美國

證券交易委員會

華盛頓特區，20549

形式 10-Q

（馬克 一）

或

委員會 檔案編號 001-39531

Processa 製藥公司。

(根據公司章程所述的註冊人的正確名稱)

7380 可口可樂大道, Suite 106,

漢諾威, 馬里蘭州。 21076

(443) 776-3133

根據《交易所法》第12(b)條登記的證券：

勾選表示公司已按照證券交易法第13或15(d)條款的規定，在過去12個月（或公司需要提交此類報告的較短期限內）提交了所有所需的報告；並且公司在過去90天內一直受到此類提交報告的要求。 是 否 ☒

請用勾選框表示，是否本登記人在過去12個月內（或本登記人應遞交此類文件的較短期間內）按照S-t條例第405條的規定，已經以電子方式提交每一份所需提交的互動資料檔案。是 否 ☒

請以勾選標記指示申報人是否是大型迅速報表申報人、迅速報表申報人、非迅速報表申報人、較小的報告公司，或新興成長公司。請參閱《交易法》第120億2條中對“大型迅速報表申報人”、“迅速報表申報人”、“較小的報告公司”和“新興成長公司”的定義。

若屬新興成長公司，則請在適用於依據第13(a)款擬定的任何新或修訂財務會計準則時，打勾表示註冊人已選擇不使用過度過渡期遵守該準則。 ☐

請勾選是否登記者為外殼公司（依照交易所法規120億2的定義）。是 ☐ 否 ☒

截至2024年10月15日，申報人的普通股優先已發行股份數 3,266,944.

PROCESSA 藥品公司，INC.

目錄

第一部分：財務資訊

項目 1：基本報表

Processa 製藥公司。

縮短的 合併資產負債表

(未經查核)

附註是這些簡明綜合財務報表的不可分割部分。

Processa 製藥公司。

綜合營運狀況簡明報告

(未經查核)

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)

事項 2. 管理層對財務狀況和營運結果的討論和分析

前瞻性陳述

本季度報告表格10-Q 包含“前瞻性陳述”，當為時，反映公司對未來涉及風險和不確定性的事件的期望或信念。前瞻性陳述經常通過“相信”，“預期”，“期望”，“估計”，“打算”，“項目”，“將會”，“將繼續”，“可能導致” 或其他類似的詞語和片語來識別。同樣，這裡描述公司目標、計劃或目標的陳述也是前瞻性陳述。實際結果可能與公司的前瞻性陳述預測、暗示或預期的內容有實質差異。可能導致實際結果不同的一些因素包括：我們有限的運營歷史、有限的現金和歷史損失；實現盈利能力的能力；我們獲得足夠的融資以資助未來業務運營的能力；我們能否為產品候選人獲得FDA或其他政府機構批准，以及尋求的指示範圍；競爭性產品、技術和價格的影響；我們是否成功開發和商業化我們的科技，包括透過授權；我們及我們授權方所擁有或授權的預期專利所提供的保護充足，以及我們為維護、執行和捍衛該等專利而費用；我們及我們授權方保護非專利智慧財產權的能力；我們面臨和捍衞第三方對我們和我們授權方預期專利和其他智慧財產權的索賠和挑戰的風險，以及我們繼續作為一個營運機構的能力。欲瞭解所有已知的可能導致實際結果與前瞻性陳述所含不同的風險和不確定性，請參閱公司截至2023年12月31日的年度報告10-k中的“風險因素”，該報告可在SEC網站 www.sec.gov上獲得。所有前瞻性陳述均在其整體性中受到這一警告性陳述的限制，並且公司不承擔修訂或更新本季度報告表格10-Q 以反映此后事件或情況的義務。

就本《財務狀況和營運結果管理層討論及分析》中，"公司"、"我們"、"我們" 或 "我們的" 的提及，指的是Processa Pharmaceuticals, Inc.及其直接和間接附屬公司在此描述期間的運營。

概覽

我們是一家臨床級生物製藥公司，專注於運用我們的規管科學方法，其中包括與美國食品藥品監督管理局的Project Optimus Oncology計畫相關的原則，以及相關的FDA草案指南，來開發下一代化療（“NGC”）腫瘤藥物產品。我們的使命是提供比目前存在的更好的治療選擇，通過延長患者的存活時間和/或改善患者的生活質量。這是通過改善已獲FDA批准、廣泛使用的腫瘤藥物或這些藥物的殺癌代謝物如何代謝和/或在身體中分佈，包括它們如何分佈到實際的癌細胞，來實現的。

我們的法規科學方法是在1990年代初期構想，當時Processa的創始人和馬里蘭大學的其他教師與FDA合作制定多個FDA指導文件。法規科學是開發新工具、標準和方法，評估所有FDA監管產品的安全性、有效性、質量和表現的科學。在過去30年裡，我們其中兩位創始人David Young博士和Sian Bigora博士通過增加專注的臨床前和臨床研究，擴展了最初的法規科學概念，以證明新藥品開發項目的效益風險評估，在為FDA批准時設計開發計畫時進行。

我們的監管科學方法確定了FDA需要的科學信息，以判斷特定人群對特定劑量和特定藥物產品的藥物的利益是否超過風險。這些研究旨在獲取支持監管決定所需的科學信息。

最近，FDA已採取措施來界定FDA對腫瘤學產品批准所需的部分監管科學。通過FDA的Project Optimus腫瘤學倡議和相關的草案指南，FDA選擇使腫瘤學藥物的開發比過去更為科學化。由於FDA的Project Optimus原則和相關的草案指南過去已被我們的監管科學方法應用在許多非腫瘤學藥物上，我們對Project Optimus原則的經驗使我們與其他生物技術公司有所區別，將我們專注於臨床科學以及同樣重要的監管過程。我們相信利用我們的監管科學方法為我們提供三個明顯的優勢：

我們的戰略優先事項是推進我們的NGC專有小分子腫瘤藥物管線。NGC產品是新的化學實體，可以改變已獲FDA批准的癌症藥物的代謝、分佈和/或排泄，或其活性代謝物，同時保持藥物在殺死癌細胞方面已證明的作用機制。我們相信我們的NGC治療將提供更好的安全性和療效特性，與它們目前上市的競品——卡培他濱、吉西他濱和吲替薊相比。

我們的藥物管道

我們的研發項目目前包括NGC-Cap、NGC-Gem和NGC-Iri（也分別標識爲PCS6422、PCS3117和PCS創業板），還有兩種非腫瘤藥物（PCS12852和PCS499）。由於我們正在尋求合作伙伴繼續進行臨床和商業開發，這兩種非腫瘤藥物不包括在上面的研發項目圖表中。下面提供了每種藥物的簡要概況。

下一代化療

在歷史上，很多腫瘤藥物的開發都是在尋找治療癌症的新穎或不同方式。我們的方法是採用目前的三種FDA批准的癌症藥物，例如吡卡培汀、吉西他濱和伊立替康，並修改和改進人體代謝和/或分佈這些NGC治療藥物的方式，與目前批准的對照化療藥物相比，同時保持殺傷癌細胞的作用機制；因此，我們稱之爲Next Generation Chemotherapy治療藥物。開發的一部分包括根據美國FDA的「Optimus計劃」和「癌症用藥最佳劑量方案指南草案」中描述的劑量-反應關係確定最佳用藥方案。到目前爲止，我們擁有的數據顯示，我們的NGC治療藥物很可能具有比目前廣泛使用的市場上對應藥物更好的安全有效性特徵，這不僅有可能使開發和批准過程更加高效，還清晰地區分我們的NGC治療藥物與現有治療的不同之處。我們相信我們的NGC治療藥物有潛力延長更多癌症患者的生存和/或生活質量，同時降低因副作用或缺乏反應而需要調整劑量或停止治療的患者數量。

下一代化療管道

我們專注於改善有針對性患者人群安全/療效特性提高，從而提高患者生存率和/或生命質量，並提供更高效和可能的FDA批准途徑，並使我們的藥品區別於市場上存在或正在開發的藥品。

我們管線中的其他藥物

2023年，我們完成了PCS12852在胃麻痹患者中的2A期臨床試驗，結果呈陽性。此外，由於2023年2月，主要是因爲在潰瘍性壞死性淋巴皮膚病罕見病的PCS499的2期試驗中無法識別和招募患者，我們決定停止PCS499試驗的進一步招募並終止該試驗。在進行PCS12852或PCS499試驗期間，我們並未遇到任何安全問題。我們繼續評估資產資產以變現這些非核心藥物資產的選擇，這可能包括將這些資產進行獲外包許可或與一個或多個第三方合作。我們目前正在與裕元就修改我們現有的PCS12852許可協議進行討論。

近期發展

股票拆分

2024年1月22日，我們進行了1比20的股票合併，在該日發行的普通股數量從24,706,474股減少至1,291,000股。普通股授權股數未相應減少，每股的面值未變。所有股份、每股價格和轉換和行權價格都已進行了回溯調整以反映這一變化。

公開發行

2024年1月30日，我們通過出售47.6萬股普通股、優先擔保購買權，最多可購買1,079,555股普通股，以及購買1,555,555股普通股的權證，在一次公開發行中募集了700萬美元的毛收益（淨收益爲630萬美元）。與銷售結束同時，優先擔保購買權以交換的形式行使，以換取1,079,555股普通股。我們將利用此次融資的淨收入繼續進行NCG-Cap的研發工作，並用於營運資金和一般企業用途。

ATM發行。

2024年5月，我們在美國證券交易委員會（SEC）提交了一份S-3表格（註冊號333-279588）的註冊聲明（「註冊聲明」），包括一份有關在一個或多個發行中最高可達5000萬美元的證券的基本招股說明書，以及一份有關我們的普通股可能根據2024年5月21日和A.G.P./全球合作伙伴（「銷售代理」）之間簽訂的銷售協議（「銷售協議」）發行和銷售的普通股的增補招股說明書，通過這份協議，我們可以發行和銷售總額最高達240萬美元（可能會調整）的普通股，時間不定地通過或向我們的銷售代理進行註冊的「現場市場發行」（ATm發行）。我們預計會逐步使用ATm發行的淨收益（如果有的話）用於我們的藥物候選品組合的持續研究和開發，尤其是我們的腫瘤產品，以及營運資金和一般公司用途。ATm發行下的股票將根據註冊聲明進行銷售和發行。截至2024年7月31日，我們通過ATm發行銷售了374,190股普通股，淨收益爲931,000美元。

新的 首席財務官

2024年7月16日，羅素·斯基布斯特(Russell Skibsted)被任命爲我們的首席財務官（「CFO」），此前的首席財務官退休。斯基布斯特先生在藥品行業擁有近30年的經驗，包括財務管理、全球業務發展、資本市場、投資者關係和運營方面的專業知識。與他的僱傭相關，斯基布斯特先生將獲得年薪40萬美元，並在他領導並實質參與融資額達到至少1500萬美元（單筆或多筆融資累積）時，有資格獲得5萬美元的年薪增加。他還有資格參與高管獎金池，目標獎金爲其基本薪水的35%。此外，薪酬委員會向斯基布斯特先生授予了2.8萬股RSUs，其歸屬如下：2025年7月16日歸屬1.4萬股RSUs；當Processa達到至少3000萬美元的市值（即Processa股票的總市值）時，另7,000 RSUs歸屬；並在獲得至少1500萬美元的累積融資後，另7,000 RSUs歸屬。根據他的僱傭協議，他還有資格獲得其他福利。

業績報告

2024年和2023年截至9月30日的三個和九個月進行比較

下表總結了我們的淨虧損情況

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

根據2023年12月31日結束的10-k表格中第1A項描述的，我們的風險因素沒有出現任何重大變化，除了新增了以下風險因素：

我們的執照在某些情況下可能會被許可方終止。

我們在被授權專利和專利申請中所聲明的發明上行使權利，須要我們的授權方遵守那些許可證的條款並且不予終止。如果我們在許可協議的某些條款或條件方面重大違約，或在某些其他情況下，我們的許可證可能會被授權方終止。我們的每份許可協議都包含允許授權方在以下情況下終止許可的規定，即（i）我們違反協議項下的任何支付義務或其他重大條款並未在書面終止通知後固定時間內補救違約；（ii）我們或我們的任何聯屬機構、被授權人或受許可方直接或間接挑戰被授權專利的有效性、可強制執行性或延長；或（iii）我們宣告破產或解散。大多數許可協議要求我們完成與新產品開發相關的盡職注意里程碑，包括含有被授權藥物的產品，否則可能被對方終止協議。我們在這些許可協議下的權利受限於我們繼續遵守許可條款，包括根據許可支付應付的權利金。任何這些許可的終止都可能阻止我們營銷部分或全部產品。由於我們產品的複雜性和我們許可的專利，確定許可範圍及相關的權利金義務可能會困難，並可能導致我們與授權方之間的爭端。若該爭端的不利解決可能導致按照許可應支付的權利金增加。如果授權方認為我們未支付許可權利金或其他未遵守許可條款，授權方可能會試圖撤銷許可。如果此類企圖成功，我們可能被禁止生產和銷售部分或全部產品。

根據我們在2024年3月31日結束的10-Q表格中先前披露的內容，於2024年5月7日，公司收到了Elion的通知，聲稱基於公司所謂的違約行為，Elion打算終止我們之間的許可協議。公司認為Elion的主張毫無根據，並表示對許可協議的有效終止存有爭議。 我們目前正進行許可協議的訴訟。公司擬執行其在許可協議下的權利，並將追求其他其認為適當的救濟措施。

如果我們未能成功或無法執行許可協議下的權利，將對我們的業務和營運結果產生不利影響。

項目 2. 未註冊出售股權和籌集資金使用情況

(a) 最近出售未註冊證券

2024年9月30日結束的三個月內，我們根據諮詢協議向Paramount Advisors，LLC發行20,000股普通股。根據《1933年證券法》修訂版（「證券法」）第4(a)(2)條的規定，出售股份豁免了證券法的登記要求。

在2024年9月30日結束的三個月內，沒有其他未註冊證券的銷售。

(b) 公開募股籌款用途

無。

(c) 發行人購買股本證券

我們在2024年9月30日結束的九個月內並未回購任何普通股。

項目 3.優先證券不履行

無。

項目 4. 礦安披露

不適用。

項目 5.其他信息

在2024年9月30日結束的三個月內，我們的董事或高級管理人員中沒有人 採用 或 終止 “Rule 10b5-1交易安排”或“非Rule 10b5-1交易安排”，如Regulation S-k的第408(a)項所定義的每個術語。

項目 6. 展覽品

* 已提交。

# 表示管理合同或報酬計畫或安排。

++ 此證明書僅用於附隨本季度報告，根據18 U.S.C.第1350條提供，並不會因此依據1934年修訂的證券交易法第18條的目的而被提交，也不得被引用至公司的任何申報文件，無論是在此日期之前還是之後製作的，無論該等申報文件中是否包含任何一般性引用條款。

簽名

根據《證券交易法》的要求，本公司已經授權下列簽署人代表本公司簽署本報告。