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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Palatin Technologies Inc New | AMEX:PTN | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.01 | 0.54% | 1.87 | 1.95 | 1.81 | 1.86 | 135,569 | 00:52:33 |
Delaware
|
001-15543
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95-4078884
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(State or other jurisdiction
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(Commission
|
(IRS employer
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of incorporation)
|
File Number)
|
identification number)
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4B Cedar Brook Drive, Cranbury, NJ
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08512
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(Address of principal executive offices)
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(Zip Code)
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PALATIN TECHNOLOGIES, INC.
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|||
Date: September 21, 2015
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By:
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/s/ Stephen T. Wills
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|
Stephen T. Wills, CPA, MST
Executive Vice President, Chief Financial Officer and Chief Operating Officer
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●
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Bremelanotide development for Female Sexual Dysfunction (FSD):
|
o
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Palatin initiated Protocols 301 and 302 of its Phase 3 reconnect study in the United States and Canada for the treatment of FSD in December 2014 and January 2015, respectively. Further information on the trial protocols can be found at clinicaltrials.gov.
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■ |
The two Phase 3 studies are progressing as planned and meeting target objectives.
|
■
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Enrollment is greater than 50% to date and is expected to be completed in the fourth quarter of calendar year 2015.
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■
|
Top-line data is expected to be available in the third quarter of calendar year 2016.
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■
|
The clinical trials are designed to randomize approximately 1100 women (~550 per trial) to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder as an on-demand, as-needed treatment. For further information visit reconnectstudy.com.
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●
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Business Development
|
o
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FSD Program
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■
|
August 2014, Palatin entered into a license agreement with Gedeon Richter (Richter) to co-develop and commercialize bremelanotide for FSD in the European Union, other European countries and additional selected countries. Palatin received €7.5 million ($9.8 million) in total upfront payments from Richter, and a milestone payment of €2.5 million ($3.1 million) upon the initiation of its Phase 3 clinical trial program in the United States.
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■
|
September 2015, Palatin entered into a termination agreement pursuant to which Palatin and Richter agreed to mutually and amicably terminate the license agreement. In connection with this termination, all rights and licenses to co-develop and commercialize bremelanotide for FSD indications held by Richter have terminated and reverted back to Palatin. Neither we nor Gedeon Richter have any future material obligations under the license agreement. There are no payment or reimbursement obligations as a result of the license agreement termination.
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■
|
Palatin now has the global rights to bremelanotide for FSD, providing the Company and its business development efforts with additional options and flexibility.
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■
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Palatin is actively engaged in licensing and collaboration discussions with multiple companies for both global and regional commercial rights to bremelanotide.
|
o
|
Natriuretic Peptide Program for Heart Failure (HF)
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■
|
Palatin is advancing its lead compound, PL-3994, towards a Phase 2A multiple dose study in HF patients.
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■
|
The Company is actively engaged in licensing and collaboration discussions with multiple companies for both global and regional rights.
|
o
|
MC1r Anti-Inflammatory Program
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■
|
Palatin is advancing its lead compound, PL-8177, towards a Phase 1 clinical trial.
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■
|
The Company is actively engaged in licensing and collaboration discussions with multiple companies for both global and regional rights.
|
o
|
MC4r Agonist Program for Obesity/Diabetes
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■
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The research collaboration and license agreement dated January 2007 with AstraZeneca (AZ) expired because AZ ceased developing a compound covered by the agreement. All rights and licenses that we granted to AZ were returned to Palatin upon expiration of the agreement.
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■
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Palatin is advancing its lead compound, PL-8905, towards a Phase 1 clinical trial.
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■
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The Company is actively engaged in licensing and collaboration discussions with multiple companies for both global and regional rights.
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●
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Financing Transactions
|
o
|
July 2015, Palatin closed on $30 million of debt and equity financing consisting of:
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■
|
$10 million venture loan, which includes an interest-only payment period for the first eighteen months of a four year secured term loan.
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■
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$20 million private placement of Series E warrants to purchase 21,917,808 shares of common stock and Series F warrants to purchase 2,191,781 shares of common stock.
|
o
|
December 2014, Palatin closed on $30 million of debt and equity financing consisting of:
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■
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$10 million venture loan, which includes an interest-only payment period for the first eighteen months of a four year secured term loan.
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■
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$20 million private placement of 2,050,000 shares of common stock and Series warrants to purchase 24,919,325 shares of common stock.
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●
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Intellectual Property - Palatin obtained patents during the year:
|
o
|
U.S. Patent 8,828,926 issued September 9, 2014, claiming uses of Palatin’s PL-3994 natriuretic peptide receptor product candidate for treatment of acute asthma and chronic obstructive pulmonary disease.
|
o
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U.S. Patent 8,846,601 issued September 30, 2014, claiming melanocortin receptor 4 specific peptides with potential utility for treatment of obesity, metabolic syndrome, diabetes and sexual dysfunction.
|
o
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U.S. Patent 8,877,890 issued November 2014, claiming melanocortin receptor-1 cyclic peptides with potential application in treatment of inflammatory and dermatologic disease indications.
|
o
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U.S. Patent 8,933,194 issued January 13, 2015, claiming linear melanocortin receptor 1 specific peptides
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●
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In December 2014, Palatin received $0.5 million in net proceeds from the sale of New Jersey State net operating loss carryforwards.
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Palatin Technologies Investor Inquiries:
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Palatin Technologies Media Inquiries:
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Stephen T. Wills, CPA, MST
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Paul Arndt, MBA, LifeSci Advisors, LLC
|
Chief Operating Officer / Chief Financial Officer
|
Managing Director
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Tel: (609) 495-2200 / info@Palatin.com
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Tel: (646) 597-6992 / Paul@LifeSciAdvisors.com
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Year Ended June 30,
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||||||||||||
2015
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2014
|
2013
|
||||||||||
REVENUES:
|
||||||||||||
License and contract
|
$ | 12,951,730 | $ | - | $ | 10,361 | ||||||
OPERATING EXPENSES:
|
||||||||||||
Research and development
|
24,560,233 | 10,826,921 | 10,528,691 | |||||||||
General and administrative
|
5,677,654 | 4,960,731 | 5,066,830 | |||||||||
Total operating expenses
|
30,237,887 | 15,787,652 | 15,595,521 | |||||||||
Loss from operations
|
(17,286,157 | ) | (15,787,652 | ) | (15,585,160 | ) | ||||||
OTHER INCOME (EXPENSE):
|
||||||||||||
Investment income
|
35,439 | 18,923 | 42,734 | |||||||||
Interest expense
|
(661,697 | ) | (6,211 | ) | (8,411 | ) | ||||||
Foreign exchange transaction loss
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(284,656 | ) | - | - | ||||||||
Increase in fair value of warrants
|
- | - | (7,069,165 | ) | ||||||||
Gain on disposition of supplies and equipment
|
- | - | 4,620 | |||||||||
Total other income (expense), net
|
(910,914 | ) | 12,712 | (7,030,222 | ) | |||||||
Loss before income taxes
|
(18,197,071 | ) | (15,774,940 | ) | (22,615,382 | ) | ||||||
Income tax benefit
|
531,508 | 1,846,646 | 1,753,208 | |||||||||
NET LOSS
|
$ | (17,665,563 | ) | $ | (13,928,294 | ) | $ | (20,862,174 | ) | |||
Basic and diluted net loss per common share
|
$ | (0.15 | ) | $ | (0.13 | ) | $ | (0.21 | ) | |||
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share
|
121,014,506 | 106,679,476 | 97,618,714 |
June 30, 2015
|
June 30, 2014
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 27,299,268 | $ | 12,184,605 | ||||
Prepaid expenses and other current assets
|
1,896,747 | 156,393 | ||||||
Total current assets
|
29,196,015 | 12,340,998 | ||||||
Property and equipment, net
|
123,158 | 160,748 | ||||||
Other assets
|
155,279 | 57,308 | ||||||
Total assets
|
$ | 29,474,452 | $ | 12,559,054 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 1,106,484 | $ | 261,280 | ||||
Accrued expenses
|
6,223,483 | 1,508,958 | ||||||
Capital lease obligations
|
25,871 | - | ||||||
Unearned revenue
|
- | 1,000,000 | ||||||
Total current liabilities
|
7,355,838 | 2,770,238 | ||||||
Notes payable, net of discount
|
9,781,086 | - | ||||||
Capital lease obligations
|
41,749 | - | ||||||
Other non-current liabilities
|
91,304 | - | ||||||
Total liabilities
|
17,269,977 | 2,770,238 | ||||||
Stockholders’ equity:
|
||||||||
Preferred stock of $0.01 par value – authorized 10,000,000 shares;
|
||||||||
Series A Convertible; issued and outstanding 4,697 shares as of June 30, 2015 and 2014, respectively
|
47 | 47 | ||||||
Common stock of $0.01 par value – authorized 300,000,000 shares;
|
||||||||
issued and outstanding 57,128,433 shares as of June 30, 2015 and 39,416,595 as of June 30, 2014, respectively
|
571,284 | 394,166 | ||||||
Additional paid-in capital
|
303,332,460 | 283,428,356 | ||||||
Accumulated deficit
|
(291,699,316 | ) | (274,033,753 | ) | ||||
Total stockholders’ equity
|
12,204,475 | 9,788,816 | ||||||
Total liabilities and stockholders’ equity
|
$ | 29,474,452 | $ | 12,559,054 |
1 Year Palatin Technologies Chart |
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