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| 8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Technologies, Inc. Reports Third Quarter
Fiscal Year 2020 Financial Results and Recent Business
Highlights
●
Dry Eye Disease Phase 2 Study Remains on Track – Data
Anticipated in 4Q20
●
$89 Million in Cash at March 31, 2020
●
Teleconference and Webcast to be held on May 12, 2020
CRANBURY, NJ – May 12, 2020 – Palatin Technologies,
Inc. (NYSE American: PTN), a specialized 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 third quarter
ended March 31, 2020.
Third Quarter Fiscal Year 2020 Financial Highlights
●
Net loss of $(5.4)
million, compared to $(5.7) million for the comparable quarter of
2019;
●
Operating expenses
of $5.7 million, compared to $5.8 million for the comparable
quarter of 2019;
●
Other income was
$331,007, compared to $35,648 for the comparable quarter of 2019;
and
Recent Business Highlights and Updates
●
Implemented
multiple measures in response to the COVID-19 pandemic to safeguard
the health and well-being of employees, their families, business
partners and healthcare providers, while continuing to advance the
Company’s programs;
●
A Phase 2 clinical
study with PL9643 for dry eye disease started in January 2020. Data
readout is targeted for the fourth quarter of calendar year
2020;
●
A Phase 2
proof-of-concept clinical study with an oral formulation of PL8177
in ulcerative colitis patients is delayed due to the pandemic and
is now targeted to start in the first half of calendar year 2021;
and
●
AMAG has stated
that they anticipate finalizing the divestiture of Vyleesi within
the next several months.
“The
entire Palatin team thanks healthcare workers across the nation for
their selfless efforts in the treatment and care of COVID-19
patients, and I would also like to thank all of our employees for
their dedication and commitment to ensure the advancement of our
development programs and clinical trial patient support,”
said Carl Spana Ph.D., President and CEO of
Palatin. “Although Palatin has experienced limited
adverse impact on operations from the pandemic, we are cognizant
there may be further disruptions to business activity based on a
resurgence of the virus and have taken steps to be as prepared as
possible for this potential outcome.”
Dr.
Spana further commented, “We continue to review AMAG’s
process related to the divestiture of Vyleesi and their obligations
under our license agreement and are prepared to take appropriate
steps to protect our rights and Vyleesi’s significant
value.”
-More-
Programs Overview
Anti-Inflammatory / Autoimmune Programs
A Phase 2 clinical study with PL9643 for dry eye disease started in
January 2020, and active patients continue treatment and monthly
clinic visits. Enrollment of additional cohorts has been delayed,
but we anticipate restarting enrollment in June 2020. Data readout
is targeted for the fourth quarter of calendar year
2020.
A Phase 2 proof-of-concept clinical study with an oral formulation
of PL8177 in ulcerative colitis patients is now targeted to start
in the first half of calendar year 2021, with data readout in the
first half of calendar year 2022.
The Company continues its assessment and development work related
to the treatment of patients with diabetic retinopathy, with an IND
targeted for mid-calendar year 2021.
The Company currently anticipates filing an IND and commencing
clinical trials with PL8177 for non-infectious uveitis, for which
FDA granted orphan drug designation, in the second half of calendar
year 2021.
Hypoactive Sexual Desire Disorder (“HSDD”) /
Vyleesi® (bremelanotide injection)
Due to the early commercial stage of Vyleesi and the sales and
marketing strategy of our North American licensee AMAG
Pharmaceuticals, Inc., including no charge for the first Vyleesi
prescription, AMAG has not generated positive net sales through
March 31, 2020. This has resulted in no royalties to Palatin during
this period.
Vyleesi
is the first as-needed treatment approved for premenopausal women
with acquired, generalized HSDD. AMAG launched Vyleesi nationally
in September 2019 through select specialty pharmacies with its
established women’s health sales force.
In
January 2020 AMAG announced that, as a result of a strategic
review, it will divest Vyleesi, which it exclusively licensed from
Palatin for North America. In May 2020 AMAG stated that it is in
negotiations regarding the divestiture of Vyleesi and will provide
an update within the next few months.
Palatin
continues to closely monitor AMAG’s process related to the
divestiture of Vyleesi and AMAG’s obligations under the
Vyleesi license agreement. Though sales of Vyleesi have been
adversely affected by the COVID-19 pandemic, the Company believes
that AMAG’s divestiture process has also adversely impacted
Vyleesi sales. Palatin is prepared to take appropriate steps to
protect its rights as the Vyleesi licensor and the significant
value of the Vyleesi program.
Palatin continues discussions on Vyleesi collaborations for
territories outside the currently licensed territories of North
America, China, and Korea, and anticipates executing multiple
agreements during the second half of calendar year 2020 and
calendar year 2021.
Natriuretic Peptide Receptor (“NPR”) System
Program
PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical
study in heart failure patients with preserved ejection fraction.
The proposed study is a collaboration with two major academic
medical centers and is supported by an American Heart Association
grant. The study is now anticipated to start patient enrollment in
the second half of calendar year 2020.
-More-
Genetic Obesity Program
Palatin’s melanocortin receptor 4 (MC4r) peptide PL8905 and
orally active small molecule PL9610 are currently under
investigation for the treatment of rare genetic metabolic and
obesity disorders. These programs are under internal evaluation for
orphan designations, potential development, and
licensing.
Third Quarter Fiscal Year 2020 Financial Results
Revenue
For the quarters ended March 31, 2020 and 2019, there were no
revenues recorded.
Operating Expenses
Total operating expenses for the quarter ended March 31, 2020 were
$5.7 million compared to $5.8 million for the comparable quarter of
2019. The decrease in operating expenses was mainly due to the
overall reduction in research and development expenses offset by an
increase in general and administrative expenses.
Other Income/Expense, net
Total other income, net, was $331,007 for the quarter ended March
31, 2020, compared to total other income, net, of $35,648 for the
quarter ended March 31, 2019. The difference is related primarily
to the increase in investment income.
Net Loss
Palatin reported a net loss of $(5.4) million, or $(0.02) per basic
and diluted share, for the quarter ended March 31, 2020, compared
to a net loss of $(5.7) million, or $(0.03) per basic and diluted
share, for the same period in 2019.
The difference in financial results between the three months ended
March 31, 2020 and 2019 was mainly attributable to the increase in
other income, net.
Cash Position
Palatin’s cash and cash equivalents were $88.9 million as of
March 31, 2020, compared to $91.5 million at December 31, 2019, and
cash, cash equivalents and accounts receivable of $103.8 million at
June 30, 2019.
Management believes that existing capital resources will be
adequate to fund the Company’s planned operations through at
least March 31, 2022.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on May 12,
2020 at 11:00 a.m. Eastern Time to discuss the results of
operations for the quarter ended March 31, 2020 in greater detail
and provide an update on corporate developments. Individuals
interested in listening to the conference call live can dial
1-888-204-4368 (US/Canada) or 1-323-994-2082 (international),
conference ID 8845359. 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 8845359. The webcast and telephone replay will be
available through May 19, 2020.
-More-
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a specialized 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 in order 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 clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates, AMAG’s plans to divest Vyleesi,
Palatin’s ongoing relationship with AMAG and ability to
protect its rights as the Vyleesi licensor, 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 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, transfer of
marketing and sale of Vyleesi in North America to another
pharmaceutical company, 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
|
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CFO/COO (609) 495-2200
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Managing Director (646) 597-6992
|
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Info@Palatin.com
|
Paul@LifeSciAdvisors.com
|
Vyleesi® is a registered trademark of AMAG Pharmaceuticals,
Inc. in North America and of Palatin Technologies, Inc. elsewhere
in the world.
###
(Financial Statement Data Follows)
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
(unaudited)
|
|
Three Months
Ended March 31,
|
Nine Months
Ended March 31,
|
||
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2020
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2019
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2020
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2019
|
|
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|
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REVENUES
|
|
|
|
|
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License and
contract
|
$-
|
$-
|
$117,989
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$34,505
|
|
|
|
|
|
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OPERATING
EXPENSES
|
|
|
|
|
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Research and
development
|
3,641,250
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3,943,982
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10,026,363
|
10,528,329
|
|
General and
administrative
|
2,072,032
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1,818,796
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6,308,567
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5,947,943
|
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Total operating
expenses
|
5,713,282
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5,762,778
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16,334,930
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16,476,272
|
|
|
|
|
|
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Loss from
operations
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(5,713,282)
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(5,762,778)
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(16,216,941)
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(16,441,767)
|
|
|
|
|
|
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OTHER INCOME
(EXPENSE)
|
|
|
|
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Investment
income
|
331,285
|
107,460
|
1,101,921
|
361,212
|
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Interest
expense
|
(278)
|
(71,812)
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(11,831)
|
(370,981)
|
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Total other income
(expense), net
|
331,007
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35,648
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1,090,090
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(9,769)
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|
|
|
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NET
LOSS
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$(5,382,275)
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$(5,727,130)
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$(15,126,851)
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$(16,451,536)
|
|
|
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|
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Basic and diluted
net loss per common share
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$(0.02)
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$(0.03)
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$(0.06)
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$(0.08)
|
|
|
|
|
|
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Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
235,322,087
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207,016,304
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234,449,813
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206,148,695
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PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Balance Sheets
(unaudited)
|
|
March
31,
2020
|
June
30,
2019
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ASSETS
|
|
|
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Current
assets:
|
|
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Cash and cash
equivalents
|
$88,947,368
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$43,510,422
|
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Accounts
receivable
|
-
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60,265,970
|
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Prepaid expenses
and other current assets
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675,443
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637,289
|
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Total current
assets
|
89,622,811
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104,413,681
|
|
|
|
|
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Property and
equipment, net
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153,660
|
141,539
|
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Right-of-use
assets
|
98,491
|
-
|
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Other
assets
|
179,916
|
179,916
|
|
Total
assets
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$90,054,878
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$104,735,136
|
|
|
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
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Current
liabilities:
|
|
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Accounts
payable
|
$1,612,164
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$504,787
|
|
Accrued
expenses
|
1,657,237
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2,848,692
|
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Notes payable, net
of discount
|
-
|
332,896
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Other current
liabilities
|
89,429
|
499,517
|
|
Total current
liabilities
|
3,358,830
|
4,185,892
|
|
|
|
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Other
liabilities
|
9,062
|
-
|
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Total
liabilities
|
3,367,892
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4,185,892
|
|
|
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Stockholders’
equity:
|
|
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Preferred stock of
$0.01 par value – authorized 10,000,000 shares; shares issued
and outstanding designated as follows:
|
|
|
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Series A
Convertible: authorized 264,000 shares: issued and outstanding
4,030 shares as of March 31, 2020 and June 30, 2019
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40
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40
|
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Common stock of
$0.01 par value – authorized 300,000,000 shares:
|
|
|
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issued and
outstanding 229,240,596 shares as of March 31, 2020 and 226,815,363
shares as of June 30, 2019
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2,292,406
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2,268,154
|
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Additional paid-in
capital
|
395,294,270
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394,053,929
|
|
Accumulated
deficit
|
(310,899,730)
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(295,772,879)
|
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Total
stockholders’ equity
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86,686,986
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100,549,244
|
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Total liabilities
and stockholders’ equity
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$90,054,878
|
$104,735,136
|