Delaware
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001-15543
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95-4078884
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(State or other jurisdiction
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(Commission
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(IRS employer
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of incorporation)
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File Number)
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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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o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
PALATIN TECHNOLOGIES, INC.
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Date: February 16, 2016
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By:
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/s/ Stephen T. Wills | |
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):
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¤
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Palatin’s two Phase 3 clinical trials for the treatment of FSD initiated in December 2014 and January 2015 are progressing as planned and meeting target objectives.
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¤
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Patient enrollment was completed in the fourth quarter of 2015.
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¤
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Top-line results are expected to be released in the third quarter of calendar year 2016.
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¤
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The clinical trials are designed to randomize approximately 1,100 women (~550 each trial) to evaluate efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder as an on-demand, as-needed treatment. For more information visit reconnectstudy.com.
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Three Months Ended December 31,
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Six Months Ended December 31,
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2015
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2014
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2015
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2014
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REVENUES:
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||||||||||||||||
License revenue
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$ | - | $ | 8,019,415 | $ | - | $ | 12,951,730 | ||||||||
OPERATING EXPENSES:
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||||||||||||||||
Research and development
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11,272,307 | 4,273,571 | 21,870,021 | 7,197,537 | ||||||||||||
General and administrative
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1,356,117 | 1,423,206 | 2,556,054 | 2,537,667 | ||||||||||||
Total operating expenses
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12,628,424 | 5,696,777 | 24,426,075 | 9,735,204 | ||||||||||||
(Loss) income from operations
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(12,628,424 | ) | 2,322,638 | (24,426,075 | ) | 3,216,526 | ||||||||||
OTHER INCOME (EXPENSE):
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||||||||||||||||
Interest income
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8,234 | 6,199 | 23,974 | 9,998 | ||||||||||||
Interest expense
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(629,494 | ) | (31,857 | ) | (1,257,502 | ) | (33,587 | ) | ||||||||
Foreign exchange transaction loss
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- | (51,700 | ) | - | (152,983 | ) | ||||||||||
Total other income (expense), net
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(621,260 | ) | (77,358 | ) | (1,233,528 | ) | (176,572 | ) | ||||||||
(Loss) income before income taxes
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(13,249,684 | ) | 2,245,280 | (25,659,603 | ) | 3,039,954 | ||||||||||
Income tax benefit
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- | 531,508 | - | 531,508 | ||||||||||||
NET (LOSS) INCOME
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(13,249,684 | ) | 2,776,788 | (25,659,603 | ) | 3,571,462 | ||||||||||
Basic net (loss) income per common share
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$ | (0.08 | ) | $ | 0.03 | $ | (0.16 | ) | $ | 0.03 | ||||||
Diluted net (loss) income per common share
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$ | (0.08 | ) | $ | 0.03 | $ | (0.16 | ) | $ | 0.03 | ||||||
Weighted average number of common shares outstanding used in computing basic net (loss) income per common share
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156,358,586 | 109,314,460 | 156,268,094 | 108,134,179 | ||||||||||||
Weighted average number of common shares outstanding used in computing diluted net (loss) income per common share
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156,358,586 | 109,815,718 | 156,268,094 | 108,888,313 |
December 31,
2015
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June 30,
2015
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ASSETS
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Current assets:
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Cash and cash equivalents
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$ | 31,990,606 | $ | 27,299,268 | ||||
Available-for-sale investments
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1,377,633 | - | ||||||
Prepaid expenses and other current assets
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1,716,058 | 1,896,747 | ||||||
Total current assets
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35,084,297 | 29,196,015 | ||||||
Property and equipment, net
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118,660 | 123,158 | ||||||
Other assets
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191,074 | 155,279 | ||||||
Total assets
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$ | 35,394,031 | $ | 29,474,452 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current liabilities:
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||||||||
Accounts payable
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$ | 2,376,279 | $ | 1,106,484 | ||||
Accrued expenses
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5,646,697 | 6,223,483 | ||||||
Notes payable, net of discount
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1,909,821 | - | ||||||
Capital lease obligations
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26,636 | 25,871 | ||||||
Total current liabilities
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9,959,433 | 7,355,838 | ||||||
Notes payable, net of discount, net of current portion
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17,665,725 | 9,781,086 | ||||||
Capital lease obligations
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28,236 | 41,749 | ||||||
Other non-current liabilities
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265,217 | 91,304 | ||||||
Total liabilities
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27,918,611 | 17,269,977 | ||||||
Stockholders’ equity:
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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, 2015 and 4,697 shares as of June 30, 2015, respectively
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40 | 47 | ||||||
Common stock of $0.01 par value – authorized 300,000,000 shares;
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||||||||
issued and outstanding 68,030,008 shares as of December 31, 2015 and 57,128,433 shares as of June 30, 2015, respectively
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680,300 | 571,284 | ||||||
Additional paid-in capital
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324,163,388 | 303,332,460 | ||||||
Accumulated other comprehensive loss
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(9,389 | ) | - | |||||
Accumulated deficit
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(317,358,919 | ) | (291,699,316 | ) | ||||
Total stockholders’ equity
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7,475,420 | 12,204,475 | ||||||
Total liabilities and stockholders’ equity
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$ | 35,394,031 | $ | 29,474,452 |