Topline data currently expected late 4Q calendar 2023

目前预计4季度晚些时候的数据2023

Interim analysis of first 120 patients demonstrated:

对前120名患者的中期分析表明：

Excellent safety and tolerability product profile

出色的安全性和耐受性产品概况

Potential for PL9643 to address multiple signs and symptoms of dry eye disease

PL9643解决干眼症的多种体征和症状的潜力

CRANBURY, N.J., Sept. 7, 2023 /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 enrollment in the PL9643 MELODY-1 Phase 3 study in dry eye disease (DED) is complete, with 570 patients enrolled.

CRANBURY，N.J.，2023年9月7日/PRNewswire/-Palatin Technologies，Inc。（NYSE American:PTN），一家生物制药公司，开发基于调节黑皮质素受体系统活性的分子的一流药物，今天宣布参加PL9643 MELODY-1干眼病（DED）3期研究已完成，共有570名患者入选。

The Company is on track to release topline results by the end of the fourth quarter of calendar year 2023..

公司正在计划在2023年日历年第四季度结束前发布顶级业绩。。

'We are committed to addressing unmet needs of DED patients. We believe that PL9643, with its novel mechanism of action and differentiated product profile for efficacy, safety and ocular tolerability, if approved, will be a first-in-class treatment option for the millions of patients who suffer from DED,' said Carl Spana, Ph.D., President and CEO of Palatin.

'我们致力于解决DED患者未满足的需求。我们相信，PL9643凭借其新颖的作用机制和不同的疗效，安全性和眼部耐受性产品特征，如果获得批准，将成为数百万患有DED的患者的一流治疗选择，“Carl Spana博士，帕拉丁总裁兼首席执行官说。

'We are optimistic about results of the Phase 3 PL9643 data based on the positive interim analysis and are pleased to have completed enrollment so promptly. I thank the patients, investigators, clinical site staff, and our employees for achieving this important milestone.'.

Palatin previously announced positive interim analysis data and recently presented portions of this data at the ARVO 2023 conference in April 2023. The excellent ocular tolerability and efficacy across multiple signs and symptoms of DED distinguishes PL9643 from currently approved treatments for DED..

Michael Raizman, MD, practicing ophthalmologist and Chief Medical Officer of Palatin, stated, 'Given the key role melanocortins play in the resolution of inflammation, we are very encouraged by the findings in the Phase 2 study and the interim analysis of the initial 120 patients in the Phase 3 study, which demonstrated the potential for PL9643 to address both signs and symptoms associated with DED as a possible treatment for the millions of patients not satisfied with current commercial therapies.'.

Palatin执业眼科医生兼首席医疗官Michael Raizman表示，“鉴于黑皮质素在炎症消退中的关键作用，我们对第2阶段研究的结果和对最初120名患者的中期分析非常鼓舞。在3期研究中，这表明PL9643有可能解决与DED相关的体征和症状，作为数百万对当前商业疗法不满意的患者的可能治疗方法。

Topline data for the PL9643 MELODY-1 Phase 3 Study is anticipated by the end of the fourth quarter of calendar year 2023. Assuming positive results, the remaining Phase 3 studies are expected to be completed by the end of calendar year 2024 and early calendar year 2025, with a New Drug Application submission to the U.S.

Food and Drug Administration (FDA) for approval mid-year calendar 2025..

食品药品监督管理局（FDA）于2025年年中批准。。

The pivotal Phase 3 MELODY-1 clinical study, being conducted in the U.S., is a multi-center, randomized, double–masked and vehicle–controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED, for multiple sign and symptom endpoints.

关键的3期MELODY-1临床研究正在美国进行，是一项多中心，随机，双盲和载体对照研究，评估黑皮质素激动剂PL9643眼用溶液与载体相比在中度至重度DED患者中的安全性和有效性，具有多种体征和症状终点。

The study design is based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-phase 2 meeting with the FDA on key elements of the pivotal Phase 3 clinical program..

该研究设计基于PL9643用于治疗DED的阳性2期结果，以及与FDA就关键3期临床计划的关键要素召开的2期结束会议。。

About Dry Eye Disease (DED)Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States.

关于干眼病（DED）干眼病是一种常见的炎症性疾病，如果不及时治疗，可能会变得非常痛苦并导致角膜和视力的永久性损害。DED影响眼睛的角膜和结膜，导致刺激，发红，疼痛和视力模糊。据估计，这将影响美国超过2000万人。

The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for DED is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity..

该疾病的特征在于眼睛前表面的水分和润滑不足，导致干燥，炎症，疼痛，不适，刺激，生活质量下降，并且在严重的情况下导致永久性视力障碍。许多医生和患者通常认为现有的DED治疗不足，并且通常需要数周或数月才能证明其活性。。

About Melanocortin Receptor Agonists and InflammationThe melanocortin receptor ('MCr') system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

关于黑皮质素受体激动剂和炎症黑皮质素受体（'MCr'）系统对炎症，免疫系统反应，新陈代谢，食物摄入和性功能有影响。有五种黑皮质素受体，MC1r至MC5r。通过使用激活受体功能的受体特异性激动剂或阻断受体功能的受体特异性拮抗剂来调节这些受体可具有医学上显着的药理作用。

Many tissues and immune cells located throughout the body, including the gut, kidney and eye, express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. Drugs based on melanocortin agonists have been approved by the FDA for treating several conditions, including female sexual dysfunction, inflammatory/autoimmune diseases, and rare forms of genetic obesity..

位于全身的许多组织和免疫细胞，包括肠道，肾脏和眼睛，表达黑皮质素受体，使我们有机会直接激活自然途径来解决疾病炎症。基于黑皮质素激动剂的药物已被FDA批准用于治疗多种疾病，包括女性性功能障碍，炎症/自身免疫性疾病和罕见的遗传性肥胖。。

About PalatinPalatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential.

关于PalatinPalatin是一家生物制药公司，开发基于调节黑皮质素受体系统活性的分子的一流药物，具有靶向的受体特异性产品候选物，用于治疗具有显着未满足的医疗需求和商业潜力的疾病。

Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech..

Palatin的战略是开发产品，然后与行业领导者形成营销合作，以最大限度地发挥其商业潜力。有关Palatin的更多信息，请访问Palatin的网站www.Palatin.com，并通过@PalatinTech在Twitter上关注Palatin。。

Forward-looking StatementsStatements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about PL9643 results, anticipated dates, and potential markets, are 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995.

本新闻稿中的前瞻性陈述不是历史事实，包括关于Palatin未来期望的陈述，例如关于PL9643结果，预期日期和潜在市场的陈述，是1933年“证券法”第27A条含义内的“前瞻性陈述”，1934年“证券交易法”第21E条以及1995年“私人证券诉讼改革法”中定义的术语。

Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements.

Palatin打算这种前瞻性的陈述受制于由此创造的安全港。此类前瞻性陈述涉及已知和未知的风险，不确定性和其他可能导致帕拉丁实际结果与其历史结果或此类前瞻性陈述所表达或暗示的任何结果实质性不同的因素。

Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission.

Palatin的实际结果可能与前瞻性声明中讨论的结果有很大不同，原因包括但不限于临床试验结果，FDA和其他监管机构的监管行动以及监管批准的必要性，Palatin资助其发展的能力技术，建立并成功完成临床试验，完成临床试验并提交监管批准申请所需的时间和成本，竞争性制药，生物制药和生物技术公司开发的产品，Palatin产品的商业接受度以及Palatin与证券交易委员会定期提交的文件中讨论的其他因素。

Palatin is not responsible for updating events that occur after the date of this press release..

Palatin不负责更新本新闻稿发布日期后发生的事件。。

Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.

PalatinTechnologies®是Palatin Technologies，Inc。的注册商标。

SOURCE Palatin Technologies, Inc.

SOURCE Palatin Technologies，Inc。