- Phase 3 PL9643 Data in Patients with Dry Eye Disease
Presented at KOL Event
-
- Analysis of Lead-In Population of Initial 120 Patients
Showed Statistical Separation for Clinical Efficacy Across
Multiple Signs and Symptoms of Dry Eye along with Excellent Patient
Safety and Tolerability
- Final Data Expected Second Half Calendar Year 2023
- Phase 2 Clinical Study of Oral PL8177 in Patients with
Ulcerative Colitis
-
- Interim Analysis Targeted for Second Half Calendar Year
2023
- Topline Results Currently Expected First Half Calendar Year
2024
- Vyleesi®
-
- Net Product Revenue Increased 16% Over the Prior
Quarter
- Prescriptions Dispensed Increased 27% Over the Prior
Quarter
- 5 Consecutive Quarters of Double-Digit Growth
- Received $4.7 Million of
Non-Dilutive Funding Through NJ Economic Development
Program
- Teleconference and Webcast to be held on May 16, 2023, at 11:00 AM
ET
CRANBURY, N.J., May 16, 2023
/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
third quarter ended March 31,
2023.
"On the development front, we are excited that the analysis of
the data for the Lead-In population of the initial 120 patients in
our Phase 3 PL9643 clinical study demonstrated statistically
significant positive effects on multiple endpoints for both signs
and symptoms, including excellent patient safety and tolerability,"
said Carl Spana, Ph.D., President
and CEO of Palatin. "On the commercial front, we are pleased with
Vyleesi's fifth consecutive quarter of double-digit growth in net
product revenue and dispenses. We are particularly pleased that
Vyleesi's quarterly net product revenue exceeds Vyleesi quarterly
operating expenses."
Business Highlights and Recent Updates
- Anti-Inflammatory / Autoimmune Programs
-
- PL9643 melanocortin agonist for the treatment of dry eye
disease (DED)
-
- Review of Phase 3 clinical study data in patients with DED at
Key Opinion Leader (KOL) Event.
-
- Analysis of Lead-In population of initial 120 patients
completing 12 weeks of treatment showed statistical separation for
clinical efficacy across multiple signs and symptoms of dry eye
along with excellent patient safety and tolerability.
- Presented initial Phase 3 clinical data at the Association of
Research in Vision and Ophthalmology (ARVO) 2023 Annual
Conference.
-
- Data demonstrated positive effects on signs and symptoms.
- Consistent clinical efficacy across multiple signs and symptoms
of dry eye along with excellent safety and tolerability - a
differentiating product profile.
- Pivotal Phase 3 clinical study patient enrollment
continuing.
-
- Final data currently expected second half 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):
-
- Interim assessment is currently expected to occur in the second
half of calendar year 2023.
- Topline results currently
expected in the first half of calendar
year 2024.
- Digestive Disease Week Annual Conference.
-
- Preclinical data shows PL8177 was found to be efficacious in
animal models of inflammatory bowel disease.
- Clinical data confirms PL8177 oral formulation is delivered and
contained in the colon.
- Frontiers in Immunology published a preclinical
study demonstrating oral PL8177 provides therapeutic effects in
inflammatory bowel disease and pharmacokinetic data showing PL8177
remains restricted to the gut.
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov/ via the
identifier NCT05466890.
- Bremelanotide BREAKOUT study (BMT 701) in patients with
diabetic kidney disease:
-
- Enrollment is currently expected to be completed in the second
half of calendar year 2023.
- Topline results currently expected first half of calendar year
2024.
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov/ via the
identifier NCT05709444.
- Preclinical data on melanocortin agonist PL8331 demonstrating
therapeutic effects in diabetic retinopathy and uveitis published
in the International Journal of Molecular Sciences.
-
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 third quarter ended March
31, 2023:
-
- Gross product sales were $3.4
million, an increase of 31% over the prior quarter, and an
increase of 165% over the comparable quarter last year.
- Net product revenue of $1.2
million increased 16% over the prior quarter and increased
453% over the comparable quarter last year.
- Total prescriptions dispensed increased 27% over the prior
quarter and increased 147% over the comparable quarter last
year.
- Refill rates, commercial insurance reimbursement, and net
revenue per prescription dispensed continued with positive and
impactful results and trends, versus the prior quarter and
comparable quarter last year.
- Issued a patent, titled "Use of Bremelanotide in Patients with
Controlled Hypertension" with a term through April 29, 2041.
- Patients and healthcare providers can learn more about HSDD and
Vyleesi
at www.vyleesi.com and www.vyleesipro.com.
- Other:
-
- Palatin received $4.7 million in
January 2023 from the State of New Jersey's Technology Business Tax
Certificate Transfer Program sponsored by The New Jersey Economic
Development Authority.
Fiscal Third Quarter Ended March 31,
2023 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 were $3.4 million,
with net product revenue of $1.2
million, compared to gross product sales of $1.3
million and net product revenue of $0.2
million for the comparable quarter last year. Gross product
sales increased 165% and net product revenue
increased 453% over the comparable quarter last
year.
Operating Expenses
Total operating expenses were
$8.5 million, compared to
$8.0 million for the comparable
quarter last year. The increase
in operating expenses was mainly
the result of higher spending on our marketing
efforts of Vyleesi.
Cash
Flows
Palatin's net cash used in operations was $1.4
million, compared to net cash used in operations of $9.5 million for the same period last year. The
decrease in net cash used in operations is mainly due to the
Company's receipt of proceeds from the sale of the State of New
Jersey NOLs and working capital changes for the quarter ended
March 31, 2023.
Net
Loss
Palatin's net loss was $7.1 million,
or $(0.63) per basic and diluted
common share, compared to a net loss of $7.6
million, or $(0.80) per basic
and diluted common share for the comparable quarter last year.
The decrease in net loss over the comparable
quarter last year, was mainly due to an increase in net product
revenue of Vyleesi of $1.0 million
offset by an increase in operating expenses of $0.5 million.
Cash Position
As of March 31,
2023, Palatin's cash and cash equivalents were approximately
$19.6 million plus $1.7 million of accounts receivables, compared to
cash and cash equivalents of $21.2
million with $6.5 million of
accounts and other receivables as of December 31, 2022, and $29.9 million with $1.8
million of accounts receivable as of June 30, 2022.
Based on its current operating plan, the Company believes that
existing cash and cash equivalents and receivables will be
sufficient to fund currently anticipated operating expenses through
calendar year 2023.
Conference Call /
Webcast
Palatin will host a conference call and audio
webcast on May 16, 2023, 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
1-888-506-0062 (US) or 1-973-528-0011 (International), participant
access code 555988. 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 1-877-481-4010 (US) or 1-919-882-2331
(International), participant access code 48459. The webcast and
telephone replay will be available through May 30, 2023.
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
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 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,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
$
1,195,675
|
|
$
216,097
|
|
$
3,091,745
|
|
$
447,719
|
|
License and
contract
|
-
|
|
-
|
|
-
|
|
250,000
|
|
Total
revenues
|
1,195,675
|
|
216,097
|
|
3,091,745
|
|
697,719
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
Cost of products
sold
|
129,235
|
|
46,908
|
|
314,438
|
|
130,012
|
|
Research and
development
|
4,830,327
|
|
4,980,074
|
|
15,224,896
|
|
13,891,235
|
|
Selling, general and
administrative
|
3,537,376
|
|
3,009,528
|
|
10,220,518
|
|
10,163,830
|
|
Gain on purchase
commitment
|
-
|
|
-
|
|
(1,027,322)
|
|
-
|
|
Total operating
expenses
|
8,496,938
|
|
8,036,510
|
|
24,732,530
|
|
24,185,077
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(7,301,263)
|
|
(7,820,413)
|
|
(21,640,785)
|
|
(23,487,358)
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
|
|
|
Investment
income
|
234,044
|
|
1,127
|
|
509,006
|
|
4,100
|
|
Foreign currency (loss)
gain
|
(77,266)
|
|
190,719
|
|
(352,121)
|
|
64,000
|
|
Interest
expense
|
(3,434)
|
|
(3,019)
|
|
(18,523)
|
|
(11,423)
|
|
Total other income
(expense), net
|
153,344
|
|
188,827
|
|
138,362
|
|
56,677
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
(7,147,919)
|
|
(7,631,586)
|
|
(21,502,423)
|
|
(23,430,681)
|
|
Income tax
benefit
|
-
|
|
-
|
|
4,674,999
|
|
-
|
|
NET LOSS
|
$
(7,147,919)
|
|
$
(7,631,586)
|
|
$ (16,827,424)
|
|
$ (23,430,681)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
$
(0.63)
|
|
$
(0.80)
|
|
$
(1.59)
|
|
$
(2.46)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares outstanding used in computing basic and diluted
net loss per common share
|
11,432,380
|
|
9,552,214
|
|
10,613,830
|
|
9,537,768
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated Balance
Sheets
|
(unaudited)
|
|
|
|
|
|
March 31,
2023
|
|
June 30,
2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
19,632,330
|
|
$ 29,939,154
|
Accounts
receivable
|
1,699,110
|
|
1,780,020
|
Inventories
|
630,033
|
|
944,471
|
Prepaid expenses and
other current assets
|
2,277,498
|
|
1,932,454
|
Total current
assets
|
24,238,971
|
|
34,596,099
|
|
|
|
|
Property and equipment,
net
|
713,567
|
|
539,314
|
Right-of-use assets -
operating leases
|
599,442
|
|
878,465
|
Other assets
|
56,916
|
|
56,916
|
Total assets
|
$
25,608,896
|
|
$ 36,070,794
|
|
|
|
|
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
2,786,313
|
|
$
3,157,617
|
Accrued
expenses
|
5,536,033
|
|
6,875,216
|
Short-term operating
lease liabilities
|
301,169
|
|
371,124
|
Short-term finance
lease liabilities
|
104,998
|
|
100,921
|
Other current
liabilities
|
3,122,850
|
|
5,754,986
|
Total current
liabilities
|
11,851,363
|
|
16,259,864
|
|
|
|
|
Long-term operating
lease liabilities
|
320,490
|
|
529,398
|
Long-term finance lease
liabilities
|
73,141
|
|
152,407
|
Other long-term
liabilities
|
3,771,400
|
|
2,861,250
|
Total
liabilities
|
16,016,394
|
|
19,802,919
|
|
|
|
|
Series B and Series C
Redeemable Convertible Preferred Stock of $0.01 par value:
authorized 9,000,000 shares, 9,000,000 shares issued and
outstanding as of June 30,
2022, with a liquidation 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 March 31, 2023: issued
and
|
|
|
|
outstanding 4,030
shares as of March 31, 2023 and June 30, 2022
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and outstanding
11,152,680 shares as of March 31, 2023 and 9,270,947 shares
as of June 30, 2022
|
111,527
|
|
92,709
|
Additional paid-in
capital
|
414,302,055
|
|
404,168,822
|
Accumulated
deficit
|
(404,821,120)
|
|
(387,993,696)
|
Total stockholders'
equity
|
9,592,502
|
|
16,267,875
|
Total liabilities,
redeemable convertible preferred stock, and stockholders'
equity
|
$
25,608,896
|
|
$ 36,070,794
|
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SOURCE Palatin Technologies, Inc.