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8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99
Palatin Technologies, Inc. Reports Fourth Quarter
And Fiscal Year 2016 Results
CRANBURY, NJ – September 20, 2016 – 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 financial results for its
fourth quarter and fiscal year ended June 30, 2016.
Significant Highlights
●
Bremelanotide
- Under development for Hypoactive
Sexual Desire Disorder (HSDD):
–
Palatin’s
two Phase 3 clinical trials for the treatment of HSDD randomized a
total of approximately 1,250 women to evaluate efficacy and safety
of subcutaneous bremelanotide in premenopausal women with HSDD as
an on-demand, as-needed treatment.
–
Patient
enrollment was completed in the fourth quarter of calendar year
2015.
–
Last
patient visits for the efficacy portion of the trials were
completed in the third quarter of calendar year 2016.
–
Topline
results are projected to be released early fourth quarter calendar
year 2016.
–
Issued
a key U.S. Patent on May 31, 2016 for methods of treating female
sexual dysfunction using the dose and formulation utilized in the
Phase 3 trials. The patent expires no earlier than November
2033.
●
Financial
Transactions:
–
August
2016, Palatin closed on an underwritten offering of units with
gross proceeds of $9.25 million, with net proceeds, after deducting
offering expenses, of approximately $8.5 million. Palatin
issued:
■
11,481,481
shares of common stock and ten-year prefunded Series I warrants to
purchase 2,218,045 shares of common stock at an exercise price of
$0.01 per share
■
Series
H warrants to purchase 10,274,646 shares of common stock at an
exercise price of $0.70 per share
–
July
2015, Palatin closed on a debt and equity financing with gross
proceeds of $30 million, with net proceeds, after deducting
offering expenses, of $29.7 million, consisting of:
■
$10
million venture loan, which includes an interest-only payment
period for the first eighteen months of a four year secured term
loan, and Series G warrants to purchase 549,450 shares of common
stock at an exercise price of $0.91 per share
■
$20
million private placement of Series E warrants to purchase
21,917,808 shares of common stock at an exercise price of $0.01 per
share and Series F warrants to purchase 2,191,781 shares of common
stock at an exercise price of $0.91 per share
1
●
Intellectual
Property:
–
Issue
Notification for U.S. Patent to issue October 4, 2016, with
composition of matter claims for a broad group of melanocortin
peptides.
–
U.S.
Patent issued September 20, 2016 with composition of matter claims
for a broad family of melanocortin receptor-1 peptides with
potential application in inflammatory disease-related and
autoimmune indications.
Fourth Quarter and Fiscal Year Ended 2016 Financial
Results
Palatin reported a net loss of $(13.4) million, or $(0.09) per
basic and diluted share, for the quarter ended June 30, 2016,
compared to a net loss of $(12.1) million, or $(0.09) per basic and
diluted share, for the same period in 2015. The difference between
the three months ended June 30, 2016 and 2015 was primarily
attributable to the increase in expenses relating to the Phase 3
clinical trial and development program with bremelanotide for HSDD
in the quarter ended June 30, 2016.
For the year ended June 30, 2016, Palatin reported a net loss of
$(51.7) million, or $(0.33) per basic and diluted share compared to
a net loss of $(17.7) million, or $(0.15) per basic and diluted
share for the year ended June 30, 2015. The increase in net loss
for the year ended June 30, 2016, compared to the net loss for the
year ended June 30, 2015 was primarily attributable to the increase
in development costs for the progression of the Phase 3 clinical
trials and development of bremelanotide for HSDD and secondarily
related to the license and contract revenue recognized in the year
ended June 30, 2015.
Revenue
There were no revenues recorded in the quarter or year ended June
30, 2016 or in the quarter ended June 30, 2015. For the year ended
June 30, 2015, Palatin recognized $12.9 million of license and
contract revenue under the agreement with Gedeon
Richter.
Operating Expenses
Operating expenses for the quarter ended June 30, 2016 were $12.7
million, compared to $11.8 million for the comparable quarter of
2015. For the year ended June 30, 2016, Palatin incurred $49.3
million of operating expenses, compared to $30.2 million for the
year ended June 30, 2015. The increase in operating expenses for
the quarter and the year ended June 30, 2016 was the result of an
increase in expenses primarily relating to the Phase 3 clinical
trial and development program with bremelanotide for
HSDD.
Other Income/Expense
Total other income (expense), net, was $(0.6) million for the
quarter ended June 30, 2016, compared to $(0.3) million for the
quarter ended June 30, 2015. For the year ended June 30, 2016,
total other income (expense), net, was $(2.5) million, compared to
$(0.9) million for the year ended June 30, 2015. Total other income
(expense) for both fiscal years ended June 30, 2016 and June 30,
2015 primarily consists of interest expense related to the venture
debt. The increase in total other income (expense), net, for the
year ended June 30, 2016 is due to the additional July 2015 venture
debt.
2
Cash Position
Palatin’s cash, cash equivalents and investments were $9.4
million as of June 30, 2016, compared to cash and cash equivalents
of $27.3 million at June 30, 2015. Current liabilities were $14.0
million as of June 30, 2016, compared to $7.4 million as of June
30, 2015.
Palatin believes that existing capital resources, together with
approximately $8.5 million received from the August 2016 financing,
will be adequate to fund our planned operations through the quarter
ending December 31, 2016. Assuming the double blind efficacy
portion of the Phase 3 clinical trial of bremelanotide for HSDD is
successful, as to which there can be no assurance, we will need
additional funding to complete required ancillary studies and
clinical trials, prepare and submit regulatory filings for product
approval, and establish commercial scale manufacturing
capability.
CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on September 20,
2016 at 11:00 a.m. Eastern Time to discuss the results of
operations in greater detail and an update on corporate
developments. Individuals interested in listening to the conference
call live can dial 1-888-516-2377 (domestic) or 1-719-457-2657
(international), conference code 3301810. 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), pass code 3301810. The webcast and
telephone replay will be available through September 27,
2016.
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.
3
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
4
PALATIN
TECHNOLOGIES, INC.
and
Subsidiary
Consolidated Statements of Operations
|
Year Ended June 30,
|
||
|
2016
|
2015
|
2014
|
|
|
|
|
REVENUES:
|
|
|
|
License
and contract
|
$-
|
$12,951,730
|
$-
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
Research
and development
|
43,071,051
|
24,560,233
|
10,826,921
|
General
and administrative
|
6,179,084
|
5,677,654
|
4,960,731
|
Total
operating expenses
|
49,250,135
|
30,237,887
|
15,787,652
|
|
|
|
|
Loss
from operations
|
(49,250,135)
|
(17,286,157)
|
(15,787,652)
|
|
|
|
|
OTHER
INCOME (EXPENSE):
|
|
|
|
Investment
income
|
50,226
|
35,439
|
18,923
|
Interest
expense
|
(2,513,027)
|
(661,697)
|
(6,211)
|
Foreign
exchange transaction loss
|
-
|
(284,656)
|
-
|
Total
other income (expense), net
|
(2,462,801)
|
(910,914)
|
12,712
|
|
|
|
|
Loss
before income taxes
|
(51,712,936)
|
(18,197,071)
|
(15,774,940)
|
Income
tax benefit
|
-
|
531,508
|
1,846,646
|
|
|
|
|
NET
LOSS
|
$(51,712,936)
|
$(17,665,563)
|
$(13,928,294)
|
|
|
|
|
Basic
and diluted net loss per common share
|
$(0.33)
|
$(0.15)
|
$(0.13)
|
|
|
|
|
Weighted
average number of common shares outstanding used in computing basic
and diluted net loss per common share
|
156,553,534
|
121,014,506
|
106,679,476
|
5
PALATIN TECHNOLOGIES, INC.
and
Subsidiary
Consolidated
Balance Sheets
|
June 30,
2016
|
June 30,
2015
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash
and cash equivalents
|
$8,002,668
|
$27,299,268
|
Available-for-sale
investments
|
1,380,556
|
-
|
Prepaid
expenses and other current assets
|
1,424,282
|
1,896,747
|
Total
current assets
|
10,807,506
|
29,196,015
|
|
|
|
Property
and equipment, net
|
97,801
|
123,158
|
Other
assets
|
146,428
|
155,279
|
Total
assets
|
$11,051,735
|
$29,474,452
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
Current
liabilities:
|
|
|
Accounts
payable
|
$713,890
|
$1,106,484
|
Accrued
expenses
|
7,767,733
|
6,223,483
|
Notes
payable, net of discount
|
5,485,392
|
-
|
Capital
lease obligations
|
27,424
|
25,871
|
Total
current liabilities
|
13,994,439
|
7,355,838
|
|
|
|
Notes
payable, net of discount
|
14,189,809
|
9,781,086
|
Capital
lease obligations
|
14,324
|
41,749
|
Other
non-current liabilities
|
439,130
|
91,304
|
Total
liabilities
|
28,637,702
|
17,269,977
|
|
|
|
Commitments
and contengencies (Note 11)
|
|
|
|
|
|
Stockholders’
(deficiency) equity:
|
|
|
Preferred
stock of $0.01 par value – authorized 10,000,000
shares;
|
|
|
Series
A Convertible; issued and outstanding 4,030 shares as of June 30,
2016 and 4,697 shares as of June 30, 2015,
respectively
|
40
|
47
|
Common
stock of $0.01 par value – authorized 300,000,000
shares;
|
|
|
issued
and outstanding 68,568,055 shares as of June 30, 2016 and
57,128,433 as of June 30, 2015, respectively
|
685,680
|
571,284
|
Additional
paid-in capital
|
325,142,509
|
303,332,460
|
Accumulated
other comprehensive loss
|
(1,944)
|
-
|
Accumulated
deficit
|
(343,412,252)
|
(291,699,316)
|
Total
stockholders’ (deficiency) equity
|
(17,585,967)
|
12,204,475
|
Total
liabilities and stockholders’ equity
|
$11,051,735
|
$29,474,452
|
6