美国

证券交易委员会

华盛顿特区，20549

形式 10-Q

（马克 一）

或

委员会 档案编号 001-39531

Processa 制药公司。

(根据公司章程所述的注册人的正确名称)

7380 可口可乐大道, Suite 106,

汉诺威, 马里兰州。 21076

(443) 776-3133

根据《交易所法》第12(b)条登记的证券：

勾选表示公司已按照证券交易法第13或15(d)条款的规定，在过去12个月（或公司需要提交此类报告的较短期限内）提交了所有所需的报告；并且公司在过去90天内一直受到此类提交报告的要求。 是 否 ☒

请用勾选框表示，是否本登记人在过去12个月内（或本登记人应递交此类文件的较短期间内）按照S-t条例第405条的规定，已经以电子方式提交每一份所需提交的互动资料档案。是 否 ☒

请以勾选标记指示申报人是否是大型迅速报表申报人、迅速报表申报人、非迅速报表申报人、较小的报告公司，或新兴成长公司。请参阅《交易法》第120亿2条中对“大型迅速报表申报人”、“迅速报表申报人”、“较小的报告公司”和“新兴成长公司”的定义。

若属新兴成长公司，则请在适用于依据第13(a)款拟定的任何新或修订财务会计准则时，打勾表示注册人已选择不使用过度过渡期遵守该准则。 ☐

请勾选是否登记者为外壳公司（依照交易所法规120亿2的定义）。是 ☐ 否 ☒

截至2024年10月15日，申报人的普通股优先已发行股份数 3,266,944.

PROCESSA 药品公司，INC.

目录

第一部分：财务资讯

项目 1：基本报表

Processa 制药公司。

缩短的 合并资产负债表

(未经查核)

附注是这些简明综合财务报表的不可分割部分。

Processa 制药公司。

综合营运状况简明报告

(未经查核)

The accompanying notes are an integral part of these condensed consolidated financial statements.

Processa Pharmaceuticals, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(Unaudited)

The accompanying notes are an integral part of these condensed consolidated financial statements.

Processa Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

The accompanying notes are an integral part of these condensed consolidated financial statements.

Processa Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

事项 2. 管理层对财务状况和营运结果的讨论和分析

前瞻性陈述

本季度报告表格10-Q 包含“前瞻性陈述”，当为时，反映公司对未来涉及风险和不确定性的事件的期望或信念。前瞻性陈述经常通过“相信”，“预期”，“期望”，“估计”，“打算”，“项目”，“将会”，“将继续”，“可能导致” 或其他类似的词语和片语来识别。同样，这里描述公司目标、计划或目标的陈述也是前瞻性陈述。实际结果可能与公司的前瞻性陈述预测、暗示或预期的内容有实质差异。可能导致实际结果不同的一些因素包括：我们有限的运营历史、有限的现金和历史损失；实现盈利能力的能力；我们获得足够的融资以资助未来业务运营的能力；我们能否为产品候选人获得FDA或其他政府机构批准，以及寻求的指示范围；竞争性产品、技术和价格的影响；我们是否成功开发和商业化我们的科技，包括透过授权；我们及我们授权方所拥有或授权的预期专利所提供的保护充足，以及我们为维护、执行和捍卫该等专利而费用；我们及我们授权方保护非专利智慧财产权的能力；我们面临和捍衞第三方对我们和我们授权方预期专利和其他智慧财产权的索赔和挑战的风险，以及我们继续作为一个营运机构的能力。欲了解所有已知的可能导致实际结果与前瞻性陈述所含不同的风险和不确定性，请参阅公司截至2023年12月31日的年度报告10-k中的“风险因素”，该报告可在SEC网站 www.sec.gov上获得。所有前瞻性陈述均在其整体性中受到这一警告性陈述的限制，并且公司不承担修订或更新本季度报告表格10-Q 以反映此后事件或情况的义务。

就本《财务状况和营运结果管理层讨论及分析》中，"公司"、"我们"、"我们" 或 "我们的" 的提及，指的是Processa Pharmaceuticals, Inc.及其直接和间接附属公司在此描述期间的运营。

概览

我们是一家临床级生物制药公司，专注于运用我们的规管科学方法，其中包括与美国食品药品监督管理局的Project Optimus Oncology计划相关的原则，以及相关的FDA草案指南，来开发下一代化疗（“NGC”）肿瘤药物产品。我们的使命是提供比目前存在的更好的治疗选择，通过延长患者的存活时间和/或改善患者的生活质量。这是通过改善已获FDA批准、广泛使用的肿瘤药物或这些药物的杀癌代谢物如何代谢和/或在身体中分布，包括它们如何分布到实际的癌细胞，来实现的。

我们的法规科学方法是在1990年代初期构想，当时Processa的创始人和马里兰大学的其他教师与FDA合作制定多个FDA指导文件。法规科学是开发新工具、标准和方法，评估所有FDA监管产品的安全性、有效性、质量和表现的科学。在过去30年里，我们其中两位创始人David Young博士和Sian Bigora博士通过增加专注的临床前和临床研究，扩展了最初的法规科学概念，以证明新药品开发项目的效益风险评估，在为FDA批准时设计开发计划时进行。

我们的监管科学方法确定了FDA需要的科学信息，以判断特定人群对特定剂量和特定药物产品的药物的利益是否超过风险。这些研究旨在获取支持监管决定所需的科学信息。

最近，FDA已采取措施来界定FDA对肿瘤学产品批准所需的部分监管科学。通过FDA的Project Optimus肿瘤学倡议和相关的草案指南，FDA选择使肿瘤学药物的开发比过去更为科学化。由于FDA的Project Optimus原则和相关的草案指南过去已被我们的监管科学方法应用在许多非肿瘤学药物上，我们对Project Optimus原则的经验使我们与其他生物技术公司有所区别，将我们专注于临床科学以及同样重要的监管过程。我们相信利用我们的监管科学方法为我们提供三个明显的优势：

我们的战略优先事项是推进我们的NGC专有小分子肿瘤药物管线。NGC产品是新的化学实体，可以改变已获FDA批准的癌症药物的代谢、分布和/或排泄，或其活性代谢物，同时保持药物在杀死癌细胞方面已证明的作用机制。我们相信我们的NGC治疗将提供更好的安全性和疗效特性，与它们目前上市的竞品——卡培他滨、吉西他滨和吲替蓟相比。

我们的药物管道

我们的研发项目目前包括NGC-Cap、NGC-Gem和NGC-Iri（也分别标识为PCS6422、PCS3117和PCS创业板），还有两种非肿瘤药物（PCS12852和PCS499）。由于我们正在寻求合作伙伴继续进行临床和商业开发，这两种非肿瘤药物不包括在上面的研发项目图表中。下面提供了每种药物的简要概况。

下一代化疗

在历史上，很多肿瘤药物的开发都是在寻找治疗癌症的新颖或不同方式。我们的方法是采用目前的三种FDA批准的癌症药物，例如吡卡培汀、吉西他滨和伊立替康，并修改和改进人体代谢和/或分布这些NGC治疗药物的方式，与目前批准的对照化疗药物相比，同时保持杀伤癌细胞的作用机制；因此，我们称之为Next Generation Chemotherapy治疗药物。开发的一部分包括根据美国FDA的“Optimus计划”和“癌症用药最佳剂量方案指南草案”中描述的剂量-反应关系确定最佳用药方案。到目前为止，我们拥有的数据显示，我们的NGC治疗药物很可能具有比目前广泛使用的市场上对应药物更好的安全有效性特征，这不仅有可能使开发和批准过程更加高效，还清晰地区分我们的NGC治疗药物与现有治疗的不同之处。我们相信我们的NGC治疗药物有潜力延长更多癌症患者的生存和/或生活质量，同时降低因副作用或缺乏反应而需要调整剂量或停止治疗的患者数量。

下一代化疗管道

我们专注于改善有针对性患者人群安全/疗效特性提高，从而提高患者生存率和/或生命质量，并提供更高效和可能的FDA批准途径，并使我们的药品区别于市场上存在或正在开发的药品。

我们管线中的其他药物

2023年，我们完成了PCS12852在胃麻痹患者中的2A期临床试验，结果呈阳性。此外，由于2023年2月，主要是因为在溃疡性坏死性淋巴皮肤病罕见病的PCS499的2期试验中无法识别和招募患者，我们决定停止PCS499试验的进一步招募并终止该试验。在进行PCS12852或PCS499试验期间，我们并未遇到任何安全问题。我们继续评估资产资产以变现这些非核心药物资产的选择，这可能包括将这些资产进行获外包许可或与一个或多个第三方合作。我们目前正在与裕元就修改我们现有的PCS12852许可协议进行讨论。

近期发展

股票拆分

2024年1月22日，我们进行了1比20的股票合并，在该日发行的普通股数量从24,706,474股减少至1,291,000股。普通股授权股数未相应减少，每股的面值未变。所有股份、每股价格和转换和行权价格都已进行了回溯调整以反映这一变化。

公开发行

2024年1月30日，我们通过出售47.6万股普通股、优先担保购买权，最多可购买1,079,555股普通股，以及购买1,555,555股普通股的权证，在一次公开发行中募集了700万美元的毛收益（净收益为630万美元）。与销售结束同时，优先担保购买权以交换的形式行使，以换取1,079,555股普通股。我们将利用此次融资的净收入继续进行NCG-Cap的研发工作，并用于营运资金和一般企业用途。

ATM发行。

2024年5月，我们在美国证券交易委员会（SEC）提交了一份S-3表格（注册号333-279588）的注册声明（“注册声明”），包括一份有关在一个或多个发行中最高可达5000万美元的证券的基本招股说明书，以及一份有关我们的普通股可能根据2024年5月21日和A.G.P./全球合作伙伴（“销售代理”）之间签订的销售协议（“销售协议”）发行和销售的普通股的增补招股说明书，通过这份协议，我们可以发行和销售总额最高达240万美元（可能会调整）的普通股，时间不定地通过或向我们的销售代理进行注册的“现场市场发行”（ATm发行）。我们预计会逐步使用ATm发行的净收益（如果有的话）用于我们的药物候选品组合的持续研究和开发，尤其是我们的肿瘤产品，以及营运资金和一般公司用途。ATm发行下的股票将根据注册声明进行销售和发行。截至2024年7月31日，我们通过ATm发行销售了374,190股普通股，净收益为931,000美元。

新的 首席财务官

2024年7月16日，罗素·斯基布斯特(Russell Skibsted)被任命为我们的首席财务官（“CFO”），此前的首席财务官退休。斯基布斯特先生在药品行业拥有近30年的经验，包括财务管理、全球业务发展、资本市场、投资者关系和运营方面的专业知识。与他的雇佣相关，斯基布斯特先生将获得年薪40万美元，并在他领导并实质参与融资额达到至少1500万美元（单笔或多笔融资累积）时，有资格获得5万美元的年薪增加。他还有资格参与高管奖金池，目标奖金为其基本薪水的35%。此外，薪酬委员会向斯基布斯特先生授予了2.8万股RSUs，其归属如下：2025年7月16日归属1.4万股RSUs；当Processa达到至少3000万美元的市值（即Processa股票的总市值）时，另7,000 RSUs归属；并在获得至少1500万美元的累积融资后，另7,000 RSUs归属。根据他的雇佣协议，他还有资格获得其他福利。

业绩报告

2024年和2023年截至9月30日的三个和九个月进行比较

下表总结了我们的净亏损情况

Revenues

We do not currently have any revenue under contract or any immediate sales prospects.

Research and Development Expenses

Our research and development costs are expensed as incurred. Research and development expenses include (i) program and testing related expenses including external consulting and professional fees related to the product testing and our development activities and (ii) internal research and development staff salaries and other payroll costs including stock-based compensation, payroll taxes and employee benefits.

Costs for the three- and nine-month periods for the periods ended September 30, 2024 and 2023 were as follows:

During the three months ended September 30, 2024, our preclinical, clinical trial and other costs increased when compared to the same period in 2023. This was attributable to an increase of approximately $1.3 million for ongoing testing and related expenses related to our Phase 1B trial for NGC-Cap and the IND/initiation of our Phase 2 trial for NGC-Cap and offset by a decrease in professional fees of approximately $181,000, mostly attributable to a decrease in patent-related legal fees. During the same period in 2023, in addition to clinical trial costs for NGC-Cap, we were incurring closing costs in our clinical trial for PCS12852 and PCS499. We also had an approximately $11,000 increase in salaries and related costs during the three months ended September 30, 2024 when compared to the same period in 2023, due to one-time bonuses and increased salary rates for the research and development team in 2024. This was offset by a decrease in stock-based compensation of approximately $23,000.

During the nine months ended September 30, 2024, we had increases in testing and related expenses of approximately $1.5 million and in salaries and related costs of approximately $87,000, when compared to the same period in 2023. These increases were offset by decreases in professional fees of approximately $315,000 and in stock-based compensation of approximately $155,000. The reasons for the changes between the nine-month periods in 2024 and 2023 are the same as the reasons between the three-month periods in 2024 and 2023.

On July 24, 2024, we received approval of our IND for our Phase 2 trial for NGC-Cap in breast cancer. On October 2, 2024, we dosed the first patient in the study. As we continue this Phase 2 trial and complete our Phase 1B clinical trial for NGC-Cap, we anticipate our research and development costs will increase. We will also continue incurring nominal costs for NGC-Gem as we prepare to meet with the FDA to discuss potential study designs and for NGC-Iri as we prepare to further define the clinical development program, GMP CMC processes and the IND-enabling toxicology studies.

The funding necessary to bring a drug candidate to market is subject to numerous uncertainties. Once a drug candidate is identified, the further development of that drug candidate may be halted or abandoned at any time due to a number of factors. These factors include, but are not limited to, funding constraints, safety or a change in market demand. For each of our drug candidate programs, we periodically assess the scientific progress and merits of the programs to determine if continued research and development is economically viable. Some programs may be terminated due to the lack of scientific progress and lack of prospects for ultimate commercialization.

Our clinical trial cost accruals are based on estimates of patient enrollment and related costs at clinical investigator sites, as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on our behalf.

We estimate preclinical and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on our behalf. In accruing service fees, we estimate the time period over which services will be performed and the level of patient enrollment and activity expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses and expensed when the services are rendered.

General and Administrative Expenses

Our general and administrative expenses for the three months ended September 30, 2024 increased by approximately $121,000 to $1.1 million from $1.0 million for the three months ended September 30, 2023. This increase was due primarily as a result of an approximately $81,000 increase in employee stock-based compensation; an approximately $12,000 increase in professional fees, mostly attributable to an increase of legal and consulting fees; an approximately $21,000 increase in salaries and other payroll-related costs from increased salary rates, primarily paid to our executive officers; and a net increase of approximately $14,000 in travel, office and other miscellaneous expenses. We also received approximately $7,000 more in reimbursements from CorLyst during the three months ended September 30, 2024 when compared to the same period in 2023.

During the nine months ended September 30, 2024, our general and administrative expenses decreased by approximately $749,000 to $3.8 million from $4.5 million for the nine months ended September 30, 2023. This was due primarily to a decrease in professional fees of approximately $943,000 as a result of a non-recurring expense that was incurred during 2023 in connection with the stock purchase warrant granted to the placement agent for our registered direct offering in February 2023; and a decrease in employee stock-based compensation of approximately $167,000 in 2024. These decreases were primarily offset by increases in salaries and other payroll-related expenses of approximately $303,000 and in office and other related expenses of approximately $51,000. We also received approximately $7,000 less in reimbursements from CorLyst during the nine months ended September 30, 2024 when compared to the same period in 2023.

Other Income, net

Other income represents interest income of approximately $40,000 and $86,000 for the three months ended September 30, 2024 and 2023, respectively, and approximately $195,000 and $271,000 for the nine months ended September 30, 2024 and 2023, respectively.

Income Tax Benefit

We did not recognize any income tax benefit for the three or nine months ended September 30, 2024 or 2023.

Cash Flows

The following table sets forth our sources and uses of cash and cash equivalents for the nine months ended September 30, 2024 and 2023:

Net cash used in operating activities

We used net cash in our operating activities of $8,997,321 and $5,939,478 during the nine months ended September 30, 2024 and 2023, respectively. The increase in cash used in operating activities was primarily attributable to increased costs related to closing our Phase 1B and commencing our Phase 2 trial for NGC-Cap, including the prepayment of expenses paid to our CRO for the Phase 2 trial; increased salaries and other payroll-related expenses; and professional fees during the nine months ended September 30, 2024.

As we continue our development of NGC-Cap and evaluate the other NGC drugs in our portfolio, we anticipate our research and development efforts and ongoing general and administrative costs will continue to generate negative cash flows from operating activities for the foreseeable future. We anticipate our clinical trial costs will increase when compared to prior periods since we have begun our Phase 2 clinical trial for NGC-Cap and our prior year activities related primarily to the completion of our Phase 1b trial for NGC-Cap.

Net cash used in investing activities

During the nine months ended September 30, 2024 and 2023, we used net cash in our investing activities of $3,244 and $2,776, respectively, to purchase property and equipment.

Net cash provided by financing activities

During the nine months ended September 30, 2024, we sold 476,000 shares of common stock, pre-funded warrants to purchase up to 1,079,555 shares of common stock in lieu of shares of common stock, all of which were exercised into shares of our common stock, and warrants to purchase up to 1,555,555 shares of our common stock pursuant to a public offering for net proceeds of $6.3 million. We also sold 374,190 shares of common stock under our ATM Offering for net proceeds of approximately $931,000. We used cash, classified as financing activities, of approximately $16,000 to pay income taxes owed on stock-based compensation, approximately $9,000 for the settlement of a stock award, and approximately $4,000 for payments owed under a financing lease obligation.

During the nine months ended September 30, 2023, we raised net proceeds of $6.4 million from the sale of 421,611 shares of our common stock.

Liquidity

We do not have sufficient cash on hand or available to fund our operations for the next twelve months. During the nine months ended September 30, 2024, we began initiation activities for our Phase 2 trial for NGC-Cap in breast cancer. At September 30, 2024, we had cash and cash equivalents totaling $2.9 million. Based on our current business plans, we will need to obtain additional funding from the sale of equity and/or debt securities or complete a strategic transaction or other funding transactions in order to continue our Phase 2 trial of NGC-Cap and conduct future preclinical studies and clinical trials for other drugs in our portfolio.

Absent additional funding, our current cash and cash equivalents will not be sufficient to fund our planned operations for a period of one year or more after the date that these condensed consolidated financial statements were available to be issued based on the timing and amount of our projected net loss from continuing operations and the related amount of cash to be used in operating activities during that period of time. Our ability to execute our longer-term operating plans, including future preclinical studies and clinical trials for our portfolio of drugs depend on our ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding transactions.

We have incurred losses since inception, currently devoting substantially all of our efforts toward research and development of our next generation chemotherapy drug product candidates, including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit of $84.5 million at September 30, 2024. During the nine months ended September 30, 2024, we generated a net loss of $9.1 million and used $9.0 million in net cash for operating activities from continuing operations. To date, none of our drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect positive cash flow from operations in the foreseeable future.

We have financed our operations primarily through public equity issuances, including an offering we closed on January 30, 2024 in which we sold 476,000 shares of our common stock, pre-funded warrants to purchase up to 1,079,555 shares of our common stock, and warrants for the purchase of up to 1,555,555 shares of our common stock for net proceeds of $6.3 million, after deducting placement agent fees and offering-related expenses. Simultaneously with the closing of the sale, the pre-funded warrants were exercised in exchange for 1,079,555 shares of our common stock.

Further, in May 2024, we filed with the SEC a registration statement on Form S-3 (Registration No. 333-279588) (the “Registration Statement”), including a base prospectus relating to the offering of up to $50,000,000 in the aggregate of the securities identified in the base prospectus from time to time in one or more offerings; and a prospectus supplement relating to the shares of our common stock that may be issued and sold under a sales agreement dated May 21, 2024 (the “Sales Agreement”) between us and A.G.P./Alliance Global Partners (the “Sales Agent”), through which we may issue and sell in a registered “at the market offering” shares of our common stock having an aggregate offering price of up to $2.4 million (subject to adjustment) from time to time through or to our Sales Agent (the “ATM Offering”). We expect to use net proceeds, if any, from the ATM Offering over time for continued research and development for our portfolio of drug candidates, especially our oncology products, and working capital and general corporate purposes. The shares under the ATM Offering will be sold and issued pursuant to the Registration Statement. During the nine months ended September 30, 2024, we received $931,000 in net proceeds from the sale of 374,190 shares of common stock under the ATM Offering on July 31, 2024.

We plan to raise additional funds in the future through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements, but will only do so if the terms are acceptable to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or planned future clinical trial plans, or research and development programs. This may also cause us to not meet obligations contained in certain of our license agreements and put these assets at risk. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. There can be no assurance that future funding will be available when needed.

Contractual Obligations and Commitments

There have been no significant changes to the contractual obligations reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

Off Balance Sheet Arrangements

At September 30, 2024, we did not have any off-balance sheet arrangements.

Critical Accounting Policies and Use of Estimates

Our discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities.

We believe that the estimates, assumptions and judgments involved in the accounting policies described in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our most recent Annual Report on Form 10-K have the greatest potential impact on our financial statements, so we consider these to be our critical accounting policies. Actual results could differ from the estimates we use in applying our critical accounting policies. We are not currently aware of any reasonably likely events or circumstances that would result in materially different amounts being reported.

There have been no changes in our critical accounting policies from those included in our most recent Annual Report on Form 10-K.

Recently Issued Accounting Pronouncements

We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our financial position or results of operations.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Item 3 is not applicable to us as a smaller reporting company and has been omitted.

Item 4. Controls and Procedures

At September 30, 2024, management, with the participation of the Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on the evaluation of its disclosure controls and procedures, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at September 30, 2024 to provide reasonable assurance that information required to be disclosed in our reports under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect the Company’s internal control over financial reporting.

Part II. Other Information

Item 1. Legal Proceedings

As of the date of this report, to our knowledge, there are no legal proceedings or regulatory actions material to us to which we are a party, or have been a party to, or of which any of our property is or was the subject matter of, and no such proceedings or actions are known by us to be contemplated, except as provided below:

As previously disclosed in our Current report on Form 10-Q for the period ended March 31, 2024, on May 7, 2024, the Company received notification from Elion purporting to terminate the license agreement by and between the Company and Elion as a result of the Company’s alleged breach thereof. The Company believes that Elion’s claims are without merit and disputes that the license agreement has been validly terminated. On July 5, 2024, the Company filed a complaint seeking monetary damages, declaratory judgement and injunctive relief. On August 14, 2024, the Company received Elion’s answer and counterclaims. On October 10, 2024, the Company filed its response to Elion’s counterclaims. The Company intends to enforce its rights under the license agreement and will pursue such other remedies as it determines are appropriate.

Item 1A. Risk Factors

根据2023年12月31日结束的10-k表格中第1A项描述的，我们的风险因素没有出现任何重大变化，除了新增了以下风险因素：

我们的执照在某些情况下可能会被许可方终止。

我们在被授权专利和专利申请中所声明的发明上行使权利，须要我们的授权方遵守那些许可证的条款并且不予终止。如果我们在许可协议的某些条款或条件方面重大违约，或在某些其他情况下，我们的许可证可能会被授权方终止。我们的每份许可协议都包含允许授权方在以下情况下终止许可的规定，即（i）我们违反协议项下的任何支付义务或其他重大条款并未在书面终止通知后固定时间内补救违约；（ii）我们或我们的任何联属机构、被授权人或受许可方直接或间接挑战被授权专利的有效性、可强制执行性或延长；或（iii）我们宣告破产或解散。大多数许可协议要求我们完成与新产品开发相关的尽职注意里程碑，包括含有被授权药物的产品，否则可能被对方终止协议。我们在这些许可协议下的权利受限于我们继续遵守许可条款，包括根据许可支付应付的权利金。任何这些许可的终止都可能阻止我们营销部分或全部产品。由于我们产品的复杂性和我们许可的专利，确定许可范围及相关的权利金义务可能会困难，并可能导致我们与授权方之间的争端。若该争端的不利解决可能导致按照许可应支付的权利金增加。如果授权方认为我们未支付许可权利金或其他未遵守许可条款，授权方可能会试图撤销许可。如果此类企图成功，我们可能被禁止生产和销售部分或全部产品。

根据我们在2024年3月31日结束的10-Q表格中先前披露的内容，于2024年5月7日，公司收到了Elion的通知，声称基于公司所谓的违约行为，Elion打算终止我们之间的许可协议。公司认为Elion的主张毫无根据，并表示对许可协议的有效终止存有争议。 我们目前正进行许可协议的诉讼。公司拟执行其在许可协议下的权利，并将追求其他其认为适当的救济措施。

如果我们未能成功或无法执行许可协议下的权利，将对我们的业务和营运结果产生不利影响。

项目 2. 未注册出售股权和筹集资金使用情况

(a) 最近出售未注册证券

2024年9月30日结束的三个月内，我们根据咨询协议向Paramount Advisors，LLC发行20,000股普通股。根据《1933年证券法》修订版（「证券法」）第4(a)(2)条的规定，出售股份豁免了证券法的登记要求。

在2024年9月30日结束的三个月内，没有其他未注册证券的销售。

(b) 公开募股筹款用途

无。

(c) 发行人购买股本证券

我们在2024年9月30日结束的九个月内并未回购任何普通股。

物品 三.高级证券违约

无。

项目 4. 矿安披露

不适用。

项目 5.其他信息

在2024年9月30日结束的三个月内，我们的董事或高级管理人员中没有人 采用 或 终止 “Rule 10b5-1交易安排”或“非Rule 10b5-1交易安排”，如Regulation S-k的第408(a)项所定义的每个术语。

物品 六.展品

* 已提交。

# 表示管理合同或报酬计划或安排。

++ 此证明书仅用于附随本季度报告，根据18 U.S.C.第1350条提供，并不会因此依据1934年修订的证券交易法第18条的目的而被提交，也不得被引用至公司的任何申报文件，无论是在此日期之前还是之后制作的，无论该等申报文件中是否包含任何一般性引用条款。

签名

根据《证券交易法》的要求，本公司已经授权下列签署人代表本公司签署本报告。