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Palatin Technologies, Inc. Reports Second Fiscal Quarter 2019 Results and Provides Corporate Update

Teleconference and Webcast to be held on February 12, 2019

CRANBURY, N.J., Feb. 12, 2019 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its second quarter ended December 31, 2018. 

Palatin Technologies, Inc.

Recent Highlights and Program Updates

Female Sexual Dysfunction / Vyleesi™ (bremelanotide)

  • Vyleesi, the trade name for bremelanotide - Under development for Hypoactive Sexual Desire Disorder ("HSDD"):

Anti-Inflammatory / Autoimmune Programs

  • Melanocortin receptor 1 and 1/5 ("MC1r", "MC1/5r") agonists under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases:

Natriuretic Peptide Receptor ("NPR") System Program

  • We have designed and are developing potential NPR candidate drugs that are selective for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C"):

Genetic Obesity Program

  • Melanocortin receptor 4 ("MC4r") peptide PL-8905 and orally-active small molecule PL-9610 under development for the treatment of rare genetic metabolic and obesity disorders:

Corporate

  • Decreased debt and related liabilities from $7.2 million at June 30, 2018 to $2.8 million at December 31, 2018.

Second Quarter Fiscal 2019 Financial Results
Palatin reported a net loss of $(5.0) million, or $(0.02) per basic and diluted share, for the quarter ended December 31, 2018, compared to net income of $3.0 million, or $0.02 per basic and $0.01 per diluted share, for the same period in 2017.    

The difference in financial results between the three months ended December 31, 2018 and 2017 was primarily attributable to the recognition of $10.6 million in license and contract revenue during the 2017 period pursuant to our license agreement with AMAG.

Revenue
There were no revenues recorded in the quarter ended December 31, 2018.

For the quarter ended December 31, 2017, 100% of the revenue Palatin recognized was related to our license agreement with AMAG.

Operating Expenses
Total operating expenses for the quarter ended December 31, 2018 were $5.1 million compared to $7.7 million for the comparable quarter of 2017.  The decrease in operating expenses was mainly attributable to the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA in HSDD in March 2018.

Other Income/Expense
Total other income, net was $7,871 for the quarter ended December 31, 2018 compared to total other expenses, net $(0.3) million for the quarter ended December 31, 2017.  The difference is related primarily to the decrease in interest expense related to Palatin's venture debt.

Income Tax
There was no income tax expense, or benefit, recorded in the quarter ended December 31, 2018.

Pursuant to the license agreements with Fosun and Kwangdong, $500,000 and $82,500, respectively, was withheld in accordance with tax withholding requirements in China and the Republic of Korea, respectively, and was recorded as an expense during the fiscal year ended June 30, 2018. For the quarter ended December 31, 2017, Palatin recorded $100,880 in income tax expense related to those withholding amounts utilizing an estimated effective annual income tax rate applied to income for the quarter and the remaining balance of $256,365 was included in prepaid expenses and other current assets at December 31, 2017. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin's valuation allowance.  The $100,880 of income tax expense was offset by a $500,000 tax benefit that Palatin recorded in the quarter ended December 31, 2017 related to the release of a valuation allowance against Palatin's federal alternative minimum tax credit as a result of the Tax Cuts and Jobs Act signed in December 2017.  Accordingly, $500,000 was included in other long-term assets at December 31, 2017.

Cash Position
Palatin's cash, and cash equivalents were $24.7 million as of December 31, 2018, compared to cash and cash equivalents of $38.0 million at June 30, 2018.  Current liabilities were $4.5 million as of December 31, 2018, compared to $10.8 million as of June 30, 2018.

Palatin believes that existing capital resources will be sufficient to fund our planned operations through at least March 31, 2020.

Palatin Drug Discovery Programs
In the conference call and webcast, management will update and discuss next steps in Palatin's portfolio of drug development programs. These include Palatin's MC1r and MC1/5r agonist peptides for treatment of anti-inflammatory and autoimmune indications, MC4r peptide and small molecule agonists for the treatment of genetic obesity indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and pulmonary indications.

Conference Call / Webcast
Palatin will host a conference call and webcast on February 12, 2019 at 11:00 a.m. Eastern Time to discuss the quarter ended December 31, 2018 results of operations in greater detail and provide an update on corporate developments.  Individuals interested in listening to the conference call live can dial 1-877-260-1479 (US/Canada) or 1-334-323-0522 (international), conference ID 4414047.  The 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 (US/Canada) or 1-719-457-0820 (international), passcode 4414047.  The webcast and telephone replay will be available through February 19, 2019.

About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, with targeted, receptor-specific product candidates 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.

(Financial Statement Data Follows)

 

PALATIN TECHNOLOGIES, INC.

and Subsidiary

Consolidated Statements of Operations

(unaudited)












Three Months Ended December 31,


Six Months Ended December 31,



2018


2017


2018


2017










REVENUES:









License and contract


$                       -


$        10,612,153


$               34,505


$        37,553,661










OPERATING EXPENSES:









Research and development


2,961,656


6,045,884


6,584,347


20,208,981

General and administrative


2,088,565


1,625,189


4,129,147


3,169,764

Total operating expenses


5,050,221


7,671,073


10,713,494


23,378,745










(Loss) income from operations


(5,050,221)


2,941,080


(10,678,989)


14,174,916










OTHER INCOME (EXPENSE):









Investment income


100,169


81,356


253,752


133,082

Interest expense


(92,298)


(391,363)


(299,169)


(848,040)

Total other income (expense), net


7,871


(310,007)


(45,417)


(714,958)










(Loss) income before income taxes


(5,042,350)


2,631,073


(10,724,406)


13,459,958

Income tax benefit


-


399,120


-


173,865










NET (LOSS) INCOME


$        (5,042,350)


$          3,030,193


$      (10,724,406)


$        13,633,823










Basic net (loss) income per common share


$                 (0.02)


$                   0.02


$                 (0.05)


$                   0.07










Diluted net (loss) income  per common share


$                 (0.02)


$                   0.01


$                 (0.05)


$                   0.07










Weighted average number of common shares

outstanding used in computing basic net (loss)

income per common share


206,487,984


197,238,056


205,724,321


197,175,316










Weighted average number of common shares

outstanding used in computing diluted net

(loss) income per common share


206,487,984


202,711,616


205,724,321


200,430,824











 

PALATIN TECHNOLOGIES, INC.

and Subsidiary

Consolidated Balance Sheets

(unaudited)






December 31, 2018


June 30, 2018

ASSETS




Current assets:




Cash and cash equivalents

$               24,658,024


$               38,000,171

Prepaid expenses and other current assets

535,147


513,688

Total current assets

25,193,171


38,513,859





Property and equipment, net

136,153


164,035

Other assets

338,916


338,916

Total assets

$               25,668,240


$               39,016,810





LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable 

$                    619,900


$                 2,223,693

Accrued expenses

1,101,045


2,103,021

Notes payable, net of discount

2,321,123


5,948,763

Other current liabilities

486,474


487,488

Total current liabilities

4,528,542


10,762,965





Notes payable, net of discount

-


332,898

Deferred revenue

-


500,000

Other non-current liabilities

-


456,038

Total liabilities

4,528,542


12,051,901





Stockholders' equity:




Preferred stock of $0.01 par value – authorized 10,000,000 shares:




Series A Convertible: issued and outstanding 4,030 shares as of

December 31, 2018 and June 30, 2018

40


40

Common stock of $0.01 par value – authorized 300,000,000 shares:




issued and outstanding 203,063,429 shares as of December 31, 2018

and 200,554,205 shares as of June 30, 2018

2,030,634


2,005,542

Additional paid-in capital

361,379,336


357,005,233

Accumulated deficit 

(342,270,312)


(332,045,906)

Total stockholders' equity 

21,139,698


26,964,909

Total liabilities and stockholders' equity 

$               25,668,240


$               39,016,810






 

Cision

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