Palatin Tech - PTN STOCK NEWS

Palatin Technologies (NYSE American: PTN) has announced it will release its second quarter fiscal year 2025 operating results on Thursday, February 13, 2025, before U.S. markets open. The company will host a conference call and audio webcast at 11:00 a.m. ET the same day, featuring executive management's review of operating results and development program updates.

The earnings release is scheduled for 7:30 a.m. ET, with the live conference call following at 11:00 a.m. ET. A replay will be available from February 13-27, 2025. Palatin is a biopharmaceutical company focused on developing first-in-class medicines based on melanocortin receptor systems for diseases with unmet medical needs.

Palatin Technologies (NYSE American: PTN) has announced a $4.7 million financing through a registered direct offering and concurrent private placement. The company will sell 4,688,000 shares of common stock at $1.00 per share in a registered direct offering to a single healthcare-focused institutional investor.

The deal includes warrants to purchase an additional 4,688,000 shares at an exercise price of $1.00 per share in a private placement. These warrants will become exercisable six months after issuance and expire after five and a half years. The offering is expected to close around February 10, 2025, with proceeds intended for general corporate purposes. A.G.P./Alliance Global Partners is leading the placement, with Laidlaw & Company as co-placement agent.

Palatin Technologies (NYSE American: PTN) has completed its Phase 2 BMT-801 clinical study examining the co-administration of MC4R bremelanotide with GLP-1/GIP tirzepatide for obesity treatment. The study enrolled 113 patients, with 96 randomized across four U.S. clinical sites - nearly double the initial target of 60 patients due to strong demand.

The primary endpoint focuses on demonstrating safety and efficacy in reducing body weight. The study design included a four-week tirzepatide-only treatment period, followed by randomization into four treatment regimens. Topline data results are expected later this quarter.

The company believes the combination of MC4R + GLP-1/GIP agonists may show additive and synergistic effects on patient weight loss. The results will inform planned clinical programs for treating general obesity, weight loss management, hypothalamic obesity, and potential rare MC4R pathway diseases.

Palatin Technologies (NYSE: PTN) has outlined key milestones for 2025, focusing on its obesity treatment programs and other therapeutic areas. The company expects topline results from its Phase 2 BMT-801 clinical study, testing bremelanotide with tirzepatide for weight reduction, in Q1 2025.

The company plans to initiate multiple clinical trials in 2H 2025 with novel MC4R compounds for general obesity and rare genetic diseases. This strategy addresses the high discontinuation rate (67%) among current obesity treatments. Palatin will commence IND enabling activities in Q1 2025, with IND filings and Phase 1 studies targeted for later in the year.

Additionally, Palatin is pursuing licensing/collaboration deals for its dry eye disease, ulcerative colitis, and diabetic nephropathy programs. The company has received FDA agreement on endpoints for Phase 3 dry eye disease trials, set to begin in 1H 2025, and expects topline results from its Phase 2 ulcerative colitis study this quarter.

Palatin Technologies (NYSE: PTN) announced positive topline data from its Phase IIb BREAKOUT study evaluating bremelanotide in patients with Type 2 diabetic nephropathy. The study, which enrolled 16 patients with 8 completing the six-month treatment, demonstrated significant efficacy:

- 71% of patients achieved >30% reduction in urine protein to creatinine ratio
- 71% achieved improved or stabilized estimated glomerular filtration rate
- 37.5% showed increased urinary VEGF levels
- 36% demonstrated reduced urinary synaptopodin losses

The treatment was well-tolerated with no serious adverse events, though skin hyperpigmentation occurred in 71% of patients. The study validates melanocortin system modulation as a potential new therapeutic strategy for this progressive kidney disease.

Palatin Technologies (NYSE American: PTN) has secured approximately $3.4 million in gross proceeds through a warrant exercise agreement with an institutional investor. The agreement involves the exercise of warrants from June 2024 and October 2023, totaling 3,907,679 shares at an amended exercise price of $0.875 per share.

As part of the inducement agreement, Palatin will issue new unregistered Series C warrants for 3,907,679 shares and Series D warrants for 1,953,839 shares, both with an exercise price of $0.875. Series C warrants are immediately exercisable with a 5-year expiration, while Series D warrants require stockholder approval. The transaction is expected to close around December 17, 2024, with proceeds intended for working capital and general corporate purposes.

Palatin Technologies (NYSE American: PTN) has completed patient enrollment in its Phase 2 study of PL8177, an oral melanocortin-1 receptor agonist, for ulcerative colitis treatment. The study involves 13 subjects and evaluates safety, efficacy, and other parameters of the drug. Topline data is expected in Q1 2025. PL8177, delivered as a once-daily pill, targets inflammation without immunosuppression, potentially offering a safer alternative to current treatments. The company aims to out-license the UC program, noting significant interest from multiple parties. Preclinical data showed PL8177's effectiveness in improving colon health and resolving inflammation.

Palatin Technologies (NYSE: PTN) reported Q1 FY2025 financial results and provided updates on its obesity programs. The company completed patient enrollment in October 2024 for its Phase 2 BMT-801 clinical study, combining MC4R agonist bremelanotide with GLP-1/GIP dual agonist tirzepatide, with topline results expected in Q1 2025. Net loss for Q1 was $7.8 million ($0.39 per share), compared to $5.2 million ($0.43 per share) in Q1 FY2024. Cash position as of September 30, 2024, was $2.4 million. The company has engaged an investment bank to explore strategic options for non-obesity programs, including its Phase 3 DED program and Phase 2 UC program.

Palatin Technologies (NYSE American: PTN) has announced it will release its first quarter fiscal year 2025 financial results on November 14, 2024, before U.S. markets open. The company will host a conference call and webcast at 11:00 a.m. ET the same day, featuring executive management's review of operating results and development program updates. The earnings release is scheduled for 7:30 a.m. ET, with a conference call replay available until November 28, 2024. Palatin is a biopharmaceutical company focused on developing first-in-class medicines based on melanocortin receptor systems.