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 ...

FDA & Palatin agree on clear regulatory path for PL9643 NDA submission in DED FDA confirms acceptability of protocols and endpoints for remaining MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Trials in DED Currently anticipate patient enrollment to start in 4Q calendar year 2024 Topline results currently expected in 4Q calendar year 2025 CRANBURY, N.J., Aug. 28, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molec ...

Complete enrollment currently expected in 3Q 2024 Topline results expected in 1Q calendar year 2025 Additional studies under assessment for multiple metabolic conditions CRANBURY, N.J., Aug. 22, 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 that patient dosing has started for the clinical study entitled: BMT-801: A Phase II ...

CRANBURY, N.J., June 21, 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 inducement agreement with an institutional investor to exercise certain outstanding warrants that the Company issued in November 2022 and October 2023 totaling 3,233,277 shares of the Compan ...

In ED patients that do not respond to PDE5i monotherapy ~30-40% of ED patients do not respond to PDE5i treatment Data from this Phase 2 clinical study is expected by end of calendar year 2024 Published clinical data and mechanisms of action support clinical study of bremelanotide in combination with a PDE5i Phase 3 clinical study with new co-formulated bremelanotide plus a PDE5i in ED patients that do not respond to PDE5i monotherapy expected to start in the 1st half of calendar year 2025 "Approximately 30- ...

Co-Administration Phase 2 study of bremelanotide with tirzepatide (GLP-1) to provide key information for melanocortin treatments of obesity Topline data expected by end of calendar year 2024 Additional studies under assessment for multiple metabolic conditions "Although GLP-1 agonists are currently the standard of care treatment for obesity, data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year," said Carl Spana, Ph.D., CEO and President of Palatin. "We b ...

Investors might want to bet on Palatin Technologies, Inc. (PTN) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the ...

Palatin Technologies, Inc. (NYSE:PTN) Q3 2024 Earnings Conference Call May 15, 2024 11:00 AM ET Company Participants Carl Spana - President, CEO & Director Stephen Wills - CFO, COO, EVP, Treasurer & Secretary Conference Call Participants Joe Pantginis - H.C. Wainwright & Co. Operator Greetings. Welcome to Palatin's Third Quarter Fiscal Year 2024 Operating Results Conference Call. [Operator Instructions]. As a reminder, this conference call is being recorded. Before we begin our remarks, I would like to remi ...