Palatin Reports 3rd Quarter Fiscal Year 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 third quarter ended March 31, 2023.

"On the development front, we are excited that the analysis of the data for the Lead-In population of the initial 120 patients in our Phase 3 PL9643 clinical study demonstrated statistically significant positive effects on multiple endpoints for both signs and symptoms, including 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 fifth consecutive quarter of double-digit growth in net product revenue and dispenses. We are particularly pleased that Vyleesi's quarterly net product revenue exceeds Vyleesi quarterly operating expenses."

Business Highlights and Recent Updates

Anti-Inflammatory / Autoimmune Programs

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

Review of Phase 3 clinical study data in patients with DED at Key Opinion Leader (KOL) Event.

Analysis of Lead-In population of initial 120 patients completing 12 weeks of treatment showed statistical separation for clinical efficacy across multiple signs and symptoms of dry eye along with excellent patient safety and tolerability.

Presented initial Phase 3 clinical data at the Association of Research in Vision and Ophthalmology (ARVO) 2023 Annual Conference.

Data demonstrated positive effects on signs and symptoms.

Consistent clinical efficacy across multiple signs and symptoms of dry eye along with excellent safety and tolerability - a differentiating product profile.

Pivotal Phase 3 clinical study patient enrollment continuing.

Final data currently expected second half 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):

Interim assessment is currently expected to occur in the second half of calendar year 2023.

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

Digestive Disease Week Annual Conference.

Preclinical data shows PL8177 was found to be efficacious in animal models of inflammatory bowel disease.

Clinical data confirms PL8177 oral...