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8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INCptn_8k.htm
 
Exhibit 99.1
 
 
 
Palatin Technologies, Inc. Reports First Quarter
Fiscal Year 2017 Results;
Teleconference and Webcast to be held on November 15, 2016
 
CRANBURY, NJ – November 15, 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 results for its first quarter ended September 30, 2016.
 
Recent Highlights
Bremelanotide - Under development for Hypoactive Sexual Desire Disorder (HSDD):
-
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, reflecting clinical meaningfulness and statistical significance.
-
Last patient visits for the efficacy portion of the trials were completed in the third quarter of calendar year 2016.
-
New Drug Application (NDA) submission to the FDA targeted for the second half of 2017.
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
 
First Quarter Fiscal 2017 Financial Results
Palatin reported a net loss of $(13.1) million, or $(0.08) per basic and diluted share, for the quarter ended September 30, 2016, compared to a net loss of $(12.4) million, or $(0.08) per basic and diluted share, for the same period in 2015.
 
The difference between the three months ended September 30, 2016 and 2015 was primarily attributable to the increase in expenses relating to our bremelanotide program for HSDD in the quarter ended September 30, 2016.
 
 
 
 
Revenue
There were no revenues recorded in the quarters ended September 30, 2016 and 2015.
 
Operating Expenses
Total operating expenses for the quarter ended September 30, 2016 were $12.4 million compared to $11.8 million for the comparable quarter of 2015. The increase in operating expenses for the quarter ended September 30, 2016 was the result of an increase in expenses primarily relating to our bremelanotide program for HSDD.
 
Other Income/Expense
Total other income (expense), net, was $(0.6) million for the quarters ended September 30, 2016 and 2015 consisting primarily of interest expense related to venture debt.
 
Cash Position
Palatin’s cash, cash equivalents and investments were $10.2 million as of September 30, 2016, compared to cash and cash equivalents of $9.4 million at June 30, 2016. Current liabilities were $20.5 million as of September 30, 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 the quarter ending December 31, 2016.
 
CONFERENCE CALL / AUDIO WEBCAST
Palatin will host a conference call and audio webcast on November 15, 2016 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 1-888-503-8171 (domestic) or 1-719-457-2664 (international), conference ID 9405459. 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 audio 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), passcode 9405459. The audio webcast and telephone replay will be available through November 22, 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.
-More-
 
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
 
 
###
(Financial Statement Data Follows)
 
 
PALATIN TECHNOLOGIES, INC.
and Subsidiary
 
Consolidated Statements of Operations
 
 
(unaudited)
 
 
 
 
 
 
 
 
 
 
Three Months Ended September 30,
 
 
 
2016
 
 
2015
 
 
 
 
 
 
 
 
REVENUES:
 
 
 
 
 
 
License revenue
 $- 
 $- 
 
    
    
OPERATING EXPENSES:
    
    
Research and development
  11,226,084 
  10,597,714 
General and administrative
  1,209,346 
  1,199,937 
Total operating expenses
  12,435,430 
  11,797,651 
 
    
    
Loss from operations
  (12,435,430)
  (11,797,651)
 
    
    
OTHER INCOME (EXPENSE):
    
    
Interest income
  6,645 
  15,740 
Interest expense
  (623,985)
  (628,008)
Total other income (expense), net
  (617,340)
  (612,268)
 
    
    
 
    
    
NET LOSS
 $(13,052,770)
 $(12,409,919)
 
    
    
Basic and diluted net loss per common share
 $(0.08)
 $(0.08)
 
    
    
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share
  165,848,269 
  156,176,618 
 
 
 
 
 
PALATIN TECHNOLOGIES, INC.
and Subsidiary
 
 
Consolidated Balance Sheets
 
 
(unaudited)
 
 
 
 
 
 
 
 
 
 
September 30, 2016
 
 
June 30, 2016
 
ASSETS
 
 
 
 
 
 
Current assets:
 
 
 
 
 
 
Cash and cash equivalents
 $8,867,930 
 $8,002,668 
Available-for-sale investments
  1,377,714 
  1,380,556 
Prepaid expenses and other current assets
  1,007,978 
  1,313,841 
Total current assets
  11,253,622 
  10,697,065 
 
    
    
Property and equipment, net
  90,171 
  97,801 
Other assets
  56,916 
  63,213 
Total assets
 $11,400,709 
 $10,858,079 
 
    
    
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY
    
    
Current liabilities:
    
    
Accounts payable
 $1,159,427 
 $713,890 
Accrued expenses
  12,884,590 
  7,767,733 
Notes payable, net of discount and debt issuance costs
  6,399,075 
  5,374,951 
Capital lease obligations
  27,827 
  27,424 
Total current liabilities
  20,470,919 
  13,883,998 
 
    
    
Notes payable, net of discount and debt issuance costs
  12,162,471 
  14,106,594 
Capital lease obligations
  7,214 
  14,324 
Other non-current liabilities
  525,314 
  439,130 
Total liabilities
  33,165,918 
  28,444,046 
 
    
    
Stockholders’ deficiency:
    
    
Preferred stock of $0.01 par value – authorized 10,000,000 shares:
    
    
Series A Convertible: issued and outstanding 4,030 shares as of September 30, 2016 and June 30, 2016
  40 
  40 
Common stock of $0.01 par value – authorized 300,000,000 shares:
    
    
issued and outstanding 92,806,710 shares as of September 30, 2016 and 68,568,055 shares as of June 30, 2016, respectively
  928,067 
  685,680 
Additional paid-in capital
  333,774,227 
  325,142,509 
Accumulated other comprehensive loss
  (2,521)
  (1,944)
Accumulated deficit
  (356,465,022)
  (343,412,252)
Total stockholders’ deficiency
  (21,765,209)
  (17,585,967)
Total liabilities and stockholders’ deficiency
 $11,400,709 
 $10,858,079