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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 2017 Results;
Teleconference and Webcast to be held on May 16, 2017
CRANBURY, NJ – May 16, 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 third quarter ended
March 31, 2017.
Quarter and Recent Highlights
●
Bremelanotide
- Under development for Hypoactive
Sexual Desire Disorder (HSDD):
–
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.
–
Closed
an exclusive North American license agreement with AMAG
Pharmaceuticals to develop and commercialize bremelanotide in
February 2017.
●
Received
$60 million upfront payment
–
Working
closely with AMAG on completing the tasks and activities necessary
to file a New Drug Application (NDA) with the Food and Drug
Administration (FDA).
–
Target
NDA filing with the FDA for the first quarter of calendar year
2018.
–
A
Notice of Allowance was issued by the U.S. Patent and Trademark
Office (USPTO) on a patent for methods of treating female sexual
dysfunction and HSDD with bremelanotide. Once issued the patent
will have a term to November 2033.
"Meeting our Phase 3 co-primary endpoints with bremelanotide and
licensing the North American rights to AMAG were truly
transformational for Palatin," said Stephen T. Wills, chief
operating officer and chief financial officer of Palatin
Technologies. "In addition to advancing the activities required to
file an NDA with the FDA, we are progressing with discussions and
negotiations with potential partners for other regions around the
globe for bremelanotide. We are also excited to now be able to
devote resources and attention to our other development programs,
which address indications such as heart failure, ophthalmic
disorders and inflammatory bowel diseases using targeted,
receptor-specific peptides which we developed."
###
(Financial Statement Data Follows)
Third Quarter Fiscal 2017 Financial Results
Palatin reported a net loss of $(3.6) million, or $(0.02) per basic
and diluted share, for the quarter ended March 31, 2017, compared
to a net loss of $(12.7) million, or $(0.08) per basic and diluted
share, for the same period in 2016.
The difference between the three months ended March 31, 2017 and
2016 was primarily attributable to the recognition of $10.8 million
in contract revenue pursuant to our license agreement with
AMAG.
Revenue
For the quarter ended March 31, 2017, Palatin recognized $10.8
million in contract revenue related to our license agreement with
AMAG. There were no revenues recorded in the quarter ended March
31, 2016.
Operating Expenses
Total operating expenses for the quarter ended March 31, 2017 were
$13.8 million compared to $12.1 million for the comparable quarter
of 2016. The increase in operating expenses was predominately
attributable to professional services incurred related to closing
our license agreement with AMAG.
Other Income/Expense
Total other income (expense), net, was $(0.6) million for the
quarters ended March 31, 2017 and 2016 consisting mainly of
interest expense related to venture debt.
Cash Position
Palatin’s cash, cash equivalents and investments were $55.4
million as of March 31, 2017, compared to cash, cash equivalents
and investments of $9.4 million at June 30, 2016. Current
liabilities were $17.4 million, net of deferred revenue of $53.8
million, as of March 31, 2017, compared to $13.9 million as of June
30, 2016.
Palatin believes that with the proceeds from our license agreement
with AMAG, capital resources will be adequate to fund our planned
operations through calendar year 2018.
Palatin Drug Discovery Programs
In the conference call and webcast, management will discuss next
steps in Palatin's portfolio of drug development programs. These
include Palatin’s melanocortin receptor1 and receptor-5
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.
###
(Financial Statement Data Follows)
Conference Call / Webcast
Palatin will host a conference call and audio webcast on May 16,
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 1-888-523-1227 (U.S./Canada) or 1-719-457-2656
(international), conference ID 3692572. 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 3692572. The webcast
and telephone replay will be available through May 23,
2017.
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.
Investor
Inquiries:
Media Inquiries:
Stephen T. Wills, CPA,
MST
Paul Arndt, MBA,
LifeSci Advisors
CFO/COO (609)
495-2200
Managing
Director (646) 597-6992
Info@Palatin.com
Paul@LifeSciAdvisors.com
###
(Financial Statement Data Follows)
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
(unaudited)
|
|
Three Months Ended March 31,
|
Nine Months Ended March 31,
|
||
|
|
2017
|
2016
|
2017
|
2016
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
Contract
revenue
|
$10,823,748
|
$-
|
$10,823,748
|
$-
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
Research
and development
|
9,062,316
|
10,676,342
|
28,422,975
|
32,546,363
|
|
General
and administrative
|
4,773,696
|
1,409,406
|
7,289,342
|
3,965,460
|
|
Total
operating expenses
|
13,836,012
|
12,085,748
|
35,712,317
|
36,511,823
|
|
|
|
|
|
|
|
Loss
from operations
|
(3,012,264)
|
(12,085,748)
|
(24,888,569)
|
(36,511,823)
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE):
|
|
|
|
|
|
Interest
income
|
6,304
|
15,062
|
18,940
|
39,036
|
|
Interest
expense
|
(558,702)
|
(625,832)
|
(1,777,222)
|
(1,883,334)
|
|
Total
other income (expense), net
|
(552,398)
|
(610,770)
|
(1,758,282)
|
(1,844,298)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
$(3,564,662)
|
$(12,696,518)
|
$(26,646,851)
|
$(38,356,121)
|
|
|
|
|
|
|
|
Basic
and diluted net loss per common share
|
$(0.02)
|
$(0.08)
|
$(0.15)
|
$(0.25)
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding used in computing basic
and diluted net loss per common share
|
196,580,519
|
156,368,617
|
179,841,133
|
156,301,259
|
PALATIN TECHNOLOGIES,
INC .
and Subsidiary
Consolidated Balance Sheets
(unaudited)
|
|
March 31,
2017
|
June 30,
2016
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash
and cash equivalents
|
$54,505,215
|
$8,002,668
|
|
Available-for-sale
investments
|
924,790
|
1,380,556
|
|
Accounts
receivable
|
4,657,577
|
-
|
|
Prepaid
expenses and other current assets
|
1,064,112
|
1,313,841
|
|
Total
current assets
|
61,151,694
|
10,697,065
|
|
|
|
|
|
Property
and equipment, net
|
74,910
|
97,801
|
|
Other
assets
|
56,916
|
63,213
|
|
Total
assets
|
$61,283,520
|
$10,858,079
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$1,243,144
|
$713,890
|
|
Accrued
expenses
|
8,316,692
|
7,767,733
|
|
Notes
payable, net of discount and debt issuance costs
|
7,792,639
|
5,374,951
|
|
Capital
lease obligations
|
21,331
|
27,424
|
|
Deferred
revenue
|
53,833,828
|
-
|
|
Total
current liabilities
|
71,207,634
|
13,883,998
|
|
|
|
|
|
Notes
payable, net of discount and debt issuance costs
|
8,250,004
|
14,106,594
|
|
Capital
lease obligations
|
-
|
14,324
|
|
Other
non-current liabilities
|
684,831
|
439,130
|
|
Total
liabilities
|
80,142,469
|
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 March 31,
2017 and June 30, 2016
|
40
|
40
|
|
Common
stock of $0.01 par value – authorized 300,000,000
shares:
|
|
|
|
issued
and outstanding 144,893,690 shares as of March 31, 2017 and
68,568,055 shares as of June 30, 2016, respectively
|
1,448,937
|
685,680
|
|
Additional
paid-in capital
|
349,752,596
|
325,142,509
|
|
Accumulated
other comprehensive loss
|
(1,419)
|
(1,944)
|
|
Accumulated
deficit
|
(370,059,103)
|
(343,412,252)
|
|
Total
stockholders’ deficiency
|
(18,858,949)
|
(17,585,967)
|
|
Total
liabilities and stockholders’ deficiency
|
$61,283,520
|
$10,858,079
|