美国
证券和交易委员会
华盛顿特区 20549
格式
| （马克 一) | ||
| | 根据美国证券交易法第13或15(d)条规定提交的季度报告 | |
截至2022年1月31日的季度期
| | 根据美国证券交易法第13或15(d)条规定的过渡报告 |
过渡期为 ______________ 至 ______________
委员会文件号
Firefly Neuroscience, Inc.
(根据其章程规定的发行人的确切名称)
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| （注册或组织的州或其他辖区） |
| （联邦税号） |
(主要执行办事处地址) (邮政编码)
(
（注册人电话，包括区号）’电话号码（包括区号）
在法案第12(b)条的规定下注册的证券：
| 每一种类别的名称 |
| 交易标的物： |
| 在以下证券交易所上市的名称 |
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请勾选以下选项以指示注册人是否在过去12个月内(或在注册人需要提交此类报告的较短时间内)已提交证券交易法1934年第13或15(d)条所要求提交的所有报告，并且在过去90天内已受到此类报告提交要求的影响。
请勾选以下内容。申报人是否已在过去12个月内（或申报人需要提交此类文件的时间较短的期间内）逐个以电子方式提交了根据规则405提交的互动数据文件。这章的交易中规定。
勾选以下选框，指示申报人是大型加速评估提交人、加速评估提交人、非加速评估提交人、小型报告公司或新兴成长型公司。关于“大型加速评估提交人”、“加速评估提交人”、“小型报告公司”和“新兴成长型公司”的定义，请参见《交易所法规》第120亿.2条。
| 大型加速文件申报人 | ☐ |
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| 加速文件提交人 | ☐ |
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| 较小的报告公司 | |
| 新兴成长公司 | |
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如果是新兴成长企业，请在复选框中打勾，以表示注册申请人已选择不使用根据证券交易法第13(a)条规定提供的任何新的或修订的财务会计准则的扩展过渡期来符合规定。☐
请打勾表明注册人是否为壳公司（根据证券交易法规则12b-2定义）。
截至2024年11月12日，注册人拥有
说明：
这是Firefly Neuroscience, Inc. ("Firefly"或"公司")截至2024年9月30日的第10-Q表格季度报告 ("第10-Q")，该公司在2024年8月12日Merger (下文定义)完成前，即它被改名为WaveDancer, Inc. ("WaveDancer")时的报告。除非另有说明或上下文另有要求，"Firefly"，"我们"，"我们"，"我们的"和"公司"指的是Merger完成后的Firefly Neuroscience, Inc.及其子公司，"WaveDancer"指的是Merger完成前的WaveDancer, Inc.，"Private Firefly"指的是Merger完成前的Firefly Neuroscience 2023, Inc.及其子公司 (原Firefly Neuroscience, Inc.）。
2023年11月15日，WaveDancer及其全资子公司FFN Merger Sub, Inc.（以下简称“FFN”），与Firefly Neuroscience, Inc.（以下简称“Private Firefly”）签署并进入了一份合并协议及计划（根据一份修正协议第1号，日期为2024年1月12日修订，及一份修正协议第2号，日期为2024年6月17日修订，“合并协议”）。根据合并协议，FFN与Private Firefly合并，Private Firefly作为WaveDancer的全资子公司继续存在。2024年8月12日，（i）根据WaveDancer, Inc.的修正及重签发公司章程，WaveDancer更名为Firefly Neuroscience, Inc.，（ii）根据Firefly的章程修正，Private Firefly更名为Firefly Neuroscience 2023, Inc.，(iii) Private Firefly与FFN向特拉华州政府申请注册了合并证书（以下简称“合并”）。2024年8月12日，合并完成了（以下简称“收盘”，收盘日期）
在合并的生效时间点，私有Firefly的每位普通股东（面值为每股0.00001美元）获得公司普通股（面值为每股0.0001美元）的股份数量等于私有Firefly普通股股东所持有的股份数量乘以汇率（“汇率”）0.1040。此外，在合并的生效时间点： (i) 任何在交割前未被行使的购买私有Firefly普通股的选项，由公司按合并协议中的某些条款假定，并成为购买新Firefly普通股的选项，需根据汇率进行调整； (ii) 在交割前立即生效的每个私有Firefly限制性股票单位根据其条款归属； (iii) 在交割前未被行使的每个购买私有Firefly普通股的认股权证由公司假定，需遵循合并协议中的某些条款。
在合并结束之前，波浪舞者在2024年8月12日纽约时间12:01下午生效，对所有待发行和未流通的火虫新普通股进行了1比3的股票合并（“合并股票逆分割”）。由于合并股票逆拆分，每三（3）股待发行和未流通的火虫新普通股自动合并为一（1）股发行和未流通的火虫新普通股，每股面值或普通股授权数量均无变化。
除非另有说明，所有在此季度报告（表格10-Q）中呈现的合并后股份和每股信息均反映合并反向拆分，然而，此季度报告中随附或通过引用纳入的某些文件和信息并未考虑合并反向拆分的影响。
请查看未经审计的简明综合基本报表附注1，获取更多信息。
萤火虫神经科学公司
| 第一部分：财务信息 |
页码 |
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| 项目1。 |
财务报表 |
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| 3 | ||
| 4 | ||
| 5 | ||
| 7 | ||
| 8 | ||
| 项目2。 |
19 | |
| 项目3。 |
27 | |
| 项目4。 |
27 | |
| 第二部分.其他信息 |
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| 项目1。 |
28 | |
| 项目1A。 |
28 | |
| 项目2。 |
58 | |
| 项目3。 |
58 | |
| 项目4。 |
58 | |
| 项目5。 |
58 | |
| 项目6。 |
展示资料 |
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| 签名 |
简明合并资产负债表
截至2024年9月30日和2023年12月31日
(以千计，除股票数据外)
| 9月30日, | 2023年12月31日, | |||||||
| 2024 | 2023 | |||||||
| (未经审计) | ||||||||
| 资产 | ||||||||
| 流动资产 | ||||||||
| 现金 | $ | $ | ||||||
| 其他应收款 | ||||||||
| 预付费用 | ||||||||
| 总流动资产 | ||||||||
| 非流动资产 | ||||||||
| 预付费用 | ||||||||
| 设备净值 | ||||||||
| 无形资产-净额 | ||||||||
| 非流动资产合计 | ||||||||
| 资产总计 | $ | $ | ||||||
| 负债 | ||||||||
| 流动负债 | ||||||||
| 应付贸易款 | $ | $ | ||||||
| 应计负债 | ||||||||
| 总流动负债 | ||||||||
| 负债合计 | ||||||||
| 业务承诺和或有事项（注9） | ||||||||
| 股东’ 资产净额（亏损） | ||||||||
| 优先股，$ 面值： 股票授权 - 2024; 股票授权 - 2023; 和 于2024年9月30日和2023年12月31日分别发行并流通 | ||||||||
| 普通股，每股 面值： 股票授权; 和 于2024年9月30日和2023年12月31日分别发行并流通 | ||||||||
| 股本溢价 | ||||||||
| 累积赤字 | ( | ) | ( | ) | ||||
| 股东总数’ 资本 | ||||||||
| 负债总额和股东’ 资本 | $ | $ | ||||||
附注为这些未经审计的简明合并财务报表的组成部分。
未经审计的简明合并利润及综合损失表
截至2024年和2023年9月30日三个和九个月的时间
(以千为单位，除每股数据及每股数值)
| 截至三个月 | 截至九个月 | |||||||||||||||
| 9月30日, | 9月30日, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 收入 | $ | $ | $ | $ | ||||||||||||
| 营业费用： | ||||||||||||||||
| 研发费用 | ||||||||||||||||
| 销售和营销费用 | ||||||||||||||||
| 一般及管理费用 | ||||||||||||||||
| 总营业费用 | ||||||||||||||||
| 营业亏损 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 其他收入（支出） | ||||||||||||||||
| 利息和银行费用 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 外汇汇率期货未实现盈亏 | ( | ) | ||||||||||||||
| 其他(费用)，净额 | ( | ) | ( | ) | ||||||||||||
| 税前亏损 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 所得税费用 | ||||||||||||||||
| 净亏损和综合亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| $0.31 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 加权平均普通股股份数 已发行、基础和稀释 | ||||||||||||||||
附注为这些未经审计的简明合并财务报表的组成部分。
股东权益变动表未经审计的简明合并财务报表’ 资产净额（亏损）
2024年9月30日和2023年
(以千计，除股票数据外)
| 优先股 | 普通股 | |||||||||||||||||||||||||||||||||||
| 数量 股份 | 数量 待发行股份 已发行 | 金额 | 数量 股份 | 数量 待发行股份 已发行 | 金额 | 附加 实缴 资本 | 累计 赤字 | 总计 股东的 股东权益（赤字） | ||||||||||||||||||||||||||||
| 2023年12月31日的余额 | ( | ) | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||
| B系列优先股转换 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| C系列优先股单位发行 | ||||||||||||||||||||||||||||||||||||
| 股份交易：WaveDancer的前股东 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| 系列C优先股转换 | ) | |||||||||||||||||||||||||||||||||||
| 定向增发减去发行费用 | ||||||||||||||||||||||||||||||||||||
| 因债务发行的股份 | ||||||||||||||||||||||||||||||||||||
| 因未来债务结算发行的股份 | ||||||||||||||||||||||||||||||||||||
| 因咨询服务发行的股份 | ||||||||||||||||||||||||||||||||||||
| 因预付服务发行的股份 | ||||||||||||||||||||||||||||||||||||
| 已发行股份 – 期权、warrants和限制性股票单位行使 | ||||||||||||||||||||||||||||||||||||
| 股份-based薪酬费用 | ||||||||||||||||||||||||||||||||||||
| 未归属股份发给董事 | ||||||||||||||||||||||||||||||||||||
| 净亏损 | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| 截至2024年9月30日的余额 | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||
| 2022年12月31日的余额 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| 定向增发普通股 | ||||||||||||||||||||||||||||||||||||
| B系列优先股发行 | ||||||||||||||||||||||||||||||||||||
| 单位发行 | ||||||||||||||||||||||||||||||||||||
| 股份-based薪酬费用 | ||||||||||||||||||||||||||||||||||||
| 净亏损 | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| 截至2023年9月30日的余额 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| 优先股 | 普通股 | |||||||||||||||||||||||||||||||||||
| 数量 股份 | 数量 待发行股份 已发行 | 金额 | 数量 股份 | 数量 待发行股份 已发行 | 金额 | 附加 实缴 资本 | 累计 赤字 | 总计 股东的 股东权益（赤字） | ||||||||||||||||||||||||||||
| 2024年6月30日的余额 | | - | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||
| 交易所：WaveDancer的前股东 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| 系列C优先股转换 | ( | ) | ||||||||||||||||||||||||||||||||||
| 定向增发减去发行费用 | ||||||||||||||||||||||||||||||||||||
| 因债务发行的股份 | ||||||||||||||||||||||||||||||||||||
| 因未来债务结算发行的股份 | ||||||||||||||||||||||||||||||||||||
| 因咨询服务发行的股份 | ||||||||||||||||||||||||||||||||||||
| 因预付服务发行的股份 | ||||||||||||||||||||||||||||||||||||
| 已发行股份 – 期权、warrants和限制性股票单位行使 | ||||||||||||||||||||||||||||||||||||
| 股份-based薪酬费用 | ||||||||||||||||||||||||||||||||||||
| 未归属股份发给董事 | ||||||||||||||||||||||||||||||||||||
| 净亏损 | - | - | - | - | ) | ) | ||||||||||||||||||||||||||||||
| 截至2024年9月30日的余额 | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||
| 2023年6月30日的余额 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| B系列优先股发行 | ||||||||||||||||||||||||||||||||||||
| C轮优先股单位发行 | ||||||||||||||||||||||||||||||||||||
| 股份-based薪酬费用 | ||||||||||||||||||||||||||||||||||||
| 净亏损 | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| 截至2023年9月30日的余额 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
附注为这些未经审计的简明合并财务报表的组成部分。
未经审计的现金流量综合表
截至2024年和2023年9月30日的九个月
(以千为单位)
| 截至九个月 9月30日, | ||||||||
| 2024 | 2023 | |||||||
| 经营活动产生的现金流量： | ||||||||
| 净亏损 | $ | ( | ) | $ | ( | ) | ||
| 调整净亏损为经营活动使用的现金净额 | ||||||||
| 折旧费 | ||||||||
| 股份-based薪酬费用 | ||||||||
| 为咨询服务发行股份和warrants | ||||||||
| 运营资产和负债的变化： | ||||||||
| 其他应收款变动 | ( | ) | ( | ) | ||||
| 预付费用变动 | ( | ) | ( | ) | ||||
| 交易应付款项变动 | ||||||||
| 应计负债变动 | ( | ) | ||||||
| 递延收入变化 | ( | ) | ||||||
| 用于经营活动的净现金 | ( | ) | ( | ) | ||||
| 投资活动产生的现金流量： | ||||||||
| 购买设备 | ( | ) | ||||||
| 产品增强- 无形资产 | ( | ) | ||||||
| 再资本化交易款项 | ||||||||
| 投资活动中使用的净现金 | ( | ) | ||||||
| 筹资活动产生的现金流量： | ||||||||
| 销售股票所得款项，扣除发行成本净额 | ||||||||
| 行使认股权收到的款项 | ||||||||
| 定向增发所得款项，扣除发行成本净额 | ||||||||
| 融资活动提供的净现金 | ||||||||
| 现金余额减少或增加 | ( | ) | ||||||
| 期初现金余额 | ||||||||
| 期末现金余额 | $ | $ | ||||||
| 补充现金流量信息 | ||||||||
| 支付的利息现金 | ||||||||
| 向WaveDancer的原股东发行普通股视作发行 | ||||||||
| 预付服务所发行的股份 | ||||||||
| 股份发行以抵债 | ||||||||
附注为这些未经审计的简明合并财务报表的组成部分。
未经审计的简明综合合并基本报表附注
(以千为单位，除每股数据及每股数值)
注意 1: 业务描述
概览
Firefly Neuroscience, Inc.（前称WaveDancer, Inc.），是一家特拉华州的公司及其全资子公司Firefly Neuroscience 2023, Inc.，是一家特拉华州的公司（前称Firefly Neuroscience, Inc.），Firefly Neuroscience Ltd.，是一家以色列公司（前称Elminda Ltd.），Elminda 2022 Inc.，是一家特拉华州的公司（前称Elminda Inc.），Firefly Neuroscience Canada Inc.，一家加拿大公司，以及Elminda Canada Inc.，一家加拿大公司（统称为"公司"），致力于开发、营销和分销医疗设备和科技，允许高分辨率可视化和评估人脑复杂的神经生理连接。
Firefly Neuroscience有限公司最初作为一家开发公司成立并开始其业务 2006 根据以色列国家法律，在 2014年5月， 通过Elminda Inc.在美国开始推广和分销业务 2022 。
在 2014年7月， 美国食品药品监督管理局（“FDA”）批准了Firefly Neuroscience Ltd.的Brain Network Analytics（“BNA” ™）产品在美国的营销。 2014年9月11日， 公司获得了Conformity European（“CE”）批准BNA™，允许其在欧盟使用。
在 2023年11月15日， WaveDancer, Inc.（“WaveDancer”）及其全资子公司FFN Merger Sub, Inc.（“FFN”）签署了一份合并协议及计划（由某某修订情况所修订） No. 1, 截至日期为 2024年1月12日， 以及某某修订情况 No. 2, 截至日期为 2024年6月17日， 与火飞神经科学(“合并协议”) 2023, 公司（“私人火飞”）。根据合并协议，FFN与私人火飞合并，私人火飞作为WaveDancer的全资子公司存续。于 2024年8月12日，((i) 根据WaveDancer, Inc.的修订和重述的公司章程，WaveDancer将其名称更改为火飞神经科学公司，(ii) 根据对其公司章程的修订，私人火飞将其名称更改为火飞神经科学公司， 2023, 并且(iii) 私人火飞和FFN向特拉华州提交了合并证书（“合并”）。 2024年8月12日， 合并已完成（“交割”及该日期为“交割日期”）。
在合并生效时，Private Firefly普通股已发行股份的每位持有人，面值美元
虽然WaveDancer在合并中是Private Firefly的合法收购方，但根据美国公认会计原则（“U.S. GAAP”），该合并被视为反向资本化，其中Private Firefly被视为会计上的收购方，而WaveDancer被视为会计上的被收购方，并且Private Firefly的历史财务报表在合并关闭后被沿用用于财务报告。因此，从会计角度来看，该合并被视为Private Firefly为WaveDancer的净资产发行股票，伴随进行资本重组。WaveDancer的净资产以账面价值列示，
该合并实体以Firefly Neuroscience, Inc.为名经营，且在 2024年8月13日， 公司开始在纳斯达克资本市场交易（纳斯达克逐笔明细符号：AIFF）。
在合并关闭后立即， 2024年8月12日， 有
注意 2: 持续经营
截至 截止到2024年9月30日， 公司累计亏损为$
(i) 与现有及新投资者协商进一步融资，以筹集额外资金；
(ii) 采取各种成本控制措施以减少运营现金消耗；并且
(iii) 商业化产品以产生持续销售。
公司的管理层合理地预期，公司能够继续筹集更多的股本，以在可预见的未来保持运营。筹集额外资金的能力将取决于诸多因素，包括财务、经济和市场状况，其中许多因素超出了我们的控制范围，可能会有 无 无法保证我们能够以令人满意的条款或根本获得额外资金。
注意 3: 财务报表的基础及重要会计政策总结
呈现基础
附页未经审计的简要合并基本报表已按照美国公认会计原则编制。在这些未经审计的简要合并基本报表中报告的结果应 不 被视为对任何后续期间或整个期间结果的必要指示。 可能 这些未经审计的简要合并基本报表及其附注应与公司截至年末的年报审计合并基本报表一起阅读， 2023年12月31日 以及公司文件中的附注 8该报告以表格的形式提交， 2024年8月12日。 某些信息根据美国公认会计原则编制的经过审计的合并基本报表中，通常包含的信息和脚注披露已在随附的未经审计的合并基本报表中进行了简缩或省略。所有金额均以千为单位披露，除了每股和每股金额。随附的未经审计的合并基本报表包含所有调整，仅由正常的经常性调整组成，除非另有说明，这些调整是对公司所有财务报表期的合并财务状况、经营成果和现金流量做出准确描述所必要的。
合并原则
这些未经审计的合并 基本报表包括公司及其子公司的财务信息。公司合并其持有控制性财务权益的法人实体。公司采用 两个-层合并模型： 一个 侧重于投票权（投票权益模型）以及 第二， 在满足12月 Tranche A 支付之后，向 Tranche b 票据的持有者支付一个 等同于并满足摊销赎回价格（如 Tranche b 票据中定义）在2025年1月2日到期的总金额（“ 侧重于对重大活动的权力进行定性分析，以及对潜在重大损失或收益的暴露（变量利益模型）。所有板块都是 首先 评估以判断它们是否是可变利益实体（“VIE”）。如果一个实体被判断 不 为VIE，则根据投票利益模型评估其投票权和其他决策权。子公司的账户为相同的报告期准备，并使用一致的会计政策。所有的公司间余额和交易在合并时被消除。
合并前的合并资产、负债和经营结果为私人萤火虫的资产。在适用于这些情况的指导下，所有比较期间的股权结构已重新编排，直至交易结束，以反映法律收购方WaveDancer的股权结构。在合并前，股票及其对应的资本金额和每股损失，已根据合并中确定的交换比例回溯重述。
在编制合并基本报表时使用估计
根据美国通用会计准则（U.S. GAAP）编制未经审计的简明合并基本报表，管理层需要做出估计和假设，这些估计和假设会影响简明合并基本报表日期资产和负债的报告金额，以及在报告期间收入和费用的报告金额。实际结果可能与这些估计有所不同。
重要的会计政策
以下重要的会计政策应与公司截至年度的经审计合并基本报表一并阅读。 2023年12月31日， 重要的会计政策及其中的注释。
设备
设备按照成本减去累计折旧后报表。折旧和摊销是使用直线法根据资产的估计使用寿命进行计算的。公司为医疗设备使用的估计使用寿命为 四个 年。
ii) 基于分享的支付
对于在公司与非雇员签订货物或服务协议之日授予的完全归属且不可撤销的股权工具，公司在授予日确认股权工具的公允价值。相应的成本视具体协议的事实和情况，确认作为即时费用或预付资产，并在服务期间进行摊销。
最近颁布的会计准则的影响
公司已经评估了已发布的会计准则更新 不 但尚未采用，并相信采用这些标准将会 不 将对其简明合并基本报表产生重大影响。
注意 4: 合并
在 2024年8月12日， Private Firefly 完成了合并。这次合并被视为反向资本重组，其中 Private Firefly 被认为是会计上的收购方，而 Private Firefly 的历史财务报表在合并结束时成为了 WaveDancer（更名为 Firefly Neuroscience, Inc.）的历史财务报表。在这种会计方法下，WaveDancer 被视为被收购方，而 Private Firefly 被视为财务报告中的收购方。
因此，在会计目的上，此次合并被视为Private Firefly为WaveDancer的净资产发行股票，并伴随资本重组。WaveDancer的净资产以账面价值列示，
以下表格将合并的要素与截至 2024年9月30日的股东权益变动综合报表进行对账： 九个月期间 个月期间结束于 2024年9月30日：
| 资本重组 | ||||
| 现金 | $ | |||
| 预付费用 | ||||
| 设备 | ||||
| 假定来自WaveDancer的非现金净营运资本 | ( | ) | ||
| 合并的影响，扣除交易成本 | ( | ) | ||
下表详细列出了合并完成后发行的普通股数量：
| 股票数量 | ||||
| WaveDancer合并前股东持有的普通股股份 | ||||
| 为私人Firefly普通股股份而发行的普通股股份 | ||||
| 合并后立即流通的普通股总股份 | ||||
除了普通股的股份外，WaveDancer的股东们保留了：
| - | |
| - | 可行使的Warrants最多为 |
合并前的合并资产、负债和经营结果均为私人萤火虫的。根据适用于这些情况下的指导，股权结构在截至交易完成的所有比较期间已重新编制，以反映法律收购方WaveDancer的股权结构。合并前的股份及相应的资本金额与每股损失，已基于反映交易所比例的股份进行追溯性重述， 0.1040 在合并中建立。
注意 5: 预付费用
预付费用余额的详细信息如下：
| 九月三十日 | 12月31日 | |||||||
| 2024 | 2023 | |||||||
| 预付服务所发行的股份 | $ | $ | ||||||
| 预付费用 | ||||||||
| 总计（当前） | $ | $ | ||||||
| 预付服务所发行的股份 | $ | $ | ||||||
| 总计（非当前） | $ | $ | ||||||
公司签订了
注意 6: 设备
设备的结余如下：
| 九月三十日 | 12月31日 | |||||||
| 2024 | 2023 | |||||||
| 医疗设备，成本 | $ | $ | ||||||
| 减少 – 累计折旧 | ( | ) | ||||||
| 设备，净值 | $ | $ | ||||||
注意 7: 无形资产
以下表格总结了截至日期的无形资产组成情况。 2024年9月30日：
| 2024年9月30日 | ||||||||||||||||
| 账面总额 | 累计摊销 | 净账面价值 金额 | 加权平均寿命 | |||||||||||||
| 未摊销的无形资产 | ||||||||||||||||
| BNA 软件 | $ | $ | $ | - | ||||||||||||
| 总无形资产 | $ | $ | $ | - | ||||||||||||
BNA软件增强项目正在进行中，摊销将在项目基本完成并软件准备好用于其预定目的后开始。软件增强项目预计将在年底完成， 2025 并具有使用寿命。 年。
注意 8: 员工在养老时的权利责任
以色列劳动法要求在解雇员工或在某些情况下终止雇佣时支付遣散费。根据第 14 条款，在以色列遣散费法下， 1963, 所有板块的员工有权按
注意 9: 承诺与或有事项
a. 版权承诺 - 以色列创新局 (“IIA”)
公司承诺通过以色列创新局（“IIA”）向以色列国家支付产品销售收益的特许权使用费，销售收益中包括IIA通过研发资助参与的产品。
利用IIA拨款开发的科技销售受到限制，并需获得IIA的批准。
b. 法律程序
公司在正常业务过程中会不时面临各种索赔、投诉和法律诉讼。经过与法律顾问咨询，公司是 不 了解当前任何待决诉讼，该诉讼的结果可能对其运营或财务状况产生重大不利影响。
注意 10: 股权
| a. | 股份 |
在 2023年8月29日， 公司提供最多
在 九个月期间 个月期间结束于 截止到2024年9月30日， 公司向其董事发行了
截至 2023年12月31日， B系列优先股的强制转换特征（“B系列优先股”）被触发，因为C系列发行的收益超过了$
在 2024年7月26日， 公司进行了定向增发交易（“PIPE”），根据该交易，公司同意发行和卖出（i）
开启 2024年7月27日， 公司签订了
在 2024年8月12日， 公司向其董事发行了
在 2024年8月12日， 根据咨询协议的条款（如下所定义），公司发行了
在 2024年8月12日， 根据限制性股票单位（“RSUs”）的条款，公司已发行和未注销的所有RSUs已归属，并且公司已发行
在 2024年8月26日， 公司向其董事发行了
在 2024年9月9日， 公司向其董事发行了
在 2024年9月19日， 部分A系列认股权证持有人（“A系列认股权证”）、A轮认股权证（“A轮认股权证”）和D系列认股权证（“D系列认股权证”）行使了这些认股权证进行购买
在 2024年9月27日， 公司向其董事发行了
| b. | Warrants |
下表总结了公司的认股权证活动情况。 九个月期间 截至月份 2024年9月30日：
| Warrants数量 | 加权平均行使价格 | 加权平均剩余生命期 | ||||||||||
| 未偿还Warrants，2024年1月1日 | $ | |||||||||||
| C系列Warrants（注10.a） | ||||||||||||
| C系列发行的经纪Warrants（注10.a） | ||||||||||||
| PIPE Warrants（注10.a） | ||||||||||||
| WaveDancer遗留Warrants（注4） | ||||||||||||
| 未偿还的Warrants，截止日期2024年9月30日 | $ | |||||||||||
截至 九个月期间 个月期间结束于 截止到2024年9月30日， 可购买最多的Warrants
在 2024年8月12日， 发行了购买至多的PIPE Warrants
在 2024年8月12日， 公司假设发行最多的Warrants
| c. | 可以兑换的Warrants数量很少或 无 无需考虑 |
可以以极少的代价行使的Warrants 无 无偿行使的Warrants是完全归属于持有人的Warrants，允许持有人以名义行使价格购买发行人指定数量的股份。以下表格总结了公司便士Warrants的活动情况。 九个月期间 截至月份 2024年9月30日：
| Warrants数量 | 加权平均剩余生命期 | |||||||
| 未到期Warrants，2024年1月1日 | ||||||||
| 预先资助的Warrants（请参见10.a） | ||||||||
| A系列Warrants（请参见10.d） | ||||||||
| D系列Warrants（请参见10.e） | ||||||||
| 咨询协议Warrants（请参见10.f） | ||||||||
| 已行使 | ( | ) | ||||||
| 截至2024年9月30日的未决Warrants | ||||||||
在 2024年7月26日， 公司已签署PIPE协议，
在 2024年9月19日， 某些A系列Warrants持有人行使了他们的Warrants，购买了总计
| d. | A轮Warrants |
开启 2023年6月15日， 该公司授予了A系列认股权证，最多可购买总额
| e. | 系列D Warrants |
在 2024年6月7日， 公司向某些投资者发行了D系列Warrants，总共可购买
| f. | 咨询协议 |
在 2024年3月15日， 公司与一位特定顾问签订了咨询协议（以下简称"咨询协议"）。根据咨询协议，顾问将提供咨询服务，以换取系列A表现Warrants（以下简称"系列A表现Warrants"），以购买最多
A轮表现权证可以以名义行使价格行使，并于 2028年6月15日到期。 A轮表现权证的可行使性取决于满足特定市值或发生流动性事件。在合并完成后， 2024年8月12日， A轮表现权证变得完全归属。公司根据授予日确定的股价，确定A轮表现权证的公允价值为$
截至 截止到2024年9月30日， 公司向其董事发行了
| g. | 员工股票期权计划 |
截至的公司股权激励计划的期权活动总结 截止到2024年9月30日， 以及截止当期的变动情况如下所示。
| 股票期权数量 | 加权平均行使价格 | 加权平均剩余合同期限（年） | 总内在价值 | |||||||||||||
| 待处理期权，2023年12月31日 | $ | $ | ||||||||||||||
| 授予期权 | - | - | ||||||||||||||
| WaveDancer期权 | - | - | ||||||||||||||
| 待处理期权，2024年9月30日 | $ | $ | ||||||||||||||
与期权相关的分享基础补偿费用 三 和 九个月期间 截至月份 截止到2024年9月30日， 为$
每个期权奖励的公允价值在授予日期时使用Black Scholes定价期权估值模型进行估算，该模型使用下面表格中所述的假设。
| 2024 | |||||
| 股票价格 | $ | ||||
| 无风险利率 | - | ||||
| 分红派息收益率 | |||||
| 预期波动率 | - | ||||
| 预期期限（以年为单位） | - | ||||
截至某个日期，公司未归属期权的汇总如下： 截止到2024年9月30日， 以及在此期间的变化 九个月期间 截至某个月的期间内，结果如下。
| 股票期权数量 | 加权平均授予日公允价值 | |||||||
| 未归属期权，2023年12月31日 | $ | |||||||
| 授予期权 | ||||||||
| 期权归属 | ( | ) | ||||||
| 未归属期权，2024年9月30日 | $ | |||||||
截至 截止到2024年9月30日， 总共有 $
在 2024年8月12日， 公司在合并完成时承担了
| h. | 管理期权 2024 |
在 2024年4月2日， 公司向其管理人员发放期权，以购买最多总计的
| i. | 管理期权 2023 |
在 2023年7月8日， 公司向其员工、高级职员、董事和顾问发行了期权，以购买总计
| j. | 限制性股票单位（“RSUs”） |
在 2023年7月8日， 公司向部分管理层和董事授予了限制性股票单位（RSUs）。RSUs的归属依赖于一个流动性事件，该事件导致公司的普通股在纳斯达克证券市场或其他认可的证券交易所上市，或在场外市场交易。
在合并完成时， 2024年8月12日， RSU归属，公司发行了
下表展示了按工具类型划分的基于股份的薪酬费用：
| 截至三个月 九月三十日 | 截至九个月 九月三十日 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 员工期权 | $ | $ | $ | $ | ||||||||||||
| 限制性股票单位 | ||||||||||||||||
| D轮Warrants | ||||||||||||||||
| 总计 | $ | $ | $ | $ | ||||||||||||
注意 11: 每股基本和稀释净亏损
基本每股净亏损是通过将归属于普通股票持有人的净亏损除以期内流通的普通股加权平均数来计算的。期内流通的普通股加权平均数的计算包括在期末日期契约上要发行的普通股以及可为少量或 无 在股价相关方面的对价。已发行且受限于归属条件的普通股为 不 在必要的服务期间视为已流通。对因应收账款而发行的普通股是否视为已流通的确定，取决于该实体是否有能力和意图在应收账款被 不 还清的情况下撤销这些股份。
每普通股的稀释净亏损是通过考虑在期间内所有潜在稀释普通股的影响来计算的，这些股票在稀释时是有效的。截止到 截止到2024年9月30日， 潜在稀释普通股包括可通过行使期权和Warrants发行的股票。
注意 12: 关联方交易
公司发生了$
在 2024年6月7日， 公司向某些投资者发行了D系列Warrants，总共可购买
在 2024年7月27日， 公司与一家全资拥有的 一个 公司的董事达成了一项战略投资协议。根据协议，公司同意发行
在 2024年8月8日， 公司完成了一笔
在 2024年8月12日， 所有已发行的和未偿还的限制性股票单位已归属，并且公司已发行
截至 截止到2024年9月30日， $
注意 13: 营业收入，净值
| 截至三个月 九月三十日 | 截至九个月 九月三十日 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 货物和服务的类型 | ||||||||||||||||
| 服务 | $ | $ | $ | $ | ||||||||||||
| 租赁 | ||||||||||||||||
| 其他杂项产品 | ||||||||||||||||
| 总计 | $ | $ | $ | $ | ||||||||||||
| 营业收入确认的时机 | ||||||||||||||||
| 在某一时刻 | ||||||||||||||||
| 随着时间推移 | ||||||||||||||||
| 总计 | $ | $ | $ | $ | ||||||||||||
注意 14: 研发支出
| 截至三个月 九月三十日 | 截至九个月 九月三十日 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 薪资和员工福利 | $ | $ | $ | $ | ||||||||||||
| 顾问和分包商 | ||||||||||||||||
| 折旧 | ||||||||||||||||
| 临床试验 | ||||||||||||||||
| 费用 - 其他 | ||||||||||||||||
| 总计 | $ | $ | $ | $ | ||||||||||||
注意 15: 销售和市场营销费用
| 截至三个月 九月三十日 | 截至九个月 九月三十日 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 薪资和员工福利 | $ | $ | $ | $ | ||||||||||||
| 专业费用 | ||||||||||||||||
| 旅游服务 | ||||||||||||||||
| 其他 | ||||||||||||||||
| 总计 | $ | $ | $ | $ | ||||||||||||
注意 16: 一般和管理费用
| 三个月结束了 九月三十日 | 九个月已经结束 九月三十日 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 工资和员工福利 | $ | $ | ( | ) | $ | $ | ||||||||||
| 专业费用 | ||||||||||||||||
| 租金和维护 | ||||||||||||||||
| 差旅费用 | ||||||||||||||||
| 其他 | ||||||||||||||||
| 总计 | $ | $ | $ | $ | ||||||||||||
管理层’对基本报表的管理层讨论与分析旨在为我们的基本报表的读者提供管理层在我们财务状况、经营成果、流动性以及可能影响我们未来业绩的其他一些因素方面的叙述。以下信息应结合本季度报告表格10-Q内包含的简明合并基本报表及其附注一起阅读（ “10-Q表格”），以及我们于2024年8月12日向SEC提交的当前报告表格8-K中包含的经过审计的合并基本报表及其附注。除非另有说明，本季度报告表格10-Q中的引用是指 “我们，” “我们，” “我们的，” 或我们的 “公司” 及类似术语指的是Firefly Neuroscience, Inc.，一家特拉华州公司及其子公司。
关于前瞻性声明的警示说明
本表格10-Q中的某些陈述可能构成根据联邦证券法和1995年私人证券诉讼改革法的“前瞻性陈述”。前瞻性陈述是指任何关注未来事件的陈述，包括但不限于关于我们业务策略、计划和目标的陈述；预期的未来营业结果和营业费用、现金流、资本资源和流动性；影响我们业务、行业和财务结果的趋势、机会和风险；使用我们解决方案的预期收益；未来扩展或增长计划以及未来增长的潜力；我们的业务前景；我们的系统和科技、未来的盈利能力；现有现金及现金等价物是否足够满足我们在未来十二个月的营运资金和资本支出需求；收购；以及我们对于未来事件的期望或信念。此外，词语“预期”、“出现”、“大约”、“相信”、“继续”、“可能”、“估计”、“期待”、“预见”、“计划”、“可能”、“潜在”、“预测”、“计划”、“寻求”、“应该”、“会”和类似表达可能识别前瞻性陈述，但缺少这些词并不意味着该陈述不是前瞻性的。前瞻性陈述既非历史事实，也非未来表现的保证，且仅基于我们当前对未来业务、未来计划和策略、预测、预期事件和趋势、经济及其他未来状况的信念、期望和假设。由于前瞻性陈述涉及未来，故而其本质上存在不确定性、风险和变化的情况，且这些情况很难预测，许多超出我们控制范围。因此，您不应对这些前瞻性陈述过于依赖。可能导致我们实际结果和财务状况与前瞻性陈述中指示的结果有实质性差异的重要因素包括但不限于以下几点：
| ● |
由于市场和行业因素，以及一般经济、政治和市场状况，我司普通股的市场价格波动和波动性； |
| ● |
我们作为持续经营企业的能力； |
| ● |
稀释对我们股东的影响，包括未来额外股权证券的发行； |
| ● |
我们实现合并预期利益的能力； |
| ● |
我们实现并购所预期税务影响的能力所带来的影响; |
| ● |
诉讼或其他程序的结果可能会在未来受到影响； |
| ● |
我们普通股票从纳斯达克资本市场（“纳斯达克”）退市或未能形成活跃的交易市场； |
| ● |
我们调整后的业务运营、策略和重点未能改善我们普通股的价值； |
| ● |
我们获得足够资金以进行计划中的运营并实现潜在利润的可用性和能力； |
| ● |
我们有限的营业历史； |
| ● |
监管环境的复杂性对我们在美国及其他地区寻求和获得其BNA平台的监管批准能力的影响； |
| ● |
如果获得监管审批，我们可能面临的挑战； |
| ● |
我们的内部人员与资本股票所有权集中对股东在公司事务中影响能力的影响。 |
| ● |
未来收购业务或产品的影响以及未能实现此类收购预期效益的潜在风险； |
| ● |
法律和监管环境变化的潜在影响，包括美国国内和国外的变化； |
| ● |
我们对第三方的依赖； |
| ● |
我们在BNA平台实现市场认可方面可能面临的挑战; |
| ● |
我们BNA平台定价的影响； |
| ● |
我们获得、维持和保护其商业机密或其他专有权利的能力，确保在不侵犯他人专有权利的情况下运营，并防止他人侵犯其专有权利； |
| ● |
我们维持足够的网络安防-半导体和信息系统的能力。 |
| ● |
我们产生足够营业收入以实现和维持盈利的能力; |
| ● |
作为一家上市公司，我们显著增加的费用和行政负担可能对我们的业务、财务状况和经营业绩产生不利影响的风险；以及 |
| ● |
本10-Q表格及我们在SEC提交的其他文件中“风险因素”部分列出的其他因素。 |
这些前瞻性声明基于截至本表格10-Q日期的可用信息以及当前的期望、预测和假设，并涉及众多判断、风险和不确定性。因此，前瞻性声明不应被视为我们在任何后续日期的观点，并且我们不承担任何义务去更新前瞻性声明，以反映其发表后的事件或情况，无论是因新信息、未来事件还是其他原因，除非根据适用的证券法有要求。
概述
我们是一家人工智能（“AI”）科技公司，致力于开发创新的神经科学解决方案，以改善精神疾病和神经系统疾病患者的脑健康结果。我们的FDA-510(k)认证的脑网络分析软件平台（“BNA平台”）专注于改善精神疾病和认知障碍患者的诊断和治疗方法，包括抑郁症、痴呆、焦虑症、脑震荡和注意力缺陷/多动障碍。我们公司花费了15年的时间和约6000万美元的投资，开发该软件，编制所需的脑电波测试数据库，获得专利保护，并获得美国食品及药物管理局（“FDA”）的批准，以市场和卖出BNA平台。BNA平台作为一种医疗解决方案的软件，使用人工智能通过对我们超过17,000名患者的高标准高定义纵向脑电图（“EEG”）的无监督机器学习（通过聚类分析）进行开发，涵盖了十二种疾病及临床正常患者。BNA平台结合FDA认证的EEG系统，可以为临床医生提供关于脑功能（认知）的全面洞察。这些洞察可以增强临床医生准确诊断精神疾病和认知障碍的能力，并评估最适合患者结果的治疗或药物。
截至本次申请提交之日，BNA平台尚未上线，且在市场上不可用。然而，公司计划在2025年上半年进行BNA平台的商业发布。公司预计，为实现这一商业发布所需的额外开发成本将不会很大。我们相信，该商业化具有巨大的潜力，既针对制药公司在其药物研究和临床试验活动中的需求，也针对医疗从业者在其诊所中的需求。为了配合BNA平台的商业化，公司正在与神经科学药物开发公司合作，以支持他们的临床战略。公司计划通过两个领域产生营业收入：一是通过美国神经学家使用BNA平台，二是通过与制药公司在支持神经科学药物开发方面的合作。
脑电图（EEG）科技在支持精神疾病和认知障碍患者获得更好结果方面的临床实用性已得到充分证明。历史上，由于解读脑电图记录的复杂性以及无法将患者的脑功能与临床正常的同龄患者进行实质比较，医疗专业人员，包括精神科医师、神经科医师、护士执业者和全科医生，对脑电图的临床采纳一直有限。Firefly相信，如果不定义一个标准偏差作为规范，就无法客观评估脑功能。通过建立脑功能的客观基线测量，BNA平台使临床医生能够优化患者护理，从而改善精神疾病和认知障碍患者的结果。
我们的价值主张得到了BNA平台的实际应用支持。将BNA平台纳入患者管理协议中，显示出改善的反应率、增强的治疗依从性、减少的非应答者比例以及降低了患者对药物转换的需求。此外，我们相信，当我们的广泛临床数据库与爱文思控股人工智能相结合时，将有机会识别出临床相关的生物标志物，通过精准医学和伴随诊断支持更好的患者结果。我们预计通过制药公司进行的临床部署和临床研究收集更多数据。这些额外数据应能让我们发现新的生物标志物，并客观测量治疗干预在不同类型患者上的影响，进一步增强我们平台的有效性。我们相信，我们将能够提高准确诊断，预测哪些治疗或药物，或其组合，最适合优化患者的结果。这代表了临床医生管理精神疾病和认知障碍患者的范式转变，具有改变脑健康的潜力。
与WaveDancer进行反向合并
在2023年11月15日，我们与WaveDancer和FFN Merger Sub, Inc.（“合并子公司”）签署了合并协议及计划（经过修订的“合并协议”），根据该协议，受合并协议中列出的条件满足或放弃的约束，合并子公司与Private Firefly合并，Private Firefly成为WaveDancer的全资子公司，并且是合并的存续公司（“合并”）。在2024年8月12日，在合并完成之前，WaveDancer实施了1比3的反向股票拆分（“反向股票拆分”）。在2024年8月12日，合并完成，2024年8月13日，我们开始在纳斯达克资本市场以逐笔明细“AIFF”进行交易。
定向增发
在2024年7月26日，在合并完成之前，我们与某些机构投资者签订了一项证券购买协议，根据该协议，我们同意发行和出售总计(i) 319,207 股定向增发股票（或根据交易所比例调整前的7,918,552 股股票和/或预付Warrants），(ii) 预付Warrants（“预付Warrants”）以购买最多504,323 股我们的普通股，以及(iii) Warrants（“Warrants”）以购买最多823,530 股普通股，在定向增发中（或在交易所比例调整前购买最多7,918,552 股普通股的Warrants）。每股定向增发股票及随附Warrant的购买价格为4.25美元（在交易所比例调整前为0.442美元），每个预付Warrant及随附Warrant的购买价格为4.249美元（在交易所比例调整前为0.4419美元）。定向增发于2024年8月12日完成，与合并的完成几乎同时。根据交易所比例调整前出售的证券数量，该交易的总毛收益约为350万美元，并且在扣除我们需支付的预估发行费用之前。
系列C融资
在2023年10月17日至2024年6月30日期间，我们通过定向增发筹集了总额为3,039,000美元，发行了596,145个（或2,374,207个系列C单位（“系列C单位”），在合并和交易所比例调整之前），这些系列C单位由系列C优先股股份和Warrants组成，Warrants可购买最多596,145个（根据合并和交易所比例调整）普通股股份，组合价格为每个系列C单位12.31美元。每个Warrant的行权价为每股24.62美元（需根据条款不时调整），在发行时可立即行使，并在初始发行日期后3年于纽约时间下午4:30到期。
财务运营概览
营业收入
营业收入包括BNA测试、设备租赁以及项目/临床研究的承接。
营业费用
研发费用
研发费用代表为进行研究和开发而产生的成本，例如BNA平台的开发。我们在发生时确认所有研发费用。研发费用主要包括以下内容：
| ● |
薪资和福利; |
| ● |
咨询安排；和 |
| ● |
其他费用用于推动我们的研究和开发活动。 |
我们营业费用最大的一部分历来是对研发活动的投资。我们预计随着对BNA平台的进一步优化和升级，研发费用在未来会增加。我们很可能会继续评估机会和战略合作伙伴关系，以获取或许可其他产品和技术，这可能会由于许可费用和/或整合而导致更高的研发费用。
销售和营销费用
销售和市场推广费用包括员工相关费用，如薪资、福利、差旅、临床费用以及其他市场推广职能，以及支付的咨询服务费用。
一般和管理费用
一般和行政费用包括与员工相关的费用，包括薪水、福利、差旅和非现金股票基础补偿，以及其他行政职能，以及支付的法律和会计服务费用、咨询费用和不包括在研发费用中的设施成本。法律费用包括一般公司法律费用和专利费用。我们预计由于作为上市公司运营而产生额外费用，包括与遵循SEC和纳斯达克的规则和法规相关的费用、额外的保险、投资者关系和其他行政费用及专业服务。
其他（收入）费用
其他（收入）费用主要包括利息、银行费用和贷款费用，汇率期货的损益以及罚款。
关键会计估计
根据美国通用会计准则（U.S. GAAP）编制未经审计的简明合并基本报表，管理层需要做出估计和假设，这些估计和假设会影响简明合并基本报表日期资产和负债的报告金额，以及在报告期间收入和费用的报告金额。实际结果可能与这些估计有所不同。
营业结果
2024年9月30日结束的三个月与2023年9月30日结束的三个月的比较
以下表格列出了截至2024年和2023年9月30日的三个月的综合损益表中的金额：
以下表格列出了我们在所示期间的经营成果：
| 截至三个月 | ||||||||||||
| 九月三十日 | ||||||||||||
| 以千美元计算 | ||||||||||||
| 2024 |
2023 | 变化（$） |
||||||||||
| 营业收入 |
33 | 23 | 10 | |||||||||
| 营业费用： |
||||||||||||
| 研发费用 |
878 | 392 | 486 | |||||||||
| 销售和市场费用 |
431 | 95 | 336 | |||||||||
| 一般和管理费用 |
2,992 | 183 | 2,809 | |||||||||
| 总营业费用 |
4,301 | 670 | 3,631 | |||||||||
| 营业损失 |
4,268 | 647 | 3,621 | |||||||||
| 其他（收入）费用 |
||||||||||||
| 利息和银行费用 |
24 | 3 | 21 | |||||||||
| 未实现（收益）损失汇率 |
2 | - | 2 | |||||||||
| 其他（收入）费用 |
(5 | ) | - | (5 | ) | |||||||
| 所得税前损失 |
4,289 | 650 | 3,639 | |||||||||
营业收入
截至2024年9月30日的三个月营业收入为33,000美元，而截至2023年9月30日的三个月营业收入为23,000美元，增加了10,000美元或43%。这一增长主要是由于客户的BNA扫描增加和临床研究开始时的初始营业收入。
营业费用
研发费用
截至2024年9月30日的三个月的研发费用为878,000美元，而截至2023年9月30日的三个月为392,000美元，增加了486,000美元，增幅为124%。此次增加主要是由于与合并完成相关的管理期权归属，其余则是由于2024年增加了额外的内部资源。
销售和营销费用
截至2024年9月30日的三个月销售和营销费用为431,000美元，而截至2023年9月30日的三个月费用为95,000美元，增加了336,000美元，增长率为354%。 增加主要由于三个主要原因；(i) 与合并完成相关的管理期权和其他补偿兑现，(ii) 相较于2023年2024年新增的内部资源，以及(iii) 合并完成后作为一家上市公司的营销服务。
一般和行政费用
截至2024年9月30日的三个月内，管理和行政费用为2,992,000美元，而截至2023年9月30日的三个月为183,000美元，增加了2,809,000美元，增幅为1535%。此次增长主要由于五个主要因素：(i)因完成合并而归属的管理期权和其他薪酬，(ii)因完成合并而归属的Warrants相关费用，(iii)因完成合并而以股权形式支付的咨询协议，(iv)因完成合并而增加的法律费用，以及(v)完成合并后作为上市公司期间持续发生的其他费用，包括购买D&O 保险。
其他（收入）费用
截至2024年9月30日的三个月内，其他（收入）费用为21,000美元，而截至2023年9月30日的三个月内为3,000美元，代表增加了18,000美元或600%。增加的主要原因与合并完成前发生的桥梁贷款利息有关。
截至2024年9月30日的九个月与截至2023年9月30日的九个月的比较
下表列出了截至2024年和2023年9月30日的九个月的压缩合并运营报表中的金额：
以下表格列出了我们在所示期间的经营成果：
| 截至九个月 | ||||||||||||
| 九月三十日 | ||||||||||||
| 以千美元计算 | ||||||||||||
| 2024 | 2023 | 变化（$） | ||||||||||
| 营业收入，净额 |
55 | 479 | (424 | ) | ||||||||
| 营业费用： |
||||||||||||
| 研发费用 |
1,517 | 712 | 805 | |||||||||
| 销售和市场费用 |
973 | 399 | 574 | |||||||||
| 一般和管理费用 |
4,183 | 879 | 3,304 | |||||||||
| 总营业费用 |
6,673 | 1,990 | 4,683 | |||||||||
| 营业损失 |
6,618 | 1,511 | 5,107 | |||||||||
| 其他（收入）费用 |
||||||||||||
| 利息和银行费用 |
36 | 13 | 23 | |||||||||
| 未实现（收益）损失汇率 |
(1 | ) | - | (1 | ) | |||||||
| 其他（收入）费用 |
22 | 2 | 20 | |||||||||
| 净亏损及全面亏损 |
6,675 | 1,526 | 5,149 | |||||||||
营业收入
截至2024年9月30日的九个月营业收入为55,000美元，而截至2023年9月30日的九个月营业收入为479,000美元，下降了424,000美元，或89%。这一下降主要是由于在2023年，当相关的合同义务被视为履行时，确认了与未完成合同相关的递延收入。
营业费用
研发费用
截至2024年9月30日的九个月研究与开发费用为1,517,000美元，而截至2023年9月30日的九个月费用为712,000美元，增加了805,000美元，增幅为113%。增加的主要原因是与合并完成相关的管理期权到期，其余部分是由于2024年增加了额外的内部资源.
销售和营销费用
截至2024年9月30日的九个月，销售和营销费用为973,000美元，而截至2023年9月30日的九个月费用为399,000美元，增加了574,000美元，或144%。这个增长主要有四个原因：(i) 管理期权在合并完成时的归属，(ii) 2024年相比于2023年增加的内部资源，(iii) 在合并完成后作为上市公司而提供的营销服务，(iv) 更新公司品牌的品牌推广计划。
一般和行政费用
截至2024年9月30日的九个月的综合管理费用为4,183,000美元， 而截至2023年9月30日的九个月为879,000美元，增加了3,304,000美元，增幅为376%。 主要增加源于五个主要因素：（i）与合并完成有关的管理期权和其他补偿的归属；（ii）与合并完成有关的某些Warrants归属的费用；（iii）与合并完成相关的股权支付咨询协议；（iv）与合并完成相关的法律费用；（iv）与截至2023年和2022年12月31日的审计基本报表及相关附注相关的审计费用；（v）与合并完成后作为上市公司相关的其他持续费用，包括购买D&O 保险。
其他（收入）费用
截至2024年9月30日的九个月期间，其他（收入）费用为57,000美元，而截至2023年9月30日的九个月期间为15,000美元，增加了42,000美元，主要是由于与加拿大和以色列的运营相关的汇率波动、与合并相关的过桥融资利息以及与历史税务延迟申报相关的罚款。
流动性和资本资源
在接下来的12个月里，我们预计将继续因运营而产生负现金流，因为我们将继续针对性地投资于销售和市场营销，以及下一代BNA平台的研发。
在接下来的12个月之后，我们实现盈利的能力取决于我们旗舰产品BNA平台的商业化。我们预计在商业化和分销我们的产品过程中，将至少在未来两到四年内产生重大成本，并且我们预计我们的开支将随着我们持续的活动而增加，特别是在我们继续进行研究和开发并根据需要扩展生产能力时。因此，我们将需要大量资金来支持我们的持续运营并推动我们的业务策略，直到我们能实现盈利。
在我们能够通过销售产品产生足够的收入来覆盖我们的营业费用和资本支出需求之前，我们预计将通过出售股票、债务融资或其他来源来融资我们的运营。没有任何保证债务或股票融资能够以商业合理的条款提供给我们，甚至可能根本无法获得。此外，我们可能无法进一步推进我们的业务计划，也可能无法继续运营。我们独立注册公共会计师事务所针对截至2023年12月31日的年度报告中指出，我们作为持续运营的能力存在重大疑虑。
我们对短期内资本资源充足性及长期获取资本资源能力的估计和假设可能是错误的，我们可能比预期更早耗尽资本资源，且可能无法以有利的条件获得资源，或者根本无法获得。
我们没有任何离表的重大安排，这些安排对我们当前或未来的财务控件、财务控件变化、收入或费用、运营结果、流动性、资本支出或对投资者重要的资本资源产生或可能产生影响。
截至2024年9月30日的九个月的现金流，与截至2023年9月30日的九个月相比
下表列出了以下时期现金的重要来源和用途：
| 截至九个月 九月三十日 |
||||||||||||
| 2024 |
2023 |
变更 |
||||||||||
| (以千为单位) |
||||||||||||
| 净现金（使用）提供 |
||||||||||||
| 运营活动 |
$ | (4,937 | ) | $ | (1,662 | ) | $ | (3,275 | ) | |||
| 投资活动 |
$ | (401 | ) | $ | — | $ | (401 | ) | ||||
| 融资活动 |
$ | 4,425 | $ | 2,497 | $ | 1,928 | ||||||
经营活动
截至2024年9月30日的九个月内，经营活动中使用的净现金为4,937,000美元，而截至2023年9月30日的九个月内为1,662,000美元，增加了3,275,000美元，增幅为197%。经营活动中使用的净现金的增加主要是由于日常运营成本的增加、负债的减少、与合并相关的成本、保险政策的预付以及与下一代BNA平台开发相关的研究成本。
投资活动
截至2024年9月30日的九个月中，投资活动使用的净现金为401,000美元，而截至2023年9月30日的九个月中投资活动没有使用现金。投资活动使用现金的增加主要归因于我们对下一代BNA平台及其相关硬件开发的投资。
融资活动
截至2024年9月30日的九个月间，来自融资活动的净现金为4,425,000美元，相较于截至2023年9月30日的2,497,000美元，增加了1,928,000美元，增幅为77%。此次增长主要是由于与合并相关的获得私募融资。
近期融资
2024年7月定向增发
在2024年7月26日，在合并完成之前，我们与某些机构投资者签订了一项证券购买协议，根据该协议，我们同意发行和出售总计 (i) 319,207 定向增发股份（或 7,918,552.03 股和/或 在此之前未进行调整的 交易所 比率的预付权证），(ii) 预付权证以购买高达 504,324 股我们的普通股，以及 (iii) 权证以购买高达 823,529 股普通股的定向增发（或在此之前未进行调整的权证以购买高达 7,918,552.03 股普通股）。每个定向增发股份及其附带权证的购买价格为 0.442 美元，每个预付权证及其附带权证的购买价格为 0.4419 美元，均在合并之前。定向增发于2024年8月12日关闭，基本与合并的完成同时进行。此交易的总毛收益约为350万，扣除我们需支付的发行费用之前。
已知的趋势、事件和不确定性
与我们行业中的其他公司一样，我们需要成功管理正常的业务和科学风险。新技术的研发本质上是不可预测的。我们不能保证我们的技术会被采用，或者我们会否能够赚取足够支持我们运营的收入，或者我们将来是否会盈利。此外，公共卫生危机的出现及其影响，例如地方性疾病和流行病是难以预测的，以色列与哈马斯之间持续战争的后果，包括相关制裁和反制措施，以及这种战争对我们在以色列的员工的影响，都是难以预测的，并可能对地缘政治和宏观经济条件、全球经济产生不利影响，并导致市场波动加剧，这可能反过来对我们的业务和运营产生不利影响。此外，除了在这份10-Q表格中提到的情况外，我们没有任何承诺的融资来源，因此可能无法在需要时筹集资金以继续我们的运营。如果我们无法在需要时筹集资金，我们可能需要大幅削减，甚至停止我们的运营。
除上述讨论和本10-Q表格其他部分外，我们并不知道任何可能对我们的财务控件产生重大影响的趋势、事件或不确定性。
Not applicable
披露控制与程序
在我们首席执行官和首席财务官的监督和参与下，我们的管理层评估了截至2024年9月30日（“评估日期”）我们的披露控制和程序的设计及其有效性（如《交易所法》第13a-15(e)和15d-15(e)条款中所定义）。根据这一评估，我们的首席执行官和首席财务官得出结论，截至评估日期，我们的披露控制和程序有效，能够确保我们在根据《交易所法》提交的报告中所需披露的信息(i) 能够在证券交易委员会的规则和表格规定的时间内被记录、处理、汇总和报告，并且 (ii) 能够被收集并传达给管理层，包括我们的首席执行官和首席财务官，以便及时做出关于所需披露的决策。
财务报告内部控制的变更
在截至2024年9月30日的季度内，与交易所法案第13a-15(d)和15d-15(d)条款要求的评估相关的内部财务报告控制没有发现任何变化，这些变化对我们的内部财务报告控制产生了重大影响，或可能合理地会产生重大影响。
控制有效性的固有限制
由于所有控制系统固有的局限性，没有任何控制系统能够绝对保证公司内所有控制问题和欺诈行为（如有）都已被发现。这些固有的局限性包括做出决策时可能出现的错误判断以及因简单错误或失误而导致的故障。此外，控制措施可能会因个人的单独行为、两人或多人之间的串通，或管理层的控制覆盖而被规避。任何控制系统的设计在某种程度上也基于对未来事件发生可能性的某些假设，因此无法保证任何设计在所有潜在未来条件下都能成功实现其既定目标。由于成本有效的控制系统固有的局限性，可能会发生因错误或欺诈而导致的误报，并可能未被发现。尽管存在这些局限性，我们认为我们的披露控制和程序旨在提供合理的保证，以实现其目标。
部分 II— 其他信息
本备忘录第9条 - b中列出的信息。 法律诉讼本季度报告的10-Q表格中包含的简明合并基本报表已通过引用并入本部分第II项第1条。
我们的业务、基本报表和运营结果可能会受到多种因素的影响，这些因素可能是已知或未知的，包括但不限于下面描述的因素，任何一个或多个因素都可能直接或间接导致我们的实际基本报表和运营结果与过去或预期的未来基本报表和运营结果显著不同。这些因素的全部或部分都可能对我们的业务、基本报表、运营结果和股价产生重大不利影响。在评估对我们证券的投资时，您应仔细考虑下面描述的风险，以及本表格10-Q中包含的其他信息，包括合并基本报表及相关附注。
以下描述的风险并不是我们面临的唯一风险。如果以下风险因素中描述的任何事件实际发生，或者如果后续出现我们目前未知或当前认为不重要的额外风险和不确定性，那么我们的业务、前景、运营结果和财务状况可能会受到重大不利影响。在这种情况下，我们普通股的交易价格可能会下跌，您可能会失去对我们股票的全部或部分投资。以下讨论的风险包含前瞻性声明，且我们的实际结果可能与这些前瞻性声明中讨论的内容存在实质性差异。
以下关于风险因素的讨论包含前瞻性陈述。这些风险因素对理解本表格10-Q中的其他陈述可能很重要。以下信息应与第I部分第1项中的简明合并基本报表及相关说明一同阅读， “基本报表” 以及第I部分第2项， “管理层’对基本报表和经营成果的讨论与分析” 在本表格10-Q中。
与我们财务状况相关的风险
我们正处于开发阶段，收入最少，并且在医疗设备或消费平台的广泛商业化方面没有运营历史。
我们处于开发阶段，面临着与新兴且未经验证的业务相关的所有风险和不确定性。我们的未来基于一个未经验证的商业计划，没有历史事实来支持预测和假设。我们作为医疗设备的分销商没有运营历史。我们目前的营业收入很少，并且不预计在成功推出BNA平台的广泛商业化之前会产生显著的营业收入。
投资者应认识到，投资一家初创业务的风险显著高于投资于任何具有显著运营历史的业务。我们无法保证将来会实现营业收入或盈利。我们的运营面临建立新企业所固有的所有风险。我们的成功可能性必须考虑到在形成无营业收入业务时经常遇到的问题、费用、困难、复杂性和延误。我们缺乏显著和相关的运营历史，这使得管理运营和预测未来的运营结果变得困难。
我们的财务报表附注包含了关于我们能否持续经营的重大疑虑的披露。
我们的基本报表附注包括关于我们持续作为持续经营实体的能力的重大疑虑的披露。截至2024年9月30日和2023年12月31日，我们的股东权益分别为负$2,776,000和$109,000。此外，截至2024年9月30日的九个月内，我们的经营活动现金流为$4,937,000，而截至2023年9月30日的九个月内，经营活动现金流为$1,662,000。此外，我们的基本报表的附注指出，截至2024年9月30日，我们持续亏损，经营收入极少。
为了增强我们在可预见的未来的流动性，我们采取了以下措施： (i) 与现有和新投资者谈判以筹集额外资金；并且 (ii) 采取各种成本控制措施以减少运营现金消耗。虽然我们的管理层相信我们能够继续筹集额外的股本资金以维持在可预见的未来的运营存续，但如果我们无法筹集到额外资金，我们可能需要采取额外措施来节约流动性。无法保证新融资会以商业上可接受的条款向我们提供，如果有的话。
我们可能无法筹集更多资金，这可能会损害我们的竞争能力。
我们预计将在BNA平台的商业化项目启动、品牌建设和产品改进方面投入大量资金。这些举措可能需要我们在未来几年增资。我们可能比预期更快地消耗现有资源，并且在需要时可能无法以可接受的条件筹集到更多的所有基金类型。
如果我们通过发行股权或可转换债务证券筹集额外资金，我们现有的股东可能会遭受重大稀释，而且我们发行的任何新股权证券可能享有优于我们普通股股东的权利、优先权和特权。尽管我们的管理团队相信我们可以继续筹集额外的股本，以在可预见的未来继续维持运营，但是如果我们无法获得足够的融资或以满意的条款获得融资，在我们需要时，我们继续追求业务目标以及应对商业机会、挑战或不可预见情况的能力可能会受到显著限制，而我们的业务、运营结果、财务状况和前景可能会受到实质性的不利影响。
与我们业务和运营相关的风险
我们面临运营风险，包括过剩或受限的产能以及操作效率低下，这可能会对我们的运营结果产生不利影响。
我们面临运营风险，包括过剩或受限的产能以及对我们内部系统和人员的压力。为了有效管理当前和预计的未来运营，我们必须不断实施和改进我们的运营、财务和管理信息系统，招聘、培训、激励、管理和留住员工。我们可能无法平衡满足现有需求的短期努力与未来客户需求，包括增加人员、创建可扩展、安全和强大的系统和操作，以及自动化长期效率所需的流程。任何此类失误都可能对我们的业务、运营和前景产生重大影响。
我们的产品和信息科技系统对我们的业务至关重要。产品开发或改进、IT系统集成、实施、更新和升级的问题可能会干扰我们的运营，并对我们的业务和经营结果产生重大影响。
我们依赖于IT系统的高效、连续和安全的事件；事件控件，并且依赖于嵌入我们产品和IT系统中的关键第三方软件，以及第三方托管的IT系统来支持我们的事件；事件控件。所有软件和IT系统都容易受到各种来源的损害、网络攻击或中断。为了有效管理和改善我们的事件；事件控件，我们的IT系统和应用程序需要持续投入大量的支出和资源，以维持、保护、升级、增强和恢复现有系统，并开发新系统，以跟上信息处理技术的持续变化、不断发展的行业和监管标准、日益复杂的网络威胁以及不断变化的消费偏好。如果未能充分保护和维护我们产品和IT系统的完整性，可能会对我们的财务状况、经营结果和现金流产生重大影响。
我们计划不断升级并发布我们的产品和客户面对的 系统 应用程序，这些都是我们的运营所依赖的。包含软件的 系统 应用程序和产品往往会包含错误或缺陷，尤其是在首次推出或新版本发布时。此外，集成到我们产品和服务中或与之兼容的第三方软件将定期达到生命周期末期，因此可能会暴露于额外的安全风险、错误和故障，这些问题可能是不可修复的或难以修复的。在我们的产品、软件应用程序或IT系统中发现缺陷、错误或安全漏洞，与未来客户的计算机操作系统和 硬件 配置不兼容以及新版本或升级版本的失败，可能导致不利后果，包括：收入延迟或损失、重大补救成本、市场接受度延迟、数据丢失、客户或患者的财务、健康或其他个人信息的泄露、产品召回、对我们声誉的损害或服务成本增加，以上任何一个都可能对我们的 业务、财务状况或运营结果以及潜在客户或 业务伙伴的运营产生重大影响。
我们的运营和财务表现依赖于全球和区域型经济控件。通货膨胀、货币兑换汇率波动、消费信心和需求变化，以及一般经济控件的疲软和威胁，或者实际的衰退，可能会实质性影响我们的业务、运营结果和财务状况。
宏观经济条件影响消费信心和可自由支配支出，这可能会对我们推出市场的任何产品的需求产生不利影响。消费支出习惯受到通货膨胀、货币兑换汇率波动、整体经济状况疲软、威胁或实际衰退、疫情、战争和军工-半导体行动、就业水平、工资、债务义务、可支配收入、利率、资本波动以及消费者对当前和未来经济状况的信心和看法等因素的影响。变化和不确定性可能会减少或改变支出，从而转向用于治疗精神疾病和认知障碍的治疗和程序，可能促使患者和临床医生选择市场上其他成本较低的选项，减少患者在临床办公室的流量，或减少对治疗精神疾病和认知障碍服务的需求。最近美国、欧洲以及某些其他国际经济体的经济前景下降或不确定，已并可能继续对消费和医疗实践支出产生不利影响。燃料和能源、食品及其他必需品的成本增加，加上高企的利率，可能会减少消费者的可支配收入，导致对像我们这样的产品的可自由支配支出减少。可支配收入和可自由支配支出的减少或消费者信心和消费习惯的变化可能会对我们的收入和经营成果产生不利影响。
通货膨胀持续对消费和交易活动产生不利影响，我们无法预测更高通货膨胀对全球和区域型经济的影响。更高的通货膨胀也增加了国内和国际运输成本、原材料价格以及劳动力费用，这可能对我们推出市场的任何产品的生产、采购和运输成本产生不利影响。如果类似的趋势在我们开始推广我们的BNA平台时继续存在，我们通过价格上涨来弥补这些成本增加的能力可能效果有限，从而对我们的经营成果施加下行压力。试图通过价格上涨来抵消成本增加可能会减少销售、增加客户不满或以其他方式损害我们的声誉。此外，我们无法预测中央银行及联邦、州和地方政府抗击高水平通货膨胀的努力所带来的影响。如果他们降低通货膨胀的努力过于激进，可能会导致经济衰退。或者，如果他们的努力不足，或者未持续足够长的时间以将通货膨胀降低到更可接受的水平，消费可能会在较长时间内受到不利影响。这些事件中的任何一个都可能对我们的业务和经营成果产生重大影响。
我们的业务可能会受到政治事件、交易和其他国际争端、战争以及恐怖主义的影响，包括俄乌之间的军工-半导体冲突。
政治事件、贸易和其他国际争端、战争和恐怖主义可能会损害或扰乱国际商业和全球经济，并可能对我们的业务以及我们的潜在客户、供应商、代工厂商、分销商和其他业务伙伴产生重大影响。
政治事件、交易和其他国际争端、战争以及恐怖主义可能导致意外的关税或贸易限制，这可能对我们的业务产生不利影响。一旦我们开始营销我们的产品，这些增加的成本可能会对我们的毛利率产生不利影响，并使我们的产品竞争力降低或需求减少。各国还可能采取其他措施，例如控制商品、科技或数据的进口或出口，这可能对我们的运营和供应链产生不利影响，并限制我们提供产品和服务的能力。这些措施可能要求我们采取各种行动，包括更换供应商或重组业务关系。遵守新的或变更的贸易限制既昂贵又耗时，并且对我们的运营造成干扰。这些限制可能在几乎没有提前通知的情况下宣布，我们可能无法有效缓解这些措施的不利影响。如果未来争端和冲突升级，各国政府采取的行动可能会更加严厉和限制，从而对我们的业务产生实质性影响。
政治动荡、威胁、紧张局势、行动以及对任何社会、经济、业务、地缘政治、军事、恐怖主义或涉及关键商业、开发或制造市场（如中国、墨西哥、以色列、欧洲或其他国家或地区）的战争行为的反应，可能会对我们进行的任何国际业务产生重大影响。例如，我们在以色列的员工可能被要求在以色列军队中履行年度预备役，并在紧急情况下被召回进行额外的现役服务。如果这些事件或条件发生，对我们、我们的员工和潜在客户的影响是不确定的，特别是在紧急情况下、武装冲突或政治不稳定或暴力升级导致我们的产品开发、数据或信息交换、工资或银行业务、我们或供应商的产品或材料运输以及其他意想不到的业务中断、停顿和电信服务或关键系统或依赖于稳定和不间断通信基础设施的应用受到限制时。
美国及全球市场因地缘政治紧张局势升级和俄乌军事冲突的开始而经历着波动和干扰。2022年2月24日，俄罗斯军队对乌克兰进行全面军事入侵的消息被报道。作为对军事冲突的回应，美国和其他北大西洋公约组织成员国以及非成员国宣布对俄罗斯实施针对性的经济制裁，包括对某些俄罗斯公民和企业的制裁，且冲突的持续可能会触发更多经济和其他制裁。冲突及相关制裁的潜在影响可能包括供应链和物流的干扰，因俄国金融机构被排除在全球银行系统之外而造成的宏观金融影响，外汇汇率和利率的波动，原材料和能源的通胀压力以及加剧的网络安全威胁。我们无法预测乌克兰冲突的进展或结果，或各国政府、企业或消费者的反应。持久的冲突、加剧的军事活动或对该地域产生更广泛影响的更严格制裁及其带来的经济影响可能对我们的业务、运营结果、财务状况、流动性、增长前景和业务前景产生重大影响。
我们在以色列进行某些运营。以色列的情况，包括哈马斯以及其他恐怖组织从加沙地带和以色列进行的近期攻击，’与他们的战争，可能会影响我们的运营。
目前我们有七名全职员工，他们位于以色列及/或居住在以色列。因此，我们的业务和运营直接受到以色列的经济、政治、地缘政治和军工-半导体条件的影响。自1948年以色列建国以来，以色列与邻国和在该地域板块活动的恐怖组织之间发生过多次武装冲突。这些冲突涉及导弹袭击、敌对渗透和针对以色列各地民用目标的恐怖主义行为，严重影响了以色列的商业环境。
2023年10月，哈马斯恐怖分子从加沙地带渗透以色列南部边界，并对平民和军工-半导体目标发动一系列攻击。哈马斯还对位于以色列与加沙地带边界及以色列其他地区的以色列人口和工业中心发起了大规模火箭攻击。袭击之后，以色列安全内阁宣布向哈马斯宣战，并开始了一场针对这些恐怖组织的军工-半导体行动，与它们持续的火箭和恐怖攻击并行。此外，以色列与黎巴嫩的真主党之间的冲突，未来可能升级为更大的区域型冲突。
与以色列有关的任何敌对行动可能会对我们的运营和运营结果产生不利影响。避难措施和居家办公措施、政府对人员流动和旅行的限制以及为应对持续冲突而采取的其他预防措施，可能会暂时干扰我们的员工’ 有效地完成他们的日常任务。
以色列国防军（"IDF"），以色列的国家军队，是一种征兵制军事服务，受特定例外情况的限制。我们的一些员工正在服役于IDF，过去曾被召集服役，现在和未来可能还会被召集。未来可能会有更多或更长的军工-半导体预备役召集，这可能会影响我们的业务，因为技术工人短缺和机构知识的流失，以及我们可能采取的必要减缓措施来应对劳动力可用性的下降，例如加班和第三方外包，这可能会产生意想不到的负面影响，并对我们的运营结果、流动性或现金流产生不利影响。
目前无法预测当前冲突的持续时间或严重程度，以及其对我们业务、运营和财务状况的影响。持续的冲突正在迅速演变和发展，可能会干扰我们的业务和运营。
我们的运营可能会受到自然灾害的影响，这些灾害可能会因气候变化而变得更加频繁或严重，进而对我们的业务和运营结果以及潜在客户和供应商产生不利影响。
自然灾害可能会影响我们和我们的潜在客户，以及对我们运营至关重要的供应商。自然灾害包括地震、海啸、洪水、干旱、飓风、野火和其他极端天气条件，这些灾害可能导致死亡、伤害和严重的健康危机，停电，食品、水、住所和宠物-医疗产品的限制和短缺，通信故障，材料稀缺，价格波动以及其他后果。气候变化可能会增加自然灾害的频率和严重性，从而对我们的业务和运营构成风险。
气候变化对区域型和全球货币经济的影响可能改变能源或其他对我们的产品和运营至关重要的资源的供应、需求或可用性，并影响我们及我们的供应商所依赖的自然资源、商品和服务的可用性或成本。
与BNA平台相关的风险
如果我们无法成功提高对我们的BNA平台的认识，推动在当前目标人群中的采用，并扩展符合条件的患者群体，我们的销售、业务、财务控件和运营结果将受到负面影响。
我们的业务目前主要依赖于成功营销我们的BNA平台，这涉及成功启动我们的商业化项目，增加目标临床医生对BNA平台的采用和利用。我们旨在提高对BNA平台的认知，同时在我们的商业化项目启动后，增加使用我们BNA平台的临床医生数量，但我们不能保证我们会成功。
我们BNA平台的商业成功将继续依赖于多个因素，包括以下几点：
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我们BNA平台的实际和感知有效性以及临床益处； |
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我们BNA平台所涉及的任何不良患者事件的发生率和严重性; |
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我们能够更早地向患者和临床医生提供有关我们的BNA平台的意识和教育； |
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临床医生和患者采用我们BNA平台的程度； |
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替代技术或治疗方法在认知障碍方面的可用性、相对成本以及被感知的优缺点； |
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关于我们BNA平台的未来临床和其他研究的结果，这些研究涉及健康、经济或其他方面的益处； |
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关键思想领袖是否接受医疗社区认为我们未来的临床效用足够有意义，以影响他们决定采纳我们的BNA平台； |
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我们在教育临床医生和患者了解我们的BNA平台的好处方面的成功程度； |
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我们在临床医生和患者中的声誉; |
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我们预测产品性能的能力； |
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我们市场营销和分销制造行业的实力，包括我们推动BNA平台使用和采纳的能力； |
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我们获得、维护、保护、执行和捍卫我们的知识产权的能力，包括覆盖我们的BNA平台的权利； |
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我们维护遵守所有法律和监管要求的能力，包括适用于我们的BNA平台的要求；以及 |
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我们继续吸引和留住关键人才的能力。 |
如果我们未能成功启动我们的广泛商业化计划，以具有成本效益的方式推广和卖出我们的BNA平台，我们的销售、业务、财务控件和运营结果将受到负面影响。
我们的商业成功将取决于未来BNA平台在诊所患者工作流程中的采用。如果我们无法成功引导人们对我们的BNA平台产生兴趣，我们的业务、财务控件及经营成果将受到损害。
我们的商业成功在很大程度上将取决于BNA平台在诊所患者工作流中的未来采用情况。我们无法预测临床医生和患者将多快地采用我们的BNA平台，甚至可能根本不会。此外，我们无法预测目前正遭受精神疾病或认知障碍但未接受治疗的患者将多快寻求治疗。我们能够推动BNA平台销售增长和市场接受度的能力将取决于成功地让临床医生和患者了解我们BNA平台的相对优势。如果我们无法成功激发对我们BNA平台的兴趣，我们的业务、财务状况和运营结果将受到损害。
我们可能无法在竞争技术中成功竞争，这可能会损害我们的销售、业务、财务控件和运营结果。
我们的行业板块竞争激烈，并且在快速发展。我们的BNA平台适用于12至85岁个体进行人类脑电图的事后统计分析，包括事件相关电位。
一旦我们启动对我们的BNA平台的大规模商业化计划，我们将面临来自竞争技术的市场竞争，并且我们预计未来会有新公司进入市场或引入新技术。第三方支付方可能会由于竞争产品或替代品的成本较低而鼓励使用竞争对手的产品。此外，治疗神经科医生可能会推广其他竞争对手的产品或替代疗法。
我们现在和未来的竞争对手可能包括一些资本雄厚、市场份额和资源都很显著的大公司。他们的销售和市场营销计划可能比我们更加成熟，并且更具知名度。除了争夺市场份额，竞争对手还可能开发或收购专利或其他权利，这可能限制我们竞争的能力。
我们相信，BNA平台的竞争优势将是我们未来成功的重要因素。我们持续的成功依赖于我们在以下方面的能力：
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成功启动我们的商业化计划，目标是临床医生（即美国的神经学家）； |
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提高对精神疾病和认知障碍患者的关注，以增加转诊至目标临床医生的患者数量； |
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吸引和留住熟练的研究、开发、销售、市场和临床人才; |
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继续创新，以改善我们的BNA平台并提升患者和提供者的体验； |
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适当地预测产品性能; |
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获得并维持监管许可和批准，包括扩展适应症的批准； |
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以成本效益高的方式营销和卖出我们的BNA平台； |
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获取、维护、保护、执行和捍卫我们的知识产权，并在不侵犯、挪用或以其他方式违反他人知识产权的情况下运营我们的业务； |
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获得与我们业务互补或必要的产品或技术。 |
器械行业竞争异常激烈，受快速变化的影响，并受到行业参与者推出的新产品和其他市场活动的显著影响。无法保证其他公司或机构不会成功开发或销售比我们的BNA平台更有效的器械和产品，或者使我们的BNA平台变得过时或失去竞争力。
使用我们的BNA平台需要适当的培训，不充分的培训可能导致医生的不良体验，这可能会损害我们的业务、财务控件和运营结果。
我们BNA平台的成功使用部分依赖于执行EEG记录和阅读BNA报告的临床医生的培训和技能。临床医生在解读BNA报告的结果时可能会遇到困难。此外，临床医生在推荐或使用我们的BNA平台时依赖于他们之前的医疗培训和经验，我们无法保证所有临床医生都具备正确使用BNA平台所需的技能。我们无法确定使用我们BNA平台的临床医生是否接受了充分的培训，而那些没有接受足够培训的临床医生可能仍会尝试在其患者身上使用我们的BNA平台。如果临床医生错误使用我们的BNA平台，或者没有遵循或完成所有相关培训，他们的患者结果可能与我们研究和任何未来临床研究中取得的结果不一致。由于错误或不当使用我们的BNA平台而产生的不良安全结果，可能会对患者获益的认知和我们BNA平台的安全性产生负面影响，尽管我们研究和任何未来临床研究的结果表明了其有效性。这些结果可能限制我们BNA平台的采用，进而影响我们的销售、业务、财务状况和运营结果。
我们非常依赖我们的高级管理团队和关键人员，如果我们无法吸引和留住对我们成功必要的人员，可能会对我们的业务造成伤害。
我们高度依赖于高级管理层和关键人员。我们的成功将取决于我们未来留住高级管理层，并吸引和留住合格的人员，包括销售和市场专业人士、工程师、科学家、数据科学专家和其他高技能人员，同时还要能够整合所有部门现有和新增的人员。
我们市场上对熟练人员的竞争非常激烈，这可能限制我们以可接受的条件（或根本无法）雇佣和留住高素质的员工。为了诱使有价值的员工留在公司，除了薪水和现金奖励外，我们还发行了随着时间推移而生效的期权、受制于归属条件的限制股份单位和某些绩效Warrants。随着时间推移而生效的期权对员工的价值可能会受到超出我们控制的股价波动的显著影响，并且在任何时候都可能不足以抵消来自其他公司的更丰厚的报价。尽管我们努力留住有价值的员工，但我们的管理层和其他关键人员可能在短时间内终止与我们的雇佣关系。我们与员工的雇佣安排提供了随意雇佣，这意味着我们的任何员工都可以在任何时候离开公司，无论是否提前通知。我们也没有为这些个人或其他员工的人身生命投保“关键人物”保险政策。
随着我们启动BNA平台的商业化计划，未来扩大我们的产品供应并增加市场营销力度，我们需要建立和扩展我们的市场营销和销售网络的覆盖范围。我们未来的成功将在很大程度上依赖于我们继续招聘、培训、保留和激励具备各领域重要技术知识的熟练员工的能力。无法吸引、招聘、培训和保留员工将会对我们的销售、业务、财务控件和运营结果造成损害。
我们预计未来会扩大组织规模，但可能会在管理这一增长的运营要素或时机方面遇到困难。如果我们无法管理或适当地安排预期的业务增长，我们未来的营业收入和运营结果可能会受到影响。
截至本文件提交的日期，我们有七名全职员工和六名承包商。随着我们的销售和市场策略的发展，以及我们启动BNA平台的商业化，我们可能需要额外的管理、运营、销售、市场、财务和其他人员。未来的增长将对管理层成员施加重大的附加责任，包括：
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识别、招聘、整合、维护和激励额外员工； |
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有效管理我们的内部开发工作，同时遵守对承包商和其他第三方的合同义务；并且 |
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改善我们的运营、财务和管理控制、报告系统和程序。 |
我们未来的财务表现以及成功营销和出售我们的BNA平台的能力，部分将取决于我们有效管理未来增长的能力，我们的管理层可能还需要将不成比例的注意力从日常活动中转移，以便投入大量时间管理这些增长活动。
随着我们BNA平台需求在未来的增加，我们需要扩展客户服务、账单和系统流程，并增强我们的内部质量保证程序。我们不能确定任何规模的增加、相关改善和质量保证是否会成功实施，或者是否会有合适的人员来促进我们业务的增长。如果我们无法满足市场需求、质量标准或临床医生的期望，我们的声誉将受到损害，我们的业务也将受到影响。此外，额外的增长可能会导致更高的固定成本，并可能减缓我们在面对产品需求突然下降时降低成本的能力。
我们可能无法实现或维持BNA平台的令人满意的定价和利润率，这可能会对我们的业务和运营结果造成损害。
器械行业有着价格竞争的历史，我们无法保证能够在竞争水平上维持我们的BNA平台或任何未来产品的满意价格。我们产品的定价可能会受到几个因素的影响，包括由于第三方支付方对使用我们BNA平台的临床医生进行脑电图检测的报销金额下降而给我们客户施加的降价压力。如果我们被迫降低价格或无法提高我们对BNA平台收取的价格，我们的毛利将会减少，这将影响我们投资和发展我们的业务的能力。如果我们无法维持我们的价格，或者我们的成本上升而我们无法通过提高价格来抵消这种上升，我们的利润可能会受到侵蚀，这可能会对我们的业务和运营结果造成伤害。
我们BNA平台未来的销售可能依赖于医疗服务提供者’ 或患者’ 从第三方支付方获取报销的能力，例如保险公司。
我们BNA平台未来的销售可能取决于医疗服务提供者或患者能否从第三方支付方（如保险公司）获得报销。如果未来可以获得此类保险或第三方报销，任何对我们BNA平台保险或其他第三方支付方报销的减少可能会造成负面价格压力，从而减少我们的收入。如果没有相应降低生产这些产品的成本，结果将是我们整体毛利润的下降。同样，任何此类产品成本的增加将在没有第三方支付方报销相应增加的情况下减少我们的整体毛利润。我们的患者或医疗服务提供客户未能获得或维持保险覆盖，或未能从第三方支付方获得足够的报销可能会对我们的业务、运营结果和财务状况产生不利影响。
如果我们无法准确预测临床医生对我们的BNA平台或未来产品的需求，我们的运营结果可能会受到损害。
我们准确预测BNA平台或未来产品需求的能力可能会受到多种因素的负面影响，包括我们未能准确管理扩张策略、竞争对手的产品推出、我们无法预测产品生命周期、客户对我们或竞争对手产品需求的增加或减少、我们未能准确预测客户对新产品的接受程度、市场条件或监管事务的意外变化以及经济状况或消费者信恳智能对未来经济状况的信心减弱。库存水平超过客户需求可能会导致库存减值或撇账，这将对我们的毛利率产生不利影响，并可能损害我们品牌的实力，从而对我们的业务、财务状况和运营结果产生负面影响。
我们BNA平台的采用依赖于积极的临床数据以及临床医生对这些数据和我们产品的接受，如果临床数据或这些临床医生的看法不佳，将会对我们的销售、业务、财务控件和运营结果造成损害。
我们产品的采用和销售率受到临床数据的严重影响。尽管我们在2023年的白皮书研究中获得了积极的研究数据，但无法保证未来的临床研究，包括证明我们BNA平台或未来产品在当前目标患者群体中的有效性的研究，以及支持我们产品标签保持和扩展的研究，将证明其临床效用和有效性。未来我们、竞争对手或第三方进行的临床研究的不利或不一致的临床数据，或内部和外部对我们临床数据的负面解读，包括来自客户、竞争对手、患者和监管机构的解读，都可能损害我们的业务、财务状况和经营结果。
我们产品的采用率和销售额也受到临床医生看法的影响。临床医生对我们产品的负面看法，包括由于负面的临床数据，可能导致我们产品的采用率或使用率下降，这将损害我们的业务、财务状况和运营结果。此外，如果我们无法与临床医生建立良好的工作关系并获得他们的建议和意见，我们产品的营销可能会受到影响，这会损害我们的业务、财务状况和运营结果。
我们未来的成功取决于患者对我们产品的体验是否符合他们的期望，以便通过积极的反馈和口碑提高临床医生对我们产品的需求。如果患者对BNA平台的期望没有得到满足，或者执行临床操作的医生没有接受充分的BNA平台使用培训，患者可能会感到不满意。如果我们产品的结果未能达到患者的期望，可能会使患者及其医疗提供者不再使用我们的设备或向他人推荐我们的产品。不满意的患者可能会通过社交媒体、倡导或其他宣发渠道表达负面意见。未能满足患者期望所导致的任何负面宣发可能会损害我们的声誉和未来的销售。
我们未来可能会收购业务或产品，或形成战略联盟，但可能无法实现这些收购的收益。
我们可能会收购额外的业务或产品，形成战略联盟，或与我们认为能补充或增强我们现有业务的第三方创建合资企业。如果我们收购具有前景的市场或技术的公司，如果我们无法将其成功整合到现有的运营和公司文化中，我们可能无法实现收购这些公司的收益。在开发、制造和营销任何源于战略联盟或收购的新产品时，我们可能会遇到许多困难，这些困难可能会延迟或阻止我们实现预期的收益或增强我们的业务。没有任何保证，在任何此类收购之后，我们将实现预期的协同效应以证明交易的合理性，而这可能会对我们的业务和前景产生重大不利影响。
与法律、监管和合规事宜相关的风险
遵守FDA及其他监管机构施行的法规既昂贵又耗时，未能遵守可能会导致巨额罚款。
我们的产品BNA平台（我们已经获得FDA 510(k)批准）以及我们未来的产品被视为医疗设备，因此受到美国及我们计划卖出产品的其他国家政府机构的严格监管。遵守这些严格的规定将影响公司的资本支出、收益和竞争地位。这些规定因国家而异，但涵盖了包括医疗设备在内的以下活动：
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设计、开发和制造业-半导体; |
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测试、标签、使用和存储说明的内容和语言； |
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产品存储与安全； |
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市场营销、销售和分销； |
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盘前审批和批准； |
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记录保持程序; |
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广告与促销; |
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召回和现场安全纠正措施; |
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市场后监测; |
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发帖市场批准研究；以及 |
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产品进出口。 |
我们所遵循的法规是复杂的。监管变化可能导致我们在开展或扩展业务方面的能力受到限制，成本超出预期或销售低于预期。我们未能遵守适用的监管要求可能会导致FDA或州机构采取执法行动，这可能包括以下任何制裁：
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警告函、罚款、禁令、同意令和民事处罚； |
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修理、替换、退款、召回或扣押我们的产品; |
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运营限制或部分停产或全面停产; |
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拒绝我们对510(k)许可或新产品、 新用途、或对现有产品的修改的请求; |
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撤回已经批准的清关或盘前审批；和 |
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刑事起诉。 |
如果发生这些事件，可能会对我们的业务造成损害。
我们可能无法获得必要的授权来推广我们的BNA平台或任何未来的新产品，任何未能及时做到这一点可能会对我们发展业务的能力产生不利影响。
在我们能够在美国销售新器械，或对已经合法销售的器械进行新的用途、新的声明或重大修改之前，我们必须首先获得FDA 510(k)许可或批准，除非有豁免适用。在510(k)许可过程中，在器械可以上市之前，申请者必须根据FD&C法第510(k)条向FDA提交市场前通知，并且FDA必须判断提议的器械与合法销售的“公掺”器械是“实质等同”的。要被视为“实质等同”，提议的器械必须与公掺器械有相同的预期用途，并且要么具有与公掺器械相同的技术特性，要么具有不同的技术特性，但不会产生与公掺器械不同的安全性或有效性问题，并且与公掺器械一样安全和有效。510(k)许可过程可能成本高昂且不确定，通常需时3到12个月，但可能会持续更长时间。与申请510(k)许可相关时可能需要临床数据。此外，即使我们获得了监管许可或批准，它们可能会对器械的适应症或预期用途施加限制，从而限制器械的市场。
Our BNA Platform is a Class II medical device, which was cleared by FDA for commercialization in the U.S. pursuant to the 510(k) notification process for the post-hoc statistical analysis of the human electroencephalogram in December 2020 for use in individuals 12 to 85 years of age.
FDA can delay, limit, or deny 510(k) clearance, or other approval or reclassification, of a device for many reasons, including:
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we may be unable to demonstrate to FDA’s satisfaction that the products or modifications are substantially equivalent to a proposed predicate device or safe and effective for their intended uses; |
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we may be unable to demonstrate that the clinical and other benefits of the device outweigh the risks; and |
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the applicable regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturers. |
Any delay or failure to obtain necessary regulatory clearances or approvals could harm our business. For example, if we decide to market the BNA Platform for a broader or additional indication(s) for use and/or make any material modifications to any element of the device and/or the manufacturing or distribution thereof in the future, an additional 510(k) submission, and FDA clearance thereof, will be required prior to making any promotional communications expressly or impliedly claiming that the device may be used for such indication(s) and/or prior to making such modification, respectively.
In addition, FDA may change its policies, adopt additional regulations, revise existing regulations, or take other actions, or Congress may enact different or additional statutory requirements, which may prevent or delay clearance of our future products under development or impact our ability to modify our currently marketed products on a timely basis. Such policy, statutory, or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict our ability to maintain our current marketing authorizations.
We received our European CE mark, indicating that we affirm our product’s conformity with European health, safety and environmental protection standards, in 2021. We will also need to obtain regulatory approval in other foreign jurisdictions in which we plan to market and sell our products. The time required to obtain registrations or approvals, if required by other countries, may be longer than that required for FDA clearance, and requirements for such registrations, clearances, or approvals may significantly differ from FDA requirements. If we modify our products, we may need to apply for additional regulatory approvals before we are permitted to sell the modified product. In addition, we may not continue to meet the quality and safety standards required to maintain the authorizations that we have received. If we are unable to maintain our authorizations in a particular country, we will no longer be able to sell the applicable product in that country.
Failure to comply with these rules, regulations, self-regulatory codes, circulars, and orders could result in significant civil and criminal penalties and costs and could have a material adverse impact on our business. Also, these regulations may be interpreted or applied by a prosecutorial, regulatory, or judicial authority in a manner that could require us to make changes in our operations or incur substantial defense and settlement expenses. Even unsuccessful challenges by regulatory authorities or private relators could result in reputational harm and the incurring of substantial costs. In addition, many of these laws are vague or indefinite and have not been interpreted by the courts and have been subject to frequent modification and varied interpretation by prosecutorial and regulatory authorities, increasing compliance risks.
Certain modifications to our products may require new 510(k) clearance or other marketing authorizations.
Once a medical device is permitted to be legally marketed in the U.S. pursuant to a 510(k) clearance, a medical device developer may be required to notify FDA of certain modifications to the device. Medical device developers determine in the first instance whether a change to a product requires a new premarket submission, but FDA may review any such decision.
While our BNA Platform received 510(k) clearance in December 2020, we may in the future apply for 510(k) clearance for updated components of our BNA Platform, which must, then, be found by the FDA to be substantially equivalent to the cleared BNA Platform and, thus, may not be lawfully marketed in the U.S. until FDA make a substantial equivalence determination and issues the requisite 510(k) clearance for the updated BNA Platform. Although the development of our BNA Platform has been carefully monitored and documented by professionals who are experienced in the FDA clearance process, there is no assurance that the FDA will agree that an updated component of our BNA Platform is substantially equivalent to the cleared BNA Platform and allow the updated BNA Platform to be marketed in the United States. The FDA may determine that the device is not substantially equivalent and require a premarket approval (“PMA”) or, more likely, a de novo reclassification, and/or require further information, such as additional test data, including data from clinical studies, before it is able to make a determination regarding substantial equivalence. By requesting additional information, the FDA can delay market introduction of an updated BNA Platform. Delays in receipt of or failure to receive any necessary 510(k) clearance, de novo classification, or PMA, or the imposition of stringent restrictions for our BNA Platform, could have a material adverse effect on our business, results of operations and financial condition.
In the future, we may make other modifications to our products, including our BNA Platform, and determine, based on our review of the applicable FDA regulations and guidance, that in certain instances new 510(k) clearances or other premarket submissions are not required. If FDA disagrees with our determinations, we may be subject to a wide range of enforcement actions, including, for example, a warning letter, among other consequences, after which we will likely have to cease marketing the applicable modified product and/or to recall distributed units of such modified product until we obtain the requisite clearance or approval.
Ongoing changes in healthcare regulation could negatively affect our revenues, business and financial condition.
The United States healthcare system has been continually evolving at the federal and state level due to comprehensive reforms relating to the payment for, the availability of and reimbursement for healthcare services. Key reforms have ranged from fundamentally changing federal and state healthcare reimbursement programs, including providing comprehensive healthcare coverage to the public under government-funded programs, to minor modifications to existing programs, and many have been challenged (with some being overturned or modified) along the way. One example, among countless others, is the Patient Protection and Affordable Care Act (the “Affordable Care Act”), which was the most significant federal healthcare reform law enacted in the U.S. in recent history. The Affordable Care Act has undergone substantial challenges and changes since its enactment in 2010, and numerous other federal healthcare reform legislation, executive orders, and judicial rulings have been implemented in the years since, most of which have been or are aimed at lowering healthcare costs in the U.S. To the extent any such reform measures or any future initiatives reduce reimbursement or coverage eligibility or any amounts or funds available (such as by reductions in reimbursement to our healthcare provider customers) for our BNA Platform and/or any future products we may market in the U.S. (if any), our business may be adversely affected.
Healthcare reform initiatives will continue to be proposed and may reduce healthcare related funding. It is impossible to predict the ultimate content and timing of any healthcare reform legislation and its resulting impact on us. If significant reforms are made to the healthcare system in the United States, or in other jurisdictions, those reforms may increase our costs or otherwise negatively effect on our business, results of operations, and financial condition.
On April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the EU Medical Device Directive and became effective on May 26, 2021. The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent, predictable, and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting innovation. The new regulations, among other things:
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strengthen the rules on placing devices on the market and reinforce surveillance once they are available; |
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establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; |
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improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; |
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set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the European Union; and |
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strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market. |
These modifications may have an effect on the way we conduct our business in the EEA.
Any change in the laws or regulations that govern the clearance and approval processes relating to our current, planned and future products could make it more difficult and costly to obtain clearance or approval for new products or to produce, market and distribute existing products. Significant delays in receiving clearance or approval or the failure to receive clearance or approval for our new products would have an adverse effect on our ability to expand our business.
Our products may cause or contribute to adverse medical events that we are required to report to FDA and other governmental authorities, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, results of operations, and financial condition. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of FDA or another governmental authority, could have a negative impact on us.
We are required to timely file various reports with FDA, including reports required by the medical device reporting regulations which require us to report to FDA when we receive or become aware of information that reasonably suggests that one of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur in the device or a similar device that we market, could cause or contribute to a death or serious injury. If we fail to comply with our reporting obligations, FDA or other governmental authorities could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance, seizure of our products, or delay in clearance of future products. FDA and certain foreign regulatory bodies have the authority to require the recall of commercialized products under certain circumstances.
A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, labeling or design deficiencies, packaging defects, or other deficiencies, or failures to comply with applicable regulations. If we do not adequately address problems associated with our devices, we may face additional regulatory requirements or enforcement action, including required new marketing authorizations, FDA warning letters, product seizure, injunctions, administrative penalties, or civil or criminal proceedings.
We may initiate voluntary withdrawals, removals, or corrections for our products in the future that we determine do not require notification of FDA because no material compliance issue or safety risk is involved. If FDA disagrees with our determinations, it could require us to report those actions and we may be subject to enforcement action. A future recall announcement or other corrective action could harm our financial results and reputation, potentially lead to product liability claims against us, require the dedication of our time and capital, and negatively affect our sales.
In addition, FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of our future products. For example, in November 2018, FDA announced that it plans to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates. It is unclear the extent to which any proposals, if adopted, could impose additional regulatory requirements on us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict our ability to maintain our current clearances.
We also cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative or executive action, either in the U.S. or abroad. For example, the Trump Administration previously enacted several executive actions that could impose significant burdens on, or otherwise materially delay, FDA’s ability to engage in routine regulatory and oversight activities. It is difficult to predict how these executive actions and executive actions that may be taken under the Biden Administration may affect FDA’s ability to exercise its regulatory authority. If these executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.
Changes in internet regulations could adversely affect our business.
Laws, rules, and regulations governing internet communications, advertising, and e-commerce are dynamic, and the extent of future government regulation is uncertain. Federal and state regulations govern various aspects of our online business, including intellectual property ownership and infringement, trade secrets, the distribution of electronic communications, marketing and advertising, user privacy and data security, search engines, and internet tracking technologies. Future taxation on the use of the internet or e-commerce transactions could also be imposed. Existing or future regulation or taxation could increase our operating expenses and expose us to significant liabilities.
Disruptions at the FDA, other agencies or notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved, or commercialized in a timely manner, or at all, which could negatively impact our business.
The ability of the FDA, other agencies and notified bodies to review and authorize or certify for marketing new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, agency’s or notified body’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the agency’s or notified body’s ability to perform routine functions. Average review times at the FDA and other agencies and notified bodies have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA, other agencies and notified bodies may also slow the time necessary for new medical devices or modifications to be reviewed and/or cleared, approved or certified by necessary agencies or notified bodies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, in recent years, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points in response to the global COVID-19 pandemic. If a prolonged government shutdown occurs, or if global health concerns, including pandemics, were to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
In the EU, notified bodies must be officially designated to certify products and services in accordance with the MDR, which regulates the development and sale of medical devices in Europe. While several notified bodies have been designated, the COVID-19 pandemic significantly slowed down their designation process and the current designated notified bodies are facing a large amount of requests with the new regulation, as a consequence of which review times have lengthened although a regulation amending the EU MDR was adopted in March 2023, extending existing transitional provisions to December 31, 2028. This situation could significantly impact the ability of notified bodies to timely review and process our regulatory submissions, which could have a material adverse effect on our business in the EU and EEA (which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland).
The misuse or off-label use of our BNA Platform may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies, particularly if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
Our BNA Platform is a Class II medical device cleared by FDA for commercialization in the U.S. pursuant to the 510(k) notification process for the post-hoc statistical analysis of the human electroencephalogram in December 2020 for use in individuals 12 to 85 years of age. We, thus, are not currently able to promote the BNA Platform for any other indications for use or make any promotional claims that are inconsistent with, or outside the scope of, such FDA clearance (often referred to as “off-label” claims). However, the assessment of whether a given claim is or is not consistent with a given FDA clearance or approval can often be subjective, and we cannot guarantee that FDA will always agree with our position regarding a particular claim or that all of our employees, representatives, and agents will abide by our marketing policies. If FDA determines that we have promoted any product without the requisite clearance or approval and/or for an off-label or unapproved use, it could take any number of enforcement actions against us, including (among others), issuing untitled or warning letters and/or pursuing an injunction, seizure, civil fine and/or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as laws prohibiting false claims for reimbursement, any of which would have a material adverse effect on our financial condition and/or business as a whole.
Additionally, we must have competent and reliable scientific evidence or, where applicable, other adequate substantiation for each reasonable interpretation of every promotional claim we make. In particular, comparative or superiority claims generally require adequate, well controlled, head-to-head clinical studies, comparing the product to the applicable competing products. To the extent we make any claims, or are otherwise held responsible for third-party claims about any product we may market in the United States, without the requisite clinical substantiation, we could be subject to enforcement action by FDA and/or the Federal Trade Commission (FTC), as well as a competitor challenge via the National Advertising Division (NAD) of the Better Business Bureau. Our plans to utilize social media as a primary promotional tool for our device(s) increases the applicable enforcement risk, as it makes it easier for our employees, affiliates, and any third parties with which we may have a relationship and/or arrangement under which we are deemed responsible for such party’s claims about our product(s) to disseminate promotional claims about our product(s) that may be inconsistent with applicable regulations governing device promotions. Further, consumers can bring private false-advertising lawsuits, including class actions, against us for any material misrepresentations and/or deceptive or unsubstantiated claims (among other similar causes of action) in our promotional materials or other advertising. Any of the foregoing could have a material adverse effect on our business.
We may be subject to certain federal, state, and foreign fraud and abuse laws, health information privacy and security laws, and transparency laws, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
There are numerous U.S. federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims, and physician transparency laws. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs. Our business practices and relationships with providers and patients are subject to scrutiny under these laws. We may also be subject to patient information privacy and security regulation by both the federal government and the states and foreign jurisdictions in which we conduct our business. The healthcare laws and regulations that may affect our ability to operate include:
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the federal healthcare Medicare and Medicaid Patient Protection Act of 1987 (the “Anti-Kickback Statute”), which prohibits, among other things, persons, and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arrange for or recommend a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid. The term “remuneration” has been broadly interpreted to include anything of value. The government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to violate. Moreover, the government may assert that a claim including items or services resulting from a violation of the federal healthcare Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration to those who prescribe, purchase, or recommend medical device products, including discounts, or engaging individuals as speakers, consultants, or advisors, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti- kickback liability. Moreover, there are no safe harbors for many common practices, such as reimbursement support programs, educational or research grants, or charitable donations; |
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the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment of federal government funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. Private individuals, commonly known as “whistleblowers,” can bring civil False Claims Act qui tam actions, on behalf of the government and such individuals and may share in amounts paid by the entity to the government in recovery or settlement. False Claims Act liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties for each false or fraudulent claim or statement. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the federal civil False Claims Act. Many pharmaceutical and medical device manufacturers have been investigated and have reached substantial settlements under the federal civil False Claims Act in connection with alleged off-label promotion of their products and allegedly providing free products to customers with the expectation that the customers would bill federal health care programs for the product. In addition, manufacturers can be held liable under the federal civil False Claims Act even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims. There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government; |
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Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the federal healthcare Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; |
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the federal Physician Payments Sunshine Act under the Affordable Care Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and applicable manufacturers and group purchasing organizations, as well as ownership and investment interests held by physicians and their immediate family members. Since January 2022, applicable manufacturers are also required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives; |
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HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations, which imposes privacy, security, and breach reporting obligations with respect to Protected Health Information (“PHI”), upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, and their respective business associates that perform services on their behalf that involve PHI. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make HIPAA compliance as well as civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; and |
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analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and local laws that require the licensure of sales representatives; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the EU, which adopted the General Data Protection Regulation, which became effective in May 2018); state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers. |
These laws and regulations, among other things, may constrain our business, marketing, and other promotional activities by limiting the kinds of financial arrangements, including sales programs, we may have with physicians or other potential purchasers of our products and consulting agreements we enter into with physicians. Further, while we do not submit claims and our future customers will make the ultimate decision on whether or how to submit any potential claims, we may provide reimbursement guidance and support regarding our products, to the extent reimbursement may be available, which could implicate these laws. Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws.
To enforce compliance with healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. For example, U.S. federal and state regulatory and enforcement agencies continue to actively investigate violations of healthcare laws and regulations, including pursuing novel theories of liability under these laws. These government agencies recently have increased regulatory scrutiny and enforcement activity with respect to manufacturer reimbursement support activities and patient support programs, including bringing criminal charges or civil enforcement actions under the federal healthcare Anti-Kickback statute, federal civil False Claims Act, the health care fraud statute, and HIPAA privacy provisions. Responding to investigations can be time and resource consuming and can divert management’s attention from the business. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity, and be costly to respond to.
If our operations are found to be in violation of any of the healthcare laws or regulations described above or any other healthcare regulations that may apply to us, we may be subject to administrative, civil and criminal penalties, damages, fines, disgorgement, substantial monetary penalties, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, additional reporting obligations, and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, reputational harm, and the curtailment or restructuring of our operations.
Since our BNA Platform will utilize cloud-based information systems and the exchange of information between patents and doctors, we will be subject to numerous U.S. federal and state laws and regulations related to the privacy and security of personally identifiable information, including health information.
Among other data-privacy and/or confidentiality laws to which we may be subject, HIPAA establishes privacy and security standards that limit the use and disclosure of PHI and require covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of individually identifiable health information in electronic form, among other requirements.
Violations of HIPAA may result in civil and criminal penalties. We must also comply with HIPAA’s breach notification rule which requires notification to affected individuals and the Secretary of Health and Human Services (“HHS”), and in certain cases to media outlets, in the case of a breach of unsecured PHI. The regulations also require business associates of covered entities to notify the covered entity of breaches by the business associate.
State attorneys general also have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information. In addition, HIPAA mandates that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance.
Many states also have laws that protect the privacy and security of sensitive and personal information, including health information. These laws may be similar to or even more protective than HIPAA and other federal privacy laws. For example, the laws of the State of California are more restrictive than HIPAA. Where state laws are more protective than HIPAA, we must comply with the state laws we are subject to, in addition to HIPAA. For example, California passed the California Consumer Privacy Act or CCPA on June 28, 2018, which went into effect January 1, 2020. On November 3, 2020, the California Privacy Rights Act of 2020 (“CPRA”), which amends the CCPA and adds new privacy protections that became effective on January 1, 2023, was enacted through a ballot initiative. While information we maintain that is covered by HIPAA may be exempt from the CCPA, other records and information we maintain related to patients or personnel may be subject to the CCPA. In certain cases, it may be necessary to modify our planned operations and procedures to comply with these more stringent state laws. Not only may some of these state laws impose fines and penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused. In addition, state and federal privacy laws subject to frequent change.
In addition to HIPAA and state health information privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain types of activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breach.
Foreign data protection, privacy, and other laws and regulations are often more restrictive than those in the U.S. The E.U., for example, traditionally has imposed stricter obligations under its laws and regulations relating to privacy, data protection and consumer protection than the U.S. In May 2018, the GDPR, governing data practices and privacy in the E.U., became effective and replaced the data protection laws of the individual member states. GDPR requires companies to meet stringent requirements regarding the handling of personal data of individuals in the E.U. These more stringent requirements include expanded disclosures to inform members about how we may use their personal data, increased controls on profiling members, and increased rights for members to access, control and delete their personal data. In addition, there are mandatory data breach notification requirements. The law also includes significant penalties for non-compliance, which may result in monetary penalties of up to 20 million Euros or 4% of a company’s worldwide turnover, whichever is higher. GDPR and other similar regulations require companies to give specific types of notice, and informed consent is required for the placement of a cookie or similar technologies on a user’s device for online tracking for behavioral advertising and other purposes and for direct electronic marketing. The GDPR also imposes additional conditions in order to satisfy such consent, such as a prohibition on pre-checked consents. It remains unclear how the U.K. data protection laws or regulations will develop in the medium to longer term and how data transfer to the U.K. from the E.U. will be regulated. Outside of the E.U., there are many other countries with data protection laws, and new countries are adopting data protection legislation with increasing frequency.
Many of these laws may require consent from individuals for the use of data for various purposes, including marketing, which may reduce our ability to market our products.
There is no harmonized approach to these laws and regulations globally. Consequently, we increase our risk of non-compliance with applicable foreign data protection laws and regulations when we expand internationally. We may need to change and limit the way we use personal information in operating our business and may have difficulty maintaining a single operating model that is compliant. Compliance with such laws and regulations will result in additional costs and may necessitate changes to our business practices and divergent operating models, limit the effectiveness of our marketing activities, adversely affect our business, results of operations, and financial condition, and subject us to additional liabilities.
Our business could be adversely affected by professional and legal challenges to our business model or by new state actions restricting our ability to provide our products and services in certain states.
Since the success of our business will be dependent on the widespread adaptation of our BNA Platform as a valid method for statistical analysis of EEG scans, neurologists across multiple geographies will be needed to use our BNA Platform and provide positive feedback and results. This will expose us to legal risk of patients or neurologists who may have a negative experience with our BNA Platform filing lawsuits claiming damages or other claims. Although we will seek insurance coverage for such legal actions, there is no assurance that the amount of coverage will be sufficient to cover these claims. In addition, such legal actions from consumers and neurologists may result in material and adverse effects on our ability to continue to conduct business due to negative press.
Security breaches, data breaches, cyber attacks, other cybersecurity incidents or the failure to comply with privacy, security and data protection laws could materially impact our operations, patient care could suffer, we could be liable for damages, and our business, operations and reputation could be harmed.
We expect to retain confidential customer personal and financial, patient health information and our own proprietary information and data essential to our business operations. We will rely upon the effective operation of our IT systems, and those of our service providers, vendors, and other third parties to safeguard the information and data. Additionally, our success may be dependent on the success of healthcare providers, many of whom are comprised of individual or small operations with limited IT experience and inadequate or untested security protocols, in managing data privacy and data security requirements. It is critical that the facilities, infrastructure and IT systems on which we depend to run our business and the products we develop remain secure and be perceived by the marketplace and our potential customers to be secure. Despite the implementation of security features in our products and security measures in our IT systems, we and our service providers, vendors, and other third parties may become subject to physical break-ins, computer viruses or other malicious code, unauthorized or fraudulent access, programming errors or other technical malfunctions, hacking or phishing attacks, malware, ransomware, employee error or malfeasance, cyber attacks, and other breaches of IT systems or similar disruptive actions, including by organized groups and nation-state actors. For example, we may experience cybersecurity incidents and unauthorized internal employee exfiltration of company information.
Further, the frequency of third-party cyber-attacks has increased over the last several years. The military conflict in Ukraine may cause nation-state actors or hackers sympathetic to either side of the conflict to carry out cyber-attacks to achieve their goals, which may include espionage, information gathering operations, monetary gain, ransomware, disruption, and destruction. Significant service disruptions, breaches in our infrastructure and IT systems or other cybersecurity incidents could expose us to litigation or regulatory investigations, impair our reputation and competitive position, be distracting to our management, and require significant time and resources to address. Affected parties or regulatory agencies could initiate legal or regulatory action against us, which could prevent us from resolving the issues quickly or force us to resolve them in unanticipated ways, cause us to incur significant expense and liability, or result in judicial or governmental orders forcing us to cease operations or modify our business practices in ways that could materially limit or restrict the products and services we provide. Concerns over our privacy practices could adversely affect others’ perception of us and deter potential customers, patients and partners from using our products. In addition, patient care could suffer, and we could be liable if our products or IT systems fail to deliver accurate and complete information in a timely manner. We have internal monitoring and detection systems as well as cybersecurity and other forms of insurance coverage related to a breach event covering expenses for notification, credit monitoring, investigation, crisis management, public relations and legal advice. However, damages and claims arising from such incidents may not be covered or may exceed the amount of any coverage and do not cover the time and effort we may incur investigating and responding to any incidents, which may be material. The costs to eliminate, mitigate or recover from security problems and cyber attacks and incidents could be material and depending on the nature and extent of the problem and the networks or products impacted, may result in network or systems interruptions, decreased product sales, or data loss that may have a material impact on our operations, net revenues and operating results.
Our business will expose us to potential liability for the quality and safety of our products and services, how we advertise and market those products and services and how and to whom we sell them, and we may incur substantial expenses or be found liable for substantial damages or penalties if we are subject to claims or litigation.
Our products and services involve an inherent risk of claims concerning their design, manufacture, safety and performance, how they are marketed and advertised in a complex framework of highly regulated domestic and international laws and regulations, how we package, bundle or sell them to potential customers, who may be private individuals or companies or public entities such as hospitals and clinics, and how we train and support doctors, their staffs and patients who administer or use our products. Moreover, consumer products and services are routinely subject to claims of false, deceptive or misleading advertising, consumer fraud and unfair business practices. Additionally, we may be held liable if any product we develop or manufacture or services we offer or perform causes injury or is otherwise found unhealthy. If our products are safe but they are promoted for off-label usage, we may be investigated, fined or have our products or services enjoined or approvals rescinded or we may be required to defend ourselves in litigation. Although we maintain insurance for product liability, business practices and other types of activities we make or offer, coverage may not be available on acceptable terms, if at all, and may be insufficient for actual liabilities. Any claim for product liability, sales, advertising and business practices, regardless of its merit or eventual outcome, could result in material legal defense costs and damage our reputation, increase our expenses and divert management’s attention.
Increased focus on current and anticipated environmental, social and governance (“ESG”) laws and increased scrutiny of our ESG policies and practices may materially increase our costs, expose us to potential liability, adversely impact our reputation, employee retention, willingness of potential customers and suppliers to do business with us and willingness of investors to invest in us.
Our operations are subject to a variety of existing local, regional and global ESG laws and regulations, and we will likely be required to comply with new, broader, more complex and more costly laws and regulations that focus on ESG matters. Our compliance obligations will likely span all aspects of our business and operations, including product design and development, materials sourcing and other procurement activities, product packaging, product safety, energy and natural resources usage, facilities design and utilization, recycling and collection, transportation, disposal activities and workers’ rights.
Environmental regulations related to greenhouse gases are expected to have an increasingly larger impact on our or our suppliers’ energy sources. Many U.S. and foreign regulators have enacted or are considering enacting new or additional disclosure requirements or limits on the emissions of greenhouse gases, including, but not limited to, carbon dioxide and methane, from power generation units using fossil fuels. The effects of greenhouse gas emission limits on power generation are subject to significant uncertainties, including the timing of any new requirements, levels of emissions reductions and the scope and types of emissions regulated. These limits may have the effect of increasing our costs and those of our suppliers and could result in manufacturing, transportation and supply chain disruptions and delays if clean energy alternatives are not readily available in adequate amounts when required. Moreover, alternative energy sources, coupled with reduced investments in traditional energy sources and infrastructure, may fail to provide the predictable, reliable, and consistent energy that we, our suppliers and other businesses need for operations.
Meeting our obligations under existing ESG laws, rules, or regulations is already costly to us and our suppliers, and we expect those costs to increase as new laws are enacted, possibly materially. Additionally, we expect regulators to perform investigations, inspections and periodically audit our compliance with these laws and regulations, and we cannot provide assurance that our efforts or operations will be compliant. If we fail to comply with any requirements, we could be subject to significant penalties or liabilities and we may be required to implement new and materially more costly processes and procedures to come into compliance. Further, these laws are subject to unpredictable changes. Even if we successfully comply with these laws and regulations, our suppliers may fail to comply. We may also suffer financial and reputational harm if future customers require, and we are unable to deliver, certification that our products are conflict free. In all of these situations, our future customers may stop purchasing products from us, and may take legal action against us, which could harm our reputation, revenues and results of operations.
Investor advocacy groups, institutional investors, investment funds, proxy advisory services, stockholders, and consumers are also increasingly focused on corporate ESG practices. Additionally, public interest and legislative pressure related to public companies’ ESG practices continues to grow. If our ESG practices fail to meet investors’ or other industry stakeholders’ evolving expectations and standards, including environmental stewardship, support for local communities, board of director and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate governance and transparency and employing ESG strategies in our operations, our brand, reputation and employee retention may be negatively impacted, potential customers and suppliers may be unwilling to do business with us and investors may be unwilling to invest in us. In addition, as we work to align our ESG practices with industry standards, we have expanded and will likely continue to expand our disclosures in these areas. We also expect to incur additional costs and require additional resources to monitor, report, and comply with our various ESG practices. If we fail to adopt ESG standards or practices as quickly as stakeholders desire, report on our ESG efforts or practices accurately, or satisfy the disclosure and other expectations of stakeholders, our reputation, business, financial performance, growth, and stock price may be adversely impacted.
We are subject to consumer protection laws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business, and changes in such regulations or laws could require us to modify our products, marketing or advertising efforts.
与我们的产品和服务的营销或广告相关，我们可能会成为与虚假、误导性、欺骗性或其他不合规的广告或营销行为相关的索赔的目标，包括根据联邦贸易委员会和各州消费者保护法。如果我们依赖第三方提供产品和服务的任何营销和广告，如果例如他们未能遵守适用的法律和监管要求，我们可能会因此承担责任，或者面临声誉损害。
如果我们被发现违反了任何消费者保护、广告、不正当竞争或其他法律法规，我们可能会面临执法措施，要求我们以可能对我们产生负面影响的方式改变我们的市场营销和业务实践。这还可能导致诉讼、罚款、处罚和不利的宣发，从而造成声誉损害和患者Trust的丧失，这可能对我们的业务产生不利影响。
与我们的知识产权相关的风险
我们的成功部分依赖于我们的专有科技，如果我们无法成功维护我们的知识产权，我们的竞争地位可能会受到损害。
我们的成功在一定程度上将依赖于我们维护现有知识产权的能力，以及在美国和其他国家获得和维护进一步的知识产权保护的能力。我们打算通过专利、商标、版权和商业秘密法律的结合，以及第三方保密和转让协议来保护我们的知识产权，包括我们的人工智能科技及相关算法。如果我们无法做到这一点，可能会损害我们的竞争地位。
我们依赖于在美国和其他国家已提交和待审的专利申请组合来保护我们大部分的知识产权和竞争地位；然而，我们目前待审或未来的专利申请可能不会导致专利的颁发。虽然我们通常会在打算制造、已经制造、使用或出售专利产品的国家申请专利，但我们可能无法准确预测所有最终需要专利保护的国家。如果我们未能及时申请专利，我们可能在以后无法再次申请。
专利权是地域性的，专利保护仅延伸至我们已颁发专利的国家。在全球所有国家和地区为我们的产品及未来产品申请、审查和维护专利将会耗费巨额费用，并且在美国以外的一些国家我们的知识产权可能不如美国广泛。许多国家对知识产权的保护程度不及美国或欧洲，并且它们的诉讼程序也不同。竞争对手可能成功挑战或规避我们的专利，或者在我们未申请专利保护的国家制造产品。美国或其他国家的专利法变更可能会削弱我们专利权的价值。由于这些和其他因素，我们的专利权的范围、有效性、可执行性以及商业价值都是不确定和不可预测的。
此外，器械公司专利的法律和事实问题非常复杂，因此，我们可能获得的任何专利权利的颁发、范围、有效性和可执行性都无法确定。虽然专利的颁发被假定为有效和可执行，但这并不意味着其有效性或可执行性有定论，且可能无法为我们提供足够的专有保护或在与类似产品的竞争对手中获得竞争优势。任何授予我们的专利可能会被质疑、失效、被认为不可执行、被规避，或者可能不够广泛，无法防止第三方生产设计上类似于我们产品的竞争产品。此外，外国专利提供的保护可能比美国专利和知识产权法下提供的更为有限。我们不能保证，任何我们的专利、授予我们的任何专利授权，或我们将来可能获得的任何专利将为我们提供竞争优势或保护我们免受其他人的侵权，或者这些专利不会被第三方（包括我们的竞争对手）成功挑战或规避。此外，我们也不能保证我们会有足够的资源来执法我们的专利。竞争对手也可能能够绕过我们的专利。其他方可能会开发并获得更有效的技术、设计或方法的专利保护。
Our ability to enforce our patent rights depends on our ability to detect infringement. It is difficult to detect infringers who do not advertise the components that are used in their products. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product, particularly in litigation in countries other than the U.S. that do not provide an extensive discovery procedure. Any litigation to enforce or defend our patent rights, if any, even if we were to prevail, could be costly and time-consuming and would divert the attention of our management and key personnel from our business operations. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded if we were to prevail may not be commercially meaningful.
Moreover, advances in AI technology may generate developments that existing IP laws do not adequately protect. The legislative and regulatory environment is out of our control, may change rapidly and unpredictably, and may negatively influence our revenue, costs, earnings, and growth. Some rules and regulations may be subject to litigation or other challenges that delay or modify their implementation and impact on us.
We also may seek to rely on protection of copyright, trade secrets, know how, and confidential and proprietary information. We generally enter into confidentiality and non-compete agreements with our employees, consultants, and collaborative partners upon their commencement of a relationship with us. However, these agreements may not provide meaningful protection against the unauthorized use or disclosure of our trade secrets or other confidential information, and adequate remedies may not exist if unauthorized use or disclosure were to occur. The exposure of our trade secrets and other proprietary information would impair our competitive advantages and could have a material adverse effect on our operating results, financial condition, and future growth prospects. In particular, a failure to protect our proprietary rights might allow competitors to copy our technology, which could adversely affect our pricing and market share. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, vendors, former employees and current employees. Further, other parties may independently develop substantially equivalent know-how and technology.
We currently own registered trademarks for our BNA Platform, and we intend to rely on both registered and common law rights for our trademarks in the future. There can be no assurance that our future trademark applications will be approved. Third parties may also oppose our trademark applications, or otherwise challenge our use of the trademarks. In the event that our trademarks are successfully challenged, we could be forced to rebrand our products and services, which could result in loss of brand recognition, and could require us to devote resources to advertising and marketing new brands. Further, there can be no assurance that competitors will not infringe our trademarks, or that we will have adequate resources to enforce our trademarks.
Litigation, interferences, oppositions, re-exams, inter partes reviews, post grant reviews, or other proceedings are, have been, and may in the future be necessary in some instances to determine the validity and scope of certain of our proprietary rights, and in other instances to determine the validity, scope, or non-infringement of certain proprietary rights claimed by third parties to be pertinent to the manufacture, use, or sale of our products or provision of our services. These types of proceedings are unpredictable and may be protracted, expensive, and distracting to management. The outcome of such proceedings could adversely affect the validity and scope of our patent or other proprietary rights, hinder our ability to manufacture and market our products and provide our services, require us to seek a license for the infringed product or technology, or result in the assessment of significant monetary damages. An unfavorable ruling could include monetary damages or, in cases where injunctive relief is sought, an injunction prohibiting us from selling our products or providing our services. Any of these results from litigation could adversely affect our business, financial condition, and results of operations.
Successful cybersecurity attacks, data breaches, unapproved use of machine learning or AI tools, or other security incidents could result in the loss of IP and key technological advantages. Security incidents could result in, for example, unauthorized access to, disclosure, modification, misuse, loss, or destruction of company, patient, or other third party data; theft or import of sensitive, regulated, or confidential data including personal information and IP, such as key innovations in AI; the loss of access to critical data or systems through ransomware; and business delays.
If we infringe or violate the patents or proprietary rights of other parties or are subject to an intellectual property infringement or misappropriation claim, our ability to grow our business may be severely limited.
Our commercial success also depends upon our ability, and the ability of any third party with which we may partner, to develop, manufacture, market and sell our products, if approved, and use our patent-protected technologies without infringing the patents of third parties. Extensive litigation over patents and other intellectual property rights is common in the medical device industry.
We may not have identified all patents, published applications or published literature that affect our business either by blocking our ability to commercialize our products, by preventing the patentability of one or more aspects of our products, or by covering the same or similar technologies that may affect our ability to market our products. For example, we may not have conducted a patent clearance search sufficient to identify potentially obstructing third party patent rights. Moreover, patent applications in the United States are maintained in confidence for up to 18 months after their filing. In some cases, however, patent applications remain confidential in the U.S. Patent and Trademark Office, or the USPTO, for the entire time prior to issuance as a U.S. patent. Patent applications filed in countries outside of the United States are not typically published until at least 18 months from their first filing date. Similarly, publication of discoveries in the scientific or patent literature often lags behind actual discoveries. We cannot be certain that we were the first to invent, or the first to file, patent applications covering our products. We also may not know if our competitors filed patent applications for technology covered by our pending applications or if we were the first to invent the technology that is the subject of our patent applications. Competitors may have filed patent applications or received patents and may obtain additional patents and proprietary rights that block or compete with our patents.
We may therefore in the future be the subject of patent or other litigation. From time to time, we may in the future receive letters from third parties drawing our attention to their patent rights. While we do not believe that we infringe upon any valid and enforceable rights that have been brought to our attention, and we take necessary steps to ensure that we do not infringe on the rights of others, there may be other more pertinent rights of which we are presently unaware. The defense and prosecution of intellectual property suits, interference proceedings, and related legal and administrative proceedings could result in substantial expense to us and significant diversion of effort by our technical and management personnel. An adverse determination of any litigation or interference proceeding to which we may become a party could subject us to significant liabilities. An adverse determination of this nature could also put our patents at risk of being invalidated or interpreted narrowly or require us to seek licenses from third parties. Licenses may not be available on commercially reasonable terms or at all, in which event, our business would be materially adversely affected. Intellectual property litigation or claims could force us to cease developing, selling or otherwise commercializing one or more of our products; to pay substantial damages for past use of the asserted intellectual property; and redesign, or rename in the case of trademark claims, our product(s) to avoid such third party rights, which may not be possible or which could be costly and time-consuming. Any of these risks coming to fruition could have a material adverse effect on our business, results of operations, financial condition and prospects.
Our failure to secure trademark registrations could adversely affect our ability to market our products and operate our business.
Any future trademark applications in the United States and any other jurisdictions where we may file may not be allowed registration, and we may not be able to maintain or enforce our registered trademarks. During trademark registration proceedings, we may receive rejections. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in corresponding foreign agencies, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our applications and/or registrations, and our applications and/or registrations may not survive such proceedings. Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our products and our business.
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
As is common in the medical device industry, we may employ individuals who were previously employed at other companies similar to ours, including our competitors or potential competitors. We may become subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the relevant patent agencies in several stages over the lifetime of the patents and /or applications. The relevant patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent application process. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which the failure to comply with the relevant requirements can result in the abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to use our technologies and know-how which could have a material adverse effect on our business, prospects, financial condition and results of operation.
Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our products are obtained, once the patent life has expired for a product, we may be open to competition from competitive products. Given the amount of time required for the development, testing and regulatory review of new products, patents protecting such products might expire before or shortly after such products are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
We may be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor or an author. For example, we may have inventorship or ownership disputes arise from conflicting obligations of consultants or others who are involved in developing our products. Litigation may be necessary to defend against these and other claims challenging inventorship or our ownership of our patents or other intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
We use AI in our business, and challenges with properly managing its use could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations.
We incorporate AI solutions into our BNA platform, services, and features, and these applications are important in our operations. Our competitors or other third parties may incorporate AI into their products more quickly or more successfully than us, which could impair our ability to compete effectively and adversely affect our results of operations.
Additionally, if the content, analyses, or recommendations that AI applications assist in producing are or are alleged to be deficient, inaccurate, or biased, our business, financial condition, and results of operations may be adversely affected. Our use of AI and machine learning is subject to risks related to flaws in our algorithms and datasets that may be insufficient or contain biased information. The development of AI technologies is complex, and there are several challenges associated with achieving the desired level of accuracy, efficiency, and reliability. The algorithms and models used in our AI systems may have limitations, including biases, errors, or inability to handle certain data types or scenarios. There is a risk of system failures, disruptions, or vulnerabilities that could compromise the integrity, security, or privacy of our platform. These failures could result in reputational damage, legal liabilities, or loss of user confidence, which could materially affect our business.
The use of AI applications has resulted in, and may in the future result in, cybersecurity incidents that implicate the personal data of patients and users of such applications. Any such cybersecurity incidents related to our use of AI applications could adversely affect our reputation and results of operations. AI also presents emerging ethical issues, and if our use of AI becomes controversial, we may experience brand or reputational harm, competitive harm, or legal liability. The rapid evolution of AI, including potential government regulation of AI, will require significant resources to develop, test and maintain our platform, services, and features to help us implement AI ethically in order to minimize unintended, harmful impact.
Legislative and governmental activity in the privacy area may result in new laws or regulations that are applicable to us and that may hinder our business, for example, by restricting use or sharing of patient data, limiting our ability to provide certain data to our customers, limiting our ability to develop or modify our AI systems, or otherwise regulating AI and machine learning, including the use of algorithms and automated processing in ways that could materially affect our business, or which may lead to significant increases in the cost of compliance.
General Risks Related To Us
We may not continue to meet the continued listing requirements of Nasdaq, which could result in a delisting of our common stock.
Our common stock is listed on Nasdaq. While we are currently in compliance, WaveDancer has been in the past been, and we may in the future be, unable to comply with certain of the listing standards that we are required to meet to maintain the listing of our common stock on Nasdaq. For instance, on August 8, 2024, WaveDancer received a letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC (the “Staff”) indicating that in the former WaveDancer’s Quarterly Report on Form 10-Q filed with the SEC on May 14, 2024, WaveDancer reported stockholders’ equity of $1,708,520 for the period ended March 31, 2024, which did not comply with Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Requirement”). Additionally, as previously reported, in a decision dated November 14, 2023, a Nasdaq Hearings Panel (the “Panel”) confirmed that we had regained compliance with the Minimum Stockholders’ Equity Requirement for a prior outstanding deficiency under the Minimum Stockholders’ Equity Requirement as related to the WaveDancer’s stockholders’ equity for the period ended March 31, 2023. In the decision, the Panel imposed a Mandatory Panel Monitor for a period of one year or until November 14, 2024, which would require the Staff to issue a Delist Determination Letter in the event that WaveDancer, prior to the consummation of the Merger, or we, following the consummation of the Merger, failed to maintain compliance with the Minimum Stockholders’ Equity Rule. On August 13, 2024, we received a notice from the Nasdaq Stock Market LLC indicating that following the Staff’s review of the Merger, the Staff determined that we now comply with the Minimum Stockholders’ Equity Requirement and that the matter is now closed.
While we have regained compliance with the continued listing requirements for Nasdaq, it cannot be assured that we will continue to do so. If Nasdaq delists our common stock from trading on its exchange for failure to meet the listing standards, an investor would likely find it significantly more difficult to dispose of or obtain our shares, and our ability raise future capital through the sale of our shares could be severely limited. Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development opportunities. Additionally, if we are unable to list on Nasdaq, it would likely be more difficult to trade in or obtain accurate quotations as to the market price of our common stock. If our securities are delisted from trading on Nasdaq, and we are not able to list its securities on another exchange or to have them quoted on Nasdaq, our securities could be quoted on the OTC Bulletin Board or on the “pink sheets.” As a result, we could face significant adverse consequences including:
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a limited availability of market quotations for its securities; |
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a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; |
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a limited amount of news and analyst coverage for us; and |
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a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3) or to obtain additional financing in the future. |
Our stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.
If we are unable to realize the full strategic and financial benefits currently anticipated from the Merger, our stockholders will have experienced substantial dilution of their ownership interests in their respective companies without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined organization is able to realize only part of the strategic and financial benefits currently anticipated from the merger. Furthermore, if we fail to realize the intended benefits of the Merger, the market price of our common stock could decline to the extent that the market price reflects those benefits.
The market price of our common stock may be subject to significant fluctuations and volatility, and the stockholders of the company may be unable to resell their shares at a profit and may incur losses.
Prior to the Merger, there has not been a public market for our common stock. The market price of our common stock could be subject to significant fluctuation. The previous business of WaveDancer differs from our business in important respects and, accordingly, our results of operations and the market price of our common stock following the Merger may be affected by factors different from those currently affecting the results of operations of WaveDancer. Market prices for securities of life sciences and medical technology companies in particular have historically been particularly volatile and have shown extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors, as well as general economic, political and market conditions such as recessions or interest rate changes, may seriously affect the market price of our common stock, regardless of our actual operating performance. Some of the factors that may cause the market price of our common stock to fluctuate include:
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investors reacting negatively to the effect of our business and prospects from the Merger; |
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the announcement of new products, new developments, services or technological innovations by us or our competitors; |
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actual or anticipated quarterly increases or decreases in revenue, gross margin or earnings, and changes in our business, operations or prospects; |
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announcements relating to strategic relationships, mergers, acquisitions, partnerships, collaborations, joint ventures, capital commitments, or other events by us or our competitors; |
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conditions or trends in the life sciences and medical technology industries; |
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changes in the economic performance or market valuations of other life sciences and medical technology companies; |
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general market conditions or domestic or international macroeconomic and geopolitical factors unrelated to our performance or financial condition; |
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sale of our common stock by stockholders, including executives and directors; |
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volatility and limitations in trading volumes of our common stock; |
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volatility in the market prices and trading volumes of the life sciences and medical technology stocks; |
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our ability to finance our business; |
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ability to secure resources and the necessary personnel to pursue our plans; |
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failure to meet external expectations or management guidance; |
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我们资本结构或分红政策的变化，未来证券的发行，股东大规模出售或分配普通股的情况； |
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我们的现金状况； |
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与融资活动相关的公告和事件，包括债务和股权证券； |
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分析师研报、推荐及推荐的变更、价格目标以及撤回覆盖； |
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关键人员的离职和增补; |
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与知识产权、专有权利和合同义务相关的争议和诉讼； |
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监管机构对我们或竞争对手运营的调查； |
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适用法律、规则、法规或会计惯例以及其他动态的变化；以及 |
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其他事件或因素，其中许多可能不在我们的控制之内。 |
在过去，经历整体市场和特定公司的证券价格波动后，通常会对这些公司提起证券集体诉讼。如果针对我们提起这种诉讼，可能会导致巨额成本以及我们管理层的注意力和资源的分散。任何此类诉讼中不利的裁决或支付以解决实际或威胁诉讼的任何金额，都可能要求我们支付大量款项。
我们目前利用适用于小型报告公司的减少披露和治理要求，这可能导致我们的普通股对投资者的吸引力降低。
我们的公开发行市值低于 $25000万，因此根据SEC的规定，我们符合小型报告公司的资格。作为小型报告公司，我们能够利用简化的披露要求，例如简化的高管薪酬披露以及减少的财务报表披露要求，来满足我们的SEC报告。由于我们作为小型报告公司的身份，在SEC报告中的披露减少可能会使投资者更难分析我们的运营结果和财务前景。我们无法预测如果我们依赖这些豁免，投资者是否会认为我们的普通股不再吸引人。如果一些投资者因此认为我们的普通股不再吸引人，可能会导致我们的普通股交易市场不活跃，并且我们的股票价格可能会更加波动。我们可以在不再是小型报告公司之前享受适用于小型报告公司的报告豁免，只有当我们公开发行市值超过 $25000万 时，这一身份才会终止。在这种情况下，如果我们的年收入低于 $10000万，且公开发行市值低于 $70000万，我们仍然可能是小型报告公司。
我们的章程规定，特拉华州衡平法院将是我们与股东之间几乎所有争议的唯一和排他性法院，这可能会限制我们的股东’ 获得有利的司法论坛来处理与我们或我们的董事、高管或员工的争议。
我们的章程规定，除非我们书面同意选择其他法院，特拉华州的衡平法庭是（i）代表公司提起的任何派生诉讼或程序的唯一和专属法院，（ii）对公司或公司股东的任何现任或前任董事、高级职员或股东所负有的信托责任违反的索赔的任何诉讼，（iii）根据《特拉华州公司法》或章程或内部章程的任何条款对公司、其现任或前任董事、高级职员或员工提出的索赔的任何诉讼，（iv）《特拉华州公司法》赋予特拉华州衡平法庭管辖权的任何诉讼，或（v）对公司、其董事、高级职员或员工提出的、受内部事务原则管辖的索赔的任何诉讼。该专属法院条款不适用于为执行《证券法》或《交易法》所产生的任何责任或义务而提起的诉讼，或任何其他联邦法院具有专属管辖权的索赔。在此范围内，任何此类索赔可能基于联邦法律索赔的情况下，《交易法》第27条对所有为执行《交易法》或其规则和条例所创建的任何责任或义务而提起的诉讼创建了专属联邦管辖权。此外，《证券法》第22条对所有为执行《证券法》或其规则和条例所创建的任何责任或义务而提起的诉讼创建了联邦和州法院的并存管辖权。
This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors, officers or employees. If a court were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
We may issue additional equity securities in the future, which may result in dilution to existing investors.
To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may, from time to time, sell additional equity securities in one or more transactions at prices and in a manner it determines. If we sell additional equity securities, existing stockholders may be materially diluted. In addition, new investors could gain rights superior to existing stockholders, such as liquidation and other preferences. In addition, the number of shares available for future grant under our equity compensation plans may be increased in the future. In addition, the exercise or conversion of outstanding options or warrants to purchase shares of capital stock may result in dilution to our stockholders upon any such exercise or conversion.
All of WaveDancer’s outstanding shares of common stock, and any shares of WaveDancer common stock that were issued in the Merger are, freely tradable without restrictions or further registration under the Securities Act, except for any shares held by our affiliates, as defined in Rule 144 under the Securities Act. Rule 144 defines an affiliate as a person who directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, us and would include persons such as our directors and executive officers and large stockholders. In turn, resales, or the perception by the market that a substantial number of resales could occur, could have the effect of depressing the market price of our common stock.
The concentration of the capital stock ownership with our insiders will likely limit the ability of our stockholders to influence corporate matters.
Following the Merger, our executive officers, directors, five percent or greater stockholders, and the respective affiliated entities beneficially own approximately 43% of our outstanding common stock. As a result, these stockholders, acting together, have control over matters that require approval by our stockholders, including the election of directors and approval of significant corporate transactions. Corporate actions might be taken even if other stockholders oppose them. This concentration of ownership might also have the effect of delaying or preventing a corporate transaction that other stockholders may view as beneficial.
Certain stockholders could attempt to influence changes, which could adversely affect our operations, financial condition and the value of our common stock.
Our stockholders may from time to time seek to acquire a controlling stake, engage in proxy solicitations, advance stockholder proposals or otherwise attempt to effect changes. Campaigns by stockholders to effect changes at publicly traded companies are sometimes led by investors seeking to increase short-term stockholder value through actions such as financial restructuring, increased debt, special dividends, stock repurchases or sales of assets or the entire company. Responding to proxy contests and other actions by activist stockholders can be costly and time-consuming and could disrupt our operations and divert the attention of the Board and senior management from our business and operations. These actions could adversely affect our operations, financial condition and the value of our common stock.
The sale or availability for sale of a substantial number of shares of common stock of could adversely affect the market price of such shares.
Sales of a substantial number of shares of common stock in the public market and other legal restrictions on resale, or the perception that these sales could occur, could adversely affect the market price of such shares and could materially impair our ability to raise capital through equity offerings in the future. As of November 11, 2024, we had approximately have outstanding approximately [ ] shares of common stock outstanding, without giving effect to the Reverse Stock Split, excluding securities underlying options and warrants, and based on the Exchange Ratio of 0.1040. This includes the shares being issued to our stockholders as merger consideration, which may be resold in the public market immediately without restriction. We are unable to predict what effect, if any, market sales of securities held by our significant stockholders, directors or officers or the availability of these securities for future sale will have on the market price of our common stock.
If securities analysts do not publish research or reports about our business, or if they publish negative evaluations, the price of our common stock could decline.
The trading market for our common stock will rely in part on the availability of research and reports that third-party industry or financial analysts publish about us. There are many large, publicly traded companies active in the life sciences and medical technology industries, which may mean it will be less likely that we receive widespread analyst coverage. Furthermore, if one or more of the analysts who do cover us downgrades our stock, our stock price would likely decline. If one or more of these analysts cease coverage of us, we could lose visibility in the market, which in turn could cause our stock price to decline. Additionally, if securities analysts publish negative evaluations of competitors in the life sciences and medical technology industries, the comparative effect could cause our stock price to decline.
Our management will be required to devote substantial time to comply with public company regulations.
As a public company, we will incur significant legal, accounting and other expenses we did not incur as a private company. The Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”), as well as rules implemented by the SEC and Nasdaq, impose various requirements on public companies, including those related to corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these requirements. Moreover, these rules and regulations will increase our legal and financial compliance costs relative to those of we incurred as a private company, and will make some activities more time consuming and costly.
The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting and disclosure controls and procedures. In particular, we must perform system and process evaluation and testing of its internal control over financial reporting to allow management and our independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act (“Section 404”). Our compliance with these requirements will require that we incur substantial accounting and related expenses and expend significant management efforts. We will likely need to hire additional accounting and financial staff to satisfy the ongoing requirements of Section 404. The costs of hiring such staff may be material and there can be no assurance that such staff will be immediately available to us. Moreover, if we are not able to comply with the requirements of Section 404, or if we or our independent registered public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, investors could lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.
We may not be able to timely and effectively implement controls and procedures required by Section 404 that are applicable to us as public company.
The standards required for a public company under Section 404 of the Sarbanes-Oxley Act are significantly more stringent than those required of a privately held company. Management may not be able to effectively and timely implement controls and procedures that adequately respond to the increased regulatory compliance and reporting requirements that will be applicable to us as a public company. If management is not able to implement the additional requirements of Section 404 in a timely manner or with adequate compliance, it may not be able to assess whether its internal control over financial reporting is effective, which may subject us to adverse regulatory consequences and could harm investor confidence and cause the market price of our common stock to decline.
We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on its financial condition, results of operations and stock price, which could cause you to lose some or all of your investment.
Although WaveDancer and Private Firefly had conducted due diligence on each other prior to the consummation of the Merger, there can be no assurances that their diligence revealed all material issues that may be present in our business, that all material issues through a customary amount of due diligence will be uncovered, or that factors outside of our control will not later arise. As a result, we may be forced to later write-down or write-off assets, restructure operations, or incur impairment or other charges that could result in losses. Even if due diligence successfully identifies certain risks, unexpected risks may arise, and previously known risks may materialize in a manner not consistent with each company’s preliminary risk analysis. Even though these charges may be non-cash items and may not have an immediate impact on liquidity, the fact that we report charges of this nature could contribute to negative market perceptions about us or our securities. In addition, charges of this nature may make future financing difficult to obtain on favorable terms or at all.
Anti-takeover provisions under Delaware corporate law may make it difficult for our stockholders to replace or remove our Board, and could deter or delay third parties from acquiring us, which may be beneficial to our stockholders.
We are subject to the anti-takeover provisions of Delaware law, including Section 203 of the DGCL. Under these provisions, which became effective upon the closing of the Merger, if anyone becomes an “interested stockholder,” we may not enter into a “business combination” with that person for three (3) years without special approval, which could discourage a third party from making a takeover offer and could delay or prevent a change of control. For purposes of Section 203 of the DGCL, “interested stockholder” means, generally, someone owning fifteen percent (15%) or more of our outstanding voting stock during the past three (3) years, subject to certain exceptions as described in Section 203 of the DGCL.
We do not anticipate that we will pay any cash dividends in the foreseeable future.
The current expectation is that we will retain our future earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, of our common stock will be your sole source of gain, if any, for the foreseeable future.
An active trading market for our common stock may not develop.
The listing of our common stock on Nasdaq does not assure that a meaningful, consistent and liquid trading market exists. An active trading market for shares of our common stock may never develop or be sustained. If an active market for our common stock does not develop, it may be difficult for investors to sell their shares either without depressing the market price for the shares or at all.
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截至2024年9月30日的三个月内，公司没有未登记的股票证券销售，除了在8-K表格的当前报告中之前报告的销售。
无。
不适用。
条目 6. 附件
请参阅此10-Q表格签名页后的“展品索引”，以获取与本季度报告10-Q表格一同提交或提供的展品列表。
展示的指数
| 附件 |
描述 |
|
| 3.1 |
Firefly Neuroscience, Inc.的修订和重述的公司章程（通过引用合并在此文中，参考公司在2024年8月12日提交给美国证券交易委员会的8-K表格的3.1附录）。 |
|
| 3.2 |
Firefly Neuroscience, Inc.的修订和重述的章程（通过引用合并在此文中，参考公司在2024年8月12日提交给美国证券交易委员会的8-K表格的3.2附录）。 |
|
| 4.1 |
C系列认股权证的表格（通过引用合并在此文中，参考公司在2024年9月27日提交给美国证券交易委员会的S-1表格的4.1附录）。 |
|
| 4.2 |
认股权证的表格（通过引用合并在此文中，参考公司在2024年7月29日提交给美国证券交易委员会的8-K表格的4.1附录）。 |
|
| 4.3 |
预付认股权证的表格（通过引用合并在此文中，参考公司在2024年7月29日提交给美国证券交易委员会的8-K表格的4.2附录）。 |
|
| 4.4 |
D系列认股权证的表格（通过引用合并在此文中，参考公司在2024年9月27日提交给美国证券交易委员会的S-1表格的4.4附录）。 |
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| 4.5 |
||
| 10.1# |
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| 10.2# |
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| 10.3# |
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| 10.4 |
||
| 10.5+ |
证券购买协议，日期为2024年7月26日，由公司及其签署投资者共同签署（参考2024年7月29日向SEC提交的公司8-K当前报告第10.1号附录）。 |
|
| 10.6# |
雇佣协议，日期为2024年8月19日，由萤火虫神经科学公司与大卫·约翰逊共同签署（参考2024年8月20日向SEC提交的公司8-K当前报告第10.1号附录）。 |
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| 31.1* |
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| 31.2* |
||
| 32.1** |
根据1934年证券交易法第13a-14(b)条或第15d-14(b)条和18 U.S.C. 第1350节的规定，首席执行官和首席金融及会计官认证书。 |
|
| 101.INS* |
内部XBRL实例文档。 |
|
| 101.SCH* |
内部XBRL分类扩展架构文档。 |
|
| 101.CAL* |
行内XBRL分类法扩展计算链接库文档。 |
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| 101.DEF* |
行内XBRL分类法扩展定义链接库文档。 |
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| 101.LAB* |
内联XBRL分类扩展标签链接库文档。 |
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| 101.PRE* |
行内XBRL分类法扩展展示链接库文档。 |
|
| 104* |
封面页面交互数据文件（格式为内嵌XBRL，包含在附件101中）。 |
| * |
随函提交。 |
| ** | 随附的家具。 |
| + |
根据《S-K规章》第601(a)(5)项的规定，本展示的某些附件或日程已被省略。公司同意在证监会要求时提供所有省略的附件和日程的副本。 |
| # |
管理合同或补偿计划或安排。 |
签名
根据1934年证券交易法的要求，注册人特此授权下述签署本报告。.
| 萤火虫神经科学公司。 |
||
| 日期：2024年11月14日 |
作者： |
/s/ 乔恩·奥尔森 |
| 乔恩·奥尔森 |
||
| 首席执行官 |
||
| (首席执行官) |
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| 作者： | /s/ 保罗·克日维基 | |
| 保罗·克日维基 | ||
| 首席财务官 | ||
| (信安金融和会计官) | ||