登記 號333-266745

2,801,330 普通股

Polyrizon Ltd.

這 招股說明書涉及本招股說明書中確定的出售股東轉售最多2，801，330股普通股，其中 無面值，或普通股。

這個 出售股東在第136頁開始的表格中列出。不，奧爾迪納RY 現將股份登記在本公司名下，供本公司出售。我們不會因出售普通股而獲得任何收益。 股東們。出售本招股說明書所涵蓋的普通股所得款項淨額將撥歸出售股東(見 “收益的使用”)。出售股票的股東正在出售他們的證券，以創建一個公開的交易市場 我們在美國的股權證券。與首次公開募股不同，出售普通股股東的任何出售 股票不是由任何投資銀行承銷的。出售股東可以出售全部或部分普通股。 不時通過任何市場進行市場交易，我們的普通股隨後在該市場上進行交易，無論是談判交易還是其他方式， 價格和條款將由當時的市場價格或按談判價格直接或通過 一名或多名經紀人，他們可以作為代理人或委託人，或通過這些銷售方法的組合。請參閱“分配計劃”。 在我們的首次公開募股(IPO)中出售普通股之前，不得出售本招股說明書所涵蓋的股份。 開始在納斯達克資本市場或納斯達克上進行交易。

在 此外，與我們的IPO有關，我們將提供958，903個單位或單位，每個單位由我們的一股普通股或 首次公開募股普通股和三份認購證，每份認購證用於購買我們的一股普通股，或每份認購證。首次公開發行 每個單位的價格為4.38美金，該單位中包含的每份令狀的行使價為每股IPO普通股4.38美金（有該行使 價格等於每單位公開發行價格）。這些單位沒有獨立的權利，也不會作為獨立的單位獲得認證或頒發 證券首次公開募股普通股和配股可立即分離，並將在我們的首次公開募股中單獨發行。提供的逮捕令 我們的IPO將於發行之日立即行使，並將於發行之日起五年內到期。這些裝置 通過單獨的招股說明書或公開發行招股說明書的方式登記與我們的IPO相關的出售

我們 已獲准在納斯達克資本市場（納斯達克）上市我們的普通股，代碼為「PLZZ」。我們不 有意申請在任何證券交易所或其他國家認可的交易系統上市該等證。

我們 根據2012年《快速啟動我們的商業初創法案》或《JOBS法案》的定義，是一家新興成長型公司，也是一家 「外國私人發行人」，根據美國聯邦證券法的定義，受精簡上市公司管轄 報告要求。請參閱「招股說明書摘要-成為新興成長型公司和外國公司的含義 公開發行招股說明書中的「私人發行人」以獲取更多信息。

投資 我們的普通股涉及高度風險。請參閱第13頁開始的「風險因素」  的 公開發行招股說明書。

既不 美國證券交易委員會（或SEC）、任何州或其他外國證券委員會均未批准或不批准 這些證券或確定本招股說明書是否真實或完整。任何相反的陳述都是刑事犯罪。

的 本招股說明書日期為2024年10月28日。

表 內容

都不是 作為IPO的銷售股東和承銷商，我們已授權任何人向您提供不同的資訊 根據本招股章程、本招股章程的任何修訂或補充，或在任何自由撰寫的招股章程中，我們可能授權 交付或提供給你。我們作為IPO的出售股東和承銷商都不對以下事項負責， 並且不能保證其他人可能向您提供的任何其他資訊的可靠性。我們，出售股份的股東和 IPO中的承銷商提出出售普通股，並僅在司法管轄區尋求購買普通股的要約 允許報價和銷售的地方。本招股說明書所載資料僅以本招股說明書正面日期為準。 招股說明書，無論本招股說明書的交付時間或任何普通股的出售。我們的業務，財務狀況， 自本招股說明書封面之日起，經營業績和前景可能已發生變化。

既不 我們、出售股東或IPO中的任何承銷商均已採取任何行動允許此次發行或擁有或分銷 本招股說明書在任何需要為此採取行動的司法管轄區（美國除外）。您需要 了解並遵守與本次發行和本招股說明書的分發有關的任何限制。

「捕獲 和Contain」和「Trap and Target」是我們在本招股說明書中使用的商標。本招股說明書還包括 屬於其他組織財產的商標、商品名和服務標記。純粹為了方便，我們的商標和商品名 本招股說明書中提到的內容通常沒有®或™符號，但這些參考並非有意 以任何方式表明，我們不會根據適用法律在最大程度上主張我們的權利或適用者的權利 我們的商標和商品名的許可人。

的 術語「謝克爾」、「以色列謝克爾」和「新錫克爾」指的是新以色列謝克爾，是以色列的合法貨幣 以色列國，術語「美金」、「美金」或「$」指的是美金， 美利堅合眾國的合法貨幣。本招股說明書中所有提及的「股份」均指的是 Polyrizon Ltd.，每股無面值。

對 2022年9月29日，該公司根據以下規定實施了（i）以1比8.80的比例對我們的已發行和已發行股份進行反向股票拆分 我們股份持有人每持有8.80股普通股即可獲得一股普通股，以及（ii）註銷面值 我們的普通股和優先股，或統稱為初始反向股份拆分。

對 2022年12月19日，公司於2022年12月19日向普通股持有人發行總計858，148股紅股 每股發行普通股獲得1.25股紅股的基礎（相當於以1.25比1的比例拆分的遠期股票），或 遠期股份分割。

對 2023年6月18日，公司以1比1.7的比例對我們的已發行和已發行股份進行了反向股票拆分，據此 我們股份的持有人每持有1.7股普通股即可獲得一股普通股，或第二次反向股份拆分。

對 2024年5月12日，公司以1比2的比例對我們的已發行和發行股份進行了反向股票拆分，據此 我們股份的持有人每持有兩（2）股普通股即可獲得一（1）股普通股，或第三次反向股份拆分。

對 2024年8月16日，公司於2024年8月16日向普通股持有人發行總計420，618股紅股 每股發行普通股為0.1494股紅股（相當於以0.1494比1的比例拆分的遠期股票），或 第二次遠期股票分割。

除非 上下文另有明確規定，此處提及的所有股份和每股金額均反映上述股份 拆分或共同拆分股份。

馬克特， 行業和其他數據

這 招股說明書包含有關我們的行業、業務和產品市場的估計、預測和其他信息 候選人基於估計、預測、預測、市場研究或類似方法的信息本質上是主題 不確定性，實際事件或情況可能與本信息中假設的事件和情況存在重大差異。 除非另有明確說明，否則我們從自己的內部估計和研究中獲得了該行業、業務、市場和其他數據 以及市場研究公司和其他第三方、行業、 醫學和一般出版物、政府數據和類似來源。本招股說明書中引用的報告或研究均未委託進行 由公司。

在 此外，對我們和我們行業未來業績的假設和估計必然存在高度的不確定性 以及多種因素造成的風險，包括「風險因素」中描述的因素。這些和其他因素可能會導致我們 未來業績與我們的假設和估計存在重大差異。請參閱「關於前瞻性陳述的特別注意事項」。

風險 影響因素

投資 我們的證券涉及高度風險。此外，您還應仔細考慮以下描述的風險和不確定性 本招股說明書中載列的其他信息，包括財務報表和中其他地方包含的相關注釋 在購買我們的證券之前，本招股說明書。我們的業務、財務狀況、現金流和運營運績可能會出現負面影響 受到這些風險的影響。在這種情況下，我們普通股的交易價格可能會下降，您可能會損失全部 或您投資的一部分。

風險 與我們的財務狀況和資本要求相關

我們 自我們成立以來已經遭受了重大損失。我們預計在可預見的時間內我們將繼續遭受重大損失 未來，我們可能永遠無法實現或保持盈利能力。

我們 是一家處於發展階段的生物技術公司。我們自成立以來就出現了運營虧損， 包括截至2023年12月31日的年度的營業虧損635,000美元和5,000美元 和2022年12月31日分別為347,000美元和325,000美元 分別截至2024年6月30日和2023年6月30日的六個月。截至2023年12月31日和 2024年6月30日，我們的累計赤字約為350美元萬和410美元萬， 分別進行了分析。我們投入了幾乎所有的財政資源來設計和 開發我們的C&C候選產品，包括臨床前研究和臨床開發 並為這些行動提供一般和行政支助。我們希望我們的 在可預見的未來，隨著我們臨床的繼續，費用和運營虧損將會增加 開發我們的C&C候選產品，以提供對抗過敏原、流感的屏障 和新冠肺炎從接觸鼻上皮組織和開發其他候選產品 使用我們的T&T平臺技術進行原料藥的鼻腔給藥。我們最終有能力 實現收入和盈利取決於我們成功完成的能力 開發我們的C&C候選產品和任何未來的候選產品，請獲得 獲得必要的監管批准，並成功製造、營銷和商業化 我們的候選產品。

我們 預計我們的費用將因多種因素大幅增加，包括我們：

至 到目前為止，我們主要通過出售股權證券、某些股東發放的可轉換貸款、 我們從以色列創新機構(IIA)獲得的支付特許權使用費和非特許權使用費的贈款。任何數量的 未來的經營虧損將在一定程度上取決於我們未來支出的比率以及我們通過股權獲得資金的能力 或債務融資、戰略合作或贈款。即使我們獲得了監管部門的批准，可以銷售一種或多種候選產品， 我們未來的收入將取決於這些候選產品獲得批准的任何市場的規模，以及我們實現 對於這些候選產品，有足夠的市場接受度、定價和第三方付款人的報銷。此外，運營虧損 我們產生的收益可能在每個季度和每年都有很大的波動，因此，對我們的結果進行逐期比較 可能不是我們未來業績的一個很好的指標。其他意想不到的成本也可能出現。

我們 從未從候選產品銷售中產生任何收入，並且可能永遠不會盈利。

我們 沒有產品獲准在任何司法管轄區營銷，並且我們從未從候選產品銷售中產生任何收入。我們 創造收入和實現盈利能力的能力取決於我們單獨或與戰略合作夥伴一起成功實現 完成我們候選產品的開發並獲得商業化所需的監管和營銷批准，或 任何未來的候選產品。我們預計至少在明年不會從候選產品銷售中產生收入。我們 從候選產品銷售中產生未來收入的能力將在很大程度上取決於我們的能力：

連 如果我們的候選產品或任何未來的候選產品被批准進行營銷和銷售，我們預計將產生顯著的增量 與此類候選產品商業化相關的成本。如果我們被要求，我們的費用可能會超出預期 FDA、EMA或其他國內或國外的監管機構，或醫療中心的道德委員會，以改變我們的製造 除了我們目前預期的研究之外，還可以進行臨床研究、非臨床研究或其他類型的研究。 即使我們成功地獲得監管部門的批准，將我們的候選技術產品或任何未來的候選產品推向市場， 我們從這些候選產品中獲得的收入將在一定程度上取決於候選產品標籤的寬度、尺寸 在我們獲得監管機構批准此類產品候選的地區市場中，此類產品的可接受價格 候選人，我們是否有能力以任何價格獲得此類產品的報銷，無論我們是否擁有這方面的商業權利 此類產品候選產品已獲批准的地區以及與製造和營銷此類產品相關的費用 這些市場的候選者。因此，即使獲得批准，我們可能也不會從銷售此類候選產品中獲得大量收入。 此外，如果我們不能從銷售我們批准的候選產品中獲得可觀的收入，我們可能會被迫削減 或者停止我們的行動。由於候選產品開發中涉及的風險和不確定性很多，因此難度很大 預測增加開支的時間或數額，或我們何時或是否能夠實現或保持盈利。

我們 預計我們將需要籌集大量額外資金，但這些資金可能無法以可接受的條件提供，或者根本無法提供。失敗 爲了以可接受的條款及時獲得資金，我們可能需要減少、推遲或終止我們的候選產品” 開發工作或其他操作。

我們 目前正在通過多個適應症的臨床前和臨床開發來推進我們的C & C候選產品，以便 以獲得監管機構的批准。開發候選產品的成本很高，我們預計我們的研發費用將會增加 與我們正在進行的活動密切相關，特別是當我們通過臨床試驗和監管推進候選產品時 批准。此外，我們預計將產生與上市公司運營相關的額外持續成本。

到 迄今爲止，我們主要通過出售股權證券爲我們的運營提供資金。截至2024年6月30日，我們有現金、現金等值物 23，000美元。我們將需要大量額外融資來資助我們的運營。我們未來的資金需求將取決於許多 因素，包括但不限於： 

識別 潛在候選產品以及進行臨床前測試和臨床試驗是一個耗時、昂貴且不確定的過程 這需要數年時間才能完成，而且我們可能永遠不會生成獲得營銷批准和實現所需的必要數據或結果 候選產品銷售。此外，我們的候選產品如果獲得批准，可能無法取得商業成功。我們的產品 候選產品收入（如果有的話）將來自或基於可能無法在市場上銷售的候選產品的銷售 如果有的話，很多年了。因此，我們需要繼續依賴額外融資來實現我們的業務目標。任何 額外的籌款工作可能會分散我們管理層的日常活動，這可能會對我們的能力產生不利影響 開發我們的候選產品並使其商業化。

我們 無法保證將以足夠的金額或我們可以接受的條款（如果有的話）以及任何條款提供融資 融資可能會對我們股東的利益或權利產生不利影響。即使我們相信我們有足夠的資金 當前或未來的運營計劃，如果市場條件有利或我們有具體的戰略，我們可能會尋求額外的資本 考慮因素。我們發行額外證券（無論是股權還是債務），或此類發行的可能性，可能會導致 我們股票的市場價格將會下跌。此外，我們籌集額外資本的能力可能會受到潛在惡化的不利影響 全球經濟狀況以及美國信貸和金融市場最近的擾亂和波動， 由於COVID-19大流行的死灰復燃，全球範圍內的疫情。

到 當我們通過出售股權或可轉換債務證券籌集資本時，您的所有權權益將被稀釋， 此類證券的條款可能包括清算或對您作爲股東的權利產生不利影響的其他偏好。債務 融資（如果有的話）可能涉及限制我們的運營或承擔額外債務的能力的契約。如果我們籌集資金 通過與第三方的合作和許可安排，可能有必要放棄對我們技術的某些權利 或我們的候選產品，或以對我們不利的條款授予許可證。

如果 我們無法以可接受的條款及時獲得資金，我們可能會被要求大幅削減、推遲或停止 我們的一個或多個研究、開發或製造計劃或任何批准的候選產品的商業化，或 無法按照需要擴大我們的業務或以其他方式利用我們的商業機會，這可能會對我們的業務產生重大影響 業務、財務狀況和經營業績。

我們 財務報表包含一個解釋性段落，涉及對我們繼續作爲持續經營企業的能力的重大懷疑，其中 可能會阻止我們以合理的條件或根本無法獲得新的融資。

我們的 截至2023年12月31日的年度經審計財務報表包含一段解釋性段落，涉及對以下事項的重大懷疑 我們作爲一家持續經營的企業繼續存在的能力。自成立以來，我們每年都有淨虧損，其中淨虧損約 截至2023年12月31日的年度爲60萬美元，截至2022年12月31日的年度爲77.9萬美元，淨虧損約爲 截至2024年6月30日的6個月爲58.8萬美元，截至2023年6月30日的6個月爲19.1萬美元。這些事件和條件，以及 對於其他事項，表明存在重大不確定性，可能會對我們繼續前進的能力產生重大懷疑 擔憂。2023年的財務報表不包括這種不確定性可能導致的任何調整。這 持續經營意見可能會大大限制我們通過發行股票或債務證券籌集額外資金的能力。 或者是其他原因。進一步的財務報表可包括一段關於我們作爲持續經營企業繼續經營的能力的解釋性段落。 在我們能夠產生可觀的經常性收入之前，我們預計將通過債務或股權融資來滿足我們未來的現金需求。我們 我們不能確定是否會以可接受的條件提供額外的資金，如果有的話。如果沒有資金，我們可能會 被要求在以下方面推遲、縮小或取消研究或開發計劃或商業化努力 給我們的候選產品。這可能會讓人對我們作爲一家持續經營的企業繼續下去的能力產生很大的懷疑。

風險 與候選產品的發現、開發和臨床測試相關

我們 取決於我們即將到來的臨床試驗中患者的入組情況，以繼續開發我們的候選產品。

我們 打算進行臨床試驗，作爲我們候選產品開發的一部分。我們預計在這些試驗中獲得數據的時間是 取決於我們招募足夠合格患者的能力以及之前需要招募的隊列的數量和規模 觀察相關試驗的劑量增加和擴展組的活動（如果完全實現的話）。集團不能保證 我們將在預期或根本完成招募或獲得試驗數據。及時完成臨床試驗 根據他們的協議，除其他外，取決於我們招募足夠數量的患者的能力 符合我們的納入和排除標準以及我們根據需要監測這些患者的能力。

我們 由於各種原因，在我們的臨床試驗中可能會遇到患者登記的困難。患者登記受到以下因素的影響 許多因素包括患者群體的大小和性質、試驗的資格標準、臨床試驗的設計 試驗，分析試驗的主要終點所需的患者群體的大小，患者與 研究地點，我們招募具有適當能力和經驗的臨床試驗研究人員的能力，招募人數 臨床站點，我們獲得和維護患者同意的能力，參加臨床試驗的患者退出的風險 完成前的試驗和相互競爭的臨床試驗(包括我們正在或將進行的其他臨床試驗 未來)以及臨床醫生和患者對正在研究的藥物的潛在優勢的看法 其他可用的治療方法，或針對同一靶點的競爭藥物，以及可能被批准用於這些適應症的任何新藥 我們正在調查。

此外， 我們必須爭奪符合嚴格參與要求的臨床地點、臨床醫生和有限數量的患者 在臨床試驗階段此外，由於臨床試驗的保密性質，我們不知道有多少符合條件的患者 參加了競爭性研究，因此我們無法參加我們的臨床試驗。我們的臨床試驗可能會推遲 或因無法招募足夠的患者而終止。延遲或無法滿足計劃的患者入組可能會導致 成本增加以及試驗的延遲或終止，這可能會對我們開發候選產品的能力產生有害影響。 雖然我們的T & t平台僅處於臨床前開發的早期階段，但上述和類似的監管風險 隨着我們T & t平台的開發進展，可能會影響我們的業務、運營業績和前景。

我們 可能無法收到或可能延遲收到我們的C & C候選產品或未來產品的必要許可或批准 候選人，以及未能及時獲得我們的C & C候選產品或未來候選產品的必要許可或批准 會對我們發展業務的能力產生不利影響。

在……裏面 美國，在我們可以銷售新的醫療設備，或新的用途，新的要求或對現有的重大修改之前 對於候選產品，我們必須首先獲得聯邦食品、藥物和化妝品法案第510(K)條的許可，或FFDCA， 或批准FDA的上市前批准申請或PMA，除非適用豁免。在橫斷面的審批過程中 FFDCA的510(K)或510(K)節，在設備可以上市之前，FDA必須確定建議的設備 等同於合法銷售的「謂詞」裝置，其定義爲先前已被清除的裝置 通過510(K)過程，1976年5月28日之前合法銷售的設備(修改前的設備)，最初是 根據批准的PMA和後來降級的設備或510(K)豁免設備在美國市場上銷售。「實質上等同」， 建議的裝置必須具有與謂詞裝置相同的預期用途，並且具有與 斷言裝置或具有不同技術特徵，不會引起不同的安全性或有效性問題 而不是謂詞裝置。有時需要臨床數據來支持實質上的等效性。在獲得PMA批准的過程中， FDA必須部分基於大量數據來確定擬議的設備對於其預期用途是安全和有效的，包括， 但不限於技術、臨床前、臨床試驗、製造和標籤數據。對於PMA，FDA正在做出決定 對於已標記的適應症，必須確定可能的益處大於該設備的可能風險，並且必須 是安全和有效的合理保證。

修改 通過PMA申請獲得批准的候選產品通常需要FDA批准。同樣，所做的某些修改 通過510(K)認證的候選產品可能需要新的510(K)認證。PMA審批和510(K)審批流程 可能是昂貴的、冗長的和不確定的。FDA的510(K)審批過程通常需要3到12個月的時間，但也可以持續 更久。獲得PMA的過程比510(K)許可過程成本高得多，也不確定，通常需要一次 到三年，甚至更長，從申請提交給FDA的時間。此外，PMA通常要求性能 一項或多項臨床試驗。儘管需要時間、精力和成本，但設備可能不會獲得FDA的批准或批准。任何延遲或故障 獲得必要的監管許可或批准可能會損害我們的業務。此外，即使我們獲得了監管許可， 或批准，它們可能包括對使用該設備的指示的重大限制或其他限制或要求， 這可能會限制該設備的市場。

在……裏面 在美國，我們預計將採取多步驟的方式進行監管審批過程。評審過程是一個迭代的過程 可能比我們預期的更昂貴和耗時，我們最終可能不會成功地完成審查過程和 FDA可能不會及時批准我們的510(K)申請，或者根本不批准。如果獲得批准，對我們C&C產品的任何修改 以前未通過的候選人可能要求我們提交新的510(K)申請並獲得批准，或提交PMA 並在實施變更之前獲得FDA的批准。具體地說，對510(K)計劃許可的設備進行的任何修改都可能顯著 影響其安全性或有效性，或會對其預期用途、設計或製造構成重大變化的，需要新的 510(K)批准或可能批准PMA。FDA要求每個製造商首先做出這一決定， 但FDA可能會審查任何製造商的決定。FDA可能不同意我們關於新的許可或 批准是必要的。我們可能會在未來修改或添加我們認爲不需要新的510(K)的功能 PMA的批准或批准。如果FDA不同意我們的決定並要求我們提交新的510(K)通知或PMA 對我們以前批准的候選產品提出的修改申請，我們已經得出結論，新的批准或批准 是不必要的，我們可能被要求停止營銷或召回修改的候選產品，直到我們獲得批准或批准， 我們可能會受到監管部門的巨額罰款或處罰。如果FDA要求我們接受更長時間、更嚴格的檢查 對於未來的候選產品或對現有候選產品的修改超出了我們的預期，產品候選介紹 或者修改可能會被推遲或取消，這可能會對我們的業務增長能力產生不利影響。

的 FDA可以出於多種原因推遲、限制或拒絕醫療器械的許可或批准，包括：

在……裏面 爲了在歐盟成員國或歐盟銷售我們的候選產品，我們的候選產品必須遵守一般 《歐盟醫療器械條例》(歐盟第2017/745號條例)的安全和性能要求，該條例廢除並取代了 歐盟醫療器械指令(理事會指令93/42/EEC)。遵守這些要求是能夠貼上 歐洲符合性，或CE，標誌着我們的候選產品，沒有它，它們就不能在歐盟銷售或營銷。全部爲內科 在歐盟市場上投放市場的設備必須符合歐盟醫療標準附件I中規定的一般安全和性能要求 設備法規包括要求醫療設備的設計和製造方式必須在正常情況下 使用條件，它是適合其預期用途的。醫療器械必須安全有效，不得損害臨床 患者的狀況或安全，或使用者的安全和健康，以及(如適用)其他人的安全和健康，前提是 任何可能與使用它們相關的風險，在與患者的益處進行權衡時，都構成可接受的風險，並且 符合高水平的健康和安全保護，考慮到公認的最先進水平。這個 歐盟委員會通過了適用於醫療器械的各種標準。這些標準包括管理共同要求的標準， 例如醫療電氣設備的滅菌和安全以及某些類型醫療器械的產品標準。確實有 還協調了與設計和製造有關的標準。雖然不是強制性的，但遵守這些標準被視爲最容易的 將滿足一般安全和性能要求的方式作爲實際事項，因爲它創建了一個可推翻的推定，即 設備滿足一般安全和性能要求。

至 證明符合一般安全和性能要求，我們必須經過合格評估程序， 根據醫療設備的類型及其(風險)分類而有所不同。作爲一般規則，醫療符合性的示範 除其他事項外，具有一般安全和性能要求的設備及其製造商必須基於評估 支持候選產品在正常使用條件下的安全性和性能的臨床數據。具體地說，一個製造商 必須證明設備在正常使用條件下達到了預期的性能，已知和可預見的風險， 以及任何不良事件，在與其預期履行的利益進行權衡時，都是最小化和可接受的，並且任何索賠 關於該裝置的性能和安全性的說法有適當的證據支持。除低風險醫療器械(第一類)外， 製造商可以根據對其候選產品的符合性的自我評估發佈EC符合性聲明 符合一般安全和性能要求(除與無菌、計量或重複使用有關的任何部件外) 合格評定程序要求歐盟成員國認可或指定的組織介入 進行符合性評估，或通知機構。根據相關的合格評定程序，被通知機構將 通常對我們設備的製造、設計和最終檢查的技術文件和質量體系進行審核和檢查。 如果認爲相關候選產品符合相關的基本要求，則通知機構將頒發證書 符合性，製造商將其用作其自身符合性聲明的基礎。然後，製造商可以應用CE標誌 該設備允許該設備在整個歐盟範圍內投放市場。如果我們未能遵守適用的歐盟法律，並且 法規和相應的歐盟成員國法律，我們將無法在我們的候選產品上貼上CE標誌，這將阻止 美國禁止在歐盟內銷售這些產品。

的 上述歐盟規則通常適用於歐洲經濟區（EEA），該區由27個歐盟成員國組成， 挪威、列支敦士登和冰島。不遵守上述要求也會阻止我們銷售我們的候選產品 在這三個國家。

我們 不計劃與FDA的CDRH舉行提交前會議來確認II類醫療器械路徑的潛力 根據我們的PL-15和PL-16候選產品的重新分類請求，直到本次首次公開募股完成後. 如果我們在從頭開始途徑下被拒絕提交，可能需要我們通過不同的途徑，例如PMA途徑， 這可能會導致我們的設備的審批流程更加複雜。

我們 不打算與FDA的CDRH舉行提交前會議，以確認II類醫療器械路徑的可能性 根據對我們的PL-15和PL-16候選產品的從頭分類請求，直到首次公開募股完成後。 如果FDA不同意我們對第二類新產品下的PL-15和PL-16候選產品的監管評估 FDA可能會要求我們接受比我們預期更長、更嚴格的檢查。這項檢查可能涉及 尋求PMA，這是FDA評估III類醫療的安全性和有效性的科學和監管審查過程 設備。與51萬或De Novo相比，PMA提交的材料必須符合更嚴格的標準，以證明設備的安全性和有效性。 通常，III類設備需要包括人類參與者在內的實驗室測試和臨床試驗。PMA是最嚴格的 FDA要求的設備營銷應用程序的類型。PMA的批准是基於FDA確定PMA含有足夠的 有效的科學證據，以確保設備的預期用途是安全和有效的(S)。PMA應用程序通常包括 關於該設備的廣泛信息，包括在該設備上進行的臨床測試的結果和對 製造過程。如果我們被要求進行PMA，我們的候選產品可能會推遲進入市場 意義重大。

立法 或者美國或歐盟的監管改革可能會使我們獲得監管許可變得更加困難和成本更高 或批准我們的候選產品或在許可或批准後製造、營銷或分銷我們的候選產品 得到了 

從… 有時，國會會起草和提交立法，這些立法可能會顯著改變管理 醫療器械的監管。此外，FDA可能會改變其審批政策，採用額外的法規或修訂 現有法規，或採取其他行動，可能會阻止或推遲對我們未來產品候選產品的批准或批准 開發或影響我們及時修改目前已獲批准的候選產品的能力。在過去幾年裏， FDA建議對其510(K)審批流程進行改革，這些建議可能包括增加對臨床數據的要求 以及更長的審查期，或者可能使製造商更難對其產品使用510(K)審批過程 候選人。例如，2018年11月，FDA官員宣佈了FDA打算採取的即將採取的步驟，以實現上市前的現代化 根據FDCA第510(K)條規定的通知途徑。在其他方面，FDA宣佈，它計劃制定提案，以 推動製造商利用510(K)途徑使用較新的謂詞設備。這些建議包括計劃潛在地 日落某些在510(K)清除路徑下用作謂詞設備的較舊設備，並可能發佈一份列表 在證明與10年以上的斷言設備基本等價的基礎上已被清除的設備的百分比 年長的。2019年5月，FDA就這些建議徵求公衆反饋。FDA要求公衆就是否應該考慮 某些操作可能需要新的權限，例如是否日落某些用作謂詞設備的舊設備 在510(K)清除途徑下。這些提案尚未最終敲定或通過，FDA可能會與國會合作實施 通過立法提出這樣的建議。因此，目前還不清楚任何提案如果被採納，可能在多大程度上增加額外的 對我們的監管要求，可能會推遲我們獲得新的510(K)許可的能力，增加合規成本，或限制 我們有能力維持目前的淨空，或者以其他方式創造競爭，這可能會對我們的業務產生負面影響。

更多 最近，在2019年9月，FDA最終確定了指導方針，描述了一項可選的「基於安全和性能」的上市前審查 根據510(K)爲「某些已被廣泛理解的設備類型」的製造商提供基本等價證明的途徑 通過證明這種裝置符合FDA建立的客觀安全和性能標準，從而避免了 製造商需要將其醫療設備的安全性和性能與許可中的特定斷言設備進行比較 進程。FDA打算開發和維護一份適用於「基於安全和性能」途徑的設備類型清單 並將繼續開發特定於產品的指導文件，以確定每種設備類型的性能標準，例如 以及在可行的情況下指導文件中建議的測試方法。FDA可以建立班級的表現標準 我們或我們的競爭對手正在尋求或目前已經獲得許可的設備，目前還不清楚這種性能在多大程度上 如果建立標準，可能會影響我們獲得新的510(K)許可的能力，或者以其他方式造成競爭，這可能會帶來負面影響 影響我們的業務。

在 此外，FDA經常以可能顯着影響我們業務的方式修訂或重新解釋FDA法規和指南 以及我們的候選產品。任何新的法規、法規或對現有法規的修訂或重新解釋都可能施加額外的規定 成本或延長任何未來候選產品的審查時間，或使其更難獲得許可或批准，製造， 營銷或分銷我們的候選產品。我們無法確定法規、法規、法律解釋或 政策（何時頒佈、頒佈或採用）可能會對我們未來的業務產生影響。這些變化除其他外， 要求：在獲得許可或批准之前進行額外測試;製造方法變更;召回、更換或停產 我們的候選產品;或額外的記錄保存。

的 FDA和其他監管機構的政策可能會發生變化，並且可能會頒佈額外的政府法規， 可能會阻止、限制或延遲對我們未來候選產品的監管許可或批准。我們無法預測可能性，自然 或美國或國外未來立法或行政行動可能產生的政府監管範圍。 如果我們緩慢或無法適應現有要求的變化或新要求或政策的採用，或者我們沒有 如果能夠維持監管合規性，我們可能會失去我們可能已經獲得但可能無法實現的任何營銷批准或許可 或維持盈利能力。

對 2017年4月5日，歐洲議會通過了《醫療器械法規》（第2017/745號法規），廢除並取代 歐盟醫療器械指令。與必須實施到歐洲經濟區成員國國家法律中的指令不同，這些法規 將直接適用，即無需在所有歐洲經濟區成員國通過歐洲經濟區成員國實施這些規定的法律 旨在消除歐洲經濟區成員國之間目前在醫療器械監管方面的差異。醫療器械法規， 旨在在整個歐洲經濟區建立統一、透明、可預測和可持續的監管框架 用於醫療設備，並確保高水平的安全和健康，同時支持創新。醫療器械法規已成爲 適用於2021年5月26日。除其他外，新的醫療器械法規包括：

These modifications may have an effect on the way we conduct our business in the EEA.

We are heavily dependent on the success of our C&C product candidates, including obtaining regulatory approval to market our C&C product candidates in the United States and the European Union.

To date, we have invested substantially all of our efforts and financial resources to research and develop our C&C technology, including conducting preclinical studies, developing and securing our intellectual property portfolio for our product candidates and technology. Our future success is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more of our current and future product candidates. Our product candidates’ marketability is subject to significant risks associated with successfully completing current and future clinical trials, including:

Many of these clinical, regulatory and commercial risks are beyond our control. Accordingly, we cannot assure you that we will be able to advance our C&C product candidates and any future product candidates through clinical development, or to obtain regulatory approval of or commercialize any product candidates. If we fail to achieve these objectives or overcome the challenges presented above, we could experience significant delays or an inability to successfully commercialize our C&C product candidates and any future product candidates. Accordingly, we may not be able to generate sufficient revenues through the sale of our product candidates to enable us to continue our business.

Additionally, approval of a product candidate in the United States by the FDA does not ensure approval of such product candidate by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. We may never obtain approval outside of the United States, which would limit our market opportunities and adversely affect our business.

Regulatory approval processes of the FDA, EMA and comparable foreign regulatory authorities are lengthy, time-consuming and unpredictable, and if we are ultimately unable to obtain regulatory approval for our current product candidates or any future product candidates, our business may fail.

The research, development, testing, manufacturing, labeling, packaging, approval, promotion, advertising, storage, recordkeeping, marketing, distribution, post-approval monitoring and reporting and export and import of drug product candidates are subject to extensive regulation by the FDA, the EMA and by foreign regulatory authorities in other countries. These regulations differ from country to country. To gain approval to market our T&T platform product candidates and future product candidates, we must provide data from well-controlled clinical trials that adequately demonstrate the safety and efficacy of the product candidates for the intended indication to the satisfaction of the FDA, EMA or other regulatory authority. We have not yet obtained regulatory approval to market any product in the United States or any other jurisdiction. The FDA, EMA or other regulatory agencies can delay, limit or deny approval of our T&T platform product candidates or any future product candidate for many reasons, including:

In the United States, we will be required to submit an NDA to obtain FDA approval before marketing our T&T platform product candidate. An NDA must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and efficacy for each desired indication. In the case of an NDA covered by Section 505(b)(2), we may rely in part on data not developed by us and for which we have not obtained a right of reference or use, including published scientific literature or the FDA’s findings of safety and/or effectiveness for a previously approved drug. The NDA must also include significant information regarding the chemistry, manufacturing and controls for the product candidates. The FDA may further inspect our manufacturing facilities to ensure that the facilities can manufacture any product candidate and any product candidates, if and when approved, in compliance with the applicable regulatory requirements, as well as inspect our clinical trial sites to ensure that our trials are properly conducted. Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and approval may not be obtained. Upon submission of an NDA, the FDA must make an initial determination that the application is sufficiently complete to accept the submission for filing. We cannot be certain that any submissions will be accepted for filing and review by the FDA, or ultimately be approved. If the application is not accepted for review or approval, the FDA may require that we conduct additional clinical or preclinical trials, or take other actions before it will reconsider our application. If the FDA requires additional trials or data, we would incur increased costs and delays in the marketing approval process, which may require us to expend more resources than we have available.

Regulatory authorities outside of the United States, such as in the European Union, also have requirements for approval of drugs for commercial sale with which we must comply prior to marketing in those areas. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of a product candidate. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and obtaining regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. However, the failure to obtain regulatory approval in one jurisdiction could have a negative impact on our ability to obtain approval in a different jurisdiction. Approval processes vary among countries and can involve additional product candidate testing and validation and additional administrative review periods. Seeking foreign regulatory approval could require additional non-clinical studies or clinical trials, which could be costly and time consuming. Foreign regulatory approval may include all of the risks associated with obtaining FDA approval. For all of these reasons, if we seek foreign regulatory approval for any product candidate, we may not obtain such approvals on a timely basis, if at all.

Even if we eventually complete clinical testing and receive approval of any regulatory filing for a product candidate, the FDA may grant approval contingent on the performance of costly and potentially time-consuming additional post-approval clinical trials or subject to contraindications, black box warnings, restrictive surveillance or Risk Evaluation and Mitigation Strategies, or REMS. Further, the FDA, EMA or other foreign regulatory authorities may also approve a product candidate for a more limited indication or a narrower patient population than we originally requested, and these regulatory authorities may not approve the labeling that we believe is necessary or desirable for the successful commercialization of any product candidate. Following any approval for commercial sale of a product candidate, certain changes to the product candidates, such as changes in manufacturing processes and additional labeling claims, as well as new safety information, will be subject to additional FDA notification, or review and approval. Also, regulatory approval for any product candidate may be withdrawn. To the extent we seek regulatory approval in foreign countries, we may face challenges similar to those described above with regulatory authorities in applicable jurisdictions. Any delay in obtaining, or inability to obtain, applicable regulatory approval for our T&T platform product candidates or any future product candidate would delay or prevent commercialization of such product candidate and would thus negatively impact our business, results of operations and prospects. While we are only in the early stages of pre-clinical development for our T&T platform, the foregoing and similar regulatory risks may impact our business, results of operations and prospects as we progress with the development of our T&T platform.

Clinical drug development is difficult to design and implement and involves a lengthy and expensive process with uncertain outcomes.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Additionally, we are only in the early stages of pre-clinical development for our T&T platform. A failure of one or more of our clinical trials can occur at any time during the clinical trial process. We do not know whether future clinical trials, if any, will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all. Clinical trials can be delayed, suspended or terminated for a variety of reasons, including failure to:

我們 臨床試驗期間或臨床試驗的結果也可能會經歷許多不可預見的事件，這可能會延遲或阻止我們的能力 獲得營銷批准或商業化任何候選產品，包括：

在……裏面 此外，新冠肺炎疫情死灰復燃造成的破壞可能會增加我們遇到此類困難的可能性 啓動、招募、進行或完成我們計劃的和正在進行的臨床試驗。我們也可能會遇到延誤，如果臨床 由我們、進行此類試驗的機構的IRBs暫停或終止試驗，由試驗的 數據安全監測委員會，由FDA、EMA或其他監管機構負責。此類主管部門可暫停或終止下列一項或多項 我們的臨床試驗由於許多因素，包括我們沒有按照相關法規進行臨床試驗 要求或臨床方案，FDA、EMA或其他監管機構對臨床試驗操作或現場的檢查 導致實施臨床擱置、不可預見的安全問題或不良副作用、未能證明從 使用藥物，政府法規或行政行動的變化，或者缺乏足夠的資金來繼續臨床試驗。

此外， 在美國境外進行臨床試驗，正如我們計劃爲我們的候選產品和任何未來的候選產品所做的那樣， 存在額外風險，可能會推遲我們臨床試驗的完成。這些風險包括入組患者未能參加 由於醫療保健服務或文化習俗的差異，美國以外的國家遵守臨床協議， 管理與外國監管計劃相關的額外行政負擔以及相關的政治和經濟風險 對於這樣的外國。

If we experience delays in completing any clinical trial of a product candidate or successfully obtaining regulatory approval, the commercial prospects of such product candidate may be harmed, and our ability to generate product candidates revenues from such product candidate will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product candidates sales and generate revenues. Any of these occurrences may significantly harm our business and financial condition. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

If the FDA does not conclude that our T&T platform product candidate satisfies the requirements under Section 505(b)(2) of the FFDCA, or Section 505(b)(2), or if we are unable to utilize the hybrid application pathway in the European Union, or if the requirements are not as we expect, the approval pathway for our T&T platform product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.

While we are only in the early stages of pre-clinical development for our T&T platform product candidates, we intend to utilize the FDA’s Section 505(b)(2) regulatory pathway, and the hybrid application pathway in the European Union, which is analogous to the Section 505(b)(2) pathway, to seek approval of our T&T platform product candidates. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, added Section 505(b)(2) to the FFDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from trials or studies that were not conducted by or for the applicant, and for which the applicant has not received a right of reference or use from the person by or for whom the investigations were conducted, which we believe could expedite the development program for our T&T platform product candidates by potentially decreasing the amount of preclinical and clinical data that we would need to generate in order to obtain FDA approval. However, while we believe that our T&T platform product candidates is a reformulation of an already-approved drug and, therefore, will be eligible for submission of an NDA under Section 505(b)(2), the FDA may disagree and determine that our T&T platform product candidates is not eligible for review under such regulatory pathway.

If we are unable to pursue these regulatory pathways as anticipated, we may need to conduct additional preclinical experiments and clinical trials, provide additional data and information and meet additional standards for regulatory approval. If this were to occur, the time and financial resources required to obtain FDA approval for T&T platform product candidates, and complications and risks associated with T&T platform product candidates, would likely increase significantly. Moreover, inability to pursue the Section 505(b)(2) or similar regulatory pathway could result in new competitive products reaching the market more quickly than T&T platform product candidates or any future product candidates, which would likely harm our competitive position and prospects. Even if we are allowed to pursue the Section 505(b)(2) or similar regulatory pathway, T&T platform product candidates may not receive the requisite approvals for commercialization, and there is no guarantee the 505(b)(2) or similar pathway would ultimately lead to faster product candidates’ development or earlier approval.

In addition, notwithstanding the approval of a number of products by the FDA under Section 505(b)(2) over the last few years, certain competitors and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section 505(b)(2) is successfully challenged, the FDA may be required to change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to special requirements designed to protect the patent rights of sponsors of previously approved drugs that are referenced in a Section 505(b)(2) NDA. These requirements may give rise to patent litigation and mandatory delays in approval of our potential future NDAs for up to 30 months depending on the outcome of any litigation. It is also not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing product candidates. If successful, such petitions can significantly delay, or even prevent, the approval of the new product candidates. However, even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition.

Moreover, even if our T&T platform product candidates or any future product candidates are approved under the Section 505(b)(2) pathway, as the case may be, the approval may be subject to limitations on the indicated uses for which the product candidates may be marketed or to other conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product candidates.

Our C&C and T&T technologies are novel technologies, which makes it difficult to accurately and reliably predict the time and cost of development and of subsequently obtaining regulatory approval of our C&C and T&T technologies product candidates or any future product candidates.

We have concentrated our efforts and product candidates research on our technologies, and our future success depends on the successful development of these technologies and product candidates based on them. There can be no assurance that any development problems we experience in the future related to our product candidates will not cause significant delays or unanticipated costs, or that such development problems can be solved. We may be unable to maintain and further develop sustainable, reproducible and scalable manufacturing processes, or transfer these processes to collaborators, which may prevent us from completing our clinical studies or commercializing our product candidates on a timely or profitable basis, if at all. To our knowledge, no regulatory authority has granted approval to any person or entity, including us, to market and commercialize therapeutics using our novel delivery system. We may never receive approval to market and commercialize any product candidates that utilize our technologies.

As an organization, we have not previously conducted pivotal clinical trials, and we may be unable to do so for any product candidates we may develop, including our T&T platform product candidates.

We will need to successfully complete pivotal clinical trials in order to obtain the approval of the FDA, EMA or other regulatory agencies to market our T&T platform product candidates or any future product candidates. Carrying out later-stage clinical trials and the submission of a successful NDA is a complicated process. As an organization, we have not previously conducted any later stage or pivotal clinical trials and have limited experience in preparing, submitting and prosecuting regulatory filings. Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials, including our ongoing Phase 3 trials, in a way that leads to marketing approval of our T&T platform product candidates. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing our T&T platform product candidates, which are in early stages of pre-clinical development. See “Risks Related to Our Reliance on Third Parties.” We rely on third parties to conduct certain elements of our preclinical and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.

We may find it difficult to enroll patients in our clinical trials due to various reasons, including possible disruption due to any resurgence of the COVID-19 pandemic, which could delay or prevent us from proceeding with such trials.

Identifying and qualifying patients to participate in our clinical trials is critical to our success. The timing of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we may experience delays in our clinical trials if we encounter difficulties in enrollment. Patient enrollment and retention in clinical trials depends on many factors, including the size of the patient population, the nature of the trial protocol, our ability to recruit clinical trial investigators with the appropriate competencies and experience, the existing body of safety and efficacy data with respect to the study drug, the number and nature of competing product candidates and ongoing clinical trials of competing drugs for the same indication, the proximity of patients to clinical sites, clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any drugs that may be approved for the indications we are investigating, the eligibility criteria for the trials, our ability to obtain and maintain patient consents and the risk that patients enrolled in clinical trials will drop out of the trials before completion.

We may not be able to identify, recruit and enroll a sufficient number of patients to complete our clinical trials because of the perceived risks and benefits of the product candidate under study, the availability and efficacy of competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients and the patient referral practices of physicians. We may also face challenges in identifying trial sites and enrolling patients in global trials such as our ongoing and planned clinical trials in the fourth quarter of 2025 for our C&C product candidates. If patients are unwilling to participate in our trials for any reason, the timeline for recruiting patients, conducting trials and obtaining regulatory approval of potential product candidates will be delayed.

Our product candidates and the administration of our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.

Undesirable side effects, including toxicology, caused by product candidates or any future product candidates, or the drugs encapsulated by such product candidates, could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, EMA or other regulatory agencies. Results of our trials could reveal a high and unacceptable severity and prevalence of these or other side effects. In such an event, our clinical studies could be suspended or terminated, and the FDA, EMA or other regulatory agencies could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications. Moreover, during the conduct of clinical trials, patients report changes in their health, including illnesses, injuries and discomforts, to their study doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions.

Drug-related, formulation-related and administration-related side effects could affect patient recruitment, the ability of enrolled patients to complete the clinical trials or result in potential product candidates liability claims, which could exceed our clinical trial insurance coverage. We do not currently have product candidates liability insurance and do not anticipate obtaining product candidates liability insurance until such time as we have received FDA, EMA or other comparable foreign authority marketing approval for one of our product candidates and such product candidates is being provided to patients outside of clinical trials.

Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such product candidates, a number of potentially significant negative consequences could result, including but not limited to:

While we are only in the early stages of pre-clinical development for our T&T platform, any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects.

Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize any of our product candidates, and the approval may be for a more narrow indication than we seek or be subject to other limitations or restrictions that limit its commercial profile.

We cannot commercialize a product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate. Even if our current or future product candidates meet safety and efficacy endpoints in pivotal clinical trials, the regulatory authorities may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. This may include approval of a product candidate for more limited indications than requested or they may impose significant limitations in the form of warnings. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product candidates’ development, clinical trials and the review process.

Regulatory authorities also may approve a product candidate for more limited indications than requested or they may impose significant limitations in the form of warnings or a REMS. These regulatory authorities may require precautions or contra-indications with respect to conditions of use or they may grant approval subject to the performance of costly post-marketing clinical trials. In addition, regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of any of our product candidates. While we are only in the early stages of pre-clinical development for our T&T platform, the foregoing and similar regulatory risks may impact our business, results of operations and prospects as we progress with the development of our T&T platform.

Even if we obtain regulatory approval for a product candidate, our product candidates and business will remain subject to ongoing regulatory obligations and review.

While we are only in the early stages of pre-clinical development for our T&T platform, if our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post- market information, including both federal and state requirements in the United States and comparable requirements outside of the United States. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the cleared intended use(s) for which the product candidates may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS as a condition of approval of our product candidates, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, EMA or other regulatory agencies and to comply with requirements concerning advertising and promotion for our product candidates. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product candidates’ approved label. As such, we may not promote our product candidates for indications or uses for which they do not have FDA, EMA or other regulatory agency approval. The holder of an approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product candidates, product candidates labeling, or manufacturing process. We could also be asked to conduct post-marketing clinical trials to verify the safety and efficacy of our product candidates in general or in specific patient subsets. An unsuccessful post-marketing trial or failure to complete such a clinical trial could result in the withdrawal of marketing approval. Furthermore, any new legislation addressing drug safety issues could result in delays in product candidates’ development or commercialization or increased costs to assure compliance. Foreign regulatory authorities impose similar requirements. If a regulatory agency discovers previously unknown problems with a product candidate, such as adverse events of unanticipated severity or frequency, or disagrees with the promotion, marketing or labeling of product candidates, such regulatory agency may impose restrictions on that product candidates or us, including requiring withdrawal of the product candidates from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our product candidates. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results will be adversely affected.

The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.

Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified product candidates from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and approve new product candidates can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs or modifications to approved drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Separately, in response to the COVID-19 pandemic, in March 2020, the FDA announced the postponement of most foreign and routine surveillance inspections of domestic manufacturing facilities, and only restarted domestic inspections on a risk-based basis in July 2020. Regulatory authorities outside the United States have adopted similar restrictions or other policy measures in response to the COVID-19 pandemic.

If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

We may be subject, directly or indirectly, to U.S. federal and state healthcare fraud and abuse laws, false claims laws, physician payment transparency laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Our current and future operations may be directly or indirectly through our relationships with U.S. healthcare providers, patients and other persons and entities, subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business or financial arrangements and relationships through which we research, market, sell and distribute our product candidates in the United States. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

Many states have analogous state laws and regulations, such as state anti-kickback and false claims laws, that may apply to our business practices, including but not limited to, research, distribution, sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. In addition, certain states require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government. Certain states and local jurisdictions require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers and register pharmaceutical sales representatives. Additionally, certain states also require pharmaceutical companies to file reports relating to pricing information or marketing expenditures and have laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, the ACA has strengthened these laws. For example, health care reform legislation, has among other things, amended the intent requirement of the U.S. Anti-Kickback statute and certain criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. Moreover, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Ensuring that our internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will likely be costly. It is possible that governmental authorities will conclude that our business practices, including arrangements we may have with physicians and other healthcare providers, some of whom may receive stock options as compensation for services provided, do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations were found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, possible exclusion from government funded healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and curtailment of our operations, any of which could substantially disrupt our operations. If the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Legislative or regulatory healthcare reforms in the United States may make it more difficult and costly for us to obtain regulatory clearance or approval of our product candidates and to produce, market and distribute our product candidates after clearance or approval is obtained.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory clearance or approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our product candidates. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our product candidates. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require:

In addition, in the United States, there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our products profitably. The pharmaceutical industry in the United States, as an example, has been affected by the passage of the ACA, which, among other things, imposed new fees on entities that manufacture or import certain branded prescription drugs and expanded pharmaceutical manufacturer obligations to provide discounts and rebates to certain government programs. There have been executive, judicial and Congressional challenges to certain aspects of the ACA. For example, on June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and the healthcare reform measures of the Biden administration will impact the ACA and our business.

Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. These changes include, among others, aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in 2013 and, due to subsequent legislative amendments to the statute, will remain in effect until 2032 unless additional Congressional action is taken. Congress is considering additional health reform measures.

Further, there has been particular and increasing legislative and enforcement interest in the United States with respect to drug pricing practices in recent years, particularly with respect to drugs that have been subject to relatively large price increases over relatively short time periods. There have been several recent U.S. Presidential executive orders, Congressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

For example, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to President Biden’s executive order, on September 9, 2021, the Department of Health and Human Services, or HHS, released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. Further, the IRA, among other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions will take effect progressively starting in fiscal year 2023. On August 29, 2023, HHS announced the list of the first ten drugs that will be subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry. Further in response to the Biden administration’s October 2022 executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the Centers for Medicare & Medicare Services, or CMS, Innovation Center which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It is unclear whether the models will be utilized in any health reform measures in the future. Further, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and in some cases, designed to encourage importation from other countries and bulk purchasing. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (SIP) proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada. Other states have also submitted SIP proposals that are pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs. In the future, there will likely continue to be proposals relating to the reform of the U.S. healthcare system, some of which could further limit coverage and reimbursement of drug products, including our product candidates. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Our results of operations could be adversely affected by the ACA and by other health care reforms that may be enacted or adopted in the future.

We face intense competition in an environment of rapid technological change and the possibility that our competitors may develop products and drug delivery systems that are similar, more advanced or more effective than ours, which may adversely affect our financial condition and our ability to successfully market or commercialize our product candidates.

的 我們經營的醫療器械和製藥行業競爭激烈，受到快速且重要的技術影響 變化我們目前意識到市場上和開發中的各種現有療法可能在未來與我們的療法競爭 候選產品，用於T & t技術在地方一級提供API的藥物輸送機制。其他方法也可以 用於預防或治療我們關注的任何適應症，並且新技術可能會出現在本地藥物中 交付.

我們 在美國和國際上都有競爭對手，包括大型跨國醫療器械和製藥公司。 我們的競爭對手可能會成功開發、收購或獨家許可更有效或成本更低的產品 比我們可能開發的任何候選產品，或更早地實現專利保護、監管批准、候選產品商業化 和市場滲透率。此外，我們的競爭對手開發的技術可能會成為我們潛在的候選產品 不經濟或過時，而且我們可能無法成功地營銷我們的候選產品以對抗競爭對手。

甚至 如果我們從FDA獲得並維持對T & t平台候選產品或其他候選產品的批准，我們 可能永遠不會在美國境外獲得批准，這將限制我們的市場機會並對我們的業務產生不利影響。

批准 FDA在美國對候選產品的審批並不能確保監管機構在 其他國家或司法管轄區，一個外國監管機構的批准並不能確保監管機構的批准 在其他國家或由食品和藥物管理局。然而，未能獲得FDA或其他監管機構的批准可能會帶來負面影響 影響我們在其他國家獲得批准的能力。我們的T&T平臺產品候選產品的銷售 美國以外的候選產品將受到管理臨床試驗和營銷的外國監管要求的約束 批准。即使FDA批准了候選產品的上市，外國的可比監管機構也 必須批准候選產品在這些國家的製造和營銷。審批程式因司法管轄區而異 並可能涉及不同於美國的要求和行政審查期限，而且比美國更繁重，包括 其他臨床前研究或臨床試驗。在美國以外的許多國家，候選產品必須獲得批准 申請報銷，然後才能批准在那個國家銷售。在某些情況下，我們打算為產品收取的價格 候選人，如果獲得批准，也要經過批准。

我們 打算向EMA提交營銷授權申請，以批准我們在歐盟的C&C產品候選， 但根據EMA的意見，獲得歐盟委員會的批准是一個漫長而昂貴的過程。即使 產品候選獲得批准時，適用的監管機構可以限制候選產品可以上市的適應症， 要求在候選產品標籤上貼上廣泛的警告，或要求昂貴且耗時的額外臨床試驗或報告 作為批准的條件。美國和歐盟以外國家的監管機構也有要求 用於批准產品候選，我們在這些國家/地區上市前必須遵守這些要求。獲得外國監管部門的批准 遵守外國監管要求可能會給我們帶來重大延誤、困難和成本，並可能延誤 或阻止我們的候選產品在某些國家/地區推出。

此外， 在一個國家進行的臨床試驗可能不被其他國家的監管機構接受。此外，監管機構的批准 候選產品可能會被撤回。如果我們不遵守監管要求，我們的目標市場將會減少， 我們充分發揮T & t平台候選產品或其他候選產品的市場潛力的能力將 受到損害，我們的業務、財務狀況、運營運績和前景將受到不利影響。

濫用 或標籤外使用我們的候選產品可能會損害我們在市場上的聲譽，導致傷害，從而導致候選產品 如果我們被認為參與了促銷活動，則會提起責任訴訟或導致監管機構進行昂貴的調查、罰款或制裁 這些用途中的任何一種都可能對我們的業務造成高昂的成本。

處方 藥品只能根據批准的標籤用於批准的適應症進行促銷。FDA和其他機構積極執行 禁止推廣標籤外用途的法律法規，以及一家被發現不當推廣標籤外用途的公司 使用可能承擔重大責任。我們將培訓我們的營銷和銷售人員不宣傳我們的候選產品， 如果獲得批准，用於任何標籤外用途。然而，我們不能阻止醫生在標籤外使用我們的候選產品 醫生認為適當的獨立專業醫學判斷。

如果 FDA、EMA或任何外國監管機構確定我們的宣傳材料或培訓構成標籤外宣傳 使用時，它可能會要求我們修改我們的培訓或宣傳材料，或使我們接受監管或執法行動，包括 發布或強制執行無標題信件，用於違規者，無需發出警告信、禁令、扣押， 民事罰款或刑事處罰。其他聯邦、州或外國執法當局也可能採取行動 根據其他監管機構（例如虛假索賠法），如果他們認為我們的業務活動構成了標籤外宣傳 使用，這可能會導致重大處罰，包括但不限於刑事、民事和行政處罰、損害賠償， 罰款、沒收、禁止參與政府醫療保健計劃以及限制我們的業務。

風險 與我們對第三方的依賴有關

我們 將依賴第三方來進行我們的臨床前研究和臨床試驗的某些部分，並為我們執行其他任務。 如果這些第三方未能成功履行其合同義務、未能滿足預期截止日期或遵守監管要求， 我們可能無法獲得監管部門的批准或將我們的候選產品商業化。

我們 將依賴包括CRO在內的第三方供應商來監控和管理我們正在進行的臨床前研究和臨床試驗的數據。 如果我們的CRO未能成功履行其合同職責或義務或未能在預期的最後期限內完成，如果他們需要更換 或者如果他們獲得的臨床數據的質量或準確性因未能遵守我們的臨床方案而受到影響， 由於法規要求或其他原因，我們的臨床試驗可能會延長、延遲或終止，並且我們可能無法獲得 監管機構批准我們的候選產品或成功將其商業化。我們將依靠這些CRO來執行我們的臨床前工作 研究和臨床試驗，我們只控制他們活動的某些方面。然而，我們將負責確保 我們的每項研究都是根據適用的協定、法律、法規和科學標準進行的，我們的 依賴供應商和CRO並不能免除我們的監管責任。我們和我們的CRO以及其他供應商將被要求 為了遵守良好的臨床實踐，cGMP、赫爾辛基宣言、國際協調會議指南向善 臨床實踐、適用的歐盟委員會臨床試驗指令、適用於進行的臨床試驗的法律法規 在其他地區，和良好的實驗室做法，或GLP，這是由FDA執行的法規和指南，主管 EEA成員國的權威機構，以及我們所有臨床候選產品的可比外國監管機構 發展。監管部門通過定期檢查研究贊助商、主要調查人員、 研究場地和其他承包商。如果我們或我們的任何CRO或供應商未能遵守適用的法規，包括Good Clinic 我們的臨床研究中產生的臨床數據可能被認為是不可靠的，FDA、EMA 或類似的外國監管機構可能會要求我們進行額外的臨床試驗，然後才能批准我們的營銷申請。 我們不遵守這些規定可能需要我們重複臨床試驗，這將推遲監管部門的批准過程。

如果 如果我們與這些第三方CRO或供應商的任何關係終止，我們可能無法與Alternative達成安排 CRO或供應商，或以商業上合理的條款這樣做。此外，我們的CRO不是我們的員工，除了可用的補救措施外 根據我們與這些CRO的協定，我們無法控制他們是否將足夠的時間和資源投入到我們正在進行的 臨床、非臨床和臨床前計劃。如果CRO沒有成功地履行其合同職責或義務或履行 預期截止日期，如果需要更換，或者如果他們獲得的臨床數據的質量或準確性因以下原因而受到影響 未能遵守我們的臨床方案、法規要求或其他原因，我們的臨床試驗可能會延長、推遲 或終止，我們可能無法獲得監管機構對我們的候選產品的批准或成功將其商業化。CRO可以 也產生了比預期更高的成本，這可能對我們的運營結果和商業前景產生不利影響 我們的產品候選，增加了我們的成本，推遲了我們創造收入的能力。

更換 或添加額外的CROs涉及額外的成本，並且需要管理時間和重點。此外，還有自然的過渡 新的合同研究人員開始工作的時期。因此，會出現延誤，這可能會嚴重影響我們滿足預期臨床需求的能力 開發時間表。儘管我們仔細管理與CROs的關係，但我們可能會遇到類似的挑戰或延遲 未來，這可能會對我們的業務、財務狀況和前景產生重大不利影響。

獨立 我們將聘請臨床研究人員和CROs進行臨床試驗可能不會投入足夠的時間或注意力 臨床試驗或能夠重複過去的成功。

我們 將依賴第三方（包括獨立臨床研究者和CROs）來進行我們的臨床試驗。CROs也可以提供協助 我們在數據收集和分析方面。有數量有限的第三方服務提供商和供應商專門或 擁有實現我們業務目標所需的專業知識。識別、資格認證和管理第三方服務的績效 提供商可能很困難、耗時，並導致我們的開發計劃延遲。

這些 調查人員和CROs將不是我們的員工，除了通過合同之外，我們將無法控制資源數量， 包括他們為我們的候選產品和臨床試驗投入的時間。如果獨立調查人員或CROs未能投入 有足夠的資源來開發我們的候選產品，或者如果其性能不達標，則可能會延遲或妥協 我們開發的任何候選產品的批准和商業化前景。此外，我們CROs的表現可能 也會因COVID-19大流行的任何死灰復燃而中斷，包括旅行或檢疫政策、 作為COVID-19患者的醫療保健提供者或優先考慮資源以應對COVID-19大流行的死灰復燃。

調查人員 我們的臨床試驗可能會不時擔任我們的科學顧問或顧問，並獲得相關補償 有這樣的服務。在某些情況下，我們可能需要向FDA或其他監管機構報告其中一些關係 當局FDA或其他監管機構可能會得出結論，認為我們與調查人員之間存在財務關係 利益衝突或以其他方式影響審判的解釋。因此，FDA或其他監管機構可能會質疑 適用臨床試驗地點生成的數據的完整性和臨床試驗本身的實用性可能會受到損害。 這可能會導致FDA或其他監管機構延遲批准或拒絕我們的營銷申請，因為 這種情況可能是，並且最終可能導致我們的一個或多個候選產品被拒絕營銷批准。

在 此外，使用第三方服務提供商要求我們向這些方披露我們的專有信息，這可能會 增加了此信息被挪用的風險。此外，FDA和其他監管機構要求我們遵守 制定標準（通常稱為GCP）來進行、記錄和報告臨床試驗，以確保數據和報告 結果可信、準確，試驗對象的權利、完整性和保密性受到保護。臨床失敗 研究者或CROs履行對我們的義務或遵守GCP程式可能會對臨床數據、結果產生不利影響 臨床研究或我們候選產品的開發並損害我們的業務。

我們 依賴第三方製造我們用來創建候選產品的原材料。如果我們的業務可能會受到損害 現有和潛在的第三方未能為我們提供足夠數量的這些材料和候選產品或未能提供 以可接受的質量水平或價格這樣做。

我們 依賴第三方供應商提供生產臨床前研究候選產品所需的某些原材料， 臨床試驗我們對原材料的可用性沒有任何控制權。如果我們或我們的製造商無法購買 這些原材料以可接受的條件、足夠的質量水平或足夠的數量（如果有的話）進行開發和商業化 我們的候選產品或任何未來的候選產品將被推遲或供應短缺，這將損害 我們有能力實現候選產品的開發目標或通過銷售任何批准的產品產生收入 候選人

甚至 在我們建立了自己的符合CGM的製造能力後，我們打算繼續依賴第三方供應商 對於這些原材料，這將繼續使我們面臨製造風險，包括：

某些 我們的原材料供應商將被要求符合CGM，並為適用成分建立藥品主文件 然後我們才能提交T & t平台候選產品的NDA。如果這些供應商未能成功履行其合同 關稅或根據監管要求製造原材料，我們將無法按計劃提交NDA 或完成或可能推遲完成批准我們的T & t平台候選產品所需的臨床試驗。在 在這種情況下，我們可能需要找到適當的替代第三方關係，該關係可能不容易獲得或不可接受 條款，這將在批准我們的C & C候選產品之前導致額外的延遲或費用增加，從而 對我們的業務、財務狀況、經營運績和前景產生重大不利影響。

此外， 我們尚未與某些第三方製造商達成具有約束力的協議來生產原材料和產品 我們用來製造我們的候選產品。雖然我們打算依靠第三方製造商提供原材料和產品 為了支持我們候選產品的製造以實現商業化，我們尚未與某些製造商達成協議。 我們可能無法與製造商談判具有約束力的協議，以支持我們在商業上合理的商業化活動 屆

Our reliance on third parties requires us to share our intellectual property, including trade secrets, which increases the possibility that a competitor will discover them or that our intellectual property will be misappropriated or disclosed.

Because we rely on third parties to provide us with the materials that we use to develop and, if appropriate in the future, manufacture our product candidates or approved product candidates, we may, at times, share trade secrets and intellectual property with such third parties. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements, or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, such as trade secrets and intellectual property. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business.

Despite our efforts to protect our trade secrets and knowhow, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets by third parties. A competitor’s discovery of our trade secrets and knowhow would impair our competitive position and have an adverse impact on our business, financial condition, results of operations and prospects.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets. If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.

We intend to rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies and product candidates. Our success depends in large part on our ability to obtain and maintain patent and other intellectual property protection in the United States and in other countries with respect to our proprietary technology and product candidates. This ability depends to a large extent on identifying aspects of the technology that are patentable, that their exposure via patent applications would not provide a third party of engineering around capabilities and on the ability to generate and identify superior data that would present a comparative edge vis-à-vis third party technologies.

We have sought to protect our proprietary position by filing patent applications in the United States, with respect to our novel technologies and product candidates, which are important to our business. These patent applications will base international and national patent filings in countries of interest to our business, such as the United States, the European Union and Israel. Patent prosecution is expensive and time consuming, and we may not be able to file and prosecute our applications in the United States, the European Union and Israel, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.

As of October 2, 2024, our growing portfolio of patent applications consists of two families that disclose our technology. We cannot offer any assurances about which, if any, patents will issue in due time, the breadth of any such patent or whether any issued patents will be found invalid and unenforceable or will be threatened by third parties. Any successful opposition to these patents or any other patents owned by or licensed to us after patent issuance could deprive us of rights necessary for the successful commercialization of any product candidates that we may develop. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be reduced.

Further, the patent position of medical device and pharmaceutical companies generally is highly uncertain and involves complex legal and factual questions for which legal principles remain unsolved. This renders the patent prosecution process particularly expensive and time-consuming. There is no assurance that all potentially relevant prior art relating to our patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue, and even if such patents cover our product candidates, third parties may challenge their validity, enforceability, or scope, which may result in such patents being narrowed, found unenforceable or invalidated. Furthermore, even if they are unchallenged, our patent applications and any future patents may not adequately protect our intellectual property, provide exclusivity for our product candidates, or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

If we cannot obtain and maintain effective patent rights for our product candidates, we may not be able to compete effectively, and our business and results of operations would be harmed.

We may not have sufficient patent lifespan to effectively protect our product candidates and business.

Patents have a limited lifespan. The natural expiration of a patent is generally 20 years counted from its filing date (or PCT filing date in case it is derived from an international application). Although various extensions may be available, they are uncommon and the protection they afford, is limited. Even if any of our patent applications matures into issued patents, if we do not have sufficient patent terms or regulatory exclusivity to protect our product candidates, our business and results of operations will be adversely affected.

Changes in patent policy and national intellectual property laws could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any issued patents.

Changes in patent laws or interpretation of patent laws in the United States and other countries may diminish the value of any patents that may issue from our patent applications, or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing. We therefore cannot be certain that we were the first to make the invention claimed in our owned patent or pending applications, or that we were the first to file for patent protection of such inventions.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in our markets of interest. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. If other entities use trademarks similar to ours in different jurisdictions, or have senior rights to ours, it could interfere with our use of our current trademarks throughout the world.

If we are unable to maintain effective proprietary rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets.

In addition to the protection afforded by any patents that may be granted, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data, trade secrets and intellectual property by maintaining the physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets and intellectual property may otherwise become known or be independently discovered by competitors.

Although we expect all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information, or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed or that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Misappropriation or unauthorized disclosure of our trade secrets and intellectual property could impair our competitive position and may have a material adverse effect on our business. Additionally, if the steps taken to maintain our trade secrets and intellectual property are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret.

Intellectual property rights of third parties could adversely affect our ability to commercialize our product candidates, and we might be required to litigate or obtain licenses from third parties in order to develop or market our product candidate. Such litigation or licenses could be costly or not available on commercially reasonable terms.

Our competitive position may suffer if patents issued to third parties or other third party intellectual property rights cover our product candidates or elements thereof, or our manufacturing or uses relevant to our development plans. In such cases, we may not be in a position to develop or commercialize our product candidates unless we successfully pursue litigation to nullify or invalidate the third party intellectual property right concerned, or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms. There may also be pending patent applications that if they result in issued patents, could be alleged to be infringed by our product candidates. If such an infringement claim should be brought and be successful, we may be required to pay substantial damages, be forced to abandon our product candidates or seek a license from any patent holders. No assurances can be given that a license will be available on commercially reasonable terms, if at all.

It is also possible that we have failed to identify relevant third party patents or applications. Patent applications in the U.S. and elsewhere are published approximately 18 months after the earliest filing to which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our product candidates or technology could have been filed by others without our knowledge. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover our technologies, our product candidates or the use of our product candidates. Third party intellectual property right holders may also actively bring infringement claims against us. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in pursuing the development of and/or marketing of our product candidates. If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing our product candidates that are held to be infringing. We might, if possible, also be forced to redesign our product candidates so that we no longer infringe the third party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There have been many lawsuits and other proceedings involving patent and other intellectual property rights in the biotechnology, medical device and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions and reexamination proceedings before the USPTO and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing product candidates. As the medical device and pharmaceutical industry expands and more patents are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights of third parties.

Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture, or methods for treatment related to the use or manufacture of our product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any materials formed during the manufacturing process or any final product candidates itself, the holders of any such patents may be able to block our ability to commercialize such product candidates unless we obtain a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable.

Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture, or methods of use, the holders of any such patents may be able to block our ability to develop and commercialize the applicable product candidate unless we obtain a license or until such patent expires or is finally determined to be invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing product candidates or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.

Because our technology may require the use of proprietary rights held by third parties, the growth of our business will likely depend in part on our ability to acquire, in-license, or use these proprietary rights. In addition, our product candidates may require specific formulations to work effectively and efficiently and the rights to these formulations may be held by others. We may be unable to acquire or in-license any compositions, methods of use, processes, or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive. These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization capabilities.

For example, we sometimes collaborate with academic institutions to accelerate our preclinical research or development under written agreements with these institutions. Typically, these institutions provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue our program.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment. If we are unable to successfully obtain rights to required third-party intellectual property rights, we may have to abandon development of that program and our business and financial condition could suffer.

We may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our intellectual property or that of our licensors that we may acquire in the future. If we or a future licensing partner were to initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Under the AIA, the validity of U.S. patents may also be challenged in post-grant proceedings before the USPTO. The outcome following legal assertions of invalidity and unenforceability is unpredictable.

Interference proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patent or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Our defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third parties, or enter into development partnerships that would help us bring our product candidates to market.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our Ordinary Shares.

We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

We employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants, or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employees’ former employers or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be subject to claims challenging the inventorship of our intellectual property.

We may be subject to claims that former employees, collaborators or other third parties have an interest in or right to compensation with respect to our patent applications, future patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or claiming the right to compensation. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. To the extent that our employees have not effectively waived the right to compensation with respect to inventions that they helped create, they may be able to assert claims for compensation with respect to our future revenue. As a result, we may receive less revenue from future product candidates if such claims are successful which in turn could impact our future profitability.

Changes in United States and international patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

Our success is heavily dependent on intellectual property. Obtaining and enforcing patents in the medical device and pharmaceutical industries involve both technological and legal complexity. Therefore, obtaining and enforcing these patents is costly, time consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent United States Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on future actions by the United States Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain patents or to enforce patents that we might obtain in the future.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States may be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.

Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export otherwise infringing product candidates to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our product candidates. Future patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products or methods of treatment, which could make it difficult for us to stop the marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our future patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our future patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Risks Related to Our Business Operations

We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

Our future financial performance and our ability to commercialize product candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth. As our development and commercialization plans and strategies develop, we expect to need additional managerial, operational, sales, marketing, financial and legal personnel. Our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of additional product candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenue could be reduced, and we may not be able to implement our business strategy.

Due to our limited resources and access to capital, we must, and have in the past decided to, prioritize development of certain product candidates over other potential candidates. These decisions may prove to have been wrong and may adversely affect our revenues.

Because we have limited resources and access to capital to fund our operations, we must decide which product candidates to pursue and the amount of resources to allocate to each. Our decisions concerning the allocation of research, collaboration, management and financial resources toward particular product candidates may not lead to the development of viable commercial product candidates and may divert resources away from better opportunities. Similarly, our decisions to delay, terminate or collaborate with third parties in respect of certain product candidates’ development programs may also prove not to be optimal and could cause us to miss valuable opportunities. If we make incorrect determinations regarding the market potential of our product candidates or misread trends in the medical device and pharmaceutical industries, in particular for our lead product candidate, our business, financial condition and results of operations could be materially adversely affected.

We may not be successful in our efforts to identify, discover or license additional product candidates.

Although a substantial amount of our effort will focus on the continued clinical testing, potential approval and commercialization of our product candidates, the success of our business also depends upon our ability to identify, discover or license additional product candidates. Our research programs or licensing efforts may fail to yield additional product candidates for clinical development for a number of reasons, including: lack of financial or personnel resources to acquire or discover additional product candidates; new product candidates may not succeed in preclinical or clinical testing, or may be shown to have harmful side effects or may have other characteristics that may make them unmarketable or unlikely to receive marketing approval; our competitors may develop alternatives that render our product candidates obsolete or less attractive; the market for a product candidate may change during our development program so that such product candidates may become unprofitable to continue to develop; new product candidates may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and new product candidates may not be accepted as safe and effective by patients, the medical community, or third-party payors.

We may be forced to abandon our development efforts for a program or programs that are unsuccessful, or we may not be able to identify, license, or discover additional product candidates, which would have a material adverse effect on our business and could potentially cause us to cease operations. Further, research programs to identify new product candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful.

European data collection is governed by restrictive regulations governing the collection, use, processing and cross-border transfer of personal information.

We may collect, process, use or transfer personal information from individuals located in the European Union in connection with our business, including in connection with conducting clinical trials in the European Union. Additionally, we intend to commercialize our product candidates, and any of our product candidates that receive marketing approval, in the European Union. The collection and use of personal health data in the European Union is governed by the provisions of the General Data Protection Regulation ((EU) 2016/679), or the GDPR, along with other European Union and country-specific laws and regulations. The United Kingdom and Switzerland have also adopted data protection laws and regulations. These legislative acts (together with regulations and guidelines) impose requirements relating to having legal bases for processing personal information relating to identifiable individuals and transferring such information outside of the EEA, including to the United States, providing details to those individuals regarding the processing of their personal information, keeping personal information secure, having data processing agreements with third parties who process personal information, responding to individuals’ requests to exercise their rights in respect of their personal information, reporting security breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments and record-keeping. The GDPR imposes additional responsibilities and liabilities in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with the new data protection rules. Failure to comply with the requirements of the GDPR and related national data protection laws of the member states of the European Union may result in substantial fines, other administrative penalties and civil claims being brought against us, which could have a material adverse effect on our business, prospects, financial condition and results of operations.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

Our research, development and manufacturing activities and our third party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous materials, including the components of our product candidates and other hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste product candidates. Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages, such liability could exceed our resources, and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. We do not currently carry biological or hazardous waste insurance coverage.

Our employees and independent contractors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of fraud or other misconduct by our employees and independent contractors. Misconduct by these parties could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we may establish, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee and independent contractor misconduct could also involve the improper use of information obtained in the course of clinical trials, including individually identifiable information, creating fraudulent data in our preclinical studies or clinical trials or illegal misappropriation of product candidates, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

Under applicable employment laws, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.

We generally enter into non-competition agreements with our employees and certain key consultants. These agreements prohibit our employees and certain key consultants, if they cease working for us, from competing directly with us or working for our competitors or clients for a limited period of time. We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees work and it may be difficult for us to restrict our competitors from benefitting from the expertise our former employees or consultants developed while working for us.

For example, Israeli courts have required employers seeking to enforce non-compete undertakings of a former employee to demonstrate that the competitive activities of the former employee will harm one of a limited number of material interests of the employer which have been recognized by the courts, such as the secrecy of a company’s confidential commercial information or the protection of its intellectual property. If we cannot demonstrate that such interests will be harmed, we may be unable to prevent our competitors from benefiting from the expertise of our former employees or consultants and our ability to remain competitive may be diminished.

Increasing scrutiny of, and evolving expectations for, sustainability and environmental, social, and governance, or ESG, initiatives could increase our costs or otherwise adversely impact our business.

Public companies are facing increasing scrutiny related to ESG practices and disclosures from certain investors, capital providers, shareholder advocacy groups, other market participants and other stakeholder groups. With this increased focus, public reporting regarding ESG practices is becoming more broadly expected. Such increased scrutiny may result in increased costs, enhanced compliance or disclosure obligations, or other adverse impacts on our business, financial condition or results of operations. If our ESG practices and reporting do not meet investor or other stakeholder expectations, which continue to evolve, we may be subject to investor or regulator engagement regarding such matters. In addition, new sustainability rules and regulations have been adopted and may continue to be introduced in various states and other jurisdictions. For example, the SEC has adopted rules that require companies to provide expanded climate-related disclosures in their periodic reporting, which may require us to incur significant additional costs to comply and impose increased oversight obligations on our management and board of directors. Our failure to comply with any applicable rules or regulations could lead to penalties and adversely impact our reputation, access to capital and employee retention. Such ESG matters may also impact our third-party contract manufacturers and other third parties on which we rely, which may augment or cause additional impacts on our business, financial condition, or results of operations.

Any resurgence of the COVID-19 pandemic could adversely affect our business, financial condition and results of operations.

In late 2019, a novel strain of COVID-19, also known as coronavirus, was reported in Wuhan, China. While initially the outbreak was largely concentrated in China, it spread to countries across the globe, including in Israel and the United States. Many countries around the world, including in Canada, Israel and the United States, implemented significant governmental measures to control the spread of the virus, including temporary closure of businesses, severe restrictions on travel and the movement of people, and other material limitations on the conduct of business.

While the potential economic impact brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, it has already caused, and could result in further, significant disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity and financial position. In addition, the trading prices for other companies have been highly volatile as a result of the COVID-19 pandemic. As a result, we may face difficulties raising capital through sales of our Ordinary Shares or other securities and such sales may be on unfavorable terms. To the extent that future waves of COVID-19 disrupt normal business operations, we may face operational challenges with our services, and we likely will have to adopt remote working and workplace protocols for employees in accordance with government requirements and other measures to minimize such impact.

The COVID-19 pandemic and its impacts continue to evolve. We cannot predict the scope and severity of any further disruptions as a result of COVID-19 or their impacts on us, but business disruptions for us or any of the third parties with whom we engage, including the manufacturers, suppliers, customers, regulators and other third parties with whom we conduct business could materially and negatively impact our ability to conduct our business in the manner and on the timelines presently planned. The extent to which the COVID-19 pandemic may continue to impact our business and financial performance will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the scope and duration of the pandemic, the extent and effectiveness of government restrictions and other actions, including relief measures, implemented to address the impact of the pandemic, and resulting economic impacts. We are unable to determine the extent of the impact of the pandemic on our operations and financial condition going forward. These developments are highly uncertain and unpredictable and may materially adversely affect our financial position and results of operations.

Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk.

Our business depends on the economic health of the global economies. If the conditions in the global economies remain uncertain or continue to be volatile, or if they deteriorate, including as a result of the impact of military conflict, terrorism or other geopolitical events, our business, operating results and financial condition may be materially adversely affected. Economic weakness, inflation and increases in interest rates, limited availability of credit, liquidity shortages and constrained capital spending have at times in the past resulted, and may in the future result, in challenging and delayed sales cycles, slower adoption of new technologies and increased price competition, and could negatively affect our ability to forecast future periods, which could result in an inability to satisfy demand for our products and a loss of market share.

In addition, increases in inflation raise our costs for commodities, labor, materials and services and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases in inflation, along with the uncertainties surrounding any resurgence of COVID-19, geopolitical developments and global supply chain disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make it more difficult, costly or dilutive for us to secure additional financing. A failure to adequately respond to these risks could have a material adverse impact on our financial condition, results of operations or cash flows.

There can be no assurance that future credit and financial market instability and a deterioration in confidence in economic conditions will not occur. Our general business strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market conditions. If equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions, it may cause short-term liquidity risk and also make any necessary debt or equity financing more difficult, more costly, more onerous with respect to financial and operating covenants and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to alter our operating plans. In addition, there is a risk that one or more of our service providers, financial institutions, manufacturers, suppliers and other partners may be adversely affected by the foregoing risks, which could directly affect our ability to attain our operating goals on schedule and on budget.

International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States or Israel.

Other than our headquarters and other operations which are located in Israel (as further described below), we currently have limited international operations, but our business strategy incorporates potentially significant international expansion, particularly in anticipation of approval of our product candidates. We plan to retain sales representatives and third party distributors and conduct physician, ENT specialist, hospital pharmacist and patient association outreach activities, as well as clinical trials, outside of the United States, European Union and Israel. Doing business internationally involves a number of risks, including but not limited to:

Any of these factors could significantly harm our future international expansion and operations and, consequently, our results of operations.

Risks Related to Commercialization of Our Product Candidates

We currently have no marketing and sales organization. If we are unable to establish marketing and sales capabilities, or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any product candidates revenue.

We have no experience selling and marketing our product candidates, and we currently have no marketing or sales organization. To successfully commercialize any product candidates that may result from our development programs, we will need to develop these capabilities, either on our own or with others. If our product candidates receive regulatory approval, we intend to establish a sales and marketing organization independently or by utilizing experienced third parties with technical expertise and supporting distribution capabilities to commercialize our product candidates in major markets, all of which will be expensive, difficult and time consuming. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact our ability to commercialize our product candidates.

Further, given our lack of prior experience in marketing and selling medical device and pharmaceutical products, our initial estimate of the size of the required sales force may be materially more or less than the size of the sales force actually required to effectively commercialize our product candidates. As such, we may be required to hire sales representatives and third party distributors to adequately support the commercialization of our product candidates, or we may incur excess costs if we hire more sales representatives than necessary. With respect to certain geographical markets, we may enter into collaborations with other entities to utilize their local marketing and distribution capabilities, but we may be unable to enter into such agreements on favorable terms, if at all. We also may enter into collaborations with large medical device and pharmaceutical companies to develop and commercialize product candidates. If our future collaborators do not commit sufficient resources to develop and commercialize our future product candidates, if any, and we are unable to develop the necessary marketing capabilities on our own, we will be unable to generate sufficient product candidates revenue to sustain our business. We may compete with companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

Our efforts to educate the medical community, including physicians, hospital pharmacists and third-party payors on the benefits of our product candidates may require significant resources and may never be successful. If any of our product candidates are approved but fail to achieve market acceptance among physicians, patients or third-party payors, we will not be able to generate significant revenues from such product candidates, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

We are subject to significant regulatory oversight with respect to manufacturing our product candidates. Delays in establishing and obtaining regulatory approval of our manufacturing process may delay or disrupt our product candidates’ development and commercialization efforts.

The preparation of drug products for clinical trials or commercial sale is subject to extensive regulation. Before we can begin to commercially manufacture our product candidates or any product candidate, we must obtain regulatory approvals from the Israeli Ministry of Health, or MOH, the FDA and similar regulatory agencies, as applicable for our manufacturing process and facility. A manufacturing authorization must also be obtained from the appropriate regulatory authorities in the European Union and worldwide. In addition, we must pass a pre-approval inspection of our manufacturing facility by the FDA before our C&C product candidates or any product candidate can obtain marketing approval. In order to obtain approval, we will need to ensure that all of our processes, methods and equipment are compliant with cGMP, and perform extensive audits of vendors, contract laboratories and suppliers. If any of our vendors, contract laboratories or suppliers is found to be out of compliance with cGMP, we may experience delays or disruptions in manufacturing while we work with these third parties to remedy the violation or while we work to identify suitable replacement vendors. For example, in the past, a cGMP audit by the MOH of the manufacturing process in the facility of our contract manufacturer for our C&C product candidates resulted in certain critical observations, which have since been resolved. There can be no guarantee, however, that future inspections by regulatory authorities of our manufacturing facilities or those of our contract manufacturers will result in MOH’s agreement that these critical observations have been resolved or that similar inspectional observations will not be identified. If we do not demonstrate to the satisfaction of the applicable regulator that our manufacturing facilities, or those of our contract manufacturers, are in compliance with applicable requirements, we may be materially delayed in the development of our product candidates, which would materially harm our business. The cGMP requirements govern quality control of the manufacturing process and documentation policies and procedures. In complying with cGMP, we will be obligated to expend time, money and effort in production, record keeping and quality control to assure that the product candidates meets applicable specifications and other requirements. If we fail to comply with these requirements, we would be subject to possible regulatory action and may not be permitted to sell any product candidate that we may develop.

Our failure to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products or product candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of any approved products and our product candidates.

If we receive marketing approval for our product candidates, sales will be limited unless the product candidates achieves broad market acceptance by physicians, patients, third-party payors, hospital pharmacists, infectious disease specialists and others in the medical community.

The commercial success of our product candidates will depend upon the acceptance of the product candidates by the medical community, including physicians, patients, healthcare payors, hospital pharmacists and infectious disease specialists. The degree of market acceptance of any approved product candidates will depend on a number of factors, including:

If our product candidates are approved but do not achieve an adequate level of acceptance by physicians, patients, healthcare payors, hospital pharmacists and infectious disease specialists, we may not generate sufficient revenue from the product candidates, and we may not become or remain profitable. In addition, our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.

It may be difficult for us to profitably sell our product candidates if coverage and reimbursement for these product candidates, or the procedures in which they are used, is limited by government authorities and/or third-party payor policies.

In addition to any healthcare reform measures which may affect reimbursement, market acceptance and sales of our product candidates, if approved, will depend on, in part, the extent to which the procedures utilizing our product candidates, performed by health care providers, will be covered by third party payors, such as government health care programs, commercial insurance and managed care organizations. Our product candidates will be purchased or provided by health care providers for utilization in certain surgical procedures. In the event health care providers and patients accept our product candidates as medically useful, cost effective and safe, there is uncertainty regarding whether our product candidates will be directly reimbursed, reimbursed through a bundled payment or if the product candidates will be included in another type of value-based reimbursement program. Third party payors determine the extent to which new product candidates or procedures will be covered as a benefit under their plans and the level of reimbursement for any covered product candidates or procedure which may utilize a covered product candidates.

When used in connection with certain procedures, our product candidates may not be reimbursed separately but their cost may instead be bundled as part of the payment received by the provider for the procedure only. Treating physicians are unlikely to use and order our product candidates unless coverage is provided and the reimbursement is adequate to cover all or a significant portion of the cost of the procedures which utilize our product candidates. A decision by a third-party payor not to cover or adequately reimburse for our product candidates or procedures using our product candidates, could reduce physician utilization of our product candidates once approved. Therefore, coverage and adequate reimbursement for procedures which utilize new product candidates is critical to the acceptance of such new product candidates.

A primary trend in the U.S. healthcare industry and elsewhere has been cost containment, including price controls, restrictions on coverage and reimbursement and requirements for substitution of less expensive products and procedures. Third party payors decide which products and procedures they will pay for and establish reimbursement and co-payment levels. Government and other third-party payors are increasingly challenging the prices charged for healthcare products and procedures, examining the cost effectiveness of procedures, and the products used in such procedures, in addition to their safety and efficacy, and limiting or attempting to limit both coverage and the level of reimbursement. We cannot be sure that coverage will be available for our product candidates, if approved, or, if coverage is available, the level of direct or indirect reimbursement.

We expect to experience pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the successful commercialization of new product candidates. Further, the adoption and implementation of any future governmental cost containment or other health reform initiative may result in additional downward pressure on the price that we may receive for any approved product candidates.

Reimbursement by a third-party payor may depend upon a number of factors including the third-party payor’s determination that use of a product candidates is:

In the United States, third-party payors, including private and governmental payors such as the Medicare and Medicaid programs, play an important role in determining the extent to which procedures using new product candidates will be covered and reimbursed. The Medicare and Medicaid programs are increasingly used as models for how private payors and other governmental payors develop their coverage and reimbursement policies. It is difficult to predict at this time what third-party payors will decide with respect to reimbursement for fundamentally novel product candidates such as ours, as there is no body of established practices and precedents for these new product candidates.

Obtaining coverage and reimbursement approval for a products from a government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost effectiveness data for the use of our product candidates to the payor.

Additionally, we may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. We cannot be sure that coverage or adequate reimbursement will be available for our product candidates, if approved. Also, we cannot be sure that reimbursement amounts will not reduce the demand for, or the price of, our future product candidates. If reimbursement is not available, or is available only to limited levels, we may not be able to commercialize our product candidates, or achieve profitably at all, even if approved.

Our business entails a significant risk of clinical trial and/or product candidates liability and our ability to obtain sufficient insurance coverage could have a material effect on our business, financial condition, results of operations or prospects.

Our business exposes us to significant clinical trial and/or product candidates liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Clinical trial and/or product candidates liability claims could delay or prevent completion of our development programs. If we succeed in marketing product candidates, product candidates liability claims could result in an FDA investigation of the safety and effectiveness of our product candidates, our manufacturing processes and facilities or our marketing programs and potentially a recall of our product candidates or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our product candidates, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary awards to trial participants or patients and a decline in our company valuation. While we currently have clinical trial liability insurance, we do not have product candidates liability insurance and do not anticipate obtaining product candidates liability insurance until such time as we have received FDA or other comparable foreign authority approval for a product candidates and there is a product candidates that is being provided to patients outside of clinical trials. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. In some countries, the institution or the doctors involved do not have sufficient insurance to cover their activities. Furthermore, clinical trial and product candidates liability insurance are becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by clinical trial and product candidates liability claims that could have a material adverse effect on our business.

Risks Related to the IPO, this Offering and Ownership of Our Securities

The market price of our securities may be highly volatile, and you may not be able to resell your Ordinary Shares at or above the initial public offering price.

Prior to the IPO, there has not been a public market for our securities. Although we have been approved to list our Ordinary Shares on Nasdaq, an active trading market for the Ordinary Shares may not develop or be sustained. If an active trading market for our Ordinary Shares does not develop following the IPO, you may not be able to sell your Ordinary Shares quickly or at the market price. The initial public offering price for the Units was determined by negotiations between us and the underwriter in the IPO and may not be indicative of prices that will prevail in the trading market.

The trading price of each of our Ordinary Shares is likely to be volatile. The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of such securities:

In addition, the stock market in general, and the Nasdaq in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of small companies. Broad market and industry factors may negatively affect the market price of our securities, regardless of our actual operating performance. Further, a systemic decline in the financial markets and related factors beyond our control may cause our share price to decline rapidly and unexpectedly.

The Warrants are speculative in nature.

Except as otherwise set forth therein, the Warrants offered in the IPO do not confer any rights of Ordinary Share ownership on their holders, such as voting rights, but rather merely represent the right to acquire Ordinary Shares at a fixed price for a limited period of time. Specifically, commencing on the date of issuance, holders of the Warrants may exercise their right to acquire Ordinary Shares and pay an exercise price of (subject to certain adjustments, see “Description of Securities We are Offering”) $4.38 per Ordinary Share (with such exercise price equal to the public offering price per Unit), prior to five years from the date of issuance, after which date any unexercised Warrants will expire and have no further value. There can be no assurance that the market price of our Ordinary Shares will ever equal or exceed the exercise price of the Warrants offered by the Public Offering Prospectus. In the event that our Ordinary Shares price does not exceed the exercise price of such Warrants during the period when such Warrants are exercisable, the Warrants may not have any value.

There is no established market for the Warrants being offered in the IPO and we do not intend to apply to list the Warrants on any securities exchange or other nationally recognized trading system.

There is no established trading market for the Warrants offered in the IPO. We do not intend to apply to list the Warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Warrants will be limited.

Future sales of our Ordinary Shares could reduce the market price of our Ordinary Shares. 

Substantial sales of our Ordinary Shares on Nasdaq, including following the IPO, may cause the market price of our Ordinary Shares to decline. Sales by us or our security holders of substantial amounts of our Ordinary Shares, or the perception that these sales may occur in the future, could cause a reduction in the market price of our Ordinary Shares.

The issuance of any additional Ordinary Shares or any securities that are exercisable for or convertible into Ordinary Shares, may have an adverse effect on the market price of our Ordinary Shares and will have a dilutive effect on our existing shareholders and holders of Ordinary Shares. 

Participation in the IPO by certain of our existing shareholders, including beneficial owners of greater than 5% of our share capital, could reduce the public float for our shares.

Prior to the IPO, there has been no public market for our Ordinary Shares. Although our Ordinary Shares have been approved for listing on Nasdaq, we cannot guarantee an active public market for our Ordinary Shares will develop or be sustained after the IPO. If an active and liquid trading market does not develop, you may have difficulty selling or may not be able to sell any of the Ordinary Shares that you purchase.

Certain of our existing shareholders, including beneficial owners of greater than 5% of our share capital, have indicated an interest in purchasing up to an aggregate of approximately $1 million of Units in the IPO, which represents approximately 24% of the total Units in the IPO, based on the public offering price of $4.38 per Unit. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters in the IPO may determine to sell more, less or no Units in the IPO to any of these shareholders, or any of these shareholders may determine to purchase more, less or no Units in the IPO. If these shareholders are allocated all or a portion of the Units in which each has indicated an interest in the IPO or are allocated more Units than each has indicated an interest in the IPO, and these shareholders purchase any such Units, such purchase could reduce the available public float for our shares.

Our executive officers, directors and principal shareholders will maintain the ability to exert significant control over matters submitted to our shareholders for approval.

As of October 2, 2024, our executive officers, directors and principal shareholders who own more than 5% of our outstanding Ordinary Shares, in the aggregate, beneficially own shares representing approximately 87% of our share capital. Upon completion of the IPO, our executive officers, directors and principal shareholders who own more than 5% of our outstanding Ordinary Shares, in the aggregate, will beneficially own approximately 67% of our outstanding ordinary shares. As a result, if these shareholders were to act together, they would be able to exert significant influence over all matters submitted to our shareholders for approval (including a prospective acquisition or other change of control of our company), as well as our management and affairs.

Our Selling Shareholders have purchased their shares at a price that is lower than the purchase price of the shares in the IPO and will be able to sell their shares after completion of the IPO subject to restrictions under the lock-up requirement.

Our Selling Shareholders have purchased their Ordinary Shares at an average price of approximately $2.15 per share, which is substantially lower than the initial public offering price of $4.38 per Unit. The Ordinary Shares issued to the Selling Shareholders are “restricted” securities under applicable U.S. federal and state securities laws and are being registered to provide the Selling Shareholders the opportunity to sell those Ordinary Shares. Because these shareholders have paid a lower price per Ordinary Share than participants in the IPO, they may be more willing to accept a lower sales price than the IPO price. This fact could impact the trading price of the Ordinary Shares following completion of the offering to the detriment of participants in the IPO. Other than certain affiliates holding Ordinary Shares, the remaining Selling Shareholders are not subject to any lock-up or leakage agreements and have the right to sell the shares being registered hereby at any time. See “Shares Eligible for Future Sale—Eligibility of Restricted Shares for Sale in the Public Market” in the Public Offering Prospectus for additional information.

Management will have broad discretion as to the use of the proceeds from the IPO.

Our management will have broad discretion in the allocation of the net proceeds and could use them for purposes other than those contemplated at the time of the IPO and as described in the section titled “Use of Proceeds.” Our shareholders may not agree with the manner in which our management chooses to allocate and spend the net proceeds.

U.S. shareholders may suffer adverse tax consequences if we are characterized as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes. 

Based on the projected composition of our income and valuation of our assets, we do not believe that we were a PFIC for 2023, and do not expect to be a PFIC for 2024 and in the future, although there can be no assurance in this regard. The determination of whether we are a PFIC is made on an annual basis and will depend on the composition of our income and assets from time to time. We will be treated as a PFIC for U.S. federal income tax purposes in any taxable year in which either (1) at least 75% of our gross income is “passive income” or (2) on quarterly average at least 50% of our assets by value produce passive income or are held for the production of passive income. Passive income for this purpose generally includes, among other things, certain dividends, interest, royalties, rents and gains from commodities and securities transactions and from the sale or exchange of property that gives rise to passive income. Passive income also includes amounts derived by reason of the temporary investment of funds, including those raised in a public offering. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account. The tests for determining PFIC status are applied annually and it is difficult to make accurate projections of future income and assets which are relevant to this determination. In addition, our PFIC status may depend in part on the market value of our Ordinary Shares. Accordingly, there can be no assurance that we currently are not or will not become a PFIC in subsequent years. If we were a PFIC in 2023, or are a PFIC in any subsequent taxable year during which a U.S. taxpayer holds our Ordinary Shares (and Warrants, which are treated as PFIC stock), such U.S. taxpayer would be subject to certain adverse U.S. federal income tax rules. In particular, if the U.S. taxpayer did not make an election to treat us as a “qualified electing fund”, or QEF, or make a “mark-to-market” election, then “excess distributions” to the U.S. taxpayer, and any gain realized on the sale or other disposition of our Ordinary Shares by the U.S. taxpayer: (1) would be allocated ratably over the U.S. taxpayer’s holding period for our Ordinary Shares; (2) the amount allocated to the current taxable year and any period prior to the first day of the first taxable year in which we were a PFIC would be taxed as ordinary income; and (3) the amount allocated to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable to each such other taxable year. In addition, if the U.S. Internal Revenue Service, or the IRS, determines that we are a PFIC for a year with respect to which we have determined that we were not a PFIC, it may be too late for a U.S. taxpayer to make a timely QEF or mark-to-market election. A U.S. taxpayer that has held our Ordinary Shares during a period when we were a PFIC will generally be subject to the foregoing rules, unless we cease to be a PFIC and such U.S. taxpayer makes a “deemed sale” election with respect to our ADSs or our ordinary shares. If we are a PFIC in any year, U.S. taxpayers may be subject to additional IRS filing requirements, including the filing of IRS Form 8621, as a result of directly or indirectly owning stock of a PFIC. We do not intend to notify U.S. taxpayers that hold our Ordinary Shares if we believe we will be treated as a PFIC for any taxable year in order to enable U.S. taxpayers to consider whether to make a QEF election. In addition, we do not intend to furnish such U.S. taxpayers annually with information needed in order to complete IRS Form 8621 and to make and maintain a valid QEF election for any year in which we are a PFIC. U.S. taxpayers that hold our Ordinary Shares are strongly urged to consult their tax advisors about the PFIC rules, including tax return filing requirements and the eligibility, manner, and consequences to them of making a QEF or mark-to-market election with respect to our Ordinary Shares in the event that we are a PFIC. See “Taxation—Certain Material U.S. Federal Income Tax Considerations—Passive Foreign Investment Companies” for additional information.

If a United States person is treated as owning at least 10% of our Ordinary Shares, such holder may be subject to adverse U.S. federal income tax consequences.

If a United States person is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our Ordinary Shares, such person may be treated as a “United States shareholder” with respect to each “controlled foreign corporation” in our Company (if any). A United States shareholder of a controlled foreign corporation may be required to annually report and include in its U.S. taxable income its pro rata share of “Subpart F income,” “global intangible low-taxed income” and investments in U.S. property by controlled foreign corporations, whether or not we make any distributions, and may be subject to tax reporting obligations. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation. A failure to comply with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of limitations with respect to your U.S. federal income tax return for the year for which reporting was due from starting. We cannot provide any assurances that we will assist any holder of our Ordinary Shares in determining whether such investors are treated as a United States shareholder with respect to any “controlled foreign corporations” in our group (if any) or furnish to any United States holders of our Ordinary Shares information that may be necessary to comply with the aforementioned reporting and tax paying obligations. A United States holder of our Ordinary Shares should consult its tax advisors regarding the potential application of these rules to its investment in the shares.

As a foreign private issuer, we are permitted, and intend, to follow certain home country corporate governance practices instead of otherwise applicable Nasdaq requirements, and we will not be subject to certain U.S. securities laws including, but not limited to, U.S. proxy rules and the filing of certain Exchange Act reports.

As a foreign private issuer, we will be permitted, and intend, to follow certain home country corporate governance practices instead of those otherwise required by the Nasdaq Stock Market for domestic U.S. issuers. Following our home country governance practices as opposed to the requirements that would otherwise apply to a U.S. company listed on The Nasdaq Global Market may provide less protection to you than what is accorded to investors under the listing rules of Nasdaq applicable to domestic U.S. issuers.

As a foreign private issuer, we will be exempt from the rules and regulations under the Securities Exchange Act of 1934, or the Exchange Act, related to the furnishing and content of proxy statements, including the applicable compensation disclosure requirements. Nevertheless, pursuant to regulations promulgated under the Israeli Companies Law, 5759-1999, or the Israeli Companies Law, we are required to disclose the annual compensation of our five most highly compensated office holders on an individual basis. Such disclosure will not be as extensive as that required of a U.S. domestic issuer. Our officers, directors and principal shareholders will also be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we will not be required under the Exchange Act to file reports and financial statements with the SEC as frequently or as promptly as U.S. domestic companies whose securities are registered under the Exchange Act and we will be exempt from filing quarterly reports with the SEC under the Exchange Act. Moreover, we will not be required to comply with Regulation FD, which restricts the selective disclosure of material information, although we intend to voluntarily adopt a corporate disclosure policy substantially similar to Regulation FD. These exemptions and leniencies will reduce the frequency and scope of information and protections to which you may otherwise have been eligible in relation to a U.S. domestic issuer.

We would lose our foreign private issuer status if a majority of our shares are owned by U.S. residents and a majority of our directors or executive officers are U.S. citizens or residents or we fail to meet additional requirements necessary to avoid loss of foreign private issuer status. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly higher. If we are not a foreign private issuer, we will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive than the forms available to a foreign private issuer. We may also be required to modify certain of our policies to comply with accepted governance practices associated with U.S. domestic issuers. Such conversion and modifications will involve additional costs. In addition, we would lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers.

We are an emerging growth company and the reduced disclosure requirements applicable to emerging growth companies may make our Ordinary Shares less attractive to investors.

We are an emerging growth company, as defined in the JOBS Act, and we may take advantage of certain exemptions from various requirements that are applicable to other public companies that are not emerging growth companies.

For as long as we remain an emerging growth company we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not “emerging growth companies.” These exemptions include:

We will remain an emerging growth company until the earliest of: (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; (iii) the date on which we are deemed to be a large accelerated filer under the rules of the SEC; or (iv) the last day of the fiscal year following the fifth anniversary of the IPO. We have opted out of the extended transition period made available to emerging growth companies to comply with newly adopted public company accounting requirements.

When we are no longer deemed to be an emerging growth company, we will not be entitled to the exemptions provided in the JOBS Act discussed above. We cannot predict if investors will find our Ordinary Shares less attractive as a result of our reliance on exemptions under the JOBS Act. If some investors find our Ordinary Shares less attractive as a result, there may be a less active trading market for our Ordinary Shares and our share price may be more volatile.

If you purchase securities in the IPO, you will incur immediate and substantial dilution in the book value of your shares.

The offering price of the Ordinary Shares is substantially higher than the net tangible book value per share of our Ordinary Shares. Therefore, if you purchase securities in the IPO, you will pay a price per Ordinary Share that substantially exceeds our net tangible book value per Ordinary Share after the IPO. Based on the public offering price of $4.38 per Unit, you will experience immediate dilution of $3.60 per Ordinary Share, representing the difference between our pro forma net tangible book value per Ordinary Share after giving effect to the IPO and the offering price. See “Dilution” for further information.

Certain recent initial public offerings of companies with public floats comparable to the anticipated public float of Polyrizon have experienced extreme volatility that was seemingly unrelated to the underlying performance of the respective company.

Our Ordinary Shares may be subject to extreme volatility that is seemingly unrelated to the underlying performance of our business. Recently, companies with comparable anticipated public floats and initial public offering sizes have experienced instances of extreme stock price run-ups followed by rapid price declines, and such stock price volatility was seemingly unrelated to the respective company’s underlying performance. Although the specific cause of such volatility is unclear, our anticipated public float may amplify the impact of the actions taken by a few shareholders on the price of our Ordinary Shares, which may cause our share price to deviate, potentially significantly, from a price that better reflects the underlying performance of our business. Should our Ordinary Shares experience run-ups and declines that are seemingly unrelated to our actual or expected operating performance and financial condition or prospects, prospective investors may have difficulty assessing the rapidly changing value of our Ordinary Shares. In addition, investors of shares of our Ordinary Shares may experience losses, which may be material, if the price of our Ordinary Shares declines after the IPO or if such investors purchase shares of our Ordinary Shares prior to any price decline.

Risks Related to Israeli Law and Our Operations in Israel

Our headquarters and other significant operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and military instability in Israel, including the recent attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them.

Our executive offices, research and development laboratories are located in Ra’anana, Israel. In addition, the majority of our key employees, officers and directors are residents of Israel. Accordingly, political, geopolitical, economic and military conditions in Israel may directly affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and groups in its neighboring countries, and between Israel and the Hamas (an Islamist militia and political group in the Gaza Strip), Hezbollah (an Islamist militia and political group in Lebanon) and other terrorist organizations active in the region.

In particular, in October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in thousands of deaths and injuries, and kidnapping of civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas and these terrorist organizations in parallel continued rocket and terror attacks. As a result of the events of October 7, 2023 whereby Hamas terrorists invaded southern Israel and launched thousands of rockets in a widespread terrorist attack on Israel, the Israeli government declared that the country was at war and the Israeli military began to call-up reservists for active duty. None of our employees were called up for active duty; however military service call ups that result in absences of personnel from us for an extended period of time may materially and adversely affect our business, prospects, financial condition and results of operations. As of the date hereof, we currently have two full-time and three part-time employees, with four employees located in Israel and 1 employee located outside of Israel.

Since the war broke out on October 7, 2023, our operations have not been adversely affected by this situation, and we have not experienced disruptions to our development. Our commercial operations, including Product Development, Regulatory Compliance, Market Research, Commercialization Strategy, Partnerships and Collaborations, Intellectual Property Management take place in the Tel Aviv, Israel area and remain unaffected by the war against Hamas. However, the intensity and duration of Israel’s current war against Hamas is difficult to predict at this stage, as are such war’s economic implications on the Company’s business and operations and on Israel’s economy in general. If the war extends for a long period of time or expands to other fronts, such as Lebanon, Syria and the West Bank, our operations may be adversely affected.

In addition, since the commencement of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization) and southern border (with the Houthi movement in Yemen). It is possible that hostilities with Hezbollah in Lebanon will escalate, and that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other hostile countries will join the hostilities.  Such clashes may escalate in the future into a greater regional conflict. In addition, Iran recently launched a direct attack on Israel involving hundreds of drones and missiles and has threatened to continue to attack Israel and is widely believed to be developing nuclear weapons. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria. These situations may potentially escalate in the future to more violent events which may affect Israel and us. Any armed conflicts, terrorist activities or political instability in the region could adversely affect business conditions, could harm our results of operations and could make it more difficult for us to raise capital. Parties with whom we do business may decline to travel to Israel during periods of heightened unrest or tension, forcing us to make alternative arrangements when necessary in order to meet our business partners face to face. In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements. Further, in the past, the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict business with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on our operating results, financial condition or the expansion of our business. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its trading partners could adversely affect our operations and results of operations.

Our commercial insurance does not cover losses that may occur as a result of events associated with the security situation in the Middle East. Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained or, if maintained, will be sufficient to compensate us fully for damages incurred. Any losses or damages incurred by us could have a material adverse effect on our business, financial condition and results of operations. Any armed conflicts or political instability in the region would likely negatively affect business conditions and could harm our results of operations.

Finally, political conditions within Israel may affect our operations. Israel has held five general elections between 2019 and 2022, and prior to October 2023, the Israeli government pursued extensive changes to Israel’s judicial system, which sparked extensive political debate and unrest. To date, these initiatives have been substantially put on hold. Actual or perceived political instability in Israel, or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.

Our operations are subject to currency and interest rate fluctuations.

Although our functional currency is the U.S. dollar, and our financial records are maintained in U.S. dollars, we also incur expenses in Euros and New Israeli Shekels. In the future, we expect that a substantial portion of our revenues will be generated in U.S. dollars, Euros and other foreign currencies, although we currently incur a significant portion of our expenses in currencies other than U.S. dollars, mainly New Israeli Shekels. As a result, we are affected by foreign currency exchange fluctuations through both translation risk and transaction risk, and our financial results may be affected by fluctuations in the exchange rates of currencies in the countries in which our prospective product candidates may be sold.

We received Israeli government grants for certain of our research and development activities, the terms of which may require us to pay royalties and to satisfy specified conditions in order to manufacture product candidates and transfer technologies outside of Israel. If we fail to satisfy these conditions, we may be required to pay penalties and refund grants previously received.

Our research and development efforts have been financed in part through royalty-bearing grants in an aggregate amount of $620,000 that we received from the IIA during 2007-2010. The last IIA-approved research and development grants ended on December 31, 2018. With respect to the royalty-bearing grants we are committed to pay royalties at a rate between 3% and 4.5% on sales proceeds from our product candidates that were developed under IIA programs up to the total amount of grants received, linked to the U.S. dollar and bearing interest at an annual rate of SOFR applicable to U.S. dollar deposits. As of October 2, 2024, our contingent liabilities regarding IIA grants received by us were in an aggregate amount of $756,000 (including accumulated interest). We are further required to comply with the requirements of the Israeli Encouragement of Industrial Research, Development and Technological Innovation Law, 5744-1984, as amended, and related regulations, or the Research Law, with respect to those past grants. When a company develops know-how, technology or product candidates using IIA grants, the terms of these grants and the Research Law restrict the transfer or license of such know-how, and the transfer of manufacturing or manufacturing rights of such product candidates, technologies or know-how outside of Israel, without the prior approval of the IIA. Therefore, the discretionary approval of an IIA committee would be required for any transfer or license to third parties inside or outside of Israel of know how or for the transfer outside of Israel of manufacturing or manufacturing rights related to those aspects of such technologies. We may not receive those approvals. Furthermore, the IIA may impose certain conditions on any arrangement under which it permits us to transfer technology or development.

The transfer or license of IIA-supported technology or know-how outside of Israel and the transfer of manufacturing of IIA-supported product candidates, technology or know-how outside of Israel may involve the payment of significant amounts, depending upon the value of the transferred or licensed technology or know-how, our research and development expenses, the amount of IIA support, the time of completion of the IIA-supported research project and other factors. These restrictions and requirements for payment may impair our ability to sell, license or otherwise transfer our technology assets outside of Israel or to outsource or transfer development or manufacturing activities with respect to any product candidates or technology outside of Israel. It should be noted that an event of change of control may be considered a transfer of our technology or assets and therefore require the prior approval of the IIA before completing such a transaction. The IIA may also require potential acquirers to execute undertakings to procure our continued adherence to the terms of the IIA grants and/or impose other restrictions on such transactions. Furthermore, the consideration available to our shareholders in a transaction involving the transfer outside of Israel of technology or know-how developed with IIA funding (such as a merger or similar transaction) may be reduced by any amounts that we are required to pay to the IIA.

Provisions of Israeli law and our amended and restated articles of association, or the Articles, may delay, prevent or otherwise impede a merger with, or an acquisition of, us, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.

以色列人 公司法監管合併，要求收購超過指定門檻的股票的要約，需要特別批准 涉及董事、高級管理人員或大股東的交易，並監管可能與該等類型有關的其他事項 交易的數量。例如，除非從合併之日起至少過了50天，否則合併不得完成 每家合併公司都向以色列公司註冊處提交了建議書，自該日期起至少已過了30天 兩家合併公司的股東均已批准合併。此外，每類證券的大部分 目標公司必須批准合併。此外，對一家公司所有已發行和流通股的收購要約只能 如果收購人收到持有至少95%已發行股本的持有人的積極回應，則完成。完成 要約收購還需要獲得在要約收購中沒有個人利益的大多數受要約人的批准，除非， 收購要約完成後，收購方將持有公司至少98%的流通股。此外， 股東，包括表示接受要約收購的股東，可以在收購後六個月內隨時 完成要約收購，聲稱收購股份的代價沒有反映其公平市場價值， 並向以色列法院請願，要求相應改變收購對價，除非收購人在其標書中規定 要約，接受要約的股東不得尋求這種評估權，並且收購人或公司公佈了所有要求 在收購要約的答覆日期之前有關收購要約的信息。

此外， 以色列的稅務考慮可能會使潛在的交易對我們或我們的股東來說不具吸引力，而我們的股東的居住國不是 與以色列有稅收條約，免除這些股東的以色列稅。例如，以色列稅法不承認免稅 股票交易所達到與美國稅法相同的程度。關於合併，以色列稅法允許在某些情況下延期繳稅。 但將延期以滿足若干條件爲條件，包括在某些情況下兩年的持有期 自交易之日起，在交易期間，參與公司的股份出售和處置須受某些條件限制 限制。此外，對於某些換股交易，遞延納稅的時間是有限的，當這種時間屆滿時， 即使沒有發生股份的處置，稅款也會被支付。這些條款可能會推遲、阻止或阻礙收購 我們或我們與其他公司的合併，即使這樣的收購或合併對我們或我們的股東有利。

It may be difficult to enforce a judgment of a U.S. court against us and our executive officers and directors in Israel or the United States, to assert U.S. securities laws claims in Israel or to serve process on our executive officers and directors and these experts.

We were incorporated in Israel. Substantially all of our executive officers and directors reside outside of the United States, and all of our assets and most of the assets of these persons are located outside of the United States. Therefore, a judgment obtained against us, or any of these persons, including a judgment based on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the United States and may not be enforced by an Israeli court. It also may be difficult for you to effect service of process on these persons in the United States or to assert U.S. securities law claims in original actions instituted in Israel. Additionally, it may be difficult for an investor, or any other person or entity, to initiate an action with respect to U.S. securities laws in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of U.S. securities laws reasoning that Israel is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proven as a fact by expert witnesses, which can be a time consuming and costly process. Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel that addresses the matters described above. As a result of the difficulty associated with enforcing a judgment against us in Israel, you may not be able to collect any damages awarded by either a U.S. or foreign court.

Our Articles shall be effective upon the closing the IPO will provide that unless the Company consents otherwise, the competent courts of Tel Aviv, Israel shall be the sole and exclusive forum for substantially all disputes between the Company and its shareholders under the Companies Law and the Israeli Securities Law.

The competent courts of Tel Aviv, Israel shall be the exclusive forum for (i) any derivative action or proceeding brought on behalf of the Company, (ii) any action asserting a claim of breach of fiduciary duty owed by any director, officer or other employee of the Company to the Company or the Company’s shareholders, or (iii) any action asserting a claim arising pursuant to any provision of the Companies Law or the Israeli Securities Law, 5728-1968 (the “Israeli Securities Law”). This exclusive forum provisions is intended to apply to claims arising under Israeli Law and would not apply to claims brought pursuant to the Securities Act or the Exchange Act or any other claim for which United States federal courts would have exclusive or concurrent jurisdiction. Such exclusive forum provision in our Articles will not relieve the Company of its duties to comply with federal securities laws and the rules and regulations thereunder, and shareholders of the Company will not be deemed to have waived the Company’s compliance with these laws, rules and regulations. This exclusive forum provision may limit a shareholders ability to bring a claim in a judicial forum of its choosing for disputes with the Company or its directors or other employees which may discourage lawsuits against the Company, its directors, officers and employees and may result in increased costs for claims required to be brought before Israeli courts.

Your rights and responsibilities as a shareholder will be governed in key respects by Israeli laws, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies.

The rights and responsibilities of the holders of our Ordinary Shares are governed by our Articles and by Israeli law. These rights and responsibilities differ in some material respects from the rights and responsibilities of shareholders in U.S. companies. In particular, a shareholder of an Israeli company has a duty to act in good faith and in a customary manner in exercising its rights and performing its obligations towards the company and other shareholders, and to refrain from abusing its power in such company, including, among other things, in voting at a general meeting of shareholders on matters such as amendments to a company’s articles of association, increases in a company’s authorized share capital, mergers and acquisitions and related party transactions requiring shareholder approval, as well as a general duty to refrain from discriminating against other shareholders. In addition, a shareholder who is aware that it possesses the power to determine the outcome of a vote at a meeting of the shareholders or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company. However, Israeli law does not define the substance of this duty of fairness. There is limited case law available to assist us in understanding the nature of these duties or the implications of these provisions. These provisions may be interpreted to impose additional obligations and liabilities on holders of our Ordinary Shares that are not typically imposed on shareholders of U.S. companies.

General Risk Factors

Our business and operations would suffer in the event of computer system failures, cyber attacks or a deficiency in our cybersecurity.

Despite the implementation of security measures intended to secure our data against impermissible access and to preserve the integrity and confidentiality of our data, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, including under data privacy laws such as the GDPR, damage to our reputation, and the further development of our drug candidates could be delayed.

Our future success depends in part on our ability to retain our senior management team and to attract, retain and motivate other qualified personnel.

We are highly dependent on the members of our senior management team. The loss of their services without a proper replacement may adversely impact the achievement of our objectives. Our employees may leave our employment at any time. Recruiting and retaining other qualified employees, consultants and advisors for our business, including scientific and technical personnel, will also be critical to our success. There is currently a shortage of skilled personnel in our industry, which is likely to continue for the foreseeable future. As a result, competition for skilled personnel is intense, and the turnover rate can be high. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous medical device and pharmaceutical companies for individuals with similar skill sets. In addition, failure to succeed in preclinical studies or clinical trials may make it more challenging to recruit and retain qualified personnel. The inability to recruit and retain qualified personnel, or the loss of the services of any members of our senior management team without proper replacement, may impede the progress of our research, development and commercialization objectives. We do not maintain key man insurance for our senior management team.

We will continue to incur significant increased costs as a result of operating as a public company in the United States, and our management will be required to devote substantial time to new compliance initiatives.

As a public company whose Ordinary Shares are listed in the United States, we are subject to an extensive regulatory regime, requiring us, among other things, to maintain various internal controls and facilities and to prepare and file periodic and current reports and statements, including reports on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002. Complying with these requirements will be costly and time consuming. We will need to retain additional employees to supplement our current finance staff, and we may not be able to do so in a timely manner, or at all. In the event that we are unable to demonstrate compliance with our obligations as a public company in a timely manner, or are unable to produce timely or accurate financial statements, we may be subject to sanctions or investigations by regulatory authorities, such as the SEC or The Nasdaq Global Market, and investors may lose confidence in our operating results and the price of our Ordinary Shares could decline.

Our independent registered public accounting firm was not engaged to perform an audit of our internal control over financial reporting, and as long as we remain an emerging growth company, as such term is defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, we will be exempt from the requirement to have an independent registered public accounting firm perform such audit. Accordingly, no such opinion was expressed or will be expressed any during any such period. Once we cease to qualify as an emerging growth company our independent registered public accounting firm will be required to attest to our management’s annual assessment of the effectiveness of our internal controls over financial reporting, which will entail additional costs and expenses.

Furthermore, we are only in the early stages of determining formally whether our existing internal control over financial reporting systems are compliant with Section 404 and whether there are any material weaknesses or significant deficiencies in our existing internal controls. These controls and other procedures are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is disclosed accurately and is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms.

We have never paid cash dividends on our share capital, and we do not anticipate paying any cash dividends in the foreseeable future.

We have never declared or paid cash dividends on our Ordinary Shares. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends in the foreseeable future. As a result, capital appreciation, if any, of our Ordinary Shares will be investors’ sole source of gain for the foreseeable future. In addition, Israeli law limits our ability to declare and pay dividends, and may subject our dividends to Israeli withholding taxes.

If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or our shares, our share price and trading volume could decline.

The trading market for our Ordinary Shares will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or provide favorable coverage. If any of the analysts who may cover us adversely change their recommendation regarding our shares, or provide more favorable relative recommendations about our competitors, our share price would likely decline. If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our share price or trading volume to decline.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

這 招股說明書包含有關我們的業務、運營和財務表現和狀況的前瞻性陳述，以及 我們對業務運營以及財務表現和狀況的計劃、目標和期望。包含的任何聲明 此處並非歷史事實陳述的內容可能被視為前瞻性陳述。在某些情況下，您可以識別具有前瞻性 通過「目標」、「預期」、「假設」、「相信」、「思考」等術語進行陳述 「繼續」、「可能」、「到期」、「估計」、「期望」、「目標」、「打算」、 「可能」、「目標」、「計劃」、「預測」、「潛力」、「定位」、 「尋求」、「應該」、「目標」、「將」、「將」和其他類似表達 是對未來事件和未來趨勢的預測或指示，或者這些術語或其他類似術語的否定。 這些前瞻性陳述包括但不限於有關以下方面的陳述：

前瞻性 報表基於我們管理層對我們的業務和 我們運營的行業以及我們管理層的信念和假設，並不是未來績效或發展的保證 並涉及已知和未知的風險、不確定性和在某些情況下超出我們控制的其他因素。因此，任何或全部 本招股說明書中我們的前瞻性陳述可能會被證明不準確。可能導致實際結果的重要因素 與當前預期存在重大差異，其中包括「風險因素」和其他地方列出的預期 在本招股說明書中。敦促潛在投資者在評估前瞻性陳述時仔細考慮這些因素。

的 本招股說明書中包含的前瞻性陳述僅限於本招股說明書日期。儘管我們相信期望 前瞻性陳述中反映的是合理的，我們無法保證未來的結果、活動水平、績效 以及前瞻性陳述中反映的事件和情況將實現或將會發生。除法律要求外，我們 不承擔以任何原因更新或修改這些前瞻性陳述的義務，即使在 未來然而，您應該審查我們不時向SEC提交的報告中描述的因素和風險 本招股說明書日期之後。請參閱「在哪裡可以找到更多信息」。

使用 收益的比例

The Selling Shareholders will receive all of the proceeds from any sales of the Ordinary Shares offered hereby. However, we will incur expenses in connection with the registration of our Ordinary Shares offered hereby.

DIVIDEND POLICY

We have never declared or paid any cash dividends to our shareholders of our Ordinary Shares, and we do not anticipate or intend to pay cash dividends in the foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors in compliance with applicable legal requirements and will depend on a number of factors, including future earnings, our financial condition, operating results, contractual restrictions, capital requirements, business prospects, our strategic goals and plans to expand our business, applicable law and other factors that our board of directors may deem relevant.

The Israeli Companies Law imposes further restrictions on our ability to declare and pay dividends. See “Description of Share Capital—Dividend and Liquidation Rights” for additional information.

Payment of dividends may be subject to Israeli withholding taxes. See “Taxation—Material Israeli Tax Considerations” for additional information.

CAPITALIZATION

The following table sets forth our cash and cash equivalents and our capitalization as of June 30, 2024:

You should read this table in conjunction with the sections titled “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included elsewhere in this prospectus.

The number of the Ordinary Shares to be issued and outstanding immediately after this offering as shown above assumes that all of the Ordinary Shares offered hereby are sold, and is based on 3,235,542, Ordinary Shares issued and outstanding as of the date of this prospectus. This number excludes:

DILUTION

If you invest in our securities, your interest will be immediately diluted to the extent of the difference between the initial public offering price per Ordinary Share in the IPO and the pro forma as adjusted net tangible book value per Ordinary Share after the IPO. Dilution results from the fact that the initial public offering price per Ordinary Share is substantially in excess of the net tangible book value per Ordinary Share. As of June 30, 2024, we had a historical net tangible book value of $(0.026) million, or $(0.01) per Ordinary Share. Our net tangible book value per share represents total tangible assets less total liabilities, divided by the number of Ordinary Shares outstanding on June 30, 2024.

Our pro forma net tangible book value as of June 30, 2024 was $0.3 million, or $0.10 per Ordinary Share. Pro forma net tangible book value per share represents total tangible assets less total liabilities, divided by the number of Ordinary Shares outstanding as of June 30, 2024, after giving effect to (i) the conversion of 104,711 preferred shares into 104,711 Ordinary Shares; (ii) the repayment of $151,000 pursuant to the 2024 convertible loan agreement; (iii) the issuance of 61,751 Ordinary Shares pursuant to a $70,000 investment; and (iv) the issuance, as consideration for the purchase of patent rights, of 320,000 ordinary shares in August 2024 pursuant to the SciSparc License Agreement, and the additional issuance as consideration for such purchase, of 364,931 pre-funded warrants and warrants to purchase 2.054,793 ordinary shares upon the same terms as the warrants to be issued in the IPO, which will be issued upon the consummation of the IPO, based on the initial public offering price of $4.38 per Ordinary Share.

After giving additional effect to the sale of 958,903 Units in the IPO at the initial public offering price of $4.38 per Unit, after deducting the estimated underwriting discounts and commissions and estimated offering expenses, our pro forma as adjusted net tangible book value at June 30, 2024 would have been $0.78 per Ordinary Share. This represents an immediate increase in pro forma as adjusted net tangible book value of $0.79 per share to existing shareholders and immediate dilution of $3.60 per Ordinary Share to new investors.

The following table illustrates this dilution per Ordinary Share:

If the underwriter in the IPO exercises in full its option to purchase additional Ordinary Shares and/or Warrants the pro forma as adjusted net tangible book value will increase to $0.89 per Ordinary Share, representing an immediate increase in pro forma as adjusted net tangible book value to existing shareholders of $0.89 per Ordinary Share and an immediate dilution of $3.49 per Ordinary Share to new investors participating in the IPO.

The following table shows, as of the date of this prospectus, on a pro forma as adjusted basis, the number of Ordinary Shares purchased from us as part of the Units, the total consideration paid to us and the average price paid per share by existing shareholders and by new investors purchasing Units in the IPO at the initial public offering price of $4.38 per Unit, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us:

The number of the Ordinary Shares to be issued and outstanding immediately after this offering as shown above assumes that all of the Ordinary Shares offered hereby are sold, and is based on 3,235,542 Ordinary Shares issued and outstanding as of the date of this prospectus. This number excludes:

To the extent that outstanding options are exercised, new options or warrants are issued or we issue additional Ordinary Shares in the future, there will be further dilution to new investors. We may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our equity holders.

Certain of our existing shareholders, including beneficial owners of greater than 5% of our share capital, have indicated an interest in purchasing up to an aggregate of $1 million of Units in the IPO, which represents approximately 24%% of the total Units in the IPO, based on the public offering price of $4.38 per Unit. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters in the IPO may determine to sell more, less or no Units in the IPO to any of these shareholders, or any of these shareholders may determine to purchase more, less or no Units in the IPO. The underwriters in the IPO will receive the same underwriting discount on any Units purchased by these shareholders as they will on any other Units sold to the public in the IPO.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS

你 應結合我們的審計財務報表（包括相關注釋）閱讀以下討論，開始 見本招股說明書F-1頁。除了歷史信息外，本討論還包含前瞻性陳述， 涉及風險和不確定性。您應閱讀本招股說明書中題為「風險因素」和「特殊」的部分 關於前瞻性陳述的注釋」，討論可能導致我們的實際結果出現重大差異的因素 來自我們的期望。

概述

我們 是一家臨床開發階段的生物技術公司，專門開發以鼻腔形式輸送的創新水凝膠 噴霧，並在鼻腔中形成薄的水凝膠防護屏障，可以提供抵禦病毒的屏障， 接觸鼻表皮組織的過敏原。我們專有的C & C水凝膠技術，由天然的混合物組成 發生的構建模塊，以鼻噴霧劑的形式遞送，並可能充當「生物口罩」， 鼻腔中的薄屏蔽防護屏障。我們正在進一步開發C & C水凝膠技術的某些方面， 作為鼻內遞送藥物的生物粘附和鼻沉積部位的長期保留。我們指的是我們單獨的平台 該技術專注於API的鼻腔遞送，作為T & t。

我們 自2005年成立以來，一直經歷了淨虧損。截至12月31日止年度，我們的淨虧損分別為600，000美金和779，000美金， 2023年和2022年12月31日，截至2024年6月30日和2023年6月30日的六個月淨虧損分別為588，000美金和191，000美金， 分別截至2023年12月31日和2024年6月30日，我們的累計赤字約為350日元和410日元， 分別我們預計在可預見的未來，我們將繼續遭受重大損失，因為我們的運營費用和 由於我們對研發活動的持續投資以及我們的招聘，資本支出大幅增加 未來幾年增加員工。此外，IPO結束後，我們預計將產生與此相關的額外費用 作為美國上市公司運營，包括重大法律、會計、投資者關係和其他費用。

為 有關我們業務和運營的更多信息，請參閱下面的「業務」。

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