CRANBURY, N.J., May 15, 2018 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a biopharmaceutical
company developing targeted, receptor-specific peptide therapeutics
for the treatment of diseases with significant unmet medical need
and commercial potential, today announced results for its third
quarter ended March 31, 2018.
Recent Highlights
- Bremelanotide - Under development for Hypoactive Sexual
Desire Disorder ("HSDD"):
-
- March 2018 – our exclusive North
American licensee for bremelanotide, AMAG Pharmaceuticals, Inc.
("AMAG"), submitted a New Drug Application ("NDA") to the U.S. Food
and Drug Administration ("FDA") for bremelanotide for the treatment
of HSDD in premenopausal women.
-
- If approved, bremelanotide would become the first and only as
desired pharmacologic option in the U.S. indicated for the
treatment of HSDD in premenopausal women.
"The submission of this NDA represents a significant milestone
for the bremelanotide clinical program and our efforts to develop a
treatment for HSDD," said Carl
Spana, Ph.D., CEO and President of Palatin Technologies.
- Melanocortin Receptor 1 Agonists ("MC1r") – under
development for inflammatory bowel diseases and ocular
indications:
-
- May 2018 – Presented positive
preclinical MC1r agonist data at TIDES: Oligonucleotide and Peptide
Therapeutics 2018 Meeting.
- April 2018 – Presented
preclinical oral formulation data on PL-8177, an investigational
MC1r agonist for Inflammatory Bowel Diseases at the 2018 Keystone
Symposia on "The Resolution of Inflammation in Health and
Disease."
- Phase 1 First-in-Human clinical study of PL-8177 is in progress
and on schedule for top line data in the third quarter of calendar
year 2018.
Third Quarter Fiscal 2018 Financial Results
Palatin
reported a net loss of $(0.7)
million, or $(0.00) per basic
and diluted share, for the quarter ended March 31, 2018, compared to a net loss of
$(3.6) million, or $(0.02) per basic and diluted share, for the same
period in 2017.
The difference in financial results between the three months
ended March 31, 2018 and 2017 was
mainly attributable to the decrease in total operating expenses of
$4.3 million that is offset by a
decrease of $1.8 million of
recognized revenue during the 2018 period pursuant to our license
agreement with AMAG.
Revenue
For the quarter ended March 31, 2018, Palatin recognized $9.0 million in license and contract revenue
compared to $10.8 million in the same
period in 2017. For both periods, 100% of the revenue Palatin
recognized was related to our license agreement with AMAG. As of
March 31, 2018, and June 30, 2017, there was $0.6 million and $35.1
million, respectively, of current deferred revenue on the
consolidated balance sheet related to this transaction.
Operating Expenses
Total operating expenses for the
quarter ended March 31, 2018 were
$9.5 million compared to $13.8 million for the same period in 2017. The
decrease in operating expenses was mainly attributable to
professional services rendered in connection with our license
agreement with AMAG, which closed in February 2017, and secondarily to the decrease in
development expenses of bremelanotide for HSDD as we continue our
progress with our bremelanotide program.
Other Income/Expense
Total other income/expense, net
was $0.2 million for the quarter
ended March 31, 2018 compared to
$0.6 million for the same period in
2017. Total other income/expense, net for both periods consisted
primarily of interest expense related to Palatin's venture
debt.
Income Tax
Palatin licensed bremelanotide to Shanghai
Fosun Pharmaceutical Industrial Development Co. Ltd. ("Fosun") for
the People's Republic of China,
Taiwan, Hong Kong and Macau, and to Kwangdong Pharmaceutical Co.
Ltd. ("Kwangdong") for the Republic of Korea. Pursuant to the
license agreements with Fosun and Kwangdong, $500,000 and $82,500, respectively, was withheld in accordance
with tax withholding requirements in China and the Republic of Korea, respectively,
and will be recorded as an expense during the fiscal year ending
June 30, 2018. For the quarter ended
March 31, 2018, Palatin recorded an
income tax benefit of $18,746 related
to those withholding amounts utilizing an estimated effective
annual income tax rate applied to the loss for the quarter and the
remaining balance of $275,111 was
included in prepaid expenses and other current assets at
March 31, 2018. Any potential credit
to be received by Palatin on its United
States tax returns is currently offset by Palatin's
valuation allowance.
Cash Position
Palatin's cash, and cash equivalents
were $25.7 million as of March 31, 2018, compared to cash, cash
equivalents, accounts receivable and investments of $55.6 million at June
30, 2017. Current liabilities were $13.6 million, net of current deferred revenue of
$0.6 million, as of March 31, 2018, compared to $19.9 million, net of deferred revenue of
$35.1 million, as of June 30, 2017.
In April 2018, Palatin entered
into an equity distribution agreement ("at-the-market program")
with Canaccord Genuity LLC, pursuant to which Palatin may, from
time to time, sell shares of its common stock at market prices.
Palatin has no obligation to sell any shares under this agreement
and may, at any time, suspend solicitation and offers under this
agreement.
Palatin believes that existing capital resources, together with
proceeds from sales of common stock in its at-the-market program
(if any), will be sufficient to fund our planned operations through
at least June 30, 2019.
Conference Call / Webcast
Palatin will host a
conference call and webcast on May 15,
2018 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
1-800-263-0877 (domestic) or 1-323-794-2094 (international),
conference ID 1551025. The 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 webcast
replay will be available approximately one hour after the
completion of the call. To access the telephone replay, dial
1-888-203-1112 (domestic) or 1-719-457-0820 (international),
passcode 1551025. The webcast and telephone replay will be
available through May 22, 2018.
About Palatin Technologies, Inc.
Palatin
Technologies, Inc. is a biopharmaceutical company developing
targeted, receptor-specific peptide therapeutics 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
and market potential for product candidates, 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, results of clinical trials,
regulatory actions by the FDA and the need for regulatory
approvals, Palatin's ability to fund development of its technology
and establish and successfully obtain regulatory approvals,
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.
(Financial Statement Data Follows)
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PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
Nine Months Ended
March 31,
|
|
2018
|
|
2017
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|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
License
and contract revenue
|
$
8,962,709
|
|
$
10,823,748
|
|
$
46,516,370
|
|
$
10,823,748
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|
|
|
|
|
|
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OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
Research
and development
|
7,068,849
|
|
9,062,316
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|
27,277,830
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|
28,422,975
|
General
and administrative
|
2,411,302
|
|
4,773,696
|
|
5,581,066
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|
7,289,342
|
Total operating expenses
|
9,480,151
|
|
13,836,012
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|
32,858,896
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|
35,712,317
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|
|
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|
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|
(Loss) Income from operations
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(517,442)
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|
(3,012,264)
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|
13,657,474
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|
(24,888,569)
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OTHER INCOME
(EXPENSE):
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Interest
income
|
86,496
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|
6,304
|
|
219,578
|
|
18,940
|
Interest
expense
|
(326,983)
|
|
(558,702)
|
|
(1,175,023)
|
|
(1,777,222)
|
Total other expense,
net
|
(240,487)
|
|
(552,398)
|
|
(955,445)
|
|
(1,758,282)
|
|
|
|
|
|
|
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|
(Loss) Income before income taxes
|
(757,929)
|
|
(3,564,662)
|
|
12,702,029
|
|
(26,646,851)
|
Income tax benefit,
net
|
18,746
|
|
-
|
|
192,611
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|
-
|
|
|
|
|
|
|
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|
NET (LOSS)
INCOME
|
$
(739,183)
|
|
$
(3,564,662)
|
|
$
12,894,640
|
|
$
(26,646,851)
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|
|
|
|
|
|
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|
Basic net (loss)
income per common share
|
$
(0.00)
|
|
$
(0.02)
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|
$
0.07
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|
$
(0.15)
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Diluted net (loss)
income per common share
|
$
(0.00)
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|
$
(0.02)
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|
$
0.06
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|
$
(0.15)
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|
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|
|
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|
Weighted average
number of common shares
outstanding used in
computing basic net (loss)
income per common
share
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197,485,758
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196,580,519
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197,277,286
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|
179,841,133
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Weighted average
number of common shares
outstanding used in
computing diluted net (loss)
income per common
share
|
197,485,758
|
|
196,580,519
|
|
202,712,963
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|
179,841,133
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PALATIN
TECHNOLOGIES, INC.
|
and
Subsidiary
|
Consolidated
Balance Sheets
|
(unaudited)
|
|
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March 31,
2018
|
|
June 30,
2017
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ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and
cash equivalents
|
$
25,736,158
|
|
$
40,200,324
|
Available-for-sale investments
|
-
|
|
249,837
|
Accounts
receivable
|
-
|
|
15,116,822
|
Prepaid
expenses and other current assets
|
701,456
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|
1,011,221
|
Total current
assets
|
26,437,614
|
|
56,578,204
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|
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Property and
equipment, net
|
165,080
|
|
198,153
|
Other
assets
|
556,915
|
|
56,916
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Total assets
|
$
27,159,609
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|
$
56,833,273
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LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIENCY)
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Current
liabilities:
|
|
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|
Accounts
payable
|
$
793,642
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|
$
1,551,367
|
Accrued
expenses
|
5,894,877
|
|
10,521,098
|
Notes
payable, net of discount and debt issuance costs
|
6,921,032
|
|
7,824,935
|
Capital
lease obligations
|
-
|
|
14,324
|
Deferred
revenue
|
585,519
|
|
35,050,572
|
Total current
liabilities
|
14,195,070
|
|
54,962,296
|
|
|
|
|
Notes payable, net of
discount and debt issuance costs
|
1,328,973
|
|
6,281,660
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Deferred
revenue
|
500,000
|
|
-
|
Other non-current
liabilities
|
909,179
|
|
753,961
|
Total liabilities
|
16,933,222
|
|
61,997,917
|
|
|
|
|
Stockholders' equity
(deficiency):
|
|
|
|
Preferred stock of $0.01 par value – authorized 10,000,000
shares:
|
|
|
|
Series A Convertible: issued
and outstanding 4,030 shares as of
March 31, 2018 and June 30, 2017
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40
|
|
40
|
Common
stock of $0.01 par value – authorized 300,000,000
shares:
|
|
|
|
issued and outstanding 195,477,332 shares as of March 31,
2018
and 160,515,361 shares as of June 30, 2017,
respectively
|
1,954,773
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1,605,153
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Additional paid-in capital
|
352,125,554
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|
349,979,373
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Accumulated other comprehensive loss
|
-
|
|
(590)
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Accumulated deficit
|
(343,853,980)
|
|
(356,748,620)
|
Total stockholders' equity
(deficiency)
|
10,226,387
|
|
(5,164,644)
|
Total liabilities and stockholders' equity
(deficiency)
|
$
27,159,609
|
|
$
56,833,273
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SOURCE Palatin Technologies, Inc.