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| 8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Technologies, Inc. Reports Second Quarter
Fiscal Year 2017 Results;
Teleconference and Webcast to be held on February 9,
2017
CRANBURY,
NJ – February 9, 2017 – Palatin Technologies, Inc.
(NYSE MKT: 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 second quarter ended
December 31, 2016.
Recent Highlights
●
Rekynda (bremelanotide) - Under development for Hypoactive
Sexual Desire Disorder (HSDD):
-
Exclusive
North American license agreement with AMAG Pharmaceuticals, Inc. to
develop and commercialize Rekynda.
-
Received
$60 million initial payment under license agreement with
AMAG.
-
November
2016 reported positive Phase 3 clinical results - both pivotal
trials met the pre-specified co-primary efficacy endpoints of
improvement in desire and decrease in distress associated with low
sexual desire.
●
Financial
Transactions:
-
December
2016, Palatin closed on an underwritten public offering of units
with gross proceeds of $16.5 million, with net proceeds, after
deducting offering expenses, of approximately $15.4 million.
Palatin issued:
●
25,384,616
shares of common stock and five year Series J warrants to purchase
12,692,310 shares of common stock at an exercise price of $0.80 per
share
"We
are confident that AMAG's commercial capabilities and expertise
will drive a successful approval and launch of Rekynda in early
2019." said Carl Spana, Ph.D., chief executive officer of Palatin
Technologies. "We are excited to now be able to devote significant
resources and attention to our other development programs, which
address diseases such as heart failure and inflammatory bowel
diseases using targeted, receptor-specific peptides which we
developed."
Second Quarter Fiscal 2017 Financial Results
Palatin
reported a net loss of $(10.0) million, or $(0.06) per basic and
diluted share, for the quarter ended December 31, 2016, compared to
a net loss of $(13.2) million, or $(0.08) per basic and diluted
share, for the same period in 2015.
1
The
difference between the three months ended December 31, 2016 and
2015 was primarily attributable to the completion of the Phase 3
clinical trials of our Rekynda program for HSDD.
Revenue
There
were no revenues recorded in the quarters ended December 31, 2016
and 2015.
Operating Expenses
Total
operating expenses for the quarter ended December 31, 2016 were
$9.4 million compared to $12.6 million for the comparable quarter
of 2015. The decrease in operating expenses for the quarter ended
December 31, 2016 was primarily attributable to the completion of
the Phase 3 clinical trials of our Rekynda program for
HSDD
Other Income/Expense
Total
other income (expense), net, was $(0.6) million for the quarters
ended December 31, 2016 and 2015 consisting primarily of interest
expense related to venture debt.
Cash Position
Palatin’s
cash, cash equivalents and investments were $13.5 million, before
giving effect to the receipt of $60 million from AMAG, as of
December 31, 2016, compared to cash and cash equivalents $9.4
million at June 30, 2016. Current liabilities were $19.6 million as
of December 31, 2016, compared to $13.9 million as of June 30,
2016.
Palatin
believes that existing capital resources will be adequate to fund
our planned operations through at least the fiscal year ending June
30, 2018.
Palatin Drug Discovery Programs
In
the conference call and webcast, management will discuss
anticipated next steps in Palatin's portfolio of drug development
programs. These include Palatin’s melanocortin
receptor1 agonist peptides for treatment of inflammatory and
dermatologic disease indications, natriuretic peptide
receptorA agonist compounds for treatment of cardiovascular
and pulmonary indications, and melanocortin receptor-4 agonist
compounds for treatment of obesity and diabetes.
Conference Call / Webcast
Palatin
will host a conference call and audio webcast on February 9, 2017
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 1-800-500-0311 (U.S./Canada) or 1-719-457-2641
(international), conference ID 9389688. 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 webcast replay will be
available approximately one hour after the completion of the call.
To access the telephone replay, dial 1-888-203-1112 (U.S./Canada)
or 1-719-457-0820 (international), passcode 9389688. The webcast
and telephone replay will be available through February 16,
2017.
2
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 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 Investor
Inquiries:
Stephen T. Wills, CPA,
MST
Chief Operating Officer / Chief Financial Officer
Tel: (609) 495-2200 /
info@Palatin.com
Palatin Technologies Media Inquiries:
Paul Arndt, MBA, LifeSci Advisors, LLC
Managing Director
Tel: (646) 597-6992 / Paul@LifeSciAdvisors.com
(Financial Statement Data Follows)
3
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
(unaudited)
|
|
Three Months Ended December 31,
|
Six Months Ended December 31,
|
||
|
|
2016
|
2015
|
2016
|
2015
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
License
revenue
|
$-
|
$-
|
$-
|
$-
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
Research
and development
|
8,134,575
|
11,272,307
|
19,360,659
|
21,870,021
|
|
General
and administrative
|
1,306,300
|
1,356,117
|
2,515,646
|
2,556,054
|
|
Total
operating expenses
|
9,440,875
|
12,628,424
|
21,876,305
|
24,426,075
|
|
|
|
|
|
|
|
Loss
from operations
|
(9,440,875)
|
(12,628,424)
|
(21,876,305)
|
(24,426,075)
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE):
|
|
|
|
|
|
Interest
income
|
5,991
|
8,234
|
12,636
|
23,974
|
|
Interest
expense
|
(594,535)
|
(629,494)
|
(1,218,520)
|
(1,257,502)
|
|
Total
other income (expense), net
|
(588,544)
|
(621,260)
|
(1,205,884)
|
(1,233,528)
|
|
|
|
|
|
|
|
|
|
|
|
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NET
LOSS
|
$(10,029,419)
|
$(13,249,684)
|
$(23,082,189)
|
$(25,659,603)
|
|
|
|
|
|
|
|
Basic
and diluted net loss per common share
|
$(0.06)
|
$(0.08)
|
$(0.13)
|
$(0.16)
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding used in computing basic
and diluted net loss per common share
|
177,798,511
|
156,358,586
|
171,823,390
|
156,268,094
|
4
PALATIN TECHNOLOGIES,
INC .
and Subsidiary
Consolidated Balance Sheets
(unaudited)
|
|
December 31,
2016
|
June 30,
2016
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash
and cash equivalents
|
$12,114,581
|
$8,002,668
|
|
Available-for-sale
investments
|
1,375,959
|
1,380,556
|
|
Prepaid
expenses and other current assets
|
838,260
|
1,313,841
|
|
Total
current assets
|
14,328,800
|
10,697,065
|
|
|
|
|
|
Property
and equipment, net
|
82,540
|
97,801
|
|
Other
assets
|
56,916
|
63,213
|
|
Total
assets
|
$14,468,256
|
$10,858,079
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS’ DEFICIENCY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$4,706,014
|
$713,890
|
|
Accrued
expenses
|
7,446,825
|
7,767,733
|
|
Notes
payable, net of discount and debt issuance costs
|
7,427,445
|
5,374,951
|
|
Capital
lease obligations
|
28,214
|
27,424
|
|
Total
current liabilities
|
19,608,498
|
13,883,998
|
|
|
|
|
|
Notes
payable, net of discount and debt issuance costs
|
10,210,275
|
14,106,594
|
|
Capital
lease obligations
|
-
|
14,324
|
|
Other
non-current liabilities
|
607,488
|
439,130
|
|
Total
liabilities
|
30,426,261
|
28,444,046
|
|
|
|
|
|
Stockholders’
deficiency:
|
|
|
|
Preferred
stock of $0.01 par value – authorized 10,000,000
shares:
|
|
|
|
Series
A Convertible: issued and outstanding 4,030 shares as of December
31, 2016 and June 30, 2016
|
40
|
40
|
|
Common
stock of $0.01 par value – authorized 300,000,000
shares:
|
|
|
|
issued
and outstanding 133,423,837 shares as of December 31, 2016 and
68,568,055 shares as of June 30, 2016, respectively
|
1,334,238
|
685,680
|
|
Additional
paid-in capital
|
349,204,164
|
325,142,509
|
|
Accumulated
other comprehensive loss
|
(2,006)
|
(1,944)
|
|
Accumulated
deficit
|
(366,494,441)
|
(343,412,252)
|
|
Total
stockholders’ deficiency
|
(15,958,005)
|
(17,585,967)
|
|
Total
liabilities and stockholders’ deficiency
|
$14,468,256
|
$10,858,079
|
5