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 ...

High selectivity for MC4R significantly reduces potential for skin pigmentation MC4R is a well-validated target for treating obesity Clinical studies with highly selective MC4R agonists targeted to commence in calendar year 2025 CRANBURY, N.J., Oct. 23, 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 system, presented a poster titled "Structural Mod ...

CRANBURY, N.J., Oct. 7, 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 system, today announced it received a notice from the staff of NYSE American LLC (the "Exchange") that Palatin was not in compliance with the Exchange's continued listing standards under Section 1003(a)(iii) of the NYSE American Company Guide. Section 1003(a)(iii) requires a lis ...

Financial Data and Key Metrics Changes - For the fourth quarter ended June 30, 2024, Palatin did not record any product sales due to the sale of Vyleesi rights, compared to gross product sales of $4.1 million and net product revenue of $1.8 million for the same quarter in 2023 [5][6] - Total operating expenses decreased to $8.7 million for the fourth quarter ended June 30, 2024, from $12.6 million in the comparable quarter last year, primarily due to reduced spending on MCR melanocortin receptor programs and elimination of selling expenses related to Vyleesi [6][7] - The net loss for the quarter was $8.6 million, compared to a net loss of $9.8 million for the same period in 2023 [7] Business Line Data and Key Metrics Changes - Gross product sales of Vyleesi for the fiscal year ended June 30, 2024, were $8.9 million, with net product revenue of $4.5 million, down from gross product sales of $12.5 million and net revenue of $4.9 million in the prior fiscal year [5][6] - The ocular program PL9643 completed its first Phase III trial, MELODY-1, demonstrating significant efficacy in treating dry eye disease, with results indicating excellent ocular tolerability and broad efficacy [9][10] Market Data and Key Metrics Changes - The global market for treatment of retinopathies is estimated to be approximately $30 billion by 2030, indicating a significant opportunity for Palatin's PL9654 program [13] Company Strategy and Development Direction - Palatin aims to continue developing key programs in obesity and dry eye disease while seeking collaborations and partnerships for its ocular programs and ulcerative colitis program [21][22] - The company is actively engaged with multiple parties for potential funding sources to support future operating cash needs [8] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the growth in pipeline programs and the potential of targeting the melanocortin system to develop differentiated therapeutics [8][9] - The company is preparing for a new drug application filing for PL9643 in the first half of calendar year 2026, following the completion of remaining clinical studies [12][22] Other Important Information - Palatin closed on an asset sale to Cosette Pharmaceuticals for up to $171 million, retaining rights to bremelanotide for obesity and male treatment indications [4] - The company raised total gross proceeds of $21 million during the fiscal year ended June 30, 2024, through registered direct and warrant inducement offerings [5] Q&A Session Summary Question: Weight loss program with GLP-1 - Management indicated that the primary analysis will compare the co-administration of bremelanotide with tirzepatide against tirzepatide alone, looking for a measurable additive effect [24] Question: Pigmentation issues - Management noted that next-generation compounds are being developed to avoid skin darkening by having substantial separation between MCR4 and MCR1 activity [25] Question: Dry eye program maturity - Management confirmed that discussions with corporate partners are progressing well, and they are ready to move forward pending appropriate funding [26] Question: Co-formulation potential - Management acknowledged the feasibility of co-formulating MCR4 agonists with GLP-1 drugs, although no work has been done yet [28]

Financial Performance - Palatin reported total revenue of $4.5 million for the fiscal year ended June 30, 2024, down from $4.9 million in the previous fiscal year, with no product sales recorded in Q4 2024 due to the sale of Vyleesi's rights[10]. - Total revenues for the period were $4,853,678, a decrease from $4,990,090 in the previous period[23]. - The net loss for the period was $29,736,113, which is an increase from a net loss of $24,036,741 in the previous period[24]. - Basic and diluted net loss per common share was $2.02, compared to $2.21 in the prior period[24]. - Palatin's net loss for Q4 2024 was $8.6 million, or $(0.51) per share, compared to a net loss of $9.8 million, or $(0.84) per share, in Q4 2023[15]. Operating Expenses - Total operating expenses decreased to $27.0 million for the fiscal year ended June 30, 2024, compared to $37.3 million in the prior fiscal year, primarily due to a $7.8 million gain from the sale of Vyleesi[11]. - Research and development expenses amounted to $22,630,577, compared to $22,400,372 in the prior period, reflecting an increase of approximately 1%[23]. Cash and Assets - As of June 30, 2024, Palatin's cash and cash equivalents were $9.5 million, a decrease from $10.0 million as of March 31, 2024[16]. - Cash and cash equivalents as of June 30, 2024, were $9,527,396, an increase from $7,989,582 as of June 30, 2023[25]. - Total current assets decreased to $9,769,668 from $16,321,513 year-over-year[25]. - Total liabilities decreased to $10,853,763 from $19,655,911 year-over-year[25]. - The company reported a total stockholders' deficiency of $(111,497) compared to $(1,979,871) in the previous year[26]. Clinical Development - The Phase 2 clinical study for the MC4R agonist plus GLP-1 in obese patients is expected to complete patient enrollment by early Q4 2024, with topline results anticipated in Q1 2025[2]. - The MELODY-2 and MELODY-3 Phase 3 studies for PL9643 in dry eye disease are expected to begin patient enrollment in Q1 2025, with topline results anticipated in Q4 2025[5]. - The pharmacokinetics study for bremelanotide co-formulated with a PDE5 inhibitor is expected to start in Q1 2025, with patient recruitment in a Phase 2/3 study anticipated in 2H 2025[6]. - Interim analysis for the Phase 2 study of PL8177 in ulcerative colitis is expected in Q4 2024, with topline results anticipated in Q1 2025[7]. Funding and Future Plans - Palatin raised total gross proceeds of $21 million during the fiscal year ended June 30, 2024, through registered direct and warrant inducement offerings[9]. - The company is actively engaging with multiple parties for potential funding sources to support future operating cash needs[16]. - The company is focused on advancing its product candidates through clinical trials and regulatory approvals, with ongoing development programs[21].

Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor (MC4R) Agonist plus Glucagon Like Peptide-1 (GLP-1) Patient Dosing Commenced 3Q Calendar Year 2024 Patient Enrollment Expected to be Completed Early 4Q Calendar Year 2024 Topline Results Expected 1Q Calendar Year 2025 Dry Eye Disease (DED): PL9643 MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies FDA Confirms Protocols and Endpoints Patient Enrollment Start Expected 1Q Calendar Year 2025 Topline Results Anticipated 4Q Calendar Year 2025 Potenti ...

Financial Performance - For the fiscal year ended June 30, 2024, the company recognized $4,490,090 in product revenue, a decrease from $4,850,678 in fiscal 2023, primarily due to the sale of Vyleesi's worldwide rights to Cosette Pharmaceuticals[69]. - The company recorded a gain of $7,781,844 on the sale of Vyleesi, which included an upfront purchase price of $9,500,000[69]. - Total revenues for the year ended June 30, 2024, were $4,490,090, a decrease of 7.5% from $4,853,678 for the year ended June 30, 2023[82]. - The net loss for the year ended June 30, 2024, was $29,736,113, compared to a net loss of $24,036,741 for the year ended June 30, 2023, representing an increase in losses of approximately 23%[85]. - Basic and diluted net loss per common share was $(2.02), an improvement from $(2.21) in the prior year[82]. - The accumulated deficit increased from $(412,030,437) in 2023 to $(441,766,550) in 2024[81]. Expenses and Costs - Total operating expenses decreased to $26,986,211 from $37,312,561, reflecting a reduction of approximately 27.5%[82]. - Selling, general and administrative expenses decreased to $12,270,046 in fiscal 2024 from $15,290,836 in fiscal 2023, largely due to reduced selling expenses related to Vyleesi[69]. - Total research and development expenses for fiscal 2024 were $22,400,372, slightly down from $22,630,577 in fiscal 2023, with specific spending on MCr programs decreasing from $16,202,432 to $15,512,149[69]. - The company incurred a net cash used in operating activities of $31,461,441 for the year ended June 30, 2024, compared to $29,271,346 for the previous year, indicating a 7.4% increase in cash outflows[85]. Cash and Liquidity - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $9,527,396 against current liabilities of $9,657,681[72]. - Cash and cash equivalents increased from $7,989,582 in 2023 to $9,527,396 in 2024, an increase of approximately 19.3%[80]. - The company had cash and cash equivalents of $9,527,396 and current liabilities of $9,657,681 as of June 30, 2024, indicating potential liquidity issues[87]. - The company anticipates needing substantial additional financing or revenues to fund its planned product development activities[87]. Funding and Financing - The company raised $20,548,891 in net cash from financing activities during the year, compared to $10,748,591 in the previous year, reflecting a 91% increase[86]. - The company is evaluating strategies to obtain additional funding, including equity financing and issuing debt[44]. - The company will need additional funding to complete required clinical trials and regulatory applications to the FDA[44]. - The company is focusing on market expansion and new product development as part of its strategic initiatives moving forward[82]. Assets and Liabilities - Total current liabilities decreased from $15,131,830 in 2023 to $9,657,681 in 2024[81]. - The total assets decreased from $17,939,440 in 2023 to $10,742,266 in 2024[81]. - Total liabilities decreased from $19,655,911 in 2023 to $10,853,763 in 2024, representing a reduction of about 44.7%[81]. - The company has aggregate lease obligations of $426,556 for the year ending June 30, 2025, and $163,782 for the years ending June 30, 2026 and 2027[44]. Research and Development - Cumulative spending on the Vyleesi program reached approximately $311,900,000, while spending on other programs totaled around $234,000,000[69]. - The company is developing new product candidates, including a co-formulation of bremelanotide with a PDE5i for erectile dysfunction, which is currently in development[87]. - Research and development costs are charged to expense as incurred, including equipment costs with no alternative future use[93]. Stock and Equity - The company issued 1,831,503 shares of common stock at a combined offering price of $5.46 during the January 2024 Offering[113]. - The October 2023 Offering generated net proceeds of $4,573,948 after deducting placement agent fees and offering expenses[114]. - The company recorded stock-based compensation related to stock options of $873,633 for the year ended June 30, 2024, an increase from $794,735 in the previous year[120]. - The total outstanding restricted stock units increased to 1,374,980 as of June 30, 2024, up from 987,521 in the previous year[121]. Tax and Valuation - The Company has recorded a full valuation allowance against its deferred tax assets due to a history of losses and uncertainty in projecting future revenues[94]. - The valuation allowance against deferred tax assets increased by $11,193,000 for the year ended June 30, 2024, compared to an increase of $5,653,000 for the year ended June 30, 2023[124]. - The Company’s net deferred tax assets were fully offset by a valuation allowance of $62,709,000 as of June 30, 2024[125]. Operational Challenges - The company has incurred operating losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[76]. - The company is evaluating strategies to obtain additional funding, including equity financing and cost reductions[88]. - The company identified a material weakness in controls over accounting for complex financial instruments, specifically regarding the valuation of warrant liability[125].

Teleconference and Webcast to be held on October 1, 2024 CRANBURY, N.J., Sept. 26, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) will announce its fourth quarter and fiscal year end 2024 operating results on Tuesday, October 1, 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 October 1, 2024 at 11:00 AM Eastern Time. The conference call will include a review of the company ...

Dry Eye Disease (DED): PL9643 MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies FDA Confirms Protocols and Endpoints Targeting Enrollment Start in 4Q Calendar Year 2024 Topline Results Anticipated 4Q Calendar Year 2025 Potential Collaboration/Funding Discussions Ongoing Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor (MC4R) Agonist + Glucagon Like Peptide-1 (GLP-1) Patient Dosing Commenced 3Q Calendar Year 2024 Topline Results Expected 1Q Calendar Year 2025 Male Sexual Dysfunction: Developme ...