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 13, 2019

 

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

 

Not Applicable

(Former name or former address, if changed since last report.)

 

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))

 

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, par value $.01 per share	PTN	NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐

 

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On November 13, 2019, we issued a press release including results for our first quarter ended September 30, 2019 and announcing a teleconference and webcast to be held November 13, 2019 at 11:00 a.m. Eastern time, which will include a discussion on results of operations in greater detail and an update on corporate developments. 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 99.1 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 99.1 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:

 

 

 

 

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 13, 2019	By:	/s/ Stephen T. Wills
		Stephen T. Wills, CPA, MST Executive Vice President, Chief Financial Officer and Chief Operating Officer

 

 

 

EXHIBIT INDEX

 

 

Exhibit 99.1

 

Palatin Technologies, Inc. Reports First Quarter

Fiscal Year 2020 Results and Provides Corporate Update

Vyleesi™ launched nationally in September

Teleconference and Webcast to be held on November 13, 2019

 

CRANBURY, NJ – November 13, 2019 – 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, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its first quarter ended September 30, 2019.

Quarter End and Recent Highlights

Hypoactive Sexual Desire Disorder / Vyleesi™ (bremelanotide injection)

Vyleesi is the first as needed treatment for premenopausal women with acquired, generalized HSDD.

AMAG Pharmaceuticals, Palatin’s North American licensee, launched Vyleesi nationally in September with its established women’s health sales force of approximately 125 sales representatives. In the four weeks since the national launch, more than 1,300 healthcare providers have prescribed Vyleesi, which has resulted in more than 3,000 prescriptions received by AMAG’s specialty pharmacy partners.

Anti-Inflammatory / Autoimmune Programs

Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis). We announced positive results of a micro-dose study of radiolabeled PL8177, a selective melanocortin receptor 1 (“MC1r”) peptide agonist, using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL8177 has potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The FDA has granted orphan drug designation for PL8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis (NIU) is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss. A Phase 2 proof-of-concept clinical study with a systemic formulation in NIU patients is anticipated to commence in the first quarter of calendar year 2020. A Phase 2 proof-of-concept clinical study with an oral formulation in ulcerative colitis patients is anticipated to commence in the second quarter of calendar year 2020.

An IND application for PL9643, a melanocortin peptide agonist, and commencement of a Phase 2 clinical study in dry eye disease, are currently anticipated in the first quarter of calendar year 2020.

 

 

Natriuretic Peptide Receptor (“NPR”) System Program

The Company has designed and is developing potential drug candidates that are selective agonist 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”). Active collaborations with several institutions are ongoing for PL3994, an NPR-A agonist that has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A, and PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis. A Phase 2A clinical trial evaluating PL3994 in heart failure patients with preserved left ventricular ejection fraction will begin enrollment in the latter half of calendar year 2019. This trial is supported by a grant from the American Heart Association.

Genetic Obesity Program

The Company’s melanocortin receptor 4 (“MC4r”) peptide PL8905 and orally, active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designation and potential development.

Corporate

Cash, cash equivalents and accounts receivable balances at September 30, 2019 total $96.8 million.

Debt and related liabilities were fully paid off in July 2019.

In September 2019, the Company’s Board of Directors approved a plan to offer to purchase and terminate certain outstanding common stock purchase warrants through privately negotiated transactions. The purchase and termination program has no time limit and may be suspended for periods or discontinued at any time.

To date, the Company entered into several warrant termination agreements to repurchase and cancel previously issued warrants. The Company repurchased and cancelled in the aggregate 6.5 million warrants at an aggregate buyback price of $2.5 million.

First Quarter Fiscal 2020 Financial Results

Palatin reported a net loss of $(4.5) million, or $(0.02) per basic and diluted share, for the quarter ended September 30, 2019, compared to a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the same period in 2018.

The difference in financial results between the three months ended September 30, 2019 and 2018 was due to reductions in operating and interest expenses combined with increases in reported license and contract revenue and investment income.

Revenue

For the quarter ended September 30, 2019, Palatin recognized as revenue $97,379 in reimbursement of shared Vyleesi costs compared to $34,505 for the quarter ended September 30, 2018.

Operating Expenses

Total operating expenses for the quarter ended September 30, 2019 were $5.0 million compared to $5.7 million for the comparable quarter of 2018. The decrease in operating expenses was mainly attributable to decreases in salaries and other employee related expenses.

 

 

Other Income/Expense

Total other income, net was $361,603 for the quarter ended September 30, 2019 compared to total other expense, net of $(53,288) for the quarter ended September 30, 2018. The difference is primarily related to an increase in investment income and secondarily to a decrease in interest expense.

Cash Position

Palatin’s cash, cash equivalents, and accounts receivable total $96.8 million as of September 30, 2019, compared to cash, cash equivalents and accounts receivable of $103.8 million at June 30, 2019. Current liabilities were $1.9 million as of September 30, 2019, compared to $4.2 million as of June 30, 2019.

Palatin Drug Discovery and Development Programs

During the conference call and webcast, management will update and discuss next steps in Palatin's portfolio of drug development programs. These include Palatin’s melanocortin receptor agonist peptides for treatment of inflammatory indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and fibrotic diseases.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on November 13, 2019 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2019 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-599-8686 (US/Canada) or 1-323-794-2575 (international), conference ID 1609183. 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 (US/Canada) or 1-719-457-0820 (international), passcode 1609183. The webcast and telephone replay will be available through November 20, 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, sales of Vyleesi in the United States and elsewhere in the world, results of clinical trials, regulatory actions by the FDA and other regulatory 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.

 

Investor Inquiries:	Media Inquiries:
Stephen T. Wills, CPA, MST	Paul Arndt, MBA, LifeSci Advisors
CFO/COO (609) 495-2200	Managing Director (646) 597-6992
Info@Palatin.com	Paul@LifeSciAdvisors.com

 

Vyleesi™ is a trademark of AMAG Pharmaceuticals, Inc. in North America and of Palatin Technologies, Inc. elsewhere in the world.

 

 

PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
(unaudited)

	Three Months Ended September 30
	2019	2018
REVENUES
License and contract	$97,379	$34,505
OPERATING EXPENSES
Research and development	3,127,489	3,622,691
General and administrative	1,832,442	2,040,582
Total operating expenses	4,959,931	5,663,273
Loss from operations	(4,862,552)	(5,628,768)
OTHER INCOME (EXPENSE)
Investment income	370,654	153,583
Interest expense	(9,051)	(206,871)
Total other income (expense), net	361,603	(53,288)
NET LOSS	$(4,500,949)	$(5,682,056)
Basic net loss per common share	$(0.02)	$(0.03)
Diluted net loss per common share	$(0.02)	$(0.03)
Weighted average number of common shares outstanding used in computing basic net loss per common share	233,113,241	205,009,278
Weighted average number of common shares outstanding used in computing diluted net loss per common share	233,113,241	205,009,278

 

 

 

PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Balance Sheets
(unaudited)

	September 30, 2019	June 30, 2019
ASSETS
Current assets:
Cash and cash equivalents	$96,698,232	$43,510,422
Accounts receivable	97,379	60,265,970
Prepaid expenses and other current assets	597,853	637,289
Total current assets	97,393,464	104,413,681
Property and equipment, net	186,166	141,539
Right-of-use assets	213,065	-
Other assets	179,916	179,916
Total assets	$97,972,611	$104,735,136
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$57,823	$504,787
Accrued expenses	1,579,460	2,848,692
Notes payable, net of discount	-	332,896
Other current liabilities	213,065	499,517
Total liabilities	1,850,348	4,185,892
Stockholders’ equity:
Preferred stock of $0.01 par value – authorized 10,000,000 shares; shares issued and outstanding designated as follows:
Series A Convertible: authorized 264,000 shares: issued and outstanding 4,030 shares as of September 30, 2019 and June 30, 2019	40	40
Common stock of $0.01 par value – authorized 300,000,000 shares:
issued and outstanding 227,697,257 shares as of September 30, 2019 and 226,815,363 shares as of June 30, 2019	2,276,973	2,268,154
Additional paid-in capital	394,119,078	394,053,929
Accumulated deficit	(300,273,828)	(295,772,879)
Total stockholders’ equity	96,122,263	100,549,244
Total liabilities and stockholders’ equity	$97,972,611	$104,735,136