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Palatin Technologies, Inc. Reports Second Quarter Fiscal Year 2021 Financial Results and Recent Business Highlights

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-- Positive Results from Phase 2 Clinical Study of PL9643 in Patients with Dry Eye Disease

-- Continue to Rebuild Commercial Infrastructure and Brand Awareness for Vyleesi®

-- Approximately $72.2 Million in Cash and Cash Equivalents at December 31, 2020

-- Teleconference and Webcast to be held on February 17, 2021 at 11:00 AM ET

CRANBURY, N.J., Feb. 17, 2021 /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, today announced results for its second quarter ended December 31, 2020.

Palatin Technologies, Inc.
Palatin Technologies, Inc.

Second Quarter Ended December 31, 2020 Financial Highlights

  • Net loss for the quarter was $(10.0) million, or $(0.04) per share, compared to a net loss of $(5.2) million, or $(0.02) per share for the comparable quarter of 2019;

  • As of December 31, 2020, the Company had $72.2 million in cash and cash equivalents and $4.7 million in accounts receivable, compared to $82.9 million in cash and cash equivalents and no accounts receivable as of June 30, 2020, with no outstanding debt.

Business Highlights and Updates

  • Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi® (bremelanotide injection)

  • Anti-Inflammatory / Autoimmune Programs

"Working through the melanocortin system, PL9643 is a novel approach to treating dry eye disease. The emerging profile of PL9643, with its rapid therapeutic onset and excellent tolerability profile, is a potentially distinct advance in dry eye therapy," stated Carl Spana, Ph.D., President and CEO of Palatin. "The positive PL9643 Phase 2 study results identify the most appropriate patient population, endpoints, and timepoints for the next study, which is a Phase 2/3 study targeted for mid-calendar year 2021, with data readout in the first half of calendar year 2022. Regarding Vyleesi, our measured plan and investment is showing positive trends and returns with a significant rise in payer reimbursement and double-digit increases to month over month prescription numbers continuing through January 2021."

Conference Call / Webcast

Palatin will host a conference call and audio webcast on February 17, 2021 at 11:00 a.m. Eastern Time to discuss the quarter ended December 31, 2020 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-866-248-8441 (US/Canada) or 1-856-344-9206 (international), conference ID 2203098. 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 2203098. The webcast and telephone replay will be available through February 24, 2021.

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 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 market potential of Palatin's products, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, Palatin's ability to manufacture and market Vyleesi, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, 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 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, Palatin's ability to establish and maintain the capability for manufacturing, marketing and distribution of Vyleesi, 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.

Palatin Technologies® and Vyleesi® are registered trademarks of Palatin Technologies, Inc.


PALATIN TECHNOLOGIES, INC.

and Subsidiary

Consolidated Statements of Operations

(unaudited)











Three Months Ended December 31,


Six Months Ended December 31,



2020


2019


2020


2019











REVENUES









Product revenue, net

$ (163,971)


$ -


$ (452,531)


$ -


License and contract

-


20,610


-


117,989



(163,971)


20,610


(452,531)


117,989


OPERATING EXPENSES









Cost of products sold

29,400


-


54,600


-


Research and development

4,011,418


3,257,624


6,935,269


6,385,113


Selling, general and administrative

5,044,913


2,404,093


7,376,519


4,236,535


Gain on license termination agreement

-


-


(1,623,795)


-


Total operating expenses

9,085,731


5,661,717


12,742,593


10,621,648











Loss from operations

(9,249,702)


(5,641,107)


(13,195,124)


(10,503,659)











OTHER (EXPENSE) INCOME









Investment income

4,800


399,982


16,935


770,636


Foreign currency loss

(745,002)


-


(745,002)


-


Interest expense

(1,871)


(2,502)


(9,360)


(11,553)


Total other (expense) income, net

(742,073)


397,480


(737,427)


759,083


NET LOSS

$ (9,991,775)


$ (5,243,627)


$ (13,932,551)


$ (9,744,576)




















Basic and diluted net loss per common share

$ (0.04)


$ (0.02)


$ (0.06)


$ (0.04)


Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share

236,405,065


234,923,592


236,375,463


234,018,417












PALATIN TECHNOLOGIES, INC.

and Subsidiary

Consolidated Balance Sheets

(unaudited)






December 31, 2020


June 30, 2020

ASSETS




Current assets:




Cash and cash equivalents

$ 72,156,110


$ 82,852,270

Accounts receivable

4,746,623


-

Inventories

6,031,088


-

Prepaid expenses and other current assets

2,556,911


738,216

Total current assets

85,490,732


83,590,486





Property and equipment, net

116,362


140,216

Right-of-use assets

1,113,685


1,266,132

Other assets

56,916


56,916

Total assets

$ 86,777,695


$ 85,053,750





LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable

$ 1,174,493


$ 715,672

Accrued expenses

4,799,561


2,899,097

Short-term operating lease liabilities

265,339


312,784

Other current liabilities

1,010,250


-

Total current liabilities

7,249,643


3,927,553





Long-term operating lease liabilities

855,626


953,348

Other long-term liabilities

10,837,300


-

Total liabilities

18,942,569


4,880,901





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 December 31, 2020 and June 30, 2020

40


40

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




issued and outstanding 230,034,307 shares as of December 31, 2020 and 229,258,400 shares as of June 30, 2020

2,300,343


2,292,584

Additional paid-in capital

397,666,196


396,079,127

Accumulated deficit

(332,131,453)


(318,198,902)

Total stockholders' equity

67,835,126


80,172,849

Total liabilities and stockholders' equity

$ 86,777,695


$ 85,053,750





Cision
Cision

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SOURCE Palatin Technologies, Inc.