根據第 424(b)(5) 條條文提交申請

登記號碼333-274083

1,360,800股A類普通股  

預先資助的認股權，可以購買多達60萬股A類普通股。

購買高達1,960,800股A類普通股的認股權證

biovie inc.

我們正在以每股1.53美元的發售價格，根據本補充說明書和附隨的基本說明書，提供1,360,800股(A類普通股，每股面值為0.0001美元)。

我們還提供預先資助的認股權證，以購買高達600,000股我們的普通股（"預先資助的認股權證"），給予那些通過此次供股購買我們的普通股會導致該購買人，連同其聯屬企業和特定相關方，於此次供股完成後尚未及所有發行和流通中的普通股中受益地擁有超過4.99%（或根據購買人的選擇，為9.99%）的人。每項預先資助的認股權證的購買價格等於本次供股向公眾出售的每股普通股價格減去$0.0001。預先資助的認股權證將立即可行使，並可在任何時間內行使，直到所有預先資助的認股權證全部得到行使為止。

股份和預先購股權正在一起出售，連同購買我們普通股的權證（“普通權證”）。 每張普通權證每股行使價格為1.53美元，立即可行使，並將在原始發行日期的第五週年到期。

股份、預資授權證和一般授權證只能一同購買，但將分開發行並在發行後立即可分割。

我們已經聘請ThinkEquity LLC（“配售代理”）作為我們此次發行活動的獨家配售代理。配售代理已同意盡其合理努力安排出售本招股書提供的證券。配售代理並不購買或出售我們所提供的任何證券，而且配售代理也無需安排任何特定數量或金額的證券的交易。我們已同意向配售代理支付配售代理費用，如下表所示，該表假設我們全部出售本招股書提供的所有證券。由於我們將在投資者資金收到後交付本次發行的證券，因此並沒有安排將資金存放在託管、信託或類似安排中。作為本次發行結束條件，並無最低發行要求的限制。由於本次發行結束並無最低發行金額的要求，我們可能售出的證券數量少於本招股書所述的所有。這可能會大幅降低我們收到的收益金額，本次發行的投資者如果我們無法售出足夠金額的證券以實現在本招股書中描述的業務目標，則不會退款。另外，由於不存在託管帳戶和最低發行金額的要求，投資者可能面臨這樣一種情況，即他們已投資於我們公司，但由於對本次發行缺乏興趣，我們無法實現所有預期目標。此外，我們出售的證券的任何收益將立即可用，儘管對於我們是否能夠有效使用這些資金來實施我們的業務計劃存在不確定性。詳情請參閱“風險因素”一節。我們將承擔所有與本次發行相關的費用。有關這些安排的更多信息，請參閱本招股書S-30頁的“分配計劃”。

我們的普通股在納斯達克資本市場（“納斯達克”）以標的“BIVI”進行交易。 截至2024年9月23日，我們的普通股收盤價為每股2.80美元，根據納斯達克報告。對於預先資助的warrants，沒有建立的交易市場，我們也不打算在任何證券交易所或國家公認的交易系統上列出預先資助的warrants。

投資這些證券涉及特定風險。請參閱本說明書補充第S-6頁的「風險因素」，以及附帶的基礎說明書，以及本說明書補充和相關的基礎說明書中所引用的風險因素，以討論您在決定購買這些證券之前應仔細考慮的因素。

美國證券交易委員會或任何州證券委員會均未核准或否決這些證券，也尚未確定本補充說明書或附隨的基本說明書是否真實或完整。任何相反的陳述皆屬犯罪。  

本次發售的股份、預先購股權(warrants)和普通購股權(warrants)的交付給購買人預計將於2024年9月25日或前後進行，需滿足特定慣例結束條件。

華衍證券

本說明書補充的日期為2024年9月23日

目 錄

招股文件補充說明書

招股證明書

關於此招股說明書補充的說明

本招股說明書補充資料和隨附的基礎招股書屬於我們於2023年8月18日向證券交易委員會（「SEC」）提交的S-3表格（文件編號333-274083）的註冊聲明的一部分，該註冊聲明於2023年8月28日由SEC採用了「貨架」註冊程序生效。本文件分爲兩部分。第一部分是本招股說明書補充資料，描述了本次發行的具體條款，並補充和更新了隨附的基礎招股書和參考文獻中包含的信息。第二部分是隨附的基礎招股書，提供了更多一般性信息，其中一些可能不適用於本次發行。通常情況下，我們在提及本招股說明書時，是指招股說明書補充資料和隨附的基礎招股書的整體內容。在本招股說明書補充資料和隨附的基礎招股書或本招股說明書之前的任何文檔所包含信息之間存在衝突的情況下，您應依賴於本招股說明書中的信息。如果其中任一文件中的陳述與另一文件中的陳述存在不一致的情況（例如，基礎招股書中已經引用的文件），具有較晚日期的文件中的陳述修改或取代較早文件中的陳述。

我們進一步注意到，我們在作爲文件展示的協議中所做的陳述，保證和契約都是僅針對此類協議的當事方（在某些情況下包括爲了在此類協議的當事方之間分配風險而作出協議的目的），並不應視爲對您的任何陳述，保證或協議。此外，此類陳述，保證或協議僅於製作時準確。因此，不應將這些陳述，保證和協議視爲準確地表示我們事務的當前狀態。

您應僅依賴於本招股說明書補充或配套的基本招股說明書或被引用於此處或其中的信息。我們未授權，發行代理也未授權任何人提供與其不同的信息。本招股說明書補充或配套的基本招股說明書中或被引用於此處或其中的信息，僅截至各自的日期才準確，無論本招股說明書補充和配套的基本招股說明書的交付時間或我們證券的銷售時間。

本招股說明書補充和隨附的基礎招股說明書中包含了部分在此提及文件中的摘要，但完整信息應參考實際文件。所有摘要都應完全符合實際文件內容。提及的部分文件副本已提交、將提交或將作爲附件被引入招股聲明，並您可以按照下文「您可以獲取更多信息的地方」一節中的描述獲取這些文件的副本。

您在做出投資決策時，應閱讀並考慮包括在本招股說明書補充文件和隨附的基礎招股說明書中（以及在此處和那裏通過引用結合在一起的文件）的所有信息。您還應閱讀並考慮我們在相應本招股說明書和隨附的基礎招股說明書中列明的「您可以查找更多信息」的部分和「通過引用合併某些信息」的部分中提及的文件中的信息。

本招股說明書補充和隨附的基礎招股說明書包含並援引以獨立行業出版物和其他公開信息爲基礎的市場數據和行業統計數據和預測。雖然我們相信這些信息源可靠，但我們不保證這些信息的準確性或完整性，也未對這些信息進行獨立核實。雖然我們並不知道在本招股說明書補充、隨附的基礎招股說明書或援引的文件中的市場和行業數據中存在任何錯誤陳述，但這些估計涉及風險和不確定性，並根據包括本招股說明書補充和隨附的基礎招股說明書中「風險因素」部分以及援引的其他文件中類似標題中討論的各種因素而可能發生變化。因此，投資者不應過分依賴這些信息。

我們提供出售，並尋求購入，本招股說明書補充所述證券，僅在允許出售與購買的司法轄區提供。本招股說明書補充及隨附的基礎招股說明書之分發，以及本招股說明書補充所述證券的發行在某些司法轄區可能受到法律限制。國外人士如獲悉本招股說明書補充及隨附的基礎招股說明書之內容，必須了解，並遵守與所述證券的發行以及本招股說明書補充及隨附的基礎招股說明書之分發有關的任何限制。本招股說明書補充及隨附的基礎招股說明書並非構成，並且不得用於就本招股說明書補充及隨附的基礎招股說明書所述任何證券的出售提供，或由任何人士在任何其屬地法律不允許作出該等出售或要約購買的司法轄區內進行這種要約購買的邀請。

除非上下文另有說明，否則本招股說明書中提到的「biovie」、「公司」、「我們」或「我們」均指內華達州公司BioVie Inc。

招股說明書補充摘要

這份摘要突出了一些關於我們的信息，以及本招股說明書補充資料中其他地方和隨附的基本招股說明書以及本招股說明書和引入的文件中包含的某些信息。此摘要不是完整的，不包含您在做出投資決定之前應該考慮的所有信息。爲了更全面地了解公司情況，您應該仔細閱讀和考慮本招股說明書及附屬基本招股說明書中包含的更詳細信息，包括在本招股說明書補充資料的S-6頁下第「風險因素」標題下描述的因素，基本招股說明書附錄第5頁開始的「風險因素」部分，以及通過引用在此處和其中納入的信息後再做投資決定。

公司概述

我們是一家處於臨床階段的公司，開發創新的藥物療法，用於治療慢性致殘疾病，包括肝病以及神經系統和神經退行性疾病。

神經退行性疾病項目

公司於2021年6月收購了NeurMedix公司（「NeurMedix」）的生物藥品資產，NeurMedix是一傢俬人持有的臨床階段藥品公司，也是相關方。.收購的資產包括NE3107。2024年4月，公司宣佈美國驗名委員會和世界衛生組織國際非專有名專家委員會已批准「bezisterim」作爲NE3107的非專有（通用）名稱。Bezisterim（NE3107）是一種正在研究的新穎口服小分子藥物，據認爲能抑制炎症驅動的胰島素抵抗和主要的病理性炎症級聯反應，具有新穎的作用機制。出現了科學共識認爲，炎症和胰島素抵抗可能在AD和PD的發展中起着基礎性作用，bezisterim（NE3107）如果獲得FDA批准，可能代表一種全新的醫療方法，用於治療這些影響約600萬名患有AD和100萬名患有PD的美國人的毀滅性疾病。

在神經退行性疾病中，bezisterim（NE3107）抑制炎症性細胞外信號調節激酶（「ERK」）和核因子κB增強活化B細胞（「NFκB」）的活化（包括與腫瘤壞死因子（「TNF」）信號等其他相關炎症途徑的相互作用），從而導致神經炎症和胰島素抵抗。Bezisterim（NE3107）不干擾它們的穩態功能（例如，胰島素信號傳導以及神經元的生長和存活）。炎症和胰島素抵抗都是阿爾茨海默病（「AD」）和帕金森病（「PD」）的發動機。

A. 阿爾茨海默病 (NCT05083260)

2023年11月29日，公司宣佈了bezisterim (NE3107)在治療輕度至中度AD的3期臨床試驗 (NCT04669028) 的頭條療效數據。該研究具有以阿爾茨海默症評估量表-認知量表 (ADAS-Cog 12) 評估認知和使用臨床失智評定-總分作爲功能方面的共同主要終點。患者被隨機分配，1:1與安慰劑相比，進行連續14天口服bezisterim (NE3107) 5毫克，然後連續14天口服10毫克，隨後口服20毫克，每天兩次，爲期26周。

在試驗完成後，由於公司開始分析試驗數據的過程中，公司發現了與方案和當前良好臨床實踐準則（"cGCPs"）在15個研究地點存在明顯偏差和違規行爲（幾乎所有這些地點都來自一個地理區域）。這種高度飛凡的疑似違規行爲水平導致公司排除了所有來自這些地點的患者，並將這些地點轉介給美國食品藥品監督管理局（"FDA"）科學調查辦公室（"OSI"）以進行可能進一步的行動。在患者排除後，修正意向治療人口中還剩下81名患者，其中57名患者屬於完全遵循協議的人口，包括完成試驗並根據藥代動力學數據驗證服用研究藥物的患者。

最初設計試驗時預計有80%的動力量，每個治療組和安慰劑組各有125名患者。不計劃排除這麼多患者導致試驗在主要終點方面動力不足。

在根據處理方案人群中，包括 那些完成試驗並進一步確認已服用研究藥物的患者（基於藥代動力學數據），與基線相比觀察到的但無統計學意義的變化似乎暗示認知損失的減緩；這些患者通過去氧核糖核酸（「DNA」）表觀遺傳學變化的測量，相對於安慰劑體現出年齡減速的優勢。年齡減速 是長壽研究人員用來衡量患者生物學年齡與實際年齡之間差異的指標，在此案例中由Horvath DNA 甲基化皮膚血液時鐘測量。此測試是一個非主要/次要 終點，其他結果測量，通過於第30周（研究結束）採集血液測試完成。

根據在本試驗中觀察到的功效信號，公司正在探討： (1) 與FDA進行討論，可能採用協議的自適應試驗功能，繼續招募患者以達到統計顯著性； 和/或 (2) 設計一個新的第3期研究，利用最新的數據和對患有AD者可能產生的潛在效應的了解，該研究涉及bezisterim（NE3107）。

帕金森病（NCT05083260）

貝西斯特林（NE3107）用於PD治療的第2期研究（NCT05083260）於2023年1月完成，是一項雙盲、安慰劑對照、安全性、耐受性和藥代動力學研究，對接受卡比多巴/左多巴和NE3107治療的PD受試者進行了研究。 隨機分配了45名存在L-多巴「關停狀態」的患者，分別給予安慰劑或貝西斯特林（NE3107）每日20毫克，每天兩次，持續28天。 此試驗的啓動具有兩個設計目標：(1) 主要目標是安全性和藥物相互作用，FDA的要求，評估貝西斯特林（NE3107）和卡比多巴/左多巴之間不良相互作用的潛力; 和(2) 次要目標是判斷是否可以在人類中看到促進活性和明顯增強左多巴活性的臨床前指標。 兩個目標均得到實現。

爲了擴展在進展中的患者中的第2期數據，公司設計了一項新的第2期研究，以Bezisterim（NE3107）作爲潛在的一線治療，用於治療新發病例。2024年7月，公司向FDA提交了這項新研究的方案，以進行監管審查。

C. 開多COVID節目

2024年4月，公司宣佈獲得了美國國防部（「DOD」）頒發的高達1310萬美元的臨床試驗獎，該獎項通過國會指導的醫學研究計劃中的點對點評審醫學研究計劃獲得。2024年8月，美國陸軍醫學研究與發展指揮部，人體研究監督辦公室（「OHRO」）批准了公司評估 NE3107（bezisterim）用於治療與長期 COVID 相關的神經症狀的計劃。FDA此前於2024年8月審查並批准了該項研究爲「安全進行」。來自OHRO的批准是公司獲得來自DOD的1310萬美元額外撥款中最後一個科學審查里程碑所需的。該獎項可爲第2期臨床試驗提供長達2年的非稀釋資金，旨在評估 NE3107（bezisterim）用於治療長期 COVID 相關的神經症狀。公司預計該試驗將於2025年初開始。研究方案已於2024年7月完成並提交給FDA進行監管審查，並於2024年8月22日FDA授權了我們的 NE3107（bezisterim）的 Investigational New Drug（「IND」）申請，使我們能夠研究一種用於治療與長期 COVID 相關的神經認知症狀的新型抗炎方法。

開多COVID是一種情況，在這種情況下COVID-19，由SARS-CoV-2病毒引起的急性呼吸道疾病的症狀持續了很長一段時間，通常是三個月或更長。最近疾控中心報告指出，美國有6.8%的成年人（超過1700萬人）目前或曾經患有長期COVID。症狀包括疲勞、認知功能障礙和睡眠障礙，令人喪失活力。生活質量和收入的損失以及增加的醫療費用造成了估計爲3.7萬億美元的巨大經濟衝擊。迄今爲止，尚沒有被證實有效的治療方法。

慢性炎症是研究人員提出的主要假設之一，用以解釋長期COVID症狀持續存在的原因。具體來說，在患有「腦霧」症狀的個體中，持續的全身炎症和持久的局部血腦屏障（「BBB」）功能障礙是關鍵的生理特徵。貝茲斯泰林（NE3107）滲透到BBB，並已顯示通過抑制NF-kb激活來調節炎症，從而代表了一個針對長期COVID症狀潛在原因的新型口服治療。

慢性神經炎症、胰島素抵抗和氧化應激是主要神經退行性疾病（包括AD、PD、額顳葉半月癲癇和肌萎縮側索硬化）中的共同特徵。Bezisterim（NE3107）是一種正在研究的口服小分子，血腦屏障可滲透，具有潛在的抗炎、胰島素敏感和ERk結合特性，可能使其能夠選擇性地抑制ERk、NFκb和TNF刺激的炎症。Bezisterim（NE3107）抑制神經炎症和胰島素抵抗的潛力構成了該公司在AD、PD和長期COVID患者中測試該分子的基礎。Bezisterim（NE3107）在美國、澳洲、加拿大、歐洲和韓國擁有專利。

肝硬化方案

在肝病領域，我們的待審藥品候選 BIV201（持續靜脈注射替利壓素）已獲得FDA快速通道和FDA孤兒藥品雙重認定，並 在獲得FDA關於第三期臨床試驗設計的指導後正在進行評估和討論，用於治療因慢性肝硬化引起的腹水。BIV201採用專利待申請的液體制劑進行給藥。

2021年6月，公司啓動了第2階段研究（NCT04112199），旨在評估BIV201（替利壓素，連續輸注兩個28天治療週期）與標準護理（"SOC"）聯合治療（與僅使用SOC相比）對難治性腹水的療效。該研究的主要終點是治療期間與治療前期相比，腹水相關併發症的發生率及腹水液體積變化。

2023年3月，公司宣佈暫停招募，第一批接受BIV201加SOC治療的15名患者表現出在治療啓動後的28天內，與治療前28天相比，腹水成交量至少減少30%。與接受SOC治療的患者相比，腹水成交量的變化明顯不同。完成BIV201治療的患者腹水液減少了53%，在治療啓動後的三個月內保持（減少43%）與治療前三個月相比。

2023年6月，公司要求並隨後收到FDA關於BIV201用於治療因肝硬化引起的腹水的最終臨床測試設計和終點的指導。 公司目前正在為BIV201用於治療因肝硬化引起的腹水的第3期研究的議定書設計做最後修改。

雖然活性成分曲環葡肽在美國和約40個國家已經獲得認可，用於治療愛文思控股相關併發症，但對於治療腹水並不包括在這些授權內。患有難治性腹水的患者常常遭受生命威脅的併發症，治療成本每年超過50億美元，預計在6至12個月內有50%的死亡率。美國食品和藥物管理局尚未批准任何藥物用於治療難治性腹水。

BIV201開發計畫由LAt Pharma LLC發起。2016年4月11日，公司收購了LAt Pharma LLC和其BIV201開發計畫的權利。公司目前擁有該藥物候選品的所有開發和行銷權。根據2016年4月11日我們前身實體LAt Pharma LLC和NanoAntibiotics, Inc.簽署的合併協議，BioVie有義務支付BIV201（連續輸注替利普酮）的淨銷售低個位數權利金，分給LAt Pharma Members、PharmaIn Corporation和The Barrett Edge, Inc。

近期發展

在2024年7月29日的股東特別大會（以下簡稱“特別大會”）上，我們的股東批准授予我們的董事會在此特別大會一週年之前行使完全酌情權，在我們的普通股的優先股在1股至6股和1股至10股之間的分割比率。根據股東授予的此項授權，我們的董事會批准對我們的普通股進行1股至10股的反向股票分割，並提交《變更證書》（以下簡稱“變更證書”）以實現反向股票分割。《變更證書》於2024年7月31日向內華達州州務卿辦公室提交，並根據《變更證書》的條款於2024年8月6日東部時間凌晨12:01生效（以下簡稱“生效時間”）。《變更證書》規定，在生效時間，我們已發行並流通的每10股普通股會自動合併成為一股已發行和流通的普通股，每股無變動，仍為0.0001美元。除非內容明確另有安排，所有提及股份和每股金額的參考均反映了此處一比十的反向股票分割。

2024年8月2日，我們向內華達州州務卿辦公室提交修正檔案證書，以更正先前於2024年7月31日提交的逆向股票拆股文件。修正檔案證書糾正了先前提交的變更檔案中的瑕疵。2024年8月5日，我們向內華達州州務卿辦公室提交終止證書，廢止了先前提交的變更檔案。上述拆股文件的條款或時間並未進行實質性更改。

公司信息

我們的總執行辦公室位於內華達州卡森城( Carson City )尼街(Lane)680號201套房，郵遞區號89703，聯絡電話為(775) 888-3162。

本次發行

這次發行後我們的普通股股份數量，基於截至2024年8月30日發行和流通的6,330,860股普通股，並不包括：

除非另有說明，本招股說明書補充內容反映並假定以下情況：

風險因素

投資我們的證券存在高風險。在決定是否投資我們的證券之前，您應該仔細考慮在我們最近的年度10-k表格中討論的風險和不確定性，以及在任何隨後提交的季度10-Q表格中討論的風險因素，以及在我們隨後向SEC提交的文件中反映的任何修訂內容，這些都已被引用並納入了本招股說明書中。請認真閱讀本招股說明書中包含的其他信息、被引用的文件、任何招股說明書以及我們可能授權的任何自由撰寫招股說明書。請還仔細閱讀標題爲「前瞻性陳述的警示說明」部分。我們目前沒有意識到的其他風險和不確定性，或我們目前認爲不重要的因素，也可能對我們的業務產生不利影響。此外，過去的財務表現可能不是未來表現的可靠指標，歷史趨勢不應該用來預測未來時期的結果或趨勢。

與我們的業務和行業有關的風險。

我們依賴並將繼續依賴第三方進行我們的臨床試驗。如果這些第三方不能成功履行其合同義務或按照預期的時間表履行，或者不能成功執行並遵守監管要求，我們可能無法獲得產品候選者的監管批准或商業化。

我們依賴並將繼續依賴第三方，包括但不限於合同研究機構（「CROs」），臨床試驗研究地點和臨床試驗首席研究員，合同實驗室，機構審查委員會（「IRBs」），製造商，供應商以及其他第三方進行我們的臨床試驗，包括針對我們的藥物候選藥物bezisterim（NE3107）和BIV201。我們在臨床試驗過程中嚴重依賴這些第三方，並且只能控制他們活動的某些方面。然而，我們對確保我們的每項研究按照方案及適用的法律、法規和科學標準進行，並且對第三方的依賴並不免除我們的監管責任負有最終責任。我們和這些第三方都需要遵守cGCPs，這是FDA和其他外國監管機構強制執行的針對處於臨床開發階段的產品候選藥物的臨床試驗的法規和指南。監管機構通過定期檢查和由原因引起的檢查來強制執行cGCPs，針對臨床試驗首席研究員和試驗地點。如果由於公司或第三方的失敗，臨床試驗未能遵守適用的cGCPs、FDA的IND要求、其他適用的監管要求或適用IRB批准的方案中規定的要求，公司可能需要進行額外的臨床試驗來支持我們的上市申請，這將延遲監管審批過程。例如，我們的藥物產品候選藥物bezisterim（NE3107）已獲得FDA批准，用於對輕度至中度AD患者進行第3期隨機、雙盲、安慰劑對照、平行組、多中心研究。該試驗的招募於2021年8月開始，計劃在2022年底/2023年初完成主要研究。2023年11月29日，公司公佈了關於bezisterim（NE3107）在輕度至中度AD治療中的第3期臨床試驗（NCT04669028）的頭條療效數據。隨着試驗的完成，公司開始分析試驗數據的過程中，發現在15個研究地點（幾乎全部位於一個地理區域）存在嚴重的與方案和cGCP違規行爲。這種高度異常的疑似違規水平導致公司排除了來自這些地點的所有患者。後來，我們通知了FDA的OSI有關研究方案嚴重違規、涉及的疑似不當行爲和研究地點的重大違規。在多個研究地點發現的研究方案重大違規和衆多GCP違規引發了有關這些研究地點數據的有效性和穩健性的問題。由於大量患者的非計劃性排除使得試驗無法滿足主要終點的動力學要求。然而，基於剩餘數據集，檢測到了初步療效信號。公司正在考慮：（1）採用方案的自適應試驗功能繼續招募患者以獲得統計學意義；和/或（2）設計一項新的bezisterim（NE3107）第3期研究，利用最新的與AD相關的科學文獻以及公司對輕至中度AD患者體內bezisterim（NE3107）效果的理解。

儘管我們爲產品候選人設計了臨床試驗，但我們的CRO負責促進和監測這些試驗。因此，我們臨床發展項目的許多方面，包括現場和研究者選擇、研究的實施、時機和監督，都超出了我們直接的控制範圍，部分或全部。我們依賴第三方進行臨床試驗，也導致對通過臨床試驗開發的數據的收集、管理和質量比我們依賴自己的員工要少直接控制。與第三方溝通也可能具有挑戰性，可能導致錯誤，以及在協調活動方面遇到困難。如果這些第三方違反適用的聯邦、州或外國法律和/或法規，包括但不限於FDA的IND法規、cGCPs、欺詐與濫用或虛假索賠法律、醫療保健隱私和數據安全法律，或向我們或政府機構提供不準確、誤導或不完整的數據，我們的業務可能會受到影響。

生物製藥品的成功開發是非常不確定的，並且依賴於許多因素，其中許多是超出我們的控制範圍的。

製造業-半導體早期開發階段表現出潛力的產品候選可能由於多種原因未能進入市場。 預臨床研究結果可能顯示產品候選不如人意（例如，研究未能達到其首要終點）或具有有害或問題性的副作用。 產品候選可能未能獲得必要的監管批准，或在獲得此類批准時可能出現延遲。 其他可能導致這種延遲的原因包括：臨床研究中招募緩慢；達到研究終點所需的時間長；數據分析額外時間要求；IND及後續新藥申請準備；與FDA進行的討論；FDA要求額外的預臨床或臨床數據；意外的安全性或製造問題；製造成本；定價或報銷問題；臨床試驗地點偏離試驗方案，犯有科研不端行爲，或違反監管要求等等-這可能導致這些地點的數據無法用於支持監管審批；或使產品在經濟上不可行的其他因素。 其他公司的專有權和其競爭產品和技術也可能導致產品無法商業化。

在臨床前和早期臨床研究取得成功，並不意味着大規模臨床研究會取得成功。臨床結果往往容易受到不同解讀的影響，可能會延遲、限制或阻止監管批准。完成臨床研究並向監管機構提交營銷批准申請以獲得最終決定所需的時間長度因產品而異，可能難以預測。無法保證我們的任何產品都會成功開發，並且如果未能開發成功，將對我們的業務產生重大不利影響，並導致您失去所有投資。

我們資產集中在某家金融機構可能對其業務、財務狀況和運營結果產生重大不利影響。

截至2025年8月30日，公司在某金融機構存放的現金超過了聯邦保險水平。公司定期監控這些金融機構的財務穩定性，並認爲在現金及現金等價物中不承擔任何重大信用風險。銀行倒閉、涉及有限流動性的事件、違約、不履行合同或其他不利發展影響金融機構，或對此類事件的擔憂或傳言，都可能導致流動性約束。在2024年，由於流動性擔憂，某些美國政府銀行監管機構採取了干預措施，影響了某些金融機構的運營，導致金融市場普遍存在較高不確定性。儘管先前的銀行倒閉沒有對公司業務產生重大直接影響，但如果針對銀行和金融機構出現進一步的流動性和財務穩定性擔憂，無論是全國範圍還是特定地區，公司獲取現金或達成新融資安排的能力可能受到威脅，這可能對其業務、財務狀況和經營業績產生重大不利影響。

我們目前正處於證券集體訴訟之中，未來可能會遭受類似或其他訴訟，所有這些都將需要大量管理時間和關注，導致重大的法律費用，並可能導致不利的結果，這可能對我們的業務、運營結果和財務狀況產生重大不利影響，同時也可能對我們普通股價格產生負面影響。

我們現在和將來可能會面臨各種起訴和索賠，這些起訴和索賠可能發生在業務的正常經營範圍之內或之外。例如，在2024年1月19日，一項所謂的股東集體訴訟投訴書，題爲Eric Olmstead訴BioVie Inc.等，案號3:24-cv-00035，在內華達州地方法院對公司及其某些高管提起訴訟。2024年2月22日，第二起與之相關的債券類集體訴訟在同一法院提起，聲稱針對相同被告提出類似索賠，題爲Way訴BioVie Inc.等，案號2:24-cv-00361。2024年4月15日，法院合併了這兩起訴訟案件，命名爲 BioVie Inc.證券訴訟案，案號3:24-cv-00035，指定了首席原告，並批准了首席律師的選定。2024年6月21日，首席原告提交了修訂後的訴狀，聲稱被告在涉及公司業務、運營、合規和前景的重要事實，包括與NM101第3期研究和bezisterim（NE3107）治療輕度至中度可能阿爾茨海默病相關的信息方面進行了實質性的虛假陳述和/或遺漏，違反了《1934年證券交易法》，並依據該法所頒佈的第10億.5條。 該集體訴訟代表公司在2022年12月7日至2023年11月28日期間購買公司證券的人，並代表該假定類別尋求未明確數額的賠償以及成本和費用，包括律師費。被告於2024年8月21日提起駁回修訂訴狀的動議。被告認爲這些索賠沒有根據，並打算積極進行辯護，但無法保證結果。

可能會有更多訴訟被提起，或者股東提出指控，涉及同樣或其他事項，並可能會將我們和/或我們的高管和董事列爲被告。這些訴訟及任何其他相關訴訟均存在固有的不確定性，實際的軍工股及解決成本將取決於許多未知因素。這類訴訟的結果必然是不確定的。我們可能被迫在進行中的訴訟和任何額外訴訟的辯護中耗費大量資源，並且可能無法獲勝。此外，我們可能會在這類訴訟中承擔重大的法律費用和成本。目前，我們無法估計這一事項可能給我們帶來的費用，因爲正在進行中的訴訟目前處於早期階段，我們無法確定解決進行中訴訟可能需要多長時間或我們可能需要支付的任何損害賠償金額。監督、提起和進行法律訴訟辯護會佔用我們管理團隊大量時間、成本昂貴，可能分散我們內部資源全力專注於開多活動。我們可能被迫在解決或辯護進行中的訴訟和任何潛在未來訴訟中耗費大量資源，並且我們可能無法在這類訴訟中獲勝。

儘管我們擁有我們認爲適用於這些行爲的保險，但該保險受到200萬美元的免賠額約束。這意味着在保險生效之前，我們需要承擔起初200萬美元的損失，其中包括辯護費和損害賠償。此外，我們的保險覆蓋可能不足，我們的資產可能不足以支付超出我們的保險覆蓋範圍的任何金額，因此我們可能需要支付損害賠償金或以其他方式與此類索賠達成和解。對我們的利益不利的對待會導致支付巨額損害賠償，或可能導致罰款，並可能對我們的業務、股價、現金流、經營業績和財務狀況產生重大不利影響。我們並未爲與未決訴訟或未來潛在訴訟相關的潛在責任設立任何準備金。在當前或未來的訴訟中的任何支付或和解安排可能對我們的業務、經營業績或財務狀況產生重大不利影響。此外，此類訴訟可能使我們更難融資經營，並影響我們支付賠償金的能力。

關於本次融資和我們的普通股相關的風險

您可能會在購買本次發行的普通股時，立即和大幅地面臨每股淨資產賬面價值的稀釋。

本次發行的每股發售價格可能超過本次發行前我公司普通股每股的淨有形資產價值。 在我們以每股1.53美元的價格銷售股票和附帶的普通權證，以及以每個預先融資權證1.5299美元的價格銷售預先融資權證及附帶的普通權證後，考慮到我們支付的放置代理費和預計的發行費用以及假設全部行使預先融資權證， 您將每股立即蒙受0.97美元的攤薄，代表了截至2024年3月31日我們淨有形資產價值每股在本次發行後生效以及假設價格的差異。未行使的權證和股票期權的行使也可能導致您的投資進一步攤薄。詳情請參閱下文第S-30頁中標題爲「攤薄」的部分，以了解您參與本次發行可能出現的攤薄情況。

我們的管理層將對本次發行所得淨收益擁有廣泛的自主權，可能會以您可能不同意的方式投資或支出所籌集的資金，並且這些收益可能不會產生顯著回報。

我們的管理層將對這項發行的所得款項擁有廣泛的自主權。我們目前打算將這項發行的淨收入用於「所得款項」的部分所述用途。但是，我們的管理層將對這項發行的淨收益的運用擁有廣泛的自主權，並且可能將其用於與在此次發行時所預期用途不同的目的。因此，您需要依靠我們管理層就這些淨收益的使用所作的判斷，您將無法作爲您的投資決策的一部分來評估這些款項是否會被適當地使用。若管理層未能有效運用這些資金，可能會導致財務損失，對我們的業務產生重大不利影響，導致我們的普通股價格下跌，並延遲我們產品候選者的發展。在使用這些資金之前，我們可能會將此次發行的淨收益投資於短期的、收益-bearing的工具中。這些投資可能對我們或我們的股東產生不利的回報，甚至沒有回報。

我們的股價可能會繼續波動，您可能無法按照您所支付的價格將我們的普通股轉售或高於該價格。

我們的普通股市場價格波動較大，可能會受許多因素的影響而出現顯著波動，其中許多因素我們無法控制，如季度財務結果波動、產品候選品發展進度以及證券分析師的推薦變動等。此外，股市普遍最近經歷了波動。我們的股價未來可能會出現顯著波動。我們的普通股價格可能會下跌，而無論我們的表現如何，持有我們的普通股的任何投資價值可能會減少。此外，我們的普通股每日交易量歷史上相對較低。由於歷史上的低交易量，我們的股東可能無法在公開市場上以不顯著降低我們普通股價值的情況下出售大量普通股。這些因素中的每一個，以及其他因素，都可能對您對我們的普通股的投資造成損害，可能導致您無法以與購買時相等或更高價格出售您購買的我們的普通股。

在過去，當股票的市場價格波動較大時，持有該股票的股東有時會對發行人提起證券集體訴訟。如果我們的股東之一對我們提起此類訴訟，我們可能會爲辯護訴訟承擔重大成本，並且我們管理層的注意力將會從我們業務的控件轉移。

我們不打算在我們的普通股上支付分紅派息，因此任何回報將僅限於我們普通股的價值。

我們目前預計會保留任何未來收益，用於資助業務的持續發展、運營和擴張。因此，我們不預計在可預見的未來宣佈或支付任何現金分紅或其他分配。如果我們不支付分紅，我們的普通股可能會變得不那麼有價值，因爲股東必須依靠普通股的價格上漲後的銷售才能實現任何投資收益。

您可能會因爲未來的股權發行或者我們發行受期權、認股權證、股票獎勵或其他安排限制的股票而遭受未來的稀釋。

爲了籌集額外資金，我們將來可能以每股價格低於我們證券的當前市價發行公司的普通股票或其他可轉換爲我們普通股票的證券，並且未來購買股票或其他證券的投資者可能擁有優於現有股東的權利。出售我們的普通股或其他可轉換爲或可交換爲我們普通股的其他證券將使所有股東的股份被稀釋，如果這些用於換股的證券的銷售價格低於2022年8月向Acuitas Group Holdings，LLC（「Acuitas」）出售的認購權（「Acuitas認購權」）的當前行權價，則這些認購權的行權價將向下調整爲認爲發行價，根據這些認購權中包含的價格調整保護。

截至2024年8月30日，尚有warrants等待行使，可購買我們普通股總計1,922,162股，行使價格範圍從$10.00到$125.00每股，以及518,076股可以行使的期權，行使價格範圍從$4.74到$420.90每股，以及34,567股限制性股票單位。此外，根據貸款和安全協議以及貸款和安全協議補充協議，分別於2021年11月30日與Avenue Venture Opportunities Fund II，L.P.以及Avenue Venture Opportunities Fund，L.P.簽訂，放貸人有權將最多500萬美元的未償還貸款金額轉換爲我們的普通股，轉換價格爲每股58.20美元。我們還可能授予額外的期權，warrants或股權獎勵。在發行此類股份的情況下，我們普通股股東的利益將被稀釋。

此外，根據2021年4月27日簽署的資產購買協議，並於2021年5月9日對此協議進行修訂的公司、NeurMedix和Acuitas之間的協議，我們有義務在實現某些藥物候選人（即bezisterim（NE3107）、NE3291、NE3413和NE3789）的臨床、監管和商業里程碑時發行普通股。這些里程碑的達成可能導致發行多達180萬股的普通股，進一步稀釋持有者對我們普通股的權益。

There is no established public trading market for the Pre-funded Warrants or Common Warrants being offered in this offering, and we do not expect a market to develop for the Pre-funded Warrants or Common Warrants.

There is no established public trading market for the Pre-funded Warrants or Common Warrants being offered and sold in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the Pre-funded Warrants or Common Warrants on any national securities exchange or other nationally recognized trading system. Without an active market, the liquidity of the Pre-funded Warrants or Common Warrants will be limited. Further, the existence of the Pre-funded Warrants or Common Warrants may act to reduce both the trading volume and the trading price of our Common Stock.

The Pre-funded Warrants or Common Warrants are speculative in nature.

Except as otherwise provided in the Pre-funded Warrants or Common Warrants, until holders of Pre-funded Warrants or Common Warrants acquire our Common Stock upon exercise of the Pre-funded Warrants or Common Warrants, holders of Pre-funded Warrants and Common Warrants will have no rights with respect to our Common Stock underlying such Pre-funded Warrants and Common Warrants. Upon exercise of the Pre-funded Warrants or Common Warrants, the holders will be entitled to exercise the rights of a stockholder of our Common Stock only as to matters for which the record date occurs after the exercise date.

Moreover, following this offering, the market value of the Pre-funded Warrants and Common Warrants is uncertain. There can be no assurance that the market price of our Common Stock will ever equal or exceed the price of the Pre-funded Warrants or Common Warrants, and, consequently, whether it will ever be profitable for investors to exercise their Pre-funded Warrants or Common Warrants.

We will not receive any meaningful amount of additional funds upon the exercise of the Pre-funded Warrants and Common Warrants.

每個預先投入的認股權證和每個普通認股權證分別可行使，直至完全行使為止，並通過支付標明現金購買價格予行使，或者分別通過支付$1.53現金購買價格予行使，或採用“無現金行使”程序。因此，在預先投入的認股權證的情況下，我們將不會在行使預先投入的認股權證或普通認股權證時獲得任何實質額外款項。

如果我們沒有保持一份當前有效的關於我們普通股發行的前款憑證或普通憑證的說明書，持有人只能以「無現金基礎」行使這些前款憑證或普通憑證。

如果我們未能保持與我們普通股可通過行使預付權證或普通權證而發行的股份相關的最新有效的招股書，當持有人希望行使這些權證時，他們只能以"無現金"方式進行行使，在任何情況下，我們都不需要向持有人支付任何現金款項或淨現金解決這些權證。因此，持有人在行使預付權證或普通權證時將獲得的普通股數量將少於如果這些持有人為現金行使了他們的預付權證或普通權證時將獲得的數量。如果我們無法保持最新有效的招股書，則持有人對我們公司的投資潛在"上升空間"可能會減少。

本公司普通股的重要持有人或受益持有人可能無法行使他們持有的預資助認股權證。

持有預先資助認股權的持有人將不具有行使任何部分預先資助認股權的權利，如果行使該部分將導致：(i) 一名持有人（及其聯屬公司）所持有的我們普通股股份之總數超過練海之後立即行使前的4.99%（或持有人選擇的9.99%）的股份數；或（ii）一名持有人（及其聯屬公司）所持有的我們證券的合併表決權超過練海之後立即行使前的4.99%（或持有人選擇的9.99%）的合併表決權，根據預先資助認股權條款所確定的股份占比。因此，在某些情況下，您可能無法在對您財務有利的時間行使您的預先資助認股權以獲得我們普通股股份。在這種情況下，您可以試圖賣出您的預先資助認股權以實現價值，但由於缺乏既定的交易市場和適用的轉讓限制，您可能無法這樣做。

這是最佳努力提供，不需要出售最低數量的證券，而且我們可能無法籌集我們認為對我們業務計劃所需的資本金。

放置代理已同意尽最大努力徵集购买此次发行中的股份、预先融资权证和普通认股权证的要约。放置代理无需从我们购买任何证券，也不需安排购买或出售任何特定数量或金额的证券。本次发行的完成并不需要销售任何最低数量的证券或金额的工作。因为本次发行的关闭不需要最低数量的证券或出售利益的金额，故实际发售数量、放置代理费用和向我们支付的款项目前无法确定，而可能远少于上述最大金额。我们可能未全部出售此次要约的证券，此举可能会大幅降低我们所获款项的数额，并且在本次发行中投资者若未能全部购买我们所提供的单位，则将不会收到退款。因此，我们可能无法筹集我们认为短期内操作所需的资本金额，可能需要筹集其他资金，但这些资金可能无法获得，或者提供的条款我们不可接受。

如果納斯達克認定本次發行股份不符合納斯達克股東批准規則所定義的公開發行標準，則納斯達克可能會尋求從交易所撤銷我們的普通股。

我們在納斯達克上市股票的持續交易取決於我們遵守納斯達克市場規則下的持續上市要求，包括但不限於Market Place Rule 5635，或股東批准規則。股東批准規則禁止超過我們已發行普通股的20％的普通股（或衍生產品）未經股東批准發行，除非該等股票以符合股東批准規則中定義的“最低價格” 或納斯達克認定為股東批准規則中定義的“公開發行”的價格出售（“公開發行”）。本次發行的證券可能按照股東批准規則中定義的“最低價格”大幅折扣出售，而我們不打算為本次發行的證券的發行獲得股東批准。因此，我們已尋求進行，並計劃繼續進行，此次發行如股東批准規則所定義的公開發行，這是基於納斯達克的定量分析，該分析基於幾個因素確定，包括通過在1933年修訂版的《證券法》下註冊的肯定銷售承諾類配售發行。在經過幾個交易日經過廣泛的公開推廣後，我們出售的證券需求以及這些證券的最終發售價格將由放置代理商確定。納斯達克還公佈了指南，即對於低於“最低價格”（例如折扣50％或更多）的證券發行通常將阻止確定該發行是否符合股東批准規則的公開發行資格。我們無法保證納斯達克將確定此次發行是否被認定為股東批准規則下的公開發行。如果納斯達克確定此次發行未按照股東批准規則進行，納斯達克可能會指出一個缺陷並決定從納斯達克摘牌我們的證券。一旦從納斯達克摘牌，我們的股票可能會在場外交易的交易商報價系統中進行交易，也更常被稱為“場外交易”。場外交易涉及與在證券交易所（如納斯達克）或更常稱作交易所上市股票的交易相比的風險。許多場外交易股票的交易頻率和交易量比交易所上市股票要低。因此，我們的股票的流動性可能比其他情況下要低。此外，場外交易股票的價格通常比交易所上市股票更易波動。此外，通常禁止機構投資者投資於場外交易股票，並且在需要時可能更難籌集資金。

公司的某些股東可能對我們公司具有重大的控制權。

截至2024年8月30日，Acuitas有利益地擁有我們普通股的3,050,397股，其中包括購買我們普通股的期權727,273張、購買我們普通股的期權6,500張，可於2024年8月30日後60天內行使，目前佔我們已發行以及流通普通股的43.2%。因此，Acuitas對我們公司的管理和事務具有實質影響力，以及控制權利提交給我們股東審批的事項結果，包括董事選舉、重大企業交易的批准，包括任何合併、合併或資產全部或實質全部出售，根據某些情況的股權發行或贖回，以及任何其他重大交易。Acuitas的利益可能並不總是與我們的利益或其他股東的利益一致，有時甚至可能相互衝突。例如，這種所有權的集中可能會延遲或阻止其他股東偏愛的控制權轉讓，並可能剝奪其他股東以優惠價收購普通股的機會。這種所有權的集中亦可能由於投資者認為存在或可能存在利益衝突，負面影響我們普通股的市價。因此，這種所有權的集中可能不符合您的最佳利益。

We may, in the future, issue additional common stock, which would reduce investors’ percent of ownership and may dilute our share value.

As of August 30, 2024, our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 6,357,186 shares of our Common Stock issued and 6,330,860 issued and outstanding. Accordingly, we may issue up to an additional 793,642,814 shares of Common Stock. The future issuance of Common Stock may result in substantial dilution in the percentage of our Common Stock held by our then existing stockholders. We may value any Common Stock in the future on an arbitrary basis. The issuance of Common Stock for future services or acquisitions or other corporate actions may have the effect of diluting the value of the shares held by our investors, might have an adverse effect on any trading market for our Common Stock and could impair our ability to raise capital in the future through the sale of equity securities.

We effected a reverse stock split on August 6, 2024, and we cannot predict the effect that such reverse stock split will have on the market price for shares of our Common Stock.

Our board of directors approved a one-for-ten (1:10) reverse stock split of our Common Stock, which became effective at 12:01 a.m. Eastern Time on August 6, 2024. We cannot predict the effect that the reverse stock split will have on the market price for shares of our Common Stock, and the history of similar reverse stock splits for companies in like circumstances has varied. Some investors may have a negative view of a reverse stock split. Even if the reverse stock split has a positive effect on the market price for shares of our Common Stock, performance of our business and financial results, general economic conditions and the market perception of our business, and other adverse factors which may not be in our control could lead to a decrease in the price of our common stock following the reverse stock split.

Furthermore, even if the reverse stock split does result in an increased market price per share of our Common Stock, the market price per share following the reverse stock split may not increase in proportion to the reduction of the number of shares of our Common Stock outstanding before the implementation of the reverse stock split. Accordingly, even with an increased market price per share, the total market capitalization of shares of our Common Stock after a reverse stock split could be lower than the total market capitalization before the reverse stock split. Also, even if there is an initial increase in the market price per share of our Common Stock after a reverse stock split, the market price many not remain at that level.

If the market price of shares of our Common Stock declines following the reverse stock split, the percentage decline as an absolute number and as a percentage of our overall market capitalization may be greater than would occur in the absence of the reverse stock split due to decreased liquidity in the market for our Common Stock. Accordingly, the total market capitalization of our Common Stock following the reverse stock split could be lower than the total market capitalization before the reverse stock split.

Risks Relating to Our Intellectual Property

We may be unable to obtain or protect intellectual property rights relating to our product candidates, which could have a materially adverse effect on our business.

Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies. We cannot assure investors that we will continue to innovate and file new patent applications, or that if filed any future patent applications will result in granted patents with respect to the technology owned by us or licensed to us. Further, we cannot predict how long it will take for such patents to issue, if at all. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations and, therefore, validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated or circumvented.

We have pending patent applications for our liquid formulations of terlipressen the following jurisdictions which claim priority to PCT/US2020/034269 filed on May 22, 2020 and published as WO2020/237170: US, Europe, China, and Japan and 6 other jurisdictions. In two jurisdictions, we have patents for our liquid formulations of terlipressen which claim priority to PCT/US2020/034269 filed on May 22, 2020 and published as WO2020/237170. We also have thirteen (13) issued U.S. patents, six (6) pending U.S. applications, three (3) pending Patent Cooperation Treaty applications, six (6) pending foreign patent applications, and six (6) issued foreign patents directed to protecting bezisterm (NE3107) and related compounds and methods of making and using thereof. However, there can be no assurance that our pending patent applications will result in issued patents, or that any issued patent claims from pending or future patent applications will be sufficiently broad to protect BIV201, bezisterim (NE3107), or any other product candidates or to provide us with competitive advantages.

We can provide no assurance that any issued patents will provide us with any competitive advantage. We cannot be certain that there is no invalidating prior art of which we and the patent examiner are unaware or that our interpretation of the relevance of prior art is correct. If a third-party patent or patent application is determined to have an earlier priority date, it may prevent our patent applications from issuing at all or issuing in a form that provides any competitive advantage for our drug candidates. Failure to obtain additional issued patents could have a material adverse effect on our ability to develop and commercialize our drug candidates. Even if our patent applications do issue as patents, third parties may be able to challenge the validity and enforceability of our patents on a variety of grounds, including that such third party’s patents and patent applications have an earlier priority date, and if such challenges are successful, we may be required to obtain one or more licenses from such third parties, if available on commercially reasonable terms, or be prohibited from commercializing our drug candidates.

We seek to protect our proprietary positions by, among other things, filing patent applications in the United States and abroad related to our current drug candidates and other drug candidates that we may identify. Obtaining, maintaining, defending and enforcing pharmaceutical patents is costly, time-consuming and complex, and we may not be able to file and prosecute all necessary or desirable patent applications, or maintain, enforce and license any patents that may issue from such patent applications, 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. Moreover, under certain of our license or collaboration agreements, we may not have the right to control the preparation, filing, prosecution and maintenance of patent applications, or to maintain the rights to patents licensed to or from third parties.

We currently are the assignee of a number of U.S. provisional patent applications. U.S. provisional patent applications are not eligible to become issued patents until, among other things, we file a non-provisional patent application within 12 months of filing one or more of our related provisional patent applications. With regard to such U.S. provisional patent applications, if we do not timely file any non-provisional patent applications, we may lose our priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications. Further, in the event that we do timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict whether any such patent applications will result in the issuance of patents or if such issued patents will provide us with any competitive advantage.

As to our material inventions, trade secrets, and intellectual property, our employees, consultants, and advisors execute confidentiality agreements and agree to disclose and assign to us all inventions conceived during the workday, using our property, or which relate to our business. However, any of these parties may breach these agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. Further, we may not be aware of all third-party intellectual property rights potentially relating to our drug candidates. 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 or, in some cases, not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

The patent position of pharmaceutical companies generally is highly uncertain, involves complex legal, technological and factual questions and has, in recent years, been the subject of much debate and litigation throughout the world. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States, or vice versa. The standards that the United States Patent and Trademark Office (the “USPTO”) (and foreign countries) use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. The issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. The subject matter claimed in a patent application can be significantly reduced or eliminated before the patent issues, if at all, and its scope can be reinterpreted or narrowed after issuance. Therefore, our pending and future patent applications may not result in patents being issued in relevant jurisdictions that protect our drug candidates, in whole or in part, or that effectively prevent others from commercializing competitive drug candidates, and even if our patent applications issue as patents in relevant jurisdictions, they may not issue in a form that will provide us with any meaningful protection for our drug candidates or technology, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Additionally, our competitors may be able to circumvent our patents by challenging their validity or by developing similar or alternative drug candidates or technologies in a non-infringing manner.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. We may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others, or other proceedings in the USPTO or applicable foreign offices that challenge priority of invention or other features of patentability. An adverse determination in any such submission, proceeding or litigation could result in loss of exclusivity or ability to sell our products free from infringing the patents of third parties, patent claims being narrowed, invalidated or held unenforceable, in whole or in part, and limitation of the scope or duration of the patents directed to our drug candidates, all of which could limit our ability to stop others from using or commercializing similar or identical drug candidates or technology to compete directly with us, without payment to us, or result in our inability to manufacture or commercialize drug candidates or approved products (if any) without infringing third-party patent rights. In addition, if the breadth or strength of the claims of our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future drug candidates, or could have a material adverse effect on our ability to raise funds necessary to continue our research programs or clinical trials. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us.

In addition, given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products or technology similar or identical to ours for a meaningful amount of time, or at all. Moreover, some of our licensed patents and owned or licensed patent applications may in the future be co-owned with third parties. If we are unable to obtain exclusive licenses to any such co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could harm our competitive position, business, financial condition, results of operations and prospects.

Further, we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures to protect our rights in the technology. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially and adversely affected. The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant problems in protecting our proprietary rights in these countries.

Our success depends in significant part on our ability to obtain, maintain, enforce and defend patents and other intellectual property rights with respect to our drug candidates and technology and to operate our business without infringing, misappropriating, or otherwise violating the intellectual property rights of others. If we are unable to obtain and maintain sufficient intellectual property protection for our drug candidates or other drug candidates that we may identify, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors and other third parties could develop and commercialize drug candidates similar or identical to ours, and our ability to successfully commercialize our drug candidates and other drug candidates that we may pursue may be impaired.

Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and disclosure of our trade secrets or proprietary information could compromise any competitive advantage that we have, which could have a materially adverse effect on our business.

Our success depends, in part, on our ability to protect our proprietary rights to the technologies used in our product candidates. We depend heavily upon confidentiality agreements with our officers, employees, consultants and subcontractors to maintain the proprietary nature of our technology. These measures may not afford us complete or even sufficient protection, and may not afford an adequate remedy in the event of an unauthorized disclosure of confidential information. If we fail to protect and/or maintain our intellectual property, third parties may be able to compete more effectively against us, we may lose our technological or competitive advantage, and/or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property. In addition, others may independently develop technology similar to ours, otherwise avoiding the confidentiality agreements, or produce patents that would materially and adversely affect our business, prospects, financial condition and results of operations, in which event you could lose all of your investment.

We may enter into licensing and collaboration agreements with third parties. If we fail to comply with our obligations in the agreements under which we license intellectual property rights to or from third parties, or these agreements are terminated, or we otherwise experience disruptions to our business relationships with our licensors or licensees, our competitive position, business, financial condition, results of operations and prospects could be harmed.

It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our products (if approved), in which case we would be required to obtain a license from these third parties. The licensing of third-party intellectual property rights is a competitive area, and more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. More established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. 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 or at all. If we are unable to license such technology, or if we are forced to license such technology on unfavorable terms, our business could be materially harmed.

We may fail to obtain any of these licenses or intellectual property rights on commercially reasonable terms. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. Licenses may not provide us with exclusive rights to use the applicable intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our drug candidates, products (if approved) and technology in the future. In that event, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we may be unable to develop or commercialize the affected products, which could materially harm our business and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation. Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors, and we may not be able to prevent competitors from developing and commercializing competitive products or technologies.

In addition, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications or to maintain, defend and enforce the patents that we license to or from third parties, and we may have to rely on our partners to fulfill these responsibilities. If our current or future licensors, licensees or collaborators fail to prepare, file, prosecute, maintain, enforce, and defend licensed patents and other intellectual property rights, such rights may be reduced or eliminated, and our right to develop and commercialize any of our drug candidates or technology that are the subject of such licensed rights could be adversely affected. In addition, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights.

If we fail to comply with our obligations, including the obligation to make various milestone payments and royalty payments, under any of the agreements under which we license intellectual property rights from third parties, the licensor may have the right to terminate the license. If any of our license agreements is terminated, the underlying licensed patents fail to provide the intended exclusivity or we otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business or be prevented from developing and commercializing our drug candidates, and competitors could have the freedom to seek regulatory approval of, and to market, products identical to ours. Termination of these agreements or reduction or elimination of our rights under these agreements may also result in our having to negotiate new or reinstated agreements with less favorable terms, cause us to lose our rights under these agreements, including our rights to important intellectual property or technology, or impede, delay or prohibit the further development or commercialization of one or more drug candidates that rely on such agreements. It is possible that we may be unable to obtain any additional licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend significant time and resources to redesign our drug candidates or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.

Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues and certain provisions in intellectual property license agreements may be susceptible to multiple interpretations. Disputes may arise between us and our licensing partners regarding intellectual property subject to a license agreement, including:

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could harm our business, financial condition, results of operations and prospects. If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms or at all, we may be unable to successfully develop and commercialize the affected drug candidates. Moreover, any dispute or disagreement with our licensing partners may result in the delay or termination of the research, development or commercialization of our drug candidates or any future drug candidates, and may result in costly litigation or arbitration that diverts management attention and resources away from our day-to-day activities, which may adversely affect our business, financial condition, results of operations and prospects.

Furthermore, current and future collaborators or strategic partners may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations. Competing products, either developed by our collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support for our drug candidates. Any of these developments could harm our product development efforts.

In addition, if our licensors fail to abide by the terms of the license, if the licensors fail to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable, our business, competitive position, financial condition, results of operations and prospects could be materially harmed.

Some of our intellectual property may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies if it is determined that our intellectual property has been discovered through government-funded programs. Compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers.

Some of the intellectual property rights we have acquired or licensed or may acquire or license in the future may have been generated through the use of U.S. government funding and may therefore be subject to certain federal regulations. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). The U.S. government also has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products relating to such intellectual property. To the extent any of our future intellectual property is also generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents directed to our drug candidates are obtained, once the patent life has expired for a drug candidate, we may be open to competition from competitive medications, including generic versions. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents directed towards such drug candidates might expire before or shortly after such drug candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing drug candidates similar or identical to ours for a meaningful amount of time, or at all.

Depending upon the timing, duration and conditions of any FDA marketing approval of our drug candidates, one or more of our owned or licensed U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act, and similar legislation in the European Union (the “EU”) and certain other countries. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. However, we may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval and only those claims for the approved drug, a method for using it or a method for manufacturing it may be extended. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for the applicable drug candidate will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and nonclinical data and launch their product earlier than might otherwise be the case, and our competitive position, business, financial condition, results of operations and prospects could be materially harmed.

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

Filing, prosecuting, maintaining, defending and enforcing patents on our drug candidates in all countries throughout the world would be prohibitively expensive, and consequently 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. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and may export otherwise infringing products to territories where we have patents, but enforcement rights are not as strong as those in the United States. These products may compete with our drug candidates and our 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 some countries do not favor the enforcement or protection of patents, trade secrets and other intellectual property, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our 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.

Many foreign countries, including some EU countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of the applicable patents and limit our potential revenue opportunities. 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, which could adversely affect our business, financial condition, results of operations and prospects.

In 2012, the European Patent Package, or EU Patent Package, regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court (“UPC”), for litigation involving European patents. Implementation of the EU Patent Package occurred in 2023. Under the UPC, all European patents, including those issued prior to ratification of the European Patent Package, will by default automatically fall under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents, and allow for the possibility of a competitor to obtain pan-European injunctions. It will be several years before we will understand the scope of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC. Under the EU Patent Package as currently proposed, we will have the right to opt our patents out of the UPC over the first seven years of the court’s existence, but doing so may preclude us from realizing the benefits of the new unified court.

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates.

Obtaining and enforcing patents in the pharmaceutical industry is inherently uncertain, due in part to ongoing changes in the patent laws. For example, in the United States, depending on decisions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents, and interpretation thereof, could change in unpredictable ways that could weaken our and our collaborators’ or licensors’ ability to obtain new patents or to enforce existing or future patents. For example, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Therefore, there is increased uncertainty with regard to our and our collaborators’ or licensors’ ability to obtain patents in the future, as well as uncertainty with respect to the value of patents once obtained.

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our and our collaborators’ or licensors’ patent applications and the enforcement or defense of our or our collaborators’ or licensors’ issued patents. For example, assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act (the “Leahy-Smith Act”), enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications are prosecuted and may also affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, particularly the first inventor-to-file provisions. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our or our licensors’ patent applications and the enforcement or defense of our or our licensors’ issued patents. Similarly, statutory or judicial changes to the patent laws of other countries may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Any of the foregoing could harm our business, financial condition, results of operations and prospects.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents directed towards our technology and drug candidates could be found invalid or unenforceable if challenged.

We are not aware that our patents directed to either BIV201 or bezisterim (NE3107), the product candidates we are currently developing, are infringed by third parties. However, there can be no assurance that our patents will not be found in the future to be infringed by others. Any patents we do obtain may be challenged by reexamination or otherwise invalidated or eventually found unenforceable. Both the patent application process and the process of managing patent disputes can be time-consuming and expensive.

Significantly, our pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Our ability to enforce patent rights also depends on our ability to identify infringement. It may be difficult to identify infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or service. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents or that our patents are invalid or unenforceable. In a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology. An adverse result in any litigation proceeding could put one or more of our owned or licensed patents at risk of being invalidated, held unenforceable or interpreted narrowly. We may find it impractical or undesirable to enforce our intellectual property against some third parties.

If we were to initiate legal proceedings against a third party to enforce a patent directed to our drug candidates, or one of our future drug candidates, the defendant could counterclaim that our patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity 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, non-enablement or insufficient written description. Grounds for a presentability assertion could be an allegation that someone connected with prosecution of the patent withheld material information from the USPTO or made a misleading statement during prosecution. Third parties may also raise similar claims before the USPTO or an equivalent foreign body, even outside the context of litigation. Potential proceedings include reexamination, post-grant review, inter partes review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our technology or any drug candidates that we may develop. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner were unaware during prosecution. These assertions may also be based on information known to us or the USPTO. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent rights directed towards the applicable drug candidates or technology related to the patent rendered invalid or unenforceable. Such a loss of patent rights would materially harm our business, financial condition, results of operations and prospects.

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 patents or patent applications. 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 materially harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all.

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.

The pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights. Moreover, the cost to us of any litigation or other proceeding relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our management’s efforts. We may not have sufficient resources to bring any such action to a successful conclusion. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations and you could lose all of your investment.

Some of our competitors are larger than we are and have substantially greater resources. They are, therefore, likely to be able to sustain the costs of complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or otherwise violating our intellectual property. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims could result in substantial costs and diversion of management resources, which could harm our business. In addition, the uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue our internal research programs, or in-license needed technology or other drug candidates. There could also be public announcements of the results of the hearing, motions, or other interim proceedings or developments. If securities analysts or investors perceive those results to be negative, it could cause the price of shares of our Common Stock to decline. Any of the foregoing events could harm our business, financial condition, results of operation and prospects.

We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims or adversely affect our ability to develop and market our drug candidates.

We cannot guarantee that any of our or our licensors’ patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending patent application in the United States and abroad that is relevant to or necessary for the commercialization of our drug candidates in any jurisdiction. For example, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the United States remain confidential until patents issue. As mentioned above, patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our drug candidates could have been filed by third parties without our knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our drug candidates or the use of our drug candidates. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our drug candidates. We may incorrectly determine that our drug candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our drug candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our drug candidates.

In addition, if we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay damages, which may be significant, we may be temporarily or permanently prohibited from commercializing any of our drug candidates that are held to be infringing. We might, if possible, also be forced to redesign drug candidates so that they 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 and could adversely affect our business, financial condition, results of operations and prospects.

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business.

Our commercial success depends upon our ability to develop, manufacture, market and sell our drug candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and other proprietary rights of third parties. There is considerable intellectual property litigation in the pharmaceutical industry. We may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our drug candidates and their manufacture and our other technology, including reexamination, interference, post-grant review, inter partes review or derivation proceedings before the USPTO or an equivalent foreign body. Numerous U.S.- and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which we are developing our drug candidates. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit.

We do not believe that either BIV201 or bezisterim (NE3107), the product candidates we are currently developing, infringe the patents of any third parties. However, there can be no assurance that our technology will not be found in the future to infringe the patents of others. Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products or product candidates infringe. For example, pending applications may exist that provide support or can be amended to provide support for a claim that results in an issued patent that our product infringes.

Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of claim scope, infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable and infringed, which could materially and adversely affect our ability to commercialize any drug candidates we may develop and any other drug candidates or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent.

If we are found to infringe, misappropriate or otherwise violate a third party’s intellectual property rights, and we are unsuccessful in demonstrating that such rights are invalid or unenforceable, we could be required to obtain a license from such a third party in order to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be or may become non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. A finding of infringement could prevent us from commercializing our drug candidates or force us to cease some of our business operations. 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 and other fees, redesign our infringing drug candidate or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.

Many of our employees were previously employed at other biotechnology or pharmaceutical companies. Although we try to ensure that our employees, consultants and advisors 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 these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s former employer. We may also be subject to claims that patents and applications we have filed to protect inventions made on our behalf by our employees, consultants and advisors, even those related to one or more of our drug candidates, are rightfully owned by their former or concurrent employer. Litigation may be necessary to defend against these claims.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs, delay development of our drug candidates and be a distraction to management. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

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

We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest (including co-ownership or ownership) in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we or our licensors or collaborators may have inventorship disputes arising from conflicting obligations of employees, consultants or others who are involved in developing our drug candidates. While it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Our and their assignment agreements may not be self-executing or may be breached, and litigation may be necessary to defend against these and other claims challenging inventorship or our or our licensors’ or collaborators’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our licensors or collaborators 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, intellectual property that is important to our drug candidates. Even if we are successful in defending against such claims, these claims may create considerable distraction to management and other employees of the company. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection, if any, afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Should any of these events occur, they could harm our business, financial condition, results of operations and prospects.

Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our Common Stock to decline.

During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, programs or intellectual property could be diminished. Accordingly, the market price of shares of our Common Stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus supplement and any accompanying base prospectus, including the documents incorporated by reference herein, contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act, that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Such forward-looking statements concern our anticipated results and progress of our operations in future periods, planned exploration and, if warranted, development of our properties, plans related to our business and other matters that may occur in the future. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management. All statements contained herein that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “may,” “will,” “could,” “leading,” “intend,” “contemplate,” “shall” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are subject to a variety of known and unknown risks, uncertainties and other factors which could cause actual events or results to differ from those expressed or implied by the forward-looking statements. The section in this prospectus supplement and accompanying prospectus entitled “Risk Factors” and the sections in our periodic reports, including our Annual Report on Form 10-K for the fiscal year ended June 30, 2023 (the “2023 Form 10-K”) entitled “Business,” and in the 2023 Form 10-K, the Quarterly Reports on Form 10-Q for the fiscal quarter ended September 30, 2023, December 31, 2023, and March 31, 2024 and any future Quarterly Report on Form 10-Qs, entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as other sections in this prospectus supplement, accompanying prospectus and the documents or reports incorporated by reference into this prospectus supplement, discuss some of the factors that could contribute to these differences. Forward-looking statements in this prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein include, but are not limited to, statements with respect to:

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with. The factors set forth above under “Risk Factors” and other cautionary statements made in this prospectus supplement and the accompanying prospectus should be read and understood as being applicable to all related forward-looking statements wherever they appear in this prospectus supplement and the accompanying prospectus. The forward-looking statements contained in this prospectus supplement and accompanying prospectus represent our judgment as of the date of this prospectus supplement and the accompanying prospectus, as applicable. We caution readers not to place undue reliance on such statements. You should read this prospectus supplement, the accompanying prospectus, and the documents incorporated by reference herein and therein completely and with the understanding that our actual future results may be materially different from the plans, intentions and expectations disclosed in the forward-looking statements we make. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available or other events occur in the future. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements contained above and throughout this prospectus supplement and the accompanying prospectus.

USE OF PROCEEDS

We estimate that the net proceeds from the sale of our Common Stock, Pre-funded Warrants, and the Common Warrants in this offering will be approximately $2,440,022, after deducting placement agent fees and estimated offering expenses payable by us. We intend to use the net proceeds from this offering for working capital and general corporate purposes. The amount excludes the proceeds, if any, from the exercise of Common Warrants in this offering. If all the Common Warrants sold in this offering were to be exercised in cash at an exercise price of $1.53 per share, we would receive additional net proceeds of approximately $2,790,022. We cannot predict when or if these Common Warrants will be exercised. It is possible that these Common Warrants may expire and never be exercised.

This expected use of the net proceeds from this offering and our existing cash represents our intentions based upon our current plans, financial condition and business conditions. The amount, timing and nature of specific expenditures of net proceeds from this offering will depend on a number of factors, including the timing, scope, progress and results of our development efforts and the timing and progress of any collaboration efforts. As of the date of this prospectus supplement, we cannot specify with certainty all of the particular uses of the proceeds from this offering. Accordingly, we will retain broad discretion over the use of such proceeds.

Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments, and government securities.

DIVIDEND POLICY

We have never declared or paid dividends on our Common Stock and we do not anticipate paying any cash dividends on our Common Stock in the foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors and will depend on applicable law and then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business.

DESCRIPTION OF SECURITIES WE ARE OFFERING

The following description is a summary of some of the terms of our securities, our organizational documents and Nevada law. The descriptions in this prospectus supplement and the accompanying prospectus of our securities and our organizational documents do not purport to be complete and are subject to, and qualified in their entirety by reference to, our organizational documents, copies of which have been or will be filed or incorporated by reference as exhibits to the registration statement of which this prospectus supplement and the accompanying prospectus form a part. This summary supplements the description of our capital stock in the accompanying prospectus and, to the extent it is inconsistent, replaces the description in the accompanying prospectus. 

We are offering 1,360,800 Shares, 600,000 Pre-funded Warrants, and 1,960,800 accompanying Common Warrants. The shares of our Common Stock or Pre-funded Warrants and accompanying Common Warrants will be issued separately. We are also registering the shares of our Common Stock issuable from time to time upon exercise of the Pre-funded Warrants and Common Warrants offered hereby.

Common Stock

A description of our Common Stock that we are offering pursuant to this prospectus supplement is set forth hereunder and under the heading “Description of Capital Stock” starting on page 8 of the accompanying prospectus. On August 30, 2024, we had 6,330,860 shares of our Common Stock issued and outstanding.

Pre-funded Warrants

The following summary of certain terms and provisions of the Pre-funded Warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the Pre-funded Warrant, the form of which will be filed as an exhibit to a Current Report on Form 8-K that we will file with the SEC. Prospective investors should carefully review the terms and provisions of the form of Pre-funded Warrant for a complete description of the terms and conditions of the Pre-funded Warrants.

Term 

The Pre-funded Warrants will not expire until they are fully exercised.

Exercisability 

The Pre-funded Warrants are exercisable at any time until they are fully exercised. The Pre-funded Warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and payment of the exercise price. No fractional shares of our Common Stock will be issued in connection with the exercise of a Pre-funded Warrant. The holder of the Pre-funded Warrant may also satisfy its obligation to pay the exercise price through a “cashless exercise,” in which the holder receives the net value of the Pre-funded Warrants in shares of our Common Stock determined according to the formula set forth in the Pre-funded Warrant.

Exercise Limitations 

Under the terms of the Pre-funded Warrants, the Company may not effect the exercise of any such warrant, and a holder will not be entitled to exercise any portion of any such warrant, if, upon giving effect to such exercise, the aggregate number of shares of our Common Stock beneficially owned by the holder (together with its affiliates, any other persons acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of our Common Stock would or could be aggregated with the holder’s for purposes of Section 13(d) or Section 16 of the Exchange Act) would exceed 4.99% of the number of shares of our Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of such warrant, which percentage may be increased or decreased at the holder’s election upon 61 days’ notice to the Company subject to the terms of such warrants, provided that such percentage may in no event exceed 9.99%.

Exercise Price 

The exercise price of our shares of our Common Stock purchasable upon the exercise of the Pre-funded Warrants is $0.0001 per share. The exercise price of the Pre-funded Warrants and the number of shares of our Common Stock issuable upon exercise of the Pre-funded Warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our shares of Common Stock, as well as upon any distribution of assets, including cash, stock or other property, to our stockholders.

Transferability 

Subject to applicable laws, the Pre-funded Warrants may be offered for sale, sold, transferred or assigned without our consent.

Exchange Listing 

We do not intend to list the Pre-funded Warrants on Nasdaq, any other national securities exchange or any other nationally recognized trading system.

Fundamental Transactions 

Upon the consummation of a fundamental transaction (as described in the Pre-funded Warrants, and generally including any reorganization, recapitalization or reclassification of our shares of Common Stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding shares of Common Stock, or any person or group becoming the beneficial owner of 50% of the voting power of our outstanding shares of Common Stock), the holders of the Pre-funded Warrants will be entitled to receive, upon exercise of the Pre-funded Warrants, the kind and amount of securities, cash or other property that such holders would have received had they exercised the Pre-funded Warrants immediately prior to such fundamental transaction, without regard to any limitations on exercise contained in the Pre-funded Warrants. Notwithstanding the foregoing, in the event of a fundamental transaction where the consideration consists solely of cash, solely of marketable securities or a combination of cash and marketable securities, then each Pre-funded Warrants shall automatically be deemed to be exercised in full in a cashless exercise effective immediately prior to and contingent upon the consummation of such fundamental transaction.

No Rights as a Stockholder 

Except by virtue of such holder’s ownership of shares of Common Stock, the holder of a Pre-funded Warrant does not have the rights or privileges of a holder of our shares of Common Stock, including any voting rights, until such holder exercises the Pre-funded Warrant.

Common Warrants

The following summary of certain terms and provisions of Common Warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the Common Warrants, the form of which will be filed as an exhibit to the registration statement of which this prospectus supplement and accompanying prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of Common Warrant for a complete description of the terms and conditions of the Common Warrants.

Term

The Common Warrants will be immediately exercisable and will expire on the fifth anniversary of the original issuance date. The exercise price and number of shares of Common Stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our Common Stock and the exercise price. The Common Warrants will be issued separately from the Shares and Pre-funded Warrants and may be transferred separately immediately thereafter.

Exercisability

The Common Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our Common Stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of any Common Warrant to the extent that the holder would own more than 4.99% of the outstanding Common Stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding Common Stock after exercising the holder’s Common Warrants up to 9.99% of the number of shares of our Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Common Warrants. No fractional shares of our Common Stock will be issued in connection with the exercise of a Common Warrant. In lieu of fractional shares, we will round up to the next whole share.

Cashless Exercise

If, at the time a holder exercises its Common Warrants, a registration statement registering the issuance of the shares of our Common Stock underlying the Common Warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of our Common Stock determined according to a formula set forth in the Common Warrants.

Exercise Price

Each Common Warrant offered hereby will have an initial exercise price per share equal to $1.53.

Transferability

Subject to applicable laws, a Common Warrant may be transferred at the option of the holder upon surrender of the Common Warrant to us together with the appropriate instruments of transfer.

Exchange Listing

There is no established public trading market for the Common Warrants, and we do not expect a market to develop. In addition, we do not intend to list the Common Warrants on any securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the Common Warrants will be limited.

No Rights as a Stockholder

Except as otherwise provided in the Common Warrants or by virtue of such holder’s ownership of shares of our Common Stock, the holders of the Common Warrants do not have the rights or privileges of holders of our Common Stock, including any voting rights, until they exercise their Common Warrants.

Anti-Takeover Effects of Our Articles of Incorporation and Bylaws

Our Articles of Incorporation and Bylaws contain certain provisions that may have anti-takeover effects, making it more difficult for or preventing a third party from acquiring control of us or changing our board of directors and management. According to our Articles of Incorporation and Bylaws, neither the holders of our Common Stock nor the holders of any preferred stock we may issue in the future have cumulative voting rights in the election of our directors. The combination of the present ownership by a few stockholders of a significant portion of our issued and outstanding Common Stock and lack of cumulative voting makes it more difficult for other stockholders to replace our board of directors or for a third party to obtain control of us by replacing our board of directors.

Anti-Takeover Effects of Nevada Law

Business Combinations

The “business combination” provisions of Sections 78.411 to 78.444, inclusive, of the Nevada Revised Statutes (“NRS”) generally prohibit a Nevada corporation with at least 200 stockholders from engaging in various “combination” transactions with any interested stockholder for a period of two years after the date of the transaction in which the person became an interested stockholder, unless the transaction is approved by the board of directors prior to the date the interested stockholder obtained such status or the combination is approved by the board of directors and thereafter is approved at a meeting of the stockholders by the affirmative vote of stockholders representing at least 60% of the outstanding voting power held by disinterested stockholders, such prohibition extends beyond the expiration of the two-year period, unless:

A “combination” is generally defined to include mergers or consolidations or any sale, lease exchange, mortgage, pledge, transfer, or other disposition, in one transaction or a series of transactions, with an “interested stockholder” having: (a) an aggregate market value equal to 5% or more of the aggregate market value of the assets of the corporation, (b) an aggregate market value equal to 5% or more of the aggregate market value of all outstanding shares of the corporation, (c) 10% or more of the earning power or net income of the corporation, and (d) certain other transactions with an interested stockholder or an affiliate or associate of an interested stockholder.

In general, an “interested stockholder” is a person who, together with affiliates and associates, owns (or within two years, did own) 10% or more of a corporation’s voting stock. The statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts to acquire our Company even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing market price.

Control Share Acquisitions

The “control share” provisions of Sections 78.378 to 78.3793, inclusive, of the NRS apply to “issuing corporations” that are Nevada corporations with at least 200 stockholders, including at least 100 stockholders of record who are Nevada residents, and that conduct business directly or indirectly in Nevada. The control share statute prohibits an acquirer, under certain circumstances, from voting its shares of a target corporation’s stock after crossing certain ownership threshold percentages, unless the acquirer obtains approval of the target corporation’s disinterested stockholders. The statute specifies three thresholds: one-fifth or more but less than one-third, one-third but less than a majority, and a majority or more, of the outstanding voting power. Generally, once an acquirer crosses one of the above thresholds, those shares in an offer or acquisition and acquired within 90 days thereof become “control shares” and such control shares are deprived of the right to vote until disinterested stockholders restore the right. These provisions also provide that if control shares are accorded full voting rights and the acquiring person has acquired a majority or more of all voting power, all other stockholders who do not vote in favor of authorizing voting rights to the control shares are entitled to demand payment for the fair value of their shares in accordance with statutory procedures established for dissenters’ rights.

A corporation may elect to not be governed by, or “opt out” of, the control share provisions by making an election in its articles of incorporation or bylaws, provided that the opt-out election must be in place on the 10^th day following the date an acquiring person has acquired a controlling interest, that is, crossing any of the three thresholds described above. We have not opted out of the control share statutes, and will be subject to these statutes if we are an “issuing corporation” as defined in such statutes.

The effect of the Nevada control share statutes is that the acquiring person, and those acting in association with the acquiring person, will obtain only such voting rights in the control shares as are conferred by a resolution of the stockholders at an annual or special meeting. The Nevada control share law, if applicable, could have the effect of discouraging takeovers of our Company.

DILUTION

If you invest in this offering, your ownership interest will be diluted to the extent of the difference between the public offering price per share and the as adjusted net tangible book value per Common Stock immediately after this offering.

Our net tangible book value as of March 31, 2024 was approximately $ 17.7 million, or $2.91 per share of Common Stock. Net tangible book value per share is determined by dividing our total tangible assets, less total liabilities, by the number of shares of our Common Stock outstanding as of March 31, 2024.

After giving effect to the sale of the Shares and Pre-funded Warrants and the accompanying Common Warrants in this offering at the combined public offering price of $1.53 per Share and $1.5299 per Pre-funded Warrant, and after deducting placement agent fees and estimated offering expenses payable by us, our as adjusted net tangible book value as of March 31, 2024 would have been approximately $20.2 million, or approximately $2.50 per share of our Common Stock. This represents an immediate decrease in the as adjusted net tangible book value of approximately $0.41 per share to our existing stockholders and an immediate dilution in as adjusted net tangible book value of approximately 0.97 per share to new investors in this offering.

The following table illustrates this per share dilution.

The number of shares of our Common Stock to be outstanding immediately after this offering is based on 6,096,985 shares of our Common Stock outstanding as of March 31, 2024, and excludes:

Except as otherwise indicated, all information in this prospectus supplement assumes no exercise, conversion, or settlement of the outstanding options, preferred stock, or warrants described above, no exercise of Common Warrants issued and sold in this offering, and no exercise of the Placement Agent’s Warrants. To the extent that any of these outstanding warrants or options are exercised at prices per share below the public offering price per share in this offering or we issue additional shares under our equity incentive plans at prices below the public offering price per share in this offering, you may experience further dilution. In addition, to the extent that we raise additional capital by issuing equity or convertible debt securities, your ownership will be further diluted.

PLAN OF DISTRIBUTION

We have engaged ThinkEquity LLC, or the placement agent, to act as our exclusive placement agent to solicit offers to purchase the Shares and/or Pre-funded Warrants and accompanying Common Warrants offered by this prospectus supplement. The placement agent is not purchasing or selling any such securities, nor is it required to arrange for the purchase and sale of any specific number or dollar amount of such securities, other than to use its “reasonable best efforts” to arrange for the sale of such securities by us. Therefore, we may not sell all of the Shares and/or pre-funded warrants and accompanying Common Warrants being offered. The terms of this offering are subject to market conditions and negotiations between us, the placement agent and prospective investors. The placement agent will have no authority to bind us by virtue of their placement agency agreement. This is a best efforts offering and there is no minimum offering amount required as a condition to the closing of this offering. The placement agent may retain sub-agents and selected dealers in connection with this offering.

Investors purchasing securities offered hereby will have the option to execute a securities purchase agreement with us. Investors who do not enter into a securities purchase agreement shall rely solely on this prospectus supplement in connection with the purchase of our securities in this offering. In addition to rights and remedies available to all purchasers in this offering under federal securities and state law, the purchasers which enter into a securities purchase agreement will also be able to bring claims of breach of contract against us.

Delivery of the shares of our Common Stock, Pre-funded Warrants and the Common Warrants offered hereby is expected to occur on or about September 25, 2024, subject to satisfaction of certain customary closing conditions.

Fees and Expenses

The following table shows the per share price and total cash fees we will pay to the placement agent in connection with the sale of the securities pursuant to this prospectus supplement.

We have agreed to pay a non-accountable expense allowance to the placement agent equal to 1% of the gross proceeds received in this offering.

We have paid an expense deposit of $50,000 to the placement agent, which will be applied against the out-of-pocket accountable expenses that will be paid by us to the placement agent in connection with this offering, and will be reimbursed to us to the extent not actually incurred in compliance with Rule 5110(g)(4)(A) of the Financial Industry Regulatory Authority (“FINRA”).

We have also agreed to pay certain of the placement agent’s expenses relating to the offering, including: (a) all fees, expenses and disbursements relating to background checks of our officers, directors and entities in an amount not to exceed $15,000 in the aggregate; (b) fees and expenses of the placement agent’s legal counsel not to exceed $125,000; (c) a $29,500 cost associated with the placement agent use of Ipreo’s book-building, prospectus tracking and compliance software for the offering; (d) $10,000 for data services and communications expenses; (e) up to $30,000 of market making and trading, and clearing firm settlement expenses for the offering; (f) up to $10,000 of the placement agent’s actual accountable “road show” expenses; and (g) the costs associated with bound volumes of the public offering materials as well as commemorative mementos and lucite tombstones.

Our total estimated expenses of the offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding placement agent fees and excluding the non-accountable expense allowance, are approximately $400,000.

Placement Agent’s Warrants

Upon closing of this offering, we have agreed to issue the placement agent warrants (“Placement Agent’s Warrants”) to purchase up to 98,040 shares of our Common Stock (5% of the aggregate number of shares of our Common Stock and Pre-funded Warrants sold in this offering). The Placement Agent’s Warrants will be exercisable at a per share exercise price equal $1.9125, which is equal to 125% of the public offering price per share in this offering. The Placement Agent’s Warrants are exercisable at any time and from time to time, in whole or in part, during the five-year period commencing 180 days from the commencement of sales of the Shares and Pre-funded Warrants and the Common Warrants in this offering.

The Placement Agent’s Warrants have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to Rule 5110(e)(1)(A) of FINRA. The placement agent (or permitted assignees under Rule 5110(e)(2)) will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities underlying these warrants, nor will they engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the warrants or the underlying securities for a period of 180 days following the commencement of sales of the securities issued in this offering. In addition, the Placement Agent’s Warrants provide for registration rights upon request, in certain cases. The sole demand registration right provided will not be greater than five years from the commencement of sales of the securities issued in this offering in compliance with FINRA Rule 5110(g)(8)(C). The piggyback registration rights provided will not be greater than seven years from the commencement of sales of the securities issued in this offering in compliance with FINRA Rule 5110(g)(8)(D). We will bear all fees and expenses attendant to registering the securities issuable on exercise of the warrants other than underwriting commissions incurred and payable by the holders. The exercise price and number of shares issuable upon exercise of the Placement Agent’s Warrants may be adjusted in certain circumstances including in the event of a stock dividend or our recapitalization, reorganization, merger or consolidation. However, the Placement Agent’s Warrant exercise price or underlying shares will not be adjusted for issuances of shares of our Common Stock at a price below the warrant exercise price.

Lock-Up Agreements

Pursuant to “lock-up” agreements, we and our executive officers and directors have agreed, for a period of 90 days from the date of this prospectus supplement not to, directly or indirectly, offer to sell, sell, pledge or otherwise transfer or dispose of any of shares of (or enter into any transaction or device that is designed to, or could be expected to, result in the transfer or disposition by any person at any time in the future of) our Common Stock, enter into any swap or other derivatives transaction that transfers to another, in whole or in part, any of the economic benefits or risks of ownership of shares of our Common Stock, make any demand for or exercise any right or cause to be filed a registration statement, including any amendments thereto, with respect to the registration of any shares of our Common Stock or securities convertible into or exercisable or exchangeable for shares of our Common Stock or any other of our securities or publicly disclose the intention to do any of the foregoing, subject to customary exceptions, without the prior written consent of the placement agent. We have also agreed to a covenant to not enter into variable rate financings for a period of 90 days following the closing of the offering.

Right of First Refusal

We have granted the placement agent an irrevocable right of first refusal (the "Right of First Refusal"), for a period of 12 months after the date the Offering is completed for aggregate net proceeds of not less than $10 million, to act, except as set forth below, as sole investment banker, sole book-runner and/or sole placement agent, at the placement agent’s sole discretion, for each and every future public and private equity offering that is not an “at-the-market” offering (an “ATM”) (an ATM executed through a broker dealer as sales agent), and sole investment banker, sole book-runner and/or sole placement agent, at the Placement Agent’s sole discretion, for each and every future debt offering (such future public and private equity offering or debt offering, a “Future Offering”), including all equity linked financings, during such twelve (12) month period for the Company, or any successor to or any subsidiary of the Company, on reasonable and customary terms, provided a Future Offering shall not be deemed to include, and no Right of First Refusal is granted to the placement agent in connection with, any of the following: (a) any equity securities directly issued by the Company pursuant to acquisitions or strategic transactions, including as part of any grant funding from a third party, or (b) any offer or sale of equity securities by the Company directly to non-U.S. persons domiciled in the following jurisdictions: China, Korea, Latin America (e.g. the Caribbean and/or the Cayman Islands) and Middle East, in each case, in a private placement not otherwise involving a public offering. Notwithstanding anything to the contrary set forth above, the placement agent acknowledges that the Company is subject to a pre-existing agreement with a third party under which such third party has a right of first refusal to act as the co-lead bookrunning underwriter, co-lead initial purchaser, co-lead placement agent or co-lead selling agent, as the case may be, on any financing involving equity securities for the Company (the “Prior ROFR”). In case the placement agent wishes to exercise its Right of First Refusal hereunder, the Company will use its commercially reasonable efforts to obtain a waiver of the Prior ROFR, subject to certain conditions.

Prior Relationships

The placement agent acted as the representative of the underwriters for our public offering that closed in August 2021. The placement agent received a commission equal to 4% of the gross proceeds of our initial public offering, and a 1% non-accountable expense allowance.

The placement agent acted as the placement agent for our public offering that closed in March 2024 (the “March 2024 Offering”). The placement agent received a commission equal to 7.5% of the gross proceeds of the March 2024 Offering, and a 1% non-accountable expense allowance.

Regulation M Compliance

The placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the sale of our securities offered hereby by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. The placement agent will be required to comply with the requirements of the Securities Act and the Exchange Act, including, without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of our securities by the placement agent. Under these rules and regulations, the placement agent may not (i) engage in any stabilization activity in connection with our securities; and (ii) bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until they have completed their participation in the distribution.

Indemnification

We have agreed to indemnify the placement agent against certain liabilities, including liabilities under the Securities Act and liabilities arising from breaches of representations and warranties contained in our placement agency agreement with the placement agent. We have also agreed to contribute to payments the placement agent may be required to make in respect of such liabilities.

Nasdaq Capital Market Listing

Our Common Stock is listed on Nasdaq under the symbol “BIVI.” There is no established trading market for the Pre-funded Warrants and we do not intend to list the Pre-funded Warrants on any securities exchange or nationally recognized trading system.

Other

From time to time, the placement agent and/or their affiliates may in the future provide, various investment banking and other financial services for us for which they may receive customary fees. In the course of their businesses, the placement agent and their affiliates may actively trade our securities or loans for their own account or for the accounts of customers, and, accordingly, the placement agent and their affiliates may at any time hold long or short positions in such securities or loans.

Except for services provided in connection with this offering, the March 2024 Offering in which the placement agent acted as the placement agent, and our initial public offering in which the placement agent acted as sole underwriter, the placement agent has not provided any investment banking or other financial services to us during the 180-day period preceding the date of this prospectus supplement.

LEGAL MATTERS

The validity of the shares Common Stock and the shares of our Common Stock underlying the Pre-funded Warrants and the Common Warrants offered hereby will be passed upon for us by Fennemore Craig, P.C. Certain legal matters related to the offering and the validity of the Pre-funded Warrants and Common Warrants will be passed upon for us by Reed Smith LLP, New York, New York. Certain legal matters related to the offering will be passed upon for the placement agent by Sheppard, Mullin, Richter & Hampton LLP, New York, New York.

EXPERTS

The balance sheets of BioVie Inc. as of June 30, 2023 and 2022, and the related statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the years then ended, have been audited by EisnerAmper LLP, independent registered public accounting firm, as stated in their report which is incorporated by reference, which report includes an explanatory paragraph about the existence of substantial doubt concerning the Company’s ability to continue as a going concern. Such financial statements have been incorporated by reference in reliance on the report of such firm given upon their authority as experts in accounting and auditing.

WHERE YOU CAN FIND MORE INFORMATION

This prospectus supplement and accompanying base prospectus is part of the registration statement on Form S-3 we filed with the SEC under the Securities Act and does not contain all the information set forth in the registration statement. Whenever a reference is made in this prospectus supplement or the accompanying base prospectus to any of our contracts, agreements or other documents, the reference may not be complete and you should refer to the exhibits that are a part of the registration statement or the exhibits to the reports or other documents incorporated by reference into this prospectus supplement for a copy of such contract, agreement or other document. Because we are subject to the information and reporting requirements of the Exchange Act, we file annual, quarterly and current reports, proxy statements and other information with the SEC. Our SEC filings are available to the public over the internet at the SEC’s website at http://www.sec.gov.

You may also access our SEC filings at our website https://bioviepharma.com/. Our website and the information contained on, or that can be accessed through, our website will not be deemed to be incorporated by reference in, and are not considered part of, this prospectus supplement. You should not rely on our website or any such information in making your decision whether to purchase our securities.

INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

The SEC allows us to incorporate by reference into this prospectus supplement the information contained in other documents we file with the SEC, which means that we can disclose important information to you by referring you to those documents. Any statement contained in any document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded, for purposes of this prospectus supplement, to the extent that a statement contained in or omitted from this prospectus supplement, or in any other subsequently filed document that also is or is deemed to be incorporated by reference herein, modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus supplement. We incorporate by reference the documents listed below which have been filed by us:

All documents we file with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, except as to any portion of any report or documents that is not deemed filed under such provisions, (1) on or after the date of filing of the registration statement containing this prospectus supplement and prior to the effectiveness of the registration statement and (2) on or after the date of this prospectus supplement until the earlier of the date on which all of the securities registered hereunder have been sold or the registration statement of which this prospectus supplement is a part has been withdrawn, shall be deemed incorporated by reference in this prospectus supplement and to be a part of this prospectus supplement from the date of filing of those documents and will be automatically updated and, to the extent described above, supersede information contained or incorporated by reference in this prospectus supplement and previously filed documents that are incorporated by reference in this prospectus supplement.

Nothing in this prospectus supplement shall be deemed to incorporate information furnished but not filed with the SEC pursuant to Item 2.02, 7.01 or 9.01 of Form 8-K. Upon written or oral request, we will provide without charge to each person, including any beneficial owner, to whom a copy of the prospectus is delivered a copy of any or all of the reports or documents incorporated by reference herein (other than exhibits to such documents, unless such exhibits are specifically incorporated by reference herein). You may request a copy of these filings, at no cost, by writing or telephoning us at the following address: BioVie Inc., 680 W Nye Lane, Suite 204, Carson City, NV 89703.

PROSPECTUS  

Primary Offering of

$300,000,000

Class A Common Stock

Preferred Stock

Warrants

Debt Securities

Rights

Units

and

Secondary Offering of

Up to 311,002 Shares of Class A Common Stock Offered by the Selling Stockholders

This prospectus relates to the offer and sale, from time to time, by BioVie Inc. (“we,” “us,” or the “Company”), in one or more offerings, any combination of Class A common stock (as defined below), preferred stock, warrants, debt securities, rights to purchase Class A common stock or other securities or units having a maximum aggregate offering price of $300,000,000. When we decide to sell a particular class or series of securities, we will provide specific terms of the offered securities in a prospectus supplement.

This prospectus also relates to the offer and resale, from time to time, by the selling stockholders named under the heading “Selling Stockholders” in this prospectus (the “Selling Stockholders”), and their donees, pledgees, transferees or other successors-in-interest, of up to 311,002 shares (the “Shares”) of common stock, par value $0.0001 per share (the “Class A common stock”), of the Company, issuable upon the exercise of the warrants to purchase 311,002 shares of Class A common stock at an exercise price per share equal to $5.82 (the “Lender Warrants”) held by the Selling Stockholders. We are registering the offer and sale of the Shares issuable upon exercise of the Lender Warrants held by the Selling Stockholders to satisfy the registration rights they were granted by the Company pursuant to the Loan and Security Agreement and the Supplement to the Loan and Security Agreement, each entered into on November 30, 2021 (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund II, L.P. (“AVOPII”) and Avenue Venture Opportunities Fund, L.P. (“AVOPI” and, together with AVOPII, the “Lenders”).

Discounts, concessions, commissions and similar selling expenses attributable to the sale of Shares covered by this prospectus will be borne by the Selling Stockholders. We will pay all expenses (other than discounts, concessions, commissions and similar selling expenses) relating to the registration of the Shares with the Securities and Exchange Commission (the “SEC”).

The prospectus supplements may also add, update or change information contained in or incorporated by reference into this prospectus. However, no prospectus supplement shall offer a security that is not registered and described in this prospectus at the time of its effectiveness. You should read this prospectus and any prospectus supplement, as well as the documents incorporated by reference or deemed to be incorporated by reference into this prospectus, carefully before you invest. This prospectus may not be used to offer or sell our securities unless accompanied by a prospectus supplement relating to the offered securities.

Our Class A common stock is listed on the Nasdaq Capital Market under the symbol “BIVI.” On August 25, 2023, the closing price for our Common Stock, as reported on The Nasdaq Capital Market was $3.37 per share. Each prospectus supplement will contain information, where applicable, as to our listing on the Nasdaq Capital Market or on any other securities exchange of the securities covered by the prospectus supplement.

These securities may be sold directly by us, through dealers or agents designated from time to time, to or through underwriters or through a combination of these methods. Additionally, the Selling Stockholders may sell or otherwise dispose of the Shares covered by this prospectus in a number of different ways and at varying prices. See “Plan of Distribution” in this prospectus. We may also describe the plan of distribution for any particular offering of our securities in a prospectus supplement. If any agents, underwriters or dealers are involved in the sale of any securities in respect of which this prospectus is being delivered, we will disclose their names and the nature of our arrangements with them in a prospectus supplement. The net proceeds we expect to receive from any such sale will also be included in a prospectus supplement.

We will not receive any proceeds from the sales of Shares by the Selling Stockholders. Upon any exercise of the Lender Warrants by payment of cash, we will receive the cash exercise price paid by the holders of the Lender Warrants. We intend to use those proceeds, if any, for working capital and general corporate purposes.

An investment in our securities involves a high degree of risk. Please carefully read the information under the headings “Risk Factors” beginning on page 5 of this prospectus, the applicable prospectus supplement and “Item 1A - Risk Factors” of our most recent Annual Report on Form 10-K and in any Quarterly Report on Form 10-Q that is incorporated by reference in this prospectus before you invest in our securities.

We may amend or supplement this prospectus from time to time by filing amendments or supplements as required. You should read the entire prospectus and any amendments or supplements carefully before you make your investment decision.

Neither the SEC nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is August 28, 2023

TABLE OF CONTENTS

ABOUT THIS PROSPECTUS

This prospectus is part of a Registration Statement that we filed with the SEC using a “shelf” registration process. Under this shelf registration process, we may offer from time to time securities having a maximum aggregate offering price of $300,000,000. In addition, the Selling Stockholders may from time to time sell up to an aggregate of 311,002 shares of Class A common stock issuable upon exercise of the Lender Warrants. Each time we or the Selling Stockholders offer any type or series of securities under this prospectus, we will prepare and file with the SEC a prospectus supplement that contains more specific information about the terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these offerings. The prospectus supplement and any related free writing prospectus that we may authorize to be provided to you may also add, update or change information contained in this prospectus or the documents incorporated herein by reference. You should read carefully both this prospectus, any prospectus supplement and any related free writing prospectuses we have authorized for use in connection with a specific offering, together with additional information described below under the caption “Where You Can Find More Information,” before buying any of the securities being offered.

This prospectus does not contain all the information provided in the Registration Statement we filed with the SEC. For further information about us or our securities offered hereby, you should refer to that Registration Statement, which you can obtain from the SEC as described below under “Where You Can Find More Information.”

Neither we nor the Selling Stockholders have authorized anyone to provide any information other than that contained or incorporated by reference in this prospectus or in any applicable prospectus supplement or any applicable free writing prospectus that we have authorized. We take no responsibility for and can provide no assurance as to the reliability of, any other information that others may give you. The securities offered hereby are not being offered in any jurisdiction where the offer is not permitted. You should not assume that the information contained in or incorporated by reference in this prospectus is accurate as of any date other than the respective dates of such document. Our business, financial condition, results of operations and prospects may have changed since those dates.

We and the Selling Stockholders may sell securities through underwriters or dealers, through agents, directly to purchasers or through any combination of these methods. We and our agents reserve the sole right to accept or reject in whole or in part any proposed purchase of securities. The prospectus supplement, which we will prepare and file with the SEC each time we offer securities, will set forth the names of any underwriters, agents or others involved in the sale of securities, and any applicable fee, commission or discount arrangements with them. See “Plan of Distribution.”

Unless the context otherwise indicates, references in this prospectus to, “BioVie,” “the Company,” “we,” “our,” or “us” mean BioVie, Inc., a Nevada corporation. The term “Selling Stockholders” refers, collectively, to the selling stockholders named under the heading “Selling Stockholders” in this prospectus and their donees, pledgees, transferees or other successors-in-interest.

PROSPECTUS SUMMARY

This prospectus summary highlights certain information about our company and other information contained elsewhere in this prospectus or in documents incorporated by reference. This summary does not contain all of the information that you should consider before making an investment decision. You should carefully read the entire prospectus, any prospectus supplement, including the matters set forth under the section of this prospectus entitled “Risk Factors” and the financial statements and related notes and other information that we incorporate by reference herein, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, before making an investment decision.

Our Company

We are a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.

Neurodegenerative Disease Program

In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits inflammatory activation of extracellular single-regulated kinase (“ERK”) and Nuclear factor kappa-light-chain-enhancer of activated B cells (“NFkB”) (e.g., tumor necrosis factor (“TNF”) signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”).

The Company is conducting a potentially pivotal Phase 3 randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate NE3107 in patients who have mild to moderate AD (NCT04669028). The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC). The program is fully enrolled and is targeting primary completion in the fourth quarter of the calendar 2023 year.

In December 2022, topline results were released from the Company’s Phase 2 study assessing NE3107’s safety and tolerability and potential pro-motoric impact in PD patients. The NM201 study (NCT05083260) was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days. The trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study (as requested by the U.S. Food and Drug Administration (“FDA”)) to demonstrate the absence of adverse interactions of NE3107 with levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity observed in a Parkinson’s disease model in monkeys can be seen in humans. Both objectives of the study were met. Patients treated with NE3107 experienced greater motor control.

The Company provided the financial support and the use of our NE3107 formulated drug product for an open-label phase 2, Investigator-Initiated Trial in mild cognitive impairment (“MCI”) and Mild AD, NCT05227820, conducted by (“The Regenesis Project”) of Sheldon Jordan. The study received FDA authorization on December 12, 2021, and was designed to measure NE3107’s effect on cognition, cerebral spinal fluid (“CSF”) and blood biomarkers, and neuro-imagining endpoints. Topline results were released September 7, 2022, and additional data was presented at the Clinical Trial in Alzheimer’s Disease (“CTAD”) annual conference in December 2022. The data showed that three months of treatment with NE3107 in patients with MCI and mild AD enhanced cognition compared to baseline, as measured using multiple rating scales, had improvement in daily function and improvements in inflammation correlated with improved cognition. No drug-related adverse events were observed.

The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”), from a related party privately held clinical-stage pharmaceutical company, in June 2021. The acquired assets included NE3107, a potentially selective inhibitor of inflammatory ERK signaling that, based on animal studies and Dr. Jordan’s study, is believed to reduce neuroinflammation. NE3107 is a novel orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of AD and PD, and NE3107 could, if approved by the FDA represent a new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.

Inflammation-driven insulin resistance is believed to be implicated in a broad range of serious diseases, and we plan to begin exploring these opportunities in the coming months using NE3107 or related compounds acquired in the NeurMedix asset purchase. NE3107 is patented in the United States (“U.S.”), Australia, Canada, Europe and South Korea.

Liver Disease Program

In liver disease, our Orphan Drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, has been evaluated in a U.S. Phase 2b study (NCT04112199) for the treatment of refractory ascites due to liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation. The study was closed before full enrollment, without clinically meaningful adverse effects associated with BIV201 treatment and data that appeared to show that treatment with BIV201 plus standard-of-care (“SOC”) resulted in a reduction in ascites fluid accumulation during treatment versus pre-treatment. In June 2023, we requested guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

While the active agent, terlipressin, is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these authorizations. Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The U.S. FDA has not approved any drug to treat refractory ascites.

The BIV201 development program was initiated by LAT Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company currently owns all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

The Securities We May Offer

This prospectus is part of a Registration Statement that we filed with the SEC utilizing a shelf registration process. Under this shelf registration process, we may sell any combination of:

in one or more offerings up to a total dollar amount of $300,000,000. This prospectus provides you with a general description of the securities we may offer. Each time we sell securities, we will provide a prospectus supplement that will contain specific information about the terms of that specific offering and include a discussion of any risk factors or other special considerations that apply to those securities. The prospectus supplement may also add, update or change information contained in this prospectus. You should read both this prospectus and any prospectus supplement together with the additional information described under the heading “Where You Can Find More Information.”

Securities Offered by the Selling Securityholders

This prospectus also relates to the resale from time to time by the Selling Stockholders identified in this prospectus of up to 311,002 shares of Class A common stock issuable upon the exercise of the Lender Warrants held by the Selling Stockholders. We are registering the offer and sale of the Shares to satisfy the registration rights they were granted by the Company pursuant to the Loan Agreement.

On November 30, 2021 (the “Loan Closing Date”), the Company entered into the Loan Agreement with the Lenders for growth capital loans in an aggregate principal amount of up to $20,000,000 (the “Loan”), with (i) $15,000,000 funded on the Loan Closing Date (“Tranche 1”) and (ii) up to $5,000,000 to be made available to the Company on or prior to September 15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00% plus the prime rate as reported in The Wall Street Journal and (b) 10.75%. The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is December 1, 2024. Up to $5,000,000 of the principal amount of the Loan outstanding may be converted, at the option of the Lenders, into shares of the Company’s Class A common stock at a conversion price of $6.98 per share.

In connection with the Loan, pursuant to the funding of Tranche 1 on the Loan Closing Date, the Company issued 361,002 Lender Warrants. The Lender Warrants, which are exercisable until November 30, 2026, were offered and sold by the Company in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act.

On March 31, 2023, the Company filed a Registration Statement on Form S-3 (File No. 333-271054), that was declared effective by the SEC on April 10, 2023, which related in part to the offer and resale, from time to time, by the Selling Stockholders of up to 50,000 shares of Class A common stock issuable upon exercise of the Lender Warrants.

The Lenders may exercise the Lender Warrants at any time, or from time to time up to and including the Expiration Date, by making a cash payment equal to the exercise price multiplied by the quantity of shares. The Lenders may also exercise the Lender Warrants on a cashless or “net issuance” basis by receiving a net number of shares calculated pursuant to the formula set forth in the Lender Warrants. The Lender Warrants are subject to anti-dilution adjustments for stock dividends, stock splits, and reverse stock splits. Pursuant to the terms of the Lender Warrants, the holders of the Lender Warrants are entitled to piggyback registration rights if the Company proposes to file a new registration statement under the Securities Act for purposes of effecting an underwritten offering of its equity securities, subject to certain limitations.

Use of Proceeds

Except as described in any applicable prospectus supplement or in any free writing prospectuses we have authorized for use in connection with a specific offering, we currently intend to use the net proceeds from the sale of the securities offered by us hereunder, if any, for working capital and general corporate purposes. We will set forth in the applicable prospectus supplement or free writing prospectus our intended use for the net proceeds received from the sale of any securities sold pursuant to the prospectus supplement or free writing prospectus. All of the securities offered by the Selling Securityholders pursuant to this prospectus will be sold by the Selling Securityholders for their respective accounts. We will not receive any of the proceeds from these sales.

Nasdaq Listing

Our Class A common stock is listed on the Nasdaq Capital Market under the symbol “BIVI.”

Corporate Information

Our principal executive office is located at 680 W. Nye Lane, Suite 201, Carson City, Nevada 89703, and our phone number is (775) 888-3162. Our website address is http://www.bioviepharma.com/. The inclusion of our website address does not include or incorporate by reference into this prospectus supplement or the accompanying prospectus any information on, or accessible through, our website. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, together with amendments to these reports, are available on the “Investor Relations” section of our website, free of charge, as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC.

RISK FACTORS

Investing in our securities involves risk. The prospectus supplement applicable to a particular offering of securities will contain a discussion of the risks applicable to an investment in BioVie and to the particular types of securities that we are offering under that prospectus supplement. Before making an investment decision, you should carefully consider the risks described under “Risk Factors” in the applicable prospectus supplement together with all of the other information contained or incorporated by reference in the prospectus supplement or appearing or incorporated by reference in this prospectus. You should also consider the risks, uncertainties and assumptions discussed under “Part I-Item 1A-Risk Factors” of our most recent Annual Report on Form 10-K and in “Part II-Item 1A-Risk Factors” in our most recent Quarterly Report on Form 10-Q filed subsequent to such Form 10-K that are incorporated herein by reference, as may be amended, supplemented or superseded from time to time by other reports we file with the SEC in the future. Our business, financial condition or results of operations could be materially adversely affected by any of these risks. The trading price of our securities could decline due to any of these risks, and you may lose all or part of your investment.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus, each prospectus supplement and the documents incorporated by reference into this prospectus and each prospectus supplement contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Such forward-looking statements concern our anticipated results and progress of our operations in future periods, planned exploration and, if warranted, development of our properties, plans related to our business and other matters that may occur in the future. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management. All statements contained herein that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “may,” “will,” “could,” “leading,” “intend,” “contemplate,” “shall” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are subject to a variety of known and unknown risks, uncertainties and other factors which could cause actual events or results to differ from those expressed or implied by the forward-looking statements. The section in this prospectus entitled “Risk Factors” and the sections in our periodic reports, including the section in the 2023 Form 10-K entitled “Business,” and the section in the 2023 Form 10-K and any future Quarterly Report on Form 10-Qs incorporated herein by reference entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as other sections in this prospectus and the documents or reports incorporated by reference into this prospectus, discuss some of the factors that could contribute to these differences. Forward-looking statements in this prospectus, each prospectus supplement, and the documents incorporated by reference herein and therein include, but are not limited to, statements with respect to:

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with. The factors set forth above under “Risk Factors” and other cautionary statements made in this prospectus should be read and understood as being applicable to all related forward-looking statements wherever they appear in this prospectus. The forward-looking statements contained in this prospectus represent our judgment as of the date of this prospectus. We caution readers not to place undue reliance on such statements. You should read this prospectus and the documents that we have filed as exhibits to this prospectus and incorporated by reference herein completely and with the understanding that our actual future results may be materially different from the plans, intentions and expectations disclosed in the forward-looking statements we make. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available or other events occur in the future. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements contained above and throughout this prospectus.

This prospectus and the documents incorporated by reference in this prospectus may contain market data that we obtain from industry sources. These sources do not guarantee the accuracy or completeness of the information. Although we believe that our industry sources are reliable, we do not independently verify the information. The market data may include projections that are based on a number of other projections. While we believe these assumptions to be reasonable and sound as of the date of this prospectus, actual results may differ from the projections.

DIVIDEND POLICY

We have never declared or paid dividends on our common stock and we do not anticipate paying any cash dividends on our common stock in the foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors and will depend on applicable law and then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business.

USE OF PROCEEDS

Except as otherwise provided in the applicable prospectus supplement, we intend to use the net proceeds from the sale of the securities covered by this prospectus for general corporate purposes, which may include, but is not limited to, working capital, capital expenditures, research and development expenditures and acquisitions of new technologies or businesses. The precise amount, use and timing of the application of such proceeds will depend upon our funding requirements and the availability and cost of other capital. Additional information on the use of net proceeds from an offering of securities covered by this prospectus may be set forth in the prospectus supplement relating to the specific offering.

We will not receive any proceeds from the sales of Shares by the Selling Stockholders.

Upon any exercise of the Lender Warrants by payment of cash, we will receive the cash exercise price paid by the holders of the Lender Warrants. We cannot assure you that any of the Lender Warrants will be exercised, or if exercised, of the quantity that will be exercised or the period in which such Lender Warrants will be exercised.

DESCRIPTION OF CAPITAL STOCK

The following sections constitute a summary as of the date of this prospectus and do not purport to be a complete description of our capital stock. We will describe in the applicable prospectus supplement relating to a particular offering the specific terms of the securities offered by that prospectus supplement. We will indicate in the applicable prospectus supplement if the terms of the securities differ from the terms we have summarized below. We will also include in the prospectus supplement information, where applicable, material United States federal income tax considerations relating to the securities.

General

The following description of common stock of the Company (the “common stock”) and preferred stock of the Company (the “preferred stock”), together with the additional information we include in any applicable prospectus supplement, summarizes the material terms and provisions of the common stock and preferred stock that we may offer under this prospectus but is not complete. For the complete terms of our common stock and preferred stock, please refer to our articles of incorporation, as may be amended from time to time (the “Articles of Incorporation”), any certificates of designation for our preferred stock, that may be authorized from time to time, and our amended and restated bylaws, as amended from time to time (the “Bylaws”). The Nevada General Corporation Law may also affect the terms of these securities. While the terms we have summarized below will apply generally to any future common stock or preferred stock that we may offer, we will describe the specific terms of any series of these securities in more detail in the applicable prospectus supplement. If we so indicate in a prospectus supplement, the terms of any common stock or preferred stock we offer under that prospectus supplement may differ from the terms we describe below.

As of August 17, 2023, our authorized capital stock consists of 800,000,000 shares of Class A common stock, par value $0.0001 per share (the “Class A common stock”), of which 36,826,648 shares of Common Stock were issued, and 36,803,768 shares were issued and outstanding; and 10,000,000 shares of preferred stock, par value $0.001 per share, none of which were issued and outstanding. The authorized and unissued shares of Class A common stock and preferred stock are available for issuance without further action by our stockholders, unless such action is required by applicable law or the rules of any stock exchange on which our securities may be listed. Unless approval of our stockholders is so required, our board of directors will not seek stockholder approval for the issuance and sale of our common stock.

Class A Common Stock

Each holder of Class A common stock is entitled to one vote for each share of Class A common stock held on all matters submitted to a vote of the stockholders, including the election of directors. Our Articles of Incorporation and Bylaws do not provide for cumulative voting rights. Subject to preferences that may be applicable to any then outstanding preferred stock, the holders of our outstanding shares of Class A common stock are entitled to receive dividends, if any, as may be declared from time to time by our board of directors out of legally available funds. In the event of our liquidation, dissolution or winding up, holders of Class A common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares of preferred stock. Holders of our Class A common stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Class A common stock. The rights, preferences and privileges of the holders of Class A common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future. All of our outstanding shares of Class A common stock are fully paid and nonassessable.

Our Class A common stock is listed on the Nasdaq Capital Market under the symbol “BIVI.” The transfer agent and registrar for our Class A common stock is West Coast Stock Transfer, Inc., Encinitas, California.

Options/Warrants/ Restricted Stock Units

As of August 17, 2023, we had outstanding options to purchase 3,952,864 shares of our Class A common stock at a weighted average exercise price of $7.10 and outstanding warrants to purchase 7,770,285 shares of our Class A common stock at a weighted exercise price of $2.06 and restricted stock units totaling 557,727.

Anti-Takeover Effects of Our Articles of Incorporation and Bylaws

Our Articles of Incorporation and Bylaws contain certain provisions that may have anti-takeover effects, making it more difficult for or preventing a third party from acquiring control of us or changing our Board of Directors and management. According to our Articles of Incorporation and Bylaws, neither the holders of our common stock nor the holders of any preferred stock we may issue in the future have cumulative voting rights in the election of our directors. The combination of the present ownership by a few stockholders of a significant portion of our issued and outstanding common stock and lack of cumulative voting makes it more difficult for other stockholders to replace our Board of Directors or for a third party to obtain control of us by replacing our Board of Directors.

Anti-Takeover Effects of Nevada Law

Business Combinations

The “business combination” provisions of Sections 78.411 to 78.444, inclusive, of the Nevada Revised Statutes (“NRS”) generally prohibit a Nevada corporation with at least 200 stockholders from engaging in various “combination” transactions with any interested stockholder for a period of two years after the date of the transaction in which the person became an interested stockholder, unless the transaction is approved by the board of directors prior to the date the interested stockholder obtained such status or the combination is approved by the board of directors and thereafter is approved at a meeting of the stockholders by the affirmative vote of stockholders representing at least 60% of the outstanding voting power held by disinterested stockholders, and extends beyond the expiration of the two-year period, unless:

A “combination” is generally defined to include mergers or consolidations or any sale, lease exchange, mortgage, pledge, transfer, or other disposition, in one transaction or a series of transactions, with an “interested stockholder” having: (a) an aggregate market value equal to 5% or more of the aggregate market value of the assets of the corporation, (b) an aggregate market value equal to 5% or more of the aggregate market value of all outstanding shares of the corporation, (c) 10% or more of the earning power or net income of the corporation, and (d) certain other transactions with an interested stockholder or an affiliate or associate of an interested stockholder.

In general, an “interested stockholder” is a person who, together with affiliates and associates, owns (or within two years, did own) 10% or more of a corporation’s voting stock. The statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts to acquire our Company even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing market price.

Control Share Acquisitions

The “control share” provisions of Sections 78.378 to 78.3793, inclusive, of the NRS apply to “issuing corporations” that are Nevada corporations with at least 200 stockholders, including at least 100 stockholders of record who are Nevada residents, and that conduct business directly or indirectly in Nevada. The control share statute prohibits an acquirer, under certain circumstances, from voting its shares of a target corporation’s stock after crossing certain ownership threshold percentages, unless the acquirer obtains approval of the target corporation’s disinterested stockholders. The statute specifies three thresholds: one-fifth or more but less than one-third, one-third but less than a majority, and a majority or more, of the outstanding voting power. Generally, once an acquirer crosses one of the above thresholds, those shares in an offer or acquisition and acquired within 90 days thereof become “control shares” and such control shares are deprived of the right to vote until disinterested stockholders restore the right. These provisions also provide that if control shares are accorded full voting rights and the acquiring person has acquired a majority or more of all voting power, all other stockholders who do not vote in favor of authorizing voting rights to the control shares are entitled to demand payment for the fair value of their shares in accordance with statutory procedures established for dissenters’ rights.

A corporation may elect to not be governed by, or “opt out” of, the control share provisions by making an election in its articles of incorporation or bylaws, provided that the opt-out election must be in place on the 10th day following the date an acquiring person has acquired a controlling interest, that is, crossing any of the three thresholds described above. We have not opted out of the control share statutes, and will be subject to these statutes if we are an “issuing corporation” as defined in such statutes.

The effect of the Nevada control share statutes is that the acquiring person, and those acting in association with the acquiring person, will obtain only such voting rights in the control shares as are conferred by a resolution of the stockholders at an annual or special meeting. The Nevada control share law, if applicable, could have the effect of discouraging takeovers of our Company.

DESCRIPTION OF WARRANTS

The following description, together with the additional information we may include in any applicable prospectus supplements, summarizes the material terms and provisions of the warrants that we may offer under this prospectus and the related warrant agreements and warrant certificates. For the avoidance of doubt, this section relates only to new warrants that we may issue and not any of our outstanding warrants, such as the Lender Warrants, and we refer to such new warrants in this prospectus for the sake of simplicity as “warrants.”

While the terms summarized below will apply generally to any warrants that we may offer, we will describe the particular terms of any series of warrants in more detail in the applicable prospectus supplement. If we indicate in the prospectus supplement, the terms of any warrants offered under that prospectus supplement may differ from the terms described below. Specific warrant agreements will contain additional important terms and provisions and will be incorporated by reference as an exhibit to the registration statement, which includes this prospectus.

General

We may issue warrants for the purchase of Class A common stock, preferred stock or debt securities, in one or more series. We may issue warrants independently or together with Class A common stock, preferred stock and/or debt securities, and the warrants may be attached to or separate from these securities.

We plan to evidence each series of warrants by warrant certificates that we will issue under a separate warrant agreement. We will enter into the warrant agreement with a warrant agent. We will indicate the name and address of the warrant agent in the applicable prospectus supplement relating to a particular series of warrants.

We will describe in the applicable prospectus supplement the terms of the series of warrants, including:

DESCRIPTION OF DEBT SECURITIES

The following description, together with the additional information we include in any applicable prospectus supplements, summarizes the material terms and provisions of the debt securities that we may offer under this prospectus. While the terms we have summarized below will generally apply to any future debt securities we may offer under this prospectus, we will describe the particular terms of any debt securities that we may offer in more detail in the applicable prospectus supplement. The terms of any debt securities we offer under a prospectus supplement may differ from the terms we describe below. As of the date of this prospectus, we have no outstanding registered debt securities.

We will issue senior notes under a senior indenture, which we will enter into with the trustee to be named in the senior indenture. We will issue subordinated notes under a subordinated indenture, which we will enter into with the trustee to be named in the subordinated indenture. We have filed forms of these documents as exhibits to the registration statement of which this prospectus is a part. We use the term “indentures” to refer to both the senior indenture and the subordinated indenture.

The indentures will be qualified under the Trust Indenture Act of 1939, as amended (the “Trust Indenture Act”). We use the term “debenture trustee” to refer to either the senior trustee or the subordinated trustee, as applicable.

The following summaries of material provisions of the senior notes, the subordinated notes and the indentures are subject to, and qualified in their entirety by reference to, all the provisions of the indenture applicable to a particular series of debt securities. We urge you to read the applicable prospectus supplements related to the debt securities that we sell under this prospectus, as well as the complete indentures that contain the terms of the debt securities. Except as we may otherwise indicate, the terms of the senior and the subordinated indentures are identical.

General

The terms of each series of debt securities will be established by or pursuant to a resolution of our board of directors and set forth or determined in the manner provided in an officers’ certificate or by a supplemental indenture. Debt securities may be issued in separate series without limitation as to aggregate principal amount. We may specify a maximum aggregate principal amount for the debt securities of any series. The particular terms of each series of debt securities will be described in a prospectus supplement relating to such series, including any pricing supplement. The prospectus supplement will set forth:

Conversion or Exchange Rights

We will set forth in the prospectus supplement the terms on which a series of debt securities may be convertible into or exchangeable for Class A common stock or other securities of ours or a third party, including the conversion or exchange rate, as applicable, or how it will be calculated, and the applicable conversion or exchange period. We will include provisions as to whether conversion or exchange is mandatory, at the option of the holder or at our option. We may include provisions pursuant to which the number of our securities or the securities of a third party that the holders of the series of debt securities receive upon conversion or exchange would, under the circumstances described in those provisions, be subject to adjustment, or pursuant to which those holders would, under those circumstances, receive other property upon conversion or exchange, for example in the event of our merger or consolidation with another entity.

Consolidation, Merger or Sale

The indentures in the forms initially filed as exhibits to the registration statement of which this prospectus is a part do not contain any covenant that restricts our ability to merge or consolidate, or sell, convey, transfer or otherwise dispose of all or substantially all of our assets. However, any successor of ours or the acquirer of such assets must assume all of our obligations under the indentures and the debt securities. If the debt securities are convertible for our other securities, the person with whom we consolidate or merge or to whom we sell all of our property must make provisions for the conversion of the debt securities into securities that the holders of the debt securities would have received if they had converted the debt securities before the consolidation, merger or sale.

Events of Default Under the Indenture

The following are events of default under the indentures in the forms initially filed as exhibits to the registration statement with respect to any series of debt securities that we may issue:

If an event of default with respect to debt securities of any series occurs and is continuing, other than an event of default specified in the last bullet point above, the debenture trustee or the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series, by notice to us in writing, and to the debenture trustee if notice is given by such holders, may declare the unpaid principal of, premium, if any, and accrued interest, if any, due and payable immediately. If an event of default specified in the last bullet point above occurs with respect to us, the principal amount of and accrued interest, if any, of each issue of debt securities then outstanding shall be due and payable without any notice or other action on the part of the debenture trustee or any holder.

The holders of a majority in principal amount of the outstanding debt securities of an affected series may waive any default or event of default with respect to the series and its consequences, except defaults or events of default regarding payment of principal, premium, if any, or interest, unless we have cured the default or event of default in accordance with the indenture. Any waiver shall cure the default or event of default.

Subject to the terms of the indentures, if an event of default under an indenture shall occur and be continuing, the debenture trustee will be under no obligation to exercise any of its rights or powers under such indenture at the request or direction of any of the holders of the applicable series of debt securities, unless such holders have offered the debenture trustee reasonable indemnity. The holders of a majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method and place of conducting any proceeding for any remedy available to the debenture trustee, or exercising any trust or power conferred on the debenture trustee, with respect to the debt securities of that series, provided that:

A holder of the debt securities of any series will only have the right to institute a proceeding under the indentures or to appoint a receiver or trustee, or to seek other remedies if:

These limitations do not apply to a suit instituted by a holder of debt securities if we default in the payment of the principal, premium, if any, or interest on, the debt securities.

We will periodically file statements with the debenture trustee regarding our compliance with specified covenants in the indentures.

Modification of Indenture; Waiver

We and the debenture trustee may change an indenture without the consent of any holders with respect to specific matters, including:

In addition, under the indentures, the rights of holders of a series of debt securities may be changed by us and the debenture trustee with the written consent of the holders of at least a majority in aggregate principal amount of the outstanding debt securities of each series that is affected. However, we and the debenture trustee may only make the following changes with the consent of each holder of any outstanding debt securities affected:

Discharge

Each indenture provides that we can elect to be discharged from our obligations with respect to one or more series of debt securities, except that the following obligations survive until the maturity date or the redemption date:

and the following obligations survive the maturity date or the redemption date:

In order to exercise our rights to be discharged, we must deposit with the debenture trustee money or government obligations sufficient to pay all the principal of, any premium, if any, and interest on, the debt securities of the series on the dates payments are due.

Form, Exchange and Transfer

We will issue the debt securities of each series only in fully registered form without coupons and, unless we otherwise specify in the applicable prospectus supplement, in denominations of $1,000 and any integral multiple thereof. The indentures provide that we may issue debt securities of a series in temporary or permanent global form and as book-entry securities that will be deposited with, or on behalf of, The Depository Trust Company, New York, New York, known as DTC, or another depositary named by us and identified in a prospectus supplement with respect to that series.

At the option of the holder, subject to the terms of the indentures and the limitations applicable to global securities described in the applicable prospectus supplement, the holder of the debt securities of any series can exchange the debt securities for other debt securities of the same series, in any authorized denomination and of like tenor and aggregate principal amount.

Subject to the terms of the indentures and the limitations applicable to global securities set forth in the applicable prospectus supplement, holders of the debt securities may present the debt securities for exchange or for registration of transfer, duly endorsed or with the form of transfer endorsed thereon duly executed if so required by us or the security registrar, at the office of the security registrar or at the office of any transfer agent designated by us for this purpose. Unless otherwise provided in the debt securities that the holder presents for transfer or exchange, we will make no service charge for any registration of transfer or exchange, but we may require payment of any taxes or other governmental charges.

We will name in the applicable prospectus supplement the security registrar, and any transfer agent in addition to the security registrar, that we initially designate for any debt securities. We may at any time designate additional transfer agents or rescind the designation of any transfer agent or approve a change in the office through which any transfer agent acts, except that we will be required to maintain a transfer agent in each place of payment for the debt securities of each series.

If we elect to redeem the debt securities of any series, we will not be required to:

Information Concerning the Debenture Trustee

The debenture trustee, other than during the occurrence and continuance of an event of default under an indenture, undertakes to perform only those duties as are specifically set forth in the applicable indenture. Upon an event of default under an indenture, the debenture trustee must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs. Subject to this provision, the debenture trustee is under no obligation to exercise any of the powers given it by the indentures at the request of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses and liabilities that it might incur.

Payment and Paying Agents

Unless we otherwise indicate in the applicable prospectus supplement, we will make payment of the interest on any debt securities on any interest payment date to the person in whose name the debt securities, or one or more predecessor securities, are registered at the close of business on the regular record date for the interest.

We will pay principal of and any premium and interest on the debt securities of a particular series at the office of the paying agents designated by us, except that, unless we otherwise indicate in the applicable prospectus supplement, we may make interest payments by check that we will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in a prospectus supplement, we will designate the corporate office of the debenture trustee in the State of Nevada as our sole paying agent for payments with respect to debt securities of each series. We will name in the applicable prospectus supplement any other paying agents that we initially designate for the debt securities of a particular series. We will maintain a paying agent in each place of payment for the debt securities of a particular series.

All money we pay to a paying agent or the debenture trustee for the payment of the principal of or any premium or interest on any debt securities that remains unclaimed at the end of two years after such principal, premium or interest has become due and payable will be repaid to us, and the holder of the debt security thereafter may look only to us for payment thereof.

Governing Law

The indentures and the debt securities will be governed by and construed in accordance with the laws of the State of Nevada, except to the extent that the Trust Indenture Act is applicable.

Subordination of Subordinated Debt Securities

The subordinated debt securities will be subordinate and junior in priority of payment to certain of our other indebtedness to the extent described in a prospectus supplement. The indentures in the forms initially filed as exhibits to the registration statement of which this prospectus is a part do not limit the amount of indebtedness that we may incur, including senior indebtedness or subordinated indebtedness, and do not limit us from issuing any other debt, including secured debt or unsecured debt.

DESCRIPTION OF RIGHTS

The complete terms of the rights will be contained in the rights agreements we enter into with rights agents. These documents will be included or incorporated by reference as exhibits to the registration statement of which this prospectus is a part. You should read the rights agreements and any related documents. You also should read the prospectus supplement, which will contain additional information and which may update or change some of the information below.

This section describes the general terms of the rights to purchase Class A common stock or other securities that we may offer to stockholders using this prospectus. Further terms of the rights will be stated in the applicable prospectus supplement (or applicable free writing prospectus). The following description and any description of the rights in a prospectus supplement (or applicable free writing prospectus) may not be complete and is subject to and qualified in its entirety by reference to the terms of any agreement relating to the rights.

Rights may be issued independently or together with any other security and may or may not be transferable. As part of any rights offering, we may enter into a standby underwriting or other arrangement under which the underwriters or any other person would purchase any securities that are not purchased in such rights offering. If we issue rights, each series of rights will be issued under a separate rights agreement to be entered into between us and a bank or trust company, as rights agent, that will be named in the applicable prospectus supplement. Further terms of the rights will be stated in the applicable prospectus supplement. The rights agent will act solely as our agent and will not assume any obligation to any holders of rights certificates or beneficial owners of rights. The rights agreements and rights certificates will be filed with the SEC as an exhibit to the registration statement of which this prospectus is a part or as an exhibit to a filing incorporated by reference in the registration statement. See “Where You Can Find Additional Information” for information on how to obtain copies of the rights agreements and rights certificates.

The prospectus supplement relating to any rights we offer will describe the specific terms of the offering and the rights, including the record date for stockholders entitled to the rights distribution, the number of rights issued and the number of shares of Class A common stock that may be purchased upon exercise of the rights, the exercise price of the rights, the date on which the rights will become effective and the date on which the rights will expire, and any applicable U.S. federal income tax considerations.

In general, a right entitles the holder to purchase for cash a specific number of shares of Class A common stock or other securities at a specified exercise price. The rights are normally issued to stockholders as of a specific record date, may be exercised only for a limited period of time and become void following the expiration of such period. If we determine to issue rights, we will accompany this prospectus with a prospectus supplement that will describe, among other things:

If fewer than all of the rights issued in any rights offering are exercised, we may offer any unsubscribed securities directly to persons other than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including pursuant to standby arrangements, as described in the applicable prospectus supplement. After the close of business on the expiration date, all unexercised rights will become void.

DESCRIPTION OF UNITS

We may issue units comprised of shares of Class A common stock, shares of preferred stock, debt securities, rights and warrants to purchase Class A common stock in any combination. We may issue units in such amounts and in as many distinct series as we wish. This section outlines certain provisions of the units that we may issue. If we issue units, they will be issued under one or more unit agreements to be entered into between us and a bank or other financial institution, as unit agent. The information described in this section may not be complete in all respects and is qualified entirely by reference to the unit agreement with respect to the units of any particular series. The specific terms of any series of units offered will be described in the applicable prospectus supplement. If so described in a particular supplement, the specific terms of any series of units may differ from the general description of terms presented below. We urge you to read any prospectus supplement related to any series of units we may offer, as well as the complete unit agreement and unit certificate that contain the terms of the units. If we issue units, forms of unit agreements and unit certificates relating to such units will be incorporated by reference as exhibits to the registration statement, which includes this prospectus.

Each unit that we may issue will be issued so that the holder of the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities included in the unit may not be held or transferred separately, at any time or at any time before a specified date.

The applicable prospectus supplement may describe:

The provisions described in this section, as well as those described under “Description of Capital Stock,” “Description of Debt Securities” and “Description of Warrants” will apply to the securities included in each unit, to the extent relevant and as may be updated in any prospectus supplements. We may issue units in such amounts and in as many distinct series as we wish. This section summarizes terms of the units that apply generally to all series. Most of the financial and other specific terms of a particular series of units will be described in the applicable prospectus supplement.

Unit Agreements

We will issue the units under one or more unit agreements to be entered into between us and a bank or other financial institution, as unit agent. We may add, replace or terminate unit agents from time to time. We will identify the unit agreement under which each series of units will be issued and the unit agent under that agreement in the applicable prospectus supplement.

The following provisions will generally apply to all unit agreements unless otherwise stated in the applicable prospectus supplement:

Modification Without Consent

We and the applicable unit agent may amend any unit or unit agreement without the consent of any holder:

We do not need any approval to make changes that affect only units to be issued after the changes take effect. We may also make changes that do not adversely affect a particular unit in any material respect, even if they adversely affect other units in a material respect. In those cases, we do not need to obtain the approval of the holder of the unaffected unit; we need only obtain any required approvals from the holders of the affected units.

Modification With Consent

We may not amend any particular unit or a unit agreement with respect to any particular unit unless we obtain the consent of the holder of that unit, if the amendment would:

    Any other change to a particular unit agreement and the units issued under that agreement would require the following approval:

These provisions regarding changes with majority approval also apply to changes affecting any securities issued under a unit agreement, as the governing document.

In each case, the required approval must be given by written consent.

Unit Agreements Will Not be Qualified Under Trust Indenture Act

No unit agreement will be qualified as an indenture, and no unit agent will be required to qualify as a trustee, under the Trust Indenture Act. Therefore, holders of units issued under unit agreements will not have the protections of the Trust Indenture Act with respect to their units.

Mergers and Similar Transactions Permitted; No Restrictive Covenants or Events of Default

The unit agreements will not restrict our ability to merge or consolidate with, or sell our assets to, another corporation or other entity or to engage in any other transactions. If at any time we merge or consolidate with, or sell our assets substantially as an entirety to, another corporation or other entity, the successor entity will succeed to and assume our obligations under the unit agreements. We will then be relieved of any further obligation under these agreements.

The unit agreements will not include any restrictions on our ability to put liens on our assets, nor will they restrict our ability to sell our assets. The unit agreements also will not provide for any events of default or remedies upon the occurrence of any events of default.

Form, Exchange and Transfer

We will issue each unit in global (i.e., book-entry) form only. Units in book-entry form will be represented by a global security registered in the name of a depositary, which will be the holder of all the units represented by the global security. Those who own beneficial interests in a unit will do so through participants in the depositary’s system, and the rights of these indirect owners will be governed solely by the applicable procedures of the depositary and its participants. We will describe book-entry securities, and other terms regarding the issuance and registration of the units in the applicable prospectus supplement.

Each unit and all securities comprising the unit will be issued in the same form.

If we issue any units in registered, non-global form, the following will apply to them:

Only the depositary will be entitled to transfer or exchange a unit in global form, since it will be the sole holder of the unit.

Payments and Notices

In making payments and giving notices with respect to our units, we will follow the procedures as described in the applicable prospectus supplement.

SELLING STOCKHOLDERS

On November 30, 2021, we entered into the Loan Agreement pursuant to which we issued and sold to the Selling Stockholders Lender Warrants to purchase 361,002 shares of Class A common stock. This prospectus covers the sale or other disposition by the Selling Stockholders and their respective donees, pledgees or other successors-in-interest of up to the total number of Shares registered on behalf of the Selling Stockholders in the manner contemplated under “Plan of Distribution” below. Throughout this prospectus, when we refer to the Shares being registered on behalf of the Selling Stockholders, we are referring to the Shares issuable upon the exercise of the Lender Warrants issued to the Selling Stockholders in the Loan, and when we refer to the Selling Stockholders in this prospectus, we are referring to those investors set forth in the table below.

On March 31, 2023, the Company filed a Registration Statement on Form S-3 (File No. 333-271054), that was declared effective by the SEC on April 10, 2023, which related in part to the offer and resale, from time to time, by the Selling Stockholders of up to 50,000 shares of Class A common stock issuable upon exercise of the Lender Warrants.

In connection with the Loan Agreement, we granted certain registration rights to the Selling Stockholders. The Loan Agreement also provide, among other things, certain indemnification rights and reimbursement by the Company of certain fees and expenses.

我們已經同賣方股東達成一致，將本招股說明書構成部分的註冊聲明保持至少12個月有效，自賣方股東首次獲得全部股份銷售機會之日起。

除非另有披露，關於出售股東和下文腳註涉及到的事項，出售股東與我們沒有過去三年內沒有任何職務、職位或其他重要關係。

下表列出了銷售股東的姓名、銷售股東所持有的A類普通股的股份數量、本招股說明書下可能提供的股份數量以及假設此處涵蓋的所有股份均已出售時銷售股東將擁有的A類普通股數量。 「擬提供股份數量」欄中的股份數量代表了銷售股東可在本招股說明書下提供的所有股份。根據證券交易所法案第13(d)條的規定，「規則13(d)」中的有益所有權包括銷售股東擁有獨立或共同投票權或投資權的所有A類普通股，以及銷售股東在2023年8月17日之前享有購買權的60天內可能獲得的任何A類普通股，但不考慮貸款者認股權證中包含的有益所有權限制（如下所述）。某些銷售股東的實際有益所有權（根據第13d條的規定確定）未必與下面「擬提供股份數量」欄中反映的股份數量相對應。

儘管在下表中呈現了股份所有權，根據借款人認股權證的條款，持有人不具備行使其所持認股權證的任何部分的權利，以便（但僅限於）在行使後，持有人（連同持有人的關聯企業以及任何與持有人或其關聯企業或任何其關聯企業共同行動的其他人員）將有權享有超過發行的A類普通股股份總數的9.99%以上的受益所有權（「受益所有權限制」）。 持有人可能在向公司發出通知後，增加或減少其認股權證的受益所有權限制，前提是受益所有權限制在任何情況下均不得超過在行使其所持認股權證的A類普通股股份後立即發行的A類普通股股份總數的9.99%。 增加受益所有權限制的任何行爲將在向公司交付通知後的第61天生效。 截止到本招股說明書日期，公司尚未收到任何該類增加通知。^{21世紀醫療改革法案}向公司發送通知後第61天開始，方可生效。 截至招股說明書日期，公司尚未收到任何增加通知。

以下所述信息基於從出售股東處獲得的信息，以及我們掌握的有關發行股票持有人行使債權證時發行的股票的信息。在本次發行之前擁有的A類普通股份比例，基於截至2023年8月17日已發行和流通的36,803,768股A類普通股。本次發行後我們擁有的A類普通股份比例，基於本次發行後我們已發行的37,114,770股A類普通股，包括2023年8月17日已發行的36,803,768股A類普通股以及根據此處涵蓋的債權證行使而發行的311,002股。

涵蓋在此的股份可能由出售股東不時提供。 出售股東可能賣出一些、全部或任何數量的股份。 我們不知道出售股東在出售股份之前將持有股份多長時間，並且我們目前與出售股東沒有關於出售或其他處置任何股份的協議、安排或諒解。

百分比用*表示的是小於1%的。

分銷計劃

我們可能賣出本文所述的證券， 出售股票的股東可能不時通過各種方式出售他們持有的部分或全部股份，其中包括以下方式：

As used in this prospectus, “Selling Stockholders” includes transferees, pledgees, donees, assignees or successors selling shares received after the date of this prospectus from a Selling Stockholder as a gift, pledge, partnership distribution or other non-sale related transfer.

We will not receive any proceeds from the sale of securities that may be sold from time to time pursuant to this prospectus by the Selling Stockholders. We will bear the costs associated with this registration in accordance with the agreements granting registration rights to the Selling Stockholders. However, the Selling Stockholders will bear any brokerage commissions, transfer taxes, or underwriting commissions and discounts attributable to their sale of securities pursuant to this prospectus. To our knowledge, there are currently no plans, arrangements or understandings between any Selling Stockholders and any underwriter, broker-dealer or agent regarding the sale of securities pursuant to this prospectus by the Selling Stockholders.

We or the Selling Stockholders may sell the securities to or through one or more underwriters or dealers (acting as principal or agent), through agents, or directly to one or more purchasers. We or the Selling Stockholders may distribute the securities from time to time in one or more transactions:

We will describe the terms of the offering of the securities and the specific plan of distribution in a prospectus supplement or supplements to this prospectus, any related free writing prospectus that we may authorize to be provided to you, an amendment to the registration statement of which this prospectus is a part or other filings we make with the SEC under the Exchange Act that are incorporated by reference. Such description may include, to the extent applicable:

Only underwriters named in the prospectus supplement will be underwriters of the securities offered by the prospectus supplement. The Selling Stockholders who participate in the sale or distribution of the securities offered by the Selling Stockholders and any dealers and agents participating in the distribution of the securities may be deemed to be underwriters, and compensation received by them on resale of the securities may be deemed to be underwriting discounts. Any Selling Stockholders identified as registered broker-dealers in the Selling Stockholders table in the section titled “Selling Stockholders” are deemed to be underwriters. If such dealers or agents were deemed to be underwriters, they may be subject to statutory liabilities under the Securities Act.

If underwriters are used in the sale, they will acquire the securities for their own account and may resell the securities from time to time in one or more transactions at a fixed public offering price or at varying prices determined at the time of sale. The obligations of the underwriters to purchase the securities will be subject to the conditions set forth in the applicable underwriting agreement. We or the Selling Stockholders may offer the securities to the public through underwriting syndicates represented by managing underwriters or by underwriters without a syndicate. Subject to certain conditions, the underwriters will be obligated to purchase all of the securities offered by the prospectus supplement, other than securities covered by any option to purchase additional shares or other option. If a dealer is used in the sale of securities, we or the Selling Stockholders, or an underwriter, will sell the securities to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to be determined by the dealer at the time of resale. To the extent required, we will set forth in the prospectus supplement the name of the dealer and the terms of the transaction. Any public offering price and any discounts or concessions allowed or reallowed or paid to dealers may change from time to time. We or the Selling Stockholders may use underwriters, dealers or agents with whom we have a material relationship. We will describe in the prospectus supplement, naming the underwriter, dealer or agent, the nature of any such relationship.

We or the Selling Stockholders may sell securities directly or through agents we designate from time to time. If required by applicable law, we will name any agent involved in the offering and sale of securities and we will describe any commissions payable to the agent in the prospectus supplement. Unless the prospectus supplement states otherwise, the agent will act on a best-efforts basis for the period of its appointment.

We may provide agents, dealers and underwriters with indemnification against civil liabilities, including liabilities under the Securities Act, or contribution with respect to payments that the agents or dealers or underwriters may make with respect to these liabilities. Agents, dealers and underwriters or their affiliates may engage in transactions with, or perform services for us in the ordinary course of business.

With respect to the offering and sale of securities under this prospectus by the Selling Stockholders, we have agreed to indemnify each Selling Stockholder and any underwriter for such Selling Stockholder (as determined in the Securities Act) against specified liabilities, including liabilities under the Securities Act. The Selling Stockholders have agreed to indemnify us against specified liabilities, including liabilities under the Securities Act. In addition, we have agreed to pay substantially all of the expenses incidental to the registration, offering and sale of securities pursuant to this prospectus by the Selling Stockholders to the public, including the payment of federal securities law and state blue sky registration fees and the reasonable fees and disbursements of one counsel for the Selling Stockholders, except that we will not bear any brokers’ or underwriters’ discounts and commissions, fees and expenses of counsel to underwriters or brokers, transfer taxes or transfer fees relating to the sale of securities by the Selling Stockholders.

We may engage in at-the-market offerings into an existing trading market in accordance with rule 415(a)(4) under the Securities Act. In addition, we or the Selling Stockholders may enter into derivative transactions with third parties, or sell securities not covered by this prospectus to third parties in privately negotiated transactions. If the applicable prospectus supplement so indicates, in connection with those derivatives, the third parties may sell securities covered by this prospectus and the applicable prospectus supplement, including in short sale transactions. If so, the third party may use securities pledged by us or the Selling Stockholders or borrowed from us, the Selling Stockholders or others to settle those sales or to close out any related open borrowings of Class A common stock, and may use securities received from us or the Selling Stockholders in settlement of those derivatives to close out any related open borrowings of our Shares. In addition, we or the Selling Stockholders may loan or pledge securities to a financial institution or other third party that in turn may sell the securities using this prospectus and an applicable prospectus supplement. Such financial institution or other third party may transfer its economic short position to investors in our securities or in connection with a concurrent offering of other securities.

The Selling Stockholders will act independently of us in making decisions with respect to the timing, manner, and size of each resale or other transfer. There can be no assurance that the Selling Stockholders will sell any or all of the securities under this prospectus. Further, we cannot assure you that the Selling Stockholders will not transfer, distribute, devise or gift the securities by other means not described in this prospectus. In addition, any securities covered by this prospectus that qualify for sale under Rule 144 of the Securities Act may be sold under Rule 144 rather than under this prospectus. A Selling Stockholder that is an entity may elect to make an in-kind distribution of the securities to its members, partners or shareholders pursuant to this prospectus by delivering a prospectus. To the extent that such members, partners or shareholders are not affiliates of ours, such members, partners or stockholders would thereby receive freely tradable shares of the securities pursuant to the distribution through this prospectus.

All securities we may offer, other than Class A common stock and the Lender Warrants, will be new issues of securities with no established trading market. Any underwriters may make a market in these securities, but will not be obligated to do so and may discontinue any market making at any time without notice. We cannot guarantee the liquidity of the trading markets for any securities.

Any underwriter may be granted an option to purchase additional shares, and engage in stabilizing transactions, short-covering transactions and penalty bids in accordance with Regulation M under the Exchange Act. An underwriter’s option to purchase additional shares involves sales in excess of the offering size, which create a short position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum price. Syndicate-covering or other short-covering transactions involve purchases of the securities, either through exercise of the option to purchase additional shares or in the open market after the distribution is completed, to cover short positions. Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the securities originally sold by the dealer are purchased in a stabilizing or covering transaction to cover short positions. Those activities may cause the price of the securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.

Any underwriters, dealers or agents that are qualified market makers on the Nasdaq may engage in passive market making transactions in our Class A common stock on the Nasdaq in accordance with Regulation M under the Exchange Act, during the business day prior to the pricing of the offering, before the commencement of offers or sales of the Class A common stock. Passive market makers must comply with applicable volume and price limitations and must be identified as passive market makers. In general, a passive market maker must display its bid at a price not in excess of the highest independent bid for such security; if all independent bids are lowered below the passive market maker’s bid, however, the passive market maker’s bid must then be lowered when certain purchase limits are exceeded. Passive market making may stabilize the market price of the securities at a level above that which might otherwise prevail in the open market and, if commenced, may be discontinued at any time.

LEGAL MATTERS

Unless otherwise indicated in the applicable prospectus supplement, the validity of the securities offered hereby will be passed upon for us by Sherman & Howard L.L.C. If the validity of the securities offered hereby in connection with offerings made pursuant to this prospectus are passed upon by counsel for the underwriters, dealers or agents, if any, such counsel will be named in the prospectus supplement relating to such offering.

EXPERTS

The balance sheets of BioVie Inc. as of June 30, 2023 and 2022, and the related statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the years then ended, have been audited by EisnerAmper LLP, independent registered public accounting firm, as stated in their report which is incorporated by reference, which report includes an explanatory paragraph about the existence of substantial doubt concerning the Company’s ability to continue as a going concern. Such financial statements have been incorporated by reference in reliance on the report of such firm given upon their authority as experts in accounting and auditing.

LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, we will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by us is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

WHERE YOU CAN FIND MORE INFORMATION

This prospectus is part of the registration statement on Form S-3 we filed with the SEC under the Securities Act and does not contain all the information set forth in the registration statement. Whenever a reference is made in this prospectus to any of our contracts, agreements or other documents, the reference may not be complete and you should refer to the exhibits that are a part of the registration statement or the exhibits to the reports or other documents incorporated by reference into this prospectus for a copy of such contract, agreement or other document. Because we are subject to the information and reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we file annual, quarterly and current reports, proxy statements and other information with the SEC. Our SEC filings are available to the public over the Internet at the SEC’s website at http://www.sec.gov.

You may also access our SEC filings at our website https://bioviepharma.com/. Our website and the information contained on, or that can be accessed through, our website will not be deemed to be incorporated by reference in, and are not considered part of, this prospectus. You should not rely on our website or any such information in making your decision whether to purchase our securities.

INFORMATION INCORPORATED BY REFERENCE

We have elected to incorporate certain information by reference into this prospectus. By incorporating by reference, we can disclose important information to you by referring you to other documents we have filed or will file with the SEC. The information incorporated by reference is deemed to be part of this prospectus, except for information incorporated by reference that is superseded by information contained in this prospectus. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any statements in the prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus incorporates by reference the documents set forth below that we have previously filed with the SEC under the Exchange Act:

All documents subsequently filed by the Registrant with the SEC pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after the date of the initial filing of the registration statement and prior to effectiveness of the registration statement that contains this prospectus and prior to the termination of the offering (except in each case the information contained in such document to the extent “furnish” and not “filed”), shall be deemed to be incorporated by reference herein and to be a part hereof from the date of filing of such documents.

Any statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this Registration Statement to the extent that a statement contained herein, or in any other subsequently filed document which also is incorporated or deemed to be incorporated by reference herein, modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Registration Statement.

1,360,800 Shares of Class A Common Stock

Pre-funded Warrants to Purchase up 600,000 Shares of Class A Common Stock

Warrants to Purchase up to 1,960,800 Shares of Class A Common Stock

PRELIMINARY PROSPECTUS SUPPLEMENT  

ThinkEquity

September 23, 2024