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Palatin Reports Fourth Quarter and Fiscal Year 2022 Financial Results and Provides Corporate Update

Phase 3 Pivotal Study of PL9643 in Patients with Dry Eye Disease Ongoing Positive Interim Analysis a?? DMC Recommended Study Sample Size of 350 Patients Topline Results Currently Expected Second Quarter Calendar 2023



VyleesiA® - Gross product sales increased 79%, net product revenue increased 257% and prescriptions dispensed increased 49%, over the prior quarter



Closed on a $15 Million Private Placement of Redeemable Convertible Preferred Stock



Patient Recruitment Initiated in a Phase 2 Clinical Study of Oral PL8177 in Patients with Ulcerative Colitis with an Interim Analysis and Topline Results Currently Expected First Half Calendar 2023



Teleconference and Webcast to be held on September 22, 2022, at 11:00 AM EDT

CRANBURY, N.J., Sept. 22, 2022 /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 financial results for its fiscal fourth quarter and fiscal year ended June 30, 2022.
Palatin Reports Fourth Quarter and Fiscal Year 2022 Financial Results and Provides Corporate Update
"We are excited to have two novel melanocortin receptor peptides with differentiating product profiles progressing in clinical trials - a Phase 3 pivotal study of PL9643 in patients with dry eye disease, and a Phase 2 clinical study of oral PL8177 in patients with ulcerative colitis," stated Carl Spana, Ph.D., President and CEO of Palatin. "Topline results from the Phase 3 study of PL9643 is currently expected in the second quarter calendar of 2023, and the interim analysis and topline results from the Phase 2 study of PL8177 currently expected in the first half of 2023."Dr. Spana further commented, "Vyleesi sales continue to grow, with our June 30, 2022, quarter showing significant increases across all value metrics, including gross product sales, net product revenue, prescriptions dispensed, refill rates, and commercial insurance reimbursement, compared to the prior quarter and comparable quarter last year."Financial Highlights for the Fourth Quarter Ended June 30, 2022

Net loss for the quarter ended June 30, 2022, was $12.8 million, or $(1.34) per common share, compared to a net loss of $13.9 million, or $(1.47) per common share, for the same period in 2021.



As of June 30, 2022, the Company had cash and cash equivalents of $29.9 million, compared to $37.7 million as of March 31, 2022 and $60.1 million as of June 30, 2021.



VyleesiA® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Gross product sales increased 79%, net product revenue increased 257% and prescriptions dispensed increased 49%, over the prior quarter.

Business Highlights and Recent Updates

Anti-Inflammatory / Autoimmune Programs



PL9643 melanocortin agonist for the treatment of dry eye disease (DED)



Positive interim analysis in ongoing Pivotal Phase 3 clinical study in patients with DED.



The independent data monitoring committee (DMC) performed their assessment on the first 120 patients to complete the study and based on their recommendation, Palatin plans to enroll up to an additional 230 patients in the study for a final sample size of 350 patients.



No safety concerns were identified by the DMC.



Topline data readout expected in the second quarter of calendar year 2023.



Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT04268069.



PL8177 oral melanocortin agonist for the treatment of ulcerative colitis (UC):



Initiated patient recruitment in a Phase 2 oral formulation study of PL8177 in patients with UC.



Interim assessment is currently expected to occur in the first quarter of calendar year 2023.



Topline data readout is currently expected in the second quarter of calendar year 2023.



Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT05466890.



VyleesiA® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate commercial product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women's healthcare company.



For the fiscal fourth quarter ended June 30, 2022:



Gross product sales increased 79% over the prior quarter, increased 91% over the comparable quarter in 2021.



Net product revenue increased 257% over the prior quarter, increased 857% over the comparable quarter in 2021.



Total prescriptions dispensed increased 49% over the prior quarter, increased 54% compared to the comparable quarter in 2021.



Refill rates, commercial insurance reimbursement, and net revenue per prescription dispensed, increased over the prior quarter and comparable quarter in 2021.



Patients and healthcare providers can learn more about HSDD and Vyleesi atwww.vyleesi.com[/u] and www.vyleesipro.com



Other:



Redeemable Convertible Preferred Stock: On May 11, 2022, Palatin entered into a securities purchase agreement with institutional investors, selling and issuing 8,100,000 shares of Series B Redeemable Convertible Preferred Stock ("Series B Preferred Stock") and 900,000 shares of Series C Redeemable Convertible Preferred Stock ("Series C Preferred Stock"). Each share of Series B Preferred Stock and Series C Preferred Stock had a purchase price of $1.67 and is convertible into Palatin common stock at an initial conversion price of $11.25 per share. The investors in the Series B Preferred Stock and Series C Preferred Stock also received warrants to purchase up to 66,666 shares of common stock at an exercise price of $12.50 per share, which expire 48 months following issuance. Total gross proceeds from the offering, before deducting offering expenses, is $15.0 million which was deposited in, and is being held in, an escrow account as of June 30, 2022, pending the investors' election to redeem the shares for cash or in notes, or convert the shares to common stock. The escrowed proceeds have been presented as a deduction to Series B and C Redeemable Convertible Preferred Stock on the Company's consolidated balance sheet at June 30, 2022.

To the extent any shares of Series B Preferred Stock or Series C Preferred Stock are converted to common shares or redeemed for debt, the Company will use such net proceeds from this offering for working capital and general corporate purposes. Additional information regarding the securities described above and the terms of the offering are included in Palatin's fiscal year ended June 30, 2022 10-K filing with the United States Securities and Exchange Commission.





Reverse Stock Split: At Palatin's Annual Meeting of Stockholders held on June 24, 2022, the Company's stockholders approved the amendment to the Company's Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company's common stock. The Board of Directors approved the implementation of a 1-for-25 reverse stock split effective as of 5:00 p.m. Eastern Time on August 30, 2022. The reverse stock split reduced the number of shares of Palatin's common stock outstanding from approximately 231,774,000 shares to approximately 9,271,000 shares but did not change the authorized number of shares of Common Stock, which remain at 300,000,000 shares of Common Stock. The Company's common stock continues to trade on the NYSE American Stock Market under the symbol "PTN."

Fourth Quarter and Fiscal Year Ended June 30, 2022 Financial ResultsAll share and per share amounts are presented on a post-reverse-split basis, giving effect to the 1- for-25 reverse stock split.
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