-- Following positive efficacy and safety results from Phase 2b QUALITY study, company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA --

-- 在第二阶段 b 期 QUALITY 研究中获得积极的疗效和安全性结果后，公司获得了 FDA 对 enobosarm 与 GLP-1 RA 联合使用的监管明确性 --

-- Incremental weight loss is an acceptable approvable primary endpoint with key secondary endpoints on physical function and body composition improvements --

-- 增量体重减轻是一个可接受的可批准主要终点，关键次要终点为身体功能和身体成分的改善 --

-- Company plans to initiate Phase 2 PLATEAU clinical study in calendar Q1 2026 --

-- 公司计划在 2026 年日历第一季度启动第二阶段 PLATEAU 临床研究 --

-- Post fiscal year end, company completed public offering for net proceeds of approximately $23.4 million --

-- 财年结束后，公司完成了公开募股，净收益约为 2340 万美元 --

-- Company to host conference call and webcast today at 8:00 a.m. ET --

-- 公司将在今天上午 8:00（东部时间）召开电话会议并进行网络直播 --

MIAMI, FL, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal year 2025 ended September 30, 2025 and provided an update on the clinical progress of its obesity program.

美国佛罗里达州迈阿密，2025年12月17日（GLOBE NEWSWIRE）-- Veru Inc.（纳斯达克：VERU），一家专注于开发用于治疗心代谢和炎症疾病的创新药物的晚期临床阶段生物制药公司，今天公布了截至2025年9月30日的 2025 财年的财务结果，并提供了其肥胖项目的临床进展更新。

“The current FDA regulatory guidance for muscle preservation drugs in combination with GLP-1 RA drugs in the treatment of obesity seems particularly well aligned for enobosarm,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “The FDA defines obesity as a disease of excess body fat, and as such, the medical objective to treat obesity should be to reduce excess body fat, NOT to reduce lean mass. Although GLP-1 RAs have demonstrated profound weight loss results, the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 RAs for patients to ONLY lose fat, while preserving lean mass and physical function for a quality weight reduction. The completed positive Phase 2b QUALITY clinical trial provided the proof of concept that enobosarm could be that next generation drug in combination with a GLP-1 receptor agonist to make the weight loss journey more selective for only fat while preserving lean mass and physical function in older patients who have obesity lessening the potential risk of loss of balance, and fractures.”

“目前 FDA 对肌肉保护药物与 GLP-1 RA 药物联合用于肥胖治疗的监管指导似乎与 enobosarm 特别契合，” Veru 的董事长、总裁兼首席执行官 Mitchell Steiner 博士表示。“FDA 将肥胖定义为一种过多体脂肪的疾病，因此，治疗肥胖的医学目标应是减少过多的体脂肪，而不是减少瘦体重。尽管 GLP-1 RA 已显示出显著的体重减轻效果，但下一代肥胖药物的策略应是与 GLP-1 RA 联合治疗，使患者仅减少脂肪，同时保持瘦体重和身体功能，以实现高质量的体重减轻。已完成的积极第二阶段 b 期 QUALITY 临床试验提供了概念验证，表明 enobosarm 可以与 GLP-1 受体激动剂联合使用，帮助患者在减重过程中更有选择性地减少脂肪，同时保持瘦体重和身体功能，降低老年肥胖患者失去平衡和骨折的潜在风险。”

Dr. Steiner added: “An emerging, common, and serious clinical and therapeutic challenge with GLP-1 RA monotherapy is that 88% of patients with obesity after one year on drug hit a weight loss plateau where they stop losing additional weight while on a GLP-1 RA. Unfortunately, 62.6% of these patients still had clinical obesity at the time they reached the weight loss plateau based on the SURMOUNT-1 study. Loss of muscle may stimulate these patients to consume more calories and may be an important reason why patients hit the weight loss plateau. The Phase 2b PLATEAU clinical trial is designed to address this problem, especially in older patients, by testing a novel combination of enobosarm and a GLP-1 RA. Enobosarm has been shown to directly burn fat and preserve muscle to increase physical function and burn more calories which could help to break through the weight loss plateau leading to incremental weight reduction. With our public offering now completed, the Phase 2b PLATEAU clinical trial is expected to start Q1 calendar year 2026 with interim analysis results anticipated Q1 calendar year 2027.”

Steiner 博士补充道：“GLP-1 RA 单药治疗的一个新兴、普遍且严重的临床和治疗挑战是，88% 的肥胖患者在使用药物一年后会达到体重减轻平台期，停止进一步减重。不幸的是，根据 SURMOUNT-1 研究，这些患者中有 62.6% 在达到体重减轻平台期时仍然患有临床肥胖。肌肉的流失可能促使这些患者摄入更多热量，这可能是患者达到体重减轻平台期的重要原因。第二阶段 b 期 PLATEAU 临床试验旨在解决这一问题，特别是在老年患者中，测试 enobosarm 与 GLP-1 RA 的新型组合。研究表明，enobosarm 可以直接燃烧脂肪并保护肌肉，以提高身体功能并燃烧更多热量，从而帮助突破体重减轻平台期，实现增量体重减轻。随着我们的公开募股现已完成，第二阶段 b 期 PLATEAU 临床试验预计将在 2026 年日历第一季度启动，初步分析结果预计在 2027 年日历第一季度公布。”

Enobosarm for chronic weight reduction program

用于慢性体重减轻计划的 enobosarm

Phase 2b QUALITY study: Enobosarm is a next generation drug that makes GLP-1 RA weight loss more selective for fat loss while preserving lean mass and physical function

第二阶段 b 期 QUALITY 研究：enobosarm 是一种下一代药物，使 GLP-1 RA 的减重更具选择性，专注于脂肪减轻，同时保持瘦体重和身体功能

In January 2025, the Company announced positive topline efficacy results from the Phase 2b QUALITY clinical study, which was a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to increase fat loss and to prevent the loss of muscle in 168 older patients (≥60 years of age) receiving a GLP-1 RA (semaglutide) for chronic weight loss.

2025 年 1 月，公司宣布第二阶段 b 期 QUALITY 临床研究的积极顶线疗效结果，该研究是一项多中心、双盲、安慰剂对照、随机、剂量寻找的临床试验，旨在评估 enobosarm 3 mg、enobosarm 6 mg 或安慰剂作为治疗 168 名接受 GLP-1 RA（semaglutide）进行慢性减重的老年患者（≥60 岁）以增加脂肪减轻和防止肌肉流失的安全性和有效性。

Highlights from the Phase 2b QUALITY clinical trial focusing on 3 mg enobosarm dose that has been selected by the Company and agreed upon by FDA for the PLATEAU clinical trial

第二阶段 b 期 QUALITY 临床试验的亮点 专注于公司选择并获得 FDA 同意用于 PLATEAU 临床试验的 3 mg enobosarm 剂量

Efficacy

疗效

The results for the 16 week active weight loss period of treatment with enobosarm 3 mg or placebo in combination with semaglutide:

enobosarm 3 mg 或安慰剂与 semaglutide 联合治疗的 16 周主动减重期结果:

The enobosarm 3 mg + semaglutide group met the primary endpoint of study, preservation of total lean mass, with a statistically significant 100% average preservation of total lean mass compared to placebo + semaglutide at 16 weeks.
Enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide with the enobosarm 3 mg group having a 12% greater fat loss at 16 weeks.
Even with having preserved lean mass, enobosarm 3 mg + semaglutide treatment resulted in a similar mean body weight loss as semaglutide alone at 16 weeks. However, it should be noted, in a subset analysis of the subjects receiving enobosarm 3 mg and had a baseline BMI ≥ 35, incremental weight loss was observed at 16 weeks:
- There was weight loss of -4.7% for semaglutide versus -5.58% for enobosarm 3 mg + semaglutide treatment group.
- Proportion of patients that lost at least 5% of body weight at 16 weeks was 47.4% for semaglutide vs 65.4% for enobosarm 3 mg + semaglutide treatment group.
- This weight loss occurred even with 84% preservation of lean mass in this subset of patients receiving semaglutide on enobosarm 3 mg.
The tissue composition of the total body weight lost on average was 34% lean mass and 66% fat mass in the placebo and semaglutide group, whereas for the enobosarm 3 mg + semaglutide group, the weight loss was 0% lean mass and 100% fat mass.

enobosarm 3 mg + semaglutide 组达到了研究的主要终点，即保持总瘦体重，与安慰剂 + semaglutide 相比，在 16 周时总瘦体重的平均保持率具有统计学显著性，达到 100%。
enobosarm + semaglutide 治疗导致脂肪质量的剂量依赖性更大损失，与安慰剂 + semaglutide 相比，enobosarm 3 mg 组在 16 周时脂肪损失增加了 12%。
尽管保持了瘦体重，enobosarm 3 mg + semaglutide 治疗在 16 周时的平均体重减轻与单独使用 semaglutide 相似。然而，需要注意的是，在接受 enobosarm 3 mg 且基线 BMI ≥ 35 的受试者的子集分析中，在 16 周时观察到了增量体重减轻：
- semaglutide 组的体重减轻为-4.7%，而 enobosarm 3 mg + semaglutide 治疗组为-5.58%。
- 在 16 周时，体重减轻至少 5% 的患者比例为 semaglutide 组的 47.4% 与 enobosarm 3 mg + semaglutide 治疗组的 65.4%。
- 即使在接受 semaglutide 的 enobosarm 3 mg 患者中，瘦体重保持率为 84%。
在安慰剂和 semaglutide 组中，平均体重减轻的组织成分为 34% 瘦体重和 66% 脂肪质量，而在 enobosarm 3 mg + semaglutide 组中，体重减轻为 0% 瘦体重和 100% 脂肪质量。

Physical function was measured by the Stair Climb Test. A prespecified responder analysis was conducted using a greater than 10% decline in stair climb power as the cut off at 16 weeks which is a decline that represents an approximate 7 to 8 years of loss of stair climb power function that naturally occurs with aging, but it occurred in 16 weeks.

通过楼梯攀爬测试测量身体功能。预先指定的应答者分析使用楼梯攀爬能力下降超过 10% 作为 16 周的截止点，这一下降代表了随着年龄增长自然发生的约 7 到 8 年的楼梯攀爬能力损失，但在 16 周内就发生了。

Semaglutide alone resulted in a loss of physical function as 44.8% of the placebo + semaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks. The Phase 2b QUALITY study is the first to confirm that older patients with obesity receiving a GLP-1 RA had a significant and relevant physical function decline as early as 16 weeks on treatment.
- In contrast, enobosarm 3 mg treatment reduced the proportion of patients receiving semaglutide to 17.6% who experienced ≥10% decline in stair climb power. This represents a 59.8% relative reduction in proportion of patients receiving enobosarm who experienced ≥10% decline in stair climb power.

单独使用 Semaglutide 导致身体功能下降，因为在 16 周时，安慰剂 +Semaglutide 组中有 44.8% 的患者楼梯攀爬能力至少下降了 10%。Phase 2b QUALITY 研究首次确认，接受 GLP-1 RA 治疗的肥胖老年患者在治疗 16 周时就出现了显著且相关的身体功能下降。
- 相比之下，3 mg 的 enobosarm 治疗将接受 Semaglutide 的患者中经历≥10% 楼梯攀爬能力下降的比例降低至 17.6%。这代表了接受 enobosarm 的患者中经历≥10% 楼梯攀爬能力下降的比例相对减少了 59.8%。

Results for the Maintenance Extension portion of the study, where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg as monotherapy for 12 weeks:

研究的维持扩展部分结果，其中所有患者停止了 Semaglutide 治疗，但继续接受安慰剂和 3 mg enobosarm 单药治疗 12 周:

The placebo monotherapy group regained 43% of body weight that was previously lost during the Phase 2b QUALITY study for a mean percent change of 2.57% (5.06 lbs) in body weight, compared to 1.41% (2.73 lbs) for the 3 mg enobosarm group. This means that the 3 mg enobosarm monotherapy significantly reduced the body weight regained by 46% after discontinuation of semaglutide.
By the way, the mean tissue composition of body weight regained was 100% lean mass, not fat for the enobosarm 3 mg compared to 28% fat and 72% lean mass in the placebo group.

安慰剂单药组恢复了在 Phase 2b QUALITY 研究中先前失去的 43% 的体重，平均变化为 2.57%（5.06 磅），而 3 mg enobosarm 组为 1.41%（2.73 磅）。这意味着 3 mg enobosarm 单药治疗显著减少了停止 Semaglutide 后恢复的体重，减少幅度为 46%。
顺便提一下，3 mg enobosarm 恢复的体重的平均组织成分为 100% 瘦体重，而安慰剂组为 28% 脂肪和 72% 瘦体重。

In fact, by end of the 28 week study, enobosarm 3 mg plus semaglutide followed by enobosarm 3 mg monotherapy regimen was more effective in preserving 100% lean mass and in losing 58% more fat compared to placebo plus semaglutide followed by placebo monotherapy.

实际上，到 28 周研究结束时，enobosarm 3 mg 加 Semaglutide 再加上 enobosarm 3 mg 单药治疗方案在保持 100% 瘦体重和减少 58% 脂肪方面比安慰剂加 Semaglutide 再加上安慰剂单药治疗更有效。

Safety

安全性

At the end of the 16 week active weight loss period, enobosarm and semaglutide combination had a positive safety profile and enobosarm did not have any added gastrointestinal (GI) adverse events compared to semaglutide alone. For the Maintenance Extension clinical trial, where semaglutide was stopped for 12 weeks, enobosarm monotherapy also had a positive safety profile. After discontinuation of semaglutide, there were essentially no GI side effects, no evidence of drug induced liver injury, and no increases in obstructive sleep apnea observed at any dose of enobosarm compared to placebo monotherapy. There were no AEs related to masculinization in women. There were no AEs of increases in prostate specific antigen in men.

在 16 周的主动减重期结束时，enobosarm 和 Semaglutide 组合具有良好的安全性特征，enobosarm 与单独使用 Semaglutide 相比没有额外的胃肠道（GI）不良事件。在维持扩展临床试验中，Semaglutide 停止 12 周后，enobosarm 单药治疗也具有良好的安全性特征。停止 Semaglutide 后，几乎没有 GI 副作用，没有药物引起的肝损伤证据，也没有观察到任何剂量的 enobosarm 与安慰剂单药相比增加的阻塞性睡眠呼吸暂停。没有与女性男性化相关的不良事件。男性中没有观察到前列腺特异性抗原升高的不良事件。

Summary

总结

The Phase 2b QUALITY clinical trial confirms that preserving lean mass with enobosarm plus semaglutide led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, enobosarm monotherapy significantly prevented the regain of both weight and fat mass such that by the end of the 28 week study there was greater loss of fat mass while preserving lean mass for a higher quality weight reduction compared to the placebo group.

Phase 2b QUALITY 临床试验确认，使用 enobosarm 加 Semaglutide 保持瘦体重在主动减重期间导致更大的脂肪损失，并且在停止 Semaglutide 后，enobosarm 单药显著防止了体重和脂肪质量的恢复，以至于在 28 周研究结束时，与安慰剂组相比，脂肪质量的损失更大，同时保持瘦体重，从而实现更高质量的减重。

FDA Regulatory Feedback

FDA 监管反馈

In September 2025, the Company announced a successful FDA meeting providing regulatory clarity for enobosarm in combination with GLP-1 RA for greater weight loss in the treatment of obesity

2025 年 9 月，公司宣布与 FDA 的会议成功，为 enobosarm 与 GLP-1 RA 联合使用以实现更大减重的监管提供了明确性。

Highlights from September 2025 FDA meeting

2025 年 9 月 FDA 会议要点

Incremental weight loss: According to FDA feedback on Veru’s clinical development program for enobosarm, FDA has guided us that there are at least 2 possible regulatory pathways forward for the development of enobosarm in combination with a GLP-1 RA and are based on incremental weight loss. First, incremental weight loss with at least a 5% placebo-corrected weight loss difference at 52 weeks of maintenance treatment with enobosarm in combination with a GLP-1 RA treatment compared to the GLP-1 RA treatment alone is an acceptable primary endpoint to support efficacy for approval. Second, if incremental weight loss difference of <5% (including similar weight loss) is observed at 52 weeks of maintenance treatment with a clinically significant positive benefit, such as clinically beneficial preservation in physical function, enobosarm in combination with GLP-1 RA may also be acceptable to support efficacy for approval.

增量减重： 根据 FDA 对 Veru 的 enobosarm 临床开发计划的反馈，FDA 指导我们，针对 enobosarm 与 GLP-1 RA 联合开发，至少有两条可能的监管路径，基于增量减重。首先，enobosarm 与 GLP-1 RA 联合治疗在维持治疗 52 周时，至少 5% 的安慰剂校正体重减轻差异是支持批准的可接受主要终点。其次，如果在维持治疗 52 周时观察到增量减重差异<5%（包括相似的体重减轻），并且具有临床显著的积极益处，例如在身体功能上有临床益处的保持，enobosarm 与 GLP-1 RA 联合使用也可能被接受以支持批准的有效性。

Enobosarm dose - FDA confirmed that enobosarm 3 mg is an acceptable dosage for future Veru clinical development.

Enobosarm 剂量 - FDA 确认 3 mg 的 enobosarm 是未来 Veru 临床开发的可接受剂量。

Planned Phase 2b PLATEAU clinical study

计划中的 Phase 2b PLATEAU 临床研究

The planned Phase 2b PLATEAU clinical trial will measure incremental weight loss in this enriched patient population that has more weight to lose (BMI ≥ 35) and more at risk for physical decline and functional limitations (age ≥ 65) to better inform the design of the Phase 3 development program. For the planned Phase 2b PLATEAU clinical trial, we will evaluate the effect of enobosarm 3 mg on total body weight, physical function, and safety in approximately 200 patients who have obesity (BMI ≥ 35) and are older (age ≥ 65) and are initiating GLP-1 RA treatment for weight reduction. The primary efficacy endpoint of the study will be the percent change from baseline in total body weight at 72 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass and fat mass, as measured by DEXA scan. Since we want to continue to evaluate enobosarm as a muscle preserving and body composition drug, the key secondary endpoints will be function endpoints, physical function (stair climb test), mobility disability status (functional limitations), and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function) as well as body composition endpoints, total fat mass, total lean mass, and bone mineral density.

计划中的 Phase 2b PLATEAU 临床试验将测量在这一富裕患者群体中增量减重，这些患者有更多的体重需要减轻（BMI≥35）且更容易出现身体功能下降和功能限制（年龄≥65），以更好地为 Phase 3 开发计划的设计提供信息。在计划中的 Phase 2b PLATEAU 临床试验中，我们将评估 3 mg enobosarm 对约 200 名肥胖患者（BMI≥35）和年龄较大的患者（年龄≥65）在开始 GLP-1 RA 减重治疗时的总体体重、身体功能和安全性的影响。研究的主要有效性终点将是 72 周时总体体重的基线变化百分比。将在 36 周时进行中期分析，以评估基线瘦体重和脂肪质量的变化百分比，测量方法为 DEXA 扫描。由于我们希望继续评估 enobosarm 作为保持肌肉和改善身体成分的药物，关键的次要终点将是功能终点、身体功能（楼梯攀爬测试）、行动残疾状态（功能限制）以及患者报告的身体功能问卷（SF-36 PF-10 和 IWQOL-lite CT 身体功能），以及身体成分终点，总脂肪质量、总瘦体重和骨矿密度。

Building on the Phase 2 QUALITY study and with greater FDA regulatory clarity, we have designed the Phase 2b PLATEAU clinical study to assess the ability of enobosarm treatment to break through the weight loss plateau in older patients (age ≥ 65) with obesity (BMI ≥ 35) receiving GLP-1 RA treatment with the expectation that patients will achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function at 52 weeks of GLP-1 weight reduction maintenance dose.

基于第二阶段 QUALITY 研究，并在 FDA 监管更加明确的情况下，我们设计了第二阶段 b PLATEAU 临床研究，以评估 enobosarm 治疗在接受 GLP-1 RA 治疗的老年患者（年龄≥65 岁）中突破体重减轻停滞期的能力，期望患者在 52 周的 GLP-1 体重减轻维持剂量下实现临床上有意义的增量体重减少，并保持肌肉质量和身体功能。

Full Year Financial Summary: Fiscal 2025 vs Fiscal 2024

2025 财年与 2024 财年的全年财务摘要

Research and development expenses increased to $15.6 million from $12.8 million
General and administrative expenses decreased to $19.9 million from $24.6 million
Operating loss from continuing operations decreased to $24.8 million from $36.2 million
Net loss from continuing operations decreased to $15.7 million, or $1.07 per share, compared to $35.3 million, or $2.61 per share
Net loss decreased to $22.7 million, or $1.55 per share, compared to $37.8 million, or $2.80 per share

研发费用从 1280 万美元增加至 1560 万美元
一般和行政费用从 2460 万美元减少至 1990 万美元
持续经营的营业亏损从 3620 万美元减少至 2480 万美元
持续经营的净亏损减少至 1570 万美元，或每股 1.07 美元，较 3530 万美元，或每股 2.61 美元有所减少
净亏损减少至 2270 万美元，或每股 1.55 美元，较 3780 万美元，或每股 2.80 美元有所减少

Balance Sheet Information

资产负债表信息

 Cash, cash equivalents and restricted cash were $15.8 million as of September 30, 2025 versus $24.9 million as of September 30, 2024
Post fiscal 2025 year end, company completed public offering for additional net cash proceeds of approximately $23.4 million

截至2025年9月30日，现金、现金等价物和受限现金为 1580 万美元，而截至2024年9月30日为 2490 万美元
在 2025 财年结束后，公司完成了额外净现金收益约 2340 万美元的公开发行

Event Details

事件详情

The audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2225332, for one week.

音频网络广播将在公司网站的主页和投资者页面上提供，网址为 www.verupharma.com。要通过电话加入会议，请拨打 1-800-341-1602（国内）或 1-412-902-6706（国际），并请求加入 Veru Inc.的电话会议。音频网络广播的存档版本将在公司网站上提供回放，约三个月。电话回放将在东部时间中午 12:00 左右提供，拨打 1-855-669-9658（国内）或 1-412-317-0088（国际），密码 2225332，持续一周。

About Veru Inc.

关于 Veru Inc.

Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass leading to improved body composition and physical function with expected clinically meaningful incremental weight reduction versus GLP-1 RA monotherapy. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease.

Veru 是一家处于临床后期的生物制药公司，专注于开发用于治疗心代谢和炎症性疾病的创新药物。公司的药物开发项目包括两种晚期新型小分子，enobosarm 和 sabizabulin。Enobosarm 是一种选择性雄激素受体调节剂（SARM），正在开发为一种新一代药物，使 GLP-1 RA 药物的体重减少更具组织选择性，以减少脂肪并保持瘦体重，从而改善身体成分和身体功能，预计与 GLP-1 RA 单药治疗相比实现临床上有意义的增量体重减少。Sabizabulin 是一种微管破坏剂，正在开发用于治疗动脉粥样硬化性心血管疾病中的炎症。

Enobosarm Obesity Program - Enobosarm is a next generation drug that in combination with GLP-1 RA results in higher quality weight reduction

Enobosarm 肥胖项目 - Enobosarm 是一种新一代药物，与 GLP-1 RA 联合使用可实现更高质量的体重减少

The Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for weight reduction. After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial ended at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the 16 week active weight loss period. While weight loss was similar across treatment groups in this short 16 week study, we anticipate that preservation of lean mass and function will lead to increased energy expenditure, and this effect coupled with the direct effects of enobosarm on the additional selective reduction in fat mass will result in incremental weight reduction in a longer clinical study in patients who have obesity.

第二阶段 b QUALITY 临床研究是一项积极的多中心、双盲、安慰剂对照、随机剂量寻找临床试验，旨在评估 enobosarm 3 mg、enobosarm 6 mg 或安慰剂作为增强脂肪损失和防止肌肉损失的治疗在 168 名接受 semaglutide（Wegovy®）进行体重减少的老年患者（≥60 岁）中的安全性和有效性。在完成第二阶段 b QUALITY 临床试验的有效性剂量寻找部分后，参与者继续进入第二阶段 b 维持扩展研究，所有患者停止 semaglutide 治疗，但继续以双盲方式接受安慰剂、enobosarm 3 mg 或 enobosarm 6 mg 作为单药治疗，为期 12 周。第二阶段 b QUALITY 和维持扩展临床试验是一项积极的研究，证明 enobosarm 加 semaglutide 能够在 16 周的主动减重期间保持瘦体重和身体功能，从而实现更大的脂肪损失。尽管在这短短的 16 周研究中，各治疗组的体重减轻相似，但我们预计保持瘦体重和功能将导致能量消耗增加，而这种效果与 enobosarm 对额外选择性减少脂肪质量的直接影响相结合，将在对肥胖患者的更长临床研究中实现增量体重减少。

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 the planned design, enrollment, timing, commencement, interim and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the planned PLATEAU Phase 2b study; whether clinically meaningful incremental weight loss in the PLATEAU Phase 2b study will continue to be seen as an acceptable primary endpoint by the FDA to support potential approval; whether the FDA will continue to accept 3 mg as an acceptable dosage for enobosarm in the planned PLATEAU Phase 2b study or in any other studies; whether the FDA will further evolve its position on the acceptable patient population for the PLATEAU Phase 2b study or any other future studies; whether the Company will be able to partner with any other company in the development of enobosarm; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass, will be replicated to the same or any degree in the planned PLATEAU Phase 2b study or in any future Phase 3 studies; whether patients treated with enobosarm in the planned PLATEAU Phase 2B study will exhibit increased energy and whether such effects will result in incremental weight reduction; whether enobosarm will reduce body weight regain for patients discontinuing GLP-1 RA or reaching weight loss plateau; whether outcome questionnaires for evaluating physical function can be developed that will be accepted by the FDA or support drug approval; whether the Company will be able to raise sufficient capital, dilutive or otherwise, to fund the PLATEAU Phase 2b study of enobosarm in patients with obesity or any other studies; whether the Company will be able to recruit a sufficient number of patients in a timely manner for the PLATEAU Phase 2b study; whether the Company will be able to obtain sufficient GLP-1 RA drugs in a timely or cost-effective manner in the planned PLATEAU Phase 2b study; whether the Company will be able to engage clinical research organizations and recruit patients for the PLATEAU Phase 2b program and in a timely or cost-effective manner; whether enobosarm will cause weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will cause weight loss in the planned PLATEAU Phase 2b study or any future Phase 3 studies or, if approved and commercialized, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study will experience weight loss or have a greater loss of body fat or greater weight loss than with GLP-1 RA drug alone; whether and when enobosarm will be approved by the FDA as a weight loss drug or a body composition drug or any other type of drug; and whether and when the Company will be able to further advance the development of sabizabulin in atherosclerotic disease. 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. 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. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies, including any interim analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from FDA on the designs of its clinical trials and intends to continue to do so, FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to protect and enforce its intellectual property; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property, securities litigation and litigation with the purchaser of the Company’s FC2 business; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.

本新闻稿包含了《1995 年私人证券诉讼改革法案》中定义的 “前瞻性声明”，包括但不限于与计划设计、入组、时间安排、开始、阶段性和完整数据读取时间、范围以及在肥胖患者中继续开发 enobosarm 的监管路径相关的明确或隐含声明，包括计划中的 PLATEAU 2b 期研究；在 PLATEAU 2b 期研究中，FDA 是否会继续将临床上有意义的增量体重减轻视为支持潜在批准的可接受主要终点；FDA 是否会继续接受 3 毫克作为计划中的 PLATEAU 2b 期研究或任何其他研究中 enobosarm 的可接受剂量；FDA 是否会进一步发展其对 PLATEAU 2b 期研究或任何未来研究的可接受患者群体的立场；公司是否能够与其他公司合作开发 enobosarm；2b 期 QUALITY 研究和 enobosarm 的延续维护研究的结果，包括体重减轻、保持瘦体重和身体功能以及脂肪质量的减少，是否会在计划中的 PLATEAU 2b 期研究或任何未来的 3 期研究中以相同或任何程度复制；在计划中的 PLATEAU 2b 期研究中，接受 enobosarm 治疗的患者是否会表现出能量增加，以及这种效果是否会导致体重减轻；enobosarm 是否会减少停止 GLP-1 RA 治疗或达到体重减轻平台期患者的体重恢复；用于评估身体功能的结果问卷是否可以开发，以便被 FDA 接受或支持药物批准；公司是否能够筹集足够的资金，无论是稀释性还是非稀释性，以资助肥胖患者的 PLATEAU 2b 期研究或任何其他研究；公司是否能够及时招募足够数量的患者参与 PLATEAU 2b 期研究；公司是否能够在计划中的 PLATEAU 2b 期研究中及时或以成本效益的方式获得足够的 GLP-1 RA 药物；公司是否能够与临床研究组织合作并及时或以成本效益的方式招募 PLATEAU 2b 期项目的患者；enobosarm 是否会导致体重减轻或保持肌肉，或满足肥胖患者的任何未满足需求，以及它是否会在计划中的 PLATEAU 2b 期研究或任何未来的 3 期研究中导致体重减轻，或者如果获得批准并商业化，是否会在临床实践中导致体重减轻；在 2b 期 QUALITY 研究中接受 enobosarm 治疗的患者是否会经历比单独使用 GLP-1 RA 药物更大的体重减轻或更大的脂肪减少；enobosarm 是否以及何时会被 FDA 批准为减肥药物或体成分药物或任何其他类型的药物；以及公司是否以及何时能够进一步推进 sabizabulin 在动脉粥样硬化疾病中的开发。"预期"、"相信"、"可能"、"期望"、"打算"、"也许"、"机会"、"计划"、"预测"、"潜在"、"估计"、"应该"、"将"、"会"和类似表达旨在识别前瞻性声明，尽管并非所有前瞻性声明都包含这些识别词。本新闻稿中的任何前瞻性声明均基于公司的当前计划和策略，并反映了公司对与其业务相关的风险和不确定性的当前评估，并在本新闻稿日期作出。公司不承担因新信息或未来事件、发展或情况而更新本新闻稿中包含的任何前瞻性声明的义务。这些前瞻性声明受到已知和未知的风险、不确定性和假设的影响，如果任何此类风险或不确定性实现，或任何假设被证明不正确，我们的实际结果可能与这些声明所表达或暗示的结果有重大差异。可能导致实际结果与这些前瞻性声明所设想的结果有重大差异的因素包括但不限于：公司产品组合的开发及临床研究结果，包括任何中期分析，可能未能成功或不足以满足适用的监管标准或保证继续开发；尽管公司已寻求并获得 FDA 对其临床试验设计的反馈，并打算继续这样做，但 FDA 最终可能不同意公司的临床试验支持批准；公司与 FDA 就其计划的临床研究的研究设计要求达成一致的能力，包括 enobosarm 作为减肥药物或体成分药物的 2b 期项目以及未来所需的 3 期研究数量及其成本；临床试验和研究的时间安排及结果可能出现的延迟，包括由于无法在临床研究中招募足够数量的受试者或无法按照计划时间表招募受试者；为计划的临床开发以及公司其他运营提供资金的能力；向 FDA 或任何其他监管机构提交的任何时间安排及 FDA 或任何其他监管机构作出的任何决定；FDA 或其他政府机构的潜在干扰可能对我们的业务产生负面影响，包括由于未来美国政府的关闭；公司任何产品如果获得批准，可能不会在商业上成功；公司在需要时以可接受的条款获得足够融资的能力，包括任何合作或协作协议，以资助开发和运营并使我们能够继续作为一个持续经营的企业；公司任何产品或候选产品的需求、市场接受度和竞争；具有更大资源和能力的新竞争对手或现有竞争对手，以及新竞争产品的批准和/或推出；监管实践或政策的变化或政府推动的医疗改革努力，包括价格压力和保险覆盖及报销的变化；公司保护和执行其知识产权的能力；诉讼的成本和其他影响，包括监管挑战、产品责任索赔、知识产权、证券诉讼以及与公司 FC2 业务购买者的诉讼；公司识别、成功谈判和完成合适收购或其他战略举措的能力；公司成功整合收购的业务、技术或产品的能力；以及公司新闻稿、股东沟通和证券交易委员会文件中不时详细列出的其他风险，包括公司截至2024年9月30日的 10-K 表格和后续的 10-Q 季度报告。这些文件可在我们网站的 “SEC 文件” 部分找到，网址为 www.verupharma.com/investors。

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

Wegovy® 是诺和诺德公司（Novo Nordisk A/S）的注册商标。

FINANCIAL SCHEDULES FOLLOW

财务报表如下



Veru Inc.
Condensed Consolidated Balance Sheets
(unaudited)

	September 30,		September 30,
	2025		2024

Cash, cash equivalents and restricted cash	$	15,794,562		$	24,916,285
Investment in equity securities		2,525,305			742,295
Prepaid expenses and other current assets		595,251			805,633
Current assets of discontinued operations		—			8,759,011
Total current assets		18,915,118			35,223,224

Property and equipment, net		364,808			481,372
Operating lease right-of-use asset		2,746,014			3,250,623
Goodwill		6,878,932			6,878,932
Other assets		930,847			989,596
Long-term assets of discontinued operations		—			13,595,025
Total assets	$	29,835,719		$	60,418,772

Accounts payable	$	3,121,448		$	2,259,668
Accrued compensation		3,510,237			4,494,278
Accrued expenses and other current liabilities		1,153,475			1,406,655
Residual royalty agreement, short-term portion		—			1,025,837
Current liabilities of discontinued operations		—			2,681,530
Total current liabilities		7,785,160			11,867,968

Residual royalty agreement, long-term portion		—			8,850,792
Operating lease liability, long-term portion		2,358,018			2,905,309
Other liabilities		1,359,871			4,477,991
Total liabilities		11,503,049			28,102,060

Total stockholders' equity		18,332,670			32,316,712
Total liabilities and stockholders' equity	$	29,835,719		$	60,418,772



Veru Inc.
简明合并资产负债表
（未经审计）

	截至 9 月 30 日，		截至 9 月 30 日，
	2025 年		2024 年

现金、现金等价物及受限现金	$	15,794,562		$	24,916,285
股权证券投资		2,525,305			742,295
预付费用及其他流动资产		595,251			805,633
停止运营的流动资产		—			8,759,011
流动资产总计		18,915,118			35,223,224

净物业及设备		364,808			481,372
租赁使用权资产		2,746,014			3,250,623
商誉		6,878,932			6,878,932
其他资产		930,847			989,596
停止运营的长期资产		—			13,595,025
资产总计	$	29,835,719		$	60,418,772

应付账款	$	3,121,448		$	2,259,668
应计薪酬		3,510,237			4,494,278
应计费用及其他流动负债		1,153,475			1,406,655
残余特许权协议，短期部分		—			1,025,837
停止运营的流动负债		—			2,681,530
流动负债总计		7,785,160			11,867,968

残余特许权协议，长期部分		—			8,850,792
租赁负债，长期部分		2,358,018			2,905,309
其他负债		1,359,871			4,477,991
负债总计		11,503,049			28,102,060

股东权益总计		18,332,670			32,316,712
负债和股东权益总计	$	29,835,719		$	60,418,772


Veru Inc.
Condensed Consolidated Statements of Operations
(unaudited)

	Year Ended
	2025			2024

Operating expenses:
Research and development	$	15,588,185			$	12,782,167
General and administrative		19,942,747				24,609,801
Total operating expenses		35,530,932				37,391,968

Gain on sale of ENTADFI® assets		10,780,290				1,222,908

Operating loss		(24,750,642	)			(36,169,060	)

Total non-operating income		9,069,385				909,122

Net loss from continuing operations		(15,681,257	)			(35,259,938	)
Net loss from discontinued operations, net of taxes		(7,045,022	)			(2,541,488	)
Net loss	$	(22,726,279	)		$	(37,801,426	)

Net loss from continuing operations per basic and diluted common shares outstanding	$	(1.07	)		$	(2.61	)
Net loss from discontinued operations per basic and diluted common shares outstanding	$	(0.48	)		$	(0.19	)
Net loss per basic and diluted common shares outstanding	$	(1.55	)		$	(2.80	)


Basic and diluted weighted average common shares outstanding		14,646,294				13,487,502


Veru Inc.
简明合并损益表
（未经审计）

	年度结束
	2025 年			2024 年

营业费用：
研发费用	$	15,588,185			$	12,782,167
一般及行政费用		19,942,747				24,609,801
营业费用总计		35,530,932				37,391,968

ENTADFI® 资产出售收益		10,780,290				1,222,908

营业亏损		(24,750,642	)			(36,169,060	)

非营业收入总计		9,069,385				909,122

持续经营的净亏损		(15,681,257	)			(35,259,938	)
停止经营的净亏损，扣除税项		(7,045,022	)			(2,541,488	)
净亏损	$	(22,726,279	)		$	(37,801,426	)

每股基本和稀释后持续经营的净亏损	$	(1.07	)		$	(2.61	)
每股基本和稀释后停止经营的净亏损	$	(0.48	)		$	(0.19	)
每股基本和稀释后净亏损	$	(1.55	)		$	(2.80	)


基本和稀释后加权平均流通股数		14,646,294				13,487,502


Veru Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)

	Year Ended
	2025			2024

Net loss	$	(22,726,279	)		$	(37,801,426	)

Adjustments to reconcile net loss to net cash used in operating activities		(3,187,918	)			15,896,600

Changes in operating assets and liabilities		(4,128,891	)			222,493

Net cash used in operating activities		(30,043,088	)			(21,682,333	)

Net cash provided by investing activities		25,142,976				146,214

Net cash (used in) provided by financing activities		(4,221,611	)			36,826,910

Net (decrease) increase in cash, cash equivalents, and restricted cash		(9,121,723	)			15,290,791

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF YEAR		24,916,285				9,625,494

CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF YEAR	$	15,794,562			$	24,916,285


Veru Inc.
简明合并现金流量表
（未经审计）

	年度结束
	2025 年			2024 年

净亏损	$	(22,726,279	)		$	(37,801,426	)

调整净亏损以对账经营活动中使用的净现金		(3,187,918	)			15,896,600

经营资产和负债的变动		(4,128,891	)			222,493

经营活动中使用的净现金		(30,043,088	)			(21,682,333	)

投资活动提供的净现金		25,142,976				146,214

融资活动使用或提供的净现金		(4,221,611	)			36,826,910

现金、现金等价物及受限现金的净（减少）增加		(9,121,723	)			15,290,791

年初现金、现金等价物及受限现金		24,916,285				9,625,494

年末现金、现金等价物及受限现金	$	15,794,562			$	24,916,285

Investor and Media Contact:

投资者和媒体联系：

Samuel Fisch

Executive Director, Investor Relations and Corporate Communications

投资者关系及企业传播执行董事

Email: veruinvestor@verupharma.com

电子邮件：veruinvestor@verupharma.com

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