Exhibit 99.2

管理层讨论与分析

财务状况和 经营业绩

以下讨论和分析应与我们基本报表和相关附注一起阅读，这些基本报表和相关附注包含在报告附录99.1中，即与本附件99.2相关的6-k表格（“6-K表格”）。本讨论和本附件99.2的其他部分以及6-k表格可能包含基于当前预期涉及风险和不确定性的前瞻性声明。我们的实际结果和选择事件的时间可能会因多种因素与这些前瞻性声明中预期的结果有很大不同，包括我们在年度报告20-F中列出的“风险因素”以及其他地方所述，该报告涵盖了截至2023年12月31日的年度报告，于2024年3月29日向证券交易委员会（“SEC”）提交，由于2024年4月1日向SEC提交的20-F/A表格的修正（我们的“2023 20-F”）。本文中对“我们”，“Genenta”，“我们”，“我们的公司”或“我们的公司”的引用是指Genenta Science S.p.A.及其子公司。

我们的报告货币和 功能货币是欧元指数。除非另有明确规定或上下文另有要求，在本附件 99.2中提到“美元”，“USD”或“$”指的是美元，提到“欧元”，“eur”， “欧元”，或“€”指的是欧洲联盟欧元。

概述

我们是一家处于临床阶段的生物技术公司，致力于开发用于固体肿瘤治疗的造血干细胞基因治疗。我们已经研发出一种涉及将治疗候选物转移至自体造血干/祖细胞（HSPCs）的新型生物平台。 离体 通过将治疗候选物基因转移至自体造血干/祖细胞（HSPCs）以将免疫调节分子直接输送到肿瘤中的浸润单核细胞/巨噬细胞（具有Tie2表达的单核细胞或TEMs），我们的技术旨在将通常具有亲瘤性并前往肿瘤的TEMs转变为“特洛伊木马”，从而抵消癌症的发展并预防肿瘤复发。由于我们的技术不是基于靶位的，我们认为它可以用于治疗各种类型的癌症。

自2014年成立以来，我们将几乎所有资源投入到组织和人员配备、业务规划、筹集资金、收购或发现产品候选物，并确保相关的知识产权，进行发现、研究和开发活动，为我们的项目筹划最终商业化。我们尚无任何获批销售的产品，也未从产品销售中获得任何营业收入。迄今为止，我们已通过股权销售获得资金支持我们的运营，截至2024年6月30日，总共筹集的毛现金收入约为6730万欧元。

我们目前没有任何产品获得批准出售，在商业销售我们的药物候选产品方面尚未产生任何营业收入，并且自我们成立以来，每年均亏损。我们能否产生足以实现盈利的产品收入，将严重依赖于我们当前或将来的一个或多个药物候选产品和项目的成功开发和最终商业化。截至2024年6月30日和2023年6月30日的六个月净亏损分别约为€400万和约为€680万。截至2024年6月30日和2023年12月31日，我们的累积赤字分别约为€5120万和€4710万。我们的绝大部分运营亏损主要源于我们的研究和开发活动产生的成本，包括我们基因治疗药物候选产品的临床前和临床开发，尤其是我们领先的产品候选药Temferon，以及与运营相关的一般管理费用。

我们预计在未来几年内，将继续产生重大费用，因为我们正推进我们的产品候选品从发现、到临床前开发和临床试验，以及寻求监管机构批准我们的产品候选品。此外，如果我们获得任何产品候选品的上市批准，我们预计将产生重大的与产品制造、营销、销售和配送相关的商业化费用。我们还可能会因与其他产品候选品的入股或收购而产生费用。此外，我们预计将继续产生作为一家公开公司运营的相关额外费用，包括重大的法律、会计、投资者关系和其他费用。

因此，针对我们的长期策略，我们需要大量额外的资金来支持我们持续的运营并推动我们的增长策略。在我们能够从产品销售中获得重要营业收入之前，如果有的话，我们预计将通过外部资金来源资助我们的运营，其中大部分资金将来自股权、债务和可转换证券的公开发行和私募，包括我们首次公开发行（“IPO”）和跟进发行的净收益。我们还计划从外部来源获取额外资金，包括但不限于进入或拓展新的借款安排；研究和发展激励支付、政府拨款、药品公司和其他公司来源；以及与药品公司或其他第三方就我们的一个或多个项目签订潜在的未来合作协议。当我们需要时，我们可能无法以有利条件或根本无法筹集到额外资金或与其他方就此类协议或安排达成一致。如果我们未能融资或在需要时与其他方达成此类协议或安排，我们可能不得不极大地推迟、规模化缩减或停止开发和最终商业化我们一个或多个产品候选品，或推迟追求潜在的许可或收购。

由于与产品开发和相关监管文件提交相关的诸多风险和不确定性，我们目前无法预测增加支出的时间或金额，或者何时能够实现或维持盈利能力。当最终能够实现产品销售时，这些销售额可能不足以实现盈利。如果我们未能实现盈利或无法持续盈利，我们可能无法按计划水平继续经营，并可能被迫减少或终止我们的经营。

截至2024年6月30日，我们的现金及现金等价物约为620万欧元，有价证券约为1070万欧元。我们相信，截至2024年6月30日的现金及现金等价物和有价证券将能够支持我们的营业费用和资本支出需求，至少足够维持未来十二个月。我们的估计是基于可能被证明错误的假设，我们可能会比预期更早耗尽可用的资本资源。请参阅“流动性和资本资源”。为了支持我们的持续运营，可能需要筹集额外的资本，但无法保证。

网络安全概念

我们认识到保持病人、业务合作伙伴、员工和其他利益相关者的信任和信心的重要性。因此，网络安全概念风险管理是我们整体风险管理和合规计划的一部分，我们目前的网络安全概念风险管理流程是根据行业最佳实践模型设计的，例如国家标准与技术研究院网络安全概念框架，用于处理与使用第三方服务提供商开发的应用程序相关的网络安全概念威胁和事件，并促进我们公司不同部门之间的协调。

我们的董事会对我们的网络安全概念风险管理负有整体监督责任；但它将网络安全概念风险管理监督权委派给我们的管理层和董事会监事。 我们的管理层和董事会监事负责确保我们建立了旨在识别和评估我们所面临的网络安全概念风险的流程，并实施流程和计划来管理网络安全概念风险并减轻网络安全概念事故。

这些过程包括评估网络安全威胁严重程度、识别威胁来源，包括是否与第三方服务提供商有关联的网络安全威胁，实施网络安全对策和减缓策略，并向管理层和我们的董事会报告重大网络安全威胁和事件。我们的信息科技顾问负责评估我们的网络安全风险管理计划，目前我们并不委托其他第三方进行此类评估。

我们的网络安全概念计划由致富金融(临时代码)和财务董事负责，他们接收我们的资讯科技顾问报告，并监控网络安全概念事件的预防、检测、缓解和补救。我们的致富金融(临时代码)和财务董事拥有超过50年不同重要性角色中的资讯科技经验。他们的经验包括监督和监管资讯科技风险管理流程。作为致富金融(临时代码)和财务董事，他们分别负责其他职责，管理我们的网络安全概念顾问，他是经认证且具丰富经验的资讯安全专业人士，负责实施和监控我们各种网络安全概念系统和工具。

管理层负责持续辨识、考虑和评估重要的网络安全概念风险，建立流程以确保这些潜在的网络安全概念风险暴露受到监控，并采取适当的缓解措施和维持网络安全概念计划，包括：

管理层，包括我们的首席财务官和财务董事，定期向我们的监查委员会更新我们的网络安全概念流程、主要网络安全风险和缓解策略。我们的监查委员会在与我们的管理层协调一致的情况下，向我们的董事会汇报所有重要的网络安全风险。

Although we are subject to ongoing and evolving cybersecurity threats, we are not aware of any material risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition.

营运结果的组成部分

营业收入

We have not generated any revenue since inception and do not expect to generate any revenue from the sale of products until we obtain regulatory approval for, and commercialize, our product candidate(s).

营业费用

我们目前的营业费用 包括两个元件 – 研究与发展费用和一般行政费用。

Research and Development Expenses

We expense research and development costs as incurred. These expenses consist of costs incurred in connection with the development of our product candidates, including:

Our research and development expenses are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs, and central laboratories in connection with our preclinical development, process development, manufacturing, and clinical development activities. Our research and development expenses by program also include fees incurred under license agreements, as well as option agreements with respect to licensing rights. We do not allocate employee costs or facility expenses, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We primarily use internal resources to oversee research and discovery activities as well as to manage our preclinical development, process development, manufacturing, and clinical development activities. These employees work across programs, and therefore, we do not track their costs by program. We elected to present the research and development credit net of the related research and development expenditure in the Consolidated Statements of Operations and Comprehensive Loss. However, some of our research and development expenses are allocated by program:

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase substantially over the next several years, particularly as we increase personnel costs, including stock-based compensation, clinical costs, contractor costs, and facilities costs, as we continue to advance the development of our product candidates. We also expect to incur additional expenses related to milestone and royalty payments payable to third parties with whom we have entered into license agreements to acquire the rights to our product candidates. The successful development and commercialization of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from any of our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with product development and commercialization, including the uncertainty of:

We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect, or be forced by regulatory authorities, to discontinue, delay, or modify clinical trials of some product candidates or focus on others. Any changes in the outcome of any of these variables with respect to the development of our product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the European Medicines Agency (“EMA”), United States (“U.S.”) Food and Drug Administration (“FDA”), or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in enrollment in or treatment as part of any of our ongoing and planned clinical trials for any reason, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate. Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive, and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and consulting fees, related benefits, travel, and stock-based compensation expenses for individuals on our Board of Directors and personnel in executive, finance, and administrative functions. General and administrative expenses also include professional fees for legal, consulting, accounting, and audit services.

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and the development of our product candidates. We also anticipate that we will continue to incur additional accounting, audit, legal, regulatory, compliance, directors and officers’ insurance costs as well as investor and public relations expenses associated with being a public company. Additionally, when we believe a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and other expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of our product candidate.

Other Income (Expense)

Other income (expense) consists primarily of interest income (expense), foreign exchange income (loss), and gain (loss) from sale or maturity of available for sale debt securities.

Income Taxes

We are subject to taxation in Italy and the U.S. Taxes are recorded on an accrual basis. Taxes therefore represent the allowances for taxes paid or to be paid for the year, calculated according to the current enacted rates and applicable laws. Due to the tax loss position reported, no income taxes were due for the six months ended June 30, 2024, and June 30, 2023.

As of each reporting date, we consider existing evidence, both positive and negative, that could impact our view regarding future realization of deferred tax assets. We believe that it is more likely than not that the benefit for deferred tax assets will not be realized. In recognition of this uncertainty, a full valuation allowance was applied to the deferred tax assets. Future realization depends on our future earnings, if any, the timing, and amount of which are uncertain as of June 30, 2024. In the future, should management conclude that it is more likely than not that the deferred tax assets are partially or fully realizable, the valuation allowance would be reduced to the extent of such expected realization and the amount would be recognized as a deferred income tax benefit in our Consolidated Statements of Operations and Comprehensive Loss.

There are open statutes of limitations for Italian tax authorities to audit our tax returns. There have been no material income tax-related interests or penalties assessed or recorded.

There is no liability related to uncertain tax positions reported in our financial statements.

In line with the legislation in force, as updated by the Italian Budget Law 2022, companies in Italy that invested in eligible research and development activities, regardless of the legal form and economic sector in which they operate, can benefit from a tax credit up to 10% of the increase of annual research and development expenses incurred, up to a maximum of €5.0 million, which can be used as compensation in order to reduce most taxes payable, including income tax or regional tax on productive activities, as well as of social security contributions. In addition, the tax credit due can only be used as compensation in three equal annual installments. The measure is provided up to the tax period ending December 31, 2031.

The Italian Budget Law 2023 established that the actual support of eligible expenses and its correspondence with the accounting documents must result from a specific certification issued by the person responsible for the legal audit and, in addition to the audit report, a technical report is also required.

Results of Operations

Comparison of the Six Months Ended June 30, 2024 to the Six Months Ended June 30, 2023

The following table summarizes our results of operations for the six months ended June 30, 2024, and June 30, 2023:

Research and Development Expenses

Research and development expenses were approximately €2.0 million for the six months ended June 30, 2024, as compared to approximately €3.9 million for the six months ended June 30, 2023. The decrease of €1.9 million was mainly due to: (1) the substantial completion of manufacturing activities related to the preparation of Lentiviral Vector (“LVV”) starting material in 2023, [incurring approximately €0.7 million]; (2) in 2023, we entered the final manufacturing phase with our manufacturing partners for the scale-up of LVV for gene therapy with residual cost in 2024, [incurring approximately €0.4 million]; (3) the completion of our technology transfer activities from AGC Biologics’ Olgettina facility to its Bresso site for drug product manufacturing, which we were obligated by contract to support, [incurring approximately €0.3 million]; (4) the last cohort of our TEM-GBM Phase 1 dose-ranging study was completed in May 2024, [incurring approximately €0.3 million more patient costs in the six months ended June 30, 2023 compared to the six months ended June 30, 2024]; (5) a reduction in fees to OSR (San Raffaele Hospital) [of approximately €0.1 million]; and (6) a reclassification of patent-related legal fees in 2024 from research and development expenses to general and administrative expenses, [incurring approximately €0.1 million].

General and Administrative Expenses

General and administrative expenses were approximately €2.5 million for the six months ended June 30, 2024, as compared to approximately €2.9 million for the six months ended June 30, 2023. The decrease of approximately €0.4 million was primarily due to: (1) lower stock compensation expenses accrued in the first six months ended June 30, 2024, [amounting to approximately €0.2 million]; (2) lower audit fees since a different auditing firm was engaged for 2024, [amounting to approximately €0.1 million]; and, (3) insurance costs decreased in the first six months ended June 30, 2024, mainly due to a reduction in our directors’ and officers’ limited liability insurance policy that was renegotiated at the end of 2023 resulting in a premium reduction [of approximately €0.1 million].

Other Income (Expenses) and Finance Income (Expenses)

Other net income and net finance income, mainly relate to financial interests and capital gain from short-term liquidity investments and amounted to approximately €0.3 million at June 30, 2024, and €0.2 million at June 30, 2023. The increase was due to the positive performance of our investment portfolio.

Foreign Exchange Gains

For the first six months ended June 30, 2024, the foreign exchange net gain was approximately €0.2 million, while for the six months ended June 30, 2023, we recorded a net foreign exchange loss of approximately €0.2 million. The increase in foreign exchange net gain was due to the strengthening of the U.S. dollar against the Euro in the six months ended June 30, 2024.

Net Loss

Our net loss was approximately €4.0 million for the six months ended June 30, 2024, as compared to approximately €6.8 million for the six months ended June 30, 2023. The decrease in our loss of approximately €2.8 million was primarily due to the reduction in overall research and development activity, as well as a decrease in professional fees, especially legal fees and audit fees as explained above.

Liquidity and Capital Resources

Overview

Since inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations. We have funded our operations to date primarily with proceeds from the sales of quotas, in prior years as an S.r.l., and through our shares, in our IPO and follow on offerings as an S.p.A. We received gross cash proceeds of approximately €33.6 million from sales of quotas prior to our IPO, approximately €32.7 million of gross proceeds from the IPO and approximately €0.3 million from our at-the-market (“ATM”) offerings. As of June 30, 2024, we had approximately €6.2 million in cash and cash equivalents and €10.7 million in marketable securities maturing short term.

Operating Activities

During the six months ended June 30, 2024, and June 30, 2023, operating activities used approximately €2.0 million and €7.6 million, respectively, of cash and cash equivalents, resulting mainly from our loss during the period. The net change in our operating assets and liabilities was primarily due to the decrease in payments to third-party vendors for manufacturing and clinical trial activities, due to the reduction of research and development activity.

The non-cash charges primarily included approximately €0.2 million of stock-based compensation expense and other minor amounts of depreciation and retirement benefit obligation expense.

Investing Activities

During the six months ended June 30, 2024, we purchased approximately €9.0 million of marketable securities, while the proceeds from maturities of marketable securities were approximately €13.3 million.

Financing Activities

During the six months ended June 30, 2024, we raised approximately €0.3 million from the sale of ADSs representing our shares through our ATM offerings.

Current Outlook

To date, we have not generated revenue and do not expect to generate significant revenue from the sale of any product candidate in the near future.

As of June 30, 2024, our cash and cash equivalents and marketable securities were approximately €16.9 million. Our primary cash obligations relate to payments to personnel, OSR for clinical trial costs, and other providers for other clinical trial related services and manufacturing activities.

Based on our estimates, operating and financial plans, our existing cash, we estimate that our funds will be sufficient to fund our operations and capital expenditure requirements for more than the next twelve months. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

In addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned. Our future capital requirements will depend on many factors, including:

Until we can generate significant revenues, if ever, we expect to satisfy our future cash needs through our existing cash, cash equivalents, short-term deposits, and short-term marketable securities, as well as through additional financings, which we may seek through a combination of private and public equity offerings, debt financings and collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships.

We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If funds are not available, we may be required to delay, reduce the scope of, or eliminate research or development plans for, or commercialization efforts with respect to, one or more applications of our product candidates.

This expected use of cash and cash equivalents represents our intentions based on our current plans and business conditions, which could change in the future as our plans and business conditions evolve. We may also use a portion of the available cash and cash equivalents to in-license, acquire, or invest in additional businesses, technologies, products, or assets.

Critical Accounting Policies

Our financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs, and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

We believe that the accounting policies described below are critical to understand the judgements and estimates used in the financial statements and to fully understand and evaluate our financial condition and results of operations.

Accrued Research and Development Expenses

As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advanced payments. We make estimates of our accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of these estimates with the service providers and make adjustments, if necessary. Examples of estimated accrued research and development expenses include fees paid to:

We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions and CROs that conduct and manage preclinical studies and clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly. Although we do not expect our estimates to be materially different from amounts incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.

Share-Based Compensation

We measure share-based awards granted to employees and directors based on the fair value on the date of the grant and recognize compensation expense for those awards over the requisite service period, which is the vesting period of the respective award. Forfeitures are accounted for as they occur. The measurement date for option awards is the date of the grant. We classify share-based compensation expense in our Statements of Operations and Comprehensive Loss in the same way the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.

With the adoption of Accounting Standards Update No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”) on January 1, 2019, the measurement date for non-employee awards is the date of the grant. The compensation expense for non-employees is recognized, without changes in the fair value of the award, over the requisite service period, which is the vesting period of the respective award.

Research and Development Tax Credit Receivables

We account for our research and development tax credit receivable in accordance with IAS 20 Accounting for Government Grants and Disclosure of Government Assistance. The receivable is recognized when there is reasonable assurance that: (1) the recipient will comply with the relevant conditions and (2) the grant will be received. We elected to present the credit net of the related expenditure on the statements of operations and comprehensive loss. While these tax credits can be carried forward indefinitely, we recognize an amount that reflects management’s best estimate of the amount reasonably assured to be realized or utilized in the foreseeable future based on historical benefits realized, adjusted for expected changes, as applicable.

Emerging Growth Company Status

We are an “emerging growth company.” Under the U.S. Jumpstart Our Business Startups Act (“JOBS Act”), an emerging growth company can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected to avail ourselves of this exemption from new or revised accounting standards, and, therefore, will not be subject to the same new or revised accounting standards as public companies that are not emerging growth companies.

Off-Balance Sheet Arrangements

We have not engaged in any off-balance sheet arrangements, such as the use of unconsolidated subsidiaries, structured finance, special purpose entities, or variable interest entities.

We do not believe that our off-balance sheet arrangements and commitments 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 are material to investors.

Quantitative and Qualitative Disclosure About Market Risk

We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our current investment policy is to invest available cash in bank deposits with banks that have a credit rating of at least A-. Accordingly, a substantial majority of our cash and cash equivalents are held in deposits that bear interest. Given the current low rates of interest we receive, we will not be adversely affected if such rates are reduced. Our market risk exposure is primarily a result of foreign currency exchange rates, which is discussed in detail in the following paragraph.

Foreign Currency Exchange Risk

Our results of operations and cash flow can be subject to significant fluctuations due to changes in foreign currency exchange rates, which could adversely impact our results of operations. Our functional currency is the Euro. Exposure to foreign currently exchange risk is derived from transactions between the Company and the U.S. Subsidiary for which the functional currency is the U.S. dollar, as well as transactions with suppliers outside the euro zone.

The following table shows the impact of up to a 10% increase in the exchange rate between the Euro and the U.S. dollar. A deterioration of the U.S. dollar versus the 1.07132 closing rate at June 30, 2024 could impact the expenses as follows:

We do not hedge our foreign currency exchange risk. In the future, we may enter into formal currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the material adverse effects of such fluctuations.

Other Events

Appointment of the New Board of Directors

As previously reported in our Form 6-K furnished to the SEC on April 8, 2024, on April 5, 2024, Mark A. Sirgo, Anthony Marucci, Roger Abravanel, and Guido Guidi resigned as directors of the Board of Directors, noting unease with the Company’s strategic approach as well as a disagreement related to the proposal of a loyalty share program through a proposed amendment to the Company’s Bylaws.

Further, as previously reported in our Form 6-K furnished to the SEC on May 3, 2024 (our “May Form 6-K”), on May 2, 2024, at the Ordinary and Extraordinary Shareholders’ Meeting of the Company (the “2024 Shareholders’ Meeting”), the Company’s shareholders approved the appointment of five directors to the Company’s Board of Directors, effective as of May 2, 2024, four of whom are new directors. The new members of the Board are: John L. Cantello, Ph.D., Lauren H. Chung, Ph.D., Armon R. Sharei, Ph.D., and Todd Wider, M.D. Pierluigi Paracchi, Chief Executive Officer, will continue to serve on the Board of Directors as Chairman. For more information regarding our new directors, see our May Form 6-K.

The term of office of the new directors is one year and the aggregate annual directors’ compensation is €213,000.

The newly appointed directors met immediately following the 2024 Shareholders’ Meeting and appointed Mr. Paracchi as Chief Executive Officer of the Company and allocated €37,500 as compensation for each director, excluding the Chairman and Chief Executive Officer who is already remunerated in his capacity as executive.

Appointment of the New Board of Statutory Auditors

As previously reported in our May Form 6-K, at the 2024 Shareholders’ Meeting, the Company’s shareholders approved also the appointment of the new Board of Statutory Auditors for the three-year period of 2024-2026, consisting of: Carlo Alberto Nicchio (Chairman), Jacopo Doveri, Giuseppe Gentile, while Luca Domenico and Adalberto Adriano were appointed as alternates. The annual Board of Statutory Auditor compensation is €18,000 for the chairman and €12,000 for each active member while no compensation is provided for the alternates unless they replace an active member. For more information regarding the new members of our Board of Statutory Auditors, see our May Form 6-K.

Full Effectiveness of Loyalty Share Program

As previously reported in our May Form 6-K, at the 2024 Shareholders’ Meeting, the Company’s shareholders approved an amendment to the Company’s Bylaws that established a loyalty share program. Following such approval, no shareholder of the Company exercised rights of withdrawal. As result, the loyalty share program is fully effective. Accordingly, each ordinary share of the Company held in registered form entitles the shareholder to a double vote (i.e. two votes for each ordinary share) if the ordinary share has been held by the same shareholder for a continuous period of not less than twenty-four months from the date of its registration in the special list maintained by the Company, and an additional vote is also granted upon the expiration of each 12-month period, following the expiration of the period referred to above, in which such ordinary share has been held by the shareholder, up to a total maximum of ten votes per ordinary share. For more information, see our May Form 6-K.

Status of Proposed Renal Cell Cancer Trials

In October 2024, we announced that the Agenzia Italiana del Farmaco had approved a new Phase 1 clinical trial for metastatic Renal Cell Cancer. We expect to commence the trial in the fourth quarter of 2024. Also, in October 2024, we entered into an agreement with OSR to conduct an open-label phase 1/2 clinical trial. The study is designed to evaluate the safety, biological response, and efficacy of a single dose of Temferon (autologous hematopoietic stem and progenitor cells enriched with CD34+ and genetically modified with human Interferon-α2) in patients with metastatic renal carcinoma.

Supplementary Risk Factor Disclosure

In addition to the risks related to healthcare legislative and regulatory changes that are discussed in our 2023 20-F in Item 3.D “Key Information—Risk Factors,” recently, the U.S. Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous. This landmark Supreme Court decision may invite more companies and other stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, including the FDA’s statutory interpretations of market exclusivities and the “substantial evidence” requirements for drug approvals, which could undermine the FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions. We cannot predict the full impact of this decision, future judicial challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action.