CRANBURY, N.J., Feb. 9, 2017 /PRNewswire/ -- 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.
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 receptor-1 agonist peptides for treatment of inflammatory and dermatologic
disease indications, natriuretic peptide receptor-A 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.
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.
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PALATIN TECHNOLOGIES, INC.
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and Subsidiary
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Consolidated Statements of Operations
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(unaudited)
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|
|
|
|
|
|
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Three Months Ended December 31,
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Six Months Ended December 31,
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2016
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2015
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2016
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2015
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REVENUES:
|
|
|
|
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License revenue
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$
-
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|
$
-
|
|
$
-
|
|
$
-
|
|
|
|
|
|
|
|
|
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OPERATING EXPENSES:
|
|
|
|
|
|
|
|
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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
|
|
|
|
|
|
|
|
|
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Loss from operations
|
(9,440,875)
|
|
(12,628,424)
|
|
(21,876,305)
|
|
(24,426,075)
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|
|
|
|
|
|
|
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OTHER INCOME (EXPENSE):
|
|
|
|
|
|
|
|
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Interest income
|
5,991
|
|
8,234
|
|
12,636
|
|
23,974
|
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Interest expense
|
(594,535)
|
|
(629,494)
|
|
(1,218,520)
|
|
(1,257,502)
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Total other income (expense), net
|
(588,544)
|
|
(621,260)
|
|
(1,205,884)
|
|
(1,233,528)
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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NET LOSS
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$ (10,029,419)
|
|
$ (13,249,684)
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|
$ (23,082,189)
|
|
$ (25,659,603)
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|
|
|
|
|
|
|
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Basic and diluted net loss per common share
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$ (0.06)
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|
$ (0.08)
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|
$ (0.13)
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|
$ (0.16)
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|
|
|
|
|
|
|
|
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Weighted average number of common shares outstanding used in computing
basic and diluted net loss per common share
|
177,798,511
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|
156,358,586
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|
171,823,390
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|
156,268,094
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PALATIN TECHNOLOGIES, INC.
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and Subsidiary
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Consolidated Balance Sheets
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(unaudited)
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December 31, 2016
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June 30, 2016
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ASSETS
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Current assets:
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Cash and cash equivalents
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$ 12,114,581
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$
8,002,668
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Available-for-sale investments
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1,375,959
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1,380,556
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Prepaid expenses and other current assets
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838,260
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1,313,841
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Total current assets
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14,328,800
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10,697,065
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Property and equipment, net
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82,540
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|
97,801
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Other assets
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56,916
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|
63,213
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Total assets
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$ 14,468,256
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|
$ 10,858,079
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|
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LIABILITIES AND STOCKHOLDERS' DEFICIENCY
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Current liabilities:
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|
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Accounts payable
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$
4,706,014
|
|
$
713,890
|
|
Accrued expenses
|
7,446,825
|
|
7,767,733
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Notes payable, net of discount and debt issuance costs
|
7,427,445
|
|
5,374,951
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|
Capital lease obligations
|
28,214
|
|
27,424
|
|
Total current liabilities
|
19,608,498
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|
13,883,998
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|
|
|
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Notes payable, net of discount and debt issuance costs
|
10,210,275
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|
14,106,594
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Capital lease obligations
|
-
|
|
14,324
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|
Other non-current liabilities
|
607,488
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|
439,130
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Total liabilities
|
30,426,261
|
|
28,444,046
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Stockholders' deficiency:
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Preferred stock of $0.01 par value – authorized 10,000,000
shares:
|
|
|
|
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Series A Convertible: issued and outstanding 4,030 shares as of December
31, 2016 and June 30, 2016
|
40
|
|
40
|
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Common stock of $0.01 par value – authorized 300,000,000 shares:
|
|
|
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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
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|
685,680
|
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Additional paid-in capital
|
349,204,164
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|
325,142,509
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Accumulated other comprehensive loss
|
(2,006)
|
|
(1,944)
|
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Accumulated deficit
|
(366,494,441)
|
|
(343,412,252)
|
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Total stockholders' deficiency
|
(15,958,005)
|
|
(17,585,967)
|
|
Total liabilities and stockholders' deficiency
|
$ 14,468,256
|
|
$ 10,858,079
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/palatin-technologies-inc-reports-second-quarter-fiscal-year-2017-results-teleconference-and-webcast-to-be-held-on-february-9-2017-300404755.html
SOURCE Palatin Technologies, Inc.