美國
證券交易委員會
華盛頓, D.C. 20549
表格
(馬克 一)
根據1934年證券交易法第13或15(d)節提交的季度報告書 |
截至季度結束
或者
過渡 根據1934年《證券交易法》第13或15(d)條提交的報告 |
委員會文件號
(公司章程中指定的準確公司名稱)
(州或其他司法管轄區 文件編號) | (國 稅 號) | |
(組織)的註冊地點 | (主要 執行人員之地址) |
(主要 執行人員之地址) | (郵政 編 碼) |
根據交易所法規(17 CFR 240.14a-12)第14a-12規定的招股材料
根據法案第12(b)節註冊的證券:
每一類別的名稱 | 交易標誌 | 在每個交易所註冊的名稱 | ||
這 |
請通過複選標記來指示註冊者:(1)在過去的12個月內(或註冊者被要求提交這些報告的更短時間內)是否已提交證券交易法案第13或15(d)條規定需要提交的所有報告;以及(2)註冊者是否在過去90天內已受制於此類提交要求:
請用勾選標記指示,公司是否在過去的12個月內按照S-t規則405條的要求,遞交了所有要求遞交的互動數據文件(或者在公司被要求提交併發帖此類文件的更短時期內);
請通過勾選來指明註冊者是大型加速報告人、加速報告人、非加速報告人、較小報告公司,還是新興成長公司。有關「大型加速報告人」、「加速報告人」、「較小報告公司」和「新興成長公司」的定義,請參見《交易所法》第120億.2條。
大型加速文件提交人 | ☐ | 加速文件提交人 | ☐ |
☒ | 小型報告公司 | ||
新興成長公司 |
如果是新興成長型企業,請打勾,以表明註冊人已選擇不使用遵守《證券交易法》第13(a)條所規定的任何新的或修訂後的財務會計準則的延長過渡期。 ☐
請在複選框中放置標記,指示註冊者是否是外殼公司(根據交易所法案規則12b-2定義): 是 ☐ 否
標明公司每類普通股的流通情況,截至最近可行日期的流通情況:
普通股股份,$ 截至2024年11月6日,共有面值爲。的普通股outstanding。
SINTX技術公司。
目錄
第I部分。財務信息 | |
截至2024年3月31日和2023年12月31日的資產負債表(未經審計) | |
壓縮的綜合資產負債表(未經審計) | 3 |
簡明合併利潤表(未經審計) | 4 |
庫藏股股東權益摘要財務報表(未經審計) | 6 |
壓縮的現金流量表(未經審計) | 7 |
基本財務報表附註(未經審計) | 8 |
項目2. 管理層對財務狀況和業績的討論與分析 | 20 |
項目3.有關市場風險的定量和定性披露 | 28 |
項目4.控制和程序 | 28 |
第二部分其他信息 | |
項目1.法律訴訟 | 29 |
項目1A.風險因素 | 29 |
項目2. 未註冊的股權銷售和款項使用 | 29 |
項目3. 面對高級證券的違約情況 | 29 |
項目4.礦山安全披露 | 29 |
項目5.其他信息 | 29 |
項目6.附件 | 30 |
簽名 | 31 |
2 |
SINTX 科技公司
簡明 合併資產負債表 - 未經審計
(以千爲單位,除了每股股份和每股數據)
2024年9月30日 | 2023年12月31日 | |||||||
資產 | ||||||||
流動資產: | ||||||||
現金及現金等價物 | $ | $ | ||||||
應收賬款及其他帳戶淨額,減少壞賬準備合計 | ||||||||
預付費用和其他流動資產 | ||||||||
存貨 | ||||||||
其他流動資產 | ||||||||
總流動資產 | ||||||||
淨存貨 | ||||||||
房地產和設備,淨額 | ||||||||
無形資產-淨額 | ||||||||
經營租賃權資產 | ||||||||
其他長期資產 | ||||||||
總資產 | $ | $ | ||||||
負債和股東權益 | ||||||||
流動負債: | ||||||||
應付賬款 | $ | $ | ||||||
應計負債 | ||||||||
債務 | ||||||||
衍生工具負債 | ||||||||
經營租賃負債流動部分 | ||||||||
其他流動負債 | ||||||||
流動負債合計 | ||||||||
經營租賃負債,減:流動部分 | ||||||||
總負債 | ||||||||
承諾和 contingencies | ||||||||
股東權益: | ||||||||
可轉換優先股乙系列,$ | 票面價值, 授權的總股數包括所有系列的優先股; 和 截至2024年9月30日和2023年12月31日,發行和流通的股份分別爲。||||||||
可轉換優先股系列C,$ | 面值, 授權的總股數包括所有系列的優先股; 2024年9月30日和2023年12月31日,已發行和流通的股份。||||||||
可轉換優先股系列D,$ | 面值, 總授權股份包括所有系列優先股; 截至2024年9月30日和2023年12月31日的已發行和流通股。||||||||
普通股,每股面值爲 $0.0001; | 面值, 股份授權; 和 自2024年9月30日和2023年12月31日分別發行和流通的股份。||||||||
額外實收資本 | ||||||||
累積赤字 | ( | ) | ( | ) | ||||
股東權益總額 | ||||||||
負債和股東權益總額 | $ | $ |
截至2023年12月31日的壓縮綜合資產負債表是使用當天的審計綜合資產負債表的信息編制的。
附註是這些簡明合併財務報表的不可分割的一部分。
3 |
SINTX技術公司。
未經審計的彙總利潤表
(以千爲單位,除了每股股份和每股數據)
截至9月30日的三個月 | 截至9月30日的九個月 | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
產品營業收入 | $ | $ | $ | $ | ||||||||||||
授予和合同營業收入 | ||||||||||||||||
總營業收入 | ||||||||||||||||
營業成本 | ||||||||||||||||
Gross profit | ||||||||||||||||
營業費用: | ||||||||||||||||
研發 | ||||||||||||||||
總務和行政 | ||||||||||||||||
銷售與市場營銷 | ||||||||||||||||
裝甲退出成本 | ||||||||||||||||
裁員 | ||||||||||||||||
撥款和合同費用 | ||||||||||||||||
總營業費用 | ||||||||||||||||
營運虧損 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
其他收入(支出): | ||||||||||||||||
利息支出 | ( | ) | ( | ) | ( | ) | ||||||||||
利息收入 | ||||||||||||||||
設備處置收益(損失) | ( | ) | ( | ) | ||||||||||||
衍生負債公允價值變動 | ||||||||||||||||
衍生負債的發行成本 | ( | ) | ( | ) | ||||||||||||
其他收入,淨 | ||||||||||||||||
總其他收入(費用),淨額 | ||||||||||||||||
稅前淨虧損 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
所得稅費用準備 | ||||||||||||||||
淨虧損 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
與可轉換優先股相關的被視爲股息 | ( | ) | ||||||||||||||
歸屬普通股東的淨虧損 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
基本和稀釋每股淨虧損 | ||||||||||||||||
基本-淨損失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
基本-轉換優先股被視爲股息 | ( | ) | ||||||||||||||
基本 - 歸屬於普通股東 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
攤薄 - 淨虧損 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
攤薄 - 兌售優先股的被視爲股息 | ( | ) | ||||||||||||||
攤薄 - 歸屬於普通股東 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
加權平均流通股數: | ||||||||||||||||
基本 | ||||||||||||||||
稀釋 |
附註是這些簡明合併財務報表的不可分割的一部分。
4 |
SINTX技術公司。
未經審計的股東權益的簡明綜合股東權益表
(以千爲單位,除了每股股份和每股數據)
優先股 | 普通股 | 已繳 | 累計 | 合計 | ||||||||||||||||||||||||
股份 | 金額 | 股份 | 金額 | 資本 | 赤字 | 股東權益合計 | ||||||||||||||||||||||
截至2022年12月31日的餘額 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
以股票爲基礎的報酬 | - | |||||||||||||||||||||||||||
普通股票發行以換取現金,減去現金費用 | - | |||||||||||||||||||||||||||
預資擔保權證發行以換取現金,減去現金費用 | - | - | ||||||||||||||||||||||||||
債權清償在權證行使時的衍生工具 | - | |||||||||||||||||||||||||||
通過行使預融資認股權出售普通股以換取現金 | - | |||||||||||||||||||||||||||
通過無需現金行使認股權發行普通股 | - | |||||||||||||||||||||||||||
優先股贖回 | ( | ) | - | ( | ) | ( | ) | |||||||||||||||||||||
發行代理認股權 | - | - | ||||||||||||||||||||||||||
合併發行股份以彌補倒掛後的股份 | - | |||||||||||||||||||||||||||
淨虧損 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
截至2023年3月31日的餘額 | ( | ) | ||||||||||||||||||||||||||
以股票爲基礎的報酬 | - | - | ||||||||||||||||||||||||||
行使認股權證後衍生負債的清償 | - | - | ||||||||||||||||||||||||||
無息認股權證行使發行普通股 | - | |||||||||||||||||||||||||||
發行普通股以轉換優先股 | ( | ) | ||||||||||||||||||||||||||
與優先股轉換相關的被視爲紅利 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
與優先股轉換相關的被視爲紅利 | - | - | ||||||||||||||||||||||||||
淨虧損 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
截至2023年6月30日的餘額 | ( | ) | ||||||||||||||||||||||||||
以股票爲基礎的報酬 | - | - | ||||||||||||||||||||||||||
淨虧損 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
2023年9月30日的餘額 | $ | $ | $ | $ | ( | ) | $ |
5 |
優先股 | 普通股 | 實繳 | 累計 | 總計 | ||||||||||||||||||||||||
分享 | 金額 | 股票 | 數量 | 資本 | 赤字 | 股票 | ||||||||||||||||||||||
截至2023年12月31日的餘額 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
股份報酬 | - | - | ||||||||||||||||||||||||||
普通股票發行以換取現金,減去現金費用 | - | |||||||||||||||||||||||||||
預資擔保權證發行以換取現金,減去現金費用 | - | - | ||||||||||||||||||||||||||
通過行使預融資認股權出售普通股以換取現金 | - | ( | ) | |||||||||||||||||||||||||
淨虧損 | ( | ) | ( | ) | ||||||||||||||||||||||||
截至2024年3月31日的餘額 | ( | ) | ||||||||||||||||||||||||||
基於股票的補償 | - | |||||||||||||||||||||||||||
發行普通股以換取現金,減去現金費用 | - | |||||||||||||||||||||||||||
履行認股權債務的消滅 | - | |||||||||||||||||||||||||||
發行普通股以轉換優先股 | ( | ) | ||||||||||||||||||||||||||
合併發行股份以彌補倒掛後的股份 | - | |||||||||||||||||||||||||||
淨損失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
截至2024年6月30日的餘額 | ( | ) | ||||||||||||||||||||||||||
以股票爲基礎的補償 | - | - | ||||||||||||||||||||||||||
發行普通股以換取現金,淨現金費用 | - | |||||||||||||||||||||||||||
發行普通股以抵銷優先股的轉換 | ( | ) | ||||||||||||||||||||||||||
淨損失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
截至2024年9月30日的餘額 | $ | $ | $ | $ | ( | ) | $ |
附註是這些精簡合併財務報表的一部分。
6 |
SINTX技術公司。
現金流量表 - 未經審計的綜合現金流量表
(以千爲單位)
截至9月30日的九個月 | ||||||||
2024 | 2023 | |||||||
經營活動現金流 | ||||||||
淨虧損 | $ | ( | ) | $ | ( | ) | ||
調整爲淨損失到經營活動現金流量淨使用: | ||||||||
折舊費用 | ||||||||
裝甲減值 | ||||||||
承租權資產攤銷 | ||||||||
無形資產攤銷 | ||||||||
基於股票的補償 | ||||||||
衍生負債公允價值變動 | ( | ) | ( | ) | ||||
(設備)處置的損益 | ( | ) | ||||||
壞賬費用 | ||||||||
運營資產和負債的變化: | ||||||||
應收賬款 | ||||||||
預付費用及其他流動資產 | ( | ) | ||||||
存貨 | ( | ) | ||||||
應付賬款及應計負債 | ( | ) | ||||||
其他負債 | ( | ) | ( | ) | ||||
經營租賃負債的支付金額 | ( | ) | ( | ) | ||||
用於經營活動的淨現金 | ( | ) | ( | ) | ||||
投資活動產生的現金流量 | ||||||||
購置固定資產等資產支出 | ( | ) | ( | ) | ||||
應收票據淨收益,扣除隱含利息 | ||||||||
出售房產和設備的收益 | ||||||||
投資活動中使用的淨現金 | ( | ) | ( | ) | ||||
籌資活動現金流量 | ||||||||
權證衍生工具負債的發行收入 | ||||||||
普通股和預先資金擔保權證的發行收入,減去現金費用 | ||||||||
與行使權證相關的普通股發行收入 | ||||||||
償還債務 | ( | ) | ( | ) | ||||
優先股E級的贖回 | ( | ) | ||||||
融資活動提供的淨現金 | ||||||||
現金及現金等價物的淨增加(減少) | ( | ) | ||||||
期初現金及現金等價物餘額 | ||||||||
期末現金及現金等價物 | $ | $ | ||||||
非貨幣性投資和融資活動 | ||||||||
預付保險發行的債務 | $ | |||||||
修訂後的租賃責任的使用權資產 | ( | ) | ||||||
分配給股權的代理權證發行成本 | ||||||||
行權權證後衍生責任減少 | ||||||||
新租賃負債的使用權資產 | ||||||||
無現金行使warrants時普通股的面值 | ||||||||
Prefunded warrants行使後普通股的面值 | ||||||||
補充現金流信息 | ||||||||
支付的利息現金 | $ | $ |
附註是這些精簡合併財務報表的一部分。
7 |
SINTX 科技公司
簡明合併財務報表附註
(未經審計)
1. 組織和重要會計政策總結。
基本報表中包括SINTX Technologies, Inc.(「SINTX」)及其全資子公司SINTX Armor, Inc.(「SINTX Armor」)和Technology Assessment and Transfer, Inc.(TA&T)等甲方的賬目,這些公司集體稱爲「我們」或「本公司」。SINTX成立於1996年12月,是一家專注於爲生物醫藥、技術和抗病原體等多個領域提供解決方案的愛文思控股公司。SINTX是一家隨着時間發展而成長的公司,從專注於硅氮化物用於人類植骨植入物的研發,轉變爲從事多個不同領域的先進陶瓷公司。公司的核心實力在於製造、研發先進陶瓷,並針對外部合作伙伴。公司目前製造各種陶瓷和陶瓷複合材料,包括硅氮化物、碳化物、氧化鋯和氧化鋁的減法和加法形式。SINTX還在開發專有的粉末、化合物、樹脂、和用於增材製造的絲材方面具備專業技能,以及在其鹽湖城和馬里蘭工廠生產成品單個元件。SINTX鹽湖城工廠已獲FDA註冊,符合cGMP和ANVISA RDC 665標準,同時具有ISO 9001:2015、ISO 13485:2016和ASD9100D認證。公司的產品主要在美國銷售。
公司在歷史上一直專注於在三個業務領域 - 抗病原體、技術和生物醫藥 - 開發營業收入機會,與現有和新客戶、合作伙伴以及製造商聯繫,以幫助實現利用高科技陶瓷專業知識創造這些領域新的、創新機會的目標。
這個
公司最初的重點是開發和商業化由氮化硅製成的用於脊柱的產品
融合以及髖關節和膝關節置換術的應用。SINTX認爲它是第一家也是唯一一家使用氮化硅的製造商
醫療應用主要集中在脊柱融合療法上。從那時起,我們開發了其他醫療器械應用程序
用於我們的氮化硅技術,並利用我們在其他應用中使用陶瓷材料方面的專業知識。在七月
2021年,公司收購了該設備並獲得了某些專有技術權利,目的是開發
使用碳化硼以及碳化硅和碳化硼的複合材料製造防護裝甲並實現商業化
用於軍事、執法和民用用途。自收購以來,裝甲廠一直未全面投入運營,
公司產生的減值費用約爲 $
流動性和資本資源
已編制的彙總簡明基本報表假定公司將繼續作爲一個持續經營的實體,這意味着在正常業務過程中資產的實現和負債的結算,並不包括任何調整,以反映從這些彙總簡明基本報表發行之日起一年內公司繼續作爲一個持續經營的實體所面臨的不確定性可能對資產的可回收性和分類或負債的金額和分類帶來的未來影響。
截至2024年9月30日和2023年9月30日的九個月期間,公司淨虧損爲$
截至目前,公司的運營主要依賴於優先股和普通股發行所獲得的收益,以及在一定程度上來自產品銷售所產生的現金。預計公司將繼續產生運營虧損,並在運營中消耗現金。公司的持續經營能力取決於其增加銷售、減少支出以及籌集額外資金的能力。公司能否及何時實現盈利和正現金流或獲得額外融資尚不確定。
截至2023年2月10日,公司完成了一次公開發行
8 |
在
2024年2月2日,公司完成了一次公開發行,
2024年3月26日,公司完成了一個公開發行的
2024年4月5日,公司完成了一項公開發行的
在2021年2月25日,公司與Maxim Group LLC(「代理商」)簽署了股權分銷協議(「ATm協議」),代表銷售代理商,根據協議的修訂日期分別爲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,面值爲$
2024年6月11日,公司收到了納斯達克證券交易所(「納斯達克」)正式通知,公司已證明符合了繼續在納斯達克資本市場上市的最低買盤價格要求,根據納斯達克上市規則5550(a)(2)(「買盤價格規則」)。公司在2024年6月11日起的一年內仍然受到「強制小組監視員」的監管,該術語在上市規則5815(d)(4)(B)中有定義。如果在這一年期限內,公司連續30個營業日未能滿足最低買盤價格門檻,納斯達克將發佈除牌決定,而不會爲公司提供恢復買盤價格規則合規性的寬限期。在這種情況下,公司將有機會請求新聽證會來解決這一不足。
我們 正在積極尋求機會來籌集額外的股權和/或債務融資。然而,這種資金並沒有得到保證,可能 無法以有利或可接受的條款提供給公司,並且可能涉及重大的限制性契約。如果公司能夠獲得額外的股權 融資,最有可能會對現有股東造成稀釋。如果公司未能及時獲得 額外的債務或股權融資,公司的影響將是重大而不利的。
董事會與管理層一起,正在對公司的業務策略和重點進行持續評估。 在2024年8月1日,董事會任命埃裏克·奧爾森爲首席執行官和總裁,負責領導評估過程。董事會還與Ascendiant Partners簽署了參與協議,以評估戰略交易,這些交易包括但不限於收購、戰略合作伙伴關係、業務部門的出售以及反向合併機會。
一種正在評估的選項是將戰略重點轉向醫療設備板塊的進步。SINTX歷史上參與工業和生物醫藥應用,將優先開發和商業化創新的醫療設備,利用我們在愛文思控股陶瓷和生物材料方面的專業知識。這樣的重拾關注將與通過創建旨在外科、骨科和其他專業醫療應用的產品來改善患者結果的承諾保持一致。我們將把資源集中在醫療板塊內高速增長的領域,在這些領域中,我們的專有材料和技術,例如氮化硅,由於其獨特的強度、耐久性和生物相容性,提供了明顯的競爭優勢。
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通過這一轉型,SINTX的目標是爲醫療社區帶來意義深遠的創新。我們當前的研發管線圍繞醫用器械展開,其中包括具有抗菌特性、增強成像能力和在生理條件下具有耐久性的器械,這對於骨科植入物、脊柱融合器械和其他手術工具至關重要。如果我們從工業應用轉向,我們預計這一戰略轉變將使我們能夠更好地服務醫療領域,滿足關鍵未滿足需求,並將SINTX定位爲醫療器械市場的領先提供商。通過與醫療機構和行業領導者的合作伙伴關係和合作,SINTX將能夠擴大在醫療器械領域的市場份額並通過可持續、高影響力的創新推動股東價值,然而,董事會尚未審批這種轉型,也不能保證會獲得這種批准或成功實現轉型。
SINTX Technologies已經與位於猶他州鹽湖城的Centerpointe位置的租賃持有者進行了討論,以探討減少公司整體租賃負擔的期權。這一舉措與我們更廣泛的策略一致,旨在簡化營業費用,並將資源重新分配到醫療器械行業的增長項目上。雖然這些討論反映了我們對財務優化的承諾,但無法保證談判會導致現有租賃負擔的減少。這些討論的結果仍然不確定,SINTX將繼續評估其他措施,以管理與我們戰略目標一致的長期義務。
在2024年8月8日,董事會批准了一項計劃,以實施全公司範圍內的裁員。這一決定是公司持續戰略審查的一部分,旨在提高運營效率和降低成本。裁員將公司的員工人數從40減少到23。在截至2024年9月30日的三個月期間,公司記錄了大約$
2024年8月12日,公司董事會批准了一項計劃,停止使裝甲工廠運營。這一決定旨在簡化業務並專注於與公司長期戰略目標一致的核心業務領域。自2021年7月收購裝甲設備以來,裝甲工廠從未完全投入運營,由於熱燒爐故障,自2023年10月起完全關閉。與此決定相關,公司在2024年9月30日結束的三個月內承擔了約$的減值損失
公司的保險承保方已經確定,燒結爐發生故障屬於保障範圍內,公司修復燒結爐的費用可獲得報銷。然而,公司全面修復受損爐子的努力仍在拖延。管理層將繼續與保險公司合作,繼續爲修復爐子提供基金。當爐子完全修復後,管理層打算賣出該爐子和相關設備給第三方。然而,無法確保該爐子和相關設備的完全修復和銷售。因此,在計算預計損耗費用的$
這些 不確定性對我們作爲持續經營單位的能力提出了重大懷疑。濃縮的合併基本報表 不包括可能因這些不確定性結果而產生的任何調整。
10 |
表述基礎
這些 未經審計的合併財務報表是根據美國 證券交易委員會(「SEC」)的規則和規定編制的,包含公司的所有資產和負債。
SEC的規則和法規允許省略在按照美國通用會計準則("U.S. GAAP")編制的財務報表中通常包括的某些信息和腳註披露,只要這些報表不具有誤導性。就管理層看來,這些財務報表和附註包含了爲了公正地呈現本報表所反映的財務狀況和業績所必要的所有調整(包括正常往復調整)。這些簡明的合併財務報表應當與公司於2024年3月27日向SEC提交的截至2023年12月31日年度報告表格10-k中包含的合併審計財務報表和相關注解一併閱讀。截至2024年9月30日的九個月的運營成果未必能反映出截至2024年12月31日年度結算的運營成果。公司的重要會計政策在其截至2023年12月31日年度報告表格10-k中的合併財務報表的註解1中闡明。
Reverse Stock Split
On
May 28, 2024, the Company effected a
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the period. Actual results could differ from those estimates. As of September 30, 2024, the most significant estimate relates to derivative liabilities relating to common stock warrants.
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Grant and Contract Revenue
Revenues from grants, contracts, and awards provided by governmental agencies are recorded based upon the terms of the specific agreements, which generally provide that revenue is earned when the allowable costs specified in the applicable agreement have been incurred or a milestone has been met. Cash received from federal grants, contracts, and awards can be subject to audit by the grantor and, if the examination results in a disallowance of any expenditure, repayment could be required.
New Accounting Pronouncements Not Yet Adopted
On
December 14, 2023, the Financial Accounting Standards Board issued Accounting Standards Update, No. 2023-09 “Improvements to Income
Tax Disclosures.” (“ASU 2023-09”). ASU 2023-09 enhances the detail that a business is required to disclose within its
income tax footnote, including, but not limited to, a breakout of the rate reconciliation into more specific categories, such as state
and local income tax, and foreign taxes. Additionally, a business must break out specific jurisdictions that encompass greater than or
equal to
The Company has reviewed all other recently issued, but not yet adopted, accounting standards, in order to determine their effects, if any, on its results of operations, financial position or cash flows. Based on that review, the Company believes that no other pronouncements will have a significant effect on its financial statements.
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period that are determined to be dilutive. Common stock equivalents are primarily comprised of preferred stock and warrants for the purchase of common stock. The Company had potentially dilutive securities that were not included in the fully diluted loss per share calculation because they would have been antidilutive totaling approximately thousand and thousand as of September 30, 2024, and 2023, respectively.
12 |
Basic Calculation | Effect of Dilutive | Diluted Calculation | ||||||||||
Numerator: | ||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
Denominator: | ||||||||||||
Number of shares used in per common share calculations: | ||||||||||||
Net loss per common share: | ||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) |
Below are basic and diluted loss per share data for the nine months ended September 30, 2024, which are in thousands except for share and per share data:
Basic Calculation | Effect of Dilutive | Diluted Calculation | ||||||||||
Numerator: | ||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
Denominator: | ||||||||||||
Number of shares used in per common share calculations: | ||||||||||||
Net loss per common share: | ||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) |
Below are basic and diluted loss per share data for the three months ended September 30, 2023, which are in thousands except for share and per share data:
Effect of | ||||||||||||
Dilutive | ||||||||||||
Basic | Warrant | Diluted | ||||||||||
Calculation | Securities | Calculation | ||||||||||
Numerator: | ||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
Deemed dividend and accretion of a discount | ||||||||||||
Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
Denominator: | ||||||||||||
Number of shares used in per common share calculations: | ||||||||||||
Net loss per common share: | ||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
Deemed dividend and accretion of a discount | ||||||||||||
Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) |
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Below are basic and diluted loss per share data for the nine months ended September 30, 2023, which are in thousands except for share and per share data:
Effect of | ||||||||||||
Dilutive | ||||||||||||
Basic | Warrant | Diluted | ||||||||||
Calculation | Securities | Calculation | ||||||||||
Numerator: | ||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
Deemed dividend and accretion of a discount | ( | ) | ( | ) | ||||||||
Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
Denominator: | ||||||||||||
Number of shares used in per common share calculations: | ||||||||||||
Net loss per common share: | ||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
Deemed dividend and accretion of a discount | ( | ) | ( | ) | ||||||||
Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) |
3. Inventories
Inventories consisted of the following (in thousands):
September 30, 2024 | December 31, 2023 | |||||||
Raw materials | $ | $ | ||||||
WIP | ||||||||
Finished goods | ||||||||
$ | $ |
As
of September 30, 2024, inventories totaling approximately $
4. Fair Value Measurements
Financial Instruments Measured and Recorded at Fair Value on a Recurring Basis
The Company has issued certain warrants to purchase shares of common stock, which are considered derivative liabilities because they have certain rights which could require a cash settlement and are re-measured to fair value at each reporting period in accordance with accounting guidance. Fair value is based on the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, under a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows:
Level 1 - | quoted market prices for identical assets or liabilities in active markets. | |
Level 2 - | observable prices that are based on inputs not quoted on active markets but corroborated by market data. | |
Level 3 - | unobservable inputs reflecting management’s assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment. |
The Company classifies assets and liabilities measured at fair value in their entirety based on the lowest level of input that is significant to their fair value measurement. No financial assets or liabilities (except the derivative liabilities explained above) were measured on a recurring basis as of September 30, 2024 and December 31, 2023. The following tables set forth the financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2024, and December 31, 2023 (in thousands):
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Fair Value Measurements as of September 30, 2024 | ||||||||||||||||
Description | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
Derivative liability | ||||||||||||||||
Common stock warrants | $ | $ | $ | $ |
Fair Value Measurements as of December 31, 2023 | ||||||||||||||||
Description | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
Derivative liability | ||||||||||||||||
Common stock warrants | $ | $ | $ | $ |
The Company did not have any transfers of assets and liabilities between Level 1 and Level 2 of the fair value measurement hierarchy during the nine months ended September 30, 2024, and 2023. The following table presents a reconciliation of the derivative liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the nine months ended September 30, 2024, and 2023 (in thousands):
Common Stock Warrants | ||||
Balance as of December 31, 2022 | $ | |||
Issuance of derivatives | ||||
Exercise of warrants | ( | ) | ||
Change in fair value | ( | ) | ||
Other | ( | ) | ||
Balance as of September 30, 2023 | $ | |||
Balance as of December 31, 2023 | $ | |||
Issuance of derivatives | ||||
Exercise of warrants | ( | ) | ||
Change in fair value | ( | ) | ||
Other | ||||
Balance as of September 30, 2024 | $ |
Common Stock Warrants
The Company has issued certain warrants to purchase shares of common stock, which are considered derivative liabilities because they have registration rights which could require a cash settlement and are re-measured to fair value at each reporting period in accordance with accounting guidance. As of September 30, 2024, and December 31, 2023, the derivative liability was calculated using the Monte Carlo Simulation valuation.
The assumptions used in estimating the common stock warrant liability using the Monte Carlo simulation valuation model as of September 30, 2024, and December 31, 2023, were as follows:
September 30, 2024 | December 31, 2023 | |||||||
Weighted-average risk-free interest rate | % | % | ||||||
Weighted-average expected life (in years) | ||||||||
Expected dividend yield | % | % | ||||||
Weighted-average expected volatility | % | % |
Other Financial Instruments
The Company’s recorded values of cash and cash equivalents, account and other receivables, accounts payable and accrued liabilities approximate their fair values based on their short-term nature. The recorded value of notes payable approximates the fair value as the interest rate approximates market interest rates.
5. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
September 30, 2024 | December 31, 2023 | |||||||
Payroll and related expense | $ | $ | ||||||
Accrued payables | ||||||||
Other | ||||||||
$ | $ |
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6. Debt
Business Loan
On
July 20, 2021, TA&T entered into a Loan Authorization and Agreement in the amount of approximately $
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 June 30, 2022 was approximately $
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 $
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 $
7. Equity
2024 April Registered Offering
On
April 5, 2024, the Company closed on a public offering
2024 March Registered Offering
On
March 26, 2024, the Company closed on a public offering
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2024 February Registered Offering
On
February 2, 2024, the “Company closed on the public offering of
2023 Registered Offering
On
February 10, 2023, the Company closed on a public offering of
2021 Equity Distribution Agreement
On
February 25, 2021, the Company entered into an Equity Distribution Agreement (as amended, the “2021 Distribution Agreement”)
with Maxim Group LLC (“Maxim”), pursuant to which the Company may sell from time to time, shares of the Company’s common
stock having an aggregate offering price of up to $
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.
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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 | ) |
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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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