MIAMI, FL, May 15, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced Steven B.

佛罗里达州迈阿密，2024年5月15日（环球通讯社）--Veru Inc.（纳斯达克：Veru），一家临床晚期生物制药公司，专注于开发用于高质量减肥，肿瘤学和病毒引起的急性呼吸窘迫综合征的保护肌肉的创新药物，今天宣布Steven B。

Heymsfield, M.D., a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana, as the Principal Investigator for the Company’s Phase 2b clinical trial of enobosarm to preserve muscle while augmenting fat loss in patients receiving a GLP-1 RA for weight loss..

医学博士海姆斯菲尔德（Heymsfield）是路易斯安那州巴吞鲁日彭宁顿生物医学研究中心（Pennington Biomedical Research Center）的一名教授兼身体成分代谢实验室主任，是该公司依诺沙姆（enobosarm）2b期临床试验的主要研究者，该试验旨在保护肌肉，同时增加接受GLP-1 RA减肥的患者的脂肪损失。。

Dr. Heymsfield is a leading authority on body composition assessment and his research focuses primarily on human obesity, including energy balance regulation, weight loss treatments, co-morbidity effects, and development of related mathematical models. He has a long term-interest in the development of methods for evaluating body composition and the application of new technologies to the study of human metabolism..

Heymsfield博士是身体成分评估方面的领先权威，他的研究主要集中在人类肥胖，包括能量平衡调节，减肥治疗，共病效应以及相关数学模型的开发。他长期致力于开发评估身体成分的方法以及将新技术应用于人体代谢研究。。

Dr. Heymsfield received a degree in medicine from Mount Sinai School of Medicine, and he completed his internship, residency, and fellowship in pharmacology at Emory University. He then joined the Emory University School of Medicine faculty, holding positions there including Associate Professor of Medicine and Assistant Director of the NIH-funded Clinical Research Unit.

海姆斯菲尔德博士获得了西奈山医学院的医学学位，并在埃默里大学完成了实习、住院和药理学研究金。然后，他加入了埃默里大学医学院，担任医学副教授和美国国立卫生研究院资助的临床研究部门助理主任等职务。

Expanding on his interests in obesity and metabolism, Dr. Heymsfield next moved to Columbia University, College of Physicians and Surgeons and there he held positions as Professor of Medicine and Deputy Director, New York Obesity Research Center at St. Luke’s-Roosevelt Hospital. He and his Columbia colleagues conducted wide ranging clinical studies on obesity with a focus on energy metabolism, body composition, and pharmacologic weight control management.

Heymsfield博士扩展了对肥胖和新陈代谢的兴趣，随后前往哥伦比亚大学内科医生和外科医生学院，并在那里担任医学教授和圣卢克·罗斯福医院纽约肥胖研究中心副主任。他和他的哥伦比亚同事对肥胖进行了广泛的临床研究，重点是能量代谢，身体成分和药物体重控制管理。

Prior to his Pennington Biomedical position, Dr. Heymsfield worked with Merck & Co. for 5 years, initially as Executive Director in the Obesity Group and then as Global Director of Scientific Affairs..

在担任Pennington Biomedical职位之前，Heymsfield博士在默克公司工作了5年，最初担任肥胖集团的执行董事，然后担任全球科学事务总监。。

Dr. Heymsfield has published more than 600 peer-reviewed papers covering topics such as obesity, malnutrition, cachexia, body composition, and caloric expenditure. His contributions to the study of human nutrition led to the TOPS Award from The Obesity Society, the Rhoads Award from the American Society of Parenteral and Enteral Nutrition (ASPEN), the Robert H.

海姆斯菲尔德博士发表了600多篇同行评议论文，涉及肥胖、营养不良、恶病质、身体成分和热量消耗等主题。他对人类营养研究的贡献获得了肥胖协会的TOPS奖、美国肠外和肠内营养学会（ASPEN）的Rhoads奖、RobertH。

Herman Memorial Award, American Society of Nutrition (ASN), the George Bray Founders Award from The Obesity Society, and he was honored for his role in the FDA ban on ephedra, receiving the 2004 NYC Mayor’s Award for Science and Technology. Dr. Heymsfield was elected Fellow of The Obesity Society in 2014, and he is an honorary member of the American Dietetic and Chilean Clinical Nutrition Associations.

赫尔曼纪念奖（Herman Memorial Award）、美国营养学会（ASN）、肥胖症学会乔治·布雷创始人奖（George Bray Founders Award），他因在美国食品和药物管理局（FDA）麻黄禁令中的作用而获得荣誉，并获得2004年纽约市市长科学技术奖。Heymsfield博士于2014年当选为肥胖协会会员，他是美国饮食和智利临床营养协会的荣誉会员。

Dr. Heymsfield is past president of ASPEN and ASN and he is vice-president of The Obesity Society..

Heymsfield博士是ASPEN and ASN的前任总裁，也是肥胖协会的副主席。。

As the Principal Investigator for the Company’s enobosarm Phase 2b clinical trial, Dr. Heymsfield will lead the clinical trial sites. He will also participate in the study analysis and contribute to reporting the results to the FDA and scientific journals and meetings.

作为该公司enobosarm 2b期临床试验的首席研究员，Heymsfield博士将领导临床试验地点。他还将参与研究分析，并将结果报告给FDA和科学期刊和会议。

“I am pleased to serve as the Principal Investigator for this important Phase 2b enobosarm clinical trial. I am enthusiastic to be participating in enobosarm’s development, a medicine that has a novel established mechanism of action that has the potential to improve the quality of weight loss for these patients,” said Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana..

路易斯安那州巴吞鲁日彭宁顿生物医学研究中心（Pennington Biomedical Research Center）的教授兼身体成分代谢实验室主任史蒂文·海姆斯菲尔德（Steven Heymsfield）说：“我很高兴担任这项重要的2b期依诺沙姆临床试验的首席研究员。我很热情地参与依诺沙姆的开发，这种药物具有一种新的既定作用机制，有可能改善这些患者的减肥质量。”。。

'Dr. Heymsfield is an expert in body composition and obesity and an ideal clinical leader to serve as the Principal Investigator of the enobosarm Phase 2b clinical trial,' said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “Veru is proud to have Dr. Heymsfield as our partner with the enobosarm clinical trial.

'博士。Veru Inc.董事长、总裁兼首席执行官、医学博士米切尔·施泰纳（Mitchell Steiner）说，海姆斯菲尔德（Heymsfield）是身体成分和肥胖方面的专家，也是担任enobosarm 2b期临床试验首席研究员的理想临床领导者。“Veru很骄傲有海姆斯菲尔德博士作为我们在enobosarm临床试验中的合作伙伴。

There is a significant unmet medical need for patients undergoing weight loss treatments with GLP-1 RAs to address the issue of muscle loss. We believe enobosarm could potentially be a great addition for patients to make their weight loss journey as healthy as possible. We look forward to enrolling this Phase 2b clinical trial expeditiously with data expected by year-end.'.

对于接受GLP-1 RAs减肥治疗的患者来说，解决肌肉损失问题的医疗需求尚未得到满足。我们相信依诺沙姆可能会为患者提供一个很好的补充，使他们的减肥旅程尽可能健康。我们期待着尽快加入这项2b期临床试验，预计年底将有数据。”。

About the Enobosarm Phase 2b clinical trial

关于依诺司ARM 2b期临床试验

The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in approximately 90 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®).

2b期，多中心，双盲，安慰剂对照，随机，剂量发现临床试验旨在评估enobosarm 3mg，enobosarm 6mg或安慰剂作为保护肌肉和增加脂肪损失的治疗方法的安全性和有效性。大约90名肌肉减少性肥胖或超重老年人（>60岁）接受semaglutide（Wegovy®）的患者。

The primary endpoint is difference in total lean body mass, and the key secondary endpoints are differences in total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States.

主要终点是总瘦体重的差异，关键的次要终点是16周时通过爬楼梯测试测量的全身脂肪量和身体机能的差异。2b期临床试验正在积极招募来自美国多达15个临床地点的患者。

Topline clinical results from the trial are expected by the end of calendar year 2024..

该试验的最终临床结果预计将于2024日历年结束。。

After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks.

在完成2b期临床试验的疗效剂量发现部分后，预计参与者将以盲法继续进入2b期延长临床试验，所有患者将停止接受GLP-1 RA，但将继续服用安慰剂，依诺沙姆3mg或依诺沙姆6mg，再服用12周。

The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025..

2b期延长临床试验将评估依诺沙姆是否可以维持肌肉并防止停止GLP-1 RA后发生的脂肪和体重增加。预计2025年第二季度将公布单独的盲法2b期扩展临床研究的最终结果。。

About Sarcopenic Obesity

关于肌肉减少性肥胖

According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss.

根据疾病预防控制中心的数据，美国41.5%的老年人患有肥胖症，可以从减肥药物中受益。这些60岁以上的肥胖患者中，高达34.4%患有肌肉减少性肥胖。这一大群肌肉减少性肥胖患者尤其有服用GLP-1药物减肥的风险，因为由于年龄相关的肌肉损失，他们的肌肉量已经非常少。

Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients..

服用GLP-1 RA药物时肌肉质量进一步减少可能导致肌肉无力，导致平衡不良，步速下降，活动障碍，独立性丧失，跌倒，骨折和死亡率增加，这是一种与年龄有关的虚弱。由于GLP-1 RA治疗减肥时肌肉损失的幅度和速度，GLP-1 RA药物可能会加速老年肥胖或超重老年患者的虚弱发展。。

About Enobosarm

关于Enobosarm

Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer.

Enobosarm（又名ostarine，MK-2866，GTx-024和VERU-024）是一种新型口服每日选择性雄激素受体调节剂（SARM），先前已在5项临床研究中进行了研究，涉及968名老年正常男性和绝经后女性以及因晚期癌症而肌肉萎缩的老年患者。

Advanced cancer simulates a “starvation state” where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass.

晚期癌症模拟“饥饿状态”，其中肌肉和脂肪量都有明显的无意损失或消耗，这与服用GLP-1 RA药物的患者所观察到的相似。我们认为，来自前五项临床试验的全部临床数据表明，依诺沙姆治疗可导致肌肉质量的剂量依赖性增加，同时改善身体机能，并显着降低脂肪质量的剂量依赖性。

The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass..

这五项依诺沙姆临床试验在老年患者和癌症诱导的饥饿样状态患者中产生的患者数据为依诺沙姆提供了强有力的临床依据。预计依诺沙姆联合GLP-1 RA可能会增加脂肪减少和总体重减轻，同时保持肌肉质量。。

Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone..

重要的是，enobosarm有一个大型安全数据库，其中包括27项临床试验，涉及1581名男性和女性，其中一些包括服用长达3年的患者。在这个大型安全数据库中，依诺沙姆通常耐受性良好，胃肠道副作用没有增加。这一点很重要，因为单独使用GLP-1 RA治疗已经存在显着且频繁的胃肠道副作用。。

About Veru Inc.

关于维鲁股份有限公司。

Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

Veru是一家临床晚期生物制药公司，专注于开发用于治疗代谢疾病，肿瘤学和ARDS的新药。该公司的药物开发计划包括两种晚期新型小分子，依诺沙姆和沙比扎布林。

Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting..

Enobosarm是一种选择性雄激素受体调节剂（SARM），目前正在开发用于两个适应症：（i）Enobosarm的2b期临床研究，用于增加肌肉减少性肥胖或超重老年患者的脂肪损失和预防肌肉损失。接受GLP-1 RA的患者有发生肌肉萎缩和肌肉无力的风险，以及（ii）在获得足够资金的情况下，Enobosarm和abemaciclib的3期ENABLAR-2临床试验，用于治疗雄激素受体阳性（AR+），雌激素受体阳性（ER+）和人表皮生长因子受体2阴性（HER2-）转移性乳腺癌。。

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources..

Sabizabulin是一种微管干扰物，正在开发作为治疗住院病毒性ARDS患者的3期临床试验。在我们从政府拨款、制药公司合作伙伴关系或其他类似的第三方外部来源获得资金之前，公司不打算进一步开发用于治疗病毒性ARDS的沙比扎布林。。

The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.

该公司还拥有FDA批准的商业产品FC2女用安全套®（内部安全套），用于防止意外怀孕和性传播感染。

Forward-Looking Statements

前瞻性声明

This press release contains 'forward-looking statements' as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Company’s scientific advisors will make valuable contributions to the Company’s enobosarm program and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology.

本新闻稿包含1995年《私人证券诉讼改革法案》中定义的“前瞻性声明”，包括但不限于与上述依诺沙姆2b期试验是否以及何时产生topline数据或患者将进入扩展研究，计划设计，此类试验的地点数量，时间安排，终点，患者人数和患者规模以及此类试验是否会成功达到其任何终点，依诺沙姆是否会增强体重减轻或保留肌肉，或满足肥胖患者的任何未满足需求，以及是否会增强体重减轻，公司的科学顾问是否会为公司的依诺沙姆计划和该公司能否成功转型为专注于肥胖和肿瘤学的晚期生物制药公司。

The words 'anticipate,' 'believe,' 'could,' 'expect,' 'intend,' 'may,' 'opportunity,' 'plan,' 'predict,' 'potential,' 'estimate,' 'should,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“预期”、“相信”、“可能”、“期望”、“打算”、“可能”、“机会”、“计划”、“预测”、“潜力”、“估计”、“应该”、“将会”、“将会”和类似的表达都是为了识别前瞻性陈述，尽管并非所有的前瞻性陈述都包含这些识别词。

Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances.

本新闻稿中的任何前瞻性声明均基于公司当前的计划和战略，反映了公司目前对其业务相关风险和不确定性的评估，并于本新闻稿发布之日做出。由于新的信息或未来的事件、发展或情况，公司没有义务更新本新闻稿中包含的任何前瞻性声明。

Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if an.

此类前瞻性陈述受到已知和未知风险、不确定性和假设的影响，如果存在。

* Wegovy® is a registered trademark of Novo Nordisk A/S

*Wegovy®是诺和诺德公司的注册商标

Investor and Media Contact:

投资者和媒体联系人：

Samuel Fisch

Samuel Fish

Executive Director, Investor Relations and Corporate Communications

投资者关系和企业传播执行董事

Email: veruinvestor@verupharma.com

电子邮件veruinvestor@verupharma.com