美國

證券交易委員會

華盛頓，特區。20549

表格10-Q

截至季度結束截至九月三十日， 2024.

或者

過渡期從________到________

委員會 文件編號：001-32188

有機物， INC。

（精確 註冊人姓名（如其章程中所述）

1990 主街 Suite 750

Sarasota, 佛羅里達 34236

(總部地址)

813-286-7900

（發行人電話號碼）

根據法案第12(b)節註冊的證券:

請用複選標記指示：註冊人（1）已在前12個月內（或註冊人要求提交此類報告的較短期間）依據1934年證券交易法第13或15（d）款的規定提交了所有要求提交的報告，並（2）在過去90天內一直受到此類報告要求的約束。 是 ☒ 不 ☐

請在勾選框內勾選，以指示註冊人在過去的12個月內(或註冊人需要提交這些文件的時間更短)是否已經電子提交了每一份互動數據文件，該提交是根據證券法規定第405條規則和本章第232.405條規則規定。是 ☒ 不 ☐

請用勾選標記指明註冊人是否爲大型加速發行人、加速發行人、非加速發行人、小型報告公司， 或新興成長公司。有關「加速發行人」、「大型加速發行人」、「小型報告公司」以及「新興成長公司」的定義， 請參見交易法第120億.2條（請勾選一項）：

如果是新興成長型企業，請打勾，以表明註冊人已選擇不使用遵守《證券交易法》第13(a)條所規定的任何新的或修訂後的財務會計準則的延長過渡期。 ☐

請勾選適用的圓圈，表示註冊登記者是否是空殼公司(根據交易所法案第12b-2條的定義)。是 ☐ 否☒

請指明截至最新可行日期，每類發行人普通權益的流通股份數量：

截至2024年11月13日，該公司已發行並流通的股份爲 12,212,680普通股的股份，$0.001 每股

部分I—財務信息

Oragenics，Inc。

簡明合併資產負債表

這個 簡明合併財務報表的附註是這些報表的組成部分。

Oragenics，Inc。

簡化合並利潤表

(未經審計)

這個 簡明合併財務報表的附註是這些報表的組成部分。

Oragenics，Inc。

壓縮版 合併股東權益變動表

這個 簡明合併財務報表的附註是這些報表的組成部分。

Oragenics，Inc。

簡明合併現金流量表。

(未經審計)

這個 簡明合併財務報表的附註是這些報表的組成部分。

Oragenics，Inc。

簡明綜合財務報表注

(未經審計)

以下信息應與本表10-Q中的縮減合併基本報表及其附註一起閱讀，並參考我們於2024年3月29日提交的截至2023年12月31日的年度報告（表格10-K）。

在本季度報告中使用的術語「我們」、「我們」、「我們的」、「Oragenics」和「公司」 指的是Oragenics, Inc.及其全資子公司Noachis Terra Inc.，除非上下文另有要求。

前瞻性 聲明

本 季度報告表格10-Q中包含了根據修訂後的1933年證券法第27A條和修訂後的1934年證券交易法第21E條的定義的「前瞻性」陳述，包括但不限於關於 公司未來業績、業務前景、事件和產品開發計劃的陳述。這些前瞻性陳述 不是歷史事實，而是基於我們行業的當前預期、估計和預測、我們的信念和假設。 這些前瞻性陳述包括關於我們的戰略、目標以及我們未來成就的陳述。在本季度報告中，如果陳述涉及（但不限於）我們對增長的預期、未來營業收入的估計、我們資金的來源和用途、我們對流動性需求的評估、我們當前或計劃的臨床試驗或研發活動、產品開發時間表、我們未來的產品、監管事項、費用、利潤、現金流資產負債表項目或對未來時期的其他指導，則這些 陳述屬於前瞻性陳述。這些陳述通常使用「相信」、「將」、「預期」、「期待」、「估計」、「意圖」、「計劃」和「會」等詞彙或短語，但並不總是如此。“這些前瞻性陳述並不保證未來的業績，並涉及可能會與這些前瞻性陳述中描述的內容顯著不同的事項。實際事件或結果可能與本季度報告表格10-Q中討論的內容顯著不同。除非適用法律需要，否則我們不承擔任何更新任何前瞻性陳述或反映本報告日期之後發生的事件或情況的義務。可能導致實際結果與這些前瞻性陳述顯著不同的重要因素在標題爲「風險要素」的部分中列出，位於下方，並在最近提交給證券交易委員會的年度報告表格10-k中，以及在本報告其他地方描述的其他風險和不確定性，以及不時在擬向證券交易委員會提交的文件、新聞稿和其他溝通中識別的其他風險。此外，本季度報告中包含的關於未來事件或發展的陳述或我們未來活動的陳述，包括但不限於關於當前或計劃的臨床試驗、預期的研發活動、預期的臨床試驗開始日期、預期的臨床試驗完成日期、預期與FDA或其他監管機構關於我們的產品候選人的會議、預期的提交以獲得所需的監管市場批准的日期、預期的產品商業化介紹日期以及關於我們未來運營和活動的其他陳述，都屬於前瞻性陳述，這些陳述都假設我們能夠在短期內獲得足夠的資金，隨後支持這些活動並及時繼續我們的運營和計劃活動。不能保證會是這樣。此外，這些陳述假設沒有重大意外的發展或事件會延遲或阻止這些活動的發生。如果未能及時獲得足夠的資金，或發生意外的發展或事件，可能會導致這些事件的發生延遲或阻止這些陳述中描述的事件的發生。

概述

Oragenics, Inc.（"公司"或"我們"，或"我們的"）成立於1996年11月。我們是一家處於開發階段的公司，致力於鼻用藥品和疫苗的研究與開發。

從2023年12月開始，我們專注於開發治療腦部相關疾病的醫療產品，我們的主要產品候選者是ONP-002，旨在進行開發、必要的臨床試驗和商業化，治療輕度創傷性腦損傷（「mTBI」或「腦震盪」）。

在購買我們的主力資產ONP-002之前，從2020年5月開始直到2023年12月31日，我們的主力資產是一種鼻用生物-疫苗候選者，旨在提供對導致COVID-19的SARS-CoV-2病毒的開多免疫力。

在2023年9月，公司終止了其在進行某些抗生素研發活動的建築物的租賃。

目前 與鼻用生物-疫苗平台以及我們的植物抗生素項目相關的研究和開發活動處於非活動狀態，我們將評估 這些項目的替代機會，隨着我們繼續加強對鼻用藥物遞送平台和藥物候選者的關注和專長。

關於 輕度創傷性腦損傷（mTBI）

腦震盪 是一種未滿足的醫療需求，影響着全球數百萬人的健康。反覆的腦震盪被認爲會增加發展 慢性創傷性腦病（「CTE」）和其他神經精神障礙的風險。估計在美國每年發生350萬 到500萬次腦震盪，其中多達50%未被報告。全球腦震盪的發生率估計爲6900萬。根據Grandview Research，2020年腦震盪治療的全球市場估計價值爲69億 美元，並預計到2027年將達到89億美元。腦震盪的常見發生場所包括接觸性體育、軍事訓練和 作戰、機動車事故、兒童玩耍和因摔倒而導致的老年人輔助生活設施。

我們的 ONP-002神經病學資產用於腦部相關疾病和損傷

繼我們於2023年12月收購Odyssey Health, Inc.（「Odyssey」）相關的某些資產之後，這些資產與Odyssey專注於開發治療腦部相關疾病和疾病的醫療產品的業務部門（「神經資產」）有關，我們的主要產品和重點是開發和商業化用於治療輕度創傷性腦損傷（mTBI）的ONP-002。

ONP-002 至今已被證明在104度下穩定18個月。該藥物候選者通過噴霧乾燥製造成粉末，並填充 至新的鼻用裝置中。藥物隨後通過獨特的鼻用給藥裝置從鼻腔給藥。新的 鼻用裝置是輕量化的，旨在便於在現場或由醫療人員自我給藥使用。

我們 相信專有的粉末配方和鼻用給藥方式可以快速、直接地進入大腦。 該設備由呼吸推動，我們預計可以讓患者用力吹氣進入設備，從而關閉位於咽部後方的軟齶，防止藥物流向肺部或食道，減少系統暴露和副作用，並且輕鬆穿過血腦屏障。 這一機制使ONP-002保留在鼻腔中，讓藥物在受損的大腦中更豐富、更快速地可用。

預計 ONP-002 產品開發時間表：

此 產品開發計劃爲估計，可能會根據資金、技術風險和監管審批的情況而有所改變。

知識產權

關於ONP-002的專利已提交和/或頒發，並且已就鼻用給藥裝置提交專利，如下所示：

ONP-002 臨床前試驗

該藥物已在老鼠和狗身上完成了毒理學研究。這些研究表明，ONP-002的預測有效劑量具有較大的安全邊際。在臨床前動物研究中，該藥物顯示出在整個大腦中的快速和廣泛的生物分佈，同時減少腫脹、炎症和氧化壓力，並具有良好的安全性。

結果 來自臨床前研究的數據顯示，ONP-002具有與相關神經類固醇等效且可能更優的神經保護效果。經過藥物處理的動物在腦震盪後，通過各種測試平台顯示出積極的行爲結果，包括改善記憶和感覺運動表現，以及減少抑鬱/焦慮行爲。

ONP-002 臨床試驗

ONP-002 已在健康人類受試者中完成了第一階段臨床試驗，顯示其安全且耐受性良好。

安全性 研究已經確立了一個爲期十四天的2次/天的給藥方案。第一階段臨床試驗是在澳大利亞的墨爾本進行的，參與單位爲合同研究組織（「CRO」）Avance Clinical Pty Ltd（「Avance Clinical」）和Nucleus Network Pty Ltd。澳大利亞這個國家在貨幣兌換方面提供了優勢，並且在我們財政年結束時從澳大利亞政府對在澳大利亞進行的所有研發給予稅收減免。

該研究爲雙盲、隨機和安慰劑對照的相1試驗（3:1，藥物:安慰劑）。相1採用單升/多升（SAD/MAD）藥物給藥設計。SAD部分爲1X治療（低、中或高劑量），MAD部分爲連續五天的1X/天治療（低劑量和中劑量）。在多個時間點收集血液和尿液樣本，以評估安全性和藥代動力學。對每個身體系統提供標準安全監測。

四十名 受試者（31名男性，9名女性）成功參與了第一階段研究。由醫療醫生組成的安全審查委員會已經 審核了試驗數據，並確定該藥物在所有劑量水平下是安全且耐受良好的。

我們 正在爲第二階段臨床試驗做準備，以進一步評估ONP-002的安全性和有效性。基於第一階段的數據，我們計劃向FDA申請新藥臨床試驗申請，並在美國進行第二階段試驗。

我們 預計將在受傷的患者中進行第二階段臨床試驗，以進行鼻用給藥ONP-002，每天兩次，持續至多十四天。第二階段可行性研究預計將在澳洲進行，目標開始日期爲2024年第四季度，隨後緊接着將在美國進行第二階段概念驗證研究。

最近 進展 – 第二階段

截至2024年9月30日的九個月內，我們與多家供應商簽署了協議，以推動我們開始第二階段臨床試驗的工作，其中包括與Avance Clinical簽訂的合同，以在澳洲進行第二階段臨床試驗。

在 2024年8月8日，我們宣佈完成了一項研究，該研究表明ONP-002不會引起心臟毒性。在進行臨床試驗之前，美國食品和藥物管理局（FDA）要求藥品在心臟受體上進行測試，以確保它們不會造成任何電氣畸形。Oragenics與查爾斯河實驗室（Charles River Laboratories）在良好實驗室規範（GLP）下對ONP-002進行了hERG（人類Ether-à-go-go相關基因）離子通道研究。與之前的非GLP hERG研究類似，抑制濃度大於10微摩爾。根據第一階段ONP-002臨床試驗的劑量和隨後的血漿濃度，預計ONP-002將具有較大的心臟安全裕度，這表明ONP-002治療腦震盪不會引起心律失常。

在2024年8月12日，我們宣佈完成了一項研究，該研究表明ONP-002不會導致DNA損傷和基因毒性， 在動物模型中進行。Oragenics進行了一個 體內 （動物）研究，以判斷多天使用ONP-002治療是否會導致DNA損傷 和癌症風險增加。使用了三種ONP-002的濃度，分別是低、中和高劑量。對動物骨髓進行解剖 並分析DNA損傷。結果顯示沒有遺傳突變的證據，表明ONP-002不會影響電芯 週期，因此不會干擾可能導致癌症的細胞分裂。Oragenics與VivoPharm公司合作在良好實驗室（GLP）條件下進行此項研究。 這些結果表明，使用ONP-002進行腦震盪多天治療不會引起基因毒性。

在 2024年8月14日，我們宣佈最近完成了ONP-002藥物批次的合成，以便進行計劃中的二期臨床試驗。 公司報告了3個月的穩定性，純度超過99%，在-20°C至104°C的溫度範圍內。Oragenics對其信念充滿信心， 認爲ONP-002在運輸和存儲過程中不需要繁瑣的冷鏈協議，即使在極端溫度下也能保持其化學結構 和功能。

接觸性體育和軍工-半導體操作的現場條件涉及可能影響急性腦震盪治療藥物穩定性和有效性的廣泛溫度區間。ONP-002已被製成噴霧乾燥粉末，以提高在極端溫度下的穩定性。相反，狹窄的溫度存儲協議可能繁瑣，並在運輸和現場操作中帶來更大的不合規風險。

在 2024年8月21日，我們宣佈完成了ONP-002的噴霧乾燥配方及其在鼻用設備中的填充。預填充配方旨在提供計劃中的IIa期所需的藥物-設備劑量。

我們的 業務發展策略

成功 在生物製藥和產品開發行業的關鍵在於持續開發新型產品候選者。大多數產品候選者無法通過臨床開發階段，這迫使公司在外部尋找創新。因此，我們期望不時通過多種形式的業務發展尋找戰略機會，這可能包括戰略聯盟、許可協議、合資企業、合作、股權或債務投資、資產處置、併購。 我們將這些業務發展活動視爲我們策略中必要的組成部分，旨在通過評估與我們當前業務相關或互補的業務發展機會，以及可能與我們現有產品候選者開發無關的新機會，來提升股東價值。我們的業務策略需要大量資本。

作爲公司努力保護現金資源並專注於開發我們的ONP-002腦震盪藥物候選產品的一部分， 公司關閉了位於佛羅里達州阿拉丘亞的設施，在那裏進行了一些與蘭替生素項目有關的工作，並且已暫停所有與我們的生物-疫苗產品候選人相關的研究和開發活動。在公司能夠獲得額外資本並判斷出一種替代解決方案以繼續這些研究和開發項目之前，這些活動將保持暫停狀態。

財務 概況

研究 和開發費用

研發 研究和開發包括與我們產品候選者的發現和開發相關的費用。這些費用 主要包括員工相關費用，其中包括薪水和福利及參加科學會議的費用；根據我們的許可協議與第三方及與醫藥外包概念、研究機構和顧問簽訂的其他協議所產生的費用，這些人員負責進行我們的臨床試驗以及大部分非臨床研究；獲取和製造臨床試驗材料的成本；設施、折舊及其他分攤費用，其中包括設施和設備的直接和分攤租金及維護費用，以及固定資產的折舊；許可費，以及與已授權產品和科技相關的里程碑付款；基於股權的補償費用；以及與非臨床活動和監管批准相關的費用。 我們將研究和開發成本在發生時計入費用。

我們的 研究和開發費用可以分爲 (i) 臨床研究和 (ii) 非臨床研究與開發活動。 臨床研究成本包括臨床試驗、製造服務、監管活動，這些主要由 第三方提供。非臨床研究和開發費用包括我們的研究活動、第三方提供的研究活動、 我們自己的非臨床研究、第三方提供的非臨床研究、進行中的研究和開發的獲取、相關 人員成本和實驗室耗材，以及我們在產品候選項開發中產生的其他成本，如租金、公用事業費、折舊和基於股票的補償。雖然我們目前專注於推進我們的產品開發項目， 但我們未來的研究和開發費用將取決於我們產品候選項的臨床成功，以及對每個產品候選項的商業潛力的持續評估。此外，我們無法以任何確定的方式預測哪些產品候選項 可能會成爲未來的合作伙伴關係，何時這些安排會得到確認，如果有的話，以及這些安排將在多大程度上影響我們的開發計劃、研究費用和資本需求。

我們的 研發費用爲2,449,234美元和4,448,623美元，分別對應於截至2024年和2023年9月30日的九個月。 在2023年，我們的研發成本包括我們的COVID生物-疫苗項目和我們的蘭替丁類抗生素項目，這兩個項目在 2023年暫停。截止2024年9月30日的九個月，我們的研發費用包括與開發 我們的ONP-002神經系統資產相關的成本。由於資源有限，儘管我們繼續進行開發工作，我們已將研發費用集中在我們的ONP-002藥物上，並暫停進一步開發我們的生物-疫苗產品和蘭替丁類抗生素研究，直到我們能夠 籌集到更多資金。

我們目前的產品開發策略考慮到持續對我們的ONP-002產品進行研究和開發。持續的研究和開發費用取決於可用的資金和我們籌集額外所需資金的能力。完成前臨床研究、臨床試驗、尋求監管批准以及擴大我們能夠提出的潛在索賠的漫長過程需要大量資源的支出。任何在完成前臨床研究、臨床試驗或獲得監管批准方面的失敗或延誤，可能會導致產品收入的產生延遲，並導致我們的研究和開發費用增加，進而對我們的運營產生重大不利影響。我們當前的產品候選在獲得FDA或其他我們可能尋求批准的司法管轄區的監管批准之前，預計尚不能商業化。

我們的 計劃是預算和管理研究和開發的支出，以確保它們以具有成本效益的方式進行，同時推動研究和開發的工作。在可用資金的條件下，整體研究和開發費用可能由於我們的腦震盪產品候選者而增加。我們目前的研究和開發項目預計將推進到可被大型藥品公司許可或合作的階段。

最近 融資

在2024年9月4日，我們宣佈出售300萬股普通股和預融資Warrants，購買500萬股普通股，面值爲0.001美元，通過與Dawson James Securities, Inc.（「Dawson James」）的配售協議，以每股普通股0.55美元的發行價格進行。本次發行的總收益爲445萬，扣除公司應支付的配售代理費用和其他預估的發行費用。我們還同意向配售代理發行Warrants（「Dawson James Warrants」），購買在本次發行中出售的證券總數的最多5%，行使價格爲普通股發行價格的125%。Dawson James Warrants可在發行交易完成日期起的五年內行使，並在發行交易完成後的六個月內首次可行使。

我們 打算將本次發行的淨收入用於繼續開發ONP-002，以及一般企業用途和 營運資金。

一般 管理費用

一般和行政費用主要包括高管、財務和行政職能人員的工資及相關成本。其他一般和行政費用包括不在研發費用中包含的設施成本、專利申請費，以及法律、諮詢、審計和稅務服務的專業費用。

我們 意識到某些一般及管理費用可能因以下原因而增加：

其他收入（費用）

其他 收入（費用）包括雜項收入以及利息收入和費用。利息收入由我們在 現金及現金等價物上賺取的利息組成。我們投資政策的主要目標是資本保全。利息費用主要由我們的債務相關的利息和費用組成。

截至2024年和2023年9月的三個月和九個月的經營結果

補助金 營業收入。 截至2024年9月30日的三個月和九個月期間沒有補助金營業收入。在2023年相應的三個月和九個月期間，補助金營業收入分別爲7,466美元和37,653美元。此減少歸因於在截至2023年9月30日的三個月期間到期的小型企業創新研究補助金獲得的獎勵。

研究 和開發。 2024年9月30日截止的三個月和九個月期間，研發費用分別爲879,041美元和2,449,234美元，與2023年9月30日截止的可比三個月和九個月期間的769,350美元和4,448,623美元相比。 這可比2024年9月30日截止的三個月和九個月期間分別增加了14%和減少了45%。

在可比的九個月期間，這一下降主要是由於與我們ONP-002腦震盪藥物的開發相關的成本降低，而與我們COVID生物-疫苗產品和我們的蘭肽類項目的開發成本相比。截止到2023年9月30日的三個月內，我們的COVID生物-疫苗和蘭肽類項目的研究與開發費用大約爲80萬，主要與外部顧問的費用相關。截止到2024年9月30日的三個月期間，與ONP-002相關的研究與開發費用大約爲90萬。在截至2024年和2023年9月30日的九個月期間，我們的ONP-002產品的研究與開發費用大約爲240萬，而我們的生物-疫苗產品和蘭肽類項目的費用約爲440萬。

一般 和管理費用。 一般和管理費用在截至2024年9月30日和2023年9月30日的三個月內分別約爲160萬和130萬。截止到2024年9月30日的九個月期間，一般和管理費用約爲480萬，相較於2023年同類九個月期間的370萬，增加了約100萬或29%。這次增加主要是由於相關費用的增加：

These expense increases were offset by decreases in:

Other Income (Expense). Other income and expense, net, was $(25,590) for the three months ended September 30, 2024, compared to $81,561 for the comparable three months in 2023. For the nine month period ended September 30, 2024 and 2023, other income and expense, net, was $(15,412) and $200,271 respectively, resulting in a change of $215,683 or 108% for the comparable nine month periods. The net change was primarily attributable to a reduction in interest income due to lower cash balances in interest earning accounts for the comparable periods.

Liquidity and Capital Resources

Since our inception, we have funded our operations primarily through the sale of equity securities in our initial public offering, the sale of equity securities and warrants in private placements, debt financing, warrant exercises, public offerings, and grants. During the nine months ended September 30, 2024 and 2023, our operating activities used cash of $6,579,029 and $6,188,335 respectively. The change is primarily driven by changes in net losses adjusted for non-cash items and changes in operating assets and liabilities. We had a working capital surplus of $1,986,837 and $2,067,593 at September 30, 2024 and December 31, 2023, respectively.

During the nine months ended September 30, 2024 and 2023, our financing activities provided cash of $6,239,577 and $464,479 respectively. The cash provided by financing activities during the nine months ended September 30, 2024 was primarily due to net proceeds from our underwritten public offerings.

The Company has made several changes to reduce cash used in operations until additional capital can be obtained. These changes include a reduction in staffing and a reduction in research and development activity. These changes have positively impacted the forecast of cash resources available for operations, which we believe will allow us to fund our operating plan through the fourth quarter of 2024.

Financing

Additional details of our financing activities for the periods reflected in this report are provided below as well as certain information on our outstanding shares of preferred stock:

At-the-Market (“ATM Program”)

On February 24, 2023 the Company entered into an ATM with Ladenburg Thalmann & Co. Inc (“Ladenburg”) to sell shares of its common stock. The Company did not issue any shares of common stock under its ATM with Ladenburg during the nine month periods ended September 30, 2024 and 2023. The Company did not sell any shares through the ATM program while it was active. The ATM program with Ladenburg terminated on January 30, 2024.

On August 8, 2024, the Company entered into an At-The-Market Issuance Sales Agreement (the “Sales Agreement”) with Ascendiant Capital Markets, LLC, as sales agent (the “Agent”), pursuant to which the Company may offer and sell through or to the Agent (the “ATM”) up to $10.0 million in shares of its common stock (the “Shares”) at-the-market. Shares offered and sold in the Offering are anticipated to be issued pursuant to the Company’s universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”) filed with the Securities and Exchange Commission (the “SEC”). Under the terms of the Sales Agreement, the Agent is entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares under the Agreement. On October 9, 2024 the Company terminated the Sales Agreement with Ascendiant Capital, and there were no shares sold under the Sales Agreement with Ascendiant Capital in the nine months ended September 30, 2024.

On October 11, 2024, Oragenics, Inc. (the “Company”) entered into an At-the-Market Sales Agreement (the “Sales Agreement”) with Dawson James Securities Inc. (“Dawson James” or the “Sales Agent”) pursuant to which the Company may issue and sell, from time to time, shares of its common stock (the “Shares”), depending on market demand, with the Sales Agent acting as the sales agent or principal (the “Offering”). Sales of the Shares may be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made directly on or through the NYSE American. The Agent will use its commercially reasonable efforts to sell the Shares requested by the Company to be sold on its behalf, consistent with the Agent’s normal trading and sales practices, under the terms and subject to the conditions set forth in the Sales Agreement. The Company has no obligation to sell any of the Shares. The Company may instruct the Agent not to sell the Shares if the sales cannot be effected at or above the price designated by the Company from time to time and the Company may at any time suspend sales pursuant to the Sales Agreement. As of November 13, 2024 there were no shares sold under the Sales Agreement with Dawson James.

Previously, on August 8, 2024, the Company entered into an At-The-Market Issuance Sales Agreement (the “Sales Agreement”) with Ascendiant Capital Markets, LLC, as sales agent (the “Agent”), pursuant to which the Company may offer and sell through or to the Agent (the “ATM”) up to $10.0 million in shares of its common stock at-the-market. On October 9, 2024, the Company terminated the Sales Agreement with Ascendiant Capital. There were no shares sold under the Sales Agreement with Ascendiant Capital in the nine months ended September 30, 2024.

Other Financings

We entered into short term financing arrangements for the payment of our annual insurance premiums for our products liability insurance, cyber coverage, products liability coverage, and directors and officers and employment practices insurance.

In July of 2024, we entered into a short-term note payable for $636,972 bearing interest at a rate of 9.55% to finance the renewals of the directors’ and officers’ liability, employment practices liability, products liability, cyber liability, and other liability policies. Principal and interest payments on the note began in August of 2024 and continue through May of 2025 based on straight-line amortization over the 10-month period.

Recent Developments

On September 4, 2024, we announced the sale of 3 million shares of our common stock and Pre-Funded Warrants to purchase 5 million shares of common stock, par value $0.001, through a placement agreement with Dawson James Securities, Inc. (“Dawson James”) at an offering price per share of common stock of $0.55. The offering resulted in gross proceeds of $4.45 million before deducting placement agent fees and other estimated offering expenses payable by the Company. We also agreed to issue placement agent warrants (“Dawson James Warrants”) to purchase up to 5% of the aggregate number of securities sold in the offering with an exercise price 125% of the offering price of the common stock in the offering. The Dawson James Warrants are exercisable for five years from the date of closing the offering and are initially exercisable six months from the closing of the Offering.

Our Outstanding Preferred Stock

Series A and Series B

During 2017, we issued shares of Series A and Series B Preferred Stock in financing transactions (the “Preferred Stock Financings”). In connection with the Preferred Stock Financings, we filed Certificate of Designations of Preferences, Rights and Limitations of Series A and Series B Preferred Stock with the Secretary of State of the State of Florida, effective May 10, 2017 and November 8, 2017, respectively. On August 26, 2022, holders of 4,000,000 shares of the Company’s Series A Convertible Preferred Stock, and 2,550,000 shares of the Company’s Series B Convertible Preferred Stock converted the Series A Convertible Preferred Stock and the Series B Convertible Preferred Stock into an aggregate of 15,167 shares of common stock. As of September 30, 2024 our outstanding Series A and Series B Preferred Stock and the amount of common stock that may be issued upon conversion is set forth below:

In addition, we issued warrants to purchase shares of Common Stock to the Series A holders, and to the Series B holders in connection with the Preferred Stock Financing. As of September 30, 2024, there are 17,742 shares of common stock able to be acquired upon exercise of the warrants held by our Series A and Series B holders respectively.

Except as otherwise required by law, the Series A and Series B Preferred Stock have no voting rights. However, as long as any shares of Series A and Series B Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A and Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A or Series B Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A and Series B Preferred Stock, (c) increase the number of authorized shares of Series A and Series B Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing. Upon any liquidation, dissolution or winding-up by us, whether voluntary or involuntary that is not a Fundamental Transaction (as defined in the Certificate of Designations), the holders of Series A and Series B Preferred Stock shall be entitled to receive out of the assets, the greater of (i) the product of the number of shares of Series A and Series B Preferred Stock then held by such holder, multiplied by the Original Issue Price; and (ii) the amount that would be payable to such holder in the Liquidation (as defined in the Certificate of Designations) in respect of Common Stock issuable upon conversion of such shares of Series A and Series B Preferred Stock if all outstanding shares of Series A and Series B Preferred Stock were converted into Common Stock immediately prior to the Liquidation. The Series A and Series B Preferred Stock is classified as permanent equity. Each of the Series A and Series B Preferred Stock have redemption rights to the extent we have funds legally available therefore, at any time after the fifth anniversary of the original issue date of the applicable Series A and Series B Preferred Stock. We have the right to redeem all or any portion of the outstanding shares of Series A and Series B Preferred Stock at the original issue price by providing at least seventy-five (75) days written notice of such redemption to all holders of the then outstanding shares of Series A and Series B Convertible Preferred Stock.

Series F

On December 28, 2023, as part of consideration paid to Odyssey and pursuant to an Asset Purchase Agreement executed with Odyssey, we issued 8,000,000 shares of convertible Series F Preferred Stock. The Series F Preferred Stock is convertible on a one-for one basis. The Series F Preferred Stock has no voting rights, is ranked junior to our Series A and Series B Preferred Stock and is at parity with our common stock, in addition there shall be no dividends paid on the Series F Preferred Stock. At the closing of the Odyssey transaction 511,308 shares of Series F Preferred Stock were converted into 511,308 shares of common stock. At September 30, 2024, there were 7,488,692 shares of Series F Preferred Stock outstanding.

Future Capital Requirements

On April 18, 2024, we received Notice from the NYSE American that we are no longer in compliance with NYSE American’s continued listing standards. Specifically, we are not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. Subsequently, the NYSE American notified the Company that it also is not in compliance with subsection (i) Section 1003(a), which requires stockholders’ equity of no less than $2,000,000 if the Company has sustained losses from continuing operations and/or net losses in two of its three most recent fiscal years.

We reported stockholders’ equity of $3.2 million as of December 31, 2023, and $3 million as of September 30, 2024. Additionally, we have reported losses from continuing operations and/or net losses in our five most recent fiscal years ended December 31, 2023.

The Notice further provides that we must submit a plan of compliance (the “Plan”) by May 18, 2024 (the “Deadline”) addressing how we intend to regain compliance with the continued listing standards by October 18, 2025. The Plan is required to include specific milestones, quarterly financial projections and details related to any strategic initiatives we plan to complete.

We submitted the Plan by the Deadline and on June 18, 2024 we were notified by the NYSE American that our Plan to regain compliance with NYSE American’s continued listing standards had been accepted. As part of the acceptance we were granted a plan period through October 18, 2025 to regain compliance. During the plan period, we will be subject to quarterly monitoring for compliance with the plan. If we do not regain compliance with NYSE American’s listing standards by October 18, 2025, or if we do not make progress consistent with our plan, the NYSE American may initiate delisting proceedings.

Our common stock will continue to be listed on NYSE American during the plan period under the symbol “OGEN” with a “below compliance” indicator appended to our ticker symbol (with the added designation of “.BC”). Our receipt of the notification from NYSE American accepting the compliance Plan does not affect our business operations or our reporting requirements with the U.S. Securities and Exchange Commission.

We are committed to undertaking a transaction or transactions in the future to achieve compliance with the NYSE American’s requirements. However, there can be no assurance that we will be able to achieve compliance with the NYSE American’s continued listing standards within the required timeframe. Additionally, we can provide no assurance that the transaction or transactions necessary to achieve compliance can be obtained or that they can be obtained with terms favorable to investors.

If the Common Stock ultimately were to be delisted for any reason, it could negatively impact the Company by (i) reducing the liquidity and market price of the Company’s Common Stock; (ii) reducing the number of investors willing to hold or acquire the Common Stock, which could negatively impact the Company’s ability to raise equity financing; and (iii) limiting the Company’s ability to use a registration statement to offer and sell freely tradable securities, thereby preventing the Company from accessing the public capital markets; and (iv) impairing the Company’s ability to provide equity incentives to its employees.

Our capital requirements for the remainder of 2024 will depend on numerous factors, including our ability raise additional capital including through possible joint ventures and/or partnerships. We expect to incur substantial expenditures to further develop or commercialize our technologies including continued increases in costs related to research, nonclinical testing and clinical trials, as well as costs associated with our capital raising efforts and being a public company. We will require substantial funds to conduct research and development and nonclinical and Phase 2 clinical testing of our licensed, patented technologies and to develop sublicensing relationships for the Phase 2 and 3 clinical testing and manufacture and marketing of any products that are approved for commercial sale. Our financing plans include seeking both equity and debt financing, alliances or other partnership agreements with entities interested in our technologies, or other business transactions that would generate sufficient resources to ensure continuation of our operations and research and development programs.

Our current available cash and cash equivalents provide us with limited liquidity. We believe our existing cash will allow us to fund our operating plan through the fourth quarter of 2024. As a result, we have implemented certain cost-saving initiatives, including reducing our efforts and staff focused on our lantibiotics program and our vaccine product candidate, which are expected to negatively impact the development of these programs. See, “Risk Factors.” We expect to manage the timing of our development expenditures and to continue to seek additional funding for our operations. Any required additional capital may not be available on reasonable terms, if at all. If we were unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned clinical testing, research and development and commercialization activities, which could harm our business. The sale of additional equity or debt securities may result in additional dilution to our shareholders. If we raise additional funds through the issuance of debt securities or preferred stock, these securities could have rights senior to those of our common stock and could contain covenants that would restrict our operations. We also will require additional capital beyond our currently forecasted amounts, for example, as we seek to move forward with the development of ONP-002 we will require additional capital. In addition, we continue to pursue other non-dilutive opportunities for our COVID-19 research and development funding opportunities through governmental and nongovernmental sources, as well as potential research collaboration arrangements with academic institutions and other commercial partners. Our ability to advance the development of our ONP-002 concussion candidate at our currently anticipated pace, is dependent upon our ability to secure additional capital resources through these funding opportunities or an alternative capital raise, such as an equity or debt financing or other strategic business collaboration.

Because of the numerous risks and uncertainties associated with research, development and clinical testing of our product candidates, we are unable to estimate the exact amounts of our working capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

We have based our estimates on assumptions that may prove to be wrong. We may need to obtain additional funds sooner or in greater amounts than we currently anticipate. Potential sources of financing include strategic relationships, grants, public or private sales of our shares or debt and other sources. We may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. We do not have any committed sources of financing at this time, and it is uncertain whether additional funding will be available when we need it on terms that will be acceptable to us, or at all. If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interest of our existing stockholders will be diluted. If we are not able to obtain financing when needed, we may be unable to carry out our business plan. As a result, we may have to significantly limit our operations and our business, financial condition and results of operations would be materially harmed.

Critical Accounting Estimates and Policies

Our discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). The preparation of condensed consolidated financial statements in accordance with US GAAP requires us to make estimates and assumptions that affect reported amounts and related disclosures. We consider an accounting estimate to be critical if it requires assumptions to be made that were uncertain at the time the estimate was made; and changes in the estimate or different estimates that could have been made could have a material impact on our results of operations or financial condition. The principal area of estimation reflected in the condensed consolidated financial statements are estimates for research and development expenses and related prepaid and accrued expenses, which are based on the percentage of completion of the Company’s contracts with Contract Research Organizations.

Recently Issued Accounting Pronouncements

There are no accounting pronouncements issued or effective during the three months ended September 30, 2024 that have had or are expected to have an impact on our condensed consolidated financial statements.

Oragenics, Inc. is a smaller reporting company as defined by Rule 12b-2 of the Securities and Exchange Act of 1934 and is not required to provide the information required under this item.

Evaluation of Disclosure Controls and Procedures

Management’s evaluation of the effectiveness of the Company’s disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act was performed under the supervision and participation of our senior management, including our President and Interim Principal Executive Officer and Chief Financial Officer. The purpose of disclosure controls and procedures is to ensure that information required to be disclosed in the reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including our President and Interim Principal Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures. Based upon that evaluation, our Interim Principal Executive Officer and Chief Financial Officer concluded that, as of the end of such period, our disclosure controls and procedures were effective as of September 30, 2024 in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported with the time periods specified in the Securities and exchange Commission’s rules and forms.

Changes in Internal Controls over Financial Reporting

Our management, with the participation of our President and Interim Principal Executive Officer and Chief Financial Officer, has concluded there were no other significant changes in our internal controls over financial reporting that occurred during our last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Limitations on the Effectiveness of Controls

Our management, including our Interim Principal Executive Officer and President, and Chief Financial Officer, does not expect that our Disclosure Controls and internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management or board override of the control.

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

PART II – OTHER INFORMATION

On December 7, 2022, the Company entered into an investment banking engagement letter with Ladenburg Thalmann, (“Ladenburg”). The engagement letter was subsequently amended at various times (together with amendments to the “Engagement Letter”). The Company terminated the Engagement Letter as of August 15, 2023. Ladenburg sent the Company an invoice in the amount of $2,500,000, and a demand letter from Ladenburg’s general counsel demanding payment thereof followed shortly thereafter. Ladenburg is of the view that a fee is owed based on the Company’s purchase of assets from Odyssey Health, Inc. The Company strongly disagrees that any such fee is due to Ladenburg and initiated a confidential action for arbitration against Ladenburg with the Financial Industry Regulatory Authority (“FINRA”) on March 12, 2024, seeking, among other things, a declaratory judgment that no such fee is owed. On April 17, 2024 Ladenburg filed a Complaint in federal court in the Southern District of Florida, and also filed motion for a temporary restraining order (“TRO”) and preliminary injunction seeking to move the venue from FINRA to the federal court in Miami-Dade County. On May 3, 2024, the Magistrate Judge assigned to the case issued a Report and Recommendation denying the motion; although Ladenburg objected to the Report and Recommendation, Magistrate Judge’s Report and Recommendation, the District Court Judge adopted the Report and Recommendation, finalizing the Court’s denial of the requested injunctive relief. On May 9, 2024, the Company filed a motion to dismiss in the federal court action, which is still currently pending. Meanwhile, the FINRA action continues and is set to be heard in February of 2025. The Company believes Ladenburg’s claims are unlikely to prevail and intends to defend itself vigorously. It is possible, however, that there could be an unfavorable outcome or resolution of the claims asserted, which could negatively and materially impact the Company’s business, consolidated financial position and results of operations. Litigation is inherently uncertain and there can be no assurance that the Company will prevail. The Company does not include an estimate of legal fees and other related defense costs in its estimate of loss contingencies.

In addition to the other information set forth in this Form 10-Q, you should carefully consider the factors discussed in Part I, Item 1A, subsection “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 which could materially affect our business, financial condition or future results of operations. The risks described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 are not the only risks that we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition and future results of operations. The following information updates, and should be read in conjunction with, the risk factors previously disclosed in Item 1A, subsection “Risk Factors” to Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed on March 29, 2024. Except as set forth below, there have been no material changes to the risk factors previously disclosed under the caption “Risk Factors” in our Annual Report on Form 10-K.

Risks Related to Our Business

We have incurred significant losses since our inception and expect to continue to experience losses for the foreseeable future.

We have incurred significant net losses and negative cash flow in each year since our inception, including net losses of approximately $7.2 million and $7.9 million for the nine months ended September 30, 2024 and 2023, respectively, and approximately $21 million for the year ended December 31, 2023. As of September 30, 2024, our accumulated deficit was approximately $213 million. We have devoted a significant amount of our financial resources to research and development, including our nonclinical development activities and clinical trials. We expect that the costs associated with our plans to begin phase 2 clinical trials, contract manufacturing and file an IND for our concussion product candidate will continue and, to have successful results, likely will require an increase in the level of our overall expenses going forward. As a result, we expect to continue to incur substantial net losses and negative cash flow for the foreseeable future. These losses and negative cash flows have had, and will continue to have, an adverse effect on our shareholders’ equity and working capital. Our current cash, cash equivalents and short-term investments are not sufficient to fully implement our business strategy and sustain our operations. As a result of our limited resources, we have undertaken cost-saving initiatives, including reducing our efforts and staff focused on our COVID vaccine candidate and our lantibiotics program. Our actual costs may ultimately vary from our current expectation, which could materially impact our use of capital and our forecast of the period of time through which our financial resources will be adequate to support our operations. Because of the numerous risks and uncertainties associated with product development and commercialization, we are unable to accurately predict the timing or amount of substantial expenses or when, or if, we will be able to generate the revenue necessary to achieve or maintain profitability. Due to of our accumulated losses and substantial doubt that we can continue as a going concern beyond December 2024, the Company is evaluating various opportunities for its Lantibiotics Program and its N-CoV2-1 vaccine product candidate, as well as alternative assets that could be acquired or developed. These opportunities could include a wide range of options including, among other things, a potential sale, spin-off, fund raising, combination or other strategic transaction, which may also include the winding down of research and development activities. The result of this process may result in the liquidation of assets for significantly less than amounts that have been invested in them, the write-off of prior expenses incurred in connection with the development of such assets and may have a material adverse effect on our results of operations and liquidity. Notwithstanding the above, the Company will seek to maximize the value of such assets to the extent possible. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate or government collaboration and licensing arrangements. If we do not succeed in raising additional funds on acceptable terms, we may be unable to complete existing nonclinical and planned clinical trials or obtain approval of our product candidates from the FDA and other regulatory authorities. We believe our existing cash will allow us to fund our operating plan only through the fourth quarter of 2024.

We may have difficulty raising additional capital, which could deprive us of the resources necessary to implement our business plan, which would adversely affect our business, results of operation and financial condition.

We need to raise additional capital to fund the development and commercialization of our product candidates and to operate our business. The need to raise additional capital is expected to increase as we continue our work research and development activities and preparation to start phase 2 clinical trials for ONP-002. In order to support the initiatives envisioned in our business plan, we will need to raise additional funds through the sale of assets, public or private debt or equity financing, collaborative relationships or other arrangements. If our operations expand faster or at a higher rate than currently anticipated, we may require additional capital sooner than we expect. We are unable to provide any assurance or guarantee that additional capital will be available when needed by our company or that such capital will be available under terms acceptable to our company or on a timely basis.

Our ability to raise additional financing depends on many factors beyond our control, including the state of capital markets, the market price of our common stock and the development or prospects for development of competitive products by others. If additional funds are raised through the issuance of equity, convertible debt or similar securities of our company, the percentage of ownership of our company by our company’s stockholders will be reduced, our company’s stockholders may experience additional dilution upon conversion, and such securities may have rights or preferences senior to those of our common stock. The preferential rights granted to the providers of such additional financing may include preferential rights to payments of dividends, super voting rights, a liquidation preference, protective provisions preventing certain corporate actions without the consent of the fund providers, or a combination thereof. We are unable to provide any assurance that additional financing will be available on terms favorable to us or at all.

If adequate funds are not available or are not available on acceptable terms, with limited capital, we expect to continue to hold research and development of our lantibiotics and Covid programs and may reduce or slow research and development activity of our ONP-002 lead asset. Thus, the unavailability of capital could substantially harm our business, results of operations and financial condition.

With limited resources we have paused our other product candidate research and development and now rely on the progress and success of ONP-002.

With limited capital, we have put the research and development of our COVID vaccine program and our lantibiotics program on hold and have chosen instead to focus the limited capital on the development of ONP-002. As such, our future success currently depends on the successful development of ONP-002, our concussion asset, of which there can be no assurances.

We are heavily dependent upon the ability and expertise of our management team and a very limited number of employees and consultants; the loss of such individuals could have a material adverse effect on our business, operating results and financial condition.

We currently have a very small management team. Our success is dependent upon the ability, expertise and judgment of our senior management and consultants. While employment agreements are customarily used as a primary method of retaining the services of key employees, these agreements cannot assure the continued services of such employees. Any loss of the services of such individuals could have a material adverse effect on our business, operating results or financial condition. Mr. Redmond continues to serve as President and CEO of Odyssey, which may give rise to conflicts of interest.

We believe that our future success with regard to the Neurology Assets depends on the skills and efforts of our senior management and other key personnel, including Jacob VanLandingham, Ph.D., one of the Company’s independent contractors. The loss of the services of any of these individuals could harm our ability to successfully pursue the development of the Neurology Assets. If any of our executive officers or key personnel left or was otherwise unable to work and we were unable to find a qualified replacement and/or to obtain adequate compensation for such loss, we may be unable to manage our business, which could harm our operating results and financial condition.

On December 5, 2022, the Mississippi Department of Human Services (“MDHS”) filed an Amended Complaint in the Circuit Court of Hinds County, Mississippi First Judicial District against Mississippi Community Education Center, Inc., a non-profit corporation, Nancy New, its director, Prevacus, Dr. VanLandingham its founder, and several other defendants, alleging, among other things, a conspiracy to defraud the MDHS. Prevacus, Inc., is the Company from whom Odyssey purchased the Neurology Assets in 2021. The MDHS is designated by Mississippi law as the State agency exclusively responsible for administering the federally-authorized and federally-funded anti-poverty (or “welfare”) program known as the Temporary Assistance for Needy Families program, or “TANF.” With regard to Prevacus and Dr. VanLandingham, the complaint alleges that $2.1 million was funneled through the Mississippi Community Education Center, a nonprofit run by Nancy New, to Prevacus and PresolMD, another company founded by Dr. VanLandingham. The MDHS, among other things, is seeking to recover $2.1 million it alleges went to Prevacus and PresolMD. Prevacus and Dr. VanLandingham have denied any wrongdoing and have denied being aware that the funds received from Community Education Center, Inc. were TANF funds. However, recently, Dr. VanLandingham plead guilty to one federal charge of wire fraud in connection with this case and is awaiting sentencing, the timing and results of which are uncertain. The Company does not believe it has any financial exposure related to the reimbursement of the funds paid to Prevacus and does not believe there are any grounds on which the Company could become embroiled in the foregoing legal proceedings. Dr. VanLandingham is not an Officer or Director of Oragenics but is instead an independent contractor. Nevertheless, any negative media related to foregoing legal proceedings, and in particular any negative media related to the Neurology Assets or Dr. VanLandingham, may negatively impact the Company’s ability to raise capital and otherwise continue the development of the Neurology Assets. Furthermore, while the Company has relationships with other experts in the field, including Frank Peacock, MD, the Company’s Chief Clinical Officer, Dr. VanLandingham’s ability to continue to assist in the development of the Neurology Assets may be negatively impacted by the foregoing legal proceedings which could negatively impact the Company’s ability to raise capital and otherwise continue the development of the Neurology Assets.

Risks Related to Our Common Stock

We cannot assure you that we will continue to be listed on the NYSE American.

Our common stock commenced trading on the NYSE American (formerly the NYSE MKT) on April 10, 2013, and we are subject to certain NYSE American continued listing requirements and standards. On April 18, 2024 we received notification (the “Notice”) from the NYSE American that we were no longer in compliance with NYSE American’s continued standards, Specifically, the letter stated that the Company was in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide (the Company Guide”). Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. On August 13, 2024, we received a second notice from the NYSE American LLC informing us that us that we also are not in compliance with subsection (i) of Section 1003(a), which requires stockholders’ equity of no less than $2,000,000 if the Company has sustained losses from continuing operations and/or net losses in two of its three most recent fiscal years. We reported stockholders’ equity of $3.2 million as of December 31, 2023, and $3 million as of September 30, 2024. Additionally, we have reported losses from continuing operations and/or net losses in our five most recent fiscal years ended December 31, 2023. On May 17, 2024, we submitted a plan of compliance (the “Plan”) to the NYSE American. On June 18, 2024, the NYSE American accepted our Plan; the Company will be able to continue its listing during the Plan period and will be subject to continued periodic review by the NYSE American staff. If we are not in compliance with the continued listing standards by October 18, 2025, or if the Company does not make progress consistent with the Plan during the Plan period, the Company will be subject to delisting procedures as set forth in the NYSE American Company Guide. The Company is committed to undertaking a transaction or transactions in the future to achieve compliance with the NYSE American’s requirements. However, there can be no assurance that the Company will be able to achieve compliance with the NYSE American’s continued listing standards within the required timeframe. Further, the Company may fall out of compliance with other provisions of the NYSE American continued listing requirements and standards, including with regard to the Company’s stock price. If the Common Stock ultimately were to be delisted for any reason, it could negatively impact the Company by (i) reducing the liquidity and market price of the Company’s Common Stock; (ii) reducing the number of investors willing to hold or acquire the Common Stock, which could negatively impact the Company’s ability to raise equity financing; (iii) limiting the Company’s ability to use a registration statement to offer and sell freely tradable securities, thereby preventing the Company from accessing the public capital markets; and (iv) impairing the Company’s ability to provide equity incentives to its employees.

The issuance of additional equity securities by us in the future would result in dilution to our existing common shareholders.

Our Board of Directors has authority, without action or vote of our shareholders, to issue all or a part of our authorized but unissued shares, except where shareholder approval is required by law or the rules of any exchange on which our shares are listed. Any issuance of additional equity securities by us in the future could result in dilution to our existing common shareholders. Such issuances could be made at a price that reflects a discount or a premium to the then-current trading price of our common stock. In addition, our business strategy may include expansion through internal growth by acquiring complementary businesses, acquiring or licensing additional products or brands, or establishing strategic relationships with targeted customers and suppliers. In order to do so, or to finance the cost of our other activities, we may issue additional equity securities that could result in further dilution to our existing common shareholders. These issuances would dilute the percentage ownership interest of our existing common shareholders, which would have the effect of reducing their influence on matters on which our shareholders vote and might dilute the book value of our common stock. For example, our outstanding shares of common stock at December 31, 2023 was 3,080,693, due to additional common stock issuances related to capital raises, at September 30, 2024 our outstanding shares of common stock was 9,387,547. Furthermore, if Odyssey or the holders of Preferred Shares Series A and B convert their preferred shares into common stock an additional 7,511,220 shares of common stock could be issued resulting in dilution to our existing common shareholders. Additionally, as of November 13, 2024, 1,139,705 Pre-Funded Warrants remain unexercised.

None, other than those previously disclosed on the Company’s Current Reports on Form 8-K.

None.

Not Applicable.

Incorporated by reference to Exhibits filed after signature page.

EXHIBIT INDEX

*Portions of the exhibits have been omitted pursuant to Item 601(b)(10)(iv).

SIGNATURES

In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on this 13th day of November 2024.