美國

證券交易委員會

華盛頓，特區。20549

表格10-Q

(馬克 一)

截至季度結束9月30日， 2024

or

在從_________過渡到 __________

佣金 文件編號: 001-36199

PULMATRIX，INC。

（公司章程中指定的準確公司名稱）

(888) 355-4440

註冊人的電話號碼，包括區號

N/A

（如果自上次報告以來名稱、地址或財年發生變化）

請勾選標記以指示註冊者是否（1）在過去12個月內（或註冊者需要提交這些報告的更短時間內）已提交證券交易所法案第13或15（d）節要求提交的所有報告，及　（2）是否已被提交要求過去90天的提交要求所制約。Yes根據交易所法規12b-2中「大型加速文件報告人」，「加速文件報告人」，「小型報告公司」和「新興增長公司」的定義，請勾選發行人是否爲大型加速文件報告人。

√ 是 表明在過去的12個月內（或者註冊人被要求在更短的時間內提交這些報告的時間）已通過電子方式提交了根據規則 405¤T法規提交所有交互式數據文件的文件。 Yes根據交易所法規12b-2中「大型加速文件報告人」，「加速文件報告人」，「小型報告公司」和「新興增長公司」的定義，請勾選發行人是否爲大型加速文件報告人。

請勾選以下相應項目，表明註冊申請人是大型加速器、加速器、非加速器、小型報告公司或新興增長公司。有關「大型加速器」、「加速器」、「小型報告公司」和「新興增長公司」的定義，請參見交易所法規120億.2條。(勾選一個):

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

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

根據證券交易法第12(b)條註冊的證券:

截至2024年11月4日，註冊人擁有 3,652,285 普通股股份共有數量。

PULMATRIX，INC。

☒季度報告，根據1934年證券交易法第13條或第15（d）條

截至2024年9月30日季度結束

目錄

第一節金融信息

項目1。簡明合併財務報表。

PULMATRIX，INC。

合併資產負債表

（以千爲單位，除了每股股份和每股數據）

附註是這些簡明綜合財務報表的一個不可或缺的部分。

PULMATRIX，INC。

綜合利潤表

（以千爲單位，除了每股股份和每股數據）

(未經審計)

這個 隨附的腳註是這些簡明合併財務報表不可分割的一部分。

PULMATRIX，INC。

合併股東權益報表

（以千爲單位，除股份數據外）

(未經審計)

附註是這些簡明綜合財務報表的一個不可或缺的部分。

PULMATRIX，INC。

現金流量表的合併報表

(以千爲單位)

(未經審計)

附註是這些簡明綜合財務報表的一個不可或缺的部分。

PULMATRIX，INC。

基本報表附註 未經審計的綜合財務報表

（以千爲單位，除了每股股份和每股數據）

第2條：「管理層討論與分析財務狀況和經營業績」。

管理層對財務狀況和經營業績的討論與分析意在從管理層的角度爲我們的財務報表讀者提供敘述，涵蓋我們的財務狀況、經營業績、流動性以及可能影響我們未來業績的一些其他因素。以下所列信息應與包含在本季度報告表格10-Q其他地方的精簡合併財務報表及附註以及包含在於2024年3月28日提交給SEC的年度報告表格10-K中的經審計的合併財務報表及附註一起閱讀。除非另有說明，在本季度報告表格10-Q中對我們、「我們」、「我們的」或我司「公司」等提及指的是Delaware州法人Pulmatrix, Inc.及其附屬公司。

前瞻性聲明

本季度報告Form 10-Q包含前瞻性陳述。除非在此特別說明，所有陳述均爲歷史事實之外的聲明，包括關於我們業務計劃或戰略、預期或預期的利益或其他後果、我們收購計劃或戰略中的預期利益，以及涉及預期收入、利潤或運營結果的預測，均爲前瞻性陳述。諸如「預計」、「假設」、「相信」、「能夠」、「可能」、「估計」、「期望」、「預測」、「指導」、「打算」、「有信心」、「可能」、「計劃」、「尋求」、「項目」、「目標」、「將」，以及它們的反義詞和類似表達，以及未來時態的陳述，均旨在確定前瞻性陳述。前瞻性陳述不應被視爲對未來業績或結果的保證，並且可能不是指示實際業績或結果將在何時實現的準確指標。前瞻性陳述基於我們在作出這些陳述時擁有的信息或我們管理層於那時對未來事件的真誠信念，受到可能導致實際業績或結果與前瞻性陳述中所表達或暗示的有重大差異的風險和不確定性的影響。可能導致這種差異的重要因素包括但不限於：

爲了更詳細討論可能影響我們業務並導致實際結果與這些前瞻性聲明中預期結果不符的其他風險，請參閱本季度報告第II部分第1A項下的所述風險因素和不確定性，並請參閱我們年度報告第I部分第1A項下的風險因素。本季度報告中包含的前瞻性聲明在其整體上均受到此警示性聲明的明確限定。我們不承諾更新任何前瞻性聲明，以反映任何該等聲明發表之日後發生的事件或情況，或反映出乎意料的事件的發生，除非法律要求。

“iSPERSE^™” 是我們年度報告第10-Q表格中使用的商標之一。本報告中出現的其他商標屬於其各自持有人所有。爲方便起見，本報告中提到的這些和其他商標、商號和服務標記沒有標有Tm和Sm標誌，但這些引用並不意味着，以任何方式，我們或這些商標的所有者將放棄根據適用法律的最大範圍主張這些商標和商號的權利 ^®，Tm和Sm符號，但這些參考並不打算表明，以任何方式，我們或這些商標的所有者將不會根據適用法律的最大範圍主張這些商標和商號的權利.

概述

按照我們所處的風險和不確定性的假設，結果和在本招股書或在任何文檔中引用的前瞻性陳述中討論的事件可能不會發生。投資者應謹慎對待這些前瞻性陳述，它們僅在本招股書或在文檔中通過引用作爲參考，其僅在本招股書或在文檔中通過引用作爲參考的文件的日期發表時存在。我們沒有任何義務，並明確聲明不承擔任何義務，更新或更改任何前瞻性陳述，無論是基於新信息、未來事件或其他原因。我們或代表我們行事的任何人作出的所有後續前瞻性陳述，都受到本節中所包含或所提到的警示性聲明的明確限制。

我們是一家臨床階段生物製藥公司，專注於開發新型吸入治療產品，旨在預防和治療呼吸道和其他疾病，滿足重要的醫療需求，使用我們的專利iSPERSE。^™ 科技。我們的專有產品線包括治療中樞神經系統（CNS）疾病，如急性偏頭痛，以及慢性阻塞性肺病（COPD）和過敏性支氣管肺麴黴病（ABPA）等嚴重肺部疾病。我們的產品候選藥基於我們的專利工程乾粉吸入遞送平台iSPERSE。^™，旨在通過優化藥代動力學和減少全身副作用來改善治療遞送到肺部，以改善患者預後。

我們基於自有的乾粉吸入技術iSPERSE，設計並開發吸入治療產品。^™可通過吸入向肺部遞送小分子或大分子藥物，用於局部或全身應用。該iSPERSE^™乾粉工程化，成爲小而密實的顆粒，具有高效的分散性和遞送至氣道的能力。iSPERSE^™乾粉可與各種乾粉吸入器技術配合使用，可配製各種藥物物質，包括小分子和生物製品。我們相信iSPERSE^™ 乾粉技術提供了增強的藥物裝載和輸送效率，優於傳統的乳糖混合吸入乾粉療法。

我們的目標是開發突破性治療產品，這些產品安全、方便，並且比現有的治療產品對呼吸和其他疾病更有效 iSPERSE^™ 具有優勢的屬性。

我們當前的臨床資產管道與這一目標保持一致，因爲我們正在開發iSPERSE^™基於治療候選產品，針對預防和治療一系列疾病，包括CNS疾病和肺部疾病。這些治療候選產品包括用於急性偏頭痛治療的PUR3100，用於慢性阻塞性肺病急性加重治療的PUR1800，以及用於哮喘合併過敏性支氣管肺麴黴病（ABPA）治療的PUR1900，適用於哮喘患者和囊性纖維化（CF）患者。每個項目都由其獨特的iSPERSE技術實現。^™ 設計用於實現特定治療目標的配方。

在獲得額外資金的前提下，我們打算利用我們的iSPERSE平台和我們在吸入治療方面的專業知識，尋找預防和治療疾病的新產品候選，並建立超越現有候選產品的產品管線。爲了推動我們治療候選品的臨床試驗並利用iSPERSE平台實現與合作化合物的交付，我們打算與包括藥品和生物技術公司或學術或私人研究機構在內的第三方建立戰略聯盟。^™ 在獲得額外資金的前提下，我們打算利用我們的iSPERSE 科技平台和我們在吸入治療方面的專業知識，尋找預防和治療疾病的新產品候選，並建立超越現有候選產品的產品管線。爲了推動我們治療候選品的臨床試驗並利用iSPERSE平台實現與合作化合物的交付，我們打算與包括藥品和生物技術公司或學術或私人研究機構在內的第三方建立戰略聯盟。^™；在獲得額外資金的前提下，我們打算利用我們的iSPERSE平台和我們在吸入治療方面的專業知識，尋找預防和治療疾病的新產品候選，並建立超越現有候選產品的產品管線。爲了推動我們治療候選品的臨床試驗並利用iSPERSE 平台實現與合作化合物的交付，我們打算與包括藥品和生物技術公司或學術或私人研究機構在內的第三方建立戰略聯盟。

在獲得額外資金的前提下，根據我們的藥物研發計劃以及我們正在進行的活動，我們預計至少在接下來的幾年裏將繼續承擔大量支出和運營虧損，因爲我們：

治療候選人

PUR3100

在 2020 年，我們開發了 PUR3100，即 iSperse^™ DHE 的配方，用於治療急性偏頭痛。目前 DHE 只有 可進行皮下、靜脈輸液或鼻內給藥。如果獲准商業化，PUR3100 就有機會 成爲第一種口服吸入式DHE治療急性偏頭痛的方法，也是其他急性療法的替代方案。鑑於口服吸入 分娩途徑，PUR3100 有望緩解快速發作的偏頭痛症狀並提供良好的耐受性 概況。

已完成3個14天GLP毒理學研究，以支持單次劑量臨床研究。我們計劃進行慢性毒理學研究，以支持長期給藥。根據與FDA的討論，這將完成非臨床要求，以支持新藥申請（NDA）。

我們與FDA的互動表明，在計劃中的2期和3期研究之外，還應該評估長期安全性，在至少一百名病人中進行爲期6個月的投藥研究和爲期12個月的投藥研究。FDA還確認需要對否則健康的哮喘患者進行安全性研究，然後才能提交新藥申請。

2022年9月26日，我們宣佈完成了在澳洲進行的I期臨床研究中患者的給藥。該研究設計採用了雙盲、雙假的試驗，旨在評估吸入式單劑PUR3100的三個劑量水平與靜脈注射安慰劑相比的安全性、耐受性和藥代動力學，同時與靜脈注射DHE (DHE甲酸鹽注射液)及吸入式安慰劑進行比較。該研究還可能提供初步的比較生物利用度數據，以支持使用505(b)(2)通道進行上市授權。共有26名健康受試者參與了該研究，每個四人小組中至少包含六名受試者。

2023年1月4日，我們宣佈了頭條結果。我們在2023年6月的美國頭痛學會第65屆年會上展示了第1期研究數據。研究顯示，PUR3100在目標治療區間內實現了峯值曝露，並且在各劑量水平的給藥後五分鐘達到最高濃度。與靜脈注射DHE劑量組中觀察到的噁心和嘔吐相比，PUR3100劑量組的噁心發生率較低，沒有嘔吐。^th 在2023年6月的年會上，研究顯示PUR3100在目標治療區間內實現峯值曝露，所有劑量水平的給藥後五分鐘即達到最高濃度。與靜脈給藥的DHE劑量組相比，PUR3100劑量組出現噁心和嘔吐的情況較少。

基於治療範圍內的快速系統暴露和相對於靜脈注射劑量而言改善的副作用配置文件，我們相信DHE的PUR3100配方可能與已批准的DHE產品或已知正在研發中的產品有所區別。如果有效性得到證明，PUR3100可能提供自我管理的便利性，並可能提供快速起效的藥代動力學特性。

2023年9月，我們宣佈FDA接受了PUR3100 IND並收到了「研究可以繼續進行」的信函，用於「一項階段2、多中心、隨機、雙盲、安慰劑對照、單事件研究，評估PUR3100（麥角衍生二胺甲磺酸鹽吸入粉末）在急性偏頭痛治療中的安全性、耐受性和療效」。我們預計一旦融資或達成合作安排，這項第2階段臨床研究將啓動。

2024年5月15日，我們宣佈發表了題爲「口服吸入單劑量PUR3100乾粉製劑與靜脈注射麥角衍生胺的安全性、耐受性和藥代動力學：健康成人的1期隨機、雙盲研究」的同行評審刊物。 年度會議。2024年5月，我們宣佈了第1階段臨床結果的同行評議出版物，發表在《頭痛：頭部和臉部疼痛雜誌》上。.

我們 認爲，在這項試驗中，與靜脈注射 DHE 相比，PUR3100 顯示出快速緩解疼痛和改善 DHE 耐受性的潛力。和 一個 T_最大值 5 分鐘和 C_最大值 在所有測試劑量的治療窗口中，我們認爲 PUR3100 具有 有可能解決急性偏頭痛患者未得到滿足的需求，我們正在尋求不同的選擇，將 PUR3100 推向一個階段 2項臨床試驗旨在進一步研究其在治療急性偏頭痛方面的前景。

完成的第1階段研究表明，與靜脈注射二氫埃羅賓相比，PUR3100具有最佳的藥代動力學和更好的耐受性。第1期試驗採用隨機、雙盲、雙假設計，評估了接受吸入PUR3100治療的三個劑量組與靜脈（IV）安慰劑相比，與單劑IV二氫埃羅賓（二氫埃羅賓甲磺酸鹽注射）與吸入安慰劑在健康志願者中的安全性、耐受性和藥代動力學（PK）。所有劑量的PUR3100通常耐受良好，與IV二氫埃羅賓相比，噁心發生率較低（21% vs. 86%），嘔吐（0% vs. 29%）和頭痛（16% vs. 57%）。PUR3100與IV二氫埃羅賓之間的PK曲線與均值時間爲C_最大 （5 vs. 5.5分鐘），AUC0–2h減少（1120-4320 vs. 6340），C_最大 （3620-14400 vs. 45000）。所有劑量的PUR3100均伴有平均C_最大 高於所需達到有效性的最低水平（1000 pg/mL）。

在美國，有超過3900萬名偏頭痛患者，目前尚無口服吸入式DHE治療選項。 PUR3100是我們口服吸入式治療候選製劑，採用iSPERSE™工程化的DHE，用於急性偏頭痛的治療。 pulmatrix目前正在考慮機會進行融資或與合作伙伴合作，以啓動潛在的2期臨床研究。

PUR1800

對皮質類固醇的降敏性降低是慢性阻塞性肺病（COPD）和急性加重性COPD（AECOPD）有效治療的重要障礙，並提供了明確的理由尋找新藥物治療這些呼吸道疾病。此外，目前的治療通常未能治療AECOPD的潛在病因，尤其是病毒或細菌感染是80%急性加重的原因，RV1162是PUR1800的活性成分，是一種新型、強效的抗炎藥物，可抑制一類狹窄範圍激酶的磷酸化。 在臨床前研究中，RV1162對病毒誘導的呼吸道炎症模型表現出直接抗炎活性。RV1162在一種捲菸煙霧誘導的炎症模型中表現出對皮質類固醇抵抗性炎症反應的減少。這些發現表明RV1162有潛力在對皮質類固醇抵抗的患者中提供有效的抗炎效果，同時減少引發急性加重的潛在炎症來源，如病毒和/或細菌呼吸道感染。

Clinical studies conducted by RespiVert/Janssen with RV1162 formulated as a lactose blend for inhalation demonstrated that the molecule was well tolerated for up to 14 days of dosing in patients with COPD. Analysis of sputum collected from patients with COPD treated with RV1162 showed reduced levels of p38 phosphorylation in sputum cells and decreases in the number of neutrophils recovered in sputum after 12 days of dosing. These findings suggest that inhalation of RV1162 may confer anti-inflammatory benefits after a short dosing regimen. Long-term toxicology studies with RV1162 as a lactose blend suggested that this formulation was not suitable for chronic dosing.

Based upon the clinical results generated by RespiVert/Janssen for RV1162 and the anticipated benefits of an iSPERSE^™ formulation of RV1162, we entered into a License, Development and Commercialization Agreement with RespiVert Ltd. (“RespiVert”), a wholly owned subsidiary of Janssen Biotech, Inc. on June 9, 2017. RespiVert granted us an exclusive, royalty-bearing license in a portfolio of narrow spectrum kinase inhibitor compounds (“NSKI”). We subsequently formulated RV1162 into PUR1800 for development as a potential therapy for AECOPD.

We completed a Phase 1b safety, tolerability, and pharmacokinetics of PUR1800 for patients with stable moderate-severe COPD. Topline data was delivered in the first quarter of 2022 and presented at the American Academy of Allergy, Asthma and Immunology conference in the first quarter of 2023.

在英國曼徹斯特的藥品評價單位進行的臨床研究是一項隨機的、三組交叉的雙盲研究，每天給藥14天，包括安慰劑和兩種PUR1800劑量中的一種，並在每個治療週期後包括28天的隨訪期。共有18名患有穩定慢性阻塞性肺病（COPD）的成年人蔘與。對安全性和耐受性以及全身藥代動力學（「PK」）進行了評估。

PUR1800 was well tolerated and there were no observed safety signals. The PK data indicate that PUR1800 results in low and consistent systemic exposure when administered via oral inhalation. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases. These data will inform the design of a potential Phase 2 study in the treatment of AECOPD.

PUR1900

PUR1900是我們的iSPERSE^™ 伊曲康唑吸入製劑是伊曲康唑的商業口服藥的一個劑型。我們開發了PUR1900用於預防和治療嚴重肺部疾病患者（包括哮喘和CF患者）的真菌感染以及對真菌的過敏/過敏反應。

On April 15, 2019, we entered into the Cipla Agreement with Cipla for the co-development and commercialization, on a worldwide, except for the Cipla Territory defined below, exclusive basis, of PUR1900, our inhaled iSPERSE^™ enabled formulation of the antifungal drug itraconazole, which is only available as an oral drug, for the treatment of all pulmonary indications, including ABPA in patients with asthma. We entered into the Second Amendment to the Cipla Agreement on November 8, 2021 and the Third Amendment on January 6, 2024. All references to the Cipla Agreement herein refer to the Cipla Agreement, as amended. The Cipla Agreement will remain in effect in perpetuity, unless otherwise earlier terminated in accordance with its terms.

Pursuant to the Third Amendment, the definition of the “Cipla Territory”, has been expanded to include all markets other than the United States.

Pursuant to the Third Amendment, all development and commercialization activities with respect to the Product in all markets other than the United States (the “Cipla Territory”) will be conducted exclusively by Cipla at Cipla’s sole cost and expense, and Cipla shall be entitled to all profits from the sale of the Product in the Cipla Territory, except that we will receive 2% royalties on any potential future net sales by Cipla outside the United States.

Pursuant to the Third Amendment, we and Cipla stopped patient enrollment for the ongoing Phase 2b clinical study. We agreed that during the period commencing on January 6, 2024 and ending July 30, 2024 (the “Wind Down Period”), we would complete all Phase 2b activities, assign or license all patents to Cipla and their registration with the appropriate authorities in the Cipla Territory, complete a physical and demonstrable technology transfer and secure all data from the Phase 2b study for inclusion in the safety database for the Cipla Territory.

For the duration of the Wind Down Period, we and Cipla were each responsible for 60% and 40%, respectively, of our Direct Costs. We shared all other development costs with Cipla that are not Direct Costs, such as the cost of clinical research organizations, manufacturing costs and other third-party costs, on a 50/50 basis. Reimbursements from Cipla to us for these costs were subject to a maximum reimbursement amount as approved by the joint steering committee.

我們在2024年第三季度完成了所有20億風險淘汰活動。因此，我們不再對在辛普拉領土內涉及該產品的商業化和開發承擔進一步的財務責任，該產品在辛普拉領土內的商業化和開發費用將在2024年1月6日後由辛普拉獨自承擔。我們將獲得辛普拉在美國境外潛在未來淨銷售額的2%版稅。在美國境內，我們和辛普拉將尋求對PUR1900進行貨幣化，這是我們的氣霧iSPERSE™伊曲康唑製劑，適用於口服吸入抗真菌藥物可能提供治療益處或滿足未滿足的醫療需求的適應症。

財務概述

Revenues

截至目前，我們還沒有產生任何產品銷售。截至2024年和2023年9月30日的三個月和九個月的營收主要來自與我們的PUR1900方案相關的Cipla協議，這項方案的收尾工作已經完成。

有關Cipla協議的更多討論，請參閱注6。 重要協議。，請查看包含在本季度10-Q表格中的我們的簡明綜合財務報表。

研發費用

研究和開發費用主要包括用於我們的臨床前和臨床候選藥物的研究和開發費用，包括：

我們會在發生時將研發費用列入營運費用。我們會根據一些特定開發活動（比如臨床試驗）的進度評估來確認費用，評估會使用諸如患者入組、臨床研究點激活等數據，或者供應商提供的信息。

研發活動是我們業務模式的核心。我們已利用內部和外部的努力結合，從早期工作推動產品開發，直至臨床試製造和臨床試驗支持。外部努力包括與顧問合作，以及與CRO和CMO進行大量工作。我們歷來支持內部研發團隊和設施，用於我們的研究管線和其他潛在開發項目，然而，2024年第三季度曼恩凱德生物醫療交易結束後，大部分研發員工被解僱，我們的設施租賃被轉讓給曼恩凱德，我們預計將利用外部資源進行進一步的發展。

To continue development of existing programs or opportunities identified for iSPERSE^™ in any new indications, we will need to secure additional funding and anticipate additional development costs would be incurred. Because of the numerous risks and uncertainties associated with product development, however, we cannot determine with certainty the duration and completion costs of these or other current or future preclinical studies and clinical trials. The duration, costs and timing of our future clinical trials and development of our product candidates will depend on a variety of factors, including the selected development path and uncertainties associated with clinical and preclinical studies, clinical trial enrollment rates and changing government regulation. In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability.

General and Administrative Expenses

General and administrative expenses consist principally of salaries, benefits and related costs such as stock-based compensation for personnel and consultants in executive, finance, business development, corporate communications and human resource functions, facility costs not otherwise included in research and development expenses, patent filing fees and legal fees. Other general and administrative expenses include travel expenses, expenses related to being a publicly traded company and professional fees for consulting, auditing and tax services.

Following the closing of the MannKind Transaction in the third quarter of 2024, we anticipate that our general and administrative expenses will decrease in the future as they relate to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer liability insurance, investor relations costs and other costs associated with being a public company.

Critical Accounting Estimates

This management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions.

There were no changes to our critical accounting estimates during the nine months ended September 30, 2024 as compared to those described in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report. It is important that the discussion of our operating results that follow be read in conjunction with the critical accounting estimates disclosed in our Annual Report.

Results of Operations

Comparison of the Three Months Ended September 30, 2024 and 2023

The following table sets forth our results of operations for each of the periods set forth below (in thousands):

Revenues — Revenues were $0.4 million for the three months ended September 30, 2024, as compared to $1.8 million for the three months ended September 30, 2023, a decrease of $1.4 million. The decrease is primarily related to the wind down of the PUR1900 Phase 2b clinical trial, for which we incurred fewer expenses eligible for reimbursement under the Cipla Agreement as compared to the corresponding period in the previous year.

Research and development expenses — Research and development expenses were $0.8 million for the three months ended September 30, 2024, as compared to $4.0 million for the three months ended September 30, 2023, a decrease of approximately $3.2 million. The decrease was primarily due to $1.7 million less employment and other operating cost following the MannKind Transaction, $1.2 million less cost incurred on the PUR1900 program, for which the winding down of the Phase 2b clinical trial was completed during the three months ended September 30, 2024, and $0.3 million less cost incurred on the PUR3100 program.

General and administrative expenses — General and administrative expenses were $2.2 million for the three months ended September 30, 2024, as compared to $1.7 million for the three months ended September 30, 2023, an increase of approximately $0.5 million. The increase was primarily due to $0.6 million of increased employment costs associated with employee terminations, partially offset by $0.1 million of decreased operating costs.

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

The following table sets forth our results of operations for each of the periods set forth below (in thousands):

Revenues — Revenues were $7.8 million for the nine months ended September 30, 2024, as compared to $5.1 million for the nine months ended September 30, 2023, an increase of $2.7 million. The increase is primarily related to a contract modification of the Cipla Agreement which resulted in a cumulative catch-up adjustment recorded during the three months ended March 31, 2024. The amount of the cumulative catch-up had been included in deferred revenue at the beginning of the period. This increase was partially offset by the Company incurring fewer expenses eligible for reimbursement under the Cipla Agreement as compared to the corresponding period in the previous year.

Research and development expenses — Research and development expenses were $7.2 million for the nine months ended September 30, 2024, as compared to $12.0 million for the nine months ended September 30, 2023, a decrease of approximately $4.8 million. The decrease was primarily due to $2.0 million less cost incurred on the PUR1900 program during the winding down of the Phase 2b clinical trial, $2.0 million less employment and other operating cost following the MannKind Transaction and $0.8 million less cost related to the PUR3100 and PUR1800 programs.

General and administrative expenses — General and administrative expenses were $5.8 million for the nine months ended September 30, 2024, as compared to $5.6 million for the nine months ended September 30, 2023, an increase of approximately $0.2 million. The increase was primarily due to $0.4 million of increased employment costs associated with employee terminations, partially offset by $0.2 million of decreased other operating costs.

Loss on MannKind Transaction — Loss on MannKind Transaction was $2.6 million on certain assets held for sale as of June 30, 2024 and disposed of during the three months ended September 30, 2024, in connection with the MannKind Transaction, as compared with no such loss for the nine months ended September 30, 2023.

Liquidity and Capital Resources

Through September 30, 2024, we incurred an accumulated deficit of $295.2 million, primarily as a result of expenses incurred through a combination of research and development activities related to our various product candidates and general and administrative expenses supporting those activities. We have financed our operations since inception primarily through the sale of preferred and common stock, the issuance of convertible promissory notes, term loans, and collaboration and license agreements. Our total cash and cash equivalents balance as of September 30, 2024 was $10.8 million.

We anticipate that we will continue to incur losses in the foreseeable future due to development costs associated with our iSPERSE^™ pipeline programs, contingent on obtaining financing or partnership to continue such development. We may raise capital through a combination of equity offerings, debt financings, other third-party funding and other collaborations and strategic alliances. We are currently exploring financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100.

We expect that our existing cash and cash equivalents as of September 30, 2024 will enable us to fund our corporate operating expenses for at least the next 12 months following the date of this Quarterly Report on Form 10-Q. We have based our projections of operating capital requirements on assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development, achievement of contingent milestones and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements.

We have no material off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

The following table sets forth the major sources and uses of cash for each of the periods set forth below (in thousands):

Net cash used in operating activities

Net cash used in operating activities for the nine months ended September 30, 2024 was $9.5 million, which was primarily the result of $7.6 million of net loss and $5.4 million in cash outflows associated with changes in operating assets and liabilities, partially offset by $3.6 million of net non-cash adjustments.

Net cash used in operating activities for the nine months ended September 30, 2023 was $14.0 million, which was primarily the result of a net loss of $12.0 million and $4.0 million in cash outflows associated with changes in operating assets and liabilities, partially offset by $2.0 million of net non-cash adjustments.

Net cash used in investing activities

Net cash used in investing activities was $0.4 million for both the nine months ended September 30, 2024 and 2023, which was due to purchases of property and equipment.

Net cash provided by financing activities

No cash was provided by financing activities for the nine months ended September 30, 2024. Net cash provided by financing activities for the nine months ended September 30, 2023 resulted from proceeds from the issuance of common stock, net of issuance costs.

Financings

In May 2021, we entered into the Sales Agreement with HCW to act as our sales agent with respect to the issuance and sale of up to $20,000,000 of our shares of common stock, from time to time in an ATM Offering. Upon filing of the Annual Report, we continued to be subject to General Instruction I.B.6 of Form S-3, pursuant to which in no event will we sell our common stock in a registered primary offering using Form S-3 with a value exceeding more than one-third of our public float in any 12 calendar month period so long as our public float remains below $75,000,000. Therefore, the amount we may be able to raise using the ATM Offering will be significantly less than $20,000,000, until such time as our public float held by non-affiliates exceeds $75,000,000.

Sales of common stock under the Sales Agreement are made pursuant to an effective shelf registration statement on Form S-3, which was filed with the SEC on May 17, 2024, and subsequently declared effective on May 30, 2024 (File No. 333-279491), and a related prospectus. HCW acts as our sales agent on a commercially reasonable efforts basis, consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of Nasdaq. If expressly authorized by us, HCW may also sell our common stock in privately negotiated transactions. There is no specific date on which the ATM Offering will end, there are no minimum sale requirements and there are no arrangements to place any of the proceeds of the ATM Offering in an escrow, trust or similar account. HCW is entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of our common stock pursuant to the Sales Agreement.

During the nine months ended September 30, 2024, no shares of our common stock were sold under the Sales Agreement.

Known Trends, Events and Uncertainties

In May 2023, the World Health Organization determined that COVID-19 no longer fit the definition of a public health emergency and the U.S. government announced its plan to let the declaration of a public health emergency associated with COVID-19 expire on May 11, 2023. In addition, ongoing geopolitical conflicts, including between Russia and Ukraine and between Israel and Hamas, and related sanctions and countermeasures, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global economy, and contribute to increased market volatility, which may in turn adversely affect our business and operations. We may not be able to raise sufficient additional capital and may tailor our drug candidate development program based on the amount of funding we are able to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.

除上文和本報告其他部分討論外，我們不知道任何可能對我們財務狀況產生重大影響的趨勢、事件或不確定因素。

項目3.關於市場風險的定量和定性披露。

項目 第8條。

項目4. 控制和程序。

信息披露控制和程序

我們的 首席執行官兼首席財務官，在評估了我們的披露控制和程序的有效性之後 （定義見根據經修訂的1934年《證券交易法》（「交易法」）頒佈的第13a-15（e）條和第15d-15（e）條） 截至本10-Q表季度報告所涉期末，我們得出的結論是，根據此類評估，我們的披露 控制和程序是有效的，可確保我們在提交或提交的報告中必須披露的信息 根據《交易法》，將在美國證券交易委員會規則規定的期限內記錄、處理、彙總和報告 表格，並積累並傳達給我們的管理層，包括我們的首席執行官和首席財務官 視情況而定，以便及時就所需的披露作出決定。

在設計和評估我們的披露控制和程序時，我們的管理層認識到，無論控制和程序設計得多麼完善和操作，都只能提供實現所需控制目標的合理保證，我們的管理層必須在評估可能的控制和程序的成本效益關係時運用自己的判斷。

財務報告內部控制的變化

在2024年9月30日結束的季度內，我們的內部財務報告控制未發生任何變化，對我們的內部財務報告控制產生了重大影響，或者有合理可能對我們的內部財務報告控制產生重大影響。

第II部分—其他信息

項目1。法律訴訟

我們偶爾會捲入正常業務過程中產生的訴訟。截至提交本文件的日期，我們不知道任何重大法律訴訟，我們或我們的任何子公司是訴訟當事方，也不知道我們的任何資產受到或可能受到的任何法律訴訟威脅或未解決的訴訟，或者任何政府機構已知計劃進行的訴訟或類似訴訟。

我們並不知曉任何實質性訴訟，其中我們的任何董事、高管、關聯方，或持有我公司超過5%普通股的任何註冊股東或實際股東，或任何上述人士的聯結人，是對我們或我們的任何子公司不利的當事方或具有利益衝突。

事項1A.風險因素。

投資我們的普通股涉及高度風險。在做出有關我們普通股的投資決定之前，您應該仔細考慮我們年度報告Form 10-K中於2023年12月31日結束的第I部分，第1A項下「風險因素」中描述的風險和不確定性，以及本季度報告Form 10-Q中包含的其他信息。如果這些風險中任何一個實際發生，我們的業務、財務狀況或經營業績可能會受到影響，股票交易價格可能會下降，您可能會部分或全部損失您的投資。

如果您還未使用您的moomoo帳戶，請使用它查看該功能。

無。

無。

項目3. 對高級證券的違約。

無。

項目4. 煤礦安全披露。

項目 第8條。

項目5. 其他信息。

無。

Item 6. Exhibits.

See “Index to Exhibits” following the signature page to this Form 10-Q for a list of exhibits filed or furnished with this Quarterly Report on Form 10-Q.

SIGNATURES

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.

INDEX TO EXHIBITS