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8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Reports Financial Results for the Third Fiscal Quarter of
2021 and Provides Corporate Update
●
Phase 3 Clinical Study of PL9643 in Patients with Dry Eye Disease
Planned for Second Half Calendar 2021
●
Phase 2 Clinical Study of PL8177 in Patients with Ulcerative
Colitis Planned for Second Half Calendar 2021
●
Vyleesi Gross Product Sales Up 89%, Net Revenue Up 154%,
Prescriptions Increased 24% Compared to Prior Quarter
●
$68.6 Million in Cash and Cash Equivalents as of March 31,
2021
●
Teleconference and Webcast to be Held Today at 11:00 AM
ET
CRANBURY, NJ – May 17, 2021 – Palatin (NYSE American:
PTN), a biopharmaceutical company developing first-in-class
medicines based on molecules that modulate the activity of the
melanocortin peptide receptor system, today announced results for
its third fiscal quarter ended March 31, 2021.
“I am excited with Palatin’s evolution
and development advancements utilizing our proprietary melanocortin
agonists to treat patients with inflammatory and autoimmune
conditions,” stated Carl Spana, Ph.D., President and CEO
of Palatin. “We are hosting a KOL webinar on May
21st
to introduce our growing portfolio of
melanocortin agonists to treat the harmful effects of inflammation
in the eye. On the clinical front, we are targeting to commence a
Phase 3 trial of PL9643 in patients with dry eye disease in the
second half of calendar year 2021. The emerging profile of PL9643,
with its rapid therapeutic onset and excellent tolerability
profile, is a potentially distinct advantage over commercially
available dry eye therapies. In addition, we are targeting to
commence a Phase 2 study with an oral formulation of PL8177 in
ulcerative colitis patients in the second half of calendar year
2021.”
“I am also pleased with the progress we have made with the
Vyleesi program,” continued Spana. “Our quarter ended
March 31, 2021 reflected significant increases in gross sales, net
sales, prescriptions, and insurance coverage over the prior
quarter.”
Business Highlights and Updates
●
Anti-Inflammatory / Autoimmune Programs
-
PL9643
for the treatment of dry eye disease (DED):
■
Announced
positive results from its Phase 2 clinical study reflecting
statistically significant improvements in multiple signs and
symptoms in the moderate to severe patient population after 2 weeks
of dosing and at the 12-week visit. There were no safety signals
identified and PL9643 had excellent ocular
tolerability.
■
A
Phase 3 clinical trial is currently planned for the second half of
calendar year 2021, with data readout potentially in the first half
of calendar year 2022.
■
Presented
two presentations of the Company’s melanocortin platform,
including Phase 2 clinical trial results for PL9643 in dry eye
disease and preclinical data in retinal disease, at the Association
for Research in Vision and Ophthalmology (ARVO) 2021 Annual
Meeting, held virtually May 1-7, 2021.
-
PL8177
for the treatment of ulcerative colitis:
■
A
Phase 2 proof-of-concept clinical study with an oral formulation of
PL8177 in ulcerative colitis patients is targeted to start second
half of calendar year 2021, with data readout potentially in
mid-calendar year 2022.
-
Key
Opinion Leader webinar planned for May 21, 2021 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:
■
Introduces
the Company’s growing portfolio of melanocortin agonists to
treat the harmful effects of inflammation in the eye.
●
Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire
Disorder (HSDD)
-
Quarter
ended March 31, 2021 gross product sales increased 89%, net revenue
increased 154%, and prescriptions increased 24%, over the prior
quarter ended December 31, 2020.
-
Geo-targeted
marketing efforts expected to drive healthcare provider and
consumer engagement. The current digital campaign applications
reach thousands of healthcare providers and millions of
premenopausal women monthly and has resulted in increased website
and telemedicine traffic and conversions.
-
The
Company continues to focus on expanding access and reimbursement
coverage. The Company estimates that it has achieved approximately
75% of commercially insured lives and approximately 50% of
commercial formulary coverage, including two of the three major
pharmacy benefit managers and numerous regional plans.
-
Prescription
increases and expanding access and reimbursement coverage have
resulted in more favorable gross-to-net adjustments and positive
quarterly net product revenue for the first time.
-
Palatin
has filed an election to extend the patent term of U.S. patent
6,794,489 to June 26, 2025. This Vyleesi patent has claims to the
bremelanotide composition of matter as well as methods for
stimulating sexual response.
Third Quarter 2021 Results
Total net revenues, consisting of net product revenues of Vyleesi,
were $88,741. There was no revenue reported for the third quarter
of 2020.
-
Vyleesi
gross sales amounted to $1,780,020, with net product revenue of
$88,741, net of allowances and accruals, compared to gross sales
for the prior quarter ended December 31, 2020 of $943,950, with net
product revenue of $(163,971), net of allowances and
accruals.
Total operating expenses were $6.6 million, compared to $5.7
million for the same period in 2020. The increase was mainly due to
commercial expenses related to Vyleesi.
Palatin’s net loss was $(5.7) million, or $(0.02) per share,
compared to a net loss of $(5.4) million, or $(0.02) per share, for
the comparable quarter of 2020.
As of March 31, 2021, the Company had $68.6 million in cash and
cash equivalents and $1.9 million in accounts receivable, compared
to $82.9 million in cash and cash equivalents and no accounts
receivable as of June 30, 2020, with no outstanding
debt.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on May 17,
2021 at 11:00 a.m. Eastern Time to discuss the quarter ended March 31, 2021 results of
operations in greater detail and provide an update on corporate
developments. Individuals interested in listening to the conference
call live can dial 1-866-248-8441 (US/Canada) or 1-856-344-9206
(international), conference ID 6765353 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 6765353.
The webcast and telephone replay will be available through May 24,
2021.
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.
Investor Inquiries:
|
Media Inquiries:
|
Stephen T. Wills, CPA, MST
|
Paul
Arndt, MBA, LifeSci Advisors
|
CFO/COO (609) 495-2200
|
Managing Director (646) 597-6992
|
Info@Palatin.com
|
Paul@LifeSciAdvisors.com
|
Vyleesi® is a registered trademark of Palatin.
PALATIN TECHNOLOGIES, INC.
|
and Subsidiary
|
Consolidated Statements of Operations
|
(unaudited)
|
|
Three Months
Ended March 31,
|
Nine Months
Ended March 31,
|
||
|
2021
|
2020
|
2021
|
2020
|
|
|
|
|
|
REVENUES
|
|
|
|
|
Product revenue,
net
|
$88,741
|
$-
|
$(363,790)
|
$-
|
License and
contract
|
-
|
-
|
-
|
117,989
|
|
88,741
|
-
|
(363,790)
|
117,989
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Cost of products
sold
|
55,440
|
-
|
110,040
|
-
|
Research and
development
|
2,509,490
|
3,641,250
|
9,444,759
|
10,026,363
|
Selling, general
and administrative
|
4,010,055
|
2,072,032
|
11,386,574
|
6,308,567
|
Gain on license
termination agreement
|
-
|
-
|
(1,623,795)
|
-
|
Total operating
expenses
|
6,574,985
|
5,713,282
|
19,317,578
|
16,334,930
|
|
|
|
|
|
Loss from
operations
|
(6,486,244)
|
(5,713,282)
|
(19,681,368)
|
(16,216,941)
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
Investment
income
|
2,834
|
331,285
|
19,769
|
1,101,921
|
Foreign currency
gain
|
753,750
|
-
|
8,748
|
-
|
Interest
expense
|
-
|
(278)
|
(9,360)
|
(11,831)
|
Total other income
(expense), net
|
756,584
|
331,007
|
19,157
|
1,090,090
|
NET
LOSS
|
$(5,729,660)
|
$(5,382,275)
|
$(19,662,211)
|
$(15,126,851)
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.02)
|
$(0.02)
|
$(0.08)
|
$(0.06)
|
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
236,832,283
|
235,322,087
|
236,525,514
|
234,449,813
|
PALATIN TECHNOLOGIES, INC.
|
and Subsidiary
|
Consolidated Balance Sheets
|
(unaudited)
|
|
March
31,
2021
|
June
30,
2020
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$68,641,312
|
$82,852,270
|
Accounts
receivable
|
1,869,120
|
-
|
Inventories
|
6,114,718
|
-
|
Prepaid expenses
and other current assets
|
2,760,242
|
738,216
|
Total current
assets
|
79,385,392
|
83,590,486
|
|
|
|
Property and
equipment, net
|
107,376
|
140,216
|
Right-of-use
assets
|
1,322,326
|
1,266,132
|
Other
assets
|
56,916
|
56,916
|
Total
assets
|
$80,872,010
|
$85,053,750
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
Current
liabilities:
|
|
|
Accounts
payable
|
$864,012
|
$715,672
|
Accrued
expenses
|
5,197,759
|
2,899,097
|
Short-term
operating lease liabilities
|
347,070
|
312,784
|
Other current
liabilities
|
3,628,000
|
-
|
Total current
liabilities
|
10,036,841
|
3,927,553
|
|
|
|
Long-term operating
lease liabilities
|
986,175
|
953,348
|
Other long-term
liabilities
|
6,972,832
|
-
|
Total
liabilities
|
17,995,848
|
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 March 31, 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 March 31, 2021 and 229,258,400
shares as of June 30, 2020
|
2,300,497
|
2,292,584
|
Additional paid-in
capital
|
398,436,738
|
396,079,127
|
Accumulated
deficit
|
(337,861,113)
|
(318,198,902)
|
Total
stockholders’ equity
|
62,876,162
|
80,172,849
|
Total liabilities
and stockholders’ equity
|
$80,872,010
|
$85,053,750
|