美国

证券交易委员会

华盛顿，特区。20549

表格10-Q

(马克 一)

截至季度结束9月30日， 2024

or

在从_________过渡到 __________

佣金 文件编号: 001-36199

PULMATRIX，INC。

（公司章程中指定的准确公司名称）

(888) 355-4440

注册人的电话号码，包括区号

N/A

（如果自上次报告以来名称、地址或财年发生变化）

请勾选标记以指示注册者是否（1）在过去12个月内（或注册者需要提交这些报告的更短时间内）已提交证券交易所法案第13或15（d）节要求提交的所有报告，及　（2）是否已被提交要求过去90天的提交要求所制约。Yes根据交易所法规12b-2中“大型加速文件报告人”，“加速文件报告人”，“小型报告公司”和“新兴增长公司”的定义，请勾选发行人是否为大型加速文件报告人。

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请勾选适用的圆圈，表示注册登记者是否是空壳公司(根据交易所法案第12b-2条的定义)。是 ☐ 否☒

根据证券交易法第12(b)条注册的证券:

截至2024年11月4日，注册人拥有 3,652,285 普通股股份共有数量。

PULMATRIX，INC。

☒季度报告，根据1934年证券交易法第13条或第15（d）条

截至2024年9月30日季度结束

目录

第一节金融信息

项目1。简明合并财务报表。

PULMATRIX，INC。

合并资产负债表

（以千为单位，除了每股股份和每股数据）

附注是这些简明综合财务报表的一个不可或缺的部分。

PULMATRIX，INC。

综合利润表

（以千为单位，除了每股股份和每股数据）

(未经审计)

这个 随附的脚注是这些简明合并财务报表不可分割的一部分。

PULMATRIX，INC。

合并股东权益报表

（以千为单位，除股份数据外）

(未经审计)

附注是这些简明综合财务报表的一个不可或缺的部分。

PULMATRIX，INC。

现金流量表的合并报表

(以千为单位)

(未经审计)

附注是这些简明综合财务报表的一个不可或缺的部分。

PULMATRIX，INC。

基本报表附注 未经审计的综合财务报表

（以千为单位，除了每股股份和每股数据）

第2条：“管理层讨论与分析财务状况和经营业绩”。

管理层对财务状况和经营业绩的讨论与分析意在从管理层的角度为我们的财务报表读者提供叙述，涵盖我们的财务状况、经营业绩、流动性以及可能影响我们未来业绩的一些其他因素。以下所列信息应与包含在本季度报告表格10-Q其他地方的精简合并财务报表及附注以及包含在于2024年3月28日提交给SEC的年度报告表格10-K中的经审计的合并财务报表及附注一起阅读。除非另有说明，在本季度报告表格10-Q中对我们、“我们”、“我们的”或我司“公司”等提及指的是Delaware州法人Pulmatrix, Inc.及其附属公司。

前瞻性声明

本季度报告Form 10-Q包含前瞻性陈述。除非在此特别说明，所有陈述均为历史事实之外的声明，包括关于我们业务计划或战略、预期或预期的利益或其他后果、我们收购计划或战略中的预期利益，以及涉及预期收入、利润或运营结果的预测，均为前瞻性陈述。诸如“预计”、“假设”、“相信”、“能够”、“可能”、“估计”、“期望”、“预测”、“指导”、“打算”、“有信心”、“可能”、“计划”、“寻求”、“项目”、“目标”、“将”，以及它们的反义词和类似表达，以及未来时态的陈述，均旨在确定前瞻性陈述。前瞻性陈述不应被视为对未来业绩或结果的保证，并且可能不是指示实际业绩或结果将在何时实现的准确指标。前瞻性陈述基于我们在作出这些陈述时拥有的信息或我们管理层于那时对未来事件的真诚信念，受到可能导致实际业绩或结果与前瞻性陈述中所表达或暗示的有重大差异的风险和不确定性的影响。可能导致这种差异的重要因素包括但不限于：

为了更详细讨论可能影响我们业务并导致实际结果与这些前瞻性声明中预期结果不符的其他风险，请参阅本季度报告第II部分第1A项下的所述风险因素和不确定性，并请参阅我们年度报告第I部分第1A项下的风险因素。本季度报告中包含的前瞻性声明在其整体上均受到此警示性声明的明确限定。我们不承诺更新任何前瞻性声明，以反映任何该等声明发表之日后发生的事件或情况，或反映出乎意料的事件的发生，除非法律要求。

“iSPERSE^™” 是我们年度报告第10-Q表格中使用的商标之一。本报告中出现的其他商标属于其各自持有人所有。为方便起见，本报告中提到的这些和其他商标、商号和服务标记没有标有Tm和Sm标志，但这些引用并不意味着，以任何方式，我们或这些商标的所有者将放弃根据适用法律的最大范围主张这些商标和商号的权利 ^®，Tm和Sm符号，但这些参考并不打算表明，以任何方式，我们或这些商标的所有者将不会根据适用法律的最大范围主张这些商标和商号的权利.

概述

按照我们所处的风险和不确定性的假设，结果和在本招股书或在任何文档中引用的前瞻性陈述中讨论的事件可能不会发生。投资者应谨慎对待这些前瞻性陈述，它们仅在本招股书或在文档中通过引用作为参考，其仅在本招股书或在文档中通过引用作为参考的文件的日期发表时存在。我们没有任何义务，并明确声明不承担任何义务，更新或更改任何前瞻性陈述，无论是基于新信息、未来事件或其他原因。我们或代表我们行事的任何人作出的所有后续前瞻性陈述，都受到本节中所包含或所提到的警示性声明的明确限制。

我们是一家临床阶段生物制药公司，专注于开发新型吸入治疗产品，旨在预防和治疗呼吸道和其他疾病，满足重要的医疗需求，使用我们的专利iSPERSE。^™ 科技。我们的专有产品线包括治疗中枢神经系统（CNS）疾病，如急性偏头痛，以及慢性阻塞性肺病（COPD）和过敏性支气管肺曲霉病（ABPA）等严重肺部疾病。我们的产品候选药基于我们的专利工程干粉吸入递送平台iSPERSE。^™，旨在通过优化药代动力学和减少全身副作用来改善治疗递送到肺部，以改善患者预后。

我们基于自有的干粉吸入技术iSPERSE，设计并开发吸入治疗产品。^™可通过吸入向肺部递送小分子或大分子药物，用于局部或全身应用。该iSPERSE^™干粉工程化，成为小而密实的颗粒，具有高效的分散性和递送至气道的能力。iSPERSE^™干粉可与各种干粉吸入器技术配合使用，可配制各种药物物质，包括小分子和生物制品。我们相信iSPERSE^™ 干粉技术提供了增强的药物装载和输送效率，优于传统的乳糖混合吸入干粉疗法。

我们的目标是开发突破性治疗产品，这些产品安全、方便，并且比现有的治疗产品对呼吸和其他疾病更有效 iSPERSE^™ 具有优势的属性。

我们当前的临床资产管道与这一目标保持一致，因为我们正在开发iSPERSE^™基于治疗候选产品，针对预防和治疗一系列疾病，包括CNS疾病和肺部疾病。这些治疗候选产品包括用于急性偏头痛治疗的PUR3100，用于慢性阻塞性肺病急性加重治疗的PUR1800，以及用于哮喘合并过敏性支气管肺曲霉病（ABPA）治疗的PUR1900，适用于哮喘患者和囊性纤维化（CF）患者。每个项目都由其独特的iSPERSE技术实现。^™ 设计用于实现特定治疗目标的配方。

在获得额外资金的前提下，我们打算利用我们的iSPERSE平台和我们在吸入治疗方面的专业知识，寻找预防和治疗疾病的新产品候选，并建立超越现有候选产品的产品管线。为了推动我们治疗候选品的临床试验并利用iSPERSE平台实现与合作化合物的交付，我们打算与包括药品和生物技术公司或学术或私人研究机构在内的第三方建立战略联盟。^™ 在获得额外资金的前提下，我们打算利用我们的iSPERSE 科技平台和我们在吸入治疗方面的专业知识，寻找预防和治疗疾病的新产品候选，并建立超越现有候选产品的产品管线。为了推动我们治疗候选品的临床试验并利用iSPERSE平台实现与合作化合物的交付，我们打算与包括药品和生物技术公司或学术或私人研究机构在内的第三方建立战略联盟。^™；在获得额外资金的前提下，我们打算利用我们的iSPERSE平台和我们在吸入治疗方面的专业知识，寻找预防和治疗疾病的新产品候选，并建立超越现有候选产品的产品管线。为了推动我们治疗候选品的临床试验并利用iSPERSE 平台实现与合作化合物的交付，我们打算与包括药品和生物技术公司或学术或私人研究机构在内的第三方建立战略联盟。

在获得额外资金的前提下，根据我们的药物研发计划以及我们正在进行的活动，我们预计至少在接下来的几年里将继续承担大量支出和运营亏损，因为我们：

治疗候选人

PUR3100

2020年，我们开发了PUR3100，iSPERSE DHE的制剂，用于治疗急性偏头痛。目前，DHE仅可通过皮下、静脉注射或鼻内给药方式使用。如果获得商业化批准，PUR3100有机会成为急性偏头痛的第一个口服吸入式DHE治疗药物，并成为其他急性疗法的替代选择。考虑到口服吸入途径的给药方式，预计PUR3100将提供缓解偏头痛症状快速发作并具有良好耐受性的优势。^™ 以提供缓解偏头痛症状快速发作并具有良好耐受性的有利特点，当前DHE仅以皮下、静脉注射或鼻内给药方式使用。如果获得商业化批准，PUR3100有望成为急性偏头痛的首个口服吸入式DHE治疗药物并可作为其他急性疗法的选择。

已完成3个14天GLP毒理学研究，以支持单次剂量临床研究。我们计划进行慢性毒理学研究，以支持长期给药。根据与FDA的讨论，这将完成非临床要求，以支持新药申请（NDA）。

我们与FDA的互动表明，在计划中的2期和3期研究之外，还应该评估长期安全性，在至少一百名病人中进行为期6个月的投药研究和为期12个月的投药研究。FDA还确认需要对否则健康的哮喘患者进行安全性研究，然后才能提交新药申请。

2022年9月26日，我们宣布完成了在澳洲进行的I期临床研究中患者的给药。该研究设计采用了双盲、双假的试验，旨在评估吸入式单剂PUR3100的三个剂量水平与静脉注射安慰剂相比的安全性、耐受性和药代动力学，同时与静脉注射DHE (DHE甲酸盐注射液)及吸入式安慰剂进行比较。该研究还可能提供初步的比较生物利用度数据，以支持使用505(b)(2)通道进行上市授权。共有26名健康受试者参与了该研究，每个四人小组中至少包含六名受试者。

2023年1月4日，我们宣布了头条结果。我们在2023年6月的美国头痛学会第65届年会上展示了第1期研究数据。研究显示，PUR3100在目标治疗区间内实现了峰值曝露，并且在各剂量水平的给药后五分钟达到最高浓度。与静脉注射DHE剂量组中观察到的恶心和呕吐相比，PUR3100剂量组的恶心发生率较低，没有呕吐。^th 在2023年6月的年会上，研究显示PUR3100在目标治疗区间内实现峰值曝露，所有剂量水平的给药后五分钟即达到最高浓度。与静脉给药的DHE剂量组相比，PUR3100剂量组出现恶心和呕吐的情况较少。

基于治疗范围内的快速系统暴露和相对于静脉注射剂量而言改善的副作用配置文件，我们相信DHE的PUR3100配方可能与已批准的DHE产品或已知正在研发中的产品有所区别。如果有效性得到证明，PUR3100可能提供自我管理的便利性，并可能提供快速起效的药代动力学特性。

2023年9月，我们宣布FDA接受了PUR3100 IND并收到了“研究可以继续进行”的信函，用于“一项阶段2、多中心、随机、双盲、安慰剂对照、单事件研究，评估PUR3100（麦角衍生二胺甲磺酸盐吸入粉末）在急性偏头痛治疗中的安全性、耐受性和疗效”。我们预计一旦融资或达成合作安排，这项第2阶段临床研究将启动。

2024年5月15日，我们宣布发表了题为“口服吸入单剂量PUR3100干粉制剂与静脉注射麦角衍生胺的安全性、耐受性和药代动力学：健康成人的1期随机、双盲研究”的同行评审刊物。 年度会议。2024年5月，我们宣布了第1阶段临床结果的同行评议出版物，发表在《头痛：头部和脸部疼痛杂志》上。.

我们 认为，在这项试验中，与静脉注射 DHE 相比，PUR3100 显示出快速缓解疼痛和改善 DHE 耐受性的潜力。和 一个 T_最大值 5 分钟和 C_最大值 在所有测试剂量的治疗窗口中，我们认为 PUR3100 具有 有可能解决急性偏头痛患者未得到满足的需求，我们正在寻求不同的选择，将 PUR3100 推向一个阶段 2项临床试验旨在进一步研究其在治疗急性偏头痛方面的前景。

完成的第1阶段研究表明，与静脉注射二氢埃罗宾相比，PUR3100具有最佳的药代动力学和更好的耐受性。第1期试验采用随机、双盲、双假设计，评估了接受吸入PUR3100治疗的三个剂量组与静脉（IV）安慰剂相比，与单剂IV二氢埃罗宾（二氢埃罗宾甲磺酸盐注射）与吸入安慰剂在健康志愿者中的安全性、耐受性和药代动力学（PK）。所有剂量的PUR3100通常耐受良好，与IV二氢埃罗宾相比，恶心发生率较低（21% vs. 86%），呕吐（0% vs. 29%）和头痛（16% vs. 57%）。PUR3100与IV二氢埃罗宾之间的PK曲线与均值时间为C_最大 （5 vs. 5.5分钟），AUC0–2h减少（1120-4320 vs. 6340），C_最大 （3620-14400 vs. 45000）。所有剂量的PUR3100均伴有平均C_最大 高于所需达到有效性的最低水平（1000 pg/mL）。

在美国，有超过3900万名偏头痛患者，目前尚无口服吸入式DHE治疗选项。 PUR3100是我们口服吸入式治疗候选制剂，采用iSPERSE™工程化的DHE，用于急性偏头痛的治疗。 pulmatrix目前正在考虑机会进行融资或与合作伙伴合作，以启动潜在的2期临床研究。

PUR1800

对皮质类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）有效治疗的重要障碍，并提供了明确的理由寻找新药物治疗这些呼吸道疾病。此外，目前的治疗通常未能治疗AECOPD的潜在病因，尤其是病毒或细菌感染是80%急性加重的原因，RV1162是PUR1800的活性成分，是一种新型、强效的抗炎药物，可抑制一类狭窄范围激酶的磷酸化。 在临床前研究中，RV1162对病毒诱导的呼吸道炎症模型表现出直接抗炎活性。RV1162在一种卷烟烟雾诱导的炎症模型中表现出对皮质类固醇抵抗性炎症反应的减少。这些发现表明RV1162有潜力在对皮质类固醇抵抗的患者中提供有效的抗炎效果，同时减少引发急性加重的潜在炎症来源，如病毒和/或细菌呼吸道感染。

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.

在英国曼彻斯特的药品评价单位进行的临床研究是一项随机的、三组交叉的双盲研究，每天给药14天，包括安慰剂和两种PUR1800剂量中的一种，并在每个治疗周期后包括28天的随访期。共有18名患有稳定慢性阻塞性肺病（COPD）的成年人参与。对安全性和耐受性以及全身药代动力学（“PK”）进行了评估。

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是我们的iSPERSE^™ 伊曲康唑吸入制剂是伊曲康唑的商业口服药的一个剂型。我们开发了PUR1900用于预防和治疗严重肺部疾病患者（包括哮喘和CF患者）的真菌感染以及对真菌的过敏/过敏反应。

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.

我们在2024年第三季度完成了所有20亿风险淘汰活动。因此，我们不再对在辛普拉领土内涉及该产品的商业化和开发承担进一步的财务责任，该产品在辛普拉领土内的商业化和开发费用将在2024年1月6日后由辛普拉独自承担。我们将获得辛普拉在美国境外潜在未来净销售额的2%版税。在美国境内，我们和辛普拉将寻求对PUR1900进行货币化，这是我们的气雾iSPERSE™伊曲康唑制剂，适用于口服吸入抗真菌药物可能提供治疗益处或满足未满足的医疗需求的适应症。

财务概述

Revenues

截至目前，我们还没有产生任何产品销售。截至2024年和2023年9月30日的三个月和九个月的营收主要来自与我们的PUR1900方案相关的Cipla协议，这项方案的收尾工作已经完成。

有关Cipla协议的更多讨论，请参阅注6。 重要协议。，请查看包含在本季度10-Q表格中的我们的简明综合财务报表。

研发费用

研究和开发费用主要包括用于我们的临床前和临床候选药物的研究和开发费用，包括：

我们会在发生时将研发费用列入营运费用。我们会根据一些特定开发活动（比如临床试验）的进度评估来确认费用，评估会使用诸如患者入组、临床研究点激活等数据，或者供应商提供的信息。

研发活动是我们业务模式的核心。我们已利用内部和外部的努力结合，从早期工作推动产品开发，直至临床试制造和临床试验支持。外部努力包括与顾问合作，以及与CRO和CMO进行大量工作。我们历来支持内部研发团队和设施，用于我们的研究管线和其他潜在开发项目，然而，2024年第三季度曼恩凯德生物医疗交易结束后，大部分研发员工被解雇，我们的设施租赁被转让给曼恩凯德，我们预计将利用外部资源进行进一步的发展。

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.

除上文和本报告其他部分讨论外，我们不知道任何可能对我们财务状况产生重大影响的趋势、事件或不确定因素。

项目3.关于市场风险的定量和定性披露。

项目 第8条。

项目4. 控制和程序。

信息披露控制和程序

我们的 首席执行官兼首席财务官，在评估了我们的披露控制和程序的有效性之后 （定义见根据经修订的1934年《证券交易法》（“交易法”）颁布的第13a-15（e）条和第15d-15（e）条） 截至本10-Q表季度报告所涉期末，我们得出的结论是，根据此类评估，我们的披露 控制和程序是有效的，可确保我们在提交或提交的报告中必须披露的信息 根据《交易法》，将在美国证券交易委员会规则规定的期限内记录、处理、汇总和报告 表格，并积累并传达给我们的管理层，包括我们的首席执行官和首席财务官 视情况而定，以便及时就所需的披露作出决定。

在设计和评估我们的披露控制和程序时，我们的管理层认识到，无论控制和程序设计得多么完善和操作，都只能提供实现所需控制目标的合理保证，我们的管理层必须在评估可能的控制和程序的成本效益关系时运用自己的判断。

财务报告内部控制的变化

在2024年9月30日结束的季度内，我们的内部财务报告控制未发生任何变化，对我们的内部财务报告控制产生了重大影响，或者有合理可能对我们的内部财务报告控制产生重大影响。

第II部分—其他信息

项目1。法律诉讼

我们偶尔会卷入正常业务过程中产生的诉讼。截至提交本文件的日期，我们不知道任何重大法律诉讼，我们或我们的任何子公司是诉讼当事方，也不知道我们的任何资产受到或可能受到的任何法律诉讼威胁或未解决的诉讼，或者任何政府机构已知计划进行的诉讼或类似诉讼。

我们并不知晓任何实质性诉讼，其中我们的任何董事、高管、关联方，或持有我公司超过5%普通股的任何注册股东或实际股东，或任何上述人士的联结人，是对我们或我们的任何子公司不利的当事方或具有利益冲突。

事项1A.风险因素。

投资我们的普通股涉及高度风险。在做出有关我们普通股的投资决定之前，您应该仔细考虑我们年度报告Form 10-K中于2023年12月31日结束的第I部分，第1A项下“风险因素”中描述的风险和不确定性，以及本季度报告Form 10-Q中包含的其他信息。如果这些风险中任何一个实际发生，我们的业务、财务状况或经营业绩可能会受到影响，股票交易价格可能会下降，您可能会部分或全部损失您的投资。

如果您还未使用您的moomoo账户，请使用它查看该功能。

无。

无。

项目3. 对高级证券的违约。

无。

项目4. 煤矿安全披露。

项目 第8条。

项目5. 其他信息。

无。

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