Primary endpoint met in the 8-week treatment study (highly statistically significant).

在为期8周的治疗研究中，主要终点已达成（具有高度统计学显著性）。

Co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001).

联合给药组体重减轻了4.4%，而安慰剂组为1.6% (p<0.0001)。

Primary analysis for the co-administered group in the 8-week treatment study showed:

8周治疗研究中，共同给药组的主要分析显示：

40% of patients achieved 5% reduction in weight (p<0.05).

40%的患者体重减轻了5%（p<0.05）。

27% achieved 6% reduction in weight (p<0.05).

27%的参与者体重减轻了6%（p<0.05）。

19% achieved 7% reduction in weight (p<0.1).

19%的患者体重减轻了7%（p<0.1）。

Low dose bremelanotide arm stopped weight regain seen post tirzepatide treatment.

低剂量布雷默兰肽组停止了在替西帕肽治疗后出现的体重反弹。

Novel next-generation MC4R long-acting peptides and oral small molecules:

新型下一代MC4R长效肽和口服小分子：

IND applications planned for 4Q25; clinical data expected 1H26.

计划于2025年第四季度提交IND申请；预计2026年上半年获得临床数据。

Phase 1 SAD/MAD studies to include hypothalamic obesity patients.

第1阶段的SAD/MAD研究将包括下丘脑性肥胖患者。

CRANBURY, N.J.

新泽西州克兰伯里

,

，

March 31, 2025

2025年3月31日

/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 its BMT-801 Phase 2 obesity co-administration study met its primary endpoint and was highly statistically significant.

/PRENewswire/ -- Palatin Technologies, Inc.（纽约证券交易所代码：PTN）是一家开发生物医药的公司，专注于基于调节黑皮质素受体系统活性分子的首创新药，今天宣布其BMT-801二期肥胖联合用药研究达到了主要终点，并具有高度统计学意义。

The Company reported positive topline data with co-administered melanocortin-4 receptor (MC4R) agonist bremelanotide plus glucagon like peptide-1/gastric inhibitory polypeptide (.

公司报告了联合使用黑皮质素-4受体（MC4R）激动剂布雷默兰otide和胰高血糖素样肽-1/胃抑制性多肽的积极顶线数据。

GLP-1

GLP-1

/GIP) tirzepatide and highlighted next steps in its obesity program for its novel next-generation MC4R long-acting peptides and oral small molecules.

/GIP）替尔泊肽，并强调了其肥胖症项目中新型下一代MC4R长效肽和口服小分子的下一步计划。

'Although the study was not designed to optimize weight loss, this 8-week study utilizing low doses of both bremelanotide and tirzepatide, met the primary endpoint and was highly statistically significant,' said

“尽管这项研究并非旨在优化体重减轻，但这个为期8周、使用低剂量布雷默兰otide和替塞帕肽的研究达到了主要终点，并且具有高度统计学意义，”

Carl Spana

卡尔·斯帕纳

, Ph.D., President & Chief Executive Officer of Palatin. 'The positive results of this signal-generating study exceeded expectations. The data demonstrated that co-administration was additive and synergistic, resulting in increased weight loss, and that co-administration did not result in increased tolerability or safety issues for patients.

，博士，Palatin公司总裁兼首席执行官。“这项信号生成研究的积极结果超出了预期。数据表明，联合给药具有相加和协同作用，能够带来更大的减重效果，且联合给药并未导致患者的耐受性或安全性问题增加。”

The data also showed that low dose MC4R agonist bremelanotide stopped the rapid weight regain seen after ending .

数据显示，低剂量的MC4R激动剂布雷默兰otide阻止了结束后的快速体重反弹。

GLP-1

GLP-1

/GIP tirzepatide treatment.'

/GIP tirzepatide 治疗。

Topline data results from the study were highly statistically significant for the study's primary endpoint, which was percent weight loss in patients for the co-administration of MC4R agonist bremelanotide plus

该研究的顶线数据结果在主要终点方面具有高度统计学显著性，主要终点是联合使用MC4R激动剂布雷默兰肽加其他药物时患者的体重减轻百分比。

GLP-1

GLP-1

/GLP tirzepatide compared to placebo, over the 8-week treatment period.

/GLP 轮替肽与安慰剂相比，在8周的治疗期内。

The co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001).

联合给药组体重减轻了4.4%，而安慰剂组为1.6% (p<0.0001)。

The primary analysis for additive effect demonstrated that:

主要的加性效应分析表明：

40% of patients in the co-administered group achieved a 5% reduction in their body weight, compared to 27% for the tirzepatide alone group (p<0.05).

联合给药组中有40%的患者体重减轻了5%，而单独使用替西帕肽的患者中有27%达到了这一效果（p<0.05）。

27% of patients in the co-administered group achieved a 6% reduction in their body weight, compared to 13% for the tirzepatide alone group (p<0.05).

共用药物组中有27%的患者体重减轻了6%，而单用替西帕肽组为13% (p<0.05)。

19% of patients in the co-administered group achieved a 7% reduction in their body weight, compared to 0% for the tirzepatide alone group (p<0.1).

与单独使用替尔泊肽的对照组相比，联合给药组中有19%的患者体重减轻了7%，而替尔泊肽单独组为0%（p<0.1）。

Increase in the percent of subjects on co-administration achieving 5%, 6% and 7% weight loss over tirzepatide alone, indicates that co-administration had a synergistic effect.

与单独使用替西帕肽相比，联合给药后达到5%、6%和7%体重减轻的受试者比例增加，表明联合给药具有协同效应。

'This study provides compelling evidence that combining an MC4R agonist with a

“这项研究提供了有力的证据，表明将MC4R激动剂与

GLP-1

GLP-1

/GIP compound creates a synergistic effect on weight loss,' said

/GIP化合物对减肥产生了协同效应，”

Jesse Richards

杰西·理查兹

, DO, of

，执行，的

Oklahoma State University

俄克拉荷马州立大学

College of Osteopathic Medicine. 'These findings align with what we observe in our clinic, where we treat patients with severe genetic obesity using both mechanisms. With a critical need for diverse weight loss solutions, this approach offers a promising improvement to

骨科医学院。 “这些发现与我们在诊所中观察到的情况一致，我们使用这两种机制治疗患有严重遗传性肥胖的患者。面对多样化的减肥方案的迫切需求，这种方法提供了很有前景的改进。”

GLP-1

GLP-1

/GIP monotherapy, particularly for those who struggle with tolerability at high doses.'

/GIP单药治疗，特别是对于那些在高剂量下难以耐受的患者。

In the study, patients first received a four-week treatment with tirzepatide alone (2.5 mg weekly) to confirm eligibility. They were then randomly assigned to one of four treatment groups for an additional four weeks: co-administration of MC4R bremelanotide (1.25 mg daily) and

在研究中，患者首先接受为期四周的单独使用替西帕肽（每周2.5毫克）治疗以确认资格。随后，他们被随机分配到四个治疗组之一，进行额外四周的治疗：联合使用MC4R布雷默兰otide（每日1.25毫克）和

GLP-1

GLP-1

/GIP tirzepatide (2.5 mg weekly), tirzepatide alone (2.5 mg weekly), bremelanotide alone (1.25 mg daily), or a placebo. A total of 113 patients were enrolled, with 96 randomized in a 3:1 ratio. Specifically, 46 patients were assigned to the MC4R plus

/GIP 轮替肽（每周2.5毫克）、单独使用轮替肽（每周2.5毫克）、单独使用布雷默兰otide（每日1.25毫克）或安慰剂。共纳入113名患者，其中96名以3:1的比例随机分配。具体而言，46名患者被分配到MC4R加...

GLP-1

GLP-1

/GIP co-administration group, while the remaining arms had 15 to 16 patients each.

/GIP联合给药组，而其余各组各有15至16名患者。

More than 50% of the lost weight was regained within two weeks after treatment cessation in both the co-administration group and the tirzepatide-only group, a common occurrence following the discontinuation of

在联合给药组和仅使用替西帕肽的组中，超过50%的减重效果在治疗停止后的两周内恢复，这是停药后的常见现象。

GLP-1

GLP-1

/GIP therapy. Importantly, the data indicated that weight regain was effectively halted in the MC4R agonist bremelanotide group. Additionally, co-administration of the MC4R agonist with the

/GIP治疗。重要的是，数据显示，在MC4R激动剂布雷默兰肽组中，体重回升得到了有效遏制。此外，MC4R激动剂与

GLP-1

GLP-1

/GIP therapy showed no increase in safety or tolerability concerns among patients.

/GIP治疗在患者中未显示出安全性和耐受性问题的增加。

Further data analysis is ongoing, including exploratory endpoints such as body composition and body mass index (BMI). The complete study results will be presented at an upcoming medical conference. Additional trial details can be accessed at

进一步的数据分析正在进行中，包括身体成分和体重指数（BMI）等探索性终点。完整的研究结果将在即将召开的医学会议上公布。更多的试验细节可以通过以下方式获取：

https://clinicaltrials.gov

https://clinicaltrials.gov

using the identifier NCT06565611.

使用标识符 NCT06565611。

Palatin is advancing the development of its next-generation MC4R long-acting peptide and oral small molecule compounds for the treatment of general obesity, weight loss management, acquired and congenital hypothalamic obesity, and potentially, rare/orphan genetically caused MC4R pathway diseases. These therapies are being explored as stand-alone treatments, as well as in combination with .

Palatin 正在推进其下一代MC4R长效肽和口服小分子化合物的开发，用于治疗普通肥胖、体重管理、获得性及先天性下丘脑肥胖，以及潜在的罕见/遗传性MC4R通路疾病。这些疗法正在作为独立治疗手段进行探索，同时也研究与其它疗法联合使用。

GLP-1

GLP-1

/GIP (incretin therapy), and as monotherapy for multiple genetic obesity disorders. Investigational New Drug (IND) applications are expected to be submitted in the fourth quarter of calendar 2025, with clinical data expected in the first half of calendar year 2026.

/GIP（肠促胰岛素治疗），以及作为多种遗传性肥胖症的单一疗法。预计将在2025年第四季度提交新药临床试验（IND）申请，并在2026年上半年获得临床数据。

'We see hypothalamic obesity as a game-changing opportunity for Palatin, addressing a massive unmet medical need in a multi-billion-dollar market with no approved treatments,' continued Dr. Spana. 'Importantly, we are one of only two companies pioneering therapies that specifically target the MC4R pathway.

“我们视下丘脑性肥胖为Palatin的一个改变游戏规则的机会，针对的是一个数十亿美元市场中未被满足的巨大医疗需求，并且目前尚无获批的治疗方法，”斯帕纳博士继续说道。“重要的是，我们是仅有的两家开拓专门针对MC4R通路疗法的公司之一。

Our highly selective, long-acting compounds—MC4R agonist peptides and the oral small molecule agonist PL7737—are designed to redefine treatment standards. Leveraging our deep expertise in MC4R agonist interactions, we have engineered these compounds to overcome critical challenges, including hyperpigmentation, hypertensive effects, the need for daily injections, and gastrointestinal side effects.'.

我们高度选择性、长效的化合物——MC4R激动剂肽和口服小分子激动剂PL7737——旨在重新定义治疗标准。凭借我们在MC4R激动剂相互作用方面的深厚专业知识，我们设计了这些化合物以克服关键挑战，包括皮肤色素沉着、高血压效应、每日注射的需求以及胃肠道副作用。

While

虽然

GLP-1

GLP-1

receptor agonists are widely used to treat obesity, alternative treatments are necessary due to several drawbacks — 67% of patients discontinue treatment because of side effects and a plateau effect in the first year. These medications can cause adverse side effects, be cost-prohibitive, lead to long-term reliance, and frequently result in weight regain upon discontinuation.

受体激动剂被广泛用于治疗肥胖症，但由于存在一些缺点，有必要寻找替代疗法——67%的患者因副作用和第一年内出现的平台效应而停止治疗。这些药物可能导致不良副作用、费用高昂、造成长期依赖，并且在停药后经常导致体重反弹。

MC4R agonists represent a validated pathway and promising therapeutic option for addressing obesity and promoting sustained weight management..

MC4R激动剂代表了一种经过验证的途径和有前景的治疗选择，用于解决肥胖问题并促进持续的体重管理。

About Melanocortin-4 Receptor Agonists Effect on Obesity

关于黑皮质素-4受体激动剂对肥胖症的影响

Genetic analysis has identified the melanocortin-4 receptor (MC4R) of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signaling in the MC4R pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders.

遗传分析已经确定下丘脑室旁核的黑皮质素-4受体（MC4R）在食欲调节中起着核心作用。抑制MC4R通路信号传导的基因突变会导致过度饮食、能量消耗减少以及早发性肥胖；这些突变已被确认为几种罕见遗传性肥胖疾病的病因。

Agouti-related peptide is an endogenous antagonist of the MC4R that works with neuropeptide Y to stimulate appetite, whereas MC4R agonists such as α- and β-melanocyte-stimulating hormone promote satiety. MC4R agonism represents an attractive target for potential obesity treatments..

食欲素相关肽是MC4R的内源性拮抗剂，与神经肽Y协同刺激食欲，而α-和β-促黑激素等MC4R激动剂则促进饱腹感。MC4R激动作用代表了潜在肥胖治疗的一个有吸引力的目标。

About Melanocortin Receptor Agonists

关于黑色素皮质素受体激动剂

The 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..

黑皮质素受体（'MCR'）系统对炎症、免疫系统反应、代谢、食物摄入和性功能有影响。共有五个黑皮质素受体，MC1R到MC5R。通过使用受体特异性激动剂（激活受体功能）或受体特异性拮抗剂（阻断受体功能）来调节这些受体，可以产生具有医学意义的药理作用。

About Palatin

关于Palatin

Palatin 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.

帕拉廷是一家生物制药公司，正在开发基于调节黑皮质素受体系统活性分子的首创新药，并拥有针对治疗具有显著未满足医疗需求和商业潜力疾病的受体特异性候选产品。

Palatin's strategy is to develop products and then form marketing collaborations to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at .

帕拉廷的策略是开发产品，然后建立营销合作以最大化其商业潜力。有关帕拉廷的更多信息，请访问帕拉廷的网站。

www.Palatin.com

www.Palatin.com

and follow Palatin on Twitter at @PalatinTech.

关注Palatin的Twitter：@PalatinTech。

Forward-looking Statements

前瞻性声明

Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates 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.

本新闻稿中的声明，如果不是历史事实，包括关于Palatin Technologies, Inc.未来预期的声明，例如有关Palatin开发中的产品、临床试验结果、监管机构可能采取的行动、监管计划、开发项目、候选产品的拟定适应症以及候选产品的市场潜力等声明，均属于《1933年证券法》第27A条、《1934年证券交易法》第21E条以及《1995年私人证券诉讼改革法案》中定义的“前瞻性声明”。

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 意图使此类前瞻性声明受到由此产生的安全港条款的保护。此类前瞻性声明涉及已知和未知的风险、不确定性以及其他可能导致 Palatin 的实际结果与其历史结果或此类前瞻性声明所表达或暗示的任何结果存在重大差异的因素。

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陈述中讨论的结果存在重大差异，原因包括但不限于临床试验结果、FDA及其他监管机构的监管行动和对监管批准的需求、Palatin资助其技术开发及建立并成功完成临床试验的能力、完成临床试验和提交监管审批所需的时间和成本、由竞争制药、生物制药和生物技术公司开发的产品、Palatin产品的市场接受度，以及Palatin向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 t.

帕拉廷不对 t 之后发生的更新事件负责。

SOURCE Palatin Technologies, Inc.

来源：Palatin Technologies, Inc.

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