|
|
-
|
Research and
development
|
3,481,800
|
|
3,933,034
|
|
12,926,559
|
|
13,959,397
|
Selling, general and
administrative
|
5,950,339
|
|
3,456,805
|
|
17,336,913
|
|
9,765,372
|
Loss on license
termination agreement
|
4,407,987
|
|
-
|
|
2,784,192
|
|
-
|
Total operating
expenses
|
13,877,926
|
|
7,389,839
|
|
33,195,504
|
|
23,724,769
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(13,702,733)
|
|
(7,389,839)
|
|
(33,384,101)
|
|
(23,606,780)
|
|
|
|
|
|
|
|
|
OTHER (EXPENSE)
INCOME
|
|
|
|
|
|
|
|
Investment
income
|
3,803
|
|
98,977
|
|
23,572
|
|
1,200,898
|
Foreign currency
loss
|
(221,274)
|
|
-
|
|
(212,526)
|
|
-
|
Interest
expense
|
(14,080)
|
|
(8,310)
|
|
(23,440)
|
|
(20,141)
|
Total other (expense)
income, net
|
(231,551)
|
|
90,667
|
|
(212,394)
|
|
1,180,757
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(13,934,284)
|
|
$
(7,299,172)
|
|
$
(33,596,495)
|
|
$
(22,426,023)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.06)
|
|
$
(0.03)
|
|
$
(0.14)
|
|
$
(0.10)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding used in computing basic and diluted net
loss per common share
|
237,025,231
|
|
235,394,831
|
|
236,650,101
|
|
234,684,776
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
|
|
|
|
June 30,
2021
|
|
June 30,
2020
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
60,104,919
|
|
$
82,852,270
|
Accounts
receivable
|
1,580,443
|
|
-
|
Inventories
|
1,162,000
|
|
-
|
Prepaid expenses and
other current assets
|
3,059,679
|
|
738,216
|
Total current
assets
|
65,907,041
|
|
83,590,486
|
|
|
|
|
Property and
equipment, net
|
94,817
|
|
140,216
|
Right-of-use
assets
|
1,237,813
|
|
1,266,132
|
Other
assets
|
56,916
|
|
56,916
|
Total
assets
|
$
67,296,587
|
|
$
85,053,750
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
640,650
|
|
$
715,672
|
Accrued
expenses
|
5,797,378
|
|
2,899,097
|
Short-term operating
lease liabilities
|
351,853
|
|
312,784
|
Other current
liabilities
|
3,721,907
|
|
-
|
Total current
liabilities
|
10,511,788
|
|
3,927,553
|
|
|
|
|
Long-term operating
lease liabilities
|
900,520
|
|
953,348
|
Other long-term
liabilities
|
6,232,907
|
|
-
|
Total
liabilities
|
17,645,215
|
|
4,880,901
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares
issued and outstanding designated as follows:
|
|
|
|
Series A Convertible:
authorized 264,000 shares: issued and outstanding
4,030 shares as of June 30, 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 June 30, 2021 and
229,258,400 shares as of June 30, 2020
|
2,300,497
|
|
2,292,584
|
Additional paid-in
capital
|
399,146,232
|
|
396,079,127
|
Accumulated
deficit
|
(351,795,397)
|
|
(318,198,902)
|
Total stockholders'
equity
|
49,651,372
|
|
80,172,849
|
Total liabilities and
stockholders' equity
|
$
67,296,587
|
|
$
85,053,750
|
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SOURCE Palatin Technologies, Inc.