美国
证券交易委员会
华盛顿,特区。20549
表格
(马克 一)
根据1934年证券交易法第13或15(d)节提交的季度报告书 |
截至季度结束
或者
根据1934年证券交易法第13或15(d)节提交的过渡报告书 |
委员会文件号
(公司章程中指定的准确公司名称)
(州或其他司法管辖区 文件编号) | (国 税 号) | |
(组织)的注册地点 | (主要 执行人员之地址) |
(主要 执行人员之地址) | (邮政 编 码) |
根据交易所法规(17 CFR 240.14a-12)第14a-12规定的招股材料
根据法案第12(b)节注册的证券:
每一类别的名称 | 交易标志 | 在每个交易所注册的名称 | ||
这 |
请通过复选标记来指示注册者:(1)在过去的12个月内(或注册者被要求提交这些报告的更短时间内)是否已提交证券交易法案第13或15(d)条规定需要提交的所有报告;以及(2)注册者是否在过去90天内已受制于此类提交要求:
请用勾选标记指示,公司是否在过去的12个月内按照S-t规则405条的要求,递交了所有要求递交的互动数据文件(或者在公司被要求提交并发帖此类文件的更短时期内);
请通过勾选来指明注册者是大型加速报告人、加速报告人、非加速报告人、较小报告公司,还是新兴成长公司。有关“大型加速报告人”、“加速报告人”、“较小报告公司”和“新兴成长公司”的定义,请参见《交易所法》第120亿.2条。
大型加速文件提交人 | ☐ | 加速文件提交人 | ☐ |
☒ | 小型报告公司 | ||
新兴成长公司 |
如果是新兴成长型企业,请打勾,以表明注册人已选择不使用遵守《证券交易法》第13(a)条所规定的任何新的或修订后的财务会计准则的延长过渡期。 ☐
请在复选框中放置标记,指示注册者是否是外壳公司(根据交易所法案规则12b-2定义): 是 ☐ 否
标明公司每类普通股的流通情况,截至最近可行日期的流通情况:
普通股股份,$ 截至2024年11月6日,共有面值为。的普通股outstanding。
SINTX技术公司。
目录
第I部分。财务信息 | |
截至2024年3月31日和2023年12月31日的资产负债表(未经审计) | |
压缩的综合资产负债表(未经审计) | 3 |
简明合并利润表(未经审计) | 4 |
库藏股股东权益摘要财务报表(未经审计) | 6 |
压缩的现金流量表(未经审计) | 7 |
基本财务报表附注(未经审计) | 8 |
项目2. 管理层对财务状况和业绩的讨论与分析 | 20 |
项目3.有关市场风险的定量和定性披露 | 28 |
项目4.控制和程序 | 28 |
第二部分其他信息 | |
项目1.法律诉讼 | 29 |
项目1A.风险因素 | 29 |
项目2. 未注册的股权销售和款项使用 | 29 |
项目3. 面对高级证券的违约情况 | 29 |
项目4.矿山安全披露 | 29 |
项目5.其他信息 | 29 |
项目6.附件 | 30 |
签名 | 31 |
2 |
SINTX技术公司。
简明 合并资产负债表 - 未经审计
(以千为单位,除了每股股份和每股数据)
2024年9月30日 | 2023年12月31日 | |||||||
资产 | ||||||||
流动资产: | ||||||||
现金及现金等价物 | $ | $ | ||||||
应收账款及其他账户净额,减少坏账准备合计 | ||||||||
预付费用和其他流动资产 | ||||||||
存货 | ||||||||
其他流动资产 | ||||||||
总流动资产 | ||||||||
净存货 | ||||||||
房地产和设备,净额 | ||||||||
无形资产-净额 | ||||||||
经营租赁权资产 | ||||||||
其他长期资产 | ||||||||
总资产 | $ | $ | ||||||
负债和股东权益 | ||||||||
流动负债: | ||||||||
应付账款 | $ | $ | ||||||
应计负债 | ||||||||
债务 | ||||||||
衍生工具负债 | ||||||||
经营租赁负债流动部分 | ||||||||
其他流动负债 | ||||||||
流动负债合计 | ||||||||
经营租赁负债,减:流动部分 | ||||||||
总负债 | ||||||||
承诺和 contingencies | ||||||||
股东权益: | ||||||||
可转换优先股乙系列,$ | 票面价值, 授权的总股数包括所有系列的优先股; 和 截至2024年9月30日和2023年12月31日,发行和流通的股份分别为。||||||||
可转换优先股系列C,$ | 面值, 授权的总股数包括所有系列的优先股; 2024年9月30日和2023年12月31日,已发行和流通的股份。||||||||
可转换优先股系列D,$ | 面值, 总授权股份包括所有系列优先股; 截至2024年9月30日和2023年12月31日的已发行和流通股。||||||||
普通股,每股面值为 $0.0001; | 面值, 股份授权; 和 自2024年9月30日和2023年12月31日分别发行和流通的股份。||||||||
额外实收资本 | ||||||||
累积赤字 | ( | ) | ( | ) | ||||
股东权益总额 | ||||||||
负债和股东权益总额 | $ | $ |
截至2023年12月31日的压缩综合资产负债表是使用当天的审计综合资产负债表的信息编制的。
附注是这些简明合并财务报表的不可分割的一部分。
3 |
SINTX技术公司。
未经审计的汇总利润表
(以千为单位,除了每股股份和每股数据)
截至9月30日的三个月 | 截至9月30日的九个月 | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
产品营业收入 | $ | $ | $ | $ | ||||||||||||
授予和合同营业收入 | ||||||||||||||||
总营业收入 | ||||||||||||||||
营业成本 | ||||||||||||||||
Gross profit | ||||||||||||||||
营业费用: | ||||||||||||||||
研发 | ||||||||||||||||
总务和行政 | ||||||||||||||||
销售与市场营销 | ||||||||||||||||
装甲退出成本 | ||||||||||||||||
裁员 | ||||||||||||||||
拨款和合同费用 | ||||||||||||||||
总营业费用 | ||||||||||||||||
营运亏损 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
其他收入(支出): | ||||||||||||||||
利息支出 | ( | ) | ( | ) | ( | ) | ||||||||||
利息收入 | ||||||||||||||||
设备处置收益(损失) | ( | ) | ( | ) | ||||||||||||
衍生负债公允价值变动 | ||||||||||||||||
衍生负债的发行成本 | ( | ) | ( | ) | ||||||||||||
其他收入,净 | ||||||||||||||||
总其他收入(费用),净额 | ||||||||||||||||
税前净亏损 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
所得税费用准备 | ||||||||||||||||
净亏损 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
与可转换优先股相关的被视为股息 | ( | ) | ||||||||||||||
归属普通股东的净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
基本和稀释每股净亏损 | ||||||||||||||||
基本-净损失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
基本-转换优先股被视为股息 | ( | ) | ||||||||||||||
基本 - 归属于普通股东 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
摊薄 - 净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
摊薄 - 兑售优先股的被视为股息 | ( | ) | ||||||||||||||
摊薄 - 归属于普通股东 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
加权平均流通股数: | ||||||||||||||||
基本 | ||||||||||||||||
稀释 |
附注是这些简明合并财务报表的不可分割的一部分。
4 |
SINTX技术公司。
未经审计的股东权益的简明综合股东权益表
(以千为单位,除了每股股份和每股数据)
优先股 | 普通股 | 已缴 | 累计 | 合计 | ||||||||||||||||||||||||
股份 | 金额 | 股份 | 金额 | 资本 | 赤字 | 股东权益合计 | ||||||||||||||||||||||
截至2022年12月31日的余额 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
以股票为基础的报酬 | - | |||||||||||||||||||||||||||
普通股票发行以换取现金,减去现金费用 | - | |||||||||||||||||||||||||||
预资担保权证发行以换取现金,减去现金费用 | - | - | ||||||||||||||||||||||||||
债权清偿在权证行使时的衍生工具 | - | |||||||||||||||||||||||||||
通过行使预融资认股权出售普通股以换取现金 | - | |||||||||||||||||||||||||||
通过无需现金行使认股权发行普通股 | - | |||||||||||||||||||||||||||
优先股赎回 | ( | ) | - | ( | ) | ( | ) | |||||||||||||||||||||
发行代理认股权 | - | - | ||||||||||||||||||||||||||
合并发行股份以弥补倒挂后的股份 | - | |||||||||||||||||||||||||||
净亏损 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
截至2023年3月31日的余额 | ( | ) | ||||||||||||||||||||||||||
以股票为基础的报酬 | - | - | ||||||||||||||||||||||||||
行使认股权证后衍生负债的清偿 | - | - | ||||||||||||||||||||||||||
无息认股权证行使发行普通股 | - | |||||||||||||||||||||||||||
发行普通股以转换优先股 | ( | ) | ||||||||||||||||||||||||||
与优先股转换相关的被视为红利 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
与优先股转换相关的被视为红利 | - | - | ||||||||||||||||||||||||||
净亏损 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
截至2023年6月30日的余额 | ( | ) | ||||||||||||||||||||||||||
以股票为基础的报酬 | - | - | ||||||||||||||||||||||||||
净亏损 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
2023年9月30日的余额 | $ | $ | $ | $ | ( | ) | $ |
5 |
优先股 | 普通股 | 实缴 | 累计 | 总计 | ||||||||||||||||||||||||
分享 | 金额 | 股票 | 数量 | 资本 | 赤字 | 股票 | ||||||||||||||||||||||
截至2023年12月31日的余额 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
股份报酬 | - | - | ||||||||||||||||||||||||||
普通股票发行以换取现金,减去现金费用 | - | |||||||||||||||||||||||||||
预资担保权证发行以换取现金,减去现金费用 | - | - | ||||||||||||||||||||||||||
通过行使预融资认股权出售普通股以换取现金 | - | ( | ) | |||||||||||||||||||||||||
净亏损 | ( | ) | ( | ) | ||||||||||||||||||||||||
截至2024年3月31日的余额 | ( | ) | ||||||||||||||||||||||||||
基于股票的补偿 | - | |||||||||||||||||||||||||||
发行普通股以换取现金,减去现金费用 | - | |||||||||||||||||||||||||||
履行认股权债务的消灭 | - | |||||||||||||||||||||||||||
发行普通股以转换优先股 | ( | ) | ||||||||||||||||||||||||||
合并发行股份以弥补倒挂后的股份 | - | |||||||||||||||||||||||||||
净损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
截至2024年6月30日的余额 | ( | ) | ||||||||||||||||||||||||||
以股票为基础的补偿 | - | - | ||||||||||||||||||||||||||
发行普通股以换取现金,净现金费用 | - | |||||||||||||||||||||||||||
发行普通股以抵销优先股的转换 | ( | ) | ||||||||||||||||||||||||||
净损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
截至2024年9月30日的余额 | $ | $ | $ | $ | ( | ) | $ |
附注是这些精简合并财务报表的一部分。
6 |
SINTX技术公司。
现金流量表 - 未经审计的综合现金流量表
(以千为单位)
截至9月30日的九个月 | ||||||||
2024 | 2023 | |||||||
经营活动现金流 | ||||||||
净亏损 | $ | ( | ) | $ | ( | ) | ||
调整为净损失到经营活动现金流量净使用: | ||||||||
折旧费用 | ||||||||
装甲减值 | ||||||||
承租权资产摊销 | ||||||||
无形资产摊销 | ||||||||
基于股票的补偿 | ||||||||
衍生负债公允价值变动 | ( | ) | ( | ) | ||||
(设备)处置的损益 | ( | ) | ||||||
坏账费用 | ||||||||
运营资产和负债的变化: | ||||||||
应收账款 | ||||||||
预付费用及其他流动资产 | ( | ) | ||||||
存货 | ( | ) | ||||||
应付账款及应计负债 | ( | ) | ||||||
其他负债 | ( | ) | ( | ) | ||||
经营租赁负债的支付金额 | ( | ) | ( | ) | ||||
用于经营活动的净现金 | ( | ) | ( | ) | ||||
投资活动产生的现金流量 | ||||||||
购置固定资产等资产支出 | ( | ) | ( | ) | ||||
应收票据净收益,扣除隐含利息 | ||||||||
出售房产和设备的收益 | ||||||||
投资活动中使用的净现金 | ( | ) | ( | ) | ||||
筹资活动现金流量 | ||||||||
权证衍生工具负债的发行收入 | ||||||||
普通股和预先资金担保权证的发行收入,减去现金费用 | ||||||||
与行使权证相关的普通股发行收入 | ||||||||
偿还债务 | ( | ) | ( | ) | ||||
优先股E级的赎回 | ( | ) | ||||||
融资活动提供的净现金 | ||||||||
现金及现金等价物的净增加(减少) | ( | ) | ||||||
期初现金及现金等价物余额 | ||||||||
期末现金及现金等价物 | $ | $ | ||||||
非货币性投资和融资活动 | ||||||||
预付保险发行的债务 | $ | |||||||
修订后的租赁责任的使用权资产 | ( | ) | ||||||
分配给股权的代理权证发行成本 | ||||||||
行权权证后衍生责任减少 | ||||||||
新租赁负债的使用权资产 | ||||||||
无现金行使warrants时普通股的面值 | ||||||||
Prefunded warrants行使后普通股的面值 | ||||||||
补充现金流信息 | ||||||||
支付的利息现金 | $ | $ |
附注是这些精简合并财务报表的一部分。
7 |
SINTX 科技公司
简明合并财务报表附注
(未经审计)
1. 组织和重要会计政策总结。
基本报表中包括SINTX Technologies, Inc.(“SINTX”)及其全资子公司SINTX Armor, Inc.(“SINTX Armor”)和Technology Assessment and Transfer, Inc.(TA&T)等甲方的账目,这些公司集体称为“我们”或“本公司”。SINTX成立于1996年12月,是一家专注于为生物医药、技术和抗病原体等多个领域提供解决方案的爱文思控股公司。SINTX是一家随着时间发展而成长的公司,从专注于硅氮化物用于人类植骨植入物的研发,转变为从事多个不同领域的先进陶瓷公司。公司的核心实力在于制造、研发先进陶瓷,并针对外部合作伙伴。公司目前制造各种陶瓷和陶瓷复合材料,包括硅氮化物、碳化物、氧化锆和氧化铝的减法和加法形式。SINTX还在开发专有的粉末、化合物、树脂、和用于增材制造的丝材方面具备专业技能,以及在其盐湖城和马里兰工厂生产成品单个元件。SINTX盐湖城工厂已获FDA注册,符合cGMP和ANVISA RDC 665标准,同时具有ISO 9001:2015、ISO 13485:2016和ASD9100D认证。公司的产品主要在美国销售。
公司在历史上一直专注于在三个业务领域 - 抗病原体、技术和生物医药 - 开发营业收入机会,与现有和新客户、合作伙伴以及制造商联系,以帮助实现利用高科技陶瓷专业知识创造这些领域新的、创新机会的目标。
这个
公司最初的重点是开发和商业化由氮化硅制成的用于脊柱的产品
融合以及髋关节和膝关节置换术的应用。SINTX认为它是第一家也是唯一一家使用氮化硅的制造商
医疗应用主要集中在脊柱融合疗法上。从那时起,我们开发了其他医疗器械应用程序
用于我们的氮化硅技术,并利用我们在其他应用中使用陶瓷材料方面的专业知识。在七月
2021年,公司收购了该设备并获得了某些专有技术权利,目的是开发
使用碳化硼以及碳化硅和碳化硼的复合材料制造防护装甲并实现商业化
用于军事、执法和民用用途。自收购以来,装甲厂一直未全面投入运营,
公司产生的减值费用约为 $
流动性和资本资源
已编制的汇总简明基本报表假定公司将继续作为一个持续经营的实体,这意味着在正常业务过程中资产的实现和负债的结算,并不包括任何调整,以反映从这些汇总简明基本报表发行之日起一年内公司继续作为一个持续经营的实体所面临的不确定性可能对资产的可回收性和分类或负债的金额和分类带来的未来影响。
截至2024年9月30日和2023年9月30日的九个月期间,公司净亏损为$
截至目前,公司的运营主要依赖于优先股和普通股发行所获得的收益,以及在一定程度上来自产品销售所产生的现金。预计公司将继续产生运营亏损,并在运营中消耗现金。公司的持续经营能力取决于其增加销售、减少支出以及筹集额外资金的能力。公司能否及何时实现盈利和正现金流或获得额外融资尚不确定。
截至2023年2月10日,公司完成了一次公开发行
8 |
在
2024年2月2日,公司完成了一次公开发行,
2024年3月26日,公司完成了一个公开发行的
2024年4月5日,公司完成了一项公开发行的
在2021年2月25日,公司与Maxim Group LLC(“代理商”)签署了股权分销协议(“ATm协议”),代表销售代理商,根据协议的修订日期分别为2023年1月10日和2023年10月12日,公司可以提供和出售公司普通股,面值为$
2024年6月11日,公司收到了纳斯达克证券交易所(“纳斯达克”)正式通知,公司已证明符合了继续在纳斯达克资本市场上市的最低买盘价格要求,根据纳斯达克上市规则5550(a)(2)(“买盘价格规则”)。公司在2024年6月11日起的一年内仍然受到“强制小组监视员”的监管,该术语在上市规则5815(d)(4)(B)中有定义。如果在这一年期限内,公司连续30个营业日未能满足最低买盘价格门槛,纳斯达克将发布摘牌决定,而不会为公司提供恢复买盘价格规则合规性的宽限期。在这种情况下,公司将有机会请求新听证会来解决这一不足。
我们 正在积极寻求机会来筹集额外的股权和/或债务融资。然而,这种资金并没有得到保证,可能 无法以有利或可接受的条款提供给公司,并且可能涉及重大的限制性契约。如果公司能够获得额外的股权 融资,最有可能会对现有股东造成稀释。如果公司未能及时获得 额外的债务或股权融资,公司的影响将是重大而不利的。
董事会与管理层一起,正在对公司的业务策略和重点进行持续评估。 在2024年8月1日,董事会任命埃里克·奥尔森为首席执行官和总裁,负责领导评估过程。董事会还与Ascendiant Partners签署了参与协议,以评估战略交易,这些交易包括但不限于收购、战略合作伙伴关系、业务部门的出售以及反向合并机会。
一种正在评估的选项是将战略重点转向医疗设备板块的进步。SINTX历史上参与工业和生物医药应用,将优先开发和商业化创新的医疗设备,利用我们在爱文思控股陶瓷和生物材料方面的专业知识。这样的重拾关注将与通过创建旨在外科、骨科和其他专业医疗应用的产品来改善患者结果的承诺保持一致。我们将把资源集中在医疗板块内高速增长的领域,在这些领域中,我们的专有材料和技术,例如氮化硅,由于其独特的强度、耐久性和生物相容性,提供了明显的竞争优势。
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通过这一转型,SINTX的目标是为医疗社区带来意义深远的创新。我们当前的研发管线围绕医用器械展开,其中包括具有抗菌特性、增强成像能力和在生理条件下具有耐久性的器械,这对于骨科植入物、脊柱融合器械和其他手术工具至关重要。如果我们从工业应用转向,我们预计这一战略转变将使我们能够更好地服务医疗领域,满足关键未满足需求,并将SINTX定位为医疗器械市场的领先提供商。通过与医疗机构和行业领导者的合作伙伴关系和合作,SINTX将能够扩大在医疗器械领域的市场份额并通过可持续、高影响力的创新推动股东价值,然而,董事会尚未审批这种转型,也不能保证会获得这种批准或成功实现转型。
SINTX Technologies已经与位于犹他州盐湖城的Centerpointe位置的租赁持有者进行了讨论,以探讨减少公司整体租赁负担的期权。这一举措与我们更广泛的策略一致,旨在简化营业费用,并将资源重新分配到医疗器械行业的增长项目上。虽然这些讨论反映了我们对财务优化的承诺,但无法保证谈判会导致现有租赁负担的减少。这些讨论的结果仍然不确定,SINTX将继续评估其他措施,以管理与我们战略目标一致的长期义务。
在2024年8月8日,董事会批准了一项计划,以实施全公司范围内的裁员。这一决定是公司持续战略审查的一部分,旨在提高运营效率和降低成本。裁员将公司的员工人数从40减少到23。在截至2024年9月30日的三个月期间,公司记录了大约$
2024年8月12日,公司董事会批准了一项计划,停止使装甲工厂运营。这一决定旨在简化业务并专注于与公司长期战略目标一致的核心业务领域。自2021年7月收购装甲设备以来,装甲工厂从未完全投入运营,由于热烧炉故障,自2023年10月起完全关闭。与此决定相关,公司在2024年9月30日结束的三个月内承担了约$的减值损失
公司的保险承保方已经确定,烧结炉发生故障属于保障范围内,公司修复烧结炉的费用可获得报销。然而,公司全面修复受损炉子的努力仍在拖延。管理层将继续与保险公司合作,继续为修复炉子提供基金。当炉子完全修复后,管理层打算卖出该炉子和相关设备给第三方。然而,无法确保该炉子和相关设备的完全修复和销售。因此,在计算预计损耗费用的$
这些 不确定性对我们作为持续经营单位的能力提出了重大怀疑。浓缩的合并基本报表 不包括可能因这些不确定性结果而产生的任何调整。
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表述基础
这些 未经审计的合并财务报表是根据美国 证券交易委员会(“SEC”)的规则和规定编制的,包含公司的所有资产和负债。
SEC的规则和法规允许省略在按照美国通用会计准则("U.S. GAAP")编制的财务报表中通常包括的某些信息和脚注披露,只要这些报表不具有误导性。就管理层看来,这些财务报表和附注包含了为了公正地呈现本报表所反映的财务状况和业绩所必要的所有调整(包括正常往复调整)。这些简明的合并财务报表应当与公司于2024年3月27日向SEC提交的截至2023年12月31日年度报告表格10-k中包含的合并审计财务报表和相关注解一并阅读。截至2024年9月30日的九个月的运营成果未必能反映出截至2024年12月31日年度结算的运营成果。公司的重要会计政策在其截至2023年12月31日年度报告表格10-k中的合并财务报表的注解1中阐明。
反向 股票拆分
在2024年5月28日,公司进行了
使用估计值
遵循美国通用会计准则编制合并财务报表需要管理层做出估计和假设,这会影响到合并财务报表日期资产和负债的报告金额以及或有资产和负债的披露,以及在此期间营业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。截至2024年9月30日,最重要的估计涉及与普通股warrants相关的衍生负债。
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拨款和合同营业收入
营业收入 来自政府机构提供的补助、合同和奖励是根据具体协议的条款进行记录的,这些条款一般指出,当适用协议中指定的允许费用已发生或达成某一里程碑时,收入便已实现。来自联邦补助、合同和奖励的现金可能会受到授予方的审计,如果审计结果导致任何支出的不允许,则可能需要偿还。
尚未采纳的新会计准则
在2023年12月14日,财务会计标准委员会发布了会计标准更新,第2023-09号“所得税披露的改进”。(“ASU 2023-09”)。ASU 2023-09增强了企业在其所得税脚注中需要披露的细节,包括但不限于将税率调和分解为更具体的类别,例如州和地方所得税以及外国税。同时,企业必须分解出占其州和地方以及外国辖区超过或等于的特定辖区
公司已审核所有其他最近发布但尚未采纳的会计准则,以判断其对运营结果、财务状况或现金流的影响(如果有)。基于该审核,公司相信没有其他公告会对其基本报表产生重大影响。
基本每股净收益(亏损)是通过将净收入(亏损)除以权重平均流通普通股数量来计算的,不考虑普通股等价物。每股摊薄净亏损是通过将净亏损除以权重平均流通普通股等价物数量来计算的,这些等价物被确定为具有稀释性。普通股等价物主要由优先股和购买普通股的认股权证组成。公司存在潜在稀释性的证券没有包含在全摊薄每股亏损的计算中,因为它们将会产生反稀释作用,合计约 千股和千股共同股票发行计划下未来可发行的股票。 千美元,分别截至2024年和2023年的9月30日。
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基本 计算法 | 发生影响的 Dilutive | 摊薄 计算法 | ||||||||||
分子: | ||||||||||||
净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
分母: | ||||||||||||
用于每普通股计算的股份数量: | ||||||||||||
每股普通股净亏损: | ||||||||||||
净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) |
以下是截至2024年9月30日的九个月的基本和稀释每股亏损数据,单位为千元,除了每股和每股数据外:
基本 计算法 | 发生影响的 Dilutive | 摊薄 计算法 | ||||||||||
分子: | ||||||||||||
净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
分母: | ||||||||||||
每股计算中使用的股份数量: | ||||||||||||
每股普通股净亏损: | ||||||||||||
净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) |
以下是截至2023年9月30日的三个月基本和稀释每股亏损数据,单位为千元,除每股和每股数据外:
发生影响的 | ||||||||||||
Dilutive | ||||||||||||
基本 | 权证 | 摊薄 | ||||||||||
计算 | 证券 | 计算 | ||||||||||
分子: | ||||||||||||
净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
视作股息和折价的增值 | ||||||||||||
归属于普通股股东的净损失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
分母: | ||||||||||||
每普通股计算所用的股份数量: | ||||||||||||
每股普通股净亏损: | ||||||||||||
净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
被视为股利和贴现的增长 | ||||||||||||
归属于普通股股东的净损失 | $ | ( | ) | $ | ( | ) | $ | ( | ) |
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以下是2023年9月30日结束的九个月的基本和稀释每股亏损数据,除份额和每股数据外,其他数值均以千为单位。
发生影响的 | ||||||||||||
Dilutive | ||||||||||||
基本 | 权证 | 摊薄 | ||||||||||
计算 | 证券 | 计算 | ||||||||||
分子: | ||||||||||||
净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
被视为股利和折价的增值 | ( | ) | ( | ) | ||||||||
归属于普通股股东的净损失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
分母: | ||||||||||||
每普通股计算中使用的股份数量: | ||||||||||||
每股普通股净亏损: | ||||||||||||
净亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
被视为股息并折现率的增加 | ( | ) | ( | ) | ||||||||
归属于普通股股东的净损失 | $ | ( | ) | $ | ( | ) | $ | ( | ) |
3. Inventories
Inventories consisted of the following (in thousands):
2024年9月30日 | 2023年12月31日 | |||||||
原材料 | $ | $ | ||||||
WIP | ||||||||
成品 | ||||||||
$ | $ |
截至2024年9月30日,存货总额约为$
4. 公允价值衡量
金融 按公允价值定期计量和记录的金融工具
公司已发行某些认股权证以购买普通股,这些权证被视为衍生负债,因为它们具有某些权利,可能需要现金结算,并根据会计指引在每个报告期重新计量公允价值。公允价值基于在计量日市场参与者之间的有序交易中,出售资产或转移负债所收到的价格或支付的金额,依据三层公允价值层级,优先考虑在测量公允价值时使用的输入如下:
第1层 - | 报价 在活跃市场中相同资产或负债的市场价格。 | |
2级 - | 可观察 根据未在活跃市场上报价但由市场数据证实的输入所定价。 | |
3级 - | 不可观察 反映管理层假设的输入,符合其他市场参与者所做的合理假设。 这些估值需要重大判断。 |
公司将以公允价值计量的资产和负债根据对其公允价值计量具有重要意义的最低输入水平进行分类。截至2024年9月30日和2023年12月31日,没有财务资产或负债(除了上述解释的衍生负债)按定期基准进行计量。下表列出了截至2024年9月30日和2023年12月31日,按公允价值层级以定期基准计量的财务负债(以千为单位):
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2024年9月30日的公允价值衡量 | ||||||||||||||||
描述 | 一级 | 二级 | 三级 | 总计 | ||||||||||||
衍生负债 | ||||||||||||||||
普通股认股权证 | $ | $ | $ | $ |
2023年12月31日的公允价值衡量 | ||||||||||||||||
描述 | 一级 | 二级 | 三级 | 总计 | ||||||||||||
衍生负债 | ||||||||||||||||
普通股认股权证 | $ | $ | $ | $ |
公司在截至2024年9月30日和2023年9月30日的九个月内,未在公允价值衡量层次的1级和2级之间进行任何资产和负债的转移。下表展示了在截至2024年9月30日和2023年9月30日的九个月内,使用重要无法观察输入(3级)对衍生性负债进行定期公允价值衡量的调整(以千为单位):
普通股 认股权证 | ||||
截至2022年12月31日的余额 | $ | |||
衍生品的发行 | ||||
执行期权 | ( | ) | ||
公允价值变动 | ( | ) | ||
其他 | ( | ) | ||
截至2023年9月30日的余额 | $ | |||
截至2023年12月31日的余额 | $ | |||
衍生品的发行 | ||||
执行期权 | ( | ) | ||
公允价值变动 | ( | ) | ||
其他 | ||||
截至2024年9月30日的余额 | $ |
普通股票认股权
公司已发行某些认购普通股的权证,这些权证被视为衍生负债,因为它们具有登记条款,可能需要现金结算,并依据会计准则,在每个报告期间重新计量为公允价值。截至2024年9月30日和2023年12月31日,衍生负债使用蒙特卡洛模拟估值计算。
在估算截至2024年9月30日和2023年12月31日期间使用蒙特卡洛模拟估值模型估算普通股权责任时所采用的假设如下:
2024年9月30日 | 2023年12月31日 | |||||||
加权平均 无风险利率 | % | % | ||||||
加权平均 预期寿命(以年为单位) | ||||||||
预期 股息率 | % | % | ||||||
加权平均 预期波动率 | % | % |
其他 金融工具
公司记录的现金及现金等价物、账户及其他应收款、应付账款和应计费用的价值大致符合其短期性质的公允价值。应付票据的账面价值大致等于公允价值,因为利率接近市场利率期货。
5. 应计负债
应计 负债包括以下内容(以千为单位):
2024年9月30日 | 2023年12月31日 | |||||||
工资和相关费用 | $ | $ | ||||||
应计应付款 | ||||||||
其他 | ||||||||
$ | $ |
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6. Debt
业务 贷款
在2021年7月20日,长益与金额约为$的贷款授权和协议达成("业务贷款")。
关联方债务
长益应该在SINTX收购TA&T之前偿还TA&T创始人向TA&T提供的某些个人贷款(“个人贷款”)。2022年6月30日,个人贷款的总金额约为$
保险 保费融资安排
在2024年3月,为了获取董事和高级职员专业责任保险,公司进入了一项保费融资安排,将保费支付延长至10个月。公司总共支付了$
在2024年6月,为了获取商业责任保险,公司签订了一个保费融资安排,将保费支付期延长至10个月。公司支付了总计$
7. 股权
2024 四月注册发行
在2024年4月5日,公司完成了一次公开发行
2024年 三月注册发行
2024年3月26日,公司完成了一次公开发行
16 |
2024 二月注册发行
开启
2024 年 2 月 2 日,“公司完成了公开发行
2023 注册发行
截至2023年2月10日,公司完成了一次公开发行
2021 股权分配协议
2021年2月25日,公司与Maxim Group LLC(以下简称“Maxim”)签订了股权分销协议(经修订的“2021分销协议”),根据该协议,公司可以不时出售公司普通股的股份,总发行价高达$
17 |
September 30, 2024 | ||||||||||||||||
Weighted- Average | Weighted- Average Remaining Contractual | Intrinsic | ||||||||||||||
Options | Exercise Price | Life (Years) | Value | |||||||||||||
As of December 31, 2023 | $ | $ | ||||||||||||||
Granted | - | - | ||||||||||||||
Exercised | - | - | ||||||||||||||
Forfeited | ( | ) | - | - | ||||||||||||
Expired | ( | ) | - | - | ||||||||||||
As of September 30, 2024 | $ | $ | ||||||||||||||
Exercisable at September 30, 2024 | $ | $ | ||||||||||||||
Vested and expected to vest at September 30, 2024 | $ | $ |
September 30, 2023 | ||||||||||||||||
Weighted- Average | Weighted- Average Remaining Contractual | Intrinsic | ||||||||||||||
Options | Exercise Price | Life (Years) | Value | |||||||||||||
As of December 31, 2022 | $ | $ | ||||||||||||||
Granted | - | - | ||||||||||||||
Exercised | - | - | ||||||||||||||
Forfeited | - | - | ||||||||||||||
Expired | - | - | ||||||||||||||
As of September 30, 2023 | $ | $ | ||||||||||||||
Exercisable at September 30, 2023 | $ | $ | ||||||||||||||
Vested and expected to vest at September 30, 2023 | $ | $ |
The Company estimates the fair value of each stock option on the grant date using the Black-Scholes-Merton valuation model, which requires several estimates including an estimate of the fair value of the underlying common stock on grant date. The expected volatility was based on an average of the historical volatility of the Company. The expected term was contractual life of option. The risk-free interest rate was based on the U.S. Treasury yield curve in effect at the time of grant for the expected term of the option. The Company did not grant any stock options during the third quarter of 2024.
Of the options outstanding as of September 30, 2024, were awarded to non-executive members of the board of directors.
Unrecognized stock-based compensation as of September 30, 2024, is as follows (in thousands):
Weighted Average | ||||||||
Unrecognized Stock-Based | Remaining of Recognition | |||||||
Compensation | (in years) | |||||||
Stock options | $ | |||||||
Stock grants | $ |
9. Commitments and Contingencies
The Company has executed agreements with certain executive officers of the Company which, upon the occurrence of certain events related to a change in control, call for payments to the executives up to three times their annual salary and accelerated vesting of previously granted stock options.
From time to time, the Company is subject to various claims and legal proceedings covering matters that arise in the ordinary course of its business activities. Management believes any liability that may ultimately result from the resolution of these matters will not have a material adverse effect on the Company’s consolidated financial position, operating results or cash flows.
18 |
10. Leases
The Company has entered into multiple operating leases from which it conducts its business.
SINTX
With
respect to SINTX operations, the Company leases
SINTX Armor
On
August 19, 2021, the Company, on behalf of SINTX Armor, entered into an Industrial Lease Agreement (the “SINTX Armor Lease”)
pursuant to which the Company has agreed to lease approximately
TA&T
In
connection with operation of its business, TA&T has entered into various leases for approximately
Leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense is recognized on a straight-line basis over the term of the lease. The Company accounts for lease components separately from the non-lease components. The depreciable life of the assets and leasehold improvements are limited by the expected lease term.
As
of September 30, 2024, the operating lease right-of-use assets totaled approximately $
Operating lease future minimum payments together with the present values as of September 30, 2024, are summarized as follows:
Years Ending December 31, | September 30, 2024 | |||
2024 | $ | |||
2025 | ||||
2026 | ||||
2027 | ||||
2028 | ||||
Thereafter | ||||
Total future minimum lease payments | ||||
Less amounts representing interest | ( | ) | ||
Present value of lease liability | ||||
Current-portion of operating lease liability | ||||
Long-term portion operating lease liability | $ |
11. Subsequent Events
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements for the year ended December 31, 2023 and the notes thereto, along with Management’s Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed separately with the U.S. Securities and Exchange Commission. This discussion and analysis contains forward-looking statements based upon current beliefs, plans, expectations, intentions and projections that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2023, and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q and in other filings with the Securities and Exchange Commission we may make from time-to-time.
Overview
SINTX Technologies is an advanced ceramics company formed in December 1996, focused on providing solutions in a variety of biomedical, technical, and antipathogenic applications. We have grown from focusing primarily on the research, development and commercialization of medical devices manufactured with silicon nitride to becoming an advanced ceramics company engaged in diverse fields, including biomedical, technical and antipathogenic applications. This diversification enables us to focus on our core competencies which are the manufacturing, research, and development of products comprised from advanced ceramic materials for external partners. We seek to connect with new customers, partners and manufacturers to help them realize the goal of leveraging our expertise in advanced ceramics to create new, innovative products across these sectors.
SINTX Core Business
Biomedical Applications: Since its inception, SINTX has been focused on medical grade silicon nitride. SINTX biomedical products have been shown to be biocompatible, bioactive, antipathogenic, and to have superb bone affinity. Spinal implants made from SINTX silicon nitride have been successfully implanted in humans since 2008 in the US, Europe, Brazil, and Taiwan. This established use, along with its inherent resistance to bacterial adhesion and bone affinity suggests that it may also be suitable in other fusion device applications such as arthroplasty implants, foot wedges, and dental implants. Bacterial infection of any biomaterial implants is always a concern. SINTX silicon nitride has been shown to be resistant to bacterial colonization and biofilm formation, making it antibacterial. SINTX silicon nitride products can be polished to a smooth and wear-resistant surface for articulating applications, such as bearings for hip and knee replacements.
We believe that silicon nitride has a superb combination of properties that make it suited for long-term human implantation. Other biomaterials are based on bone grafts, metal alloys, and polymers- all of which have well-known practical limitations and disadvantages. In contrast, silicon nitride has a legacy of success in the most demanding and extreme industrial environments. As a human implant material, silicon nitride offers bone ingrowth, resistance to bacterial and viral infection, ease of diagnostic imaging, resistance to corrosion, and superior strength and fracture resistance, all of which claims are validated in our large and growing inventory of peer-reviewed, published literature reports. We believe that our versatile silicon nitride manufacturing expertise positions us favorably to introduce new and innovative devices in the medical and non-medical fields.
In June 2022, we acquired Technology Assessment and Transfer, Inc. (TA&T), a nearly 40-year-old business with a mission to transition advanced materials and process technologies from a laboratory environment to commercial products and services. TA&T has supplied ceramics for use in several biomedical applications. These products were made via 3D printing and include components for surgical instruments as well as conceptual and prototype dental implants.
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Technical Applications: It is our belief that our silicon nitride has the best combination of mechanical, thermal, and electrical properties of any technical ceramic material. It is a high-performance technical ceramic with high strength, toughness, and hardness, and is extremely resistant to thermal shock and impact. It is also an electrically insulating ceramic material. Typically, it is used in applications where high load-bearing capacity, thermal stability, and wear resistance are required. We have obtained AS9100D certification and ITAR registration to facilitate entry into the aerospace and protective armor markets.
TA&T’s primary area of expertise is material processing and fabrication know-how for a broad spectrum of monolithic ceramic, ceramic composite, and coating materials. Primary technologies include Additive Manufacturing (3D Printing) of ceramics and metals, low-cost fabrication of fiber reinforced ceramic matrix composites (CMCs) and refractory chemical vapor deposited (CVD) coatings, transparent ceramics for ballistic armor and optical applications, and magnetron sputtered (PVD) coatings for lubrication, wear resistance and environmental barrier coatings for CMCs. TA&T also provides a host of services that include 3D printing, PVD-CVD coatings, material processing-CMCs, CIP, PS, HP, HIP, and material characterization for powders and finished parts-TGA/DSC, PSD. SA, Dilatometry, UV-VIS and FTIR transmission, haze and clarity.
Antipathogenic Applications: Today, there is a global need to improve protection against pathogens in everyday life. SINTX believes that by incorporating its unique composition of silicon nitride antipathogenic powder into products such as face masks, filters, and wound care devices, it is possible to manufacture surfaces that inactivate pathogens, thereby limiting the spread of infection and disease. The discovery in 2020 that SINTX silicon nitride inactivates SARS-CoV-2, the virus which causes the disease COVID-19, has opened new markets and applications for our material.
We presently manufacture advanced ceramic powders and components in our manufacturing facilities based in Salt Lake City, Utah and Millersville, Maryland.
Components of our Results of Operations
We manage our business within one reportable segment, which is consistent with how our management reviews our business, makes investment and resource allocation decisions and assesses operating performance.
Revenue
Our product revenue is derived from the manufacture and sale of products. These revenue sources include coatings, materials, and components for aerospace and medical device markets, toll processing services, and government contracts and grants. We generally recognize revenue from sales where control transfers at a point in time as the title and risk of loss passes to the customer, which is at the time the product is shipped. In general, our customer does not have rights of return or exchange.
We derive grant and contract revenue from awards provided by governmental agencies. The goal of these grants and contracts is ultimately to develop revenue producing products.
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Cost of Revenue
The expenses that are included in cost of revenue include all in-house manufacturing costs for the products we manufacture.
Gross Profit
Our gross profit measures our product revenue relative to our cost of revenue.
Research and Development Expenses
Our research and development costs are expensed as incurred. Research and development costs consist of engineering, product development, clinical trials, test-part manufacturing, testing, developing and validating the manufacturing process, manufacturing, facility and regulatory-related costs. Research and development expenses also include employee compensation, employee and non-employee stock-based compensation, supplies and materials, consultant services, and travel and facilities expenses related to research and development activities.
We expect to incur additional research and development costs as we continue to develop new medical devices, industrial and ceramic armor products, product candidates for antipathogenic applications, and other products which may increase our total research and development expenses.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation for certain members of our executive team and other personnel employed in finance, compliance, administrative, information technology, customer service, executive and human resource departments. General and administrative expenses also include other expenses not part of the other cost categories mentioned above, including facility expenses and professional fees for accounting and legal services.
RESULTS OF OPERATIONS
The following is a tabular presentation of our unaudited condensed consolidated operating results for the three and nine months ended September 30, 2024 and 2023 (in thousands):
Three Months Ended September 30, | $ | % | Nine Months Ended September 30, | $ | % | |||||||||||||||||||||||||||
2024 | 2023 | Change | Change | 2024 | 2023 | Change | Change | |||||||||||||||||||||||||
Product revenue | $ | 367 | $ | 168 | $ | 199 | 118 | % | $ | 1,054 | $ | 643 | $ | 411 | 64 | % | ||||||||||||||||
Grant and contract revenue | 432 | 510 | (78 | ) | -15 | % | 1,291 | 1,082 | 209 | 19 | % | |||||||||||||||||||||
Total revenue | 799 | 678 | 121 | 18 | % | 2,345 | 1,725 | 620 | 36 | % | ||||||||||||||||||||||
Cost of revenue | 210 | 117 | 93 | 79 | % | 657 | 339 | 318 | 94 | % | ||||||||||||||||||||||
Gross profit | 589 | 561 | 28 | 5 | % | 1,688 | 1,386 | 302 | 22 | % | ||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||
Research and development | 796 | 2,525 | (1,729 | ) | -68 | % | 4,492 | 6,889 | (2,397 | ) | -35 | % | ||||||||||||||||||||
General and administrative | 802 | 990 | (188 | ) | -19 | % | 2,997 | 3,313 | (316 | ) | -10 | % | ||||||||||||||||||||
Sales and marketing | 87 | 259 | (172 | ) | -66 | % | 589 | 877 | (288 | ) | -33 | % | ||||||||||||||||||||
Armor exit costs | 4,457 | - | 4,457 | 100 | % | 4,457 | - | 4,457 | 100 | % | ||||||||||||||||||||||
Reduction in force | 407 | - | 407 | 100 | % | 407 | - | 407 | 100 | % | ||||||||||||||||||||||
Grant and contract expenses | 448 | 401 | 47 | 12 | % | 1,061 | 942 | 119 | 13 | % | ||||||||||||||||||||||
Total operating expenses | 6,997 | 4,175 | 2,822 | 68 | % | 14,003 | 12,021 | 1,982 | 16 | % | ||||||||||||||||||||||
Loss from operations | (6,408 | ) | (3,614 | ) | (2,794 | ) | 77 | % | (12,315 | ) | (10,635 | ) | (1,680 | 16 | % | |||||||||||||||||
Other income (expense) | 169 | 424 | (255 | ) | -60 | % | 2,986 | 4,697 | (1,711 | ) | -36 | % | ||||||||||||||||||||
Net loss before taxes | (6,239 | ) | (3,190 | ) | (3,049 | ) | 96 | % | (9,329 | ) | (5,938 | ) | (3,391 | ) | 57 | % | ||||||||||||||||
Provision for income taxes | - | - | - | - | - | - | ||||||||||||||||||||||||||
Net loss | $ | (6,239 | ) | $ | (3,190 | ) | $ | (3,049 | ) | 96 | % | $ | (9,329 | ) | $ | (5,938 | ) | $ | (3,391 | ) | 57 | % |
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Revenue
For the three months ended September 30, 2024, and 2023 total product revenue increased $0.2 million, or 118% as compared to the same period in 2023. During the quarter ended September 30, 2024, grant and contract revenue decreased $0.1 million or -15% as compared to the same period in 2023.
For the nine months ended September 30, 2024, total product revenue increased $0.4 million, or 64% as compared to the same period in 2023. During the nine months ended September 30, 2024, grant and contract revenue increased $0.2 million, or 19% as compared to the same period in 2023.
The increases were primarily due to new orders for silicon nitride aerospace components and government grants and contracts in our Salt Lake City operation as well as commercial and government contract revenue in our Maryland operation.
Cost of Revenue and Gross Profit
For the three months ended September 30, 2024, cost of revenue increased $0.1 million, or 79% as compared to the same period in 2023. This increase was primarily attributable to the increase in revenue mentioned above.
For the nine months ended September 30, 2024, cost of revenue increased $0.3 million, or 94% as compared to the same period in 2023. Gross profit increased $0.3 million, or 22%, as compared to the same period in 2023. This increase was primarily attributed to the increase in revenue mentioned above.
Research and Development Expenses
For the three months ended September 30, 2024, research and development expenses decreased $1.7 million, or -68%, as compared to the same period in 2023. This decrease was primarily attributable to a decrease in payroll and benefit costs, consulting and contracting, patent expenses and tooling costs.
For the nine months ended September 30, 2024, research and development expenses decreased $2.4 million, or -35%, as compared to the same period in 2023. This decrease was primarily attributable to a decrease in payroll and benefit costs, consulting and contracting, rent expense, patent expenses and tooling costs.
General and Administrative Expenses
For the three months ended September 30, 2024, general and administrative expenses decreased $0.2 million, or -19%, as compared to the same period in 2023. This decrease is primarily due to a decrease in employee payroll and benefit costs and employee recruiting expenses.
For the nine months ended September 30, 2024, general and administrative expenses decreased $0.3 million, or -10%, as compared to the same period in 2023. This decrease is primarily due to a decrease in employee payroll and benefit costs, costs for computer software and employee recruiting expenses.
Sales and Marketing Expenses
For the three months ended September 30, 2024, sales and marketing expenses decreased $0.2 million, or -66%, as compared to the same period in 2023. This decrease was primarily attributable to an overall decrease in payroll related costs, travel costs, and costs for outside consulting.
For the nine months ended September 30, 2024, sales and marketing expenses decreased $0.3 million, or -33%, as compared to the same period in 2023. This decrease was primarily attributable to an overall decrease in payroll related costs and costs for outside consulting.
23 |
Armor Exit Costs
For the three months ended September 30, 2024, Armor exit costs increased $4.5 million, or 100%, as compared to the same period in 2023. This increase was primarily attributable to an increase in asset impairment costs at the SINTX Armor facility.
For the nine months ended September 30, 2024, Armor exit costs increased $4.5 million, or 100%, as compared to the same period in 2023. This increase was primarily attributable to an increase in asset impairment costs at the SINTX Armor facility.
Reduction in Force Expenses
For the three months ended September 30, 2024, reduction in force expenses increased $0.4 million, or 100%, as compared to the same period in 2023. This increase was primarily attributable to payroll expenses related to severance and accrued vacation payouts.
For the nine months ended September 30, 2024, reduction in force expenses increased $0.4 million, or 100%, as compared to the same period in 2023. This increase was primarily attributable to payroll expenses related to severance and accrued vacation payouts.
Grant Expenses
For the three months ended September 30, 2024, grant and contract expenses remained primarily unchanged.
For the nine months ended September 30, 2024, grant and contract expenses increased by $0.1 million, or 13%, as compared to the same period in 2023. This increase was primarily attributable to a general increase in grant and contract revenue when compared to the prior year.
Other Income, Net
For the three months ended September 30, 2024, other income decreased $0.2 million, or -60%, as compared to the same period in 2023. This decrease was primarily due to a $0.2 million decrease associated with the change in the fair value of the derivative liabilities.
For the nine months ended September 30, 2024, other income decreased $1.7 million, or -36%, as compared to the same period in 2023. This decrease was primarily due to a $1.9 million decrease associated with the change in the fair value of the derivative liabilities, offset by a $0.2 million increase in costs associated with derivative liabilities.
Liquidity and Capital Resources
The condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern within one year from the date of issuance of these condensed consolidated financial statements.
For the nine months ended September 30, 2024 and 2023, the Company incurred a net loss of $9.3 million and $5.9 million, respectively, and used cash in operating activities of $7.5 million and $11.0 million, respectively. The Company had an accumulated deficit of $280.0 million and $270.7 million as of September 30, 2024, and December 31, 2023, respectively. We will require substantial future capital in order to continue operating our business, conduct research and development and regulatory clearance and approval activities necessary to bring our products to market, and to establish effective marketing and sales capabilities. Our existing capital resources are not sufficient to enable us to fund the completion of the development and commercialization of all our product candidates.
To date, the Company’s operations have been principally financed from proceeds from the issuance of preferred and common stock and, to a lesser extent, cash generated from product sales. It is anticipated that the Company will continue to generate operating losses and use cash in operations. The Company’s continuation as a going concern is dependent upon its ability to increase sales, decrease expenses and raise additional funding. Whether and when the Company can attain profitability and positive cash flows from operations or obtain additional financing is uncertain.
On February 10, 2023, the Company closed on a public offering of 10,750 units, with each unit consisting of one share of common stock, or one pre-funded warrant to purchase one share of its common stock, one Class C Warrant to purchase one share of common stock, and one half of one Class D Warrant with each whole Class D Warrant entitling the holder to purchase one share of common stock. Gross proceeds, before deducting offering expenses, totaled approximately $12.0 million. Of the $12.0 million of gross proceeds, approximately $5.4 million were allocated to common stock and prefunded warrants ($4.8 million net of offering costs) and approximately $6.7 million were allocated to derivative liabilities (with approximately $0.7 million of cash offering costs and $0.1 million of agent warrant offering costs recorded as derivative expense).
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On February 2, 2024, the Company closed on a public offering of 80,000 units, with each unit consisting of one share of its common stock, or one pre-funded warrant to purchase one share of its common stock, one Class E Warrant with each warrant entitled to purchase one share of common stock, and one Class F Warrant with each warrant entitled to purchase one share of common stock. Each unit was sold at a public offering price of $50.00 resulting in gross proceeds to the Company of $4 million before deducting offering fees and expenses. The Class E and Class F Warrants were immediately exercisable at a price of $50.00 per share. The Class E Warrants expire five years from the date of issuance and the Class F Warrants expire eighteen months from the date of issuance. Of the $4.0 million of gross proceeds, approximately $0.6 million were allocated to common stock and prefunded warrants ($0.5 million net of offering costs) and approximately $3.4 million were allocated to derivative liabilities (with approximately $0.5 million of cash offering costs and $0.1 million of agent warrant offering costs recorded as derivative expense).
On March 26, 2024, the Company closed on a public offering of 142,000 shares of the Company’s common stock, (the “March 26 Offering”). Each Share was sold at a public offering price of $9.40. The aggregate proceeds to the Company from the March 26 Offering were approximately $1.3 million before deducting placement agent fees and other estimated offering expenses payable by the Company.
On April 5, 2024, the Company closed on a public offering of 358,000 shares of the Company’s common stock, (the “April 5 Offering”). Each Share was sold at a public offering price of $4.20. The aggregate proceeds to the Company from the April 5 Offering were approximately $1.5 million before deducting placement agent fees and other offering expenses payable by the Company.
On February 25, 2021, the Company, entered into an Equity Distribution Agreement (the “ATM Agreement”) with Maxim Group LLC (the “Agent”), as sales agent, as amended on January 10, 2023 and October 12, 2023, pursuant to which the Company could offer and sell shares of the Company’s common stock, par value $0.01 per share (the “Shares”), initially up to an aggregate offering price of $15,000,000, from time to time in an at-the-market public offering. On March 22, 2024, the Company suspended sales under the ATM Agreement and terminated the continuous offering. On July 11, 2024, the Company filed a Prospectus Supplement with the SEC adjusting the amount available for sale under the ATM Agreement to $3.1 million and shortly thereafter begin offering and selling Shares under the ATM Agreement to the public. During the three months ended September 2024, 595,560 Shares were sold under the ATM Agreement for gross proceeds of approximately $3.1 million. During the nine months ended September 30, 2024, 602,357 Shares were sold under the ATM Agreement for gross proceeds of approximately $3.7 million. Because the Company is subject to General Instruction I.B.6 of Form S-3, it is restricted from selling securities in a public primary offering with a value exceeding one-third of its public float (the market value of our common stock held by our non-affiliates) in any 12-month period so long as its public float remains below $75.0 million. As of September 30, 2024, there was no capacity to offer and sell Shares under the ATM Agreement.
On June 11, 2024, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has evidenced compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). The Company remains subject to a “Mandatory Panel Monitor,” as that term is defined in Listing Rule 5815(d)(4)(B), for a period of one year from June 11, 2024. If, within the one-year period, the Company fails to satisfy the minimum $1.00 closing bid price threshold for 30 consecutive business days, Nasdaq will issue a delist determination rather than provide the Company with a grace period to regain compliance with the Bid Price Rule. In that event, the Company would have the opportunity to request a new hearing to address the deficiency.
We are actively seeking opportunities to raise additional equity and/or debt financing. However, such funding is not guaranteed and may not be available to the Company on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing, if available to the Company, will most likely be dilutive to its current stockholders. If the Company is not able to obtain additional debt or equity financing on a timely basis, the impact on the Company will be material and adverse.
The Board of Directors, together with management, is performing an ongoing evaluation of the Company’s business strategy and focus. On August 1, 2024, the board of directors appointed Eric Olson to the office of Chief Executive Officer and President to lead the evaluation process. The Board of Directors also entered into an engagement agreement with Ascendiant Partners to evaluate strategic transactions including, but not limited to, acquisitions, strategic partnerships, sell of business divisions, and reverse merger opportunities.
An option being evaluated is a change in strategic emphasis to advancements in the medical device sector. Historically engaged in both industrial and biomedical applications, SINTX would prioritize the development and commercialization of innovative medical devices, leveraging our expertise in advanced ceramics and biomaterials. Such a renewed focus would align with a commitment to improving patient outcomes through the creation of products designed for surgical, orthopedic, and other specialized medical applications. We would concentrate our resources on high-growth areas within the healthcare sector where our proprietary materials and technologies—such as silicon nitride—provide a distinct competitive advantage due to their unique strength, durability, and biocompatibility.
Through this transformation, SINTX’s aim would be to deliver meaningful innovations to the medical community. Our current research and development pipeline is centered on medical-grade devices that incorporate antimicrobial properties, enhanced imaging capabilities, and durability under physiological conditions, which are critical for orthopedic implants, spinal fusion devices, and other surgical tools. If we transition away from industrial applications, we anticipate this strategic shift will enable us to better serve the medical sector, address critical unmet needs, and position SINTX as a leading provider in the medical device market. By focusing on partnerships and collaborations with healthcare institutions and industry leaders, SINTX is positioned to expand its footprint in the medical device sector and drive shareholder value through sustainable, high-impact innovations, however, such a transition has not been approved by the Board of Directors, nor can such approval or successful transition be assured.
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SINTX Technologies has initiated discussions with the leaseholder for our Centerpointe location in Salt Lake City, Utah to explore options for reducing the Company’s overall lease liability. This action aligns with our broader strategy to streamline operating expenses and the option to reallocate resources towards growth initiatives in the medical device sector. While these discussions reflect our commitment to financial optimization, there can be no assurance that negotiations will lead to a reduction in the existing lease liability. The outcome of these discussions remains uncertain, and SINTX will continue to evaluate additional measures to manage long-term obligations in alignment with our strategic objectives.
On August 8, 2024, the Board of Directors approved a plan to implement a Company-wide reduction in the workforce. This decision is part of the Company’s ongoing strategic review of its operations aimed at improving operational efficiency and reducing costs. The reduction in force reduced the number of employees of the Company from 40 to 23. During the three months ended September 30, 2024, the Company recorded expenses of approximately $407,000 associated with the reduction in workforce.
On August 12, 2024, the Board of Directors of the Company approved a plan to cease efforts to make the armor plant operational. This decision was made to streamline operations and focus on core business areas that align with the Company’s long-term strategic goals. The armor plant has not been fully operational since the acquisition of the armor equipment in July 2021 and has been completely shut down since October 2023 due to the malfunctioning of the sintering furnace. In connection with this decision the Company incurred an impairment charge of approximately $4.5 million during the three months ended September 30, 2024. This charge primarily relates to the write-down of certain long-lived assets associated with the armor plant to their estimated fair value.
The Company’s insurance carrier has determined that a covered loss occurred when the sintering furnace malfunctioned, and coverage is available for the Company’s repair of the sintering furnace. However, the Company’s efforts to fully repair the damaged furnace continue to be delayed. Management will work with the insurance company to continue to fund the repair of the furnace. When the furnace is fully repaired, management intends to sell the furnace, and related equipment, to a third party. However, the full repair and sale of the furnace, and related equipment, cannot be assured. Therefore, in the calculation of the $4.5 million estimated impairment charge, management has assumed no proceeds will be received from a potential sale of the furnace and related equipment.
These uncertainties raise substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.
Cash Flows
The following table summarizes, for the periods indicated, cash flows from operating, investing and financing activities (in thousands) – unaudited:
Nine Months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Net cash used in operating activities | $ | (7,518 | ) | $ | (10,987 | ) | ||
Net cash used in investing activities | (204 | ) | (439 | ) | ||||
Net cash provided by financing activities | 9,196 | 11,400 | ||||||
Net increase (decrease) in cash | $ | 1,474 | $ | (26 | ) |
26 |
Net Cash Used in Operating Activities
Net cash used in operating activities was $7.5 million during the nine months ended September 30, 2024, compared to $11.0 million used during the nine months ended September 30, 2023, a decrease of $3.5 million. The decrease in the net loss from operations, and related non-cash add backs to the net loss, was $2.6 million from 2024 when compared to 2023. The decrease in cash used for operating activities during 2024 was primarily due to the $2.6 million mentioned above plus changes in the movement of working capital items during 2024 as compared to the same period in 2023 as follows: a $0.5 million decrease in cash used for inventory, a $0.5 million decrease in cash used in prepaid expenses, a $0.4 million decrease in cash used in other liabilities, a $0.3 million decrease in accounts receivable, a $0.2 million decrease in payments on operating lease liability, all offset by a $1.0 million increase in cash used in accounts payable and accrued liabilities.
Net Cash Used in Investing Activities
Net cash used in investing activities was $0.2 million during the nine months ended September 30, 2024, compared to $0.4 million used during the nine months ended September 30, 2023, a decrease of $0.2 million. The decrease in cash used for investing activities during 2024 was primarily due to a $0.3 million increase in proceeds from notes receivable, offset by a $0.1 increase in the purchase of property and equipment.
Net Cash Provided by Financing Activities
There was $9.2 million in cash provided by financing activities during the nine months ended September 30, 2024, compared to $11.4 million in cash provided by financing activities during the same period in 2023. The $2.2 million decrease to net cash provided by financing activities was primarily attributable to a decrease in proceeds from issuance of warrant derivative liabilities of $3.3 million a $0.1 million increase in payments on debt offset by an increase in proceeds from issuance of common stock of $1.2 million.
Indebtedness
Business Loan
On July 20, 2021, TA&T, entered into a Loan Authorization and Agreement in the amount of approximately $350,000 (the “Business Loan”). The Company made a one-time $35,000 buy down payment when acquiring the loan. The Business Loan bore interest at a rate of 3.75% per annum. The Business Loan was secured by a general security interest in all of the assets of TA&T. The Business Loan contained other standard provisions that are customary of loans of this type. The business loan was paid in full during the first quarter of 2023 and there was no outstanding balance at September 30, 2024.
Related Party Debt
TA&T is obligated to repay certain personal loans made by the founders of TA&T to TA&T prior to SINTX’s acquisition of TA&T (the “Personal Loans”). The total amount of the Personal Loans at September 30, 2022, was approximately $350,000. The Company agreed to repay the outstanding balance of the Personal Loans in (i) 24 equal monthly installments beginning September 1, 2022, and each month thereafter until paid in full as one prior owner’s portion of the Personal Loans totaling $157,000, and (ii) for the other owner’s portion of the Personal Loans totaling $193,000. The related party debt was paid in full during the third quarter of 2024 and there was no outstanding balance at September 30, 2024.
Wells Fargo Line of Credit
Prior to SINTX’s acquisition of TA&T, TA&T entered into a revolving line of credit with Wells Fargo. As of September 30, 2024, the line of credit with Wells Fargo had no outstanding balance and the account has been closed.
Insurance Premium Finance Arrangements
In March 2024, in connection with securing Director and Officer professional liability insurance, the Company entered into a Premium Finance Arrangement to extend the premium payment out for a period of 10 months. The Company paid a total of $40,000 up front toward the insurance premium and financed approximately $239,000. The Company will make 10 equal payments under the terms of the Premium Finance Agreement. The Premium Finance Agreement bears interest at an annual percentage rate of 8.510%. As of September 30, 2024, there was an outstanding balance of $70,000.
In June 2024, in connection with securing commercial liability insurance, the Company entered into a Premium Finance Arrangement to extend the premium payment out for a period of 10 months. The Company paid a total of $26,000 up front toward the insurance premium and financed approximately $117,000. The Company will make 10 equal payments under the terms of the Premium Finance Agreement. The Premium Finance Agreement bears interest at an annual percentage rate of 8.75%. As of September 30, 2024, there was an outstanding balance of $64,000.
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Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) of Regulation S-K.
Critical Accounting Policies and Estimates
A summary of our significant accounting policies and estimates is discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations and in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to those policies for the nine months ended September 30, 2024. The preparation of the consolidated financial statements in accordance with U.S. generally accepted accounting principles requires us to make judgments, estimates and assumptions regarding uncertainties that affect the reported amounts of assets and liabilities. Significant areas of uncertainty that require judgments, estimates and assumptions include the accounting for income taxes and other contingencies as well as valuation of derivative liabilities, asset impairment and collectability of accounts receivable. We use historical and other information that we consider to be relevant to make these judgments and estimates. However, actual results may differ from those estimates and assumptions that are used to prepare our condensed consolidated financial statements.
New Accounting Pronouncements Not Yet Adopted
See discussion under Note 1, Organization and Summary of Significant Accounting Policies, to the Condensed Consolidated Financial Statements included in Item 1 of Part I of this Quarterly Report on Form 10-Q, for information on new accounting pronouncements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES
This Report includes the certifications of our Chief Executive Officer and Principal Financial Officer required by Rule 13a-14 of the Securities Exchange Act of 1934 (the “Exchange Act”). See Exhibits 31.1 and 31.2. This Item 4 includes information concerning the controls and control evaluations referred to in those certifications.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”), that are designed to ensure that information required to be disclosed in the reports filed or submitted under the Exchange Act, is recorded, processed, summarized, and reported within the time periods specified by the Commission’s rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act are properly recorded, processed, summarized and reported within the time periods required by the Commission’s rules and forms.
We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (principal executive officer and principal financial officer), of the effectiveness of the design and operation of these disclosure controls and procedures, as such term is defined in Exchange Act Rule 13a-15(e), as of September 30, 2024. Based on this evaluation, the Chief Executive Officer concluded that our disclosure controls and procedures were effective as of September 30, 2024, the end of the period covered by this Quarterly Report on Form 10-Q.
There were no changes in our internal control over financial reporting that occurred during the third quarter of 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II
ITEM 1. LEGAL PROCEEDINGS
We are not aware of any pending or threatened legal proceeding against us that could have a material adverse effect on our business, operating results or financial condition. The medical device industry is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result, we may be involved in various additional legal proceedings from time to time.
Item 1A. Risk Factors
The Company may not be successful in its efforts to transition it focus to advancements in the medical device sector
The Company is focusing its strategic efforts to emphasize advancements in the medical device sector. SINTX is now prioritizing the development and commercialization of innovative medical devices, leveraging our expertise in advanced ceramics and biomaterials. There can be no assurance that SINTX will be successful in these efforts. If we fail in any of these endeavors or experience delays in pursuing them, we will not generate revenues as planned and will need to curtail operations or seek additional financing earlier than otherwise anticipated.
Our success will depend on our acquiring revenue generating assets. We may not be successful in acquiring revenue generating assets which will impact our ability fund operations.
To accelerate this transformation, SINTX is also actively exploring the acquisition of revenue-generating assets that will strengthen our position in the medical device field. These acquisitions are aimed at diversifying our product offerings, expanding market reach, Further, Ascendiant Capital Markets, LLC was retained to assist in identifying strategic business opportunities that align with our renewed focus on the medical device sector. If we fail in any of these endeavors or experience delays in pursuing them, we will not generate revenues as planned and will need to curtail operations or seek additional financing earlier than otherwise anticipated.
The delay in the divesture of our armor, aerospace and defense segments could delay development of our medical device focus resulting in a delay in future revenue.
We are pursuing the sale of our armor, aerospace, and defense segments, Divesting these industrial applications will allow us to reallocate resources and capital toward the high-growth medical device sector. Any delay in such divestitures will impact adversely on our reallocation of resources and capital toward the medical device sector. If we fail in any of these endeavors or experience delays in pursuing them, we will not generate revenues as planned and will need to curtail operations or seek additional financing earlier than otherwise anticipated.
The August 8, 2024 reduction in force may result in the Company not having the necessary personnel to pursue its strategic objectives.
On August 8, 2024, the Board of Directors approved a plan to implement a Company-wide reduction in the workforce. This decision is part of the Company’s ongoing strategic review of its operations aimed at improving operational efficiency and reducing costs. The reduction in force reduced the number of employees of the Company from 40 to 23. As a result we may not have sufficient personnel to effectuate our business strategy. The members of our current senior management team may not be able to successfully implement our strategy. There are no assurances that the services of any of these individuals will be available to us for any specified period of time. The successful integration of our senior management team, the loss of members of our senior management team, engineering team and key external advisors, or our inability to attract or retain other qualified personnel or advisors could have a material adverse effect on our business, financial condition and results of operations.
Additional information regarding risk factors appears in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 27, 2024.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
None.
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ITEM 6. EXHIBITS
Exhibit Number |
Exhibit Description | Filed Herewith |
Incorporated by Reference herein from Form or Schedule |
Filing Date |
SEC File/ Reg. | |||||
31.1 | Certificate of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
31.2 | Certificate of the Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
32 | Certifications of the Chief Executive Officer and Principal Accounting Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
101.INS | Inline XBRL Instance Document | X | ||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | X | ||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | X | ||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | X | ||||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | X | ||||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | X | ||||||||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SINTX Technologies, Inc. | |
Date: November 12, 2024 | /s/ Eric Olson |
Eric Olson | |
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) |
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