10-Q

請在以下複選框中打勾，指示註冊人：(1)在前12個月(或註冊人被要求提交這些報告的更短期間內)已經提交了1934年證券交易法第13或15(d)條規定需要提交的所有報告；以及(2)在過去的90天內一直受到了此類文件提交要求的限制。是☒ 不是 ☐

請在勾選標誌處表示註冊人是否已經在過去12個月內（或者在註冊人要求提交這些文件的較短時期內）按照規則405 of協議S-T（本章節的§232.405）提交了每個交互式數據文件。 ☒ 沒有 ☐是☒ 不是 ☐

請勾選標記以說明註冊人是大型快速申報人、加速申報人、非加速申報人、較小的報告公司還是新興成長型公司。請查看《交易所法》第120億.2條中「大型快速申報人」、「加速申報人」、「較小的報告公司」和「新興成長型公司」的定義。

如果公司無法符合證券交易法第13(a)條規定，使用延長過渡期來遵守任何新的或修訂的財務會計準則，請在複選框中指示。 ☒

請在以下方框內打勾，以指示註冊人是否爲殼公司（如交易所法規第12b-2條規定）。是 ☐ 否 ☒

截至2024年11月11日，註冊人持有 37,823,394 s每股面值$0.0001的普通股份，現有。

1. 組織和重要會計政策摘要

組織

HCW生物製品公司（以下簡稱「公司」）是一家生物製藥公司，專注於發現和開發新型免疫治療方法，通過打破慢性低度炎症與年齡相關疾病之間的聯繫，延長健康壽命。公司認爲與年齡相關的低度慢性炎症，或者稱爲「炎老化」，是導致多種慢性疾病和病症的重要因素，例如癌症、心血管疾病、糖尿病、神經退行性疾病和自體免疫疾病。公司位於佛羅里達州米拉馬，於2018年4月在特拉華州註冊成立。

流動性和持續經營

根據FASB會計準則法規（「ASC」）205-40，財務報表的呈現-持續經營（「主題205-40」），管理人員必須評估是否有多種條件和事件（作爲整體考慮），對公司能否在公司的簡明中期財務報表發佈之日起至少12個月持續爲持續經營提出重大疑問。這種評估不考慮管理層的未完全實施或不在公司控制範圍內的計劃可能產生的減輕作用。當以這種方法存在重大疑問時，管理層評估其計劃的減輕效果是否足以減輕公司能否持續經營的重大疑問。然而，只有當（1）計劃在財務報表發佈之日後一年內可能被有效實施，且（2）在實施後該計劃可能減輕引起對公司能否繼續作爲持續經營提出重大疑問的相關條件或事件在財務報表發佈之日後一年內，才會考慮管理計劃的減輕作用。

截至2024年9月30日，公司尚未從內部開發的免疫治療產品的商業銷售中產生任何營業收入，用於治療癌症和其他與年齡有關的疾病。在開發活動期間，公司持續虧損，並預計在可預見的將來繼續出現虧損。自創立至2024年9月30日，公司累計淨虧損員工福利計劃94.5 百萬。這些損失反映在2024年5月1日提交給證券交易委員會（「SEC」）的8-k表中報告的事件，涉及一項計劃，導致公司帳戶中約$1.3 百萬被轉移到第三方操控的欺詐帳戶。公司已通過保險索賠尋求救濟，並向法律部門報告了這一犯罪行爲。管理層預計未來將繼續承擔額外損失以進行產品研發，並認識到需要籌集額外資本以完全實施其業務計劃。截至2024年9月30日，公司擁有現金及現金等價物1,500萬美元的美國聯邦淨營業虧損（NOL）結轉。1.0 百萬美元。

公司於2022年8月15日與Cogent銀行簽訂了一項貸款和安全協議（「2022貸款協議」），根據該協議獲得了$美元。6.5 百萬美元，用於購買一幢即將成爲公司新總部的大樓。該貸款以該建築物的首位優先留置權爲擔保。截至2024年9月30日，部分分包商已因與公司新制造設施和升級研究實驗室施工相關的未支付發票而登記了力擔保。2022年貸款協議包含一項關於自由選擇違約的條款，即公司未能支付與改善工程相關的款項時可能發生違約；然而，截至報告日期，債權人尚未選擇這樣做。請參見第I部分，第4項--「控制和程序」。截至2024年9月30日，公司已將該貸款列爲短期債務淨額，以反映借款人有權根據自由選擇違約條款加速貸款的權利。公司繼續尋求完成建設項目所需的融資，與貸款人和留置權人合作。

公司迄今主要通過發行股票、發行優先擔保票據以及通過與Wugen公司簽訂的獨家全球許可協議所獲得的收入來資助運營。根據該協議，Wugen授予了有限權利，開發、製造和商業化基於公司內部開發的兩種多細胞雙細胞融合蛋白分子的癌症細胞治療。在2023年和2024年9月30日結束的三個月內，公司分別從向Wugen供應臨床和研究級材料中獲得了營業收入$853,102 and $426,423；在2023年和2024年9月30日結束的九個月內，公司分別從向Wugen供應臨床和研究級材料中獲得了營業收入$1.5 百萬美元和美元2.2 百萬，分別爲。

公司在2024年第三季度推出了一項融資計劃。該計劃包括多項籌資活動，如發行擔保票據、股權融資，以及業務拓展交易，如與保證最低支付的許可協議。截至2024年10月31日，公司發行了總額爲$6.9 萬美元的擔保票據。在

九月 2024年25日，公司與一家有意許可公司某個臨床前分子的方達成了非約束性備忘錄。公司預計將在2024年第四季度完成此次許可交易。擬議的許可協議包括預計在期限的第一年內的最低保證付款。2024年11月13日，我們與Maxim集團簽署了聘用信，擔任多步驟股權融資的獨家配售代理。如果公司在這些活動中未能成功籌集到額外資金，管理層打算修訂業務計劃。如果此類修訂不足，公司可能需要縮減或停止運營。

公司已收到納斯達克證券市場有限責任公司（「納斯達克」）上市資格員工的書面通知，告知公司未符合納斯達克全球市場的持續上市要求。根據納斯達克上市規則，公司自通知日期起有180個日曆天的時間恢復合規，其首個截止日期目前定於2024年12月16日。公司打算採取所有合理的措施，以恢復納斯達克全球市場的持續上市要求，包括利用上訴納斯達克的權利，基於良好的財務計劃延長恢復合規的截止日期。雖然公司正在努力維護其普通股在納斯達克的上市，但不能保證公司能夠恢復或維持符合納斯達克上市規則中規定的適用的持續上市標準。

截至2024年9月30日，進行持續經營評估的結論是公司繼續作爲持續經營的能力存有重大疑慮。公司考慮了未來12個月的融資計劃，以及預期的持續經營虧損和與過去法律程序相關的費用負擔。管理層得出的結論是，沒有任何緩解情況減輕其繼續作爲持續經營的能力的重大疑慮。

根據公司於2024年7月18日提交的8-k表格及下文第II部分第1項「法律程序」的進一步說明，截至2024年7月13日，公司與公司創始人兼首席執行官戈赫·C·旺博士與ImmunityBio及其附屬機構簽訂了一份機密和解協議（「和解協議」）。和解協議包括各方之間的相互一般釋放。任何一方在和解協議下不要求向任何其他方或個人支付任何金錢，並且每一方將承擔與此事項相關的自身費用。公司已基本完成與和解協議條款相符合所需的補救程序。

公司簽訂和解協議是爲了避免進一步訴訟帶來的成本、干擾和分心。在截至2024年9月30日的隨附簡明資產負債表中，公司報告了一項未支付法律費用的餘額爲$14.4 百萬美元，這部分費用已包含在應付賬款中，以及在應計負債與其他當前負債中計提法律費用的$35,000 公司正在與參與此事項的律師事務所進行討論，以安排一項針對這些法律費用的合理付款計劃。通過簽署和解協議，公司解決了仲裁結果的不確定性及其他複雜性，並啓動了新的融資計劃。

隨附的臨時基本報表是根據持續經營假設準備的，這考慮了在正常業務過程中資產的實現和負債的滿足。財務報表不包括任何與記錄資產金額的可回收性和分類或可能因上述不確定性結果而導致的負債金額和分類有關的調整。公司認爲，至少在公司臨時基本報表發佈之日後的12個月內，其繼續作爲持續經營體的能力存在重大懷疑，並且其持續經營分析中存在的重大懷疑並未得到緩解。

重要會計政策摘要

呈現基礎

該截至2024年9月30日的未經審計的簡明資產負債表，2023年和2024年截至9月30日的運營簡明報表，以及股東權益（赤字）變化的簡明報表和截至2023年和2024年9月30日的現金流量簡明報表，所有相關的披露內容均已根據美國公認會計原則（「U.S. GAAP」）爲臨時財務信息所準備，並遵循修訂後的1933年證券法第10條和其相關規定（「證券法」）。因此，這些報表並未包含U.S. GAAP規定的完整財務報表所需的所有信息和說明。這些未經審計的簡明臨時財務報表僅包含公司認爲必要的正常和經常性調整，以公正反映公司的財務狀況及其運營和現金流的結果。2024年9月30日結束的三個月和九個月期間的結果不一定表明對於整個財年或任何後續中期預期的結果。2023年12月31日的簡明臨時資產負債表是根據該日期的審計財務報表得出的，但不包含所有要求的披露內容。

美國基本報表的營業收入按照美國通用會計準則進行。因爲這裏未包括所有美國通用會計準則所要求的完整財務報表披露，因此，這些未經審計的精簡中期財務報表及附註應與公司截至2023年12月31日的審計完整財務報表一起閱讀，這些完整財務報表可在公司截至2023年12月31日的年度報告（即於2024年5月15日提交給美國證券交易委員會的10-k表格所載的年度報告）以及其他提交給美國證券交易委員會的文件中找到。

重新分類之前期法律費用的呈現。

某些之前期金額已重新分類以區分一般和管理費用以及與描述在附註1中的仲裁和和解協議相關的法律費用。關於與法律訴訟相關的法律費用的重新分類影響了合併中期損益表。對前期經營業績的報告結果沒有影響。

使用估計

按照美國通用會計準則編制財務報表要求管理層對影響財務報表和附註中報告金額的估計和假設進行。管理層在此過程中必須運用重大判斷。公司通過使用歷史經驗和其他因素對其估計和假設進行持續評估，並在事實和情況要求時調整這些估計和假設。實際結果可能與估計有所不同。

公允價值衡量

公允價值定義爲在計量日期，市場參與者之間在一項有序交易中將資產出售或轉讓負債所能獲得的價格，財務會計準則委員會(FASB)會計準則法典(ASC)第820號公允價值計量(「主題820」)爲那些以公允價值計量的工具建立了一個公允價值等級制度，區分了基於市場數據(可觀察輸入)和基於公司自身假設(不可觀察輸入)的公允價值計量。這一等級制度最大程度利用可觀察輸入並最小化不可觀察輸入的使用。用於計量公允價值的三個輸入級別分別是：

Level 1: 可觀察到的輸入，例如活躍市場中的報價；

第2級：除了在活躍市場中的報價價格外，可以直接或間接觀察到的輸入；

Level 3: 非觀察到的輸入，幾乎沒有市場數據，需要報告實體開發自己的假設。

公允價值的衡量基於對衡量所需的最重要輸入的最低級別進行分類。公司對特定輸入對公允價值衡量的重要性的評估需要判斷，這可能影響資產和負債的估值及其在公允價值層次結構中的位置。公允價值的確定考慮了公司金融資產和負債的市場情況、相關信用風險以及其他必要因素。公司將那些發生的資產或負債的交易頻率和成交量足以提供定價信息的市場視爲活躍市場。

收入確認

公司根據ASC 606《與客戶訂立的合同的營業收入》（以下簡稱「Topic 606」）計提營業收入。爲確定適用於Topic 606範圍內安排的收入確認，公司執行以下五個步驟：（i）識別與客戶的合同；（ii）識別合同中的履行義務；（iii）確定交易價格；（iv）將交易價格分配給合同中的履行義務；和（v）當公司滿足（或作爲）履行義務時確認收入。公司僅適用五步模型於當有可能收回所應收的對換提供給客戶的商品或服務時的合同。

在合同初始階段，公司評估每個合同中承諾的商品或服務，確定履行義務，並評估每個承諾的商品或服務是否是獨立的。然後，公司僅在滿足（或作爲）履行義務時，確認分配給各自履行義務的交易價格金額作爲營業收入。迄今爲止，公司的營業收入僅來源於與Wugen的交易。Wugen許可協議包括

知識產權的許可、成本報銷、預付款項、里程碑付款以及未來被許可人產品銷售的版稅。此外，公司與Wugen有一項材料供應協議，公司也在此基礎上確認營業收入。

許可授予：

對於包括對公司知識產權的許可授予的外部授權安排，公司考慮該許可證授予是否與安排中包含的其他履約義務是獨立的。對於那些獨立的許可證，公司在許可證期限開始並且公司已向客戶提供了有關基礎知識產權的所有必要信息時確認非可退款預付款和分配給許可證的其他對價的營業收入，這通常在安排開始時或接近開始時發生。

里程碑和或有付款：

在安排開始時以及之後的每個報告日期，公司評估是否應在交易價格中包含任何里程碑和或有付款或其他形式的變量對價，採用最可能金額法。如果在不確定性解決時，累計營業收入不會發生重大逆轉的可能性較高，則相關的里程碑金額將被納入交易價格。在每個後續報告期結束時，公司重新評估每個里程碑的實現概率及其相關限制，並在必要時調整其總體交易價格的估算。由於里程碑和或有付款可能在臨床研究的啓動或申請或獲得監管批准時支付給公司，因此公司會審查相關事實和情況，以判斷何時應更新交易價格，這可能在觸發事件之前發生。當公司更新里程碑和或有付款的交易價格時，公司將交易價格的變更按與初始分配相同的基礎分配給協議中的每個履約義務。任何此類調整均在調整的期間按累計補追基礎記錄，這可能導致在該期間確認之前已完成的履約義務的營業收入。公司的被許可人通常將在達到觸發事件後支付里程碑付款。

材料供應：

公司提供臨床和研究級材料，以便被許可方能夠基於授權分子開發產品。公司計劃在被許可方進入其公司的商業階段時簽訂商業供應協議。賬單金額在公司滿足履行義務時確認作爲營業收入，一旦公司判斷合同存在。

2021年6月18日，公司簽署了一項有關提供材料用於已授權產品臨床開發的主服務協議。爲了滿足主題606下資格作爲合同的所有標準，公司必須簽署臨床和研究級材料的工作聲明。公司判斷所供應的臨床和研究材料的製造每一項代表一個單一的履行義務，該義務隨着時間的推移而滿足。公司使用基於所發生成本相對於總預期成本的輸入法確認營業收入，這會判斷公司完成的進度程度。作爲對這些安排會計處理的一部分，公司必須制定估計和假設，這需要判斷來判斷完成的進度。公司根據可用的最佳信息審查其完成進度的估計，以在每個報告期末確認累積的完成進度，並在每個報告期間如果事實和情況發生變化，會修訂這些估算。

截至2023年9月30日的三個月和九個月，公司確認與向Wugen銷售開發供應材料相關的營業收入爲$853,102 and $1.5 百萬。截止到三個月和九個月的結束。 2024年9月30日公司分別認定了$426,423 and $2.2 與Wugen的開發供應材料銷售相關的營業收入爲百萬。

投資

公司持有Wugen的少數股權，按照計量替代方法進行會計處理，即以成本減去減值進行記錄，並根據相同或類似投資的可觀察價格變化進行調整。 No 已確認減值。截至2024年9月30日和2023年12月31日，公司包含$百萬投資於Wugen，記入隨附的簡明 interim 資產負債表中。1.6 公司利用其在Wugen的股權作爲擔保，通過擔保債券。請參見注釋3。債務，淨額。

經營租賃

該公司在成立時判斷一個安排是否爲租賃。運營租賃包括在其他資產、應計負債和其他流動負債，以及其簡明中期資產負債表上的其他負債。基於未來最低租賃付款的現值，確認運營租賃使用權（「ROU」）資產和運營租賃負債。

3. 債務，淨值

Cogent 銀行貸款

在2022年8月15日，公司與Cogent 銀行簽署了2022貸款協議，根據該協議，公司獲得了$6.5 百萬資金，用於購買將成爲公司新總部的建築。該貸款以建築物的第一優先權利作爲擔保。只付利息的階段爲一年，之後爲48個月的本金和利息均等支付從2023年9月15日開始，基於25年的攤銷率。未攤銷餘額到期於 2022年貸款協議的利息只付期爲1年，之後的48個月平均本息付款以2023年9月15日爲基準，按照25年攤銷率。未攤銷餘額應在2027年8月15日（到期日）歸還，且按固定年利率計息。到期日時，應還清未攤銷本金的最後一筆付款。截至2024年3月31日，公司已遵守所有契約條款。公司有權在到期日之前無罰金預付貸款的餘額。 (「到期日」)，並按固定的年利率計息，利率爲 5.75在到期日，未攤銷本金的最終付款將到期。公司有權選擇在到期日前提前償還未償貸款餘額，且無須支付罰金。

截至2024年9月30日，某些分包商已就與公司新制造設施和升級研究實驗室施工相關的未支付發票提交了機械留置權。2022年貸款協議包含了一項自願違約條款，若公司未能支付與任何改進施工相關的應付款項，貸方可行使此權利；然而，截至報告日期，貸方未選擇這樣做。截至2024年9月30日，公司將該貸款列爲短期債務，以反映貸方有權依據自願違約條款加速還款。, $6.3 百萬被包含在短期債務中，淨額爲附帶的簡明中期資產負債表。

高級擔保票據

在2024年3月31日，公司與購買者（在票據購買協議中定義）簽訂了票據購買協議，根據該協議，公司可以發行總本金金額最高達$10.0 百萬（"擔保票據"）。

截至2024年9月30日，公司收到$6.5 來自發行擔保票據的資金爲百萬美元，這在附帶的簡明中期資產負債表中包含在淨債務內。2.4 投資者包括首席執行官兼創始人Dr. Hing C. Wong，投資金額爲百萬美元;220,000Rebecca Byam, 首席財務官，投資金額爲百萬美元;25,000Lee Flowers，業務發展高級副總裁，投資金額爲百萬美元;140,000Scott T. Garrett, 公司董事會主席，投資金額爲百萬美元;60,000Gary M. Winer, 我們董事會的一員，投資金額爲百萬美元;25,000Rick S. Greene, 董事會成員, 投資金額爲百萬美元，以及無關方。

自2024年7月2日起，有擔保票據的現有投資者一致同意經修訂和重述的票據購買協議及相關文件（「經修訂和重述的票據購買協議」）。2024年9月30日，現有投資者批准了經修訂和重述的票據購買協議的修正案，該修正案將最後截止日期延長至2024年10月31日。其他條款未更改。根據經修訂和重述的票據購買協議的條款，有擔保票據繼續e 按利率支付利息 9每年%，按季度拖欠支付。擔保票據將於到期 2026年8月30日（「到期日」），根據經修訂和重述的票據購買協議的條款，本金餘額、應計但未付的利息和其他款項應在這一天到期並支付。該公司質押了其在Wugen的股權，相當於 5.6截至2024年9月30日，該公司的所有權百分比（「質押抵押品」）。質押抵押品將根據託管協議的條款作爲有擔保票據的擔保進行持有和發行。

如果公司選擇在2024年12月31日當天或之前預付優先票據，則有 5% 預付款罰款。有擔保票據有強制性預付款條款，根據該條款，在某些情況下，公司必須在到期日之前預付有擔保票據。如果是強制性預付款，有擔保票據可能會根據出售質押抵押品的總收益獲得獎金。如果有擔保票據在到期日償還，則除了支付未償本金以及應計和未付利息外，持有人還將獲得固定獎金。如果支付了獎金，則沒有預付款罰款。經修訂和重述的票據購買協議還包含違約條款，根據該條款，在違約事件發生後，公司可能需要按美元按比例向購買者分配質押抵押品10.0 發行了100萬張有擔保票據，完全償還了擔保票據所證明的債務。

截至2024年9月30日，嵌入式衍生品的公允價值並不重要，其中包含某些事件發生的可能性。因此，截至2024年9月30日，公司未在隨附的簡明財務報表中確認嵌入式衍生品。

如果在到期日償還有擔保票據，公司使用實際利率法，將獎金計入到期日到期日到期的全額金額，從而將要支付的獎金入賬。截至2024年9月30日，公司尚未確認獎金的增加，這被認爲對隨附的簡明財務報表不重要。

截至2023年12月31日和2024年9月30日公司分別擁有未行使的權證作爲負債。 10,000,000股。沒有發行的股票。

5. 每股淨損失

下表總結了基本每股和攤薄每股淨損失的計算：


	截至9月30日的三個月						截至9月30日的九個月
	2023			2024			2023			2024
分子：
淨虧損	$	(4,938,641	)	$	(3,902,288	)	$	(14,313,746	)	$	(26,650,541	)
分母：
加權平均普通股股數		35,926,921			37,823,394			35,907,123			37,623,459
每股基本和攤薄淨虧損	$	(0.14	)	$	(0.10	)	$	(0.40	)	$	(0.71	)

下表總結了被排除在稀釋每股淨虧損計算之外的未償還潛在稀釋證券，因爲它們的加入將是反稀釋的：


	截至9月30日，
	2023		2024
普通股期權		1,869,492		1,788,137
潛在稀釋證券		1,869,492		1,788,137

6. 金融工具的公允價值

公司的金融工具的賬面金額，包括現金及現金等價物、應收賬款、預付費用及其他流動資產、到期日不超過一年的美國政府擔保證券、應付賬款及應計負債，由於其短期到期日，接近公允價值。

包括在現金及現金等價物中的貨幣市場基金和美國政府擔保證券的公允價值依據活躍市場中的報價來衡量，這些報價被認為是第1級輸入。在報告期間內不存在級別之間的轉移。下表展示了公司的資產，這些資產在 2023年12月31日和2024年9月30日的公允價值：


	截至2023年12月31日：
	第1級		第2級		Level 3		總計
資產：
貨幣市場基金	$	1,626,129	$	—	$	—	$	1,626,129
總計	$	1,626,129	$	—	$	—	$	1,626,129


	截至2024年9月30日：
	第1級		第2級		Level 3		總計
資產：
貨幣市場基金	$	83,814	$	—	$	—	$	83,814
總計	$	83,814	$	—	$	—	$	83,814

公司通過使用預測的年度實際稅率來計算其季度所得稅費用/（利益），並調整在季度內出現的任何離散項目。公司於2023年12月31日和2024年9月30日無所得稅（當前或递延稅費用）提存。公司將繼續對總递延稅資產保留著%的評估減值準備金。公司認為相關的递延稅資產不太可能實現。因此，公司的實際稅率將保持在%，因為沒有任何項目（預估或離散項目）會影響稅款提存。 no截至2023年12月31日和2024年9月30日，公司沒有對所得稅（當前或递延稅費用）提存。公司將繼續保留對總递延稅資產的%評估準備金。公司認為相關的递延稅資產不太可能實現。因此，公司的實際稅率將維持在%，因為沒有任何預估或離散項目會影響所得稅提存。 100公司對全递延稅資產保留%的評估減值準備金。公司認為相關递延稅資產較不可能實現。因此，由於沒有預估項目或離散項目會對稅款提存產生影響，公司的實際稅率將維持在%。 0.00由於沒有任何預估或離散項目會影響稅款提存，公司的有效稅率將保持在%。

8。承諾和意外開支

運營租賃

截至2022年3月1日，公司輸入了兩年租約，包括兩份經營租約，價格約爲 12,250 平方英尺的空間位於佛羅里達州米拉瑪。這些租約開始後，公司使用了其增量借款利率爲 6.0% 用於確定 ROU 資產和租賃負債的確認金額。

2024 年 3 月 1 日，公司輸入了一年租用相同的空間，該空間的到期日爲 2025年2月28日。如果租約的期限爲12個月或更短，則該租賃有資格獲得ASC 842-20-25-2規定的短期租賃豁免。該公司選擇利用這一豁免，將在租賃期內按直線方式覈算這筆租約，因此不會確認ROU資產和租賃負債。新的短期租約下的剩餘租賃付款爲e $114,510. T公司在融資租賃下沒有義務。

在截至2023年9月30日和2024年9月30日的三個月中，公司確認的租金支出爲美元42,400 和 $49,500，分別是 $22,200 和 $25,900分別包含在研究和開發中，載於所附的簡要中期運營報表中。在截至2023年9月30日和2024年9月30日的九個月中，公司確認的租金支出爲美元127,200 和 $146,400，分別是 $66,600 和 $75,300，分別包含在所附的簡要中期運營報表的研發中。

合同承諾

該公司承諾向第三方製造組織提供臨床級材料。截至2024年9月30日，根據合同，其義務爲 $12,500 它預計將在截至2024年12月31日的年度內付款。截至2023年12月31日和2024年9月30日，公司承諾爲美元提供資金4.4 一百萬個d $2.5 百萬，分別用於與擴建其新總部和製造設施相關的施工成本。

項目融資

2024年1月10日（「終止日期」），公司行使了終止其授信協議（「授信協議」）的權利，該協議簽訂於2023年4月21日，與Prime Capital Ventures，LLC（「貸方」）簽訂，在授信協議條款允許的情況下。這些資金原本用於公司新總部（「物業」）的建設和翻修。終止是由於資金撥款反覆延遲及相關擔憂所致。終止日期時，授信協議下沒有借款，公司也沒有因協議終止而產生任何罰款。公司行使終止協議的權利後，有權收回公司爲與貸方建立利息儲備帳戶而存入的$5.3 百萬。但是，貸方未能履行返還利息儲備存款的義務。鑑於從貸方收回資金的時間是否及何時存在不確定性，公司截至2023年12月31日已承認了一項$5.3 百萬信貸損失準備金。公司打算通過法律訴訟、託管和保險等手段，盡一切可能收回這些資金。

公司繼續尋求融資，以完成公司新總部的建設和翻修，包括生物製品生產設施、升級研究實驗室設施、活體實驗室和辦公以及升級公共區域。

營運外損失

公司提交的8-k表格於2024年5月1日向證券交易委員會提交，公司發現自己成爲犯罪計劃的受害者，該計劃涉及假冒購買者，在未能購買公司$8.0 百萬擔保票據的法律約定的違約情況下。此計劃導致大約$1.3 百萬美元被轉移到公司帳戶存款到第三方控制的欺詐帳戶。公司正在採取一切可用的方法來收回這筆損失。考慮到迄今爲止這些努力在資金回收方面的有限成功，公司確認一項損失$1.3 百萬，於2024年9月30日結束的三個月和九個月期間。

法定儲備金

法律訴訟

公司不時參與或以其他方式參與法律訴訟，包括訴訟、評估、監管行動和調查，通常是由於業務正常發展所引起的。此外，公司訂立可能包括賠償條款的協議，根據該條款，公司同意對受賠償方因賠償而遭受或發生的損失進行賠償、使其免受損失併爲他們辯護。當公司認爲這樣一件事情的結果會導致可能已經發生或可能產生潛在損失的責任時，或者可以合理估計的損失範圍時，公司將計提一項負債，並在財務報表附註中進行適當披露。

仲裁、和解和一般解除

2022年12月23日，Altor BioScience，LLC和NantCell，Inc.（「Altor/NantCell」）在加利福尼亞對公司的創始人和首席執行官Dr. Hing C. Wong提起仲裁，指控違約和違反義務等其他索賠。在同一日期，Altor/NantCell對公司提起了一項在聯邦法院的訴訟，稱公司侵犯了商業祕密、誘使違約和違約責任等其他針對公司的指控。2023年4月26日，各方約定Altor/NantCell對公司的訴訟將與Altor/NantCell對王博士的仲裁要求合併。2023年4月27日，法院批准了各方的約定，並下令各方進行仲裁。2023年5月1日，Altor/NantCell在JAMS之前對公司提起了訴訟。2023年5月3日，Altor/NantCell撤銷了聯邦法院的訴訟，法院下令撤銷了該案件並結案。Altor/NantCell對公司的訴訟在JAMS之前進行仲裁，並與Altor/NantCell對王博士發起的仲裁合併（「仲裁」）。2024年3月26日，Altor/NantCell在特拉華州法院對公司提起了貢獻法律費用和到王博士提供的費用的投訴（「投訴」）。

根據公司於2024年7月18日提交的8-k表格以及以下第二部分第1項 - 下文所述「法律訴訟」內容，截至2024年7月13日，公司與公司創始人兼首席執行官黃青Chun博士（Dr. Hing C. Wong）簽署了一項保密和解協議（「解決協議」），與Altor BioScience，LLC（「Altor」），NantCell，Inc.（「NantCell」）和ImmunityBio，Inc.（Altor和NantCell的母公司及ImmunityBio的母公司，以及Altor和NantCell一起，「ImmunityBio」）解決了之前在JAMS提起的Altor和NantCell提起的仲裁以及Altor在特拉華州州立法院對公司提起的關於向黃博士支出的法律費用和開支的投訴。解決協議包括當事方之間的相互一般解除。根據解決協議，各方無需向任何其他方或人支付任何貨幣，每方將承擔其在其中發生的費用

與此事項有關。公司已基本完成爲遵守和解協議條款所需的補救程序。和解協議規定，在完成這些程序後，各方共同同意撤銷仲裁和投訴。

截至申請日期，和解協議各方正共同努力完成通知及相關的最終文件，以獲得撤銷仲裁和投訴的批准。

該公司的任何回購活動，無論是與債券定價同時進行，還是根據其股份回購計劃的要求或其他情形，都可能增加或減少ADSs和普通股市場價格和票據價格的下跌幅度。

截至2024年9月30日，某些分包商已針對與公司建設新制造業-半導體設施和升級研究實驗室相關的未支付發票提出了機械留置權。2022年貸款協議中包含了一項規定，在公司未能支付與任何改進建設相關的款項時可選擇性默認；然而，截至報告日期，據公司了解，貸方尚未選擇這樣做。

通貨膨脹成本環境、銀行危機、供應鏈中斷和宏觀經濟環境

公司的運營受到諸多阻力的影響，包括通貨膨脹壓力、逐漸上升的利率期貨、因中東戰爭、俄羅斯與烏克蘭衝突、中國與臺灣關係等地緣政治緊張局勢導致的持續全球供應鏈中斷，金融市場波動和貨幣變動。公司受到通貨膨脹的影響，並可能在採購新總部建設所需材料、招聘和留住員工以及其他與員工相關的費用時繼續受到影響。管理層採取多種策略有效應對這些問題，包括產品重新設計、替代採購及在預算和時間表中建立應急措施。未來在這些和其他領域的發展存在重大不確定性和風險，可能對公司的臨床試驗、IND賦能活動、新總部的建設、以及公司的財務狀況和運營結果產生影響。這些事件和控件的程度和持續時間，以及對我們運營的影響，都是高度不可預測的。

應該與我們在本季度報告表格10-Q中的未經審核的簡明中期基本報表及其他地方出現的相關註釋（i）一起閱讀，以及與在2023年12月31日結束的財政年度中包含的在美國證券交易所委員會（“SEC”）於2024年5月15日提交的年度報告表格10-k中的已審計的基本報表及相關註釋和在“管理層的討論與分析財務狀況及業務結果”標題下的討論（ii）之連貫。我們的歷史結果不一定代表未來任何時期可以預期的結果。除非上下文另有要求，在本季度報告表格10-Q中，對“公司”，“hcw生物製品”，“hcwb”，“我們”，“我們”和“我們的”處的引用均指hcw生物製品公司。

本季度報告（表格10-Q）包含根據1933年證券法第27A條及1934年證券交易法第21E條的定義所作的前瞻性聲明。此季度報告中除歷史事實聲明外的所有聲明，包括有關我們未來營運結果和財務狀況、業務策略、潛在產品、產品批准、研究和開發成本、我們臨床試驗的時間和成功可能性、管理層對未來運營的計劃和目標、我們現金資源和營運資金的充足性、未來經濟條件或表現，以及預期產品的未來結果等聲明，均為前瞻性聲明。這些聲明涉及已知和未知的風險、不確定性及其他重要因素，可能導致我們的實際結果、表現或成就與任何前瞻性聲明所表達或暗示的未來結果、表現或成就存在重大差異。

在某些情況下，您可以通過一些術語來識別前瞻性聲明，例如“可能”、“將”、“應該”、“期望”、“計劃”、“預期”、“可以”、“打算”、“目標”、“項目”、“考慮”、“相信”、“估計”、“預測”、“潛在”或“繼續”，或這些術語的否定形式或其他類似表達。此季度報告表單10-Q中的前瞻性聲明僅為預測。我們主要基於對可能影響我們的業務、財務狀況和經營結果的未來事件和財務趨勢的當前期望和預測來制定這些前瞻性聲明。這些前瞻性聲明受到某些風險和不確定性的影響，可能導致實際結果與這些前瞻性聲明中預期的結果存在重大差異。可能導致此差異的因素包括但不限於在本報告第二部分第1A項“風險因素”中所討論的因素，以及我們不時向SEC提交的其他文件。反映在我們前瞻性聲明中的事件和情況可能不會實現或發生，實際結果也可能與前瞻性聲明中預測的結果存在重大差異。此外，我們在不斷發展的環境中運作。新的風險因素和不確定性可能不時出現，管理層無法預測所有的風險因素和不確定性。這些前瞻性聲明僅代表截至本文所述日期的觀點。除非適用法律要求，否則我們不打算公開更新或修訂本文所包含的任何前瞻性聲明，不論是出於任何新信息、未來事件、變更的情況或其他原因。

hcw biologics inc.是一家臨床階段的生物製藥公司，專注於發現和開發新型免疫療法，以通過打斷慢性低度炎症與年齡相關疾病之間的聯繫來延長健康壽命。我們認為年齡相關的慢性低度炎症，或稱為「炎症老化」，是導致多種疾病和狀況的主要因素，包括癌症、心血管疾病、糖尿病、神經退行性疾病和自身免疫疾病。在衰老的人體內，低度炎症的誘導和持續主要是由於不可增殖但具有代謝活性的衰老細胞的積累，這也可能是由於先天免疫細胞中稱為炎症小體的蛋白質複合體的持續活化所造成的。

這兩個因素在促進促炎蛋白質的分泌方面具有共通機制，並且在許多情況下，相互作用驅動衰老，從而導致炎症老化。我們的新穎方法是通過多條途徑減少衰老細胞並系統性地消除它們分泌的促炎因子。我們相信我們的方法有潛力從根本上改變對抗衰老相關疾病的治療。衰老細胞以及與衰老相關的促炎因子的積累被認為是導致許多衰老相關病理的重要來源，這些病理伴隨著慢性無菌性炎症。我們的免疫治療方法的關鍵是消除衰老細胞及它們分泌的促炎因子。

本公司、黃博士、阿特爾公司、NantCell公司和免疫生物公司所訂定的和解協議於2024年7月13日生效，該協議詳見下文第II部分第1項「法律訴訟」，消除了先前披露的仲裁程序結果的不確定性，為我們臨床發展的未來方向和重點提供了明確性。

策略。這項和解涉及公司開發的知識產權，包括專有的TOBITM 藥物發現平臺以及用於創建包含多個元素的蛋白融合分子的獨特組織因子支架，包括多個蛋白靶點，如細胞因子、單鏈抗體和配體，還有專有的基於TOBI的分子。

兩個新穎藥物發現平台。 HCW生物製品創建了兩個新穎的藥物發現平台，使用兩種完全不同的支架來鞏固免疫治療融合物的組成。這導致產生具有不同作用機制的分子，開啟了治療受慢性炎症促進的疾病的不同途徑。

TOBITm (組織因子基底融合) 平台. 這個專利的藥物發現平台是建立在一個組織因子支架上。 TOBITM 平台結合多個蛋白質靶標，包括細胞因子、單鏈抗體和配體，形成一個單一融合分子。這些分子能夠激發免疫刺激功能，並同時影響多條信號通路。其中一些融合蛋白複合體具有體外和體內應用，儘管公司主要專注於使用皮下注射開發的藥物。通過TOBITM 平台創造的分子可重複製，並適合cGMP製造業。我們已在cGMP製造業環境中製造了四種基於TOBI的分子的數量。

HCW9218. 這是一種臨床階段的雙功能分子，能通過減少衰老細胞（即衰老細胞減少效應）來影響衰老，並消除它們分泌的促炎因子（即衰老形態效應）。HCW9218的皮下注射可激活Nk細胞、先天淋巴細胞1類以及CD8+ t細胞，並中和TGF-β。我們未來的HCW9218計劃包括在卵巢癌的輔助治療階段進行二期研究。HCW9218未來臨床發展的主要重點將放在其他與衰老相關的疾病和狀況上，超出癌症範疇。

本公司擁有獨家權利，使用HCW9218開發除癌症以外所有其他與年齡相關的疾病的治療方案。我們將能夠利用建議的第二階段劑量（"RP2D"）以及基於2024年初結束的第一階段研究結果的其他學習。

本公司擁有在新輔助治療中開發HCW9218治療卵巢癌的非專屬權利。匹茲堡醫療中心（"UMPC"）是正在進行的第二期臨床研究的贊助方，此研究旨在評估HCW9218在新輔助治療卵巢癌中的效果。在這項研究中，HCW9218將與新輔助化療聯合使用，作為一線治療，而僅使用新輔助化療則作為對照組。公司已得知，由於該機構的一些變更，UPMC可能會更換該研究的主要研究者。患者招募正在進行中，但截至報告日尚未有患者登記參加此研究。根據和解協議的條款，UPMC有直到年底的時間來啟動這項研究。

本公司、黃醫生、Altor、NantCell及ImmunityBio之間的和解協議於2024年7月13日簽署，並在下方第二部分，項目1 – "法定程序"中有所描述，消除了先前披露的仲裁程序結果的不確定性，並為我們的臨床發展策略的未來方向和重點提供了清晰性。然而，根據和解協議，本公司同意將HCW9218母電芯轉讓給ImmunityBio。作為回報，ImmunityBio同意在2025年1月底之前與本公司簽訂供應協議，以確保HCW9218的臨床供應可用於繼續臨床研究。

HCW9302。 HCW9302是公司自體免疫計劃的基礎。 HCW9302的皮下注射旨在啟動和擴張T細胞。reg 減少衰老的T細胞是通過壓制携帶inflammasome的免疫細胞和它們分泌的炎症因子的活動而實現的。

本公司已向美國食品藥物管理局（“FDA”）提交了我們的IND申請，該申請目前正在審核中。本公司正在尋求批准進行臨床研究，以評估HCW9302在自體免疫指標上的應用。本公司無法保證FDA將及時授權其啟動計劃中的臨床試驗，或者根本不會授予。如果FDA不接受本公司的IND，本公司可能還需要尋求反饋，而反饋可能是不利的。如果本公司未能及時收到反饋，或者本公司被要求更改臨床方案的設計或解決其他反饋，則產品的臨床開發將會延遲，並且成本可能會增加。此外，如果FDA不接受本公司的IND，本公司可能需要進行額外的臨床前測試或其他IND啟動活動，這將導致進一步的延遲和額外的成本。

我們打算探索HCW9302在其他與老化相關的疾病中的用途，例如神經退行性疾病，在相關的動物模型中進行研究。我們的計劃是在一項評估HCW9302於自體免疫指標的第十億期臨床試驗中確定患者的RP2D，然後在利用此RP2D的第二期試驗中擴展到神經退行性疾病指標。

HCW9206。 HCW生物製品保留HCW9206注射劑形式的權利。這種HCW9206形式是臨床前階段，我們正在開始IND啟動活動。體外權利已被授予Wugen。這種HCW9206形式已進入臨床階段，Wugen正在評估其在與HCW9201合併使用於第1期臨床試驗中的效果。

HCW9201。這是Wugen目前在急性骨髓性白血病進行一期臨床試驗的臨床前分子，作為一種基於細胞的治療。我們還未開展任何臨床試驗來評估HCW9201在其他適應症中的作用。我們保留皮下注射的權利。 HCW9201具有獨特設計，形成具有三種強效細胞因子IL-12、IL-15和IL-18的多功能化合物，在單一蛋白質複合物中。我們正在探索HCW9201的腫瘤內注射治療癌症。

新型藥物發現平台，採用新穎的蛋白質支架。我們最近發現的一個新藥開發平台使用了一種不基於組織因子的嶄新蛋白支架，這使其與TOBI平台有所區別。TM 通過這個不基於組織因子的全新平台，我們擴展了可以治療的疾病和狀況。公司已經利用這種新型蛋白質支架構建了幾個免疫療法融合體，我們正測試以判斷最有潛力的計劃，這些計劃包括那些可以授權給其他公司的。

本公司正在進行嚴格的前臨床動物研究，使用幾種不同的模型來特徵化這些新化合物，並確定哪些化合物顯示出在癌症及其他由慢性炎症促進的疾病治療中具有最大的潛力。臨床開發計劃是至少有一種使用這一新型平台構建的分子在2026年進入臨床開發，無論是通過公司自有項目還是通過外部授權項目。

該公司正在探索具有潛在應用的大量其他分子。該公司認為，業務發展交易，例如授權協議，是我們的融資策略的基本要素，以提供未來所需的非稀釋資本，以資助該公司領先免疫療法計劃的臨床開發。

我們在2020年底簽署了首個外授許可協議，這是一項與Wugen, Inc.（「Wugen」）的獨家全球許可（「Wugen許可」），該公司專注於癌症的電芯療法。作為前期授權費的一部分，公司收到Wugen普通股的股份，根據已完全轉換的已發行和流通股份，目前代表5.6%的所有權利益。Wugen獲得有限的權利，以根據我們內部開發的兩種多細胞因子融合蛋白分子HCW9201和HCW9206來開發、製造和商業化針對癌症的電芯療法。這些獲得授權的分子是Wugen記憶型Nk細胞療法計劃的基礎。Wugen還擁有一個有前途的CAR-t計劃，基於其主要分子WU-CARt-007。WU-CART007計劃獲得了FDA和歐盟的兩項監管認可，分別加快了監管審查。Wugen已獲准於2025年第一季度啟動其首個創新型抗CD7 CAR-t電芯療法WU-CARt-007的關鍵第二期研究，針對復發或難治（R/R）T細胞急性淋巴細胞白血病或T細胞淋巴母細胞瘤（t-ALL/LBL）患者。

我們計劃繼續與國立衛生研究院和新華保險（“NCI”）合作，進行合作協議並協助資金支持研究和臨床研究。在2022年，公司簽署了一項合作研究與發展協議（“CRADA”），根據該協議，我們與NCI合作進行了針對晚期/轉移性和化療難治/化療抵抗的胰腺癌患者的1b/2期臨床研究。我們的計劃是利用這些關係來促進HCW9206的臨床開發及我們未來在癌症指標中創建的免疫療法融合。

該公司仍然致力於對我們的臨床物資供應以及我們授權者的授權分子供應建立一定的控制。該公司保留了根據Wugen許可證的授權分子的製造權，並打算在未來如果進入其他授權協議時採用相同的框架。2024年9月9日，眾議院通過了BIOSECURE法案（以下稱“法案”）。在強大的兩黨支持下，此法案預計將在2024年成為法律。相對不尋常的是，該法案明確列出了某些公司，自動符合“受關注的生物技術公司”的資格。期望該法案的這一條款將有效禁止美國公司與五家中國企業開展業務，包括藥明康德、Complete Genomics和MGI Tech。在生命科學公司中，藥明康德是全球最大的合同開發和製造服務提供商之一。根據某些估計，藥明康德是許多生物技術和製藥公司的重要合作夥伴，參與開發美國使用的25%的藥物。該法案將有效禁止藥明康德在美國開展業務，這預計將擾亂生命科學公司的供應鏈。預期結果是，這將在未來幾年內造成延遲、價格上漲和供應短缺，因為行業正在取代藥明康德及法案中列出的其他公司的產能。

Inflationary Cost Environment, Banking Crisis, Supply Chain Disruption and the Macroeconomic Environment

Our operations have been affected by many headwinds, including inflationary pressures, rising interest rates, ongoing global supply chain disruptions resulting from increased geopolitical tensions such as the war between Russia and Ukraine, the war in the Middle East, China-Taiwan relations, financial market volatility and currency movements. These headwinds, specifically the supply chain disruptions, have adversely impacted our ability to procure certain services and materials, which in some cases impacts the cost and timing of clinical trials and IND-enabling activities. In addition, we have been impacted by inflation when procuring materials required for the buildout of our new headquarters, the costs for recruiting and retaining employees and other employee-related costs. Further, rising interest rates have also increased borrowing costs. The Company uses a number of strategies to effectively navigate these issues, including product redesign, alternate sourcing, and establishing contingencies in budgeting and timelines. However, the extent and duration of such events and conditions, and resulting disruptions to our operations, are highly unpredictable.

For discussion of risks related to potential impacts of supply chain, inflation, geopolitical and macroeconomic challenges on our operations, business results and financial condition, see Part II, Item 1A. – “Risk Factors” in the Company’s Annual Report.

We have no products approved for commercial sale and have not generated any revenue from commercial product sales of internally-developed immunotherapeutic products for the treatment of cancer and other age-related diseases. The principal source of our revenues to date have been generated from our Wugen License and Master Services Agreement (the “MSA”) with Wugen. See Note 1 to our condensed interim financial statements included elsewhere in this Quarterly Report for these definitions and more information.

We derive revenue from a license agreement granting rights to Wugen to further develop and commercialize products based on two of our internally-developed molecules. Consideration under our contract included a nonrefundable upfront payment, development, regulatory and commercial milestones, and royalties based on net sales of approved products. Additionally, HCW Biologics retained manufacturing rights and has agreed to provide Wugen with clinical and research grade materials for clinical development and commercialization of licensed products under separate agreements. We assessed which activities in the Wugen License should be considered distinct performance obligations that should be accounted for separately. We develop assumptions that require judgement to determine whether the license to our intellectual property is distinct from the research and development services or participation in activities under the Wugen License.

Performance obligations relating to the granting a license and delivery of licensed product and R&D know-how were satisfied when transferred upon the execution of the Wugen License on December 24, 2020. The Company recognized revenue for the related consideration at a point in time. The revenue recognized from a transaction to supply clinical and research grade materials entered into under the MSA and covered by a Statement of Work, represents one performance obligation that is satisfied over time. The Company recognizes revenue generated for supply of material for clinical development using an input method based on the costs incurred relative to the total expected cost, which determines the extent of the Company’s progress toward completion.

Our operating expenses are reported as research and development expenses and general and administrative expenses.

Our research and development expenses consist primarily of costs incurred for the development of our product candidates, which include:

We expense research and development costs as they are incurred. Costs for contract manufacturing are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the agreement, and the pattern of payments for goods and services will change depending on the material. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses and expensed as the related goods are delivered or the services are performed.

We expect research and development expenses to increase substantially for the foreseeable future as we continue the development of our product candidates. We cannot reasonably determine the nature, timing, and costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. Product candidates in later stages of development generally have higher development costs than those in earlier stages. See “Risk Factors – Risks Related to the Development and Clinical Testing of Our Product Candidates,” in our Annual Report for a discussion of some of the risks and uncertainties associated with the development and commercialization of our product candidates. Any changes in the outcome of any of these risks and uncertainties with respect to the development of our product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.

General and administrative expenses consist primarily of employee-related expenses, including salaries, related benefits, and stock-based compensation expense for employees in the executive, legal, finance and accounting, human resources, and other administrative functions. General and administrative expenses also include third-party costs such as insurance costs, fees for professional services, such as legal fees in the ordinary course of business, auditing and tax services, facilities administrative costs, and other expenses.

We expect general and administrative expenses incurred in the normal course of business for other purposes, such as costs for recruitment and retention of personnel, service fees for consultants, advisors and accountants, as well as costs to comply with government regulations, corporate governance, internal control over financial reporting, insurance and other requirements for a public company, to continue to increase for the foreseeable future as we build our clinical programs.

Legal expenses consist of fees incurred by the Company in its own defense and that of officers and employees in connection with a legal matter brought against the Company and Dr. Hing C. Wong, our Founder and Chief Executive Officer, by a former employer of Dr. Wong.

During the period ended December 31, 2022, Altor/NantCell initiated legal proceedings against Dr. Wong and the Company. On April 26, 2023, the parties stipulated that Altor/NantCell’s action against the Company would be consolidated with the Altor/NantCell arbitration demand against Dr. Wong. On April 27, 2023, the U.S. District Court for the Southern District of Florida (the “Court”) with jurisdiction over the lawsuit against the Company approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Proceedings against the Company and Dr. Wong were consolidated in the arbitration before JAMS (“Arbitration”). On March 26, 2024, Altor/NantCell filed a complaint (the “Complaint”) against the Company in the Chancery Court of the State of Delaware for the contribution of legal fees and expenses advanced to Dr. Wong. The arbitration hearing was held on May 20, 2024 to May 31, 2024, after which the parties entered into settlement negotiations.

As reported in the Company’s Form 8-K filed on July 18, 2024 and further described in Part II, Item 1. – “Legal Proceedings” below, as of July 13, 2024, the Company and Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, entered into a confidential Settlement Agreement and Release (the “Settlement Agreement”) with Altor BioScience, LLC (“Altor”), NantCell, Inc. (“NantCell”), and ImmunityBio, Inc. (the parent of Altor and NantCell, together with Altor and NantCell, “ImmunityBio”), to resolve the previously disclosed Arbitration before JAMS brought by Altor and NantCell as well as a Complaint Altor filed against the Company in the Chancery Court of the State of Delaware for the contribution of legal fees and expenses advanced to Dr. Wong. The Settlement Agreement includes mutual general releases by and among the parties thereto. No party is required to make any monetary payments to any other party or person under the Settlement Agreement and each party will bear its own expenses incurred in connection with the matter. The Company has substantially completed remediation procedures required to be in compliance with the terms of the Settlement Agreement. Under the Settlement Agreement, upon completion of these procedures, the parties mutually agreed to stipulate that the Arbitration and Complaint should be dismissed. In accordance with 17 CFR 229.601 (Item 601), the Company has included the Settlement Agreement in this Quarterly Report on Form 10-Q. As of the filing date, the parties to the Settlement Agreement are working together to finalize the notices and related final documentation to obtain dismissal of the Arbitration and Complaint.

As reported in the Company’s Form 8-K filed on May 1, 2024 with the SEC, the Company became aware that it was the victim of a criminal scheme involving the impersonation of a purchaser upon the default on a legally binding commitment to purchase $8.0 million of secured notes from the Company. The scheme resulted in the misdirection of approximately $1.3 million held in Company accounts to a fraudulent account controlled by a third party. The Company is pursuing all available remedies to recover this loss. Given the limited success that these efforts have had to date for the recovery of funds, the Company recognized a loss of $1.3 million in the nine-month period ended September 30, 2024.

Interest expense includes interest paid on debt. This includes interest due on the Cogent Bank loan and senior secured notes issued by the Company.

Other income, net consists of interest earned on our cash, cash equivalents, unrealized gains and losses related to our investments in U.S. government-backed securities, and other income and expenses related to non-operating activities.

The Company recognized revenues of $853,102 and $426,423 for the three months ended September 30, 2023 and 2024, respectively. Revenues were derived exclusively from the sale of licensed molecules to Wugen. Under the terms of the supply agreement between Wugen and the Company, the Company earns an industry-standard gross margin. Occasionally, Wugen acquires product which is part of inventory we made for our own use. In these instances, we do not apply the standard costs since the cost of manufacturing these materials would have already been expensed in a prior period.

The following table summarizes our research and development expenses for the three months ended September 30, 2023 and September 30, 2024:

Research and development expenses decreased by $480,529, or 29%, from $1.7 million for the three months ended September 30, 2023 to $1.2 million for the three months ended September 30, 2024. The decrease was primarily attributable to a decrease in expenses for manufacturing and materials, preclinical activities and clinical studies.

Salaries, benefits, and related expenses decreased by $39,740, or 6%, from $692,607 for the three months ended September 30, 2023 to $652,867 for the three months ended September 30, 2024. The decrease reflects cost cutting measures put in place in the second quarter of 2024, which resulted in a $11,572 decrease in salaries and related taxes and a $29,801 decrease in costs related to employee benefits for the three-month period ended September 30, 2024.

Manufacturing and materials expense decreased by $158,402, or 77%, from $206,150 for the three months ended September 30, 2023 to $47,748 for the three months ended September 30, 2024. In the three months ended September 30, 2023, costs were incurred primarily for master cell bank characterization for HCW9101H, a high-producing cell line of a key component of the manufacturing process for the Company's proprietary molecules including those licensed to Wugen, as well as ancillary activities such as shipping, insurance and storage. In the three months ended September 30, 2024, costs were associated with ancillary activities such as shipping and storage.

Expenses associated with preclinical activities decreased by $161,598, or 53%, from $306,344 for the three months ended September 30, 2023 to $144,746 for the three months ended September 30, 2024. In the three months ended September 30, 2023 and 2024, costs were incurred primarily for IND-enabling studies to prepare for the submission of an IND application to evaluate HCW9302 in a clinical study.

Expenses associated with clinical activities decreased by $179,682, or 52%, from $343,821 for the three months ended September 30, 2023 to $164,139 for the three months ended September 30, 2024. The decrease in costs was primarily attributable a $188,637 decrease in the expenses associated with patient fees, partially offset by a $9,290 increase in consulting and other professional fees.

Subject to our ability to successfully execute our plans to obtain financing, we anticipate expenses related to clinical activities will increase substantially in the future, in the event that we successfully advance our immunotherapeutic fusion molecules in clinical development. If we are unable to complete planned capital-raising transactions and business development transactions for out-licensing, we may have to curtail or cease operations.

Other expenses, which include overhead allocations, increased by $58,893, or 50%, from $118,520 for the three months ended September 30, 2023 to $177,413 for the three months ended September 30, 2024. This increase is primarily attributable to a change in allocation of overhead to cost of good sold and a $62,031 decrease in travel-related expenses partially offset by a $9,786 increase in costs associated with IT, office supplies and other office equipment.

The following table summarizes our general and administrative expenses for the three months ended September 30, 2023 and September 30, 2024:

General and administrative expenses related to the ordinary course of business increased by $129,216, or 9%, from $1.5 million for the three months ended September 30, 2023 to $1.6 million for the three months ended September 30, 2024. The increase is primarily attributable to an increase in professional services, mainly legal fees related to patents, and an increase in other expenses, mainly costs related to insurance, offset by a decrease in salaries and benefits.

Salaries, benefits and related expenses decreased by $156,886, or 20%, from $775,956 for the three months ended September 30, 2023 to $619,070 for the three months ended September 30, 2024. The decrease reflects cost cutting measures put in place in the second quarter of 2024, which resulted in a $152,332 decrease in salaries and related taxes and a $15,511 decrease in costs related to employee benefits for the three-month period ended September 30, 2024. These costs were offset by an increase of $10,957 in expenses related to stock-based compensation.

Professional services increased by $169,095, or 81%, from $207,815 for the three months ended September 30, 2023 to $376,910 for the three months ended September 30, 2024. Professional services include corporate legal services, legal services for procuring patents, as well as other professional services, such as auditing and tax advisory fees. The increase is primarily attributable to a $133,263 increase legal fees for services incurred in connection with procuring patents and a $35,832 increase in costs related to other professional services such as auditing and tax advisory fees. As a result of the Settlement Agreement, the Company agreed to maintain patent protection for rights retained under the agreement.

Facilities and office expenses decreased by $41,114, or 23%, from $175,694 for the three months ended September 30, 2023 to $134,580 for the three months ended September 30, 2024, primarily due to a $62,791 decrease in software and other licensing fees, partially offset by a $13,558 increase in other IT related expenses and a $10,818 increase in facilities expenses such as electricity and waste disposal.

Other expenses increased by $139,046, or 55%, from $251,016 for the three months ended September 30, 2023 to $390,046 for the three months ended September 30, 2024. The increase is primarily attributable to a $115,668 increase in insurance-related costs and a $37,730 increase in finance costs.

Legal expenses were $2.1 million in the three months ended September 30, 2023 and $1.0 million for the three months ended September 30, 2024. In the three months ended September 30, 2023, costs were incurred in connection with several legal proceedings which culminated by consolidating Altor/NantCell’s action against the Company with the Altor/NantCell arbitration demand against Dr. Wong. Thereafter, proceedings against the Company and Dr. Wong were consolidated in the arbitration before JAMS.

In the three months ended September 30, 2024, the Company reached a Settlement Agreement with the other parties to the arbitration and undertook the necessary steps for remediation and transfer of information required under the terms of the agreement. As of the filing date, the parties to the Settlement Agreement are working together to finalize the notices and related final documentation to obtain dismissal of the Arbitration and Complaint. While the Company has relief from the future burden of ongoing legal expenses related to these proceedings, we incurred significant legal expenses for our defense and for the defense of officers and employees. We require a reasonable payment plan to prevent these expenses from overwhelming the Company’s resources. We are engaged in discussions with the law firms involved with this matter to work out payment plans.

On August 15, 2022, we entered into a loan and security agreement with Cogent Bank to partially fund our purchase of the property we acquired on that same date. We borrowed $6.5 million under this agreement. Amounts outstanding on the loan accrue interest at a rate per annum equal to 5.75%. We were obligated to make interest-only payments on this loan from September 2022 through August 2023 and principal and interest payments in 47 equal monthly installments, based on a 25-year maturity schedule, commencing September 15, 2023. We paid $95,514 and $93,936 in cash for interest on the Cogent Bank loan for the three months ended September 30, 2023 and 2024, respectively. For the three months ended September 30, and September 30, 2024, interest was expensed.

As of September 30, 2024, the Company had issued $6.5 million in senior secured notes which bear interest at an annual rate of 9%, payable quarter in arrears. We paid $87,386 in cash interest on the senior secured notes for the three months ended September 30, 2024. There were no senior secured notes outstanding in 2023.

Other income, net decreased from $234,753 for the three months ended September 30, 2023 to $11,310 for the three months ended September 30, 2024. The decrease is primarily attributable to a decline in interest earned from money market deposits and a decrease in unrealized gains from investments in U.S. government-backed securities. In addition, for the three months ended September 30, 2023, Other income included rental income. On August 15, 2022, the Company entered into a short-term, market-rate lease with the former owner of the building we purchased on the same date, which terminated in the year ended December 31, 2023. We received rental income of $60,003 for the three months ended September 30, 2023.

The Company recognized $1.5 million and $2.2 million of revenues for the nine months ended September 30, 2023 and 2024, respectively. Revenues were derived exclusively from the sale of licensed molecules to Wugen. Under the terms of the supply

agreement between Wugen and the Company, the Company earns an industry-standard gross margin. Occasionally, Wugen acquires product which is part of inventory we made for our own use. In these instances, we do not apply the standard costs since the cost of manufacturing these materials would have already been expensed in a prior period.

The following table summarizes our research and development expenses for the nine months ended September 30, 2023 and September 30, 2024:

Research and development expenses decreased by $200,536, or 4%, from $5.5 million for the nine months ended September 30, 2024 to $5.3 million for the nine months ended September 30, 2024, primarily due to an increase in manufacturing and materials expenses, partially offset by a decrease in preclinical and clinical expenses.

Salaries, benefits, and related expenses decreased by $6,015, or 0%, from $2.2 million for the nine months ended September 30, 2023 to $2.2 million for the nine months ended September 30, 2024. This decrease was primarily attributable to a difference in the costs allocated to cost of goods sold, as well as a $121,139 decrease in salaries, benefits and related expenses as a result of cost cutting measures put in place in the second quarter of 2024, consisting of a $83,893 decrease in salaries, bonuses and related taxes and a $29,185 decrease in costs related to employee benefits, for the nine-month period ended September 30, 2024.

Manufacturing and materials expense increased by $752,045, or 121%, from $623,785 for the nine months ended September 30, 2023 to $1.4 million for the nine months ended September 30, 2024. In the nine months ended September 30, 2023, costs were incurred primarily for production activities associated with the master cell bank characterization for a high production cell line for HCW9101; a 200L cGMP manufacturing run of HCW9302; and ancillary activities such as shipping, insurance and storage. In the nine months ended September 30, 2024, costs were primarily attributable to the costs of production and materials related to manufacturing the high producing cell-line of HCW9101, which is used in the manufacturing process for all TOBI-based molecules.

Expenses associated with preclinical activities decreased by $679,415, or 50%, from $1.4 million for the nine months ended September 30, 2023 to $688,310 for the nine months ended September 30, 2024. In the nine months ended September 30, 2023, costs were incurred to complete the toxicology study and for additional studies required for submission of the HCW9302 IND. In the nine months ended September 30, 2024, toxicology and other IND-enabling studies were winding down, and the IND application was finalized, submitted and is now under review.

Expenses associated with clinical activities decreased by $292,206, or 37%, from $788,116 for the nine months ended September 30, 2023 to $495,910 for the nine months ended September 30, 2024. The decrease was primarily attributable to a $341,271 decrease in patient fees, partially offset by a $61,080 increase costs for post-clinical studies that we conducted through collaborations. In the nine months ended September 30, 2023, there were two ongoing clinical trials, including a Phase 1 study sponsored by the University of Minnesota to evaluate HCW9218 in the treatment of various solid tumors, and a Company-sponsored Phase 1b clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant pancreatic cancer. In the nine months ended September 30, 2024, we completed enrollment in the Phase 1/1b clinical trials and the majority of our activities were focused on post-clinical correlative studies which we conducted through collaborations. As a result of the Settlement Agreement, ImmunityBio has the exclusive right to the use of HCW9218 in the treatment of pancreatic cancer. We will continue to evaluate HCW9218 in combination with neoadjuvant chemotherapy in the treatment of ovarian cancer.

Other expenses, which include overhead allocations, increased by $25,055, or 4%, from $565,028 for the nine months ended September 30, 2023 to $590,083 for the nine months ended September 30, 2024. The decrease in other expenses is primarily attributable to a decrease in the allocation of depreciation to cost of goods sold, partially offset by a $38,055 decrease in travel-related expenses.

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2023 and September 30, 2024:

General and administrative expenses related to the ordinary course of business decreased by $307,237, or 6%, from $5.1 million for the nine months ended September 30, 2023 to $4.8 million for the nine months ended September 30, 2024. The decrease is primarily attributable to a decrease in salaries and bonuses as a result of cost-cutting measures put in place in the second quarter of 2024.

Salaries, benefits and related expenses decreased by $552,962, or 23%, from $2.4 million for the nine months ended September 30, 2023 to $1.9 million for the nine months ended September 30, 2024. The decrease is primarily attributable to a $212,014 decrease in salaries and related taxes, a $19,372 decrease in expenses for employee benefits, and a $304,175 decrease resulting from the waiver of performance-based bonuses earned in 2022 but deferred.

Professional services decreased by $48,127, or 5%, from $1,008,807 for the nine months ended September 30, 2023 to $960,680 for the nine months ended September 30, 2024. Professional services include corporate legal services, legal services for procuring patents, as well as other professional services, such as auditing and tax advisory fees. The decrease is primarily attributable to a $69,797 decrease in legal fees incurred in connection with procuring patents, partially offset by a $21,670 increase in fees for other professional services such as audit and tax advisory fees. As a result of the Settlement Agreement, the Company agreed to maintain patent protection for rights retained under the agreement.

Facilities and office expenses increased by $103,517, or 24%, from $439,373 for the nine months ended September 30, 2023 to $542,890 for the nine months ended September 30, 2024, primarily due to a $78,185 increase in software and other licensing fees and a $21,157 increase in costs for waste disposal.

Other expenses increased by $138,175, or 15%, from $943,122 for the nine months ended September 30, 2023 to $1.1 million for the nine months ended September 30, 2024. The increase is primarily attributable to a $227,470 increase in financing expenses primarily related to our search for a lender to complete the construction of the Company’s new headquarters and a $30,528 increase in insurance-related costs, partially offset by a $102,505 decrease in Delaware franchise taxes.

Legal expenses were $4.6 million in the nine months ended September 30, 2023 and $15.8 million for the nine months ended September 30, 2024. In the nine months ended September 30, 2023, costs were incurred in connection with several legal proceedings which culminated by consolidating Altor/NantCell’s action against the Company with the Altor/NantCell arbitration demand against Dr. Wong. Thereafter, proceedings against the Company and Dr. Wong were consolidated in the arbitration before JAMS.

In the nine months ended September 30, 2024, preparations for the arbitration were taking place with witness preparation and depositions. The arbitration hearing was held from May 20, 2024 to May 31, 2024, which required a large team of lawyers to represent the Company; Dr. Wong; Dr. Peter Rhode, our Chief Scientific Officer and Vice President of Clinical Affairs and an officer of the Company; as well as other employees. The hearing was followed by an extended period of intense negotiations which culminated in a Settlement Agreement entered into by the Company and Dr. Wong as of July 13, 2024 with Altor/NantCell and its parent, ImmunityBio. While the Company has relief from the future burden of ongoing legal expenses related to these proceedings, we incurred significant legal expenses for our defense and for the defense of officers and employees. We require a reasonable payment plan to prevent these expenses from overwhelming the Company’s resources. We are engaged in discussions with the law firms involved with this matter.

On August 15, 2022, we entered into a loan and security agreement with Cogent Bank to partially fund our purchase of the property we acquired on that same date. We borrowed $6.5 million under this agreement. Amounts outstanding on the loan accrue interest at a rate per annum equal to 5.75%. We were obligated to make interest-only payments on this loan from September 2022 through August 2023 and principal and interest payments in 47 equal monthly installments, based on a 25-year maturity schedule, commencing September 15, 2023. We paid $284,465 and $282,098 in cash for interest related to the Cogent Bank loan for the nine months ended September 30, 2023 and 2024, respectively. For the nine months ended September 30,2023, interest was expensed. Interest was capitalized the last quarter of 2023 and ceased in the second quarter of 2024. In all other periods, interest was expensed.

As of September 30, 2024, the Company had issued $6.5 million in senior secured notes which bear interest at an annual rate of 9%, payable quarter in arrears. We paid $152,679 in cash interest on the senior secured notes for the nine months ended September 30, 2024. There were no senior secured notes outstanding in 2023.

Other income, net decreased from $919,688 for the nine months ended September 30, 2023, to $52,397 for the nine months ended September 30, 2024. The decrease is primarily attributable to a decrease interest earned for money market deposits and unrealized gains for investments in U.S. government-backed securities. Other income included rental income for the nine months ended September 30, 2023. On August 15, 2022, the Company entered into a short-term, market-rate lease with the former owner of the building we purchased on the same date, which terminated in the year ended December 31, 2023. We received rental income of $178,910 for the nine months ended September 30, 2023.

As of September 30, 2024, we concluded that there is substantial doubt over as to whether the Company has sufficient capital to operate for the next 12 months from the issuance date of this Quarterly Report based on our liquidity, revenues and ongoing operating losses, as well as the legal fees incurred in conjunction with an arbitration with ImmunityBio prior to the Settlement Agreement executed in the third quarter of 2024. As of September 30, 2024, our principal source of liquidity was $1.0 million in cash and cash equivalents. To date, the Company has funded operations primarily through the sale of stock, issuance of senior secured notes and revenues generated the Wugen License, pursuant to which Wugen licensed limited rights to develop, manufacture, and commercialize cell therapy treatments for cancer based on two of the Company’s internally-developed multi-cytokine fusion protein molecules, and its manufacturing and supply arrangement with Wugen. As of September 30, 2024, the Company had not generated any revenue from commercial product sales of its internally-developed immunotherapeutic products for the treatment of cancer and other age-related diseases. In the course of its development activities, the Company has sustained operating losses and expects to continue to incur operating losses for the foreseeable future.

On August 15, 2022, the Company entered into the 2022 Loan Agreement with Cogent Bank, pursuant to which it received $6.5 million in proceeds to purchase a building that will become the Company's new headquarters. The loan is secured by a first priority lien on the building. As of September 30, 2024, certain subcontractors have filed mechanics liens related to unpaid invoices issued in connection with the Company’s construction of its new manufacturing facilities and upgraded research laboratories. The 2022 Loan Agreement contains a provision for a discretionary default in the event that the Company fails to pay sums due in connection with construction of any improvements; however, as of the reporting date, the lender has not elected to do so. As of September 30, 2024, the Company has reflected this loan as Short-term debt, net, to reflect that the lender has the right to accelerate the loan under a discretionary default provision. The Company continues to seek the financing required to complete the construction project, with the cooperation of the lender and lien holders. See Part I, Item 4. -- “Controls and Procedures.”

In 2024, we have raised $9.4 million in financings. On February 20, 2024, we completed a $2.5 million private placement of common stock in which we sold an aggregate of 1,785,718 shares to certain of our officers and directors, at a purchase price of $1.40 per share. As of September 30, 2024, we received $6.5 million from the issuance of Secured Notes, and subsequent to the reporting period, the Company issued an additional $375,000 in Secured Notes. Of the total issuance of Secured Notes, the Company issued $2.9 million to members of the Company’s board of directors and officers, including $2.4 million purchased by Dr. Hing C. Wong, Founder and CEO, $220,000 purchased by Rebecca Byam, Chief Financial Officer, $140,000 purchased by Scott T. Garrett, Chairman of the board of directors, $60,000 purchased by Gary M. Winer, member of the board of directors, $25,000 purchased by Lee Flowers, Senior Vice President for Business Development, and $25,000 purchased by Rick S. Greene, member of the board of directors. The Company expects the funds raised through the issuance of Secured Notes to be sufficient capital to reach a milestone in the fourth quarter of 2024. Management has made some reductions in costs and there may be further reductions or restructuring in the future after we complete the reassessment of our clinical development strategy.

A benefit of reaching a Settlement Agreement and concluding the Arbitration is a release from restrictions related to protection of privileged information, which hampered investor ability to conduct due diligence. As a result, we believe that other avenues of financing are now available to us, namely, capital-raising activities for equity and equity-like investments as well as business development transactions such as out-licensing agreements for rights for our proprietary molecules. However, there can be no assurance of our success in our capital-raising activities. If we are not successful in raising additional capital, we have the ability to revise our business plan and reduce costs. If such revisions are insufficient, we may have to curtail or cease operations.

The Company and Dr. Wong, our Founder and Chief Executive Officer, entered into a Settlement Agreement and Release on a previously reported Arbitration as of July 13, 2024. See Part II., Item 1. - “Legal Proceedings.” While the Settlement Agreement has resolved uncertainty regarding the outcome of these proceedings and the ongoing legal expenses, the Company incurred significant legal expenses in the period leading up to the Settlement Agreement. As of September 30, 2024, we reported a balance of $14.4 million for legal fees incurred but not yet paid in the accompany condensed balance sheet. In order not to overwhelm the Company’s resources, a reasonable payment plan will be required. The Company is engaged in discussions with the law firms involved with this matter.

We considered elements of our financing plan that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient mitigate the substantial doubt in our going concern analysis. The Company launched a financing plan in the third quarter of 2024. The plan includes several capital-raising activities, such as issuance of secured notes, equity financings, as well as business development transactions, such as license agreements with guaranteed minimum payments. Through October 31, 2024, the Company had issued an aggregate of $6.9 million in secured notes. On September 25, 2024, the Company entered into a nonbinding term sheet with a party interested in licensing one of the Company’s preclinical molecules. The Company expects to close this license transaction in the fourth quarter of 2024. The proposed terms of the license include a guaranteed minimum payments which are expected within the first year of the term. On November 13, 2024, we entered into an engagement letter with the Maxim Group to act as the exclusive placement agent for a multi-step equity financing. If the Company is not successful in raising additional capital through these activities, management intends to revise its business plan and reduce costs. If such revisions are insufficient, the Company may have to curtail or cease operations.

The accompanying interim financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. The Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the date of issuance of the Company’s condensed interim financial statements, without additional funding or financial support. After considering management’s plan for financing and funds raised that are probable to occur within one year, as well as that the Company expects to continue to incur losses from operations for the foreseeable future, management concluded that the substantial doubt that existed in its going concern analysis was not alleviated.

Because of the numerous risks and uncertainties associated with the clinical development and commercialization of immunotherapeutics, we are unable to estimate the exact amount of capital requirements to pursue these activities. Our funding requirements will depend on many factors, including, but not limited to:

A change in the outcome of any of these or other factors with respect to the clinical development and commercialization of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures.

Comparison of the Cash Flows for the Nine Months Ended September 30, 2023 and September 30, 2024

The following table summarizes our cash flows for the nine months ended September 30, 2023 and September 30, 2024:

Net cash used in operating activities were $18.6 million for the nine months ended September 30, 2023 and $11.4 million for the nine months ended September 30, 2024.

Cash used in operating activities for the nine months ended September 30, 2023 consisted primarily of a net loss of $14.3 million, as well as a deposit $5.3 million used to establish an interest reserve for future interest payments, as required under the terms of the Credit Agreement intended to be used to fund the construction and renovation of the Company’s new headquarters. In addition, other uses of cash include a $292,383 increase in accounts receivable and a $251,008 increase in prepaid expenses and other current assets, partially offset by cash provided by a $392,802 net increase in accounts payable and other current liabilities. Further offset to the use of cash resulted from net noncash adjustments of $1.1 million, consisting primarily of $860,634 of cash provided by an adjustment for depreciation and amortization, $742,477 of cash provided by an adjustment for stock-based compensation, reduced by $248,445 of cash used for an adjustment for unrealized gains on investments.

Cash used in operating activities for the nine months ended September 30, 2024 consisted primarily of net loss for the period of $26.7 million, partially offset by a $12.4 million increase in accounts payable and other liabilities, a decrease of $883,917 in accounts receivable and a decrease of $829,043 in prepaid expenses and other current assets. Further offset to the use of case resulted from noncash adjustments of $1.2 million, consisting primarily of $501,882 of cash provided by an adjustment for depreciation and amortization and $716,940 of cash provided by an adjustment for stock-based compensation.

Cash used by investing activities for the nine months ended September 30, 2023, consisted of $10.0 million of cash provided when short-term investments reached maturity, partially offset by $2.5 million of cash used to purchase equipment.

Cash used by investment activities for the nine months ended September 30, 2024 consisted of $148,205 used for purchases of property and equipment.

Cash provided by financing activities for the nine months ended September 30, 2023 resulted from issuance of common stock upon exercise of vested employee stock options, partially offset by a principal repayment under the 2022 Loan Agreement related to the acquisition financing used to purchase a building.

Cash provided by financing activities for the nine months ended September 30, 2024 resulted from a $2.5 million private placement of the Company’s common stock and $6.5 million from the issuance of Secured Notes, partially offset a $88,388 principal repayment under the 2022 Loan Agreement related to the acquisition financing used to purchase a building.

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed interim financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of

contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgements and estimates.

We recognize revenue under the guidance of Topic 606. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of Topic 606, we perform the following five steps: (i) identification of the contract(s) with the customer, (ii) identification of the promised goods or services in the contract and determination of whether the promised goods or services are performance obligations, (iii) measurement of the transaction price, (iv) allocation of the transaction price to the performance obligations, and (v) recognition of revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to our customer. See Note 1 to our condensed interim financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for more information.

Other than the above, there have been no material changes to our critical accounting policies and estimates from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies, Significant Judgements and Use of Estimates” in our Annual Report.

As of September 30, 2024, we had cash and cash equivalents of $1.0 million including cash, cash equivalents and market investments. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. We are exposed to market risk related to the marketability of our Wugen common stock reported within Investments in the accompanying condensed interim balance sheet. Until such time as these shares become publicly traded, we will have limited access to liquidity for these securities.

As of September 30, 2024, our management, with participation of our principal executive officer and principal financial officer, performed an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a – 15(e) under the Exchange Act). While the Company implemented an Authorization Matrix and a Remediation Plan in the second quarter of 2024, our management believes the strengthened controls designed to address the material weaknesses identified in prior periods have not been in place for a sufficient time to conclude on whether or not they have been operating effectively as of September 30, 2024. Our management will continue to evaluate the effectiveness of the internal controls over financing reporting, including the Authorization Matrix and Remediation Plan, in future reporting periods.

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) under the Exchange Act). Internal control over financial reporting is a process designed under the supervision and

with the participation of our management, including our principal executive officer and our principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles in the United States.

As of September 30, 2024, our management assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework. Based on this assessment, two material weaknesses over financial reporting were identified (described below). A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that a reasonable possibility exists that a material misstatement of our annual or condensed interim financial statements would not be prevented or detected on a timely basis.

Two of the material weaknesses were identified in a prior period, as the Company reported in a Current Report on Form 8-K filed with the SEC on May 1, 2024. The Company was a victim of a criminal scheme involving the impersonation of a purchaser of Secured Notes. The scheme resulted in the misdirection of approximately $1.3 million held in Company accounts to a fraudulent account controlled by a third party and a default on a legally binding commitment to purchase Secured Notes. As a result of the default and the related misdirection of funds, management re-evaluated the effectiveness of our disclosure controls and procedures and internal control over financial reporting as of December 31, 2023. Based on this assessment, management identified material weaknesses in two areas, including the methods used to review, evaluate and accept financing proposals from investors and lenders and the process used to enter unusual significant transactions. As a result of the material weakness to protect the Company’s assets from fraud committed by third parties, there was a $1.3 million loss recognized on the Company’s interim condensed financial statements.

During the period ended June 30, 2024, a Remediation Plan was implemented. See “Remediation Plan for Material Weaknesses in Internal Control over Financial Reporting.” Our principal executive officer and principal financial officer concluded there was not yet enough evidence due to the infrequency of significant transactions to assess the effectiveness of internal controls during the period ended September 30, 2024. We will continue to assess the effectiveness of the internal controls in each reporting period, especially those related to significant or unusual transactions contained in the Remediation Plan.

As of September 30, 2024, the Company identified two additional material weaknesses in internal controls over financing reporting related to the classification of the Cogent Loan and accounting for the Secured Notes. On August 15, 2022, the Company entered into the 2022 Loan Agreement with Cogent Bank, pursuant to which we received $6.5 million in proceeds to purchase a building. The loan is secured by a first priority lien on the building. As of September 30, 2024, certain subcontractors have filed mechanics liens related to unpaid invoices issued in connection with the Company’s construction and improvements on the building. The 2022 Loan Agreement contains a provision for a discretionary default in the event that the Company fails to pay sums due in connection with construction of any improvements. The Company did not identify and account for the loan as Short-term debt, net, to reflect that the lender has the right to accelerate the loan under a discretionary default provision as of September 30, 2024. As a result, we will enhance the controls we use to evaluate triggering events in debt agreements, to appropriately classify debt as current or noncurrent in the correct period.

The second material weakness identified as of September 30, 2024 related to accounting for complex transactions. This involved appropriately accounting for the Secured Notes and disclosing the amended terms that were executed during the third quarter of 2024. The Secured Notes were deemed to be a hybrid instrument, consisting of a debt host with embedded derivatives requiring bifurcation and accounting for separately. Prior to correcting the initial accounting treatment for the Secured Notes, as amended, the Company neglected to identify and account for the embedded derivatives. In addition, the disclosures for the Secured Notes would not have identified the embedded derivatives. The aggregation of these factors could have resulted in a material misstatement in the Company’s financial statements. As of September 30, 2024, there was no impact to the financial statements related to correcting the accounting treatment for embedded derivatives. Another amended term for the Secured Notes is a fixed bonus payment that holders will receive if the Secured Notes are repaid on the Maturity Date. The Company determined that the fixed bonus payment should be accreted to the principal owed to holders over the term. As of and for the three and nine months ended September 30, 2024, the Company did not accrete the fixed bonus payment. Accretion during this reporting period does not materially misstate the amount owed to the holders. In subsequent periods, the Company will accrete the fixed bonus payment as it will be material. If the Company did not correct the accounting treatment, we would understate our obligations. Over the term, this could have resulted in a material misstatement in the Company’s financial statements. Management resolved to allow for more time and resources to determine proper accounting for complex transactions.

Remediation Plan for Material Weakness in Internal Control over Financial Reporting

We are committed to establishing and maintaining a strong internal control environment. In response to the identified material weakness as described above, the Company’s Board of Directors and its Audit Committee have conducted an internal investigation to determine the root cause of the material weaknesses, with advice from outside advisors. Along with the advice of outside advisors, the board of directors worked with management to evaluate internal controls over financial reporting based on criteria set forth in “Internal Control – Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. As a result, the following two actions were taken by the board of directors:

On May 13, 2024, the board of directors adopted a Delegation of Management Authorities (“Authorization Matrix”), which provides for authorization thresholds for significant and unusual transactions, budget and strategic plans, audit and policies, personnel actions, contracts, litigation, major projects, credit or loans, and consulting agreements.

On June 11, 2024, the board of directors adopted a Remediation Plan designed to implement and strengthen controls and prevent re-occurrence of fraud on the Company:

While we strive to create a stronger control environment, we recognize that it is impossible for our internal controls over financial reporting to 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. 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 our 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 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. While we are committed to continuously improve and strengthen our control environment, over time, our internal controls over financial reporting may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Projections of any evaluation of effectiveness to future periods are subject to the risk that internal controls over financial reporting may become inadequate because of

changes in conditions, or that 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.

There have been no changes in our internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act during the three months ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

From time to time, the Company is a party to or otherwise involved in legal proceedings, including suits, assessments, regulatory actions and investigations generally arising out of the normal course of business. Such proceedings can be costly, time consuming, and unpredictable. Therefore, no assurance can be given on the outcome of any proceeding or the potential impact on our results of operations or financial condition.

During the period ended December 31, 2022, Altor/NantCell initiated legal proceedings against Dr. Wong and the Company. On April 26, 2023, the parties stipulated that Altor/NantCell’s action against the Company would be consolidated with the Altor/NantCell arbitration demand against Dr. Wong. On April 27, 2023, the U.S. District Court for the Southern District of Florida (the “Court”) with jurisdiction over the lawsuit against the Company approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Proceedings against the Company and Dr. Wong were consolidated in the arbitration before JAMS. The arbitration hearing was held from May 20, 2024 to May 31, 2024, after which the parties entered into settlement negotiations.

As reported in the Company’s Form 8-K filed on July 18, 2024, as of July 13, 2024, the Company and Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, entered into a confidential Settlement Agreement and Release (the “Settlement Agreement”) with Altor BioScience, LLC (“Altor”), NantCell, Inc. (“NantCell”), and ImmunityBio, Inc. (the parent of Altor and NantCell, together with Altor and NantCell, “ImmunityBio”), to resolve the previously disclosed arbitration before JAMS brought by Altor and NantCell (the “Arbitration”) as well as a complaint Altor filed against the Company in the Chancery Court of the State of Delaware for the contribution of legal fees and expenses advanced to Dr. Wong (“Complaint”). The Settlement Agreement includes mutual general releases by and among the parties thereto. No party is required to make any monetary payments to any other party or person under the Settlement Agreement and each party will bear its own expenses incurred in connection with the matter. The Company has completed the required remediation procedures. As of the filing date, the parties to the Settlement Agreement are working together to finalize the notices and related final documentation to obtain dismissal of the Arbitration and Complaint. In accordance with 17 CFR 229.601 (Item 601), the Company has included the Settlement Agreement in the Quarterly Report on this Form 10-Q.

Pursuant to the Settlement Agreement, the Company transferred and assigned to ImmunityBio ownership of certain intellectual property (including issued patents, pending patent applications, and know-how) for TOBITM-based molecules for use in the oncology field. The Company retains the worldwide, perpetual, irrevocable, fully paid-up, royalty-free, exclusive right and license to exploit HCW9218 for all age-related diseases other than cancer, with the exception of the treatment of ovarian cancer, which is also retained by the Company and is currently being studied in a Phase 2 clinical trial at the University of Pittsburgh Medical Center. The Company also retains the right to develop treatments for all indications with respect to HCW9302 and HCW9206, which, along with HCW9218, are the lead product candidates in the Company’s clinical development pipeline. ImmunityBio has the exclusive right to pursue oncology indications with all of the TOBITM-based molecules designed with a TGF-β domain, including HCW9218, with the exception of the treatment of ovarian cancer with HCW9218 in combination with neoadjuvant chemotherapy, which is retained by the Company. Under the Settlement Agreement, ImmunityBio also receives an exclusive license to exploit fusion proteins, molecules and/or antibodies created utilizing the TOBITM Platform directed to the receptors of PDL-1, IL-7, IL-12, IL-18, and IL-21, and one additional target to be selected by ImmunityBio within six months from the date of the Settlement Agreement, at its sole discretion, in the oncology field. The Company’s ownership and rights with respect to HCW9302, HCW9206 and HCW9201 are expressly excluded from the rights transferred to ImmunityBio for oncology indications. In addition, ImmunityBio received a non-exclusive license to exploit HCW9201 administered by injection for oncology indications.

The Company retains ownership and control of the TOBITM platform and TOBI-based molecules, with no restrictions under the Settlement Agreement on our ability to use the TOBITM platform for protein-fusion molecules for non-oncology indications. We have rights to pursue oncology indications, in particular using HCW9302, HCW9206 and HCW9201. Further, the Company retains ownership of the Wugen license and shares of Wugen common stock transferred to the Company as the upfront licensing fee from Wugen for granting the Wugen license. For our lead molecule, HCW9218, we maintain the non-exclusive right to use HCW9218 in combination with neoadjuvant chemotherapy in ovarian cancer, in addition to exclusive rights for clinical development and use of HCW9218 in the treatment of all non-oncological diseases. We retain ownership of our lead molecule, HCW9302, which expands Treg cells and is designed to treat autoimmune diseases and other proinflammatory diseases, including cancer, and the ownership of HCW9206, a preclinical molecule which we are developing for the treatment of cancer and other age-related diseases. The Company agreed to provide ImmunityBio with a right of first refusal to enter a licensing agreement for oncology indications for HCW9206. We have no restrictions on the development of HCW9206 for our own clinical development activities, including oncology indications. Under the terms of the Settlement Agreement, ImmunityBio will own the cell line and supply for HCW9218, and the

parties agreed that within six months from the date of the Settlement Agreement they will enter into a supply agreement providing the Company with a continuing supply of HCW9218 molecules. The Company also retains in vivo rights to HCW9201, a combination of IL-12, IL-15, and IL-18 in a single protein complex which is designed to stimulate activation and proliferation signals in human NK cells. The Company retains ownership of the cell lines for HCW9302, HCW9206 and HCW9201, and thus will retain independent control over manufacturing and supply for these compounds.

There have been no material changes to the risk factors previously disclosed by us in our Annual Report. The risk factors included the Annual Report continue to apply to us and describe risks and uncertainties that could cause actual results to differ materially from the results expressed or implied by the forward-looking statements contained in this Quarterly Report. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business, financial condition and results of operations.

On February 20, 2024 (the “Purchase Date”), we entered into subscription agreements (the “Subscription Agreements”) with certain officers and directors of the Company, including our Founder and Chief Executive Officer, our Chief Financial Officer and the Chairman of the Company’s Board of Directors, pursuant to which the Company sold an aggregate of 1,785,718 shares (the “Shares”) of our common stock, par value $0.0001 per share (the “Common Stock”), at a purchase price of $1.40 per share for an aggregate purchase price of $2.5 million. The per share purchase price represents a 25% premium to the per share closing price of the Common Stock as reported on the Nasdaq Global Market on the Purchase Date and a 19% premium to the 5-day volume weighted average closing price per share of the Common Stock as reported on the Nasdaq Global Market for the period ending on the Purchase Date.

The Shares issued pursuant to the Subscription Agreements were not registered under the Securities Act of 1933, as amended, in reliance upon exemptions provided by Section 4(a)(2) of the Securities Act of 1933, as amended.

During the fiscal quarter ended September 30, 2024, none of our directors or officers informed us of the adoption, modification or termination of a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408.

The following information is being included in this Item 5 in lieu of filing such information on a Current Report on Form 8-K under Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant and Item 8.01:

On March 28, 2024, the Company entered into a senior secured note purchase agreement (the “Note Purchase Agreement”) with the Purchasers (as defined in the Note Purchase Agreement), pursuant to which we agreed to issue senior secured notes in an aggregate principal amount of up to $10.0 million (“Secured Notes”) to certain accredited investors, including unrelated parties as well

as officers and directors of the Company. As of March 31, 2024, the Company had an initial closing and issued $2.0 million in Initial Secured Notes. As of June 30, 2024, all existing investors approved an Amended and Restated Note Purchase Agreement (“Amended and Restated Note Purchase Agreement”), with terms described below. As of September 30, 2024, the Amended and Restated Note Purchase Agreement was amended to extend the last closing date to issue Additional Secured Notes to October 31, 2024. No other terms were amended. The material terms of the Additional Secured Notes are identical to the terms of the Initial Secured Notes.

As of September 30, 2024, the Company issued an aggregate of $6.5 million of Secured Notes, with $2.8 million from the Company’s officers and members of the board of directors, including $2.4 million purchased by Dr. Hing C. Wong, Founder and CEO, $220,000 purchased by Rebecca Byam, Chief Financial Officer, $140,000 purchased by Scott T. Garrett, Chairman of the board of directors, $60,000 purchased by Gary M. Winer, member of the board of directors, $25,000 purchased by Lee Flowers, Senior Vice President for Business Development, and $25,000 purchased by Rick S. Greene, member of the board of directors.

During October 2024, the Company issued $375,000 of Additional Secured Notes, including $50,000 purchased by Dr. Wong on October 31, 2024.

The Senior Notes bear interest at a rate of 9% per annum, payable quarterly in arrears, and mature on August 30, 2026 (the “Maturity Date”), on which date the principal balance, accrued but unpaid interest, and other amounts that may be due under the terms of the Amended and Restated Note Purchase Agreement shall be due and payable. The Secured Notes may be prepaid on or prior to December 31, 2024, but will be subject to a 5% prepayment penalty (“Premium Amount”). Thereafter, the Senior Notes may be repaid upon a Mandatory Redemption event or at the end of the term.

As a condition to entering into the Amended and Restated Note Purchase Agreement, the Company, Mercedes M. Sellek, P.A. (“Escrow Agent”), and the Purchasers entered into that certain Escrow Agreement and Amended and Restated Pledge Agreement, dated July 2, 2024, pursuant to which the Company agreed to pledge our equity ownership interest in Wugen, which was equivalent to a 5.6% ownership stake in that company as of September 30, 2024 (the “Pledged Collateral”), to be held and released by Escrow Agent according to the terms of the Escrow Agreement, as security for the Secured Notes.

Upon a qualifying event Mandatory Redemption involving a transaction such as an acquisition, merger or initial public offering in which the Pledged Collateral can be sold or liquidated prior to the Maturity Date, subject to certain limitations (such as a threshold price per share in the case of an initial public offering), the Company agreed to repay all indebtedness (including accrued interest) related to the Secured Notes plus a Bonus Payment (as defined in the Amended and Restated Note Purchase Agreement). If there is no such Mandatory Redemption prior to the Maturity Date, the Company agreed to pay the holders of Secured Note a Bonus Payment under certain circumstances.

Upon a bona fide equity offering (as defined in the Amended and Restated Note Purchase Agreement), Senior Note holders have the right to convert to shares of the Company’s common stock (as defined in the Amended and Restated Note Purchase Agreement). The Amended and Restated Note Purchase Agreement sets forth preliminary terms that are subject to final documentation.

Upon an Event of Default (as defined in the Amended and Restated Note Purchase Agreement), the Company will have a thirty (30) day cure period (the “Cure Period”), and if the Event of Default is not so cured at the end of the Cure Period, the Company is required to distribute the Pledged Collateral to the Purchasers on a pro rata basis, determined based on the issuance of $10.0 million in Secured Notes, in full satisfaction of the indebtedness evidenced by the Secured Notes.

The foregoing descriptions of the Amended and Restated Note Purchase Agreement, Amended and Restated Senior Notes, Escrow Agreement and Amended and Restated Pledge Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Form of Amended and Restated Senior Secured Note Purchase Agreement, Form of Senior Secured Promissory Note, Form of the Amended and Restated Pledge Agreement and Form of Amended and Restated Escrow Agreement, copies of which are filed as Exhibit 10.1, Exhibit 10.2, Exhibit 10.3 and Exhibit 10.4, respectively, to this Quarterly Report and are incorporated herein by reference.

The issuance of the Additional Secured Notes was exempt from the registration requirements of the Securities Act of 1933, as amended, in accordance with Section 4(a)(2), as a transaction by an issuer not involving a public offering. In addition, our Board of Directors and the Audit Committee of our Board of Directors reviewed the transaction under our policy for Related Party Transactions (the “Policy”) and determined that the issuance of the Additional Secured Notes was in compliance with the Policy.

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


特拉華州	82-5024477
（國家或其他管轄區的公司成立或組織）	（IRS僱主唯一識別號碼）

2929 N. 商業大道 Miramar, 佛羅里達	33025
(主要行政辦公室地址)	(郵政編碼)


		頁面
第I部分	財務信息	1
項目1。	基本報表	1
	2019年9月30日和2020年9月30日截止的未經審計的簡明中期財務基本報表：
	資產負債表	1
	經營報表	2
	股東權益（赤字）變動表	3
	現金流量表	4
	基本報表附註	5
項目2。	分銷計劃	14
項目3。	有關市場風險的定量和定性披露	29
項目4。	控制和程序	29
第二部分	其他信息	33
項目1。	法律訴訟	33
項目1A。	風險因素	34
項目2。	未註冊的股票股權銷售和籌款用途	34
項目3。	對優先證券的違約	34
項目4。	礦山安全披露	34
項目5。	其他信息	34
項目6。	展示資料	36
簽名		37


	2023年12月31日,			9月30日,
	2023			2024
				未經審計
資產
流動資產：
現金及現金等價物	$	3,595,101		$	998,221
應收賬款，淨額		1,535,757			651,840
預付費用		1,042,413			356,156
其他流動資產		230,916			88,131
總流動資產		6,404,187			2,094,348
投資		1,599,751			1,599,751
物業、廠房和設備，淨值		20,453,184			22,833,904
其他資產		56,538			28,476
總資產	$	28,513,660		$	26,556,479
負債和股東權益（赤字）
負債
流動負債:
應付賬款	$	6,167,223		$	22,666,107
應計的負債和其他流動負債		2,580,402			1,056,716
短期債務，淨額		—			6,340,511
總流動負債		8,747,625			30,063,334
淨債務		6,304,318			6,462,769
總負債		15,051,943			36,526,103
承諾和 contingencies（注8）
股東權益（赤字）：
普通股：
一般，$0.0001面值； 250,000,000已授權股份數以及 36,025,104 在2023年12月31日發行的股份； 250,000,000股份授權和 37,823,3942024年9月30日發行的股份數		3,603			3,782
追加實收資本		83,990,437			87,209,457
累積赤字		(70,532,323	)		(97,182,863	)
股東權益（赤字）		13,461,717			(9,969,624	)
負債和股東權益（赤字）總額	$	28,513,660		$	26,556,479


	截至三個月 9月30日,						截至九個月 9月30日,
	2023			2024			2023			2024
營業收入:
收入	$	853,102		$	426,423		$	1,517,792		$	2,171,988
收入成本		(678,325	)		(341,138	)		(1,210,077	)		(1,291,546	)
淨收入		174,777			85,285			307,715			880,442

運營費用：
研發		1,667,442			1,186,913			5,539,919			5,339,383
一般和行政		1,509,936			1,639,152			5,106,674			4,799,437
法律費用		2,075,279			949,455			4,610,091			15,761,531
非經營損失		—			—			—			1,300,000
總營業費用		5,252,657			3,775,520			15,256,684			27,200,351
營業損失		(5,077,880	)		(3,690,235	)		(14,948,969	)		(26,319,909	)
利息支出		(95,514	)		(223,363	)		(284,465	)		(383,029	)
其他（費用）收益，淨		234,753			11,310			919,688			52,397
淨虧損	$	(4,938,641	)	$	(3,902,288	)	$	(14,313,746	)	$	(26,650,541	)
每股基本和攤薄淨虧損	$	(0.14	)	$	(0.10	)	$	(0.40	)	$	(0.71	)
基本及攤薄加權平均股本		35,926,921			37,823,394			35,907,123			37,623,459


	股東權益
	普通股				額外的實收資本		累計			總計股東權益
	股份		金額		資本		虧損			股權
2022年12月31日餘額		35,876,440	$	3,588	$	82,962,964	$	(45,538,046	)	$	37,428,506
行使期權時發行普通股		10,195		1		1,900		—			1,901
基於股票的補償		—		—		259,206		—			259,206
淨虧損		—		—		—		(5,070,686	)		(5,070,686	)
2023年3月31日的結存		35,886,635	$	3,589	$	83,224,070	$	(50,608,732	)	$	32,618,927
行使期權時發行普通股		40,086		4		7,708		—			7,712
基於股票的補償		—		—		263,423					263,423
淨虧損		—		—		—		(4,304,420	)		(4,304,420	)
餘額，2023年6月30日		35,926,721	$	3,593	$	83,495,201	$	(54,913,152	)	$	28,585,642
行使期權時發行普通股		600		—		84		—			84
基於股票的補償		—		—		219,848		—			219,848
淨虧損		—		—		—		(4,938,641	)		(4,938,641	)
餘額，2023年9月30日		35,927,321	$	3,593	$	83,715,133	$	(59,851,793	)	$	23,866,933


☒	根據1934年《證券交易法》第13條或第15（d）條提交的季度報告


☐	根據1934年證券交易法第13或15(d)節的轉型報告書


大型加速報告人	☐	加速文件提交人	☐

非加速文件提交人	☒	較小的報告公司	☒

新興成長公司	☒


	股東權益（虧損）
	普通股				額外的實收資本		累計			總計股東權益
	股份		金額		資本		虧損			股本（赤字）
2023年12月31日餘額		36,025,104	$	3,603	$	83,990,437	$	(70,532,323	)	$	13,461,717
行使期權時發行普通股		12,572		1		2,254		—			2,255
根據股權認購發行普通股票		1,785,718		178		2,499,827		—			2,500,005
基於股票的補償		—		—		244,685		—			244,685
淨虧損		—		—		—		(7,468,061	)		(7,468,061	)
2024 年 3 月 31 日餘額		37,823,394	$	3,782	$	86,737,203	$	(78,000,384	)	$	8,740,601
行使期權時發行普通股		—		—		—		—			—
基於股票的補償		—		—		239,821		—			239,821
淨虧損		—		—		—		(15,280,191	)		(15,280,191	)
餘額，2024年6月30日		37,823,394	$	3,782	$	86,977,024	$	(93,280,575	)	$	(6,299,769	)
行使期權時發行普通股		—		—		—		—			—
基於股票的補償		—		—		232,433		—			232,433
淨虧損		—		—		—		(3,902,288	)		(3,902,288	)
餘額，2024年9月30日		37,823,394	$	3,782	$	87,209,457	$	(97,182,863	)	$	(9,969,624	)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2023			2024			2023			2024
Revenues:
Revenues	$	853,102		$	426,423		$	1,517,792		$	2,171,988
Cost of revenues		(678,325	)		(341,138	)		(1,210,077	)		(1,291,546	)
Net revenues		174,777			85,285			307,715			880,442

Operating expenses:
Research and development		1,667,442			1,186,913			5,539,919			5,339,383
General and administrative		1,509,936			1,639,152			5,106,674			4,799,437
Legal expenses		2,075,279			949,455			4,610,091			15,761,531
Nonoperating loss		—			—			—			1,300,000
Total operating expenses		5,252,657			3,775,520			15,256,684			27,200,351
Loss from operations		(5,077,880	)		(3,690,235	)		(14,948,969	)		(26,319,909	)
Interest expense		(95,514	)		(223,363	)		(284,465	)		(383,029	)
Other income, net		234,753			11,310			919,688			52,397
Net loss	$	(4,938,641	)	$	(3,902,288	)	$	(14,313,746	)	$	(26,650,541	)



*	This certification is deemed not filed for purpose of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
#	Certain information in this document has been excluded pursuant to Item 601(a)(5) or (a)(6) of Regulation S-K. The Registrant agrees to furnish supplementally such information to the SEC upon request.


	HCW Biologics Inc.

Date: November 14, 2024	By:	/s/ Hing C. Wong
		Hing C. Wong
		Chief Executive Officer
		(Principal Executive Officer)

Date: November 14, 2024	By:	/s/ Rebecca Byam
		Rebecca Byam
		Chief Financial Officer
		(Principal Financial and Accounting Officer)


	截至9月30日的九個月
	2023			2024
經營活動現金流量：
淨虧損	$	(14,313,746	)	$	(26,650,541	)
調整爲淨損失到經營活動現金流量淨使用：
折舊和攤銷		860,634			501,882
基於股票的補償		742,477			716,940
投資未實現損失（利潤）淨額		(248,445	)		—
投資的實現損失（收益），淨額		(15,625	)		—
使用權資產的賬面價值變動		(1,045	)		(418	)
運營資產和負債的變化：
應收賬款		(292,383	)		883,917
利息準備金存入資金		(5,250,000	)		—
預付款和其他資產		(251,008	)		829,043
應付賬款和其他負債		392,802			12,383,171
經營租賃負債		(242,990	)		(56,541	)
用於經營活動的淨現金		(18,619,329	)		(11,392,547	)
投資活動現金流量：
購買物業和設備		(2,486,950	)		(148,205	)
短期投資的出售或到期收益		10,000,000			—
投資活動產生的淨現金流量		7,513,050			(148,205	)
融資活動的現金流：
普通股發行收入		9,697			2,502,260
發行債務所得款項		—			6,530,000
發行成本		—			—
債務償還		(8,981	)		(88,388	)
融資活動提供的淨現金		716			8,943,872
現金及現金等價物淨增加額（減少額）		(11,105,563	)		(2,596,880	)
期初現金及現金等價物餘額		22,326,356			3,595,101
期末現金及現金等價物	$	11,220,793		$	998,221
現金流信息的補充披露：
支付的利息淨額，減去資本化的金額	$	284,465		$	340,988
非現金的經營、投資和融資活動：
已計提但尚未支付的資本支出	$	2,095,724		$	1,910,698
包括在應付賬款和其他負債中的物業和設備採購	$	—		$	829,207