- Phase 3 Pivotal Study of PL9643 in Patients with Dry Eye
Disease Ongoing
-
- Positive Interim Analysis – DMC Recommended Study Size of
350 patients
- Topline Results Currently Expected Second Quarter
Calendar 2023
- Vyleesi® - Net Product Revenue Increased 13% and
Prescriptions Dispensed Increased 17%, Over the
Prior Quarter
-
- Prescription Refills Exceed 50% of Total Prescriptions
Dispensed
- Phase 2 Clinical Study of Oral PL8177 in Patients with
Ulcerative Colitis Commenced
-
- Planned Interim Analysis First Quarter Calendar
2023
- Topline Results Currently Expected Third
Quarter Calendar 2023
- Closed on a $10 Million
Registered Direct Offering
- Teleconference and Webcast to be held on November 14, 2022, at 11:00 AM ET
CRANBURY, N.J., Nov. 14,
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 receptor system,
today announced financial results for its fiscal
first quarter ended September 30,
2022.
"Topline results from our Phase 3 pivotal study of PL9643 is
currently expected in the second quarter calendar of 2023, and the
interim analysis from the Phase 2 study of oral PL8177 is currently
expected in the first calendar quarter of 2023, with topline data
expected in the third calendar quarter of 2023," stated
Carl Spana, Ph.D., President and CEO
of Palatin. "We closed on a $10
million equity offering earlier this month, which
strengthened our balance sheet, providing us an operating cash
runway through calendar year 2023."
Dr. Spana further commented, "Vyleesi brand value metrics
continue to reflect significant growth. In fact, prescription
refills, which is a top indicator of patient satisfaction, exceeds
50% of total prescriptions dispensed. Furthermore, net product
revenue increased 13% and prescriptions dispensed increased 17%
over the last quarter."
Financial Highlights for the Fiscal First Quarter Ended
September 30, 2022
- The Company reported a net loss for the quarter ended
September 30, 2022, of $8.3 million, or $(0.86) per common share, compared to a net loss
of $7.1 million, or $(0.75) per common share, for the same period in
2021.
- The Company had $21.2 million in
cash and cash equivalents as of September
30, 2022, compared to $29.9
million as of June 30,
2022.
- Vyleesi® (bremelanotide injection) for the treatment of
Hypoactive Sexual Desire Disorder (HSDD): Gross product sales to
pharmacy distributors amounted to $2.3
million, while net product revenue increased 13% and
prescriptions dispensed increased 17%, over the prior quarter.
Business Highlights and Recent Updates
- Anti-Inflammatory / Autoimmune Programs
-
- PL9643 melanocortin agonist for the treatment of dry eye
disease (DED)
-
- Positive interim analysis in ongoing pivotal Phase 3 clinical
study in patients with DED.
-
- The independent data monitoring committee (DMC) performed their
assessment on the first 120 patients to complete the study and
based on their recommendation, Palatin plans to enroll a total of
350 patients.
- No safety concerns were identified by the DMC.
- Topline data readout expected in the second quarter 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):
-
- Commenced patient enrollment in a Phase 2 oral formulation
study of PL8177 in patients with UC.
- Interim assessment is currently expected to occur in the first
quarter of calendar year 2023.
- Topline data readout is currently expected in the third quarter
of calendar year 2023.
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov/ via the
identifier NCT05466890.
- 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 first quarter ended September 30, 2022:
-
- Gross product sales were $2.3
million for the quarter ended September 30, 2022 and the prior quarter,
increased 64% over the comparable quarter in 2021.
- Net product revenue increased 13% over the prior quarter,
increased 445% over the comparable quarter in 2021.
- Total prescriptions dispensed increased 17% over the prior
quarter, increased 108% 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:
-
- Registered Direct Offering: On October
31, 2022, Palatin entered into a securities purchase
agreement with a certain institutional investor, selling and
issuing an aggregate of (i) 1,020,000 shares of Palatin common
stock, $0.01 par value per share,
(ii) prefunded warrants (the "Pre-Funded Warrants") to purchase up
to 798,182 shares of Palatin common stock, and (iii) common
warrants (the "Common Warrants") to purchase up to 1,818,182 shares
of Palatin common stock. Each share of common stock was offered
with one accompanying Common Warrant for a combined offering price
of $5.50. Each Pre-Funded Warrant was
offered with one accompanying Common Warrant for a combined
offering price of $5.4999. The
Offering was completed on November 2,
2022. The Common Warrants have an exercise price of
$5.83 per share, are exercisable
beginning six months after the date of issuance and will expire
five and one-half years from the date of issuance. The Pre-Funded
Warrants have an exercise price of $0.0001 per share, are exercisable upon issuance,
and will expire when exercised in full.
- Reverse Stock Split: The Board of Directors approved the
implementation of a 1-for-25 reverse stock split effective as of
5:00 p.m. Eastern Time on
August 30, 2022. The reverse stock
split reduced the number of shares of Palatin's common stock
outstanding from approximately 231,774,000 shares to approximately
9,271,000 shares but did not change the authorized number of shares
of Common Stock, which remain at 300,000,000 shares of Common
Stock.
Fiscal First Quarter Ended September
30, 2022 Financial Results
All share and per share amounts are presented on a
post-reverse-split basis, giving effect to the 1- for-25 reverse
stock split.
Revenue
Total revenue consists of gross product sales of Vyleesi, net of
allowances and accruals. Vyleesi gross product sales to pharmacy
distributors for the quarter ended September
30, 2022, were $2.3 million,
with net product revenue of $869,654,
compared to gross product sales of $1.4
million, with net product revenue of $159,482, for the comparable quarter in 2021.
Gross product sales increased 64% and net product revenue increased
445% over the comparable quarter in 2021.
Operating Expenses
Total operating expenses for
the quarter ended September 30, 2022,
were $9.6 million, compared to
$7.4 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 and Phase 2
clinical trial of oral PL8177, offset by decreased commercial
expenses related to Vyleesi.
Other Income / (Expenses)
Total other income, net, consist mainly
of unrealized foreign
currency transaction gains, of $418,376 for the quarter ended September 30, 2022, compared to $107,359 for the comparable quarter
in 2021.
Cash Flows
Palatin's net cash used in operations for the quarter
ended September 30, 2022, was $8.6
million, compared to net cash used in operations of $6.4 million for the same period in 2021. The
difference in net cash used in operations is mainly due to
increased operating expenses in the quarter ended September 30, 2022.
Net Loss
Palatin's net loss for the quarter
ended September 30, 2022, was $8.3 million,
or $(0.86) per basic and diluted
common share, compared to a net loss of $7.1
million, or $(0.75) per basic
and diluted common share for the same period in 2021.
The increase in net loss for the quarter ended September 30, 2022 over the quarter
ended September 30, 2021, was mainly due to the
increase in operating expenses offset by an increase in net product
revenue of Vyleesi.
Cash Position
As of September 30, 2022, Palatin's
cash and cash equivalents were $21.2
million with $2.0 million of
accounts receivable, compared to cash and cash equivalents of
$29.9 million with $1.8 million of accounts receivable as of
June 30, 2022.
The $21.1 million of cash and cash
equivalents as of September 30, 2022,
does not include $9.1 million of net
proceeds from the Registered Direct Offering, which closed in
November 2022, and the $15 Million Private Placement of Redeemable
Convertible Preferred Stock. This $15
million is being held in an escrow account, pending
the investors' election to redeem
the shares for cash or in notes,
or convert the shares to common stock. Palatin
currently expects an operating cash runway through calendar year
2023.
Conference Call / Webcast
Palatin will host a conference call and audio
webcast on November 14, 2022, 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
1-866-580-3963 (US) or 1-786-697-3501 (International), conference ID 5980994#.
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 1-866-583-1035 (US) or +44
(0) 20 8196 1480 (International), passcode 5980994#. The webcast
and telephone replay will be available through November
21, 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 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
September 30,
|
|
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
Product revenue,
net
|
$
869,654
|
|
$
159,482
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
Cost of products
sold
|
86,496
|
|
53,933
|
|
|
Research and
development
|
6,027,031
|
|
3,484,764
|
|
|
Selling, general and
administrative
|
3,508,798
|
|
3,836,542
|
|
|
Total operating
expenses
|
9,622,325
|
|
7,375,239
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(8,752,671)
|
|
(7,215,757)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
Investment
income
|
88,489
|
|
1,410
|
|
|
Foreign currency
gain
|
418,376
|
|
107,359
|
|
|
Interest
expense
|
(9,602)
|
|
(5,631)
|
|
|
Total other income
(expense), net
|
497,263
|
|
103,138
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
(8,255,408)
|
|
$
(7,112,619)
|
|
|
Basic and diluted net
loss per common share
|
$
(0.86)
|
|
$
(0.75)
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares outstanding
used in computing basic and diluted net loss per common
share
|
9,634,684
|
|
9,529,322
|
|
|
|
|
|
PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated Balance
Sheets
|
(unaudited)
|
|
|
|
|
|
September 30,
2022
|
|
June 30,
2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
21,191,875
|
|
$
29,939,154
|
Accounts
receivable
|
2,022,750
|
|
1,780,020
|
Inventories
|
857,975
|
|
944,471
|
Prepaid expenses and
other current assets
|
2,104,855
|
|
1,932,454
|
Total current
assets
|
26,177,455
|
|
34,596,099
|
|
|
|
|
Property and equipment,
net
|
620,917
|
|
539,314
|
Right-of-use assets -
operating leases
|
786,731
|
|
878,465
|
Other assets
|
56,916
|
|
56,916
|
Total assets
|
$
27,642,019
|
|
$
36,070,794
|
|
|
|
|
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS'
EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
3,774,399
|
|
$ 3,157,617
|
Accrued
expenses
|
6,116,841
|
|
6,875,216
|
Short-term operating
lease liabilities
|
343,749
|
|
371,124
|
Short-term finance
lease liabilities
|
102,264
|
|
100,921
|
Other current
liabilities
|
5,523,748
|
|
5,754,986
|
Total current
liabilities
|
15,861,001
|
|
16,259,864
|
|
|
|
|
Long-term operating
lease liabilities
|
465,091
|
|
529,398
|
Long-term finance lease
liabilities
|
126,333
|
|
152,407
|
Other long-term
liabilities
|
2,740,250
|
|
2,861,250
|
Total
liabilities
|
19,192,675
|
|
19,802,919
|
|
|
|
|
Series B and Series C
Redeemable Convertible Preferred Stock of $0.01 par value:
authorized, issued, and
outstanding 9,000,000
shares as of September 30, 2022 and June 30, 2022, with a
liquidiation preference of
$15,000,000
|
15,000,000
|
|
15,000,000
|
Escrowed
proceeds
|
(15,000,000)
|
|
(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 September 30, 2022: issued and
outstanding 4,030 shares
|
|
|
|
as of September 30,
2022 and June 30, 2022
|
40
|
|
40
|
Common stock of $0.01
par value – authorized 300,000,000 shares:
|
|
|
|
issued and outstanding
9,290,504 shares as of September 30, 2022 and 9,270,947 shares as
of June 30, 2022
|
92,905
|
|
92,709
|
Additional paid-in
capital
|
404,605,503
|
|
404,168,822
|
Accumulated
deficit
|
(396,249,104)
|
|
(387,993,696)
|
Total stockholders'
equity
|
8,449,344
|
|
16,267,875
|
Total liabilities,
redeemable convertible preferred stock, and stockholders'
equity
|
$
27,642,019
|
|
$
36,070,794
|
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SOURCE Palatin Technologies, Inc.