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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): December 19, 2023
PALATIN TECHNOLOGIES, INC. |
(Exact name of registrant as specified in its charter) |
Delaware |
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001-15543 |
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95-4078884 |
(State or other jurisdiction |
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(Commission |
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(IRS employer |
of incorporation) |
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File Number) |
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identification number) |
4B Cedar Brook Drive, Cranbury, NJ |
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08512 |
(Address of principal executive offices) |
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(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 |
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Trading Symbol(s) |
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Name of Each Exchange on Which Registered |
Common Stock |
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PTN |
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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 1.01 Entry into a Material Definitive Agreement.
On December 19, 2023, Palatin Technologies, Inc. (“Palatin”) entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Cosette Pharmaceuticals, Inc. (“Cosette”) pursuant to which Cosette acquired from Palatin worldwide rights to Vyleesi®. Vyleesi is a U.S. Food and Drug Administration approved melanocortin receptor agonist, bremelanotide injection, for as-needed treatment of premenopausal women with hypoactive sexual desire disorder in anticipation of sexual activity.
Under the terms of the Purchase Agreement, Palatin sold certain assets (the “Purchased Assets”) to Cosette, comprising the exclusive right to market and sell Vyleesi for treatment of hypoactive sexual desire disorder in women. The Purchased Assets include applicable intellectual property pertaining to the marketing and sale of Vyleesi, including patents, patent applications, trademarks and copyrights. In addition, Cosette acquired records pertaining to the historical sales and distribution of Vyleesi, as well as quality control and pharmacovigilance records and other records. Palatin will receive up to $171 million, consisting of an upfront purchase price of $12 million plus contingent, sales-based milestone payments of up to $159 million. The closing of the transaction took place simultaneously with the signing of the Purchase Agreement.
The Purchase Agreement includes customary representations, warranties and covenants, as well as standard mutual indemnities covering losses arising from any material breach of the Purchase Agreement or inaccuracy of representations and warranties.
Simultaneously and in connection with entering into the Purchase Agreement, the parties have also entered into certain supporting agreements, including a customary transitional services agreement, pursuant to which, during a transition period, Palatin will continue Vyleesi operations and Cosette and Palatin will transition regulatory and distribution responsibility for Vyleesi to Cosette.
The foregoing description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Purchase Agreement, which will be filed with the U.S. Securities and Exchange Commission as an Exhibit to Palatin’s Quarterly Report on Form 10-Q for the quarter ending December 31, 2023.
Item 2.01 Completion of Acquisition or Disposition of Assets.
The disclosure under Item 1.01 of this Current Report on Form 8-K is herein incorporated by reference.
Item 8.01 Other Events.
On December 20, 2023, the Company issued a press release relating to the matters described in Item 1.01 of this Current Report on Form 8-K, a copy of which is attached hereto as Exhibit 99.1.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
Forward-Looking Statements
The Company cautions you that statements included in this Current Report on Form 8-K that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include any statements regarding the Company’s expectations regarding the timing and any receipt of sales-based milestone payments under the Purchase Agreement. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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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.
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PALATIN TECHNOLOGIES, INC. |
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Date: December 20, 2023 |
By: |
/s/ Stephen T. Wills |
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Stephen T. Wills, CPA, MST |
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Executive Vice President, Chief Financial Officer and Chief Operating Officer |
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EXHIBIT INDEX
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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EXHIBIT 99.1
Palatin Completes Sale of Vyleesi® to
Cosette Pharmaceuticals for up to $171 Million
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| · | Palatin to receive $12 million upfront, plus sales-based milestones of up to $159 million |
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| · | Palatin’s focus is solely on its development and clinical pipeline based on the melanocortin receptor system |
CRANBURY, NJ – December 20, 2023 /PRNewswire/ – Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the sale of Vyleesi® to Cosette Pharmaceuticals, a US based, specialty pharmaceutical company, for up to $171 million, consisting of an upfront purchase price of $12 million plus contingent, sales-based milestone payments of up to $159 million. Vyleesi is the first and only as-needed treatment approved by the Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
“The divestiture of Vyleesi is consistent with our strategic decision to concentrate on our robust development and clinical pipeline,” stated Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “Our focus now is solely on developing novel therapeutics that modulate the melanocortin receptor system. Our Phase 3 PL9643 clinical study for dry eye disease has completed patient enrollment and treatment, and we look forward to the availability of topline data results in the near future. Our Phase 2 study of oral PL8177 in patients with ulcerative colitis is expected to have an interim analysis readout in the first quarter and topline trial results in the second quarter of calendar year 2024.”
“Vyleesi is an important product for the millions of women suffering from HSDD. Cosette is committed to women’s healthcare, and we are pleased they will make Vyleesi a priority in their current product portfolio,” concluded Dr. Spana.
“Vyleesi is an important addition to our rapidly expanding women’s health platform,” said Apurva Saraf, President and Chief Executive Officer of Cosette. “HSDD is the most prevalent form of female sexual dysfunction, affecting approximately six million premenopausal women in the U.S. Through this acquisition, our mission is to give hope, support, and a safe and effective treatment option for millions of women.”
Under the terms of the asset purchase agreement with Cosette, Palatin will receive $12 million upfront. Palatin is also eligible to receive up to $159 million contingent upon the achievement of sales milestones ranging from annual net sales of $15 million to $200 million. Palatin will transfer to Cosette all information, data, and assets related exclusively to Vyleesi. Palatin will provide certain transitional services to Cosette for a period of time to ensure continued patient access to Vyleesi while Vyleesi is operationally separated from Palatin. Cosette will reimburse Palatin for the costs of the transition services. Palatin is also eligible to receive regulatory approval milestones of $10.5 million associated with the previous licensing of Vyleesi, consisting of $7.5 million related to Fosun for China and $3.0 million related to Kwangdong for S. Korea.
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About Cosette Pharmaceuticals, Inc,
Cosette Pharmaceuticals, Inc. (“Cosette”) is a US-based, fully integrated pharmaceutical company with a fast-growing portfolio of branded pharmaceuticals consisting of products in women’s health, cardiology and dermatology. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by 300+ dedicated employees across all functional areas. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. www.cosettepharma.com.
About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin 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 and follow Palatin on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about Vyleesi results and potential market, 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 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 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 |
Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.
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