Palatin Reports 4th Quarter and Fiscal Year Ended 2023 Financial Results and Provides Corporate Update.

CRANBURY, N.J: 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, 2023.

"On the development front, our Phase 3 PL9643 clinical study is fully enrolled, and we are excited that the comprehensive interim analysis of the data for the Lead-In population of the initial 120 patients demonstrated statistically significant positive effects on multiple endpoints for both signs and symptoms, with an excellent patient safety and tolerability," said Carl Spana, Ph.D., President and CEO of Palatin. "On the commercial front, we are pleased with Vyleesi's quarter over quarter double-digit increases across all value metrics, notably net product revenue increased 47% and prescriptions dispensed increased 16% over the prior quarter. We are excited that Vyleesi quarterly net product revenue continues to exceed Vyleesi quarterly operating expenses."

Fourth Quarter Fiscal Year Ended 2023 Business Highlights and Recent Updates

Anti-Inflammatory / Autoimmune Programs

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

Pivotal Phase 3 MELODY-1 clinical study patient enrollment completed.

Topline data is currently expected late fourth quarter of calendar year 2023.

Final data is currently expected first quarter of calendar year 2024.

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):

Interim assessment is currently expected in the first quarter of calendar year 2024.

Topline data is currently expected in the first half of calendar year 2024.

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

Bremelanotide BREAKOUT study (BMT 701) in patients with diabetic kidney disease:

Enrollment is ongoing and currently expected to be completed in the second half of calendar year 2023.

Topline results are currently expected in the first half calendar year 2024.

Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT05709444.

Vyleesi(r) (bremelanotide injection) /...