UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act Of 1934
Date of Report (Date of earliest event reported): November 14, 2012
Palatin Technologies, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-15543 | 95-4078884 |
| (State or other jurisdiction | (Commission | (IRS employer |
| of incorporation) | File Number) | identification number) |
| 4B Cedar Brook Drive, Cranbury, NJ | 08512 |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (609) 495-2200
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
£Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
£Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
£Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
£Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On November 14, 2012, we issued a press release including results for our first quarter ended September 30, 2012, and announcing a teleconference and webcast to be held November 14, 2012 at 11:00 a.m. Eastern Time, which will include a discussion of positive top-line results, including the achievement of statistical significance for the primary endpoint and key secondary endpoints, in our Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for treatment of female sexual dysfunction. We have attached a copy of the press release as an exhibit to this report.
The information in this Item 2.02 and the corresponding information in the attached Exhibit 99 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information contained in this Item 2.02 and the corresponding information in the attached Exhibit 99 shall not be incorporated into any registration statement or other document filed with the Securities and Exchange Commission by the company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
| 99 | Press Release dated November 14, 2012 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PALATIN TECHNOLOGIES, INC. | |||
| Date: November 14, 2012 | By: | /s/ Stephen T. Wills | |
|
Stephen T. Wills, CPA, MST Executive Vice President, Chief Financial Officer and Chief Operating Officer |
|||
EXHIBIT INDEX
99 Press Release dated November 14, 2012
Palatin Technologies, Inc. 8-K
Exhibit 99.1
Palatin Technologies, Inc. Reports First Quarter Fiscal Year 2013 Results; Teleconference and Webcast to be held on November 14, 2012
CRANBURY, NJ – November 14, 2012 – 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 first quarter ended September 30, 2012.
Recent Highlights
On July 3, 2012, Palatin closed on a private placement of 3,873,000 shares of its common stock, Series A 2012 warrants to purchase up to 31,988,151 shares of its common stock, and Series B 2012 warrants to purchase up to 35,488,380 shares of its common stock. Aggregate gross proceeds to Palatin were $35,000,000, with net proceeds, after deducting offering expenses, of $34,407,446.
On September 27, 2012, at a special meeting Palatin stockholders voted to increase its authorized common stock from 100,000,000 to 200,000,000 shares, and Palatin filed a certificate of amendment with the Secretary of State of Delaware the same day. This satisfied certain contractual obligations relating to the Series B 2012 warrants in its 2012 private placement, so that interest will not be payable on the value of the Series B 2012 warrants and Palatin will not be required to redeem the Series B 2012 warrants for failure to increase the number of authorized shares.
On November 8, 2012, Palatin reported positive top-line results, including the successful achievement of statistical significance for the primary endpoint and key secondary endpoints in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for treatment of female sexual dysfunction (FSD). The primary endpoint data analysis of 327 pre-menopausal women with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or a combination of both disorders, the most common types of FSD, demonstrate that women taking bremelanotide showed clinically meaningful and statistically significant increases in the number of Satisfying Sexual Events (SSEs) and also showed clinically meaningful and statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared to placebo. Bremelanotide was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. Adverse events that most commonly led to discontinuation were nausea and emesis. No serious adverse events were attributable to bremelanotide during the trial. Based on the results of discussions with the U.S. Food and Drug Administration (FDA) and external advisors regarding the results of this trial and further development steps, Phase 3 activities are anticipated to start in the second-half of calendar year 2013.
First Quarter Fiscal 2013 Financial Results
Palatin reported a net loss of $10.5 million, or $(0.15) per basic and diluted share, for the quarter ended September 30, 2012, compared to a net loss of $3.4 million, or $(0.10) per basic and diluted share, for the same period in 2011.
The increase in net loss for the quarter ended September 30, 2012, compared to the same period last fiscal year, was mainly attributable to a non-cash, non-operating expense of $7.1 million, which represented the increase in fair value of the warrants, which were previously liability classified until our increase in our authorized shares.
Costs and Expenses
Total operating expenses were $3.4 million for the quarter ended September 30, 2012 and September 30, 2011. Operating expenses consist of $1.1 million of general and administrative expenses and $2.3 million of research and development for the quarter ended September 30, 2012 and 2011. General and administrative expenses consist mainly of compensation and related costs and research and development expenses are primarily costs relating to Palatin’s Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for the treatment of FSD.
Cash Position
Palatin’s cash and cash equivalents were
$33.5 million as of September 30, 2012, compared to $3.8 million at June 30, 2012, with current liabilities of $1.6 million as
of September 30, 2012 compared to $3.5 million as of June 30, 2012.
Palatin believes that its existing capital resources will be adequate to fund its currently planned operations, including completing analysis of results of the Company’s Phase 2B clinical trial with bremelanotide for FSD, submitting an end-of-phase 2 meeting request to the FDA, and commencing Phase 3 activities, through at least calendar year 2013.
CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on November 14, 2012 at 11:00 a.m. Eastern Time to discuss the results of operations and an update on corporate developments in greater detail. Individuals interested in listening to the conference call live can dial 1-888-428-9460 (domestic) or 1-719-325-2354 (international), pass code 9649528. The webcast and replay can be accessed by logging on to the “Investor/Media Center-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 9649528. The webcast and telephone replay will be available through November 20, 2012.
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.
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:
Carney Noensie, Burns McClellan
Vice President, Investor Relations
Tel: (212) 213-0006 / cnoensie@burnsmc.com
###
(Financial Statement Data Follows)
| PALATIN TECHNOLOGIES, INC. | ||||||||
| and Subsidiary | ||||||||
| Consolidated Statements of Operations | ||||||||
| (unaudited) | ||||||||
| Three Months Ended September 30, | ||||||||
| 2012 | 2011 | |||||||
| REVENUES: | $ | 3,806 | $ | 27,217 | ||||
| OPERATING EXPENSES: | ||||||||
| Research and development | 2,343,313 | 2,284,383 | ||||||
| General and administrative | 1,061,016 | 1,109,382 | ||||||
| Total operating expenses | 3,404,329 | 3,393,765 | ||||||
| Loss from operations | (3,400,523 | ) | (3,366,548 | ) | ||||
| OTHER INCOME (EXPENSE): | ||||||||
| Investment income | 14,371 | 15,040 | ||||||
| Interest expense | (2,282 | ) | (2,973 | ) | ||||
| Increase in fair value of warrants | (7,069,165 | ) | — | |||||
| Gain on disposition of supplies and equipment | 4,620 | — | ||||||
| Total other income (expense), net | (7,052,456 | ) | 12,067 | |||||
| NET LOSS | $ | (10,452,979 | ) | $ | (3,354,481 | ) | ||
| Basic and diluted net loss per common share | $ | (0.15 | ) | $ | (0.10 | ) | ||
| Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share | 71,669,170 | 34,900,591 | ||||||
| PALATIN TECHNOLOGIES, INC. | ||||||||
| and Subsidiary | ||||||||
| Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| September 30, 2012 | June 30, 2012 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 33,461,066 | $ | 3,827,198 | ||||
| Accounts receivable | 31,437 | 27,631 | ||||||
| Restricted cash | — | 350,000 | ||||||
| Prepaid expenses and other current assets | 851,844 | 532,010 | ||||||
| Total current assets | 34,344,347 | 4,736,839 | ||||||
| Property and equipment, net | 299,735 | 318,653 | ||||||
| Other assets | 58,748 | 324,992 | ||||||
| Total assets | $ | 34,702,830 | $ | 5,380,484 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Capital lease obligations | $ | 22,707 | $ | 22,277 | ||||
| Accounts payable | 321,621 | 294,894 | ||||||
| Accrued expenses | 1,285,215 | 2,706,496 | ||||||
| Accrued compensation | — | 433,333 | ||||||
| Total current liabilities | 1,629,543 | 3,457,000 | ||||||
| Capital lease obligations | 14,068 | 19,909 | ||||||
| Deferred rent | 63,372 | 72,677 | ||||||
| Total liabilities | 1,706,983 | 3,549,586 | ||||||
| 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 September 30, 2012 and 4,997 as of June 30, 2012 | 47 | 50 | ||||||
| Common stock of $0.01 par value – authorized 200,000,000 shares; | ||||||||
| issued and outstanding 38,947,912 shares as of September 30, 2012 and 34,900,591 as of June 30, 2012, respectively | 389,479 | 349,006 | ||||||
| Additional paid-in capital | 282,302,585 | 240,725,127 | ||||||
| Accumulated deficit | (249,696,264 | ) | (239,243,285 | ) | ||||
| Total stockholders’ equity | 32,995,847 | 1,830,898 | ||||||
| Total liabilities and stockholders’ equity | $ | 34,702,830 | $ | 5,380,484 | ||||