Open label study designed to evaluate the safety, tolerability, and efficacy of bremelanotide in patients with Type 2 diabetic nephropathy Demonstrated efficacy at 6 months 71% percent of patients achieved a >30% reduction in the urine protein to creatinine ratio (UP/Cr) 71% of patients achieved improved or stabilized estimated glomerular filtration rate (eGFR) Bremelanotide therapy increased urinary VEGF levels in 37.5% of patients and reduced urinary synaptopodin losses in 36% of patients CRANBURY, N. ...

CRANBURY, N.J., Dec. 16, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) ("Palatin" or the "Company"), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that it has entered into a warrant exercise inducement agreement (the "inducement agreement") with an institutional investor to exercise certain outstanding warrants that the Company issued in June 2024 and October 2023 total ...

Oral PL8177 may provide a safe, effective, and tolerable treatment option for ulcerative colitis patients prior to immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns Preclinical data demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and to resolve damaging inflammation Data expected 1Q calendar year 2025CRANBURY, N.J., Nov. 25, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical ...

Financial Data and Key Metrics - For Q1 FY2025, the company did not record any product sales to pharmacy distributors due to the sale of Vyleesi's worldwide rights in December 2023 [4] - Gross product sales for Q1 FY2024 were $4.6 million, with net product revenue of $2.1 million [5] - Total operating expenses for Q1 FY2025 were $7.8 million, down from $8.2 million in the same period last year, primarily due to the elimination of Vyleesi selling expenses [5] - Net cash used in operations for Q1 FY2025 was $7 million, compared to $5.9 million in Q1 FY2024, mainly due to increased net loss [6] - Net loss for Q1 FY2025 was $7.8 million, up from $5.2 million in Q1 FY2024, primarily due to the elimination of Vyleesi net product revenue [7] - Cash and cash equivalents as of September 30, 2024, were $2.4 million, down from $9.5 million as of June 30, 2024 [8] Business Line Data and Key Metrics - The company is focusing its future investment and activities on its core obesity programs, while exploring strategic options for non-obesity programs [9] - The Phase 2 study BMT-801, evaluating the combination of bremelanotide and tirzepatide for obesity, is fully enrolled with top-line results expected in Q1 2025 [10][11] - The obesity and weight loss management portfolio includes novel Melanocortin-4 receptor peptide agonists and orally active MCR4 selective small molecule agonists, with IND-enabling activities and clinical studies planned for 2025 [12] - The Phase 2 study for PL8177, an orally selective MCR1 treatment for ulcerative colitis, is expected to have top-line data in Q1 2025 [14] Market Data and Key Metrics - The pharmacological treatment of obesity is in the early stages of a multiyear cycle of innovation, with a market value expected to exceed $100 billion annually [16] - The Melanocortin system plays a critical role in regulating stored energy and food intake, and Melanocortin-4 receptor agonists are expected to be an important part of future obesity treatment [16] Company Strategy and Industry Competition - The company is focusing its research and development efforts on MCR-4 obesity assets to drive substantial shareholder value [18] - The company is exploring multiple strategic options for its non-obesity programs, including out-licensing, engagement with investors, and potential business combinations [19] - The company believes its ocular assets, including the Phase 3 dry eye disease program and lead compounds in glaucoma and retinal diseases, have significant value and are worthy of continued investment [18] Management Commentary on Operating Environment and Future Outlook - The company is optimistic about its position in the obesity treatment market, with high interest in its Melanocortin-based therapeutics [44] - The company is actively engaging in business development discussions for its ulcerative colitis program, with significant interest from multiple large companies [21] Other Important Information - The company received a $2.5 million deferred payment in November 2024 from Cosette Pharmaceuticals related to the sale of Vyleesi, which is not included in the September 30, 2024, cash balance [8] Q&A Session Summary Question: Options for the ulcerative colitis program following data - The company is exploring typical partnering discussions with larger companies, with significant interest from multiple parties under CDA [21] Question: Success criteria for the BMT-801 study and next steps - The study aims to demonstrate increased weight loss by combining Melanocortin mechanism with incretin therapy, with additional focus on weight loss maintenance and lean muscle mass preservation [22][23][24][25][26][27][28] Question: Potential for MCR-4 long-acting peptide and oral small molecule approaches - The company views these approaches as having broad applicability, including weight loss maintenance, add-on therapy, and potential monotherapy for patients failing other treatments [29][30][31][32][33] Question: Position in the broader obesity market, particularly hypothalamic obesity - The company believes its Melanocortin approaches have broad applicability and are evaluating their role in hypothalamic obesity [34][35][36] Question: Mix of financial approaches for business development opportunities - The company is considering a variety of financial approaches, including out-licensing, corporate combinations, and project finance, depending on the specific program and potential return [38][39][40][41] Closing Remarks - The company is excited about its position in the obesity treatment market and the potential of its Melanocortin-based therapeutics to build substantial value [44][45]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number: 001-15543 PALATIN TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) Delaware 95-4078884 | - ...

EX-99.1 2 ptn_ex991.htm EX-99.1 EXHIBIT 99.1 Palatin Reports First Quarter Fiscal Year 2025 Operating/Financial Results · Obesity programs: o Core focus on obesity includes exploratory co-administration BMT-801 study and two novel development drug candidates o Phase 2 BMT-801 clinical study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide ■ Patient enrollment completed October 2024 ■ Topline results expected 1Q calendar year 2025 o Multiple clinical trials targeted in calendar year 20 ...

Obesity programs: Core focus on obesity includes exploratory co-administration BMT-801 study and two novel development drug candidates Phase 2 BMT-801 clinical study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide Patient enrollment completed October 2024 Topline results expected 1Q calendar year 2025 Multiple clinical trials targeted in calendar year 2025 with long-acting MC4R peptide and oral small molecule compounds General obesity, weight loss management, and rare MC4R pathw ...

CRANBURY, N.J., Nov. 8, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) will announce its first quarter fiscal year 2025 operating results on Thursday, November 14, 2024, before the open of the U.S. financial markets.Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on November 14, 2024, at 11:00 a.m. ET. The conference call will include a review of the company's operating results and an update on programs under development. Sch ...

Oral PL7737 significantly decreased food intake and body weight Oral small molecule melanocortin 4 agonist (MC4R) could address unmet needs and challenges of current obesity treatments Multiple clinical trials targeted in calendar year 2025 for the Company's obesity programsCRANBURY, N.J., Nov. 4, 2024 /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 (MC ...

Topline results expected in 1Q calendar year 2025 Study is assessing the co-administration of bremelanotide and tirzepatide on reducing body weight Data will inform and support the Company's obesity programs using novel, long-acting and highly selective MC4R peptide and small molecule compounds for treating general obesity, weight loss management, and rare/orphan MC4R pathway diseases, including hypothalamic obesityCRANBURY, N.J., Oct. 31, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN ...