根據2024年10月25日提交給證券交易委員會的文件
註冊聲明書編號333-
美國
證券交易委員會
華盛頓,特區。20549
表格S-3
註冊申報
根據1933年證券法
BEYOND AIR,INC。
(公司章程中指定的準確公司名稱)
特拉華州 | 47-3812456 | |
(註冊地或組織所在管轄區) 文件號碼) |
(美國國稅局僱主號碼) 108 Gateway Blvd |
900 斯圖爾特大道301號辦公室
花園城,紐約 11530
(516) 665-8200
(包括註冊人主要行政辦公室的地址,郵政編碼以及電話號碼(包括區號))
史蒂芬 麗斯
主席兼首席執行官
Beyond 空氣公司。
900 斯圖爾特大道301號辦公室
花園城,紐約 11530
(516) 665-8200
代理服務人的姓名、地址(包括郵政編碼)和電話號碼(包括區號)
副本寄送至:
格里高利 施恩西亞律師 艾維塔 佩爾曼律師 Sichenzia Ross Ference Carmel LLP 美洲大道1185號,31層,21世紀醫療改革法案樓層 紐約,NY10036 (212) 930-9700 |
亞當
紐曼 法律顧問 Beyond Air, Inc. 900 Stewart Avenue, Suite 301 紐約州長島花園城市11530 (516) 665-8200 |
擬議中的公開發售開始日期: 自本註冊聲明生效日期之後,不時進行。
如果此表格中唯一的註冊證券是根據股息或利息再投資計劃提供的,請勾選下面的框。☐
如果本表格中註冊的任何證券將根據1933年證券法規第415條規定,按延遲或連續方式除非僅作爲分紅或利息再投資計劃或類似目的的證券而發行,請勾選以下方框 ☒
如果此表格是根據《證券法》規定第462(b)條規定的註冊額外證券的表格,請勾選下面的框,並列出該名早期有效註冊聲明的《證券法》註冊聲明編號,以供同一發行使用。☐
如果此表格是根據《證券法》規定第462(c)條而提交的後期有效修改的表格,請勾選下面的框,並列出同一發行的早期有效證券法註冊聲明的《證券法》註冊聲明編號。☐
如果此表格是根據I.D.常規指導原則(General Instruction I.D.)或其後期修正而提交的註冊聲明,在提交給證券交易委員會時應根據《證券法》第462(e)條生效,請勾選下面的框。☐
如果此表格是根據I.D.常規指導原則(General Instruction I.D.)提交的後期有效修改的註冊聲明,並根據《證券法》第413(b)條提交以註冊其他證券或其他類證券的,請勾選下面的框。☐
在勾選標記處表示註冊人是大型加速提交人、加速提交人、非加速提交人、小型報告公司還是新興增長公司。請參閱證券交易法120億條規則中「大型加速提交人」、「加速提交人」、「小型報告公司」和「新興增長公司」的定義。
大型加速歸檔者 ☐ | 加速歸檔者 ☐ |
非加速歸檔者 ☒ | 小型報告公司 ☒ |
新興增長公司☐ |
如果是新興成長公司,請勾選方框,表明申報人已選擇不使用依據證券法第7(a)(2)(B)條規定提供的任何新的或修訂的財務會計準則的擴展過渡期進行合規。 ☐
在證券法1933年修正案第8(a)條的規定下,發行人特此修改本註冊聲明的生效日期,或在證券交易委員會根據該第8(a)條的規定確定的日期之前,提交一份進一步修改宣言,其中明確說明本註冊聲明在此後生效,或者本註冊聲明在證券交易委員會根據該第8(a)條採取行動確定的日期生效。
本初步招股說明書中包含的信息並不完整,可能會發生變化。在證券交易委員會提交的註冊聲明生效之前,列名的售股股東可能不會出售這些證券。本初步招股說明書並不是要出售這些證券的要約,也不是在任何不允許該要約或銷售的司法管轄區內徵求買入這些證券的要約。
待完成,日期爲2024年10月25日
初步招股說明書
81,697,422 普通股份
本招股說明書中所列的出售股東可能使用本招股說明書不時出售總計81,697,422股我們的普通股,每股面值$0.0001,包括(i) 24,999,999 股已發行並流通的普通股("普通股"),(ii) 15,848,712 股可通過預融資認股權行使而發行的普通股("預融資權證"),(iii) 40,848,711股可通過行使普通認股權而發行的普通股("普通認股權",與預融資權證合稱爲"認股權"),前述認股權由我們向參與於2024年9月26日簽訂的證券購買協議的出售股東定向增發。普通股和行使認股權獲得的普通股股份在此共稱爲"股份"。
根據本招股說明書,我們不出售任何普通股,並且不會收到任何出售股份的股東所得的款項。但是,我們將收到所有以現金行使的任何認購權的淨收益。
賣方股東可以以多種方式和不同價格出售或以其他方式處置股份。關於賣方股東如何出售或以其他方式處置本招股說明書所涵蓋的股份,我們在第12頁的「分銷計劃」部分提供了更多信息。與股份銷售相關的折扣、優惠、佣金和類似銷售費用將由賣方股東承擔。我們將支付所有與股份在美國證券交易委員會(「SEC」)登記相關的費用(除折扣、優惠、佣金和類似銷售費用外)。
我們的普通股在納斯達克資本市場上市,股票代碼爲「XAIR」。2024年10月24日,在納斯達克資本市場上,我們的普通股最後報價爲每股0.3949美元。
投資我們的證券涉及高風險。請參閱本招股說明書第4頁開始的「風險因素」,以及納入本招股說明書的參考文件中的類似標題。
美國證券交易委員會和任何州證券委員會均未覈准或不覈准這些證券,也未對本招股說明書的充分性或準確性作出評價。任何相反陳述均構成犯罪行爲。
本招股說明書日期爲2024年
目錄
i |
本說明書涉及在本說明書中標明為“售股股東”的售股股東,不時地,出售高達81,697,422股本公司普通股的權利。我們不在本說明書下出售任何股份,並且我們將不會從此處售出的普通股的銷售中得到任何收益,雖然我們可能從行使認股權獲得現金。
您應僅依賴本招股說明書中包含的資訊。我們及出售股票的股東未授權任何人提供您其他未經授權的資訊,除非是在本招股說明書中提供或參照的資訊,對於您依賴任何未經授權的資訊或陳述,風險由您自行承擔。本招股說明書僅可在許可進行這些證券的發行和銷售的司法轄區中使用。您應該假設出現在本招股說明書中的資訊僅截至本招股說明書的日期為止的時點屬實,而參照的任何資訊僅在參照文件的日期為止的時點屬實,不管本招股說明書的交付時期如何,或者我們證券的任何銷售。自那些日期以來,我們的業務、財務狀況和營運結果可能已經發生變化。
本招股說明書中所載資料、本招股說明書所引入的文件及任何授權在本發行中使用的自由書面招股說明書僅於其各自日期準確,無論其各自文件的交付時間或本招股說明書所涵蓋的證券銷售的情況如何。您不應假設本招股說明書所含或所引入的資料,或任何授權在本發行中使用的自由書面招股說明書,除各自日期外的任何日期是準確的。
另外,我們進一步指出,在包含在此所引用的任何文件中的任何協議的展示檔中,我們所作的任何陳述、保證和契約僅為該等協議各方當事人的利益而作,包括在某些情況下,為了在該等協議各方當事人之間分配風險的目的,不應被視為對您的陳述、保證或契約。而且,這些陳述、保證或契約只在其作出的日期準確。因此,不應依賴這些陳述、保證和契約來準確代表我們目前的狀況。
在本招股说明书中的信息与在本招股说明书发行日之前与美国证券交易委员会(SEC)提出的任何作为参照文件的文件中包含的信息之间存在冲突的情况下,您应该依赖本招股说明书中的信息。如果参照文件中的陈述与另一个参照文件中的陈述相冲突且有较迟日期的话,具有较迟日期的文件的陈述将修改或取代较早日期的陈述。
我們和賣方股東均未採取任何行動,可以使得這份招股說明書在任何規定需要針對此目的的司法管轄區進行發行、持有或分發,在美國以外的其他司法管轄區。在美國以外的司法管轄區取得這份招股說明書及任何自由書面招股說明書的人士,必須自行了解並遵守該司法管轄區對於本次發行、招股說明書及任何自由書面招股說明書之配額的任何限制。
行業板塊 及市場數據
本招股書及參考文件中包含有關我們行業板塊、業務、LungFit產品候選品的估計、預測、市場研究和其他信息® PH和我們的產品候選品,及這些市場的規模,特定醫療條件的患病率,LungFit PH市場訪問、處方數據以及其他醫師、患者和支付者數據。 除非另有明確聲明,我們獲得這些信息的來源包括市場研究機構和其他第三方、行業、醫療和一般出版物、政府數據以及我們的內部估計和研究,以及第三方代表我們進行的出版物、研究、調查和研究。基於估計、預測、市場研究或類似方法的信息 inherently 受到不確定性的影響,實際事件或情況可能與本信息所反映的事件和情況存在實質差異。因此,我們提醒您切勿過分重視此類信息。® 此類信息除非另有明確聲明,否則我們從市場研究機構和其他第三方、行業、醫療和一般出版物、政府數據以及類似來源獲得,同時也從我們自身的內部估計和研究以及第三方代表我們進行的出版物、研究、調查和研究中獲得。基於估計、預測、市場研究或類似方法的信息 inherently 受到不確定性的影響,實際事件或情況可能與本信息所反映的事件和情況存在實質差異。因此,我們提醒您切勿過分重視此類信息。
備註 有關商標
beyond air™, beyond air 商標和其他 beyond air, inc. 在本說明書中出現的商標或服務標誌是 beyond air, inc. 的財產。本說明書中提到的所有其他商標、服務標記或商標名稱是其各自擁有者的財產。僅僅出於方便起見,本說明書中的商標和商標名稱有時會被引用時沒有 ® 和 ™ 符號,但這些參考並不意味著我們不會在適用法律的最大程度下主張我們的權利,或者該適用擁有者不會主張其對這些商標和商標名稱的權利。我們不打算使用或顯示其他公司的商標和貿易名稱以暗示我們與其他公司、產品或服務之間存在關係,或得到其他公司對我們的認可或贊助。
ii |
本摘要突顯了本招股證書中其他地方詳細內容中包含的信息。本摘要並不完整,並且未包含所有您在做出投資決定時應考慮的信息。在投資我們的證券之前,您應詳細閱讀整份招股書。您應仔細考慮,其中包括我們的基本報表及相關附註,以及“風險因素”和“財務狀況、經營情況討論和營運結果分析”一節,該一節包含在本招股證書中其他地方或者通過參考收錄在本招股證書中。
當我們提及 beyond air 及其子公司時,我們使用“beyond air”、“公司”、“我們”和“我們的”這些術語。
概覽
我們是一家商業階段的醫療器械和生物製藥公司,開發了一系列一氧化氮(NO)發生器和遞送系統(“LungFit®平台”),能夠從環境空氣中生成NO。我們的第一款器械,LungFit® PH,在2022年6月獲得了美國食品和藥物管理局(FDA)的預市批准(PMA)。LungFit® PH系統生成的NO被指示用於改善氧合和減少需額外使用體外膜氧合的失氧性呼吸衰竭的足月和近足月(>34周懷孕)新生兒,其具有與呼吸支持和其他適當藥劑相結合的臨床或超聲心動圖證據相關的肺動脈高壓。這種狀況通常被稱為新生兒持續性肺動脈高壓(PPHN)。LungFit®平台可將NO生成量提升至每百萬部份(“ppm”)400,並將其直接遞送至患者的肺部,或透過呼吸機進行遞送。LungFit®可以連續或在不同流速下固定時間內遞送NO,並具有根據需求調整劑量或保持固定劑量的能力。我們於2022年7月開始在美國作為醫療器械推廣LungFit® PH,用於PPHN。
LungFit®可以用於治療需要NO的呼吸器患者,以及患有慢性或急性嚴重肺部感染的患者,通過呼吸面罩或相似裝置進行傳遞。此外,我們認為對於某些嚴重肺部感染患者存在著醫療上的高度未滿足需求,LungFit®平台可能可以應對。我們目前專注於LungFit®在PPHN、病毒性社區獲得性肺炎(VCAP)包括COVID-19、支氣管炎(BRO)、非結核分枝桿菌(NTM)肺部感染以及患有各種基於慢性阻塞性肺病(COPD)的嚴重肺部感染的患者。我們目前的產品候選者將需接受FDA的市前審查和批准,通過歐盟的機構進行合格評估以取得CE標記認證,以及通過可比的外國監管機構進行審核。
隨著愛文思控股專注於NO及其對人類狀況的影響,還有兩個不使用我們的LungFit®系統的額外計劃。透過我們的控股聯營子公司Beyond Cancer, Ltd.(“Beyond Cancer”),NO被用於針對實體腫瘤。LungFit®平台不會用於實體腫瘤指示,因為需要使用超高濃度的氣態一氧化氮(“UNO”)。已經開發出一種專有的交付系統,旨在安全地將UNO超過10,000 ppm直接傳遞到實體腫瘤。該計劃已經進展到第1期臨床試驗。
於2021年11月4日,我們將腫瘤業務進行了重組,成立了一家名為Beyond Cancer的新私營公司。我們的臨床前腫瘤團隊以及利用UNO治療固形腫瘤的知識產權權利現在歸屬於Beyond Cancer。Beyond Air擁有Beyond Cancer 80%的所有權。
第二個程序不利用 LungFit® 平台,部分抑制大腦中的神經元氧化氮合酶(nNOS) 治療神經系統疾病。第一個目標跡象是自閉症譜障礙(」阿斯德」)。自閉症是嚴重的 神經發展和行為障礙,也是兒童最殘疾的疾病和慢性疾病之一。自閉症包括 由社交互動異常表現出現的神經行為缺陷核心的廣泛發展障礙, 溝通缺陷,興趣受限和重複行為。2023 年,CDC 報告稱,大約每 36 名兒童中有 1 名 在美國被診斷出患有自閉症。2015 年,照顧自閉症患者的美國人的成本已達到 268 億美元,並將增加到 在整個生命週期沒有更有效的干預和支持的情況下,到 2025 年為止,則為 4.61 億美元。我們期望這個計劃會進行 從臨床前試驗到 2025 年的第一期人類臨床試驗。超越航空已成立一家全資子公司名為 NeuronOS 有限公司(愛爾蘭)負責臨床前和臨床開發。
1 |
龍健® PH 是第一個 FDA 認可的系統,採用我們專利的等離子脈衝技術,從環境空氣中產生隨需的 NO,無論如何 用量或流量,將其交付到呼吸器電路。該設備使用醫療空氣壓縮機來驅動室內空氣通過等離子室 在單元的中心,在兩個電極之間產生放電脈衝。系統使用等效功率 到一個 60 瓦的燈泡以離子化氮和氧分子,然後將其結合為 NO 和低水平的二氧化氮(」第二號」) 作為副產品創建。然後將產品通過智能過濾器,從內部電路中去除有毒的 NO2。與 對於 PPHN 而言,新型 LungFit® PH 的設計旨在將 NO 劑量輸送到肺部,符合當前指導方針。 用於通風患者輸送 20 ppm NO,範圍為 0.5 ppm — 80 ppm(低濃度 NO)。
我們相信LungFit® PH從環境空氣中生成NO的能力為我們提供了許多競爭優勢,勝過目前在美國、歐盟、日本和其他市場使用的NO傳遞系統。例如,LungFit® PH不需要使用高壓氣瓶,不需要繁瑣的清洗程序,並且減輕了醫院工作人員執行安全程序的負擔。
我們的新型LungFit®平台也可以將高濃度(>150 ppm)的NO直接遞送到肺部,我們相信這有可能消除微生物感染,包括細菌、真菌和病毒等。我們認為目前FDA批准的NO擴血管治療在治療微生物感染方面可能成功有限,因為NO的濃度低(<100 ppm)。鑑於NO是身體自然產生的固有免疫機制,補充高劑量的NO應該有助於身體抗感染。根據我們的臨床前研究和臨床試驗,我們認為150 ppm是實現所需肺部抗微生物效果的最低治療劑量。迄今為止,無論是FDA還是其他國家或地區可比的外國監管機構都尚未批准任何>80 ppm的NO配方和/或遞送系統。
近期 發展情況
截至2024年10月4日,公司通過支付500萬美元一次性付清與Avenue Capital Management II, L.P.、Avenue Venture Opportunities Fund, L.P. 和 Avenue Venture Opportunities Fund II, L.P.(以下簡稱「Avenue」)的貸款和安防協議,同意在2024年9月30日消除債務,並在2024年10月4日完成後支付1285萬美元的最後一筆款項。該協議消除了從2024年10月1日到2026年6月30日應支付給Avenue的1200萬美元的債務和利息支付。
艾文投資了335萬美元的證券,根據購買協議的條款和條件,與所有投資者和所有基金類型一樣,這些資金於2024年9月27日收到。
企業 信息
我們於2015年4月28日根據特拉華州法律成立。於2019年6月25日,我們的名稱從AIt Therapeutics,Inc.更改為Beyond Air, Inc. 我們的主要行政辦公室位於紐約州加登市史都華大道900號301室,電話號碼為(516) 665-8200。 我們的網站地址為www.beyondair.net。 我們不將網站上或通過網站可訪問的信息納入本招股說明書中,您不應將我們網站上或通過網站可訪問的任何信息視為本招股說明書的一部分。
2 |
Common Stock to be offered by the selling stockholders | Up to 24,999,999 shares of common stock, 15,848,712 shares of common stock issuable upon exercise of Pre-funded Warrants and 40,848,711 shares of common stock issuable upon Common Warrants. | |
Terms of the Offering: | The selling stockholders will determine when and how it will sell the shares of common stock offered in this prospectus, as described in “Plan of Distribution.” | |
Common Stock outstanding prior to this offering | 47,187,636 shares of common stock as of October 23, 2024 | |
Use of proceeds | We will not receive any proceeds from the sale of shares of common stock offered hereby by the selling stockholders, although we may receive cash from the exercise of the Warrants. | |
Risk Factors | An investment in our securities involves a high degree of risk. See “Risk Factors” beginning on page 4 of this prospectus and the similarly titled sections in the documents incorporated by reference into this prospectus. | |
Nasdaq Capital Market symbol | Our common stock is listed on the Nasdaq Capital Market under the symbol “XAIR.” We do not intend to apply for listing of the Warrants on any securities exchange or nationally recognized trading system. |
3 |
An investment in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should carefully consider the risks discussed under the section captioned “Risk Factors” contained in our Annual Report on Form 10-K for the fiscal year ended March 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and other documents that we file with the SEC, which are incorporated by reference in this prospectus, together with the information included in this prospectus and documents incorporated by reference herein, and in any free writing prospectus that we have authorized for use in connection with this offering. If any of these risks actually occurs, our business, financial condition, results of operations or cash flow could be harmed. In such case, the trading price of our common stock could decline, and our shareholders may lose all or part of their investment in the shares of our common stock. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business. In addition to the other information contained in this prospectus, including the reports we incorporate by reference, you should consider the following factor before investing in our securities.
We are currently not in compliance with the continued listing standards of the Nasdaq Capital Market, and if we are unable to regain compliance, our common stock will be delisted from the exchange.
Our common stock is currently listed for trading on the Nasdaq Capital Market under the symbol “XAIR”. The continued listing of our common stock on Nasdaq is subject to our compliance with a number of listing standards. On August 8, 2024, we received a letter from the Listing Qualifications Staff of Nasdaq (the “Staff”) notifying the Company that for the last 30 consecutive business days, the bid price of the Company’s common stock had been below the minimum closing bid price of $1.00 per share, required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). In June 2024, our shares began trading below $1.00, and the trading price of our shares has not yet risen above that price for a minimum of ten consecutive business days, as required by the listing standards to regain compliance.
The notification letter has no immediate effect on the Company’s listing on the Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 days, or until February 4, 2025 (the “Compliance Date”) to regain compliance with the minimum bid price requirement. There can be no assurance that we will be able to regain compliance with these requirements or that our common stock will continue to be listed on Nasdaq. If we are unable to regain compliance by the Compliance Date, we may be eligible for consideration of a second 180-day compliance period. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market with the exception of the minimum bid price requirement and provide Nasdaq with written notice of our intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company does not meet the other listing standards, Nasdaq could provide notice that the Company’s common stock will become subject to delisting. There can be no assurance that, if we were to effect a reverse stock split after obtaining the required approvals and intending to regain compliance, the reverse stock split would cause our common stock to meet the bid price requirement. If the Company fails to regain compliance with the Nasdaq continued listing standards, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. At that time, the Company may appeal the delisting determination to a Hearings Panel.
Such a delisting or even notification of failure to comply with such requirements would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In addition, the delisting of our common stock could lead to a number of other negative implications such as a loss of media and analyst coverage, a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and likely result in a reduced level of trading activity in the secondary trading market for our securities, and materially adversely impact our ability to raise capital on acceptable terms or at all. Delisting from Nasdaq could also have other negative results, including the potential loss of confidence by our current or prospective third-party providers and collaboration partners, the loss of institutional investor interest, and fewer licensing and partnering opportunities. In the event of a delisting, we expect to take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
4 |
If our common stock were no longer listed on Nasdaq, investors might only be able to trade on one of the over-the-counter markets. There is no assurance, however, that prices for our common stock would be quoted on one of these other trading systems or that an active trading market for our common stock would exist, which would materially and adversely impact the market value of our common stock and your ability to sell our common stock.
The sale of a substantial amount of our common stock, including resale of the shares of common stock held by the selling stockholders in the public market, could adversely affect the prevailing market price of our common stock.
This prospectus covers the resale of 81,697,422 shares of our common stock held by the selling stockholders. Sales of substantial amounts of our common stock in the public market, or the perception that such sales might occur, could adversely affect the market price of our common stock. We cannot predict if and when selling stockholders may sell such shares in the public market.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference herein contain forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this prospectus, any prospectus supplement or the documents incorporated herein and therein by reference, including statements regarding our future results of operations and financial position, business strategy, approved product and product candidates, certifications or approvals, timing of our clinical development activities, research and development costs, our commercialization plans and the expected timing thereof, timing and likelihood of success, and the plans and objectives of management for future operations and future results of anticipated products are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements express or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “expect,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar conditional expressions. The forward-looking statements in this prospectus or the documents incorporated herein by reference are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this prospectus and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described under Item 1A “Risk Factors” contained in our most recently filed Annual Report on Form 10-K, as well as the following:
● | our ability to successfully commercialize our LungFit® PH system in the U.S.; |
5 |
● | our ability to obtain a CE Certificate of Conformity to CE mark LungFit® in the European Union; |
● | our expectation to incur losses for the next few years; |
● | our ability to predict accurately the demand for our products, and products under development and to develop strategies to address markets successfully; |
● | the possibility that products may contain undetected errors or defects or otherwise not perform as anticipated; |
● | the anticipated development of markets we sell our products into and the success of our products in these markets; |
● | our future capital needs and our need to raise additional funds; |
● | our ability to build a pipeline of product candidates and develop and commercialize our approved products; |
● | our ability to enroll patients in clinical trials, timely and successfully complete those trials and receive necessary certifications or regulatory approvals; |
● | our ability to maintain our existing or future collaborations or licenses; |
● | our ability to protect and enforce our intellectual property rights; |
● | federal, state, and foreign regulatory requirements, including the FDA regulation of our approved product and product candidates; |
● | our ability to remain listed on Nasdaq; |
● | our ability to obtain and retain key executives and attract and retain qualified personnel; and |
● | our ability to successfully manage our growth, including as a commercial-stage company. |
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. The risks set forth under Item 1A of our Annual Report on Form 10-K for the fiscal year ended March 31, 2024, as revised or supplemented by our Quarterly Reports on Form 10-Q and other documents we file with the SEC, describe major risks to our business, and you should read and interpret any forward-looking statements together with these risks. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements.
You should read this prospectus and the documents that we incorporate by reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
The net proceeds from any disposition of the Shares will be received by the selling stockholders. We will not receive any of the proceeds from any such Shares offered by this prospectus. We will, however, receive the net proceeds of any Warrants exercised for cash. We expect to use the proceeds received from the exercise of the Warrants, if any, for the general working capital purposes.
6 |
We have never declared or paid cash dividends on our common stock. Moreover, we do not anticipate paying periodic cash dividends on our common stock for the foreseeable future. We currently intend to retain all available funds and any future earnings to support our operations and finance the growth and development of our business. Any future determination about the payment of dividends will be made at the discretion of our board of directors and will depend upon our earnings, if any, capital requirements, operating and financial conditions and on such other factors as our board of directors deems relevant.
PRIVATE PLACEMENT OF SHARES OF STOCK, PRE-FUNDED WARRANTS AND COMMON WARRANTS
On September 26, 2024, we entered into the Purchase Agreement with certain accredited investors for a private placement offering, or the Private Placement, of the Company’s common stock, Pre-funded Warrants and Common Warrants. Pursuant to the Purchase Agreement, we sold (i) 24,999,999 common shares together with Common Warrants to purchase up to 24,999,999 shares of common stock, and (ii) 15,848,712 Pre-funded Warrants with each Pre-funded Warrant exercisable for one share of common stock, together with Common Warrants to purchase up to 15,848,712 shares of common stock. Each common share and accompanying Common Warrant were sold together at a combined offering price of $0.5043, and each Pre-funded Warrant and accompanying Common Warrant were sold together at a combined offering price of $0.5042 for gross proceeds to the Company of approximately $20,600,000. The Pre-funded Warrants have an exercise price of $0.0001 per share, and the Common Warrants have an exercise price of $0.38 per share. The Private Placement closed on September 30, 2024 (the “Closing Date”).
Pursuant to the Purchase Agreement, the Company has agreed to use its best efforts to convene an annual or special meeting of its stockholders within 180 days following the Closing Date. At the meeting, the Company’s board of directors will recommend stockholders approve: (i) increasing the number of authorized shares of Common Stock to ensure the availability of sufficient shares for the full issuance of shares of Common Stock issuable upon exercise of the outstanding Warrants (the “Authorized Share Proposal”) and (ii) allowing for the exercise price of the Common Warrants to be adjusted in accordance with the terms of the Common Warrants pursuant to the rules and regulations of the Nasdaq Stock Market (the “Warrant Proposal”). The Company will actively solicit proxies from stockholders in support of these proposals, and management-appointed proxyholders will vote their proxies in favor of the proposals. If stockholder approval is not obtained at the initial meeting, the Company will continue to use its best efforts to hold additional meetings every 180 days thereafter to seek stockholders’ approval, until either the approval is obtained or the Common Warrants are no longer outstanding.
The Pre-funded Warrants are exercisable on or after the date on which the Company obtains stockholder approval of the Authorized Share Proposal (the “Initial Exercise Date”) and shall expire when exercised in full. The Common Warrants are exercisable on or after the Initial Exercise Date and will have a term that expires five years following the Initial Exercise Date. Both the Pre-funded Warrants and Common Warrants are exercisable on a cashless basis in the event that, at the time of exercise, there is not an effective registration statement for the resale of the shares underlying the Pre-funded Warrants or Common Warrants, as applicable. The respective Pre-funded Warrants or Common Warrants may not be exercised to the extent such exercise would cause the holder to beneficially own more than 4.99% or 9.99% of the Company’s issued and outstanding common stock. The exercise price of the Warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events and also upon any distributions of assets, including cash, stock or other property to our stockholders. Subject to certain exemptions outlined in the Common Warrant, if at any time while the Common Warrants are outstanding, the Company issues or sells, or is deemed to have issued or sold, shares of Common Stock at an effective price per share less than the exercise price of the Common Warrants then in effect, the exercise price of the Common Warrant shall be reduced in accordance with a weighted average formula. The Common Warrant provides that if the Warrant Proposal has not been approved by 180 days after the Closing Date, the Company will be obligated to pay liquidated damages to the holders.
7 |
In connection with the Purchase Agreement, we entered into a registration rights agreement, or the Registration Rights Agreement, with the investors. Pursuant to the Registration Rights Agreement, we are required to file a resale registration statement, or the Registration Statement, with the SEC to register for resale the common shares and shares issuable upon exercise of the Warrants by October 26, 2024, and to have such Registration Statement declared effective. We will be obligated to pay certain liquidated damages to the investors if we fail to file the resale registration statement when required, fail to cause the Registration Statement to be declared effective by the SEC when required, or if we fail to maintain the effectiveness of the Registration Statement. The Company is filing this registration statement in satisfaction of its obligation to file a registration statement under the Registration Rights Agreement.
The common stock being offered by the selling stockholders, or the Shares, are those common shares issued to the selling stockholders in the Private Placement and the shares of common stock issuable to the selling stockholders upon exercise of the Warrants issued in the Private Placement. We are registering the Shares in order to permit the selling stockholders to offer the Shares for resale from time to time. The selling stockholders may sell all, some or none of their Shares in this offering. See “Plan of Distribution”.
Except as set forth in the footnotes below, neither the selling stockholders, nor any persons having control over the selling stockholders, have held any position or office with us or our affiliates within the last three years or have had a material relationship with us or any of our predecessors or affiliates within the past three years. We currently have no agreements, arrangements or understandings with the selling stockholders regarding the sale of any of the Shares.
The table below lists the selling stockholders and other information regarding the beneficial ownership of the shares of common stock by each of the selling stockholders. The second column lists the number of shares of common stock beneficially owned by each selling stockholder, based on its ownership of the shares of common stock and warrants, as of October 23, 2024, assuming exercise of the Warrants held by the selling stockholders on that date, without regard to any limitations on exercises. Except as noted herein, beneficial ownership is determined in accordance with Section 13(d) of the Exchange Act and Rule 13d-3 thereunder. The third column lists the Shares being offered by this prospectus by each selling stockholder. The fourth column assumes the sale of all of the Shares offered by the selling stockholders pursuant to this prospectus.
8 |
The percentage of shares beneficially owned prior to the offering is based on 72,187,636 shares of our common stock actually outstanding as of October 23, 2024.
Name of Selling Stockholder | Shares Beneficially Owned Before this Offering | Shares to be Sold in this Offering |
Shares | Percentage of Outstanding Shares Beneficially Owned After this Offering | ||||||||||||
Alyeska Master Fund, L.P. | 29,744,200 | (1) | 29,744,200 | - | * | |||||||||||
Avenue Venture Opportunities Fund, L.P. | 5,447,835 | (2) | 5,314,298 | 133,537 | * | |||||||||||
Avenue Venture Opportunities Fund II, L.P. | 8,171,752 | (3) | 7,971,446 | 200,306 | * | |||||||||||
Atlas Diversified Master Fund, Ltd. | 11,897,680 | (4) | 11,897,680 | - | * | |||||||||||
YA II PN, Ltd. | 8,923,260 | (5) | 8,923,260 | - | * | |||||||||||
Steven Lisi | 10,322,537 | (6) | 3,965,894 | 6,356,643 | 4.0 | % | ||||||||||
Robert F. Carey | 17,626,551 | (7) | 3,965,894 | 13,660,657 | 8.3 | % | ||||||||||
Quantum Partners LP | 3,965,902 | (8) | 3,965,902 | - | * | |||||||||||
Ellen-Maria Gorrissen Trust II U/A Dated June 3, 1993 | 1,982,946 | (9) | 1,982,946 | - | * | |||||||||||
AIGH Investment Partners, LP | 6,304,348 | (10) | 1,470,386 | 4,833,962 | 3.8 | % | ||||||||||
WVP Emerging Manager Onshore Fund, LLC – AIGH Series | 1,676,293 | (11) | 398,700 | 1,277,593 | * | |||||||||||
WVP Emerging Manager Onshore Fund, LLC – Optimized Equity Series | 481,447 | (12) | 113,866 | 367,866 | * | |||||||||||
Alice W Lytton Family LLC | 1,550,598 | (13) | 991,476 | 559,122 | * | |||||||||||
M. Kingdon Offshore Master Fund, LP | 1,459,852 | (14) | 892,326 | 567,526 | * | |||||||||||
Kingdon Healthcare Master Fund, LP | 99,148 | (15) | 99,148 | - | * |
* Less than 1%.
(1) | Consists of (i) 7,144,899 shares of common stock issued in the Private Placement, (ii) 7,727,201 shares of common stock underlying Pre-Funded Warrants, and (iii) 14,872,100 shares of common stock underlying Common Warrants. Alyeska Investment Group, L.P., the investment manager of Alyeska Master Fund, L.P. (the “Selling Securityholder”), has voting and investment control of the shares held by the Selling Securityholder. Anand Parekh is the Chief Executive Officer of Alyeska Investment Group, L.P. and may be deemed to be the beneficial owner of such shares. Mr. Parekh, however, disclaims any beneficial ownership of the shares held by the Selling Securityholder. The registered address of Alyeska Master Fund, L.P. is at c/o Maples Corporate Services Limited, P.O. Box 309, Ugland House, South Church Street George Town, Grand Cayman, KY1-1104, Cayman Islands. Alyeska Investment Group, L.P. is located at 77 W. Wacker, Suite 700, Chicago IL 60601. |
9 |
(2) | Consists of (i) 1,978,679 shares of common stock issued in the Private Placement, (ii) 678,470 shares of common stock underlying Pre-Funded Warrants, (iii) 2,657,149 shares of common stock underlying Common Warrants, (iv) 93,537 shares of common stock issuable upon exercise of June 2023 warrants, and (v) 40,000 shares of common stock issuable upon exercise of June 2024 warrants. Avenue Venture Opportunities Fund, L.P. is a Delaware limited partnership. Marc Lasry is the managing member of Avenue Venture Opportunities Fund, L.P. Mr. Lasry may be deemed to be the indirect beneficial owner of the securities reported by reason of his ability to direct the vote and/or disposition of such securities. The address of Avenue Venture Opportunities Fund, L.P. and its affiliates, is 11 West 42nd Street, 9th Floor, New York, New York 10036. |
(3) | Consists of (i) 2,968,018 shares of common stock issued in the Private Placement, (ii) 1,017,705 shares of common stock underlying Pre-Funded Warrants, (iii) 3,985,723 shares of common stock underlying Common Warrants, (iv) 140,306 shares of common stock issuable upon exercise of June 2023 warrants, and (v) 60,000 shares of common stock issuable upon exercise of June 2024 warrants. Avenue Venture Opportunities Fund II, L.P. is a Delaware limited partnership. Marc Lasry is the managing member of Avenue Venture Opportunities Fund II, L.P. Mr. Lasry may be deemed to be the indirect beneficial owner of the securities reported by reason of his ability to direct the vote and/or disposition of such securities. The address of Avenue Venture Opportunities Fund II, L.P., and its affiliates, is 11 West 42nd Street, 9th Floor, New York, New York 10036. |
(4) | Consists of (i) 2,941,176 shares of common stock issued in the Private Placement, (ii) 3,007,664 shares of common stock underlying Pre-Funded Warrants and (iii) 5,948,840 shares of common stock underlying Common Warrants. Balyasny Asset Management L.P. (“BAM”) serves as investment advisor to Atlas Diversified Master Fund, Ltd. (“ADMF”). Dmitry Balyasny indirectly controls the general partner of BAM and shall be deemed o have sole voting and dispositive power over all of the shares. The business address of ADMF is c/o Maples Corporate Services Limited, P.O. Box 309, Ugland House, Grand Cayman KY1- 1104, Cayman Islands, and the business address of BAM and Mr. Balyasny is 444 West Lake Street, 50th Floor, Chicago, IL 60606. |
(5) | Consists of (i) 3,322,409 shares of common stock issued in the Private Placement, (ii) 1,139,221 shares of common stock underlying Pre-Funded Warrants and (iii) 4,461,630 shares of common stock underlying Common Warrants. Yorkville Advisors Global, LP is the Investment Manager to YA II PN, Ltd. Mark Angelo is the control person of Yorkville Advisors Global, LP. Investment decisions for YA II PN, Ltd. are made by Mark Angelo, and Mr. Angelo may therefore be deemed to hold voting and dispositive power with respect to such shares. The business address of YA II PN, Ltd. is 1012 Springfield Ave, Mountainside, NJ 07092. |
(6) | Consists of (i) 1,476,626 shares of common stock issued in the Private Placement, (ii) 506,321 shares of common stock underlying Pre-Funded Warrants, (iii) 1,982,947 shares of common stock underlying Common Warrants, (iv) 1,210,000 vested options to purchase shares of common stock, (v) 3,373,858 shares of common stock issuable upon exercise of the warrants, and (vi) 1,772,785 shares acquired directly through open market transactions or private placements prior to September 2024. Mr. Lisi is the Chairman and Chief Executive Officer of the Company. The business address of Mr. Lisi is 900 Stewart Avene, Suite 301, Garden City, New York, NY 11530. |
(7) | Consists of (i) 1,476,626 shares of common stock issued in the Private Placement, (ii) 506,321 shares of common stock underlying Pre-Funded Warrants, (iii) 1,982,947 shares of common stock underlying Common Warrants, (iv) 94,750 vested options to purchase shares of common stock, (v) 602,410 shares of common stock issuable upon exercise of the warrants from the March 2024 Securities Purchase Agreement, (vi) 9,886,633 shares of common stock issuable upon exercise of the warrants from the loan to the Company on September 27, 2024, and (vii) 3,076,864 shares acquired directly through open market transactions or private placements prior to September 2024. Mr. Carey is a Director of the Company. The business address of Mr. Carey is 900 Stewart Avene, Suite 301, Garden City, New York, NY 11530. |
10 |
(8) | Consists of (i) 1,476,626 shares of common stock issued in the Private Placement, (ii) 506,325 shares of common stock underlying Pre-Funded Warrants and (iii) 1,982,951 shares of common stock underlying Common Warrants. The shares listed herein are held for the account of Quantum Partners LP, a Cayman Islands exempted limited partnership (“Quantum Partners”). Soros Fund Management LLC (“SFM LLC”) serves as principal investment manager to Quantum Partners. As such, SFM LLC has been granted investment discretion over portfolio investments, including the shares, held for the account of Quantum Partners. George Soros serves as Chairman of SFM LLC and has sole discretion to replace FPR Manager LLC, the manager of SFM LLC. The address for Quantum Partners is c/o Soros Fund Management LLC, 250 W 55th Street, New York, NY 10019. |
(9) | Consists of (i) 738,313 shares of common stock issued in the Private Placement, (ii) 253,160 shares of common stock underlying Pre-Funded Warrants and (iii) 991,473 shares of common stock underlying Common Warrants. As Trustee of Ellen-Maria Gorrissen Trust II U/A Dated June 3, 1993, Michael M. Kellen, may be deemed to be the beneficial owner of the securities held by Ellen-Maria Gorrissen Trust II U/A Dated June 3, 1993. The address of Ellen-Maria Gorrissen Trust II U/A Dated June 3, 1993 is c/o Michael Kellen, 1345 Avenue of the Americas, 4th Floor, New York, NY 10105-4700. |
(10) | Consists of (i) 482,030 shares of common stock issued in the Private Placement, (ii) 253,163 shares of common stock underlying Pre-Funded Warrants, (iii) 735,193 shares of common stock underlying Common Warrants, (iv) 2,117,388 shares of common stock, and (v) 2,716,574 shares of common stock issuable upon exercise of warrants. Mr. Orin Hirschman is the managing member of AIGH Capital Management, LLC, a Maryland limited liability company (“AIGH CM”), who is an advisor with respect to the securities held by AIGH Investment Partners, L.P. (“AIGH LP”). Mr. Hirschman has voting and investment control over the securities indirectly held by AIGH CM, directly held by AIGH LP and directly held by Mr. Hirschman and his family. The address for AIGH CM, AIGH LP and Mr. Hirschman is 6006 Berkeley Avenue, Baltimore, MD 21209. |
(11) | Consists of (i) 199,350 shares of common stock issued in the Private Placement, (ii) 199,350 shares of common stock underlying Common Warrants, (iii) 580,797 shares of common stock, and (iv) 696,796 shares of common stock issuable upon exercise of warrants. Mr. Orin Hirschman is the managing member of AIGH Capital Management, LLC, a Maryland limited liability company (“AIGH CM”), who is a sub-advisor with respect to the securities held by WVP Emerging Manager Onshore Fund, LLC - AIGH Series. Mr. Hirschman has voting and investment control over the securities indirectly held by AIGH CM and directly held by Mr. Hirschman and his family directly. The address for AIGH CM and Mr. Hirschman is 6006 Berkeley Avenue, Baltimore, MD 21209 |
(12) | Consists of (i) 56,933 shares of common stock issued in the Private Placement, (ii) 56,933 shares of common stock underlying Common Warrant, (iii) 166,493 shares of common stock, and (iv) 201,088 shares of common stock issuable upon exercise of warrants. Mr. Orin Hirschman is the managing member of AIGH CM, who is a sub-advisor with respect to the securities held by WVP Emerging Manager Onshore Fund, LLC - Optimized Equity Series. Mr. Hirschman has voting and investment control over the securities indirectly held by AIGH CM and directly held by Mr. Hirschman and his family directly. The address for AIGH CM and Mr. Hirschman is 6006 Berkeley Avenue, Baltimore, MD 21209. |
(13) | Consists of (i) 369,157 shares of common stock issued in the Private Placement, (ii) 126,581 shares of common stock underlying Pre-Funded Warrants, (iii) 495,738 shares of common stock underlying Common Warrants, (iv) 257,917 shares of common stock, and (v) 301,205 shares of common stock issuable upon exercise of warrants. The controlling person of Alice W Lytton Family LLC is Laurence Lytton, who may be deemed to be the beneficial owner of the securities held by Alice W Lytton Family LLC. The address of Alice W Lytton Family LLC is 467 Central Park West, 17A, New York, NY 10025. |
(14) | Consists of (i) 332,241 shares of common stock issued in the Private Placement, (ii) 113,922 shares of common stock underlying Pre-Funded Warrants, (iii) 446,163 shares of common stock underlying Common Warrants, and (iv) 567,526 shares of common stock. Mark Kingdon, as the managing member of Kingdon GP, LLC, which is the general partner of M. Kingdon Offshore Master Fund, LP has voting or investment control over the securities held by M. Kingdon Offshore Master Fund, LP. The address of M. Kingdon Offshore Master Fund, LP is c/o Kingdon Capital Management, LLC, 152 W. 57th Street, 50th Floor, New York, NY 10019. |
(15) | Consists of (i) 36,916 shares of common stock issued in the Private Placement, (ii) 12,658 shares of common stock underlying Pre-Funded Warrants and (iii) 49,574 shares of common stock underlying Common Warrants. Mark Kingdon, as the managing member of Kingdon GP II, LLC, which is the general partner of Kingdon Healthcare Master Fund, LP, has voting or investment control over the securities held by Kingdon Healthcare Master Fund, LP. The address of Kingdon Healthcare Master Fund, LP is c/o Kingdon Capital Management, LLC, 152 W. 57th Street, 50th Floor, New York, NY 10019.. |
11 |
Each selling stockholder of the Shares and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their respective securities covered hereby on markets or exchanges on which the Shares are listed or quoted for trading on the date in question, or in private transactions. These sales may be at fixed or negotiated prices. A selling stockholder may use any one or more of the following methods when selling securities:
● | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; | |
● | block trades in which the broker-dealer will attempt to sell the Shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; | |
● | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; | |
● | an exchange distribution in accordance with the rules of the applicable exchange; | |
● | privately negotiated transactions; | |
● | in transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such securities at a stipulated price per security; | |
● | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; | |
● | settlement of short trades entered into after the date of this prospectus; | |
● | by pledge to secure debts and other obligations; | |
● | a combination of any such methods of sale; or | |
● | any other method permitted pursuant to applicable law. |
A selling stockholder may also sell securities under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus.
Broker-dealers engaged by a selling stockholder may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from a selling stockholder (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.
A selling stockholder may enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
A selling stockholder and any broker-dealers or agents that are involved in selling the Shares may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the Shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each selling stockholder has informed us that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the Shares.
We are required to pay certain fees and expenses incurred by us incident to the registration of the Shares. We have agreed to indemnify any selling stockholder against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
We agreed to keep this prospectus effective until the earlier of (i) the date on which the Shares may be resold by the selling stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for us to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the Shares have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws.
Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the selling stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by a selling stockholder or any other person. We will make copies of this prospectus available to a selling stockholder and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with and reliance on Rule 172 under the Securities Act).
12 |
The following summary of the terms of our common stock is subject to and qualified in its entirety by reference to our certificate of incorporation and bylaws, copies of which are on file with the SEC as exhibits to previous filings with the SEC. Please refer to “Where You Can Find More Information” below for directions on obtaining these documents.
Our certificate of incorporation authorizes us to issue up to 110,000,000 shares, 100,000,000 of which is designated as common stock with a par value of $0.0001 per share. As of October 23, 2024, there were 72,187,636 shares of common stock outstanding, held by 115 stockholders of record. This figure does not reflect the number of beneficial owners of shares of our common stock as a single stockholder of record often holds shares in nominee name (also referred to as, in “street name”) on behalf of multiple beneficial owners.
Voting Rights
Holders of shares of our common stock are entitled to one vote for each share held of record on all matters to be voted on by stockholders, including the election of directors. When a quorum is present at any meeting, a plurality of the votes properly cast for election to any office shall elect to such office and a majority of the votes properly cast upon any question other than an election to an office shall decide the question, except when a larger vote is required by law, by our certificate of incorporation or by our bylaws.
Our certificate of incorporation and bylaws do not provide for cumulative voting rights. Because of this, the holders of a majority of the shares of common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they should so choose.
Dividend Rights
Subject to the preferences that may be applicable to any then outstanding preferred stock, the holders of our outstanding shares of 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. We have never paid a dividend and we do not anticipate paying a dividend in the foreseeable future.
Liquidation Rights
In the event of our liquidation, dissolution or winding up, holders of our 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.
Other Rights and Preferences
The terms of our common stock do not include any preemptive, conversion or subscription rights, nor any redemption or sinking fund provisions. The common stock is not subject to future calls or assessments by us. The rights, preferences and privileges of the holders of our common stock are subject to, and may be adversely affected by, the rights of shares of any series of our preferred stock that we may classify and issue in the future.
Registration Rights
We are parties to that certain Registration Rights Agreement dated as of September 26, 2024 - See “Private Placement of Shares of Common Stock, Pre-Funded Warrants and Common Warrants”.
Outstanding Stock Options
As of October 23, 2024, we had outstanding options to purchase 11,018,223 shares of our common stock at a weighted-average exercise price of $4.37 per share, of which 10,808,223 were underlying options granted pursuant to the 2013 Plan. The remaining options were options to purchase 210,000 shares of our common stock at a weighted-average exercise price of $4.45 per share issued outside of our equity compensation plans as an inducement material to certain individuals entering into employment with us in accordance with Nasdaq Listing Rule 5635(c)(4). As of October 23, 2024, there were 697,979 shares of our common stock reserved for future issuance under our 2013 Plan.
13 |
Outstanding Restricted Stock Units
As of October 23, 2024, we had 610,100 shares of our common stock underlying outstanding restricted stock units, none of which was underlying outstanding restricted stock units which were issued outside of our equity compensation plans as an inducement material to certain individuals entering into employment with us in accordance with Nasdaq Listing Rule 5635(c)(4).
2021 Employee Stock Purchase Plan
As of October 23, 2024, there were 750,000 shares of our common stock reserved for future issuance under our 2021 Employee Stock Purchase Plan.
Outstanding Warrants
As of October 23, 2024, we had outstanding warrants to purchase up to an aggregate of 25,384,090 shares of our common stock at a weighted-average exercise price of $1.14 per share (which number does not include the Warrants issued in connection with the Private Placement described above).
Description of Certain Provisions of Delaware Law and our Certificate of Incorporation and Bylaws
Section 203 of the Delaware General Corporation Law
We are subject to the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a three-year period following the time that this stockholder becomes an interested stockholder, unless the business combination is approved in a prescribed manner. Under Section 203, a business combination between a corporation and an interested stockholder is prohibited unless it satisfies one of the following conditions:
● | prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder; |
● | the interested stockholder owned at least 85% of the voting stock of the corporation outstanding upon consummation of the transaction, excluding for purposes of determining the number of shares outstanding (1) shares owned by persons who are directors and also officers and (2) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
● | on or subsequent to the consummation of the transaction, the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66-2/3% of the outstanding voting stock which is not owned by the interested stockholder. |
Section 203 defines a business combination to include:
● | any merger or consolidation involving the corporation and the interested stockholder; |
● | any sale, transfer, lease, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation; |
● | subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; |
14 |
● | subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; and |
● | the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation. |
In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling or controlled by the entity or person.
Certificate of Incorporation and Bylaws
Provisions of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change of control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock. Among other things, our certificate of incorporation and our bylaws:
● | permit our board of directors to issue up to 10,000,000 shares of preferred stock, with any rights, preferences and privileges as it may designate, which issuance could result in the loss of voting control by other stockholders; |
● | subject to the rights of the holders of any series of preferred stock, provide that all vacancies on our board of directors, including as a result of newly created directorships, may, except as otherwise required by law, be filled only by the affirmative vote of a majority of directors then in office, even if less than a quorum; |
● | provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice; |
● | do not provide for cumulative voting rights, thereby allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election; |
● | provide that special meetings of our stockholders may be called only by the (i) the chairperson of the board; (ii) our chief executive officer; or (iii) a majority of the number of authorized directors; and |
● | provide that the Court of Chancery of the State of Delaware is the sole and exclusive forum for: (A) any derivative action or proceeding brought on behalf of us; (B) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders; (C) any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws; or (D) any action asserting a claim against us governed by the internal affairs doctrine. Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock shall be deemed to have notice of and to have consented to the foregoing exclusive forum. Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. In addition, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Securities Act or any other claim for which the federal and state courts have concurrent jurisdiction. |
The Nasdaq Capital Market
Our shares of common stock are listed for trading on the Nasdaq Capital Market under the symbol “XAIR.”
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Action Stock Transfer Corporation.
15 |
Certain legal matters relating to the issuance of the securities offered hereby will be passed upon for us by Sichenzia Ross Ference Carmel, LLP.
The consolidated financial statements as of and for the years ended March 31, 2024 and 2023 incorporated by reference in this registration statement have been audited by Marcum LLP, an independent registered public accounting firm, as stated in their report (which report includes an explanatory paragraph about the Company’s ability to continue as a going concern). Such financial statements are incorporated by reference in reliance upon the report of such firm given upon their authority as experts in accounting and auditing.
The SEC allows us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus, and subsequent information that we file with the SEC will automatically update and supersede that information. Any statement contained in this prospectus or a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or a subsequently filed document incorporated by reference modifies or replaces that statement.
This prospectus and any accompanying prospectus supplement incorporate by reference the documents set forth below that have previously been filed with the SEC:
● | our Annual Report on Form 10-K for the year ended March 31, 2024, filed on June 24, 2024; |
● | our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 filed on August 6, 2024; |
● | our Current Reports on Form 8-K (other than portions thereof furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits accompanying such reports that relate to such items) filed with the SEC on June 18, 2024. June 27, 2024, August 9, 2024, September 27, 2024, October 2, 2024, and October 9, 2024; and |
● | the description of our common stock contained in our Registration Statement on Form 8-A filed on May 3, 2019, as updated by Exhibit 4.7 to our Annual Report on Form 10-K for the fiscal year ended March 31, 2020, including any amendments or reports filed for the purpose of updating such description. |
We also incorporate by reference into this prospectus all documents (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such items) that are filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of the initial registration statement of which this prospectus is a part and prior to the effectiveness of such registration statement and all documents that are filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus but prior to the termination of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as well as proxy statements.
Any statement contained herein or in a document incorporated or deemed to be incorporated by reference into this document will be deemed to be modified or superseded for purposes of the document to the extent that a statement contained in this document or any other subsequently filed document that is deemed to be incorporated by reference into this document modifies or supersedes the statement.
You may request, orally or in writing, a copy of any or all of the documents incorporated herein by reference. These documents will be provided to you at no cost, by contacting: Beyond Air, Inc., General Counsel, at 900 Stewart Avenue, Suite 301, Garden City, New York 11530. In addition, copies of any or all of the documents incorporated herein by reference may be accessed at our website at www.beyondair.net. The information on such website is not incorporated by reference and is not a part of this prospectus.
16 |
WHERE YOU CAN FIND MORE INFORMATION
We filed with the SEC a registration statement under the Securities Act for the securities offered by this prospectus. This prospectus does not contain all of the information in the registration statement and the exhibits and schedule that were filed with the registration statement. For further information with respect to us and our securities, we refer you to the registration statement and the exhibits and schedule that were filed with the registration statement. Statements contained in this prospectus about the contents of any contract or any other document that is filed as an exhibit to the registration statement are not necessarily complete, and we refer you to the full text of the contract or other document filed as an exhibit to the registration statement. The SEC maintains a website that contains reports, proxy and information statements, and other information regarding registrants that file electronically with the SEC. The address of the website is www.sec.gov.
We file periodic reports under the Exchange Act, including annual, quarterly and special reports, and other information with the SEC. These periodic reports and other information are available for inspection and copying at the SEC regional offices, public reference facilities and on the website of the SEC referred to above.
We make available free of charge on or through our internet website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. The information found on our website, www.beyondair.net, other than as specifically incorporated by reference in this prospectus, is not part of this prospectus.
17 |
81,697,422 Shares of Common Stock
PROSPECTUS
, 2024
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the expenses to be incurred in connection with the offering described in this registration statement, other than underwriting discounts and commissions, all of which will be paid by us. All amounts are estimates except the SEC registration fee.
Amount | ||||
SEC registration fee | $ | 4,253 | ||
Accountant’s fees and expenses | 15,000 | |||
Legal fees and expenses | 225,000 | |||
Printing and miscellaneous expenses | 3,000 | |||
Total expenses | $ | 247,253 |
Item 15. Indemnification of Directors and Officers.
Section 102 of the Delaware General Corporation Law (the “DGCL”) permits a corporation to eliminate the personal liability of its directors or its stockholders for monetary damages for a breach of fiduciary duty as a director, except where the director breached his or her duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our certificate of incorporation provides that the liability of our directors for monetary damages shall be eliminated to the fullest extent under applicable law.
Section 145 of the DGCL provides that a corporation has the power to indemnify a director, officer, employee or agent of the corporation and certain other persons serving at the request of the corporation in related capacities against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlements actually and reasonably incurred by the person in connection with an action, suit or proceeding to which he or she is or is threatened to be made a party by reason of such position, if such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation, no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnification for such expenses which the Court of Chancery or such other court shall deem proper.
Our certificate of incorporation provides that we are authorized to provide indemnification of (and advancement of expenses to) our directors, officers and agents (and any other persons to which applicable law permits us to provide indemnification) through bylaw provisions, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise in excess of the indemnification and advancement otherwise permitted by such applicable law. Our bylaws provide that (i) we shall indemnify our directors and executive officers (as defined under the Exchange Act); provided, however, that we may modify the extent of such indemnification by individual contracts with its directors and executive officers and (ii) we shall have power to indemnify its other officers, employees and other agents as set forth in the DGCL or any other applicable law.
We maintain a general liability insurance policy that covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as directors or officers.
Insofar as the forgoing provisions permit indemnification of directors, executive officers, or persons controlling us for liability arising under the Securities Act, we have been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
II-1 |
Item 16. Exhibits and Financial Statement Schedules.
(a) Exhibits
See the Exhibit Index List below, which is incorporated by reference herein.
II-2 |
Item 17. Undertakings.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act;
(ii) To reflect in the prospectus any facts or events arising after the effective date of this registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high and of the estimated maximum offering range may be reflected in the form of prospectus filed with the Securities and Exchange Commission (the “Commission”) pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) To include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in this registration statement;
provided, however, that paragraphs (1)(i), (1)(ii) and (1)(iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser:
(i) Each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(ii) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date;
The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the 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, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
II-3 |
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned thereunto duly authorized in the city of Garden City, State of New York, on this 25 day of October, 2024.
BEYOND AIR, INC. | ||
By: | /s/ Steven Lisi | |
Name: | Steven Lisi | |
Title: | Chairman and Chief Executive Officer |
KNOW ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Steven Lisi and Adam Newman as his or her true and lawful attorney-in-fact and agent, with the full power of substitution, for him or her and in his or her name, place or stead, in any and all capacities, to sign any and all amendments to this registration statement (including post-effective amendments), and any other registration statements for the same offering pursuant to Rule 462(b) of the Securities Act of 1933, as amended, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature | Title | Date | ||
/s/ Steven Lisi | Chairman
and Chief Executive Officer (Principal Executive Officer) |
October 25, 2024 | ||
Steven Lisi | ||||
/s/ Douglas Larson | Chief
Financial Officer (Principal Financial and Accounting Officer) |
October 25, 2024 | ||
Douglas Larson | ||||
/s/ Erick Lucera | Director | October 25, 2024 | ||
Erick Lucera | ||||
/s/ Yoori Lee | Director | October 25, 2024 | ||
Yoori Lee | ||||
/s/ William Forbes | Director | October 25, 2024 | ||
William Forbes | ||||
/s/ Ron Bentsur | Director | October 25, 2024 | ||
Ron Bentsur | ||||
/s/ Robert Carey | Director | October 25, 2024 | ||
Robert Carey |
II-4 |