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表格10-Q

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或者

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在从_____________到_____________的过渡期间

佣金 文件编号: 001-38325

enVVeno 医疗公司

（公司章程中指定的准确公司名称）

70 多普勒

Irvine, 加利福尼亚 92618

(总部地址)

(949) 261-2900

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截至2024年10月28日，有 17,536,000股普通股。

ENVVENO 医疗公司

目录

部分I—财务信息

项目 1 - 基本报表

ENVVENO 医疗公司

简化资产负债表

(未经审计)

查看 这些未经审计的简明财务报表附注

ENVVENO 医疗公司

捷孚道，有限合伙

(未经审计)

查看 这些未经审计的简明财务报表附注

ENVVENO 医疗公司

压缩 股东权益变动表

(除非另有说明，以千为单位)

(未经审计)

查看 这些未经审计的简明财务报表附注

ENVVENO 医疗公司

现金流量表摘要

(单位为千，除非另有说明)

(未经审计)

查看 这些未经审计的简明财务报表附注

ENVVENO 医疗公司

附注-简化财务报表

(未经审计)

项目 2：管理层对财务控件和运营结果的讨论与分析

以下讨论应与我们包含在本文中的未经审计的简明基本报表及附注一同阅读。在与我们希望利用《1995年私人证券诉讼改革法》"安全港"规定相关的同时，我们在下文及本季度报告中以及我们或代表我们作出的任何其他陈述中对某些前瞻性陈述对读者提出警告，无论是在未来的提交给证券交易委员会的文件中还是其他地方。前瞻性声明不是基于历史信息的声明，涉及未来业务、战略、财务结果或其他发展。这样的前瞻性声明涉及重大风险和不确定性。前瞻性声明必然基于自身受重大商业、经济和竞争不确定性和不确定性和其他情况的估计和假设，其中许多情况超出我们的控制范围，对于未来的业务决策，情况可能发生变化。这些不确定性和情况可能影响实际结果，导致实际结果与我们或代表我们所做的任何前瞻性声明中表达的结果实际上有重大差异。"预计"、"估计"、"计划"、"持续"、"正在进行"、"期待"、"相信"、"打算"、"可能"、"将"、"应该"、"可能"等类似表达用于识别前瞻性声明。此类前瞻性声明还涉及可能导致我们的实际结果、绩效或成就与此类前瞻性声明明示或暗示的任何将来结果、绩效或成就有实质差异并且在不同报告期间可能显著变化的其他因素。尽管管理层认为所做的假设和前瞻性声明中反映的期望是合理的，但无法保证基础假设实际上会被证明是正确的，或实际未来结果不会与本季度报告中表达的期望不同。我们不承诺公开更新任何前瞻性声明，除非根据适用法律要求。

除非上下文另有要求，否则本文档中对“NVNO”、“我们”、“我们的”、“我们”或者“公司”的引用均指enVVeno医疗公司。

概览

enVVeno 医疗公司是一家专注于推进创新的生物修复性（基于组织的）解决方案，提高静脉疾病治疗标准的临床后期医疗器械公司。慢性静脉疾病（CVD）是全球最常见的慢性疾病，约影响美国成年人口的70%。慢性静脉功能不全（CVI）是CVD的一个大的子集，在这种情况下，腿部静脉内的瓣膜受损，导致血液逆流，血液在下肢积聚，腿部静脉内压力增加（静脉高压），在严重情况下，会导致难以愈合的静脉溃疡。该公司正在为患有严重下肢深静脉CVI的患者开发手术和非手术替代性静脉瓣膜。

公司的主要产品是VenoValve®，这是一种潜在的首创外科替代静脉瓣，目前正在美国进行名为SAVVE试验（外科抗反流静脉瓣内植入物）的关键研究。SAVVE一年的最终数据预计将在2024年第四季度发布。

该公司还在开发下一代替代性静脉瓣膜 enVVe®，该瓣膜将通过经导管送达，而不是传统的开放手术。公司正在对 enVVe 进行临床前测试，并目前预计将于 2025 年中期准备就绪，以申请 enVVe 关键试验的IDE批准。

VenoValve和enVVe均设计为单向瓣膜，帮助推动血液回流至腿部静脉，返回心脏和肺部。

VenoValve和enVVe首先正在被美国食品和药物管理局（"FDA"）批准。我们预计将有资格在2024年第四季度申请VenoValve的FDA批准，大约三年后跟着是enVVe。如果获得批准，我们预计VenoValve和enVVe将共存，VenoValve作为外科手术替代静脉瓣膜选项，enVVe作为非外科替代静脉瓣膜选项，尽管我们无法保证VenoValve或enVVe将获得FDA的批准。目前没有任何设备获得外科或非外科替代静脉瓣膜的批准，也没有针对由不称职的瓣膜引起的深静脉CVI的有效治疗方法。

我们的管理人员和董事团队曾参与过 numerous 个获得 FDA 批准或 CE 标志并取得商业成功的医疗设备。我们在加利福尼亚州尔湾的一家占地 14,000 平方英尺的租赁制造设施中开发和制造 VenoValve 和 EnVVe，该设施已获得 ISO 13485-2016 认证，用于组织、开发和制造基于组织的可植入医疗设备。

CVI 背景

慢性 静脉病（cvd设备）是世界上最常见的慢性疾病。cvd设备通过一种称为CEAP（临床、病因、解剖和病理生理）的标准化系统进行临床分类。CEAP系统包含七个临床分类（C0到C6），其中C4、C5和C6是最严重的cvd设备类别。

慢性静脉功能不全（CVI）是CVD的一个重要子类型，通常用于描述C4至C6 CVD的患者。CVI是一种影响腿部静脉系统引起疼痛、肿胀、水肿、皮肤变化和溃疡的病症。

人体的腿部包含三个静脉系统：深层静脉系统、浅表静脉系统和将深层系统连接到浅表系统的穿孔静脉系统。深层静脉系统位于腿部中心部位的肌肉和筋膜下方，大约负责90%的血液流动。为了让血液从脚部、踝部和小腿返回心脏，小腿肌肉充当泵，推动血液逆着重力通过腿部的静脉，并穿过一系列单向瓣膜。每个瓣膜在血液流过时应该打开，然后在血液向上通过腿部的静脉到达下一个瓣膜时关闭。慢性静脉功能不全(CVI)发生在腿部静脉的单向瓣膜故障并丧失功能时。当瓣膜失效时，重力造成血液逆流并朝着错误的方向流动(反流)。随着血液在下肢蓄积，静脉内部压力增加(静脉高压)。反流和由此导致的静脉高压导致腿部肿胀，引起难以忍受的疼痛，在最严重的情况下，会出现静脉溃疡。

严重 患有严重慢性静脉功能不全（CVI）的人生活质量显著降低。日常活动如准备餐点、家庭清洁、穿衣和 个人卫生（洗澡和沐浴）因行动能力减弱而变得困难。对于许多严重的CVI患者来说，夜间频繁发生的强烈疼痛使他们无法获得充足的睡眠。严重CVI患者缺勤工作日的比例比普通工人多出约40%。又有很高比例的静脉溃疡患者经历严重的瘙痒、腿部肿胀以及有异味的分泌物。每周需更换数次的伤口敷料可能非常痛苦。因深静脉CVI导致的静脉溃疡愈合难度极大，且有相当比例的静脉溃疡在一年以上依然未愈。即使愈合，静脉溃疡在第一年内的复发率被认为很高（20%到40%），而五年后的复发率高达60%。严重CVI患者常常成为废人，因行动不便而导致社会隔离。因此，有研究表明，活动性静脉溃疡患者的焦虑和抑郁发生率更高，焦虑报告率高达30%，抑郁高达40%。老年人因静脉溃疡引起的抑郁发生率甚至更高，有48%的老年静脉溃疡患者有严重的抑郁症状。

患病率通常定义为人口中具有特定控件的比例。估计显示，在美国患有严重、深静脉CVI（C4至C6病）伴反流的人口患病率约为2000万。发病率通常定义为在一定时间内发展出某种疾病的新病例数量。我们估计，每年有大约350万新的患有严重深静脉CVI的患者在美国被诊断出，包括发生静脉性腿溃疡（C6患者）的患者。寻求静脉溃疡治疗的平均患者每年在伤口护理上花费高达30000美元，从静脉溃疡患者的直接医疗费用总数估计超过30亿美元。

VenoValve

VenoValve是由enVVeno Medical开发的一种替代静脉瓣，旨在外科植入腿部深静脉系统，以治疗因瓣膜功能不全引起的严重慢性静脉疾病（CVI）。通过降低腿部深静脉系统内的压力（静脉高血压），VenoValve有潜力减轻或消除严重深静脉CVI的症状，包括愈合反复出现的静脉腿部溃疡。VenoValve通过在上大腿处做5到6英寸的切口，在开放式外科手术中植入患者的股静脉。作为我们计划初步进入替代静脉瓣市场的产品，我们估计每年在美国，约有250万人因严重深静脉CVI而适合使用VenoValve。VenoValve已获得FDA的突破性设备认证。

VenoValve 临床状态

2021年3月，我们获得了FDA对VenoValve关键研究的IDE批准。在进行三类医疗器械的关键试验之前，医疗器械公司需要获得FDA的调查性器械豁免或IDE。这一批准使我们得以展开VenoValve的美国关键研究，即所谓的SAVVE（外科抗逆流静脉瓣内支架）临床研究。SAVVE研究是一个前瞻性的、非盲法、单臂、多中心研究，招募了21个美国研究点的75名CVI患者。

SAVVE关键研究的疗效终点包括rVCSS评分，用于提供临床显著利益的证据，以及反流时间测量、VAS疼痛评分、生活质量测量、溃疡愈合（针对CEAP C6类患者）以及手术期间和一年的静脉通畅性和瓣膜功能。安全终点包括与设备相关的事件和与手术相关的事件，包括死亡、肺栓塞、同侧深静脉血栓、感染和出血。

我们 在2023年9月1日完成了SAVVE试验75名受试者的全部入组，在研究的最后两（2）个月内共招募了18名患者。

2023年11月16日，在第50届VEITH年会上，我们提出了与设备相关的初步30天设备相关不良事件（“MAE”）数据。完全招募了75名受试者进行的研究显示，设备相关的MAE率为百分之八（8%）。SAVVE研究的MAEs定义为所有原因死亡、肺栓塞（“PEs”）、同侧深静脉血栓形成（“DVTs”）、出血和深部感染，在入组后的三十（30）天内发生，无论是设备相关还是程序相关。会议上提出的设备相关MAEs显示，75名完全入组的患者中没有死亡，没有肺栓塞，也有六（6）例DVT。在VEITH展示后，SAVVE临床事件委员会（“CEC”）对这两（2）例DVT进行了裁定为中度，而对四（4）例DVT裁定为轻度。除了DVT，安全报告还指出，在手术后的头两（2）周内，淋巴瘤切除术后居于典型位置的口袋创面血肿的发生率高于预期（在手术腔内，与目标静脉外发生的抗凝剂相关出血），被CEC裁定为中度严重性，并且在皮肤切口部位发生预期的程序相关创面感染率。出血和创面感染性质急性，并且对患者健康或临床结果没有持久的负面影响。

2024年3月6日，我们在佛罗里达州坦帕举行的VENOUS2024美国静脉论坛年会上发布了SAVVE研究的初步六个月顶线修订静脉临床严重性评分（rVCSS）疗效数据。VENOUS 2024发布的数据表明，接受VenoValve治疗的研究患者中，有97%在六个月时的rVCSS测量中显示出临床改善，相较于基线，74%的研究患者的rVCSS改善了三（3）分或更多，证明了VenoValve的临床显著益处（“临床显著益处”）。在临床显著益处群体中，平均改善为8分，超过证明VenoValve提供临床显著益处所需的rVCSS改善量的两倍半。

在2024年4月24日，在英国伦敦举行的第46届查令十字研讨会上，展示了后续初步rVCSS数据。在加权平均的随访时间为11.64个月的情况下，临床显著益处（≥ 3分rVCSS改善）患者群体的平均改善为8.46分，其中，两年里程碑患者的改善为9.29分，一年里程碑患者的改善为8.08分，六个月里程碑患者的改善为8.71分。所有rVCSS评估均基于患者最近的临床访问，与基线相比。总体而言，94%的接受VenoValve治疗的研究患者在rVCSS的测量下显示出临床改善，在临床改善群体的加权平均患者随访为11.04个月，72%的研究患者改善了三分或更多的rVCSS分数，这一点能够证明VenoValve的临床显著益处，在临床显著益处群体的加权平均患者随访为11.64个月。临床改善群体的总患者随访为762个月，而临床显著益处群体的总患者随访为582个月。

在2024年6月21日，公司展示了SAVVE研究中接受治疗的静脉溃疡患者显著改善的数据 在芝加哥举办的2024年血管外科学会血管年会上。所展示的数据包括二十一名静脉溃疡患者 已经达到一年里程碑，代表三十个静脉溃疡。总体而言，评估一年后的静脉溃疡患者中，有91% 要么完全愈合，要么有明显改善。该组中，100%的静脉溃疡在VenoValve手术前持续时间为一年或更短 在手术后90天内完全愈合，绝大多数（67%）。对于那些在VenoValve手术前持续时间超过一年的静脉/ulcer患者，89% 在一年内要么完全愈合，要么有所改善，代表平均静脉溃疡数量减少了85%。此外，所有完全愈合的静脉溃疡患者都没有 经历过溃疡复发。

FDA表示，在完成VenoValve的上市前批准（"PMA"）申请之前，所有患者的一年数据将是必要的。2024年8月14日，公司宣布已提交并且FDA已批准其PMA申请中所需的五个模块中的四个。公司预计将在2024年第四季度提交其PMA申请的第五个也是最后一个模块。

EnvVe

在 2022年9月21日，我们宣布开发一种名为enVVe®的非手术经导管替代静脉瓣，用于治疗深静脉的慢性静脉功能不全（CVI）。enVVe设计为通过一种微创 程序输送到患者的股静脉中，该程序不需要全身麻醉，也不需要住院过夜。由于该程序的微创特性，我们预计能够接触到患有较轻度CVI的患者或那些可能不适合手术设备的患者，并估计美国 的enVVe市场约为350万患者。

2024年10月28日，我们宣布了enVVe六个月GLP预临床研究的成功开始。长期受试者的第一波植入物已成功完成，较短期受试者的最终波次计划于12月进行。GLP研究是寻求FDA批准开始enVVe美国关键研究的先决条件。公司预计将在2025年年中申请enVVe关键研究的IDE批准。

Capital

We finished 2023 with approximately $46.4 million of cash and investments and had approximately $48.4 million of cash and investments at September 30, 2024. Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials, related product development costs, and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter as we conduct our clinical trials and work toward bringing our product candidates to market.

On September 30, 2024, we closed a public offering raising approximately $13.6 million net cash proceeds. Based on management’s current expectations, this capital has the potential to fund the Company through several significant milestones, including the anticipated FDA pre-market approval of the VenoValve, the beginning of preparations for VenoValve commercialization, and the initial stages of the pivotal trial for enVVe. Although we expect our quarterly cash burn rate will increase over time to support these milestones, after the additional proceeds from our offering, we believe we have sufficient cash to fund operations past what we expect will be regulatory approval of the VenoValve and the start of the enVVe pivotal trial.

Comparison of the three months ended September 30, 2024 and 2023

Overview

We reported net losses of $5.6 million and $5.0 million for the three months ended September 30, 2024 and 2023, respectively, representing an increase in net loss of $0.6 million or 12%, due to an increase in operating expenses of $0.8 million, and an increase in other income of $0.2 million.

Revenues

As a developmental stage Company, we are not currently generating revenue and our future revenue, if any, is expected to be diminutive in the near future and dependent on our ability to commercialize our product candidates.

Research and Development Expenses

For the three months ended September 30, 2024, research and development expenses increased by $0.1 million or 2%, to $2.9 million from $2.8 million for the three months ended September 30, 2023. This increase primarily resulted from $0.2 million in increased personnel costs to support the SAVVE study and enVVe development, partially offset by a $0.1 million decrease in lab costs.

Selling, General and Administrative Expenses

For the three months ended September 30, 2024, selling, general and administrative expenses increased by $0.7 million or 27%, to $3.3 million from $2.6 million for the three months ended September 30, 2023. This increase was due to a $0.2 million increase in consulting expense related to market research for the Company’s products, and a $0.7 million increase in legal costs, partially offset by a $0.1 million decrease in share-based compensation, and a $0.1 million decrease in travel expenses due to full enrollment of the SAVVE study during 2023 resulting in less travel to study sites in 2024.

Other Income

For the three months ended September 30, 2024, other income increased $0.2 million or 52.0% to $0.5 million from $0.3 million for the three months ended September 30, 2023. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in US Treasury bills.

Comparison of the nine months ended September 30, 2024 and 2023

Overview

We reported net losses of $15.6 million and $17.9 million for the nine months ended September 30, 2024 and 2023, respectively, representing a decrease in net loss of $2.3 million, or 13%, due to a decrease in operating expenses of $1.8 million, and an increase in other income of $0.4 million.

Revenues

As a developmental stage Company, we are not currently generating revenue and our future revenue, if any, is expected to be diminutive in the near future and dependent on our ability to commercialize our product candidates.

Research and Development Expenses

For the nine months ended September 30, 2024, research and development expenses decreased by $1.9 million or 18%, to $8.7 million from $10.6 million for the nine months ended September 30, 2023.

This decrease resulted from a $2.7 million reduction in costs related the SAVVE study as it reached full enrollment during the 2023 period requiring less study related enrollment activity during the 2024 period, partially offset by $0.8 million higher compensation cost due to increases in staffing.

Selling, General and Administrative Expenses

For the nine months ended September 30, 2024, selling, general and administrative expenses of $8.4 million were flat when compared to the nine months ended September 30, 2023. This is due to $1.0 million in lower share-based compensation from the reduction in expense from grants made during 2021, the cost for portions of which have been fully recognized, a $0.1 million decrease in travel expenses due to full enrollment of the SAVVE study during 2023 resulting in less travel to study sites in 2024, partially offset by $0.8 million in higher legal cost and a $0.3 million increase in consulting expense related to market research for the Company’s products.

Other Income

For the nine months ended September 30, 2024, other income increased $0.4 million to $1.5 million from $1.1 million for the nine months ended September 30, 2023. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in U.S. bills.

Liquidity and Capital Resources

For the nine-months ended September 30, 2024, the Company incurred a net loss of $15.6 million and used $11.7 million cash in operating activities. Net cash used in operating activities for the period ended September 30, 2024 decreased by $2.2 million from $13.9 million for the period ended September 30, 2023.

The losses and the uses of cash are primarily due to the Company’s administrative and product research and development activities. Administrative functions relate to costs to support the Company’s public reporting and investor relations activities, readying for commercial development of its lead product candidate in the event of receiving PMA approval from the FDA, and internal administrative functions. Research and development activities are for continued product development and clinical trials for our product candidates, currently the VenoValve® and enVVe®. The Company will continue to incur these costs to complete its clinical trials, enhance products, develop new products, and operate as a public company. Although we have discretion in how we use the Company’s cash resources, we expect to continue these activities for the foreseeable future as we seek to develop and obtain regulatory approval for our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize one or more of our product candidates.

Our cash flows from investing activity consist of maturities and purchases of US Treasury bills from our program to invest excess cash, and purchases of property and equipment for our lab and offices. During the nine months ended September 30, 2024 we purchased $33.4 million of treasury bills and $45.8 million of them matured generating $1.4 million in realized gains and interest income. We expect to continue investing as the treasury bills mature and as allowed by the cash requirements of our operations. In the nine months ended September 30, 2024, our purchases of property and equipment consisting primarily of lab and test equipment, were less than $0.1 million.

We do not currently have material commitments for capital expenditures or other expenditures except for our facility lease commitment of $0.4 million per year. However, we expect a modest increase in purchases of property and equipment as we continue SAVVE, plan for commercialization of the VenoValve and continue development of enVVe. Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market.

We have historically funded our operations through financing activities. On September 30, 2024, we closed an offering issuing stock and warrants and raising approximately $13.6 million net cash proceeds. Based upon our cash and working capital as of September 30, 2024 we have sufficient capital resources to meet our obligations as they become due for at least one year after the date of this Report and sustain operations, although we expect to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain our operations, pursue our product development initiatives and penetrate markets for the sale of our products. Any inability to raise additional financing in the foreseeable future would have a material adverse effect on us.

As of October 28, 2024, we had cash and investments of $47.1 million.

Off-Balance Sheet Arrangements

None.

Contractual Obligations

As a smaller reporting company, we are not required to provide the information requested by paragraph (a)(5) of this Item.

Critical Accounting Policies and Estimates

For a description of our critical accounting policies, see Note 3 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosure About Market Risk

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item.

Item 4: Controls and Procedures

Disclosure Controls and Procedures

Our management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer (who is our Principal Executive Officer) and our Chief Financial Officer (who is our Principal Financial Officer and Principal Accounting Officer), of the effectiveness of the design of our disclosure controls and procedures (as defined by Exchange Act Rules 13a-15(e) or 15d-15(e)) as of September 30, 2024, pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2024.

Changes in Internal Control over Financial Reporting

During the nine months ended September 30, 2024, there were no changes in our internal controls over financial reporting, or in other factors that could significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations of Controls

Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and all fraud. Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

PART II - OTHER INFORMATION

Item 1. Legal Proceedings

From time to time we may be subject to litigation and arbitration claims incidental to its business. Such claims may not be covered by our insurance coverage, and even if they are, if claims against us are successful, they may exceed the limits of applicable insurance coverage.

The Company was party to litigation with former employee, Robert Rankin, who resigned on March 30, 2020. The matter was resolved on October 21, 2024 and all complaints and cross complaints were dismissed with prejudice.

Item 1A. Risk Factors

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item. Our current risk factors are set forth in our Form 10-K, filed with the SEC on February 29, 2024.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults upon Senior Securities

None.

Item 4. Mine and Safety Disclosure

Not applicable.

Item 5. Other Information

Trading Arrangements

On September 19, 2024, Marc Glickman, our Chief Medical Officer, entered into a pre-arranged trading plan (the “10b5-1 plan”) that is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. Under the 10b5-1 plan, Mr. Glickman can sell up to 653,526 shares of our common stock between December 19, 2024 and December 31, 2025, subject to price and trading limitations under the plan.

Item 6. Exhibits

The following is a complete list of exhibits filed as part of this Form 10-Q. Exhibit numbers correspond to the numbers in the Exhibit Table of Item 601 of Regulation S-K.

SIGNATURES

Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.